Ex Parte Yu et al

Patent Trial and Appeal Board

Feb 13, 2019

12943644 (P.T.A.B. Feb. 13, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/943,644 11/10/2010
26698 7590 02/13/2019
MYRIAD GENETICS INC.
INTELLECTUAL PROPERTY DEPARTMENT
320WAKARA WAY
SALT LAKE CITY, UT 84108
FIRST NAMED INVENTOR
Dihua Yu
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.
1203-50-lC 4073
EXAMINER
DENT, ALANA HARRIS
ART UNIT PAPER NUMBER
1643
MAIL DATE DELIVERY MODE
02/13/2019 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DIHUA YU, XIAOY AN ZHOU, YOICHI NAGATA,
FRANCISCO J. ESTEY A, and A YSEGUL A. SARIN
Appeal2018-005144
Application 12/943,644
Technology Center 1600
Before DONALD E. ADAMS, MICHAEL J. FITZPATRICK, and
JOHN G. NEW, Administrative Patent Judges.
FITZPATRICK, Administrative Patent Judge.
DECISION ON APPEAL
Dihua Yu, Xiaoyan Zhou, Yoichi Nagata, Francisco J. Esteva, and
Aysegul A. Sahin ("Appellants") 1 appeals under 35 U.S.C. § 134(a) from the
Examiner's final decision rejecting claims 44, 47, 52, and 64---68. We have
jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
1 Appellants identify the Board of Regents, the University of Texas System,
and Myriad Genetics as the real parties in interest. Appeal Br. 3.
Appeal2018-005144
Application 12/943,644
STATEMENT OF THE CASE
The Specification
The claimed invention "relates generally to the fields of molecular
biology and oncology" and, "[ m Jore particularly, it concerns diagnostic,
prognostic, and therapeutic methods and compositions involving ErbB2-
overexpressing cancers and potential efficacy of ErbB2 targeting agents to
treat such cancers." Spec. ip. "The invention involves evaluating PTEN
expression and/or activity to evaluate and/or predict efficacy or possible
resistance to such agents." Id.
"PTEN is a phosphatase and its activity can be observed and
measured." Id. ,II 7. Applicants discovered "that a deficiency in PTEN
activity in cancer cells is significantly associated with the resistance of those
cells to ErbB2-targeting agents that are used to treat cancer." Id. ,I7. Thus,
their invention aims to predict "whether a particular cancer patient is more
or less likely to respond or be resistant to an ErbB2 targeting agent that is
being considered as a therapeutic agent for an ErbB2-overexpressing
cancer." Id. "In certain embodiments, the therapeutic agent is trastuzumab.
In others it can be inhibitors of PI3K [i.e., 'phosphatidylinositol 3-Kinase']
family proteins." Id. n22, 41.
The Rejected Claims
Claims 44, 47, 52, and 64---68 are pending and rejected. Final Act. 1.
Claim 44 is representative and reproduced below.
44. A method for administering a treatment regimen
comprising an effective amount of a PI3K inhibitor, said
method comprising:
( 1) assaying a patient sample comprising at least one test
cancer cell to measure the amount of PTEN protein
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Application 12/943,644
having the amino acid sequence of SEQ ID N0:2 using
at least one technique chosen from the group consisting
of immunohistochemistry, immunoprecipitation, enzyme
linked immunosorbent assay (ELISA),
radioimmunoassay (RIA), immunoradiometric assay,
fluoroimmunoassay, chemiluminescent assay,
bioluminescent assay, western blot, antibody array, and
F ACS analysis;
(2) comparing the amount of PTEN protein measured in ( 1)
to a reference amount of PTEN protein in reference
cancer cells of a reference cohort of patients who are not
candidates for said treatment regimen; and
(3) administering said treatment regimen to a test patient for
whom said at least one test cancer cell is measured in ( 1)
to have an absence of detectable PTEN protein or an
amount of PTEN protein that is no more than 50% of said
reference amount of PTEN protein in (2).
Appeal Br. 1 7.
The Appealed Rejection
The following rejection is before us for review: claims 44, 47, 52, and
64---68 under 35 U.S.C. § 112(a)/i-fl. Final Act. 2---6; Ans. 4--8. 2
DISCUSSION
The Examiner rejected these claims and those that depend from them
under 35 U.S.C. § 112(a)/i-fl.
Section 112 ,II states the following:
The specification shall contain a written description of the
invention, and of the manner and process of making and using it,
in such full, clear, concise, and exact terms as to enable any
2 The Final Action included other rejections (see Final Act. 7-11), but they
have been withdrawn. See Ans. 3.
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Application 12/943,644
person skilled in the art to which it pertains, or with which it is
most nearly connected, to make and use the same[.]
35 U.S.C. § 112 ,II (pre-AIA); see also 35 U.S.C. § 112(a) (post-AIA)
(stating the same). The Federal Circuit has held that this provision requires:
a "written description of the invention" which is separate and
distinct from the enablement requirement. The purpose of the
"written description" requirement is broader than to merely
explain how to "make and use"; the applicant must also convey
with reasonable clarity to those skilled in the art that, as of the
filing date sought, he or she was in possession of the invention.
The invention is, for purposes of the 'written description'
inquiry, whatever is now claimed.
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991).
The Examiner's rejection is based on the written description, not
enablement, requirement of§ 112( a )/,II. See, e.g., Final Act. 4 ( finding a
lack of "possession of the claimed invention"). The Examiner's specific
findings are that:
While the specification notes implementing two PI3K inhibitors
(L Y294002 and Wortmannin) ... , Applicants' claims do[] not
identify the vast number of PI3K inhibitors that are encompassed
by the broad term. . ..
With the exception of LY294002 and Wortmannin, the skilled
artisan cannot envision the detailed structure or activity of all
PI3K inhibitors.
Final Act. 4--5.
Independent claim 44 recites: "[a] method for administering a
treatment regimen comprising an effective amount of a PI3K inhibitor."
Independent claim 65 similarly recites "[a] method for administering a first
treatment regimen comprising an effective amount of a PI3K inhibitor."
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Application 12/943,644
Appellants argue that their application need not describe and enable
every PI3K inhibitor or even a representative number of PI3K inhibitors
because Appellants are not claiming the genus of PI3K inhibitors. Instead,
Appellants are claiming a method for administering a treatment regimen
comprising an effective amount of a PI3K inhibitor. See Appeal Br. 10 ("In
the present case, however, what is claimed is a method of treatment using
PI3K inhibitors in combination with a biomarker assay, not PI3K inhibitors
themselves."). Appellants further argue:
The [Final Office Action] alleges that there was unpredictability
in the art regarding efficacy of PI3K inhibitors. FOA, p. 3-4.
Setting aside the apparent conflation of enablement and written
description in this statement, questions about the efficacy of
PI3K inhibitors, while relevant if Appellants were making broad
composition claims to PI3K inhibitors as such, are irrelevant in
deciding whether Appellants had possession of the methods of
treatment as recited in the claims.
Appeal Br. 10.
We are persuaded of error in the Examiner's rejection.
We disagree that a person of ordinary skill in the art would not
envisage from the application as filed that the inventors conceived and
possessed the idea of using PI3K inhibitors generally (as opposed to merely
L Y294002 and Wortmannin). This is so because the application as filed
explicitly describes using that genus. See Spec. i-f22 ("In certain
embodiments, the therapeutic agent is trastuzumab. In others it can be
inhibitors of PI3K family proteins." ( emphasis added)).
The claims are directed to "[a] method for administering a treatment
regimen comprising an effective amount of a PI3K inhibitor." See, e.g.,
Appeal Br. 17 (claim 44). Notably, the Examiner has not found that the
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Application 12/943,644
application fails to describe ( or enable) any step recited in the claims. In
other words, and as Appellants point out, their application adequately
describes and enables the claimed inventions (i.e., the claimed methods)
regardless of whether their application could support a composition claim to
the genus of PI3K inhibitors.
For the reasons discussed, we reverse the Examiner's rejection of
claims 44, 47, 52, and 64---68 under 35 U.S.C. § 112(a)/i-fl.
DECISION
The Examiner's rejection of claims 44, 47, 52, and 64--68 is reversed.
REVERSED
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