Ex Parte Schneider et al

Patent Trial and Appeal Board

Dec 27, 2017

14310619 (P.T.A.B. Dec. 27, 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.
14/310,619 06/20/2014 Jay Schneider UTSD.P1845US.D1 7895
108197 7590 12/29/2017
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
Austin, TX 78746
EXAMINER
OTTON, ALICIA L
ART UNIT PAPER NUMBER
1626
NOTIFICATION DATE DELIVERY MODE
12/29/2017 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):
docket @ phiplaw .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAY SCHNEIDER, JENNY HSIEH,
DOUGLAS FRANTZ, STEVEN L. MCKNIGHT,
and JOSEPH M. READY1
Appeal 2017-004290
Application 14/310,619
Technology Center 1600
Before RICHARD E. LEBOVITZ, JOHN G. NEW, and
RICHARD J. SMITH, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellants state that the real parties-in-interest are The Board of Regents,
University of Texas System, assignee, and the licensee, Lone Star Heart.
App. Br. 3
Appeal 2017-004290
Application 14/310,619
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 14—16 and 27 as unpatentable under
35 U.S.C. § 112, first paragraph, for failure to comply with the written
description requirement.2
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CFAIMED INVENTION
Appellants’ invention is directed to compounds and methods for
inducing neuronal differentiation in normal neural stem cells and brain
cancer stem cells. Abstract.
REPRESENTATIVE CLAIM
Claim 14 is representative of the claims on appeal and recites:
14. A method of inducing neuronal differentiation in a stem
cell comprising contacting said stem cell with a compound
of formula (II):
2 The Examiner’s rejection of claims 17—26 as unpatentable under 35 U.S.C.
§ 112, second paragraph, as being indefinite, has been withdrawn. See
Final Act. 3; Ans. 4.
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Application 14/310,619
Ri is substituted or unsubstituted thiophenyl or a substituent of
formula (A):
(A)
wherein:
Ra, Rb and Rc are each independently selected from the group
consisting of hydrogen, halogen, alkyl or cycloalkyl,
aralkyl, aryl, cyano, and nitro; and
G is O, -NH, or S;
R2 is hydrogen, hydroxy, halogen, nitro, aryl, alkyl, alkoxy,
alkenyl, alkenyloxy, alkynyl, alkynyloxy, aralkyl, -CHO,
-C(0)R9, -OC(0)R9, -OC(0)OR9, -0(CN)OR9, -
C(0)NR9Rio, -OC(0)NR9Rio, -NR9ORio or -S03R9;
wherein
R9 and Rio are each independently hydrogen, alkyl, aryl,
or aralkyl;
R3 is -NH-O-alkyl, -NH-OH, -ORn or-NRnRi2, wherein
R11 and R12 are each independently hydrogen, alkyl,
alkenyl, alkynyl, aryl, or aralkyl; or
Rl 1 and R12 together with the nitrogen to which they are
bound form a cyclic group;
X is O, S or -NR13, wherein R13 is hydrogen, alkyl, aryl, or
aralkyl;
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Application 14/310,619
or a stereoisomer, solvate, hydrate, or pharmaceutically
acceptable salt thereof.
App. Br. 9-10.
ISSUES AND ANALYSES
We adopt the Examiner’s findings of fact and conclusion that the
appealed claims are not supported by the requisite written description. We
address the arguments raised by Appellants below.
Issue
Appellants argue that the Examiner erred in finding inadequate
written support in Appellants’ Specification for the limitation of claim 14
that X can be S (i.e., a sulfur atom) in formula II. App. Br. 5.
Analysis
The Examiner finds that Appellants’ Specification and the claims as
originally filed showed that there was no disclosure that X can be S in
formula II. Final Act. 4. The Examiner finds the disclosure for formula (II),
in its most generic sense, is located at page 6 of the Specification, where it is
disclosed that X is O or -NRb. The Examiner also finds that formula (III),
said to be a subgenus of formula (II), defined at pages 7—8, discloses that X
is defined as O, NH or S. Id. However, although X as S is disclosed for this
particular subgenus of compounds of formula III, there is no disclosure of X
as S over the entire spectrum of disclosed compounds falling outside of
formula (III). Id. The Examiner further finds that there are no examples in
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Application 14/310,619
the Specification of compounds corresponding to the claimed formula where
X is S. Id.
Appellants argue that the Specification expressly discloses that
formula II can be further defined as formula III, i.e., the compounds of
formula III are a subgenus of formula II. App. Br. 5. In order for formula
III to be a subset of formula II, Appellants assert, X being S must be an
option for formula II, given that S is expressly an option as set forth formula
III. Id. According to Appellants, the fact that X can S for formula II is not
explicitly disclosed by the Specification is immaterial. Id. at 5—6.
Appellants assert that a skilled artisan would recognize that formula II
should in fact include the possibility of S for X based upon the subsequent
descriptions of formula III, which shows X as an option for formula III. Id.
at 6.
Appellants contend that there is no logical explanation why S would
be excluded as an option for X in the broader structure of formula II when it
clear is an option for the narrower version of formula III. App. Br. 6.
(citing Ex parte Marsili, USPQ 904, 906 (BPAI 1979) (“Amending a
specification by inserting an inherent property or correcting an erroneous
structural formula of a compound which is necessarily produced by a
disclosed process or example does not involve prohibited ‘new matter’”).
Appellants argue that they are simply correcting an erroneous structural
formula of a compound which is necessarily produced by the disclosed
process or example for which the errors would be obvious to a person of an
ordinary skill in the art. Id.
Appellants next point to an exemplary embodiment disclosed in the
Specification that they contend illustrates that X can be S:
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Application 14/310,619
>
/7"H
C?' -
O
H
N V
\/
App. Br. 7; see Spec. 21. Appellants contend the presence of this particular
example showing X as S is dispositive of the issue. Id.
The Examiner responds that although it would be clear to a person of
ordinary skill that there is an error in the definition of the claimed
compounds with respect to X, a review of Appellants’ Specification and
claims as originally filed does not lend any clarity to the question of whether
the error was an error of omission of X as S from Formula II or an error of
inclusion of X as S in Formula III. Ans. 5. The Examiner finds that despite
Appellants’ contention that the inclusion of X as S in the “narrower”
Formula III would have provided the requisite description to insert X as S
into the broader Formula II, the Examiner finds that Formula III, as
originally described and claimed, was not a narrower subset in every respect
because the definition of X was broader in the supposedly narrower subset.
Id.
The Examiner does not disagree that there is obviously an error in the
way the generic compounds have been defined in the specification. Ans. 6.
However, the Examiner finds the issue is whether a skilled artisan would
have known “with reasonable clarity” that Appellants intended to include X
as S in the broad description of formula II. Id. The Examiner concludes that
it would have been just as reasonable for the skilled artisan to believe that
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Application 14/310,619
the inclusion of X as S in the subgeneric formula (Ill) is, in fact, the error,
because it was not recited in the broader formula (II). Id.
Additionally, the Examiner finds Appellants’ reliance upon Mars Hi is
misplaced. Ans. 5. The Examiner finds that, in the present instance, the
compounds where X is S are not “necessarily produced by a disclosed
process or example” since there is no disclosed process or example having X
as S. Id. (emphasis added).
Finally, the Examiner disagrees with Appellants’ assertion that the
embodiment depicted on page 21 of the Specification describes S as being X
in Formula II. Formula II is depicted below:
Fh
m
The embodiment from page 21 is similarly reproduced below:
The Examiner finds the page 21 embodiment does not teach X as S as
depicted in Formula II because Formula II requires that X be positioned
directly adjacent to the N on the pentyl ring structure, and it is not so
positioned in the embodiment depicted on page 21. Ans. 7.
We find that the Examiner has the better position. As an initial
matter, we agree with the Examiner’s finding, for the reasons explained by
the Examiner, that the embodiment depicted on page 21 of the Specification
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Application 14/310,619
does not depict an embodiment of the claimed Formula II with an S at the
claimed position of X.
Moreover, we are not persuaded that Marsili, upon which Appellants
rely, is apposite to the facts of this appeal. Claim 14 does not recite a
process, or an example, that necessarily, and thus inherently, contains S at
the X position; rather, S in claim 14 is one of a number of possible
substituents at X.
Furthermore, we agree with both Appellants and the Examiner that the
discrepancy as to what constitutes X in Figure 2 is likely the result of a
drafting error by Appellants. Claim 14 recites that, with respect to Formula
II: “X is O, S or -NRb.” In the Specification, however, X in Formula II is
described as“X is O or -NRb,” with no express or implicit disclosure that X
can be S. Spec. 6. We note that claim 14 did not originally recite S as a
substituent for X, which was subsequently added by amendment of the
claim, although claim 17, which depends from claim 14, does list S as a
possible X. See claims 14, 17, filed June 20, 2014.
However, the Specification also discloses that: “In particular
embodiments, a compound of formula (II) is further defined as a compound
of formula (III).” Spec. 7. X in Formula III is located in the same position
as X in Formula II, however the Specification discloses that, for Formula III:
“X is O, NH, or S.” Id. at 8.
There thus exists an ambiguity between claim 14 and Appellants’
Specification: does X in Formula II include S, as recited in the claims, or
does it not, as disclosed in the Specification? We agree with the Examiner’s
point that a person of ordinary skill in the art would be unable to determine
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Application 14/310,619
whether the existence of S in the claim but not in the Specification
represents an error of omission or commission.
Appellants argue that it is but common sense that errors of omission
(i.e., that the absence of X as S for Formula II in the Specification is an
inadvertent omission) are more common and understandable by a skilled
artisan than errors of commission (i.e., that the presence of X as S for
Formula II in claim 14 is an error of commission) (see App. Br. 7; Reply Br.
6), but in the absence of any objective evidence that this was the case in the
current instance, Appellants’ contention is no more than attorney argument,
to which we accord little probative weight. See In re De Blauwe, 736 F.2d
699, 705 (Fed. Cir. 1984) (Arguments and conclusions unsupported by
factual evidence carry no evidentiary weight).
Rather, a newly added claim limitation, such as the addition of S for X
in claim 14, must be supported in the Specification through express, implicit,
or inherent disclosure. 35 U.S.C. § 112, first paragraph; see also MPEP
§ 2163(I)(B). An amendment to correct an obvious error does not constitute
new matter where one skilled in the art would not only recognize the
existence of the error in the specification, but also recognize the appropriate
correction. Id.; see In re Oda, 443 F.2d 1200, 1204 (C.C.P.A. 1971)
(“[AJmendments may be made to patent applications for the purpose of
curing defects, obvious to one skilled in the art, in the drawings or written
descriptions of inventions”). But Appellants have not provided any
objective evidence, such as a declaration by a person of skill in the art, to
support their contention that such a person of ordinary skill would recognize
that S is an obvious substituent (such as for O) at X and would recognize the
appropriate correction, viz., the addition of S as an X substituent. Absent
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Application 14/310,619
such objective evidence, we cannot conclude that the drafting error in
Appellants’ claims is a mistake that would have been obvious to a person of
ordinary skill in the art.
Moreover, the Specification’s disclosure that X can be S in Formula
III only compounds the ambiguity with respect to claim 14. Both Formulae
II and III depict an X in the same position adjacent to the N, but the X in
Formula III includes S, whereas the Specification discloses that X in
Formula II does not include S.
We note particularly, however, that this analysis does not invalidate
the subgenus of Formula III itself. Formula III is recited in Appellants’
claim 17:
The method of claim 14, wherein the compound of formula (II)
is further defined as a compound of formula (III):
wherein:
Ri and R2 are both hydrogen; or
Ri is hydrogen and R2 is selected from the group consisting of
substituted or unsubstituted Ci-C6 alkyl, C3-C6
cycloalkyl, C2-C6 alkenyl, C2-C6 alkynyl and benzyl; or
Ri and R2 may be joined together to form a ring selected from
azetidinyl, pyrrolidinyl, piperidinyl, piperazinyl and
morpholinyl;
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Application 14/310,619
R2, R3 and R4 are independently selected from the group
consisting of hydrogen, halogen, C1-C6 alkyl, C3-C6
cycloalkyl, substituted or unsubstituted aromatic or
heteroaromatic ring, cyano, nitro, and a carbonyl group;
X is O, NH, or S; and
Y is O, NH, or S,
or a stereoisomer, solvate, hydrate, or pharmaceutically
acceptable salt thereof.
The Examiner’s objection to claim 17 has been withdrawn. Ans. 4.
In summary, we are not persuaded, absent any objective evidence, by
Appellants’ argument that a person of ordinary skill in the art would
understand, with reasonable clarity, that X in Formula II includes S. The
direct ambiguity between the Specification’s description of X in Formula II
and the recitation of the composition of X in claim 14 would have caused a
person of ordinary skill in the art to be uncertain as to whether the drafter’s
error was in the Specification or in the claim. Nor are we persuaded by
Appellants’ contention that the Specification’s description of X as including
S in Formula III resolves this issue by requiring that, at least in the Formula
III subgenus, X must include S. As we have explained, we find that this
merely compounds the Specification’s ambiguity. We consequently affirm
the Examiner’s rejection.
DECISION
The Examiner’s rejection of claims 14—16 and 27 as unpatentable
under 35U.S.C. § 112, first paragraph, is affirmed.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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