Ex parte Pachence et al.

Board of Patent Appeals and Interferences

Jul 26, 1999

08385290 (B.P.A.I. Jul. 26, 1999)

Application for patent filed February 10, 1995. 1
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1)
was not written for publication in a law journal and (2) is
not binding precedent of the Board.
Paper No. 25
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte JAMES M. PACHENCE, SALLY FRENKEL
and DAVID MENCHE
__________
Appeal No. 97-1192
Application 08/385,2901
___________
HEARD: July 15, 1999
___________
Before McQUADE, GONZALES and CRAWFORD, Administrative Patent
Judges.
McQUADE, Administrative Patent Judge.
DECISION ON APPEAL
James M. Pachence et al. appeal from the final rejection
of claims 1, 3, 4 and 6 through 10. Claims 2 and 5, which
have been indicated by the examiner as containing allowable
subject matter, stand objected to as depending from rejected
Appeal No. 97-1192
Application 08/385,290
2
base claims. Claims 11 through 16, the only other claims
pending in the application, stand withdrawn from consideration
pursuant to 37 CFR § 1.142(b).
The invention relates to a template for the regenerative
repair of cartilage defects. Claim 1 is illustrative and
reads as follows:
1. A template for the repair of cartilage defects
leading to the regeneration of hyaline-like cartilage, the
template comprising:
a) a first layer comprising a dense collagen membrane
having a pore size of less than 1 micrometer which is cross-
linked with a non-cytotoxic agent to increase strength and
lengthen resorption time, to provide a barrier against
movement of cells from the subchondral plate, the membrane
being sufficiently permeable to allow the passage therethrough
of fluids, nutrients, cytokines, and other endogenous factors
necessary for healing; and
b) a second layer secured to the first layer and
comprising a porous collagen matrix having pore size of 50 to
200 micrometers, which permits the ingrowth of cells.
The references relied upon by the examiner as evidence of
obviousness are:
Lyng 3,526,228 Sept. 1,
1970
Tomoatsu Kimura et al., “Chondrocytes Embedded in Collagen
Gels Maintain Cartilage Phenotype During Long-term Cultures,”
Clinical Orthopaedics, Vol. 186, pp. 231-39 (June 1984)
(Kimura)
Appeal No. 97-1192
Application 08/385,290
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Claims 1, 3 and 7 through 10 stand rejected under 35
U.S.C. § 103 as being unpatentable over Lyng, and claims 4 and
6 stand rejected under 35 U.S.C. § 103 as being unpatentable
over Lyng in view of Kimura.
Reference is made to the appellants’ brief (Paper No. 20)
and to the examiner’s answer (Paper No. 21) for the respective
positions of the appellants and the examiner with regard to
the merits of these rejections.
Lyng discloses a collagen fabric/film laminate that can
be used as a prosthesis in reparative surgery. In Lyng’s
words,
an improved prosthesis can be constructed using as a
framework or support a collagen fabric woven,
knitted, crocheted or braided of collagen strands.
The collagen strands may be tanned either prior to
manufacture of the fabric or subsequent thereto. In
the prosthesis of the present invention the
interstices between the collagen strands are filled
and rendered bloodtight by tanned collagen fibrils,
which form a sheet of film that is laminated to at
least one surface of the fabric.
It is an advantage of the prosthetic material of
the present invention that it has a high tensile
strength and is somewhat elastic when wet. The
fabric layer of the laminate contributes good suture
holding properties and the collagen fibril layer of
the laminate provides a semi-permeable microbial
barrier that is non-adhesiogenic. The prosthesis of
the present invention is slowly absorbed with
concomitant replacement by autologous fibrous tissue
Appeal No. 97-1192
Application 08/385,290
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[column 1, lines 34 through 50].
Lyng goes on to describe five specific examples (Examples I-V)
of the laminate (see column 2, line 25 et seq.). The
description of Example I includes a discussion of the fabric
layer’s weave.
In support of the rejection of independent claim 1, the
examiner states that
Lyng discloses a crosslinked collagen fabric, which
constitutes the second layer as claimed, impregnated
with a collagen film which constitutes the first
layer as claimed, but Lyng fails to disclose the
size of the pores thereof of the two layers.
However, the Examiner asserts that the collagen film
must have pores smaller than about 1 micron since it
is semi-permeable and prevents microbes from passing
through it; see the whole document, especially Col.
1, lines 27-50, Col. 2, lines 8-17 and Example I.
Specifically, the Examiner reasons that, since the
film membrane is semi-permeable, it allows fluids
and small molecules therethrough. Furthermore,
since microbes [are] on the order of about 1 micron
in size, it seems reasonable to assume that the
pores of Lyng are in the range of less than about 1
micron in size.
With respect to the dimensions of the second
layer of Lyng, the examiner posits that the fabric
disclosed in Example I of Lyng would obviously
result in pores size and thickness in the claimed
range.
Hence, it is the Examiner’s position that the
Appeal No. 97-1192
Application 08/385,290
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claimed invention is obvious in view of Lyng since
none of the slight differences therefrom patentably
distinguish it from Lyng [answer, pages 3 and 4].
Rejections based on 35 U.S.C. § 103 must rest on a
factual basis. In re Warner, 379 F.2d 1011, 1017, 154 USPQ
173, 177-78 (CCPA 1967). In making such a rejection, the
examiner has the initial duty of supplying the requisite
factual basis and may not, because of doubts that the
invention is patentable, resort to speculation, unfounded
assumptions or hindsight reconstruction to supply deficiencies
in the factual basis. Id.
As conceded by the examiner, Lyng does not expressly meet
the pore size limitations in claim 1. The appellants’
specification indicates that these pore sizes play an
important role in accomplishing the stated objectives of the
claimed template. The examiner’s attempt to explain away
Lyng’s deficiencies in this regard is replete with speculation
and unfounded assumptions having no reasonable foundation in
the Lyng disclosure. We are therefore constrained to conclude
that Lyng does not provide the factual basis necessary to
justify the obviousness rejection of claim 1. Kimura, applied
in a secondary capacity to support the rejection of dependent
Appeal No. 97-1192
Application 08/385,290
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claims 4 and 6, does not cure this fundamental flaw in the
primary reference.
Accordingly, we shall not sustain the standing 35 U.S.C.
§ 103 rejection of independent claim 1 or of claims 3, 4 and
6 through 10 which depend therefrom.
Appeal No. 97-1192
Application 08/385,290
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The decision of the examiner is reversed.
REVERSED
)
JOHN P. McQUADE )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
MURRIEL E. CRAWFORD )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
JOHN F. GONZALES )
Administrative Patent Judge )
Appeal No. 97-1192
Application 08/385,290
8
Caesar, Rivise, Berstein,
Cohen and Pokotilow, Ltd
12th Floor, Seven Penn Center
1635 Market Street
Philadelphia, PA 19103-2212
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