Ex Parte Anderson

Patent Trial and Appeal Board

Jun 16, 2017

13747916 (P.T.A.B. Jun. 16, 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.
13/747,916 01/23/2013 James Anderson 2001.1561101 4418
11050 7590 06/20/2017
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
MILLER, CHERYL L
ART UNIT PAPER NUMBER
3738
NOTIFICATION DATE DELIVERY MODE
06/20/2017 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):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES ANDERSON
Appeal 2015-0017061
Application 13/747,9162
Technology Center 3700
Before MICHAEL C. ASTORINO, JAMES A. WORTH, and
CYNTHIA L. MURPHY, Administrative Patent Judges.
WORTH, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s final
rejection of claims 1—20. We have jurisdiction under 35 U.S.C. §§ 134
and 6(b).
We AFFIRM-IN-PART.
1 Our decision refers to the Appellant’s Appeal Brief (“Appeal Br.,” filed
Sept. 22, 2014) and Reply Brief (“Reply Br.,” filed Nov. 24, 2014), and the
Examiner’s Final Office Action (“Final Act.,” mailed May 6, 2014) and
Answer (“Ans.,” mailed Oct. 7, 2014).
2 According to Appellant, the real party in interest is “Boston Scientific
Scimed, Inc., formerly known as Scimed Life Systems, Inc.” (Appeal Br. 3).
Appeal 2015-001706
Application 13/747,916
Introduction
Appellant’s application relates to “heart valve implants such as for
percutaneous aortic valve implantation in patients having heart disease.”
(Spec. 11).
Claims 1 and 16 are the independent claims on appeal. Claim 1,
reproduced below, is illustrative of the subject matter on appeal:
1. A percutaneous prosthetic heart valve assembly
comprising:
a radially expandable, anchor docking member, the
anchor docking member having an unexpanded state and an
expanded state, in the expanded state, the anchor docking
member comprising a mechanism for receiving and engaging an
implantable heart valve; and
a bioabsorbable gasket member disposed about the
anchor docking member, the bioabsorbable gasket member
comprising a bioabsorbable polymer material, the
bioabsorbable gasket member having an unexpanded and an
expanded state.
(Appeal Br., Claims App.)
Rejections on Appeal
The Examiner maintains, and Appellant appeals, the following
rejections:
I. Claims 1, 2, 7, 9—13, and 16—19 stand rejected under (pre-AIA)
35 U.S.C. § 102(b) as being anticipated by Stacchino
(US 7,857,845 B2, iss. Dec. 28, 2010).
II. Claims 1, 2, and 7—18 stand rejected under (pre-AIA) 35 U.S.C.
§ 102(b) as being anticipated by Hojeibane
(US 2005/0096735 Al, pub. May 5, 2005).
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III. Claims 14 and 15 stand rejected under (pre-AIA) 35 U.S.C.
§ 103(a) as being unpatentable over Stacchino and Righini
(US 2010/0161045 Al, pub. June 24, 2010).
IV. Claims 1, 2, 4, 5, 7, 9—16, and 18—20 stand rejected under (pre-
AIA) 35 U.S.C. § 103(a) as being unpatentable over Richter
(US 2010/0185275 Al, pub. July 22, 2010) and Gorman
(US 2012/0303116 Al, pub. Nov. 29, 2012).
V. Claims 1—3, 6, 9, and 11—13 stand rejected under (pre-AIA) 35
U.S.C. § 103(a) as being unpatentable over Ortiz
(US 2004/0167620 Al, pub. Aug. 26, 2004) and Chinn
(US 7,641,687 B2, iss. Jan. 5, 2010).
ANALYSIS
Rejection I (Anticipation)
Appellant asserts that claim 1 is directed to “a pre-valve assembly”
“for receiving and engaging a heart valve” (see Appeal Br. 9). The
Examiner determines, and we agree, that the feature of a “pre-valve
assembly” is not written into the claim language, and is not a claim
requirement as such (see Ans. 11). The argued phrase is found in the
Specification: “The percutaneous heart valve assembly disclosed herein
includes ... a pre-valve assembly” (Spec. 122). However, this portion of
the Specification is exemplary, rather than definitional, and does not create a
lexicographic requirement for the claims. See Laryngeal Mask Co. Ltd. v.
AmbuA/S, 618 F.3d 1367 (Fed. Cir. 2010). Nevertheless, independent
claim 1 does recite an “anchor docking member, . . . comprising a
mechanism for receiving and engaging an implantable heart valve.” To the
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extent Appellant is arguing this latter limitation, we agree with Appellant
that the “anchor docking member” must include a mechanism that is capable
of “receiving and engaging” an implantable heart valve.
With this understanding, we agree with Appellant that Stacchino fails
to disclose a mechanism for “receiving and engaging” a valve (see Appeal
Br. 9). The Examiner finds that Stacchino discloses that sutures are threaded
through holes 26 (in bars 24 of docking member 2) to attach valve 3a, 3b, 3c
to docking member 2 (see Final Act. 6). The Examiner determines that
Stacchino’s docking member meets the limitation of “receiving and
engaging” a valve based on the Examiner’s interpretation that the term
“engag[ed]” means “against,” i.e., Stacchino’s valve is against the inner wall
of the docking member (see Ans. 12). However, the Examiner does not cite
a dictionary or other source in support of this interpretation. We determine
that “engage” means “to interlock with.” See www.merriam-
webster.com/dictionary/engage (definition 2c) (last visited June 16, 2017).
Stacchino’s docking mechanism with holes 26 fails to interlock with heart
valves 3a, 3b, and 3c without the further modification of sutures. As such,
Stacchino’s anchor docking mechanism does not “engage” the heart valve.
Nor is Stacchino’s anchor docking mechanism “for receiving” the heart
valves without further modification; holes 26 receive sutures rather than
receiving the heart valve. We, therefore, do not sustain the Examiner’s
rejection under § 102 of independent claim 1 as anticipated by Stacchino.
For the same reason, we do not sustain the Examiner’s rejection under § 102
of claims 2, 7, and 9—13, which depend therefrom.
Independent claim 16 contains similar language and requirements as
independent claim 1. We do not sustain the Examiner’s rejection under
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§ 102 of independent claim 16, and of dependent claims 17—19, as
anticipated by Stacchino, for similar reasons as independent claim 1.
Rejection II (Anticipation)
Appellant argues that Hojeibane fails to disclose a “pre-valve
assembly with an anchor docking member and bioabsorbable gasket,” which
Appellant contends to be required by independent claim 1 (see Appeal
Br. 13). However, as discussed above with respect to the rejection over
Stacchino, independent claim 1 does not require a “pre-valve assembly.”
Instead, the Examiner finds that Hojeibane discloses docking member
101 that receives and engages annular heart valve 102 with gasket 109 that
may be composed of a bioabsorbable polymer (Final Act. 6—7 (citing, e.g.,
Hojeibane Tflf 37, 105 & Figs. IB, 6D)). We agree with the Examiner’s
findings. For example, Hojeibane discloses that structural frame 101
consists of anchor structure 104 connected by at least one connecting
member 105 to a proximal collar 108, and cantilever struts 107 extend from
proximal collar 108 and are attached to biocompatible membrane assembly
102 (Hojeibane 38—39; see also id. 1105 & Fig. IB). Hojeibane
discloses that the gasket may be a bioabsorbable material {id. 137).
Appellant also argues that Hojeibane’s anchor is the distal end of the
valve and is part of the valve framework, not a separate structure from the
valve framework (Appeal Br. 13). However, there is no claim requirement
that the anchor be separate from the valve framework. See also Skedco, Inc.
v. Strategic Operations, Inc., No. 2016-1349, 2017 WF 1497202, slip op. at
6 (Fed. Cir. Apr. 24, 2017) (non-precedential) (“In this case, nothing in the
claims requires the pump and valve to be physically separated.”).
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Accordingly, we sustain the Examiner’s rejection under § 102 of
independent claim 1 as anticipated by Hojeibane. Appellant does not argue
the rejection of claims 2 and 7—18 separately from that of independent
claim 1. We, therefore, sustain the Examiner’s rejection under § 102 of
claims 2 and 7—18 as anticipated by Hojeibane, for similar reasons as for
independent claim 1.
Rejection III (Obviousness)
Claims 14 and 15 each depend from claim 1 and stand rejected under
§ 103 as unpatentable over Stacchino and Righini. The Examiner’s reliance
on Righini’s disclosure does not remedy the deficiency in the rejection of
independent claim 1 under § 102 as anticipated by Stacchino. We, therefore,
do not sustain the Examiner’s rejection of claims 14 and 15 under § 103 as
unpatentable over Stacchino and Righini, for the same reasons as for the
Examiner’s rejection of independent claim 1 under § 102 as anticipated by
Stacchino.
Rejection IV (Obviousness)
Appellant argues that, in Gorman, “[tjhere is no expandable anchor
member separate from the heart valve having a bioabsorbable gasket
disposed therein for engaging a heart valve,” as recited in independent
claims 1 and 16, i.e., “a bioabsorbable gasket member disposed about the
anchor docking member” (Appeal Br. 14). We are persuaded by Appellant’s
argument inasmuch as the Examiner does not explain how cuff 10a, 10b of
Gorman is proposed to be disposed about support 20 of Richter (see id.;
Final Act. 9; Ans. 18—19). As such, we cannot evaluate on this record,
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whether and how the proposed combination would meet the requirements of
independent claims 1 and 16. We, therefore, do not sustain the Examiner’s
rejection of independent claims 1 and 16 under § 103 as unpatentable over
Richter and Gorman. For the same reasons, we do not sustain the
Examiner’s rejection of dependent claims 2, 4, 5, 7, 9—15, and 18—20 under
§ 103 as unpatentable over Richter and Gorman.
Rejection V (Obviousness)
The Examiner relies on absorbable cover sleeve 84 of Ortiz as a
gasket (Final Act. 10), but finds that Ortiz “does not show the absorbable
cover sleeve 84 on the embodiments with the heart valve” (id. at 11 (citing
Figs. 26, 27, 39)). The Examiner also finds that “it is unclear how the
projection would engage the groove [if] a cover sleeve were present” (id.).
The Examiner proposes to modify the device of Ortiz with the teachings of
Chinn, finding that “Chinn further teaches that the heart valve may attach to
the anchor support ring even when an outer sleeve is present, by providing
cut-outs in the sleeve where grooves are to be located for example, in order
to provide access to the grooves . . . .” (id. (citing col. 4,11. 40-51)). Chinn
states that “a hole or holes are introduced in the cloth, before or after
gathering around the stiffening ring 18, to reveal each opening 216” (Chinn,
col. 4,11. 46-48).
Appellant contends that the proposed combination fails to disclose a
gasket, as recited in independent claim 1 (see Appeal Br. 15—16). Appellant
relies on a definition of “gasket” as “a shaped piece or ring ... for sealing
the junction between two surfaces” (Appeal Br. 16). We determine that a
gasket is “a material (such as rubber) or a part (such as an O-ring) used to
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make a joint fluid-tight.” See www.merriam-webster,com/dictionary/gasket
(last visited June 16, 2017). The Examiner reasons that:
The purpose of the sleeve to aid in ease of insertion, by
providing a surface between the anchor and tissue during
insertion of low friction. The sleeve coating 84 surrounds the
anchor and protects the anchor from contacting adjacent tissue
during insertion, thus provides a barrier between the anchor and
the tissue when implanted, thus is considered to serve as a
“gasket”.
(Ans. 20). We are persuaded by Appellant’s contention inasmuch as the
Examiner does not adduce evidence or reasoning to explain how Chinn’s
sleeve serves to create a fluid-tight joint. As such, we agree with Appellant
that the Examiner does not explain how the proposed combination discloses
a “gasket,” as recited by independent claim 1. We, therefore, do not sustain
the Examiner’s rejection under § 103 of independent claim 1 as unpatentable
over Ortiz and Chinn. For the same reason, we do not sustain the
Examiner’s rejection of dependent claims 2, 3, 6, 9, and 11—13 under § 103
as unpatentable over Ortiz and Chinn.
DECISION
The Examiner’s decision to reject claims 1, 2, 7, 9—13, and 16—19
under § 102 as being anticipated by Stacchino is reversed.
The Examiner’s decision to reject claims 1, 2, and 7—18 under § 102
as being anticipated by Hojeibane is affirmed.
The Examiner’s decision to reject claims 14 and 15 under § 103 as
being unpatentable over Stacchino and Righini is reversed.
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The Examiner’s decision to reject claims 1, 2, 4, 5, 7, 9—16, and 18—
20 under § 103(a) as being unpatentable over Richter and Gorman is
reversed.
The Examiner’s decision to reject claims 1—3, 6, 9, and 11—13 under
§ 103(a) as being unpatentable over Ortiz and Chinn is reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED-IN-PART
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