Ex Parte Blaser et al

Patent Trials and Appeals Board

Jun 28, 2019

14399790 - (D) (P.T.A.B. Jun. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/399,790 11/07/2014 David Blaser
25885 7590 07/02/2019
ELI LILLY & COMPANY
PATENT DIVISION
P.O. BOX 6288
INDIANAPOLIS, IN 46206-6288
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.
X20573 2280
EXAMINER
NGUYEN, JOHN P
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
07/02/2019 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):
patents© lilly .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID BLASER, JACQUES BOUVIER, MARTIN FINK,
JOHN GERARD MCHENERY, and STEVE NANCHEN1
Appeal2018-009173
Application 14/399,790
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and DAVID COTTA,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of controlling sea lice in fish, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm but designate the affirmance a new ground of rejection.
STATEMENT OF THE CASE
"The basis of sea louse control in commercial salmonid farming is
largely still a treatment with chemicals such as organophosphates, synthetic
1 Appellants identify the Real Party in Interest as Blanco Tiergesundheit
AG, a wholly owned subsidiary of Eli Lilly and Company. Appeal Br. 1.
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Application 14/399,790
pyrethroids, chitin synthesis inhibitors," etc. Spec. 1. The "invention relates
to the control of sea lice ... [with] the known chitin synthesis inhibitor
lufenuron in form of a particular formulation and according to a particular
treatment schedule." Id. The Specification states that, "[ s ]urprisingly, a very
long-lasting and convenient control of sea lice infesting fish, and in
particular salmon, may be obtained by an in-feed treatment of the fish with
lufenuron before transfer to sea or whilst at sea." Id.
Claims 1, 3-8, 10, 11, and 15-24 are on appeal. Claim 1 is
representative and reads as follows:
1. A method for controlling sea lice in a fish population, said method
comprising oral administration of lufenuron or a veterinary acceptable salt
thereof to said fish population, wherein the oral administration comprises
administering a daily dose of 1 to 30 mg lufenuron/kg of fish biomass for a
time period of 3 to 14 days.
DISCUSSION
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 103 (a) as obvious based on Martinsen 2 and Leadbeater. 3 Final Action 4 3.
The Examiner finds that Martinsen teaches "a method to control parasitic
infestations including sea lice infestation in farmed fish that comprises
administration of a chitin synthesis inhibitor in the form of ... bath
treatment, orally or injections." Final Action 3. The Examiner also finds that
2 Alexandersen et al., CA 2 616 765 Al, Open to Public Insp. Dec. 16, 1999.
The Examiner and Appellants refer to this reference as "Martinsen," so we
do as well.
3 Barratt et al., WO 92/06599, published April 30, 1992. The Examiner and
Appellants refer to this reference as "Leadbeater," so we do as well.
4 Office Action mailed March 2, 2018.
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Application 14/399,790
"Martinsen discloses use of lufenuron for the control of parasitic infestations
in fish" and "discloses administration of chitin synthesis inhibitors orally for
[] 7 days." Id. at 4.
The Examiner finds that "Martinsen does not specifically teach oral
administration of lufenuron to fish and at a daily dose of 1 to 30 mg," but
concludes that this limitation, and therefore the method of claim 1 as a
whole, would have been obvious when Martinsen's teachings were
combined with those of Leadbeater. Id. at 4---6.
We agree with the Examiner that the method of claim 1 would have
been obvious based on Martinsen. We do not find that Leadbeater' s
disclosure is needed to support a prima facie case of obviousness. We
therefore base our affirmance on the teachings of Martinsen alone. Because
the basic thrust of our reasoning differs from that of the Examiner, we
designate the affirmance a new ground of rejection. See In re Kronig, 539
F.2d 1300, 1302---03 (CCPA 1976).
Martinsen states that parasitic infestations are a problem in the fish
farming industry. Martinsen 1: 15-16. "Infestation with sea lice ... is
considered to be one of the most important disease problems in the farming
of salmonids, especially in Atlantic salmon ... and rainbow trout." Id. at
1:18-20.
"Substances such as chitin synthesis inhibitors, diflubenzuron and
teflubenzuron, ... if administered orally, can be effective against parasitic
diseases in fish." Id. at 2:12-14. "[O]ral treatments ... [using the] chitin
synthesis inhibitors, diflubenzuron and teflubenzuron, have been
documented for use against sea lice in salmon." Id. at 3:21-23.
"Diflubenzuron and teflubenzuron, which belong to the same substance
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group as hexaflmnuron, act by inhibiting the production of chitin." Id. at
3 :26-27. "Diflubenzuron and teflubenzuron are administered to the fish via
the feed, absorbed and distributed to skin and mucus, where the
concentration will be high enough to inhibit the development of the
parasite." Id. at 3 :33 to 4: 1.
Martinsen states that its "invention pertains in a first aspect to
hexaflumuron for controlling parasitic infestations in fish." Id. at 5:7-8. The
"hexaflumuron can be administered to the fish orally, by adding it to the
habitat of the fish or by injection." Id. at 5: 16-17. "Hexaflumuron can be
added to pre-manufactured fish feed or pellets." Id. at 7:2. "[T]he fish will
absorb the active substance, and therapeutic concentration of the substance
will be maintained for a certain time." Id. at 7:14--16.
Martinsen discloses "a method of controlling infestations in fish with
parasites ... comprising administering an antiparasitically active substance
to the fish by injection. In this context, useful active substances are chitin
synthesis inhibitors including ... hexaflumuron, ... lufenuron," etc. Id. at
9: 1-5. "The method is e.g. useful in the control of infestations with sea lice."
Id. at 9:7.
Martinsen's Example 2 describes treating salmon infested with sea
lice with hexaflumuron, orally administered at a dosage of either 3 .0
mg/kg/day or 9.0 mg/kg/day, 5 for 7 days. Id. at 11 :29 to 12:7. Martinsen
5 Martinsen actually states that the "Dose per day" was either 9.0 mg or 3.0
mg. Martinsen 12, Table 1. However, in describing the results of Example 2,
Martinsen states that "[t]he treatment dosage varied between 3 - 9 mg
hexaflumuron ... per kg fish per day for 7 days." Id. at 9:25-26 ( emphasis
added). We therefore understand Martinsen's Table 1 to describe the dosage
in mg/kg.
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states that "the hexaflmnuron treatment reduced the number of lice ... more
than 70% as compared to the control treatment in all the groups treated with
hexaflumuron .... For the groups given the highest dosage, the reduction
was> 99%." Id. at 12:10-12.
Martinsen's Example 6 describes treating salmon with hexaflumuron,
orally administered at a dosage of 5.6 mg/kg/day, for 7 days. Id. at 15:25-
27. Another group of salmon "was given oral treatment with a daily dosage
of 10 mg teflubenzuron per kg fish for 7 days, while the last group remained
untreated." Id. at 15:29-30. "The fish were then exposed to natural sea lice
infestation." Id. at 15:33.
Martinsen reports that the results of the experiment in Example 6 were
that "fish treated with hexaflumuron had a significantly lower number of lice
larger than Chalimus II at 5, 8 and 11 weeks." Id. at 16:5-6.6 "The group
treated with teflubenzuron had the same number of lice as the untreated
control group at each assessment, which demonstrates that teflubenzuron
does not have the same protective effect as hexaflumuron." Id. at 16:6-9.
After 11 weeks, all the fish not treated with hexaflumuron were bathed with
deltamethrin, "which ma[ de] it difficult to determine the exact protection
period. The fish were, however, protected for at least 11 weeks." Id. at 17-
18.
Martinsen's Example 8 describes testing "9 different active substances
... for protective effect against sea lice." Id. at 18: 15. The substances tested
included the following chitin synthesis inhibitors: "hexaflumuron,
buprofezin, diflubenzuron, fluazuron, [and] lufenuron," all of which were
6 Chalimus II is an early developmental stage of a sea louse. Martinsen 11: 1.
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injected "at a dosage of about 50 mg/kg." Id. at 18:27-31. Martinsen reports
that "[ fJish injected with lufenuron showed good protection against lice until
... 128 days after injection. Hexaflumuron ... conferred significant
protection against sea lice until ... 9 months after injection." Id. at 19:20-
22. Martinsen does not report results for any of the other chitin synthesis
inhibitors tested (i.e., buprofezin, diflubenzuron, and fluazuron).
Martinsen states that
[i]t is very surprising that hexaflumuron, in addition to having a
therapeutic effect, also protects fish from new attacks by
juvenile parasites for an extended period of time after
completing the treatment. ... This is in great contrast to the
closely related substances, diflubenzuron and teflubenzuron,
which do not protect against new establishments by sea lice
(see Examples 6 and 8).
Id. at 8:12-18.
Notably, while Martinsen's specification seems to focus on
hexaflumuron, its claims are all directed to using lufenuron to treat parasitic
infestations in fish. See id. at 22-23.
We conclude that a person of ordinary skill in the art would have
found it obvious, based on Martinsen's disclosure, to control sea lice in fish
by orally administering lufenuron at a daily dose of 1-30 mg/kg of fish
biomass for a period of 3-14 days. A skilled artisan would have found this
method obvious based on a combination of Martinsen's disclosures.
First, Martinsen's claimed invention is directed to using lufenuron to
treat parasitic, including sea lice, infestations in fish. Martinsen's claim 2
does not specify the route of administration; claim 3 depends from claim 2
and specifies injection, which implies that claim 2 encompasses other routes
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of administration. See Martinsen 22. The other routes of administration
described by Martinsen are oral administration and by bath. Id. at 5: 16-1 7.
Second, Martinsen teaches that three other chitin synthesis inhibitors
( diflubenzuron, teflubenzuron, and hexaflumuron) are effective in treating
sea lice infestations in fish when orally administered. Id. at 3:21-23, 16:5-6.
Third, Martinsen teaches that lufenuron, like hexaflumuron, provides
long-term protection when administered by injection. Id. at 19:10-15.
Martinsen reports that the same experiment showed that diflubenzuron does
not provide long-term protection. Id. at 19: 12-13 ("only the groups injected
with hexaflumuron, lufenuron or moxidectin showed protection," emphasis
added). Similarly, Martinsen teaches that hexaflumuron also provides long-
term protection against sea lice when administered orally at 5.6 mg/kg/day
for seven days (id. at 15:26-27, 16:5---6), and "teflubenzuron does not have
the same protective effect as hexaflumuron" (id. at 16:8-9).
In summary, because both lufenuron and hexaflumuron provided
long-term protection against sea lice when injected, and hexaflumuron was
shown to provide long-term protection when administered orally at 5.6
mg/kg/day for seven days, it would have been obvious to administer
lufenuron orally at 5.6 mg/kg/day for seven days with a reasonable
expectation that doing so would provide effective protection against sea lice
infestation.
The evidence is equivocal about whether orally administering
lufenuron in the same dosage, for the same time period, as the administration
ofhexaflumuron in Martinsen's Example 6 would have been expected to
provide the same long-term protection as Martinsen found for hexaflumuron.
However, Appellants' claim 1 does not require long-term protection. And
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Martinsen discloses that oral administration of diflubenzuron or
teflubenzuron were known treatments for sea lice infestation (Martinsen
3:21-23), even though those compounds did not provide long-term
protection (id. at 16:8-9, 19: 12-13). Thus, the evidence shows that those
skilled in the art recognized treatments for sea lice infestation as effective
even if they did not provide long-term protection. The method made obvious
by Martinsen therefore meets the limitations of Appellants' claim 1.
Appellants argue that Martinsen's disclosure is focused on
administration of active agents by injection. Appeal Br. 3. This argument is
unpersuasive because Martinsen expressly describes administration orally,
by bath, or by injection (Martinsen 5: 16-17) and provides a working
example of administration orally and by bath (id. at 15:26-28). Martinsen's
disclosure therefore is not limited to administration by injection.
Appellants also argue that "Martinsen does not provide a basis to
select lufenuron for further development as a lead compound." Appeal Br. 3.
This argument is also unpersuasive. A "lead compound" analysis
applies "[i]n cases involving the patentability of a new chemical compound."
Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1291 (Fed. Cir.
2012) (emphasis added). See also id. ("[W]hether a new chemical compound
would have been prima facie obvious over particular prior art compounds
ordinarily follows a two-part inquiry. First, the court determines whether a
chemist of ordinary skill would have selected the asserted prior art
compounds as lead compounds, or starting points, for further development
efforts."); id. at 1292 ("The second inquiry in the analysis is whether the
prior art would have supplied one of ordinary skill in the art with a reason or
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motivation to modify a lead compound to make the claimed compound with
a reasonable expectation of success.").
Here, claim 1 requires no modification of a prior art compound to
make a claimed compound; lufenuron was known in the art. The difference
between the prior art and the claimed invention is not in the compound that
is administered, but in the manner of administering the known compound
recited in the claimed method. For the reasons discussed above, we conclude
that the administration of lufenuron that is recited in claim 1 would have
been obvious to a skilled artisan based on Martinsen.
Appellants argue that Leadbeater relates to "a very different problem
from oral delivery of an active ingredient," Appeal Br. 4, and "[t]here is no
reason for a skilled person to combine Martinsen and Leadbeater," id. at 5.
However, as noted above, we conclude that the method of claim 1 would
have been prima facie obvious over Martinsen alone.
Finally, Appellants argue that the "data in present specification,
indeed, shows surprisingly long-lasting and convenient control of sea lice."
Appeal Br. 6. Specifically, Appellants argue that
Id.
Example 2, Table 4 shows oral treatment with a dose as low as
1 mg/kg of lufenuron for 7 days (meaning an overall amount of
7 mg/kg lufenuron) showed about the same prophylactic
efficacy as the 50 mg/kg injectable treatment disclosed in
Martinsen. Example 1, Table 1, shows long lasting protection at
a dose of 3 mg/kg/ day ( an overall amount of 21 mg/kg of fish
biomass) of lufenuron, and Table 2 shows about 9 months of
protection at 5 mg/kg for 7 days ( an overall amount of 3 5
mg/kg of fish biomass, Table 2). When compared to
Martinsen's disclosure of 50 mg/kg lufenuron by injection, see
Figure 8, T7 ( about 6 months), the data in the Specification
shows an unexpected effect.
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This argument is unpersuasive because it is based on a comparison of
the results shown in the Specification's working examples with the results
shown in Martinsen's working examples. Thus, the data relied on do not
represent a side-by-side comparison of fish treated with lufenuron
administered orally or by injection, but a comparison of the results from an
experiment, conducted under certain conditions, in which lufenuron was
administered orally, with results from a different experiment, conducted
under different conditions, in which lufenuron was administered by
injection. It is therefore unclear what probative weight the evidence should
be given with respect to nonobviousness.
In addition, the record lacks a persuasive explanation, based on
evidence, of why the results shown in the Specification would have been
considered unexpected to a person of ordinary skill in the art. Martinsen
states that
[i]t is very surprising that hexaflumuron, in addition to having a
therapeutic effect, also protects fish from new attacks by
juvenile parasites for an extended period of time after
completing the treatment. Salmon species are protected from
new establishments of sea lice for a period of at least 8 weeks
such as at least 12 weeks including at least 6 months and even
up to 10 months after transfer to sea water.
Martinsen 8:12-16.
Specifically, Martinsen's experiments show that orally administered
hexaflumuron protected fish from sea lice for at least 11 weeks (id. at 16: 18)
and injected hexaflumuron protected fish from sea lice for 9 months (id. at
19:21-22). Given that it was known from Martinsen that hexaflumuron-a
chitin synthesis inhibitor, like lufenuron-gave long-term protection against
sea lice when orally administered, it is unclear why a skilled artisan would
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have been surprised to see similar results from orally administered
lufenuron. Although the Specification uses the word "[ s ]urprisingly" (Spec.
1 ), and Appellants argue that the results were unexpected (Appeal Br. 6),
"[i]t is well settled that unexpected results must be established by factual
evidence. Mere argument or conclusory statements in the specification does
not suffice." In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984).
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) based on Martinsen. "All of the claims stand or fall together."
Appeal Br. 3. Claims 3-8, 10, 11, and 15-24 therefore fall with claim 1.
Our basic reasoning differs from that of the Examiner, and we
therefore designate the affirmance as a new ground of rejection.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b). Section 4I.50(b) provides "[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review." Section 4I.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
( 1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
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Application 14/399,790
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under§ 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure§ 1214.01.
AFFIRMED
37 C.F.R. § 4I.50(b)
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