MW Encap Limited

Patent Trials and Appeals Board

May 14, 2021

2020001881 (P.T.A.B. May. 14, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/855,846 04/03/2013 Victor Morrison Young 9156-92618-01 4251
120501 7590 05/14/2021
Klarquist Sparkman, LLP (Capsugel)
121 SW Salmon Street, Suite 1600
Portland, OR 97204
EXAMINER
MATTISON, LORI K
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
05/14/2021 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docketing@klarquist.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD

Ex parte VICTOR MORRISON YOUNG

Appeal 2020-001881
Application 13/855,846
Technology Center 1600

Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 27–32, 34, 35, 37–41, 43, and 44.2 We
have jurisdiction under 35 U.S.C. § 6(b). We REVERSE.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies MW Encap Limited as the real party in
interest. Appeal Br. 3.
2 After filing its Appeal Brief, Appellant submitted an amendment canceling
claims 46–51. See Amdt. 3 (Amendment filed Dec. 2, 2019).
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CLAIMED SUBJECT MATTER
Appellant’s Specification discloses that “abuse of pharmaceutical
medicaments has now become a high profile topic. This abuse often takes
the form of extracting, injecting, chewing or snorting different prescription
drugs.” Spec. 1.
To prevent such abuse of prescription drugs, the Specification
discloses “an abuse resistant capsule comprising a hard shell filled with a
pharmaceutical medicament and at least one modifier selected to prevent
abuse of the pharmaceutical medicament.” Spec. 4–5.
The Specification discloses that “[t]he modifier may be a waxy
substance. Advantageously this prevent[s] abuse of the pharmaceutical
medicament as it will neither melt at injectable temperatures, dissolve
readily in water, or be crushable to a powder.” Spec. 5.
The Specification discloses that the medicament/modifier composition
is “liquid filled” into the hard capsule at a temperature of preferably above
50°C. Spec. 8. The Specification explains further:
Hard shell liquid fill has inherent advantages when choosing a
foundation from which to build in abuse resistance to a dosage
unit. The excipients that may be used to confer abuse resistance
may be used in other dosage forms (e.g. waxes in sustained
release tablets)[;] however, in hard shell liquid fill, they confer
abuse resistance because they can be used in concentrations
greatly exceeding that possible in other dosage unit forms
(greater than 10%).
Spec. 8–9; see also id. at 15 (disclosing an embodiment in which enteric-
coated particles containing a water soluble opioid drug “are suspended in
beeswax (50%), hydroxyl propyl methyl cellulose (18%) and fumed silica
(2%) then filled as a liquid suspension into hard shell capsules”).
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Application 13/855,846

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Appellant’s claim 27, the sole independent claim on appeal, is
representative and reads as follows:
27. An abuse resistant capsule comprising a
hard shell capsule having a fill composition therein, the
fill composition comprising
at least one pharmaceutical medicament,
at least one waxy substance having a melting point
greater than about 50 °C, present in an amount ranging
from about 10% to about 98.8% w/w, and
at least one water-soluble excipient, the at least
one water-soluble excipient capable of forming channels
through the waxy substance in the fill composition when
the fill composition is exposed to an aqueous solution;
and
wherein the fill composition forms a single, solid
or semi-solid matrix at room temperature within the hard
shell capsule and exhibits a melting point from about
35 °C to about 90 °C, and
wherein the pharmaceutical medicament is
incorporated in the fill composition as particles
suspended in the at least one waxy substance.
Appeal Br. 13 (indentation and paragraph spacing added; emphasis added to
show disputed limitation at issue).
REFERENCE(S)
The prior art relied upon by the Examiner is:
Name Reference Date
Benjamin Oshlack et al.
(“Oshlack”)
US 2003/0068371 A1 Apr. 10, 2003
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Application 13/855,846

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REJECTION(S)
In the Non-Final Action from which this appeal is taken,3 the
Examiner entered multiple rejections involving claims 46–51. See Non-
Final Act. 3–14 (mailed Nov. 2, 2018).
After filing its Appeal Brief, Appellant submitted an amendment
canceling claims 46–51. See Amdt. 3 (Amendment filed Dec. 2, 2019). The
Examiner entered the post-Appeal Brief amendment. See Advisory Act.
(item 3) (mailed Jan. 6, 2020).
Accordingly, the sole rejection before us for review is the Examiner’s
rejection of claims 27–32, 34, 35, 37–41, 43, and 44 under 35 U.S.C.
§ 103(a) as being unpatentable over Oshlack. See Advisory Act. (item 4).
DISCUSSION
The Examiner’s Prima Facie Case
As explained in the Advisory Action, the Examiner’s rationale for
rejecting Appellant’s claims over Oshlack appears at pages 4–9 of the
Examiner’s Answer mailed October 7, 2019. See Advisory Act. (item 4).
The Examiner cited Example 13 of Oshlack as describing a hard shell
capsule containing sustained release pellets composed of ingredients which
all have melting points above 50°C, as recited in Appellant’s claim 27. Ans.
4–6.
As to the channel-forming water-soluble excipient recited in
Appellant’s claim 27, the Examiner noted that, in addition to the ingredients
used in the pellets of Oshlack’s Example 13, Oshlack teaches that

3 See Notice of Appeal (entered Mar. 4, 2019; appealing from Non-Final
Action mailed Nov. 2, 2018).
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hydroxypropylmethylcellulose (HPMC) is a preferred polymer for use in
matrices for sustained drug release. Ans. 7 (citing Oshlack ¶ 124); see also
Spec. 13, 15 (disclosing inclusion of HPMC in wax filler to allow drug
release through channels formed in wax upon dissolution of HPMC in
aqueous media).
Based on Oshlack’s teachings, the Examiner concluded that it would
have been obvious “to complement OSHLACK’s Example 13 hydrocodone
capsule by adding a HPMC to the melt-extruded matrix of the hydrocodone
pellets.” Ans. 8.
The Examiner reasoned further:
With regard to the fill is a single solid or semi-solid
matrix (claim 27), the matrix of OSHLACK’s particles are
single and solid or semi-solid matrices. Nonetheless, changes
in size are obvious, especially when increased size results in a
slower sustained release since the pharmaceutical must migrate
through a larger volume (see MPEP 2144.054. IV).
Ans. 9.
Analysis
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
In the present case, Appellant argues that, rather than describing a
hard shell capsule having a fill composition in the form of a single solid or
semi-solid matrix as recited in independent claim 27, Oshlack, including in
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Example 13, only teaches or suggests including multiple pellets in its hard
shell capsule. Appeal Br. 8–11.
In response, the Examiner contends that “[t]he issue is not the word,
‘single’, but rather the transitional language of ‘having’ in claim[]27 . . .
which recite[s] a hard shell capsule having a fill composition.” Ans. 16.
The Examiner contends that because claim 27 initially uses the term
“having” in relation to the claimed capsule’s fill composition, claim 27
should be interpreted as encompassing multiple particles within the
capsule’s hard shell:
MPEP 2111.IV states “[t]ransitional phrases such as “having”
must be interpreted in light of the specification to determine
whether open or closed claim language is intended. See, e.g.,
Lampi Corp. v. American Power Products Inc., 228 F.3d 1365,
1376, 56 USPQ2d 1445, 1453 (Fed. Cir. 2000) (interpreting the
term “having” as open terminology, allowing the inclusion of
other components in addition to those recited). The term
“having” is not defined in specification or embodiments.
Further Examples 2 & 4 of the specification disclose the fill is
liquid while Example 3 discloses the composition comprises
particles and granules[;] thereby, the transitional phrase
“having” is interpreted as open claim language “comprising”.
This interpretation permits a multitude of particles.
Ans. 16–17.
The Examiner notes that during prosecution suggested claim language
was proposed to Appellant to remedy the alleged deficiency in claim 27:
This claim interpretation and the suggestion to restructure and
close the claim by using the term “consisting of” to reflect a
single/continuous fill claim was previously made on pg. 13 of
the office action mailed 11/02/2018. For example, “comprising
a hard shell capsule consisting of a single solid fill composition
consisting of . . .” (Office Action mailed 11/02/2018; pg. 13,
¶ 2).
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Ans. 17.
We find that Appellant has the better position. As Appellant
contends, and the Examiner concedes, Oshlack describes its hard capsules as
containing multiple pellets composed of sustained release materials. See
Oshlack ¶¶ 333–334 (“Fill size #2 clear gelatin capsules with the pellets.”
“The sequestered naltrexone formulation of Example 9 can be incorporated
in a capsule with the hydrocodone pellets. Preferably, the sequestered
naltrexone pellets are indistinguishable from the hydrocodone pellets.”)
(Example 13); see also id. ¶ 146 (describing inclusion of “melt-extruded
matrix multiparticulates within a capsule” (emphasis added)).
In contrast, Appellant’s claim 27 recites “[a]n abuse resistant capsule
comprising a hard shell capsule having a fill composition therein . . .
wherein the fill composition forms a single, solid or semi-solid matrix at
room temperature within the hard shell capsule.” Appeal Br. 13. Thus,
although claim 27 initially uses the term “having” in relation to the fill
composition within the claimed capsule, claim 27 nonetheless expressly
requires the fill composition to be in the form of “a single . . . matrix at room
temperature within the hard shell capsule.” Id. (emphasis added).
Because claim 27 expressly requires the fill composition to be in the
form of a single matrix, we agree with Appellant that claim 27 does not
encompass the capsules containing multiple particles or pellets described in
Oshlack. Moreover, as noted above, consistent with claim 27’s requirement
for the fill composition to be in the form of a single matrix, Appellant’s
Specification uniformly describes preparing the capsules of Appellant’s
invention by filling the hard capsules with the matrix material in liquid form
above the material’s melting temperature. See, e.g., Spec. 8–9, 14–15.
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We recognize that there is sometimes “a fine line between reading a
claim in light of the specification, and reading a limitation into the claim
from the specification.” Comark Commc’ns, Inc. v. Harris Corp., 156 F.3d
1182, 1186 (Fed. Cir. 1998) (citations omitted). As our reviewing court has
explained, however, the “correct inquiry in giving a claim term its broadest
reasonable interpretation in light of the specification is . . . an interpretation
that corresponds with what and how the inventor describes his invention in
the specification, i.e., an interpretation that is ‘consistent with the
specification.’” In re Smith Int’l, Inc., 871 F.3d 1375, 1382–83 (Fed. Cir.
2017) (quoting In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997)).
In the present case, given the express language in claim 27 requiring
the fill composition to be in the form of a single matrix, and further given
the Specification’s consistent description of preparing the capsules of
Appellant’s invention by filling the hard capsules with the matrix material in
liquid form above the material’s melting temperature, the Examiner does not
persuade us that claim 27 is properly interpreted as encompassing a capsule
filled with multiple particles or pellets, as taught in Oshlack. See In re Smith
Int’l, 871 F.3d at 1383 (“[A]doption of a broadest possible interpretation of a
claim term, irrespective of repeated and consistent descriptions in the
specification that indicate otherwise. . . is not properly giving the claim term
its broadest reasonable interpretation in light of the specification.”).
We acknowledge, as the Examiner contends, that the Specification
describes embodiments in which, within the matrix material, the
pharmaceutical medicament is in the form of particles. See Spec. 15.
However, rather than being in the form of multiple discrete particles like the
capsules of Oshlack, the drug particles described in Appellant’s
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Specification are suspended within the single waxy matrix that forms the fill
composition. See Spec. 15 (“The coated ‘particles’ (30%) are suspended in
beeswax (50%), hydroxyl propyl methyl cellulose (18%) and fumed silica
(2%) then filled as a liquid suspension into hard shell capsules.” (emphasis
added)). Indeed, Appellant’s claim 27 recites this precise embodiment. See
Appeal Br. 13 (reciting “wherein the pharmaceutical medicament is
incorporated in the fill composition as particles suspended in the at least one
waxy substance”).
In sum, for the reasons discussed, the Examiner does not persuade us
that claim 27 is properly interpreted as encompassing a capsule filled with
multiple particles or pellets, as taught in Oshlack. We are not persuaded,
moreover, that the Examiner has explained sufficiently why a skilled artisan
would have modified Oshlack’s capsules to contain a fill composition in the
form of a single matrix, instead of the multiple particles or pellets taught in
the reference. We therefore reverse the Examiner’s rejection of claim 27,
and its dependent claims, for obviousness over Oshlack.
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
27–32, 34,
35, 37–41,
43, 44
103(a) Oshlack 27–32, 34,
35, 37–41,
43, 44

REVERSED