Indivior UK Limited

Patent Trials and Appeals Board

Jun 2, 2020

IPR2019-00329 (P.T.A.B. Jun. 2, 2020)

Trials@uspto.gov Paper 49
571-272-7822 Entered: June 2, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

DR. REDDY’S LABORATORIES S.A. and DR. REDDY’S
LABORATORIES, INC.,
Petitioners,

v.

INDIVIOR UK LIMITED,
Patent Owner.

IPR2019-00329
Patent 9,687,454 B2

Before SUSAN L. C. MITCHELL, ZHENYU YANG, and RICHARD J.
SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining Some Challenged Claims Unpatentable
35 U.S.C. § 318(a)

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I. INTRODUCTION
Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s Laboratories, Inc.
(“Petitioners”) filed a Petition to institute an inter partes review of claims 1–
5 and 7–14 (“the challenged claims”) of U.S. Patent No. 9,687,454 B2 (the
“’454 patent”). Paper 1 (“Pet.”).
On June 3, 2019, we entered our Decision on Institution (Paper 21,
“Inst. Dec.” or “Institution Decision”) instituting inter partes review of all
challenged claims under the only asserted ground. Inst. Dec. 28. Patent
Owner filed a Response (Paper 33, “PO Resp.”), Petitioner filed a Reply
(Paper 42, “Reply”), and Patent Owner filed a Sur-reply (Paper 45, “Sur-
reply”).1
Petitioners and Patent Owner requested an oral hearing. Papers 43,
44. An oral hearing was held on March 3, 2020, and a transcript of that
hearing has been entered into the record. Paper 48 (“Tr.”).
We have jurisdiction under 35 U.S.C. § 6(b). This Final Written
Decision is issued pursuant to 35 U.S.C. § 318(a). Having reviewed the
arguments of the parties and the supporting evidence, we find that
Petitioners have demonstrated by a preponderance of the evidence that
claims 1–5, 7, and 9–14 of the ’454 patent are unpatentable, but have not
demonstrated by a preponderance of the evidence that claim 8 of the ’454
patent is unpatentable.

1 Petitioners and Patent Owner filed objections to the other party’s evidence,
but did not file motions to exclude to preserve any objection. Papers 23, 24,
35; 37 C.F.R. § 42.64(c).
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A. Real Parties-in-Interest
Petitioners identify the real parties-in-interest as Dr. Reddy’s
Laboratories S.A. and Dr. Reddy’s Laboratories, Inc. Pet. 42.
Patent Owner identifies Indivior UK Limited and Indivior Inc. as the
real parties-in-interest. Paper 4, 1.
B. Related Matters
Petitioners and Patent Owner indicate that the ’454 patent is involved
in litigation in the District of New Jersey in three separate actions: Indivior
Inc. v. Dr. Reddy’s Laboratories S.A., No. 2:17-cv-07111 (D.N.J.)
(Consolidated); Indivior Inc. v. Alvogen Pine Brook, Inc., No. 2:17-cv-07106
(D.N.J.) (Consolidated); and Indivior Inc. v. Teva Pharmaceuticals USA,
Inc., 2:17-cv-07115 (D.N.J.) (Consolidated). Paper 3, 2; Paper 4, 1.
According to the parties, the ’454 patent is also involved in litigation in the
District of Delaware in Indivior Inc. v. Actavis Laboratories UT, Inc.,
No. 1:18-cv-00499 (D. Del.). Paper 3, 2; Paper 4, 1.
Petitioners state that the ’454 patent is commonly owned with, shares
the same specification as, and is a direct descendant of, U.S. Patent No.
8,475,832 (“the ’832 patent”). Paper 3, 2. According to Petitioners, claims
of the ’832 patent were previously found invalid by the District of Delaware
in Reckitt Benckiser Pharmaceuticals Inc. v. Watson Labs., Inc., No. CV 13-
1674-RGA, 2016 WL 3186659, at *1 (D. Del. June 3, 2016) (Ex. 1006, “the
Delaware Opinion”). Id. at 2–3. Petitioners state that aspects of that
decision that do not involve the ’832 patent are currently on appeal in:
Indivior Inc. v. Dr. Reddy’s Laboratories, S.A., No. 17-2587 (Fed. Cir.);
Indivior Inc. v. Actavis Laboratories UT, Inc., No. 18-1405 (Fed. Cir.); and
Indivior Inc. v. Alvogen Pine Brook LLC, No. 18-1949 (Fed. Cir.). Id. at 3.
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Patent Owner states that the ’454 patent descends from the ’832
patent, and that claims 15–19 of the ’832 patent were canceled on June 30,
2015, in Case No. IPR2014-00325. BioDelivery Sciences Int’l Inc. v. RB
Pharm. Ltd, IPR2014-00325, slip op. at 47 (Paper 43) (PTAB June 30,
2015). Paper 4, 1. Patent Owner indicates that decision was affirmed by the
Federal Circuit. RB Pharm. Ltd. v. BioDelivery Sciences Int’l, Inc., 667 Fed.
Appx. 997 (Fed. Cir. 2016). Id. Patent Owner also states that the Delaware
district court separately found that certain asserted claims of the ’832 patent,
including claims 15–19, were invalid. Id. at 1–2 (citing the Delaware
Opinion); Ex. 1006.
The parties also identify U.S. Patent Application Serial No.
15/483,769, filed on April 10, 2017, that claims the benefit of the ’454
patent, and Petitioners’ filing of a second petition for inter partes review of
the ’454 patent in Case No. IPR2019-00328.2 Paper 3, 3; Paper 4, 1.
C. The ’454 Patent
The ’454 patent “relat[es] to films containing therapeutic actives . . .
[and] more particularly relates to self-supporting film dosage forms which
provide a therapeutically effective dosage, essentially matching that of
currently-marketed tablets containing the same active.” Ex. 1001, 1:20–25.
The ’454 patent states that “[s]uch compositions are particularly useful for
treating narcotic dependence while providing sufficient buccal adhesion of
the dosage form.” Id. at 1:25–27.

2 Institution of a trial based on that second petition was denied on June 3,
2019. See Dr. Reddy’s Labs. S.A. v. Indivior UK Ltd., IPR2019-00328,
Paper 21 at 21 (PTAB June 3, 2019).
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The ’454 patent explains that “[c]urrently, treatment of opioid
dependence is aided by administration of Suboxone®, which is an orally
dissolvable tablet. This tablet . . . provides a combination of buprenorphine
(an opioid agonist) and naloxone (an opioid antagonist).” Id. at 4:67–5:4.
However, the ’454 patent states that tablet forms have the potential for abuse
and, in some instances, “the patient who has been provided the drug may
store the tablet in his mouth without swallowing the tablet, then later extract
the agonist from tablet and inject the drug into an individual’s body.” Id. at
2:1–5.
The ’454 patent further states that “the invention relates to the
treatment of opioid dependence in an individual, while using a formulation
and delivery that hinders misuse of the narcotic.” Id. at 4:64–67. The ’454
patent further explains that “the present invention provides a method of
treating narcotic dependence by providing an orally dissolvable film dosage,
which provides a bioequivalent effect to Suboxone®. The film dosage
preferably provides buccal adhesion while it is in the user’s mouth,
rendering it difficult to remove after placement.” Id. at 5:4–10.
The ’454 patent further states that “[t]he film dosage composition
preferably includes a polymer carrier matrix. Any desired polymeric carrier
matrix may be used, provided that it is orally dissolvable.” Id. at 5:11–13.
According to the ’454 patent, “[t]he film may contain any desired level of
self-supporting film forming polymer, such that a self-supporting film
composition is provided.” Id. at 13:1–3.
The ’454 patent describes film compositions that “desirably contain[]
a buffer so as to control the local pH of the film composition.” Id. at 13:26–
27. The ’454 patent also describes several examples and states that “[t]he
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data indicates that not only is the local pH of significant importance, but the
amount of buffer present in the formula is also important.” Id. at 23:54–56.
D. Illustrative Claims
Claim 1 recites:
1. An oral, self-supporting, A mucoadhesive film comprising:
(a) about 40 wt % to about 60 wt % of a water-soluble
polymeric matrix;
(b) about 2 mg to about 16 mg of buprenorphine or a
pharmaceutically acceptable salt thereof;
(c) about 0.5 mg to about 4 mg of naloxone or a pharmaceutically
acceptable salt thereof; and
(d) an acidic buffer;
wherein the film is mucoadhesive to the sublingual mucosa or
the buccal mucosa;
wherein the weight ratio of (b):(c) is about 4:1;
wherein the weight ratio of (d):(b) is from 2:1 to 1:5; and
wherein application of the film on the sublingual mucosa or the
buccal mucosa results in differing absorption between
buprenorphine and naloxone, with a buprenorphine Cmax[3]
from about 0.624 ng/ml to about 5.638 ng/ml and a
buprenorphine AUC[4] from about 5.431 hr*ng/ml to about
56.238 hr*ng/ml; and a naloxone Cmax from about 41.04
pg/ml to about 323.75 pg/ml and a naloxone AUC from
about 102.88 hr*pg/ml to about 812.00 hr*pg/ml.
Ex. 1001, 24:25–46.
Claim 5 recites:
5. The film of claim 1, wherein the weight ratio of (b):(a) is from
about 1:3 to about 1:11.5.
Id. at 24:53–54.
Claim 13 recites:

3 “[T]he term Cmax refers to the mean maximum plasma concentration after
administration of the composition to a human subject.” Ex. 1001, 3:23–25.
4 “[T]he term AUC refers to the mean area under the plasma concentration-
time curve value after administration of the compositions formed herein.”
Ex. 1001, 3:25–28.
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13. A method for treating opioid dependence in a patient in need
thereof comprising sublingually or buccally administering the
mucoadhesive film of claim 1 to a sublingual or buccal mucosal
tissue of the patient to treat the opioid dependence.
Id. at 25:8–12.
E. The Asserted Ground of Unpatentability and Declaration Evidence
Petitioners contend that the challenged claims are anticipated by U.S.
Patent Publication No. US 2011/0033541 A1, filed August 7, 2009, and
published February 10, 2011 (Ex. 1010, “Myers”), under post-AIA5 35
U.S.C. § 102(a)(1) (Pet. 7), as shown in the chart below:
Claims Challenged 35 U.S.C. § Reference(s)/Basis
1–5, 7–14 102(a)(1) Myers
Petitioners rely on the Corrected Declaration of Nandita Das, Ph.D.
Ex. 1003. Patent Owner relies on the Declaration of Karsten Cremer, Ph.D,
submitted with Patent Owner’s Response. Ex. 2008.
Patent Owner also filed a Declaration of Dr. Karsten Cremer, Ph.D.
dated March 7, 2019 (Ex. 2001, “First Cremer Declaration”) with its
Preliminary Response (Paper 12). Dr. Cremer testified during trial that he
still held all the opinions expressed in the First Cremer Declaration, and was
not withdrawing any of those opinions. Ex. 1030, 12:2–7; Reply 5–6 & n.2.
II. DISCUSSION
A. Level of Ordinary Skill in the Art
Petitioners assert that a person of ordinary skill in the art (“POSA”)
with respect to the technology disclosed in the ’454 patent, “would include a
person who possessed a Master’s or Ph.D. in pharmaceutical sciences,

5 Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125 Stat.
284, 287–88 (2011).
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formulation chemistry, or a related field, plus a number of years of relevant
experience in developing drug formulations.” Pet. 16 (citing Ex. 1003 ¶ 42).
Petitioners further state that “[a]s part of a collaborative team working to
develop a new drug product, the POSA would have consulted as needed with
others possessing the skills that are typically employed in drug development
and manufacturing.” Id. at 16–17 (citing Ex. 1003 ¶ 42).
Patent Owner does not oppose Petitioners’ proposed description of a
POSA or set forth an alternative description of a POSA. See generally PO
Resp.; Sur-reply.
We adopt and apply Petitioners’ assessment of a POSA because it
appears to be consistent with the level of ordinary skill in the art at the time
of the invention as reflected in the prior art in this proceeding. See Okajima
v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific
findings regarding ordinary skill level are not required “where the prior art
itself reflects an appropriate level and a need for testimony is not shown”
(quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
163 (Fed. Cir. 1985))). We also find on this record that Dr. Das and Dr.
Cremer are persons of at least ordinary skill in the art under this standard.
See Ex. 1004; Ex. 1003 ¶¶ 3–12; Ex. 2008, Appendix A, ¶¶ 5–15.
B. Claim Construction
In this inter partes review, filed November 13, 2018,6 we construe the
claims of the ’454 patent using the same claim construction standard that
would be used to construe the claim in a civil action under 35 U.S.C.

6 The claim construction standard to be employed in inter partes reviews has
changed for proceedings in which the petition was filed on or after
November 13, 2018. 37 C.F.R. § 42.100(b) (2019).
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§ 282(b), including construing the claim in accordance with the ordinary and
customary meaning of such claim as understood by one of ordinary skill in
the art and the prosecution history pertaining to the patent. 37 C.F.R.
§ 42.100(b) (2019); see also Phillips v. AWH Corp., 415 F.3d 1303 (Fed.
Cir. 2005).
We determine that we need not expressly construe any claim terms.
See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d
1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in
controversy, and only to the extent necessary to resolve the controversy’”)
(quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
(Fed. Cir. 1999)).
C. General Principles of Law
To prevail in their challenge to the patentability of the challenged
claims, Petitioners must demonstrate by a preponderance of the evidence
that the challenged claims are unpatentable. 35 U.S.C. § 316(e); 37 C.F.R.
§ 42.1(d). “In an [inter partes review], the petitioner has the burden from
the onset to show with particularity why the patent it challenges is
unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review
petitions to identify “with particularity . . . the evidence that supports the
grounds for the challenge to each claim”)). This burden of persuasion never
shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics,
Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in
inter partes review).
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D. Priority Date of the Challenged Claims
The ’454 patent issued on June 27, 2017, from Application No.
14/989,669, filed January 6, 2016 (“the ’669 application”). Ex. 1001, codes
(21), (22), (45). The ’669 application is one of a series of continuation
applications claiming priority to Application No. 12/537,571, filed on
August 7, 2009 (“the ’571 application”),7 that published as Myers. Ex.
1010, codes (21), (22); Ex. 1001, code (63). The first continuation
application after the filing of the ’571 application was Application No.
13/923,749, filed June 21, 2013 (“the ’749 application”). Ex. 1001, code
(63).
On September 9, 2016, during prosecution of the ’669 application,
pending claims 1–10 were cancelled and new claims were added. Ex. 1002,
615–22. Those new claims included the limitations “about 40 wt % to about
60 wt % of a water-soluble polymeric matrix” (issued claim 1), “wherein the
film comprises about 48.2 wt % to about 58.6 wt % of the water soluble
polymeric matrix” (issued claims 7, 12), “about 48.2 wt % of the water
soluble polymeric matrix” (issued claim 8), and “wherein the weight ratio of
(b):(a) is from about 1:3 to about 1:11.5” (issued claims 5, 12). Id. at 16–18.
At the time the new claims were added, Patent Owner directed the
Examiner to paragraph 33 of the ’669 application (paragraph 32 of the ’571
application) as providing written description support for the limitation in
claim 1 of “about 40 wt % to about 60 wt % of a water-soluble polymeric
matrix.” Ex. 1002, 619. As Petitioners explain, paragraph 32 of the ’571

7 The ’571 application issued on July 2, 2013, as the ’832 patent. Ex. 1005.
References to “the ’571 application” herein are to its Specification as of its
filing date of August 7, 2009.

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application refers to “about 40% to about 60% by weight” of the polymer
component, which refers to “the total amount of polymer components added
together, without regard to the other ingredients” (i.e. a different weight
percentage than claimed in the ’454 patent). Pet. 23 n.6 (citing Ex. 1003
¶¶ 64, 65; Ex. 1011, 1436 ¶ 32). Patent Owner does not dispute that this
paragraph 32/33 does not provide written description support for the claimed
polymer weight percentage limitation of “about 40 wt % to about 60 wt %.”
Reply 2–3 n.1 (citing Ex. 1030, 87:11–89:15; PO Resp. 29–30). Patent
Owner now points to other disclosure in the Specification of the ’571
application, such as exemplary test formulations, as providing such written
description support. PO Resp. 11–61.
According to Petitioners, the effective filing date of the ’454 patent is
no earlier than June 21, 2013, the filing date of the ’749 application, because
the ’571 application does not provide written description support for the
above-referenced limitations that were added during prosecution of the ’669
application. Pet. 18–30. Patent Owner disagrees, and argues that the
challenged claims have written description support in the ’571 application,
and that the ’454 patent is thus entitled to a filing date of August 7, 2009, the
filing date of the ’571 application. PO Resp. 11–61. Therefore, according to
Patent Owner, Myers is not prior art to the ’454 patent and, thus, does not
anticipate the challenged claims. Id. at 1.
E. Analysis
Our decision in this case turns on whether any of the challenged
claims of the ’454 patent can effectively claim priority to the ’571
application based on satisfaction of the written description requirement of 35
U.S.C § 112. Specifically, the issue before us is whether the claimed
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polymer weight percentage and ranges of polymer weight percentages, and
claimed range of buprenorphine:polymer/(b):(a) ratios, have written
description support in the ’571 application.
We first determine whether any of the challenged claims lack written
description support in the ’571 application. As to any challenged claim for
which we find no written description support, we then determine whether
that challenged claim is anticipated by Myers, as asserted by Petitioners.
1. Written Description
Claim 1 recites that the film comprises “(a) about 40 wt % to about 60
wt % of a water-soluble polymeric matrix.” Ex. 1001, 24:27–28.
Dependent claims 7 and 12 narrow that range to “about 48.2% to about
58.6%,” and dependent claim 8 recites “about 48.2%” of the water soluble
polymeric matrix. Id. at 24:57–61; 25:3–7. Claims 5 and 12 depend directly
on claim 1, and recite that “the weight ratio of (b):(a) is from about 1:3 to
about 1:11.5.” Ex. 1001, 24:53–54, 25:4–5.
a) Petitioners’ Arguments
Petitioners argue that the ’571 application lacks written description
support for limitations directed toward the amount of polymer in the claimed
films. Pet. 20. As Petitioners explain, those limitations take the form of
(1) expressing the amount of polymer as a percentage of the overall weight
of the film (claims 1, 7, 8, and 12), and (2) limiting the amount of polymer
in the film by requiring the film to have a ratio of buprenorphine-to-polymer
((b):(a)) that falls within a specified range (claims 5 and 12).
(1) Paragraph 65
Petitioners argue that “[t]here is nothing in the text of the ’571
application that demonstrates the inventors believed that the polymer weight
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percentages and (b):(a) ratios later added to the challenged claims were part
of their invention.” Pet. 21. Petitioners support this assertion by referring to
paragraph 65 of the ’571 application that reads as follows:
The film may contain any desired level of self-supporting film
forming polymer, such that a self-supporting film composition
is provided. In one embodiment, the film composition contains
a film forming polymer in an amount of at least 25% by weight
of the composition. The film forming polymer may alternatively
be present in an amount of least 50% by weight of the
composition.
Id. (quoting Ex. 1011, 1444 ¶ 65 (emphasis added by Petitioners)).8
Petitioners argue that paragraph 65 is the only discussion in the ’571
application concerning the amount of polymers that should be in the films.
Pet. 21. According to Petitioners, paragraph 65 makes clear that “the ’571
application does not limit the amount of polymer to a closed range or
express it as a (b):(a) ratio, but instead instructs that ‘any desired level of . . .
polymer’ can be used in the films.” Id. Moreover, according to Petitioners,
this short description of open-ended ranges does not provide a POSA any
guidance to, and directs a POSA away from, the polymer weight percentage
ranges recited in claims 1, 5, 7, 8, and 12. Id. (citing Ex. 1003 ¶ 61).
Petitioners further argue that “there is nothing in the ’571 application
that suggests that the bottom end of the range should be ‘40 wt %’ (claim 1)
or ‘48.2 wt %’ (claims 7 and 12),” and there is no disclosure “of the top-end
[of the] range, whether it is ‘60 wt %’ (claim 1) or ‘58.6 wt %’ (claims 7 and
12).” Pet. 21–22 (citing Ex. 1003 ¶ 61). Petitioners argue that “[i]t is well
established that ‘[t]he disclosure of a broad range of values does not by itself

8 Original claim 5 recites “[t]he composition of claim 1, wherein said
polymeric carrier matrix comprises at least one polymer in an amount of at
least 25% by weight of said composition.” Ex. 1011, 1459 (claim 1).
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provide written description support for a particular value within that range.’”
Id. at 22 (quoting Gen. Hosp. Corp. v. Sienna Biopharm., Inc., 888 F.3d
1368, 1372 (Fed. Cir. 2018)). In this case, according to Petitioners, “given
the complete lack of guidance in the specification, ‘one is left to select[]
from the myriads of possibilities encompassed by the broad disclosure, with
no guide indicating or directing that [] this particular selection should be
made rather than any of the many others which could also be made.’” Id.
(quoting In re Ruschig, 379 F.2d 990, 995 (CCPA 1967)). Petitioners argue
further that the ’571 application “describes only open-ended ranges, i.e.,
‘greater than’ and provides no direction that other values or narrower ranges
were within the scope of the invention.” Id. at 22–23 (citing Ex. 1003 ¶ 61).
Petitioners also argue that “[t]he ’571 application is entirely silent as
to the claimed (b):(a) ratios,” and does not refer to a (b):(a) ratio at all or any
(b):(a) ratio ranges claimed in the ’454 patent. Pet. 24 (citing Ex. 1003
¶ 69). Petitioners further argue that the ’571 application does not provide
any guidance to a POSA to craft a ratio of buprenorphine-to-polymer,
although it “lists dozens of ‘optional components’ that may be included in
the films, and that can be expressed in thousands of different ratios to one-
another.” Id. (citing Ex. 1003 ¶ 69). According to Petitioners, this lack of
disclosure “stands in sharp contrast to the other ingredients the inventors
specifically expressed in the form of a ratio,” such as the (d):(b) ratio and the
(b):(c) ratio. Id. at 24–25 (citing Ex. 1003 ¶ 70; Ex. 1011, 1445 ¶¶ 66, 67)
(emphasis added by Petitioner). Petitioners thus argue that, although “the
’571 application makes clear when the applicants regarded certain ratios to
be within the scope of the invention,” a POSA would not understand that the
inventors were in possession of the claimed (b):(a) ratios because no similar
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discussion appears anywhere in the ’571 application. Id. at 25 (citing
Ex. 1003 ¶ 67).
Petitioners argue that there is nothing in the ’571 application that
directs a POSA to the specific (b):(a) range claimed in the ’454 patent,
asserting that the ’571 application discloses only that “any desired level” of
polymer may be used for the “(a)” component of the ratio and that “[a]ny
desired level of agonist” may be used for the “(b)” component. Pet. 25
(citing Ex. 1011, 1445 ¶ 66; see also id. ¶ 65). Petitioners thus argue that
“[t]here is simply no reason a POSA would understand the inventors to have
been in possession of limitations directed toward specific ratios of two
ingredients that the application taught could be present in ‘any’ amount.” Id.
at 25–26 (citing Ex. 1003 ¶¶ 67–70).
(2) Table 1
Petitioners assert that, during prosecution of the ’669 application that
lead to the ’454 patent, Patent Owner claimed that Table 1 of the ’669
application provided written description support for the claimed polymer
weight percentage ranges, and that Patent Owner “appears to contend that
written description requires only that one can back-calculate seemingly
random ranges and ratios from one of the many examples in the
specification.”9 Pet. 26 (citing Ex. 1003 ¶ 58; Ex. 1011, 190–97). Table 1
provides components and amounts thereof for various compositions of film
dosages, and is set forth below:

9 Petitioners note that “[a]s a factual matter, Table 1. . . discloses polymer
weight percentages of 48.2% and 58.6%.” Pet. 26 n.8.
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Ex. 1011, 1449–50, ¶ 81.10 Table 1 above is a listing of various
compositions of film dosages.
Petitioners argue that the Federal Circuit’s decision in Purdue Pharma
L.P. v. Faulding Inc., 230 F.3d 1320 (Fed. Cir. 2000), controls in this case,
and that “the application itself must provide sufficient ‘blaze marks’
directing POSAs to the specific ranges and ratios claimed,” but that “[h]ere,
no such blaze marks exist.” Pet. 26 (citing Ex. 1003 ¶¶ 73–80). Petitioners
argue that the claims at issue in Purdue “were directed to the administration
of opioid analgesics where the maximum amount of drug in the bloodstream

10 The four polymer components identified by the parties in Table 1 are the
three “Polyethylene Oxide, NF” components (with different molecular
weights) and hydroxypropylmethyl cellulose (HPMC). Ex. 1011, 1433 ¶ 25;
Ex. 2008 ¶ 31.
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(Cmax) is ‘more than twice’ the amount of drug in the bloodstream after 24
hours (C24).” Id. at 26–27 (citing Purdue Pharma, 230 F.3d at 1322–23).
Petitioners quote Purdue as stating that “[a]lthough the examples provide the
data from which one can piece together the Cmax/C24 limitation, neither the
text accompany[ing] the examples, nor the data, nor anything else in the
specification in any way emphasizes the Cmax/C24 ratio.” Id. at 27 (quoting
Purdue Pharma, 230 F.3d at 1326). Petitioners further argue that “[t]he
Court found that there was nothing in the specification ‘that would suggest
to one skilled in the art that the Cmax/C24 ratio is an important defining
quality of the formulation, nor does the disclosure even motivate one to
calculate the ratio,’” and that “[f]inding no blaze marks, the Federal Circuit
held the claimed ratios found no written description support.” Id. (quoting
Purdue Pharma, 230 F.3d at 1326–28).
Petitioners argue that, like Purdue, Patent Owner “crafted claim
limitations directed toward disparate characteristics of formulas in a single
table [Table 1] of the ’571 application,” but the ’571 application “does not
mention those characteristics, even ‘in passing.’” Pet. 27 (quoting Purdue
Pharma, 230 F.3d at 1327). According to Petitioners, there is no indication
in the ’571 application that the inventors gave any importance to the amount
of polymer in the film and, to the contrary, “the ’571 application states that
‘any’ amount of polymer can be used in the purportedly inventive films.”
Id. at 27–28 (citing Ex. 1011, 1444 ¶ 65). Petitioners further argue that “[i]t
is no surprise, therefore, that the ’571 application does not provide direction
that the claimed polymer weight ranges and (b):(a) ratios impart any
desirable mucoadhesive, absorption, dissolution, or pharmacokinetic
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properties in the inventive films.” Id. at 28 (citing Ex. 1003 ¶¶ 62, 63, 71,
72, 75, 76).
Petitioners argue that “the ’571 application identifies that the principal
objectives of the inventive films are to (i) provide an active agent for treating
narcotic dependence and (ii) provide sufficient buccal properties.” Pet. 28
(citing Ex. 1011, 1463). Petitioners further argue that “[a] POSA reading the
specification would have understood the primary focus of the purported
invention of the ’571 application was the use of buffering agents that would
adjust the pH of the films in order to achieve a pharmacokinetic profile that
was bioequivalent to the prior art Suboxone® tablets.” Id. (citing Ex. 1003
¶ 62). However, as argued by Petitioners, the ’571 application “contains no
description that the specific amount of polymers used in the films had any
impact on these properties of the film,” and does not “communicate to a
POSA that the amount of polymer in the films impacts the mucoadhesive or
disintegration properties of the film.” Id. (citing Ex. 1003 ¶¶ 63, 71).
(3) Table 5
Petitioners argue that “there is specific data in the specification that
directs a POSA away from concluding that the polymer weight ranges and
(b):(a) ratios had any significance to the inventors.” Pet. 29 (citing Ex. 1003
¶¶ 76–80 (discussing Table 5)) (emphasis added by Petitioner). According
to Petitioners, the three formulations used to test the bioequivalence of
certain films to Suboxone® tablets (the principal objective in the ’571
application) are reported in Table 5 (not Table 1). Id. (citing Ex. 1011,
1430, ¶ 13, 1453 ¶ 89; Ex. 1003 ¶ 76). Table 5 provides three formulations
of test films at various pH levels, and is set forth below:
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Ex. 1011, 1453, ¶ 89.
Table 5 above is a listing of three formulations of test films at various
pH levels.
Petitioners argue that “Test formulation 1” and “Test formulation 3”
of Table 5 did not produce films that were bioequivalent to Suboxone®
tablets, yet they had polymers in amounts “that fell within the polymer
weight ranges recited in claims 1, 7, 8, and 12.” Pet. 29 (citing Ex. 1011,
1453–56; Ex. 1003 ¶ 77 (reporting polymer weight percentage of 50.6% for
Test formulation 1 and 48.2% for Test formulation 3)). Petitioners further
argue that Test formulation 2 and Test formulation 3 had the same (b):(a)
ratio, but Test formulation 2 succeeded and Test formulation 3 failed. Id.
(citing Ex. 1003 ¶ 78 (reporting same (b):(a) ratio of 1:2.8 for Test
formulations 2 and 3)). Petitioners thus argue that “[i]n view of this
conflicting data and the explicit instruction that a POSA could use ‘any’
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amount of polymer, there is no reason that a POSA would understand the
applicants placed any significance on particular weight ranges for polymers
or specific (b):(a) values from Table 1.” Id. (citing Ex. 1003 ¶¶ 70–72, 75,
76, 80). Rather, according to Petitioners, the experiments reflected in Table
5 would have “indicated to a POSA that variations in the amount of buffer,
not variations in polymer amounts, were the focus of the purported
invention.” Id. (citing Ex. 1003 ¶¶ 70–72, 75, 76, 80).
b) Patent Owner’s Response, Petitioners’ Reply, and Patent
Owner’s Sur-reply Regarding Polymer Weight Percentages
Patent Owner argues that “[a] POSA would have understood that the
inventors possessed the polymer weight percentages recited in challenged
claims 1, 7, 8, and 12.” PO Resp. 11.
(1) Polymer Weight Percentage of “about 48.2 wt %”
Patent Owner argues that the limitation in claim 8 of “about 48.2 wt
%” is directly supported by the 48.2 wt % polymer amount in the 16/4, 12/3,
and 8/2 formulations in Table 1, as well as Test Formulation 2 in Table 5.
PO Resp. 12–14 (citing Ex. 2008 ¶ 34; Ex. 1011, 1457 ¶ 101, 1432 ¶ 22;
Ex. 2009, 118:14–119:2 (Petitioners’ expert conceding that inventors
“[gave] us an example of a film that has 48.2% polymer”), 119:22–121:7.
Patent Owner also points to Petitioners’ acknowledgment that Table 1
discloses the polymer weight percentage of 48.2%. Id. at 14 (citing Pet. 26
n.8).
(2) Polymer Weight Percentage Range of “about 48.2
wt % to about 58.6 wt %”
Patent Owner argues that the ’571 application “reasonably conveys to
a POSA that the inventors possessed the polymer weight percentage range of
‘about 48.2 wt % to about 58.6 wt %’ recited in Claims 7 and 12.” PO Resp.
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14 (Ex. 2008 ¶¶ 36–45). Patent Owner also argues that “this range is not
only within the disclosed range of ‘at least 25%’ . . . but each endpoint is
also directly supported by the 48.2% and 58.6% polymer weight percentages
disclosed in the exemplary film formulations provided in Tables 1 and 5.”
Id. at 14–16 (citing Ex. 1011, 1444 ¶ 65, 1459 (claim 5); Ex. 2008 ¶ 36;
Ex. 1003 ¶¶ 74, 77) (emphasis added by Patent Owner).
Petitioners reply to the argument that the recited range of “about 48.2
wt % to about 58.6 wt %” is within the disclosed range of “at least 25%”
(PO Resp. 14–15) by arguing that paragraph 65 does not provide any upper
endpoint for the polymer weight range, citing Dr. Cremer. Reply 3–4 (citing
Ex. 1011 ¶ 65; Pet. 21; Ex. 1030, 51:7–53:5, 54:1–15 (“Q. But there’s no
upper limit identified in paragraph 65 numerically, right? A. That’s what I
said. Yes.”); see also 55:3–16). Petitioners advance the same argument with
respect to originally filed claim 5. Id. at 3–4 (citing Ex. 1030, 55:3–16).
Petitioners reply to the argument that each endpoint is directly
supported by the polymer weight percentages of 48.2% and 58.6% disclosed
in the exemplary film formulations in Table 1 and Table 5 (PO Resp. 15–16)
by arguing that neither Table 1 nor Table 5 disclose the total polymer weight
percentage. Reply 4 (citing Ex. 1011, Tables 1 & 5; Ex. 1030, 57:10–58:17,
59:14–60:1, 62:3–19, 63:10–20, 121:11–122:8). Petitioners further argue
that “Dr. Cremer back-calculated . . . the total polymer weight percentage
values from these example formulations by summing the concentrations of
each of the individual polymer weights and calculating the percentage of the
total polymer component as compared to the total weight of the
formulation.” Id. (citing Ex. 2008 ¶¶ 31–33). As argued by Petitioners,
“[t]he ’571 application provides no direction to perform these calculations,
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and even then Dr. Cremer obtains only two fixed values (48.2% and 58.6%),
not a range.” Id.; see also Reply 1.
Patent Owner replies that “Dr. Das conceded the ’571 Application
discloses polymer weight percentages and that a POSA would have
understood their importance to the inventive films (because of functions
expressly disclosed in the ’571 application).” Sur-reply 6; see also id. at 4–5
citing Ex. 1003 ¶¶ 74, 77; Ex. 2009, 50:7–51:24, 57:17–25, 59:8–12; 93:19–
23, 107:7–16, 118:14–120:3.
Patent Owner advances the following additional arguments in support
of its contention that a POSA would have understood that the inventors
possessed the claimed polymer weight percentage range of “about 48.2% to
about 58.6%.” PO Resp. 16–22.
(a) Formulations in Table 1 and Test
Formulation 2 in Table 5
Patent Owner argues that “[a] POSA would . . . have understood that
the inventors possessed formulations with polymer weight percentages of
48.2% and 58.6%” based on the formulations in Table 1 and Test
Formulation 2 in Table 5. PO Resp. 17 (citing Ex. 2009, 107:7–16, 118:14–
120:3). Patent Owner further argues that “a POSA ‘would have understood
that the exemplary formulations in Table 1 and Test Formulation 2 in
Table 5 all pertained to the same invention with generally the same
properties, the same operability, and the same ability to achieve any desired
result.’” Id. (quoting Ex. 2008 ¶ 38). Patent Owner also quotes Dr. Cremer
to argue that “[a] POSA would have understood that ‘the inventors
possessed not only polymer weight percentages of 48.2% and 58.6%, but
also the polymer weight percentages between those two values, that is, the
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polymer weight percentage range of 48.2% to 58.6%.’” Id. (quoting
Ex. 2008 ¶ 38).
Petitioners reply by arguing that the ’571 Application does not
disclose a bounded range, and also reply to Patent Owner’s “same
invention” argument, as further discussed below. See infra Section
II.E.1.b)(2)(c); Reply 5–9.
(b) “about 48.2 wt % to about 58.6 wt %” and
Optional Ingredients
Patent Owner argues that the exemplary film formulations disclosed
in the ’571 application contain optional ingredients, such as flavors and
sweeteners. PO Resp. 18. Patent Owner further argues that “a POSA would
have recognized that the amounts of these ingredients could vary, changing
the polymer weight percentage of the film,” and that a POSA “would
therefore have immediately discerned . . . that the inventors possessed not
merely the polymer weight percentage of 48.2%, but also a range of polymer
weight percentages encompassing that value, such as a range extending from
7.2% below to 12.8% above 48.2%.” Id. (citing Purdue, 230 F.3d at 1323)
Patent Owner also argues that “[a] POSA would have understood that a
polymer weight percentage of 61.0% (48.2% + 12.8%) is ‘about 58.6%.’”
Id.
According to Patent Owner, the exemplary formulas in Table 1 and
Test Formulation 2 in Table 5 of the ’571 application give examples of the
amounts of flavor and sweetener that could be added or removed, thereby
changing the polymer weight percentage of the films, while staying within
the invention. PO Resp. 18 (citing Ex. 2008 ¶ 40); see also id. at 15 n.9.
Patent Owner quotes Dr. Cremer for the assertion that “films prepared
according to the ’571 Application would remain within the scope of the
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disclosed invention even if the flavor and sweetener were removed, added,
or varied in amount by a reasonable degree.” Id. at 19 (quoting Ex. 2008
¶ 40).
Patent Owner argues that the foregoing assertion by Dr. Cremer is
illustrated by five examples derived from disclosed formulations in which,
by Dr. Cremer’s calculations, (1) flavor and sweetener are removed from the
Table 1 formulations and Test Formulation 2 in Table 5, resulting in
polymer weight percentages of 52.9% or 61.0% rather than 48.2%
(Examples 1 and 3) or 64.4% rather than 58.6% (Example 2), or
(2) sweetener is added to formulations in Table 1, resulting in polymer
weight percentages of 42.2% rather than 48.2% (Example 4) or 51.4% rather
than 58.6% (Example 5). Id. at 19–20 (citing Ex. 2008 ¶ 41). According to
Patent Owner, these examples “demonstrate that polymer weight
percentages could be decreased by at least 7.2% or increased by at least
12.8% of the total weight of the films while staying within the scope of the
invention.” Id. at 20 (citing Ex. 2008 ¶¶ 41, 42). Patent Owner thus argues
that “a POSA would have understood that the inventors possessed the
claimed polymer weight percentage range of ‘about 48.2% to about 58.6%.’”
Id.; see also id. at 15 n.9.
Petitioners reply that “Dr. Cremer’s opinions based on altering the
presence or quantity of particular ‘optional ingredients’ in the formulations
of Tables 1 and 5—and his examples based thereon (Ex. 2008, ¶¶ 40–41)—
are arbitrary, unsupported, and inconsistent with his other opinions,” and
“should therefore be disregarded.” Reply 9. Petitioners argue that
Dr. Cremer “undertook multiple steps ungrounded in the explicit disclosure
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of the ’571 application” in obtaining these exemplary formulations, and
“each step is questionable in its reasoning.” Id. at 9–10.
According to Petitioners, Dr. Cremer first looked at Tables 1 and 5
and determined “which of the ingredients in those formulations could be
considered optional.” Reply 10. Petitioners argue that Dr. Cremer testified
that the optional ingredients in the Table 1 formulations included the
sweetener (Ace-K), colorant, and flavor, but that Dr. Cremer would not say
whether maltitol (a sugar alcohol) should also be understood as an optional
ingredient, even though the ’571 application identified maltitol as an
optional ingredient. Id. (citing Ex. 1030, 66:12–69:4; Ex. 1011, ¶¶ 34, 39).
Petitioners further argue that Dr. Cremer testified that he had not “performed
that analysis for maltitol” and that his analysis would have changed had he
considered maltitol to be an optional ingredient in the Table 1 formulations.
Id. (citing Ex. 1030, 70:8–71:6, 74:10–77:21, 82:4–84:5). Petitioners thus
argue that Dr. Cremer’s analysis “fails at step one, and shows the degree of
speculation and unbounded variation required by a POSA to proceed with
Dr. Cremer’s ‘optional ingredients’ theory.” Id.
Petitioners further argue that the “optional” ingredients theory is
flawed because Dr. Cremer “bases his opinion on which components could
be added or removed without ‘substantially affect[ing]’ the overall
formulation.” Reply 10–11 (citing Ex. 1030, 72:3–12). According to
Petitioners, “Dr. Cremer testified in a conclusory manner that if an optional
component is varied in a ‘reasonable’ amount, it will not ‘substantially
affect’ product characteristics—yet, he refused to explain what he meant by
‘reasonable.’” Id. at 11 (citing Ex. 1030, 72:3–73:2, 73:18–21). Petitioners
further argue that Dr. Cremer “said that the particular examples he proposed
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would not require testing to determine whether the presence or absence of a
specific component would affect the product characteristics, but admitted
that he relied on no scientific literature to support this opinion.” Id. (citing
Ex. 1030, 74:10–76:10). Thus, according to Petitioners, “Dr. Cremer’s
opinion about which ingredients are properly considered ‘optional’ in the
Table 1 and Table 5 formulations is therefore speculative and not credible.”
Id.
Petitioners then argue that “Dr. Cremer took the ingredients he
determined to be optional, varied their amounts within the formulations
disclosed, and re-calculated the polymer weight percentage amounts that
resulted from his decisions on what to add or remove,” but Dr. Cremer
“made the decision of how to vary, add, or remove the ‘optional’ ingredients
without relying on any direction from the specification.” Reply 11 (citing
Ex. 2008 ¶¶ 41, 42; Ex. 1030, 78:14–82:19; Ex. 1011, Tables 1 and 5).
Thus, as argued by Petitioners, there is no reason for a POSA to alter the
disclosed formulations by adding, removing, or changing the amounts of the
ingredients based on the ’571 application, and Dr. Cremer’s explanation for
doing so (a “POSA would not expect instructions like that”) is neither
supported by objective evidence nor credible. Id. at 11–12 (quoting
Ex.1030, 80:22–81:1).
Petitioners next argue that Dr. Cremer used his re-calculated values
“to support a theory that the application actually discloses polymer weight
percentages of 52.9%, 64.4%, 61.0%, 42.2%, and 51.4%.” Reply 12 (citing
Ex. 2008 ¶¶ 41–42). Petitioners further argue that that “Dr. Cremer opines
that a POSA would understand that the polymer weight percentages of the
films could be decreased by at least 7.2% or increased by at least 12.8%
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while staying within the scope of the invention.” Id. at 12–13 (citing
Ex. 2008 ¶ 42; PO Resp. 19–20 (citing Ex. 2008 ¶¶ 41, 42); Ex. 1030,
116:20–117:6). But, according to Petitioners, “Dr. Cremer admitted that he
crafted his examples of potential formulations by choosing at random how to
vary the amounts or presence of ‘optional’ ingredients,” and “emphasized
that one could obtain different values depending on the variation of optional
ingredients and amounts chosen.” Id. at 13 (citing Ex. 1030, 82:4–84:4,
117:3–6, 134:8–135:15).
Petitioners argue that Dr. Cremer’s “optional ingredients” analysis is
arbitrary, and “not based on any express disclosure or direction in the ’571
application.” Reply 13. Petitioners cite to Dr. Cremer’s testimony that his
examples are “formulations that are not specifically disclosed in here.” Id.
(citing Ex. 1030, 134:8–135:5) (Petitioners’ emphasis omitted). Petitioners
further argue that “even if Dr. Cremer’s ‘optional ingredients’ analysis
would have been obvious to a POSA reading the ’571 application, that
would still be insufficient to render the subject matter disclosed for purposes
of priority.” Id. (citing cases).
Petitioners further argue that Dr. Cremer’s “optional ingredients”
opinions should be disregarded because he used the same formulation to
support two different claimed endpoints. Reply 13–14. Specifically,
Petitioners point to Test Formulation 2 in Table 5 (calculated by Dr. Cremer
as 61% polymer weight), and Dr. Cremer’s opinions that (1) 61% is “about
58.6%” and supports the upper endpoint of 58.6% in claims 7 and 12, and
(2) the 61% polymer weight derived from the same formulation provides
written description support for the 60% upper bound in claim 1. Id. at 14
(citing PO Resp. 19–20, 31; Ex. 2008 ¶ 41, 42, 48; Ex. 1030, 119:14–18).
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Petitioners thus argue that Dr. Cremer’s “optional ingredients” opinions do
not solve the problem of the absence of a disclosure of a range endpoint, but
rather “they show the degree of speculation required by a POSA to derive a
bounded range from the disclosure in the ’571 application, or even to reach
the conclusion that a range is disclosed at all.” Id.
Patent Owner replies that Dr. Cremer explained “why the disclosure
of optional ingredients reasonably conveys to a POSA that the invention
includes polymer weight percentage ranges.” Sur-reply 8 (citing Ex. 2008
¶ 40; Ex. 1030, 72:3–12). Patent Owner further replies that “the polymer
weight percentages . . . could be decreased . . . or increased . . . while staying
within the scope of the claimed invention,” and that “a POSA would have
immediately discerned that the inventors possessed not only the polymer
weight percentage of 48.2%, but also a range of polymer weight percentages
that encompasses that value.” Id. at 8–9 (quoting Ex. 2008 ¶¶ 39, 41, 42).
Patent Owner further replies that “[a]lthough Petitioners attempt to
criticize Dr. Cremer for not defining the outer bounds of reasonable
variation in flavor and sweetener amounts, there was no reason or need to do
so because he provided examples of such variation in his Examples 1–5.”
Sur-reply 9 (citing Ex. 2008 ¶ 41). According to Patent Owner, the removal
of flavor and sweetener and the addition of sweetener was “based on a
POSA’s understanding that [formulations in Table 1 and Test Formulation 2
in Table 5] pertained to the same invention,” and were not selected “at
random.” Id. (citing Ex. 2008 ¶¶ 38, 41); see also id. at n.2 (citing Reply
13). Patent Owner further argues that “[w]hatever the outer bounds of
reasonable variation, it includes at least the variation in Examples 1–5,” and
that “Dr. Cremer testified that the extent of reasonable variation would have
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been ‘clear’ to a POSA from ‘the application as a whole.’” Id. at 9–10
(citing Ex. 1030, 72:14–74:6).
Patent Owner also argues that “the outer bounds of reasonable
variation are immaterial to Dr. Cremer’s testimony that the invention
encompasses variation in optional ingredient amounts and polymer weight
percentages, and thus includes ranges of polymer weight percentages around
the disclosed embodiments of 48.2% and 58.6%.” Sur-reply 10. According
to Patent Owner, Dr. Cremer testified that “‘the gist of [his] examples’ is
that, in light of permissible variation in optional ingredient amounts, it
would be ‘apparent to the POSA’ that the inventors possessed not only the
disclosed embodiments, but also ‘a margin or a range that encompasses’
them.” Id. (citing Ex. 1030, 123:14–124:21).
Patent Owner replies to Petitioners’ argument regarding Dr. Cremer’s
lack of “testing or other basis to say” that varying the amounts of flavor or
sweetener by a reasonable degree would result in a film pertaining to the
same invention (Reply 9–11), by arguing that “given the disclosed
formulations in Tables 1 and 5 and the express disclosure that the flavor and
sweetener are optional . . . there was no reason or need for Dr. Cremer to cite
testing or additional scientific literature.” Sur-reply 10 (citing Ex. 2008
¶¶ 39–40 (citing Ex. 1011, 1436–37 ¶¶ 34, 35)). Patent Owner further
argues that “the written description requirement asks what a POSA would
have understood from the ’571 Application, not from independent testing or
research, and Dr. Cremer is qualified to opine on that.” Id. at 10–11; see
also id. at 2–4.
Patent Owner further replies that “Petitioners wrongly allege that
Dr. Cremer ‘could not explain’ his decision not to consider whether maltitol
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was optional.” Sur-reply 11 (citing Reply 9–10). Patent Owner argues that,
“[t]o the contrary, Dr. Cremer testified that ‘he did not need to analyze’
maltitol in his analysis of varying the amount of flavor and sweetener as
exemplary optional ingredients,” and further that “because maltitol can
perform several functions and ‘we don’t know for sure [its] predominant’
function in the inventive films, he decided to ‘work[] with other ingredients’
whose functions are unambiguous.” Id. (citing Ex. 1030, 70:4–7, 77:6–21).
Patent Owner replies to “Petitioners’ argument that there is ‘no
direction from the specification’ to perform the exact calculations in
Dr. Cremer’s Examples 1–5 . . . is inapposite,” because “Examples 1–5 ‘are
just examples,’. . . which ‘illustrate’ that films ‘would remain within the
scope of the disclosed invention even if the flavor and sweetener were . . .
varied in amount by a reasonable degree.” Sur-reply 11–12 (citing Reply
11–14; Ex.1030, 82:20–84:4; Ex. 2008 ¶¶ 40–41).
Patent Owner also argues that “Petitioners posit a conflict in
Dr. Cremer’s testimony that the 61.0% polymer weight percentage from his
Example 3 is both ‘about 58.6%’ and ‘about 60%’” (Reply 13–14), but that
is not correct because “Dr. Cremer’s testimony simply reflects his judgment
that a POSA would have understood ‘about 58.6%’ and ‘about 60%’ to
overlap in the context of the invention,” and “a disclosure may support
several claim limitations.” Sur-reply 12 (citing Ex Parte Bo L. Tran, 2016
WL 4128591, at *1–2 (PTAB July 14, 2016)).
(c) Polymer Weight Percentage Range of “25%
to About 58.6”
Patent Owner argues that the ’571 application discloses a polymer
weight percentage range of “at least 25%” and a polymer weight percentage
of 58.6% (calculated from the 2/0.5 formulation), and that “a POSA would
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have understood that this polymer weight percentage [58.6%] is an example
of the amount of polymer that could be included in the inventive films in
light of the constraints imposed by the presence of other ingredients.” PO
Resp. 21 (citing Ex. 1011, 1444 ¶ 65, 1459 (claim 5); quoting Ex. 2008
¶ 43). Patent Owner thus argues that “a POSA would have understood that
the inventors possessed a polymer weight percentage range of 25% to
58.6%,” and further that, because other optional ingredients could be
included in varying amounts, “a POSA also would have understood that the
inventors possessed a polymer weight percentage range of 25% to about
58.6%.” Id. at 21–22 (quoting Ex. 2008 ¶ 44).
Patent Owner further argues that “[a] POSA also would have
understood that the inventors possessed the narrower range of about 48.2%
to about 58.6%.” PO Resp. 22. Patent Owner supports this argument with
the contentions that the ’571 application discloses a polymer weight
percentage of 48.2%; “the disclosed range of 25% to about 58.6%
encompasses the claimed range from about 48.2% to about 58.6%; and films
with polymer weight percentages within the two respective ranges pertain to
the same invention with generally the same properties, operability, and
ability to achieve any desired result.” Id. (citing Ex. 2008 ¶ 45; In re
Wertheim, 541 F.2d 257, 264 (CCPA 1976)); Sur-reply 12–15.
Petitioners reply that Patent Owner repeatedly refers to the
“disclosed” range of about 25%–58.6% (and about 25–60%) as if they are
explicitly discussed on the face of the ’571 Application, but “all the ’571
Application discloses are polymer weights of ‘at least 25%’ and ‘at least
50%.’” Reply 5 (citing PO Resp. 16, 21–22, 24–25, 26, 30–33); Ex. 1011
¶ 65, claim 5). Petitioners also argue that while these ranges of at least 25%
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and at least 50% “are necessarily limited to some end point, that end point is
not disclosed in the ’571 application,” and that “Dr. Cremer conceded as
much at his deposition.” Id. (quoting Inst. Dec. 19; citing Ex. 1030, 52:1–
53:5, 54:1–15, 55:3–16, 57:10–58:17, 59:14–60:1, 62:3–19, 63:10–20).
Thus, as argued by Petitioners, “despite Patent Owner’s characterizations to
the contrary, there is no bounded range ‘disclosed’ by the ’571 application in
any respect.” Id.
Petitioners contend that “Patent Owner now argues that films within
the two fictional ranges of 25%–58.6% and 25%–60%, as well as the
claimed ranges of 48.2%–58.6% and 40%–60%, ‘pertain to the same
invention with generally the same properties, operability, and ability to
achieve any desired result.’” Reply 7 (citing PO Resp. 22 (citing Ex. 2008
¶ 45), 32 (citing Ex. 2008 ¶ 50)). According to Petitioners, this argument by
Patent Owner “is based on Dr. Cremer’s conclusory opinion that changes in
polymer weight percentages within these ranges would have no effect on the
‘operability’ of the films,” but that “Dr. Cremer performed no testing and
does not rely on any discussion in the ’571 application to support this
conclusion.” Id. (citing Ex. 2008 ¶¶ 45, 49–50). Petitioners further argue
that Dr. Cremer “cited no scientific literature anywhere in his declarations,
despite his assertion that his opinions in this regard are based on the
‘variability that would be typical in this field.’” Id. (citing Ex. 1030,
105:17–106:5, 152:7–22; Ex. 2008 ¶¶ 45, 49–50). Petitioners also argue that
“Dr. Cremer testified that he did not even consider whether there would be
any difference in operability between films with 40% (as in claim 1) or
48.2% (as in claim 8) total polymer weight.” Id. (citing Ex. 1030, 102:22–
104:10, 106:20–108:11).
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Patent Owner’s reply to Petitioners’ lack of testing argument is set
forth above. See infra Section II.E.1.b)(2)(b).
(d) Patent Owner’s Case Law Arguments and
Petitioners’ Reply
Patent Owner argues the Federal Circuit’s recent decision in
Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc., 934 F.3d
1344 (Fed. Cir. 2019),11 petition for cert. filed (No. 19-1131), March 13,
2020, supports a finding of adequate written description. PO Resp. 22–23.
According to Patent Owner, the court in Nalpropion “held that the
specification’s embodiments of 39% and 67% naltrexone release in one hour
and 62% and 85% naltrexone release in two hours adequately supported
claimed ranges of ‘between 39% and 70% naltrexone released in one hour’
and ‘between 62% and 90% of naltrexone released in two hours.’” Id.
(citing Nalpropion 934 F.3d at 1349–51). Patent Owner further argues that
the court in Nalpropion “emphasized that ‘[i]t is not necessary that the exact
terms of a claim be used in haec verba in the specification’ and that
‘[r]igidity should yield to flexible, sensible interpretation.’” Id. (citing
Nalpropion, 934 F.3d at 1350–51).
Patent Owner argues that the written description support for the
claimed range of about 48.2% to about 58.6% “is far stronger” because the
’571 Application “discloses a range of 25% to about 58.6% as well as an
embodiment of 48.2%, and discloses that films containing 48.2 wt % and
58.6 wt % polymer also contain optional ingredients,” and that those
optional ingredients could be removed, added, or varied in amount, “which a
POSA would have understood to correspondingly change the polymer

11 Patent Owner cites to Nalpropion’s Westlaw citation, 2019 WL 3819335.
PO Resp. 22. Citations herein are to the Federal Reporter.
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weight percentage with no change in the functionality of the invention.” Id.
at 23 (citing Ex. 2008 ¶¶ 39–42).
Patent Owner also argues that the court in Wertheim held that a
description of solid contents within the range of 25–60%, along with specific
embodiments of 36% and 50%, provided written description support for
processes employing a 35–60% solids content range. PO Resp. 23 (citing
Wertheim, 541 F.2d at 265). Patent Owner cites to language from Wertheim
to argue that Petitioners “proffered ‘no evidence . . . that there is in fact any
distinction, in terms of the operability of [the inventive films] or of the
achieving of any desired result,’ . . . between the disclosed polymer weight
percentage range from 25% to about 58.6% and the encompassed claimed
range from about 48.2% to about 58.6%.” Id. at 23–24 (citing Ex. 2008
¶ 45; Wertheim, 541 F.2d at 264). Thus, according to Patent Owner, “the
’571 Application’s disclosed range of 25% to about 58.5% and a specific
embodiment of 48.2% clearly supports the claimed polymer weight
percentage range of about 48.2% to about 58.6%,” and “the claimed polymer
weight percentage range of about 48.2% to about 58.6% is fully
encompassed by the polymer weight percentage range of 25% to 58.6%.”
Id. at 24.
Petitioners reply that Nalpropion and Wertheim do not support Patent
Owner’s position because there are no bounded ranges disclosed in the ’571
application. Reply 8. Petitioners assert that “Nalpropion is distinguishable
because, unlike here, both upper and lower boundary limits of the claimed
range were actually disclosed in the specification.” Id. (citing Nalpropion,
934 F.3d at 1349). Petitioners further assert that Wertheim is likewise
distinguishable “because the disclosure in that case included a range of 25%
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to 60% with a specifically disclosed endpoint of 60%.” Id. (citing Inst. Dec.
21 (citing Wertheim, 541 F.2d at 264)). Patent Owner states in reply that
satisfaction of the written description requirement is stronger here than in
Nalpropion and Wertheim because a POSA would have understood that the
’571 application discloses “the precise claimed endpoints of 48.2% and
58.6%, and the range between them,” and “a range of 25% to about 58.6%
. . . which ‘describes the somewhat narrower claimed range’ of about 48.2%
to about 58.6%, especially given the disclosure of 48.2%.” Sur-reply 15–16
(citing Wertheim, 541 F.2d at 264).
Patent Owner also cites to In re Molenda, 2017 WL 3620343 (PTAB
Aug. 18, 2017) (Decision on Appeal), and asserts that the original
application in Molenda disclosed polymer concentration ranges, as well as
an embodiment of 3.5% that fell within those ranges. PO Resp. 24–25
(citing Molenda, 2017 WL 3620343, at *7). Patent Owner further asserts
that “[t]he Board found that this disclosure adequately supported a claimed
polymer concentration of about 5% even though that concentration was not
explicitly disclosed.” PO Resp. 25 (citing Molenda, 2017 WL 3620343, at
*7). Petitioners reply that the Board in Molenda found that the claimed
concentration was within a range disclosed in the specification, whereas the
’571 application does not disclose bounded ranges of polymer weights.
Reply 8–9 (citing Molenda, 2017 WL 3620343, at *6–7). Patent Owner
argues in reply that the written description support is stronger here than in
Molenda for the same reasons argued with respect to Nalpropion and
Wertheim. Sur-reply 16 n.5 (citing Molenda, 2017 WL 3620343, at *7).
Patent Owner also advances arguments that “[t]he decisions cited by
Petitioners are inapposite.” PO Resp. 25. Patent Owner argues that General
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Hospital is distinguishable because the disclosed range minimally
overlapped with the claimed range whereas “here the disclosed range
completely encompasses the claimed range.” Id. at 26 (citing General
Hospital, 888 F.3d at 1372–73). Patent Owner further argues that the
concentration claimed in General Hospital was merely one discrete point
within much broader disclosed ranges, “here the claimed ranges of about
48.2% to about 58.6% and about 40% to about 60% claim a much larger
portion of the disclosed ranges of 25% to about 58.6% or 25% to about
60%.” Id. (citing General Hospital, 888 F.3d at 1372).
Patent Owner further argues that in Ruschig “the court found no
written description support for a specific claimed compound not mentioned
in the specification.” PO Resp. 27 (citing Ruschig, 379 F.2d at 996). Patent
Owner asserts that the court explained that “[s]pecific claims to single
compounds require reasonably specific support disclosure” and that
“something more than the disclosure of [a large class of] compounds is
required.” Id. (citing Ruschig, 379 F.2d at 994). According to Patent
Owner, “the written description support is significantly stronger than in
Ruschig” because the claimed polymer weight percentages are within “the
disclosed polymer weight percentage range of 25% to about 58.6%,” and
there is support in the ’571 Application “for each specific polymer weight
percentage recited in the challenged claims.” Id. (citing Ex. 2008 ¶¶ 30–51).
According to Patent Owner, “Wertheim recognized that the issue in Ruschig
of whether a disclosed compound genus supports a claimed compound
species is different from the issue of whether a disclosed percentage range
supports a claimed percentage range within the disclosed range.” Id. at 27–
28 (citing Wertheim, 541 F.2d at 264). Patent Owner also points to the
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district court’s decision, affirmed in relevant part in Nalpropion, to argue
that the district court rejected “the defendant’s argument that the
specification ‘fails to provide ‘blazemarks’ that would direct a [POSA] to
select th[e] specific bounds’ of the claimed range of dissolution profiles.”
Id. at 28 (citing Orexigen Therapeutics, Inc. v. Actavis Labs. FL, Inc., 282 F.
Supp. 3d 793, 803 (D. Del. 2017), aff’d in part, rev’d in part sub nom.
Nalpropion, 934 F.3d 1344).
(3) Polymer Weight Percentage Range of “about 40
wt % to about 60 wt %”
Patent Owner argues that the ’571 application reasonably conveys to a
POSA that the inventors possessed the polymer weight percentage range of
“about 40 wt % to about 60 wt %” as recited in claim 1. PO Resp. 29 (citing
Nalpropion, 934 F.3d at 1349–51). Patent Owner also argues that “this
claimed range is within the disclosed range of ‘at least 25%’ . . . and it
encompasses the 48.2% and 58.6% polymer weight percentages disclosed in
Tables 1 and 5.” Id. at 29–30 (citing Ex. 1011, 1444 ¶ 65, 1459 (claim 5);
Ex. 2008 ¶ 46; Ex. 1003 ¶¶ 74, 77).
Petitioners’ reply arguments regarding the lack of a disclosure of
bounded ranges in the ’571 Application is set forth above. See supra
Section II.E.1.b)(2)(c). In addition, Petitioners further reply that, as for the
lower claimed value, Patent Owner takes the position that the claimed 40%
lower endpoint is supported by the ’571 application because it is “closer to”
48.2% than 25%. Reply 5–6 (citing Paper 12, 13; Ex. 2001 ¶ 42).
According to Petitioners, “[u]nder this ‘closer to’ logic, the patentee could
have claimed any percentage value between 25% and 48.2% as the lower
boundary, so long as the chosen number was ‘closer to’ 48.2% than 25%
(i.e. anything greater than 36.6%).” Id. at 6. Petitioners further argue that
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“Dr. Cremer refused to offer an opinion as to whether 41%, 42%, etc. could
have also been claimed as the lower endpoint, stating that he only considered
whether ‘about 40%’ was supported by the ’571 application.” Id. (citing
Ex. 1030, 101:4–102:11, 104:1–10). Patent Owner replies that “Dr. Cremer
did not say that being ‘closer to’ 48.2% than 25% would itself be sufficient
for written description support, but rather that this is one consideration that,
together with the other facts discussed in his declarations, reasonably
conveys to a POSA that the inventors possessed the range of about 40% to
about 60%.” Sur-reply 17.
(a) “about 40 wt % to about 60 wt %” and
Optional Ingredients
Patent Owner argues that “[a] POSA would have understood that
optional ingredients may be removed, added, or varied in amount by a
reasonable degree while staying within the invention,” and that a POSA
would have therefore understood “that the inventors possessed polymer
weight percentages extending about 7.2% below and about 12.8% above the
disclosed embodiment of 48.2%, that is, a range of 41.0% to 61.0%.”
PO Resp. 31 (citing previous arguments, see supra Section II.E.1.b)(2)(b)).
According to Patent Owner, “[a] POSA would have understood that a
polymer weight percentage of 41.0% is a polymer weight percentage of
‘about 40%’ and a polymer weight percentage of 61% is a polymer weight
percentage of ‘about 60%.’” Id. (citing Ex. 2008 ¶ 48). Patent Owner
further argues that “a POSA would have understood that films with a
polymer weight percentage in the range of 41.0% to 61.0% and films with a
polymer weight percentage in the range of 40% to 60% pertain to the same
invention with generally the same properties, operability, and ability to
achieve any desired result.” Id.; Sur-reply 16–17.
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Petitioners’ reply arguments regarding optional ingredients and Patent
Owner’s reply thereto are set forth above. See supra Section II.E.1.b)(2)(b).
(b) Polymer Weight Percentage Range of “25%
to About 60%”
Referring back to its previous arguments (see supra Section
II.E.1.b)(2)(c)), Patent Owner argues that “a POSA would have understood
that the inventors possessed a polymer weight percentage range of 25% to
about 58.6%,” that a “polymer weight percentage of about 58.6% is a
polymer weight percentage of about 60%,” and that a “polymer weight
percentage of about 60% is also within the disclosed ranges of ‘at least
25%.’” PO Resp. 31–32 (citing Ex. 2008 ¶ 49; Ex. 1011, 1444 ¶ 65, 1459
(claim 5); Ex. 2009, 100:3–17, 101:5–12). Patent Owner further argues that
“films with a polymer weight percentage within the range of 25% to 58.6%
and films with a polymer weight percentage within the range of 25% to 60%
pertain to the same invention with generally the same properties, operability,
and ability to achieve any desired result.” Id. at 32 (citing Ex. 2008 ¶ 49;
Wertheim, 541 F.2d at 264).
Petitioners’ reply to this argument is set forth above. See supra
Section II.E.1.b)(2)(c).
Patent Owner cites to Nalpropion and Wertheim as support for the
conclusions that “[t]he disclosed polymer weight percentage range of 25% to
about 60% would have reasonably conveyed to a POSA that the inventors
also possessed the claimed polymer weight percentage range of about 40%
to about 60%” (citing Nalpropion), and that “[f]ilms with a polymer weight
percentage within the range of 25% to 60% and films with a polymer weight
percentage within the range of 40% to 60% pertain to the same invention
with generally the same properties, operability, and ability to achieve any
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desired result” (citing Ex. 2008 ¶ 50; Wertheim, 541 F.2d at 264). PO Resp.
32.
Petitioners’ reply to Patent Owner’s reliance on Nalpropion and
Wertheim, and Patent Owner’s Sur-reply thereto, is set forth above. See
supra Section II.E.1.b)(2)(d).
(4) Particular Polymer Weight Percentages and
Bounded Polymer Weight Percentage Ranges
Patent Owner challenges Petitioners’ assertion that “the ’571
application ‘provides no direction’ that particular polymer weight
percentages or weight percentage ranges ‘were within the scope of the
invention’” with several arguments. PO Resp. 33 (citing Pet. 22–23).
Patent Owner points to paragraph 65 and original claim 5 as
disclosing “embodiments of the inventive films containing a polymer in an
amount of at least 25% or at least 50% by weight of the composition.”
PO Resp. 34 (citing Ex. 1011, 1444 ¶ 65, 1459 (claim 1)). Patent Owner
also points to Table 5 as “specifically identif[ying] percent by weight of the
polymers in each disclosed formulation,” and Table 1 as identifying both the
polymer weight and the total weight for each formulation. Id. (citing
Ex. 1011, 1453 (Table 5), 1449–50 (Table 1)) (emphasis added by Patent
Owner). According to Patent Owner, “[t]hese express disclosures
reasonably convey to a POSA that the inventors possessed particular
polymer weight percentages,” and “Petitioners’ assertion that ‘there is no
reason that a POSA would understand the applicants placed any
significance’ on polymer weight percentages . . . strains credulity.” Id. at
34–35 (citing Ex. 2008 ¶¶ 53–54; Pet. 29; Nalpropion, 934 F.3d at 1349–
51).
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(a) Bounded Polymer Weight Percentage
Ranges
Patent Owner also challenges Petitioners’ assertion that “the ’571
Application discloses only open-ended polymer weight percentage ranges,”
and directs a POSA away from the claimed polymer weight percentage
ranges (Pet. 21–23), by arguing that Petitioners “attempt to isolate individual
disclosures from the ’571 Application, which is inconsistent with well-
established precedent holding that the written description analysis considers
what ‘the specification as a whole’ would have reasonably conveyed to a
POSA.” PO Resp. 35 (citing Pet. 21–22; Ex. 1003 ¶ 61; Ex. 1011, 1444
¶ 65); see also Kolmes v. World Fibers Corp., 107 F.3d 1534, 1539 (Fed.
Cir. 1997).
According to Patent Owner, a POSA would have understood that “the
aim of the ’571 Application is to create a pharmaceutical film,” (quoting
Ex. 2008 ¶ 56), that the polymer is an important component of the inventive
films, that the ’571 Application discloses minimum polymer weight
percentages of at least 25% or at least 50%, that the polymer weight
percentages can vary because they can include different amounts of optional
ingredients, and that “the necessary presence of actives and a buffer,
together with the optional presence of other ingredients, would constrain the
possible polymer weight percentage in the film.” PO Resp. 35–36 (citing
Ex. 2008 ¶ 56; Ex. 2009, 109:21–110:12; Ex. 1011, 1459 (claim 1), 1443
¶ 60, 1445 ¶ 67, 1463, Abstract). Patent Owner thus argues that “a POSA
reading the ’571 Application as a whole would have understood that there is
an upper bound to the polymer weight percentages of the inventive films.”
Id. at 36 (citing Ex. 2008 ¶ 56). Patent Owner cites to Rimfrost AS v.
Biomarine Antartic AS., PGR2018-00033, Paper 9 at 15–16, 2018 WL
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4183083 (PTAB Aug. 29, 2018) (Denying Institution of Post Grant Review)
as construing a claim reciting a minimum amount of astaxanthin esters, and
stating that “one skilled in the art would understand that the upper boundary
is not infinity.” Id. (citing Rimfrost, 2018 WL 4183083, at *7).
Petitioners’ reply arguments regarding the lack of disclosure of
bounded ranges are set forth above. See supra Section II.E.1.b)(2)(c).
Petitioners reply to Patent Owner’s Rimfrost discussion by arguing that the
claim limitation at issue in Rimfrost only set forth the minimum amount of
astaxanthin esters. Reply 8 (citing Rimfrost, 2018 WL 4183083, at *7).
Patent Owner argues that the exemplary formulations in Table 1 and
Test Formulation 2 in Table 5 illustrate the constraints that other ingredients
place on the polymer weight percentage ranges. PO Resp. 36–38 (citing Ex.
2008 ¶¶ 57–59). Patent Owner also argues that the “optional ingredients”
that may be included in the films could further restrain the polymer weight
percentage of the inventive films. Id. at 38–39 (citing Ex. 1011, 1438 ¶ 39,
1436–42 ¶¶ 34–57; Ex. 2008 ¶ 60). Patent Owner thus argues that “a POSA
would have understood that the ’571 Application discloses an upper bound
to the disclosed polymer weight percentage ranges in light of the necessary
presence of the actives and buffer and the optional presence of other
ingredients.” Id. at 39 (citing Ex. 2008 ¶ 60).
Petitioners’ arguments regarding optional ingredients and the lack of
disclosure of a bounded range, and Patent Owner’s reply thereto, are set
forth above. See supra Section II.E.1.b)(2)(b) & (2)(c).
(b) Importance of Polymer and Amount of
Polymer
Patent Owner argues that “[t]he ’571 Application discloses that
polymers are important to the inventive films,” because of its disclosure that
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“[t]he film dosage composition preferably includes a polymeric carrier
matrix,” and that the polymers provide a “self-supporting film composition.”
PO Resp. 39 (citing Ex. 1011, 1432 ¶ 23, 1444 ¶ 65, 1459 (claim 1);
Ex. 2009, 39:15–18, 111:9–112:20; Ex. 2008 ¶ 61). Patent Owner further
argues that the carrier “performs a crucial role in a pharmaceutical
composition,” and that the ’571 Application “teaches that the polymers
‘provide mucoadhesive properties to the film, as well as a desired
dissolution and/or disintegration rate,’” and “explains that these properties
are important to the inventive films.” Id. (citing Ex. 2008 ¶ 61; Ex. 1011,
1435–36 ¶¶ 30, 31). Patent Owner also argues that a POSA would also have
understood that the polymer is important to the inventive films “from the
’571 Application’s disclosure that the inventive films can comprise at least
25% by weight polymer or at least 50% by weight polymer,” that “each
formulation in Tables 1 and 5 . . . includes a polymer,” and that a polymer is
required by the independent claims of the ’571 application. Id. at 39–40
(Ex. 1011, 1444 ¶ 65, 1459 (claim 5), 1449–50, 1453, 1459–61). Patent
Owner further argues that “Dr. Das conceded at her deposition that ‘all
mucoadhesive pharmaceutical films . . . use polymers.” Id. at 40 (citing
Ex. 2009, 19:13–16; 112:12–20).
Patent Owner argues that a POSA would have immediately discerned
from reading the ’571 Application that “not only the polymer, but also the
amount of the polymer in the film is important to the invention.” PO Resp.
40. Patent Owner quotes Dr. Cremer to assert that a POSA would have
understood that “the amount of polymer would generally need to be selected
in light of the total weight of the film so that the polymer weight percentage
was within a range that enabled the polymer to function effectively as a
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carrier, provide a self-supporting film, and achieve the desired
mucoadhesion level and dissolution and/or disintegration rates.” Id. (citing
Ex. 2008 ¶ 62).
Patent Owner also cites to the testimony of Dr. Das to argue that “a
POSA would have understood that the polymer weight percentage of a film
‘could potentially impact the [film’s] adhesive properties and drug release
profile,’ both of which ‘have relevance for a pharmaceutical film.’” PO
Resp. 40–41 (citing Ex. 2009, 50:7–51:24, 54:4–15, 57:17–25, 76:20–77:14,
113:24–114:9). Patent Owner further cites to the testimony of Dr. Das to
argue that “a POSA would have understood that, ‘if I take an individual
polymer and I vary the concentration of that, will I expect an impact on all
of the properties of my formulation? The answer is yes.” Id. at 41 (citing
Ex. 2009, 58:2–59:25). Patent Owner also cites to the testimony of Dr. Das
to argue that, prior to 2004, “[t]here [were] plenty of published papers” that
would have indicated to a POSA that different polymer concentration levels
could lead to different film properties, further citing to a paper co-authored
by Dr. Das and published in 2006.12 Id. (citing Ex. 2009, 30:18–33:21,
53:2–54:15; Ex. 2007, 381, 386).
(c) Constant Polymer Weight Percentage
Patent Owner argues three of the four formulations in Table 1 and
Test Formulation 2 in Table 5 had a polymer weight percentage of 48.2%
with total film weights ranging from 50 mg to 100 mg. PO Resp. 41 (citing
Ex. 1011, 1449–50, 1453). Thus, according to Patent Owner, a POSA

12 M.S. Surapaneni et al., Effect of Excipient and Processing Variables on
Adhesive Properties and Release Profile of Pentoxifylline From
Mucoadhesive Tablets, DRUG DEV. AND INDUS. PHARMACY 32, 377–87
(2006). Ex. 2007.
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reading the ’571 Application “would have noticed that the polymer weight
percentages of these formulations were kept constant because the POSA
would have been attuned to polymer weight percentages.” Id. at 41–42
(quoting Ex. 2008 ¶ 63). Patent Owner cites to the testimony of Dr. Das that
“any formulator would be very geared to see the numbers [in formulations
16/4, 12/3, and 8/2] and how they move and recognize that this is not three
different formulations but, indeed, one single formulation, just three
different portion sizes pulled out from there.” Id. (citing Ex. 2009, 117:7–
118:13).
Patent Owner argues that a “POSA would have read the disclosure [of
the ’571 Application] with an eye toward how to make a pharmaceutical
film,” and “would have been particularly attuned to the weight percentages
and ratios of the required ingredients in a film,” especially the polymer
weight percentages. PO Resp. 42–43 (citing Ex. 2008 ¶¶ 64–68).
According to Patent Owner, “[a] POSA would have appreciated the
similarity between the polymer weight percentages of these four
formulations and would have been led to calculate the percentages.” Id. at
43–44 (citing Ex. 2009, 85:11–86:6). Patent Owner thus argues that
“[o]bserving that the inventors kept the polymer weight percentage constant
across films with widely varying total weights, a POSA would have
understood that the inventors possessed polymer weight percentages and
considered them important in constructing the inventive films.” Id. at 44
(citing Ex. 2008 ¶ 68).
Petitioners reply that the argument that the inventors in most cases
kept the polymer weight percentage constant “conflicts with Patent Owner’s
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argument that a POSA would understand polymer weight percentage ranges
to be disclosed.” Reply 22 n.5.
(d) pH and Polymer Weight Percentages
Patent Owner contests Petitioners’ argument that the ’571 application
shows that the inventors focused their testing on the pH of the films, and that
the pH determined whether the films were bioequivalent to the Suboxone®
tablets. PO Resp. 44 (citing Pet. 29–30; Ex. 1003 ¶¶ 75–80). Patent Owner
refers to Dr. Cremer’s explanation that there could have been any number of
reasons why the testing disclosed in Examples 5–8 of the ’571 Application
“focused on the inventive films’ pH instead of their polymer weight
percentages, such as that the inventors already knew which polymer weight
percentages worked well in the inventive films and thus did not need to
perform testing directed to this parameter.” Id. at 44–45 (quoting Ex. 2008
¶ 69). Patent Owner further cites to Dr. Cremer’s testimony for the assertion
that the disclosure of testing directed to pH rather than polymer weight
percentages “would not have indicated to a POSA that the inventors
considered this [polymer] parameter unimportant, but simply that the
inventors were interested in the relationship between pH and bioequivalence
to the Suboxone tablet.” Id. at 45 (quoting Ex. 2008 ¶ 69).
Patent Owner cites to Nalpropion and Vas-Cath Inc. v. Mahurkar, 935
F.2d 1555 (Fed. Cir. 1991), to argue that the written description requirement
does not require a disclosure “that the claimed element be essential to the
invention or even important to achieving the invention’s objectives.”
PO Resp. 45–46 (citing Nalpropion, 934 F.3d at 1350, and Vas-Cath, 935
F.2d at 1565); see also Sur-reply 20 n.9. Thus, Patent Owner argues that
“there is ample disclosure that the polymer weight percentages and (b):(a)
ratios were important to the invention . . . , but even without these
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disclosures, there would still be sufficient written description support
because the ’571 Application reasonably conveys to a POSA the inventors’
possession of them” at the time of filing the ’571 Application. Id. at 46.
c) Patent Owner’s Response, Petitioners’ Reply, and Patent
Owner’s Sur-reply Regarding Buprenorphine:Polymer/(b):(a)
Ratios
Petitioners’ arguments in its Petition regarding the lack of written
description support for the claimed buprenorphine:polymer/(b):(a) ratios and
range are set forth above. See supra Section II.E.1.a). Patent Owner
responds by arguing that dependent claims 5 and 12 recite a (b):(a) ratio
range of “about 1:3 to about 1:11.5,” that this recited range is directly
supported by Tables 1 and 5 of the ’571 application, and that the ’571
application discloses that (b):(a) ratios were an aspect of the inventive films.
PO Resp. 46–61.
(1) Buprenorphine:Polymer Ratio Range
Patent Owner cites to the Cremer Declaration to argue that “a POSA
would have understood that the 16/4, 12/3, and 8/2 formulations in Table 1
as well as Test Formulation 2 in Table 5 each contain (b):(a) ratios of 1:2.8,
and the 2/0.5 formulation contains a (b):(a) ratio of 1:10.9.” PO Resp. 46–
47 (citing Ex. 2008 ¶ 71). Patent Owner also cites to the testimony of
Dr. Das to argue that he conceded that the inventors created films with
(b):(a) ratios of 1:2.8 and 1:2.9.13 Id. at 47 (citing Ex. 1003 ¶¶ 74, 78;
Ex. 2009, 122:22–124:2).
Patent Owner further argues that a POSA would have understood the
cited test formulations having a (b):(a) ratio of 1:2.8 “pertain to the same

13 It appears that Patent Owner intended to write 1:10.9 rather than 1:2.9.
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invention with generally the same properties as the 2/0.5 formulation in
Table 1, which had a (b):(a) ratio of 1:10.9,” and that a POSA would have
understood that the inventors possessed not just those discreet ratios, “but
also the range of (b):(a) ratios of 1:2.8–1:10.9.” PO Resp. 48 (citing
Ex. 2008 ¶ 72). Patent Owner also argues that the disclosed (b):(a) ratio of
1:2.8 is a ratio of about 1:3, the disclosed (b):(a) ratio of 1:10.9 is a ratio of
about 1:11.5, and that “a POSA would have understood that films with a
(b):(a) ratio within the range of 1:2.8–1:10.9 and films with a (b):(a) ratio
within the range of 1:3–1:11.5 pertain to the same invention with generally
the same properties, operability, and ability to achieve any desired result.”
Id. (citing Ex. 2008 ¶ 73; Wertheim, 541 F.2d at 264).
Petitioners reply that there is no mention of the
buprenorphine:polymer ratio in the ’571 application, and no reason for a
POSA to calculate the (b):(a) ratio. Reply 15. Petitioners further argue that
there is no discussion in the ’571 application “of mucoadhesive, absorption,
dissolution, or pharmacokinetic properties based on the (b):(a) ratio that
would give a POSA a reason to calculate the ratios.” Id. (citing Ex. 1030,
148:13–22, 150:4–19).
Petitioners argue that “Patent Owner points only to values Dr. Cremer
calculated from Tables 1 and 5 as support for the claimed ratio range,” and
that Dr. Cremer’s two calculated (b):(a) ratios from Tables 1 and 5 (1:2.8
and 1:10.9) are not the endpoints of the claimed (b):(a) ratio range. Reply
15–16 (citing PO Resp. 46–48; Ex. 1030, 153:10–154:20, 156:8–157:1;
Ex. 2008 ¶ 71 n.8, 9). Petitioners contest Dr. Cremer’s “arbitrary and
unsupported” opinions “that a POSA would have understood that the
formulations with a (b):(a) ratio of 1:2.8 ‘pertain to the same invention with
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generally the same properties’ as the formulation with a (b):(a) ratio of
1:10.9.” Id. at 16 (citing PO Resp. 48). Petitioners specifically argue that
“Dr. Cremer cites no literature or other support for his assumptions
concerning the properties of films with the various ratios . . . [and] he did not
conduct any testing or experiments that could have shown the ratio had no
effect on the ultimate film within this range.” Id. at 16–17 (citing Ex. 2008
¶¶ 72, 73).
Petitioners next contest “Patent Owner’s argument that the calculated
(b):(a) ratio of 1:2.8 is ‘about’ the claimed 1.3 ratio and the calculated 1:10.9
is ‘about’ the claimed 1:11.5” as lacking any credible support from
Dr. Cremer. Reply 17 (citing PO Resp. 48). Petitioners argue that the ratio
1:11.5 has no logical connection to the ratio 1:10.9, and “Dr. Cremer did not
identify one,” despite Dr. Cremer’s assertions “that he ‘looked at 1:11.5’ and
determined it was the ‘same’ as 1:10.9.” Id. (citing Ex. 1030, 158:16–
160:10; Ex. 2001 ¶ 76; Ex. 2008 ¶ 73). According to Petitioners, “[u]nder
this theory, the inventors could have claimed any value between 1:10.9 and
1:11.5, evidencing the arbitrariness of the claimed ratio.” Id.
Petitioners further argue that Dr. Cremer “would not offer an opinion
as to whether a value of 1:10.9 would have also supported a claimed range
of up to 1:11, rather than 1:11.5.” Reply 17 (citing Ex. 1030, 159:14–
160:16). Petitioners assert that Dr. Cremer testified at his deposition that he
“ha[dn’t] really thought it through,” because the challenged claims do not
recite a ratio of 1:11, and thus “[i]t’s not a question that [he] analyzed.” Id.
(citing Ex. 1030, 155:9–156:5). According to Petitioners, “[t]his again
speaks to the fact that Dr. Cremer’s analysis here proceeded by first looking
at the claim limitation and then attempting to find support for it in the
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specification, contrary to the requirement that a POSA ‘immediately discern
the limitation at issue in the claims’ based on the disclosure in the
specification.” Id. at 17–18 (citing Purdue Pharma, 230 F.3d at 1323).
Patent Owner contests Petitioners’ argument that there is no reason for
a POSA to calculate the (b):(a) ratio (Reply 15) by citing to Dr. Cremer’s
explanation that “a POSA reading the ’571 Application ‘would have been
focused on the ratios between the necessary ingredients—the active
ingredients, buffer, and polymer—because such ratios are important to
constructing pharmaceutical films.’” Sur-reply 18–19 (citing Ex. 2008
¶¶ 74, 79; Ex. 2009, 106:20–107:6 (calculating (b):(a) ratio is within the
capability of POSA)). Patent Owner also restates its “same invention”
arguments and asserts that Petitioners “mistakenly criticize Dr. Cremer for
not citing testing or literature outside the ’571 Application . . . [because] the
written description requirement asks what the ’571 Application reasonably
conveys to a POSA, and it is undisputed that Dr. Cremer’s education and
experience qualify him to testify about that.” Id. at 22–23 (citing Reply 15–
17 (emphasis added by Patent Owner); Sur-reply 2–4 (discussing Dr.
Cremer’s education and experience (Ex. 2008 ¶¶ 4–7, 12, 22))). Patent
Owner also contests Petitioners’ argument that “1:11.5 has no logical
connection to 1:10.9” (Reply 17) by arguing that “[t]his argument is
inapposite: the issue is how a POSA would have understood ‘about 1:11.5,’
and Dr. Cremer’s unrebutted expert opinion is that a POSA would have
understood that ‘1:10.9 is . . . about 1:11.5.’” Id. at 23 (citing Ex. 2008 ¶ 73;
see also id at 23 n.10 (noting that “the written description requirement does
not require a ‘logical connection’ between the disclosure and claim
limitation.”).
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(2) Buprenorphine:Polymer Ratios
Patent Owner argues that “a POSA reading the ’571 Application
would have been attuned to the ratios between required ingredients,” and
advances several arguments in support of the contention that the ’571
Application “discloses that the buprenorphine:polymer ratio in particular
was an aspect of the inventive films.” PO Resp. 48–49.
(a) Buprenorphine and Polymer Components
Patent Owner argues that “[a] POSA would have understood from the
’571 Application that buprenorphine is an especially important ingredient in
the inventive films.” PO Resp. 49. Patent Owner supports that argument by
asserting that “a POSA would have understood that the buprenorphine is the
active that directly treats narcotic dependence, while the naloxone is used
only to prevent abuse of the buprenorphine,” and that “buprenorphine is the
largest active ingredient by mass” in each exemplary formulation in Table 1,
as well as Test Formulation 2 in Table 5. Id. at 49–50 (citing Ex. 1011,
1432 ¶ 21, 1448 ¶ 78, 1449–50, 1453; Ex. 2008 ¶ 75).
Patent Owner argues that “[a] POSA would have understood from the
’571 Application that the polymer is a critical component in the inventive
films.” PO Resp. 50. Patent Owner refers back to its discussion of polymer
importance in connection with polymer weight percentages (see supra
Section II.E.1.b)(4)(b)), and further argues that the polymer is the largest
inactive ingredient by mass in the subject film formulations, which a POSA
would have immediately discerned. Id. (citing Ex. 2008 ¶ 76). Patent
Owner quotes Dr. Cremer’s testimony that “a POSA reading the ’571
Application would immediately have discerned that the buprenorphine and
polymer are especially important components of the inventive films and are
the largest active ingredient by mass . . . [and] the largest inactive ingredient
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by mass.” Id. (quoting Ex. 2008 ¶ 77). Thus, according to Patent Owner
“[t]he buprenorphine:polymer ratio would . . . have been ‘especially salient
to a POSA, who would already have been paying attention to the ratios
between the required ingredients in the disclosed films.’” Id. at 50–51
(quoting Ex. 2008 ¶ 77).
Petitioners reply that “[t]he relative weights of the components alone,
however, cannot inform a POSA of the ‘importance’ of these components,
let alone the ‘importance’ of the ratio between these two components,”
citing to Dr. Cremer’s testimony that a component of a formulation may be
“important” regardless of its concentration. Reply 19 (citing Ex. 1030,
142:5–17 (“[i]t is not necessarily so that every [inactive] ingredient that is
present in small amounts is not important to take into consideration.”).
Patent Owner replies that Dr. Cremer did not rely on the relative
weights of buprenorphine and polymer alone, but “instead explained that the
buprenorphine and polymer are important based on both their weights and
their disclosed functions.” Sur-reply 19 (citing Ex. 2008 ¶¶ 74–76, 83–84;
Ex. 2009, 19:13–16, 39:15–18, 111:9–112:20; Ex. 1030, 138:7–139:11,
148:13–151:7).
(b) (b):(a) Ratio Consistent and Scaled Up from Unit
Formulas
Patent Owner argues that “[i]n light of her focus on the weight
percentages and ratio of the actives, polymer, and buffer, . . . ‘a POSA
would have immediately noticed the similarity between the
buprenorphine:polymer ratios of the disclosed formulations with varying
dosage strengths.” PO Resp. 51 (quoting Ex. 2008 ¶ 78; citing Ex. 1011,
1449–50, 1453). Patent Owner points to the example formulations (with
different dosage strengths) having a (b):(a) ratio of 1:2.8. Id. (citing Ex.
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2008 ¶ 78; Ex. 1011, 1449–50, 1453; Ex. 1003 ¶ 74). According to Patent
Owner, “[a] POSA would have been led to calculate the
buprenorphine:polymer ratios of the disclosed films because they are
important to constructing those films, and the POSA would have seen that
the (b):(a) ratios were in most cases kept consistent across the different
disclosed formulations,” and that “[t]his would have indicated to a POSA
that these (b):(a) ratios were chosen deliberately by the inventors, and thus
that the inventors possessed buprenorphine:polymer ratios and considered
them important in constructing the inventive films.” Id. (citing Ex. 2008
¶ 79).
Patent Owner also argues that “[t]he inventors actually prepared films
according to the formulations in Tables 1 and 5, which disclose the
ingredient weights on a ‘mg per film’ basis.” PO Resp. 52 (citing Ex. 1011,
1449 ¶ 81, 1453 ¶ 89; Ex. 2009, 94:23–95: 9). Patent Owner specifically
asserts that Table 10 of the ’571 application “discloses that the inventors
produced at least 14 films according to Test Formulation 2.” Id. (citing
Ex. 1011, 1456, Table 10 (n=14)). According to Patent Owner, “[a] POSA
would have understood that, ‘to scale up from the disclosed unit formulas to
multi-unit batches, the inventors would have kept the weight percentage of
each ingredient and the ratios between ingredients constant,’” and that
“Dr. Das admitted that a POSA would have expected the polymer weight
percentage of a film to remain constant when the formulation was scaled up
to create larger batches.” Id. at 52–53 (quoting Ex. 2008 ¶ 81; Ex. 2009,
43:25–44:16). Patent Owner thus contends that “the ’571 Application
reasonably conveys to a POSA that the inventors possessed polymer weight
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percentages and buprenorphine:polymer ratios.” Id. at 53 (citing Ex. 2008
¶ 81).
Petitioners reply that Patent Owner’s arguments that the calculated
ratio is largely consistent across the formulations in Tables 1 and 5, and that
the inventors scaled up from the unit formulations, “conflict[] with Patent
Owner’s opinion that ranges were disclosed by the values calculated from
Tables 1 and 5.” Reply 21 (citing PO Resp. 51–52). Petitioners argue that
this conflict is exemplified by Patent Owner’s argument that, on the one
hand, “to move from a dosage form with 8 mg buprenorphine to a dosage
form with 12 mg buprenorphine while maintaining the same properties, the
polymer amount would generally need to be adjusted proportionately to the
amount of buprenorphine, maintaining a constant buprenorphine:polymer
ratio,” while, on the other hand, “Patent Owner argues that a POSA would
understand that a film with any ratio within the claimed range would have
the same properties and operability.” Id. (citing PO Resp. 54, 48).
Petitioners further argue that “[b]ased on Patent Owner’s own logic, then, a
POSA who calculated the ratio values (notwithstanding that there is no
reason for doing so) would not understand a range to be disclosed but rather
a ‘consistent’ value that is ‘constant’ across scaled up and scaled down
formulations.” Reply 21–22.
Patent Owner replies by restating the generally “constant” (b):(a) ratio
and further arguing that “Dr. Cremer testified that a POSA would have
‘look[ed] at compositions in terms of the relative content of the ingredients
quantitatively in order to be able to understand the formulation and to be
able to scale it up or . . . down.’” Sur-reply 20–21 (citing Ex. 1030, 160:22–
161:17).
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(c) Importance of Buprenorphine:Polymer Ratio
Referring back to its prior arguments regarding the functions of the
polymer, Patent Owner asserts that the amount of polymer is important to
constructing the inventive films (see supra Section II.E.1.b)(4)(b)), and that
“[a] POSA would further have understood that the buprenorphine:polymer
ratio is important to the invention.” PO Resp. 53 (citing Ex. 2008 ¶ 82).
Patent Owner quotes Dr. Cremer as stating that a POSA would have
“understood that the amount of polymer would generally need to be selected
in light of the amount of buprenorphine so that the buprenorphine:polymer
ratio was within a range that enabled the polymer to achieve the desired
mucoadhesion level and dissolution and/or disintegration rates,” and have
further understood that, “for the polymer to function effectively as a carrier
and provide a self-supporting film, the amount of polymer would generally
need to be selected in light of the amount of buprenorphine as well as other
ingredients.” Id. at 53–54 (quoting Ex. 2008 ¶ 83). Patent Owner also
argues that “the (b):(a) ratio isolates the important relationship between the
buprenorphine and polymer, two critical ingredients in the disclosed films,”
and that a POSA “would therefore have understood that the (b):(a) ratio is
important to constructing the inventive films.” Id. at 54 (citing Ex. 2008
¶ 84).
Petitioners reply that the ’571 application would have directed a
POSA “away from concluding the buprenorphine:polymer ratio had any
significance to the inventors,” because Test Formulation 3 in Table 5 had the
same ratio (1:2.8) calculated for the 16/4, 12/3 and 8/2 formulations in Table
1 and Test Formulation 2 in Table 5, relied on by Patent Owner to support
the claimed 1:3 endpoint. Reply 19. However, as argued by Petitioners,
“Test Formulation 3 had negative results in terms of bioequivalency to the
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prior art tablet, the object of the invention claimed in the ’454 patent . . . and
was not considered an embodiment of the invention by the applicants.” Id.
(citing Ex. 1011, 1453–56; Pet. 29–30). According to Petitioners,
“[b]ecause the same buprenorphine:polymer ratio resulted in two
formulations, one that was operable and one that was not, a POSA would not
have understood the ratio to have any significance in the invention
(assuming a POSA would have calculated the ratio in the first place).” Id.
(citing Pet. 29–30). Patent Owner replies by generally repeating its
arguments regarding the importance of the (b):(a) ratio. Sur-reply 19.
(d) Patent Owner’s Challenge to Petitioners’
Arguments
(i) Purdue Pharma
Patent Owner asserts that the court in Purdue Pharma found that
“[a]lthough the examples provide the data from which one can piece
together the Cmax/C24 limitation, neither the text accompanying the examples,
nor the data, nor anything else in the specification in any way emphasizes
the Cmax/C24 ratio,” and “one of ordinary skill in the art would not be
directed to the Cmax/C24 ratio as an aspect of the invention.” PO Resp. 55
(quoting Purdue Pharma, 230 F.3d at 1326). Patent Owner further cites to
Purdue Pharma as stating that “there is nothing in the written description of
Examples 1 and 3 that would suggest to one skilled in the art that the
Cmax/C24 ratio is an important defining quality of the formulation, nor does
the disclosure even motivate one to calculate the ratio.” Id. (quoting Purdue
Pharma, 230 F.3d at 1327).
According to Patent Owner, “the support in the ’571 Application for
the claimed polymer weight percentages and (b):(a) ratios is far more
extensive than the support for the Cmax/C24 ratio in Purdue.” PO Resp. 55.
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Patent Owner argues that “[w]hereas the specification in Purdue did not
disclose Cmax or C24 values for any examples disclosed as embodiments of
the invention, much less that embodiments of the invention had a Cmax/C24
ratio greater than 2,” the specification of the ’571 application disclosed that
Test Formulation 2 (Table 5) had a polymer weight percentage of 48.2% and
a (b):(a) ratio of 1:2.8, which were both within the claims, and for the Table
1 formulations, the buprenorphine and polymer weights were disclosed, and
the polymer weight percentages and (b):(a) ratios were within the claims.
Id. at 55–56 (citing Ex. 1011, 1457 ¶ 101, 1432 ¶ 22). Patent Owner further
argues that “[t]he ’571 Application provides ‘blaze marks directing the
skilled artisan’ to polymer weight percentages and (b):(a) ratios,” which
were “important to the invention and [a POSA] would have been motivated
to calculate them.” Id. at 56–57 (quoting Purdue Pharma, 230 F.3d at
1326); see supra Sections II.E.1.b)(4) & c)(2)(a)–(c))
Petitioners’ arguments regarding Purdue are set forth above. See
supra Section II.E.1.a).
(ii) Recitation of a Claimed Ratio
Patent Owner argues that Petitioners incorrectly suggest that a
claimed ratio must be referenced explicitly in the disclosure to have
adequate written description support. PO Resp. 57 (citing Pet. 24–25).
Patent Owner argues that, to the contrary, “a claimed ratio may be supported
even if it is not explicitly recited in the specification.” Id. (citing Wertheim,
541 F.2d at 265).
Patent Owner cites to Ex Parte Lomaga, 2017 WL 657405 (PTAB
Feb. 10, 2017) (Decision on Appeal) to argue that “the Board found support
for a claimed ‘ratio of acetaminophen to ibuprophen [of] 0.8125:1 to 2.5:1’
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even though the specification did not disclose ratios of acetaminophen to
ibuprofen.” PO Resp. 57 (citing Lomaga, 2017 WL 657405, at *1–2).
According to Patent Owner, the Board found that a table in the specification
of exemplary pharmaceutical formulations listing amounts of ibuprofen,
acetaminophen, and pseudoephedrine, similar to Tables 1 and 5 of the ’571
application, “would convey to one skilled in the art that Appellant had the
claimed invention in his possession.” Id. at 57–58 (citing Lomaga, 2017
WL 657405, at *2). Patent Owner further asserts that “[t]he Board reasoned
that the claimed ratios were ‘derived from specific formulations recited in
the Specification,’ and ‘calculating the ratios is well within the capability of
one skilled in the art and need not be disclosed in the Specification.” Id. at
58 (citing Lomaga, 2017 WL 657405, at *2). Patent Owner also cites to Ex
Parte Siemens Engergy, Inc., 2010 WL 5137101, at *3, *5 (BPAI Dec. 15,
2010) (Decision on Appeal) for the proposition that the “claimed ‘ratio of
heated fuel to non-heated fuel’ in the mixed fuel stream was adequately
supported by the disclosure of controlling the temperature of the mixed fuel
stream by adjusting the amount of unheated fuel, even though [the] claimed
ratio was not explicitly disclosed.” Id. (citing Ex. 2003).
Patent Owner argues that “[j]ust as the acetaminophen and ibuprofen
were two of the principal ingredients of the formulations in Lomaga and the
heated and non-heated fuel were principal components of the mixed fuel in
Siemens, the buprenorphine and polymer are two of the principal and
necessary ingredients in the inventive films. PO Resp. 58. Patent Owner
further argues that “calculating the [buprenorphine:polymer] ratios is well
within the capability of one skilled in the art,” and “a POSA would have
understood from the ’571 Application that the inventors possessed
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buprenorphine:polymer ratios and considered them important in constructing
the inventive films.” Id. at 58–59 (citing Ex. 2008 ¶ 79; Ex. 2009, 106:20–
107:6; Lomaga, 2017 WL 657405, at *2).
Petitioners reply that Lomaga is distinguishable because “unlike here,
the claimed ranges were supported by the disclosure in the specification of
both the endpoints of the ranges as well as the points between those
endpoints.” Reply 20 (citing Lomaga, 2017 WL 657405, at *2). Petitioners
further reply that Siemens is also distinguishable because the Board “found
that ‘the description on which the Patent Owner relies’ provided adequate
support, ‘including the concept of adjusting the relative amounts of heated
and unheated fuels (i.e., ‘a desired ratios of heated fuel to non-heated fuel’
as recited in claim 1) to control the temperature of the mixed fuel.” Id.
(citing Siemens Energy, 2010 WL 5137101, at *3). According to
Petitioners, “[t]here is no similar disclosure concerning the relative amounts
of the buprenorphine and polymer here,” and in neither Lomaga nor Siemens
“did the Board rely on a finding that two ingredients were ‘principal and
necessary’ for support for a claimed ratio, as Patent Owner suggests.” Id.
(citing PO Resp. 58).
Patent Owner replies that Petitioners cannot distinguish Lomaga and
Siemens. Sur-reply 21–22. According to Patent Owner, Petitioners “ignore
Lomaga’s core holding: that the claimed ‘ratio of acetaminophen to
ibuprofen’ was adequately supported by disclosed formulations including
acetaminophen and ibuprofen . . . even though the claimed ratio itself was
not expressly disclosed.” Id. at 21 (citing Lomaga, 2017 WL 657405, at *1–
2; Ex. 2002, 21). Patent Owner asserts that “[s]imilarly here, although the
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(b):(a) ratio was not expressly disclosed, it is supported by, inter alia, the
exemplary formulations in Tables 1 and 5.” Id. (citing Ex. 2008 ¶¶ 71–73).
Patent Owner also asserts that Petitioners’ discussion of Siemens is
misleading. Sur-reply 21–22. According to Patent Owner, the specification
in Siemens did not expressly disclose “the relative amounts of heated and
unheated fuels” (Reply 20), “but rather disclosed altering the amount of
unheated fuel in the mixed fuel stream, which the Board found ‘more than
adequately supports . . . the concept of adjusting the relative amounts of
heated and unheated fuel (i.e., ‘a desired ratio of heated fuel to non-heated
fuel’ . . .).” Id. (citing Siemens Energy, 2010 WL 5137101, at *5). Patent
Owner asserts that “[s]imilarly here, the ’571 Application’s disclosure of, for
example, the importance of the buprenorphine and polymer, and the
functions of the polymer that are affected by its ratio to the buprenorphine,
would reasonably convey to a POSA that the inventors possessed the (b):(a)
ratio.” Id. at 22 (citing Ex. 2008 ¶¶ 82–84).
(iii) Express Disclosure of Other Ratios
Patent Owner challenges Petitioners argument that, because certain
ratios are expressly disclosed while the buprenorphine:polymer ratio is not,
“a POSA would not understand that the inventors were in possession of that
ratio.” PO Resp. 59 (citing Pet. 24–25; Ex. 1003 ¶ 70). Patent Owner
argues, however, that “the invention claimed does not have to be described
in ipsis verbis in order to satisfy the written description requirement of
[section] 112.” Id. (quoting Wertheim, 541 F.2d at 265). According to
Patent Owner, “[t]he lack of express disclosure of buprenorphine:polymer
ratios in the ’571 Application does not convey to a POSA that the inventors
did not consider such ratios an aspect of their invention,” but rather “a
POSA would have understood from the ’571 Application that the inventors
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possessed buprenorphine:polymer ratios and considered them important to
constructing the inventive films.” Id. (citing Ex. 2008 ¶ 86; see supra
Section II.E.1.c)(2); Nalpropion, 934 F.3d at 1349–51).
Petitioners repeat their argument that “where the inventors did
consider a ratio to be significant, they expressly discussed it in the
specification,” but “there is no indication in the ’571 application that the
inventors considered the claimed buprenorphine:polymer ratio to be part of
the allegedly inventive film, as there is indisputably no mention of it
anywhere.” Reply 20 (citing Pet. 25; Ex. 1003 ¶¶ 69, 70; Ex. 1030, 146:9–
151:7). Patent Owner replies that a POSA would not have concluded that
from the lack of an express “mention” of the (b):(a) ratio, that the inventors
did not consider such ratios an aspect of their inventive films. Sur-reply 20
(citing Ex. 2008 ¶ 86).
(iv) Petitioners’ Argument that the ’571
Application Discloses Unlimited Amount of
Buprenorphine and Polymer
Patent Owner challenges Petitioners’ argument that the ’571
Application discloses “[a]ny desired level of agonist,” such as
buprenorphine, and “any desired level of . . . polymer,” and that such
disclosures “teach away from the claimed (b):(a) ratios because a POSA
allegedly would not ‘understand the inventors to have been in possession of
limitations directed toward specific ratios of two ingredients that the
application taught could be present in ‘any’ amount.’” PO Resp. 60 (citing
Ex. 1011, 1445 ¶ 66, 1444 ¶ 65, 1447 ¶ 75; Pet. 25–26; Ex. 1003 ¶ 67).
According to Patent Owner, “Petitioners confuse amounts with ratio,” and
that “[e]ven if the amounts of the buprenorphine and polymer were truly
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unbounded, that would have nothing to do with the ratio between the
amounts of those ingredients.” Id. (citing Ex. 2008 ¶¶ 87–89).
Patent Owner argues that the ’571 Application discloses a closed
range of buprenorphine amounts because of the disclosure that the inventive
films would “desirably be bioequivalent to Suboxone tablets” containing
dosages of 2 mg to 16 mg buprenorphine, “the requirement that the films be
administered orally constrains the total film weight,” and the disclosure of
limited ranges of buprenorphine amounts (e.g. about 2 mg to about 16 mg).
Id. at 60–61 (citing Ex. 1011, 1432 ¶ 22, 1431 ¶ 18, 1445–47 ¶¶ 66, 72, 75,
1459 (claim 8), 1462 (claim 30); Ex. 2009, 101:14–102:6, 110:13–25).
Patent Owner also reasserts its argument that the ’571 Application discloses
“that the inventors possessed a closed range of polymer amounts,” and “a
lower bound based on the need for the film to be self-supporting and an
upper bound based on the need for the film to be administered orally and to
include ingredients other than the polymer.” Id. at 61; see supra Section
II.E.1.b)(2)(c) & b)(4).
d) Analysis of Written Description Requirement
We first determine whether the challenged claims have written
description support in the ’571 application. We set forth below our findings
that address the parties’ respective arguments.
“[T]he hallmark of written description is disclosure,” and “the test [for
satisfaction of the written description requirement] requires an objective
inquiry into the four corners of the specification from the perspective of a
person of ordinary skill in the art.” Ariad Pharms., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The written description
“must ‘clearly allow persons of ordinary skill in the art to recognize that [the
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inventor] invented what is claimed,’” and “reasonably” convey to those
skilled in the art “that the inventor had possession of the claimed subject
matter as of the filing date.”14 Id. (alteration in original, internal citations
omitted). Stated another way, “one skilled in the art, reading the original
disclosure, must immediately discern the limitation at issue in the claims.”
Purdue Pharma, 230 F.3d at 1323. “Whether a claim satisfies the written
description requirement is a question of fact.” Nalpropion, 934 F.3d at 1348
(citing Ariad, 598 F.3d at 1351).
(1) The ’571 Application
The ’571 application was filed on August 7, 2009, and its express
disclosure at that time included paragraph 65, Table 1, Table 5, and original
claim 5 as set forth above. Ex. 1011, 1415, 1444, 1449–50, 1453; Ex. 1003
¶ 55. The ’571 application published as Myers on February 10, 2011.
Ex. 1010, code (43); Ex. 1003 ¶ 55 n.5.
(2) Specific Polymer Weight Percentages
Table 1 of the ’571 application discloses the weight (mg per film
strip) of the components of various film compositions, including unit
formulas 16/4, 12/3, and 8/2 from which a polymer weight percentage of
48.2 wt % could be calculated by a POSA, and unit formula 2/0.5 from
which a polymer weight percentage of 58.6 wt % could be calculated by a
POSA. Pet. 26 n.8; Ex. 1003 ¶ 74; Ex. 2009, 93:19–23, 118:14–119:11.
Petitioners acknowledge that “[a]s a factual matter, Table 1 . . . discloses
polymer weight percentages of 48.2% and 58.6%.” Pet. 26 n.8. Table 5 also

14 The court in Ariad clarified that “possession as shown in the disclosure” is
a more complete formulation than simply “possession,” because the term
“possession” implied that production of written records outside of the patent
specification could show “possession.” Ariad, 598 F.3d at 1351.
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discloses Test Formulations 2 and 3 from which a polymer weight
percentage of 48.2 wt % could be calculated by a POSA, and Test
Formulation 1 from which a polymer weight percentage of 50.6 wt % could
be calculated by a POSA. Ex. 1003 ¶ 77; Ex. 2009, 119:12–120:3.
Accordingly, we find that the ’571 application provides written
description support for the limitation “wherein the film comprises about 48.2
wt % of the water soluble polymeric matrix,” as recited in dependent claim
8.
(3) Ranges of Polymer Weight Percentages
We find that paragraph 65 of the ’571 application, and original
claim 5, are the only discussion in the ’571 application of the amount of
polymer that should be in the film compositions, and only describe open-
ended ranges (e.g. at least 25% by weight of the composition) that, rather
than providing guidance to a POSA to specific bounded ranges, lead a POSA
away from concluding that the ’571 application discloses the claimed
polymer weight percentage ranges of “about 40 wt % to about 60 wt %” and
“about 48.2 wt % to about 58.6 wt %.” Ex. 1003 ¶¶ 60, 61; Ex. 1011, 1444;
see generally Ex. 1011, 1427–63. We further find that the ’571 application
does not suggest, or reasonably convey to a POSA, a “bottom end” of the
claimed ranges (40 wt % or 48.2 wt %) or a “top-end” of the claimed ranges
(60 wt % or 58.6 wt %). Ex. 1003 ¶ 61; see generally Ex. 1011, 1427–63.
We also find that the ’571 application does not reasonably convey to a
POSA any focus or emphasis on the amount of polymer in the film
composition, referring instead to “any desired level” of polymer such that a
self-supporting film composition is provided, and does not reasonably
convey to a POSA any indication that particular polymer weight
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percentages, let alone ranges thereof, impart any desirable properties in the
films, focusing instead on pH based on the amount of buffer in the film
composition. Ex. 1011, 1444 ¶ 65; Ex. 1003 ¶¶ 62, 63, 71, 72, 75, 76. We
find that Table 5 of the ’571 application also leads a POSA away from
specific polymer weight percentages and ranges thereof because Test
formulation 1 and Test formulation 3 had polymer weight percentages of
50.6% and 48.2%, respectively, that fell within the claimed ranges, but did
not produce films bioequivalent to Suboxone® tablets. Ex. 1003 ¶¶ 76–80;
Ex. 1011, 1453–57; see also supra Section II.E.1.a).
We address Patent Owner’s arguments below.
(a) Range Endpoints
Patent Owner argues that the ’571 application reasonably conveys to a
POSA possession of the claimed polymer weight percentage ranges because
both ranges are within the disclosed range of “at least 25%,” and that
(1) exemplary formulations in Tables 1 and 5 directly support each endpoint
of 48.2 wt % and 58.6 wt %, and (2) the range of “at least 25%”
encompasses the polymer weight percentage endpoints of 40% and 60%.
See supra Sections II.E.1.b)(2) and II.E.1.b)(3). However, there is no
mention of, and a POSA would not have immediately discerned, any
polymer weight percentage “endpoint” in the ’571 application, other than the
“lower” endpoint disclosures of “at least 25% by weight” or “at least 50% by
weight.” Ex. 1011, 1444 ¶ 65; Ex. 1003 ¶ 61. This is confirmed by the
testimony of Patent Owner’s expert: “in this paragraph [65] there’s no
express limitation here . . . [a POSA] would understand that there must be an
upper limit to that . . . in paragraph 65, there’s expressly no numeric number
[identified for that upper end point] . . . [original claim 5] does not expressly
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provide an upper limit, a numerical upper limit.” Ex. 1030, 52:1–54:15.
Moreover, the disclosure of at least 25% (or at least 50%) “does not by itself
provide written description support for a particular value within that range.”
See Gen. Hosp. Corp., 888 F.3d at 1372.
Accordingly, based on the foregoing, we find that the ’571 application
does not reasonably convey to a POSA or disclose any closed or bounded
ranges, and that the calculated polymer weight percentages of 48.2 wt % and
58.6 wt % are simply disclosures of discrete values associated with
particular “exemplary” formulations rather than range endpoints.
(b) Variation of Optional Ingredients
The ’571 application discloses that “[a] variety of optional
components and fillers may also be added to the films.” Ex. 1011, 1436–37
¶ 34; see also id. at ¶¶ 35–52; Pet. 24 n.7; Ex. 1003 ¶ 69. Patent Owner
argues that, for both claimed polymer weight percentage ranges, the ability
of a POSA to add or remove optional ingredients establishes the claimed
range, relying on Dr. Cremer’s calculations. See supra Sections
II.E.1b)(2)(b) and II.E.1b)(3)(a). However, the ’571 application does not
disclose or reasonably convey any direction or reason for a POSA to
perform the specific calculations undertaken by Dr. Cremer, and Dr. Cremer
conceded that one could obtain different weight percentage values
depending on the variation of optional ingredients and amounts chosen. See
Ex. 1030, 83:20–84:4 (“Q. You might end up with different numbers
depending on which variation you took, right? A. If you mean . . . that my
choices are just examples and there could be more, that’s correct. There
could be more examples.”); see generally Ex. 1011, 1427–63.
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Accordingly, we agree that the ’571 application discloses that the film
compositions may include optional ingredients, and further agree that a
POSA could obtain different values of polymer weight percentages
depending on the variation of optional ingredients and amounts chosen. Ex.
1030, 82:4–84:4, 117:3–6, 134:8–135:5. We also find that Dr. Cremer’s
calculated polymer weight percentages (Examples 1–5) only show that “any
desired level” of polymer weight percentage, sufficient to provide a self-
supporting film composition, may be used in the film compositions, but not
that the ’571 application discloses a particular polymer weight percentage or
a defined or bounded range of polymer weight percentages.
(c) Same Invention
Patent Owner also argues that a POSA would have understood that the
exemplary formulations in Table 1 and Test formulation 2 in Table 5, as
well as polymer weight percentage ranges of “25% to about 58.6%,” “about
48.2% to about 58.6%,” “41% to 61%,” and “40% to 60%” pertain to “the
same invention with generally the same properties, the same operability and
the same ability to achieve any desired result.” See supra Sections
II.E.1.b)(2)(a), (2)(c), & (3)(a). However, we find that the disclosure of the
’571 application would not lead a POSA to conclude that formulations
having polymer weight percentages within the asserted ranges pertain to the
same invention. That is because the ’571 application also discloses that Test
formulations 1 and 3 of Table 5 are not the “same” invention, yet their
polymer weight percentages are 50.6% and 48.2%, respectively, and fall
within both of the claimed polymer weight percentage ranges. Ex. 1003
¶¶ 76–80; Ex. 1011, 1453–57 (Test Formulations 1 (pH 6.5) and 3 (pH 5–
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5.5) “did not provide a bioequivalent” effect or result as the Suboxone®
tablet for both buprenorphine and naloxone).
Accordingly, we find that in the ’571 application, films having the
same polymer weight percentage, or polymer weight percentages within the
claimed ranges, are not necessarily the “same” invention.
(d) Range of 25% to about 58.6%
Patent Owner argues that the disclosure of a polymer weight
percentage range of “25% to about 58.6%” shows possession of polymer
weight percentage ranges of “about 48.2 wt % to about 58.6 wt %” and
“about 40 wt % to about 60 wt %.” See supra Sections II.E.1b)(2)(c) and
II.E.1b)(3)(b). According to Patent Owner, the ’571 application “discloses”
the range of “25% to about 58.6%” because it discloses the range of “at least
25%” and the specific weight percentage of 58.6%, and “a POSA would
have understood that the inventors possessed a polymer weight percentage
range of 25% to 58.6%.” PO Resp. 21 (citing Ex. 2008 ¶ 44).
Patent Owner’s reasoning regarding a polymer weight percentage
range of “25% to about 58.6%” seemingly ignores the absence of any
disclosure that the polymer weight percentage of 58.6% is an endpoint or
that any such bounded range was even contemplated by the inventors, let
alone disclosed. See Ex. 2008 ¶ 44; Ex. 1003 ¶¶ 59, 60; see generally
Ex. 1011, 1427–63. To the extent that Patent Owner’s argument that the
’571 application discloses a polymer weight percentage range of 25% to
58.6% relies on Patent Owner’s “range endpoints,” “optional ingredients,”
or “same invention” arguments, we find those arguments are unpersuasive
for the reasons discussed above.
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Accordingly, for the foregoing reasons, we find that the ’571
application does not disclose, or provide written description support for, a
polymer weight percentage range of “25% to about 58.6%,” or show
possession by the inventors of polymer weight percentage ranges of “about
48.2 wt % to about 58.6 wt %” or “about 40 wt % to about 60 wt %.”
(e) Weight Percentages as Aspect of Films
Patent Owner argues that claimed polymer weight percentage ranges
are an aspect of the inventive films. See supra Section II.E.1b)(4). We find,
as argued by Patent Owner and in considering the ’571 application as a
whole, that the ’571 application reasonably conveys to a POSA (1) the
specific polymer weight percentages of 48.2% and 58.6%; (2) that the
polymer weight percentage of 48.2% is constant across three formulations in
Table 1 and Test formulation 2 in Table 5; (3) that the presence of other
ingredients in the film compositions would result in a polymeric carrier
matrix weight percentage of less than 100%; and (4) that variations in the
amounts of ingredients (including optional ingredients) would also vary the
polymer weight percentage. See Pet. 26 n.8; Ex. 2008 ¶ 63; Ex. 1030, 82:4–
84:4, 117:3–6, 134:8–135:5. We also find that, because a polymeric carrier
matrix is required by the claims and that the level of polymer should be
sufficient to provide a self-supporting film composition, a POSA reading the
’571 application would have considered the amount of polymer chosen by
the POSA to be “important” to the film composition. Ex. 1011, 1444 ¶ 65,
1459 (claim 1).
Although we find that the polymer weight percentage of 48.2% is
constant across three formulations in Table 1 and Test formulation 2 in
Table 5, that fact is inconsistent with Patent Owner’s argument that ranges
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of polymer weight percentages are disclosed in the ’571 application. See id.
at 1449 (Table 1), 1453 (Table 5); Ex. 2008 ¶¶ 36, 46, 63; Ex. 1003 ¶¶ 74,
77.
(4) Buprenorphine:Polymer Ratios and Range
We find that the ’571 application does not refer to a (b):(a) ratio, or
any (b):(a) ratio ranges, or mention any reason for a POSA to calculate the
(b):(a) ratio, which stands in contrast to other ingredient ratios that were
expressed in the ’571 application in the form of a ratio (e.g. (d):(b) and
(b):(c)). Ex. 1003 ¶¶ 69, 70; Ex. 1011, 1445; see generally Ex. 1011, 1427–
63. We thus find that the inventors expressly disclosed those ratios that they
actually considered part of the claimed invention. See, e.g., 1011, 1459
(claim 6, ratio of buffer to buprenorphine). We further find that the ’571
application discloses that “[a]ny desired level of agonist” may be used for
the “(b)” component of the claimed ratios, and “any desired level” of
polymer may be used for the “(a)” component of the claimed ratios, thereby
evidencing that the disclosure of the ’571 application would not have
reasonably conveyed to a POSA any particular range of (b):(a) ratios. Ex.
1011, 1444–45 ¶¶ 65, 66. We also find that data in Table 5 of the ’571
application is further evidence that a POSA would not attribute any
significance to the (b):(a) ratio because Test formulation 2 and Test
formulation 3 had the same (b):(a) ratio of 1:2.8, but Test formulation 2 was
considered within the scope of the invention whereas Test formulation 3 was
not. Ex. 1011, 1453–57.
Patent Owner advances several arguments in support of its position
that the ’571 application provides written description support for the claimed
range of (b):(a) ratios (about 1:3 to about 1:11.5).
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(a) Specific (b):(a) Ratios
Tables 1 and 5 of the ’571 application disclose film formulations from
which a POSA could calculate the (b):(a) ratio. Ex. 1011, 1449–50 (Table
1), 1453 (Table 5); Ex. 1003 ¶¶ 74, 78. Patent Owner argues that the 16/4,
12/3, and 8/2 formulations in Table 1, and Test Formulation 2 in Table 5,
have a calculated (b):(a) ratio of 1:2.8, and that the 2/0.5 formulation in
Table 1 has a calculated (b):(a) ratio of 1:10.9. PO Resp. 46–47 (citing
Ex. 2008 ¶ 71). Petitioners do not dispute the calculation of those specific
(b):(a) ratios from those disclosed formulations. Ex. 1003 ¶¶ 74, 78;
Ex. 2009, 122:22–124:2. Accordingly, there is no dispute on this point, and
we find that there is written description support in the ’571 application for
the specific (b):(a) ratios of 1:2.8 and 1:10.9.
(b) Range of (b):(a) Ratios
Patent Owner argues that a POSA would have understood that the
inventors also possessed the (b):(a) ratio range of 1:2.8–1:10.9; that the
(b):(a) ratio of 1:2.8 is about 1:3; that the (b):(a) ratio of 1:10.9 is about
1:11.5; and that films with a (b):(a) ratio of 1:2.8–1:10.9 and a (b):(a) ratio
of 1:3–1:11.5 pertain to the “same invention with generally the same
properties, operability, and ability to achieve any desired result.” See supra
Section II.E.1.c)(1). Regarding the challenged connection between 1:10.9
and 1:11.5, Patent Owner argues that the proper issue is how a POSA would
have understood “about 1:11.5,” and that Dr. Cremer’s unrebutted expert
opinion is that a POSA would have understood that 1:10.9 is about 1:11.5.
Sur-reply 23 (citing Ex. 2008 ¶ 73).
We find that the contention that the inventors even contemplated that
the polymer portion ((a)) of the claimed (b):(a) ratio would be constrained
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by the amount of buprenorphine ((b)) is inconsistent with the express
disclosure of the ’571 application that “any desired level” of polymer may
be used, such that a self-supporting film composition is provided. Ex. 1011,
1444 ¶ 65; Ex. 1003 ¶ 67. We also find that the ’571 application would not
have led a POSA to conclude that polymers having a (b):(a) ratio within the
claimed range pertain to the “same” invention, because such a conclusion is
inconsistent with the express disclosure of the ’571 application that Test
formulation 3 of Table 5 had a (b):(a) ratio of 1:2.8, yet that formulation was
not the “same” invention as Test formulation 2 having a (b):(a) ratio of
1:2.8. Ex. 1003 ¶ 78; Ex. 1011, 1453–57.
(c) (b):(a) Ratio as Aspect of Inventive Films
Patent Owner also argues that the (b):(a) ratio is an aspect of the
inventive films because a POSA would have understood that buprenorphine
and polymer are important ingredients in the inventive films; that because
they are important to constructing pharmaceutical films, a POSA would have
been focused on ingredient ratios; that because of their importance, a POSA
would have been led to calculate their ratio and would have seen that in most
cases the ratio was kept consistent; and that to scale up from unit formulas to
multi-unit batches, the ratios between ingredients would have been kept
constant. See supra Section II.E.1.c)(2). Patent Owner also argues that,
merely because some ratios of ingredients were expressly disclosed in the
’571 application and the (b):(a) ratio was not, does not mean that inventors
did not consider the (b):(a) ratio an aspect of the invention because the
claimed invention does not have to be described in ipsis verbis. See supra
Section II.E.1.c)(2)(d)(iii). Patent Owner also responds to Petitioners’
argument regarding the disclosure of unlimited amounts of buprenorphine
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and polymer by arguing that Petitioners confuse amounts with ratio, and that
even if the amounts were unlimited, that would have nothing to do with the
ratio between those amounts. See supra Section II.E.1.c)(2)(d)(iv).
We find that the ’571 application does not disclose, or reasonably
convey to a POSA, that the buprenorphine to polymer ratio, or any range of
(b):(a) ratios, was an aspect of the invention disclosed in the ’571
application. Ex. 1011, 1459–62; Ex. 1003 ¶¶ 70, 76; see generally Ex. 1011,
1427–63. We further find that the disclosure of the ’571 application would
not indicate to a POSA that any such (b):(a) ratio or range of ratios was an
aspect of the invention because the calculated (b):(a) ratio of 1:2.8 was kept
consistent across most formulations, including formulations that were not
within the scope of the invention, and because the inventors clearly
identified ratios that were an aspect of the invention, including (d):(b) and
(b):(c). Ex. 1003 ¶¶ 70, 74, 76; Ex. 1011, 1445; Ex. 2008 ¶ 78. We further
find that the express disclosure in the ’571 application that “any” desired
level of (b) or (a) may be used in the film compositions indicates that no
particular (b):(a) ratio was contemplated by the inventors, and certainly no
range of ratios. Ex. 1011, 1444–45 ¶¶ 65, 66.
(5) Credibility of Arguments
We find that several of Patent Owner’s arguments lack credibility,
based on the testimony of Dr. Cremer. For example, although Patent Owner
argues that films having polymer weight percentage ranges of “25% to about
58.6%,” “about 48.2% to about 58.6%,” “41% to 61%,” and “40% to 60%”
all pertain to “the same invention,” Dr. Cremer testified that he did not
consider whether there would be any difference in operability or ability to
achieve a desired result between films with 40 wt % polymer and 48.2 wt %
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polymer. Ex. 1030, 106:20–107:5 (“Q. What about the difference between
40 percent and 48.2 percent? Would you expect any difference in operability
or ability to achieve a desired result between those—with that difference?”
[Object. Scope.] “A. I haven’t looked—I haven’t thought about that.” . . . “I
don’t think I’ve performed the analysis of 40 percent versus 48.2 percent.
So I would like to not say anything about that.”). In our view, it is not
credible to assert that films having polymer weight percentages within a
range pertain to the same invention, but then be unwilling to say whether
films having particular polymer weight percentages within that range also
pertain to the same invention.
Similarly, Dr. Cremer refused to offer an opinion on whether the
inventors could have claimed the range of about 45% to about 60% and still
have written description support, notwithstanding his opinions that the ’571
application “disclosed” a range of “about 40 wt % to about 60 wt %” and
that films within that polymer weight percentage range pertain to the same
invention. See Ex. 1030, 102:2–11 (“Q. So could have [the] inventors have
claimed the range of about 45 percent to about 60 and still had support, in
your opinion? [Objection form] A. [I]t’s a fictitious question . . . there’s no
[45% to 60%] range claimed in the ’454 patent, so I did not perform that
analysis. . . . I don’t think I want to offer an opinion on that.”). In our view,
it is not credible to allege that the ’571 application supports a particular
range of polymer weight percentages and that films having a polymer weight
percentage within that range pertain to the same invention, but then be
unwilling to say whether the ’571 application also supports a narrower range
within that range.
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Dr. Cremer’s also testified that a (b):(a) ratio of 1:10.9 is about 1:11.5,
but refused to testify whether a (b):(a) ratio of 1:10.9 would also be about
1:11. Ex. 1030, 155:9-156:5, 159:14–160:16. Given his opinion that 1:10.9
is “about” 1.11.5, that opinion would seem to necessarily justify the opinion
that a ratio of 1:11 (which is closer to 1:10.9 than 1.11.5) is also about
1:10.9. Dr. Cremer also testified, with respect to Patent Owner’s “optional
ingredients” argument, that “if an optional component is present in
reasonable amounts or varied in reasonable amounts . . . it will not
substantially affect the product characteristics.” Ex. 1030, 72:8–12;
Ex. 2008 ¶ 36 n.3 (Dr. Cremer testifying that his calculations varied optional
ingredients “by a reasonable degree . . . while staying within the invention”).
But when questioned about what he meant by “reasonable amounts,” Dr.
Cremer testified “I mean not unreasonable amounts . . . I think it’s not easy
to give a generally applicable definition. I have not worked on a definition
of what the scope of reasonable is. But I think that . . . it would be clear to
the POSA what the unreasonable or reasonable amount of . . . optional
ingredients is.” Ex. 1030, 72:14–73:7.
(6) Case Law Analysis of Claimed Ratio and Ranges
Patent Owner attempts to distinguish Purdue by arguing that “the
specification in Purdue did not disclose Cmax or C24 values for any examples
disclosed as embodiments of the invention, much less that embodiments of
the invention had a Cmax/C24 ratio greater than 2.” PO Resp. 55–56 (citing
Purdue Pharma, 230 F.3d at 1323, 1326–27). In contrast, according to
Patent Owner, the specification of the ’571 application disclosed that Test
Formulation 2 (Table 5) had a polymer weight percentage of 48.2% and a
(b):(a) ratio of 1:2.8, which were both within the claims, and, for the Table 1
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formulations, the buprenorphine and polymer weights were disclosed, and
the polymer weight percentages and (b):(a) ratios were within the claims.
Id. at 55–56 (citing Ex. 1011, 1457 ¶ 101, 1432 ¶ 22).
We are not persuaded by Patent Owner’s distinction of Purdue.
Patent Owner actually calculated the specific polymer weight percentages
and (b):(a) ratios from data in Tables 1 and 5, without any direction or
reason provided in the ’571 application to do so, thereby providing data that
Patent Owner “piec[ed] together” to arrive at the claimed ranges of polymer
weight percentages and ratios. Ex. 1003 ¶ 74, 75; Purdue Pharma, 230 F.3d
at 1326. Moreover, like Purdue, there is no mention or discussion in the
’571 application that emphasizes any (b):(a) ratio or range, or polymer
percentage ranges, or suggests to one skilled in the art that the specific
(b):(a) ratios or any of the claimed ranges are an important defining quality
of the formulation, nor does the ’571 application even motivate one to
calculate the specific (b):(a) ratios or claimed ranges. See Purdue Pharma,
230 F.3d at 1327.
Patent Owner argues that Nalpropion supports a finding of adequate
written description in the present case. See supra Section II.E.1.b)(2)(d).
We disagree. Nalpropion involved a claim (claim 11) to a method of
treating overweight or obesity that included administration of naltrexone and
bupropion in sustained-released formulations. Nalpropion, 934 F.3d at
1349. The claim also recited a dissolution profile wherein between 39% and
70% of naltrexone is released in one hour and between 62% and 90% of
naltrexone is released in two hours based on a dissolution test referred to as
USP Apparatus 2 Paddle Method (“USP 2”). Id. The Federal Circuit
affirmed the district court’s finding of adequate written description support
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based on Example 1 which released 39% of its naltrexone at one hour and
62% at two hours, and Example 3 which released 67% of its naltrexone in
one hour and 85% in two hours. Id. at 1349–50. Thus, both Example 1 and
Example 3 produced their own closed range of naltrexone dissolution
(between one and two hours), and the district court found that the bounded
range of Example 3 “fell squarely within the claimed range in claim 11.” Id.
at 1349 (citation omitted). Nalpropion is distinguishable because no such
closed or bounded range is disclosed in the ’571 application.
Patent Owner refers to the Federal Circuit’s statement in Nalpropion
that “[r]igidity should yield to flexible, sensible interpretation.” PO Resp.
22–23 (citing Nalpropion, 934 F.3d at 1351); Sur-reply 1. That statement
arises out of the “peculiarity of claim 11,” in which the dissolution profile
“relates only to the measurement of resultant in vitro parameters, not to the
operative steps to treat overweight or obesity.” Nalpropion, 934 F.3d at
1350. Moreover, claim 11 recited that the dissolution profile was measured
by “USP 2,” whereas the data listed in Examples 1 and 3 was arguably
obtained using “USP 1,” which the district court concluded was a
“substantially equivalent” dissolution profile method. Id. at 1350–51. The
Federal Circuit thus determined that “[w]hile as a general matter written
description may not be satisfied by so-called equivalent disclosure, in this
case, buttressed by the district court’s fact finding, and where the so-called
equivalence relates only to resultant dissolution parameters rather than
operative claim steps, we affirm the district court’s conclusion.” Id. at 1351
(emphasis added). It is in that context, and following that sentence, that the
court states “[r]igidity should yield to flexible, sensible interpretation.” Id.
Here, the limitations at issue are affirmatively recited in the body of the
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challenged claims as “operative” aspects of the film. Nalpropion is
distinguishable for this reason as well.
Wertheim and Molenda are similarly distinguishable because bounded
ranges were disclosed in both cases. Wertheim, 541 F.2d at 265; Molenda,
2017 WL 3620343, at *6–7. Lomaga and Siemens are nonbinding PTAB
decisions in an ex parte appeal or ex parte reexamination proceeding,
respectively. Lomaga, 2017 WL 657405; Siemens Engergy, 2010 WL
5137101. However, Lomaga is distinguishable because the claimed ratio
and weight percentage ranges were supported by the express disclosure of
multiple examples showing both endpoints and multiple values in between
those endpoints. Id. at 2017 WL 657405, at *2. As discussed above, the
’571 application does not disclose bounded ranges. Siemens is also
distinguishable because its express disclosure discussed mixing unheated
fuel with heated fuel in a manner that would decrease or increase the
temperature of the heated fuel. Siemens, 2010 WL 5137101, at *3. That
express disclosure was found to support a claim limitation to a mixed fuel
stream having a desired ratio of heated fuel to non-heated fuel. Id. at *2.
The ’571 application does not disclose the desirability of a particular (b):(a)
ratio, let alone a range of (b):(a) ratios as claimed. Rimfrost is also a
nonbinding PTAB decision denying institution of post grant review.
Rimfrost, 2018 WL 4183083. In Rimfrost, the claim limitation recited
“astaxanthin esters in amount of greater than about 100 mg/kg of said krill
oil.” Rimfrost, 2018 WL 4183083, at *2. Patent Owner stated in its
Preliminary Response that “the limitation at issue only sets forth the
minimum amount of astaxanthin esters” and the “upper boundary is not
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infinity.” Id. at *7. Here, we agree that the upper boundary of the “at least
25% by weight” embodiment is not infinity.
(7) Summary of Written Description Analysis
We find that all of the disputed ranges and ratios in claims 1–5, 7, and
9–14 place limits on the amount of polymer in the claimed films, but that no
such limits are disclosed in the ’571 application sufficient to provide written
description support for those limitations. Neither paragraph 65, nor Tables 1
or 5, discuss or refer to bounded or closed ranges of polymer weight
percentages. Ex. 1011, 1444 ¶ 65, 1449–50 (Table 1), 1453 (Table 5). As
we stated in our Institution Decision, although “we agree with Patent Owner
that the disclosures of ‘at least 25% by weight’ and ‘at least 50% by weight’
are necessarily limited to some end point, that end point is not disclosed in
the ’571 application.” Ins. Dec. 19. We also find that the express statement
in the ’571 application that “[t]he film may contain any desired level of self-
supporting film forming polymer” would lead a POSA away from a
particular bounded range of polymer levels. Ex. 1011, 1444 ¶ 65.
We also find that the ’571 application does not mention or describe
any (b):(a) ratio at all, although it does disclose formulations from which a
(b):(a) ratio could be calculated if a POSA had a reason or desire to do so.
Moreover, we further find that if a POSA actually calculated (b):(a) ratios
from the disclosed formulations, she would find that a successful formula
within the scope of the invention had the same (b):(a) ratio (1:2.8) as an
unsuccessful formulation outside the scope of the invention, thereby
evidencing the lack of any significance of the (b):(a) ratio. We further find
that the ’571 application provides no written description support for a range
of (b):(a) ratios.
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The testimony of Patent Owner’s expert, Dr. Cremer, reflects an
improper approach of simply working backward from the disputed claim
limitations to “find” some alleged written description support, but the proper
analysis is “from the standpoint of one with no foreknowledge of the [claim
limitation].” Ruschig, 379 F.2d at 995; see, e.g., Ex. 1030, 123:1–3
(unclaimed polymer weight percentages “not a question that had to be
evaluated”); 102:2–11 (refusal to offer opinion regarding support for the
polymer weight percentage range of about 45% to about 60% because that
range was not claimed in the ’454 patent); 155:9-156:5, 159:14–160:16
(testifying that 1:10.9 is about 1:11.5 but refusing to say whether 1:11 would
also be about 1:10.9); see also Sur-reply 23 (“the issue is how a POSA
would have understood ‘about 1:11.5’”); see id. at 18 (“Dr. Cremer
appropriately focused his analysis on the challenged claim limitations”).
“Working backward from a knowledge of [the claim limitation], that
is by hindsight” (Ruschig, 379 F.2d at 995), Dr. Cremer uses the challenged
claims and the ’571 application to opine on what the inventors envisioned, or
what would have been obvious from the ’571 application. But that approach
fails to establish written description support. See Lockwood v. Am. Airlines,
Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (“It is not sufficient for purposes
of the written description requirement of § 112 that the disclosure, when
combined with the knowledge in the art, would lead one to speculate as to
modifications that the inventor might have envisioned, but failed to
disclose.”); Research Corp. Techs., Inc. v. Microsoft Corp., 627 F.3d 859,
870 (Fed. Cir. 2010) (“Entitlement to a filing date extends only to subject
matter that is disclosed; not to that which is obvious.”).
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We acknowledge that “[i]t is not necessary that the exact terms of a
claim be used in haec verba in the specification, and equivalent language
may be sufficient.” Nalpropion, 934 F.3d at 1350. Indeed, polymer weight
percentages of 48.2 wt % and 58.6 wt %, as well as (b):(a) ratios of 1:2.8
and 1:10.9, have been found to be supported by formulations disclosed in the
’571 application, notwithstanding the absence of any express disclosure of
those values. Although “equivalent language may be sufficient,” the law of
written description is based on disclosure as of the filing date, and whether a
POSA would have “immediately discerned the limitation at issue” from such
disclosure. Id.; Purdue Pharma, 230 F.3d at 1323.
Accordingly, we find that a POSA, reading the ’571 application,
would not have immediately discerned the disputed limitations in claims 1,
5, 7, and 12. Thus, we also find that Petitioners have shown by a
preponderance of the evidence that the ’571 application fails to provide
written description support for the claim limitations “about 40 wt % to about
60 wt % of a water-soluble polymeric matrix” (claim 1), “about 48.2 wt % to
about 58.6 wt % of the water soluble polymeric matrix” (claims 7 and 12),
and “wherein the weight ratio of (b):(a) is from about 1:3 to about 1:11.5”
(claims 5 and 12).15 We also find that claims 2–5, 9–11, 13, and 14 also lack
written description support due to their dependency from claim 1. See

15 Patent Owner cites Dynamic Drinkware in its Sur-reply to argue that
Petitioners “have failed to meet their burden.” Sur-reply 4 (citing Dynamic
Drinkware, 800 F.3d at 1379–80). Patent Owner argues that, having filed its
Response and the Cremer Declaration, Petitioners failed to file a reply
declaration by Dr. Das. Id. at 3–4. But, as Dynamic Drinkware makes clear,
the burden of production is not the same as the burden of persuasion, and we
find that Petitioners have met their burden of persuasion as to claims 1–5, 7,
and 9–14. See Dynamic Drinkware, 800 F.3d at 1379–1380.
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Lockwood, 107 F.3d at 1572. However, we also find that Petitioners have
not shown by a preponderance of the evidence that the ’571 application fails
to provide written description support for the specific polymer weight
percentage (about 48.2 wt %) recited in claim 8.
2. Anticipation
Having found that claims 1–5, 7, and 9–14 do not have written
description support in the ’571 application, we find that those claims have an
effective filing date of no earlier than June 21, 2013, and turn to the issue of
whether Myers anticipates challenged claims 1–5, 7, and 9–14 under 35
U.S.C. § 102(a)(1).
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631
(Fed. Cir. 1987). “It is also an elementary principle of patent law that when,
as by a recitation of ranges or otherwise, a claim covers several
compositions, the claim is ‘anticipated’ if one of them is in the prior art.”
Titanium Metals Corp. v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985)
(citation omitted). Anticipation is a question of fact. Atlas Powder Co. v.
Ireco, Inc., 190 F.3d 1342, 1346 (Fed. Cir. 1999).
Petitioners identify disclosures in Myers that they argue disclose the
limitations of the challenged claims. Pet. 33–41. Other than its arguments
regarding written description support by the ’571 application, and
corresponding entitlement to a priority date of August 7, 2009, Patent Owner
does not contest Petitioners’ anticipation arguments. See generally PO
Resp.; Sur-reply; see also Tr. 44:8–13.
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a) Claim 1
Claim 1 is set forth above. See supra Section I.D. Petitioners identify
the disclosures in Myers corresponding to each limitation of claim 1. Pet.
33–36 (citing Ex. 1010, 9 (Table 1), ¶¶ 6, 12, 30, 31, 58, 64–67, 72, 85;
Ex. 1003 ¶¶ 82–88; see also Ex. 1001, 24:25–46). Regarding the limitation
of “about 40 wt % to about 60 wt % of a water-soluble polymeric matrix,”
Petitioners cite to film formulations disclosed in Myers that fall within this
range, including formulations in Table 1 that contain about 48.2% and about
58.6% polymer by weight. Id. at 33 (citing Ex. 1003 ¶ 82). We find that
Petitioners have shown by a preponderance of evidence that claim 1 is
anticipated by Myers.
b) Claims 2, 3, and 14
Claims 2, 3, and 14 depend from claim 1 and further narrow the
weight ratio of (d):(b) recited in claim limitation 1(g).16 Ex. 1001, 24:47–50,
25:13–14. Petitioners identify the disclosures in Myers corresponding to the
limitations of claims 2, 3, and 14, and further assert that claims 2, 3, and 14
are anticipated by Myers for the same reasons that Myers anticipates the
ratios of acidic buffer to buprenorphine recited in claim limitation 1(g). Pet.
36–37, 40–41 (citing Ex. 1010 ¶ 67; Ex. 1003 ¶¶ 90, 91, 102). We find that
Petitioners have shown by a preponderance of evidence that claims 2, 3, and
14 are anticipated by Myers.

16 The four wherein clauses in claim 1 are identified (in order) in the Petition
and herein as 1(e), 1(f), 1(g), and 1(h) for purposes of clarity. Claim
limitation 1(g) recites “wherein the weight ratio of (d):(b) is from 2:1 to
1:5.” Ex. 1001, 24:37.
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c) Claim 4
Claim 4 depends from claim 3 and recites “wherein the acidic buffer
is citric acid.” Ex. 1001, 24:51–52. Petitioners identify the disclosure in
Myers that “the buffer may include sodium citrate, citric acid, and
combinations thereof.” Pet. 37 (citing Ex. 1010 ¶ 67). We find that
Petitioners have shown by a preponderance of evidence that claim 4 is
anticipated by Myers.
d) Claim 5
Claim 5 recites “wherein the weight ratio of (b):(a) is from about 1:3
to about 1:11.5.” Ex. 1001, 24:53–54. Petitioners identify the 2/0.5 dosage
strength in Table 1 of Myers as having a (b):(a) ratio of 1:10.9, which is
included in the range recited in claim 5. Pet. 37–38 (citing Ex. 1003 ¶ 93).
We find that Petitioners have shown by a preponderance of evidence that
claim 5 is anticipated by Myers.
e) Claim 7
Claim 7 recites “wherein the film comprises about 48.2 wt % to about
58.6 wt % of the water soluble polymeric matrix.” Ex. 1001, 24:57–59.
Petitioners assert that “these values are anticipated by the polymer weight
percentages in the formulations in Table 1” of Myers. Pet. 38 (citing
Ex. 1003 ¶¶ 94, 95). We find that Petitioners have shown by a
preponderance of evidence that claim 7 is anticipated by Myers.
f) Claim 8
Claim 8 recites “[t]he film of claim 7, wherein the film comprises
about 48.2 wt % of the water soluble polymeric matrix.” Ex. 1001, 24:60–
61. Petitioners assert that this value is anticipated by the polymer weight
percentage in three formulations in Table 1 of Myers. Pet. 38 (citing
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Ex. 1003 ¶ 96). However, the 48.2 wt % limitation has written description
support in the ’571 application, and Petitioners have thus not established that
Myers is prior art to claim 8. See supra Section II.E.1.b)(1). We find that
Petitioners have not shown by a preponderance of evidence that claim 8 is
anticipated by Myers.
g) Claims 9, 10, and 11
Claim 9 recites “wherein the water-soluble polymeric matrix
comprises a polyethylene oxide polymer alone or in combination with a
hydrophilic cellulosic polymer,” claim 10 recites “[t]he film of claim 9,
wherein the hydrophilic cellulosic polymer is hydroxypropyl cellulose,
hydroxypropylmethyl cellulose, or a combination thereof,” and claim 11
recites “[t]he film of claim 10, wherein the hydrophilic cellulose polymer is
hydroxypropylmethyl cellulose.” Ex. 1001, 24:62–25:2. Meyers discloses
that “[i]n some embodiments, the water-soluble polymer may include
hydrophilic cellulosic polymers, such as hydroxypropyl cellulose and/or
hydroxypropylmethyl cellulose.” Pet. 38–39 (citing Ex. 1010 ¶ 32; Ex. 1003
¶¶ 97–99). We find that Petitioners have shown by a preponderance of
evidence that claims 9, 10, and 11 are anticipated by Myers.
h) Claim 12
Claim 12 recites “wherein the weight ratio of (d):(b) is from about 1:1
to 1:5; wherein the weight ratio of (b):(a) is from about 1:3 to about 1:11.5;
and wherein the film comprises about 48.2 wt % to about 58.6 wt % of the
water soluble polymeric matrix.” Ex. 1001, 25:3–7. Petitioners assert that
claim 12 contains the same limitations as claims 2, 5, and 7, and that claim
12 is anticipated for the same reasons as claims 2, 5, and 7. Pet. 40 (citing
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Ex. 1003 ¶ 100). We find that Petitioners have shown by a preponderance of
evidence that claim 12 is anticipated by Myers.
i) Claim 13
Claim 13 is set forth above. See supra Section I.D. Petitioners
identify disclosures in Myers describing the method of claim 13. Pet. 40
(citing Ex. 1010 ¶¶ 79, 80; Ex. 1003 ¶ 101). We find that Petitioners have
shown by a preponderance of evidence that claim 13 is anticipated by
Myers.
III. CONCLUSION17
For the foregoing reasons, we conclude that Petitioners have
established by a preponderance of evidence that claims 1–5, 7, and 9–14 of
the ’454 patent are unpatentable. We also conclude that Petitioners have
failed to establish by a preponderance of the evidence that claim 8 of the
’454 patent is unpatentable.
In summary:

17 Should Patent Owner wish to pursue amendment of the challenged claims
in a reissue or reexamination proceeding subsequent to the issuance of this
decision, we draw Patent Owner’s attention to the April 2019 Notice
Regarding Options for Amendments by Patent Owner Through Reissue or
Reexamination During a Pending AIA Trial Proceeding. See 84 Fed. Reg.
16,654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue application
or a request for reexamination of the challenged patent, we remind Patent
Owner of its continuing obligation to notify the Board of any such related
matters in updated mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2).
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Claims

35
U.S.C. §
Reference(s)/Basis Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
1–5, 7–
14
102(a)(1) Myers 1–5, 7, 9–14 8
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IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that Petitioners have proven by a preponderance of the
evidence that claims 1–5, 7, 9–14 of U.S. Patent No. 9,687,454 B2 are
unpatentable;
FURTHER ORDERED that Petitioners have failed prove by a
preponderance of the evidence that claim 8 of U.S. Patent No. 9,687,454 B2
is unpatentable; and
FURTHER ORDERED that, because this is a Final Written Decision,
parties to the proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

Overall
Outcome
1–5, 7, 9–14 8
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For PETITIONERS:

Ira J. Levy
Robert Frederickson
GOODWIN PROCTER LLP
ilevy@goodwinprocter.com
rfrederickson@goodwinlaw.com

For PATENT OWNER:

David A. Garr
Peter P. Chen
COVINGTON & BURLING LLP
dgarr@cov.com
pchen@cov.com