Ex Parte Hassan et al

Patent Trial and Appeal Board

Oct 5, 2012

10529984 (P.T.A.B. Oct. 5, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte EMADELDIN M. HASSAN, AQEEL A. FATMI,
and NACHIAPPAN CHIDAMBARAM
__________

Appeal 2011-013217
Application 10/529,984
Technology Center 1600
__________

Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to an enteric soft capsule shell. The Patent Examiner
rejected the claims for obviousness. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.
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STATEMENT OF THE CASE
Claims 20 and 24-40 are on appeal. Claim 20 is representative and
reads as follows (emphasis added):
20. An enteric soft capsule shell formed from a gel mass composition
comprising:
(a) a film-forming, water-soluble polymer,
(b) an acid-insoluble polymer; and
(c) an alkaline aqueous solvent;
wherein the ratio of acid-insoluble polymer to film-forming, water-soluble
polymer is from 30:70 to 45:55 by weight;
the final pH of the gel mass is less than or equal to about 9 pH units; and
the moisture content of the enteric soft capsule shell formed from the
gel mass composition is from about 2% to about 10%.

The Examiner rejected the claims as follows:
 claims 20, 24, 25, and 27-40 under 35 U.S.C. § 103(a) as unpatentable
over Venkateswara,1 Ullah ‘316,2 and Matthews;3
 claim 26 under 35 U.S.C. § 103(a) as unpatentable over
Venkateswara, Ullah ‘316, Matthews, and Shank;4
 claims 20, 24, 25, and 27-40 under 35 U.S.C. § 103(a) as unpatentable
over Venkateswara, Ullah ‘188,5 and Matthews;
 claim 26 under 35 U.S.C. § 103(a) as unpatentable over
Venkateswara, Ullah ‘188, Matthews, and Shank;
 claims 20, 24, 25, and 27-40 under 35 U.S.C. § 103(a) as unpatentable
over Okajima,6 Ullah ‘188, and Matthews;

1 Pavuluri Venkateswara Rao et al., WO 01/24780 A2, published April 12,
2001.
2 Ismat Ullah et al., US 6,331,316 B1, issued Dec. 18, 2001.
3 James W. Matthews et al., US 4,816,259, issued March 28, 1989.
4 Joseph L. Shank, US 4,500,453, issued Feb. 19, 1985.
5 Ismat Ullah et al., US 2001/0051188 A1, published Dec. 13, 2001.
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 claim 26 under 35 U.S.C. § 103(a) as unpatentable over Okajima,
Ullah ‘188, Matthews, and Shank;
 claims 20, 24, 25, and 27-40 under 35 U.S.C. § 103(a) as unpatentable
over Okajima, Ullah ‘316, and Matthews; and
 claim 26 under 35 U.S.C. § 103(a) as unpatentable over Okajima,
Ullah ‘316, Matthews, and Shank.

I. Rejections based on Venkateswara
Appellants contend that Venkateswara “does not disclose the claimed
ratio of acid-insoluble polymer to film-forming, water-soluble polymer.”
(App. Br. 5.) Claim 20 recites that the capsule shell is formed from a gel
mass composition “wherein the ratio of acid-insoluble polymer to film-
forming, water-soluble polymer [in the gel mass composition] is from 30:70
to 45:55 by weight.”
The Examiner found that Venkateswara disclosed the ratio:
Venkateswara et al. discloses an enteric soft capsule shell
formed from a gel mass composition comprising a film-forming,
water-soluble polymer, including gelatin, an acid-insoluble polymer,
including hydroxypropyl methylcellulose phthalate, and an alkaline
aqueous solvent (ammonia solution) (pg. 5, lines 21-40; Examples).
Venkateswara et al. discloses the acid-insoluble polymer can be 40%
by weight of the dried shell (pg. 5, lines 25-27). Given this disclosed
weight percent of acid-insoluble polymer therefore, it can be
concluded that the remaining polymer is present at ratio of 30:70
(42%).

6 Yakutaro Okajima, US 4,138,013, issued Feb. 6, 1979.
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(Ans. 6.) The rejection does not explain how it can be concluded that 40%
insoluble polymer by weight of dried shell means a 30:70 ratio of insoluble
to soluble polymer.
After reviewing the evidence and considering the arguments, we agree
with Appellants that Venkateswara did not disclose a composition having
the recited ratio. As the rejections did not resolve this difference between
the claimed composition and Venkateswara’s composition, they must be
reversed.

II. Rejections based on Okajima
The Issue
The Examiner found:
Okijama et al. teaches a gel mass composition comprising a
film-forming, water-soluble polymer (gelatin or hydroxypropyl
methylcellulose), an acid-insoluble polymer (cellulose acetate
phthalate or hydroxypropyl methylcellulose phthalate), an alkaline
aqueous solvent (dilute aqueous solution of ammonium hydroxide),
and optionally a plasticizer (PEG), and optionally, a coloring agent
(col. 3, lines 54-64; col.4, lines 31-38). Okajima et al. illustrates in
Example 2 the ratio of acid-insoluble polymer to film-forming
polymer being 50:50.

(Ans. 10-11.) Regarding the ratio of insoluble to soluble polymer, the
Examiner explained:
With respect to claims, 20, 39 and 40, the percentage of specific
components present in the composition is clearly a result effective
parameter that a person of ordinary skill in the art would routinely
optimize. Optimization of parameters is a routine practice that would
be obvious for a person of ordinary skill to determine the optimal
amount of each ingredient needed to achieve the desired results. Thus,
absent some demonstration of unexpected results f[ro]m the claimed
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parameters, the optimization of ingredient amounts would have been
obvious at the time of applicant's invention.

(Id. at 11-12.)
Appellants contend that Okajima does not teach the claimed ratio of
acid-insoluble to film-forming polymer, nor can the claimed ratio be inferred
or implied from Okajima. (App. Br. 17.) Appellants conclude:
Accordingly, Okajima fails to teach or suggest the composition in
claim 20 and neither secondary reference, Matthews or the Ullah
publication, independently or in combination, cures the deficiencies of
Okajima.

(Id. at 18.)

Principles of Law
“[W]here the general conditions of a claim are disclosed in the prior
art, it is not inventive to discover the optimum or workable ranges by routine
experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235
(CCPA 1955). “[T]he discovery of an optimum value of a variable in a
known process is usually obvious.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d
1348, 1368 (Fed. Cir. 2007). The rationale for determining the optimal
parameters for prior art result effective variables “flows from the ‘normal
desire of scientists or artisans to improve upon what is already generally
known.’” Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir.
2003)).
“Only if the results of optimizing a variable are unexpectedly good
can a patent be obtained for the claimed critical range.” In re Geisler,
116 F.3d 1465, 1470 (Fed. Cir. 1997) (quotations omitted).

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Analysis
Okajima disclosed an enteric soft capsule shell formed from a gel
mass composition comprising an acid-insoluble polymer and a film-forming,
water-soluble polymer. The Examiner directed attention to Okajima’s
disclosure at column 3, which reads in part:
In manufacturing enteric capsules in a series of steps according
to the invention, CAP, HPMCP or MA acid/ester copolymer is first
dissolved in a dilute aqueous solution of ammonium hydroxide.
Sufficient ammonium hydroxide is used to effect complete solution;
any excess is removed subsequently as described below. Gelatin or
HPMC is then added to the resulting aqueous solution of the
ammonium salt (of CAP, HPMCP or MA acid/ester copolymer) and is
dissolved in any suitable way, optionally with heating, for a time
sufficient to allow complete solution.

(Okajima, col. 3, ll. 54-64.) Giving weight to both Okajima’s general
instructions, and working Example 2 disclosing a 50:50 polymer ratio, we
agree with the Examiner that optimizing the ratio would have been routine
and obvious. The Examiner’s analysis is consistent with precedent. E.g.,
Aller, Pfizer, Peterson, cited above.
Appellants point to the fact that Okajima did not disclose or imply the
claimed ratio, and argue that the claimed ratio cannot be inferred from
Okajima. That may be so, but obviousness must also take into account the
level of skill in the art, which included the ability to apply Okajima’s general
instructions and adjust the relative amounts of ingredients. We agree with
the Examiner that adjusting the amounts of the polymers would have been
routine and that the compositions having polymer ratios in the claimed range
would have been prima facie obvious. See Geisler, 116 F.3d at 1470.
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Appellants apply the same argument to all the rejections over Okajima, but
as we find it unpersuasive, we affirm them.

SUMMARY
We reverse the rejection of claims 20, 24, 25, and 27-40 under
35 U.S.C. § 103(a) as unpatentable over Venkateswara, Ullah ‘316, and
Matthews.
We reverse the rejection of claim 26 under 35 U.S.C. § 103(a) as
unpatentable over Venkateswara, Ullah ‘316, Matthews, and Shank.
We reverse the rejection of claims 20, 24, 25, and 27-40 under
35 U.S.C. § 103(a) as unpatentable over Venkateswara, Ullah ‘188, and
Matthews.
We reverse the rejection of claim 26 under 35 U.S.C. § 103(a) as
unpatentable over Venkateswara, Ullah ‘188, Matthews, and Shank.
We affirm the rejection of claims 20, 24, 25, and 27-40 under
35 U.S.C. § 103(a) as unpatentable over Okajima, Ullah ‘188, and
Matthews.
We affirm the rejection of claim 26 under 35 U.S.C. § 103(a) as
unpatentable over Okajima, Ullah ‘188, Matthews, and Shank.
We affirm the rejection of claims 20, 24, 25, and 27-40 under 35
U.S.C. § 103(a) as unpatentable over Okajima, Ullah ‘316, and Matthews.
We affirm the rejection of claim 26 under 35 U.S.C. § 103(a) as
unpatentable over Okajima, Ullah ‘316, Matthews, and Shank.

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

AFFIRMED

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