Ex Parte CHARNEAU et al

Patent Trial and Appeal Board

Feb 4, 2019

14613657 (P.T.A.B. Feb. 4, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/613,657 02/04/2015 Pierre CHARNEAU
76392 7590 02/06/2019
ARRIGO, LEE, GUTTMAN & MOUTA-BELLUM LLP
2200 Pennsylvania Ave NW
Suite 400E
WASHINGTON, DC 20037
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
DI99-79-F 4455
EXAMINER
ANGELL, JONE
ART UNIT PAPER NUMBER
1635
NOTIFICATION DATE DELIVERY MODE
02/06/2019 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):
SAL© ARRIGO. US
scott@arrigo.us
carla@arrigo.us
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PIERRE CHARNEAU, VERONIQUE ZENNOU, FRANCOISE
PFLUMIO, AUDE SIRVEN, and ANNE DUBART KUPPERSCHMITT
(APPLICANT: Institut Pasteur, Centre National De La Recherche
Scientifique, and Institut National De La Sante et De La Recherche
Medicale
Appeal2017-007404
Application 14/613,657 1
Technology Center 1600
Before FRANCISCO C. PRATS, RACHEL H. TOWNSEND, and DAVID
COTTA, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of expressing a protein of interest in vivo, which have been rejected as being
unpatentable on the ground of nonstatutory double patenting. Oral argument
1 Appellants identify the real party in interest as Institut Pasteur, Centre
National De La Recherche Scientifique and Institut National De La Sante et
De La Recherche Medicale. (Appeal Br. 3.)
Appeal2017-007404
Application 14/613,657
was heard on January 17, 2019. 2 We have jurisdiction under 35 U.S.C.
§ 6(b ).
We reverse.
STATEMENT OF THE CASE
"[L ]entiviruses have been shown to infect both dividing and non-
dividing cells." (Spec. 2.) They "have evolved a nuclear import strategy
which allows their DNA genome to cross the nuclear membrane of a host
cell." (Id.) In addition, "at the origin of their in vivo replication strategy and
hence of their pathogenicity" replication of lentiviruses is mitosis-
independent (Id.) "The invention provides a nucleic acid comprising a
triple-stranded (triplex) structure, such as one from a lentivirus[, which] ...
stimulates entry of nucleic acids into the nucleus of cells." (Id. at 4.)
Claims 44--53 are on appeal. Claim 44 is representative and reads as
follows:
44. A method of expressing a protein of interest in vivo
compnsmg:
b) administering a lentiviral particle encoding the protein
of interest to an individual;
c) transducing a cell of the individual with the lentiviral
particle; and
d) expressing the protein of interest encoded by the
lentiviral particle in the cell of the individual,
wherein the lentiviral particle comprises:
at least one copy of lentiviral cPPT and CTS
reg10ns;
a heterologous nucleic acid sequence encoding the
protein of interest under the control of an internal
2 Administrative Patent Judge Katz, who heard oral argument, but otherwise
did not participate in this decision, was replaced by Administrative Patent
Judge Prats. See Panel Change Order entered, January 25, 2019.
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Application 14/613,657
promoter not naturally associated with the heterologous
nucleic acid sequence;
a lentiviral L TR that is deleted for the promoter
and the enhancer of U3;
(Appeal Br. 17 .)
a lentiviral integrase protein;
a lentiviral reverse transcriptase protein;
a lentiviral Gag protein; and
an envelope protein.
The following ground of rejection by the Examiner is before us on
review:
Claims 44--53 on the ground of non-statutory obviousness-type double
patenting as being unpatentable over claims 1-20 of U.S. Patent No.
8,512,993.
DISCUSSION
The Examiner finds that
the method of claim 1 of the issued patent [US Patent No.
8,512,993] is drawn to a method comprising transducing a cell
with a lentiviral vector particle comprising a cPPT and CTS
sequence of a retrovirus which induces a three-stranded DNA
structure, a heterologous sequence, and a HIV- I L TR that is
deleted for the promoter and enhancer of U3.
(Final Action 5.) The Examiner notes that the claims on appeal are
drawn to a method of expressing a protein of interest by
administering a lentiviral particle encoding the protein of
interest such that is transduces a cell and expressed the protein
of interest wherein the lentiviral particle comprises a number of
specific limitations including a lentiviral L TR deleted for the
promoter and enhancer of U3.
(Id. at 4.) According to the Examiner the broader claims on appeal "are
anticipated by the narrower embodiments of the issued claims." (Id. at 5.)
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In particular, the Examiner contends that the issued claims are a species
embraced within the broader genus claims on appeal. (Id. at 6.)
According to the Examiner, "using the disclosure of the ... '993
patent[] to define the specific embodiments encompassed by the patented
claims, it is clear that the instant claims and the patented claims are not
patentably distinct." (Id. at 10.) In that regard, the Examiner finds that
"although the [patented] claims do not explicitly indicate that the cell is in
vivo, the specification [ of the '993 patent] clearly indicates that the cell may
be in vivo" and that "the specification [ of the '993 patent] also discloses that
the method also encompasses expressing the protein of interest." (Id. at 9.)
The Examiner finds that the "specification of the '993 patent also indicates
that the heterologous nucleic acid of interest can be under the control of a
promoter not naturally associated with the heterologous nucleic acid
sequence." (Id.) Finally, the Examiner finds that while the patented claims
do not explicitly recite all of the protein components of the lentiviral particle
recited in the claims on appeal, the specification indicates that the
production of the particle "is the exact same way the instant application
describes production of lentiviral vector particles." (Id.) Consequently, the
Examiner concludes that "producing the lentiviral vectors as disclosed in the
[ '993] specification ( as evidenced by Yee et al., 1994 and N aldini et al.
1996) would necessarily result in a lentiviral vector particle comprising the
four indicated proteins (lentiviral integrase, reverse transcriptase, Gag, and
envelope proteins)." (Id.)
We conclude that the Examiner has erroneously used Appellants'
specification as prior art against them in coming to the conclusion that the
claims on appeal are obvious variants of the '993 patent claims. While it is
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permissible to look to a reference patents' disclosures of utility in
determining whether the claims of the reference patent directed to a
compound are patentably distinct from the claims in a later expiring patent
directed to a method of using that compound, see, e.g., Abbvie Inc. v.
Mathilda & Terence Kennedy Institute of Rheumatology Trust, 764 F.3d
1366, 1380 (Fed. Cir. 2014) (citing In re Vogel, 422 F.2d 438, 441--42
(CCPA 1970)), see also Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d
1381, 1387-88 (Fed. Cir. 2010), that is not the case here. The two sets of
claims are not compound claims and methods of their use.
Moreover, the Examiner did not simply look to the reference patent
for purposes of assessing the utility of compound claims, but rather for how
one might extend the method invention recited in the claims of the '993
patent. As Appellants explain, the '993 patent claims are directed to a
method of introducing a heterologous nucleic acid sequence into the nucleus
of a cell, which cell may be "in vivo." The claimed invention on appeal is
directed to a method of expressing a protein of interest in vivo. Introducing
a nucleic acid sequence does not require protein expression. The fact that
there is overlap between the two sets of claims, in that the cell has to be
transduced with the nucleic acid of interest, is not dispositive of whether the
additional requirements of the claims on appeal that enable protein
expression result in an obvious variation of the reference patent claims. The
Examiner has failed to identify the missing elements from the reference
patent as being in the prior art. Instead, the Examiner simply notes that the
Appellants' Specification teaches these missing elements in a method of
expressing proteins. One would of course expect such a disclosure in the
reference patent, since the specification of the reference patent is the same as
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the one supporting the claimed invention. That however, does not establish
that these elements were in the prior art, nor does the Examiner make such
an assertion.
Moreover, the Examiner has failed on this record to establish some
reason that would have led one of ordinary skill in the art to modify the
invention of the reference patent to make the invention on appeal with a
reasonable expectation of success.
Thus, we do not sustain the Examiner's obviousness-double patenting
rejection.
SUMMARY
We reverse the rejection of claims 44--53 on the ground of non-
statutory obviousness-type double patenting as being unpatentable over
claims 1-20 of U.S. Patent No. 8,512,993.
REVERSED
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