Ex Parte Hlavka et al

Board of Patent Appeals and Interferences

May 24, 2012

10622207 (B.P.A.I. May. 24, 2012)

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.
10/622,207 07/18/2003 Edwin J. Hlavka 0185/0776-US1 4023
76808 7590 05/24/2012
Leason Ellis LLP
One Barker Avenue
Fifth Floor
White Plains, NY 10601-1526
EXAMINER
MATTHEWS, WILLIAM H
ART UNIT PAPER NUMBER
3774
MAIL DATE DELIVERY MODE
05/24/2012 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte EDWIN J. HLAVKA and PAUL A. SPENCE
__________

Appeal 2010-004161
Application 10/622,207
Technology Center 3700
___________

Before SCOTT R. BOALICK, CARLA M. KRIVAK, and
BRADLEY W. BAUMEISTER, Administrative Patent Judges.

BAUMEISTER, Administrative Patent Judge.

DECISION ON APPEAL
Appeal 2010-004161
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SUMMARY
Claims 1-59 and 68-70 are canceled. Claims 60-67 are pending.
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner‟s rejection
of claims 60-67, each of which stands rejected under 35 U.S.C. § 112, ¶ 1, as
failing to satisfy the written description and enablement requirements. We
affirm.

THE INVENTION
An annuloplasty is a surgical repair of a heart valve. (Spec. 4:13-15.)
Appellants‟ Fig. 4, reproduced below, is a plan view of a heart‟s aortic valve
(left), mitral valve 316, and implanted annuloplasty ring 304. (Spec. 4:22-
26; 8:21-26.) During an open-heart procedure, the ring 304 is stitched to the
mitral valve 316 in a manner that slackens the valve tissue 318, 320 and
thereby permits the valve to close more tightly, e.g., so as to remedy the gap
220 of Appellants‟ Fig. 2b (not reproduced). (Spec. 4:31-5:3.).

Appellants‟ Fig. 4 shows a plan view of a heart‟s aortic valve
(left), mitral valve 316, and implanted annuloplasty ring 304.
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Appellants disclose a less invasive catheter-based annuloplasty, not an
open-heart procedure. (Spec. 6:16-28.) Appellants‟ Fig. 10, reproduced
below, shows Appellants‟ step of affixing an implant 924 to valve tissue 970
via non-plicating T-bar fasteners 1012 (only one fastener 1012 is illustrated).
(Spec. 14:21-30.) The implant 1124 is a mesh-covered coil. (Spec. 16:7-8.)
A catheter 1004 delivers the fasteners 1012 to the inside of the implant 924
and presses the fasteners 1012 through the abutting walls of the implant 924
and valve tissue 970. (Spec. 15:1-4.) Once the entire implant 924 has been
tacked to the valve tissue 970, the catheter 1004 is removed. (Spec. 15:4-7.)

Appellants‟ Fig. 10 shows a perspective side view of the
invention‟s T-bar delivery catheter 1004 when tacking an
implant 924 to valve tissue 970 via T-bar fasteners 1112.
Figs. 11a and 11b respectively show a mitral valve 1128 before and
after the implant 1124 is activated to close the valve opening 1130.
1
(Spec.

1
The same components of Figs. 10 and 11a-b have similar but not identical
reference numbers. Cf., 37 C.F.R. § 1.84(p)(4) (“[S]ame part of an invention
… must always be designated by the same reference character[.]”).
Particularly, the implant has reference numbers 924 in Fig. 10 and 1124 in
Figs. 11a-b, the fasteners have reference numbers 1012 in Fig. 10 and 1112
in Figs. 11a-b, and the tacked valve tissue has reference numbers 970 in Fig.
10 and 1170 in Figs. 11a-b.
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15:21-16:13.) As shown, the implant 1124 surrounds the valve opening
1130. (Spec. 16:7-8.) A string 1140 is attached to the interior of the implant
1124 (Spec. 15:32-16: 27), ostensibly traversing the length of the implant
1124 and attaching to the far end (right end).
2
The string 1140 is pulled to
shorten the implant 1124 and thereby draw the fasteners 1112 closer to the
valve opening 1130. (Spec. 16:6-13.) As the valve tissue 1170, 1134, 1132
accordingly slackens around the valve opening 1130, the unwanted gap (Fig.
11a) of the valve opening 1130 closes shut (Fig. 11b) to complete the valve
repair. (Spec. 15:29-32.)

Appellants‟ Figs. 11a-b show plan views of a mitral valve 1128
before (Fig. 11a) and after (Fig. 11b) being repaired by the
invention.
Pending claims 60-67 include independent claim 60 and dependent
claims 61-67. We reproduce claim 60 below with emphasis on the only
disputed limitation.

2
The Specification does not state the manner in which the string 1140 is
attached to the implant 1124. We infer the stated attachment from the
disclosed movements of the string 1140, implant 1124, and fasteners 1112.
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60. A device for use in a catheter-based annuloplasty
procedure on a heart valve, the device comprising:
three or more non-plicating fasteners configured to be
individually fixed to tissue adjacent the annulus of the heart
valve at spaced locations by piercing the tissue without
plicating the tissue at the spaced locations;
at least one catheter having a lumen capable of delivering
and inserting the plurality of non-plicating fasteners into the
tissue adjacent the annulus;
an elongate tensioning element coupled with the non-
plicating fasteners and configured to be tensioned by pulling on
only one end thereof to place the plurality of non-plicating
fasteners in an activated state positioned closer together to
plicate the tissue between the fasteners; and
a locking feature operative to fix the plurality of non-
plicating fasteners in the activated state.

WRITTEN DESCRIPTION
In rendering the written description rejection, the Examiner
determined that the “coupled” language of claim 60 encompasses only direct
couplings between the tensioning element and non-plicating fasteners, while
the Specification describes only an indirect coupling; particularly the above-
noted coupling of the string 1140 and fasteners 1112 via the implant 1124.
(Ans. 5-6.) Appellants respond that “the term „coupled‟ is a common term
in the mechanical arts that is generally recognized as referring to both direct
and indirect connections[.]” (Reply Br. 3.)
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We agree with Appellants‟ construction. The plain meaning of
“coupled” encompasses both direct and indirect connections.
3

Consistent with the plain meaning, the Specification uses “coupled” to
describe both direct and indirect connections of various components;
e.g., a direct connection between a steerable catheter tip and attached
balloon (Spec. 17:28-30) and an indirect connection between an air
supply and that balloon (Spec. 18:22-25).
However, the Examiner has nonetheless made a prima facie
showing that the Specification fails to describe the direct coupling
encompassed by the claim scope, i.e., a direct coupling between a
tensioning element and non-plicating fasteners, whereby pulling the
tensioning element draws the fasteners closer together to plicate the
tissue. The Examiner‟s burden of presenting a prima facie case is
explained in Hyatt v. Dudas, 492 F.3d 1365 (Fed. Cir 2007), which
sets forth the general purpose of the prima facie case (id. at 1370)
(quotation marks and citation omitted):
[I]ts purpose is simply to provide sufficient notice to the
applicant to facilitate his effective submission of information.
Since the applicant is in the best position to cheaply provide
information about the purported invention, the PTO‟s authority
to shift the burden to obtain this information is crucial to ensure
that the PTO is not making patentability determinations on
insufficient facts and information.

3
See “couple” (verb). Dictionary.com. Dictionary.com Unabridged.
Random House, Inc., http://dictionary.reference.com/browse/connect
(accessed: April 21, 2012) (meaning “to fasten, link, or associate together in
a pair or pairs” and “to join; connect”).
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Hyatt explains the corresponding burden for written description
rejections (id.) (footnote omitted):
In the context of the written description requirement, an
adequate prima facie case must therefore sufficiently explain to
the applicant what, in the examiner‟s view, is missing from the
written description.
Hyatt further explains (id.) (quotation marks and citations omitted):
Adequate written description means that, in the specification,
the applicant must convey with reasonable clarity to those
skilled in the art that, as of the filing date sought, he or she was
in possession of the claimed invention. When no such
description can be found in the specification, the only thing the
PTO can reasonably be expected to do is to point out its
nonexistence.
The Examiner has met this burden. The Examiner has shown,
and Appellants agree, that the claim scope includes a direct coupling
of the tensioning element and fasteners. The Examiner has also
shown that the Specification does not describe a direct coupling,
particularly by showing that the solely disclosed embodiment of the
claimed invention (Figs. 10 and 11a-b) describes only an indirect
coupling of the string 1140 and fasteners 1112 (via the implant 1124).
Given the prima facie case, Appellants must show that the
Specification conveys possession of the full claim scope. See Pandrol
USA LP v. Airboss Railway Products Inc., 424 F.3d 1161, 1165 (Fed.
Cir. 2005); see also Chiron Corp. v. Genentech, Inc., 363 F.3d 1247,
1259 (Fed. Cir. 2004). Instead, Appellants merely point to the
indirect coupling of the string 1140 and fasteners 1112 (App. Br. 4, 7,
and 8) without stating how that disclosure conveys possession of a
direct coupling between the tensioning elements and non-plicating
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fasteners. Appellants‟ failure to present any such rebuttal evidence or
argument is fatal to meeting their burden of showing reversible error.
See In re Jung, 637 F.3d 1356, 1365-66 (Fed. Cir. 2011).
We need not reach our conclusion based solely on Appellants‟
insufficiency of rebuttal evidence asserted, though. It is also
noteworthy that the Specification does not, in fact, convey possession
of a direct coupling. The issue to be resolved, then, is whether a
claimed genus is adequately described by a disclosed species. The
Federal Circuit has addressed this issue in LizardTech, Inc. v. Earth
Resource Mapping, Inc., 424 F.3d 1336, 1346 (Fed. Cir. 2005), as
well as In re Curtis, 354 F.3d 1347 (Fed. Cir. 2004).
In LizardTech, the patentee generated a “seamless DWT” by
maintaining updated sums of DWT coefficients, but claimed a method
that generically created a seamless DWT, i.e., omitted the step of
maintaining the updated sums. 424 F.3d at 1344. The court stated
(id.) that the claimed method lacked a written description because:
The specification provides only a single way of creating a
seamless DWT, which is by maintaining updated sums of DWT
coefficients. There is no evidence that the specification
contemplates a more generic way of creating a seamless array
of DWT coefficients.
The court further stated (id. at 1345):
After reading the patent, a person of skill in the art would not
understand how to make a seamless DWT generically and
would not understand LizardTech to have invented a method
for making a seamless DWT, except by “maintaining updating
sums of DWT coefficients.”
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In Curtis, Applicant coated a low-friction filament (“PTFE”
filament) with a specific friction-enhancing wax, but claimed the
filament with a friction-enhancing “coating.” 354 F.3d at 1348-49. In
determining that the claimed genus (coating) was not described by the
disclosed species (wax coating), the court emphasized that the wax
was disclosed as being uniquely capable of bonding to the filament.
Id. at 1357.
Uniqueness of the species was not required to evidence that the
inventors lacked possession of the genus, but the touted uniqueness of
the disclosed species was strong evidence of non-possession of the
genus. Id. The court stated that, given the inventors‟ view of the wax
as uniquely able to coat the filament, a skilled artisan would not have
considered the inventor to possess other coatings. Id. The court
further stated that a disclosed species describes a genus that “would
naturally occur to a person of ordinary skill in the art after reading the
disclosure,” id. at 1356, and not a genus for which the skilled artisan
“would be hard-pressed to instantly recall any other species,” id. at
1357.
LizardTech and Curtis indicate “a disclosure that names one
species encompassed within a genus will adequately describe a claim
directed to that genus only if the disclosure „indicates that the patentee
has invented species sufficient to constitute the genus.‟” Curtis, 354
F.3d at 1358 (citation omitted). In LizardTech, a unique feature of the
disclosed species–maintaining updated sums–was described as
making the claimed seamless DWT possible. Similarly in Curtis, a
unique feature of the disclosed species–binding to the filament–was
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described as making the claimed filament possible. Thus, the
disclosures gave an impression that the inventors considered the
features of the disclosed species to be what made the invention viable.
Appellants‟ Specification suffers the same problem. The
claimed subject matter embodies a process of affixing non-plicating
fasteners to tissue, coupling a tensioning element to the fasteners, and
then plicating the tissue by pulling the tensioning element to draw the
fasteners closer together. The solely disclosed embodiment of this
process relies on the shortening of the implant 1124–that is, relies on
the indirect coupling of the fasteners 1112 and string 1140–to draw
the fasteners 1112 closer together by pulling the string 1140.
Appellants‟ reliance on this particular implant is further shown by the
Specification‟s emphasis on an implant within the “SUMMARY OF
THE INVENTION” (Spec. 6-8) and by the use of the disclosed
implant 1124 to replace the background art annuloplasty ring 304
implanted by an invasive open-heart procedure (Spec. 4-5; Fig. 3).
Given Appellants‟ apparent reliance on the particular implant
disclosed, a skilled artisan would not have understood the inventors as
possessing an alternative implant having a direct coupling between the
tensioning elements and non-plicating fasteners. See LizardTech, 424
F.3d at 1345.
Furthermore, there is no evidence that a direct coupling would
not “naturally occur” to a skilled artisan. See Curtis, 354 F.3d at
1356. There are two species of the claimed genus before us: direct
and indirect coupling. Given Appellants‟ description of the indirect
coupling, a skilled artisan would not have reasonably predicted the
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now sought inclusion of a direct coupling. As explained in Curtis, an
applicant “will not be deemed to have invented species sufficient to
constitute the genus by virtue of having disclosed a single species
when, as is the case here, the evidence indicates ordinary artisans
could not predict the operability in the invention of any species other
than the one disclosed.” Id. at 1358.
For the above reasons, we sustain the written description
rejection of the pending claims.

ENABLEMENT
The Examiner rejects claims 60-67 as failing to comply with
the enablement requirement because (Ans. 3-4):
The claim(s) contains subject matter which was not described in
the specification in such a way as to enable one skilled in the art
to which it pertains, or with which it is most nearly connected,
to make and/or use the invention. As the specification fail [sic]
to disclose fasteners coupled to the tension element, the
specification fails to enable one of ordinary skill in the art to
make or use the invention as claimed.
The Examiner also adds that “there is no suggestion or disclosure to
connect, contact, or couple the tensioning element to the fasteners.”
(Ans. 6.)
The Examiner has addressed only whether the Specification
describes a direct coupling. The lack of such description does not
alone establish a lack of enablement. See Invitrogen Corp. v.
Clontech Labs., Inc., 429 F.3d 1052, 1071 n.17 (Fed. Cir. 2005)
(“„[W]ritten description‟ requirement is distinct from the enablement
requirement”). The Examiner must therefore address the test for
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enablement, which is whether the as-filed disclosure would enable a
skilled artisan to make and use the claimed invention without undue
experimentation. See In re Wands, 858 F.2d 731, 737 (Fed. Cir.
1988). As the Examiner has not addressed this issue, he simply has
not made the requisite findings to establish that the appealed claims
lack enablement.
For the above reasons, we do not sustain the enablement
rejection.

DECISION
The Examiner‟s rejection of claims 60-67 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).

AFFIRMED

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