BOSTON SCIENTIFIC SCIMED, INC.

Patent Trials and Appeals Board

Jul 14, 2020

2019005427 (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.
14/845,824 09/04/2015 Sumit Agrawal 1001.3579101 3479
11050 7590 07/14/2020
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
HOLWERDA, KATHLEEN SONNETT
ART UNIT PAPER NUMBER
3771
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 SUMIT AGRAWAL, NAWAZ MADITHETI,
ERIC M. PETERSEN, STEPHEN J. OOMMEN, and JAMES A. SCHMIDT

Appeal 2019-005427
Application 14/845,824
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 1–20. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE and enter a NEW GROUND OF REJECTION
pursuant to our authority under 37 C.F.R. § 41.50(b).

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. 3.
Appeal 2019-005427
Application 14/845,824

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BACKGROUND
The Specification states that “[t]he present disclosure pertains to
medical devices, and methods for manufacturing and/or using medical
devices. More particularly, the present disclosure pertains to locking
mechanisms for a replacement heart valve.” Spec. 1, ll. 8–10.

CLAIMS
Claims 1 and 19 are the independent claims are on appeal. Claim 1 is
illustrative of the appealed claims and recites:
1. A medical device, comprising:
an elongate delivery sheath;
a valve replacement implant disposed within a lumen of
the elongate delivery sheath, the implant including an anchor
member reversibly actuatable between a delivery configuration
and a fully deployed configuration;
wherein the implant includes at least one locking element
configured to reversibly lock the anchor member in the fully
deployed configuration; and
at least one actuator element configured to engage a
component of the at least one locking element and actuate the
anchor member between the delivery configuration and the fully
deployed configuration and further having an unlocking
member;
wherein the unlocking member is configured to compress
a first locking portion of the at least one locking element, thereby
unlocking the anchor member from the fully deployed
configuration.
Appeal Br. 22.
Appeal 2019-005427
Application 14/845,824

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REJECTIONS2
1. The Examiner rejects claims 1–9 and 13–20 under 35 U.S.C. § 102(a)(1)
as anticipated by Salahieh. 3
2. The Examiner rejects claims 1–9 and 13–20 under 35 U.S.C. § 103 as
unpatentable over Salahieh in view of Sutton.4
3. The Examiner rejects claims 10–12 under 35 U.S.C. § 103 as
unpatentable over Salahieh in view of Sutton and Hutchinson.5
DISCUSSION
New Ground of Rejection
We reject independent claims 1–20 as indefinite because we
determine that it is not reasonably possible to interpret the claim language
“unlocking the anchor member from the fully deployed configuration” in
claim 1 and the similar language “unlock the anchor member from the
expanded deployed configuration” in claim 19 with sufficient clarity to
satisfy 35 U.S.C. § 112(b). See In re Packard, 751 F.3d 1307, 1313 (Fed.
Cir. 2014) (per curiam). We determine that this claim language is amenable
to at least two plausible interpretations, and the written portion of the
Specification does not provide further clarity to determine the specific scope
of the claims. See Ex parte Miyazaki, 2008 WL 5105055, at *5 (BPAI Nov.
19, 2008) (precedential) (“[I]f a claim is amenable to two or more plausible
claim constructions, the USPTO is justified in requiring the applicant to

2 The Examiner withdrew the rejections under 35 U.S.C. § 112(a), (b) and
added a rejection under 35 U.S.C. § 102(a)(1) in the Answer. See Ans. 9.
3 Salahieh et al., US 2005/0137687 A1, pub. June 23, 2005.
4 Sutton et al., US 2013/0123796 A1, pub. May 16, 2013.
5 Hutchinson, US 5,113,553, iss. May 19, 1992.
Appeal 2019-005427
Application 14/845,824

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more precisely define the metes and bounds of the claimed invention by
holding the claim unpatentable . . . as indefinite.”).
First, we find that is not readily apparent from the claim language
itself what would be “the fully deployed configuration” or “the expanded
deployed configuration” of the claimed device. Claim 1 recites a valve
replacement implant disposed within a lumen of a delivery sheath and
including an anchor member that is “reversibly actuatable between a
delivery configuration and a fully deployed configuration.” Appeal Br. 22.
Claim 19 similarly recites an implant with an anchor member “reversibly
actuatable between an elongated delivery configuration and an expanded
deployed configuration.” The claims also require a locking element on the
implant that can reversibly lock the anchor member in the fully deployed or
expanded deployed configuration.
Based on the claim language alone, one could reasonably interpret
“the fully deployed configuration” or the “expanded deployed
configuration” as the state the implant is in when it is fully expanded and
properly placed, but before it is “released” from the remaining structure of
the device, i.e. the claimed actuator element and the delivery sheath.
Alternatively, one could interpret the language, (particularly, the “fully
deployed”) language, as the state the implant is in after it is released from
the remaining structure of the device. In short, it is not clear whether or not
the “fully deployed configuration” and the “expanded deployed
configuration” require that the implant is released from the sheath and
unlocking member.
Second, the Specification can be interpreted as supporting either
construction. We note that we have been unable to locate either of the
Appeal 2019-005427
Application 14/845,824

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phrases “fully deployed” and “expanded deployed” in the written disclosure
portion of the Specification. The Specification does provide a distinction
between a deployed configuration and released configuration, and that
difference is defined by whether the unlocking member is still attached to
the locking member of the implant. Spec. 17, ll. 2–14. But this distinction
raises the question of whether “fully deployed” simply means deployed or
released or something in between.
Accordingly, we conclude that claims 1 and 19 are indefinite under
35 U.S.C. § 112(b). We also conclude that dependent claims 2–18 and 20
are indefinite for the same reasons.
Rejections on Appeal
In view of our determination that claims 1–20 are indefinite, and
because we find that an analysis of the Examiner’s rejections would
necessarily be based on a speculative assumption as to the meaning of the
claims,6 we do not sustain the rejections under 35 U.S.C. § 102 and § 103.
See In re Steele, 305 F.2d 859, 862-63 (CCPA 1962). However, it should be
understood that our decision in this regard is pro forma and based solely on
the indefiniteness of the claimed subject matter, and does not reflect in any
way on the adequacy of the Examiner’s analysis in rejecting the claims.

CONCLUSION
We pro forma reverse the Examiner’s rejections of claims 1–20.

6 We note that Appellant raises the issue regarding the appropriate
construction of “fully deployed” in the context of its application and
identifies the conflict between Appellant’s proposed construction and the
Examiner’s proposed construction. See Reply Br. 2–3.

Appeal 2019-005427
Application 14/845,824

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In a new ground of rejection, we reject claims 1–20 under 35 U.S.C.
§ 112(b) as indefinite.

In summary:
Claims
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed New
Ground
1–9, 13–
20
102(a)1 Salahieh 1–9, 13–20
1–9, 13–
20
103 Salahieh, Sutton 1–9, 13–20
10–12 103 Salahieh, Sutton,
Hutchinson
10–12
1–20 112(b) Indefiniteness 1–20
Overall
Outcome
1–20 1–20

This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). Section 41.50(b) provides that “[a] new ground of
rejection . . . shall not be considered final for judicial review.”
Section 41.50(b) also provides that Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment
of the claims so rejected or new Evidence relating to the claims
so rejected, or both, and have the matter reconsidered by the
examiner, in which event the prosecution will be remanded to the
examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record.
Appeal 2019-005427
Application 14/845,824

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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv) (2017).

REVERSED
37 C.F.R. § 41.50(b)