Ex Parte Brough

Patent Trial and Appeal Board

Dec 28, 2017

14024749 (P.T.A.B. Dec. 28, 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.
14/024,749 09/12/2013 Douglas E. Brough 714249 7206
23460 7590 01/02/2018
LEYDIG VOIT & MAYER, LTD
TWO PRUDENTIAL PLAZA, SUITE 4900
180 NORTH STETSON AVENUE
CHICAGO, IL 60601-6731
EXAMINER
MOLOYE, TITILAYO
ART UNIT PAPER NUMBER
1632
NOTIFICATION DATE DELIVERY MODE
01/02/2018 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):
Chgpatent @ ley dig. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DOUGLAS E. BROUGH
Appeal 2017-004157
Application 14/024,7491
Technology Center 1600
Before RICHARD M. LEBOVITZ, ELIZABETH A. LaVIER, and
RICHARD J. SMITH, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a serotype 28 adenoviral
vector comprising a nucleic acid sequence encoding an atonal-associated
factor and methods of using it to generate sensory hair cells. The Examiner
rejected the claims under 35 U.S.C. § 103 as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). The rejections are affirmed.
1 The application is referred to in this Decision as “the ’749 Application.”
The Appeal Brief (“Br.”) identifies GenVec, Inc., as the real-party-in-
interest. Br. 1.
Appeal 2017-004157
Application 14/024,749
STATEMENT OF THE CASE
Claims 1-5 and 9-34 stand rejected by the Examiner as follows
(Examiner’s Answer (“Ans.”) 2-3).
1. Claims 1-5, 9-11, and 16-20 under pre-AIA 35 U.S.C. § 103(a) as
unpatentable and obvious in view of Zoghbi et al. (U.S. Patent 6,838,444
Bl, iss. Jan. 4, 2005) (“Zoghbi”) and Kaplan et al. (U.S. Patent 6,358,507
Bl, iss. Mar. 19, 2002) (“Kaplan”).
2. Claim 12 under pre-AIA 35 U.S.C. § 103(a) as unpatentable and
obvious in view of Zoghbi, Kaplan, and Kovesdi et al. (U.S. Patent
5,851,806, iss. Dec. 22, 1998) (“Kovesdi”).
3. Claim 13-15 under pre-AIA 35 U.S.C. § 103(a) as unpatentable
and obvious in view of Zoghbi, Kaplan, and Lalwani et al. (The
Laryngoscope, 112: 1325-1334, 2002) (“Lalwani”)
4. Claim 21 under pre-AIA 35 U.S.C. § 103(a) as unpatentable and
obvious in view of Zoghbi, Kaplan, and Wickham et al. (U.S. Patent
5,712,136, iss. Jan. 27, 1998) (“Wickham”).
5. Claims 22-34 under pre-AIA 35 U.S.C. § 103(a) as unpatentable
and obvious in view of Zoghbi, Kaplan, Kovesdi, and Lalwani.
There are three independent claims on appeal, claims 1, 22, and 27.
Each of the claims comprise a serotype 28 adenoviral vector encoding an
atonal associated factor. See Br. 2. Appellant did not provide separate
arguments for the claims nor did Appellant provide separate arguments for
the five rejections. Rather, Appellant argued the claims and rejections as a
group. Consequently, we have selected claim 1 as representative to decide
all issues in this appeal. See 37 C.F.R. § 41.37(c)(l)(iv).
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Application 14/024,749
Claim 1 reads as follows:
1. A method of changing the sensory perception of an
animal, wherein the method comprises administering to the
inner ear a pharmaceutical composition comprising a serotype
28 adenoviral vector comprising a nucleic acid sequence
encoding an atonal-associated factor and a pharmaceutically
acceptable carrier, wherein the nucleic acid sequence is
expressed in the animal to produce the atonal-associated factor
resulting in generation of sensory hair cells that allow
perception of stimuli in the inner ear.
DISCUSSION
The Examiner found that Zoghbi teaches administering a
pharmaceutical composition comprising a replication deficient adenoviral
vector comprising an atonal associated factor (MATH1 and HATH1) to the
inner ear of a human as required by claim 1. Office Action 14 (entered
March 23, 2015). The Examiner acknowledged that Zoghbi does not
describe that the replication deficient adenoviral vector is a serotype 28
adenoviral vector as recited in all the claims. Id. at 15. However, the
Examiner found Kaplan describes a serotype 28 adenoviral vector as
required by the claims and its use to achieve persistent expression of a
transgene. Id. Based on these teachings, the Examiner determined it would
have been obvious to one of ordinary skill in the art to have utilized
Kaplan’s vector in Zoghbi’s method with a reasonable expectation of
success. Id. at 16-17. The Examiner further cited additional publications to
reach additional limitations in the dependent claims and in independent
claims 22 and 27. See Br. 5.
Appellant does not deny that Kaplan describes the adenovirus
serotype 28 vector, but contends the serotype 28 vector:
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Application 14/024,749
is not disclosed or suggested by Kaplan as providing any
particularly useful property as compared to other “preferred”
adenovirus serotypes, such as “Ad9, Adi5, Adl7, Adl9, Ad20,
Ad22, Ad26, Ad27, Ad28, Ad30, or Ad 39” and “[preferred
serotypes includ[ing] the Ad2 and Ad5 serotypes,” especially in
the context of changing the sensory perception of an animal or
generating a hair cell in differentiated sensory epithelia in vivo,
as required by the appealed claims.
Br. 6-7.
Appellant contends that the “claimed invention involves surprising
and unexpected results, as demonstrated by the Declaration under 37 C.F.R.
§ 1.132 of Douglas E. Brough,” the only named inventor of the ’749
Application. Id. at 7. Appellant states:
The Brough declaration discusses experimental results
demonstrating that an El/E4-deficient serotype 28 adenoviral
vector expressing an atonal-associated gene (i.e., Hathl) to
provide an atonal associated factor (i.e., the Hathl protein)
more effectively regenerates hair cells in damaged sensory
epithelium in mouse utricle explant tissue as compared to an
El/E4-deficient serotype 5 adenoviral vector comprising the
same Hathl expression cassette.
Id. at 7-8.
Dr. Brough describes an experiment utilizing mouse utricles in
culture. Brough Decl. ^ 4. A utricle is a thickened sac in the inner ear
containing hair cells.2 Dr. Brough stated that sensory cells in the utricle
were ablated by treatment with neomycin and then exposed to an adenoviral
vector containing HATH1, of either serotype Ad28 or Ad5. Brough Decl. ^
2 http://www.tutis.ca/Senses/L10Balance/L10Balance.pdf (accessed Dec. 6,
2017).
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Appeal 2017-004157
Application 14/024,749
4. Only one atonal-associated gene was used, namely, Hathl. Claim 1 is
not limited to a specific atonal-associated factor.
Dr. Brough stated in his Declaration that the serotype Ad28 vector
“surprisingly induced a higher level of sensory cell regeneration as
compared to the serotype 5 CGF166 adenoviral vector [Ad5 vector], and this
difference was statistically significant.” Id. ^f 5. In the Brief, but not in the
Declaration, it was stated that the Ad28 vector provided approximately 550
total cells, whereas the Ad5 vector provided only 350 total hair cells. Br.
10-11. These numbers were said to be shown in the bar graph attached as
Exhibit 2 to Dr. Bough’s declaration. Id. at 11. Exhibit 2, as reproduced in
the Brief, was not labeled with the actual numbers referred to in the Brief.
Rather, the bar graph has the Y-axis labeled as “Total Hair Cell Counts”
which is marked in increments of 100. It is not clear whether Appellant
derived the cell count numbers from the bar graph or from data unreported in
the Brough Declaration.
The Examiner did not find the data adequate to establish patentability
for the full scope of the claim. The Examiner stated that the evidence is not
“commensurate in scope” with the claims. Ans. 13. The Examiner also
found that the experiments did not persuasively establish unexpected results
because they utilized utricle explants treated with neomycin to ablate the
cells, while the “conditions” recited in the claims are different. Ans. 13.
Appellant did not provide a response to this argument, e.g., by filing a Reply
Brief under 37 C.F.R §§ 41.40 and 41.41.
We agree with the Examiner’s determination. See Ans. 13.
“Unexpected results” must be commensurate in scope with the claim to
ensure that such results are representative of the entire claim scope to which
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Application 14/024,749
the patent applicant is entitled. In re Harris, 409 F.3d 1339, 1344 (Fed. Cir.
2005).
In this case, the representative claim 1 is directed to “administering to
the inner ear a pharmaceutical composition comprising a serotype 28
adenoviral vector comprising a nucleic acid sequence encoding an atonal-
associated factor.” The method, as stated by Appellant, is an in vivo method
(“especially in the context of changing the sensory perception of an animal
or generating a hair cell in differentiated sensory epithelia in vivo, as
required by the appealed claims”). Br. 7. The results reported by
Dr. Brough in his declaration are for an in in vitro method performed on
utricle explants placed in culture (“utrical cultures”). Brough Decl. ^ 4.
Appellant did not explain why the results from an in vitro model establish
unexpected results for an in vivo method performed on an animal. Thus, the
Examiner reasonably found that the conditions were different and not
commensurate in scope with claim 1 which is directed to an in vivo method.
Furthermore, as indicated by the Examiner, the results were obtained
by ablation with neomycin (Ans. 13) and using a single atonal-associated
gene, Hathl (Office Action 31). However, the claims are unrestricted as to
the state of the inner ear and the atonal-associated gene used to generate
sensory hair cells. Appellant did not provide evidence that the results obtain
with the in vitro model, utilizing neomycin to ablate cells and the Hathl
gene, would produce unexpected results for the full scope of the claim.
Thus, we agree with the Examiner that the Declaration evidence is not
commensurate with the full scope of claim 1, and thus fails to establish
unexpected results for the claim. Accordingly, because Appellant did not
identify a defect in the prima facie obviousness rejections, each of which are
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Application 14/024,749
based on the combination of Zoghbi and Kaplan, nor establish unexpected
results for the scope of the claim, we affirm the rejection of claim 1 as
obvious in view of Zoghbi and Kaplan. Claims 2-5 and 9-34 fall with claim
1 because separate arguments for their patentability were not provided. See
37C.F.R. §41.37(c)(l)(iv).
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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