Ex Parte Tuval et al

Patent Trials and Appeals Board

Jan 31, 2019

12914611 - (D) (P.T.A.B. Jan. 31, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/914,611 10/28/2010
77218 7590 02/04/2019
Medtronic Vascular - APV Division
c/o IP Legal Department
3576 Unocal Place
Santa Rosa, CA 95403
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Yosi Tuval
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
P0038517.00 6132
EXAMINER
WOZNICKI, JACQUELINE
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
02/04/2019 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):
rs. docketingapv@medtronic.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YOSI TUV AL, ILIA HARITON,
IGOR KOVALSKY, and ELI BEN-HAMOU
Appeal 2018-001155
Application 12/914,611
Technology Center 3700
Before DANIEL S. SONG, WILLIAM A. CAPP, and
JEFFREY A. STEPHENS, Administrative Patent Judges.
CAPP, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134(a) of the final
rejection of claims 1, 8-13, 15-19, and 41--48 under 35 U.S.C. § 112, first
paragraph, as failing to satisfy the written description requirement. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
Appeal 2018-001155
Application 12/914,611
THE INVENTION
Appellants' invention relates to prosthetic heart valves. Spec. ,r 1.
Claim 1, reproduced below, is illustrative of the subject matter on appeal.
1. Apparatus comprising a mitral valve prosthesis for
implantation at a native mitral valve complex of a subject, the
prosthesis comprising:
an inner support structure having a downstream section and
an upstream section, the upstream section having a cross-
sectional area greater than the downstream section, the inner
support structure being configured to be positioned at least
partially on an atrial side of the native valve complex, and to
prevent the prosthesis from being dislodged into a left ventricle
by applying an axial force directed toward the left ventricle;
a prosthetic valve having prosthetic valve leaflets coupled
to the inner support structure; and
an outer support structure coupled to the inner support
structure, the outer support structure having more than two
arms, wherein the more than two arms of the outer support
structure extend in an upstream direction, are disposed radially
outside of the inner support structure, and at least partially
overlap the inner support structure, wherein a first arm of the
more than two arms is longer than a second arm of the more
than two arms, and wherein at least the first arm is configured
to clamp portions of leaflets of the native valve between the
inner support structure and the first arm.
OPINION
35 US.C. § 112, First Paragraph,
The Written Description Requirement
The specification of a patent as filed must "contain a written
description of the invention." 35 U.S.C. § 112. A specification has an
adequate written description when it "reasonably conveys to those skilled in
the art that the inventor had possession of the claimed subject matter as of
the filing date" of the patent. Ariad Pharm., Inc. v. Eli Lilly & Co., 598
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Appeal 2018-001155
Application 12/914,611
F.3d 1336, 1351 (Fed. Cir. 2010) (en bane). "[T]he test requires an
objective inquiry into the four comers of the specification from the
perspective of a person of ordinary skill in the art ... [to] show that the
inventor actually invented the invention claimed." Id. The written
description requirement is met when the disclosure "allow[ s] one skilled in
the art to visualize or recognize the identity of the subject matter purportedly
described." Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed.
Cir. 2002).
Claims 1, 8-13, and 15-19
The Examiner determines that there is no support in the written
description, as originally filed, for a mitral valve prosthesis with "more than
two arms" as claimed in claim 1. Final Action 4. Claims 8-13 and 15-19
are rejected as being dependent, directly or indirectly, from claim 1. Id.
Appellants argue, among other things, that support for "more than two
arms" appears on page 19 of the Specification, which recites:
For some applications, mitral valve prosthesis 100 includes
three engagement arms 106, three leaflets, and/ or three
commissure posts 108, or a different number of the
aforementioned components.
Spec. 19, 11. 16-19 (emphasis added). In response, the Examiner concedes
that there is support for "more than two arms." Ans. 11. However, the
Examiner then takes the position that there is no support in the Specification
for a first arm being longer than a second arm as recited in claim 1. Id.
However, in their Appeal Brief, Appellants argued that anterior
engagement arm 106A is longer than the posterior engagement arm 106P, a
position that the Examiner failed to specifically address in the Answer.
Appeal Br. 8. In their Reply Brief, Appellants reiterated that they pointed
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Application 12/914,611
out in their Appeal Brief where the Specification discloses that one
engagement arm may be longer than another. Reply Br. 3.
In the Specification, Appellants disclose various ratios of differential
length between the anterior and posterior engagement arms. See Spec. 9,
11. 18-30. This is sufficient to support Appellants' position that one
engagement arm is longer than another.
In view of Appellants' explicit disclosure of three engagement arms
(Spec. 19) and explicit disclosure that the anterior and posterior arms may
have different lengths (Spec. 9), the Examiner's position on lack of written
description support for these limitations is not supported by the record
before us. Accordingly, we do not sustain the Section 112, first paragraph,
rejection of claims 1, 8-13, and 15-19.
Claims 41-48
The Examiner determines that there is no support in the Specification
for the limitation in claim 41 that the outer support structure includes four
arms. Final Action 5. Appellants argue that the embodiment of Figure 11 A
includes four arms. Appeal Br. 11. Appellants' position is based on the
underlying premise that each of two connecting frame 121 elements in
Figure 1 lA constitutes an "arm." Id. at 11-12. In response, the Examiner
takes the position that Figures 1 lA-D show only two arms (engagement
arms 106), each of which is connected to a connecting frame 121. Ans. 5.
According to the Examiner, connecting frame elements 121 do not constitute
"arms." Id. In reply, Appellants reiterate that connecting frame elements
121 should be considered "arms" for purposes of claim 41. Reply Br. 3--4.
The Examiner has stated the better position. Engagement arms 106
and connecting frame 121 are described as separate structures in the
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Appeal 2018-001155
Application 12/914,611
Specification and called out as separately numbered elements in the
drawings. The term "arm" is not operationally defined in the Specification.
See generally Spec. Appellants do not direct our attention to any language
in the Specification by which a person of ordinary skill in the art would
understand that connecting frame 121 is an "arm" or vice versa.
We sustain the Examiner's Section 112, first paragraph, rejection of
claim 41 and of claims 42--48 that depend therefrom.
DECISION
The decision of the Examiner to reject claims 1, 8-13, and 15-19 is
REVERSED.
The decision of the Examiner to reject claims 41--48 is AFFIRMED.
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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