Ex Parte Treacy et al

Board of Patent Appeals and Interferences

Jun 29, 2012

11931434 (B.P.A.I. Jun. 29, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/931,434 10/31/2007 Michael Frank TREACY ACY33562-D-9 1175
26474 7590 06/29/2012
NOVAK DRUCE DELUCA + QUIGG LLP
300 NEW JERSEY AVENUE NW
FIFTH FLOOR
WASHINGTON, DC 20001
EXAMINER
QAZI, SABIHA NAIM
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
06/29/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MICHAEL FRANK TREACY, RAYMOND FRANK
BORYSEWICZ, KURT ALLEN SCHWINGHAMMER,
PAUL E. RENSNER, and HASSAN OLOUMI-SADEGHI
__________

Appeal 2011-008520
Application 11/931,434
Technology Center 1600
__________

Before ERIC GRIMES, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to
synergistic formulations of insecticides. The Examiner has rejected the
claims as obvious over Takagi,1 Hatton2 and Appellants’ disclosure in the
Specification. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 Takagi et al. U.S. Pat. No. 5,543,573, issued Aug. 6, 1996.
2 Hatton et al. U.S. Pat. No. 5,232,940, issued Aug. 3, 1993.
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STATEMENT OF THE CASE
The present invention is directed to synergistic insecticidal
compositions, and to methods of insect control using the synergistic
insecticidal compositions. The active ingredient combinations employed in
Appellants’ composition and methods comprise a synergistically effective
amount of a neuronal sodium channel antagonist and one or more GABA (γ-
aminobutyric acid) antagonist compounds.
Claims 34, 37-41, and 44-57 are on appeal, and may be found in the
Claims Appendix to the Appeal Brief (App. Br. 22-26). Claims 34 and 41
are the sole independent claims. The claims are directed to “[a] synergistic
insecticidal composition comprising a synergistically effective amount of a
neuronal sodium channel antagonist in combination with one or more
GABA antagonist compounds, wherein the neuronal sodium channel
antagonist is a compound of formula (I) . . .” (App. Br. 22).
The claims stand rejected as follows:
Claims 34, 37-41, and 44-57 are rejected under 35 U.S.C. §103(a) as
obvious over Takagi, Hatton and Appellants’ disclosure in the
Specification.3

3 It is noted that although Appellants make separate arguments for claim
combinations 54/56, 38/45 and 39/36, here we do not address these claim
combinations separately because our ultimate conclusion is that Appellants’
secondary evidence is sufficient to overcome the prima facie case made by
the Examiner.
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Issue
The issues are: Has the Examiner set forth a prima facie case of
obviousness and, if so, have Appellants provided sufficient evidence of
secondary considerations that outweighs the evidence supporting the
conclusion of obviousness for the synergistic insecticidal composition
comprising a neuronal sodium channel antagonist with one or more GABA
antagonist compounds, as claimed?

Findings of Fact
Findings of Fact – Prima Facie Obviousness
FF1. Neuronal sodium channel antagonists of formula (I) are known (Ans.
4-5; App. Br. 8, Spec. 4).
FF2. The neuronal sodium channel antagonist (Ia) is depicted in the
Specification (Spec. 17).
FF3. GABA antagonists are known (Ans. 5-6; App. Br. 9, Spec. 10-11).
FF4. The Examiner finds that the neuronal sodium channel antagonists can
be mixed with other insecticides to reduce the dosage (Ans. 5; Takagi, col.
64, ll. 57-63).

Findings of Fact – Secondary Considerations
FF5. “Synergism’ as used in this application means a cooperative action
encountered in a combination of two or more biologically active components
in which the combined activity of the two or more components exceeds the
sum of the activity of each component alone” (Spec. 3).
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FF6. Southern armyworm larvae were treated with a combination of the
neuronal sodium channel antagonist of formula Ia and the GABA
antagonistic compound fipronil (Bucci Dec.4 5/20/08, 4). Here the larva
were treated and their mortality was assessed 4-days post treatment.
Treatment with the neuronal sodium channel antagonist of formula Ia alone
resulted in a 17.9% observed mortality rate. Treatment with fipronil alone
resulted in a 3.6% mortality rate. The combination of neuronal sodium
channel antagonist of formula Ia with fipronil resulted in the observed larval
mortality rate of 25%. The expected mortality was calculated at 20.9%
using Limpel’s formula. (Id. at 2, 4.)
FF7. Tobacco budworm eggs were treated with a composition combining
the neuronal sodium channel antagonist of formula Ia with the GABA
antagonist compound fipronil (Langewald Dec.5 2/12/10, 3). Here eggs
treated with the neuronal sodium channel antagonist of formula Ia resulted in
egg and larva mortality of 50% after 5 days. Eggs treated with the GABA
antagonist compound fipronil alone resulted in egg and larva mortality of
0% after 5 days. Treatment with the combination of neuronal sodium
channel antagonist of formula Ia with the GABA antagonist compound
fipronil resulted in 100% egg and larval mortality after 5 days. (Id.)
FF8. Tobacco budworm eggs were treated with a composition combining
the neuronal sodium channel antagonist of formula Ia with the GABA
antagonist compound ethiprole (Langewald Dec. 2/12/10, 3). Here eggs
treated with the neuronal sodium channel antagonist of formula Ia resulted in

4 Declaration of Toni Bucci, dated May 20, 2008.
5 Declaration of Jurgen Langewald, dated February 12, 2010.
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egg and larva mortality of 50% after 5 days. Eggs treated with the GABA
antagonist compound ethiprole alone resulted in egg and larva mortality of
0% after 5 days. Treatment with the combination of neuronal sodium
channel antagonist of formula Ia with the GABA antagonist compound
ethiprole resulted in 75% egg and larval mortality after 5 days. (Id.)
FF9.
Declarations filed on 6/24/08 have been fully considered. Only
one declaration contains the data of the elected invention i.e.
combination of compound Ia and fipronil. The declaration
show[s] that the observed mortality was found 25% and
expected was 20.9%.

(Final Rej. 5/12/10, 12.)
FF10. The Examiner finds that the results shown in the Langewald Dec.
2/12/10 are unexpected (Ans. 10).

Principles of Law
“If a prima facie case is made in the first instance, and if the applicant
comes forward with reasonable rebuttal, whether buttressed by experiment,
prior art references, or argument, the entire merits of the matter are to be
reweighed.” In re Hedges, 783 F.2d 1038, 1039 (Fed. Cir. 1986).
“If an applicant demonstrates that an embodiment has an unexpected
result and provides an adequate basis to support the conclusion that other
embodiments falling within the claim will behave in the same manner, this
will generally establish that the evidence is commensurate with [the] scope
of the claims.” In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011).
Appeal 2011-008520
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Analysis
The Examiner has rejected claims 34, 37-41, and 44-57 as obvious
under 35 U.S.C. § 103(a). The Examiner finds that the presently claimed
invention is drawn to synergistic insecticidal compositions and methods of
insect control using synergistically effective amount of a neuronal sodium
channel antagonist of formula (I) in combination with one or more GABA
antagonists. Because compounds having each of these properties are
individually known in the art (FF 1-3), the Examiner finds that it would have
been obvious to the ordinary artisan to mix a neuronal sodium channel
antagonist with another insecticide to reduce the dosage required to achieve
insect control (FF4). We conclude that the Examiner has met the initial
burden of setting out a prima facie case shifting the burden on the Appellants
to rebut this finding.
Appellants contend that “[s]ynergistic effects are generally
unpredictable, and neither one of the references suggests or implies that a
synergistic co-action may result when the particular compounds specified in
appellants’ claims are combined and employed in the manner claimed”
(App. Br. 12). After carefully considering all of the Appellants’ rebuttal
evidence we conclude that Appellants have provided sufficient evidence to
overcome the prima facie case set out by the Examiner.
During the prosecution of the present Application, Appellants have
provided evidence of synergistic effect (FF5) for insecticidal compositions
comprising a combination of neuronal sodium channel antagonist Ia with
two GABA antagonists (FF6-8). The Answer only addressed the declaration
of Langewald submitted 2/12/10, it did not specifically address the
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remaining declarations submitted by Appellants during the prosecution of
the application (App. Br. 27). The Answer notes that these declarations
make reference to Application No. 10/145,784 (Ans. 10) leaving open a
question whether these declarations have been considered on the merits
(Reply Br. 2). A review of the prosecution history shows that the Examiner
did in fact consider all the submitted declarations (FF9) but found them to be
unpersuasive because only one of them provides data directed to the
presently claimed invention which is limited to a combination of a neuronal
sodium channel antagonist in conjunction with a GABA antagonist (Final
Rej. 5/12/10, 12).
In the final rejection the Examiner only considered the data that
looked at the combination of a neuronal sodium channel antagonist with a
GABA antagonist. The data shows treating southern armyworm larva with a
combination of the neuronal sodium channel antagonist Ia and fipronil. This
combination resulted in an observed mortality of 25% (FF6). The expected
mortality was calculated at 20.9% using Limpel’s formula. (Id.) Adding the
activity of each component alone (see FF5), 17.9 % mortality with the
neuronal sodium channel antagonist of formula Ia and 3.6% mortality with
fipronil alone, would provide a mortality rate of 21.5%. Here the observed
mortality rate of 25% is greater than either the calculated expected mortality
rate or the mortality rate by simply adding the individual components.
However, the Examiner has not explained why these results are expected
and why they are not synergistic. To meet the criteria for synergism the data
for the combination of antagonists must merely exceed the sum of the
activity of each component alone. Although the Examiner may not find this
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data set impressive, we cannot reach the conclusion that the data is not
synergistic.
Additional data with a different insect population shows more
impressive results (FF7). Here, treating tobacco budworm eggs with a
combination of the neuronal sodium channel antagonist and fipronil, a
GABA antagonist, results in a 100% observed mortality rate, compared with
a calculated mortality rate of 50% based on the sum of the individual
components alone (FF7). Here the experiment treats tobacco budworm
eggs, a different insect population as compared to southern armyworms, and
the combination is synergistic because the observed mortality rate is greater
than the sum of the individual components (id.).
Treating tobacco budworm eggs with a combination of the neuronal
sodium channel antagonist and ethiprole, another GABA antagonist, results
in an observed 75% mortality rate, compared with a calculated mortality rate
of 50% based on the sum of the individual components alone (FF8). This
data also shows synergistic action between the two antagonists.
After carefully considering Appellants’ rebuttal evidence we conclude
that Appellants have provided sufficient evidence to overcome the prima
facie case set out by the Examiner. Here Appellants have provided
experiments using the neuronal sodium channel antagonist Ia in combination
with two GABA antagonists (FF6-FF8). Furthermore, these experiments
utilized two different insect populations, specifically, southern armyworms
and tobacco budworms (id.).
In the Answer, the Examiner specifically addressed only the evidence
provided in one of the declarations presented by Appellants, the declaration
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of Langewald signed on 2/12/10. The Examiner asserts that the data
presented in the declaration is not commensurate with the scope of the
claims (Ans. 10). Specifically, the Examiner asserts that “[t]here are over
100,000 known insect species and the combination of hundreds of
compounds in formula (I) and GABA antagonists in unlimited
concentrations of applications” (id.). It appears the Examiner is asking
Appellants to provide further experimental evidence showing synergistic
effects between the neuronal sodium channel antagonist in conjunction with
a GABA antagonist. Although secondary evidence must be reasonably
commensurate in scope with the claims, Appellant is not required to test
every embodiment that falls within the scope of the claims. See In re Kao,
639 F.3d at 1068. Here, the Examiner has not provided any rational
explanation as to why the untested embodiments encompassed by the claims
– i.e., combinations of other compounds also having activity as neuronal
sodium channel antagonists and GABA antagonists – would not be expected
to show synergism given the scope of the data provided in the Specification
and declarations.
Conclusion of Law
Appellants’ rebuttal evidence in the form of secondary considerations
is sufficient to overcome the rejection under 35 U.S.C. §103(a).
SUMMARY
We reverse the rejection of claims 34, 37-41 and 44-57 under 35
U.S.C. §103(a) as obvious over Takagi, Hatton and Appellants’ disclosure in
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Application 11/931,434

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the Specification, in view the secondary considerations in the form
experimental evidence provided in the Specification and declarations.

REVERSED

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