Ex Parte Snyder

Patent Trial and Appeal Board

Sep 29, 2016

13515603 (P.T.A.B. Sep. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/515,603 06/13/2012
120636 7590
Eli Lilly and Company
500 West Madison Street
34th Floor
Chicago, IL 60661
09/29/2016
FIRST NAMED INVENTOR
Daniel Earl Snyder
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.
Xl8921 6294
EXAMINER
JIANG, SHAOJIA A
ART UNIT PAPER NUMBER
1673
MAILDATE DELIVERY MODE
09/29/2016 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 EARL SNYDER
Appeal2015-001546
Application 13/515,603
Technology Center 1600
Before RICHARD M. LEBOVITZ, JOHN G. NEW, and TA WEN CHANG,
Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a method of controlling or
treating bot larvae in the gastrointestinal tract of an equine animal which
comprises orally administering an effective amount of a spinosyn to said
animal. The Examiner rejected the claims as obvious under 35 U.S.C. §
103(a) and on the grounds of non-statutory obviousness-type double-
patenting. We have jurisdiction under 35 U.S.C. § 134. The obviousness
rejection is affirmed and the double-patenting rejection is moot.
STATEMENT OF CASE
Appellant appeals the Examiner's final rejection of claims 24--35.
Claim 24, the only independent claim on appeal, is reproduced below:
Appeal2015-001546
Application 13/515,603
24. A method of controlling or treating bot larvae in the
gastrointestinal tract of an equine animal which comprises
orally administering an effective amount of a spinosyn to said
animal, wherein said spinosyn is spinosad or a physiologically
acceptable salt thereof or spinetoram or a physiologically
acceptable salt thereof.
The claims stand rejected by the Examiner as follows:
1. Claims 24--35 on the ground of non-statutory double patenting as
obvious over of claims 56-81 of co-pending Application No. 13/879,082.
Final Rej. 3. The rejection is provisional because the claims in the co-
pending Application have not been patented. Id.
2. Claims 24--35 under 35 U.S.C. § 103(a) as obvious in view of
DeAmicis et al. (US 6,001,981, issued Dec. 14, 1999) ("DeAmicis") and
Snyder (US 6,664,237 Bl, issued, Dec. 16, 2003). Final Rej. 4.
The obvious-type double-patenting rejection is moot because co-
pending Application No. 13/879,082 is abandoned. Notice of Abandonment
in Application No. 13/879;082; mailed June 10; 2016.
OBVIOUSNESS REJECTION
Claim 24 is directed to a method "of controlling or treating bot larvae
in the gastrointestinal tract of an equine animal." The method comprises a
single recited step of "orally administering an effective amount of a spinosyn
to said animal." The spinosyn is recited in the claim to be "spinosad or a
physiologically acceptable salt thereof or spinetoram or a physiologically
acceptable salt thereof." Dependent claim 32 recites that the bot larvae "is
Gasterophilus intestinalis, Gasterophilus nasalis, or Gasterophilus
haemorrhoidalis."
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Claims 29 to 31, and 33, which depend from claim 24, recite specific
amounts of the spinosyn:
• "between about 1 and 100 mg/kg of equine animal body weight"
(claims 29, 33);
• "between about 5 and 50 mg/kg of equine animal body weight"
(claim 30); and
• "from about 10 to about 20 mg/kg of equine animal body weight"
(claim 31 ).
Claim 28, which depends from claim 24, further limits claim 24 to
where "administration is carried out in a single dose."
The Examiner found that DeAmicis teaches that spinosyn compounds
are effective in controlling Gasterophilus intestinalis (the common horse fly)
(DeAmicis, col. 12, 11. 7-34) and that the compounds can be administered
orally (id., col. 13, 11. 15-16). Final Rej. 4. The Examiner further found that
Snyder describes treating Gasterophilus intestinalis with a single oral dosage
of a spinosyn compound. Id. The Examiner concluded that it would have
been obvious to one of ordinary skill in the art "to administer spinosad in a
single dose to an equine animal in order to control or treat bot larvae with a
reasonable expectation of success." Id.
DeAmicis does not describe "controlling or treating bot larvae in the
gastrointestinal tract of an equine animal" as recited in the preamble of claim
24. Rather, as acknowledged by the Examiner (Answer 4), DeAmicis
teaches:
In yet another embodiment, the present compounds can be used
to control insects and arachnids which are pests in the feces of
cattle and other animals. In this embodiment, the compounds
are administered orally and the compounds travel through the
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Application 13/515,603
intestinal tract and emerge in the feces. Control of pests in the
feces indirectly protects the animals from the pests.
DeAmicis, col. 13, 11. 13-19.
The Examiner found that the "spinosyn compounds must travel
through intestinal tract. While travelling through intestinal tract said
compounds would inherently control or treat any pests present in the
intestinal tract, such as bot larvae." Answer 4.
Appellant contends that "DeAmicis and Snyder, individually or in
combination, provide no teaching or suggestion as to what dosage is needed
for orally administering a spinosyn to an equine for controlling or treating
bot larvae infestation in the gastrointestinal tract of an equine." Reply Br. 6.
Appellant states that there is no specific teaching in DeAmicis of bot larvae.
Appeal Br. 8. Appellant argues:
Id.
This is significant because controlling or treating bot larvae is
very different from controlling or treating bot eggs or adult
bots. Bot larvae infest the gastrointestinal tract of an equine for
a period of between two to twelve months. Thus, a spinosyn for
controlling or treating bot larvae must be effective in the
gastrointestinal tract rather than externally, which would be the
case for bot eggs and adult bots.
Appellant contends that the Examiner is "merely speculating that at
the time of the invention orally administering a spinosyn to an equine would
result in controlling or treating bot larvae in the gastrointestinal tract of an
equine." Reply Br. 6. Appellant argues that it was unknown at the time of
the invention that a spinosyn compound could be used to control or treat bot
larvae in the gastrointestinal tract of an equine animal, and obviousness
cannot be based on what was unknown at the time of the invention. Id. at 7-
8. Appellant states that Snyder teaches treating ectoparasites on the skin
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surface which would make its dosages inapplicable to treating a
gastrointestinal infestation. Appeal Br. 9-10. Appellant concludes that "the
Examiner has failed to show a reasonable expectation, or some
predictability, that the DeAmicis or Snyder compounds would be able to
control or treat bot larvae in the gastrointestinal tract of an equine animal if
administered in the dosage disclosed by Snyder." Reply Br. 10.
Discussion
The spinosyn compounds recited in the claims were known at the
time of the invention to have activity against insects (Snyder, col. 1, 11. 11-
16 & col. 4, 11. 57-66), including Gasterophilus intestinalis (the common
horse bot fly) (DeAmicis, col. 12, 11. 32-33; Abstract), which is the same
insect encompassed by the rejected claims (see claim 32). Both DeAmicis
and Snyder teach controlling ectoparasites with oral administration of
spinosyn compounds (DeAmicis, col. 12, 11. 1---6; Snyder, col. 2, 11. 1-7).
DeAmicis teaches administering the compounds orally so that they "travel
through the intestinal tract and emerge in the feces." Id., col. 13, 11. 15-17.
DeAmicis teaches that controlling the "pests in the feces indirectly protects
the animals from the pests." Id., col. 13, 11. 18-19.
The principal issue in this rejection is whether a skilled worker would
have reasonably expected that administering the effective amounts described
in DeAmicis and Snyder for controlling pests outside the body would have
controlled or treat a bot larvae in the gastrointestinal tract of an equine
animal, such as a horse.
To begin, we note that the claim preamble of claim 24 requires that
the method is for "controlling or treating bot larvae in the gastrointestinal
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tract of an equine animal." Neither DeAmicis nor Snyder teach such a
method. However, it is well-established by legal precedent that the
preamble of a method claim which states the purpose for which a method is
to be performed is not sufficient to distinguish it from prior art which carried
out the same steps of the method claim, although for a different purpose. In
re Cruciferous Sprout Litig., 301F.3d1343, 1351 (Fed. Cir. 2002); see also
In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990); MEHL/Biophile Int'! Corp.
v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999); Perricone v. Medicis
Pharm. Corp., 432 F.3d 1368, 1378-79 (Fed. Cir. 2005); In re Omeprazole
Patent Litig., 483 F.3d 1364, 1373 (Fed. Cir. 2007) ("the inherency cases").
Although these cases were decided in the context of inherent anticipation,
they stand for the principle that a claim preamble stating a purpose of a
method does not alone distinguish it from prior art when the method steps
are the same.
Claim 24 has only one recited step of "orally administering an
effective amount of a spinosyn" to an equine animal. As established by the
Examiner and discussed above, both DeAmicis and Snyder describe oral
administration of spinosyn. Because the same method step which is claimed
is also described by DeAmicis and Snyder, the principles enunciated in the
inherency cases are applicable here, namely, the preamble of claim 24 does
not patentably distinguish it from the methods described in DeAmicis and
Snyder.
However, the inquiry does not end here, because the claim also
requires that an "effective amount of a spinosyn" is administered to the
animal to control or treat the bot larvae in the gastrointestinal tract of an
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equine animal. It must be shown that DeAmicis or Snyder disclose or
suggest such effective amounts.
To meet the burden of establishing obviousness, the Examiner does
not have to prove that the amounts disclosed or suggested by the prior art
treat or control bot larvae. However, the Examiner must have a reasonable
basis for drawing this conclusion, which may arise from identity or
substantial identity between the claimed process and the process described in
the prior art.
Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by identical
or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
See In re Ludtke, supra. Whether the rejection is based on
"inherency" under 35 U.S.C. § 102, on "prima facie
obviousness" under 35 U.S.C. § 103, jointly or alternatively,
the burden of proof is the same, and its fairness is evidenced by
the PTO's inability to manufacture products or to obtain and
compare prior art products. See In re Brown, 459 F .2d 531, 59
CCPA 1036 (1972).
In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
For the following reasons, we conclude that the Examiner had a
reasonable basis to find that following the direction of DeAmicis and Snyder
would necessarily result in treating bot larvae as claimed.
DeAmicis teaches administering an oral dosage of a spinosyn
compound which protects the animal by necessarily traveling through the
intestinal tract and emerging in the feces where it protects the animal from
pests. DeAmicis, col. 13, 11. 13-19. DeAmicis also teaches that activity "is
achieved when the compounds contact the pests. The contact can be of the
egg, larvae, adult, or other life stage. 'Contact' includes ingestion of the
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compound by the pest." Id. at col. 12, 11. 52-55. Thus, a sufficient dosage
of the spinosyn compound is administered to the animal such that enough
compound emerges from the intestine to treat the pest. DeAmicis also
teaches that the larvae in feces can be treated with the compound. Id. It is
therefore reasonable that the amount of compound in the intestine would be
effective to treat intestinal pests, such as bot larvae, because the amount
which emerges from the intestine must possess such potency. Consequently,
it would be obvious to have utilized an amount of spinosyn to treat larvae in
feces, where such effective amount would necessarily travel through the
intestine and be available for treating the larvae inside the gastrointestinal
tract. It is not necessary that the skilled worker had recognized that larvae
inside the gastrointestinal tract were treated. Merely appreciating the result
of the method does not patentably distinguish it from prior art because it
does not change how the method is performed.
The obviousness determination does not require having any
knowledge that the gastrointestinal bot larvae are treated or controlled.
Rather, following DeAmicis' s guidance that larvae can be treated in the
feces, and choosing such amounts to do so, 1 would have necessarily resulted
in treating larvae inside the gastrointestinal tract. Thus, while Appellant is
correct that DeAmicis does not expressly teach amounts of a spinosyn
compound to treat or control bot larvae in the gastrointestinal tract of an
equine animal, the Examiner reasonably found that routinely selecting
dosages to treat in feces would also treat those in the intestine.
1 "The amount of compound applied to the loci of insects and mites is not
critical and can easily be determined by those skilled in the art." DeAmicis,
col.11,11.21-23.
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Snyder teaches a single oral dosage for treating ectoparasites. Snyder,
Abstract. Snyder teaches that "ectoparasites include the egg, larval, pupal,
nymphal and adult stages of fleas, lice, mosquitoes, mites, ticks and blood-
sucking, biting or nuisance fly species." Id., col. 4, 11. 57---64. Snyder also
teaches effective dosages for this purpose:
In general, an effective amount refers to a dose of from about 1
to about 100 mg of the spinosyn/kg of body weight of the
companion animal. More commonly, the effective amount is
from about 10 to about 50 mg/kg of body weight of the animal.
Id., col. 5, 11. 46-50.
As noted by the Examiner, these dosages correspond to or encompass
the amounts recited in claims 29-31 and 33 (Answer 4), namely:
• "between about 1 and 100 mg/kg of equine animal body weight"
(claims 29, 33);
• "between about 5 and 50 mg/kg of equine animal body weight"
(claim 30); and
• "from about 10 to about 20 mg/kg of equine animal body weight"
(claim 31 ).
Based on the identity of dosages, the Examiner found there would
have been a reasonable expectation of success that, when treating an
ectoparasitic bot larvae with an oral dosage, bot larvae inside the
gastrointestinal tract would be treated. Answer 4--5.
Because all equine animals are susceptible to bot larvae infestation,
following DeAmicis or Snyder's guidance on dosage would necessarily
result in treating such bot larvae in the intestine. Perricone, 432 F.3d at
1379.
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Appellant cites Jn re Shetty, 566 F.2d 81(CCPA1977), as holding
that an obviousness rejection cannot be predicated on that which was
unknown at the time of the invention. Reply Br. 8-9. "The use of a
spinosyn compound to control or treat bot larvae in the gastrointestinal tract
of an equine animal would have been unknown at the time the presently
claimed invention was made." Id. at 8. Citing from Shetty, Appellant
contends:
As in In re Shetty, the Examiner has failed to show a reasonable
expectation, or some predictability, that the DeAmicis or
Snyder compounds would be able to control or treat bot larvae
in the gastrointestinal tract of an equine animal if administered
in the dosage disclosed by Snyder. Similarly, here, the
Examiner's mere hindsight assertion that dosages corresponding
between the presently claimed invention and Snyder render
Appellant's method obvious is untenable.
Id. at 10.
This argument does not persuade us that the Examiner erred. In
Shetty, the court held:
The Patent Office has failed to shmv a reasonable expectation,
or some predictability, that Brake's compound would be an
effective appetite suppressant if administered in the dosage
disclosed by Narayanan. The 1nere hindsight assertion that
corresponding dosages render appellant's method obvious is
untenable.
Shetty, 566 F.2d at 86.
This case is distinguishable because, as explained above, there is a
reasonable expectation that the effective dosages in DeAmicis and Snyder
would treat bot larvae in the gastrointestinal tract. Once the Examiner
provides such evidence of a reasonable expectation of success, Appellant has
the burden of coming forward with rebuttal evidence to show that the prior
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art method would not produce or would not be expected to produce the
claimed subject matter. In re Kumar, 418 F.3d 1361, 1368 (Fed. Cir. 2005).
In this case, Appellant has provided no persuasive evidence to this effect.
For the foregoing reasons, we affirm the rejection of claim 24. Claims
25-35 were not argued separately and thus fall with claim 24. 37 C.F.R. §
41.37(c)(iv).
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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