Ex Parte Straub et al

Patent Trial and Appeal Board

Feb 17, 2016

12108920 (P.T.A.B. Feb. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/108,920 04/24/2008
26813 7590 02/17/2016
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581336
MINNEAPOLIS, MN 55458-1336
FIRST NAMED INVENTOR
Darren E. Straub
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
293.00400102 2495
EXAMINER
TONGUE, LAKIA J
ART UNIT PAPER NUMBER
1645
MAILDATE DELIVERY MODE
02/17/2016 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 DARREN E. STRAUB and DARYLL A. EMERY1
Appeal2013-000561
Application 12/108,920
Technology Center 1600
Before MELANIE L. McCOLLUM, ULRIKE W. JENKS, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
McCOLLUM, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
Fusobacterium spp. whole cell composition. The Examiner has rejected the
claims as failing to comply with the written description requirement. We
have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The Specification discloses "compositions including an isolated whole
cell preparation of a Fusobacterium spp .... , the cells includ[ing] a metal
regulated polypeptide" (Spec. 7: 24--26). The Specification also discloses
1 Appellants identify the real party in interest as Epitopix LLC (App. Br. 2).
Appeal2013-000561
Application 12/108,920
that "one class of metal regulated polypeptide produced by Fusobacterium
spp. is not expressed at detectable levels during growth of the microbe in
high metal conditions but is expressed at detectable levels during growth in
low metal conditions" (id. at 11: 29 to 12: 1 ). In addition, the Specification
discloses that "[l]ow metal conditions are generally the result of the addition
of a metal chelating compound to a bacteriological medium" (id. at 21: 13-
15).
Claims 33-37 and 39--41 are pending and on appeal (App. Br. 2).
Claim 33 is representative and reads as follows:
33. A composition comprising an isolated whole cell preparation of a
Fusobacterium spp., wherein the cells comprise at least two metal regulated
polypeptides having molecular weights between 7 6 kDa and 86 kDa,
between 62 kDa and 68 kDa, between 45 kDa and 53 kDa, between 34 kDa
and 43 kDa, or between 24 kDa and 35 kDa, wherein molecular weight is
determined by electrophoresis on a sodium dodecyl sulfate-polyacrylamide
gel, wherein the metal regulated polypeptides are natively expressed by a
_llusobacterium spp. \'l1hen incubated in medium that includes a metal
chelator and not natively expressed at a detectable level when grown in the
medium in the absence of a metal chelator.
Claims 33-37 and 39--41 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement
(Ans. 4).
The Examiner finds:
[T]he specification lacks full written description for polypeptides
that are natively expressed at a detectable level by a
Fusobacterium spp. when incubated in medium comprising a
metal chelator and are not natively expressed by the
Fusobacterium spp. at a detectable level when grown in the
medium without the metal chelator .... The claim requires that
the polypeptides are natively expressed at a detectable level by a
Fusobacterium spp. when incubated in medium comprising a
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Application 12/108,920
metal chelator and are not natively expressed by the
Fusobacterium spp. at a detectable level when grown in the
medium without the metal chelator; however, Figure 3 shows a
comparison of proteins with a chelator and proteins without a
chelator. At almost every molecular weight, which includes the
claimed weight ranges, there are proteins present for both
conditions, with or without chelators. While the molecular
weight of the proteins with the chelator (in the iron deplete
medium) appear to have a higher intensity than the proteins that
lack the chelator in the iron deplete medium, proteins are indeed
present under both conditions and at the molecular weight ranges
as claimed.
(Id. at 5.)
The Examiner also finds: "[T]he SDS-Page gel demonstrated proteins
of the claimed molecular weights expressed at a detectable level by
Fusobacterium in mediums with metal chelators and without metal chelators.
Further, ... while the densitometry scan may not have been normalized[,]
... the gels demonstrate bands at the molecular weights as claimed." (Id. at
7.)
In addition, the Examiner finds:
The proteins presented on Figure 3 contradict the claimed
invention because the claimed invention requires that the
polypeptides are not expressed by the Fusobacterium spp. at a
detectable level when grown in the medium without the metal
chelator. This is further evidenced by Bakken et al. [2J (used as
art in [a] previous office action), where Applicant has pointed out
that the medium in said reference is "metal rich" and
polypeptides within the ranges claimed are identified. Therefore,
making it impossible to have written description for polypeptides
2 Vidar Bakken et al., Outer Membrane Proteins of Fusobacterium
Nucleatum Fevl, 132 J. General Microbiology 1069-78 (1986) (hereinafter
"Bakken").
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Appeal2013-000561
Application 12/108,920
using weight and the presence of a chelator to determine the
polypeptide that is present.
(Id. at 7-8.)
PRINCIPLES OF LAW
The Examiner "bears the initial burden ... of presenting a prima facie
case ofunpatentability." In re Oetiker, 977 F.2d 1443, 1445 (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
specification contains a description of the claimed invention,
albeit not in ipsis verb is (in the identical words), then the
examiner ... , in order to meet the burden of proof, must provide
reasons why one of ordinary skill in the art would not consider
the description sufficient.
In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996) (quoting In re Wertheim,
541F.2d257, 263 (CCPA 1976)).
ANALYSIS
Specification Figure 3 depicts a comparison "of membrane proteins
derived from F. necrophorum grown under iron-replete and iron-depleted
growth conditions" (Spec. 9: 5-7). In Example 3, the results of which are
depicted in Figure 3, the Specification discloses that a "number of metal
regulated proteins were observed with molecular weights of approximately
82.9 kDa, 79.3 kDa, 65.4 kDa, 49 kDa, 39 kDa, 38.5 kDa, 31 kDa, and
27.9 kDa and non-iron regulated proteins having molecular weights of
approximately 45.2 kDa, 40.4 kDa, 39.9 kDa, and 33.6 kDa" (id. at 36: 8 to
37: 19). In addition, the Specification discloses that a "number of metal
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Appeal2013-000561
Application 12/108,920
regulated proteins having molecular weights of approximately 140.5 kDa,
72.9 kDa, 42.7 kDa, and 33 kDa appeared to be enhanced or up-regulated
when grown under iron-deplete conditions as compared to the same band
expressed under iron-replete conditions" (id. at 37: 19-23).
Based on the disclosure of Example 3, specifically the polypeptides
with molecular weights of approximately 82.9 kDa, 79.3 kDa, 65.4 kDa,
49 kDa, 39 kDa, 38.5 kDa, 31 kDa, and 27.9 kDa, Appellants argue that they
"discovered that the Fusobacterium spp. produced certain polypeptides ...
at detectable levels only when grown under the iron-restricted conditions"
and that this disclosure supports the present claims (App. Br. 6). We
conclude that Appellants have the better position.
According to Appellants' Declaration, 3 Specification "Figure 3 shows
no detectable expression (i.e., optical density of polypeptide equals baseline
optical density) of polypeptides having molecular weights ... of 27.9 kDa,
31 kDa, 39.0 kDa, 49 kDa, 65.4 kDa, 79.3 kDa, and 82.9 kDa when the
Fusobacterium was grown in iron-replete medium" (Deel. i-f 4). The
Examiner does not adequately explain why this is incorrect or why the
disclosure of these polypeptides is insufficient to support the genus of
polypeptides recited in claim 33.
Instead, the Examiner's concern appears to be that there are
polypeptides within the claimed molecular weight ranges, such as the ones
disclosed in Bakken, that are natively expressed by the Fusobacterium spp.
at a detectable level when grown in the medium without the metal chelator.
3 Declaration under 3 7 C.F .R. § 1.132 of Daryll A. Emery dated August 11,
2011 (filed August 12, 2011).
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Application 12/108,920
However, the Examiner does not explain why such polypeptides would be
within the scope of claim 33, which specifically states that the polypeptides
are "not natively expressed at a detectable level when grown in the medium
in the absence of a metal chelator" (App. Br. Claims Appendix 1 (emphasis
added)). Thus, it is not clear to us how the existence of such polypeptides
"mak[ es] it impossible to have written description for [the claimed]
polypeptides" (Ans. 8).
CONCLUSION
The Examiner has not set forth a prima facie case that the claims lack
written description. We therefore reverse the written description rejection.
REVERSED
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