BOSTON SCIENTIFIC SCIMED, INC.

Patent Trials and Appeals Board

Jul 14, 2020

2019005348 (P.T.A.B. Jul. 14, 2020)

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.
14/220,849 03/20/2014 Susan M. Shoemaker 2001.1526103 8720
11050 7590 07/14/2020
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
PRONE, CHRISTOPHER D
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
07/14/2020 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):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte SUSAN M. SHOEMAKER, JASON P. HILL,
PAUL F. CHOUINARD, and LEONARD B. RICHARDSON

Appeal 2019-005348
Application 14/220,849
Technology Center 3700
____________

Before NINA L. MEDLOCK, JAMES A. WORTH, and
KENNETH G. SCHOPFER, Administrative Patent Judges.

SCHOPFER, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 22–28 and 30–42. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as Boston
Scientific Scimed, Inc. Appeal Br. 4.
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BACKGROUND
The Specification discloses that “[t]he present invention relates
generally to apparatus, systems, and methods for use in a lumen; and more
particularly to venous valve apparatus, systems, and methods for use in the
vasculature system.” Spec. ¶ 2.
CLAIMS
Claims 22, 37, and 40 are the independent claims on appeal. Claim 22
is illustrative of the appealed claims and recites:
22. A valve, comprising:
a tubular frame having a first frame end and an opposing
second frame end, the tubular frame comprising:
a first serpentine ring of struts interconnected by
turns, the turns comprising first turns forming a first frame
end and second turns positioned between the first frame
end and the second frame end;
a plurality of zig-zagging frame members arrayed
sequentially toward the second frame end from the first
serpentine ring, the zig-zagging frame members including
a first frame member fixed to the first serpentine ring, and
one or more additional frame members, each fixed to an
immediately preceding frame member of the plurality of
zig-zagging frame members; and
a second serpentine ring of struts interconnected by
turns, the turns comprising third turns positioned between
the first frame end and the second frame end and fourth
turns forming the second frame end; and
a cover disposed over at least a portion of an outer surface
of the tubular frame and at least a portion of an inner surface of
the tubular frame, wherein the cover wraps from the outer surface
around the first frame end to the inner surface, the first frame end
being an inflow end of the valve;
wherein the cover forms first and second valve leaflets
within and movable relative to the tubular frame, the valve
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leaflets defining a reversibly sealable opening for unidirectional
flow of a liquid through the valve;
wherein at least a portion of the cover extends along and
is supported by the inner surface of the tubular frame between
the first frame end and the first and second valve leaflets.
Appeal Br. 21 (Claims Appendix).
REJECTIONS
1. The Examiner rejects claims 22–28, 30–33, and 36 under 35 U.S.C.
§ 103(a) as unpatentable over Bailey2 in view of Bessler.3
2. The Examiner rejects claims 34 and 35 under 35 U.S.C. § 103(a) as
unpatentable over Bailey in view of Bessler and Keast.4
3. The Examiner rejects claims 37–42 under 35 U.S.C. § 103(a) as
unpatentable over Bailey in view of Bessler and Chun.5
DISCUSSION
Independent claim 22 recites a cover disposed over an outer surface of
a tubular frame and a portion of the inner surface of the tubular frame and
requires that “the cover wraps from the outer surface around the first frame
end to the inner surface.” Appeal Br. 21. Independent claims 37 and 40
include similar requirements. Id. at 23–24. We are persuaded by
Appellant’s argument that the Examiner has not established that it would
have been obvious to modify the art of record to include a cover disposed on
a tubular frame as claimed.

2 Bailey et al., US 2001/0021872 A1, pub. Sept. 13, 2001.
3 Bessler et al., US 5,855,601, iss. Jan. 5, 1999.
4 Keast et al., US 2002/0111619 A1, pub. Aug. 15, 2002.
5 Chun et al., US 2003/0209835 A1, pub. Nov. 13, 2003.
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With respect to claim 22, the Examiner finds that Bailey discloses a
cover that is disposed over an inner and outer surface of a tubular frame.
Final Act. 3. The Examiner acknowledges that “Bailey does not specifically
disclose how the cover member encompasses both the inner and outer
surfaces,” i.e., whether it is continuous and wraps from the outer surface to
the inner surface. Id. The Examiner then finds and determines:
Bessler teaches that it is old and well known in the art of
implantable valves to include covers that extend continuously
and wrap around the inflow end of a frame to the inner surface.
This configuration permits the cover to extend over both the
inner and outer surfaces of the frame while preventing blood flow
from penetrating between the two layers causing them to separate
and leading the valve to fail.
It would have been obvious to one having ordinary skill in
the art at the time the invention was made to modify the cover of
Bailey to fully wrap around the entire inflow end so that a
continuous sheet can be used to form the cover and the valve
members and separation of layers will be prevented.
Id. at 3–4. The Examiner also finds that Bailey “specifically discloses the
cover extending over both the luminal and abluminal surfaces of the frame”
and “Bessler discloses a cover which extends from the outer surface (cuff
portion) around the first end and extends along the inner surface of the frame
to form leaflets.” Id. at 6. The Examiner also notes that the rejection does
not rely “on Bessler for any teachings other than the wrapping of a cover
around the end of the frame.” Id.
There is some dispute between the Examiner and Appellant as to
whether Bessler discloses a cover that wraps around the end of Bessler’s
tubular frame. See Ans. 9–10; Appeal Br. 15–16. Yet, even if we were to
agree with the Examiner that Bessler teaches such a configuration, we are
persuaded by Appellant’s argument that the Examiner has not established
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that it would have been obvious to modify Bailey’s device to include a cover
disposed around the end of the device as required by the claims.
In determining that the modification of Bailey would have been
obvious, the Examiner determines that it would have been obvious “to
modify the cover of Bailey to fully wrap around the entire inflow end so that
a continuous sheet can be used to form the cover and the valve members and
separation of layers will be prevented.” Final Act. 4. Regarding this
determination, the Examiner does not provide further evidence or
explanation, and without such, it is not clear that a person of ordinary skill in
the art would have had any reason to modify Bailey as proposed. The
Examiner reasons that such a modification would prevent “separation of
layers.” Yet, Bailey discloses that the cover is attached to the struts of the
device, and thus, it is not clear how the modification proposed by the
Examiner would provide any further prevention of separation of layers of the
device. See Bailey ¶ 21.
In the Answer, the Examiner further determines “that a continuous
cover could be used to wrap over one end which would provide numerous
known benefits (ease of manufacture, prevention of openings or leaks,
promoting ingrowth throughout, and many other well-known motivations
within the art.)” Ans. 9. The Examiner does not provide further explanation
as to how or why one of ordinary skill in the art would have modified
Bailey’s cover to achieve these benefits. Even if we were to agree that these
are known benefits of such a configuration, the Examiner has not established
that they would have provided a person of ordinary skill in the art with a
reason for making the specific modification to Bailey’s device that the
Examiner is proposing. In short, the Examiner does not explain specifically
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what the proposed modification is or how it would achieve the benefits
asserted, as compared to Bailey’s unmodified design.
“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” KSR Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007) (quoting
In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)); see also Ball Aerosol and
Specialty Container, Inc. v. Ltd. Brands, Inc., 555 F.3d 984, 993 (Fed. Cir.
2009) (“[T]he analysis that ‘should be made explicit’ refers not to the
teachings in the prior art of a motivation to combine, but to the court's
analysis.”). We note that the Examiner’s reasoning for making the proposed
combination need not be explicitly found in the prior art. In re Kotzab,
217 F.3d 1365, 1370 (Fed. Cir. 2000) (internal citations omitted). However,
as indicated above, the Examiner does not provide any connection between
the proposed reasoning and the art that the Examiner proposes to modify, i.e.
the Examiner fails to explain how the reasoning would be applied in order to
show that a modification of Bailey would have been obvious to one of
ordinary skill in the art.
Based on the foregoing, we do not sustain the rejection of independent
claim 22 as obvious over Bailey in view of Bessler. For the same reasons,
we do not sustain the rejection of dependent claims 23–28, 30–33, and 36.
With respect to the rejection of claims 34 and 35, the Examiner relies on the
same reasoning discussed above and does not provide further analysis or
point to further evidence that cures the deficiency in the rejection of
claim 22. Thus, we also do not sustain the rejection of claims 34 and 35.
Regarding the rejection of claims 37–42, the Examiner relies on the same
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reasoning with respect to independent claims 37 and 40 as that provided
with respect to claim 22 regarding the limitations discussed above. The
Examiner does not provide further evidence or reasoning that cures the
deficiency in the Examiner’s analysis regarding these limitations in
independent claims 37 and 40. Thus, we also do not sustain the rejection of
independent claims 37 and 40 or dependent claims 38, 39, 41, and 42 for the
reasons discussed above.

CONCLUSION
We REVERSE the rejections of claims 22–28 and 30–42.
In summary:
Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
22–28, 30–
33, 36
103(a) Bailey, Bessler 22–28,
30–33,
36
34, 35 103(a) Bailey, Bessler,
Keast
34, 35
37–42 103(a) Bailey, Bessler,
Chun
37–42
Overall
Outcome
22–28,
30–42

REVERSED