SE Tylose USA, Inc. et al.

Patent Trials and Appeals Board

Jun 29, 2020

2019004353 (P.T.A.B. Jun. 29, 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.
15/132,627 04/19/2016 Anisul Quadir 073369.0003 6582
45309 7590 06/29/2020
Williams Mullen
8300 Greensboro Drive
Suite 1100
Tysons, VA 22102
EXAMINER
NGUYEN, COLETTE B
ART UNIT PAPER NUMBER
1732
NOTIFICATION DATE DELIVERY MODE
06/29/2020 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):
ip@williamsmullen.com
jassenza@williamsmullen.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ANISUL QUADIR and SAKAE OBARA
____________

Appeal 2019-004353
Application 15/132,627
Technology Center 1700
____________

Before JEFFREY T. SMITH, LILAN REN, and
MERRELL C. CASHION, JR., Administrative Patent Judges.

CASHION, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE

Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from a Final
Office Action, dated April 7, 2017, rejecting claims 8–11. We have
jurisdiction under 35 U.S.C. § 6.
We AFFIRM.

1We 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 SE Tylose USA, Inc.
and Shin-Etsu Chemical Co., Ltd. Appeal Br. 1.
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Application 15/132,627

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Claim 8 is illustrative of the subject matter on appeal and is
reproduced below:
8. An aqueous enteric coating composition
comprising:

a) 5 to 20 percent hydroxypropylmethylcellulose acetate
succinate;

b) 0.05 to 1.0 percent L-alginine, L-histidine, or L-lysine;

c) 0.5 to 10 percent plasticizer;

d) 0.1 to 10 percent anti-tacking agent;

e) 0.05 to 0.5 percent surfactant; and

f) 65 to 95 percent water.

Appellant requests review of the Examiner’s rejection of claims 8–11
under 35 U.S.C. § 103 as unpatentable over Hardee (US 2012/0322851 A1,
published December 20. 2012). Appeal Br. 2; Final Act. 2.
Appellant does not argue any claim separate from the other. See
generally Appeal Br. Accordingly, we select claim 8 as representative of the
subject matter on appeal and decide the appealed ground of rejection based
on the arguments Appellant makes in support of the patentability of claim 8.

OPINION
After review of the respective positions the Appellant and the
Examiner present, we AFFIRM the Examiner’s rejection of claims 8–11
under 35 U.S.C. § 103 for the reasons the Examiner provides in the Final
Action and the Answer. We add the following for emphasis.
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Claim 8 recites an aqueous enteric coating composition comprising
hydroxypropylmethylcellulose acetate succinate (HPMCAS).
The Examiner determines that Hardee teaches an aqueous enteric
coating composition satisfying all of the limitations of claim 8, including the
use of HPMCAS in the composition, and concludes Hardee would have
rendered the claim obvious. Final Act. 2–3.
Appellant argues that, even though Hardee teaches the use of
HPMCAS and the claimed amino acids, there is no reason to modify
Hardee’s composition by replacing or modifying hydroxypropylmethyl-
cellulose (HPMC) with HPMCAS, and then adding the claimed amino acid
to arrive at the claimed invention. Appeal Br. 4–6. According to Appellant,
there is no recognition that either HPMC or HPMC-AS contributes to anti-
agglomeration properties of the composition and, therefore, one skilled in
the art would not have an expectation of success in achieving the anti-
agglomeration properties of the claimed invention. Appeal Br. 5–6.
Appellant’s arguments are not persuasive of reversible error.
Appellant’s arguments do not dispute that Hardee discloses HPMCAS
and the claimed amino acids as components of the disclosed composition.
See generally Appeal Br. Instead, the premise of Appellant’s arguments is
that Hardee does not teach the specifically claimed composition. Id. at 5–6.
Such arguments are appropriate for addressing an anticipation rejection
under 35 U.S.C. § 102. But, this is not the rejection before us for review on
appeal. The rejection presented for review on appeal is under 35 U.S.C. §
103.
We note that the Examples in the Specification attribute the anti-
agglomeration/anti-coagulation properties to the addition of the claimed
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amino acids. Spec. ¶¶ 28–31 (discussing a comparison between a
conventional formulation having no amino acid with an inventive Example 1
having L-histidine). Given that Hardee discloses compositions that
encompass compositions comprising the claimed HPMCAS and amino
acids, Appellant fails to explain adequately why one skilled in the art would
not have been capable of arriving at the claimed invention from Hardee’s
teachings and reasonably expect Hardee’s composition to also possess anti-
agglomeration properties. In re O'Farrell, 853 F.2d 894, 904 (Fed. Cir.
1988) (“For obviousness under § 103, all that is required is a reasonable
expectation of success.”). Thus, Appellant does not explain adequately why
one skilled in the art, using no more than ordinary creativity, would not have
been able to arrive at the claimed invention from Hardee’s teachings. See
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“A person of
ordinary skill is also a person of ordinary creativity, not an automaton.”); see
also In re Sovish, 769 F.2d 738, 743 (Fed. Cir. 1985) (presuming skill on the
part of one of ordinary skill in the art).
Appellant contends that the Examples in the Specification shows
unexpected results for the claimed invention because they demonstrate that
the inventive Examples reduce agglomeration and act as a processing aid to
avoid nozzle clogging during a coating application when compared against a
composition having no amino acids. Appeal Br. 6.
When evidence of secondary considerations is submitted, we begin
anew and evaluate the rebuttal evidence along with the evidence upon which
the conclusion of obviousness was based. In re Rinehart, 531 F.2d 1048,
1052 (CCPA 1976). The burden of establishing unexpected results rests on
the Appellant. Appellant may meet this burden by establishing that the
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difference between the claimed invention and the closest prior art was an
unexpected difference. See In re Klosak, 455 F.2d 1077, 1080 (CCPA
1972). The unexpected results must be established by factual evidence;
attorney statements are insufficient to establish unexpected results. See In re
Geisler, 116 F.3d 1465, 1470–71 (Fed. Cir. 1997). Further, a showing of
unexpected results supported by factual evidence must be reasonably
commensurate in scope with the degree of protection sought by the claims
on appeal. In re Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983); In re
Clemens, 622 F.2d 1029, 1035 (CCPA 1980).
We have considered Appellant’s evidence of unexpected results and
find it insufficient to overcome a prima facie case of obviousness. First, it is
not clear that Appellant has compared the claimed invention against the
closest prior art (Hardee). Further, the evidence presented in the
Specification compares a limited number of inventive compositions having a
either 10% or 13% HPMCAS and either 0.03% or 0.33% amino acid.
Appellant does not explain why the limited number of inventive
compositions tested is representative of the broad scope of compositions
claimed.
Thus, on this record, Appellant has not explained adequately why the
evidence relied upon would have been unexpected by one of ordinary skill in
the art or is reasonably commensurate in the scope with the claims.
Accordingly, we affirm the Examiner’s prior art rejection of claims
8–11 under 35 U.S.C. § 103 for the reasons the Examiner presents and we
give above.

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CONCLUSION
In summary:

Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
8–11 103 Hardee 8–11

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED