Ex Parte Warner et al

Patent Trial and Appeal Board

Feb 2, 2018

14040393 (P.T.A.B. Feb. 2, 2018)

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.
14/040,393 09/27/2013 John C. Warner 141-027 7269
36844 7590 02/06/2018
Pp.rmak Nalcaiima Rr Mofrnwan T T P
EXAMINER
127 S. Peyton Street, Suite 200
ALEXANDRIA, VA 22314
DESAI, RITA J
ART UNIT PAPER NUMBER
1625
NOTIFICATION DATE DELIVERY MODE
02/06/2018 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):
CGOODE@cnmiplaw.COM
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN C. WARNER, JEFFERY ALLEN GLADDING,
SRINIVASA R. CHERUKU, DIEU NGUYEN,
JEAN R. LOEBELENZ, JAMES J. NORMAN,
SAMBAIAH THOTA, JOHN W. LEE JR., and
CRAIG ROSENFELD
Appeal 2016-006032
Application 14/040,3931
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a compound
for use in treating an ocular or neurodegenerative disease. The Examiner
entered final rejections that the claims are indefinite and for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify the Real Party in Interest as Collaborative Medicinal
Development LLC, of Sausalito, California. App. Br. 2.
Appeal 2016-006032
Application 14/040,393
STATEMENT OF THE CASE
Background
Presently, there [is] no known prevention or cure for
neurodegenerative diseases or disorders such as Alzheimer’s disease (AD),
Parkinson’s disease (PD) and prion diseases (PrDs). It has been
demonstrated that an aberrant protein has a propensity to misfold in the
presence of certain concentrations of metal ions. Spec. 12.
There is a continuing need for the synthesis and development of novel
and effective compounds that are selective neuroactive agents for the
treatment of diseases of the central nervous system (CNS) and for
oncological diseases. Id. 13.
The Specification discloses “compounds, compositions and methods
for the treatment of such diseases or disorders.” Id. 12.
The Claims
Claims 1—13, 15—20, and 22—33 are pending. Ans. 2. Claims 23—33
are withdrawn. Id. Claims 1—13, 15—20, and 22 are under examination and
are rejected. Id. Claim 1 is illustrative and reads as follows:
1. A compound of the formula 1:
i • ■* v. \. * .•- . .
E:b? • v • R: •’
wherein:
2
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Application 14/040,393
X1 is -OH or-NRiR2;
2 3
X is selected from the group consisting of -NR -, -O- and
-S(0)!.2.;
A is selected from the group consisting of -C(O)- and -CH2;
2
A is selected from the group consisting of -C(O)- and -CH2;
1 2
R and R are each independently H, substituted or unsubstituted
Ci-C6 alkyl, X-C1-C6 alkyl, substituted or unsubstituted C5-10 aryl,
substituted or unsubstituted -C1-6 alkyl-C6-io aryl, substituted or
unsubstituted Ci_6 alkylC(O)-, X-C1-6 alkylC(O)-, substituted or
unsubstituted C1 _e alkylS(O)1"2", substituted or unsubstituted C1-6
alkylNR'C(O)-, X-C1.6 alkylNR'C(O)-, X-Ci-6 alkoxyC(NR")- and
substituted or unsubstituted Ci_6 alkoxyC(NR")-;
R’ and R” are each independently selected from the group
consisting of H, substituted or unsubstituted Ci_6 alkyl and substituted
and unsubstituted Ci_6 alkyl-C6-io aryl;
3
R is H or selected from the group consisting of substituted or
unsubstituted C\s alkyl, substituted or unsubstituted C5-10 aryl, substituted
or unsubstituted -C\.e alkyl-C6-io aryl, substituted or unsubstituted -C1-6
alkyl-Cs-io heteroaryl, substituted or unsubstituted C1-6 alkylC(O)-,
substituted or unsubstituted Ci_6 alkyl-S(O) 1 _2-, substituted or unsubstituted
Ci-6 alkylNHC(O)- and substituted or unsubstituted C1 _e alkoxyC(NR')-;
R , R and R are each independently H or substituted or
unsubstituted Ci_6 alkyl;
13
R is H or is selected from the group consisting of X, halo,
substituted or unsubstituted C1.6 alkyl;
each X is independently selected from the group consisting of1311,
124 1 , 125 1 , 3H,1231,18F, 19F, ^Br and 76Br; or
a pharmaceutically acceptable salt thereof.
App. Br. 14 (Claims App.).
3
Appeal 2016-006032
Application 14/040,393
The Issues
The following rejections are before us to review:
Claims 1—13, 15—20, and 22 are rejected under 35 U.S.C. § 112(b) or
35 U.S.C. § 112 (pre-AIA), second paragraph, as indefinite. Ans. 3.
Claims 1—13, 15—20, and 22 are rejected under 35 U.S.C. § 103 as
obvious over Brana2 and Hamel.3 Id. at 6.
I - INDEFINITENESS
The Examiner finds that the claims “ha[ve] many variables and use[]
the term ‘substituted’ without any clear definition of what these substituents
are. The full scope of the claims cannot be envisioned and the metes and
bounds are not clear.” Ans. 3. The Examiner finds:
According to the specifications these substituents are defined as
some groups “and the like”. R3 still has so many different
substituents, and the core itself has so many variable with X2
being a N, O or a S, and these groups are further substituted.
This does not clearly define the full scope of the claims.
Final Act. 2.4
The Examiner cites a passage from the Federal Register stating in part
“that a Markush group that encompasses a massive number of distinct
alternative species may be indefinite under $112, |2 if one skilled in the art
2 Miguel F. Brana, et al., Synthesis, Biological Activity, and Quantitative
Structure—Activity Relationship Study of Azanaphthalimide and
Arylnaphthalimide Derivatives, 47: J. Med. Chem., 2236—2242 (2004)
(“Brana”).
3 US 2010/0314556 Al, pub. Dec. 16, 2010 (“Hamel”).
4 Examiner’s Final Action, mailed March 18, 2015 (“Final Act.”).
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Appeal 2016-006032
Application 14/040,393
cannot determine the metes and bounds of the claim due to an inability to
envision all of the members of the Markush group.”5 Id. at 4.
Appellants argue that “there is no guidance in the MPEP or elsewhere
as to what constitutes a ‘massive number’ of distinct alternative species,
such that they might render the claim indefinite.” App. Br. 7. Appellants
cite to claim 1 from U.S. Patent No. 8,916,564 (“’564 patent”), which they
allege is similar in scope. Id. at 7—10. Appellants further argue that the
Examiner, during a personal interview, “expressed concern that the claim
term ‘heteroaryl’ encompassed an inconceivably large number of possible
substituents” while claim 1 of the ’564 patent also recites “heteroaryl” and
“the claims are not rejected as indefinite on the basis that the metes and
bounds of the claim are unclear because of the term ‘heteroaryl.’” Id. at 10.
Finally, Appellants argue the skilled artisan “armed only with a pencil and
paper, could sketch out the chemical structure of any compound
encompassed by the rejected claims.” Id. al 11.
The issue with respect to this rejection is whether the Examiner erred
in concluding that “substituted” as used throughout the claims renders the
claims indefinite.
The independent claims recite that each of the R groups of the claimed
compound is a specified molecule, or “substituted or unsubstituted” species
(e.g., “R’ and R” are each independently selected from the group
consisting of H, substituted or unsubstituted Ci_6 alkyl and substituted and
unsubstituted -Cl.6 alkyl-Cs-io aryl).
Appellants’ Specification defines “substituted or unsubstituted” as:
5 Federal Register Vol. 76, Feb. 2011.
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Appeal 2016-006032
Application 14/040,393
[0050] “Substituted or unsubstituted” or “optionally
substituted” means that a group such as, for example, alkyl,
aryl, heterocyclyl, (Ci-g)cycloalkyl, hetrocyclyl(Ci-8)alkyl,
aryl(Ci-g)alkyl, heteroaryl, heteroaryl(Ci-g)alkyl, and the like,
unless specifically noted otherwise, may be unsubstituted or
may substituted by 1, 2 or 3 substitu[]ents selected from the
group such as halo, trifluoromethyl, trifluoromethoxy, methoxy,
carboxy, -NH2, -N02, -OH, -SH, -SMe, -NHCH3, -N (CH3)2,
-CN and the like.
Spec. 1 50.
We agree with the Examiner that “the like” as used in the
Specification is broad. However, the fact that a claim is broad does not
mean that it is indefinite, and even undue breadth is not indefiniteness. In re
Johnson, 558 F.2d 1008, 1016 n.17 (CCPA 1977). See also In re Miller,
441 F.2d 689, 693 (CCPA 1971) (cf. MPEP § 2173.04).
Our reviewing court has held that prior to issuance, the test for
indefiniteness under 35 U.S.C. § 112, second paragraph is a “lack of clarity
(in its several forms) based on the perspective of one of ordinary skill in the
art in view of the entire written description and developing prosecution
history.” In re Packard, 751 F.3d 1307, 1312 (Fed. Cir. 2014).
We are persuaded by Appellants that a person having ordinary skill in
the art would have understood the variations for substitution of the R groups
in the compounds as guided by the Specification. We find “the like” as used
above would have informed the ordinarily skilled artisan that substitutions
should be made using chemically similar compounds as taught elsewhere in
the Specification (e.g., Spec. ]Hf 42-47), which would have been within the
scope of the artisan’s understanding upon reading the Specification. While
we understand the need for the Examiner to object or reject claims to ensure
clarity of the precise scope of the claims, we find the preponderance of the
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Application 14/040,393
evidence supports the Appellants’ position that the bounds of the claims
would be understood by one of skill in the art. We reverse the indefiniteness
rejection.
II - OBVIOUSNESS
Issue
The Examiner finds that Brana discloses compounds as formula 14 as
shown below:
! OV/ .» \
l ^ ws?/ ••••••••-";x,
t \^ / X
1 X /"■
i/- 5
*
'’"VfU,, y
L
%
^ 2
lit: « fcrsVA 12 ¥' » pHrgrVs
it:: V « 'OH
If: Y ■* »o
'■ “ c
Ans. 7.
The Examiner finds Hamel discloses that compounds of the formula
shown below, having a substitution “at the same position as appellant’s
claims.” Id.
The Examiner finds that Brana discloses its formulations 14 and 15,
“wherein the OH is next to the N of the ring are not so active because of the
formation of the carbonyl bond.” Id. at 8.
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Application 14/040,393
The Examiner finds that Brana’s reported inactivity is “a problem to
solve,” and that the skilled artisan “would be motivated to move the -OH
group to a different location of the compound, to a place where it would not
form a carbonyl group, i.e. not in the ring with a N” and that Hamel teaches
substitution of this kind “is easily made at the position wherein appellant’s
XI group is substituted.” Id. The Examiner concludes the skilled artisan
would have been motivated to “make a substitution at that position” to arrive
at the claimed compound. Id.
Appellants argue, inter alia, that the rejection should be reversed
because the skilled artisan would not have been motivated to combine
Hamel and Brana. App. Br. 11. Appellants argue that the “Examiner does
not provide any rationale, scientific or otherwise” in support of the
motivation to combine, and that because the Brana molecule identified by
the Examiner is inactive, “Brana teaches away from the presently claimed
invention.” Id. at 12.
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that the skilled artisan
would have been motivated to modify Formula 14 or 15 of Brana.
Although the Supreme Court has emphasized “an expansive and
flexible approach” to the obviousness question, KSR Int 7 Co. v. Teleflex
Inc., 550 U.S. 398, 415 (2007), the Court, nonetheless, has also reaffirmed
the importance of determining “whether there was an apparent reason to
combine the known elements in the fashion claimed by the patent at issue.”
Id. at 418. In other words, the Court has explained, “there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness.” Id. (citation and quotation marks omitted).
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Application 14/040,393
In the present case, Appellants persuade us that a preponderance of
the evidence does not support the Examiner’s prima facie case of
obviousness as to the independent claims. In particular, we agree with
Appellants that the Examiner has not advanced a sufficiently rational
underpinning that explains why an ordinary artisan would have been
motivated to modify Formula 14 or 15 of Brana, given that those compounds
were deemed inactive. We reverse the rejection.
SUMMARY
We reverse both rejections on appeal.
REVERSED
9