Ex Parte Thomas et al

Patent Trial and Appeal Board

Nov 26, 2012

10479770 (P.T.A.B. Nov. 26, 2012)

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.
10/479,770 12/05/2003 Lawrence J. Thomas TCS-425.1P US 5779
7590 11/27/2012
Leon R Yankwich
Yankwich & Associates
201 Broadway
Cambridge, MA 02139
EXAMINER
BASKAR, PADMAVATHI
ART UNIT PAPER NUMBER
1645
MAIL DATE DELIVERY MODE
11/27/2012 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 LAWRENCE J. THOMAS, ANGELO SCORPIO,
and DAVID T. BEATTIE
____________

Appeal 2011-010824
Application 10/479,770
Technology Center 1600
____________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
STEPHEN WALSH, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1-4, 39, and 40
(App. Br. 3-4; Ans. 2).
1
We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to an immunogenic composition. Claims 1
and 3 are representative and are reproduced in the Claims Appendix of
Appellants’ Brief.

1
Pending claims 5-38 stand withdrawn from consideration (App. Br. 3-4;
Ans. 2).
Appeal 2011-010824
Application 10/479,770

2
Claims 1, 39, and 40 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by Miller.
2

Claims 1, 3, 39, and 40 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Leppla.
3

Claims 1, 3, 4, 39, and 40 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Collier.
4

Claim 3 stands rejected under 35 U.S.C. § 102(e) as being anticipated
by Klimpel.
5

The anticipation rejection over Miller is affirmed. The anticipation
rejections of claim 3 over Leppla; claims 3 and 4 over Collier; and claim 3
over Klimpel are affirmed. All other grounds of rejection are reversed.

Miller:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Miller teaches Appellants’ claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Appellants define rPA as “a recombinantly produced polypeptide
having the functional activity of the native Protective Antigen protein of
Bacillus anthracis” or “alternatively, as a polypeptide produced according to
recombinant DNA techniques and having the ability to elicit an antibody
response in mammals … which antibodies are immunologically cross-

2
J. Miller et al., Production and purification of recombinant protective
antigen and protective efficacy against Bacillus anthracis, 26 LETTERS IN
APPLIED MICROBIOLOGY 56-60 (1998).
3
Leppla et al., US 5,591,631, issued January 7, 1997.
4
Collier et al., WO 97/23236, published July 3, 1997.
5
Klimpel et al., US 6,592,872 B1, issued July 15, 2003.
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3
reactive with natural B. anthracis Protective Antigen” (Spec. 7: 21-23 and
25-28).
FF 2. We adopt the Examiner’s findings concerning the scope and content
of the prior art (Ans. 3), and provide the following findings for emphasis.
FF 3. For clarity, Miller’s Table 1 is reproduced below:

(Miller 59: Table 1; see generally Ans. 3-5.)
ANALYSIS
The claims were not separately argued and therefore stand or fall
together. 37 C.F.R. § 41.37(c)(1)(iv). Claim 1 is representative.
Appellants contend “that the rPA of Miller did not possess biological
activity, as it was statistically unsuccessful in eliciting protection” (App. Br.
9). We are not persuaded. As Appellants recognize Miller teaches that rPA
“combined with Ribi adjuvant showed statistically significant survival
against challenge, 100%” (id. (emphasis removed); Reply Br. 4).
Appellants’ Claim 1 does not exclude the presence of adjuvant as
exemplified by Appellants’ claim 2, drawn to an “immunogenic composition
of Claim 1 formulated without adjuvant” (Claim 2). Therefore, we are not
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persuaded by Appellants’ contention regarding Ribi adjuvant or that
Appellants’ use of the transitional phrase “consisting essentially of”
excludes an adjuvant, such as Ribi (App. Br. 10-12).
Further, we are not persuaded by Appellants’ contention that Miller’s
results establish “rPA + saline and rPA + alhydrogel essentially offered the
same protection as the alhydrogel control alone” (App. Br. 9 (emphasis
removed); Reply Br. 4-5). Notwithstanding Appellants’ contentions to the
contrary, Miller’s Table 1 establishes that rPA + saline provided 16%
survival, while rPA + alhydrogel or alhydrogel alone provided 7% survival
(see FF 3). Appellants proffer no persuasive argument or evidence to
support a conclusion that a 16% survival is not a statically significant
improvement over 7% survival.
Lastly, for the foregoing reasons, Appellants failed to establish an
evidentiary basis on this record to support a conclusion “that the rPA of
Miller did not exhibit significant biological activity” or is “not identical” to
Appellants’ rPA composition (App. Br. 9; Reply Br. 2-3; Cf. FF 1-3). There
is no persuasive evidence or argument on this record to support a conclusion
that Miller’s rPA polypeptide is not “produced according to recombinant
DNA techniques … [or does not have] the ability to elicit an antibody
response in mammals … which antibodies are immunologically cross-
reactive with natural B. anthracis Protective Antigen” (Cf. FF 1).
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner’s
finding that Miller teaches Appellants’ claimed invention. The rejection of
claim 1 under 35 U.S.C. § 102(b) as being anticipated by Miller is affirmed.
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5
Claims 39 and 40 are not separately argued and fall together with claim 1.
37 C.F.R. § 41.37(c)(1)(iv).

Leppla:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Leppla teaches Appellants’ claimed invention?
FACTUAL FINDINGS (FF)
FF 4. Examiner’s findings concerning the scope and content of the prior art
may be found at pages 7-8 of the Examiner’s Answer.
ANALYSIS
Claim 3:
As Appellants recognize, Leppla relates to the administration of a
composition, to a mammal, that comprises Bacillus anthracis PA and a
truncated Lethal Factor (LFn), wherein both proteins are produced
recombinantly and the LFn is fused to an additional antigen (FF 4; App. Br.
14). There is no persuasive evidence or argument on this record to support a
conclusion the transitional phrase “consisting essentially of” prohibits the
administration of a composition comprising rPA and LFn, wherein LFn is
fused to another antigen (Cf. App. Br. 15). There is also no persuasive
evidence or reasoning on this record to support a conclusion that the
administration of the foregoing composition would not be capable of raising
an anti-B. anthracis antigen immune response in a mammal as required by
Appellants’ claim 3 (id.). Accordingly, we find no error in Examiner’s
prima facie case. “[I]n an ex parte proceeding to obtain a patent, . . . the
Patent Office has the initial burden of coming forward with some sort of
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evidence tending to disprove novelty.” See In re Wilder, 429 F.2d 447, 450
(CCPA 1970). Where, as here, “the PTO shows sound basis for believing
that the products of the applicant and the prior art are the same, the applicant
has the burden of showing that they are not.” In re Spada, 911 F.2d 705,
708 (Fed. Cir. 1990) (emphasis added). Appellants failed to meet their
burden on this record.

Claims 1, 39, and 40:
Claims 1, 39, and 40 stand on a different footing. Each of these
claims requires that the “immunogenic composition excludes B. anthracis
components other than rPA” (see Appellants’ Claims 1, 39, and 40).
Examiner failed to identify, and we do not find, a teaching in Leppla of a
composition that “excludes B. anthracis components other than rPA.”
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner’s
finding that Leppla teaches the subject matter of Appellants’ claim 3. The
rejection of claim 3 under 35 U.S.C. § 102(b) as being anticipated by Leppla
is affirmed.
The preponderance of evidence on this record fails to support
Examiner’s finding that Leppla teaches the subject matter of Appellants’
claims 1, 39, and 40. The rejection of claims 1, 39, and 40 under 35 U.S.C.
§ 102(b) as being anticipated by Leppla is reversed.

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Collier:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Collier teaches Appellants’ claimed invention?
FACTUAL FINDINGS (FF)
FF 5. Examiner’s findings concerning the scope and content of the prior art
may be found at page 8 of the Examiner’s Answer.
ANALYSIS
Claim 3:
Appellants recognize that Collier, like Leppla, relates to the
administration of a composition, to a mammal, that comprises Bacillus
anthracis PA and a truncated Lethal Factor (LFn), wherein both proteins are
produced recombinantly and the LFn is fused to an additional antigen (FF 5;
App. Br. 14). Appellants contest Examiner’s reliance on Collier for the
same reasons as Leppla discussed above (App. Br. 14-15). We are not
persuaded for the reasons set forth above with respect to Leppla.

Claims 1, 39, and 40:
Claims 1, 39, and 40 stand on a different footing. Each of these
claims requires that the “immunogenic composition excludes B. anthracis
components other than rPA” (see Appellants’ Claims 1, 39, and 40).
Examiner failed to identify, and we do not find, a teaching in Collier of a
composition that excludes B. anthracis components other than rPA.”
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner’s
finding that Collier teaches the subject matter of Appellants’ claim 3. The
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rejection of claim 3 under 35 U.S.C. § 102(b) as being anticipated by Collier
is affirmed. Claim 4 is not separately argued and falls together with claim 3.
37 C.F.R.
§ 41.37(c)(1)(iv).
The preponderance of evidence on this record fails to support
Examiner’s finding that Collier teaches the subject matter of Appellants’
claims 1, 39, and 40. The rejection of claims 1, 39, and 40 under 35 U.S.C.
§ 102(b) as being anticipated by Collier is reversed.

Klimpel:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Klimpel teaches Appellants’ claimed invention?
FACTUAL FINDINGS (FF)
FF 6. We adopt the Examiner’s findings concerning the scope and content
of the prior art (Ans. 6).
ANALYSIS
Appellants recognize that Klimpel, like Leppla and Collier, relates to
the administration of a composition, to a mammal, that comprises Bacillus
anthracis PA and a truncated Lethal Factor (LFn), wherein both proteins are
produced recombinantly and the LFn is fused to an additional antigen (FF 6;
App. Br. 13). Appellants contest Examiner’s reliance on Klimpel for the
same reasons as Leppla and Collier discussed above (App. Br. 14-15). We
are not persuaded for the reasons set forth above with respect to Leppla and
Collier.
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CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner’s
finding that Klimpel teaches Appellants’ claimed invention. The rejection of
claim 3 under 35 U.S.C. § 102(e) as being anticipated by Klimpel is
affirmed.

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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