Ex Parte Dalton et al

Patent Trial and Appeal Board

Nov 16, 2016

11826195 (P.T.A.B. Nov. 16, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111826, 195 07/12/2007
49443 7590 11/18/2016
Pearl Cohen Zedek Latzer Baratz LLP
1500 Broadway
12th Floor
New York, NY 10036
FIRST NAMED INVENTOR
James T. Dalton
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.
P-9767-US 1031
EXAMINER
BARKER, MICHAEL P
ART UNIT PAPER NUMBER
1626
NOTIFICATION DATE DELIVERY MODE
11/18/2016 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):
USPTO@PearlCohen.com
Arch-USPTO@PearlCohen.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES T. DALTON and DUANE D. MILLER1
Appeal2014-007036
Application 11/826, 195
Technology Center 1600
Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims relating to a
chemical compound, which have been rejected as anticipated and obvious.
We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
STATEMENT OF THE CASE
The Specification discloses "substituted acylanilide compounds and
uses thereof in treating a variety of diseases or conditions in a subject,
1 Appellants identify the Real Parties in Interest as the University of
Tennessee Research Foundation and GTx, Inc. (Appeal Br. 1.)
Appeal2014-007036
Application 11/826, 195
including, inter-alia, a muscle wasting disease and/or disorder or a bone-
related disease and/or disorder." (Spec. 1 i-f 2.)
Claims 2, 4, 80, and 81 are on appeal. Claim 2 is representative and
reads as follows:
2. A compound represented by the structure of formula S-(I)
S-(I).
The claims stand rejected as follows:
Claims 2, 4, 80, and 81 under 35 U.S.C. § 102(b) as anticipated by
Steiner2 (Ans. 2) and
Claims 2, 4, 80, and 81under35 U.S.C. § 103(a) as obvious based on
Steiner (Ans. 9).
I
The Examiner has rejected all of the claims on appeal as anticipated
by Steiner. The Examiner finds that Steiner discloses a chemical formula
that includes compound S-(I) as part of a limited genus. (Ans. 3.) The
Examiner also finds that Steiner's exemplary compounds would have led a
person of ordinary skill in the art to a subgenus (id. at 4--8) that is small
2 Steiner et al., US 2005/0038110 Al, Feb. 17, 2005.
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Application 11/826, 195
enough that "[t]he skilled artisan would at once envisage each member of
this subgenus," including compound S-(I). (Id. at 9.)
We agree with the Examiner that Steiner's disclosure effectively
describes the claimed compound. Steiner describes
a selective androgen receptor modulator (SARM) compound
represented by the structure of formula (IIA):
wherein
Xis O;
z
Z is N02, CN, COR, or CONHR;
Y is I, CF 3, Br, Cl, or SnR3;
R is an alkyl group or OH; and
Q is CN.
(Steiner i-fi-f 17-23.) Steiner also describes an embodiment in which "Zin
compound (IIA) is CN." (Id. i125.)
Thus, Steiner describes an embodiment of compound (IIA) that differs
from the claimed compound S-(I) only in the choice of substituent Y: Cl in
compound S-(I); any of I, CF3, Br, Cl, or SnR3 in compound (IIA). We
agree with the Examiner that the person of ordinary skill in the art would
immediately envisage compounds having any of I, CF 3, Br, Cl, or SnR3 at
position Y, and therefore Steiner's disclosure anticipates claim 2 on appeal.
See In re Petering, 301F.2d676, 681-82 (CCPA 1962) (A disclosure that
allows one skilled in the art to "at once envisage each member of [a] limited
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Appeal2014-007036
Application 11/826, 195
class" describes each member of the class "as if [the reference] had drawn
each structural formula or had written each name.").
Appellants argue, however, that Petering does not apply here.
Appellants argue that the possible substituents at position Y of Steiner's
compound (IIA) include SnR3, where R can be alkyl or OH, and "[a]t its
broadest R may have 1-12 carbons." (Appeal Br. 8.) Appellants argue that
"SnR3 represents Sn(alkyl)3, Sn(alkyl-1 )(alkyl-2)(alkyl-3), Sn(alkyl-1 )2(alkyl-
2), Sn(alkyl)20H, Sn(alkyl-l)(alkyl-2)0H, and Sn(alkyl)(OH)2 were [sic]
alkyl may vary from 1-12 carbons and be substituted or unsubstituted." (Id.)
Thus, Appellants argue, "the genus of Formula IIA contains an impractically
large number of compounds." (Id.)
We disagree with Appellants' characterization of Steiner's substituent
Y. Steiner defines Y as I, CF 3, Br, Cl, or SnR3; thus, there are only five
possibilities for Y and only SnR3 includes more than one chemical group.
So even if the subgenus of SnR3 substituents is large, the genus of
substituents for the Y position is limited to five possibilities.
Appellants also argue that Steiner shows a clear preference for CF 3 at
the Y position, and does not exemplify any compounds of formula IIA
where Y is Cl. (Appeal Br. 11.) However, Steiner expressly states that the
Y substituent can be chlorine and therefore a skilled artisan would have at
once envisaged Steiner's disclosed embodiment in which Z=CN, and the Y
substituent is Cl.
Claims 4, 80, and 81 have not been argued separately and therefore
fall with claim 2. 37 C.F.R. § 41.37(c)(l)(iv).
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Appeal2014-007036
Application 11/826, 195
II
The Examiner has rejected claims 2, 4, 80, and 81 as obvious in view
of Steiner. The Examiner finds that Steiner's formula (IIA) defines a genus
of compounds that includes compound S-(I), and that Steiner's compound
N-4 is the same as compound S-(I) except at position Y, where N-4 has CF3
instead of Cl, as claimed. (Ans. 11.) The Examiner also finds that Steiner's
compound 7 is the same as compound S-(I) except at position Q, where N-4
has F instead of CN, as claimed. (Id.) The Examiner concludes that the
claimed compound would have been obvious in view of Steiner (id. at 14)
and Appellants' evidence of nonobviousness does not outweigh the evidence
favoring obviousness (id. at 15).
We agree. Even if a person of ordinary skill in the art did not at once
envisage compound S-(I) based on Steiner's disclosed embodiment in which
position Z is CN and position Y can only be I, CF 3, Br, Cl, or SnR3, it would
have been obvious to choose Cl for position Y, and thus result in the claimed
compound.
Appellants argue that the claimed compound would not have been
prima facie obvious based on Steiner (Appeal Br. 14--18) but, for the reasons
discussed above, we disagree.
Appellants also argue that the Dalton Declaration 3 presents evidence
that the claimed compound has unexpectedly superior properties compared
to the closest prior art. (Id. at 18-22.)
3 Declaration under 37 C.F.R. § 1.132 of James T. Dalton, signed April 15,
2013.
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Appeal2014-007036
Application 11/826, 195
We have considered the Dalton Declaration but do not agree that it
presents objective evidence of nonobviousness that outweighs the evidence
favoring obviousness. Dr. Dalton declared that the Specification's Example
4 shows that compound S-(I) inhibits progesterone receptor activity,
"indicating it possesses an unexpected anti-progestin activity." (Dalton
Deel. i-f 7.) However, the Specification's Example 4 shows results only for
compounds S-(I), S-(II), and S-(III). (Spec. 128-131.) Compounds S-(II)
and S-(III) are not encompassed by Steiner's formula (IIA). Thus, the
Specification does not provide a comparison to the closest prior art, which
would be Steiner's exemplified compound N-4.
Dr. Dalton, however, states that a "[ d]irect comparison of
progesterone receptor (PR) antagonist activity of S-1 versus compound N-4,
as presented in Exhibit 1 [of the declaration], shows a IO-fold increased
potency for S-1, i.e., increased antagonist activity." (Dalton Deel. i-f 8.)
Exhibit 1 attached to the Dalton Declaration shows a "Comparison of
S-(I) and N4 on PR Activity," and states that S-(I) has an IC50of17 .05 nM
and N4 has an IC50of162.92 nM, a roughly ten-fold difference in their
effect on "RLU," the parameter measured in Exhibit 1. But Dr. Dalton does
not explain what, if any, experiments were done to generate the graph shown
in Exhibit 1 or, if the data were drawn from references, what those
references are. Therefore, we have no way to determine whether the graph
shows a valid, side-by-side comparison of the two compounds. Because we
cannot tell whether Exhibit 1 of the Dalton Declaration shows results for
compounds S-(I) and N-4 under comparable conditions, we give the
evidence presented therein little weight.
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Application 11/826, 195
The same applies to Exhibit 4 of the Dalton Declaration. Dr. Dalton
states that, in dogs, compound S-(I) "demonstrates a pharmacokinetic half-
life of: ty, (h) = 10.4 ± 0.5 .... and a clearance of CL (mL/min/kg) = 1.68 ±
0.13." (Dalton Deel. i-f 11, citing Example 7 of the Specification.) Dr.
Dalton states that Exhibit 4 of the declaration shows that "[ t ]he higher
clearance (CL of 1.68 mL/min/kg vs. 0.59 mL/min/kg for compound N-4)
affords the shorter half-lives for S-1 compared to compound N-4 by all
routes studied, which better mimics endogenous testosterone levels." (Id.)
Again, however, Dr. Dalton does not describe how the data presented
in Exhibit 4 were derived. Neither Appellants' Specification nor the Dalton
Declaration describes how the data in the Specification's Example 7 and the
Dalton Declaration's Exhibit 4 were generated. Thus, we cannot determine
whether the data represent a valid, side-by-side comparison of the claimed
S-(I) compound and the prior art N-4 compound. We therefore give the
evidence presented in Exhibit 4 of the Dalton Declaration little weight.
Dr. Dalton also declares that compound "S-1 demonstrates enhanced
tissue selective anabolic activity with respect to Steiner's ... Compound 7 ."
(Dalton Deel. i-f 10.) Dr. Dalton states that the data in the declaration's
Exhibit 2 "shows increased levator ani muscle agonist efficacy in
orchidectimized subjects of a compound of S-1, i.e.> 100% levator ani
weight at 0.3 mg/d." (Id.)
However, Steiner's compound 7 is not encompassed by its formula
(IIA) because it has a fluorine (F) at position Q, while formula (IIA) requires
position Q to be CN. Steiner discloses that its compound N-4, which differs
from the claimed compound S-(I) only at position Y (CF3 in N-4, Cl in S-(I))
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Application 11/826, 195
"significantly increased the weight of the levator ani muscle to ...
142%±17% ... of that observed in intact controls." (Steiner i-f 190.)
Appellants have not explained why the activity of compound S-(I) (> 100%)
would have been unexpected when compared to that of the prior art
compound N-4 (142%±17%). The preponderance of evidence thus supports
a conclusion that compound S-(I) would have been obvious based on
Steiner.
Claims 4, 80, and 81 have not been argued separately and therefore
fall with claim 2. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm both of the rejections 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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