Ex Parte Tuefferd et al

Patent Trial and Appeal Board

Jul 15, 2016

13131131 (P.T.A.B. Jul. 15, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/131, 131 05/25/2011
23557 7590 07119/2016
SALIW ANCHIK, LLOYD & EISENSCHENK
A PROFESSIONAL ASSOCIATION
PO Box 142950
GAINESVILLE, FL 32614
FIRST NAMED INVENTOR
Marianne Tuefferd
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.
SER.170 3573
EXAMINER
GOLDBERG, JEANINE ANNE
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
07/19/2016 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):
euspto@slepatents.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARIANNE TUEFFERD, JEROME DAUVILLIER, ARNAUD
DELA YE, and SONIA SCHNIEPER-SAMEC 1
Appeal2014-005639
Application 13/131, 131
Technology Center 1600
Before JEFFREYN. FREDMAN, RICHARD J. SMITH, and
RYAN H. FLAX, 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
for treating Growth Hormone Deficiency (GHD). We have jurisdiction
under 35 U.S.C. § 6(b ).
We affirm.
1 According to Appellants, the real party in interest is Merck Serono SA.
(Br. 3.)
Appeal2014-005639
Application 13/131, 131
STATEMENT OF THE CASE
Background
"[T]he present invention relates ... to genetic markers associated with
the clinical response to Growth Hormone in Growth Hormone Deficiency
(GHD) .... The invention further discloses specific polymorphisms or
alleles of several genes that are related to GHD." (Spec. 1, 11. 6-12.)
Claims on Appeal
Claims 50, 52, and 56-59 are on appeal. (Claims Appendix, Br. 9-
10.) Independent claim 50 is illustrative and reads as follows:
50. A method for treating Growth Hormone Deficiency (GHD) in an
individual comprising identifying the level of response to treatment with
growth hormone (GH) by an individual, said identifying comprising:
(a)(i) obtaining a DNA sample of said individual; and
(a)(ii) determining whether in PTPNl -rs941798 the AA genotype is
present, the presence of the AA genotype identifying the individual as
a low responder to GH treatment; or
(b )(i) obtaining a DNA sample of said individual;
(b )(ii) determining \vhether in PTPNl -rs941798 the ii .. 1A .. genotype
and/or in CDK4 - rs2270777 the GG or GA genotype is present, the
presence of the AA genotype in PTPNl -rs941798 or the presence of
the GG or GA genotype in CDK4 - rs2270777 the identifying the
individual as a low responder to GH treatment; and
treating an individual identified as a low responder to GH treatment with a
long-acting analogue of GH or with a dose of growth hormone that is
increased compared to the standard dose.
Examiner's Rejection
Claims 50, 52, and 56-59 stand rejected under 35 U.S.C. § 101 as
directed to non-statutory subject matter; namely, as claiming a law of nature.
(Ans. 2.)
2
Appeal2014-005639
Application 13/131, 131
Appellants argue claims 50, 52, and 56-59 as a group, and we
therefore limit our discussion to claim 50.
ISSUE
Whether a preponderance of evidence of record supports the
Examiner's conclusion that claim 50 is directed to non-statutory subject
matter.
ANALYSIS
We adopt as our own the findings and reasons set forth by the
Examiner in ( 1) the action from which this appeal is taken (Final Act. 3-7)
and (2) the Examiner's Answer in response to Appellants' Appeal Brief
(Ans. 2-11), and concur with the conclusions reached by the Examiner.
Moreover, we agree with the Examiner that claim 50 sets forth a patent-
ineligible law of nature; specifically, the correlation between particular
alleles and response to GH treatment. (Ans. 4.) We highlight the following
for emphasis.
We follow, as did the Examiner, the analytical framework set forth by
the Supreme Court in Mayo Collaborative Services v. Prometheus
Laboratories, Inc., 132 S.Ct. 1289 (2012). Moreover, similar to the claims
found patent-ineligible in Mayo, claim 50 is directed to a method for
optimizing treatment by adjusting administration of a therapeutic agent
based on a law of nature. See id. at 1295-96. In addition, just as in Mayo,
claim 50 "inform[ s] a relevant audience about certain laws of nature; any
additional steps consist of well-understood, routine, conventional activity
already engaged in by the scientific community; and those steps, when
viewed as a whole, add nothing significant beyond the sum of their parts
taken separately." See id. at 1298.
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Appeal2014-005639
Application 13/131, 131
CONCLUSION
A preponderance of evidence of record supports the Examiner's
conclusion that claim 50 is directed to non-statutory subject matter. Claims
52 and 56-59 were not argued separately and fall with claim 50.
SUMMARY
We affirm the rejection of all claims on appeal.
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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