ULTIMOVACS AS

Patent Trials and Appeals Board

Mar 25, 2021

2020004394 (P.T.A.B. Mar. 25, 2021)

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.
15/498,728 04/27/2017 Gustav Gaudernack 0332.0001US2/
PN791356USA
5677
107992 7590 03/25/2021
HoustonHogle LLP
1666 Massachusetts Avenue
Suite 12
Lexington, MA 02420
EXAMINER
MCCOLLUM, ANDREA K
ART UNIT PAPER NUMBER
1646
NOTIFICATION DATE DELIVERY MODE
03/25/2021 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):
docketing@houstonllp.com
grant.houston@houstonllp.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte GUSTAV GAUDERNACK,
ANNE-MARIE RASMUSSEN, and
ELSE MARIT INDERBERG SUSO
____________

Appeal 2020-004394
Application 15/498,728
Technology Center 1600
____________

Before DONALD E. ADAMS, RACHEL H. TOWNSEND, and
MICHAEL A. VALEK, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1, 3–16, and 18–34 (Appeal Br. 1). 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. Appellant identifies the real party in interest as
“ULTIMOVACS AS” (Appellant’s December 2, 2019, Appeal Brief
(Appeal Br.) 1).
Appeal 2020-004394
Application 15/498,728

2
STATEMENT OF THE CASE
Appellant’s disclosure relates, inter alia, to methods of eliciting an
immune response in a patient with cancer or in an individual prior to any
symptoms of cancer comprising the administration of a polypeptide or
cocktail of polypeptides to the patient or individual (see generally Spec.2
¶¶ 4, 69, and 127). Appellant’s claims 1, 3, 4, and 16 are reproduced below:
1. A method of eliciting an immune response in a patient with
cancer or in an individual prior to any symptoms of cancer,
comprising administering to the patient or the individual at least
one selected from the group consisting of:
a) a polypeptide comprising a sequence selected from the
group consisting of:
i) SEQ ID NOS: 1, 2, 3, 7 or 8; and
ii) the sequence of an immunogenic fragment of i)
comprising at least eight amino acids, wherein the
immunogenic fragment is not one of SEQ ID NOS:
6, or 11 to 16, or 56,
wherein the polypeptide is less than or equal to 50 amino
acids in length and wherein the polypeptide does not
comprise the sequence of SEQ ID NO: 10 and does not
consist of the sequence of SEQ ID NO: 56;
b) a polypeptide consisting of a sequence of SEQ ID NO:
4; and
c) a pharmaceutical composition comprising the
polypeptide of part a) or b) and a pharmaceutically
acceptable adjuvant, diluent or excipient.
(Appeal Br. 31.)

2 Gaudernack et al., US 2017/0232087 A1, published Aug. 17, 2017.
Appeal 2020-004394
Application 15/498,728

3
3. The method according to claim 1, part a), subpart ii),
wherein the sequence of the immunogenic fragment of SEQ ID
NO: 1, comprises at least 20 amino acids.
(Id.)
4. The method according to claim 1, wherein the immunogenic
fragment has the sequence of any one of SEQ ID NOS: 17 to
40.
(Id.)
16. A method of eliciting an immune response in a patient with
cancer or in an individual prior to any symptoms of cancer,
comprising administering to the patient or the individual at least
one selected from the group consisting of:
a) a cocktail of polypeptides comprising at least first and
second different polypeptides wherein the first
polypeptide comprises a sequence selected from the
group consisting of:
i) SEQ ID NO: l; and
ii) the sequence of an immunogenic fragment of i)
comprising at least eight amino acids;
and wherein the second polypeptide comprises a
sequence selected from the group consisting of:
iii) SEQ ID NOS: 2 to 10; and
iv) the sequence of an immunogenic fragment of iii)
comprising at least eight amino acids;
wherein each polypeptide is less than or equal to 50
amino acids in length;
and
b) a pharmaceutical composition comprising the cocktail
of polypeptides of part a) and a pharmaceutically
acceptable adjuvant, diluent or excipient.
(Id. at 33.)

Appeal 2020-004394
Application 15/498,728

4
Grounds of rejection before this Panel for review:
Claims 1, 3–16, and 18–34 stand rejected under the enablement
provision of 35 U.S.C. § 112(a).
Claims 1, 3, 4, 6–11, 16, 19–25, and 27–29 stand rejected under 35
U.S.C. § 102(e) as anticipated by Brix.3
Claims 1, 6–8, 10, and 28 stand rejected under 35 U.S.C. § 102(e) as
anticipated by Chen.4
Claims 1, 6–8, 10, and 11 stand rejected under 35 U.S.C. § 103 as
unpatentable over Chen.

Enablement:
ISSUE
Does the evidence of record support Examiner’s conclusion that
undue experimentation would be required to practice the full scope of
Appellant’s claimed invention?
ANALYSIS
Examiner finds that Appellant’s claimed “method requires
administration of a polypeptide comprising SEQ ID NO:1-4, 7, or 8, wherein
the polypeptide is less than 50 amino acids in length” and fragments,
thereof, that are at least eight amino acids in length, which are “able to elicit
an immune response upon administration” (Ans. 4). Thus, Examiner finds
that Appellant’s claims recite 6 separate polypeptides, with over 50 different
possible immunogenic fragments containing exactly 8 amino acids, and even
more when examining additional possible lengths of fragments (i.e., 9, 10,

3 Brix et al., WO 2010/037395 A2, published Apr. 8, 2010.
4 Chen et al., US 2003/0143228 A1, published July 31, 2003.
Appeal 2020-004394
Application 15/498,728

5
11, amino acids) (id.). Specifically, Examiner explains, that “[i]f one
immunogenic peptide fragment of 8 amino acids was selected, the additional
sequence that is attached at the N- and/or C-terminals could be up to 42
amino acids” in length (id.; see also Appeal Br. 14 (Appellant does “not
disagree that the claims encompass this subject matter”); Ans. 15 (Examiner
finds that Appellant “agrees that the claims encompass administration of any
8 or more amino acid fragment of the enumerated sequences, surrounded by
up to 42 additional amino acids to make final sequences totaling 9 to 50
amino acids in length”)).
Examiner finds that although Appellant’s Specification “discloses
SEQ ID NO:1-9, as well as 17-40 which are fragments of SEQ ID NO:1, as
being capable of the required functions” (Ans. 4; see also id. at 14–15
(“Examiner indicated . . . that a method comprising producing an immune
response with peptides of SEQ ID NO: 1-10 is enabled”)), Appellant’s
Specification:
[D]oes not provide pointers or direction that would lead the
skilled artisan to any of the specific fragments, or fragments
with additional undescribed sequence[s] that are encompassed
by the instant claims, that would have the requirement function
of immunogenicity. Therefore, the skilled person would be
required to test all of the millions of possible peptides in order
to determine which were capable of eliciting an immune
response.
(Id. at 6.) Examiner finds that undue experimentation would be required of a
person of ordinary skill in this art to test the millions of peptides
encompassed by the full scope of Appellant’s claimed invention (id.). Thus,
Examiner finds that Appellant’s Specification “does not enable any person
skilled in the art to which it pertains, or with which it is most nearly
connected, to make and use the invention commensurate in scope with”
Appeal 2020-004394
Application 15/498,728

6
Appellant’s claimed invention (Ans. 2). See In re Wright, 999 F.2d 1557,
1561 (Fed. Cir. 1993) (“[T]o be enabling, the specification of a patent must
teach those skilled in the art how to make and use the full scope of the
claimed invention without ‘undue experimentation.”’).
Appellant contends, however, that:
Polypeptides, such as those of the present invention, are
presented on MHC class I or class H molecules in order to elicit
a CD8+ or CD4+ T-cell immune response respectively. MHC
class I/class II molecules bind to polypeptides of different
lengths (e.g. MHC class I molecules bind to polypeptides that
are between 8 and 10 amino acids in length whereas MHC class
II molecules bind to polypeptides that are generally longer,
typically between 15 and 24 amino acids in length; see [0132]
of the specification as filed. There are cellular pathways by
which polypeptides are processed for presentation by MHC
class I and class II molecules. Therefore, even if a polypeptide
of the present invention comprises certain additional amino
acids at the N- and/or C-terminus, it would still be expected to
induce an immune response because it could be degraded and
processed into an appropriately sized fragment for presentation
by MHC class I/class II molecules. In fact, as discussed at
paragraph [0132], polypeptides that are longer than would
normally be accommodated in either an MHC class I/class II
molecule have been shown to induce particularly robust
immune responses.
(Appeal Br. 11 (alteration original); see also Reply Br. 7–9 (citing Roitt5).)
Appellant’s Specification discloses:
[D]epending upon the class of T-lymphocyte response to be
elicited, different lengths of polypeptide are preferred. More
specifically, in order to elicit a CD8+ T-cell response, the
polypeptide must be presented on MHC class I molecules
which will typically only bind polypeptides which are between
8 and 10 amino acid residues in length. On the other hand, in

5 Roitt’s Essential Immunology, 95–103 (11th ed., 2006).
Appeal 2020-004394
Application 15/498,728

7
order to elicit a CD4+ T-cell response, it is necessary for the
polypeptide to be presented on an MHC class II molecule for
which the polypeptides may generally be longer, typically
between 15 and 24 amino acid residues in length. It is to be
noted that some of the polypeptides of the present invention
(e.g. the polypeptide of SEQ. ID NO. 1) are longer than would
normally be accommodated in either an MHC class I or class II
molecule. Peptides of this length have been shown to induce
more robust immune responses, e.g by groups working on HPV
and cervical cancer vaccination. . . . Without wishing to be
bound by theory, it is believed that such polypeptides,
following their administration to a patient, are endocytosed by
cells, subjected to proteolytic degradation in the proteasome
and then presented on an MHC class I or class II molecule.
Thus such polypeptides may give rise to an MHC class I and/or
an MHC class II restricted T-cell response. It is also to be
appreciated that longer polypeptides remain extant within a
patient for a greater period of time than shorter polypeptides
and therefore there is a longer period of time during which they
may elicit an immune response. This is particularly significant
as regards those polypeptides which have a relatively low MHC
binding affinity.
(Spec. ¶ 132.)
Thus, Appellant contends that “[a]dditional amino acids attached to
the immunogenic peptides, insofar as is currently claimed, do not harm and
may even improve the immunogenicity of those peptides” (Appeal Br. 13;
see also id. at 14 (Appellant contends that “the unspecified amino acids do
not eliminate, and may in fact improve, the immunogenicity of a peptide
comprising the immunogenic sequence or fragments specified”); id. at 16
(Appellant contends that “[b]y obtaining positive results for key sequences,
one skilled in the art would reasonably believe that similar sequences can be
expected to have the same immunogenic effect”)). We are not persuaded.
Appeal 2020-004394
Application 15/498,728

8
Examiner finds “no evidence [on this record to support a finding] that
processing of every one of the encompassed longer peptides would result in
the specific fragments that [Appellant] believes will produce an immune
response” (Ans. 19). As Examiner explains:
Even if a peptide can, theoretically, bind to an MHC-receptor,
that does not in any way demonstrate that the antigen from
which the peptide is obtained is, in fact, processed in such a
way as to give rise to the peptide in vivo. For example, the
peptide may have a proteolytic cleavage site within it meaning
that the peptide is not presented in vivo. Applicant relies on the
fact that the peptides merely “could be degraded and processed
into appropriately sized fragment for presentation by MHC
class I/class II,” (emphasis added by the Examiner) without any
actual evidence that this occurs, or showing the predictability of
processing without the use of a computer algorithm, which
Applicant indicates is unreliable. However, identification of
one fragment peptide of SEQ ID NO:1 that is immunogenic
(i.e. SEQ ID NO:2) does not prove that processing of all of the
millions of encompassed sequences (which are largely untested)
would be predictable, or that the processed antigens would
necessarily induce an immune response in vivo.
(Id. at 19–20 (quoting Appeal Br. 11).) In short, Examiner finds that “[i]t is
not reasonable to assume that just because a long peptide contains a
fragment of the claimed sequences, that processing for antigen presentation
would result in an immunogenic peptide consisting of that fragment” (Ans.
20). We agree.
In addition, we are not persuaded by Appellant’s reliance on prior art
results obtained from HPV and cervical cancer vaccination work (see
generally Appeal Br. 11 (citing Spec. ¶ 132)). At best, Appellant’s
disclosure, and Appellant’s reliance thereon, suggests that this prior work
provides an interesting area for experimentation to identify polypeptides that
“may” be useful in eliciting an immune response (see Spec. ¶ 132). This,
Appeal 2020-004394
Application 15/498,728

9
however, is not sufficient to support the enablement requirement of 35
U.S.C. § 112(a).
Patent protection is granted in return for an enabling disclosure
of an invention, not for vague intimations of general ideas that
may or may not be workable. See Brenner v. Manson, 383 U.S.
519, 536 . . . (1966) (stating, in context of the utility
requirement, that “a patent is not a hunting license. It is not a
reward for the search, but compensation for its successful
conclusion.”). Tossing out the mere germ of an idea does not
constitute enabling disclosure. While every aspect of a generic
claim certainly need not have been carried out by an inventor,
or exemplified in the specification, reasonable detail must be
provided in order to enable members of the public to
understand and carry out the invention.
Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997).
To be complete, we recognize Examiner’s finding that (a) “a method
comprising producing an immune response with peptides of SEQ ID NO:1-
10 is enabled” (see Ans. 14–15; cf. Appeal Br. 6–8 (citing Inderberg-Suso6);
Appeal Br. 11–13 (citing Spec. ¶ 170)); (b) “there is agreement that the post-
filed experimental data demonstrates the efficiency of the peptides from
Tables 4, 6, and 7 of [Gaudernack ’8147] to generate an immune response,
even in the absence of [a] checkpoint inhibitor” and, thus, Appellant’s
“arguments regarding the enablement of a method comprising administration
of these peptide sequences are moot” (Ans. 15; cf. Appeal Br. 8–11 and 15–
16); and (c) “[t]here is no dispute over the term ‘clinical non-responder,’

6 Inderberg-Suso et al., Widespread CD4+ T-cell reactivity to novel hTERT
epitopes following vaccination of cancer patients with a single hTERT
peptide GV1001, 1 OncoImmunology 1–17 (2012) (Exhibit A of Appellant’s
Brief).
7 Gaudernack et al., WO 2017/207814 A1, published Dec. 7, 2017 (Exhibit
B of Appellant’s Brief).
Appeal 2020-004394
Application 15/498,728

10
therefore the argument is moot” (Ans. 20; cf. Appeal Br. 14–15). The issue
for the enablement rejection, however, is whether one of skill could practice
the full scope of peptides recited in the claim, which as explained above far
exceeds the peptides of SEQ ID NO:1–10.
In addition, we note that “Attorney’s argument in a brief cannot take
the place of evidence.” In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974).
Therefore, we are not persuaded by Appellant’s unsupported contention that:
The theoretical mechanisms suggested by the Examiner could
mean in theory that a very small subset of sequences may not
have an immunogenic effect. However, the claims clearly
recite a “method of eliciting an immune response”. If a selected
peptide fragment that falls within the claim definition so
happens to be incapable of producing an immune response for
an unforeseen reason, then it would not fall within the overall
claim scope since it would not be “eliciting an immune
response”.
(Appeal Br. 17.) While it may be that non-operative peptide fragments are
excluded from the claim, the problem for Appellant is that the record does
not show that a skilled artisan would be able to distinguish those fragments
capable of eliciting an immune response from those that are not without
undertaking undue experimentation. Nor is there an evidentiary basis on this
record to support a finding that the set of sequences encompassed by the
breadth of Appellant’s claimed invention is so small that undue
experimentation would not be required to practice Appellant’s claimed
invention. See PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558,
1564 (Fed. Cir. 1996) (“[T]he question of undue experimentation is a matter
of degree. The fact that some experimentation is necessary does not
preclude enablement; what is required is that the amount of experimentation
Appeal 2020-004394
Application 15/498,728

11
‘must not be unduly extensive.’” (quoting Atlas Powder Co. v. E.I. DuPont
De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984))).
CONCLUSION
The evidence of record supports Examiner’s conclusion that undue
experimentation would be required to practice the claimed invention.
The rejection of claim 1 under the enablement provision of 35 U.S.C.
§ 112(a) is affirmed. Claims 3–16 and 18–34 are not separately argued and
fall with claim 1.
Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Brix or Chen teaches Appellant’s claimed
invention?
FACTUAL FINDINGS (FF)
FF 1. Brix “relates to MHC-peptide complexes and uses thereof in the
treatment of a disease in an individual” (Brix. 1:20–21; see also id. at 7:4–6
(Brix discloses that it’s “MHC multimers . . . can be used in . . . vaccine and
therapy related to [cancer]”); id. at 24:11–12 (Brix discloses “an antigenic
peptide not bound to a MHC molecule or an antigenic polypeptide featuring
one or more antigenic peptides”); see Ans. 8).
FF 2. Brix “also relates to a composition for cancer vaccination . . . a
method of making the composition for cancer vaccination . . . [and] a
method for cancer vaccination comprising administration to an individual in
need thereof an effective amount of a cancer vaccine composition” (Brix
7:26–31; see Ans. 8).

Appeal 2020-004394
Application 15/498,728

12
FF 3. Brix’s
antigenic peptide . . . can be selected from the group consisting
of sequences disclosed in the sequence listing starting with SEQ
ID NO 1 and ending with SEQ ID NO 146508. An isolated
antigenic peptide can according to the invention be selected
from the group consisting of sequences identified by SEQ ID
NO 1-105978 and SEQ ID NO 107384-109570 and SEQ ID
NO 116661-146508.
(Brix 24:26–31; Ans. 8 (citing Brix 269) (Examiner finds that Brix discloses
a sequence “SVLNYERARRPGLLG” in SEQ ID NO: 44230 that is
identical to Appellant’s SEQ ID NO: 2); Ans. 8 (citing Ans. 9: Sequence
Alignment) (Examiner finds that Brix discloses a sequence “VLGLDDIHR”
in SEQ ID NO: 137479 that is identical to Appellant’s SEQ ID NO: 27,
which is a nine amino acid fragment of Appellant’s SEQ ID NO: 1); see also
Spec. 11–12:Table 3; Spec 13:Table 4.)
FF 4. Examiner finds that Brix’s “antigenic peptides can comprise 8-30
amino acids” (Ans. 8 (citing Brix 24:22–23)).
FF 5. Examiner finds that Brix’s “MHC-multimer complex includes
conjugation to an additional protein (MHC), which would be an
immunogenic carrier” (Ans. 8 (citing Brix 754:14–34); see also Ans. 8
(citing Brix 821 and 832) (Examiner finds that Brix’s “antigenic peptides
can be formulated in a pharmaceutical composition containing acceptable
carriers, diluents, adjuvants or other additives” and “that the composition
can be a pharmaceutical composition”)).
FF 6. Examiner finds that Brix discloses that its disclosed peptide antigen
vaccine results in an immune response “that includes peptide-specific T-cell
precursors, peripheral blood lymphocytes and antibodies that bind the
peptides” (Ans. 8 (citing Brix 837–838)).
Appeal 2020-004394
Application 15/498,728

13
FF 7. Chen “relates to the identification of hTRT restricted epitopes and
the use of these identified epitopes to elicit an immune response against the
epitope” and “[m]ore particularly, the present invention uses the identified
epitopes to treat hyperproliferative diseases” (Chen ¶ 4; Ans. 11 (citing Chen
¶¶ 4 and 227) (Examiner finds that Chen’s “hyperproliferative disorder can
be breast or pancreatic cancer”)).
FF 8. Chen discloses that a pharmaceutical composition comprising its
peptides “can be administered to [a] subject” in need thereof (Chen ¶ 9; see
Ans. 11 (citing Chen ¶¶ 9 and 241–242)).
FF 9. Examiner finds that Chen discloses “SEQ ID NO:52
(WRTFVLRVRAQDPPP),” which “comprises a 14 amino acid fragment
of [Appellant’s] SEQ ID NO:7” (Ans. 11 (citing Chen ¶¶ 77–79)).
FF 10. Examiner finds that Chen discloses that its peptide “can be
conjugated to one or more other agents, including polypeptides such as KLH
or BSA” adjuvants (Ans. 11 (citing Chen ¶ 99)).
FF 11. Examiner finds that Chen “describes measurement of specific T-cell
responses to administration of hTERT peptides” (Ans. 11 (citing Chen
¶¶ 357–366 (Examples 30–32))).
ANALYSIS
The rejection over Brix:
Examiner finds that Brix teaches Appellant’s claimed invention (see
Ans. 7–9; FF 1–10).

Claim 1:
Appellant’s claim 1 is reproduced above.
Appeal 2020-004394
Application 15/498,728

14
Appellant contends that Brix “does not demonstrate that even one
species of [its disclosed] . . . peptides is antigenic, immunogenic or activates
T-cells” (Appeal Br. 18). Appellant, therefore, contends that “it would take
an excessive amount of experimentation in order to identify any peptide in
Brix . . . that would elicit an immune response” (id. (citing Gaudernack
Decl.8)). Gaudernack declares that Brix does not provide “experimental
data . . . for the majority of [its disclosed] sequences” and “constructing a
cancer vaccine of randomly selected peptides with no information linking
the peptides to the HLA molecules that are capable of presenting the epitope,
will not result in a useful vaccine” (Gaudernack Decl. ¶¶ 5–6; see also
Appeal Br. 19). Gaudernack further declares that the “NetMHC algorithm
software . . . [Brix] used to predict [its] antigenic peptide epitopes . . . were
(and still are) far from perfect and of limited use in predicting binding of
longer peptides, i.e. HLA class-II epitopes” and Brix “provides no guidance
in identifying the potentially relevant peptides hiding within their list of
peptides,” thus “the only option to identify relevant peptides for use in MHC
multimers or for cancer vaccines is in vitro experimentation,” which “require
huge laboratory resources,” therefore, “it is not practicable to test all of the
peptides listed in Brix . . . in order to identify the relevant peptides, for
example, for use in MHC multimers or cancer vaccines” (Gaudernack Decl.
¶¶ 8–11; see also Appeal Br. 19–23; Reply Br. 2–7). Thus, Appellant
contends that “based on the disclosure of Brix . . ., without extensive and
undue experimentation, the public was not in possession of the claimed

8 Declaration of Gustav Gaudernack, signed Nov. 8, 2018 (Exhibit D of
Appellant’s Appeal Brief).
Appeal 2020-004394
Application 15/498,728

15
invention at the time of filing and Brix . . . does not anticipate the claimed
invention” (Appeal Br. 19).
We are not persuaded.
“[A]nticipation does not require actual performance of
suggestions in a disclosure. . . .” Bristol–Myers Squibb Co. v.
Ben Venue Labs., Inc., 246 F.3d 1368, 1379 (Fed. Cir. 2001)
(citing In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985) (“It
is not, however, necessary that an invention disclosed in a
publication shall have actually been made in order to satisfy the
enablement requirement.”)). “Whether a prior art reference is
enabling is a question of law based upon underlying factual
findings.” SmithKline Beecham [Corp. v. Apotex Corp.], 403
F.3d [1331,] 1342–43 [(Fed. Cir. 2005)] (citation omitted).
Novo Nordisk Pharmaceuticals, Inc. v. Bio-Technology General Corp., 424
F.3d 1347, 1355 (Fed. Cir. 2005). Therefore, we are not persuaded by
Appellant’s contention, and Gaudernack’s statements, relating to Brix’s lack
of experimental data (see, e.g., Appeal Br. 18–19; Gaudernack Decl. ¶¶ 5–
6).
The method of eliciting an immune response in a patient with cancer,
set forth in Appellant’s claim 1, comprises administering to the patient a
polypeptide comprising a sequence having SEQ ID NO: 2 (see Appeal Br.
31).
On this record, Examiner found that Brix discloses an antigenic
peptide that is identical to Appellant’s SEQ ID NO: 2 for use in a vaccine
that is administered to an individual in need thereof to elicit an immune
response (see FF 1–6; see also Ans. 23 (Examiner finds that “[t]he
disclosure of Brix is more than an idea, plan, or invitation for
experimentation. The reference discloses specific, enumerated peptides that
have been predicted . . . to be antigenic” and “directs the reader to administer
Appeal 2020-004394
Application 15/498,728

16
these peptides in a suitable formulation to induce an immune response in a
cancer patient”); Ans. 24 (Examiner finds that “Brix has described specific
amino acid sequences, and has given specific steps to perform to achieve the
goal of immunogenic response”)).
In sum, Brix discloses a method of eliciting an immune response in a
patient with cancer, comprising administering to the patient a polypeptide
comprising a sequence having SEQ ID NO: 2 and, thus, teaches the method
of Appellant’s claim 1 (see FF 1–6; Ans. 23–24; cf. Appeal Br. 31).
We find no limitation in Appellant’s claim 1 that requires a specific
type of immune response (see Appeal Br. 31). Therefore, we are not
persuaded by Gaudernack’s statement that Brix’s algorithm is “far from
perfect and of limited use in predicting binding of longer peptides, i.e. HLA
class-II epitopes” (Gaudernack Decl. ¶ 8). For the same reason, we are not
persuaded by Appellant’s contention that Brix fails to establish that its
peptides “activate[] T-cells” (see Appeal Br. 18). Simply stated, Appellant
failed to establish a persuasive evidentiary basis on this record to support a
finding that Brix’s method would not result in an immune response within
the scope of Appellant’s claim 1.
For the foregoing reasons, we are not persuaded by Appellant’s
contentions, and Gaudernack’s statements, that undue experimentation
would have been required to practice Brix’s method of eliciting an immune
response in a patient with cancer, comprising administering to the patient a
polypeptide comprising a sequence having SEQ ID NO: 2 (see Appeal Br.
19–23; Gaudernack Decl. ¶¶ 5–11).
Appeal 2020-004394
Application 15/498,728

17
For the foregoing reasons, we are not persuaded by Appellant’s
characterization of Brix’s disclosure as “[t]he mere tossing out of an idea, or
merely naming a peptide” (see Appeal Br. 18; see also id. at 23).
To be complete, we recognize, but are not persuaded by Appellant’s
contentions regarding Impax Laboratories, Inc., v. Aventis Pharmaceuticals
Inc., 468 F.3d 1366 (Fed. Cir. 2006). See Reply Br. 3–6. As discussed in
Wrigley, the “issue in Impax was whether the use of the drug riluzole for
treating amyotrophic lateral sclerosis (‘ALS’) was anticipated . . . there are
important distinctions between that case and this one. . . . the only mention
of riluzole in the prior art reference in Impax was to disclaim it from the
disclosed invention.” Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC,
683 F.3d 1356, 1361–62 (Fed. Cir. 2012). Thus, unlike the record in this
Appeal or Wrigley, Impax disclaimed the drug from the disclosed invention
and, in addition, failed to provide the requisite dosage information necessary
to practice the invention claimed therein.
In contrast, Wrigley supports the anticipation rejection on this record.
In Wrigley, the prior art patent, Shahidi, disclosed “several categories of
components that can be included in the compositions” including “WS-3 and
WS-23 as two of three ‘particularly preferred cooling agents’” and “menthol
as one of 23 listed flavoring agents.” Id. at 1361. Wrigley found the
“question for purposes of anticipation is therefore whether the number of
categories and components in Shahidi was so large that the combination of
WS-23 and menthol would not be immediately apparent to one of ordinary
skill in the art.” Id. Wrigley concluded that “the Shahidi reference clearly
identifies the combination.” Id. at 1362. The same reasoning applies here,
where Brix discloses polypeptides, including those falling within the scope
Appeal 2020-004394
Application 15/498,728

18
of Appellant’s claimed invention, and teaches that the peptides will produce
an immune response when administered to an individual (see FF 1–6).
Therefore, we are not persuaded by Appellant’s contentions regarding Impax
(Reply Br. 3–6).

Claim 3:
Appellant’s claim 3 is reproduced above. Appellant contends that
Brix does not teach an “immunogenic fragment of SEQ ID NO. 1 [that] is at
least 20 amino acids in length” (see Appeal Br. 23–24). Examiner does not
dispute Appellant’s contention, therefore, the rejection of claim 3 is
reversed.

Claim 4:
Appellant’s claim 4, reproduced above. Appellant’s claim 4 depends
from and further limits Appellant’s claim 1 to require that “the immunogenic
fragment has [, i.e. comprises,] the sequence of any one of SEQ ID NOS: 17
to 40” (Appeal Br. 31).
Appellant contends that “[c]laim 4 recites specific peptide sequences
not recited in Brix” (Appeal Br. 24). We are not persuaded. As Examiner
explains, Brix discloses a sequence “VLGLDDIHR” in SEQ ID NO: 137479
that is identical to Appellant’s SEQ ID NO: 27 (FF 3). Thus, Brix teaches
the method of Appellant’s claim 4 (see FF 1–6).

Claim 16:
Appellant’s claim 16 is reproduced above. The method of eliciting an
immune response in a patient with cancer, set forth in Appellant’s claim 16,
Appeal 2020-004394
Application 15/498,728

19
comprises, inter alia, administering to the patient a cocktail of polypeptides
comprising at least first and second different polypeptides wherein the first
polypeptide is an immunogenic fragment of SEQ ID NO: 1 comprising at
least eight amino acids and wherein the second polypeptide is a sequence
having SEQ ID NO: 2 (see Appeal Br. 31).
Examiner finds that Brix “anticipates a combination of one or more
[of its disclosed] peptide species” and expressly discloses sequences
identical to Appellant’s SEQ ID NOs: 2 and 27, wherein Appellant’s SEQ
ID NO: 27 is a nine amino acid fragment of Appellant’s claim 1 (FF 3).
Examiner, therefore, reasons that “one possible combination of Brix would
be . . . [the combination of Brix’s SEQ ID NOs: 2 and 27], which would
constitute a ‘cocktail’ of polypeptides comprising two different polypeptides
selected from the polypeptides encompassed by [Appellant’s] claim 16”
(Ans. 24). We are not persuaded.
In order to support an anticipation rejection, a prior art “reference
must clearly and unequivocally disclose the claimed [invention] or direct
those skilled in the art to the [invention] without any need for picking,
choosing, and combining various disclosures not directly related to each
other by the teachings of the cited reference.” In re Arkley, 455 F.2d 586,
587 (CCPA 1972) (emphasis added). For a finding of anticipation, “it is not
enough that the prior art reference . . . includes multiple, distinct teachings
that [an ordinary] artisan might somehow combine to achieve the claimed
invention.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed.
Cir. 2008).
As Appellant explains, “[c]laim 16 recites a method of eliciting an
immune response comprising administering a specific cocktail of
Appeal 2020-004394
Application 15/498,728

20
polypeptides” and, although, Brix “may make a general disclosure regarding
a plurality of antigenic peptides . . . there is no disclosure of the specific
combination of peptides as recited in . . . claim 16” (Appeal Br. 24). We
agree.
On this record, Examiner failed to provide an evidentiary basis to
support a finding that Brix teaches the specific combination of polypeptides
required by Appellant’s claim 16, without resorting to improperly picking
and choosing from among the various polypeptides disclosed by Brix.

Claims 8, 9, 21, and 22:
Appellant’s claims 8 and 9 depend directly or indirectly from
Appellant’s claim 30 (see Appeal Br. 32). Appellant’s claims 21 and 22
depend directly or indirectly from Appellant’s claim 34 (see Appeal Br. 35).
Examiner did not include claims 30 and 34 in the rejection under 35
U.S.C. § 102(e) as anticipated by Brix (see Ans. 7).
Because claims 8, 9, 21, and 22 depend from non-rejected claims, we
reverse the rejection of claims 8, 9, 21, and 22 over Brix.

The rejection over Chen:
Examiner finds that Chen teaches Appellant’s claimed invention (see
Ans. 10–11; FF 11–15).

Claim 1:
Appellant’s claim 1 is reproduced above. The method of eliciting an
immune response in a patient with cancer, set forth in Appellant’s claim 1,
comprises administering to the patient a polypeptide comprising a sequence
Appeal 2020-004394
Application 15/498,728

21
of an immunogenic fragment of SEQ ID NO: 7 comprising at least eight
amino acids, wherein the immunogenic fragment is not one of SEQ ID NOS:
6, or 11 to 16, or 56, wherein the polypeptide is less than or equal to 50
amino acids in length and wherein the polypeptide does not comprise the
sequence of SEQ ID NO: 10 and does not consist of the sequence of SEQ ID
NO: 56 (see Appeal Br. 31).
On this record, Examiner found that Chen discloses an antigenic
peptide that comprises a 14 amino acid fragment of Appellant’s SEQ ID
NO: 7 for use in a vaccine that is administered to an individual in need
thereof to elicit an immune response (see FF 7–11; see also Ans. 10–11). In
sum, Chen discloses a method of eliciting an immune response in a patient
with cancer comprising administering to the patient a polypeptide
comprising a sequence of an immunogenic fragment of Appellant’s SEQ ID
NO: 7 comprising at least eight amino acids, wherein the immunogenic
fragment is not one of SEQ ID NOS: 6, or 11 to 16, or 56, wherein the
polypeptide is less than or equal to 50 amino acids in length and wherein the
polypeptide does not comprise the sequence of SEQ ID NO: 10 and does not
consist of the sequence of SEQ ID NO: 56 and, thus, teaches the method of
Appellant’s claim 1 (see FF 7–11; Ans. 23–24; cf. Appeal Br. 31).
We find no limitation in Appellant’s claim 1 that requires a specific
type of immune response (see Appeal Br. 31). Therefore, we are not
persuaded by Appellant’s contention that Chen does “not disclose that SEQ
ID NO: 52 can elicit a T-cell response” and is, therefore, “clearly not
suitable for use in [Appellant’s] claimed methods of eliciting an immune
response” (see Appeal Br. 25). Simply stated, Appellant failed to establish a
persuasive evidentiary basis on this record to support a finding that Brix’s
Appeal 2020-004394
Application 15/498,728

22
method would not result in an immune response within the scope of
Appellant’s claim 1.
For the foregoing reasons, we are not persuaded by Appellant’s
contention that Chen provides “no data . . . on the immunogenicity of any of
the polypeptides falling within the scope of [Appellant’s] claim 1” (id. at
26). For the same reasons, we are not persuaded by Appellant’s contention
that Chen fails to provide an enabling disclosure (id.; see also Reply Br. 2–
7). See Novo Nordisk Pharmaceuticals, Inc. v. Bio-Technology General
Corp., 424 F.3d at 1355 (“[A]nticipation does not require actual
performance of suggestions in a disclosure.” (citations omitted)).
Claim 8:
Appellant’s claim 8 depends from Appellant’s claim 30 (see Appeal
Br. 32). Examiner did not include claim 30 in the rejection under 35 U.S.C.
§ 102(b) as anticipated by Chen (see Ans. 10).
Because claim 8 depends from non-rejected claim 30, we reverse the
rejection of claim 8 over Chen.
CONCLUSION
The preponderance of evidence on this record supports Examiner’s
finding that Brix teaches Appellant’s claimed invention. The rejection of
claims 1 and 4 under 35 U.S.C. § 102(e) as anticipated by Brix is affirmed.
Claims 6, 7, 10, 11, 25, and 28 are not separately argued and fall with claim
1.
The preponderance of evidence on this record fails to support
Examiner’s finding that Brix teaches Appellant’s claimed invention with
respect to claims 3, 8, 9, 16, 19, 20–24, 27, and 29. The rejection of claims
Appeal 2020-004394
Application 15/498,728

23
3, 8, 9, 16, 19, 20–24, 27, and 29 under 35 U.S.C. § 102(e) as anticipated by
Brix is reversed.
The preponderance of evidence on this record supports Examiner’s
finding that Chen teaches Appellant’s claimed invention with respect to
claims 1, 6, 7, 10, and 28. The rejection of claim 1 under 35 U.S.C. § 102(b)
as anticipated by Chen is affirmed. Claims 6, 7, 10, and 28 are not
separately argued and fall with claim 1.
The preponderance of evidence on this record fails to support
Examiner’s finding that Chen teaches Appellant’s claimed invention with
respect to claim 8. The rejection of claim 8 under 35 U.S.C. § 102(b) as
anticipated by Chen is reversed.
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 12. Examiner relies on Chen as discussed above (see Ans. 12–13; see
also FF 7–11).
ANALYSIS
Examiner concludes that, at the time Appellant’s invention was made,
Chen makes obvious the subject matter of Appellant’s claimed invention
(see generally Ans. 13–14). “[A]nticipation is the epitome of obviousness.”
Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983).
Therefore, having found Appellant’s claim 1 anticipated by Chen, we find
no error in Examiner’s conclusion that Chen makes obvious the subject
matter of Appellant’s claim 1.
Appeal 2020-004394
Application 15/498,728

24
Claim 1:
For the reasons discuss above, with respect to the anticipation
rejection over Chen, we are not persuaded by Appellant’s contention that
Chen does “not provide an enabling disclosure of [Appellant’s claimed]
method” (see Appeal Br. 27).
As discussed above, Chen discloses a method of eliciting an immune
response in a patient with cancer comprising administering to the patient a
polypeptide comprising a sequence of an immunogenic fragment of
Appellant’s SEQ ID NO: 7 comprising at least eight amino acids, wherein
the immunogenic fragment is not one of SEQ ID NOS: 6, or 11 to 16, or 56,
wherein the polypeptide is less than or equal to 50 amino acids in length and
wherein the polypeptide does not comprise the sequence of SEQ ID NO: 10
and does not consist of the sequence of SEQ ID NO: 56 and, thus, teaches
the method of Appellant’s claim 1 (see FF 7–12).
Because Chen teaches an immunogenic fragment of Appellant’s SEQ
ID NO: 7 will produce an immune response when administered to an
individual (see id.), we are not persuaded by Appellant’s contention that
Chen fails to provide a reasonable expectation of success in practicing
Appellant’s claimed invention (see Appeal Br. 28–29; see generally Reply
Br. 7).
A reference disclosure is not limited only to its preferred
embodiments, but is available for all that it discloses and suggests to one of
ordinary skill in the art. In re Lamberti, 545 F.2d 747, 750 (CCPA 1976);
see also In re Susi, 440 F.2d 442, 446 n.3 (CCPA 1971) (Disclosed
examples and preferred embodiments do not constitute a teaching away from
a broader disclosure or non-preferred embodiments.). Therefore, we are not
Appeal 2020-004394
Application 15/498,728

25
persuaded by Appellant’s contention that Chen teaches away from
Appellant’s claimed invention because Chen did not select a peptide that is
an immunogenic fragment of Appellant’s SEQ ID NO: 7, i.e., Chen’s SEQ
ID NO: 52, “for further testing” (Appeal Br. 28).
For the foregoing reasons, we are not persuaded by Appellant’s
contention that they obtained an “unexpected technical effect” by practicing
Chen’s method, wherein an “improved immune response” was elicited “in
patient samples” using Chen’s SEQ ID NO: 52 compared to other
immunogenic peptides disclosed by Chen (Appeal Br. 28–29). To the
contrary, the “technical effect” observed by Appellant, was a direct result of
practicing the method disclosed by Chen.
Claim 8:
Appellant’s claim 8 depends from Appellant’s claim 30 (see Appeal
Br. 32). Examiner did not include claim 30 in the rejection under 35 U.S.C.
§ 103 as being unpatentable over Chen (see Ans. 12).
Because claim 8 depends from non-rejected claim 30, we reverse the
rejection of claim 8 over Chen.
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 1 under 35 U.S.C. § 103
as unpatentable over Chen is affirmed. Claims 6, 7, 10, and 11 are not
separately argued and fall with claim 1.
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness, with respect to claim 8. The rejection
of claim 8 under 35 U.S.C. § 103 as unpatentable over Chen is reversed.

Appeal 2020-004394
Application 15/498,728

26
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3–16, 18–34 112(a) Enablement 1, 3–16,
18–34

1, 3, 4, 6–11,
16, 19–25,
27–29
102(e) Brix 1, 4,
6, 7, 10,
11, 25, 28
3, 8, 9,
16, 19,
20–24,
27, 29
1, 6–8, 10, 28 102(b) Chen 1, 6, 7, 10,
28
8
1, 6–8, 10, 11 103 Chen 1, 6, 7, 10,
11
8
Overall
Outcome
1, 3–16,
18–34

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