Ex Parte Martin

Patent Trial and Appeal Board

Mar 22, 2016

11986546 (P.T.A.B. Mar. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111986,546 11120/2007 John Francis Martin
22925 7590 03/24/2016
PHARMACEUTICAL PATENT ATTORNEYS, LLC
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United States Patent and Trademark Office
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ATTORNEY DOCKET NO. CONFIRMATION NO.
Ark- GB9622852.3 2674
EXAMINER
SCHNIZER, RICHARD A
ART UNIT PAPER NUMBER
1674
NOTIFICATION DATE DELIVERY MODE
03/24/2016 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 JOHN FRANCIS MARTIN
Appeal2013-007245
Application 11/986,546
Technology Center 1635
Before DONALD E. ADAMS, DEMETRA J. MILLS, and ERIC B.
GRIMES, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 20-22, 30-32,
and 40-42 (App. Br. 3). 2 Examiner entered rejection under the written
description provision of 35 U.S.C. § 112, first paragraph. We have
jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellant identifies the Real Party in Interest as "Health Science Funding,
LLC" (App. Br. iv).
2 Examiner finds claims 1-9, 11, 15-17, 19, 25, 26, 28, 29, 35, 36, 38, and
39 allowable (Ans. 3).
Appeal2013-007245
Application 11/986,546
STATEMENT OF THE CASE
Appellant's "invention relates to the therapeutic use of a growth
factor, and particularly to the treatment and prevention of intimal
hyperplasia of blood vessels and other conditions, especially hypertension"
(Spec. 13-15). Claim 20 is representative and reproduced in the Claims
Appendix of Appellant's Brief.
Claims 20-22, 30-32, and 40-42 stand rejected under the written
description provision of 35 U.S.C. § 112, first paragraph.
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that Appellant's Specification fails to provide written
descriptive support for the claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Examiner finds that Appellant's original disclosure fails to provide
written descriptive support for a "non-viral vector comprising an epithelial
cell," as required by "[c]laims 20-22, 30-32, and 40-42[, which] were newly
presented in [Appellant's] amendment filed 7/27/2012" (Ans. 5).
FF 2. Examiner finds that Appellant's Specification discloses that
"[ s Jui table non-viral vectors include oligonucleotides, plasmids,
liposomes, cationic liposomes, pH-sensitive liposomes,
liposome-protein complexes, immunoliposomes, liposome-
protein-polylysine derivatives, water-oil emulsions,
polyethylene imines and dendrimers." Preferred non-viral
vectors include plasmids and plasmid/liposome complexes. See
paragraph bridging pages 12 and 13. In other words, the only
things that the specification discloses as "vectors" are nucleic
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Application 11/986,546
acids and compositions that facilitate the delivery of nucleic
acids to cells.
(Ans. 6 (alteration original); see id. at 8 ("Epithelial cells are not nucleic
acids and they do not function to deliver nucleic acids to cells, so they are
not members of the genus of vectors as described in [Appellant's]
[ S ]pecification").)
FF 3. Examiner finds that Appellant's "[S]pecification as filed never
discloses the use of any cell as a vector in any context, much less in
association with a nucleic acid" and "does not disclose the words 'epithelial'
or 'epithelium"' (Ans. 6 and 8).
FF 4. Examiner finds a person of ordinary skill in this art would have
understood Appellant's use of the phrase "non-viral vector" to describe
compositions that "either consist of nucleic acids, or are non-cellular
compositions capable of delivering nucleic acids to a cell. [Appellant's]
[S]pecification does not provide any description whatsoever of the use of a
cell as a non-viral vector, either literally, expressly, inherently, or by
implication" (Ans. 6).
FF 5. Thong3 discloses the "successful restoration of immunity in the
DiGeorge syndrome with fetal thymic epithelial transplant" (Thong, Title
and Summary).
ANALYSIS
Examiner finds that Appellant's Specification lacks written
descriptive support (FF 1 ).
3 Y. H. Thong et al., Successful restoration of immunity in the Di George
syndrome with fetal thymic epithelial transplant, 53 ARCHIVES OF DISEASE IN
CHILDHOOD 580-584 (1978).
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Appeal2013-007245
Application 11/986,546
The method of Appellant's claim 20 comprises the periadventitial
administration to a blood vessel of (a) an effective amount of an agent that is
an agonist of a receptor to which VEGF binds, or (b) vector containing a
nucleic acid encoding the agonist; wherein the nucleic acid is in association
with a viral or non-viral vector; wherein the vector comprises at least one
non-viral vector; and wherein the non-viral vector comprises at least one
epithelial cell (see Appellant's claim 20).
Appellant concedes that Examiner correctly finds that Appellant's
Specification "as filed does not disclose [the] use of epithelial cells as
vectors, e.g. as cells for use in transplantation or implementation" (App. Br.
9; see FF 1, 3, and 4; Ans. 7). Appellant contends, however, that a
"[S]pecification need not teach matter that was commonly known when the
application was filed. See Hybritech, Inc. v. Monoclonal Antibodies, Inc.,
802 F.2d 1367, 1384 (Fed. Cir. 1986)" (App. Br. 9; Reply Br. 2). In this
regard, Appellant directs attention to Thong to support Appellant's
contention that the "'use of epithelial cells as vectors ... for use in
transplantation or implantation' was known in the art prior to the effective
filing date of [Appellant's] application" (App. Br. 9-10; see Reply Br. 1-2).
We are not persuaded.
Notwithstanding Appellant's contention to the contrary, Appellant
failed to establish an evidentiary basis on this record to support a finding that
either of Appellant's Specification or Thong disclose the use of an epithelial
cell as a vector, much less a vector containing a nucleic acid encoding an
agonist of a receptor to which VEGF binds (see App. Br. 9-1 O; Reply Br. 1-
2; see Appellant's claim 20; cf FF 1-5). In this regard, we agree with
Examiner's finding that Hybritech fails to support Appellant's contention
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Application 11/986,546
that the combination of Appellant's Specification and Thong provides
written descriptive support for Appellant's claims that require a non-viral
vector that comprises at least one epithelial cell (see e.g., Appellant's claim
20). See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.
Cir. 2010)( en bane) ("[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."). Therefore, we are not persuaded by Appellant's contention that
Examiner incorrectly "speculates about how the skilled artisan would have
read the inventor's disclosure" [and] "does not bother to provide the Board
with any evidence to support [t]his speculation (Reply Br. 4; cf FF 4). In
this regard, Appellant contends that
the Board cannot rely on the Examiner's late-raised factual
allegation because such reliance would be reversible error. See
In re Oetiker, 977 F.2d 1443, 1440 (Fed. Cir. 1992) ("The
examiner cannot sit mum, leaving the applicant to shoot arrows
into the dark hoping to somehow hit a secret objection harbored
by the examiner."), In re Kronig, 539 F2d 1300, 1303 (Fed. Cir.
1976) (Applicant must have a "fair opportunity" to respond to
the Examiner's evidence).
(Reply Br. 5---6; see also id. at 7-8.)
Simply stated,
while the description requirement does not demand any
particular form of disclosure, Carnegie Mellon Univ. v.
Hoffmann-La Roche Inc., 541F.3d1115, 1122 (Fed. Cir.
2008), or that the specification recite the claimed invention in
haec verba, a description that merely renders the invention
obvious does not satisfy the requirement, Lockwood v. Am.
Airlines, 107 F.3d 1565, 1571-72 (Fed. Cir. 1997).
Ariad, 598 F.3d at 1352. See Ans. 10.
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Appellant appears to contend that Examiner entered a new ground of
rejection in the Answer (Reply Br. 4 ("While the Answer is well-written, it
depends on a newly-raised factual speculation. That speculation is baseless .
. . . It is also untimely ... [and] constitutes reversible error")). Whether an
Answer contains an undesignated new ground of rejection, however, can be
reviewed only by way of petition. See MPEP 1207.03(IV) ("If appellant
believes that an examiner's answer contains a new ground of rejection not
identified as such, appellant may file a petition under 3 7 C.F .R. 1.181 (a) ...
requesting that a ground of rejection set forth in the answer be designated as
a new ground of rejection."). Appellant did not file a petition seeking to
have the rejection in the Answer designated a new ground of rejection.
Therefore, we are not persuaded by Appellant's contentions regarding a new
ground of rejection.
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner's
finding that Appellant's Specification fails to provide written descriptive
support for the claimed invention.
The rejection of claim 20 under the written description provision of 35
U.S.C. § 112, first paragraph is affirmed. Claims 21, 22, 30-32, and 40-42
are not separately argued and fall with claim 20.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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