Ex Parte Martinon et al

Patent Trial and Appeal Board

Jan 19, 2018

13111020 (P.T.A.B. Jan. 19, 2018)

% United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/111,020 05/19/2011 Olivier Michel Martinon PC71661A 4695
110408
'Znetis;
7590 01/23/2018 EXAMINER
10 Sylvan Way
Parsippany, NJ 07054
CHESTNUT, BARRY A
ART UNIT PAPER NUMBER
1648
NOTIFICATION DATE DELIVERY MODE
01/23/2018 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):
AnimalHealthDocketing @ zoetis .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte OLIVIER MICHEL MARTINON and
NANDA KUMAR D REDDY
Appeal 2017-000218
Application 13/111,020
Technology Center 1600
Before DEMETRA J. MILLS, JOHN G. NEW, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants1 submit this appeal under 35 U.S.C. § 134(a) involving
claims to a recombinant parapoxvirus. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Zoetis Services LLC. App.
Br. 3.
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Application 13/111,020
STATEMENT OF THE CASE
Appellants’ “invention relates to recombinant parapoxviruses that
contain heterologous DNA derived from a rabies vims (RV) and to their use
in immunogenic compositions and vaccines.” Spec. 1:10—14.
As background, the Specification explains that “[vjiruses of the
Poxviridae family are oval, quite large, double-stranded DNA viruses,” and
that “[t]he genus Parapoxvims (PPV) is included among these viruses.” Id.
at 1:16—17. Also, the Specification explains, “PPV can have an
immunomodulatory effect because they stimulate generalized (non-specific)
immune reactions in vertebrates,” and “have been used successfully in
veterinary medicine for increasing general resistance in animals.” Id. at 2:9—
11. Furthermore, PPV “can be combined with homologous and/or
heterologous antigen to provide vaccines that have pathogen-specific effect
which lasts for months to years, as well as a rapid non-pathogen-specific
effect.” Id. at 2:11-14.
Claims 1—8 and 15 are on appeal. Claim 1 is illustrative:
1. A recombinant parapoxvims comprising parapoxvims and
heterologous DNA derived from a rabies vims, wherein the
heterologous DNA is inserted into the genome of the
parapoxvims.
App. Br. 12 (Claims App.).
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The claims stand rejected under 35 U.S.C. § 103(a) as obvious over
Rziha2 and Brun,3 as further evidenced by Tordo.4 Ans. 3—6.
A rejection of claim 8 under 35 U.S.C. § 112, first paragraph, based
on the deposit of biological material, has been withdrawn. Ans. 2.
DISCUSSION
Issue
Has the Examiner established by a preponderance of the evidence that
claims 1—8 and 15 would have been obvious over Rziha and Brun, as
evidenced by Tordo?
Findings of Fact (FF)
The Examiner’s findings of fact and statement of the rejection are
provided at pages 3—8 of the Final Rejection mailed Feb. 24, 2015 (“Final
Act.). See also Ans. 3—9; Adv. Act. 2 (mailed May 15, 2015). The
following findings are provided for emphasis and convenient reference.
FF 1. Rziha teaches “Orf virus (OV) is an epitheliotropic poxvirus
and belongs to the genus Parapoxvirus (PPV).” Rziha, Abstract. Rziha
teaches “PPV, especially OV, is regarded as a promising candidate for an
expression vector.” Id. According to Rziha, “strain D1701 represents a
highly attenuated OV strain with clearly reduced pathogenicity,” and Rziha
describes “potentially non-essential genes or regions of D1701, which might
2 Rziha et al., Generation of recombinant parapoxviruses: non-essential
genes suitable for insertion and expression of foreign genes, 83 J. OF
Biotech. 137—45 (2000).
3 Brun et al., Antigen delivery systems for veterinary vaccine development
Viral-Vector based delivery systems, 26 Vaccine 6508—28 (2008).
4 Tordo et al., EP 0 237 686 Al, published Sept. 23, 1987.
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be suitable for insertion and expression of foreign genes.” Id. In this regard,
Rziha “show[s] that foreign genes can be inserted and functionally expressed
in the vegf-e locus, also leading to the induction of a specific immune
response in the non-permissive host.” Id.; see also id. at 139 (Fig. 1,
describing formation of recombinant D1701 with an insertion for the
antigenic site of the VP1 protein of Foot-and-Mouth disease virus).
FF 2. Rziha teaches “parapoxviruses and in particular OV are
regarded as promising candidates for vector vaccines.” Id. at 138. Among
other things, Rziha describes “[t]he ability of OV to stimulate rapid cellular
immune defence mechanisms including the attraction of very potent antigen-
presenting cells,” as making PPV/OV “especially attractive for its use as a
recombinant vaccine.” Id. Also, Rziha teaches, OV strain D1701 “exhibits
clearly reduced pathogenicity . . . after subcutaneous application and was
licensed as a live vaccine.” Id. According to Rziha, “[d]ue to its safety and
the possibility for cell culture propagation, this OV strain should be an
excellent tool for the construction of new recombinant vaccines.” Id.; see
also id. Table 1 (identifying properties of OV).
FF 3. Bran teaches “[rjeplicating poxvirus vectors can induce long-
lasting immunity after a single injection and can activate both humoral and
cellular immunity depending upon the promoter controlling the expression
of the immunogen.” Bran 6510. Bran identifies a number of recombinant
poxvirus vectors, including, without limitation, vectors of vaccinia virus
(VV) and ALVAC canarypox strain. Id. at 6510-12; see also id. 6511
(Table 1). Bran also describes recombinant poxvirus strains for the
protection against rabies and other viral infections. See, e.g., id. at 6510
(describing a recombinant VV “Copenhagen strain expressing the rabies
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vims surface glycoprotein”) and 6512 (“ALVAC strains were developed to
protect dogs and ferrets against rabies ... or canine distemper vims.”)
FF 4. Bmn teaches “[t]he vims type species Orf virus (ORFV) from
the genus Parapoxviridae (PPV) has been proposed as a candidate for novel
marker vector vaccines.” Id. at 6512. Bmn teaches “the D1701 [strain of
ORFV] is highly attenuated with a markedly reduced pathogenicity after
subcutaneous application,” and that “[t]his strain presents several advantages
for use as a viral vector including its ability to be propagated on a cell line
and its ability to induce a strong immune-stimulating and regulating
response in non-permissive hosts.” Id. Bmn describes “[a]n additional
benefit of this vector is that only a short-term vector specific immunity,
without the formation of neutralizing antibodies against PPV, is induced . . .
thus avoiding immune interference following repeated inoculations.” Id.
FF 5. Bmn describes ORFV “as a new safe poxvims vector.” Id.
Bmn teaches “[t]he capability of ORFV recombinants to induce antigen
specific memory immune responses and to control acute or persistent
infections requiring different immune mechanisms demonstrates their
potential as a promising new poxvims delivery system.” Id.', see also id. at
6512 (describing reports on the protective capacity following inoculation of
different recombinant ORFV (strain D1701)) and 6513 (Table 2, showing
ORFV as a vector for multiple veterinary vaccine antigens of different
pathogens such as Aujezsky disease vims and canine herpesvirus)).
FF 6. Tordo relates to “DNA fragments belonging to the genome of
the rabies vims . . . [and] microorganisms transformed by said DNA
fragments.” Tordo, Abstract; see also id. at 2:1—5 (teaching DNA
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recombinants, particularly vectors, modified by DNA sequences derived
from the genome of the rabies virus) and Figs. 7—9 (rabies virus sequence).
Principles of Law
The “case law is clear that obviousness cannot be avoided simply by a
showing of some degree of unpredictability in the art so long as there was a
reasonable probability of success. . . . [A] rule of law equating
unpredictability to patentability . . . would mean that any new salt—
including those specifically listed in the [prior art] itself—would be
separately patentable, simply because the formation and properties of each
salt must be verified through testing. This cannot be the proper standard
since the expectation of success need only be reasonable, not absolute.”
Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Moreover,
“[t]he reasonable expectation of success requirement refers to the likelihood
of success in combining references to meet the limitations of the claimed
invention.” Intelligent Bio-Systems Inc. v. Illumina Cambridge Ltd., 821
F.3d 1359, 1367 (Fed. Cir. 2016).
Analysis
Claim 1
Appellants do not provide separate argument regarding the claims.
Rather, Appellants assert, “claims 1—8 and 15 stand and fall together.” App.
Br. 6. Accordingly, we choose claim 1, the only independent claim, as
representative of the claims on appeal. 37 C.F.R. § 41.37(c)(l)(iv).
We start with claim interpretation as a prerequisite to comparing
claim 1 to the prior art. Here, no further claim construction is necessary.
The words of claim 1 are plain on their face.
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At the outset, we nonetheless emphasize what claim 1 is not. We do
so as a precursor to addressing Appellants’ arguments, which are discussed
further below. Claim 1 does not recite a “vaccine.” Nor is claim 1 a method
of preventing rabies. Neither does claim 1 recite nor require a particular
therapeutic result or effectiveness. To the contrary, claim 1 is directed to a
virus with foreign DNA inserted into its genome. More specifically, claim 1
is a recombinant parapoxvirus with DNA derived from a rabies virus
inserted into the parapoxvirus genome — nothing more, nothing less.
The Examiner finds that Rziha teaches a parapoxvirus, particularly the
D1701 strain of Orf virus (OV), is a “promising” expression vector. Final
Act. 4. The Examiner cites Rziha’s teaching of suitable insertion sites on the
PPV genome for foreign genes. Id. And, the Examiner identifies various
advantages of PPV as an expression vector, e.g., safety and reduced
pathogenicity, which make it “an excellent tool for the construction of new
recombinant vaccines” as evidenced by Rziha. Id. at 5 (quoting Rziha, 138).
The Examiner finds that Rziha differs from claim 1 insofar as Rziha
“does not teach the inclusion of heterologous DNA derived from the rabies
virus,” and thus the Examiner turns to Brun and Tordo. Id. at 5—6. The
Examiner finds, among other things, that “Brun shows examples of viral
antigens expressed in different poxvirus vectors and lists canine distemper
virus as one of the viral antigens (claims 4-5 a rabies virus)” and further
cites Tordo as teaching the nucleotide sequence for rabies virus, including
for the G protein. Id. The Examiner further identifies Brun’s teaching of
parapoxvirus as a promising candidate for vector vaccines, and Bran’s
teaching of its advantages (e.g., “markedly reduced pathogenicity” and no
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“formation of neutralizing antibodies against PPV . . thus avoiding
immune interference following repeated innoculations.”) Id. at 5—6.
According to the Examiner, it would have been obvious “to generate a
recombinant [Parapoxvirus ovis] strain D1701 with heterologous DNA as
taught by Rziha from a rabies virus as taught by Brun.” Id. at 7. The
Examiner reasons that the skilled artisan “would have been motivated to
have a highly attenuated parapox virus that ‘can accommodate large
amounts (over 25 kb) of extra DNA thus several transgenes can be expressed
simultaneously providing a multi-valent vaccine approach.” Id. Further, the
Examiner reasons, the skilled artisan “would have been motivated to
generate the recombinant for the advantage of having a highly attenuated
parapoxvirus strain that is safe and possible for cell culture propagation” as
evidenced by the prior art. Id. at 8. And, the Examiner reemphasizes the
art’s teaching that PPV (D1701 strain) “would ‘be an “excellent tool for the
construction of new recombinant vaccines.’” Id. The Examiner determines
the skilled artisan “would have had a reasonable expectation of success
because Rziha demonstrates the construction of a recombinant parapoxvirus
strain D1701 with an insert for a foreign gene encoding the VP1 protein of
Foot-and-Mouth disease virus.” Id. The Examiner, thus, concludes claim 1
would have been obvious over Rziha, Brun, as evidenced by Tordo. Final
Act. 7—8.
The preponderance of the evidence supports the Examiner’s
conclusion of obviousness. Rziha and Brun teach that parapoxvirus is a
promising vector for development of recombinant vaccines. FF 1—5. In that
regard, Rziha describes PPV as “especially attractive” and an “excellent
tool,” thus motivating the skilled person to use it for designing recombinant
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vectors. FF 2. Because both Rziha and Brun cite several advantages to PPV
viral vectors (e.g., safety, lower immune interference, ability to be
propagated on a cell line), this provides further reason for the skilled person
to use it. Final Act. 7—8; FF 2, 4—5.5 As for the rabies virus DNA, the
sequence was known (FF 6), and other recombinant poxvirus vectors had
been designed to include foreign rabies sequences and express rabies virus
proteins (as antigens). FF 3. Given the numerous advantages recognized in
the art for using a parapoxvirus vector, it would have been obvious to design
a recombinant parapoxvirus having rabies DNA inserted in the PPV genome.
And the skilled artisan would have had a reasonable expectation of success
in making it because Rziha and Brun teach that recombinant PPV constructs
had been made with several other foreign DNA sequences, expressing a
variety of antigens. FF 1, 5; see also Rziha 139 (Fig. 1); Brun 6513 (Table
2). Appellants’ arguments and evidence do not outweigh the evidence of
obviousness on this record as we discuss further below.
Appellants argue “the Examiner has not established the prima facie
case of obviousness because of unpredictability in the field of recombinant
vaccines.” App. Br. 6. According to Appellants, “the Examiner has to
establish a motivation to combine the references and reasonable expectation
that the combination would be successful.” Id. Appellants contend “without
5 In describing the background of the invention, Appellants’ Specification
cites Rziha and the ’393 patent (discussed infra) and echoes the known
“remarkable advantages” of using parapoxvirus as a vector, “including a
very narrow host range, lack of systemic infection, short-term vector-
specific immunity (allowing repeated immunizations), early vaccination
(induction of immunity can be started in the presence of material
antibodies), and beneficial immune modulating properties.” Spec. 2:15—20.
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predictability in the art, reasonable expectation of success cannot be
established.” Id.
Appellants’ contentions are unpersuasive. As explained above,
claim 1 does not require a “vaccine,” and no particular therapeutic result is
recited. Claim 1 is a viral construct with foreign DNA corresponding to a
known sequence/pathogen (rabies). The advantages cited by the Examiner
and evidenced in the art for parapoxvirus-based viral vectors provide
sufficient reason to design a recombinant parapoxvirus encompassed by the
claims. FF 2, 4—5. Whether the construct yields a therapeutically effective
vaccine that protects against rabies is not the issue — further testing may be
required to determine if a specific efficacy and immunity is conferred. But
testing to determine unclaimed potential benefits and functionality does not
show that claim 1 is nonobvious. What is required here is a reason for the
skilled person to have made the recombinant virus of claim 1. That reason
exists because the art teaches that parapoxvirus is, inter alia, a safe,
promising, and excellent tool for the design of recombinant veterinary
vaccines, several of which had been designed. FF 1, 5.6 Appellants provide
no persuasive argument or evidence that making the claimed recombinant
parapoxvirus would have been unpredictable.
Appellants contend “parapoxvirus-vectored rabies vaccine is not
mentioned in Rziha, Tordo, or Brun” and that “three questions need to be
answered to assess whether the field of recombinant vaccines was
6 Table 2 of Brun (Brun 6513) does disclose immunological activity upon
administration of various pathogen-specific recombinant PPV vectors (e.g.,
“[sjtrong anti-gC humoral response after single dose” and “[induction of B-
cells, plasma cells and T cells.”).
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predictable.” App. Br. 6. Appellants pose the questions: (1) whether results
obtained with parapoxvirus and non-rabies antigen can be extrapolated to
parapoxvirus-vectored rabies vaccine; (2) whether poxvirus-vectored rabies
vaccine can be extrapolated to parapoxvirus-vectored rabies vaccine; and (3)
whether a reasonable expectation exists that parapoxvirus would be an
effective vector for a random antigen. Id. at 6—7. Appellants contend “each
of these questions must be answered in the negative” and, in support,
Appellants cite Hanwell,7 8Bran, U.S. Patent No. 6,365,393s (“the ’393
patent”), and the Raue Declaration.9 Id. at 7.
That none of the cited references alone disclose parapoxvirus-
vectored rabies vaccine is not decisive because the rejection is based on the
combined teachings of the art, and the rejection based on obviousness. In re
Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
As to Appellants three questions, and the evidence cited in support,
we remain unpersuaded this overcomes the evidence of obviousness on this
record. Here too, Appellants’ “questions” focus on the alleged
unpredictability of parapoxvirus or poxvirus vectors as specific vaccines.
That is, whether these viruses as vaccines would be expected, a priori, to be
effective at inducing specific immune responses to specific antigens.
Appellants cite, for example, Hanwell as showing that, for a certain
7 Hanwell et al., Murine Responses to RecombinantMVA Versus ALVAC
Vaccines Against Tumor-associated Antigens, gplOO and 5T4, 36 J.
Immunother. 238-247 (2013).
8 Schmeer et al., US 6,365,393 Bl, issued Apr. 2, 2002.
9 Declaration of Rudiger Raue, Ph.D., dated Jan. 30, 2014 (“Raue Decl.”).
The Raue Declaration does not include page numbers. We address,
however, as if the pages were consecutively numbered with pages 1^4.
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population of transgenic mice, a poxvirus vector (MVA) for a gplOO antigen
was effective in eliciting a CD8 T-cell response, while the poxvirus vector
(MVA) was ineffective in eliciting a CD8 T-cell response for a 5T4
peptide.10 Thus, Appellants assert, ‘“vector-transgene combinations must be
assessed individually when designing vaccines.’” App. Br. 7 (quoting
Hanwell, Abstract).* 11 But claim 1 does not recite a vaccine and requires no
specific immune response. The skilled person need not have predicted an
unclaimed antigen-specific response, provided there was a reason to make a
recombinant parapoxvirus as claimed, and a reasonable expectation of
success in designing the claimed recombinant virus. See Intelligent Bio-
Systems, 821 F.3d at 1367. The record shows sufficient reasons for the
skilled person to have made the claimed virus, and a reasonable expectation
of success in doing so as discussed above.
Appellants argue Brun also shows “no predictability in the art of
recombinant vaccines exists.” App. Br. 8. Appellants point to a disclosure
10 Although not discussed by Appellants, the portion of Hanwell cited by
Appellants appears to show that, for a different population of mice, the
various vectors (MVA or ALVAC, and for gplOO or 5T4 antigen) elicited an
antibody/humoral immune response. App. Br. 7. Thus, under certain
circumstances, each of the identified vectors provided some type of immune
response. Claim 1, as pointed out, is not limited to any particular therapeutic
activity or efficacy. Appellants have not, in any event, shown that the
skilled person would not reasonably expect some type of immune response
in a subject administered the claimed recombinant PPV vector. The cited art
(Brun and Rziha) suggests the opposite. FF 1—5.
11 Hanwell (published in 2013) post-dates the putative priority date of the
invention (2010 or 2011). We are not persuaded this post-filing evidence
detracts from the advantages and reasons for designing a recombinant
parapoxvirus known to skilled persons at the time of the invention, as
evidenced in at least Rziha and Brun. FF 2, 4—5; see also Spec. 2:15—20.
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in Brim that “we cannot yet predict the most appropriate delivery technology
to make an effective vaccine. We still do not know why certain antigens
appear to work better than others using the same delivery system.” Id.
(quoting Bran 6521) (emphasis added by Appellants).
This argument fails for similar reasons. Claim 1 does not require a
vaccine, or specify how effective it must be. Also, obviousness does not
require selection of the most appropriate or most effective combination; a
prior art combination may be expected to be less effective, yet be obvious
nonetheless. In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994); In re Mouttet,
686 F.3d 1322, 1334 (Fed. Cir. 2012). Bran teaches “the capability of
ORFV [PPV] recombinants to induce antigen specific memory immune
responses and to control acute and persistent infections requiring different
immune mechanisms demonstrates their potential as a promising new
poxvirus delivery system.” FF 5. Bran thus suggests — and provides a
reasonable expectation of— at least some antigen-specific immune response
with the use of PPV recombinants at the time of the invention. And, at
minimum, the art suggests a reason to design the claimed recombinant
parapoxviras, even assuming that design required further testing to confirm
its effectiveness as a vaccine against rabies.
Appellants cite a disclosure in the ’393 patent about differences
between genera of poxviruses and “that insights obtained from avipox,
racoonpox, capripox .. . [etc.] cannot be transferred to PPV.” App. Br. 8;
’393 patent, 2:11—15. We remain unpersuaded. The ’393 patent, on
balance, does not help Appellants’ arguments. Quite the opposite, the
disclosure about other poxvirus vectors, in context, contrasts those viruses
with the invention described in the ’393 patent — recombinant PPV vectors
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and their use in vaccines. Id. at 1:5—25. Whatever can be said about other
poxvirus vectors, the ’393 patent teaches broadly that “[expression of the
foreign DNA in the genome of parapoxviruses elicits, for example in a
vaccinated individual, a defensive reaction against the pathogens which are
represented by the foreign hereditary information.” Id. at 1:19—23.
Moreover, the ’393 patent teaches “non-specific resistances of the
vaccinated individual can also be stimulated.” Id. at 1:23—24; see also id. at
1:35—47. Thus, far from discouraging or diminishing the reasons a skilled
person would have had for designing the claimed parapoxvirus, the ’393
patent, like Rziha and Bran, reinforces those reasons and adds to the
reasonable expectation of success in making the claimed construct (while
further evidencing a reasonable expectation that at least some immune
response would be observed with a vaccine including the claimed
recombinant PPV).12
Appellants argue the advantages of PPV vectors cited by the
Examiner “are drawn to the properties of the parapoxvirus and do not bear
any relevance onto whether a parapoxviras-vectored rabies vaccine would be
effective.” App. Br. 9—10.13 This argument is unpersuasive. The reasons
12 Appellants note that an inventor of the ’393 patent is Dr. Rziha (whose
publication the Examiner relies on for the rejection). App. Br. 8. This also
does not help Appellants. The ’393 patent (via international counterpart)
published in 1997, yet the Rziha publication relied upon by the Examiner
published over two years later and continues to laud advantages of PPV
vectors and suggest their use and design for new vaccines. FF 1—2. We
discern nothing in Rziha or the ’393 patent that persuasively rebuts the
Examiner’s conclusion of obviousness.
13 Appellants later argue the functional aspects and advantages of PPV relied
upon by the Examiner as providing a motivation to make the claimed
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cited by the Examiner (e.g., safety) provide a reason for the skilled artisan to
have used PPV with various viral antigens like rabies even if a specific
efficacy as a rabies vaccine was not known beforehand. Ans. 5—6. The
reason that motivates the skilled person need not be the same as what
motivated the inventor. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419
(2007) (“In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed purpose of the
patentee controls.”). And, as explained above, claim 1 does not recite or
require a vaccine with any particular immunogenic efficacy.
Finally, Appellants argue the Raue Declaration illustrates the
unpredictability of parapoxvirus vaccines. App. Br. 9-11. Dr. Raue states
that “ten parapox-vectored constructs were created” and, among those
constructs, “only parapox-vectored rabies construct resulted in an effective
vaccine.” Raue Deck 1. The Declaration, however, cites no data or further
information about this parapox-vectored rabies vaccine. Dr. Raue then
describes a first study about a parapox-vectored FeLV (feline leukemia
virus) vaccine, which Dr. Raue opines did not provide sufficient efficacy (5
out of 6 cats demonstrated persistent antigenemia after challenge) and that a
canarypox-vectored FeFV provided different results (3 of 6 cats
construct are the same immunogenic properties for which Appellants
contend there is no reasonable expectation of success. Reply Br. 1—3. We
are unpersuaded. Some of the Examiner’s reasons may touch upon an
expectation that PPV-rabies vector would induce some immune response
specific to a rabies antigen (as that is what the combination of the cited art
suggests). But the Examiner has identified further reasons that reflect the
advantages of recombinant PPV for designing vaccines more generally (e.g.,
safety, etc.). Ans. 3—6.
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demonstrated persistent antigenemia). Id. at 1—2. Dr. Raue then describes a
second study about the effect of a vaccine comprising parapox-vectored VP-
2 protein of Bluetongue Virus 8 (BTV-8). Id. at 2—3. Dr. Raue states that
“the parapox vector system resulted in no reduction of viraemia,” which Dr.
Raue contrasts with other information in the literature showing “that
Myxoma virus (a member of Poxviridae family) vectored VP2 of BTV-8
resulted in reduction of viremia.” Id. From this, Dr. Raue opines “it cannot
be concluded that an insert which showed good results in a study with non-
parapox vector would give similar results in a study with applicant’s vector
system.” Id. at 3.
On this record, the Raue Declaration is unpersuasive in overcoming
the evidence of obviousness. The Examiner did not need to show an
expectation of a specific therapeutic efficacy as a vaccine because claim 1 is
directed to the recombinant PPV alone. The Declaration focuses on more
specific (and unclaimed) immunogenic properties of vaccines. If anything,
the Declaration suggests that making parapoxvirus vectors having a variety
of foreign DNA inserts in the PPV genome is not unpredictable. Whether a
particular immune response would have been reasonably predicted before
testing does not show that claim 1 is nonobvious, as explained above.
Conclusion of Law
The preponderance of the evidence on this record supports the
Examiner’s conclusion that claim 1 would have been obvious over Rziha
and Bran, as evidenced by Tordo. Claims 2—8 and 15 have not been argued
separately and fall with claim 1. In this decision we consider only those
arguments actually made by Appellant. Arguments that Appellant could
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have made but chose not to make in the Briefs have not been considered and
are deemed to be waived. See 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 1—8 and 15 as obvious.
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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