BioDelivery Sciences International, Inc.v.MonoSol Rx, LLC

Patent Trial and Appeal Board

Nov 5, 2014

13853237 (P.T.A.B. Nov. 5, 2014)

Trials@uspto.gov Paper No. 7
Tel: 571.272.7822 Entered: November 5, 2014

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________

BIODELIVERY SCIENCES INTERNATIONAL, INC.,
Petitioner,

v.

MONOSOL RX, LLC,
Patent Owner.
_______________

Case IPR2014-00794
Patent 8,652,378 B1
_______________

Before JACQUELINE WRIGHT BONILLA, BRIAN P. MURPHY, and
ZHENYU YANG, Administrative Patent Judges.

YANG, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

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I. INTRODUCTION
BioDelivery Sciences International, Inc. (“Petitioner”) filed a Petition
to institute an inter partes review of claims 1–29 of U.S. Patent No.
8,652,378 B1 (“the ’378 patent”). Paper 2 (“Pet.”). MonoSol Rx, LLC
(“Patent Owner”) timely filed a Preliminary Response. Paper 6 (“Prelim.
Resp.”). We have jurisdiction under 35 U.S.C. § 314.
For the reasons provided below, we determine Petitioner has not
established a reasonable likelihood that it would prevail in showing the
unpatentability of at least one of the challenged claims. Because the Petition
fails to meet the threshold requirement set forth in 35 U.S.C. § 314(a), we
deny the Petition.
A. Related Matters
The ’378 patent is terminally disclaimed over U.S. Patent No.
7,897,080 (“the ’080 patent”), which is terminally disclaimed over U.S.
Patent Nos. 7,357,891 (“the ’891 patent”), 7,425,292 (“the ’292 patent”),
7,666,337 (“the ’337 patent”), and 8,685,437 (“the ’437 patent”). The ’437
patent is terminally disclaimed over, in addition to the ’891, ’292, and ’337
patents, U.S. Patent No. 7,824,588 (“the ’588 patent”). Pet. 1–3; Paper 5, 3.
Each of the ’891, ’292, ’337, ’080, and ’588 patents was reexamined
(control numbers 90/012,098, 90/012,097, 95/002,171, 95/002,170, and
95/001,753, respectively). Pet. 1–3; Paper 5, 3. The reexamination
certificates for the ’891 and ’292 patents have been issued, with all original
claims cancelled or amended. Pet. 2; Paper 5, 3. All claims of the ’588
patent were finally rejected and the Board affirmed the rejections. Ex. 1017.
All claims of the ’080 and ’337 patents were also finally rejected. Pet. 2–3.
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Patent Owner has appealed the rejections and the appeals are pending before
the Board.
B. The ’378 Patent
The ’378 patent discloses methods for making rapid dissolve thin film
drug delivery compositions for the oral administration of active components.
Ex. 1001, Abstract. The compositions may be formed by wet casting
methods, where the film is cast and controllably dried. Id. at Abstract, 6:53–
64. According to the Specification, the active components are provided as
particles uniformly distributed throughout the film composition. Id. at
Abstract.
C. Illustrative Claims
Claims 1 and 27 are independent claims. Claims 2–26 depend from
claim 1, and claims 28 and 29 depend from claim 27. Claim 1 reads:
1. A process for manufacturing a resulting pharmaceutical
film suitable for commercialization and regulatory approval
said resulting pharmaceutical film having a substantially
uniform distribution of a desired amount of a pharmaceutical
active in individual doses of the resulting pharmaceutical film,
comprising the steps of:
(a) forming a visco-elastic polymer matrix by mixing, said
matrix comprising a polymer selected from the group
consisting of water-soluble polymers, water-swellable
polymers and combinations thereof, a solvent selected
from the group consisting of water, a polar organic
solvent and combinations thereof, and pharmaceutical
active, which polymer matrix during film casting is a
shear-thinning pseudoplastic fluid when exposed to shear
rates of 10-105 sec-1, said polymer matrix having a
substantially uniform distribution of said pharmaceutical
active;
(b) casting said polymer matrix;
(c) conveying said polymer matrix through a drying
apparatus and drying said polymer matrix, to rapidly
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remove at least a portion of said solvent from said matrix
to form a visco-elastic film having said pharmaceutical
active substantially uniformly distributed throughout by
rapidly increasing the viscosity of said polymer matrix
upon initiation of drying within about the first 4 minutes
to maintain said uniform distribution of said
pharmaceutical active by locking-in or substantially
preventing migration of said pharmaceutical active,
wherein the temperature of the polymer matrix is 100° C.
or less, wherein content uniformity of said active in
substantially equal sized individual dosage units of said
visco-elastic film is such that the amount of the active
varies by no more than 10% from the desired amount;
and
(d) forming the resulting pharmaceutical film having a water
content of 10% or less and a thickness of about 0.1 mils
to about 10 mils from said visco-elastic film, wherein
said resulting pharmaceutical film having said
substantially uniform distribution of pharmaceutical
active by said locking-in or substantially preventing
migration of said pharmaceutical active is maintained,
such that content uniformity of said active in
substantially equal sized individual dosage units of said
resulting pharmaceutical film is such that the amount of
the active varies by no more than 10% from the desired
amount.
Claim 27 additionally requires, in step (c):
wherein any top air flow does not overcome the inherent
viscosity of the visco-elastic film and any top air flow is
insufficient to cause one or more of the following: (i) surface
skinning prior to drying the depth of the film; (ii) surface
rippling; (iii) self-aggregation of components; (iv) non-
uniformity in thickness of the film; and (v) non-uniformity of
mass per unit volume . . . .
Claim 27 further differs from claim 1 in that step (d) of claim 27 does
not recite the resulting pharmaceutical film “having a water content of 10%
or less and a thickness of about 0.1 mils to about 10 mils.”
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D. The Asserted Grounds of Unpatentability
Petitioner asserts that claims 1–13, 15, and 23–29 are unpatentable
under 35 U.S.C. § 102(b) over Chen.1 Petitioner also contends that
claims 1–29 are unpatentable under 35 U.S.C. § 103(a) over Chen alone,
over the combination of Chen and Staab,2 or over the combination of Chen
and Strobush.3

II. DISCUSSION
A. Claim Construction
In an inter partes review, the Board interprets a claim term in an
unexpired patent according to its broadest reasonable construction in light of
the specification of the patent in which it appears. 37 C.F.R. § 42.100(b).
Under that standard, we assign claim terms their ordinary and customary
meaning, as understood by a person of ordinary skill in the art, in the context
of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249,
1257 (Fed. Cir. 2007).
All claims either recite, or through their dependency require, the
limitation of “polymer matrix during film casting is a shear-thinning
pseudoplastic fluid when exposed to shear rates of 10-105 sec-1.” Patent
Owner asks us to construe this term. Prelim. Resp. 6–10. Although

1 Chen et al., Int’l Pub. No. WO 00/42992, published on July 27, 2000
(Ex. 1003) (“Chen”).
2 Staab, U.S. Patent No. 5,393,528, issued on Feb. 28, 1995 (Ex. 1004)
(“Staab”).
3 Strobush et al., U.S. Patent No. 5,881,476, issued on Mar. 16, 1999
(Ex. 1005) (“Strobush”).
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Petitioner does not propose any construction, the declarations of Drs. Cohen
and Reitman, Petitioner’s witnesses, provide some relevant discussion. See
Declaration by Edward D. Cohen, Ph.D. (Ex. 1007), ¶¶ 29, 30, 44;
Declaration by Maureen Reitman Sc.D. (Ex. 1006), Figure 1, Table 1.
According to Patent Owner, the plain and ordinary meaning of the
phrase “shear-thinning pseudoplastic fluid” is a “non-Newtonian fluid that
has a viscosity that decreases with an increasing shear rate.” Prelim.
Resp. 7. Dr. Cohen states that “[a]ll polymers are shear thinning, even when
they appear to be Newtonian in the usual viscometers.” Ex. 1007 ¶ 30.
Dr. Cohen, however, agrees that the shear-thinning or pseudoplastic
behavior “means that the viscosity decreases with increasing shear rate.” Id.
¶ 29. We are satisfied that the Specification of the ’378 patent supports
construing a “shear-thinning pseudoplastic fluid” as a “fluid having a
viscosity that decreases with an increasing shear rate.” See Ex. 1001, 24:54–
56. This determination as to the scope of this term is sufficient for purposes
of this Decision, and we need not address further whether such a fluid must
be non-Newtonian.
In step (a), independent claims 1 and 27 require the polymer matrix to
exhibit shear-thinning pseudoplastic behavior “when exposed to shear rates
of 10-105 sec-1.” Patent Owner emphasizes that the use of the plural term
“rates” dictates that the polymer matrix must be a shear-thinning
pseudoplastic fluid during film casting over multiple potential shear rates.
Prelim. Resp. 7. Patent Owner also contends that the claim language
mandates that “the polymer matrix must be a shear-thinning pseudoplastic
fluid when exposed to shear rates throughout the entire range of 10-105
sec-1,” and not just a portion of the range. Id. We agree.
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First, the claim language “shear rates,” in the plural form, limits the
polymer matrix, as recited in step (a) of claims 1 and 27, to one that must
exhibit the shear-thinning property when exposed to multiple shear rates.
Petitioner does not explicitly discuss the significance of the plural form of
the phrase “shear rates.” We observe, however, that in support of the
Petition, Dr. Reitman tested the viscosity of allegedly reproduced prior-art
polymer matrix at multiple shear rates. See Ex. 1006, Figure 1, Table 1.
Second, regarding the limitation “exposed to shear rates of 10-105
sec-1,” Petitioner does not address whether this language requires exposure
to the entire range. Instead, citing Dr. Cohen’s declaration, Petitioner asserts
that “the recited range of shear rates is so broad as to encompass any shear
rate that might be encountered in the coating field.” Pet. 20 (citing Ex. 1007
¶ 44). Assuming this statement is correct, the broad range of shear rates is
not, as Dr. Cohen declares, “meaningless.” See Ex. 1007 ¶ 44. To the
contrary, requiring the polymer matrix to exhibit shear-thinning
pseudoplasticity when exposed to the entire range of shear rates imposes a
stringent limitation. This conclusion is supported by the ’378 patent:
The rheology requirements for the inventive compositions and
films are quite severe. This is due to the need to produce a
stable suspension of particles, for example 30-60 wt %, in a
viscoelastic fluid matrix with acceptable viscosity values
throughout a broad shear rate range. During mixing,
pumping, and film casting, shear rates in the range of 10-105
sec.-1 may be experienced and pseudoplasticity is the preferred
embodiment.
Ex. 1001, 24:60–67 (emphases added). When read in view of the
Specification, the claims require that the polymer matrix during film casting
must be a shear-thinning pseudoplastic fluid when exposed to shear rates
throughout the entire range of 10–105 sec-1.
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The parties also dispute the construction of the following terms:
“substantially uniform distribution,” “film suitable for commercialization
and regulatory approval,” and “forming the resulting . . . film.” Pet. 9–17;
Prelim. Resp. 10–28. Because the construction of the shear-rates-related
term discussed above is dispositive, we decline to construe these three terms
for purposes of this Decision.
B. Patentability Analysis
1. Anticipation
Petitioner asserts that Chen anticipates claims 1–13, 15, and 23–29 of
the ’378 patent. Pet. 19–37. Specifically, Petitioner refers to Chen for
disclosing forming a polymer matrix by mixing a polymer, a solvent, and a
pharmaceutical active, as recited in step (a) of independent claims 1 and 27.
Id. at 19 (citing Ex. 1003, 15:19–26). Petitioner, however, does not point to
any disclosure in Chen for disclosing “polymer matrix during film casting is
a shear-thinning pseudoplastic fluid when exposed to shear rates of 10-105
sec-1,” also recited in step (a). Instead, Petitioner attempts to establish the
unpatentability of these claims through the inherency doctrine. In support,
Petitioner relies on the declaration of Dr. Reitman, who states that she
reproduced the pharmaceutical films according to Example 7 in Chen, and
then tested them. See Ex. 1006 ¶¶ 5–13. According to Petitioner,
“Dr. Reitman observed that a polymer matrix formed according to Chen’s
Example 7 was a shear-thinning pseudoplastic fluid when exposed to shear
rates of 10 to 103 sec-1.” Id. at 20–21 (citing Ex. 1006 ¶ 13).
Patent Owner counters that Petitioner fails to show inherent
anticipation by Chen. Prelim. Resp. 34–44. Among other challenges, Patent
Owner criticizes Dr. Reitman’s “re-creation” of Example 7 and questions the
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reasoning and methodology underlying Dr. Reitman’s testimony. Id. at 36–
44. We need not address the majority of these disputes because we
determine that the information presented in the Petition fails to establish a
reasonable likelihood that the polymer matrix formed according to Chen’s
Example 7 is a shear-thinning pseudoplastic fluid when exposed to shear
rates above 103 sec-1, specifically, in the range of 103–105 sec-1. See id. at
43.
As explained above in the claim construction section, the claim
language, read in view of the Specification, dictates that the polymer matrix
during film casting must be a shear-thinning pseudoplastic fluid throughout
the entire shear rate range of 10–105 sec-1. See supra Section II.A.
Dr. Reitman testifies that “[t]he viscosity as a function of shear rate was
recorded from 10 to 103 sec-1” (Ex. 1006 ¶ 12); and Petitioner accurately
presents the results that the polymer matrix formed according to Example 7
is “a shear-thinning pseudoplastic fluid when exposed to shear rates of 10 to
103 sec-1” (Pet. 20–21). Nowhere in the Petition, however, does Petitioner
address whether the same polymer matrix exhibits the shear-thinning
pseudoplastic property when exposed to shear rates above 103 sec-1 and up to
105 sec-1.
We observe that Dr. Cohen testifies that “[t]he person of ordinary skill
in the art would have expected that this behavior would to [sic] continue at
shear rates above 103 sec-1.” Ex. 1007 ¶ 75. Petitioner, however, does not
make this argument or refer to this statement in the Petition. As a result,
pursuant to our Rules, we decline to consider this information. See
37 C.F.R. § 42.22(a)(2); 37 C.F.R. § 42.6(a)(3). Further, even if we did
consider it, this statement would fail to support Petitioner’s inherent
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anticipation argument for two reasons. First, because Dr. Cohen does not
cite to credible evidence or provide persuasive explanation to support this
opinion, we would accord it little weight. See Ashland Oil, Inc. v. Delta
Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of
factual support for expert opinion going to factual determinations . . . may
render the testimony of little probative value in a validity determination.”).
Second, anticipation by inherency requires that “the missing descriptive
matter is necessarily present in the thing described in the reference.”
Continental Can Co. v. Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir.
1991). Dr. Cohen’s unexplained, conclusory testimony that a skilled artisan
“would have expected” a certain result constitutes probabilities or
possibilities, which is insufficient to establish inherency. See id. at 1269.
In sum, Petitioner has failed to establish a reasonable likelihood that
the polymer matrix formed according to Example 7 in Chen is a shear-
thinning pseudoplastic fluid “when exposed to shear rates of 10-105 sec-1.”
As a result, Petitioner has failed to establish a reasonable likelihood that
Chen anticipates claims 1–13, 15, and 23–29.
2. Obviousness
Petitioner contends that Chen, either alone or in combination with
Staab or Strobush, would have rendered claims 1–29 obvious. Pet. 37–54.
Petitioner does not rely on Staab or Strobush for teaching “polymer matrix
during film casting is a shear-thinning pseudoplastic fluid when exposed to
shear rates of 10-105 sec-1.” In fact, Petitioner does not further address this
limitation in its obviousness analysis. Thus, Petitioner relies on the same
inherency theory discussed above. “[T]he inherency doctrine may apply to
an otherwise obvious claim as well.” Allergan, Inc. v. Sandoz Inc., 726 F.3d
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1286, 1294 n.1 (Fed. Cir. 2013). Petitioner’s failure to account for the
shear-thinning pseudoplasticity of Chen’s polymer matrix when exposed to
shear rates of 103–105 sec-1, however, similarly dooms its patentability
challenge of claims 1–29 for obviousness.
III. CONCLUSION
For the reasons given above, the information presented in the Petition
fails to establish a reasonable likelihood that Petitioner would prevail in
showing the unpatentability of at least one challenged claim of the ’378
patent.

IV. ORDER
Accordingly, it is
ORDERED that the Petition is denied.

FOR PETITIONER:

Danielle Herritt
dherritt@mccarter.com

Kia Freeman
kfreeman@mccarter.com

FOR PATENT OWNER:

Harold Fox
hfox@steptoe.com

Stephanie Schonewald
sschonew@steptoe.com