Receptor Logic, Inc.

Patent Trials and Appeals Board

Dec 16, 2020

2020001456 (P.T.A.B. Dec. 16, 2020)

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.
14/053,012 10/14/2013 Jon A. Weidanz TECH:1153CON2 9657
34725 7590 12/16/2020
CHALKER FLORES, LLP
14951 NORTH DALLAS PARKWAY
SUITE 400
DALLAS, TX 75254
EXAMINER
DIBRINO, MARIANNE
ART UNIT PAPER NUMBER
1644
MAIL DATE DELIVERY MODE
12/16/2020 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JON A. WEIDANZ
Appeal 2020-001456
Application 14/053,012
Technology Center 1600
BEFORE JOHN E. SCHNEIDER, RYAN H. FLAX, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 21–25, 27–36, and 38–47. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real parties in interest as Texas Tech
University System, Receptor Logic, Inc., and Pure MHC, LLC. Appeal
Br. 2.
Appeal 2020-001456
Application 14/053,012
2
CLAIMED SUBJECT MATTER
The claims are directed to methods for assaying vaccine potency.
Claim 21, reproduced below, is illustrative of the claimed subject matter:
21. A method of assaying the potency of a vaccine composition,
the method comprising the steps of:
delivering a recombinant vaccine composition to antigen
presenting cells so that the antigen presenting cells display at
least one peptide/MHC complex having an epitope derived
from the vaccine composition on their cell surface;
contacting the antigen presenting cells with antibodies or
binding fragments thereof that specifically bind to the
peptide/MHC complex, wherein the MHC is a Class I MHC
selected from HLA-A *0201, HLA-A2, HLA-A2.l, or HLA A
*02;
measuring the number of peptide/MHC complexes
expressing the epitope on the surface of each of the antigen
presenting cells based on the bound antibodies or binding
fragments thereof;
calculating the potency of the vaccine composition based
on the number of peptide/MHC complexes on the antigen
presenting cells compared to a comparison antigen presenting
cell not displaying the peptide; and
determining the potency of the vaccine composition based
on the measured number of peptide/MHC complexes on the
surface of the antigen presenting cells to stimulate CTLs.
REFERENCES
The prior art relied upon by the Examiner is:2

2 In addition to the following prior art references, the Examiner also relies on
the applicant’s admissions in the Specification at ¶¶ 48 and 98. Ans. 3–4.
Appeal 2020-001456
Application 14/053,012
3
Name Reference Date
Hoogenboom et al. WO 03/07052 A2 August 28, 2003
Cohen at al., Recombinant antibodies with MHC-restricted, peptide
specific, T-cell receptor like specificity: new tools to study antigen
presentation and TCR-peptide-MHC interactions, 16 J. Mol. Recognit.
324 (2003) (“Cohen”)
He at al., A Novel Cancer Vaccine Elicits Cellular Response to the
Tumor-Associated Antigen, Human Chorionic Gonadotropin β, 10 Clin,
Cancer Res. 1920 (2004) (“He”)
World Health Organization, WHO Guidelines on Nonclinical Evaluation
of Vaccines (2003) (“WHO”)
Porgador, et al., Localization, Quantification, and In Situ Detection of
Specific Peptide-MHC Class I Complexes Using a Monoclonal Antibody,
6 Immunity 715 (1997) (“Porgador”)

REJECTIONS3
The Examiner has rejected the pending claims as follows:4
Claims 21–25, 27–36, and 38–47 have been rejected under 35 U.S.C.
§ 112, first paragraph, for failure to comply with the written description
requirement.
Claims 21–25, 27–44, and 47 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Cohen in view of He and WHO and
Appellant’s admission in the Specification.
Claims 21–25, 29–36, 40–44, and 47 have been rejected under
35 U.S.C. § 103(a) as unpatentable over Hoogenboom in view of Porgador.

3 The Examiner also initially rejected claims 27 and 38 under 35 U.S.C.
§ 112, second paragraph, as indefinite. Final Act. 4. The Examiner withdrew
this rejection in the Answer, rendering it moot. Ans. 3.
4 Appellant also addresses the Examiner’s objection to claim 21. Appeal
Br. 14. Objections to the claims are not the proper subject of an appeal. See
37 C.F.R. § 41.31 (a)(1) (claims rejected twice may be appealed).
Appeal 2020-001456
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4
Claims 21–25, 29–36, 40–44, and 47 have been rejected under
35 U.S.C. § 103(a) as unpatentable over Cohen in view of Porgador.
Claims 21–25, 27–36, and 39–47 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Hoogenboom in view of He and WHO.
OPINION
WRITTEN DESCRIPTION
Issue
The issue with respect to this rejection is whether the Examiner has
properly determined that the Specification’s disclosure does not reasonably
convey to those skilled in the art that the inventor had possession of the
claimed subject matter as of the filing date.
The Examiner finds that the term “antibodies or fragments thereof that
specifically bind to the peptide/MHC complex” is not supported by the
present disclosure. Final Act. 2–4. The Examiner finds that the Specification
only discloses two species of antibodies which meet the recited limitation
and that this is not a representative number of species. Id. at 3. The
Examiner also finds
There is no evidence of record for the structure of the
generic antibodies (i.e., the sequences of the combination of the
CDRs for particular antibodies) that corresponds to the
functional property of binding to the generic peptide/ HLA-
A*0201, HLA-A2, HLA-A2.1, or HLA-A*02 complexes. Since
there is not adequate written description for the recited
antibodies, there is also not adequate written description for the
method that uses the said antibodies. In light of this, a skilled
artisan would reasonably conclude that Applicant was not in
possession of the genus of all the said antibodies at the time the
instant application was filed.

Id. at 3–4.
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5
Appellant contends that the present disclosure contains an adequate
written disclosure. Appellant contends that the inventors were in possession
of a genus of antibodies that specifically bind to a peptide/HLA complex as
recited in the claims. Appeal Br. 5. Appellant contends that given the
disclosure of the genus, one skilled in the art would understand that the
disclosed method would work with other peptide/HLS complex antibodies.
Id. Appellant argues that while there may be a large number of peptide/HLA
complexes that can be used in practice of the invention, once one skilled in
the art learned that the antibodies for the complexes could be made it would
only require routine experimentation to develop additional antibodies. Id.
Appellant also contends that the present disclosure teaches one skilled in the
art how to make and use the antibodies used in the claimed method. Id.
Principles of Law
A description adequate to satisfy 35 U.S.C. § 112, first paragraph,
must ‘clearly allow persons of ordinary skill in the art to
recognize that [the inventor] invented what is claimed.’ In
other words, the test for sufficiency is whether the disclosure of
the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject
matter as of the filing date.

Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
(en banc) (citation omitted, alteration in original).
A “sufficient description of a genus instead requires the disclosure of
either a representative number of species falling within the scope of the
genus or structural features common to the members of the genus so that one
of skill in the art can ‘visualize or recognize’ the members of the genus.” Id.
at 1350 (Fed. Cir. 2010) (en banc).
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6
The written description requirement is separate from the enablement
requirement. Id. at 1345.

Analysis
We have considered the arguments presented by Appellant and the
Examiner and find that the Examiner has the better argument. The rejected
claims define generic antibodies for use in the claimed method by reference
to specific binding to a broadly recited antigen, namely a peptide/class I
MHC complex presenting an epitope derived from the vaccine, wherein the
Class I MHC is selected from HLA-A *0201, HLA-A2, HLA-A2. l, or HLA
A *02. Appeal Br. 16 (Claims App’x). First, we note that the antigen is only
partly characterized. In other words, Appellant is attempting to describe a
genus of unknown antibodies by the ability to bind to another unknown.
Second, even given that part of the antigen recited in the claims is known,
e.g., the MHC portion of the antigen, an adequate written description
requirement still must contain “a representative number of species falling
within the scope of the genus or structural features common to the members
of the genus so that one of skill in the art can visualize or recognize the
members of the genus.” See Amgen, Inc. v. Sanofi, Aventisub, LLC., 872
F.3d 1367, 1373 (Fed. Cir. 2017) (internal quotations and citations omitted).
Appellant apparently concedes that the Specification does not provide
the structural features that are common to the members of the claimed genus,
as Appellant only argues that the Specification provides a representative
number of species. Indeed, we agree that there is not a sufficient description
of the relevant structural features to meet the written description requirement
for a genus of antibodies. Noelle v. Lederman, 355 F.3d 1343, 1349–50
(Fed. Cir. 2004) (attempting to describe a genus of unknown antibodies by
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7
the ability to bind to another unknown is not sufficient to meet the written
description requirement).

Appellant contends that the Specification describes a representative
genus of antibodies and that based on its disclosure, one skilled in the art
could make other antibodies that can be sued in practice of the claimed
method. Appeal Br. 4–5. We are not persuaded by this argument.
We note that Appellant appears to equate the written description
requirement with the enablement requirement. However, as our reviewing
court has made clear, they are separate and distinct requirements under
Section 112. Ariad, 598 F.3d at 1345. While the present claims may be
enabled, that does not mean that they also meet the written description
requirement. See University of Rochester v. G.D. Searle & Co., 358 F.3d
916, 921 (Fed. Cir. 2004) (“[A]n invention may be enabled even though it
has not been described.”)
With respect to the disclosure of a representative number of species,
we agree with the Examiner that the present Specification does not meet this
requirement. Ans. 6–8. We agree with the Examiner that
The examples of TCRm disclosed in the specification are not
representative of the breadth and structural diversity of the
genus of TCRm antibodies/binding fragments thereof recited in
the instantly claimed method, nor representative of the breadth
of the peptide in the complex of one of the HLA-A2 subtypes
recited in the instant claims.
Id at 8.
Conclusion
Based on the foregoing we conclude that the Examiner properly
concluded that the rejected claims do not satisfy the written description
requirement.
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8
OBVIOUSNESS BASED ON COHEN
COMBINED WITH HE AND WHO
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that the subject matter of
claims 21–25, 27–44, and 47 would have been obvious to one of ordinary
skill in the art at the time the invention was made over Cohen combined with
He and WHO and Appellants’ admission in the Specification.
The Examiner finds that Cohen teaches a method for studying
antibody presentation on antigen presenting cells (“APCs”) using T cell
receptor mimic antibodies (“TCRm”) and for determining that alterations in
major histocompatibility complex (“MHC”)/ peptide complex expression on
APCs before, during and after vaccination protocols. Final Act. 6. The
Examiner finds that Cohen teaches the claimed method steps of “delivering a
peptide vaccine to APCs or contacting APCs with a peptide vaccine and
measuring binding of the TCRm to the APC(s) and measuring the binding of
the TCRm to the APCs before, during and after vaccination protocols with
peptides.” Id. The Examiner finds that Cohen does not explicitly teach
calculating vaccine potency nor does Cohen teach determining the level of
antigen specific T cell stimulation, nor including wherein the T cell
stimulation is cytotoxic T lymphocyte (“CTL”) stimulation. Id.
The Examiner finds that Cohen inherently teaches determining the
potency of a vaccine in that Cohen teaches
the inability of a patient’s immune system to elicit an effective
immune response is often due to poor antigen presentation,
wherein use of TCRm antibodies to directly detect, visualize,
count and study peptide/MHC present on the surface of APCs
assess this situation, including before, during and after
vaccination protocols with peptides.
Appeal 2020-001456
Application 14/053,012
9

Id. The Examiner finds
It would have been prima facie obvious to one of
ordinary skill in the art at the time the invention was made to
have compared the number of peptide/HLA-A2 complexes on
the APCs with that on a control APC not displaying the
particular peptide/HLA-A2 complex.
One of ordinary skill in the art at the time the invention
was made would have been motivated to do this in order to
evaluate the vaccine ability with regard to antigen presentation,
because Cohen et al teach evaluating antigen presentation using
a TCRm antibody before, during and/or after vaccination and
because Cohen et al teach the evaluating TCRm staining above
control levels on cells not expressing the MHC/peptide
complex of interest, and also because it was well known to one
of ordinary skill in the art to compare a result to a baseline
value.

Id. at 6–7.
With respect to the claimed step calling for determining the level of
antigen specific T cell stimulation, including wherein the T cell stimulation
is CTL stimulation, the Examiner finds that this step is taught by He. Id. at 7.
Specifically, the Examiner finds that He teaches that “CTL responses are
major and important with respect to the biological function elicited by the
vaccine. He et al teach that peptide (from the vaccine)/MHC class I
complexes are the targets of the biologically important CTLs.” Id.
The Examiner goes on to find
WHO Guidelines teaches that potency tests measure the
biological activity of a vaccine, and are often used to verify the
consistency of the manufacturing process. Said reference
teaches that where no suitable animal challenge model exists,
potency is often based on measurement of immune responses.

Id.
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The Examiner concludes
It would have been prima facie obvious to one of
ordinary skill in the art at the time the invention was made to
have added a further step of testing level of CTL activity
against the APCs loaded or contacted with the vaccine in the
method taught by Cohen et al.
One of ordinary skill in the art at the time the invention
was made would have been motivated to do this in order to
measure the vaccine potency of the preparation, particularly in
light of the teaching of WHO Guidelines of the usefulness of
measuring immune responses in the assay of vaccine potency.

Id.
Appellant contends that while Cohen teaches quantifying
HLA/Peptide complexes on the surface of virus infected and tumor cells,
Cohen does not teach the steps of
“calculating the potency of the vaccine composition
based on the number of peptide/MHC complexes on the antigen
presenting cells compared to a comparison antigen presenting
cell not displaying the peptide,” “determining the potency of
the vaccine composition based on the measured number of
peptide/MHC complexes on the surface of the antigen
presenting cells to stimulate CTLs,” or “selecting the vaccine
composition with a determined number of peptide/MHC
complexes and admixing the vaccine composition with a
pharmaceutically acceptable carrier based on having a higher
potency[.],”

Appeal Br. 7–8. Appellant also contends that Cohen does not teach “the step
of determining the CTL activity of the APCs that have processed the antigen
for presentation.” Id.
Appellant also contends that while He may teache a CTL assay, none
of the references teaches or suggests using the assay to calculate the potency
Appeal 2020-001456
Application 14/053,012
11
of a vaccine. Id. 9. Appellant contends that any teaching regarding the use of
a CTL assay stems solely from the present disclosure. Id.
Appellant also contends that the teaching in WHO would not have
lead one skilled in the art to use the recited method to determine vaccine
potency. Id. at 10. Appellant contends that WHO would have lead one
skilled in the art to measure an immune response by more conventional
means. Id.
Principles of Law
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
The test of obviousness is “whether the teachings of the prior art,
taken as a whole, would have made obvious the claimed invention.” In re
Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991).
“Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references. . . . [The reference] must be read, not in
isolation, but for what it fairly teaches in combination with the prior art as a
whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Analysis
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
Answer regarding this rejection. We find the Examiner has established a
prima facie showing that the subject matter of the claims would have been
obvious over Cohen combined with He and WHO to a person of ordinary
skill in the art at the time the invention was made. Appellant has not
Appeal 2020-001456
Application 14/053,012
12
produced evidence showing, or persuasively argued, that the Examiner’s
determinations on obviousness are incorrect. Only those arguments made by
Appellant in the Brief (no Reply to the Examiner’s Answer was filed) have
been considered in this Decision. Arguments not presented in the Brief are
waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2015). We have identified claim
21 as representative and Appellant does not argue any claim separately;
therefore, all claims fall with claim 21. We address Appellants’ arguments
below.
Appellant contends that Cohen does not teach or suggest the limitation
calling for calculating the potency of a vaccine composition based on the
number of peptide/MHC complexes on the APCs compared to a control.
Appeal Br. 7–8. We are not persuaded by this argument.
The Specification teaches
The potency of the vaccine is then determined, based on
the quantitative measurement of the number of specific
peptide/MHC complex present on the surface of the vaccine-
treated antigen presenting cell.
Potency is measured by comparing the threshold amount
or activity of the vaccine to induce a T-cell response, such as
but not limited to a CTL response or T-cell anergy, such that it
is meaningful to a biological effect in vivo. In this manner, the
T cell receptor mimic binding assay determines the correlative
density of the HLA-peptide complexes on the antigen
presenting cell.

Spec. ¶¶ 110–111. Cohen teaches a method that includes measuring
peptide/MHC complexes on the surface of APCs and that the measurement
can be done as part of a vaccination protocol. Cohen, Abstract, 328, 329.
Cohen also teaches comparing the number of complexes on the APCs to
APCs not displaying the peptide. Id. Thus, we agree with the Examiner that
Cohen teaches the recited step.
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13
Appellant also contends that Cohen does not teach the step of
determining the CTL activity of the APCs that have processed the antigen
for presentation. Appeal Br. 8. Appellant contends that, although He may
teach a CTL assay, there is nothing in the reference to teach or suggest such
an assay’s use to calculate vaccine potency. Id. at 9. Again, we are not
persuaded by these arguments.
As the Examiner points out, He teaches that “CTL responses are
major and important with respect to the biological function elicited by a
peptide vaccine.” Ans. 9. We agree with the Examiner that this teaching,
combined with that of Cohen, would lead one skilled in the art to combine
the teachings of the references. See id.
We are similarly unpersauded by Appellant’s contention that the
teachings of WHO would not lead to the present method, but would lead one
skilled in the art to select a more conventional method. Appeal Br. 10. We
agree with the Examiner that
Appellant is once again arguing the references separately, as
Cohen et al teach measuring the number of a specific
peptide/MHC class 1 complex on the surface of an antigen
presenting cell prior, during or after vaccination with a
composition comprising the said peptide, while both Cohen et
al and He et al associate number of a particular MHC class
1/peptide complex with stimulation of a CTL having a cognate
T cell receptor thereon. With regard to the WHO Guidelines
reference, one of ordinary skill in the art would have been
motivated to actually test CTL stimulation in order to confirm
the activity with different CTLs and to insure lot to lot
comparability (the latter as is taught as being a desirable goal
by the said art reference).

Ans. 12.
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Conclusion
Based on the foregoing, we conclude that a preponderance of the
evidence supports the Examiner’s conclusion that the subject matter of claim
21 would have been obvious over Cohen combined with He and Who.
Claims 22–25, 27–44, and 47 have not been separately argued and therefore
fall with claim 21.37 C.F.R. § 41.37(c)(iv).
OBVIOUSNESS BASED ON HOOGENBOOM AND PORGADOR
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that the subject matter of
claims 21–25, 29–36, 40–44, and 47 would have been obvious to one of
ordinary skill in the art at the time the invention was made over
Hoogenboom combined with Porgador.
The Examiner finds that Hoogenboom teaches the use of TCRm
antibodies of fragments of antibodies to quantify the number of
MHC/peptide complexes on the surface of APCs in connection with
recombinant vaccination protocols. Final Act. 10. The Examiner finds that
Hoogenboom
implicitly teaches the instantly recited method steps of
delivering a peptide vaccine to APCs or contacting APCs with a
peptide vaccine, measuring binding of the TCRm to the APC(s)
and measuring the binding of the TCRm to the APCs before,
during and after vaccination protocols with peptides.
[Hoogenboom] teaches that the inability of a patient's immune
system to elicit an effective immune response is often due to
poor antigen presentation, wherein use of TCRm antibodies to
directly detect, visualize, count and study peptide/MHC present
on the surface of APCs assess this situation, including before,
during and after vaccination protocols with peptides.

Id.
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The Examiner find that Hoogenboom does not teach or suggest
“determining the level of antigen specific T cell stimulation, nor including
wherein the T cell stimulation is CTL stimulation, nor does it explicitly
teach calculating the potency of the vaccine composition based on the
number of peptide/MHC complexes on the APCs compared to a comparison
APC not displaying the peptide.” Id. at 11. The Examiner finds that
Porgador teaches these limitations. Specifically, the Examiner finds
“Porgador et al teach[es] that TCRm antibodies can detect the threshold
number of peptide/MHC complexes needed to activate CTLs, making them a
suitable reagent for quantitatively evaluating antigenic complex expression
at low but physiologically relevant levels.” Id.
The Examiner concludes
It would have been prima facie obvious to one of
ordinary skill in the art at the time the invention was made to
have evaluated the potency of the vaccine composition of the
primary art reference according to a determined threshold
number of peptide/MHC complexes sufficient to activate CTLs,
in particular using the high affinity TCRm antibody taught by
the primary art reference, as well as to actively correlate the
number of peptide/MHC complexes for the ability to stimulate
a CTL. It would also have been prima facie obvious to one of
ordinary skill in the art at the time the invention was made to
have formulated a vaccine composition that was tested before
vaccination and determined to be potent via the number of
expressed peptide/MHC complexes per cell in a
pharmaceutically acceptable carrier.

Id.
Appellant contends that Hoogenboom does not teach or suggest the
limitations of
“calculating the potency of the vaccine composition based on
the number of peptide/MHC complexes on the antigen
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presenting cells compared to a comparison antigen presenting
cell not displaying the peptide,” “determining the potency of
the vaccine composition based on the measured number of
peptide/MHC complexes on the surface of the antigen
presenting cells to stimulate CTLs,” or “selecting the vaccine
composition with a determined number of peptide/MHC
complexes and admixing the vaccine composition with a
pharmaceutically acceptable carrier based on having a higher
potency,” as claimed.

Appeal Br. 11. With respect to Porgador, Appellant contends “Porgador
combined with the [Hoogenboom] fails to teach that a vaccine is used, that
the vaccine potency is calculated, or that the potency for CTL activation
determined, as claimed.” Appellant contends that the Examiner improperly
found that there was not a “manipulative difference” between the steps
recited in the claimed method and those found in the prior art. Id. at 12.
Appellant also contends that the Examiner erred in finding that the
claims represented a new benefit for an old process. Id. Appellant contends
that the claims recite specific steps that are not taught or suggested by the
prior art.
Finally, Appellant contends that the Examiner’s rejection is based on
conclusory statements without any evidentiary support. Id. at 12–13.
Analysis
We agree with and so adopt the Examiner’s findings of fact, reasoning
on scope and content of the prior art, and conclusions set out in the Final
Action and Answer regarding this rejection. See Final Act. 10–13. We find
the Examiner has established a prima facie showing that the subject matter
of the claims would have been obvious over Hoogenboom combined with
Porgador to a person of ordinary skill in the art at the time the invention was
made. Appellant has not produced evidence showing, or persuasively
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argued, that the Examiner’s determinations on obviousness are incorrect.
Only those arguments made by Appellant in the Brief have been considered
in this Decision. Arguments not presented in the Brief are waived. See
37 C.F.R. § 41.37(c)(1)(iv) (2015). We have identified claim 21 as
representative and Appellant does not argue any claims separately; therefore,
all claims fall with claim 21. We address Appellant’s arguments below.
Appellant contends that Hoogenboom does not teach or suggest
“calculating the potency of the vaccine composition based on the number of
peptide/MHC complexes on the antigen presenting cells compared to a
comparison antigen presenting cell not displaying the peptide.” Appeal Br.
11.
We are not persuaded by this argument. As the Examiner points out
Hoogenboom teaches “multiple instances of using cells expressing HLA-A2
with the peptide cognate for the specificity of the TCRm antibody of interest
while using a control cell not loaded with said peptide as a negative control.”
Ans. 12. For Example, Hoogenboom teaches the use of a control or
reference sample as part of a method to detect and measure MHC/peptide
complexes. Hoogenboom, 87–88, 104. We also agree with the Examiner that
Hoogenboom teaches
quantifying the number of peptide/MHC complexes on the
surface of an antigen presenting cell before, during and after
vaccination using a TCRm that binds a specific MHC class
1/peptide complex, and the claims equate “potency” with the
measured number of peptide/MHC complexes on the surface of
antigen presenting cells, the primary art reference implicitly
teaches assaying or determining the potency of a vaccine
composition as is recited in the instant claims.

Ans. 13.
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Appellant contends that the Examiner erroneously found that the
claims did not impart a manipulative difference from the prior art. Appeal
Br. 12. Appellant contends that the manipulative difference standard only
applies to the statements recited in the preamble. Id.
Again, we are not persuade by Appellant’s argument. As the
Examiner points out, although the references do not explicitly refer to
potency of a vaccine, the steps taught by the references are the same as those
recited in the claims including measuring the number of peptide/MHC
complexes on the surface of the antigen presenting cells that are identified
and quantified by use of the specific TCRm antibody which the
Specification teaches is the measure of potency. Ans. 13, see Spec. ¶¶ 110–
111; Hoogenboom, 90.
Appellant contends that, “while Porgador teaches CTL activation,
Porgador combined with the Hoogenboom] fails to teach that a vaccine is
used, that the vaccine potency is calculated, or that the potency for CTL
activation determined, as claimed.” Appeal Br. 12. We are unpersuaded that
the rejection was in error.
The Examiner cited Porgador for the teaching that “TCRm antibodies
can detect the threshold number of peptide/MHC complexes needed to
activate CTLs, making them a suitable reagent for quantitatively evaluating
antigenic complex expression at low but physiologically relevant levels.”
Final Act. 11 (citing Porgador 715, 723). The remaining limitations are
taught, either expressly or implicitly, by Hoogenboom. See Final Act. 10–11.
Appellant contends that the rejection is based on conclusory
statements by the Examiner that are without support. Appeal Br. 13.
Appellant also contends that the rejection was based on the improper use of
hindsight. Id.
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We are not persuaded by these arguments. The Examiner’s analysis,
both in the Final Rejection and the Examiner’s Answer, is based on the
specific teachings of the references. See Final Act. 10–11; Ans. 12–13. With
respect to the use of hindsight, we discern no evidence that the Examiner
improperly relied on knowledge gleaned from the Specification. In re
McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971) (“Any judgment on
obviousness is in a sense necessarily a reconstruction based upon hindsight
reasoning, but so long as it takes into account only knowledge which was
within the level of ordinary skill at the time the claimed invention was made
and does not include knowledge gleaned only from applicant’s disclosure,
such a reconstruction is proper.”)
Conclusion
Based on the foregoing, we conclude that a preponderance of the
evidence supports the Examiner’s conclusion that the subject matter of claim
21 would have been obvious over Cohen combined with He and Who.
Claims 22–25, 29–36, 40–44, and 47 have not been separately argued and
therefore fall with claim 21.37 C.F.R. §41.37(c)(iv).
THE REMAINING REJECTIONS
Although Appellant has argued the remaining rejections separately,
these arguments merely refer back to the arguments made with respect to the
first and second rejections. Appeal Br. 13–14. For the reasons stated above,
we find these arguments unpersuasive. Accordingly, we affirm the
remaining rejections.
CONCLUSION
The Examiner’s rejections are affirmed.
More specifically,
Appeal 2020-001456
Application 14/053,012
20
The rejection of claims 21-25, 27–36, and 38–47 under 35 U.S.C.
§ 112, first paragraph, for failure to comply with the written description
requirement is affirmed.
The rejection of claims 21–25, 27–44, and 47 under 35 U.S.C.
§ 103(a) as unpatentable over Cohen in view of He and WHO is affirmed.
The rejection of claims 21–25, 29–36, 40–44, and 47 under 35 U.S.C.
§ 103(a) as unpatentable over Hoogenboom in view of Porgador is affirmed.
The rejection of claims 21–25, 29–36, 40–44, and 47 under 35 U.S.C.
§ 103(a) as unpatentable over Cohen in view of Porgador is affirmed.
The rejection of claims 21-25, 27–36, and 39–47 under 35 U.S.C.
§ 103(a) as unpatentable over Hoogenboom in view of He and WHO is
affirmed.

Appeal 2020-001456
Application 14/053,012
21
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
21-25, 27–
36, 38–47
112 Written
Description
21-25, 27–
36, 38–47

21–25, 27–
44, 47
103(a) Cohen, He, WHO 21–25, 27–
44, 47

21–25, 29–
36, 40–44,
47
103(a) Hoogenboom,
Porgador
21–25, 29–
36, 40–44,
47

21–25, 29–
36, 40–44,
and 47
103(a) Cohen, Porgador 21–25, 29–
36, 40–44,
and 47

21-25, 27–
36, 39–47
103(a) Hoogenboom, He,
WHO
21-25, 27–
36, 39–47

Overall
Outcome
21–25, 27–
36, 38–47

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFRIMED