Ex Parte Miller

Patent Trial and Appeal Board

Mar 6, 2017

12907340 (P.T.A.B. Mar. 6, 2017)

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.
12/907,340 10/19/2010 Jeffrey Miller H-US-02464 (203-6779 II) 1839
50855 7590
Covidien LP
60 Middletown Avenue
c/o Legal - Mailstop MS 54
North Haven, CT 06473
EXAMINER
LYNCH, ROBERT A
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
03/08/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
mail @ cdfslaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEFFREY MILLER
Appeal 2015-006236
Application 12/907,340
Technology Center 3700
Before JACQUELINE WRIGHT BONILLA, LINDA M. GAUDETTE, and
JEFFREY R. SNAY, Administrative Patent Judges.
SNAY, Administrative Patent Judge.
DECISION ON APPEAL1
Appellant2 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 1—5, 7—17, 19, and 20. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
1 We refer to the Specification (“Spec.”) filed Oct. 19, 2010, amended Nov.
30, 2012; Final Office Action (“Final Act.”) dated Aug. 1, 2014; Appellant’s
Appeal Brief (“App. Br.”) dated Jan. 9, 2015; Examiner’s Answer (“Ans.”)
dated Apr. 6, 2015; and Appellant’s Reply Brief (“Reply Br.”) dated June 8,
2015.
2 Appellant identifies Covidien LP as the real party in interest. App. Br. 2.
Appeal 2015-006236
Application 12/907,340
BACKGROUND
The subject matter on appeal relates to hemostatic tapes employing
first and second hydrogel precursors which, upon exposure to physiological
fluid, react to form a biocompatible cross-linked material to provide
hemostasis and adhere the tape on injured tissue. Spec. 126. Claims 1 and
15—the only independent claims on appeal—are reproduced below from the
Claims Appendix of the Appeal Brief:
1. A hemostatic tape comprising:
a first hydrogel precursor;
a second hydrogel precursor;
a first layer including a porous substrate and the first
hydrogel precursor disposed within pores of the porous
substrate;
a second layer including a film applied to the porous
substrate, the film including the second hydrogel precursor,
wherein the first and second hydrogel precursors are in different
layers, and
a release sheet disposed on at least one of the porous
substrate and the film.
15. A hemostatic tape comprising:
a first hydrogel precursor;
a second hydrogel precursor;
a first layer including a mesh including fibers of oxidized
cellulose and a coating containing the first hydrogel precursor
encapsulating the fibers of the mesh;
a second layer including a film applied to the first layer
and including the second hydrogel precursor, wherein the first
and second hydrogel precursors are in different layers, and
a release sheet disposed on at least one of the mesh and
the film, wherein the hemostatic tape is in a rolled
configuration.
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Application 12/907,340
REJECTIONS
I. Claims 1—5, 8, 9, 11, 12, 14, and 20 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Sawhney I,3 Sawhney II,4 and Martineau.5
II. Claim 7 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
Sawhney I, Sawhney II, Martineau, and Schaar.6
III. Claims 10, 15—17, and 19 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Sawhney I, Sawhney II, Martineau, and Huey.7
IV. Claim 13 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Sawhney I, Sawhney II, Martineau, and Garvin.8
DISCUSSION
I
With regard to Rejection I, Appellant argues the rejected claims as a
group, with the exception of claim 9, which is argued separately. App. Br.
3—10. In accordance with 37 C.F.R. § 41.37(c)(l)(iv), we select claim 1 as
representative and decide the appeal as to Rejection I based on the
representative claim alone. Claim 9 is separately considered and discussed
below.
Claim 1
Appellant does not dispute the Examiner’s finding that Sawhney I
discloses an adherent hemostatic composition comprising first and second
3 US 6,703,047 B2, issued March 9, 2004 (“Sawhney I”).
4 US 2003/0108511 Al, published June 12, 2003 (“Sawhney II”).
5 US 2003/0149406 Al, published Aug. 7, 2003 (“Martineau”).
6 US 4,212,296, issued July 15, 1980 (“Schaar”).
7 US 2007/0276308 Al, published Nov. 29, 2007 (“Huey”)
8 US 2007/0021779 Al, published Jan. 25, 2007 (“Garvin”).
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Application 12/907,340
hydrogel precursors formed as different layers, with the second precursor
layer coated on the first precursor layer. Compare Final Act. 4 with App.
Br. 4 (“Sawhney I described a coating technique that may be employed to
deposit separable layers of dehydrated hydrogel precursors . . . such that,
after deposition of a first layer of the first precursor, a second layer of the
second precursor is deposited in such a manner as not to be reactive with the
first precursor.”) (internal quotes and brackets omitted). See also Sawhney
I, col. 6,11. 6—15. In use as a sealant for tissue fluid leaks, the hydrogel
precursor layers of Sawhney I are applied to an open wound site, such that
uptake of blood or other tissue fluid initiates transformation of the precursors
to an insoluble, crosslinked solid. Id. at col. 3,11. 2—30.
Acknowledging that Sawhney I does not disclose a porous substrate
support for the first hydrogel precursor, the Examiner found that Sawhney II
teaches that supporting hydrogel precursors with a porous substrate provides
surgical adhesion materials with advantageous mechanical properties,
including reinforcement, flexibility, strength and tear resistance, that one of
ordinary skill would have deemed beneficial to the adherent composition
disclosed in Sawhney I. Final Act. 5—6.
Appellant argues that, in Sawhney II, the hydrogen precursors are
“mixed and added to a fiber cloth in liquid form to form a crosslinked
hydrogel,” and, for that reason, Sawhney II does not describe or render
obvious the provision of a porous substrate where the first and second
hydrogel precursors are in different layers. App. Br. 5—6. Appellant’s
argument in this regard is not persuasive of reversible error by the Examiner.
As articulated by the Examiner, Sawhney I discloses the provision of first
and second hydrogel precursors in different layers. The fact that Sawhney II
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Application 12/907,340
involves both precursors in the same porous matrix does not negate Sawhney
II’s teaching that use of a porous support material for accommodating
hydrogel components yields advantageous physical properties. Nor does it
refute the Examiner’s finding that one of ordinary skill in the art would have
recognized the mechanical property advantages taught by Sawhney II to be
desirable in the adherent composition of Sawhney I. The teachings in
Sawhney I that the adherent compositions may be provided as “patches,”
Sawhney I, col. 7,11. 28—31, and that “introduction of macroporosity into the
structure of a shaped article formed from dehydrated precursors is expected
to enable a rapid uptake of a fluid, such as blood,” id. at col. 5,11. 45^47, are
consistent with the Examiner’s finding that one of ordinary skill would have
had a reason to add the porous substrate of Sawhney II to the hemostatic
material of Sawhney E
For the foregoing reasons, Appellant does not persuade us of
reversible error in the Examiner’s rejection of claim 1. Appellant does not
present any additional argument particularly directed to any of claims 2—5, 8,
11, 12, 14, and 20. Accordingly, we sustain Rejection I as applied to each of
these claims.
Claim 9
Claim 9 recites:
The hemostatic tape of claim 1, further comprising an adhesive
positioned on a surface of the porous substrate that faces a
wound.
App. Br. 16 (Claims Appendix).
The Examiner found that Martineau teaches a hemostatic tape which
includes “an adhesive (24) on the tissue-facing surface for providing
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Appeal 2015-006236
Application 12/907,340
attachment to the patient.” Final Act. 6 (citing Martineau 148). Appellant
points to various passages in Sawhney I that refer to the disclosed
hemostatic material as “adherent compositions” or “adhesive sealants,” and
contends on that basis that the Examiner “has not shown that a person of
ordinary skill in the art would have understood ‘attachment’ to be an issue
that remained to be improved upon with respect to Sawhney I’s
compositions.” App. Br. 7—8. We disagree. Sawhney I teaches that prior
art in situ therapy compositions involving low viscosity precursor solutions
suffer a limitation in that the precursor solutions “may flow away and be
cleared from an application site before transformation and solidification
occurs.” Sawhney I, col. 1,11. 26—29. Thus, the skilled artisan would have
understood from Sawhney I that adhesion of the precursor materials to a
wound site prior to uptake of tissue fluid and crosslinking was desirable. On
this record, we are persuaded that a preponderance of the evidence supports
the Examiner’s finding that the skilled artisan would have had a reason to
include a tissue-facing adhesive to Sawhney I’s precursor tape, so as to
enhance its attachment to a wound site prior to occurrence of fluid uptake
and the resulting hydrogel formation.
Accordingly, we also sustain Rejection I as applied to claim 9.
II-IV
With regard to Rejections II—V, Appellant relies on the same
arguments presented in connection with Rejection I. See App. Br. 10—13;
Reply Br. 6—8. Thus, we sustain each of these rejections for the same
reasons give above with regard to Rejection I.
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Appeal 2015-006236
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DECISION
The Examiner’s decision rejecting claims 1—5, 7—17, 19, and 20 is
affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.
AFFIRMED
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