Ex Parte Yu et al

Patent Trial and Appeal Board

Oct 24, 2014

12408541 (P.T.A.B. Oct. 24, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte QINGZHONG YU, CARLOS ESTEVEZ, DANIEL J. KING,
DAVID L. SUAREZ, and PATTI J. MILLER1
__________

Appeal 2012-005414
Application 12/408,541
Technology Center 1600
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
Newcastle Disease vaccine, which have been rejected as anticipated. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
“Newcastle Disease Virus (NDV) is a diverse and deadly avian
pathogen. . . . Poultry infected with a virulent NDV typically develop
respiratory and/or nervous symptoms that can be fatal.” (Spec. 2, ¶ 3.)

1 According to Appellants, the Real Party in Interest is The United States of
America, as represented by the Secretary of Agriculture (Br. 3).
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“Vaccines for control of Newcastle disease have been used for over fifty
years. The available vaccines do tend to reduce mortality and the severity of
symptoms in infected birds. Unfortunately however, known vaccines do not
prevent infection of susceptible birds.” (Id. at 3, ¶ 7.) The Specification
discloses “a Newcastle Disease vaccine that comprises a recombinant
attenuated virulence Newcastle disease virus” (id. at 3, ¶ 10).
Claims 1–4 are on appeal. Claim 1 is illustrative and reads as follows:
1. A Newcastle Disease vaccine effective for prevention of Newcastle
disease in poultry, the vaccine comprising: a recombinant attenuated
virulence Newcastle disease virus;
wherein
the recombinant attenuated virulence Newcastle disease virus
comprises at least one substituted gene that is homologus [sic]
to a corresponding gene of a virulent challenge strain of
Newcastle disease virus, and
wherein
the at least one substituted gene is a member selected from the
group consisting of a hemagglutinin neuraminidase (HN) gene
and a fusion (F) gene or a combination thereof.

DISCUSSION
Issue
The Examiner has rejected claims 1–4 under 35 U.S.C. § 102(b) as
anticipated by Huang2 (Ans. 4). The Examiner finds that Huang discloses
two recombinant, chimeric attenuated Newcastle Disease viruses (NDVs) in
which the HN gene from one strain was substituted into the genome of the

2 Huang et al., The Hemagglutinin-Neuraminidase Protein of Newcastle
Disease Virus Determines Tropism and Virulence, 78 J. VIROL. 4176–4184
(2004).
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other strain (id.). The Examiner concludes that Huang’s recombinant NDVs
“meet[ ] all structural limitation[s] of the claimed recombinant NDV” (id.).
Appellants contend that Huang does not anticipate the claims on
appeal because it only discloses recombinant viruses and “a chimeric virus
in and of itself does not a vaccine make” (Br. 11). Appellants contend that
“to function as a vaccine, a chimeric Newcastle disease virus must be used
in a particular relationship to a disease causing Newcastle disease virus”
(id.) and therefore “a vaccine is not a chimeric virus alone, but rather a
system and a relationship” (id. at 12).
The issue presented is whether the broadest reasonable interpretation
of the claimed “vaccine” encompasses a composition disclosed by Huang.
Findings of Fact
1. The Specification states that “as is known in the art, Newcastle
disease virus occurs as three different pathotypes which reflect their
virulence in poultry: lentogenic (low virulence), mesogenic (moderate
virulence), and velogenic (high virulence)” (Spec. 8, ¶ 38).
2. The Specification states that “[t]he term ‘attenuated virulence
Newcastle disease virus’ as used herein refers to any Newcastle disease virus
whose level of virulence is less than that of the high virulence (velogenic)
pathotype” (id. at 8, ¶ 40).
3. Huang discloses that “the HN genes of a virulent recombinant
NDV strain, rBeaudette C (rBC), and an avirulent recombinant NDV strain,
rLaSota, were exchanged” (Huang 4176, abstract).
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4. Huang refers to the rBC strain that includes the rLaSota HN gene
as “rBC LaSoHN” and the rLaSota strain that includes the rBeaudette C HN
gene as “rLaSo BCHN” (id. at 4176, right col.).
5. Huang discloses that “recombinant chimeric viruses rBC LaSoHN
and rLaSo BCHN were grown in the allantoic cavities of 9-day-old
embryonated chicken eggs. After 2 days, the allantoic fluid was harvested
and clarified, and the virus was purified.” (Huang 4177, left col.)
6. Huang discloses that “[t]o test the pathogenicities of the recovered
viruses in vivo, . . . 103 PFU of each virus/chicken was inoculated intra-
cerebrally into groups of 10 1-day-old SPF chicks” (id. at 4178, left col.).
7. Huang discloses that the pathogenicity of each recombinant virus
was determined by calculating intracerebral pathogenicity index (ICPI)
values for the inoculated birds (id.). “The ICPI value was the mean score
per bird per observation. Highly virulent (velogenic) viruses give values
approaching 2; avirulent (lentogenic) viruses give values close to 0.” (Id. at
4178, right col.)
8. Huang discloses that “[t]he recombinant rLaSo BCHN virus had an
ICPI of 0.75 while its lentogenic parental strain, rLaSota, had an ICPI of
0.00. . . . The rBC LaSoHN virus, on the other hand, showed a reduced ICPI
value of 1.02 relative to its mesogenic parental virus, rBC, with an ICPI of
1.58.” (Id. at 4179, right col.)
Principles of Law
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000).
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“[T]he patentability of apparatus or composition claims depends on
the claimed structure, not on the use or purpose of that structure.” Catalina
Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir.
2002).
“It is well settled that the recitation of a new intended use for an old
product does not make a claim to that old product patentable.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
Analysis
Claim 1 is directed to a vaccine comprising a recombinant attenuated
virulence Newcastle disease virus. The Specification defines “attenuated
virulence” to encompass any level of virulence less than that of a highly
virulent (velogenic) strain of Newcastle disease virus (FF 2). Claim 1 also
requires that the recombinant virus in the claimed vaccine comprises a
substituted HN or F gene that is homologous to a corresponding gene of a
virulent challenge strain of Newcastle disease virus.
Huang discloses Newcastle disease virus (NDV) strains rBC LaSoHN
and rLaSo BCHN (FF 4), which were made by exchanging the HN genes of
the virulent recombinant strain rBeaudette C and the avirulent recombinant
strain rLaSota (FF 3). Huang states that velogenic NDV strains give ICPI
values approaching 2 (FF 7), and that the recombinant rLaSo BCHN and
rBC LaSoHN had ICPI values of 0.75 and 1.02, respectively (FF 8). Huang
also states that the mesogenic rBeaudette C strain has an ICPI of 1.58 (FF 8).
Thus, the rBC LaSoHN and rLaSo BCHN viruses disclosed by Huang
meet all of the structural requirements of claim 1. Huang also discloses
compositions comprising each of the recombinant viruses (FF 5) and use of
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these compositions to inoculate chicks (FF 6). Huang’s viruses and virus-
containing compositions anticipate claim 1.
Appellants argue that “as claimed by Appellants, to function as a
vaccine, a chimeric Newcastle disease virus must be used in a particular
relationship to a disease causing Newcastle disease virus” (Br. 11).
Appellants also argue that “a vaccine is not a chimeric virus alone, but rather
a system and a relationship” (id. at 12).
Claim 1, however, is directed to a product, not to a method of using
the product. “[T]he patentability of . . . composition claims depends on the
claimed structure, not on the use or purpose of that structure.” Catalina
Mktg., 289 F.3d at 809. That Appellants may intend to use the claimed
product in a different way than disclosed by Huang does not make the claim
patentable. See In re Schreiber, 128 F.3d at 1477 (“[A] new intended use for
an old product does not make a claim to that old product patentable.”).
Appellants have not pointed to any structural requirement of the
vaccine of claim 1 that is not disclosed by Huang. The fact that Huang does
not refer to its recombinant viruses or virus-containing compositions as
“vaccines” is not determinative; what matters is whether a product disclosed
in the prior art meets all of the structural limitations of the claimed
invention, which is the case here.
Conclusion of Law
The broadest reasonable interpretation of the claimed “vaccine”
encompasses a composition disclosed by Huang. Claim 1 is anticipated by
Huang. Claims 2–4 have not been argued separately and therefore fall with
claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
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SUMMARY
We affirm the rejection of claims 1–4 as anticipated by Huang.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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