Ex Parte Kolter et al

Patent Trial and Appeal Board

Jul 31, 2017

13790101 (P.T.A.B. Jul. 31, 2017)

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.
13/790,101 03/08/2013 Karl Kolter 0000073404US01 2966
(BSE0136)
48394 7590 08/02/2017
SFRVTT T A WHTTNFY T T C EXAMINER
33 WOOD AVE SOUTH GHALI, ISIS A D
SUITE 830
ISELIN, NJ 08830 ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
08/02/2017 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):
docket @ dsiplaw. com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KARL KOLTER, SILKE GEBERT,
MICHAEL KLEMENS MULLER, and MAXIMILIAN ANGEL
Appeal 2016-005474
Application 13/790,101
Technology Center 1600
Before DEMETRA J. MILLS, TAWEN CHANG, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
Appeal 2016-005474
Application 13/790,101
STATEMENT OF CASE
According to the Specification, the present invention relates to
pharmaceutical protective coatings with good resistance in a neutral
environment. Spec. 1. The Specification further discloses that exceptional
taste masking results from the insolubility of the polymers according to the
invention at pH values greater than 6 and the rapid solubility at pH values
below 6. Spec. 23.
The following claims are representative.
1. A pharmaceutical coating obtained from a film-
forming coating composition based on a copolymer of N,N-
diethylaminoethyl methacrylate (DEAEMA) and methyl
methacrylate (MMA) comprising a weight ratio of
DEAEMA:MMA in the range of 35:65 to 55:45, where the
copolymer is partially neutralized with a C3-Cio-dicarboxylic
acid.
6. The coating of claim 1, wherein the copolymer is partially
neutralized to 2 to 15 mol%.
Cited References
Angel et al. US 2011/0033532 A1 Feb. 10, 2011
(“Angel”)
Danek-Bulius et al. WO 2012/089778 Al July 5, 2012
(“Danek-Bulius”)
Kollicoat® Smartseal 30 D, BASF, October 2010.
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Application 13/790,101
Grounds of Rejection
Claims 1—9 are rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Angel in combination with the article Kollicoat®
Smartseal 30 from BASF, and Danek-Bulius.
FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Examiner’s
Answer at pages 2—16 and at pages 4—10 of the Final Rejection dated May 8,
2015.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
“It is well settled that a generic claim cannot be allowed to an
applicant if the prior art discloses a species falling within the claimed
genus.” In re Slayter, 276 F.2d 408, 411 (CCPA 1960). “It is also an
elementary principle of patent law that when, as by a recitation of ranges or
otherwise, a claim covers several compositions, the claim is ‘anticipated’ if
one of them is in the prior art.” Titanium Metals Corp. of America v.
Banner, 778 F.2d 775, 782 (Fed. Cir. 1985).
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Appeal 2016-005474
Application 13/790,101
Obviousness Rejection
The Examiner finds that
Angle [sic] teaches polymer preparation suitable for coating
pharmaceutical dosage forms. The polymer displays pH-
dependent solubility properties and suitable for masking active
ingredients with unpleasant tastes (10021). The polymer
comprises 25-65% N,N-diethylaminoethyl methacrylate
(DEAEMA) and 35-75% methyl methacrylate (MMA)
(110022-0025, 0037-0049, 0175, 0176). The weight ratio of
DEAEMA:MMA in the range overlapping with the claimed
ratio of 35:65 to 55:45. During polymerization, pH is adjusted
using inorganic or organic acids such as carboxylic acids, and
polybasic carboxylic acids (H 0035, 0064).
Final Act. 4. The Examiner finds that, “Angel teaches using mono or
polybasic carboxylic acid during polymerization to adjust pH, i.e. as buffer.”
Ans. 7; Angel 1 64. Examples of carboxylic acids in Angel include lactic
acid (C3) and tartaric acid (C4). Angel H 35, 64. Angel teaches the use of
pH adjusting buffers. Id. H 35, 137, 207. The Examiner further finds that
Angel “suggested addition of carboxylic acid during polymerization[;]
however, the reference does not explicitly teach C3-Cio-dicarboxylic acid as
instantly claimed by claim 1.” Final Act. 5.
The Examiner reasons that
one having ordinary skill in the art would have neutralized the
polymer of Angle [sic] and BASF using unbranched
dicarboxylic acid as taught by Danek-Bulius because Angle
[sic] teaches using carboxylic acid as buffer and Danek-Bulius
teaches equivalency between mono- and di-carboxylic acids as
buffers for pharmaceuticals and teaches adipic acid, which is
unbranched dicarboxylic acid having 6 carbon atoms, as
preferred buffer.
Final Act. 6.
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Application 13/790,101
Appellants contend that “[t]he difference between the prior art and
claims 1-5 and 8-9 is that the claims 1-5 and 8-9 recite that the copolymer is
partially neutralized with a C3-Cio-dicarboxylic acid.” Br. 9. Appellants
argue that
the proposed combination of references lacks a rational
technical basis. In Angel, the use of inorganic or organic bases
and acids is to adjust pH during polymerization or subsequent
thereto. Angel at [0035]. Danek-Bulius is not concerned with
polymerization conditions or forming a polymer that is partially
neutralized. Rather, Danek-Bulius uses its mono-or
dicarboxylic acids as a buffer in parenteral pharmaceutical
formulations comprising a biopharmaceutical drug in order to
reduce drug aggregations. Danek-Bulius does not discuss
polymerization conditions at all. In addition, Danek-Bulius
makes no reference to the use of polymers in its formulations.
Therefore, the listing of mono- or dicarboxylic acids with a
backbone of 2-6 C-Atoms of Danek-Bulius is not relevant to
the aqueous polymer dispersion based on N,N-diethyl-
aminoethyl methacrylate of Angel. One skilled in the art
starting with the polymer dispersion of Angel which is for
masking taste of active ingredients would not turn to the
parenteral formulations of Danek-Bulius for a suggestion of
which acid to use for adjusting pH during polymerization or
subsequent thereto.
Br. 10. Additionally, Appellants rely on alleged unexpected results for the
claimed group of carboxylic acids. Br. 14—15.
ANALYSIS
Appellants argue two separate groupings of claims: claims 1—5 and
8—9 (Br. 9—13), and claims 6—7 (Br. 13—14). We select claim 1 and 6 as
representative claims in each of these claim groupings. We agree with the
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Application 13/790,101
Examiner’s fact finding, statement of the rejection and responses to
Appellants’ arguments as set forth in the Answer. We find that the
Examiner has provided evidence to support a prima facie case of
obviousness. We provide the following additional comment to the
Examiner’s determinations set forth in the Final Rejection and Answer.
Claims 1—5, 8—9
Appellants allege the “lack of a rational basis to combine” Angel,
BASF and Danek-Bulius (e.g., Br. 6, 10, 11) to meet the dicarboxylic acid
limitation in the claim. We are not persuaded. Angel itself discloses a
specific species of dicarboxylic acid, tartaric acid, to adjust pH during
polymerization of the polymer dispersion/coating. Angel 164. Compare,
Specification, p. 36—37, Example 20 (tartaric acid example). See also Spec.
6:11—15 and claim 5 (“The coating of claim 1, wherein the dicarboxylic acid
is selected from . . . tartaric acid”). Angel states:
The cationic groups of component d) are preferably
nitrogen-containing groups such as primary, secondary and
tertiary amino groups, and quaternary ammonium groups.
The nitrogen-containing groups are preferably tertiary amino
groups or quaternary ammonium groups. Charged cationic
groups can be generated from the amine nitrogens either by
protonation, e.g. with monobasic or polybasic carboxylic
acids, such as lactic acid or tartaric acid, or mineral acids such
as phosphoric acid, sulfuric acid and hydrochloric acid ...
Angel 164.
Angel also teaches that suitable acids for adjusting pH during
polymerization include tartaric acid. Id. 135. Therefore, Angel itself
suggests the claim limitation, “where the copolymer is partially neutralized
with a C3-Cio-dicarboxylic acid,” and a skilled artisan would have reason to
combine prior art elements to arrive at the invention of claim 1. See
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Application 13/790,101
generally In re Bush, 296 E2d 49 K 496 (CCPA 1961 j may
on less than all of the references relied upon by Examiner). That is, since
Angel discloses a species, tartaric acid, falling within the claimed genus of
C3-C10 -dicarboxylic acids, the generic claim limitation to the genus of
dicarboxylic acids does not distinguish over the prior art. In re Slayter, 276
F.2d 408, 411 (CCPA 1960). Furthermore, Danek-Bulius also teaches
dicarboxylic acid buffers acceptable for use in pharmaceutical compositions.
Ans. 4.
Claims 6—7
With respect to claims 6 and 7, Appellants contend that, “Angel fails
to teach or suggest a mol % of partial neutralization in the claimed range.”
Br. 13.
The Examiner responds that
the reference [Angel] teaches pH of polymerization mixture between
8 and 10, and the claims recite “partially neutralized”. Hence, in view
of the expression “partially neutralized”, the claimed pH is not
completely neutral, that may be above or below neutral pH of 7.0,
which is close enough to the pH of 8.0 and not lower than 7.5 taught
by the reference. The examiner maintains her position that pH can be
optimized. It is well settled that “the 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)).
Ans. 14. Appellants have failed to establish on this record that the level of
partial neutralization would not have been recognized by one of ordinary
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Application 13/790,101
skill in the art to be an optimizable variable in view of the cited prior art.
We find that the Examiner has the better position and the rejection of claims
6—7 is affirmed for the reasons of record.
Unexpected Results
With respect to Appellants’ arguments regarding unexpected results,
we are also not persuaded. Appellants argue that the
[ajctive ingredient-containing pharmaceutical dosage forms prepared
using the polymeric coatings disclosed herein protect against
premature active ingredient release in an aqueous environment at pH
6.8. As-filed Application at p. 5, lines 3-6. The use of copolymers that
are partially neutralized with a C3-C10-dicarboxylic acid provide such
protection, whereas unexpectedly, neutralization by other types of
acids do not provide such protection.
Br. 14. Appellants argue that the comparative examples in the Specification
show that, “monocarboxylic acid is not equivalent to an unbranched
dicarboxylic acid for the purposes of neutralizing a copolymer of N,N-
diethylaminoethyl methacrylate (DEAEMA).” Br. 14. However, the
Appellants acknowledge on page 14 of the Brief, that tartartic acid, Example
20 in the Specification, provided 100% resistance to degradation in buffer
pH 6.8 at 30 min. Angel discloses the same use of tartaric acid buffer.
Angel 135.
Appellants have not established unexpected results over the tartaric
acid Angel disclosed as suitable for use in adjusting the pH during
polymerization, or unexpected results commensurate in scope with the
claimed coating over the cited prior art. In re Baxter Travenol Labs., 952
F.2d 388, 392 (Fed. Cir. 1991) (“[Wjhen unexpected results are used as
evidence of nonobviousness, the results must be shown to be unexpected
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Application 13/790,101
compared with the closest prior art.”). Appellants have failed to rebut the
Examiner’s prima facie case of obviousness, and the obviousness rejection is
affirmed for the reasons of record.
CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejection,
which is affirmed for the reasons of record. All pending, rejected claims
fall.
TIME PERIOD
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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