Ex Parte Milliman

Board of Patent Appeals and Interferences

Jul 26, 2011

11728698 (B.P.A.I. Jul. 26, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte KEITH L. MILLIMAN
____________

Appeal 2009-014520
Application 11/728,698
Technology Center 3700
____________

Before STEVEN D.A. McCARTHY, MICHAEL W. O’NEILL, and
STEFAN STAICOVICI, Administrative Patent Judges.

O’NEILL, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Keith L. Milliman (Appellant) appeals under 35 U.S.C. § 134 from
the Examiner’s decision rejecting claims 1-17 and 20-36 under 35 U.S.C.
§ 103(a) as unpatentable over Gallagher (US 5,758,814, iss. Jun. 2, 1998)
and Resnick (US 4,903,697, iss. Feb. 27, 1990) and claims 18, 19, and 37-46
under 35 U.S.C. § 103(a) as unpatentable over Gallagher and Keipert (US
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5,962,120, iss. Oct. 5, 1999). We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
The Invention
The claims on appeal relate to an improved cut ring for an anvil staple
assembly which is used with a surgical stapler during an anastomosis
procedure. Spec. 1:8-13.
Claim 7, reproduced below, is illustrative of the subject matter on
appeal.
Claim 7: A cut ring assembly for use with an anvil
assembly comprising:
a body and a cover fastened to a proximal
surface of the body, the cover including a first
layer formed of a first material having a first
hardness to allow penetration of the cover by a
knife of a surgical stapler and at least one
additional layer formed of a second material
having a second hardness greater than the first
hardness to minimize penetration of the cover by a
knife of a surgical stapler as the knife translates
distally along a knife path, wherein at least a
portion of the body and at least a portion of the
cover are positioned in the knife path.

OPINION
We have carefully reviewed the Examiner’s rejection in light of the
Appellant’s arguments and the Examiner’s response. As a result of this
review, we determine that the issue that needs to be resolved in this appeal is
whether Gallagher discloses a cover formed of a material that is harder than
the body of the cut ring assembly, and as such, minimizes penetration by a
knife as the knife translates distally along a knife path.
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We find that Gallagher is essentially silent with respect to any
hardness of any of the materials that Gallagher uses to construct the anvil
assembly for use with a circular stapler. We note that Gallagher
prophetically mentions that an ideal cut ring would be one having a
combination of semi-rigid and rigid materials in a knife path in order to
effectively sever both tissue and staples during an anastomosis procedure.
Gallagher, col. 3, ll. 23-35. We note that the Examiner’s rejection does not
acknowledge this portion of Gallagher. The Board of Patent Appeals and
Interferences is a review body, rather than a place of initial examination. As
such, we decline to conclude what such a disclosure would lead a person
having ordinary skill in the art to glean from Gallagher. We leave it to the
Examiner to determine the appropriateness of any further course of action
based on such a disclosure.
We note that the express, implicit, and inherent disclosures of a prior
art reference may be relied upon in the rejection of claims under 35 U.S.C.
§§ 102 or 103. “The inherent teaching of a prior art reference, a question of
fact, arises both in the context of anticipation and obviousness.” In re
Napier, 55 F.3d 610, 613 (Fed. Cir. 1995).
However, the fact that a certain result or characteristic may occur or
be present in the prior art is not sufficient to establish the inherency of that
result or characteristic. See In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir.
1993) (reversed rejection because inherency was based on what would result
due to optimization of conditions, not what was necessarily present in the
prior art); In re Oelrich, 666 F.2d 578, 581-82 (CCPA 1981). “To establish
inherency, the extrinsic evidence ‘must make clear that the missing
descriptive matter is necessarily present in the thing described in the
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reference, and that it would be so recognized by persons of ordinary skill.’
‘Inherency, however, may not be established by probabilities or possibilities.
The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.’” In re Robertson, 169 F.3d 743, 745 (Fed.
Cir. 1999) (citations omitted). “In relying upon the theory of inherency, the
examiner must provide a basis in fact and/or technical reasoning to
reasonably support the determination that the allegedly inherent
characteristic necessarily flows from the teachings of the applied prior art.”
Ex parte Levy, 17 USPQ2d 1461, 1464 (BPAI 1990).
Here, Gallagher is silent as to the hardness of the materials used to
construct what the Examiner has found to satisfy the cover with two layers
of differing hardness. See Ans. 3-5 and 16 (element 126 satisfying the first
layer, element 128 satisfying the additional layer, and, since as shown in
Figure 6, these elements are in the same housing and do not move relative to
each other, the combination of elements satisfies the claimed cover and its
construction of two layers having materials of differing hardness). As such,
the Examiner appears to be finding the positioning of the parts and lack of
relative motion suffices to satisfy the claimed functional relationship of
hardness.
Arguendo, a person having ordinary skill in the art would concur that
Gallagher’s backing plate 128 corresponds to Appellant’s claimed cover;
there is still no explicit disclosure in Gallagher as to the material that makes
up its construction, compares its constructed material to the material of the
resilient member 126, nor a disclosure that the material of backing plate 128
is of such hardness so as to minimize penetration by a knife. Moreover, we
find no disclosure, teaching, or suggestion in Gallagher that backing plate
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128 in any way contacts the knife 30 such that inferentially it could be found
that the combination of elements 126 and 128 would lead to finding a cover
formed of a material that has at least a portion harder than the body of the
cut ring assembly and minimizes knife penetration. A review of figure 6
reveals a gap between the outer diameter of the backing plate 128 and the
cutting edge of the knife 30 when the knife 30 translates distally. As such,
the Examiner’s technical reasoning based on the relative position and lack of
motion of the elements 126 and 128 is insufficient to establish that Gallagher
inherently discloses the claimed functional hardness relationship as set forth
in the claims.
The Examiner fails to use Resnick or Keipert to remedy the
aforementioned deficiency concerning Gallagher’s disclosure.
For the reasons above, we find that the Examiner’s rejection lacks
sufficient findings of fact or analysis to factually conclude that Gallagher
discloses a cover formed of a material that is harder than the body of the cut
ring assembly and minimizes penetration by a knife as the knife translates
distally along a knife path. As a result of such a resolution of the issue, we
are constrained to conclude that the Examiner’s proffered rejection fails to
establish that the claimed invention would have been obvious to a person
having ordinary skill in the art.

DECISION
The decision of the Examiner to reject claims 1-46 under 35 U.S.C.
§ 103(a) as unpatentable over Gallagher, Resnick, and Keipert is reversed.

REVERSED
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