Ex Parte Parker et al

Patent Trial and Appeal Board

Sep 25, 2017

13932202 (P.T.A.B. Sep. 25, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/932,202 07/01/2013 Nigel PARKER FKD - 61/670,330 7140
22925 7590 09/27/2017
PHARMACEUTICAL PATENT ATTORNEYS, LLC
55 MADISON AVENUE
4THFLOOR
MORRISTOWN, NJ 07960-7397
EXAMINER
MONTANARI, DAVID A
ART UNIT PAPER NUMBER
1632
NOTIFICATION DATE DELIVERY MODE
09/27/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docket @ LicensingLaw. net
administration @LicensingLaw.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NIGEL PARKER and SEPPO YLA-HERTTUALA
Appeal 2016-008089
Application 13/932,2021,2
Technology Center 1600
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and
RICHARD J. SMITH, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to methods of treating a
cancerous organ comprising administering a chemotherapeutic agent and a
recombinant virus, where the recombinant virus comprises a homeomimetic
transgene. The Examiner rejected the claims under 35 U.S.C. §§ 102(b) and
103. We have jurisdiction under 35 U.S.C. § 6(b). The rejections are
affirmed.
1 The Appeal Brief (“Appeal Br.”) identifies FKD Therapies as the real-
party-in-interest.
2 “The ’202 Application.”
Appeal 2016-008089
Application 13/932,202
STATEMENT OF THE CASE
The claims stand rejected by the Examiner as follows:
1. Claims 1-9, 11-19 and 21-30 under pre-AIA 35 U.S.C. § 102(b)
as anticipated by Sterman (A Trial of Intrapleural Adenoviral-mediated
Interferon-a2b Gene Transfer for Malignant Pleural Mesothelioma, 184
Am. J. Respir. Crit. Care Med. 1395-99 (2011)); issue of Dec. 15, 2011).
Ans. 2.
The Examiner found that Sterman was originally published as DOI:
10.1164/rccm.201103-0554CR on June 3, 2011, which is more than a year
before the provisional application 61/670,330 filing date of July 11, 2012,
and the provisional application 61/692,828 filing date of August 24, 2012, to
which the ’202 Application claims benefit.
2. Claim 10 under pre-AIA 35 U.S.C. § 103(a) as obvious over
Sterman in view of Giaccone {Pleural mesothelioma: combined modality
treatments 13, Suppl. 4 Eur. Soc. Med. Oncol. 217-25, (2002)). Ans. 3^1.
3. Claims 11, 12 and 20 under pre-AIA 35 U.S.C. § 103(a) as obvious
over Sterman in view of Lengyel (Ovarian Cancer Development and
Metastasis 177(3) Amer. J. Pathol. 1053—64. (Sep. 2010)). Ans. 5.
The ’202 Application is the parent application of continuation
application 14/030,399 which was the subject of Appeal 2016-003044 to the
PTAB. A decision on the appeal was decided on May 24, 2017, affirming
the Examiner’s rejection. The decision has been appealed to the Federal
Circuit Court of Appeals. Appellants did not list this related appeal in their
Appeal Brief.
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Appeal 2016-008089
Application 13/932,202
CLAIMED SUBJECT MATTER
Independent claim 1 is representative and reads as follows:
1. In a method of treating a human diagnosed as having
cancerous organ by administering chemotherapeutic agent, the
improvement comprising administering to said human a
recombinant virus, said recombinant virus comprising a
homeomimetic transgene.
REJECTIONS
Appellants contend that Sterman “does not qualify as prior art”
because it was published December 15, 2011, which “is less than one year
before the priority date of the instant application.” Appeal Br. 1. Appellants
have presented no other patentability argument for Rejections 1,2, and 3.
Consequently, the appeal from all three rejections turns on the issue of
whether Sterman is prior art to the rejected claims.
The ’202 Application in this appeal claims benefit to a provisional
applications filed July 11, 2012 and August 24, 2012, respectively. Sterman
was published in the issue of American Journal of Respiratory and Critical
Care Medicine dated Dec. 15, 2011, which is less than a year before the
provisional filing dates and thus constitutes prior art under pre-AIA 35
U.S.C. § 102(a) (“(a) the invention was known or used by others in this
country, or patented or described in a printed publication in this or a foreign
country, before the invention thereof by the applicant for a patent”).
Because Appellants did not establish that the authors of Sterman were not
“others,” Appellants’ statement that Sterman “does not quality as prior art”
is not factually correct. A rejection under § 102(a), however, was not made
by the Examiner.
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Appeal 2016-008089
Application 13/932,202
The Examiner found that Sterman is prior art under pre-AIA 35
U.S.C. § 102(b) based on the statement in Sterman that it was “Originally
Published in Press as DOI: 10.1164/rccm.201103-0554CR on June 3, 2011”
which is more than a year before the July 11, 2012 provisional application
filing date. Final Act. 6. Because the complete journal article was published
in December of 2011, it is reasonable that the phrase “Originally Published”
refers to this complete article, rather than just a part of it, such as an abstract
only. We find that such statement constitutes sufficient evidence that the
manuscript and the experiments therein relied upon by the Examiner to
establish unpatentability of the claimed subject matter was available on June
3,2011.
Appellants argue that the only material from Sterman that was
published on June 3, 2011 was the abstract. Reply Br. 4. Appellants
contend that the Examiner conceded that only the abstract was available.
Id., 5.
The Examiner made no such concession. Rather, the Examiner
directed Appellants’ attention to the publisher’s guidelines which expressly
states “Manuscripts accepted for publication will immediately (within 48
hours of acceptance) be published online in the Articles in Press section of
the A.JRCCM.” Ans. 8. Appellants contend that the “publisher's previous
publication guidelines could potentially be legally relevant here. In contrast,
the publisher’s current guidelines provide no information on how the
publisher in fact treated the Sterman manuscript six years ago.” Reply Br. 5.
We disagree. There is no evidence that the policy has changed.3 The
3 It seemed rather simple to confirm with the publisher of the journal that the
manuscript was available as indicated in the printed statement that
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Appeal 2016-008089
Application 13/932,202
journal guidelines reproduced by the Examiner stating that manuscripts are
“published online in the Articles in Press section” is fully consistent with the
statement in Sterman, published Dec. 15, 2011, that the complete journal
article was “Originally Published in Press ... on June 3, 2011” containing
the experiments relied upon by the Examiner to establish unpatentability.
Appellants have not provided evidence that the statement in the Dec. 15,
2011 journal article about being originally published in press on June 3,
2011 is any less than what it says to be true.
Appellants’ allegation that the guidelines are not of record is not
persuasive. The Examiner’s citation to the guidelines is responsive to the
new argument made by Appellants in the Appeal Brief for apparently the
first time concerning the editing and creation of the PDF file for the Dec. 15
2011 journal article. See Ans. 7—8. We could not find this argument made
earlier, e.g., in Appellants’ Remarks filed July 13, 2015.
The Examiner clearly identified where the information concerning the
guidelines appeared. Ans. 8. Appellants had the opportunity to respond to
the Examiner’s finding in their Reply Brief, and did. Reply Br. 5.
Appellants did not explain why Examiner’s response to Appellants’ new
argument is improper and should be ignored when it is of record in the
Answer and Appellants are on notice of it. Indeed, Appellants introduced
new evidence in this appeal regarding the creation of the Sterman pdf file.
accompanied the publication on December 15, 2011. We did just that, and
as indicated in the attached email, the publisher advised us that “just
abstracts” are not posted. However, it is unnecessary to rely on this email
because, as explained in this Decision, Appellants did not establish that the
statement “Originally Published in Press ... on June 3, 2011” means that
only the abstract of the journal article was published.
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Appeal 2016-008089
Application 13/932,202
Under 37 C.R.F. § 41.37(c)(2), the “brief shall not include any new or non-
admitted amendment, or any new or non-admitted affidavit or other
Evidence.”
Appellants further argue that the pdf of the Sterman publication is
freely available to download from the publisher’s website and that “[t]he
‘Document Properties’ for that pdf file says the file was created on Nov. 24,
2011 — shortly before the Dec. 15 edition was published.” Appeal Br. 3.
Based on this date, Appellants contend
the metadata on the article pdf file shows that publisher created
that file on Nov. 24, 2011, after the critical date. That file could
not possibly have been published before the critical date
because it did not exist before the critical date.
Id., 6.
We do not see the relevance of the date of when the final publication
was created to the finding by the Examiner that an earlier manuscript was
published online on June 4, 2011. To the contrary, the fact that the final
version was created months later is consistent with the statement in the
Sterman publication that an earlier manuscript was available online after
acceptance. Appellants appear to have confused the pdf available today with
the online manuscript availability on June 4, 2011; these are not the same.
Appellants also contend:
What was published on June 3, 2011, however, appears to have
been merely the Abstract only, not the entire paper. Searching
“Sterman 2011” on the www.atsjoumals.org website identifies
six articles, including the instant one. Clicking on the link to
“10.1164/rccm.201103-0554CR” leads to a page with only the
Abstract:
Id., 7.
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Appeal 2016-008089
Application 13/932,202
Appellants’ argument is not persuasive. The “link” directs to a page
with the abstract and tabs for “Full Text”, “References”, “Suppl. Materials”,
“Cited by”, and “PDF.” Consequently, we find Appellants’ argument that
the aforementioned “link” establishes that only the abstract was available on
the disputed date is unavailing because the link contains the complete
publication as published on Dec. 15, 2011. There is no evidence that this is
the same link available on June 3, 2011.
In sum, there is no persuasive evidence before us that the disclosure in
Sterman’s December 15, 2011 publication indicating it was “Originally
Published in Press as DOI: 10.1164/rccm.201103-0554CR on June 3, 2011”
was not the complete, albeit unedited for publication, manuscript and the
disclosure of the experiments relied by the Examiner to reject the claims. To
the extent we have considered Appellants’ new argument and new evidence
regarding the creation of the December 15, 2011 pdf file, we find it
unpersuasive because such argument and new evidence do not rebut the
finding that an earlier manuscript was publicly available on the journal
website at the cited DOI number.
SUMMARY
For the foregoing reasons, Rejections 1, 2, and 3 of all pending claims
are affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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