Ex Parte Formenti et al

Patent Trial and Appeal Board

Apr 19, 2017

13580437 (P.T.A.B. Apr. 19, 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.
13/580,437 08/22/2012 Andrea Formenti SS122-1067 8724
122515 7590
Silvia Salvadori, P.C.
Silvia Salvadori
270 Madison Avenue, 8th Floor
New York, NY 10016
EXAMINER
SOROUSH, LAYLA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
04/21/2017 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):
silvia@salvadorilaw.com
silvia30121 @ me. com
eofficeaction @ appcoll.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANDREA FORMENTI and FILIPPO FORMENTI1
Appeal 2016-005792
Application 13/580,437
Technology Center 1600
Before MELANIE L. McCOLLUM, RICHARD J. SMITH, and
DAVID COTTA, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating inflammation in animals. We have jurisdiction under 35 U.S.C.
§ 6(b).
We reverse.
STATEMENT OF THE CASE
Background
“Non-steroidal anti-inflammatory drugs (NSAIDs) are one of the
classes of drugs most commonly used in current out-patient practice to treat
1 According to Appellants, the real party in interest is FORMEVET S.R.L.
(Br. 3.)
Appeal 2016-005792
Application 13/580,437
inflammation and pain. . . . One of the main limitations of their use is the
appearance of side effects, mainly affecting the gastrointestinal tract,
kidneys, haemostatic system, etc. . . . Firocoxib is a member of the category
of [NSAIDs] belonging to the coxib group.” (Spec. 3,11. 18—20 and 25—27;
4,11. 21-22.)
“Opioids are a group of drugs with central analgesic activity, which
are used to treat moderate to severe pain. . . .Tramadol can be defined as a
centrally-acting analgesic . . . and combines rapid activity with fewer and
less serious side effects than other opioids.” {Id. at 4,1. 26—5,1. 4.)
Claims on Appeal
Claims 2—6 are on appeal.2 (Claims Appendix, Br. 17.) Claim 2, the
only independent claim, is illustrative and reads as follows:
2. Method of treating inflammation in animals in need thereof
comprising
preparing a medicament comprising a combination of Tramadol and
Firocoxib;
administering an effective dose of said combination to said animals,
said Firocoxib being administered below a minimum effective anti­
inflammatory dose; and
treating said inflammation.
Examiner’s Rejections
1. Claims 2—6 stand rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Chen I.3 (Ans. 3 4.)
2. Claims 2—6 stand rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Chen II.4 {Id. at 4—5.)
2 Claim 1 is withdrawn. (Final Act. 1, dated Sept. 25, 2015.)
3 Chen et al., US 2007/0020335 Al, pub. Jan. 25, 2007 (“Chen I”).
4 Chen et al., US 2008/0220079 Al, pub. Sept. 11, 2008 (“Chen II”).
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Appeal 2016-005792
Application 13/580,437
ISSUE
Whether a preponderance of evidence of record supports the
Examiner’s rejections under 35 U.S.C. § 103(a).
ANALYSIS
Both of the obviousness rejections are based on similar teachings from
Chen I and Chen II. (Ans. 3—5.) In particular, the Examiner finds that both
references teach methods for reducing pain or fever (inflammation) in an
animal, such as a dog or cat, using a composition comprising tramadol and
an NS AID such as firocoxib, at certain dosages. (Id.) Appellants argue that
Chen I and Chen II fail to provide the rationale to sustain a prima facie case
of obviousness because those references fail to suggest that a low,
ineffective dose of firocoxib exhibits “anti-inflammatory activity when
administered with an analgesic dose of Tramadol.” (Br. 14 and 16.)5
The Examiner bears the initial burden of establishing a prima facie
case of obviousness, and has not done so. See In re Oetiker, 977 F.2d 1443,
1445 (Fed. Cir. 1992). A prima facie case of obviousness “requires a
suggestion of all limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp.,
349 F.3d 1333, 1342 (Fed. Cir. 2003), and “a reason that would have
prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does” KSR Int 7 Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007). Here, the Examiner fails to
establish that Chen I or Chen II suggest the limitation of “said Firocoxib
being administered below a minimum effective anti-inflammatory dose,”
and fails to provide a persuasive reason why a person of ordinary skill in the
5 Appellants rely on the same arguments for Rejection No. 2 (Chen II) as
advanced in connection with Rejection No. 1 (Chen I). (Br. 16.)
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Appeal 2016-005792
Application 13/580,437
art would have been prompted to use “below a minimum effective anti­
inflammatory dose” in a method for treating inflammation.
In this case, Appellants rely on test data, illustrated in Figure 1 of the
Specification, and a Declaration of Paola Sacerdote6 to establish that
tramadol is a pain medication that is not known for its inflammatory activity,
and that a sub-effective dose of firocoxib alone similarly fails to provide a
sufficient anti-inflammatory effect. (Br. 6—9; Decl. Tfl[ 11—14.) However,
according to Appellants, the combination recited in claim 2 provides an anti­
inflammatory effect, albeit with a sufficiently low dose of firocoxib to avoid
its undesirable side effects. (Br. 6, 9; Decl. 25 and 45.)
The Examiner does not point to any teaching or suggestion in Chen I
or Chen II of administering the NS AID (i.e. firocoxib) at below a minimum
effective anti-inflammatory dose. Rather, the Examiner states that “it would
be obvious to lower the concentration of a drug [firocoxib] when in
combination with another drug [tramadol] that provides the same efficacy
versus the same drug as a monotherapy.” (Ans. 7.) However, claim 2
recites a method of treating inflammation by combining tramadol, which is
not known as an anti-inflammatory, with firocoxib at “below a minimum
effective anti-inflammatory dose.” (Br. 17.) The Examiner does not
adequately explain why such a combination would be expected to treat
inflammation.
We are persuaded that neither Chen I nor Chen II teach or suggest all
of the limitations of claim 2, and thus reverse the rejection of claims 2—6.
6 Declaration of Paola Sacerdote, filed Jan. 22, 2015 (“Deck”).
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Appeal 2016-005792
Application 13/580,437
CONCLUSION OF LAW
A preponderance of evidence of record fails to support the
Examiner’s rejections of claims 2—6 under 35 U.S.C. § 103(a) based on
Chen I or Chen II.
SUMMARY
We reverse the rejections of all claims on appeal.
REVERSED
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