Ex Parte Grote et al

Board of Patent Appeals and Interferences

Dec 5, 2003

09412258 (B.P.A.I. Dec. 5, 2003)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.
Paper No. 23
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte TODD MICHEL GROTE,
BRIAN KEITH HUCKABEE,
THOMAS MULHERN,
DENIS MARTIN SOBIERAY,
and
ROBERT DANIEL TITUS
____________
Appeal No. 2003-1991
Application No. 09/412,258
____________
ON BRIEF
____________

Before WINTERS, WILLIAM F. SMITH, and LIEBERMAN, Administrative Patent Judges.
LIEBERMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the decision of the examiner
refusing to allow claims 3 and 30, which are all the claims pending in this application.

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THE INVENTION
According to the appellants, the invention is directed to a C1 to C6 alkyl ester of 3-
cyano-5-methyl hexanoic acid. The invention is characterized by the formula in the
following illustrative claim.
THE CLAIM
Claim 3 is illustrative of
appellants’ invention and is
reproduced below:
3. The compound having the
formula
wherein R1 is C1-C6 alkyl.
THE REFERENCE OF RECORD
As evidence of obviousness, the examiner relies upon the following reference:
Benneville et al. (Benneville) 3,110,723 Nov. 12, 1963
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THE REJECTION

Claims 3 and 30 stand rejected under 35 U.S.C. §103(a) as being unpatentable
over Benneville.
OPINION
We have carefully considered all of the arguments advanced by the appellants and
the examiner, and agree with the examiner for the reasons stated in the Answer and those
set forth herein that the rejection of claims 3 and 30 under 35 U.S.C. § 103(a) is well
founded. Accordingly, we affirm the rejection.
As an initial matter, it is the appellants’ position that, “[c]laims 3 and 30 be
grouped separately.” See Brief, page 3. Accordingly, separate consideration will be given
to each of the two claims to the extent required in our decision. See 37
CFR1.192(c)(7)(2002).
The Rejection under Section 103(a)
There is no dispute that the reference to Benneville is sufficient to establish a prima
facie case of obviousness with respect to the claimed subject matter. The appellants readily
concede that, “the subject matter of pending claim 3 and 30 is prima facie obvious over
the disclosure of Benneville.” See Brief, page 5.
Accordingly, the burden of proof of showing patentability shifts to the appellants to
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present evidence rebutting the prima facie case of obviousness established by the examiner.
In doing so, “it falls upon the applicant to at least establish: (1) that there actually is a
difference between the results obtained through the claimed invention and those of the
prior art, In re Klosak, 455 F.2d 1077, 59 CCPA 862 (1972); and (2)
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that the difference actually obtained would not have been expected by one skilled in the art
at the time of the invention, Id.; In re D’Ancicco, 439 F.2d 1244, 58 CCPA 1057
(1971).” See In re Freeman, 474 F.2d 1318, 1324, 177 USPQ 139, 142 (CCPA
1973).
On the record before us, the claimed subject matter is directed to an intermediate
compound, i.e., a C1 to C6 alkyl ester of 3-cyano-5-methyl hexanoic acid. The
intermediate is thereafter hydrogenated to form the corresponding C1 to C6 alkyl ester of
3-aminomethyl-5-methyl hexanoic acid, also known as isobutyl-GABA. See specification,
page 1, lines 16-18. The invention also provides for the resolution of racemic isobutyl-
GABA to obtain the S-stereo isomer. See specification, page 3, lines 12-16.
The single reference before us to Benneville generically discloses the compounds of
claims 3 and 30 and as admitted by the appellants is sufficient to establish a prima facie
case of obviousness with respect to the claimed subject matter. The appellants in
attempting to rebut the prima facie case of obviousness established by the examiner have
introduced a declaration by Charles P. Taylor undisputedly presenting data that shows that
racemic isobutyl-GABA and the S(+)-isobutyl isomer called pregabalin possess superior
properties than corresponding homologous and analogous compounds. See Answer, pages
8 and 9.
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It is the examiner’s position that, “[t]he activity relied upon here, however, relates
to known compounds known to possess the activity. By any definition a known property of
a known compound cannot be characterized as unexpected.” See Answer, pages 9-10.
On the record before us, we generally concur with the position by the examiner.
The appellants have presented a declaration directed not to the claimed
intermediate but to the final product possessing pharmacological properties relying heavily
upon In re Magerlein, 602 F.2d 366, 372-73, 202 USPQ 473, 479 (CCPA 1979) for
its teaching that, “the capacity of an intermediate to contribute to an end product that
feature which causes the end product to possess an activity or property that is unexpectedly
superior to that of a prior art end product is a ‘property’ that inures to the benefit of the
intermediate and that can be considered as part of the ‘subject matter as a whole’ in
determining the nonobviousness of the intermediate.”
Although, the submission of data directed to the end product in the case before us,
would generally appear to be appropriate, in our view the facts before us are
distinguishable from those of In re Magerlein cited above. On the record before us, the
appellants admit that racemic isobutyl GABA was prepared in 1989. See specification,
page 3, lines 1-3. They further admit that it was known in 1994 that the stereo selective
isomer (S)-isobutyl GABA has anticonvulsant activity. See specification, page 2, lines 13-
20.
Furthermore, the appellants have attached to the declaration of Charles P. Taylor a
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publication by Taylor et al., Exhibit D, entitled “3-Alkyl GABA and 3-alkylglutamic acid
analogues: two new classes of anticonvulsant agents,” Epilepsy Res., pp. 103-110, Vol.
11 (Elsevier, 1992). We find that Table II on page 106 contains data directed to the
prevention of seizures in mice by low intensity electroshock treatment after administration
of 3-alkyl GABA. We find in this respect that the raw data tabulated in the publication
substantially corresponds to that presented in the declaration before us. We find that in the
original declaration of Charles P. Taylor the evidence submitted was likewise directed to the
evaluation of compounds in protecting rodents, i.e., mice from seizures by being subjected
to low intensity electroshock 2 hours after administration of various test compounds. See
Exhibit A pages 1 and 2.
Turning to page 3 of the declaration of Charles P. Taylor, we find data submitted
regarding the n-propyl analog of isobutyl GABA. We find the data reported in the
declaration at levels of 3.0 mg/kg and 10 mg/kg identical with that of Table II of Exhibit
D in terms of the number of mice wherein the n-propyl analog inhibited seizures. Similarly,
on page 4 of the declaration the data reported for the number of mice wherein the
isopropyl analog inhibited seizures is identical with that of Table II of Exhibit D. The same
findings apply to the n-butyl analog on page 4 of the declaration, with respect to dosages at
the 10mg/kg and 30mg/kg level. Even more significantly, the data for the racemic
isobutyl derivative, declaration page 4, relied upon by the appellants to show
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unusual and unexpected results are identical at all dosage levels. Indeed Taylor in his 1992
publication, Exhibit D, concludes that 3-isobutyl GABA prevents tonic extensor seizures
from low intensity electroshock when given intravenously with an ED50 dose of 2.1 mg/kg.
See pages 105-106. Accordingly, the effects of isobutyl GABA relied upon by the
appellants to show unusual or unexpected results were well known in 1992, years prior to
the effective filing date of the instant application.
As we stated supra, a requirement of evidence to rebut a prima facie case of
obviousness is that the difference actually obtained be unexpected by one skilled in the art
at the time of the invention. The corollary to that requirement has been explicitly stated
by the courts. When the results obtained by appellants, are expected beneficial results,
they are evidence of obviousness, just as unexpected results are evidence of unobviousness.
In re Gershon, 372 F.2d 535, 537, 152 USPQ 602, 604 (CCPA 1967). See also In
re Skoner, 517 F.2d 947, 950, 186 USPQ 80, 82 (CCPA 1975)(“[e]xpected
beneficial results are evidence of obviousness of a claimed invention just as unexpected
beneficial results are evidence of unobviousness”). Accord In re Skoll, 523 F.2d 1392,
1396-97, 187 USPQ 481, 484 (CCPA 1975).
Accordingly, unlike the situation of In re Magerlein, wherein the appellants
established the unexpected superiority of the end product, on the record before us, the
evidence discloses that the results obtained by the appellants for the end product is
expected beneficial results known at the time of the invention. Therefore, the results do
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not inure to the benefit of the intermediate of the claimed subject matter.
Based upon the above reasons, we have determined that the examiner has
established a prima facie case of obviousness. Upon reconsideration of all the evidence and
argument submitted by appellants, we have, determined from the totality of the record
that the preponderance of the evidence weighs in favor of obviousness within the meaning
of 35 U.S.C. § 103. See In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443,
1444 (Fed. Cir. 1992).
In light of the above dispositive issue, no further discussion of claim 30 is needed in
affirming the decision of the examiner.
DECISION
The rejection of claims 3 and 30 under 35 U.S.C. §103(a) as being unpatentable
over Benneville is affirmed.
The decision of the examiner is affirmed.
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No time period for taking any subsequent action in connection with this appeal may
be extended under 37 CFR § 1.136(a).

AFFIRMED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
)
)
) BOARD OF PATENT
WILLIAM F. SMITH ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
)
PAUL LIEBERMAN )
Administrative Patent Judge )
PL:hh
Appeal No. 2003-1991
Application No. 09/412,258
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