PATHEON SOFTGELS INC.

Patent Trials and Appeals Board

Mar 2, 2020

14679233 - (D) (P.T.A.B. Mar. 2, 2020)

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.
14/679,233 04/06/2015 Saujanya Gosangari 15804-185 2471
149398 7590 03/02/2020
Michael Best & Friedrich LLP (Patheon)
100 East Wisconsin Avenue
Suite 3300
Milwaukee, WI 53202
EXAMINER
SOROUSH, LAYLA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
03/02/2020 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):
beth.obrien@thermofisher.com
mkeipdocket@michaelbest.com
pair_thermofisher@firsttofile.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte SAUJANYA GOSANGARI, GEORGE VAMVAKAS,
TATYANA DYAKONOV, and AQEEL FATMI
____________

Appeal 2019-006426
Application 14/679,233
Technology Center 1600
____________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
ELIZABETH A. LAVIER, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals2 from Examiner’s
decision to reject claims 1, 9, 11, 18, 23, 26, 27, 29, 30, 38, 42, 43, 49, 70,
and 72–75. 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. Appellant identifies the real party in interest as “Patheon
Softgels Inc.,” which “is wholly owned by Thermo Fisher Scientific Inc.”
(Appellant’s May 20, 2019 Appeal Brief (Appeal Br.) 3).
2 This Appeal is related to co-pending Appeal 2019-006408, Application
14/877,208 (see generally Appeal Br. 4).
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STATEMENT OF THE CASE
Appellant’s disclosure relates to “abuse deterrent controlled release
oral pharmaceutical compositions and methods for making the same. In
particular, an abuse deterrent controlled release oral pharmaceutical
composition comprising a soft capsule and an abuse deterrent controlled
release matrix comprising an active pharmaceutical ingredient are
described” (Spec. 1: 13–16). Appellant’s independent claims 1 and 49 are
reproduced below:
1. An abuse deterrent oral pharmaceutical composition
comprising a soft gelatin capsule shell encapsulating a tamper
resistant, homogenous viscous, yet flowable matrix consisting
essentially of
(a) about 50% to about 70% by mass olive oil, soybean oil, or a
combination thereof;
(b) about 1 % to about 10% by mass carnauba wax, bee's wax,
or a combination thereof;
(c) about 3% to about 10% by mass ethylcellulose;
(d) about 2% to about 15% by mass methylcellulose;
(e) about 4% to about 11 % by mass polyethylene glycol having
a molecular weight of about 200 to about 8000;
(f) about 1 % to about 35% by mass of one or more active
pharmaceutical ingredients that is dissolved in the flowable
matrix; and
(g) optionally one or more antioxidants.
(Appeal Br. 20.)
49. A tamper resistant oral pharmaceutical composition
comprising a soft gelatin capsule shell encapsulating a tamper
resistant, homogenous viscous, yet flowable matrix consisting
essentially of:
(a) about 50% to about 70% by mass soybean oil;
(b) about 1 % to about 7% by mass ethylcellulose;
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(c) about 1 % to about 7% by mass bee's wax;
(d) about 1 % to about 7% by mass carnauba wax;
(e) about 2% to about 15% by mass methylcellulose; and
(f) about 4% to about 11 % by mass of polyethylene glycol 400;
(g) about 10.5% by mass of hydrocodone or oxycodone; and
optionally
(h) about 0.25% by mass BHT; and
(i) about 0.1 % by mass BHA.
(Id. at 23–24.)

Grounds of rejection before this Panel for review:
Claims 1, 9, 11, 27, 29, 30, 42, 43, 70, and 72–75 stand rejected under
35 U.S.C. § 103(a) as unpatentable over the combination of Rariy3 and
Cohen.4
Claims 18, 23, 26, 38, and 49 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Rariy, Cohen, and Holm.5
Claims 1, 9, 11, 18, 23, 26, 27, 29, 30, 38, 42, 43, 49, 70, and 72–75
stand provisionally rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over the claims of
co-pending Application 14/877,208.

3 Rariy et al., US 2011/0142943 A1, published June 16, 2011.
4 Cohen et al., US 4,795,642, issued Jan. 3, 1989.
5 Holm et al., US 2007/0122482 A1, published May 31, 2007.
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Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Rariy relates to “pharmaceutical compositions, specifically
compositions that are designed to reduce the potential for improper
administration of drugs, such as those subject to abuse and methods of
making thereof” (Rariy ¶ 2; see Ans.6 4).
FF 2. Examiner finds that Rariy discloses that its pharmaceutical
compositions comprise “drug containing multiparticulates or drug particles
encapsulated into hard or soft shell capsules” (Ans. 4; see Rariy ¶¶ 16, 54–
60, 64, 71–81 and 93; see also Rariy 15: col. 1, ll. 5–11 and col. 2, ll. 1–3).
FF 3. Rariy discloses that its “drug containing multiparticulates . . . [may
be] blended with extragranular material and filled into hard shell capsules,”
wherein “the extragranular material is a natural or synthetic gel forming
excipient, added to form a gel or viscous environment around the particles
when exposed to an aqueous environment” (Rariy ¶ 94; see Ans. 5
(Examiner finds that “Rariy teaches examples of suitable ‘extragranular
material, is a natural or synthetic gel forming excipient, added to form a gel
or viscous environment around the particles when exposed to an aqueous
environment’,” which “reads on a homogenous viscous yet flowable
semisolid”)).

6 Examiner’s August 6, 2019 Answer.
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FF 4. Examiner finds that Rariy “fails to specify soybean oil, the amounts
of each agent, the pharmaceutical ingredient percent mass to the matrix
percent mass ratio, or the shell comprising gelatin, glycerol, and water”
(Ans. 5).
FF 5. Cohen discloses “[a] controlled-release pharmaceutical unit dosage
form . . . comprising a gelatin capsule enclosing a solid matrix formed by the
cation-assisted gelation of a liquid fill incorporating vegetable gum and a
pharmaceutically-active compound, as well as methods for the preparation
thereof” (Cohen, Abstract; see Ans. 5).
FF 6. Examiner finds that the combination of Rariy and Cohen fails “to
specify the [use of] ethyl cellulose having a viscosity of 3 cP to about 20 cP,
methylcellulose having a viscosity of about 500 to about 10,000, Ethocel 20
cP, or Methocel A4M” and relies on Holm to make up for this deficiency in
the combination of Rariy and Cohen (Ans. 6–7).
ANALYSIS
The rejection over the combination of Rariy and Cohen:
Based on the combination of Rariy and Cohen, Examiner concludes
that, at the time Appellant’s invention was made, it would have been prima
facie obvious
to use soybean oils, the amounts of the pharmaceutical
ingredient and matrix components in the ratios, and the shell
comprising gelatin, glycerol, and water. The motivation comes
from the teaching of Rariy . . . that the tamper-resistant
pharmaceutical composition having controlled release can
comprise a vegetable oil, carnauba wax, beeswax, gelatin, and
glycerol. Cohen . . . teaches fill components of a gelatin-
encapsulated controlled-release composition may comprise
vegetable oils such as soybean oil and controlled-release
composition are coated with a soft gelatin shell comprising
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gelatin, glycerin, and water. Therefore, the skilled artisan
would have had reasonable expectation of successfully
achieving similar efficacy and results with the soft shell
encapsulated controlled release formulation. Further, it would
have been obvious to one having ordinary skill in the art before
the effective filing date to modify the amounts and ratios, since
it has been held that where the general conditions of a claim are
disclosed in the prior art, discovering the optimum or workable
ranges involves only routine skill in the art.
(Ans. 5–6 (citing In re Aller, 220 F.2d 454, 456 (CCPA 1955).) We are not
persuaded.
As Appellant explains, “Examiner provides no reasonable rationale
that would suggest modifying the solid multiparticulates of Rariy into a
flowable abuse deterrent matrix that is encapsulated in a softgel with any
reasonable expectation of success” (Appeal Br. 13). Similarly, Appellant
explains that “Cohen’s gelled fill comprising gums (gelled by cations) is not
analogous to Appellants’ matrix composition because it is a gel (not a
flowable viscous liquid)” (id.). In this regard, Appellant explains that its
“claim terms ‘homogenous’ and ‘dissolved’ both indicate that the matrix fill
is uniform and the . . . [active pharmaceutical ingredient] is dissolved within
the matrix, i.e., that there are not particles. The presence of particles would
not be a homogenous compositions” (Reply Br.7 5). We agree.
“[E]xaminer bears the initial burden, on review of the prior art or on
any other ground, of presenting a prima facie case of unpatentability.” In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Obviousness requires more than a mere showing that the
prior art includes separate references covering each separate
limitation in a claim under examination. KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418, 127 S.Ct. 1727, 167 L.Ed.2d

7 Appellant’s August 29, 2019 Reply Brief.
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705 (2007). Rather, obviousness requires the additional
showing that a person of ordinary skill at the time of the
invention would have selected and combined those prior art
elements in the normal course of research and development to
yield the claimed invention. Id. at 421, 127 S.Ct. 1727.
Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir.
2011). Further, “rejections on obviousness grounds cannot be sustained by
mere conclusory statements; instead, there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
On this record, Examiner has, at best, established that pharmaceutical
compositions may be formulated using Appellant’s claimed ingredients (see
Ans. 4–5; see generally FF 1–5). Examiner, however, failed to establish an
evidentiary basis on this record to support a conclusion that the combination
of Rariy and Cohen would have directed a person of ordinary skill in this art
to a composition comprising a soft gelatin capsule shell encapsulating a
tamper resistant, homogenous viscous, yet flowable matrix, consisting
essentially of the ingredients required by Appellant’s claimed invention (see,
e.g., Appeal Br. 17 (“Examiner has not shown that Rariy and Cohen
specifically guide a person of ordinary skill to the general composition of the
flowable matrix composition specified by Appellant[]”)).
The “flowable” limitation, on this record, is particularly problematic.
Although Examiner states that this is “recognized in the pharmaceutical art”
(see Non-Final Act.8 3), Examiner has not established and evidentiary basis
on this record to support a conclusion that the prior art soft gelatin capsules
are actually “flowable”. Stated differently, Examiner failed to establish an

8 Examiner’s February 21, 2019 Non-Final Office Action.
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evidentiary basis on this record that rebuts Appellant’s contention that a gel
is “not a flowable viscous liquid” (Appeal Br. 13).
The rejection over the combination of Rariy, Cohen, and Holm:
Based on the combination of Rariy and Cohen, Examiner concludes
that, at the time Appellant’s invention was made, it would have been prima
facie obvious to formulate the pharmaceutical compositions of Rariy and
Cohen with “methylcellulose polymers such as Methocel A4M and
ethylcellulose such as Ethocel ® (ethylcellulose 20 cps),” because Holm
discloses that they “are useful as fillers, diluents and/or binders and
controlled release in modified release pharmaceutical composition[s]” (Ans.
7). We are not persuaded.
As Appellant explains, Holm fails to make up for the deficiency in the
combination of Rariy and Cohen discussed above (see Appeal Br. 18).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1, 9, 11, 27, 29, 30, 42, 43, 70, and 72–75
under 35 U.S.C. § 103(a) as unpatentable over the combination of Rariy and
Cohen is reversed.
The rejection of claims 18, 23, 26, 38, and 49 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Rariy, Cohen, and Holm is
reversed.

Appeal 2019-006426
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Obviousness-type Double Patenting:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness-type double patenting?
ANALYSIS
Examiner provisionally rejected claims 1, 9, 11, 18, 23, 26, 27, 29, 30,
38, 42, 43, 49, 70, and 72–75 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over the claims of
co-pending Application 14/877,208 (see Ans. 8–9). Office records,
however, establish that on July 26, 2018 the Office approved Appellant’s
this Terminal Disclaimer filed July 26, 2018 relating to Application
14/877,208 (see generally Appeal Br. 6). Thus, this provisional
obviousness-type double patenting rejection is moot.
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness-type double patenting. The provisional
rejection of claims 1, 9, 11, 18, 23, 26, 27, 29, 30, 38, 42, 43, 49, 70, and
72–75 under the judicially created doctrine of obviousness-type double
patenting as being unpatentable over the claims of co-pending Application
14/877,208 is reversed.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 9, 11, 27,
29, 30, 42,
43, 70, 72–75
103 Rariy, Cohen 1, 9, 11,
27, 29, 30,
42, 43, 70,
72–75
18, 23, 26,
38, 49
103 Rariy, Cohen,
Holm
18, 23, 26,
38, 49
1, 9, 11, 18,
23, 26, 27,
29, 30, 38,
42, 43, 49,
70, 72–75
Provisional
Obviousness-type
Double Patenting
14/877208
1, 9, 11,
18, 23, 26,
27, 29, 30,
38, 42, 43,
49, 70, 72–
75
Overall
Outcome
1, 9, 11,
18, 23, 26,
27, 29, 30,
38, 42, 43,
49, 70, 72–
75

REVERSED