Ex Parte Hallakou-Bozec et al

Patent Trial and Appeal Board

Nov 21, 2013

11997470 (P.T.A.B. Nov. 21, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte SOPHIE HALLAKOU-BOZEC, CHRISTINE CHARON,
BJOERN HOCK, and OLIVER POESCHKE
____________

Appeal 2012-002118
Application 11/997,470
Technology Center 1600
____________

Before LORA M. GREEN, ERICA A. FRANKLIN, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims directed to
a method of treating diabetes with an NMDH (N-methyl-D-aspartate)
receptor antagonist compound. The Examiner has rejected the claims as
obvious, and on the ground of nonstatutory obviousness-type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 Appellants identify Merck Patent Gesellschaft as the Real Party in Interest
(App. Br. 1).
Appeal 2012-002118
Application 11/997,470

2
STATEMENT OF THE CASE
Claims 1-8 and 10 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. Claims 1 and 3 are illustrative of the claims
on appeal, and read in relevant part:
1. A method of treating diabetes, metabolic syndrome, a
condition related to glucose homeostasia and energy
expenditure, or obesity comprising administering to a patient in
need thereof a therapeutically effective amount of a compound
formula (I) . . . .

3. A method according to claim 1 wherein the compound of
formula (I) is: 4-Hydroxy-2,3-dimethyl-5-phenyl-7 H-
thieno[2,3-b]pyridin-6-one. . . .
The Examiner has rejected the claims as follows:
I. claims 1-8 and 10 under 35 U.S.C. § 103(a) as unpatentable
over Gottschlich2 in view of Herrling3 and further in view of
Kato;4 and
II. claims 1-8 and 10 on the ground of nonstatutory obviousness-
type double patenting over U.S. Patent No. 5,602,144
(Gottschlich) in view of Herrling and further in view of Kato.
In response to the Election/Restriction requirement of Jan. 14, 2010,
Appellants elected 4-hydroxy-2,3-dimethyl-5-phenyl-7 H-thieno [2,3-
b]pyridin-6-one, having the structural formula as depicted below (see
response filed Feb. 16, 2010):

2 Rudolf Gottschlich et al., 5,602,144, issued Feb. 11, 1997.
3 Paul L. Herrling et al., 5,162,311, issued Nov. 10, 1992.
4 Martha M. Kato et al., Prevalence of Metabolic Syndrome in
Hispanic and Non-Hispanic Patients with Schizophrenia, 6 PRIMARY CARE
COMPANION CLIN. PSYCHIATRY (2004).
App
App

spec
elect
take
inclu
USP

I.
Gott
7 H-
discl
treat
schiz
that
struc
b]py
NMD
treat
conc
eal 2012-0
lication 11
When th
ies for exa
ed species
no positio
ding the r
Q2d 1461
The Issu
The Exa
schlich dis
thieno[2,3
osed that t
ment of ne
ophrenia
while “the
turally dif
ridin-6-on
A antago
ment of di
ludes that
02118
/997,470
e Examine
mination,
. It is app
n respectin
emaining,
(Bd. Pat. A
e: Obvious
miner find
closed the
-b ]pyridin
his compo
urodegene
(Ans. 11; s
specific N
ferent from
e, both typ
nists, whic
abetes mel
“one ordin
r has requ
the issue o
ropriate to
g the pate
non-electe
pp. Int. 1
ness over
s, and App
elected sp
-6-one (A
und is an N
rative dise
ee also FF
MDA ant
4-hydrox
es of com
h activity
litus” (An
ary skill i
3
ired the ap
n appeal i
limit discu
ntability o
d species.
987).
Gottschlic
ellants do
ecies 4-hy
ns. 6). Fu
MDA re
ase such a
s 2, 3). T
agonists ta
y-2,3-dim
pounds are
Herrling t
s. 11). Th
n the art w
plicant to
s the paten
ssion to t
f the broad
See Ex pa
h, Herrlin
not dispu
droxy-2,3
rthermore,
ceptor anta
s Alzheim
he Examin
ught by H
ethyl-5-ph
taught to
eaches is u
erefore, th
ould have

elect sing
tability of
hat single
er generic
rte Ohsak
g, and Ka
te (App. B
-dimethyl-
Gottschli
gonist use
er’s disea
er acknow
errling et.
enyl-7H-t
have activ
seful in th
e Examine
been moti
le chemica
the single
issue and
claims,
a, 2
to
r. 5), that
5-phenyl-
ch
ful for the
se and
ledges
al. are
hieno[2,3-
ity as
e
r
vated to
l

App
App

treat
NMD

conc
diab
patie

Find

scop
refer

hydr
Gott
form
eal 2012-0
lication 11
diabetes w
A antago
The issu
lusion that
etes mellit
nt?
ings of Fa
FF 1. W
e and cont
ence conv
FF 2. Th
oxy-2,3-di
schlich ex
FF 3. G
ula I, repr
exhibit a
in parti
(glutama
methyl-D
treating
diseases
02118
/997,470
ith anothe
nist” (Ans
e is: Does
the comb
us by adm
ct
e adopt th
ent of the
enience.
e Examin
methyl-5-
ample 4, c
ottschlich
oduced be
high affin
cular for
te) bindin
-aspartate
neurodege
. The nov
r compou
. 11).
the eviden
ination of
inistering
e Examine
prior art. T
er finds th
phenyl-7 H
ol. 7, ll. 50
disclosed t
low:
ity for bin
the gly
g site of
). The co
nerative d
el active
4
nd taught i
ce of reco
references
an NMDH
r’s finding
he follow
at Gottsch
-thieno[2
-64).
hat compo
ding sites
cine, pol
the NMD
mpounds
iseases, in
compound
n the art t
rd support
arrives at
receptor a
s and ana
ing facts a
lich disclo
,3-b ]pyrid
unds havi

of amino
yamine a
A recepto
are suitabl
cluding c
s may al
o have acti
the Exam
a method
ntagonist
lysis conce
re repeate
sed the co
in-6-one (
ng the gen
acid recep
nd/or NM
r (NMDA
e, therefor
erebrovas
so be use
vity as an
iner’s
of treating
to a
rning the
d for
mpound 4
Ans. 5; se
eric
tors,
DA
=N-
e for
cular
d as

-
e
Appeal 2012-002118
Application 11/997,470

5
analgesics or anxiolytics as well as for treating epilepsy,
schizophrenia, Alzheimer’s, Parkinson’s or Huntington’s
diseases, cerebral ischaemias or infarctions. In addition, they
are suitable for treating psychoses which are due to excessively
high amino acid levels.
(Gottschlich col. 1, l. 64 to col. 2, l. 6; Ans. 5).
FF 4. Herrling disclosed that:
As a result of their NMDA receptor antagonism the compounds
are useful in inhibiting GH and LH secretion and therefore
useful i) in the treatment of disorders having an etiology
comprising or associated with excess GH-secretion e.g. in the
treatment of diabetes mellitus and angiopathy as well as of
acromegaly and ii) in the treatment of disorders having an
etiology associated with or modulated by excess LH-secretion
e.g. in the treatment of prostate hypertrophy or in the treatment
of menopausal syndrome.
(Herrling col. 15, ll. 40-61; Ans. 6.)
FF 5. Herrling disclosed that “[a]s a result of their NMDA receptor
antagonism the compounds of the invention are further useful in the
treatment of anxiety, schizophrenia and depression or of CNS degenerative
disorders, such as Huntington’s, Alzheimer’s or Parkinson’s diseases.”
(Herrling col. 15, ll. 62-66.)

Principle of Law
“The fact that a combination was obvious to try might show that it
was obvious under § 103.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421
(2007). “Common sense teaches, however, that familiar items may have
obvious uses beyond their primary purposes, and in many cases a person of
ordinary skill will be able to fit the teachings of multiple patents together
like pieces of a puzzle.” Id. at 420.
Appeal 2012-002118
Application 11/997,470

6
Analysis
We are not persuaded by Appellants’ contention that there would be
no reasonable expectation of success in the combination of references
because “Herrling’s formula I are structurally very dissimilar to the
presently claimed compound,” as well as the compounds disclosed in
Gottschlich. (Reply, Br. 2).
Gottschlich disclosed the specifically elected compound (FF 2),
teaches that this class of compound exhibits high affinity for the NMDA
binding site of the NMDA receptor and is useful for treating schizophrenia
(FF 3). Herrling disclosed that NMDA receptor antagonist are useful for
treating diabetes as well as schizophrenia (FFs 4, 5). We find that the
Examiner has articulated a reasonable rationale for combining the teachings
of Gottschlich and Herrling, namely that a person of ordinary skill in the art
would have been motivated to use Gottschlich’s NMDA receptor antagonist
to treat diabetes because Herrling taught that NMDA receptor antagonists
are useful for such treatment (Ans. 6). Herrling’s teaching relates to the
activity of the compounds as NMDA receptor antagonists and not to their
structural formula. Based upon these facts, we agree with the Examiner that
a person of ordinary skill would have had a reasonable expectation of
treating diabetes with Gottschlich’s compound. “Obviousness does not
require absolute predictability of success . . . all that is required is a
reasonable expectation of success.” In re Droge, 695 F.3d 1334, 1338 (Fed.
Cir. 2012) ((quoting In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009)
(citing In re O'Farrell, 853 F.2d 894, 903-04 (Fed.Cir.1988)).
We are also not persuaded by Appellants’ contention that
“overlapping patient populations in no way means that both disorders should
Appeal 2012-002118
Application 11/997,470

7
be treated with the same compound.” (Reply Br. 2.) We agree with the
Examiner’s findings and conclusions:
[Kato recognized] that individuals with schizophrenia are at
increased risk for developing diabetes mellitus. . . . [While
Herrling] teaches that NMDA antagonists have utility for
treating diabetes mellitus in addition to schizophrenia . . .
therefore, the prior art provides support that an agent having
activity as an NMDA antagonist has utility for treating diabetes
mellitus in addition to CNS disorders, including schizophrenia.
(Ans. 13).
We recognize, but are not persuaded by, Appellants’ contention that
“the literature indicates that the NMDA receptor is composed of multiple
subunits and there are a myriad of different binding potentials, a finding that
one type of structure can affect the receptor in one way in no way suggests
different structures would do the same” (App. Br. 6, Reply Br. 2). Even if
the NMDA receptor is composed of multiple subunits Appellants have not
pointed to any persuasive evidence in the record that would suggest the
compounds of Gottschlich and Herrling bind to different subunits of the
receptor. Additionally, the claims are not directed to an NMDA receptor
antagonist that targets a particular subunit of the receptor. Appellants fail to
identify any evidentiary basis on this record that rebuts the Examiner’s
reasoning that “NMDA antagonist which is useful for treating conditions
such as schizophrenia, while Herrling et. al. teaches that NMDA receptor
antagonists are also effective for the treatment of diabetes mellitus” as well
as schizophrenia (Ans. 6). In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir.
1997) (Argument of counsel cannot take the place of evidence).
We conclude that the preponderance of the evidence of record
supports the Examiner’s conclusion that the combination of Gottschlich,
Appeal 2012-002118
Application 11/997,470

8
Herrling, and Kato renders obvious the method of treating diabetes mellitus
with the compound of claim 1. We thus, affirm the rejection of the elected
species hydroxy-2,3-dimethyl-5-phenyl-7 H-thieno[2,3-b ]pyridin-6-one of
claim 1 under 35 U.S.C. § 103(a) as being obvious, as claims 2-8 and 10 fall
with that claim, we affirm the rejection as to those claims as well. 37 C.F.R.
§ 41.37(c)(1)(vii).

II. The Issue: Nonstatutory Obviousness-Type Double Patenting
Appellants contend that the obviousness-type double patenting is in
error essentially for the same reasons discussed in the obviousness rejection
(App. Br. 8).
As discussed above, we have found no error in the Examiner’s
combination of Gottschlich, Herrling, and Kato. Accordingly, Appellants
have not persuaded us that the Examiner has erred in rejecting claims 1-8
and 10 on the ground of non-statutory obviousness-type double patenting.
We will sustain the Examiner’s rejection.

SUMMARY
We affirm the rejection of claims 1-8 and 10 under 35 U.S.C. § 103(a)
as unpatentable over Gottschlich in view of Herrling and further in view of
Kato.
We affirm the rejection of claims 1-8 and 10 on the ground of
nonstatutory obviousness-type double patenting over U.S. Patent No.
5,602,144 (Gottschlich) in view of Herrling and further in view of Kato.

Appeal 2012-002118
Application 11/997,470

9
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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