Ex Parte Bangera et al

Patent Trial and Appeal Board

Feb 24, 2017

11807337 (P.T.A.B. Feb. 24, 2017)

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
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/807,337 05/25/2007 Mahalaxmi Gita Bangera 1003-002-002M-000000 4513
44765 7590 02/28/2017
INTELLECTUAL VENTURES - ISF
ATTN: DOCKETING, ISF
3150- 139th Ave SE
Bldg. 4
Bellevue, WA 98005
EXAMINER
BRUSCA, JOHN S
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
02/28/2017 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):
ISFDocketInbox@intven.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MAHAL AXMI GITA BANGERA, MURIEL Y. ISHIKAWA,
EDWARD K. Y. JUNG, NATHAN P. MYHRVOLD,
ELIZABETH A. SWEENEY, RICHA WILSON
and LOWELL L. WOOD JR.
Appeal 2014-0011331
Application 11/807,3372
Technology Center 1600
Before LORA M. GREEN, RICHARD M. LEBOVITZ, and ULRIKE W.
JENKS, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to computer programs for
identifying computable epitopes in a protein sequence and projecting, with
reference to a database, predictable changes in the epitopes.
1 The Appeal Brief (“Appeal Br.”) 3 lists Searete, LLC, in Bellevue, WA, an
affiliate of Intellectual Ventures Management, LLC, as the real-party-in-
interest.
2 “The ’337 Application.”
Appeal 2014-001133
Application 11/807,337
The Examiner rejected the claims as obvious under 35 U.S.C. § 103(a)
and under non-statutory obviousness-type double-patenting. We have
jurisdiction under 35 U.S.C. § 134. The rejections are affirmed.
The application in this appeal is related to numerous related
applications. Appeal Br. 3—5.
STATEMENT OF CASE
Appellants appeal from the final rejection by the Examiner of claims
1—36. Final Rej. Summary. The claims stand rejected by the Examiner as
follows:
1. Claims 1, 2, 4, 5, 7—14, 16, 17, 19—26, 28, 29, and 31—36 under
35 U.S.C. § 103(a) as obvious in view of Chirino3 and Soudeyns.4 Final Rej.
5.
2. Claims 6, 18, and 30 under 35 U.S.C. § 103(a) as obvious in view
of Chirino, Soudeyns, and Herbeck.5 Final Rej. 9.
3. Claims 3, 15, and 27 under 35 U.S.C. § 103(a) as obvious in view
of Chirino, Soudeyns, and Saif.6 Final Rej. 10-11.
4. Claim 1, 2, 7-9, 12-14, 19, 20, 2A-26, 31, 32, and 36 on the
ground of non-statutory obviousness-type double-patenting over claims 1, 2,
3 US 2003/002285 Al, published Jan. 30, 2003.
4 Soudeyns et al., Selective pressure exerted by immunodominant HIV-1-
specific cytotoxic T lymphocyte responses during primary infection drives
genetic variation restricted to the cognate epitope, 29 Eur. J. Immunol.
3629-35 (1999).
5 Herbeck et al., Human immunodeficiency virus type 1 env evolves toward
ancestral states upon transmission to a new host, J. Virol., 80:1637-1644,
2006.
6 Saif, M.W., HIV-Associated Autoimmune Hemolytic Anemia: An Update,
AIDS PATIENT CARE and STDs, 15(4): 217-224, 2001.
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12, 15, and 40-42 of Application 11/728,950 (“the ’950 Application”).
Final Rej. 13.
Claim 1, reproduced below, is representative (bracketed numbers have
been added to the claim to number the clauses; this numbering system was
utilized by Appellants in their discussion of the claim):
1. A system comprising:
at least one computer program on non-transitory media
for use with at least one computer system and wherein the
computer program includes a plurality of instructions including
but not limited to:
[1] one or more instructions for accepting, in a computer
system, information identifying a virus in tissue obtained from
a human host, the information including at least a partial protein
sequence of the virus in the human host at a first time point;
[2] one or more instructions for identifying, in the
computer system, a computable epitope of the virus within the
partial protein sequence of the virus, wherein the computable
epitope of the virus is predicted to be presented by an antigen
processing cell of the immune system of the human host;
[3] one or more instructions for projecting, in the
computer system, with reference to at least one database, a
predictable mutational change in the computable epitope of the
virus in the human host at a second time point in the future;
[4] one or more instructions for selecting, in the
computer system, one or more antibodies predicted to bind to
the predictable mutational change in the computable epitope of
the virus at the second time point in the future; and
[5] one or more instructions for communicating at least
one selected antibody to at least one system user.
THE PERSON OF ORDINARY SKILL IN THE ART
When making a patentability determination under 35 U.S.C., we
consider the claims and the scope and content of the prior art to be directed
to one of ordinary skill in the art. Thus, a determination as to whether the
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claims conform to the patentability requirements of 35 U.S.C., including the
requirements of 35 U.S.C. §§ 103 and 112, is made from the perspective of
one of ordinary skill in the art. In this case, the claimed subject matter
involves a computer program for performing bioinformatics on the
components (proteins, antibodies, epitopes) of an antibody response. The
cited prior art includes a published patent application and peer-reviewed
scientific journal publications. The latter is the forum for scientists who
typically have Ph.D. or are working towards a Ph.D. or master’s degree in
the pertinent field. Here, the pertinent fields are molecular biology,
immunology, and bioinformatics as evidenced by the subject matter of the
cited prior art publications. Accordingly, the person of ordinary skill in the
art is a scientist, who publishes work in peer-reviewed scientific
publications, has at least a post-graduate level understanding of molecular
biology, immunology, and bioinformatics, and is able to perform
bioinformatics analysis on proteins.
CLAIM 1
The Examiner found that Chirino describes computational methods
for modifying proteins having epitopes that bind to antibodies. Final Rej. 6.
These steps correspond to clauses 1 and 2 of the claimed method. The
Examiner also found that Chirino teaches utilized the variant proteins to
make antibodies {id.) which corresponds to clause 4 of the claimed method.
The Examiner acknowledged that Chirino does not “show analysis of
a viral epitope at a first time point and a second time point in the future in a
human host” {id., 7), a reference to clause 1 of identifying a virus obtained
from a human host at a first time point, and clauses 3 and 4 reciting
instructions for predicting a change in the epitope of the virus at a future
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second time points. To meet these claimed limitations, the Examiner cited
Soudeyns for its teaching of identifying changes in the envelope protein of
HIV during HIV infection {id.), i.e., at first and second time points, and
Soudeyns’ conclusion that such information should be taken into
consideration in the design of strategies aimed at the development of
candidate HIV vaccines and immune-based interventions {id., 8), i.e.,
instructions for projecting predictable mutational changes and making
antibodies to the predictable changes as recited in clauses 3 and 4. The
Examiner also found that it would have been obvious to have executed the
process with a programmed computer. Id., 9.
Clauses 1 through 5 of claim 1 are addressed below.
[1] one or more instructions for accepting, in a computer system,
information identifying a virus in tissue obtained from a human host,
the information including at least a partial protein sequence of the
virus in the human host at a first time point
Appellants contend that the Examiner did not establish the clause 1 is
taught by the prior art publications. Appeal Br. 18—19. We do not agree.
The Examiner found that Chirino shows computer mediated analysis
of sequence information. Final Rej. 6. The Examiner specifically stated that
Chirino “shows . . . methods of modifying the immunogenicity of a
polypeptide by computational methods of modifying the amino acid
sequence of the polypeptide.” Id. In order to make such modifications, the
protein sequence would necessarily have to be inputted and accepted by the
computer system as required by the claim. Furthermore, as found by the
Examiner, Chirino specifically teaches obtaining sequences from known
databases, such as GenBank. Id.: Chirino 177.
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With respect to the claimed requirement “of the virus in the human
host at a first time point,” the Examiner cited Soudeyns teachings of a
patient infected with HIV who would constitute a patient infected with HIV
for the first time and at a first time point. Final Rej. 7. Chirino also teaches
making vaccines against viral pathogens. Chirino 1261.
Appellants argue that Soudeyns does not teach accepting sequence
information into a computer system. Appeal Br. 19. However, the
Examiner did not rely upon Soudeyns for the computer system. Rather, the
Examiner specifically cited Chirino for a computer system and the
obviousness of using it to implement a bioinformatics method. Final Rej. 8.
As shown by Chirino, bioinformatics analysis is typically carried out by a
computer so it would have been within the skill of the ordinary skilled
worker to create a program to perform such an analysis. See also section
titled “The person of ordinary skill in the art.”
Appellants also dispute the Examiner’s finding regarding Soudeyns
teaching of the analysis of sequence variation in the HIV envelope “gene,”
stating that “[o]n its face, a ‘gene’ refers to nucleic acid sequence” and not
information that includes “at least a partial protein sequence of the virus” as
claimed. Appeal Br. 19.
Appellants have mischaracterized Soudeyns. Soudeyns describes
studying changes in protein epitopes of the HIV envelope protein that occur
during HIV infection. Soudeyns states that their results “provide compelling
evidence that the CTL epitope mutations directly resulted from the selective
pressure exerted by the virus-specific cytotoxic response.” Abstract. The
protein epitope mutations were detected by DNA sequencing (“Here we
report detailed longitudinal analysis of DNA sequence variation performed
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over the entire HIV-1 envelope in two subjects during primary HIV
infection.” Id.) Soudeyns teaches:
Thus, the progressive accumulation of dN nucleotide
substitutions within the DNA sequence of the IPRRIRQGL
epitope resulted in the emergence of virus variants that were no
longer recognized by the HIV specific CTL.
Soudeyns 3632.
Thus, Soudeyns is clearly utilizing protein sequence information.
Appellants’ contention that Soudeyns is “a nucleic-acid based study” reflects
a misunderstanding of Soudeyns’ purpose, namely, using the nucleic acid
sequence information to determine the changes in the protein epitopes of the
HIV envelope protein. The claim does not exclude the system from
accepting both nucleic acid and protein sequence information.
[2] one or more instructions for identifying, in the computer system, a
computable epitope of the virus within the partial protein sequence of
the virus, wherein the computable epitope of the virus is predicted to
be presented by an antigen processing cell of the immune system of
the human host.
Appellants contend that the Examiner did not demonstrate that
Chirino describes identifying “the computable epitope of the virus is
predicted to be presented by an antigen processing cell of the immune
system of the human host.” Appeal Br. 20. We not agree that the Final
Rejection is deficient for its failure to teach the recited limitation.
The Examiner found that Chirino describes “modifying the
immunogenicity of a polypeptide by computational methods of modifying
the amino acid sequence of the polypeptide.” Final Rej. 6. Consistent with
the Examiner’s finding, Chirino teaches “the use of. . . computational
methods for modulating the immunogenicity of proteins by identifying and
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then altering potential amino acid sequences that elicit an immune response
in a host organism.” Chirino, Abstract. The Examiner also found that
Chirino describes utilizing the variant proteins produced by its computation
methods to produce antibodies and that such methods can involve T-cell
epitopes. Final Rej. 6—7.
An epitope can be a protein sequence which is antigenic or
immunogenic, i.e., capable of eliciting an immune response, such as
antibodies. ’337 Application 32: 29—30; 31: 21—23. To make a modification
to a protein for the purpose of eliciting an immune response as taught by
Chirino, the skilled worker would identify the epitope within a protein
sequence and such epitope would necessarily be “presented by an antigen
processing cell of the immune system of the human host” because that is the
mechanism by which epitopes are processed by the immune system. Chirino
116, 7, 43.
With respect to the limitation of a “computable epitope of the virus”
which presented to the immune system, Soudeyns was expressly used for its
teaching of HIV envelope epitopes (“Evidence is provided that the mutations
appearing in an HIV-specific CTL epitope resulted from the selective
pressure exerted by the virus-specific cytotoxic response.” Soudeyns 3629).
Final Rej. 4.
In sum, while Appellants contend that the rejection is defective with
respect to clause 2, they did not address the factual findings made by the
Examiner nor the disclosures in Chirino and Soudeyns, cited by the
Examiner, considered relevant to clause 2.
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[3] one or more instructions for projecting, in the computer system,
with reference to at least one database, a predictable mutational
change in the computable epitope of the virus in the human host at a
second time point in the future.
The Examiner cited Soudeyns disclosure of the predicted change in
the envelope protein epitopes during HIV infection. Specifically, Examiner
found that Soudeyns teaches “longitudinal analysis of sequence variation in
the envelope (env) gene of HIV in two human subjects during primary HIV
infection.” Final Rej. 4. The Examiner identified disclosure in Soudeyns
which showed that mutations which changed the polypeptide sequence
accumulated over time. Id. Based on this finding, the Examiner cited
Soudeyns’ conclusion that:
It is conceivable that an immunodominant HIV-specific
CTL response directed against a single epitope may favor the
emergence of virus mutants that escape the immune response.
The latter issue should be taken into consideration in the design
of strategies aimed at the development of candidate HIV
vaccines and immunobased interventions.
Soudeyns 3633. The cited disclosure from Soudeyns shows “predictable
mutational change in the computable epitope of the virus in the human host
at a second time point in the future.”
The Examiner determined that one of ordinary skill in the art would
have had reason to apply this teaching to Chirino:
It would have been further obvious to analyze epitopes of
a human host infected with HIV at a first time point and a
second time point in the future because Soudeyns et al. shows
that epitopes encoded by the HIV env gene mutate during
infection, and that eight variable regions in the env gene are
sites of variation, and that the variant epitopes escape host
cytotoxic T lymphocytes. Soudeyns et al. provides guidance
that future variation in the env gene that escape preexisting host
CTL specificities should be considered in HIV vaccines.
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Final Rej 8.
Appellants contend that the Examiner did not establish that Soudeyns
describes “projecting, in the computer system, with reference to at least one
database, a predictable mutational change in the computable epitope” as
recited in clause 3 of claim 1 “for at least the reason that Soudeyns is a
‘longitudinal analysis’ that followed clinical progression of two patients over
time. The description of clinical history made by Soudeyns does not include
any form of ‘projecting, in the computer system, with reference to at least
one database’ as recited in clause 3 of claim 1.” Appeal Br. 23.
The Examiner did not rely on Soudeyns for a database. Rather, the
Examiner specifically found that Chirino describes the use of databases in a
computer system and that it would have been obvious to execute the
processes in a computer. Final Rej. 6, 9. Consequently, Appellants’
arguments do not identify an error in the Examiner’s rejection.
[4] one or more instructions for selecting, in the computer system, one
or more antibodies predicted to bind to the predictable mutational
change in the computable epitope of the virus at the second time point
in the future.
As found by the Examiner, Soudeyns teaches taking into account the
“predictable mutational change in the computable epitope of the virus” by
taking “into consideration” the “progressive accumulation of mutations”
observed in the HIV envelope protein during infection.” Soudeyns 3632.
Thus, Soudeyns teaches predicting future changes in the HIV envelope
protein based on past mutational changes in the viral envelope protein.
While Soudeyns does not expressly teach making this extrapolation in a
“computing system” (clause 3), the sequencing analysis is performed in an
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automatic sequencer. Soudeyns 3634. Chirino, as found by the Examiner
describes making changes in a protein using computational methods (Final
Rej. 6), thus the Examiner’s determination that it would have been obvious
to have performed Soudeyns’ prediction steps in Chirino’s computer system
is supported by factual evidence. Id., 8—9. In fact, as evidenced by Chirino,
bioinformatics analysis is typically carried out by a computer so it would
have been within the skill of the ordinary skilled worker to create program to
perform such an analysis.
Appellants contend that Soudeyns does not teach “one or more
antibodies predicted to bind to the predictable mutational change in the
computable epitope of the virus at the second time point in the future.”
Appeal Br. 25. Appellants’ argument is not supported by any evidence. As
already mentioned, Soudeyns expressly teaches showing changing variations
in the HIV envelope protein and states that such changes should be taken
into account when designing vaccines and immune-based interventions.
Soudeyns 3633.
Appellants contend that the Soudeyns does not teach such predicted
changes and not with reference to a database. Appeal Br. 25.
This argument is not persuasive. Appellants did not address the
express disclosure in Soudeyns cited by the Examiner regarding taking into
account variations in the HIV envelope protein for the purpose of making
antibody vaccines (see above). In addition, the Examiner did not rely on
Soudeyns for teaching a database and computational aspects, but rather cited
Chirino for these teachings. Thus, Appellants’ argument does not address
the basis of the rejection, but rather attacks the teachings of only one of the
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cited prior art publications. Appellants did not identify a specific defect in
the Examiner’s findings nor conclusion. Id.
[5] one or more instructions for communicating at least one selected
antibody to at least one system user.
Appellants contend that the Examiner did not demonstrate that the
cited publications teach “communicating at least one selected antibody to at
least one system user.” Appeal Br. 26.
Chirino expressly teaches the computer modification of epitopes to
develop more effective vaccines comprising antibodies. Chirino, Abstract.
It is commonsense that it would be necessary to communicate such
information produced by the computer to the user. “A person of ordinary
skill is also a person of ordinary creativity, not an automaton.” KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 421 (2007). Consequently, Appellants
contentions do not persuade us that the Examiner erred in finding that
Chirino and Soudeyns reasonably suggest clause 5 of claim 1.
CLAIMS 2, 4, 5, AND 7-12
Appellants contend that the Examiner “made no specific allegations
regarding the specific recitations of any of claims 2, 4, 5 and 7-12” and that
therefore prima facie obviousness was not established for these claims.
Appeal Br. 27.
The Examiner specifically pointed out teachings in the cited Chirino
and Soudeyns publications which describe the limitation in the claims. For
example:
Chirino teaches computable portions of proteins and Soudeyns teaches
the HIV envelope protein which is a viral protein as in claim 2 (Final Rej.
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6); Soudeyns teaches HIV infection which is a disease state and pathogen as
in claim 4 and 5 {id., 7); Soudeyns teaches HIV viral envelope protein
epitopes as in claim 7 {id.); Chirino teaches B-cell and T-cell epitopes (“a
part of’ a “T cell” or B cell”) as in claims 8—11 {id., 6); and Chirino teaches
a database as in claim 12 {id.)
CLAIM 13
Independent claim 13 is directed to a system with “circuitry.” The
Examiner included claim 13 in the same rejection as claim 1 because the
“circuitry” is recited to accomplish the same steps (clauses 1—4) as the
“instructions” in claim 1. Claim 13, however, lacks clause 5.
Appellants did not point to a definition of “circuitry” in the ’337
Application or provide guidance as to its meaning. The Application
describes “electrical circuitry” as “forming a general purpose computing
device configured by a computer program” (’336 Application 64: 1— 15), but
does not identify “circuitry” that is not “electrical circuitry.”
Appellants argue that the Examiner did not demonstrate prima facie
obviousness of clauses 1 to 4 of claim 13. Appeal Br. 28. However, we
have compared the arguments made for claim 1 to those made for claim 13
and they appear to be substantially the same. Consequently, because
Appellants have not distinguished claim 1 from claim 13, we affirm the
rejection of claim 13 for the same reasons as for claim 1.
CLAIMS 14, 16, 17, AND 19-24
Appellants contend that the Examiner did not address the specific
limitations in these claim 14, 16, 17, and 19—24. Appeal Br. 33. However,
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such limitation appear to be substantially the same as the recitations in
claims 2, 4, 5 and 7—12 which were addressed above. Consequently, for the
same reasons, we conclude that the Examiner’s determination that claims 14,
16, 17, and 19—24 are obvious is supported by a preponderance of the
evidence.
Claims 25, 26, 28, 29, AND 31-36
Appellants’ arguments for claims 25, 26, 28, 29, and 31—36 are
duplicative (Appeal Br. 34-41) to those made for claim 13 and its
dependents. Consequently, for the same reasons, we conclude that the
Examiner’s determination that claims 25, 26, 28, 29, and 31—36 are obvious
is supported by a preponderance of the evidence.
TECHNICAL REASON TO COMBINE
Appellants contend that the Examiner did not “articulate a convincing
technical rationale to combine Chirino and Soudeyns.” Appeal Br. 41.
The Examiner identified specific deficiencies in Chirino with respect
to claim 1. Final Rej. 7. These included lack of “analysis of a viral epitope
at a first time point and a second time point in the future in a human host”;
“communicating to a user a designated antibody, T cell, or B cell.” Id. The
Examiner found that Soudeyns described several of the elements said to
missing from Chirino, and the remainder, the Examiner found would have
been obvious to one of ordinary skill in the art based on Chirino’s
disclosure. Id., 7—8. The Examiner explained that it would have been
obvious to have implemented “analysis of a viral epitope at a first time point
and a second time point in the future in a human host” in Chirino “because
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Soudeyns et al. shows that epitopes encoded by the HIV env gene mutate
during infection [second time point] . . . that the variant epitopes escape host
cytotoxic T lymphocytes.” Id., 8. Furthermore, the Examiner stated
Soudeyns “provides guidance that future variation in the env gene that
escape preexisting host CTL specificities should be considered in HIV
vaccines,” a clear reference to the requirement in the claim of “[4] one or
more instructions for selecting, in the computer system, one or more
antibodies predicted to bind to the predictable mutational change in the
computable epitope of the virus at the second time point in the future.” Id.
Based on these findings and determinations by the Examiner, Appellants
were appraised of the thrust of the rejection, including the obviousness of
implementing Soudeyns teachings about analyzing changing viral epitopes
at two time points in the computer system of Chirino and of using Chiron’s
computer system to select antibodies predicted to bind to the env mutations
described in Soudeyns. Appellants did not demonstrate an error in the
Examiner’s fact-finding or rationale.
CLAIMS 6, 18, AND 30
Claims 6, 18, and 30 are dependent claims which further comprise
“projecting a predictable mutational change in the computable epitope of the
virus associated with agent transmission in the human host at a second time
point in the future.”
Appellants contend the Examiner “failed to show how any cited
reference, alone or in combination, teach or suggest all the claim
limitations.” Appeal Br. 43. Appellants’ argument is not supported by any
evidence. To reach the specific claim limitations, the Examiner further cited
Herbeck, finding that it would have been obvious to modify Chirino and
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Soudeyns with Herbeck’s teachings because Herbeck “shows that the env
gene of HIV acquires mutations after transmission that revert to ancestral
sequences, and that HIV vaccines should be designed to include viral
sequences that protect against env mutations that appear after infection of a
host.” Final Rej. 9—10. Appellants did not identify any error in the
Examiner’s fact-finding nor reasoning.
CLAIMS 3, 15, AND 27
Claims 3, 15, and 27 are dependent claims which further comprise
“identifying an association of the computable epitope of the virus with an
autoimmune response.” The Examiner found that Saif “shows in the
Abstract that HIV infection is associated with autoimmune hemolytic
anemia.” Final Rej. 11. The Examiner found it obvious to combine “to
analyze changes in HIV epitopes associated with an autoimmune response
because Saif shows that HIV infection is associated with autoimmune
hemolytic anemia.” Id.
Appellants contend that the Examiner erred because “the text of Saif
states that the autoimmune hemolytic anemia (AIHA) seen in HIV-infected
patients is not associated with any HIV viral epitope, including a HIV viral
epitope that is a ‘computable epitope’ and ‘presented by an antigen
processing cell of the immune system of the human host’ as recited in
Appellant's claims 3, 15 and 27.” Appeal Br. 45.
Appellants did not direct our attention to where Saif teaches that
AIHA is not associated with any HIV viral epitope. Saif teaches: “Several
mechanisms have been postulated to explain why AIHA develops in patients
with AIDS.” Saif 218. Saif also teaches: “Different mechanisms have been
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proposed to explain this phenomenon that includes abnormal B-cell
regulation by HIV-infected T cells, direct activation of B cells by HIV, or a
B-cell response to coincident infection with Epstein-Barr virus or
cytomegalovirus (CMV).” Id. Saif also teaches: “Despite the production of
such antibodies, the pathophysiology of AIHA in patients with AIDS is
unclear and further studies should be conducted.” These disclosures provide
a reason for one of ordinary skill in the art to conduct “further studies” and
investigate “why AIHA develops in patients with AIDS,” and to determine
associations “of the computable epitope of the virus with an autoimmune
response” (claims 3, 15, and 27) as exhibited in AIHA.
Accordingly, we conclude that the Examiner’s determination it would
have been obvious to analyze changes in HIV epitopes associated with
AIHA to be supported by a preponderance of the evidence.
Appellants contend that the pertinence of the cited publications have
not been explained. Appeal Br. 46. Appellants’ argument is not persuasive.
The argument makes generalized statements about the rejections being
deficient, without addressing the specifically cited factual-findings as set
forth in the Final Rejection. As explained above, the Examiner made
express findings and determinations with regard to the cited publications
which put Appellants on notice about the thrust of the rejections. “[A] 11 that
is required of the office to meet its prima facie burden of production is to set
forth the statutory basis of the rejection and the reference or references relied
upon in a sufficiently articulate and informative manner as to meet the notice
requirement of § 132.” In re Jung, 637 F.3d 1356, 1363 (Fed. Cir. 2011).
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OBVIOUSNESS TYPE DOUBLE PATENTING
The Examiner provisionally rejected the claims under non-statutory
obviousness-type double-patenting over claims 1, 2, 12, 15, and 40-42 of the
’950 Application. The Examiner found the ’950 Application claims the
subject matter of the ’337 Application “except for claiming the virus in a
generic location rather than a human host, analyzing a nucleic acid sequence
rather than a polypeptide epitope sequence and not claiming a computer that
executes the process or a computer program.” Final Rej. 14. The Examiner
explained:
It would have been obvious to a person of ordinary skill
in the art at the time the invention was made to consider a virus
in a human host for the purpose of providing a result of human
clinical significance and because Chirino et al. uses information
of variant proteins for clinical purposes. It would have been
further obvious to convert the nucleic acid sequences to the
encoded polypeptide sequences because the claims of
copending Application No. 11/728,950 analyze polypeptide
epitope sequences and Chirino et al. shows analysis of
polypeptide sequences can be used to design variations of
preexisting epitopes.
Id.
Appellants contend that the Examiner’s rejection is defective but did
not address the Examiner’s fact-based and well-reasoned basis for the
rejection as summarized above. Appeal Br. 50.
SUMMARY
The obviousness rejection of claims 1, 2, 4, 5, 7—14, 16, 17, 19—26,
28, 29, and 31—36 under 35 U.S.C. § 103(a) in view of Chirino and
Soudeyns is affirmed. Final Rej. 5.
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Application 11/807,337
The obviousness rejection of claims of 6, 18, and 30 under
35 U.S.C. § 103(a) in view of Chirino, Soudeyns, and Herbeck is affirmed.
The obviousness rejection of claims 3, 15, and 27 under
35 U.S.C. § 103(a) in view of Chirino, Soudeyns, and Saif is affirmed.
The provisional rejection of claims 1, 2, 7—9, 12—14, 19, 20, 24—26,
31, 32, and 36 on the ground of non-statutory obviousness-type double­
patenting over claims 1, 2, 12, 15, and 40-42 of Application 11/728,950 is
affirmed.
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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