Ex Parte Roth et al

Patent Trial and Appeal Board

Jun 13, 2018

13322159 (P.T.A.B. Jun. 13, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/322, 159 11/23/2011 Erna Roth
151167 7590 06/15/2018
Gruneberg and Myers PLLC
1775 Tysons Blvd
5th Floor
Tysons, VA 22102
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
000268US 7557
EXAMINER
THOMAS, TIMOTHY P
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
06/15/2018 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):
patent@gandmpatent.com
kg@gandmpatent.com
em@gandmpatent.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ERNA ROTH, RUEDIGER ALEXOWSKY,
HANS-ULRICH PETEREIT, and CHRISTIAN MEIER
Appeal2016-008570
Application 13/3 22, 159 1
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS and DAVID COTTA,
Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
powdery or granulated composition. The Examiner rejected the claims on
appeal under 35 U.S.C. § 103(a) as obvious.
We reverse.
1 According to Appellants, the real party in interest is Evonik Roehm GmbH.
App. Br. 2.
Appeal 2016-008570
Application 13/322,159
STATEMENT OF THE CASE
Claims 1-5, 14 and 15 are on appeal. Claim 1 is illustrative and reads
as follows:
1. A powdery or granulated composition, comprising at
least 30% by weight of a mixture comprising:
(a) a copolymer comprising, in polymerized form, a C1-
to C4-alkyl ester of acrylic or methacrylic acid and an
alkyl(meth)acrylate monomer comprising a tertiary amino
group in an alkyl radical;
(b) 0.5 to 10% by weight based on (a) of a dicarboxylic
acid comprising 4 to 10 carbon atoms; and
(c) 5 to 20 % by weight based on (a) of a linear, saturated
fatty monocarboxylic acid comprising 8 to 18 carbon atoms;
wherein
a molar ratio of the dicarboxylic acid to the tertiary
amino groups of copolymer (a) is from O. 8/100 to 17 /100,
a molar ratio of the fatty monocarboxylic acid to the
tertiary amino groups of copolymer (a) is from 5/100 to 45/100,
and
a dispersion or solution preparation time of the
composition is less than 3 hours.
App. Br. 15. In response to a requirement for restriction and for election of
species, Appellants elected "Eudragit® EPO" as the claimed copolymer,
"malic acid as the dicarboxylic acid," and "caprylic acid as the fatty
monocarboxylic acid." Ans. 3; Office Action, Mailed April 17, 2013, 2--4.
The claims stand rejected as follows:
Claims 1-5, 14, and 15 were rejected under 35 U.S.C. § 112 as
indefinite. In the Examiner's Answer, the Examiner withdrew this rejection.
Ans. 2. Accordingly, this rejection is no longer a part of this appeal.
2
Appeal 2016-008570
Application 13/322,159
Claims 1-5, 14, and 15 were rejected under 35 U.S.C. § I03(a)
as obvious over the combination of Watanabe2 and Skalsky. 3
ANALYSIS
As stated inJn re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
"[T]he examiner bears the initial burden ... of presenting a prima facie case
of unpatentability." Appellants have persuaded us that the Examiner has not
carried the burden of establishing that the claimed invention would have
been obvious over the cited art.
\Vith reference to Appellants' elected species, claim l requires
specific molar ratios of malic acid (the elected dicarboxylic acid) and of
caprylic acid ( the claimed fatty monocarboxylic acid) to the tertiary amino
groups of Eudragit® EPO (the elected copolymer). In finding claim 1
obvious, the Examiner relies on Watanabe's disclosure of the total amount
of acid present and Watanabe's general teaching that "[ o ]ne or a
combination of 2 or more" of 39 different acids "can be used." Watanabe
,r 83; Final Act 8-13. The Examiner, however, does not identify any
disclosure in Watanabe that speaks to the amount of malic acid to use
relative to the amount of caprylic acid. The Examiner asserts "[ w ]hen
obvious equal masses of the two acids, malic acid + caprylic acid are used,
the skilled artisan would start with half of each of these ratios, i.e., at least
2.5 moles malic acid+ at least 5 moles caprylic acid/ 100 mole of tertiary
amino groups of Eudragit EPO, to satisfy the minimal 10% acid
2 Watanabe et al., US Patent Publication No. 2005/0112206 Al, published
May 26, 2005 ("Watanabe").
3 Skalsky et al., Chemistry and Application Properties of Polymethacrylate
Systems, AQUEOUS POLYMERIC COATINGS FOR PHARMACEUTICAL DOSAGE
FORMS, 3rd Ed. McGinity et al., Eds. (2008) ("Skalsky").
3
Appeal 2016-008570
Application 13/322,159
neutralization taught by Watanabe." Final Act. 9. However, the Examiner
does not identify an evidentiary basis to support a conclusion that a person
of ordinary skill in this art would have found it obvious to select equal
masses of the two acids.
The Examiner also posits that it would have been obvious to start
with 19. 7% by weight malic acid, as disclosed in one of Watanabe's
embodiments, replace the 19.7% malic acid with 9.8% malic acid and 9.8%
caprylic acid, and then "optimize the amounts used, via routine optimization
of conditions, starting with half the amounts for each of malic acid and
caprylic acid as the exemplified malic acid amount, then optimiz[ e] the
amounts to achieve the purposes taught by this reference [Watanabe], giving
other embodiments within the scope of the recited ranges." Id. at 13-14.
We are not persuaded because the Examiner does not provide an evidentiary
basis for concluding that routine optimization would result in the claimed
ratios. 4 In this regard, we note Watanabe is directed to increasing the
bioavailability of active drugs while the claimed composition is directed to
a compound having an improved dispersion or solution preparation time.
See, claim 1 (reciting "a dispersion or solution preparation time of the
composition is less than 3 hours"); Spec. 2; Watanabe ,r 2 ("The present
invention pertains to an oral agent for improving absorption that enhances
drug permeability.")
Skalsky does not resolve the deficiencies identified above.
Accordingly, we reverse the Examiner's rejection of claims 1-5, 14, and 15
as obvious over the combination of Watanabe and Skalsky.
4 We note that the Examiner also did not provide an evidentiary basis for
starting with "half the amounts for each of malic acid and caprylic acid."
4
Appeal 2016-008570
Application 13/322,159
SUMMARY
For these reasons and those set forth herein, we reverse the Examiner's
decision to reject claims 1-5, 14, and 15 under 35 U.S.C. § 103(a) as obvious
over the combination of Watanabe and Skalsky.
REVERSED
5