Ex Parte Parker et al

Patent Trial and Appeal Board

May 22, 2017

14030399 (P.T.A.B. May. 22, 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.
14/030,399 09/18/2013 Nigel PARKER FKD - 61/670,330 5885
22925 7590 05/24/2017
PHARMACEUTICAL PATENT ATTORNEYS, LLC
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4THFLOOR
MORRISTOWN, NJ 07960-7397
EXAMINER
WEHBE, ANNE MARIE SABRINA
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
05/24/2017 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 2016-003044
Application 14/030,3991,2
Technology Center 1600
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to methods of treating organ
cancer comprising administering a chemotherapeutic agent and a
recombinant vims, where the recombinant vims comprises a homeomimetic
transgene. The Examiner rejected the claims under 35 U.S.C. § 102(b). We
have jurisdiction under 35 U.S.C. § 6(b). The rejection is affirmed.
1 The Appeal Brief (“Appeal Br.”) lists FKD Therapies Oy, Kuopio Finland,
as the real-party-in-interest.
2 “The ’399 Application.”
Appeal 2016-003044
Application 14/030,399
STATEMENT OF THE CASE
Appellants appeal from the Examiner’s final rejection of claims 1—9,
11—19, and 21—30 under pre-AIA 35 U.S.C. § 102(b) as anticipated by
Sterman (Am. J. Respir. Crit. Care Med., 184:1395—99, 2011; issue ofDec.
15, 2011). Final Action (“Final Act.”; Jan. 14, 2015) 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 to
which the ’399 Application claims benefit. Id. at 2—3.
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 [spelled throughout the ’399 Application as
“homomimetic”] transgene, said recombinant virus administered
to a site remote from said cancerous organ.
CLAIM INTERPRETATION
There are four independent claims. Claims 1 and 11 are directed to
methods of treating a human that has a “cancerous organ.” Claim 21 is
directed to a method of treating “organ cancer.” Claim 30 is directed to a
method of treating “cancer.” The interpretation of “cancerous organ” and
“organ cancer” are in dispute.
The Examiner construed “cancerous organ” and “organ cancer” as
cancer involving the tissues of an organ (“malignant pleural mesothelioma is
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Application 14/030,399
a malignant cancer which in later stages involves the lung tissue and as such
qualifies as a ‘lung cancer’”). Final Act. 4. Appellants contend “internal
organs derive from embryonic endoderm .... Organ cancer is cancer of an
organ, i.e., endoderm-derived tissue.” Appeal Br. 7.3 Appellants distinguish
an “organ cancer” from a cancer of a mesothelioma which is a sac which
covers internal organs. Id. Appellants argue that an organ cancer must arise
from cancerous cells of the organ (“Lung cancer is a different [sic, cancer?],
arising not from cancerous mesothelium cells, but from cancerous lung
cells.”). Id. at 8. See also Reply Br. 1—2.
Appellants did not provide adequate factual support for the argument
that an organ is derived from endodermal cells. It is well-known that not all
organs derive from the endoderm. For example, the brain is an organ and it
arises from the ectoderm and the spleen and heart, also organs, arise from
the mesoderm.4
Nonetheless, regardless of the embryonic origin of an “organ,” the
issue is whether the terms “cancerous organ” or “organ cancer” require the
cancer to have originated in the organ.
During patent examination proceedings, claim terms are given “the
broadest reasonable meaning ... in their ordinary usage as they would be
understood by one of ordinary skill in the art, taking into account whatever
enlightenment by way of definitions or otherwise that may be afforded by
3 Appellants did not number the pages of the Appeal Brief. The numbering
used throughout this Decision begins with the title page of the Appeal Brief
numbered as page 1.
4 http://discovery.lifemapsc.com/library/review-of-medical-
embryology/chapter-25-germ-layers-and-their-derivatives. Accessed April
2, 2017.
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Application 14/030,399
the written description contained in the applicant’s specification.” In re
Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
The Specification does not provide a definition of either term. Thus,
we turn to the ordinary usage of these terms.
In the term “organ cancer,” “organ” is used as an adjective to describe
the type of cancer, namely, the cancer is associated with an organ, namely,
the organ has cancerous cells present in it. Neither word requires the cancer
of the organ to have originated in the organ. For example, the cancer could
have metastasized to, or invaded a particular organ, and the cancerous cells
would still would be present in the organ.
In the term “cancerous organ,” “cancerous” is an adjective and thus
describes the organ as being “affected” with a cancer.5 Again, neither word
in the term “cancerous organ” requires the cancer to have a specific history;
a “cancerous organ” can result from cells that originated in the organ, or,
from cells originating from another location in the body that subsequently
invaded the organ.
We have not been directed to a definition in the Specification, or an
extrinsic definition, that would guide us to a narrower interpretation,
particularly the interpretation urged by Appellants that cancer must originate
in the organ to qualify as an organ cancer or cancerous organ.
Consequently, we adopt the Examiner’s claim construction as the broadest
reasonable interpretation of the disputed terms and construe “organ cancer”
and “cancerous organ” to mean that cancer is present in the organ.
5 http://www.thefreedictionary.com/cancerous. Accessed April 2, 2017.
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REJECTION
The claims are directed to methods of treating cancer comprising
administering 1) a chemotherapeutic agent and 2) a recombinant virus to a
human, where the recombinant virus comprises a homeomimetic transgene.
Appellants elected IFN-alpha as the species of the homeomimetic transgene6
and lung as the species of cancerous organ. Ans. 2.
The Examiner found that Sterman teaches “methods of treating
malignant pleural mesothelioma (MPM) in human patients by intrapleural
catheter infusion of a saline solution comprising an adenoviral vector
encoding interferon-alpha 2b, wherein patients receiving the treatment
exhibited antitumor immune responses and in some cases stable disease or
even tumor regression . . . .” Id. at 3. The patients had also received a
chemotherapeutic agent. Id. Because the Examiner found that all
limitations of the claim are described by Sterman, the Examiner concluded
the claim is anticipated. Id.
Appellants contend that mesothelioma is not an organ cancer or a
cancerous organ. Appeal Br. 7—8. Appellants state:
Organ cancer is cancer of an organ, i. e., endoderm-derived tissue.
In contrast, mesothelioma is, as the name implies, cancer of the
mesothelium-derived sac that covers many internal organs. The
two types of cancers differ in location (one occurs in the organ,
the other in the surrounding sac) and biology (endoderm and
mesoderm cells differ).
Id.
6 A homomimetic transgene is defined in the ’399 Application as “a
transgene which codes for a polypeptide which mimics an effect of a
naturally-occurring human polypeptide.” ’399 Application 2:18—20.
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Appellants also contend that lung cancer must arise from cancerous
lung cells, not mesothelioma cells which migrate into the lung. Id. at 9.
Discussion
The broadest reasonable interpretation of “organ cancer” and
“cancerous organ” is of a cancer that is present in an organ, which in this
case would be the elected organ, the lung. Contrary to Appellants’
interpretation, the claims do not require the cancer to originate from the cells
of the organ. Accordingly, the issue in the anticipation rejection is whether
the mesothelioma described by Sterman is present in lung tissue.
The Examiner relied upon an online publication (at https://www.
pleuralmesothelioma.com/cancer/staging.php) (“pleuralmesothelioma.com”)
describing the staging of mesothelioma to establish that the lung contains
mesothelioma cells in Stage T2. Final Act. 4; Ans. 5. According to this
publication, at Stage T2:
The tumor involves the pleural lining of the chest wall on one
side of the chest, as well as the pleural lining of the diaphragm,
mediastinum and the lung. The cancer has also grown into at least
one of the following:
• The diaphragm muscle
• Tissue of the lung itself
Stage T2 occurs in Stages II through IV of mesothelioma
(pleuralmesothelioma.com). Sterman specifically discloses that
several of the treated patients were in Stages III and IV (Sterman
1396, Table 1). Stage III and Stage IV patients would have Stage T2
cancer where the mesothelioma is in the lung tissue. Thus, the
Examiner had sufficient factual basis to conclude that Sterman treated
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lung cancer. Final Act. 4; Ans. 5. Appellants have not provide
adequate arguments or evidence to rebut this fact-based
determination.
Appellants contend that the migration of cells into the lung is
not a lung cancer. Appeal Br. 8. However, such claim construction is
not the broadest reasonable interpretation of the claim. Accordingly,
this argument does not persuade us that the Examiner erred.
Remote
Claim 1 requires that the “recombinant virus [is] administered to a site
remote from said cancerous organ . . . .” Appeal Br. 7. The Examiner found
that Sterman describes “intrapleural catheter infusion of a saline solution
comprising an adenoviral vector encoding interferon-alpha 2b.” Ans. 3.
The Examiner also found that “intrapleural catheter infusion involves the
delivery of the vector to the intrapleural space, the space between the
mesothelium and the lung, and as such qualifies as a site ‘remote’ from a
cancerous [lung] organ.” Id. Appellants respond that “Sterman’s
mesothelium is cancerous, so Sterman teaches administration directly onto
cancerous tissue, not ‘remote’ from it.” Reply Br. 5.
This argument does not demonstrate error because the rejection is
based on administration of the transgene to the intrapleural space which is at
a remote location to the lung.
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Is Sterman prior art?
Appellants contend that “Sterman (2011) was first published in
December 2011 and therefore does not qualify as prior art.” Reply Br. 7.
The ’399 Application in this appeal claims benefit to a provisional
application filed July If 2012. 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 date and thus
constitutes prior art under pre-AIA 35 U.S.C. § 102(a). Consequently,
Appellants’ statement that Sterman “does not qualify as prior art” has no
factual support in this record.
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 provisionaEfiling date.
See Ans. 2. Appellants argue, without providing the Board with any
evidence in this proceeding, that the only material published was the
abstract. Reply Br. 7. Appellants contend that the DOI document is of
record “in the parent case,” but did not identify the “parent case” nor provide
the Board, as a courtesy, with such document. Id.
Sterman clearly states “Originally Published in Press,” indicating that
the article was itself published. Appellants had the opportunity throughout
this proceeding to provide evidence to the Examiner that it was only the
abstract which was published, but did not. For example, the Sterman
rejection was made by the Examiner in a non-final Office Action entered
June 11, 2014. Appellants responded to the rejection on Sept. 10, 2014
without making the allegation that Sterman is not prior art to their
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application and without providing evidence that the Examiner erred in
finding Sterman’s publication date to be June 3, 2011.
Nonetheless, Sterman is prior art under pre-AIA 35 U.S.C. § 102(a).
Consequently, even if Sterman was not published more than before the
provisional filing date of the ’399 Application, it is still prior art to the
application.
SUMMARY
For the foregoing reasons, the anticipation rejection of independent
claims 1, 11,21, and 30 is affirmed. Dependent claims 2—9, 12—19, and 22—
29 were not argued separately and fall with the independent claims. 37
C.F.R. §41.37(c)(iv)(l)
TIME PERIOD
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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