Ex Parte BENEDICT

Patent Trial and Appeal Board

Sep 14, 2018

14924136 (P.T.A.B. Sep. 14, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/924,136 10/27/2015 William F. BENEDICT
22925 7590 09/18/2018
PHARMACEUTICAL PATENT ATTORNEYS, LLC
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United States Patent and Trademark Office
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ATTORNEY DOCKET NO. CONFIRMATION NO.
Canji - 60/528525 9792
EXAMINER
ANGELL, JONE
ART UNIT PAPER NUMBER
1674
NOTIFICATION DATE DELIVERY MODE
09/18/2018 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):
docket@LicensingLaw.net
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM F. BENEDICT
Appeal2017-008598
Application 14/924, 136
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FRED MAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a
composition of matter. The Examiner rejected the claims as anticipated
under 35 U.S.C. 102(b), or alternatively under 35 U.S.C. 102(e), and
obvious under 35 U.S.C. § 103(a). The Examiner also rejected claim 3 under
1 Appellant identifies the Real Party in Interest as FKD Therapies Oy (see
App. Br. 1).
2 We have considered and herein refer to the Specification of October 27,
2015 ("Spec."); Final Office Action of Apr. 22, 2016 ("Final Act."); Appeal
Brief of Sept. 12, 2016 ("App. Br."); Examiner's Answer of Jan. 18, 2017
("Ans."); Provisional Application 60/528,525 ("'525 application"), filed
Dec. 10, 2003; Application 11/009,689 ("'689 application"), filed Dec. 10,
2004; Application 12/706,625 ("'625 application"), filed Feb. 16, 2010;
Examination Support Document of October 27, 2015 ("ESD"); and Petition
to Make Special dated Oct. 27, 2015 ("Pet.")
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Application 14/924, 13 6
35 U.S.C. 112, 1st paragraph. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
Statement of the Case
Background
"The present invention further provides compositions useful in the
treatment of interferon resistant tumors using recombinant vectors encoding
interferons" (Spec. iF). "[M]any patients present cancer which is
'interferon-resistant'; that is, showing little or no response to intravenously-
injected interferon polypeptide" (App. Br. 1:14--16). "Gene therapy
employing recombinant vectors encoding interferon species provides a
promising alternate approach to the treatment of refractory superficial
bladder cancer" (Spec. i-f6). The "experiments demonstrate that recombinant
vector delivered interferons possess unique properties distinct from
commercially available recombinant IFN protein and that vectors encoding
IFN can overcome resistance to the IFN protein" (Spec. ,I46).
The Claims
Claims 1-9 are on appeal. Claim 1 is representative and reads as
follows:
1. A composition of matter comprising: a non-interferon
agent which induces interferon production in human cells
which are exposed to it, said agent being replication-deficient,
said agent formulated in normal saline as a non-emulsified
suspension suitable for intravesical irrigation, said formulation
providing said agent in an amount sufficient to induce
interferon production in human bladder cells, said formulation
further providing said agent in an amount effective to treat non-
muscle invasive bladder cancer.
2
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The Rejections3
A. The Examiner rejected claims 1--4 and 6-8 under 35 U.S.C. § 102(b)
as anticipated by Ahmed4 (Ans. 9--11).
B. The Examiner rejected claims 1-9 under 35 U.S.C. § 103(a) as
obvious over Ahmed and Yamashita5 (Ans. 13-14).
C. The Examiner rejected claims 1-8 under 35 U.S.C. § 102(b), or
alternatively under 35 U.S.C. 102(e), as anticipated by Connor6 (Ans. 8).
D. The Examiner rejected claims 1-9 under 35 U.S.C. § 103(a) as
obvious over Connor (Ans. 11 ).
E. The Examiner rejected claims 1-9 under 35 U.S.C. § 103(a) as
obvious over Benedict7 and Connor (Ans. 12-13).
F. The Examiner rejected claim 3 under 35 U.S.C. 112, 1st paragraph as
failing to comply with the written description requirement (Ans. 5-7).
3 The Examiner objected to the specification for failing to provide support for the
claimed subject matter but did not reject the claims under 35 U.S.C. § 112, first
paragraph as containing new matter (Final Act. 4--6). The propriety of the Examiner's
objections relate to petitionable matters and not to appealable matters. Objections are
petitionable matters under 3 7 C.F .R. § 1.181 to the Director of the US PTO. See
MPEP § 706.01. Accordingly, we will decline to address the objections of record.
4 Ahmed et al., Interferon a2b gene delivery using adenoviral vector causes
inhibition of tumor growth in xenograft models from a variety of cancers,
8(10) CAN. GENE THERAPY, 788-795 (2001).
5 Yamashita et al., Syn3 provides high levels of intravesical adenoviral-
mediated gene transfer for gene therapy of genetically altered urothelium
and superficial bladder cancer, 9 CAN. GENE THERAPY, 687-691 (2002).
6 Connor et al., US 7,355,056 B2, issued April 8, 2008.
7 Benedict et al., lntravesical Ad-IFNa Causes Marked Regression of
Human Bladder Cancer Growing Orthotopically in Nude Mice and
Overcomes Resistance to IFN-a Protein, 10(3) MOL. THERAPY, 525-532
(2004).
3
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A andB. Anticipation over Ahmed and Obviousness over Ahmed and
Yamashita
Because both of these rejections tum on the same issue and rely upon
Ahmed, we will consider them together.
We begin with claim interpretation. The Specification states that
recombinant adenoviral vectors have been demonstrated to be
safe and effective in human beings in the dosage range between
lx105 and lxl0 12 viral particles per dose in a multiple dosing
regimen over a period of several weeks. Consequently,
administration of recombinant adenoviral vectors encoding
interferon may be used in such dosage ranges. In the preferred
practice of the present invention for the treatment of superficial
bladder cancer in human beings, [a] course of treatment
comprising a dose of from lxl0 10/ml to lxl0 12/ml (most
preferably approximately 1x10 11 /ml) recombinant adenoviral
particles encoding interferon a2b in a volume of approximately
100 ml is instilled intravesically for a period of approximately
one hour.
(Spec. ifif58-59).
Therefore, consistent with the Specification, we interpret a
formulation providing said agent in "an amount sufficient to induce
interferon production in human bladder cells" as required by claim 1 as
encompassing an amount in the range of lxl0 10/ml to lx10 12/ml.
The Examiner finds that Ahmed teaches "a composition of matter
comprising a non-interferon agent which induces interferon production in
human cells which are exposed to it[,] said agent being replication-deficient,
said formulation providing said agent in an amount sufficient to induce
interferon production in human bladder cells" (Ans. 9).
The Examiner finds that "Ahmed specifically teaches that lxl0 10
particles of the recombinant adenovirus was formulated in 100µ1 PBS for
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administration" and that this formulation is "suitable for intravesical
irrigation" (Ans. 18).
The issue with respect to these rejections is: Does the evidence of
record support the Examiner's conclusion that Ahmed anticipates the claims
or, in combination with Yamashita, renders the claims obvious?
Findings of Fact
"A composition of matter comprising a non-interferon agent which
induces interferon production in human cells which are exposed to it"
1. Ahmed teaches a "recombinant adenovirus expressing human
interferon a2b driven by the cytomegalovirus promoter, IACB was shown to
produce and secrete biologically active ... human interferon" (Ahmed
abstract).
2. The recombinant adenovirus is non-interferon, because it is a
recombinant adenovirus that expresses interferon and not interferon itself
(see ESD 2).
3. The recombinant adenovirus is a composition of matter (see
ESD 2).
"said agent being replication-deficient"
4. Ahmed teaches "the use of a replication-deficient adenovirus
expressing interferon a2b" (Ahmed 788).
"said agent formulated in normal saline as a non-emulsified
suspension"
5. Ahmed teaches that "[p ]hosphate buffered saline [PBS] ... was
used as the 'vehicle control' for in vivo studies," thereby indicating that the
vehicle is PBS. (Ahmed 789).
5
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"suitable for intravesical irrigation"
6. Ahmed teaches that "lxl010 particles of IACB ... in 100 µL
were administered" (Ahmed 789).
7. The Specification states that "[ w ]hen the delivery system is
formulated as a solution or suspension, the delivery system is in an
acceptable carrier, preferably an aqueous carrier. A variety of aqueous
carriers may be used, e.g., water, buffered water, 0.8% saline, 0.3% glycine,
hyaluronic acid and the like" (Spec. ,r 51 ).
"said formulation providing said agent in an amount sufficient to
induce inteiferon production in human bladder cells"
8. Ahmed teaches a "recombinant adenovirus expressing human
interferon a2b driven by the cytomegalovirus promoter, IACB was shown to
produce and secrete biologically active ... human interferon" (Ahmed
abstract).
"said formulation further providing said agent in an amount effective
to treat non-muscle invasive bladder cancer"
9. Ahmed teaches "lxl010 particles ofIACB ... in 100 µL were
administered" (Ahmed 789). lxl0 10 particles in 100 µL= 100 µL of a lxl0 11
particles/mL solution, because 100 µL = 0 .1 mL.
10. The Specification states
[i]n the preferred practice of the present invention for the
treatment of superficial bladder cancer in human beings, [a]
course of treatment comprising a dose of from lxl0 10/ml to
lxl0 12/ml (most preferably approximately lxl0 11/ml)
recombinant adenoviral particles encoding interferon a2b in a
volume of approximately 100 ml is instilled intravesically for a
period of approximately one hour
(Spec. i-f 59).
6
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11. Yamashita teaches that "Syn3, when injected intravesically for
1 hour at 1 mg/ml on two consecutive days, markedly increases rAd-B-gal
intravesical gene transfer and expression" in "human bladder cancer"
(Yamashita abstract).
Principles of Law
Anticipation under 35 U.S.C. § 102 requires that "'each and every
element as set forth in the claim is found, either expressly or inherently
described, in a single prior art reference"' In re Robertson, 169 F.3d 743,
745 (Fed. Cir. 1999).
"It is well settled that 'anticipation is the epitome of obviousness."'
In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002).
Analysis
We adopt the Examiner's findings of fact and conclusions of law (see
Ans. 9-24; FF 1-11) and agree that Ahmed anticipates the claims and
therefore renders the claims obvious. We also find the combination with
Yamashita renders the rejected claims obvious. We address Appellant's
arguments below.
Appellant contends that claim "1 requires an amount sufficient to
induce interferon in human bladder. In contrast, Ahmed teaches treating
Buffalo rats and mice" (App. Br. 16).
We find this argument unpersuasive because Claim 1 requires "an
amount sufficient to induce interferon production in human bladder cells."
Ahmed teaches, consistent with our claim interpretation, treatment with
lxl0 11 particles/mL solution (FF 6, 9), a dosage amount squarely within the
range of lxl0 10/ml to lxl0 12/ml disclosed as functional by the Specification
(Spec. ,r 59). We therefore agree with the Examiner that the formulation
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necessarily provides an amount sufficient to induce interferon production in
human bladder cells (see Ans. 18).
We further note that Claim 1 does not require the administration of the
composition to a human, but rather simply requires an "amount sufficient to
induce interferon production in human bladder cells." At best, this
limitation is an attempt to import a method step into a product claim.
However, the "addition of a method step in a product claim, which product
is not patentably distinguishable from the prior art, cannot impart
patentability to the old product." In re Dilnot, 300 F.2d 945, 950 (CCPA
1962). Moreover, even if the claim recited the intended use of treatment of
humans, a "mere statement of a new use for an otherwise old or obvious
composition cannot render a claim to the composition patentable." In re
Zierden, 411 F.2d 1325, 1328 (CCPA 1969).
Appellant contends that "[ c ]laim 1 requires an agent formulated to be
'suitable for intravesical irrigation.' In contrast, Ahmed teaches formulating
an agent for intravenous injection and intra-tumoral injection, not
intravesical irrigation." (App. Br. 16).
We do not find this argument persuasive. While Claim 1 requires the
formulation of the agent to be "suitable for intravesical irrigation," neither
the Specification nor Claim 1 identify any specific structural formulation
requirements necessary for "intravesical irrigation" that distinguish the
claimed composition from the composition of Ahmed prepared in PBS (FF
5). "[ A Jpparatus claims cover what a device is, not what a device does."
Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed.
Cir. 1990). The same principle applies to a claimed composition of matter.
Appellant provides no evidence, as opposed to attorney argument, that the
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Application 14/924, 13 6
composition of Ahmed would not be suitable for intravesical irrigation. See
In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (Arguments and
conclusions unsupported by factual evidence carry no evidentiary weight.)
Appellant contends the Examiner erred in finding inherency for two
reasons (App. Br. 17-18). Appellant contends "Ahmed teaches that the
allegedly inherent characteristic is not necessarily present. To the contrary,
Ahmed shows how the claimed efficacy might not be present" (App. Br. 18).
Appellant notes that "Ahmed's own data therefore show that even between
two very similar routes of systemic injection, either intravenous or
intratumoral, response varied unpredictably" (App. Br. 19).
We do not find this argument persuasive because none of the claims
rejected based on Ahmed are drawn to a methods of treatment, but rather
these claims are drawn to particular compositions. Appellant provides no
specific evidence related to either intravesical administration or bladder
cancer that rebuts the Examiner's inherency position; instead, Appellant
points to evidence related to other modes of administration or other types of
cells (see App. Br. 18-20). We find this unpersuasive because"[ w ]here, as
here, the claimed and prior art products are identical or substantially
identical, or are produced by identical or substantially identical processes,
the PTO can require an applicant to prove that the prior art products do not
necessarily or inherently possess the characteristics of his claimed product."
In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Appellant has not satisfied
this burden of production by directly comparing the product of Ahmed by
intravesical administration into human bladder cells to demonstrate that the
product would not necessarily produce interferon in these cells in a sufficient
amount as required by Claim 1. In other words, "[ w ]hen the claimed
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compositions are not novel they are not rendered patentable by recitation of
properties, whether or not these properties are shown or suggested in the
prior art." In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990).
Appellant argues that the "Examiner correctly notes that Ahmed fails
to teach Syn3, as is required by claims 5 and 9. Yamashita and Ahmed fail
to establish prima facie obviousness" (App. Br. 21 ).
In the Petition to Make Special Under Accelerated Examination
Program, filed on October 27, 2015, Appellant agreed "not to separately
argue the patentability of any dependent claim during any appeal in the
application. Specifically, the applicant agrees that the dependent claims will
be grouped together with and not argued separately from the independent
claim from which they depend in any appeal brief filed in the application"
(Pet. 1 b)
We summarily affirm the Examiner's rejection, because Appellant
agreed not to argue the dependent claims (in this case, claims 5 and 9)
separately.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
Ahmed anticipates the claims. Moreover, the evidence of record supports
the Examiner's conclusion that Ahmed and Yamashita render the claims
obvious.
C, D, andE. Anticipation over Connor and Obviousness over Connor,
or alternatively, Benedict and Connor
Because all of the rejections tum on the same issue, we will consider
them together.
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This application is a continuation of Application 12/706,625 ("'625
application"), filed Feb. 16, 2010. The '625 application is a continuation of
11/009,689 ("'689 application"), filed December 10, 2004. Application
11/009,689 claims the benefit of 60/528,525 ("'525 application"), filed
December 10, 2003.
The Examiner denies these priority claims, finding the claim
limitations of "non-interferon agent which induces interferon production in
human cells which are exposed to it, said agent being replication deficient"
and "non-emulsified" were not described by the '525 application, the '689
application, or the '625 application (Ans. 3-5). The Examiner therefore
finds that "the effective filing date of the examined claims is 10/27/2015"
(Ans. 5).
The issue with respect to these rejections is: Does the evidence of
record support the Examiner's conclusion that the instant claims are not
entitled to the benefit of priority to the '525 application, the '689 application
and the '625 application?
Findings of Fact
"a non-inteiferon agent which induces interferon production in
human cells which are exposed to it, said agent being replication deficient"
12. The '525 provisional application teaches antigenic viruses
( adenovirus) which produce interferon, specifically teaching interferon
"concentrations reached almost 10,000,000 pg/ml (-2,500,000 IU) six days
after treatment with 50 MOI of Ad-IFNa2b" ('525 Spec. 19:20-21).
13. The '525 provisional application teaches interferon transgenes,
in teaching "promoters that facilitate transcription of the interferon
transgene" ('525 Spec. 9:26-27).
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14. The '525 provisional application teaches that the recombinant
adenovirus "may be engineered to be replication deficient" ('525 Spec.
11 :20-22).
"said agent formulated in normal saline as a non-emulsified
suspension"
15. The '525 provisional application teaches that the composition
can be formulated in saline as well as other aqueous carriers. ('525 Spec.
23:2-3).
16. The '525 provisional application teaches that the agent can be
encapsulated in liposomes and liposomes can include emulsions ('525 Spec.
21:29 to 22:9).
Principles of Law
Under 35 U.S.C. § 120, "in a chain of continuing applications, a claim
in a later application receives the benefit of the filing date of an earlier
application so long as the disclosure in the earlier application meets the
requirements of 35 U.S.C. § 112, ,r 1, including the written description
requirement, with respect to that claim." Tech. Licensing Corp. v. Videotek,
Inc., 545 F.3d 1316, 1326 (Fed. Cir. 2008).
Analysis
We adopt the Examiner's findings of fact and conclusions of law (see
Ans. 3-27; FF 12-16) and agree that Connor and Benedict are prior art
under 35 U.S.C. § 102(b). We therefore find that Connor anticipates the
claimed invention, and Benedict and Connor render the claims obvious. We
address Appellant's arguments below.
Appellant contends "the Examiner alleges that the inventor's priority
application fails to enable the instant claims. See Office Action (22 April
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2016) at 2-4. As support, the Examiner raises two arguments. The Examiner,
however, fails to provide the Board the evidence you would need to affirm
either one" (App. Br. 9).
We do not find Appellant's general statement of the issue persuasive
because it mischaracterizes the Examiner's priority issue as enablement
rather than written description. The Examiner found that the "prior
applications were searched but support for the composition as claimed in
claim 1 could not be found" (Final Act. 3). That is, the Examiner's priority
issue revolved around a failure to satisfy the written description requirement.
Under the written description requirement of 35 U.S.C. § 112, first
paragraph, the disclosure of the application relied upon must reasonably
convey to the artisan that, as of the filing date of the application, the inventor
had possession of the later-claimed subject matter. Vas-Cath, Inc. v.
Mahurkar, 935 F.2d 1555, 1562---63 (Fed. Cir. 1991).
Therefore, the written description requirement necessitates that in
order for a claim in an application to receive the benefit of priority to a
particular parent application, that parent application must provide descriptive
support for each and every element of that claim. Applying that rule here,
Appellant's independent claim 1 must be fully supported by the disclosures
provided in the '525 application, the '689 application, or the '625
application in order for the claims to receive priority benefit.
"Non-emulsified suspension"
Appellant contends "a disclosure contains not only its explicit
teachings, but also the inherent properties thereof' (App. Br. 9). Appellant
then contends that "formulating in buffered saline inherently produces a
non-emulsified suspension" and that a "'non-emulsified' suspension is
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therefore inherent in the priority application teaching of formulation in
saline" (App. Br. 10).
We agree with Appellant that the Examiner acknowledged that a
saline solution may be non-emulsified (see Final Act. 9: "Connor teaches a
composition ... formulated in normal saline ( and thus is a non-emulsified
solution"). In addition, the priority documents, as exemplified by the '525
provisional application, do teach that a "variety of aqueous carriers may be
used, e.g., water, buffered water, 0.8% saline" ('525 Spec. 23:2-3).
Therefore, we agree with Appellant that there is descriptive support for a
"non-emulsified suspension" as recited in claim 1.
"Replication deficient agents"
Appellant contends the "Examiner again errs by ignoring the
applicable legal standard. That legal standard says that claims need not be
limited to the specific examples in a disclosure. Rather, a specification
satisfies the enablement requirement as long as the specification discloses at
least one method to make the claimed invention" (App. Br. 11 ).
We find this argument unpersuasive because the Examiner's priority
issue was descriptive support, not enablement. The Examiner found that
the prior applications do not appear to provide support for the
broadly claimed "non-interferon agent which induces interferon
production in human cells which are exposed to it, said agent
being replication deficient". This limitation is very broad in the
sense that it encompasses any replication-deficient non-
interferon agent which induces interferon production in human
cells, and is much broader than that which is disclosed in any of
the prior applications. The prior applications do not provide
direct or implicit support for this broad limitation.
(Final Act. 3).
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The issue is not one of enablement, but one of adequate written
description. "Although there is often significant overlap" between the
enablement and written description requirements, "they are nonetheless
independent of each other." University of Rochester v. G.D. Searle & Co.,
358 F.3d 916, 921 (Fed. Cir. 2004). An "invention may be enabled even
though it has not been described." Id. To satisfy the written description
requirement an applicant must describe the invention is such a way as to
convey to one skilled in the art that applicant had the invention in his
possession when the application was filed. Ariad Pharms., Inc. v. Eli Lilly &
Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane).
In cases such as the instant application where a genus is claimed, the
specification must contain "either a representative number of species falling
within the scope of the genus or structural features common to the members
of the genus so that one of skill in the art can 'visualize or recognize' the
members of the genus." Id. at 1350.
The '525 application identifies only two types of "non-interferon
agent which induces interferon production in human cells which are exposed
to it" with general descriptions of viral and nonviral vectors (see '525 Spec.
9: 1-16). The '525 application details a single specific adenoviral vector (see
'525 Spec. 29: 12-21) with only general guidance ofnonviral vectors (see
'525 Spec. 10: 18 to 11 :2).
However, the unbounded claim recitation of a "non-interferon agent
which induces interferon production" encompasses any agent that induces
production of any interferon species, any viral vector, and any non-viral
vector, whether described in the prior art or not. Accordingly, this claim
recitation reasonably encompasses agents not described in any way in the
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Specification or in the priority applications, such as small molecules that
function to induce interferon production such as endotoxin or BCG (see ESD
10:2 "live BCG in stimulating cytokine signaling and interferon
expression.")
Therefore, we agree with the Examiner that neither the instant
Specification nor the '525 provisional application provide descriptive
support for a representative number of species sufficient to demonstrate
possession of the genus of "a non-interferon agent which induces interferon
production" as recited in Claim 1.
Therefore, because the priority documents do not provide sufficient
description support of Claim 1, this application is not entitled to the
December 10, 2003 filing date of the '525 application. Therefore, Connor
and Benedict are prior art under at least 35 U.S.C. § 102(b) and (e). 8
Appellant also argues that Connor is disqualified as prior art under 3 5
U.S.C. § 103(c), because it was commonly owned by the assignee of the
instant application (App. Br. 14--15). The cited statute, however, states that
"[s]ubject matter developed by another person,which qualifies as prior art
only under one or more ofsubsections (e), (!), and (g) of section 102 of this
title,shall not preclude patentability." 35 U.S.C. § 103(c) (emphasis added).
For the reasons discussed above, we conclude that Connor qualifies as prior
art under 35 U.S.C. § 102(b), and thus 35 U.S.C. § 103(c) does not apply.
Appellant does not address the merits of the 35 U.S.C. § 102(b)
rejection over Connor or the 35 U.S.C. § 103(a) rejection over Benedict in
8 We note that Appellant indicates an intention to submit a Declaration that
would antedate Connor (see App. Br. 14, footnote). However, no such
Declaration is currently of record, and we therefore do not address this issue.
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view of Connor. Appellant merely asserts that these references are not prior
art (App. Br. 8-15; 23).
Therefore, we affirm the rejection of claims 1-8 under 35 U.S.C.
§ 102(b), or alternatively 35 U.S.C. § 102(e), as anticipated by Connor. We
also affirm the rejections of claims 1-9 under 35 U.S.C. § 103(a) based on
35 U.S.C. § 102(b) as obvious over Connor, or alternatively, the
combination of Benedict and Connor.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
Connor anticipates the claims. Moreover, the evidence of record supports
the Examiner's conclusion that Connor, or alternatively, Benedict and
Connor, render the claims obvious.
F. Rejection of Claim 3 under 35 US.C. 112, 1st Paragraph
The Examiner finds
Claim 3 was amended by the claim amendment submitted
12/10/2015. The amendment introduced the new limitation
indicating that the antigen comprises a viral antigen of a
replication-deficient virus. Applicant has not indicated where
support for the new limitation can be found, and a search of the
original disclosure did not identify support for the new
limitation. Therefore, the claim is rejected under 35 USC 112,
first paragraph as it include[s] new matter not supported by the
original disclosure.
(Ans. 6).
Appellant contends: "Whatever 'new matter' is, it does not include the
inherent physical properties of materials discussed in a specification. To the
contrary, inherent properties of materials discussed in the specification are
inherently disclosed in that specification" (App. Br. 6: 18-21 ). Appellant
contends "the Specification teaches a variety of antigenic viruses. See
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Specification 10: 15-17. These viruses inherently have antigens. Those
antigens inherently induce interferon expression. See e.g., Specification at
10:32 (adenovirus elicits an antibody response in humans; antibodies are
made in response to antigen)" (App. Br. 7:12-16).
We agree with the Examiner that
the disclosure is not commensurate in scope with the new
limitation because the newly claimed genus of antigens that is
any viral antigen of any replication-deficient virus is much
broader than that which was disclosed in the application as
filed, and there is nothing in the specification that would
indicate that applicant envisioned the newly claimed genus of
antigens at the time the application was filed.
(Ans. 29).
The Federal Circuit confronted facts analogous to those here in
University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916 (Fed. Cir.
2004). In that case, the patent claimed a method of selectively inhibiting the
enzyme PGHS-2 (also known as COX-2) by "administering a non-steroidal
compound that selectively inhibits activity of the PGHS-2 gene product to a
human." Id. at 918. The patent "describe[d] in detail how to make cells that
express either COX-I or COX-2, but not both ... as well as 'assays for
screening compounds, including peptides, polynucleotides, and small
organic molecules to identify those that inhibit the expression or activity of
the PGHS-2 gene product.[']" Id. at 927.
Rochester held that the disclosure of general classes of compounds
such as the "viral antigen of a replication-deficient virus" in instant claim 3
was not adequate to describe compounds having the desired activity without
disclosure of which peptides, polynucleotides, or small organic molecules
have the desired characteristic, and therefore the claims failed to meet the
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Application 14/924, 13 6
description requirement of§ 112. See id. ("As pointed out by the district
court, ... the '850 patent does not disclose just 'which "peptides,
polynucleotides, and small organic molecules" have the desired
characteristic of selectively inhibiting PGHS-2.' ... Without such
disclosure, the claimed methods cannot be said to have been described.").
Similar to Rochester, the present application discloses a broad genus
of viruses (see Spec. 10:14--17) including genetically modified viruses (see
Spec. 10: 18-25), but the claims are limited to only those antigens having the
desired function for the agent "which induces interferon production in
human cells which are exposed to it" as recited in claim 1.
The present Specification does not identify an example of antigen that
induces interferon, nor does the Specification describe such an antigen. It is
the breadth of that function of inducing interferon, unconstrained by
structure or representative species, which underlies the Examiner's written
description rejection. See Regents of the University of California v. Eli Lilly
& Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997) ("[N]aming a type of material
generally known to exist, in the absence of knowledge as to what that
material consists of, is not a description of that material.")
SUMMARY
In summary, we affirm the rejections of claim 1 as anticipated by
Ahmed and Connor.
We affirm the rejections of claim 1 as obvious over Ahmed, Connor,
and the combination of Benedict and Connor. Pursuant to 37 C.F.R. §
41.3 7 ( c )(1) and the Petition to Make Special, we also affirm the prior art
rejections over claims 2-9.
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Application 14/924, 13 6
We affirm the rejection of claim 3 under 35 U.S.C. 112, 1st paragraph
as failing to comply with the written description requirement.
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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