Ex Parte Perzborn

Patent Trial and Appeal Board

Apr 22, 2016

12513363 (P.T.A.B. Apr. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/513,363 01/08/2010
21839 7590 04/26/2016
BUCHANAN, INGERSOLL & ROONEY PC
POST OFFICE BOX 1404
ALEXANDRIA, VA 22313-1404
FIRST NAMED INVENTOR
Elisabeth Perzborn
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.
0081565-00005 1721
EXAMINER
CORNET, JEAN P
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
04/26/2016 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):
ADIPDOC 1@BIPC.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ELISABETH PERZBORN1
Appeal2013-009766
Application 12/513,363
Technology Center 1600
Before JEFFREY N. FREDMAN, KIMBERLY McGRAW, and
RICHARD J. SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
combination comprising the drugs rivaroxaban, acetylsalicylic acid (aspirin),
and clopidogrel. (Appeal Br. 2.) We have jurisdiction under 35 U.S.C.
§ 6(b ).
We affirm.
1 According to Appellant, the real party in interest is Bayer Intellectual
Property GmbH. (Appeal Br. 2.)
Appeal2013-009766
Application 12/513,363
STATEMENT OF THE CASE
Claims on Appeal
Claims 14--16 are on appeal. (Appendix A, Appeal Br. 10.) Claim 14
is representative and reads as follows:
14. A combination comprising:
A) a compound that is 5-chloro-N-( { (5S)-2-oxo-3-[ 4-(3-oxo-4-
morpholinyl)phenyl]-1,3-oxazolidin-5-yl} methyl)-2-
thiophenecarboxamide of the formula
B) acetylsalicylic acid
and
C) clopidogrel.
Examiner's Rejection
Claims 14--16 stand rejected under 35 U.S.C. § 102(b) as anticipated
by Straub.2 (Ans. 4.)
Claims 14--16 were not argued separately, and we therefore limit our
discussion to claim 14.
2 Straub et al., US 2004/0242660 Al, published Dec. 2, 2004 ("Straub").
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Application 12/513,363
FINDINGS OF FACT
We adopt as our own the findings and analysis of the Examiner
concerning the teachings of Straub. The following findings are included for
emphasis and reference convenience.
FF 1. Straub teaches that "[ o ]xazolidinones of the formula (I) can
additionally also be given in combination with platelet aggregation-
inhibiting substances (platelet aggregation inhibitors) for the prophylaxis
and/or treatment of arterial, intracardiac and venous thromboembolic
disorders." (Straub i-f 233.)
FF 2. Straub teaches that "[p]articularly suitable for combination
therapy are combinations of an oxazolidinone of the formula (I) with platelet
aggregation inhibitors such as, for example, aspirin, ticlopidin (Ticlid),
clopidogrel (Plavix); fibrinogen receptor antagonists; (glycoprotein Ilb/
Illa antagonists) such as, for example, abciximab, eptifibatide, tirofiban,
lamifiban, lefradafiban." (J d.)
FF 3. The Examiner finds that Straub teaches a combination
comprising oxazolidinones of the formula (I), aspirin, and clopidogrel
having enhanced antithrombotic effect. (Final Act. 3. )3
FF 4. The Examiner finds that Straub teaches that the "very particular
preference" of oxazolidinones of the formula (I) is:
3 Office Action dated May 9, 2012.
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Application 12/513,363
(Id., citing Straub i-f 142.)
Appellant does not dispute that this compound is rivaroxaban, and the same
compound as recited in section A of claim 14. (Appeal Br. 2; Reply Br. 1.)
FF 5. The Examiner finds that Straub' s teaching of a combination of
oxazolidinone of the formula (I), with platelet aggregation inhibitors such as
aspirin, ticlopidin, and clopidogrel, anticipates claim 14. (Final Act. 4.)
ISSUE
\Vhether a preponderance of evidence of record supports the
Examiner's finding that claim 14 is anticipated by Straub.
PRINCIPLES OF LAW
A claim is anticipated if a prior art reference discloses every limitation
of the claimed invention, either explicitly or inherently. In re Schreiber, 128
F.3d 1473, 1477 (Fed. Cir. 1997). In considering the disclosure ofa
reference for anticipation, it is proper to take into account not only specific
teachings of the reference but also the inferences that one skilled in the art
would reasonably be expected to draw therefrom. In re Preda, 401 F .2d
825, 826 (CCP A 1968).
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Application 12/513,363
Anticipation is a question of fact. Jn re Rambus, Inc., 753 F.3d 1253,
1256 (Fed. Cir. 2014).
ANALYSIS
Appellant acknowledges the Examiner's reliance on paragraph 233 of
Straub concerning combination therapy with oxazolidinones of the formula
(I) and platelet aggregation inhibitors, but argues that "many other
oxazolidinone combinations are disclosed in Straub beyond this one
paragraph." (Appeal Br. 3.) Appellant argues that "Straub does not disclose
a narrow genus of possible combinations," pointing to paragraphs 8-10, 227,
229, and 231-233 of Straub. (Id. at 3---6.) Appellant also takes issue with
the Examiner's interpretation of the plural "inhibitors" in paragraph 233 of
Straub as meaning the inclusion of more than one platelet aggregation
inhibitor in the combination. (Id. at 6.) According to Appellant, the use of a
plural for "inhibitors" is more likely to suggest "that the subgenus of platelet
aggregation inhibitors that is suitable for use with the invention of Straub
has more than one member." (Id. at 7.)
Appellant also provides calculations of the possible drug
combinations, based on Appellant's interpretation of paragraph 233 of
Straub, concluding that:
Just including the possible two, three and four drug combinations
with the particularly listed examples of platelet aggregation
inhibitors and fibrinogen receptor antagonists, we calculate
provides 92 different combinations. This addition continues until
a combination of all nine drugs is reached. The result is a very
large genus allowing for combinations of two or more drugs and
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Application 12/513,363
relying on just the eight specifically named drugs from the last
sentence of para. [00233].4
(Id. at 7-8.)
Appellant's arguments are thus based on the contention that the genus
of possible combinations taught by Straub "is too large to render the specific
three-drug combination of the present claims 'at once envisaged,' to
paraphrase In re Petering." (Id. at 3 (paraphrasing In re Petering, 301 F.2d
676, 681(CCPA1962)).) In fact, Appellant argues that, even under the
Examiner's interpretation of Straub, the number of possible combinations of
drugs is twenty-eight, and thus larger than the genus found to anticipate in In
re Petering. (Id. at 8.)
We are not persuaded by Appellant's arguments. As an initial matter,
we find that Straub' s use of the plural "inhibitors" would be understood by
one of skill in the art to at least include the use of more than one platelet
aggregation inhibitor in a combination. (See FF 1, 2.) 1A .. ppellant's
arguments regarding In re Petering, 301 F.2d 676 (CCPA 1962), are
addressed below.
The court in Petering noted the "broad generic disclosure" in the prior
art reference (Karrer), but found that "Karrer discloses certain specific
preferences ... [and] that the pattern of Karrer's specific preferences in
connection with his generic formula constitutes a description of a definite
and limited class of compounds." Id. at 681. In affirming a finding of
4 We note that, because of the use of the open-ended transitional phrase
"comprising," claim 1 reads on any combination that includes rivaroxaban,
aspirin, and clopidogrel, regardless of the inclusion of additional drugs in the
combination.
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Application 12/513,363
anticipation, the court stated that the limited class contains "only 20
compounds" but "that it is not the mere number of compounds in this limited
class which is significant here but, rather, the total circumstances involved."
Id. Similar to the Karrer reference in Petering, Straub states specific
preferences for the claimed oxazolidinone (FF 4) and combinations with, for
example, aspirin and clopidogrel listed by name (FF 2).
We find the facts of the instant case analogous to those in Wm.
Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356 (Fed. Cir.
2012). The claim at issue in Wrigley was directed to a chewing gum
composition that included WS-23 and menthol. Id. at 13 59. The claim was
held to be anticipated by a prior art reference (Shahidi) that disclosed a
number of different combinations of cooling and flavoring elements. Id. at
13 61. One of those combinations was of menthol, identified by Shahidi as
one of the "most suitable" flavoring agents, with WS-23, identified by
Shahidi as among a group of three "particularly preferred cooling agents."
Id.
The court in Wrigley distinguished those cases in which the issue of
anticipation turned on whether the genus disclosed in a prior art reference
"was of such a defined and limited class that one of ordinary skill in the art
could 'at once envisage' each member of the genus." Id. (citing Eli Lilly &
Co. v. Zenith Goldfine Pharm., Inc., 471 F.3d 1369, 1376 (Fed. Cir. 2006).)
Rather, the question for anticipation in Wrigley was "whether the number of
categories and components in Shahidi was so large that the combination of
WS-23 and menthol would not be immediately apparent to one of ordinary
skill in the art." Id.
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Appellant focuses on the number of possible combinations of drugs.
(Appeal Br. 7-8.) In Wrigley, the number of possible two-ingredient
combinations (69) was much higher than the 20 compounds in Petering.
However, following the admonition in Petering, we find that the proper
focus is on the "total circumstances" rather than the "mere number of'
possible combinations. See Petering, 301 F.2d at 681. Focusing on all the
circumstances is also consistent with the factual nature of anticipation.
The facts of the instant case establish that Straub teaches the
combination of oxazolidinones of the formula (I) with platelet aggregation
inhibitors (FFl), that "[v]ery particular preference" is given to the claimed
oxazolidinone (rivaroxaban) (FF 4), and that aspirin and clopidogrel are
examples of "[p ]articularly suitable" platelet aggregation inhibitors for use
in combination therapy (FF 2). Furthermore, the drug categories and
preferred components disclosed in Straub are limited. (FF 1, 2, 4.)
Accordingly, based on the facts of the instant case, we find the claimed
combination of rivaroxaban, acetylsalicylic acid (aspirin), and clopidogrel
would be "immediately apparent" to one of ordinary skill in the art, and thus
anticipated by Straub. See Wrigley, 683 F.3d at 1361.
CONCLUSION
A preponderance of evidence of record supports the Examiner's
finding that claim 14 is anticipated by Straub.
Claims 15 and 16 were not argued separately and fall with claim 14.
SUMMARY
We affirm the rejection on appeal.
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TIME PERIOD FOR RESPONSE
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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