Ex Parte Durocher et al

Patent Trial and Appeal Board

Aug 8, 2017

10477148 (P.T.A.B. Aug. 8, 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.
10/477,148 07/22/2004 Yves Durocher 1036-0006 3451
36844 7590 08/10/2017
Pp.rmak Nalcaiima Rr Mofrnwan T T P
EXAMINER
127 S. Peyton Street, Suite 200
ALEXANDRIA, VA 22314
MARVICH, MARIA
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
08/10/2017 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):
CGOODE@cnmiplaw.COM
IP@cnmiplaw.com
ACERM AK @ cnmiplaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YVES DUROCHER, SYLVIE PERRET, PHUONG LAN PHAM,
and AMINE A. KAMEN
Appeal 2015-007665
Application 10/477,1481
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and DAVID
COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
expression vector for expression of a recombinant protein. The Examiner
rejected the claims on appeal under 35 U.S.C. § 112, first paragraph as
failing to comply with the written description requirement.
We affirm.
1 According to Appellants, the real party in interest is The National Research
Council of Canada.
Appeal 2015-007665
Application 10/477,148
STATEMENT OF THE CASE
The Specification discloses: “The invention relates to processes for
producing recombinant proteins, in particular to a new process for an
enhanced transient expression of a recombinant protein in host mammalian
cells, and to new expression vectors, cell lines and culture media adapted to
carrying out the process.” Spec. 1.
Claims 65, 66, and 72—84 are on appeal. Claim 65 is illustrative and
reads as follows (claim language at issue emphasized):
65. An expression vector for expression of a recombinant protein,
said vector comprising a first DNA sequence encoding the
recombinant protein, said first DNA sequence being under control of a
CMV5 promoter, said expression vector further comprising a second
DNA sequence, wherein the second DNA sequence comprises the
nucleotide sequence as set forth in SEQ ID NO: 1 or a fragment
thereof containing 9 to 20 EBNA1 binding sites, the EBNA1 binding
sites selected from the group consisting of nucleotides 36—53 of SEQ
ID NO: 1, nucleotides 66—83 of SEQ ID NO:l, nucleotides 126—143
of SEQ ID NO: 1, nucleotides 276-293 of SEQ ID NO: 1 and
nucleotides 302—319 of SEQ ID NO: 1; the second DNA sequence is
located 3’ to the CMV5-promoter; and the second DNA sequence
enhances transcriptional activity of the promoter and transient
expression of the recombinant protein when present in a cell
expressing EBNA1 protein, wherein the size of the vector minus an
antibiotic resistance cassette and said first DNA sequence is from
about 4285 base pairs to about 6000 base pairs.
App. Br. 9.
The Examiner rejected claims 65, 66 and 72—84 under 35 U.S.C.
§112, first paragraph for failing to comply with the written description
requirement.
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Application 10/477,148
FINDINGS OF FACT
1. Claim 44 of the present application, as originally filed, recites:
“An expression vector according to claim 43, wherein the fragment of the
EBV oriP sequence comprises at least one EBNA1 binding site (EBS).”
Spec. 28.
2. The Specification discloses: “Fig. 7 is a graph showing the
effect of various oriP truncations on transient gene expression. . . . The
pTTn/GFP vector was obtained by digesting pTTm/GFP vector with BstxXl,
followed by re-circularisation. This construct has an FR fragment containing
only 9 EBNA1 binding sites (see Fig. 8).” Id. at 6—7.
3. The Specification discloses: “Fig. 8 shows the sequence of the
oriP’s Family of Repeats (FR). The FR contains 20 EBNA1 binding sites
(EBS) (boxed).” Id.
4. The Specification discloses the following vectors: pTT (id. at 5
and Fig. 2A), pTTm (id. at 6 and Fig. 7), pTTn (id. at 7 and Fig. 7), pTTo
(id.), pTT4a (id. and Fig. 9), pTT4b (id.), and pTT4c (id.). The Figures
disclosing these vectors identify the number of base pairs in each vector.
For Example, Figure 2 (reproduced below) indicates that the pTT vector has
5925 base pairs.
Figure 2 shows a genetic map of a pTT vector drawn to scale. Id. at 5.
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Application 10/477,148
5. Appellants assert, and the Examiner does not dispute, that each
of the pTT, pTTm, pTTn, pTTo, pTT4a, pTT4b, and pTT4c vectors,
excluding the antibiotic resistance cassette and the first DNA sequence,
“range in size from about 4285bp to about 5925bp.” App. Br. 6.
ANALYSIS
A description adequate to satisfy 35U.S.C. § 112, first paragraph,
must ‘“clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed.’” AriadPharms., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (enbanc) (citation omitted, alteration
in original). “[T]he test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date.”
Id. “If. . . the specification contains a description of the claimed invention,
albeit not in ipsis verbis (in the identical words), then the examiner . . . , in
order to meet the burden of proof, must provide reasons why one of ordinary
skill in the art would not consider the description sufficient.” In re Alton, 76
F.3d 1168, 1175 (Fed. Cir. 1996). “[T]he [Examiner] has the initial burden
of presenting evidence or reasons why persons skilled in the art would not
recognize in the disclosure a description of the invention defined by the
claims.” In re Wertheim, 541 F.2d 257, 263 (CCPA 1976).
The Examiner found that the claims did not comply with the written
description requirement for two separate reasons. First, the Examiner found
that the Specification did not provide support for the claim requirement that
the second DNA sequence contain “9—20 EMNA1 binding sites.” Ans. 2.
Second the Examiner found that the Specification did not provide support
for the claim requirement that “the size of the vector minus an antibiotic
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Appeal 2015-007665
Application 10/477,148
resistance cassette and said first DNA sequence is from about 4285 base
pairs to about 6000 base pairs.” Id. We find that the Specification provides
support for the 9—20 binding site requirement, but not for the requirement
the requirement that the size of the vector be about 4285—6000 base pairs.
We address each claim requirement separately.
9—20 EMNA1 binding sites
The present application, as filed, included dependent claim 44, which
requires that the second DNA sequence comprise “at least one EBNA1
binding site (EBS).” FF1. The Specification thus discloses a range of one
or more EBNA1 binding site. Hyatt v. Boone, 146 F.3d 1348, 1352 (Fed.
Cir. 1998) (“The claims as filed are part of the specification, and may
provide or contribute to compliance with § 112.”). The Specification also
provides examples of vectors where the second DNA sequence comprises 9
and 20 EBNA1 binding sites. FF2 and FF3.
The Examiner contends:
In this case, applicants established a generic disclosure of at
least one EBS followed by specific examples of 9, 10 and 20.
There was no indication that a range of 9-20 was intended.
Neither were applicants directing one to establishing vectors
with 9—20 EBNA1 sites. The fact pattern does not lead one to
creation of the 9—20 range based on a generic disclosure even
when species are disclosed.
Ans. 8. We are not persuaded.
The Specification discloses the broad range of one or more EBNA1
binding site (FF1), and claims a narrower range that falls within that broad
range. In this case, the recitation of a range of one or more EBNA1 binding
sites, and the exemplification of DNA sequences with 9 and 20 binding sites,
reasonably conveys to the skilled artisan that the inventors were in
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Application 10/477,148
possession of DNA sequences with binding cites that fall in between the
range bounded by the endpoints of 9 and 20 binding sites. See, In re
Wertheim, 541 F.2d at 265 (“in light of the description of the invention as
employing solids contents within the range of 25—60% along with specific
embodiments of 36% and 50%, we are of the opinion that, as a factual
matter, persons skilled in the art would consider processes employing a 35—
60% solids content range to be part of appellants’ invention”).
4285—6000 base pairs
The Specification discloses pTT, pTTm, pTTn, pTTo, pTT4a, pTT4b,
and pTT4c vectors. FF4. Appellants assert, and the Examiner does not
dispute, that when the first DNA sequence and the antibiotic resistance
cassette are excluded, these vectors range in size from 4285—5925 base pairs.
FF5.
The Examiner finds that the “disclosure of the 7 vectors does not have
implicit or inherent teachings that led one to vectors limited to sizes between
4285 and 6000 bp.” Ans. 9. The Examiner contends that the Specification
includes “no explicit disclosure of a range requirement” and that Appellants
“have created artificial size designations culled from vectors [disclosed in
the Specification].” We agree with the Examiner that the Specification does
not provide written description support for vector size limitation of “about
4285 to about 6000 base pairs.” We adopt the Examiner’s findings of fact
with respect to this limitation as our own and address Appellants’ arguments
below.
Appellants argue that “7 embodiments are specifically exemplified”
and that “7 explicit embodiment are clearly sufficient to describe the genus
recited in the claims, and clearly demonstrate a sufficient number of
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Application 10/477,148
representative species within the claimed genus.” App. Br. 6—7. We are not
persuaded.
Although we agree that seven species may be sufficient to describe a
genus, the number of species disclosed does not, by itself, determine
whether a genus is sufficiently described in the Specification. In order for a
genus to be disclosed for purposes of written description, there must be some
indication that the inventors considered the genus to be part of their
invention. See, Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1328
(Fed. Cir. 2000) (“Because the specification does not clearly disclose to the
skilled artisan that the inventors of the [patent at issue] considered the
Cmax/C24 ratio to be part of their invention, it is immaterial what range for the
Cmax/C24 ratio can be gleaned from the examples when read in light of the
claims.”).
Here, Appellants do not identify, and we do not find, any teaching in
their Specification that would reasonably convey to the skilled artisan that
the inventors considered “the size of the vector minus an antibiotic
resistance cassette and said first DNA sequence” to be a part of their
invention. It is thus immaterial whether the range of 4285 base pairs to
about 6000 base pairs can be extracted from the individual examples
provided in the Specification. Accordingly, we affirm the Examiner’s
rejection of claims 65, 66, and 72—85.
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SUMMARY
For these reasons and those set forth in the Examiner’s Answer and
Final Office Action, the Examiner’s rejection of claims 65, 66, and 72—85 is
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)(1).
AFFIRMED
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