Ex Parte Vogels et al

Patent Trial and Appeal Board

May 18, 2017

12460678 (P.T.A.B. May. 18, 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.
12/460,678 07/23/2009 Ronald Vogels 2578-7188.1US 8638
24247 7590 05/22/2017
TRASKBRITT, P.C.
P.O. BOX 2550
SALT LAKE CITY, UT 84110
EXAMINER
MARVICH, MARIA
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
05/22/2017 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):
U S PTOMail @ traskbritt .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RONALD VOGELS, ANGELIQUE A.C. LEMCKERT, and
MENZO J.E. HAVENGA
Appeal 2015-000875
Application 12/460,678
Technology Center 1600
Before CHRISTOPHER G. PAULRAJ, TAWEN CHANG, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a recombinant adenoviral gene therapy or a recombinant
adenoviral vaccination vector. Claims 26—28 and 35—37 are on appeal as
rejected under 35 U.S.C. § 112, first paragraph, as failing under the written
description requirement. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
Appeal 2015-000875
Application 12/460,678
STATEMENT OF THE CASE
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claims 26 and 35 are the independent claims on appeal and
read as follows:
26. A recombinant adenoviral gene therapy or a recombinant
adenoviral vaccination vector, comprising
a heterologous gene of interest operatively linked to a promoter,
wherein the adenovirus is adenovirus serotype 49,
with the proviso that the heterologous gene of interest does not
comprise a nucleic acid sequence encoding antigens of the
Ag85A, Ag85B and TB10.4 open reading frames of
Mycobacterium tuberculosis in the 5 ’ to 3 ’ direction, and
with the further proviso that the heterologous gene of interest
does not comprise a nucleic acid encoding a polyprotein
comprising at least an antigen, a protease-recognition site and a
protease.
35. A recombinant adenoviral gene therapy or a recombinant
adenoviral vaccination vector, comprising
a heterologous gene of interest operatively linked to a promoter,
wherein the adenovirus is adenovirus serotype 49,
with the proviso that the heterologous gene of interest does not
comprise a nucleic acid sequence encoding an antigen of
Mycobacterium tuberculosis, and
with the further proviso that the heterologous gene of interest
does not comprise a nucleic acid encoding a polyprotein
comprising at least an antigen, a protease-recognition site and a
protease.
App. Br. 22—23 (Claims App’x).
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Application 12/460,678
The following rejection is on appeal:
Claims 26—28 and 35—37 stand rejected under 35U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
Final Action 6.
DISCUSSION
We adopt the Examiner’s findings of fact, reasoning, and conclusions
set out in the Final Action and Answer. We find the Examiner has
established that the claims lack written description support under 35 U.S.C.
§112, first paragraph. Appellants have not produced evidence showing, or
persuasively argued, that the Examiner’s determinations are incorrect. Only
those arguments made by Appellants in the Briefs have been considered in
this Decision. Arguments not presented in the Briefs are waived. See 37
C.F.R. § 41.37(c)(l)(iv) (2015). We find claim 35 to be representative and
Appellants, essentially, argue all claims together.1 Therefore, all claims fall
with claim 35.
A specification may satisfy the written description requirement when,
at a minimum, ‘“the essence of the original disclosure’ conveys the
necessary information — ‘regardless of how it’ conveys such information,
and regardless of whether the disclosure’s ‘words [a]re open to different
interpretation^].’” Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1354 (Fed.
Cir. 2015) (quoting In re Wright, 866 F.2d 422, 424—25 (Fed.Cir.1989)
(citation and internal quotation marks omitted)). Nevertheless, to satisfy the
1 Although Appellants set claim 26 apart in a separate section, the arguments
for the patentability thereof are cumulative of those made for claim 35. App.
Br. 20.
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written description requirement, the specification must describe an invention
understandable to the skilled artisan and show that the inventor actually
invented the claimed invention, and the specification must clearly allow the
skilled artisan to recognize such invention by the inventors. Ariad Pharm.,
Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.Cir.2010) (enbanc); Vas-
Cathlnc. v. Mahurkar, 935 F.2d 1555, 1562—63 (Fed.Cir.1991).
While “negative claim limitations” are governed by the same general
law covering the written description requirement as positively recited claim
elements, our reviewing court has also specifically addressed this category
of claim limitations. In particular, the Federal Circuit has held that
“[njegative claim limitations are adequately supported when the
specification describes a reason to exclude the relevant limitation.”
Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1351 (Fed. Cir. 2012).
However, “Santarus did not create a heightened written description standard
for negative claim limitations and . . . properly described, alternative features
are sufficient to satisfy the written description standard of § 112, paragraph 1
for negative claim limitations.” Inphi, 805 F.3d at 1357 (“distinction
‘reasonably conveys’ a reason to exclude”).
The Examiner
‘bears the initial burden ... of presenting a prima facie case of
unpatentability.’ In re Oetiker, 977 F.2d 1443, 1445, 24
USPQ2d 1443, 1444 (Fed. Cir. 1992). Insofar as the written
description requirement is concerned, that burden is discharged
by ‘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.’ ... If the applicant claims
embodiments of the invention that are completely outside the
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scope of the specification, then the examiner . . . need only
establish this fact to make out aprima facie case.
In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996).
Here, we identify the claim language at issue in this appeal to be
negative claim limitations, that is, limitations expressly excluding certain
nucleic acid sequences from the heterologous gene of interest in the
“recombinant gene therapy” or “vector” of the claimed invention. App. Br.
23; see also claim 35 above. The claim recites: “the heterologous gene of
interest does not comprise a nucleic acid sequence encoding an antigen of
Mycobacterium tuberculosis, and . . . does not comprise a nucleic acid
encoding a polyprotein comprising at least an antigen, a protease-recognition
site and a protease.” Based on the guidance of our reviewing court,
therefore, the rejection and Appellants’ arguments present us with the
following questions of fact:
Question: does the Specification identify any reason to exclude
the recited nucleic acid sequences?
Question: is there any evidence that genes encoding an antigen
of Myobacterium tuberculosis (and/or encoding a polyprotein
comprising an antigen, protease-recognition site, and protease)
are so well known in the art as included in adenoviral gene
therapy as claimed, such that their omission from a nucleic acid
sequence (or vector) would be understood by the skilled artisan
simply by their not being mentioned?
Question: does the Specification identify alternative features
where the nucleic acid sequences recited by the claims as
excluded from the invention are identified as such alternatives?
We find the answer to each of these questions to each be “no.”
Because each answer is “no,” we agree with the Examiner that the
Specification does not include a written description of the claimed invention.
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Appellants argue:
In rejecting claim 35, the Examiner erroneously concluded that
this claim lacks adequate written description, because the
appellants did not adequately describe subject matter that has
been omitted from the scope of the claim by amendment; vectors
wherein the heterologous gene of interest is a nucleic acid
sequence encoding an antigen of Mycobacterium tuberculosis.
In reaching this conclusion, the Examiner applies an
inappropriate legal analysis. The correct analysis addresses the
question of whether the scope of what is claimed (as opposed to
what is not) is described by the as-filed application, in view of
the understanding of one skilled in the art.
App. Br. 6. This is an incorrect statement of the facts. Here, the claims
affirmatively and expressly recite as a limitation what must not be present in
the invention — in other words, negative limitations. Contrary to
Appellants’ contention, therefore, the Examiner has not required description
of features that are merely omitted from the claims. For these reasons,
Appellants’ argument is not persuasive.
Appellants argue the Examiner has not met the initial burden of
presenting evidence that the skilled artisan would not have recognized the
inventors as being in possession of the claimed invention (claim 35). App.
Br. 6. We are not persuaded by this argument.
The Examiner has identified that the Specification fails to mention
any gene encoding antigens of Ag85A, Ag85b, or TB10.4 open reading
frames (of claim 26), or any gene encoding a Mycobacterium tuberculosis
antigen or a gene encoding a polyprotein comprising an antigen and a
protease recognition site and a protease (of claims 26 and 35). Final Action
5. Thus, the Examiner concluded there is no description in the specification
supporting the negative limitations. Final Action 5; Ans. 3. “When no . . .
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description can be found in the specification, the only thing the PTO can
reasonably be expected to do is to point out its nonexistence.” Hyatt v.
Dudas, 492 F.3d 1365, 1370 (Fed. Cir. 2007). The Examiner also
determined that there would, likewise, be no support in the Specification for
including the nucleotide sequences identified (as omitted) in the appealed
claims in an embodiment of the invention (e.g., as alternatives). Final
Action 7. Thus, there is no literal support for excluding the claim elements
and no support for them as alternatives.
We are satisfied that the lack of any mention in the Specification of
the claimed subject matter in question presents a prima facie case that the
claims fail under 35 U.S.C. § 112, first paragraph, as not supported by a
written description. If something in the Specification beyond a literal
disclosure must suffice as a supporting disclosure, Appellants must produce
evidence of such, and mere attorney argument will not do. “Attorneys’
argument is no substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d
1574, 1581 (Fed. Cir. 1989).
Appellants contend, “[cjlaim 35 is supported by adequate written
description in the as-filed application, because one of skill in the art at the
time the invention was made would have recognized the appellants to have
been in possession of every vector claimed therein.” App. Br. 8. However,
Appellants do not present any evidence to support this contention, but only
attorney argument. Again, this will not suffice. Johnston, 885 F.2d at 1581.
SUMMARY
The rejection of claims 26—28 and 35—37 under 35 U.S.C. § 112, first
paragraph, is affirmed.
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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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