Ex Parte Bettuchi et al

Board of Patent Appeals and Interferences

Aug 2, 2012

11238497 (B.P.A.I. Aug. 2, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MICHAEL J. BETTUCHI, DAVID FOWLER,
AHMAD ROBERT HADBA, CHRISTOPHER J. CRISCUOLO,
and JOHN KENNEDY
__________

Appeal 2011-007712
Application 11/238,497
Technology Center 3700
__________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to an anastomosis
device. The device comprises a seal disposed between the two tissue lumens
to be joined. The seal comprises two materials: a material promoting tissue
ingrowth and an adhesive sealant. We have jurisdiction under 35 U.S.C.
§ 6(b).
We reverse.
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Statement of the Case
Background
The present invention relates to a “composite seal element for use in
anastomosis” (Spec. 2, ¶6). “[T]he seal element is disposed between the
proximal and distal ends of an anastomosis before the tissue is approximated
and staples are fired.” (Id.). The seal comprises two materials: the first is “a
porous material for allowing tissue ingrowth,” the second is “a sealant.” (Id.
at ¶7).
The Claims
Claims 16-30 are on appeal. Claim 16 is representative and reads as
follows:
16. An assembly for disposing a seal element between
tissue lumens comprising:
a circular surgical stapling device comprising an anvil
assembly and a tubular body portion wherein the anvil
assembly comprises an anvil member and a first shaft and
the tubular body portion comprises a plurality of surgical
staples in a circular configuration and a second shaft
disposed inwardly of the surgical staples, the first shaft
being attachable to the second shaft; and
a seal element disposable between tissue lumens, the
seal element comprising a first material and a second
material wherein the first material promotes tissue ingrowth
and the second material comprises a sealant.
The Issue
The Examiner rejected claims 16-30 under 35 U.S.C. § 103(a) as
obvious over Huxel1 and Shalaby2 (Ans. 3).

1 U.S. Patent No. 6,503,259 B2 (issued Jan. 7, 2003).
2 U.S. Patent No. 6,299,631 B1 (issued Oct. 9, 2001). 
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The Examiner finds Huxel discloses a surgical stapling device having
all of the elements of claim 16 (Ans. 3). The Examiner also finds Huxel
discloses “a seal element . . . comprising a compressible porous material that
promotes tissue ingrowth.” (Final Rejection 2, ¶2). The Examiner notes
Huxel does not disclose the seal being composed of a second material
comprising a sealant (id.).
The Examiner finds Shalaby “teaches it is known to use adhesive in
anastomosis procedures . . . to provide proper sealing.” (Ans. 3).
Therefore, the Examiner concludes “it would have been obvious to
one of ordinary skill in the art at the time the invention was made to have
included an adhesive on the seal of Huxel et al. to provide more compliant
sealing of the tissue to the seal element.” (Ans. 3).
Appellants contend Huxel teaches away from both the use of staples
and the location of the seal between the two tissue lumens (App. Br. 5, 6).
Appellants also contend “Huxel’s mechanical connection does not suggest
the use of a first material that promotes tissue ingrowth” (App. Br. 11).
The issue with respect to this appeal is: Does the evidence of record
support the Examiner’s conclusion that Huxel and Shalaby render claims 16-
30 obvious?
Findings of Fact
1. Huxel teaches a gasket for use in an anastomosis device helping to
“maintain[] the integrity of the junction.” (Huxel col. 2, lines 64-65,
col. 4, line 57).
2. Huxel teaches “gasket 16 is preferably composed of one of the
following materials: fluropolymers, polyurethanes, aliphatic polymers,
poly(amino acids), copoly(etheresters), polyalkylenes oxalates,
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polyamides, poly(iminocarbonates), polyorthoesters, polyoxaesters,
polyamidoesters, polyoxaesters containing amine groups,
poly(anhydrides) and polyphosphazines.” (Huxel col. 8, lines 41-47).
3. Huxel teaches “[s]uitable monomers include but are not limited to
lactic acid, lactide . . . glycolic acid, glycolide, []caprolactone . . .
trimethylene carbonate” (Huxel col. 8, lines 53-55).
Principles of Law
“During examination, ‘claims . . . are to be given their broadest
reasonable interpretation consistent with the specification.’” In re Am. Acad.
of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) (quoting In re Bond,
910 F.2d 831, 833 (Fed. Cir. 1990)).
“In proceedings before the Patent and Trademark Office, the
Examiner bears the burden of establishing a prima facie case of obviousness
based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992).
“If the examiner fails to establish a prima facie case, the rejection is
improper and will be overturned.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993).
Analysis
We agree with Appellants that the Examiner has failed to establish a
prima facie case of obviousness as to claim 16. Specifically, the Examiner
has failed to explain how the device of Huxel teaches a material that
“promotes tissue ingrowth” (App. Br. 16).
We must first interpret the language of claim 16. See, e.g., In re Am.
Acad. of Sci. Tech. Ctr., 367 F.3d at 1365. Thus, we must accord the claim
term ‘promotes tissue ingrowth’ the “broadest reasonable interpretation
consistent with the specification.” Id. at 1364; In re Hyatt, 211 F.3d 1367,
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1372 (Fed. Cir. 2000). The Specification teaches “a bioabsorbable material
that promotes tissue ingrowth” (Spec. 4 ¶ 0019). The Specification explains
that “this material is desirably porous enough to allow tissue to grow
through it” (Spec. 5 ¶ 0019). We can confirm that this is the ordinary and
customary meaning of “ingrowth” by the dictionary definition. See, e.g.,
Markman v. Westview Instruments, Inc., 52 F.3d 967, 980-81 (Fed. Cir.
1995). The dictionary defines term ‘ingrowth’ to mean ‘growth into.’ See
Merriam-Webster Dictionary, http://www.merriam-
webster.com/medical/ingrowth. Thus, we construe the language of the claim
to require a material which promotes growth of tissue into and through the
material.
In the Final Rejection, the Examiner takes the position that Huxel
teaches “a seal element (16) comprising a compressible porous material that
promotes tissue ingrowth.” (Final Rejection 2, ¶2). In the Answer, the
Examiner reformulates the position, stating Huxel teaches “a seal element
(16) comprising a compressible material that promotes tissue ingrowth (for
example, through the gaps in the seal at 44).” (Ans. 3).
We agree with the Appellants that the Examiner has failed to establish
a prima facie case of obviousness as to claim 16. Here, in both the Non-
Final and Final Office Actions, the Examiner has failed to clearly explain or
particularly point out how the materials used in Huxel promotes growth of
tissue into the material of the gasket. See 37 C.F.R. § 1.104.
We note that both the instant Specification and Huxel use common
materials such as polyurethanes, lactides, glycolides, caprolactone, and
trimethylene carbonate (compare Huxel col 8, lines 42, 53-55, with Spec. 5,
¶19; FF 2,3). Yet the Examiner has not cited this teaching of Huxel and has
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provided no explanation whether, or even if, these materials are those which
would inherently or necessarily promote tissue ingrowth. Given the large
variability in the properties of different polymers, there is insufficient
evidence of record to demonstrate that the material of Huxel would
inherently satisfy the “ingrowth” requirement of the claim. Moreover, the
Examiner has not provided any clear explanation as to why an ordinary
artisan would have considered it obvious to use ingrowth-promoting
materials to make Huxel’s gasket.
Accordingly, we are constrained to reverse the Examiner’s prima
facie case of obviousness.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Huxel and Shalaby render claim 16 obvious.
SUMMARY
In summary, we reverse the Examiner’s rejection of claims 16-30
under 35 U.S.C. § 103(a) as obvious over Huxel and Shalaby.

REVERSED

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