Persimmune, Inc.

Patent Trials and Appeals Board

Nov 9, 2020

2019003997 (P.T.A.B. Nov. 9, 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.
14/594,757 01/12/2015 Maria Antonia VITIELLO 52707-701.501 6210
20322 7590 11/09/2020
SNELL & WILMER L.L.P. (Main)
400 EAST VAN BUREN
ONE ARIZONA CENTER
PHOENIX, AZ 85004-2202
EXAMINER
HALVORSON, MARK
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
11/09/2020 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):
IPDOCKET@swlaw.com
chauff@swlaw.com
dgiancaterin@swlaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARIA ANTONIA VITIELLO
Appeal 2019-003997
Application 14/594,757
Technology Center 1600
Before FRANCISCO C. PRATS, TAWEN CHANG, and
DAVID COTTA, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON REQUEST FOR REHEARING
Appellant1 requests rehearing of the decision entered June 2, 2020
(“Decision”), which affirmed the Examiner’s rejection of claims 32, 34, 35,
42, and 44–60 as obvious over Hacohen, Castle, Johnston, Leen, and Lee.
We deny the requested relief.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42.
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DISCUSSION
A. The Decision does not constitute a new ground of rejection
Appellant contends that the Decision includes a new ground of
rejection because it changed the thrust of the Examiner’s rejection.
Appellant contends that “Examiner Halvorson relied on Leen solely for its
disclosure of HLA-matched T cells” and “cited only two paragraphs—
paragraphs 10, 253—in Leen for his prima facie case.” Req. Reh’g 3.
Appellant contends that, in contrast, the Decision “repeatedly relies on
Leen’s disclosure of using T cells and APCs from the same donor in a two-
step process that requires altering the APCs before contacting the APCs with
the T cells,” “devotes three primary Fact Findings to these new teachings
and cites 11 new Leen paragraphs to support those Fact Findings,” and
includes the paragraphs cited by the Examiner “only as a ‘see also’ citation”
in a finding of fact cited only once “to support half a sentence in the
analysis.” Id. at 3; see also id. at 5–6.
We are not persuaded. In Leithem, our reviewing court held that
“[t]he thrust of the Board’s rejection changes when . . . it finds facts not
found by the examiner regarding the differences between the prior art and
the claimed invention, and these facts are the principal evidence upon which
the Board’s rejection was based.” In re Leithem, 661 F.3d 1316, 1320 (Fed.
Cir. 2011) (citing In re Kumar, 418 F.3d 1361, 1368 (Fed. Cir. 2005)).
Moreover, although “[m]ere reliance on the same statutory basis and the
same prior art references, alone, is insufficient to avoid making a new
ground of rejection,” the Board “need not recite and agree with the
examiner’s rejection in haec verba to avoid issuing a new ground of
rejection.” Leithem, 661 F.3d at 1319. Likewise, “[a] new ground of
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rejection . . . generally will not be found based on the Board ‘further
explain[ing] the examiner’s rejection’ or the Board’s thoroughness in
responding to an applicant’s argument.” In re Biedermann, 733 F.3d 329,
337 (Fed. Cir. 2013) (quoting In re Jung, 637 F.3d 1356, 1364–65 (Fed. Cir.
2011)).
In this case, the basis of the affirmance in the Decision remains the
same as that in the Examiner’s rejection. As an initial matter, the Decision
“adopt[ed] the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art” in affirming the obviousness rejection.
Dec. 15. More particularly, Leen is cited for teaching “the use of HLA-
matched donor T cells to create tumor-associated antigen-specific CTLs.”
Dec. 16. Lee is cited for “suggest[ing] not only that HLA-matched donor
APCs may be used to generate leukemia-cell-specific CTLs, but also that”
using such donor APCs provided desirable effects. Id. Finally, the primary
reasons to combine Lee and Leen is Lee’s teaching that HLA-matched donor
mDCs have advantages as compared to autologous or leukemic DCs, and
because “[t]he combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predicable
results.” Id. at 17–18 (quoting KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,
416, 418 (2007).
Appellant appears to object to the following four statements in the
Decision and their supporting findings of fact (Req. Reh’g 4, 6):
I. On page 16, the Decision states:
As an initial matter, we disagree with Appellant’s contention
that Leen requires the use of autologous APCs, because Leen
also teaches preparing DCs from a patient or a donor for use as
APCs. FF22. Indeed, Leen teaches methods of generating
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CTLs using APCs and T cells from the PBMCs of the same
individual, including from the PBMCs of a donor. FF23, FF24.

II. On page 18, in responding to Appellant’s argument that “the
claims are not obvious because of ‘Leen’s strong and express preference for
only the use of autologous APCs of the cancer patient,’” the Decision
repeats that the Board “disagree[s] with Appellant that Leen teaches that
only autologous APCs should be used in its method. FF22, FF24”
III. On page 18, the Decision states:
Given that Lee and Leen suggest using APCs and T cells from
HLA-matched donors to produce cancer-specific CTLs, we agree
with the Examiner that it would have been obvious to use the
APCs and T cells from the same HLA-matched donor, absent
evidence that such a combination yielded unpredictable results.
This is particularly the case given that Lee[n] expressly teaches
that APCs and T cells used for generating CTLs may be obtained
from the PBMCs of the same individual, including PBMCs of
donors. FF23, FF24.

IV. On pages 19–20, in distinguishing Appellant’s citation to
Polaris Industries, Inc. v. Arctic Cat, Inc., 882 F.3d 1056 (Fed. Cir. 2018),
the Decision explains that, in contrast to the appellant in Polaris, who
introduced undisputed evidence that a proposed modification would have
resulted in a design acknowledged in the prior art to be disadvantageous,
Appellant here “points at most to the fact that a prior art reference (Hacohen)
does not discuss using HLA-matched donor APCs in its method,” observing
in a footnote that, “[a]s discussed above, Leen teaches using either donor-
derived or autologous APCs.”
As can be seen from the context of these statements, they and any
additional fact findings cited in support merely explain or support the
Examiner’s rejection, which combines Leen’s teaching of using HLA-
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matched donor T cells to create tumor-associated antigen-specific CTLs with
Lee’s teaching of using HLA-matched donor APCs to generate leukemia-
cell-specific CTLs. More specifically, the objected-to statements correct
Appellant’s factually inaccurate assertion that Leen requires the use of
autologous APCs and thus render the claims on appeal non-obvious and/or
unsuitable for combination with Lee.
We are cognizant that our reviewing court has held, in the context of
the Board finding a Rule 1.131 Declaration to be ineffective in removing a
reference as prior art under 35 U.S.C. § 102(a) where “the examiner never
raised the question of whether [the reference] was § 102(a) prior art, never
addressed that argument, never expressed any concerns as to any alleged
deficiencies with the Declaration, and never issued a rejection using [the
reference] as § 102(a) prior art,” that “the mere fortuity that [appellant]
addressed the validity of the Declaration on its own, without the issue being
raised by the examiner, does not permit the Board to reject the Declaration
as ineffective without designating its decision as a new ground of rejection.”
In re Stepan Co., 660 F.3d 1341, 1343, 1345 (Fed. Cir. 2011).
Unlike the situation in Stepan, however, the objected-to statements
and factual findings in this case are not “the principal evidence upon which
the Board’s rejection was based” and do not change the thrust of the
rejection.2 Leithem, 661 F.3d 1316, 1320 (Fed. Cir. 2011). For instance,

2 For the same reason, Appellant’s citation to Kumar is inapposite. Req.
Reh’g 4–5. In Kumar, the claim on appeal recited “a collection of particles
comprising aluminum oxide” having certain particle size distributions.
Kumar, 418 F.3d at 1364. The Board found the claims to be obvious
because, based on calculations performed by the Board, the claimed
distributions overlapped those in the prior art. Id. at 1364–1365. In other
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although the Decision notes that the Board disagreed with Appellant’s
statement that Lee requires the use of autologous APCs because Leen in fact
teaches generating CTLs using APCs and T cells from the PBMCs of a
donor, the Decision goes on to state the basis of the affirmance, which is that
“‘[n]on-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references” and that the Board “agreed with the Examiner
that the combination of Leen and Lee would have suggested to a skilled
artisan a method of producing cancer cell-specific CTLs using ‘mononuclear
cells from [an] HLA-matched donor . . . wherein the mononuclear cells from
the HLA-matched donor comprise antigen presenting cells and T cells’ as
recited in claim 32.” Dec. 16.
Similarly, the principal bases stated in the Decision for finding the
requisite motivation to combine and reasonable expectation of success are
that 1) “Lee suggests that . . . allogeneic mDCs[] from HLA-matched donors
have advantages as compared to autologous or leukemic DCs” and 2) KSR
held that “[t]he combination of familiar elements according to known
methods is likely to be obvious when it does not more than yield predictable
results,” and “Lee and Leen suggest using APCs and T cells from HLA-
matched donors to produce cancer-specific CTLs.” Dec. 17–18. While the
Decision goes on to note that “Lee[n] expressly teaches that APCs and T
cells used for generating CTLs may be obtained from the PBMCs of the

words, and in contrast to the instant factual scenario, the alleged new
findings by the Board (i.e., the calculations) were the principal evidence
upon which the Board’s rejection was based and changed the thrust of the
rejection.
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same individual, including PBMCs of donors,” Dec. 18, the context of the
statement makes clear that it is not necessary to the affirmance, much less
the principal basis for the affirmance.
The Decision’s analysis that Leen does not require the use of a cancer
patient’s autologous APCs is further consistent with the thrust of the
Examiner’s rejection, even if the Examiner did not cite to the specific
passages in Leen noted in the Decision’s findings of fact. In particular, in
response to Appellant’s argument that “the Examiner has failed to articulate
the requisite motivation for one of skill in the art to [combine Lee and
Leen],” with a reasonable expectation of success, which Appellant contends
is “notable in the face of Leen’s strong and express preference for only the
use of autologous APCs of the cancer patient,” the Examiner noted that
“preferred embodiments do not constitute a teaching away from
nonpreferred embodiments.” Ans. 14–15. This response makes clear that
the Decision and the Examiner’s rejection are in accord that Leen does not
require the use of autologous APCs.
Given the above, we conclude that the this case is more similar to
Noznick, where the predecessor to our reviewing court found that the Board
had not made a new rejection because it was “merely explaining to
appellants why their arguments were ineffective to overcome the rejection
made by the examiner.” In re Nozick, 391 F.2d 946, 949 (CCPA 1968). See
also In re Adler, 723 F.3d 1322, 1328 (Fed. Cir. 2013) (explaining that,
“[w]hile the Board’s explanation [of the rejection] may go into more detail
than the examiner’s, that does not amount to a new ground of rejection”); In
re Biedermann, 733 F.3d at 337.
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Appellant contends that the Decision “repeatedly cites [new] Fact
Findings to change the thrust of the rejection from a 5-reference rejection
using T Cells from Leen and APCs from Lee to a 4-reference rejection using
T Cells and APCs from Leen.” Req. Reh’g 4. Appellant also contends that
the Decision uses the “Fact Findings [devoted to new teachings from Leen]
throughout its Analysis section to change the scope and content of the prior
art and alter the KSR rationale applied by the Examiner.” Id. at 3–4; see
also id. at 5.
We are not persuaded for the reasons discussed above. Not only did
the Decision adopt the Examiner’s findings of fact and reasoning regarding
the scope and content of the prior art in affirming the rejection, Dec. 15, the
Decision explicitly relies on the combination of Lee and Leen as teaching
step g of claim 32, i.e., “contacting mononuclear cells from the HLA-
matched donor with one or more of the isolated peptides of step f) for a
sufficient time to provide CTLs specific for the cancer cell-specific
mutations, wherein the mononuclear cells from the HLA-matched donor
comprise antigen presenting cells and T cells.” See, e.g., Dec. 13–15, FF28–
FF36 (findings of fact regarding Lee); id. at 16 (“agree[ing] with the
Examiner that the combination of Leen and Lee would have suggested to a
skilled artisan a method of producing cancer cell-specific CTLs using
‘mononuclear cells from [an] HLA-matched donor . . . wherein the
mononuclear cells from the HLA-matched donor comprise antigen
presenting cells and T cells’ as recited in claim 32”); id. at 17–18
(“agree[ing] with the Examiner that a skilled artisan would have reason . . .
and a reasonable expectation of success[] of using mDCs and T cells from
HLA-matched donors to produce cancer cell-specific CTLs” because “Lee
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and Leen suggest using APCs and T cells from HLA-matched donors to
produce cancer-specific CTLs” and “Lee suggests that . . . allogeneic
mDCs[] from HLA-matched donors have advantages as compared to
autologous or leukemic DCs”); id. at 19 (distinguishing Polaris in part
because “in the instant case the combination of references provides an
express reason to use Lee’s HLA-matched donor APCs in a method for
producing cancer-cell specific CTLs, including with donor T cells such as
those described by Leen, namely that such donor APCs have certain
advantages in comparison to autologous or leukemic APCs in producing
cancer-cell specific CTLs”).
Finally, Appellant contends that “[f]airness requires [Appellant] be
given the chance to respond.” Req. Reh’g 6–7. Appellant contends that “the
new teachings of Leen are now inextricably interwined in the rejection,” that
“[a]ny further review in the courts or proceedings before the Examiner will
inevitably focus on the three-references-plus-Leen theory developed in the
Opinion,” and that “[a]rguments against Lee, which dominated the exchange
between Applicant and Examiner will likely be deemed irrelevant moving
forward.” Id. at 7.
We agree that, “[w]hen considering whether the Board issued a new
ground of rejection, the ‘ultimate criterion of whether a rejection is
considered ‘new’ in a decision by the Board is whether applicants have had
fair opportunity to react to the thrust of the rejection.’” Biedermann, 733
F.3d at 337 (quoting Leithem, 661 F.3d at 1319). However, we disagree that
Appellant has not had a fair opportunity to react to the thrust of the rejection
for the reasons discussed above.
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Contrary to Appellant’s contention, the findings of fact with respect to
Leen were cited in the affirmance (1) to show that Leen teaches the use of
HLA-matched donor T cells to create tumor-associated antigen-specific
CTLs—a fact that the Examiner also found and that had not been disputed
previously by Appellant in the Appeal or Reply Briefs (Ans. 8, 11–12; Dec.
16 (citing Appeal Br. 15)), and (2) as discussed above, to explain why the
Board is not persuaded by Appellant’s primary argument against the
rejection made by the Examiner, i.e., that Leen requires the use of autologous
APCs. These citations to Leen does not change the thrust of the rejection.
We note that the new arguments and evidence submitted by Appellant
do not appear to dispute that Leen does not require the use of autologous
APCs. Instead, Appellant appears to present arguments against a rejection
of claim 32 as obvious over Hacohen, Castle, Johnston, and Leen – a
rejection made by neither the Examiner nor the Board.
More problematically, Appellant attempts to present new arguments
and evidence against the Examiner’s prima facie case, which could have
been presented to the Examiner during prosecution, but which were not.
For instance, in the Appeal and Reply Briefs Appellant did not dispute
the Examiner’s finding that Leen teaches using HLA-matched donor T cells
to create tumor-associated antigen-specific CTLs, Appeal Br. 15, and argued
only that a skilled artisan would not have combined Leen with Lee to arrive
at the claimed invention because Leen requires the use of autologous APCs.
Appeal Br. 15, 16–17; see also Reply Br. 6–7. Appellant now argues,
however, that the requisite motivation to combine is lacking because Leen
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uses memory T cells rather than naïve T cells – a distinction Appellant never
raised before this rehearing request:
[T]he purported combination would use memory T cells that
fall outside the scope of the claims. See discussion of FF23, 24.
One of skill in the art reading Leen’s cited disclosure would not
be motivated to combine Leen and Lee with references
Hacohen, Johnston, and Castle to yield the claimed invention.
Req. Reh’g. 21; see also id. at 16–17 (arguing that Examiner’s citation to
paragraphs 10 and 253 of Leen in the original rejection is inapposite because
“[t]he T cells used by Leen ¶ 253 cannot be naïve to the antigens, but the T
cells in the claims are naïve to the ‘isolated peptides having the cancer-cell
specific mutations”).
Likewise, although Appellant did not appear to have made any
arguments with respect to objective indicia of nonobviousness during
prosecution, Appellant now attempts to cite to the Vitiello Declaration3 and
the attached references to argue that the claims are not obvious in light of the
evidence of praise of others and unexpected results. Req. Reh’g 22.
Appellant states that it did not initially include arguments of objective
indicia because “applicant considered Examiner’s 5-reference rejection
unsustainable” and wished to “avoid procedural reopening of prosecution for
obviousness.” Id. at 27.
We are not persuaded. The Decision does not change the thrust of the
rejection, and, in this situation, Appellant’s belated submission of additional

3 Declaration of Marie Antonia Vitiello under 37 C.F.R. § 1.132 (“Vitiello
Declaration”). Appellant acknowledges that the Vitiello Declaration was
originally submitted in response to a 35 U.S.C. § 101 rejection. Req. Reh’g
22.
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arguments and evidence unfairly denies the Board the benefit of the
Examiner’s response.
Accordingly, for the reasons discussed above, we deny Appellant’s
request to designate the affirmance in the Decision as a new ground of
rejection.
B. Appellant’s Presentation of New Arguments and Evidence Is
Improper
Appellant cites to 37 C.F.R. § 41.50(b) to argue that Appellant is
“entitled to . . . request rehearing ‘by the Board upon the same Record,’” and
to 37 C.F.R. § 41.30 to argue that Record as “the items listed in the content
listing of the Image File Wrapper of the official file of the application.”
Req. Reh’g 7.
As the Board did not designate a new ground of rejection, however,
the request for rehearing properly falls under 37 C.F.R. § 41.50(c). While
37 C.F.R. § 41.52 permits “[n]ew arguments responding to a new ground of
rejection designated pursuant to § 41.50(b)” and “[n]ew arguments that the
Board’s decision contains an undesignated new ground of rejection,” 37
C.F.R. § 41.52 does not permit new arguments responding to an alleged
undesignated new ground of rejection. As discussed above, we determine
that the Decision does not constitute a new ground of rejection.
Accordingly, for the reasons stated above, we deny Appellant’s
Request for Rehearing and decline to consider the new arguments and
evidence submitted with the request.

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CONCLUSION
In summary:
Outcome of Decision on Rehearing:

Claims 35 U.S.C § Reference(s)/Basis Denied Granted
32, 34, 35,
42, 44–60
103(a) Hacohen, Castle,
Johnson, Leen, Lee
32, 34, 35,
42, 44–60

Final Outcome of Appeal after Rehearing:

Claims 35 U.S.C. § Reference(s) /
Basis
Affirmed Reversed New
Ground
32, 34,
35, 42,
44–60
103(a) Hacohen,
Castle,
Johnson,
Leen, Lee
32, 34,
35, 42,
44–60

32, 34,
35, 42,
44–60
112 (pre-
AIA), first
paragraph
Lack of
written
description
32, 34,
35, 42,
44–60

Overall
Outcome
32, 34,
35, 42,
44–60

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).

DENIED