Ex Parte Ecker et al

Patent Trial and Appeal Board

Dec 9, 2015

12206648 (P.T.A.B. Dec. 9, 2015)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/206,648 09/08/2008
22440 7590 12/11/2015
GOTTLIEB RACKMAN & REISMAN PC
270 MADISON A VENUE
8THFLOOR
NEW YORK, NY 10016-0601
FIRST NAMED INVENTOR
William Ecker
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.
4316/209 9233
EXAMINER
WAX, ROBERT A
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
12/11/2015 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):
patenteaction@grr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM ECKER and LANCE HEMSAR TH
Appeal2013-004672
Application 12/206,648
Technology Center 1600
Before DONALD E. ADAMS, JACQUELINE T. HARLOW, and TA WEN
CHANG, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 1---6, 8-11, and
13-21 (App. Br. 5). Examiner entered rejections under 35 U.S.C. § 103(a).
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
Appellants' "invention relates generally to a method of controlling
parasites and formulating and applying topical formulations that can have
significant parasiticidal or anti-parasite activity, such as one suitable to use
on house pets such as dogs and cats" (Spec. i-f 2). Independent claims 1 and
1 Appellants identify the Real Party in Interest as "The Hartz Mountain
Corporation" (App. Br. 3).
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Application 12/206,648
8 are representative and reproduced in the Claims Appendix of Appellants'
Brief.
Claims 1-6, 8-11, and 13-19 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Miller2 and either of Y ang3 or
Gimeno. 4
Claims 1-5, 8, 9, 11, 13-16, and 19-21 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Miller and Narayanan. 5
This record is unclear as to the status of Appellants' claim 4 (see App.
Br. 19-20). Claim 4 depends from and further limits claim 1 to require that
"the non-mobile insect growth regulator and the mobile insect growth
regulator are packaged in a first container and the adulticide is packaged in a
second container isolated from the contents of the first container, preventing
interaction with the contents of the first container prior to administering the
topical formulation" (see Appellants' claim 4). Examiner's April 12, 2012
Final Rejection addresses Appellants' claim 4 only in the context of a
subsequently withdrawn§ 102 rejection over Cottrell, 6 and Examiner's
Answer does not address the requirements of claim 4. At best, Examiner's
July 20, 2012 Advisory Action asserts that "[t]he packaging of claim 4 is
seen as a preference, not as a basis for patentability, as individual packages
of 2 or more actives are art recognized modes of kits & containers to
facilitate storage & sales" (July 20, 2012 Advisory Action 2). Given claim
2 Miller, EP 0 714 601 Al, published June 5, 1996.
3 Yang et al., WO 2007/041127 Al, published Apr. 12, 2007.
4 Gimeno et al., WO 03/051116 Al, published June 26, 2003.
5 Narayanan et al., WO 93/00809, published Jan 21, 1993.
6 Cottrell et al., U.S. Patent No. 6,867,223 B2, issued Mar. 15, 2005.
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Application 12/206,648
4' s dependence on claim 1 and the ambiguity on this record, we included
claim 4 in each of the rejections set forth above.
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellants define a "mobile IGR[7J" as "an IGR that exists in liquid
form or as a sublimating solid at room temperature under one atmospheric
pressure, which is capable of translocation (vaporizing and redepositing
from one area to another area). Examples of a mobile IGR include
methoprene and hydroprene" (June 1, 2012 Amended Spec. i-f 10).
FF 2. Appellants define a "non-mobile IGR" as "an IGR that exist[s] in
solid form without sublimation at room temperature under one atmospheric
pressure, which is not capable of translocation. An example of a non-mobile
IGR is pyriproxyfen" (id.).
FF 3. Appellants define the term "adulticide" as an "insecticide capable of
providing insecticidal activity on the adult insect" (id. i-f 12).
FF 4. Miller
relates to the use of a residue forming concentration of certain
compounds comprising synthetic pyrethroid insecticides or
certain insect growth regulator compounds [] on
homo[ e ]othermic or warm-blooded animals by their application
in long acting shampoo formulations, and in [an ]other
embodiment by the combination in said shampoo formulations
of both synthetic pyrethroid insecticide and insect growth
7 Appellants define the acronym "IGR" as "insect growth regulator" (Spec.
,-r 5).
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Application 12/206,648
regulator at a concentration such that each has the ability to
resist post shampooing washout from the animal's haircoat.
(Miller 2: 1-8.)
FF 5. Miller discloses
a long lasting residue forming shampoo for the residual control
of ectoparasites which attack warm-blooded animals
comprising a detergent and at least one active compound
selected form the group consisting of:
(1) nitrogen containing heterocyclic compounds of the formula
R ,.. . .s 4 f',l R
'«\f 'n I I: v yv~~x.a,
RJ (R~) 111
[,which may be pyriproxyfen or another compound;]
(2) synthetic pyrethroids;
(3) other insect growth regulators; and
( 4) mixtures thereof.
(Miller 4: 17 - 5: 26; see Ans. 3 and 6).
FF 6. Miller discloses "compositions comprising the nitrogen containing
heterocyclic ovicide" and "synthetic pyrethroid" with
one or more active ingredients selected from the group
consisting of permethrin, cypermethrin, cyhalothrin,
lambdacyhalothrin, deltamethrin, tralomethrin, cyfluthrin,
flucythrin, flumethrin, fluvalinate, fenvalerate, methoprene,
fenoxycarb, benzoylphenyl urea, substituted benzoylphenyl
urea, pyriproxifen, or nitrogen containing heterocyclics f[ ro ]m
the class defined above, in combination with a shampoo base
comprising one or more of the above listed additives.
(Miller 9: 32--43 (emphasis added); see also id. at 11. 18; see generally Ans.
3.)
FF 7. Miller discloses that "it is desirable to have a multiplicity of agents
and methods available for controlling fleas" and notes that "[p ]rior art
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Application 12/206,648
methods have included numerous toxic agents such as [] pyrethroids (e.g.,
natural pyrethrins, permethrin and related synthetic pyrethroids )" (Miller 3:
15-17; see Ans. 3).
FF 8. Miller exemplifies a "[f]lea sterilizing and flea and tick killing
shampoo containing 0.25% pyriproxifen and 1.0% permethrin," wherein
"methoprene, fenoxycarb or a benzoylphenyl urea, or another nitrogen
containing heterocyclic within the class defined above may be substituted
for pyriproxifen and cypermethrin, cyhalothrin, lambdacyhalothrin,
deltamethrin, tralomethrin, cyfluthrin, flucythrin, flumethrin, fluvalinate or
fenvalerate may be substituted for permethrin" (Miller 11: 49-55; Ans. 3).
FF 9. Examiner finds that Miller fails to disclose "Etofenprox,
phenyllpyrazoles [sic], or neonicotinoid alternatives" (Ans. 3).
FF 10. Yang "provides lignin-pesticide complexes, methods for making
lignin-pesticide complexes, and methods for treating, controlling,
preventing, and/ or reducing insect infestations on animals by administering
such complexes. Advantageously, in preferred embodiments, the lignin-
pesticide complexes of [Yang's] invention can be formulated as feed-
through products to control insect infestation on livestock and pets" (Yang
ii 8).
FF 11. Yang discloses that "insect growth regulators vary widely in
chemical composition, with two of the more prominent classes comprising 2,
4-dienoic acids and phenoxyphenoxy compounds," wherein "[ e ]xamples of
2,4-dienoic acids and related compounds include, without limitation,
methoprene, hydroprene, neotenin, and epiphenonane" (Yang ii 49; Ans. 4).
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FF 12. Yang discluses that
Suitable IGRs for use in [Yang's] invention include, without
limitation, chitin synthesis inhibitors such as bistrifluron,
buprofezin, chlorfluazuron, cyromazine, diflubenzuron,
flucycloxuron, flufenoxuron, hexaflumuron, lufenuron,
novaluron, noviflumuron, penfluron, teflubenzuron and
triflumuron; juvenile hormone mimics such as epofenonane,
fenoxycarb, hydroprene, kinoprene, methoprene, pyriproxyfen,
and triprene; juvenile hormones such as juvenile hormone I,
juvenile hormone II, and juvenile hormone III; molting
hormone agonists such as chromafenozide, halofenozide,
methoxyfenozide, and tebufenozide; molting hormones such as
a-ecdysone and ecdysterone; molting inhibitors such as
diofenolan; precocenes such as precocene I, precocene II, and
precocene III; unclassified insect growth regulators such as
dicyclanil; other IGRs; and mixtures thereof. Preferred IGRs
include, for example, methoprene, hydroprene, kinoprene,
fenoxycarb, pyriproxifen, cyromazine, diflubenzuron,
novaluron, and mixtures thereof. In a particularly preferred
embodiment, the IGR is methoprene.
(Yang ii 50).
FF 13. "Suitable adulticides for use in [Yang's] invention include, for
example, [] neonicotinoid insecticides" (Yang ii 51; Ans. 4).
FF 14. Gimeno "relates to the treatment of infestation in animals by
ectoparasites, such as fleas and ticks" and "provides a microencapsulated
insecticide which is prepared by oil-in-water interfacial polymerisation"
(Gimeno 1: 1-2 and 2: 16-17).
FF 15. "Examples of insecticides which may be used in [ Gimeno' s]
invention," include "Fipronil" and "Etofenprox" (Gimeno 4: 11, 15, and 27;
see Ans. 4).
FF 16. Gimeno 's "microencapsulated insecticide may include an insect
growth regulator," which are "well known to the skilled person and include,
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for example, Brevioxime, Buprofozin, Chlortluazuron, Cyromazine,
Diflubenzuron, Diofenolan, Famesol, Fenoxycarb, Fluoromevalonate,
Fluvastatin, Hexafumuron, Hydroprene, Imidazole, Indomethazine,
Ketokonazole, Kinoprene, Methoprene, Mevinolin, Novaluron,
Pyriproxyfen, Tebufenozide, Teflubenzuron, Triflumuron and Triprene"
(Gimeno 7: 22-29 (emphasis added); see generally Ans. 4).
FF 17. Narayanan "relates to an emulsifiable concentrate of difficult to
dissolve agricultural chemicals making use of biodegradable solvents"
(Narayanan 1: 5-8).
FF 18. Examiner finds that Narayanan suggests a composition comprising
"between 1 % and 99% of' an "N, N dialkyl fatty acid amide" (Ans. 5).
ANALYSIS
The combination of Miller and either of Yang or Gimeno:
Based on the combination of Miller and either of Yang or Gimeno,
Examiner concludes that, at the time Appellants' invention was made, it
would have been prima facie obvious "to use any[] art recognized means, as
of MILLER modified with the specific & equivalent pesticides of [Yang or
Gimeno] as desired to increase toxicity to the desired pests while decreasing
toxicity to host animals" (Ans. 4).
The method of Appellants' independent claim 1 comprises: topically
co-administering: (1) a non-mobile insect growth regulator component
comprising pyriproxyfen, (2) a mobile insect growth regulator component
comprising methoprene or hydroprene, and (3) an adulticide component to
the animal (see Appellants' claim 1 ).
The formulation of Appellants' independent claim 8 comprises: an
effective amount of: (1) a non-mobile insect growth regulator component
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comprising pyriproxyfon, (2) a mobile insect growth regulator component
comprising methoprene or hydroprene, and (3) an adulticide component
sufficient to reduce the parasitic infestation of a non-human animal treated
with the formulation (see Appellants' claim 8).
Miller discloses a formulation, and method of treating parasitic
infestation in a non-human animal with a topical composition, that
comprises a mixture of: (1) a "nitrogen containing heterocyclic ovicide,"
which may be pyriproxifen or another compound, (2) an adulticide, i.e., a
"synthetic pyrethroid," and (3)
one or more active ingredients selected from the group
consisting of permethrin, cypermethrin, cyhalothrin,
fambdacyhalothrin, deltamethrin, tralomethrin, cyfluthrin,
flucythrin, flumethrin, fluvalinate, fenvalerate, methoprene,
fenoxycarb, benzoylphenyl urea, substituted benzoylphenyl
urea, pyriproxifen, or nitrogen containing heterocyclics f1 ro ]m
the class defined above, in combination with a shampoo base
comprising one or more of the above listed additives.
(FF 5-6).
Miller suggests the combination of a number of different insect
growth regulators with no suggestion as to whether the insect growth
regulators selected for combination should be mobile, non-mobile, or a
combination of mobile and non-mobile regulators (see FF 5-8; see App. Br.
12 ("Miller does not discuss using both a mobile and a non-mobile insect
growth regulator in the same treatment")). Yang and Gimeno also list
various insect growth regulators with no suggestion as to whether the insect
growth regulators selected for combination should be mobile, non-mobile, or
a combination of mobile and non-mobile regulators (FF 10-16). In contrast,
Appellants' claimed formulation and method requires a specific combination
of, inter alia, a mobile insect growth regulator that comprises pyriproxyfen
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and a non-mobile insect growth regulator that comprises methoprene or
hydroprene (see Appellants' claims 1 and 8).
"[E]xaminer bears the initial burden, on review of the prior art or on
any other ground, of presenting aprimafacie case ofunpatentability." In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). In satisfying this initial
burden, "[i]t is impermissible to use the claimed invention as an instruction
manual or 'template' to piece together the teachings of the prior art so that
the claimed invention is rendered obvious." In re Fritch, 972 F.2d 1260,
1266 (Fed. Cir. 1992). Stated differently, to establish obviousness, there
must be "an apparent reason to combine the known elements in the fashion"
recited in the claims. KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418
(2007).
Examiner correctly established that the combination of Miller with
Yang or Gimeno suggests a variety of insect growth regulators (see FF 5-
16). We are, however, not persuaded by Examiner's conclusion that, at the
time of Appellants' claimed invention, it would have been prima facie
obvious to a person of ordinary skill in this art to select any combination of
insect growth regulators, including those specifically required by
Appellants' claimed invention, to achieve a desired effect (see Ans. 4).
Obviousness requires more than a mere showing that the
prior art includes separate references covering each separate
limitation in a claim under examination. KSR Int'! Co. v.
Teleflex Inc., 550 U.S. 398, 418 [] (2007). Rather, obviousness
requires the additional showing that a person of ordinary skill at
the time of the invention would have selected and combined
those prior art elements in the normal course of research and
development to yield the claimed invention. Id. at 421.
Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir.
2011).
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On this record, Examiner failed to establish an evidentiary basis that
supports a conclusion that the combination of Miller with Yang or Gimeno
makes obvious the specific selection and combination of mobile and non-
mobile insect growth regulators, as required by Appellants' claimed
invention, from the various insect growth regulators suggested by the prior
art.
The combination of Miller and Narayanan:
Based on the combination of Miller and Narayanan, Examiner
concludes that, at the time Appellants' invention was made, it would have
been prima facie obvious "to combine NARA YANAN's specific
diluent/solvent in making a composition as per MILLER, so as to make a
composition which is more effective" (Ans. 5). We are not persuaded. As
discussed above, Miller suggests the combination of a number of different
insect growth regulators with no suggestion as to whether the insect growth
regulators selected for combination should be mobile, non-mobile, or a
combination of mobile and non-mobile regulators (see FF 5-8). Examiner
failed to establish an evidentiary basis on this record that supports a
conclusion that Miller makes obvious the specific selection and combination
of mobile and non-mobile insect growth regulators, as required by
Appellants' claimed invention, from the various insect growth regulators
suggested by Miller. Examiner further failed to establish that Narayanan
makes up for the foregoing deficiency in Miller (see FF 17-18; see also
App. Br. 18 ("Narayanan does not describe insect growth regulators such as
pyriproxyfen, methoprene, and/or hydroprene in the first instance, much less
recognize or express any advantage of having two differently-acting insect
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growth regulators or discuss using both a mobile and a non-mobile insect
growth regulator in the same treatment")).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1---6, 8-11, and 13-19 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Miller and either of Yang
or Gimeno is reversed.
The rejection of claims 1-5, 8, 9, 11, 13-16, and 19-21 under
35 U.S.C. § 103(a) as unpatentable over the combination of Miller and
Narayanan is reversed.
REVERSED
lp
11