Ex Parte Hurley

Patent Trial and Appeal Board

Feb 13, 2013

11906588 (P.T.A.B. Feb. 13, 2013)

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.
11/906,588 10/03/2007 Scott B. Hurley 12411-2 8103
20694 7590 02/14/2013
WOLFF & SAMSON, P.C.
ONE BOLAND DRIVE
WEST ORANGE, NJ 07052
EXAMINER
NELSON, KERI JESSICA
ART UNIT PAPER NUMBER
3772
MAIL DATE DELIVERY MODE
02/14/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte SCOTT B. HURLEY
__________

Appeal 2011-002460
Application 11/906,588
Technology Center 3700
__________

Before LORA M. GREEN, JEFFREY N. FREDMAN, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to
contraceptive method. The Examiner rejected the claims as indefinite and as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

Statement of the Case
Background
The Specification teaches “a contraception method having a
concomitant use of an immunocontraceptive agent with another method of
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contraception to boost the real world efficacy rate of the primary
contraceptive method to between 95% and 100% efficacy” (Spec. 5 ¶ 0009).
The Claims
Claims 1-11 and 13-17 are on appeal. Claim 1 is representative and
read as follows:
1. A contraceptive method, comprising the steps of:
using a primary contraceptive; and
administering a secondary, immunocontraceptive;
wherein the administering of the secondary,
immunocontraceptive is initiated prior to the using of the
primary contraceptive.

The issues
A. The Examiner rejected claims 9, 10, and 13 under 35 U.S.C. § 112,
second paragraph, as indefinite (Ans. 3-4).
B. The Examiner rejected claims 1-9, 11, and 13-17 under 35 U.S.C. §
103(a) as obvious over Oko
1
(Ans. 5-7).
C. The Examiner rejected claim 10 under 35 U.S.C. § 103(a) as obvious
over Oko and Miller
2
(Ans. 7).
D. The Examiner rejected claims 15 and 16 under 35 U.S.C. § 103(a) as
obvious over Oko and Saffir
3
(Ans. 7-8).
A. 35 U.S.C. § 112, second paragraph
The Examiner finds that “further limiting the method with the step of
„repeating the administering at predetermined intervals‟ is unclear and
indefinite since the controlling independent claim requires

1
Oko et al., US 6,995,252 B2, issued Feb. 7, 2006.
2
Miller et al., US 2006/0013821 A1, published Jan. 19, 2006.
3
Saffir et al, US 2,853,071, issued Sep. 23, 1958.
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immunocontraceptive administration initiation prior to the using of the
primary contraceptive” (Ans. 4). The Examiner finds “it is unclear if
claims 9 and 10 are attempting to further limit subsequent administration(s)
of the immunocontraceptive” (id.). The Examiner also finds, regarding
claim 13, that “it is unclear how a subsequent method step is to be achieved
which limits „during use‟ or simultaneous administration of
immunocontraceptive and primary contraceptive. The claim is indefinite,
because it is unclear what applicant is attempting to claim” (id.).
Appellant “submit[s] that there is no indefiniteness based on the use
of the term „initiate‟ as is commonly used and as used in the claims” (App.
Br. 4). Appellant contends that the claims are “directed to subsequent
administrations of the secondary immunocontraceptive after the initial
administration” (id.). Appellant contends that these “subsequent
administrations may be prior to, during, or subsequent to administration of
the primary contraceptive” (id.). Appellant contends that “[c]laim l3 further
limits claim 1 indicating that the immunocontraceptive is also administered
during use of the primary contraceptive” (id. at 5).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that claims 9, 10, and 13 are
indefinite?
Principles of Law
“The test for definiteness is whether one skilled in the art would
understand the bounds of the claims when read in light of the specification.”
Miles Laboratories, Inc. v. Shandon, Inc., 997 F.2d 870, 875 (Fed. Cir.
1993).
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Analysis
We agree with Appellant that the hypothetical person of ordinary skill
in the art would reasonably interpret claims 9 and 10, in light of the
Specification, as simply requiring that, after an initial administration of the
immunocontraceptive prior to the use of a primary contraceptive consistent
with claim 1, additional doses of the immunocontraceptive are administered
to the patient, before or after the use of the primary contraceptive. We also
agree that claim 13 simply further limits the claim to require that at least one
second or later dose of the immunocontraceptive is administered during the
use of the primary contraceptive.
Contrary to the Examiner‟s concern, these claims simply require that
additional doses of the immunocontraceptive are administered, after an
initial dose prior to primary contraceptive use, without providing a specific
time frame for the additional doses. Consistent with claims 9 and 10, the
additional doses may, like the first dose, be administered prior to the
initiation of the primary contraceptive, or unlike the first dose, be
administered later, after initiation of the primary contraceptive.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that claims 9, 10, and 13 are indefinite.
B. 35 U.S.C. § 103(a) over Oko
The Examiner finds that “Oko discloses a contraceptive method,
comprising the steps of using a primary contraceptive; and administering a
secondary, immunocontraceptive such as PT32 and c-Yes proteins (col 21,
lines 33-36) to boost overall efficacy of the contraceptives” (Ans. 5). The
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Examiner finds that “Oko fails to explicitly disclose in which order the
contraceptives are administered, specifically administering the
immunocontraceptive prior to using the primary contraceptive” (id.).
The Examiner finds it obvious “that in order to achieve an effective
contraceptive means utilizing an immunocontraceptive, the peptide product
must be administered well in advance of intercourse to ensure that the
immunocontraceptive has reached an effective titer level in the user to be
efficacious” (id.). The Examiner finds “reliance upon a combination of
contraceptive means is well known in the art. For instance, it is common for
a user to be using a pill based contraceptive, which is ingested or initiated
prior to insertion of a sponge or diaphragm before intercourse” (id.).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that Oko renders claim 1 obvious?
Findings of Fact
1. Oko teaches that the “PT32 and c-Yes proteins also are useful
in the field of contraception. Specifically, the PT32 and/or c-Yes protein can
be used as targets in conventional immunocontraception methods” (Oko, col.
21, ll. 34-37).
2. Oko teaches that “a chimeric protein containing all or an
antigenic portion of PT32 or c-Yes is administered to the mammal in a
contraceptively effective dosage” (Oko, col. 21, ll. 45-48).
3. Oko teaches that the proteins “may be administered with a
suitable . . . depot (slow release) formulation to allow prolonged exposure of
the protein to the host mammal's immune system. A contraceptively
effective dosage is a dosage sufficient to elicit the production of an immune
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response (e.g., antibody or immune cell production) in the mammal” (Oko,
col. 21, ll. 50-56).
4. Oko teaches that “conventional foams, gels, sponges,
suppositories, creams, tablets, controlled delivery devices, vaginal-soluble
waffles, ointments, lotions, sprays, jellies, patches, and lubricants (e.g., for
condoms, diaphragms, cervical caps), and the like can be used in
conjunction with the molecules of the invention” (Oko, col. 22, ll. 44-49).
5. Oko teaches that “[s]uch foams, creams, and the like can be
administered, e.g., intravaginally, to a mammal to provide a contraceptive
(e.g., a contraceptive barrier) in a contraceptive method (e.g., to inhibit
fertilization)” (Oko, col. 22, ll. 54-58).
6. Oko teaches that “[p]olypeptides and other molecules of the
present invention may be employed alone or in conjunction with other
compounds, such as therapeutic or contraceptive compounds” (Oko, col. 22,
ll. 61-63).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417. As noted by the Court in KSR, “[a] person of
ordinary skill is also a person of ordinary creativity, not an automaton.” 550
U.S. at 421.
“Appellant contends that the references taken singly or together do not
teach his characteristic four steps . . . . There is no merit in the point here in
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the absence of any proof in the record that the order of performing the steps
produces any new and unexpected results.” In re Burhans, 154 F.2d 690,
692 (CCPA 1946).
Analysis
Oko teaches a method of using an immunocontraceptive (FF 1-3).
Oko further teaches that “conventional foams, gels, sponges, suppositories,
creams, tablets, controlled delivery devices, vaginal-soluble waffles,
ointments, lotions, sprays, jellies, patches, and lubricants (e.g., for condoms,
diaphragms, cervical caps), and the like can be used in conjunction with the
molecules of the invention” (Oko, col. 22, ll. 44-49; FF 4).
The Examiner acknowledges that Oko “fails to explicitly disclose in
which order the contraceptives are administered” (Ans. 5).
We agree with the Examiner that “the peptide product must be
administered well in advance of intercourse to ensure that the
immunocontraceptive has reached an effective titer level in the user to be
efficacious” (id.). Therefore, when the “primary contraceptive” in use is one
of condoms, sponges, cervical caps, foams, suppositories, diaphragms, or
other barrier type methods, it is a necessary and inherent result that the
immunocontraceptive will be initiated prior to the use of the primary
contraceptive, since unlike the immunocontraceptive which would be
administered well in advance of intercourse, primary barrier contraceptives
would be administered immediately prior to intercourse.
Appellant “submits that this fails to disclose or suggest the feature of
claim 1 that the administering of the secondary, immunocontraceptive is
initiated prior to the using of the primary contraceptive” (App. Br. 7).
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We are not persuaded. We find that the reasoning in Burhans applies.
In Burhans, the Appellant identified four steps for making an enriched flour,
where each of the steps was disclosed in the prior art. See Burhans, 154 F.2d
691-2. The court was unpersuaded, finding that in the absence of a
secondary consideration, the selection of any order of known process steps
would have been obvious. Id. We conclude that the same reasoning applies
in the instant case, where Oko expressly teaches the combination of
immunocontraceptives with other forms of contraception, and either order of
administration of immunocontraceptives and hormonal contraceptives or
IUDs would have been obvious to the ordinary artisan at the time the
invention was made in light of Oko‟s teachings (FF 1-6).
Appellant contends that “Oko teaches away from using an
immunocontraceptive prior to a primary contraceptive since Oko discloses
using „polypeptide, antibodies, or test compounds‟ with a carrier and/or
device conventionally used for delivering contraceptive or fertility-
enhancing agents” (App. Br. 7).
We do not find the teaching away argument persuasive. A teaching
away requires a reference to actually criticize, discredit, or otherwise
discourage the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed.
Cir. 2004) (“The prior art‟s mere disclosure of more than one alternative
does not constitute a teaching away from any of these alternatives because
such disclosure does not criticize, discredit, or otherwise discourage the
solution claimed”). Appellant does not identify, and we do not find, any
teaching in Oko which criticizes, discredits, or otherwise discourages the
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initiation of immunocontraception prior to the use of other forms of
contraceptives.
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that Oko
renders claim 1 obvious.
C. 35 U.S.C. § 103(a) over Oko and Miller
The Examiner finds “Miller discloses an immunocontraceptive
vaccine in which an immune response can be maintained for a period of
months up to years” (Ans. 7). The Examiner finds it obvious to “practice the
method steps of Oko according to the administration time frame of between
once a month and once every five years as taught by Miller in order to
provide an elongated period of contraceptive efficacy that would not require
frequent immune boosters” (id.).
The Examiner provides sound fact-based reasoning for combining
Miller and Oko. We adopt the fact finding and analysis of the Examiner as
our own. Appellant‟s arguments are directed Oko, but not at the combination
of Oko and Miller. Therefore, consistent with the rejection which we
affirmed above, we affirm this rejection for the reasons stated by the
Examiner.
D. 35 U.S.C. § 103(a) over Oko and Saffir
The Examiner finds “Saffir discloses medicament vial or medicament
container or bottles for hypodermic solutions including single dose . . . and
multiple dose vials” (Ans. 8). The Examiner finds it obvious to package “the
contraceptives of Oko with packaging the secondary contraceptive as a
single dose, and packaging the secondary contraceptive as a multiple dose
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vial in order to provide known packaging techniques that are in line with the
needs of different users” (id.).
The Examiner provides sound fact-based reasoning for combining
Saffir and Oko. We adopt the fact finding and analysis of the Examiner as
our own. Appellant‟s arguments are directed Oko, but not at the combination
of Oko and Saffir. Therefore, consistent with the rejection which we
affirmed above, we affirm this rejection for the reasons stated by the
Examiner.
SUMMARY
In summary, we reverse the rejection of claims 9, 10, and 13 under 35
U.S.C. § 112, second paragraph.
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as
obvious over Oko. Pursuant to 37 C.F.R. § 41.37(c)(1)(2006), we also
affirm the rejection of claims 2-9, 11, and 13-17, as these claims were not
argued separately.
We affirm the rejection of claim 10 under 35 U.S.C. § 103(a) as
obvious over Oko and Miller.
We affirm the rejection of claims 15 and 16 under 35 U.S.C.
§ 103(a) as obvious over Oko and Saffir.
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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