Ex Parte Ebersole et al

Patent Trial and Appeal Board

Sep 26, 2017

12572352 (P.T.A.B. Sep. 26, 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.
12/572,352 10/02/2009 Garrett Ebersole H-US-00894 CIP 2 3723
(203-546
50855 7590
Covidien LP
60 Middletown Avenue
Mailstop 54, Legal Dept.
North Haven, CT 06473
09/28/2017 EXAMINER
ORKIN, ALEXANDER J
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/28/2017 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 GARRETT EBERSOLE, MARWA CHOUDHURY,
RONALD OSTAPOFF, BRIAN NENTWICK, and
RICHARD P. STEVENSON1
Appeal 2016-008133
Application 12/572,352
Technology Center 3700
Before ERIC B. GRIMES, TAWEN CHANG, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a reinforcing
material comprising a buttress. The Examiner entered final rejections for
anticipation and obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants state “the real party in interest is the assignee of this patent
application, Covidien LP. The ultimate parent of Covidien LP is Medtronic,
pic.” App. Br. 1.
Appeal 2016-008133
Application 12/572,352
STATEMENT OF THE CASE
Background
The present disclosure relates to articles of polymeric
materials in tape, ribbon, sheet, and/or film configurations.
These polymeric materials may be formed so that they possess
no orientation or multi-directional orientation, which may
enhance the integrity of the polymeric material when
multidirectional forces are applied thereto. The polymeric
materials of the present disclosure may be utilized in numerous
applications including, in embodiments, as surgical buttresses
or reinforcing tapes for staple or suture lines.
Spec. 1:12-18.
“While buttresses may be used in conjunction with stapling devices or
sutures to enhance sealing of wounds, materials possessing a unidirectional
orientation as described above may crack or tear with the application of
small amounts of force.” Id. at 2:23 to 3:3. “Thus, it would be
advantageous to provide a material for use with existing wound closure
methods to enhance the sealing of a wound. Such materials may be utilized
in conjunction with a surgical stapling device as well as sutures and other
wound closure methods.” Id. at 3:7—10.
The Claims
Claims 1—7 and 9-15 are on appeal. Final Act. I.2 Claim 1 is
illustrative and reads as follows:
1. A reinforcing material comprising a buttress made
from a polymeric film which possesses no orientation or a
multi-directional orientation and includes at least one of
glycolide, lactide, dioxanone, trimethylene carbonate, and
2 Examiner’s Final Action, mailed September 10, 2015.
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Application 12/572,352
caprolactone, wherein the buttress comprises etched portions
which extend parallel and continuously along an entire length
of the buttress to increase a surface area of the reinforcing
material.
Appeal Br. 11 (Claims Appendix).
The following rejections are before us to review:
Claims 1—3, 5, 6, 9-11, 14, and 15 are rejected under 35 U.S.C.
§ 102(e) as anticipated by Bergin.3 Final Act. 2.
Claim 12 is rejected under 35 U.S.C. § 103(a) as obvious over
Bergin in view of McNiven.4 5Id. at 6.
Claims 1—7, 9—11, and 13—15s are rejected under 35 U.S.C.
§ 102(e) as anticipated by O’Brien.6 Id. at 4.
Claim 12 is rejected under 35 U.S.C. § 103(a) as obvious over
O’Brien in view of McNiven. Id. at 6.
I
The Examiner has rejected claims 1—3, 5, 6, 9—11, 14, and 15 as
anticipated by Bergin. The Examiner finds Bergin discloses all of the
limitations of claim 1. Final Act. 2—3.7 Specific to the issues on appeal, the
3 US 2007/0118229 Al, published May 24, 2007 (“Bergin”).
4 US 7,989,018 B2, issued Aug. 2, 2011 (“McNiven”).
5 Although the Final Action lists claim 16 among the rejected claims,
Appellants cancelled claim 16. App. Br. 12.
6 US 2007/0112421 Al, published May 17, 2007 (“O’Brien”).
7 In the Answer, the Examiner states:
The Product-by-Process interpretations in both the rejection of
claims 1—3, 5, 6, 9-11, 14, and 15 under 35 U.S.C. § 102(e) as
being anticipated over U.S. Patent Publication 2007/0118229 to
Bergin et al and the rejection of claims 1—7, 9-11 and 13—16
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Application 12/572,352
Examiner finds Bergin discloses “a reinforcing material [an article]
comprising a buttress.” Id.
The issue in this rejection is whether a preponderance of the evidence
supports the Examiner’s finding that Bergin anticipates the rejected claims.
Among other arguments, Appellants argue Bergin “describes ‘ [a]n
intramedullary implant for mounting within an intramedullary canal of a
bone. However, nowhere does Bergin disclose or suggest a
buttress.” App. Br. 3^4. Appellants argue the Examiner’s interpretation of
“buttress” is unreasonably broad in light of the Specification. Id. at 4.
Appellants argue the Specification defines “buttress” as follows:
In embodiments, the polymeric materials may be utilized to
form buttresses or similar materials for use in conjunction
with wound closure devices such as staplers and sutures to
enhance wound closure. The term “buttress” as used herein
includes a device, such as a pledget* * * * * * * [8], which provides
support (i.e., mechanical) to the suture or staple line, and
also to the surrounding tissue.
under 35 U.S.C. § 102(e) as being anticipated over U.S. Patent
Publication 2007/0112421 to O'Brien et al have been
withdrawn. However, both Bergin and O’Brien rejections still
stand based on anticipating the limitations without only
depending on the product by process interpretation as argued in
the office action filed 09/10/2016 and in the response to
arguments below.
Ans. 2—3. We restrict our analysis to the Examiner’s findings accordingly.
8 A pledget is “a small flat absorbent pad used to medicate, protect, or
absorb drainage from a wound or sore.” The American Heritage Dictionary
of Medicine (2nd ed.). Boston, MA: Houghton Mifflin.
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Application 12/572,352
App. Br. 4—5, citing Spec. 6:5—9 (emphasis in brief). Appellants argue that
in light of this disclosure, the skilled artisan would recognize that Bergin’s
intramedullary implant is not a buttress. Id. at 5.
The Examiner responds that “[t]he claim limitation of ‘buttress’ does
not positively recite that it will be used with a suture or staple line.
Therefore it can be read as a ‘supportive structure’ to surrounding tissue.”
Ans. 4. The Examiner states that Bergin “discloses an article ‘200’ that can
act as a buttress that will be supportive to surrounding tissue as seen in
figure 6.” Id. at 4. The Examiner further states that Bergin discloses
embodiments with “bone engaging features” and devices used for
“stabilizations which can further read on a buttress function that ‘supports
surrounding tissue.’” Id.
In reply, Appellants argue that “the claims must be given the broadest
reasonable interpretation consistent with the specification,” citing In re Am.
Acad. ofSci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Reply Br. 2.
According to Appellants, the skilled artisan “would recognize that the
recited films are used as buttresses or similar materials used with wound
closure devices [which] Bergin does not disclose.” Id. at 3.
Principles of Law
“The protocol of giving claims their broadest reasonable interpretation during
examination does not include giving claims a legally incorrect interpretation. This
protocol is solely an examination expedient, not a rule of claim construction.” In re
Skvorecz, 580 F.3d 1262, 1267 (Fed. Cir. 2009).
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Analysis
We agree with Appellants that Bergin’s reinforcing material does not
meet the limitations of the claims on appeal. Bergin discloses “[a]n
intramedullary implant for mounting within an intramedullary canal of
bone.” Bergin Abstract. Bergin, which pertains to components of
prostheses for orthopedic surgery (see Abstract) discloses that a “stem” is
one of three parts of a replacement joint used for shoulder or hip surgery. Id.
| 5. Figure 6, which the Examiner relies on to show that the reinforcing
article “can act as a buttress that will be supportive to surrounding tissue”
(Ans. 4) is disclosed by Bergin as “a side plan view of fixation points of the
stem” and as showing that “the fit obtained inside the intramedullary canal
will be stable three-point fixation.” Id. 35/70.
Bergin’s stem is therefore disclosed for use in bone fixation and not to
stabilize a wound closure. The Examiner has not pointed us to any other
disclosures in Bergin supporting the Examiner’s interpretation. We are not
persuaded by the Examiner’s reasoning that “buttress” requires a positive
recitation in the claim that it will be used with a suture or staple line (Ans.
4). Rather, we agree with Appellants that, under the holding of American
Academy, the claims are to be given the broadest reasonable interpretation
consistent with the specification as understood by the ordinarily skilled
artisan (App. Br. 4, American Academy, 367 F.3d at 1364). As shown in the
passage quoted by Appellants above, “buttress” would have been understood
by the skilled artisan to mean a device that provides support to a suture or
staple line and its surrounding tissue, not a device to be fixed within bone.
We therefore reverse the rejection under 35 U.S.C. § 102(e).
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Application 12/572,352
II
The Examiner has rejected claim 12 over Bergin in view of McNiven.
Final Act. 6. This rejection relies upon the underlying anticipation rejection
over Bergin. Having reversed the Bergin rejection for the reasons given
above, we necessarily reverse the obviousness rejection based on Bergin and
McNiven, as the Examiner does not rely upon McNiven to address the
“buttress” limitation of independent claim 1.
III
The Examiner has rejected claims 1—7, 9-11, and 13—15 as anticipated
by O’Brien. The Examiner finds O’Brien discloses all of the limitations of
claim 1. Final Act. 4. Specific to the issues on appeal, the Examiner finds
O’Brien discloses “a reinforcing material [an article] comprising a buttress.”
Id.
The issue in this rejection is whether a preponderance of the evidence
supports the Examiner’s finding that O’Brien anticipates the rejected claims.
Among other arguments, Appellants argue O’Brien “has not been
shown to have described a reinforcing material including ‘a buttress . . .’ as
recited in amended claim 1.” App. Br. 6. Rather, Appellants argue, O’Brien
“describes a medical device, such as a stent, for treating a body lumen” that
is not “the recited buttresses.” Id. Appellants incorporate their reasoning as
applied to the Bergin rejection above with respect to the interpretation of
“buttress” by the ordinarily skilled artisan in light of the Specification. Id.
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Application 12/572,352
The Examiner responds that “O’Brien teaches an article ‘50’ that can
support surrounding tissue as seen in figure 9, lOa-d, and paragraph 36, 41
in that they contact the surrounding the vessel upon expansion.” Ans. 4.
In reply, Appellants reiterate that “the Office’s interpretation of the
claims ignores the recitations of both a buttress and/or a film. . . . O’Brien’s
stents are neither.” Reply Br. 3.
We agree with Appellants that O’Brien’s stent does not meet the
limitations of the claims on appeal. O’Brien discloses “medical devices,
such as stents, for providing a medical treatment to an area of a patient, such
as a body lumen.” O’Brien Abstract. O’Brien discloses its invention as:
A medical device is described comprising: a stent having
at least a first strut, wherein the first strut comprises an outer
surface configured to engage a body lumen when the stent is
expanded, an inner surface opposite the outer surface, and at
least one side surface extending between the outer surface and
the inner surface; a coating disposed on a portion of at least one
strut surface; and at least a first groove disposed in the coating
and situated along the at least one strut surface.
Id. 14.
Figure 9, which the Examiner relies on to show that the stent can
support surrounding tissue (Ans. 4), discloses “cross-sectional views of
various groove arrangements on an exemplary strut.” Id. 131. Figures 10a—
d, similarly relied upon the Examiner, disclose “a top view, partially in
section, of the stent in an unexpanded state within a body lumen,” followed
by views depicting positioning and expansion of the stent within the lumen.
Id. 1131-34.
O’Brien’s stent is therefore disclosed for use in a body lumen such as
a blood vessel and not to stabilize a wound closure. The Examiner has not
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Application 12/572,352
pointed us to any other disclosures in O’Brien supporting the Examiner’s
interpretation. As above, we are persuaded by Appellants that “buttress”
would have been understood by the skilled artisan to mean a device that
provides support to a suture or staple line and its surrounding tissue, not a
device to be affixed within a body lumen. We therefore reverse the rejection
under 35 U.S.C. § 102(e).
IV
The Examiner has rejected claim 12 over O’Brien in view of
McNiven. Final Act. 6. This rejection relies upon the underlying
anticipation rejection over O’Brien. Having reversed the O’Brien rejection
for the reasons given above, we necessarily reverse the obviousness rejection
based on O’Brien and McNiven, as the Examiner does not rely upon
McNiven to address the “buttress” limitation of independent claim 1.
SUMMARY
We reverse the rejection of claims 1—3, 5, 6, 9-11, 14, and 15 under
35 U.S.C. § 102(e) as anticipated by Bergin.
We reverse the rejection of claim 12 under 35 U.S.C. § 103(a) as
obvious over Bergin in view of McNiven.
We reverse the rejection of claims 1—7, 9-11, and 13—15 under 35
U.S.C. § 102(e) as anticipated by O’Brien.
We reverse the rejection of claim 12 under 35 U.S.C. § 103(a) as
obvious over O’Brien in view of McNiven.
REVERSED
9