Ex Parte Shah et al

Patent Trial and Appeal Board

Jan 11, 2016

11608906 (P.T.A.B. Jan. 11, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
11/608,906 12/11/2006 Faraia Shah
20306 7590 01/11/2016
MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP
300 S. WACKER DRIVE
32NDFLOOR
CHICAGO, IL 60606
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.
14-1167-WO-US 1185
EXAMINER
TSAY,MARSHAM
ART UNIT PAPER NUMBER
1656
MAILDATE DELIVERY MODE
01111/2016 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 F ARAIA SHAH, RACHAEL CLARK, PA TRICK JOHN
TROTTER, PAUL WILLIAM WATT, and BREDA MARY CULLEN1
Appeal2013-005476
Application 11/608,906
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and
TA WEN CHANG, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
of treating mammalian wounds, which have been rejected as obvious. We
have jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
1 Appellants identify the Real Party in Interest as Systagenix Wound
Management (US), Inc. (Appeal Br. 3.)
Appeal2013-005476
Application 11/608,906
STATEMENT OF THE CASE
According to the Specification, "[t]here [is] a need ... for the early
diagnosis and prognosis of wound infection, and for devices and wound
dressings for use in carrying out such methods." (Spec. 2: 1 7-19.) The
Specification states that "higher levels of vimentin[, a cytoskeletal
component,] ... are present in ... infected fluid than in ... non-infected
fluid" and that "[ v ]imentin and associated markers could therefore be used
as a diagnostic or prognostic of infection .... " (Id. at 3:24--31, 4: 14--15.)
Claims 10-13 and 16 are on appeal. 2 Claim 10 is the only
independent claim and reads as follows:
10. A method for the treatment of a mammalian wound
comprising the steps of measuring in a wound fluid the presence or
level of a marker in a wound fluid collected from the wound, and
applying an antimicrobial wound dressing to the wound selectively if
the presence or level of said marker is indicative of an infection in the
wound, wherein the marker is a cytoskeletal component or a
breakdown product thereof, further wherein the marker is indicative of
an infection in the wound if the level of the marker is elevated.
2 We note that claim 16 as set forth in the Claims Appendix of the Appeal
Brief depends from claim 19, which had been previously withdrawn. We
assume that this is a typographical error and that claim 16 depends from
claim 10. Compare Reply Pursuant to 37 C.F.R. § 1.111 at3 (Dec. 6, 2011).
2
Appeal2013-005476
Application 11/608,906
The claims stand rejected as follows:
Claims 10-13 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Cullen, 3 Raffetto, 4 and Hilfenhaus. 5
Claim 16 is rejected under 35 U.S.C. 103(a) as being unpatentable
over Cullen, Raffetto, Hilfenhaus, and Bucala. 6
DISCUSSION
Issue
The Examiner has rejected claims 10-13 under 35 U.S.C. § 103(a) as
being unpatentable over Cullen, Raffetto, and Hilfenhaus. The Examiner
finds that Cullen discloses
a method of predicting or diagnosing clinical infection of a wound
comprising measuring the concentration of a marker associated with
an inflammatory response in wound fluid . . . . Cullen discloses [that]
examples of markers associated with an inflammatory response
include fibronectin and collagen . . . . Cullen discloses that a method
of detecting a clinical infection of a wound as early as possible allows
for the infection to be treated topically as opposed to having to use
3 Cullen, U.S. Patent No. 7,794,925 B2, issued Sep. 14, 2010.
4 Raffetto et al., Changes in Cellular Motility and Cytoskeletal Actin in
Fibroblasts from Patients with Chronic Venous Insufficiency and in
Neonatal Fibroblasts in the Presence of Chronic Wound Fluid, 33 J.
VASCULAR SURGERY 1233 (2001).
5 Hilfenhaus et al., U.S. Patent No. 7,270,721 B2, issued Sep. 18, 2007.
6 Bucala et al., Circulating Fibrocytes Define a New Leukocyte
Subpopulation That Mediates Tissue Repair, 1 MOLECULAR MED. 71 (1994).
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Appeal2013-005476
Application 11/608,906
antibiotics . . . . Cullen discloses wounds that can be diagnosed for
infection can be chronic, i.e. chronic ulcers ....
(Ans. 4--5.) The Examiner further finds that "Cullen discloses ... which
[concentration] levels [of the markers of the inflammatory response] would
reasonably indicate the presence of a clinical infection." (Id. at 7 .)
The Examiner finds that Cullen does not teach "the presence or level
of [a cytoskeletal protein] in the wound fluid" and does not explicitly teach
applying a wound dressing to the wound. (Id. at 5.) However, the Examiner
finds that Raffetto discloses
a method of measuring[,] in a chronic venous ulcer wound fluid, the
presence of cytoskeletal protein a-smooth muscle actin ( a-sma),
where an increased level of a-sma was observed in samples obtained
from ulcer patients compared with samples from patients with chronic
venous insufficiency (CVI) but no ulcers present . . . . [Raffetto]
further suggest[ s] that a-sma can be quantified by W estem blot
analysis . . . . [Raffetto] disclose[ s] that a-sma is present in fibroblasts
of wounded tissue ... but not present in tissues with no ulcerations
present . . . . In addition to a-sma, [Raffetto] also disclose[ s] that
collagen and fibronectin proteins are also produced in wounded tissue
(Id. 5.) The Examiner further finds that Hilfenhaus discloses that "an
antimicrobial wound dressing can be applied for treating skin wounds." (Id.)
The Examiner concludes that it would have been obvious to a skilled
artisan to modify Cullen's method by using the level of cytoskeletal protein
disclosed in Raffetto (i.e., the level of a-sma) as an indicator for infection
and further to apply Hilfenhaus' antimicrobial wound dressing where an
elevated level of a-sma indicates an infection. (Id. at 5---6.) The Examiner
finds that Raffetto provides the motivation to modify Cullen's method as
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Appeal2013-005476
Application 11/608,906
described, because Raff etto discloses that "an elevated level of a-sma [in] a
wound fluid is indicative of a pathological condition, i.e., an ulcer" and
Cullen and Hilfenhaus teach that "protein markers expressed in wounded
tissue and/ or associated with an inflammatory response in a wound fluid can
be used to diagnose wound infections," which can be "treated topically with
an antimicrobial wound dressing." (Id. at 6-7; see also id. at 21, 24.)
With respect to claim 16, the Examiner additionally relies on Bucala
for disclosing "a method of measuring in a wound fluid the presence of
vimentin" and for disclosing vimentin as "positively expressed in ...
fibroblast-like cell found at sites of tissue injury." (Id. at 8.) The Examiner
concludes that it would have been obvious to a skilled artisan to modify
Cullen's method in view of Raffetto and Hilfenhaus, "by substituting the
step of measuring [Bucala's] vimentin ... for the step of measuring [the] a-
sma of Raffetto." (Id.) The Examiner concludes that Bucala would have
provided the motivation to make such a modification, because it discloses
that vimentin, which is also a cytoskeletal protein like a-sma, is positively
expressed by fibroblasts at wound sites. (Id.)
Appellants contend that the cited references do not suggest the
claimed step of "measuring in a wound fluid the presence or level of a
marker ... wherein the marker is a cytoskeletal component or breakdown
product thereof, further wherein the marker is indicative of an infection in
the wound if the level of the marker is elevated." (Appeal Br. 6.) Among
other things, Appellants argue that none of the cited references suggests that
cytoskeletal components (such as a-sma and vimentin) may be an infection
indicator, much less that different wound dressing should be applied
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Application 11/608,906
depending on the level of cytoskeletal components. (Id. at 6-8, 11-12.)
Appellants further contend that, because the cited art provide no correlation
between the markers of infection disclosed in Cullen and any cytoskeletal
component, a skilled artisan would have neither motivation nor reasonable
expectation of success by modifying Cullen's method to use a cytoskeletal
component as the infection marker. (Id. at 8, 11-12.)
The issue with respect to this rejection is whether it would have been
obvious to modify Cullen's method of predicting or diagnosing infections by
measuring the level of a cytoskeletal component or breakdown product, such
as the a-sma disclosed in Raffetto or the vimentin disclosed in Bucala.
Analysis
On balance, we agree with Appellants that Examiner has not
established a prima facie case for obviousness.
A rejection for obviousness must include "articulated reasoning with
some rational underpinning to support the legal conclusion." KSR Int 'l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007) (quoting In re Kahn, 441F.3d977,
988 (Fed. Cir. 2006)).
In this case, the Examiner has not sufficiently articulated a reason to
modify Cullen's method of predicting or diagnosing infection by measuring
the level of the cytoskeletal components disclosed in Raff etto ( a-sma) and
Bucala (vimentin). Cullen teaches using certain structural proteins
associated with inflammatory response to diagnose or predict infection, but
does not disclose using a-sma and vimentin to predict infection. While
Raffetto and Bucala disclose that a-sma and vimentin may be present in the
wound environment and/or associated with certain pathological conditions
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Application 11/608,906
such as ulcers (Ans. 5-6, 8), the Examiner has not provided a sufficient
evidentiary basis to support a conclusion that all structural proteins present
in wound environments are markers associated with an inflammatory
response. Similarly, the Examiner does not explain why the mere presence
or increased level of proteins such as a-sma or vimentin in wound fluid
would suggest to a skilled artisan that these components would be useful as a
marker for predicting or diagnosing infection, given that not all wounds or
ulcers become infected.
Accordingly, we reverse the Examiner's rejection of claims 10-13
under 35 U.S.C. § 103(a) as being unpatentable over Cullen, Raffetto, and
Hilfenhaus. We also reverse the Examiner's rejection of claim 16 under 35
U.S.C. § 103(a) as being unpatentable over Cullen, Raffetto, Hilfenhaus, and
Bucala.
SUMMARY
We reverse the rejection of claims 10-13 as obvious over Cullen,
Raffetto, and Hilfenhaus.
We also reverse the rejection of claim 16 as obvious over Cullen,
Raffetto, Hilfenhaus, and Bucala.
REVERSED
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