Ex Parte Sheetrit et al

Patent Trial and Appeal Board

Mar 8, 2018

12563667 (P.T.A.B. Mar. 8, 2018)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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Alexandria, Virginia 22313-1450
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/563,667 09/21/2009 Eyal Sheetrit ETH5484USNP 6875
27777 7590 03/12/2018
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
BOWMAN, ANDREW J
ART UNIT PAPER NUMBER
1717
NOTIFICATION DATE DELIVERY MODE
03/12/2018 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EYAL SHEETRIT, ISRAEL NUR,
LILIANA BAR, and LIOR WEISSMAN
Appeal 2017-006663
Application 12/563,667
Technology Center 1700
Before TERRY J. OWENS, DEBRA L. DENNETT, and
JANE E. INGLESE, Administrative Patent Judges.
OWENS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
The Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’
rejection of claims 1—3, 5—9, and 21. We have jurisdiction under
35 U.S.C. § 6(b).
The Invention
The Appellants claim a method for making an implantable mesh.
Claim 1 is illustrative:
1. A method for producing an improved implantable
mesh for repairing an opening or a defect in a soft tissue, the
mesh having a visceral and a non-visceral surface, and the
visceral surface is the portion of the surface which faces away
from the fascia defect and allows reduction of postoperative
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Application 12/563,667
adhesions, the method comprising the steps of: applying at
room temperature to a visceral surface of a mesh a defined
volume of an aqueous solution comprising fibrinogen and an
aqueous solution comprising a proteolytic enzyme that reacts
with fibrinogen to convert the fibrinogen into a homogeneously
distributed fibrin coating on the visceral surface, adding a
solute capable of binding free water and having a molecular
weight of about 1,000 Dalton or less; and drying the fibrin
coating,
thereby obtaining a ready to use implantable mesh
comprising a stabilized dry and homogenous fibrin coating on
the visceral surface for placing the non-visceral surface of the
mesh facing the opening or defect and for placing the visceral
surface facing away from the opening or defect for reducing
postoperative adhesions.
Nikolaychik
The References
US 5,660,873 Aug. 26, 1997
Tayot US 2001/0008930 A1 July 19, 2001
Su US 2005/0100654 A1 May 12, 2005
MacPhee US 2009/0075891 A1 Mar. 19, 2009
The Rejections
The claims stand rejected under 35 U.S.C. § 103 as; follows: claims 1,
3, 5—8, and 21 over MacPhee in view of Nikolaychik, claim 2 over MacPhee
in view of Nikolay chik and Su and claim 9 over MacPhee in view of
Nikolay chik and Tayot.
OPINION
We reverse the rejections. We need address only the sole independent
claim, i.e., claim l.1
1 The Examiner does not rely upon Su or Tayot for any disclosure that
remedies the deficiency in the references applied to the independent
claim (Final Act. 5—6).
2
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Application 12/563,667
MacPhee discloses “a method for treating wounded internal tissue in a
mammal comprising applying to wounded internal tissue at least one
haemostatic material consisting essentially of a fibrinogen component and a
fibrinogen activator for a time sufficient to reduce the flow of fluid from the
wounded tissue” (137). The haemostatic material most preferably is made
by mixing an aqueous solution of the fibrinogen component and the
fibrinogen activator under conditions which minimize activation of the
fibrinogen component by the fibrinogen activator (170). The fibrinogen
component/fibrinogen activator mixture can be dried by freeze drying or
another process (e.g., spray drying, vacuum drying or vitrification) to reduce
the moisture content to a level where the dressing is solid (id.). The
haemostatic material can be on a support which can be gauze plastic (H 82,
85). When the haemostatic material is applied to the wounded tissue, the
fibrinogen component and the fibrinogen activator are activated by the
patient’s endogenous fluids escaping from the wound or by a suitable,
physiologically acceptable liquid (1 102). In an example a mesh support is
placed into a mold, fibrinogen and thrombin (fibrinogen activator) solutions
are dispensed at 4 ± 2 -C into the mold after the mold is removed from
a -80 °C freezer, the mold containing the fibrinogen and thrombin is returned
to the -80 -C freezer for at least two hours, and then the material in the mold
is freeze dried (1291).
Nikolaychik discloses “fibrin-coated stents” (col. 1,11. 5—6) and
teaches that “[cjompared to stents implanted without a fibrin coating, the
incorporation of a fibrin coating on an implanted stent reduces significantly
the likelihood of blood vessel blockage after implantation” (col. 1,11. 51—
55). To reduce the coating’s thrombogenicity, Nikolaychik uses a
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Appeal 2017-006663
Application 12/563,667
substantial amount of natured fibrin and a limited amount of denatured fibrin
(col. 3,11. 63—67). Nikolaychik dries the fibrin-coated stent to provide the
fibrin with a high degree of adhesion to the stent and a high shear stress
resistivity to blood flow (col. 2,11. 29-33; col. 3,11. 58—63; col. 4,11. 8—18).
The fibrin coating “can be stable outside the body and stored for extended
periods before use” (col. 3,11. 46-48). “Before use, the dried fibrin coating
is preferably contacted with water and salts to increase the flexibility and
non-thrombogenicity of the coating to acceptable levels for implantation”
(col. 8,11. 34—37).
The Examiner concludes that “it would have been obvious to one of
ordinary skill in the art at the time of invention to dry the fibrin implants of
MacPhee in order to make them storable for long periods of time and also to
save time and the need for certain equipment for preparing the coating at the
actual point of use” (Final Act. 4).
Establishing a prima facie case of obviousness requires an apparent
reason to modify the prior art as proposed by the Examiner. See KSR Int 7
Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
MacPhee does not convert the haemostatic material’s fibrinogen to
fibrin until the haemostatic material is applied to wounded tissue, at which
time the fibrin contributes to clotting which reduces fluid flow from the
wounded tissue flflf 37, 70, 102). The Examiner does not establish that
Nikolaychik’s disclosure of drying a fibrin-coated stent so the fibrin has a
high degree of adhesion to the stent (col. 3,11. 58—61; col. 4,11. 9-14; col. 7,
11. 40-58) would have provided one of ordinary skill in the art with an
apparent reason to dry MacPhee’s fibrin-coated substrate such that the fibrin
has a high degree of adhesion to the substrate rather than being available to
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Application 12/563,667
contribute to MacPhee’s desired clotting which reduces fluid flow from
wounded tissue. Nikolaychik’s dried fibrin coating, both prior to and after
water and salt are added to it before implantation, has low thrombogenicity
(col. 8,11. 27-36).
DECISION/ORDER
The rejections under 35 U.S.C. § 103 of claims 1,3, 5—8, and 21 over
MacPhee in view of Nikolaychik, claim 2 over MacPhee in view of
Nikolaychik and Su and claim 9 over MacPhee in view of Nikolaychik and
Tayot are reversed.
ft is ordered that the Examiner’s decision is reversed.
REVERSED
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