Ex Parte Straub et al

Patent Trial and Appeal Board

Feb 17, 2016

11212115 (P.T.A.B. Feb. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111212, 115 08/25/2005
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.
293.00400101 5474
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
Appeal2013-000465
Application 11/212, 115
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 an
isolated polypeptide and a composition comprising at least two polypeptides.
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 "a composition including isolated
polypeptides isolatable from a Fusobacterium spp." (Spec. 6: 8-9). The
1 Appellants identify the real party in interest as Epitopix LLC (App. Br. 2).
Appeal2013-000465
Application 11/212, 115
Specification also discloses 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 23-26, 28-32, 94, 95, 98, and 99 are on appeal (App. Br. 2).2
Claim 94 is representative and reads as follows:
94. An isolated Fusobacterium spp. polypeptide, wherein the
polypeptide has a molecular weight between 76 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 and is natively expressed at a
detectable level by a Fusobacterium spp. when incubated in medium
comprising a metal chelator and is not natively expressed at a detectable
level by the Fusobacterium spp. when grown in the medium without the
metal chelator, \'I/herein molecular \'l1eight is determined by electrophoresis
on a sodium dodecyl sulfate-polyacrylamide gel.
Claims 23-26, 28-32, 94, 95, 98, and 99 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
2 Claims 62---64, 66-76, 78-93, and 101-105 are also pending but have been
withdrawn from consideration (App. Br. 2).
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Appeal2013-000465
Application 11/212, 115
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
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.
(Id. at 6.)
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
7-8.)
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. [3J (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,
3 Vidar Bakken et al., Outer Membrane Proteins of Fusobacterium
Nucleatum Fevl, 132 J. General Microbiology 1069-78 (1986) (hereinafter
"Bakken").
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Appeal2013-000465
Application 11/212, 115
making it impossible to have written description for polypeptides
using weight and the presence of a chelator to determine the
polypeptide that is present.
(Id. at 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 TVertheim,
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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Appeal2013-000465
Application 11/212, 115
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. 6-7). We
conclude that Appellants have the better position.
According to Appellants' Declaration, 4 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 claim 94.
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.
However, the Examiner does not explain why such polypeptides would be
4 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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Appeal2013-000465
Application 11/212, 115
within the scope of claim 94, which specifically states that the polypeptide
"is not natively expressed at a detectable level by the Fusobacterium spp.
when grown in the medium without the metal chelator" (App. Br. Claims
Appendix 10 (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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