Ex Parte Plana-Duran et al

Board of Patent Appeals and Interferences

Jul 11, 2011

11244574 (B.P.A.I. Jul. 11, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JUAN PLANA-DURAN, RUT VILA-QUINTANA,
JORDI TARRES-CALL, and MAHESH KUMAR
__________

Appeal 2010-004905
Application 11/244,574
Technology Center 1600
__________

Before DEMETRA J. MILLS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claims 1-9, 11-17, and 20. We have jurisdiction
under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
The claims are drawn to vaccine compositions and methods of
preventing or ameliorating an outbreak of Avian Influenza virus using the
vaccine composition. Claim 1 is representative of the claims on appeal, and
read as follows:
1. A vaccine composition which is effective in preventing or ameliorating
Avian Influenza Virus infection, which comprises at least two inactivated
strains of avian influenza virus, wherein the combined hemagglutinin
(HA) total is at least about 200 HA units/dose of said vaccine
composition, and wherein each of said strains presents at least about 128
HA units/dose, and further wherein at least one of said strains is an H5N9
avian influenza virus, and wherein at least one of said strains is an H7N1
avian influenza strain.

The following ground of rejection is before us for review:
Claims 1-9, 11-17, and 20 stand rejected under 35 U.S.C. § 103(a) as
being rendered obvious by the combination of Fatunmbi,
1
Capua,
2
and
Donatelli.
3

We reverse.
ISSUE
Has the Examiner established by a preponderance of the evidence that
the combination of Fatunmbi, Capua, and Donatelli renders obvious a

1
Fatunmbi et al., Efficacy of avridine and liposomes as adjuvants for avian
influenza virus antigens in turkeys, 21 AVIAN PATHOLOGY 225-237 (1992).
2
Capua et al., Development of a DIVA (Differentiating Infected from
Vaccinated Animals) strategy using a vaccine containing a heterologous
neuraminidase for the control of avian influenza, 32 AVIAN PATHOLOGY 47-
55 (2002).
3
Donatelli et al., Characterization of H5N2 influenza viruses from Italian
poultry, 82 J. GEN. VIROL. 623-630 (2001).
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vaccine composition containing an inactivated H5N9 strain of avian
influenza virus?

FINDINGS OF FACT
FF1. The Examiner‟s statement of the rejection may be found at pages 3-4
of the Answer.
FF2. The Examiner relies on Fatunmbi for teaching multivalent influenza
vaccines (Ans. 3).
FF3. Fatunmbi teaches that “[i]nactivated whole virus vaccines containing
the currently prevalent virus strains have been used to immunize chickens
and turkeys in the control of avian influenza” (Fatunmbi, p. 225).
FF4. The Examiner finds that Fatunmbi fails to teach H7N1 and H5N9 in
the vaccines (Ans. 3).
FF5. The Examiner relies on Capua for teaching that H7N1 causes
epidemics in birds (id.).
FF6. The Examiner also relies on Capua for teaching “that low pathogenic
strains cause disease in turkeys” (id. at 4).
FF7. Specifically, Capua teaches that “[t]raditionally, inactivated oil
emulsion vaccines have been used worldwide to control low pathogenicity
avian influenza virus (LPAI) infections in poultry” (Capua, p. 47, second
column).
FF8. Capua teaches further that “[d]uring 1999 and 2000, poultry in north-
eastern Italy was affected by 4 epidemic waves of infection caused by
viruses of low and high pathogenicity of the H7N1 subtype” (id. at 48, first
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column). Capua also teaches that turkeys are more susceptible to LPAI than
chickens (id. at 52, first column).
FF9. The Examiner relies on Donatelli for teaching that “H5N9 is a non-
pathogenic virus isolated along with more virulent strains during
surveillance” (Ans. 4).
FF10. The Examiner further finds that Donatelli teaches “that highly
pathogenic influenza are derived from nonpathogenic influenza . . . and the
H5N9 is found in bird populations” (id. at 5).
FF11. Specifically, Donatelli teaches that “highly pathogenic strains do not
constitute distinct influenza virus lineages but are derived from
nonpathogenic avian strains that have acquired mutations that render the HA
cleavable by intracellular proteases” (Donatelli, p. 623, second column).
FF12. The Examiner concludes that “[o]ne would have known to include
low pathogenic strains because Capua et al. teach that influenzas are found
in both types and that low pathogenic strains cause disease in turkeys” (Ans.
4).
FF13. The Examiner further concludes that the ordinary artisan would have
been motivated to vaccinate against H5N9 as Donatelli teaches that that
highly pathogenic influenza are derived from nonpathogenic influenza (id. at
5).

PRINCIPLES OF LAW
While the analysis under 35 U.S.C. § 103 allows flexibility in
determining whether a claimed invention would have been obvious, KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007), it still requires showing
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that “there was an apparent reason to combine the known elements in the
fashion claimed by the patent at issue.” Id. An invention “composed of
several elements is not proved obvious merely by demonstrating that each of
its elements was, independently, known in the prior art.” Id. “Often, it will
be necessary . . . to look to interrelated teachings of multiple [references] . . .
and the background knowledge possessed by a person having ordinary skill
in the art, all in order to determine whether there was an apparent reason to
combine the known elements in the fashion claimed[.]” Id. “[T]his analysis
should be made explicit,” and it “can be important to identify a reason that
would have prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention does.” Id. “We
must still be careful not to allow hindsight reconstruction of references to
reach the claimed invention without any explanation as to how or why the
references would be combined to produce the claimed invention.”
Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir.
2008).

ANALYSIS
Appellants argue that Donatelli teaches that the isolated H5N9 A1
strain is non-pathogenic, and that the ordinary artisan would not “be
motivated to make an „inactivated‟ H5N9 A1” (App. Br. 7). According to
Appellants, “[i]t is simply non-sensical to suggest making an „inactivated‟
from a virus that is already non-pathogenic” (id.).
Appellants further assert:
The Examiner has provided no logical reason to conclude that
the nonpathogenic H5N9 virus is among “viruses of interest”
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for formulating into a vaccine. Nor does the Examiner provide
any logical reason to conclude that a vaccine comprising the
nonpathogenic H5N9 virus would be expected to treat
influenza. The Examiner thus provides no rationale to modify
Fatunmbe [sic] to arrive at the vaccine compositions called for
in the claims.

(Reply Br. 5.)
We conclude that Appellants have the better position. The
Examiner‟s position is essentially that it would have been prima facie
obvious to use any known avian influenza strain in the vaccine composition
of Fatunmbi, regardless of the pathogenicity of the strain. We decline to so
hold.
In the selection of viruses for its vaccine, Fatunmbi inactivated
currently prevalent virus strains (see FF3). Capua teaches a vaccine
development strategy, but teaches the use of a heterologous neuroamidase in
the vaccine (see Capua, Abstract). Capua also teaches that the strategy
could be used to control HPAI (high pathogenic avian influenza) and LPAI,
“provided that only one subtype is circulating at a given time” (Capua, p. 52,
second column). Donatelli teaches that the H5N9 strain is non-pathogenic
(see FF9).
The Examiner‟s rationale for including H5N9 in the inactivated
vaccine composition of Fatunmbi is that H5N9 is a known strain, and that
highly pathogenic influenza are derived from nonpathogenic influenza (see
FF13). The Examiner has provided no evidence or scientific reasoning,
however, that the ordinary artisan would reasonably expect vaccines against
the non-pathogenic strain to also work against a pathogenic strain derived
from that non-pathogenic strain. Nor has the Examiner provided any
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scientific reasoning or evidence as to why the ordinary artisan would
inactivate a virus that is already non-pathogenic. We are thus compelled to
reverse the rejection.

CONCLUSION OF LAW
We conclude that the Examiner has not established by a
preponderance of the evidence that the combination of Fatunmbi, Capua,
and Donatelli renders obvious a vaccine composition containing an
inactivated H5N9 strain of avian influenza virus. We thus reverse the
rejection of claims 1-9, 11-17, and 20 under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Fatunmbi, Capua, and Donatelli.

REVERSED

cdc