Ex Parte Baroni et al

Patent Trial and Appeal Board

Sep 9, 2016

13201141 (P.T.A.B. Sep. 9, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/201,141 08/11/2011
89300 7590 09/13/2016
Sanofi/Genzyme c/o Morrison & Foerster LLP
755 Page Mill Road
Palo Alto, CA 94304
FIRST NAMED INVENTOR
Marco Baroni
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.
183952008400 7154
EXAMINER
BERNHARDT, EMILY A
ART UNIT PAPER NUMBER
1624
NOTIFICATION DATE DELIVERY MODE
09/13/2016 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):
EOfficeP A@mofo.com
PatentDocket@mofo.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARCO BARONI and LETIZIA PULEO
Appeal2015-001685
Application 13/201,141
Technology Center 1600
Before DONALD E. ADAMS, JOHN G. NEW, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 1---6, 8, 9, 11-
14, and 17-19 (App. Br. 2). Examiner entered rejections under obviousness-
type double patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Appellants' disclosure "relates to substituted 3-benzofuranyl-indol-2-
one-3-acetamidopiperazine derivatives, to their preparation and to their
therapeutic application" (Spec. 1: 6-8).
1 Appellants identify the Real Party in Interest as "Sanofi" (see App. Br. 2).
Appeal2015-001685
Application 13/201, 141
Claims 1 and 5 are representative and reproduced below:
1. A compound of formula (I):
wherein:
RI represents a hydrogen atom or a (Cl-6)alkyl, -
C(=O)(Cl-6)alkyl or---C(=O)aryl group;
R2, R3 and R4, which may be identical or different,
located on any of the available positions of the phenyl nucleus,
independently represent a hydrogen atom, a halogen atom, CN,
OH, a (C 1-6)alkyl group optionally substituted with a halogen
atom or an OH; perhalo(Cl-3)alkyl, (Cl-6)alkoxy, perhalo(Cl-
3)alkoxy, aminocarbonyl, (C 1-6)alkylaminocarbonyl, di(C 1-
6)alkylaminocarbonyl, aryl, aryloxy; heteroaryl;
the aryl, aryloxy or heteroaryl group possibly being
optionally substituted with a halogen atom, CN, OH or a (Cl-
6)alkyl, perhalo(Cl-3)alkyl or (Cl-6)alkoxy group; it being
understood that at least one from among R2, R3 and R4 is other
than Hand that the aryl, aryloxy or heteroaryl group may be
optionally substituted with a halogen atom, CN, OH or a (Cl-
6)alkyl, perhalo(Cl-3)alkyl or (Cl-6) alkoxy group;
R5 and R6, which may be identical or different, represent
a hydrogen atom or a group (Cl-6)alkyl or R5 and R6 together
form a C3-C6 ring;
R7 represents a group (Cl-C6)alkyl or a group (C2-
6)alkenyl;
R8 and R9 represent a hydrogen atom, a group (Cl-
C6)alkyl or a group (C2-6)alkenyl, it being understood that at
least one from among R8 and R9 is other than H;
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Appeal2015-001685
Application 13/201, 141
or two from among R7, R8 and R9 together form a C3-
C6 ring;
it being understood that R8 and R9 may be in the geminal
position on the same carbon atom;
n represents 1 or 2;
in the form of the base or of an acid-addition salt.
(Emphasis added.)
5. The compound according to Claim 1, wherein the compound is:
Compound No. 1: (+ )-N-[ 4,6-dichloro-3-(benzofuran-5-yl)-2-oxo-
2,3dihydro-1H-indol-3-yl]-2-( 4-ethyl-3,5-dimethylpiperazin-1-yl)acetamide;
in the form of the base or of an acid-addition salt.
Claims 1---6, 8, 9, 11, 14, and 17-19 stand provisionally rejected under
the judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims 1---6, 8, 9, 11-14, 18, and 19 of Baroni '996.2,3
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness-type double patenting?
2 Baroni et al., US 2012/0040996 Al (Application 13/201, 138), published
Feb. 16, 2012. See Appellants' Sept. 11, 2014 App. Br. 15-22: Claims
Appendix (listing "[a] clean version of the claims on appeal"). We note,
however, that Appellants' App. Br. does not include pending claim 17.
3 Baroni '996 is the subject matter of Appeal 2015-001684. All reference to
Baroni '996's claims refer to the claims as they appear in the Appeal Brief
of Appeal 2015-001684
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Appeal2015-001685
Application 13/201, 141
FACTUAL FINDINGS (FF)
FF 1. Claim 1 of Baroni '996 is reproduced below:
A compound corresponding to formula (I):
in which:
~J ~--... o, , . / 'N--R5
~~ ,.--N .. , /
l. . ~I H. •• j. 1'-t~ ~., I N·--». n
R4 4".- . 0
!>X~ ·;?.
R;fb.· j . t -~·~o
e.')(.._,.,..~N"'
R2 ""'; 1'
Ri
(I\ . t
RI represents a hydrogen atom or a (Cl-6) alkyl, -C(=O)(Cl-6)alkyl
or -C(=O)aryl group;
R2, R3 and R4, which may be identical or different, located on any of
the available positions of the phenyl nucleus, independently represent a
hydrogen atom, a halogen atom, CN, OH, a (Cl-6)alkyl group optionally
substituted with a halogen atom or an OH; perhalo(Cl-3)alkyl, (Cl-
6)alkoxy, perhalo(C 1-3)alkoxy, aminocarbonyl, (C 1-6)alkylaminocarbonyl,
di(Cl-6)alkylaminocarbonyl, aryl, aryloxy; heteroaryl; the aryl, aryloxy or
heteroaryl group possibly being optionally substituted with a halogen atom,
CN, OH or a (Cl-6)alkyl, perhalo(Cl-3)alkyl or (Cl-6)alkoxy group; it
being understood that at least one from among R2, R3 and R4 is other than
Hand that the aryl, aryloxy or heteroaryl group may be optionally
substituted with a halogen atom, CN, OH or a (Cl-6)alkyl, perhalo(Cl-
3)alkyl or (C 1-6)alkoxy group;
R5 represents a (C 1-6)alkyl or (C2-6)alkenyl group;
n represents 1 or 2;
in the form of the base or of an acid-addition salt.
(Baroni '996, claim 1 ).
FF 2. Baroni '996's claim 5 is directed to "[t]he compound according to
claim 1 wherein said compound is (+)-N-[4,6-dichloro-3-(benzofuran-5-yl)-
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Appeal2015-001685
Application 13/201, 141
2-oxo-2,3-dihydro-lH-indol-3-yl]-2-( 4-ethylpiperazin-1-yl)acetamide; in the
form of the base or of an acid-addition salt" (Baroni '996, claim 5).
FF 3. Examiner finds that "the sole difference" between Appellants' claim
1 and Baroni '996 "is the requirement [in Appellants' claim 1] that one of
the R8/R9 [ substituents] on the piperazine carbons be other than hydrogen"
(Ans. 2).
FF 4. Examiner finds that "alkyl" falls within the scope of the "R8/R9"
substituents in Appellants' claim 1, wherein "the simplest member [of the
alkyl is] methyl" and Appellants' claim 5 includes "two methyl groups on
piperazine carbons," whereas the piperazine carbons of Baroni '996's claim
5 contain hydrogens (Ans. 2).
FF 5. Examiner finds that the substitution of a hydrogen for a methyl "in
otherwise similar compounds is not considered patentable absent evidence of
superior, unexpected results" (Ans. 2; see generally Ans. 4--9).
FF 6. Appellants claim a method of suppressing appetite in a patient in
need thereof by administering a therapeutically effective amount of a
pharmaceutical composition comprising the compound of Appellants' claim
1 to the patient (see Appellants' claims 1, 12, and 14).
FF 7. Baroni '996 claims a method of suppressing appetite in a patient in
need thereof by administering a therapeutically effective amount of a
pharmaceutical composition comprising the compound of Baroni '996's
claim 1 tothepatient(Baroni '996, claims 1, 14, and 19).
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Appeal2015-001685
Application 13/201, 141
ANALYSIS
The provisional obviousness-type double patenting rejection over Baroni
'996:
Based on Baroni '996, Examiner concludes that, "[a]lthough the
conflicting claims are not identical, they are not patentably distinct from
each other because" they represent adjacent homologs that differ only in the
presence (Appellants' claim 1) or absence (Baroni '996's claim 1) of a
methyl on a carbon atom of the piperazine (see Ans. 2-3; see id. at 5; FF 1-
5; cf Appellants' claims 1 and 5).
Appellants contend that Examiner failed to provide "sufficient
motivation for the artisan to modify the subject matter of [Baroni '996]" or
provide "a reasonable expectation of success" in making such a modification
(App. Br. 4; see id. at 8-9). Appellants further contend that Examiner
"presents no meaningful rationale for the proposed substitution of [methyl] .
. . for R8 and R9 in appealed Claim 1, for a fixed ring hydrogen of the
skeleton structure in Claim 1 of [Baroni '996]" (App. Br. 7; see also id. at 8-
9; Reply Br. 2). We are not persuaded.
Structural similarity creates a prima facie case of obviousness (see
Ans. 3--4). See In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990); In re
Shetty, 566 F.2d 81, 85-86 (CCPA 1977); cf In re Taborsky, 502 F.2d 775,
780-81 (Fed. Cir. 1974) ("To arrive at [Taborsky's] fluoro-substituted
compounds, one must modify the closest prior art compound ... in two
essential ways [i.e., position and identity of the relevant substituent]" and
"comparative evidence demonstrates that [Taborsky's] compounds possess
biological activities which are beyond what could reasonably be predicted
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Appeal2015-001685
Application 13/201, 141
by the person of ordinary skill in the art [of the other structurally similar
compounds]").
On this record, Examiner reasoned that the hydrogen containing
compounds of Baroni '996 are so closely related to the methyl containing
compounds of the appealed claims that there would have been an
expectation that they would have similar properties (see e.g., Ans. 2-3
(Appellants' claimed invention encompasses a compound that differs from
Baroni '996 by a single methyl group on a piperazine carbon)). Given that
the structural difference at issue is the change of a single hydrogen
substituent to a methyl , it is not surprising that the evidence on this record
establishes that compounds within the scope of both Baroni '996's claims
and Appellants' claims share the same utility (FF 6-7). In this regard, unlike
Taborsky, Appellants' fail to identify any unexpected difference between the
compounds of Baroni '972's claims and those claimed by Appellants. See
Taborsky, 502 F.2d 781; see also Dillon, 919 F.2d at 692-93.
Therefore, absent evidence to the contrary, we find that the evidence
on this record supports a conclusion that a person of ordinary skill in this art
would have found that compounds within the scope of Appellants' claimed
invention are obvious variants of compounds within the scope of Baroni
'996's claimed invention (see e.g., Ans. 3--4; see e.g., Appellants' claims 1
and 5; cf Baroni '972's claims 1 and 5; FF 1-7).
For the reasons set for by Examiner, we are not persuaded by
Appellants' contention that "[t]o the extent the instant application and
[Baroni '996] are considered to be filed on the same day via their respective
priority dates, then the ODP rejection should be withdrawn in the instant
case on the basis of' Appellants' interpretation of the Manual of Patent
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Application 13/201, 141
Examining Procedure (MPEP) § 804(l)(B)(l) (App. Br. 11-12; Reply Br. 2-
3; cf Ans. 9-10; see MPEP § 1490(V)(D)).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness-type double patenting.
The provisional rejection of claim 1 under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1---6, 8, 9, 11-14, 18, and 19 of Baroni '996 is affirmed. Claims 2-5,
8, 9, 11, 14, and 17-19 are not separately argued and fall with claim 1.
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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