Ex Parte Prudence et al

Patent Trial and Appeal Board

Nov 16, 2017

12594284 (P.T.A.B. Nov. 16, 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.
12/594,284 01/14/2010 Kevin Prudence ES-4662-1302 2606
23117 7590 11/20/2017
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON, VA 22203
EXAMINER
FAY, ZOHREH A
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
11/20/2017 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):
PTOMAIL@nixonvan.com
pair_nixon @ firsttofile. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KEVIN PRUDENCE,
CHRISTOPH RIEGGER, and WOLFGANG SCHALCH
Appeal 2016-004603
Application 12/594,2841
Technology Center 1600
Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to methods of
treating dry eye syndrome by administering the isoflavone compound
genistein. The Examiner rejected the claims for failure to comply with the
written description requirement, and for anticipation.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 As to the Real Party in Interest, Appellants state that the “assignee, DSM
IP Assets B.V., holds all rights in this application, as well as the invention
disclosed and claimed therein, by the assignment as recorded in the Patent
and Trademark Office (PTO) starting at reel 023782 and frame 0703 on
January 14, 2010.” Br. 3.
Appeal 2016-004603
Application 12/594,284
STATEMENT OF THE CASE
Claims 13—24 are pending (see Br. 12—13) and stand rejected as
follows:
(1) Claims 21—24, under 35 U.S.C. § 112, first paragraph, for failure
to comply with the written description requirement (Final Act. 2—3 (entered
March 21, 2012)); and
(2) Claims 13—24, under 35 U.S.C. § 102(b), as anticipated by
Fischer2 (Final Act. 3—4).
Appellants state that “[t]he rejections of claims 21—24 are not being
appealed. They form no part of the appeal and, in due course, will be
canceled. Only claims 13—20 are at issue in this appeal.” Br. 5.
Based on this statement, the Examiner indicates that the written
description rejection of claims 21—24 has been withdrawn. Ans. 4. Also, in
restating the rejection for anticipation over Fischer, the Examiner does not
include claims 21—24. Id. at 3.
As explained in our rules, however, “[a]n appeal, when taken, is
presumed to be taken from the rejection of all claims under rejection unless
cancelled by an amendment filed by the applicant and entered by the
Office.” 37 C.F.R. § 41.31(c).
In the present case, claims 21—24 have not yet been canceled, as
evidenced by their presence in the Claims Appendix in the Appeal Brief. Br.
13. Claims 21—24, therefore, remain under rejection.
Because Appellants do not submit argument as to the patentability of
claims 21—24, we summarily affirm (a) the Examiner’s rejection of claims
2 US 2004/0197272 A1 (published Oct. 7, 2004).
2
Appeal 2016-004603
Application 12/594,284
21—24 for failure to comply with the written description requirement, and (b)
the Examiner’s rejection of claims 21—24 as anticipated by Fischer. See
MPEP § 1205.02 (Arguments and evidence not presented in an Appeal Brief
“are waived for purposes of the appeal and the Board may summarily sustain
any grounds of rejections not argued.”)
Claims 13—20, therefore, remain for consideration on the merits.
Claims 13 and 17 are representative and read as follows:
13. A method of inducing tear production in a subject having
dry eye syndrome or lachrymal kerato-conjunctivitis (LCK) by
administering to a subject in need thereof an effective amount
of a composition containing genistein as the sole active
ingredient.
17. A method of treating dry eye syndrome or lachrymal
kerato-conjunctivitis (LCK) by administering to a subject in
need thereof an effective amount of a composition containing
genistein as the sole active ingredient.
Br. 12.
DISCUSSION
As stated in In 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. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In the present case, Appellants do not persuade us that a
preponderance of the evidence fails to support the Examiner’s prima facie
case of anticipation.
As the Examiner finds (see Final Act. 4; Ans. 3), | 62 of Fischer
discloses the following:
3
Appeal 2016-004603
Application 12/594,284
Any flavone or isoflavone, or ascorbate compound (e.g.,
ascorbic acid, ascorbate, or a derivative thereof), that stimulates
(e.g., increases with statistical significance) chloride transport
within at least one of the assays described herein may be used
for therapy of diseases characterized by defective chloride
transport as provided herein including, for example, . . . dry eye
syndrome. . . . Preferred compounds include genistein ....
Fischer | 62.
We acknowledge, as Appellants argue (Br. 7—9), that Fischer might
describe other embodiments that expressly exclude genistein, or that treat
cystic fibrosis. Those disclosures, however, do not undermine the express
description in Fischer, identified by the Examiner and quoted above, of
treating the disorder recited in Appellants’ claims 13 and 17, using the
compound required by the claims.
As to Appellants’ contention that Fischer does not enable practicing
the claimed invention of inducing tear production recited in claim 13 (Br. 9),
Appellants do not advance persuasive evidence or reasoned argument
explaining why Fischer’s description of administering the same compound as
claimed, to patients suffering from the same disorder as claimed, would fail
to achieve the result recited in the claim.
Appellants also do not persuade us (see Br. 9-11) that Fischer fails to
describe using genistein as the sole active ingredient. As the quoted
paragraph above, cited by the Examiner, indicates, a singular compound may
be used. See Fischer | 62 (“Any flavone or isoflavone, or ascorbate
compound . . . may be used . . . .”). Fischer further discloses that “[f]or in
vivo use, a compound as described herein is generally incorporated into a
pharmaceutical composition prior to administration. Within such
4
Appeal 2016-004603
Application 12/594,284
compositions, one or more therapeutic compounds as described herein are
present as active ingredient(s). . . Id. ^ 91 (emphasis added).
In sum, for the reasons discussed, Appellants do not persuade us that a
preponderance of the evidence fails to support the Examiner’s prima facie
case of anticipation as to either claim 13 or claim 17. We, therefore, affirm
the Examiner’s rejection of those claims as anticipated by Fischer. Claims
14—16 and 18—20 fall with claims 13 and 17.
SUMMARY
For the reasons discussed, we affirm the Examiner’s rejection of
claims 21—24, under 35 U.S.C. § 112, first paragraph, for failure to comply
with the written description requirement.
For the reasons discussed, we also affirm the Examiner’s rejection of
claims 13—24, under 35 U.S.C. § 102(b), as anticipated by Fischer.
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
5