Haritha Samaranayake et al.

Patent Trials and Appeals Board

Sep 4, 2019

13877246 - (R) (P.T.A.B. Sep. 4, 2019)

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.
13/877,246 08/07/2013 Haritha Samaranayake GB11/00804.2 1025
22925 7590 09/04/2019
Pharmaceutical Patent Attorneys, LLC
801 Brickell Avenue
9th Floor #9101
Miami, FL 33131-4924
EXAMINER
SGAGIAS, MAGDALENE K
ART UNIT PAPER NUMBER
1632
NOTIFICATION DATE DELIVERY MODE
09/04/2019 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):
administration@LicensingLaw.net
docket@LicensingLaw.net
mark.pohl@licensinglaw.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte HARITHA SAMARANAYAKE,
JERE PIKKARAINEN, ANN-MARIE MAATTA,
SEPPO YLA-HERTTUALA1
____________

Appeal 2018-001996
Application 13/877,246
Technology Center 1600
____________

Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
DAVID COTTA, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

REQUEST FOR REHEARING
This is a request for rehearing under 37 C.F.R. 41.79 (“Req. Reh’g”)
of the Decision on Appeal entered May 30, 2019 (“Dec. App.”).
Appellants argue that three erroneous factual findings were made in
the Decision on Appeal. Req. Reh’g 1. We have considered Appellants’
arguments, but we are not persuaded to change the outcome of the Decision.
Each of three arguments made by Appellants are discussed below.

1 The Appeal Brief (“Appeal Br.” entered July 27, 2016) lists Trizell Limited
as the Real Party in Interest. Appeal Br. 1.
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Application 13/877,246

2
Is Hegi (2008) of record?
Appellants contend that Hegi (J. Clin. Oncol. 26: 4189–4199, 2008)
(“Hegi (2008)”) is not of record. Req. Reh’g 1.
Hegi (2008) was cited in the Answer, but not in the Final Office
Action, as part of a new ground of rejection.2 Ans. 14, 19. The Examiner
stated that Hegi (2008) was cited in an Information Disclosure statement
(“IDS”). Ans. 14, 19. The Decision on Appeal agreed that Hegi was of
record because it was cited in an IDS. Dec. App. 18. However, as pointed
out by Appellants, the “Hegi” publication listed in the IDS is not the same
Hegi (2008) publication cited in the Answer. Req. Reh’g 1. Thus, the
statement that Hegi (2008) was listed on the IDS is an error.
Nonetheless, we do not agree with Appellants that Hegi (2008) is not
of record. Hegi (2008) was made of record in the Examiner’s Answer
because the Examiner provided a full citation to it. Even if the publication
was not listed by the Examiner on a disclosure form, this deficiency does not
mean it is not “of record.” The Manual of Patent Examining Procedures
(“MPEP”) (Ninth Edition, Last Revised January 2018) explains the purpose
of listing a publication on a disclosure form:
MPEP 707.05(a) Copies of Cited References
. . .
To assist in providing copies of, or access to, references, the
examiner should:
(A) Type the citation of the references on form PTO-892,
“Notice of References Cited” using OACS;

2 Appellants had the option to reopen prosecution in response to the new
ground, but did not do so and addressed the Hegi (2008) reference in the
Reply Brief (see Reply Br. 12).

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(B) Include in the eRed Folder all of the references cited by the
examiner which are to be furnished to the applicant.
The MPEP does not indicate that the failure to list a publication on
form PTO-892 establishes that a publication is “not of record” as stated by
Appellants. Rather, the purpose is to assist in providing a copy or access to
the publication. The Answer provided Appellants with the complete citation
to Hegi (2008) in the Answer and thus Hegi (2008) is recorded in the
examination record. Appellants did not provide legal basis for the assertion
Hegi (2008) is not of record, that they lacked access to the reference, or that
they were prejudiced in any way.

Antibody detection in the ’855 patent
In the Decision on Appeal, Appellants’ statement that “certain cancer
therapies should not be given to immunocompetent patients” was addressed.
Dec. App. 9. In addressing this argument, the declaration by Mr. Seppo Yla-
Herttuala describing results reported in U.S. Pat. 6,579,855 (“the ’855
patent”) was discussed. Mr. Yla-Herttuala is a co-inventor of the ’855
patent and also a co-inventor of the application involved in this appeal.
It was stated in the Decision on Appeal:
The declaration [describing the results in U.S. Pat. 6,579,855]
does not say patients were “only” treated “if” antivirus antibody
was below the detectable level as asserted by Appellants.
Instead, Mr. Yla-Herrtuala [Yla-Herttuala] states that antibody
was not measured before gene transfer because it would have
been below detection levels. The apparent reason for this is
because the patients had not yet been exposed to the viral vector
and had not yet developed an immune reaction it.
Dec. App. 10.
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Appellants state the Decision erred in finding that antibody was not
measured in the ’855 patent before gene transfer. Req. Reh’g 3. We agree
this is an error, but the error does not change our conclusion that patients
having a normal immune response were treated in the cited prior art
publication. Dec. App. 9. The reasoning set forth in the Decision on Appeal
is unchanged.
We clarify that the ’855 patent states that antibodies were measured
before and after gene therapy. ’855 patent, col. 4: 9–10, 53–54. However,
Mr. Yla-Herttuala makes the following statement in his declaration:
The patent does not disclose the measure of anti-virus
antibodies measured before gene transfer.
This is because as measured before gene transfer, anti-virus
antibody was below detectable limits for all patients.
Yla-Herttuala ¶ 3.
Thus, antibody was measured, but not reported in the ’855 patent
before gene transfer because it was “below detectable limits.”

Does Ulasov teach a transgene?
Claim 1 recites a step of “administering to said human patient a viral
gene therapy vector having a transgene.” As explained in the Decision on
Appeal, the Examiner found that Ulasov describes introducing the E1A gene
into a viral vector and driving its expression with a survivin promoter, which
the Examiner determined met the claimed requirement of a “transgene.” As
explained in the Decision:
Ulasov discloses “CRAd-Survivin-pk7 (CRAd-S-pk7), a novel
oncolytic adenoviral vector that utilises the survivin promoter
to drive E1A expression and binds to heparan sulphate
proteoglycans expressed on malignant glioma.” Ulasov 1155.
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The E1A gene, normally present in the virus, was not the copy
that was used in Ulasov’s experiment. Instead, Ulasov teaches
that “the survivin-controlled E1 expression cassette was placed
in the native E1 region of the Ad genome to avoid nonspecific
viral replication.” Id. For this reason, we do not agree with
Appellants that reading the term “transgene” on the E1
expression cassette would “read” the limitation out of the claim,
allegedly because all the viral DNA would be considered a
transgene. Reply Br. 3. Rather, the Examiner correctly found
that the E1A expression cassette is a “transgene” because it was
introduced into the adenovirus and is not native to it. The E1A
expression cassette is an E1 gene operably connected to the
non-native survivin promoter.
Dec. App. 7–8.
Appellants contend that the Examiner erred in finding that Ulasov
describes a “transgene,” and that such finding was made only after
prosecution had been closed (“She raised it only after she had closed the
record to the introduction of rebuttal evidence.”). Req. Reh’g 3–4.
Appellants also state that the Board invited Appellants to provide rebuttal
evidence, and “[i]n response to the Board’s kind invitation to do so,
however, Appellant here provides the rebuttal evidence you request: a
Declaration (July 2019) from Professor Yla-Herttuala explaining how the
voluminous evidence of record contradicts the Examiner's incorrect
interpretation of the term ‘transgene.’” Req. Reh’g 4.
While the Examiner did not raise the transgene issue with respect to
Ulasov until the Answer, Appellants had the opportunity to reopen
prosecution (Ans. 33) and introduce new evidence at that time. Appellants
chose not to reopen prosecution, but instead filed a Reply Brief. The
Declaration was not provided at this time. The Decision on Appeal did not
subsequently “invite” Appellants to provide rebuttal evidence. New
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evidence is not permitted in a Request for Rehearing “except as permitted by
paragraphs (a)(2) through (a)(4) of” 37 C.F.R § 41.52(a). Appellants did not
establish that such conditions were met, and thus the new Declaration is not
permitted and has not been considered.
The term “transgene” does not appear in the Specification as
originally filed. In the Appeal Brief, Appellants identified page 1, line 6 of
the Specification as providing support for the term. Appeal Br. 1. The
complete sentence spanning line 6 of the Specification is reproduced below:
Herpes simplex virus type 1, thymidine kinase (HSV-tk) gene
therapy is based on the prodrug activating enzyme that converts
a non-toxic compounds such as ganciclovir, (GCV) into a toxic
metabolite.
Spec. 1:6–8. This disclosure does not elucidate the meaning of “transgene.”
In the Reply Brief, Appellants defined a “transgene” as “foreign
genetic material.” Reply Br. 2. Appellants further state that the transgene
must code for a polypeptide. Req. Reh’g 4. Appellants also argue that the
E1 gene is native to adenovirus and therefore not a foreign gene. Id. at 3.
The E1A gene utilized in Ulasov codes for a protein and is not the
same copy that is present in the vector, but instead was introduced into the
vector. Ulasov 1155. The E1A gene is therefore “foreign” to the adenoviral
genome present in the vector because it is not the “native” copy present in
the adenoviral genome. Accordingly, we decline to change our
determination that Ulasov describes a transgene consistent with the broadest
reasonable interpretation of that term as it would have been understood by
an ordinary artisan. “[D]uring patent prosecution when claims can be
amended, ambiguities should be recognized, scope and breadth of language
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explored, and clarification imposed.” In re Zletz, 893 F.2d 319, 321 (Fed.
Cir. 1989).

REHEARING DENIED