PHARNEXT

Patent Trials and Appeals Board

Sep 16, 2020

14426014 - (D) (P.T.A.B. Sep. 16, 2020)

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.
14/426,014 03/04/2015 Daniel Cohen COHEN100 6487
1444 7590 09/16/2020
Browdy and Neimark, PLLC
1625 K Street, N.W.
Suite 1100
Washington, DC 20006
EXAMINER
NEAGU, IRINA
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
09/16/2020 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DANIEL COHEN, SERGUEI NABIROCHKIN, and
ILYA CHUMAKOV
Appeal 2019-006841
Application 14/426,0141
Technology Center 1600

Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims related to
a method of treating epilepsy using acamprosate and baclofen. The
Examiner rejected the claims as obvious under 35 U.S.C. § 103(a). We
heard oral argument on July 16, 2020. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as
PHARNEXT. Appeal Br. 1.
Appeal 2019-006841
Application 14/426,014
2
CLAIMED SUBJECT MATTER
Claims 19, 22, 24, 27, and 29 are pending. Final Act. 2; Ans. 10
(indicating cancellation of claim 23). Claim 19, reproduced below, is
illustrative of the claimed subject matter:
19. A method of treating epilepsy in a mammalian subject in
need thereof, the method comprising administering to said
subject an effective amount of acamprosate and baclofen, or
salt(s), or sustained release formulation(s) thereof.
Appeal Br. 19 (Claims Appendix).
REJECTIONS
Claims 19, 22, 24, 27, and 29 stand rejected under 35 U.S.C. § 103 as
being unpatentable over Picaud2 and Kozachuk.3 Final Act. 12.
Claims 19, 22, 24, 27, and 29 stand rejected under 35 U.S.C. § 103 as
being unpatentable over Barlow.4 Id. at 15.
OPINION
Because the same issues are dispositive of both pending rejections, we
address the rejections together. We select claim 19 as representative of the
claims subject to each of the appealed rejections. See 37 C.F.R.
§ 41.37(c)(1)(iv); see also Appeal Br. 5 (asserting that the dependent claims
stand or fall with independent claim 19), 16 (same).

2 Picaud et al., US 2010/0184707 A1, published July 22, 2010.
3 W. E. Kozachuk, US 2010/0076075 A1, published March 25, 2010.
4 Barlow et al., WO 2007/053596 A1, published May 10, 2007.
Appeal 2019-006841
Application 14/426,014
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Summary of Examiner’s Findings
The Examiner found that Picaud teaches a method for treating
epilepsy, comprising administration of a GABA receptor agonist such as
baclofen, and a taurine analog such as acamprosate, which results in
inhibiting the undesirable side effects caused by increased extracellular
GABA or GABA transmission. Final Act. 12 (citing Picaud at, e.g., ¶¶ 6, 8,
10, 12, 13, 19, 46, 53). The Examiner found that Kozachuk teaches that
acamprosate is an NMDA receptor antagonist with therapeutic uses
including neuroprotection in epilepsy and decreasing the frequency of
seizures. Id. at 13–14 (citing Kozachuk at, e.g., ¶¶ 25–30, 125). The
Examiner found that it would have been obvious to a person of ordinary skill
in the art “to combine the teachings of Picaud and Kozachuk, to arrive at the
instant invention,” because “Kozachuk provides the mechanistic rational[e]
for using an NMDA antagonist, such as acamprosate, in a method of treating
epilepsy,” and “Picaud teaches a method for treating convulsive disorders,
including epilepsy, comprising administering to a patient in need thereof a
first active ingredient that induces a high level of GABA, such as, for
example, baclofen, in combination with a taurine analog such as, for
example, acamprosate.” Id. at 14.
With respect to the rejection over Barlow, the Examiner found that
Barlow
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teaches (page 1, lines 9-12) a method for treating diseases and
conditions of the central nervous system such as, for example,
epilepsy (page 25, line 24) by administering to a subject in need
thereof a GABA agent such as, for example, baclofen (page 26,
line 26; preferred GABA agent in examples, also Figures 1-12),
in combination with another neurogenic agent such as, for
example, acamprosate (page 87, lines 29-30).
Id. at 16.
Summary of Appellant’s Arguments
Appellant argues that “baclofen, despite being an agonist of a
particular GABA receptor, does not have anticonvulsant properties and is
not useful for treatment of epilepsy.” Appeal Br. 6. Specifically, Appellant
quotes Ghanavatian et al., Baclofen, StatPearls Publishing (updated Oct. 27,
2018), available at https://www.ncbi.nlm.nih.gov/books/NBK526037/
(“Ghanavatian”), as stating:
Baclofen was originally designed in 1960 to treat epilepsy.
However, the result was not satisfactory. Baclofen was then
reintroduced in 1971 when it was found to treat muscle spasticity
and has been widely used since.
Id. (quoting Ghanavatian 1). According to Appellant, Ghanavatian
demonstrates that “the art has been aware since the 1960’s that baclofen is
ineffective in the treatment of epilepsy.” Id.
Appellant also argues that baclofen “has been considered to be
epileptogenic, i.e., causing epileptic seizures, under certain circumstances.”
Id. Appellant quotes Mott et al., Baclofen has a proepileptic effect in the rat
dentate gyrus, 249(3) J. Pharmacol. Exp. Ther. 721–25 (1989) (“Mott”), as
stating that “the net effect of baclofen was proepileptic because its
disinhibitory effect was substantially greater than its suppressive effect on
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synaptic excitation.” Id. at 6–7 (quoting Mott 721 (Abstract)). Appellant
further argues that Mott “confirms the above-quoted statement in
Ghanavatian 2018 that ‘baclofen has not proved to be an effective
antiepileptic in humans.’” Id. at 7 (quoting Mott 721). Appellant also points
to statements in Mott that baclofen has a “proepileptic, or lack of
antiepileptic, effects in intact animals and humans,” and “can have net
excitatory effects in some areas, [which] may explain why baclofen has
never proven to be a clinically effective antiepileptic and has actually
induced seizures at toxic levels.” Id. (quoting Mott 724, 725). Appellant
argues that Ghanavatian and Mott “teach away from the use of baclofen in
Picaud’s composition for the treatment of epilepsy,” or “at least establish the
lack of a reasonable expectation that baclofen could be successfully used to
treat epilepsy.” Id.
As to Kozachuk, Appellant argues that because “no experimental
work [is] presented” in Kozachuk, “there is significant question as to
whether Kozachuk would provide persons of ordinary skill in the art a
reasonable expectation that acamprosate would actually work as theorized
for the treatment of patients with epilepsy.” Id. at 9.
With respect to the rejection over Barlow, Appellant argues that
“Barlow has pages and pages of diseases,” and “[h]idden among these ten
pages of indications is epilepsy.” Id. at 16. Appellant argues that “a person
of ordinary skill in the art would have [had] no expectation that each listed
drug will work against each listed indication,” and as discussed above, “the
art is aware that baclofen is ineffective against epilepsy and has even been
reported to be proepileptic under certain conditions.” Id. at 16, 17.
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Analysis
Considering the totality of the evidence of record, we adopt the
Examiner’s findings of fact and reasoning regarding the scope and content of
the prior art, and agree that the appealed claims would have been obvious
over the combination of Picaud and Kozachuk, and over Barlow, for the
reasons the Examiner articulated. For example, Picaud teaches a method for
treating epilepsy comprising administering a combination of baclofen and
acamprosate, and Kozachuk additionally provides motivation to administer
acamprosate for this purpose. See, e.g., Picaud ¶¶ 2, 19–21, 46, 53;
Kozachuk ¶¶ 26–28, 125. Barlow also teaches a method for treating
epilepsy comprising administering a combination of baclofen and
acamprosate. Barlow 16:18–28, 26:25–26, 87:29–30.
We are not persuaded by Appellant’s arguments concerning a lack of
motivation, lack of reasonable expectation of success, or purported teaching
away based on purported knowledge that baclofen was ineffective in treating
epilepsy in humans and known to be proepileptic. See, e.g., Appeal Br. 11.
In support of its argument that baclofen is not an antiepileptic, Appellant
points to Ghanavatian, which states that baclofen “was originally designed in
1960 to treat epilepsy,” but “the result was not satisfactory.” Id. at 6
(quoting Ghanavatian 1). Ghanavatian, however, provides no further
explanation for these statements. Accordingly, on this record, we are unable
to ascertain what research was done with respect to the use of baclofen to
treat epilepsy, and in what way the “result was not satisfactory.” Moreover,
Appellant asserts that Ghanavatian dates to 2018 (Appeal Br. 6), which is
years after the earliest possible priority date of the instant application, i.e.,
September 5, 2012. See BIB Data Sheet; Reply Br. 4 (noting that the present
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invention was made “circa 2012”). On this record, we are unable to
ascertain whether, at the time of the claimed invention, a person of ordinary
skill in the art would have been aware of the information reported in
Ghanavatian about the alleged history of baclofen.
Similarly, while Mott states that “baclofen has not proved to be an
effective antiepileptic in humans” and “baclofen has never proven to be a
clinically effective antiepileptic,” Appellant has not pointed us to further
context or support for these statements, e.g., details on what tests, if any,
were performed with respect to use of baclofen as a treatment for epilepsy.
Mott 721, 724. Appellant also refers to “failed clinical trials” for the use of
baclofen to treat epilepsy (Reply Br. 4), but the record is devoid of any detail
on such alleged clinical trials. Hr’g Tr. 4:19–5:12. Thus, on this record, we
are again unable to ascertain what research was done with respect to the use
of baclofen to treat epilepsy, and the results of that research. Accordingly,
on this record we are not persuaded that at the time of the present invention,
a person of ordinary skill in the art would have had reason to doubt Picaud
and Barlow’s teachings regarding treating epilepsy with baclofen.
With regard to Appellant’s argument that baclofen is proepileptic,
Mott states that “toxic doses of baclofen have been reported to cause
seizures in nonepileptic patients.” Mott 721. We are not persuaded that this
statement demonstrates that skilled artisans would have had a lack of
motivation or reasonable expectation of success in using baclofen to treat
epilepsy, because, as the Examiner stated, “[a] person of ordinary skill in the
art would not [have] administer[ed] baclofen at toxic levels to treat
epilepsy.” Ans. 12. Additionally, while Mott concludes that the results of
its in vitro experiments in the rat dentate gyrus “suggest the net effect of
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Application 14/426,014
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baclofen was proepileptic” in this system, Mott concedes that “[t]he direct
relevance of baclofen’s suppression of recurrent inhibition in rat dentate
gyrus to its proepileptic, or lack of antiepileptic, effects in intact animals and
humans is unknown.” Mott 721 (Abstract), 724. Indeed, Mott indicates that
other research has shown that “the net effect reported for baclofen has been
inhibitory and antiepileptic,” and asserts that “the net effect of baclofen in
any given brain region will depend on whether it is more effective at
suppressing excitation or inhibition.” Id. at 721, 724.
With respect to Kozachuk, Appellant argues that because “no
experimental work [is] presented,” “there is significant question as to
whether Kozachuk would provide persons of ordinary skill in the art a
reasonable expectation that acamprosate would actually work as theorized
for the treatment of patients with epilepsy.”5 Appeal Br. 9. With respect to
Barlow, Appellant similarly argues that “Barlow has pages and pages of
diseases,” and “a person of ordinary skill in the art would have [had] no
expectation that each listed drug will work against each listed indication.”
Id. at 16. We are not persuaded by these arguments, because Appellant has
not submitted any persuasive evidence suggesting that a person of ordinary
skill in the art would have discounted or doubted the teachings of Kozachuk
based on a lack of experimental work, or the teachings of Barlow based on
the extent of the disclosure. See Johnston v. IVAC Corp., 885 F.2d 1574,
1581 (Fed. Cir. 1989) (noting that attorney argument is “no substitute for
evidence”).

5 Appellant argues that Picaud alone would not have rendered the claims
obvious. Appeal Br. 11. We need not address this argument, because the
Examiner’s rejection is based on the combination of Picaud and Kozachuk.
Final Act. 12.
Appeal 2019-006841
Application 14/426,014
9
CONCLUSION
We affirm the rejection of claims 19, 22, 24, 27, and 29 under 35
U.S.C. § 103 as being unpatentable over Picaud and Kozachuk.
We affirm the rejection of claims 19, 22, 24, 27, and 29 under 35
U.S.C. § 103 as being unpatentable over Barlow.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
19, 22, 24,
27, 29
103 Picaud, Kozachuk 19, 22, 24,
27, 29

19, 22, 24,
27, 29
103 Barlow 19, 22, 24,
27, 29

Overall
Outcome:
19, 22, 24,
27, 29

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED