Ex Parte LASHINSKI et al

Patent Trial and Appeal Board

Dec 20, 2018

13450356 (P.T.A.B. Dec. 20, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/450,356 04/18/2012
20995 7590 12/25/2018
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
FIRST NAMED INVENTOR
RANDALL T. LASHINSKI
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.
PDLB.001C2 1014
EXAMINER
GANESAN, SUBA
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
12/25/2018 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):
j ayna.cartee@knobbe.com
efiling@knobbe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RANDALL T. LASHINSKI
and GORDON B. BISHOP
Appeal2018-002397
Application 13/450,356 1
Technology Center 3700
Before JEREMY M. PLENZLER, LISA M. GUIJT, and
NATHAN A. ENGELS, Administrative Patent Judges.
ENGELS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from a rejection of claims
9-19. Claims 1-8 are canceled. We have jurisdiction under 35 U.S.C.
§ 6(b).
We affirm.
1 Appellants identify Direct Flow Medical, Inc. as the real party in interest.
Br. 3.
Appeal2018-002397
Application 13/450,356
ILLUSTRATIVE CLAIM
Claims 9 and 14 are independent claims and are copied below with
italics added to highlight certain disputed limitations:
9. An implantable prosthetic valve comprising:
an inflatable support structure comprising at least one
annular ring;
an occluder attached to the inflatable support structure, the
at least one annular ring providing commissural support to the
occluder;
a tubular cuff around the occluder; and
an one way valve on the inflatable support structure,
wherein the one way valve is configured for coupling to an
inflation lumen for inflating the support structure with an
inflation media and for sealing off the inflatable support structure
after decoupling from the inflation lumen.
14. A catheter system comprising:
a delivery catheter comprising at least one inflation lumen
extending therethrough; and
an implantable prosthetic valve comprising an inflatable
support structure, an occluder attached to the inflatable support
structure, a tubular cuff around the occluder,
and an one way valve on the inflatable support structure,
wherein the one way valve is detachably coupled to the inflation
lumen and allows the inflatable support structure to be inflated
by an inflation medium through the inflation lumen, the
inflatable support structure comprising a first inflatable ring
providing commissural support to the occluder.
THE REJECTIONS
Claims 9-19 stand rejected under 35 U.S.C. § I03(a) as being
unpatentable in view of Salahieh et al. (US 2005/0137687 Al; June 23,
2005) and Rogers et al. (US 5,697,968; Dec. 16, 1997).
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Appeal2018-002397
Application 13/450,356
ANALYSIS
Among other findings in the Examiner's rejection of claims 9 and 14,
the Examiner finds Salahieh teaches an implantable prosthetic valve that
includes inflatable annular rings as claimed. Final Act. 3---6; see also id. at 4--
6 ( citing Rogers as teaching the claimed one-way valve). Specifically,
explaining that "providing commissural support" is a functional limitation,
the Examiner states that Salahieh teaches inflatable sacs having the same
structure as the annular ring in claims 9 and 14, and that Salahieh's
inflatable sacs are at least capable of providing commissural support. Final
Act. 2-3 (citing MPEP 2114); Ans. 6-8
Appellants argue Salahieh does not teach "at least one annular ring
providing commissural support to the occluder" as recited in claim 9, nor "a
first inflatable ring providing commissural support" as recited in claim 14.
Br. 5---6. According to Appellants, Salahieh's sacs are disposed around the
exterior of an anchor to provide more efficient sealing, not to provide
commissural support. Br. 5 ( citing Salahieh ,r,r 107, 108), 6 ( citing Salahieh
,r 88). Appellants argue that instead of support provided by the sacs,
Salahieh teaches that an anchor exerts outward radial force to provide
support and securement of the replacement valve. Br. 5---6 ( citing Salahieh ,r
77). In other words, Appellants argue that Salahieh discloses other functions
for its sacs and other structures in Salahieh's device that provide
commissural support.
Notably, Appellants' arguments center on the functional language
"providing commissural support" in the disputed limitations; Appellants do
not dispute the Examiner's findings regarding the structures disclosed in the
prior art. When the structural limitations recited in an apparatus claim are
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Appeal2018-002397
Application 13/450,356
found in the prior art, the absence of a disclosure relating to the intended
function will not defeat patentability where the prior art structures are
capable of performing the claimed function. Homeland Housewares, LLC v.
Whirlpool Corp., 865 F.3d 1372, 1379 (Fed. Cir. 2017) (citing In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997)). Further, where an
examiner identifies structures believed to be capable of performing a
claimed function, the burden shifts to the applicant to show otherwise.
Schreiber, 128 F.3d at 1478.
We agree with the Examiner, and Appellants do not dispute, that
Salahieh teaches or reasonably suggests an inflatable annular ring by
disclosing compliant sacs disposed around the exterior of a replacement
valve. Salahieh ,r,r 107-108. We also agree that "providing commissural
support" is functional language in claims 9 and 14, and neither the claims
nor Appellants' Specification defines "providing commissural support." As
cited by Appellants (Br. 4 (citing ,r,r 70-71 as written-description support for
claims 9 and 14)), the Specification describes an inflatable support structure
that comprises at least one annular ring. Spec. ,r 70. The Specification
explains that after positioning the disclosed valve, inflatable chambers such
as the claimed annular rings may be "inflated to the desired size and/ or
pressure" (id.) after positioning in the pulmonary vein to "provide
commissural support and/or stabilize the valve 90, depending upon the
occlude (i.e. leaflet) configuration as will be appreciated by those of skill in
the art in view of the disclosure herein" (id. at ,r 71 ). See Figs. 9F, 9G, 9H,
1 1.
Salahieh teaches that its sacs may be inflated to seal the valve against
the surface of a patient's natural valve leaflets. Salahieh ,r,r 107-108.
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Appeal2018-002397
Application 13/450,356
Salahieh states that "[ c ]ompliant sacs 200 may be disposed about the
exterior of anchor 30 to provide a more efficient seal along irregular
interface I" between the replacement valve the patient's natural valve
leaflets. Id.
Even if Salahieh's anchor provides commissural support, reading
claims 9 and 14 in light of the Specification, we agree with the Examiner
that Salahieh's teachings regarding inflatable sacs that improve the seal fall
within the claims' scope. Nothing in the claims excludes devices that
include an anchor or other structures that provide support in addition to the
claimed inflatable annular ring (see Spec. ,r,r 83-86 (describing Appellants'
anchoring methods)), and Appellants have not persuasively rebutted the
Examiner's reasoning that Salahieh's inflatable sacs fall within the scope of
the claimed structures and are capable of performing the claimed functions.
Having considered the Examiner's rejection in light of each of
Appellants' arguments and the evidence of record, we agree with the
Examiner and sustain the Examiner's rejection of independent claims 9 and
14, as well as dependent claims 10-13 and 15-19, which Appellants do not
separately argue. See Br. 6-7.
DECISION
We affirm the Examiner's rejection of claims 9-19.
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).
AFFIRMED
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