Ex Parte Sabbah et al

Patent Trial and Appeal Board

Apr 25, 2017

11900005 (P.T.A.B. Apr. 25, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
3220-024-1 9159
EXAMINER
HAYMAN, IMANI N
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
11/900,005 09/07/2007
7590 04/25/2017134129
Patnstr, APC
(Peter Jon Gluck, Esq.)
31878 del Obispo Street
Suite 118-320
San Juan Capistrano, CA 92675-3224
Hani N. Sabbah
04/25/2017 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 PATENT TRIAL AND APPEAL BOARD
Ex parte HANIN. SABBAH, RANDALL J. LEE, and
ANDREW G. HINSON
Appeal 2015-000681
Application 11/900,005
Technology Center 3700
Before GEORGE R. HOSKINS, LISA M. GUIJT, and
PAUL J. KORNICZKY, Administrative Patent Judges.
HOSKINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Hani N. Sabbah et al. (“Appellants”)1 appeal under 35 U.S.C. § 134
from the Examiner’s decision rejecting claims 1—6, 13—16, 29, 43, 45, and 46
under 35 U.S.C. § 103(a) as unpatentable over Taylor (US 2002/0169360 Al,
pub. Nov. 14, 2002) and Jayaraman (US 2002/0056461 Al, pub. May 16,
2002). The Board has jurisdiction over the appeal under 35 U.S.C. § 6(b).
An oral hearing was held on April 14, 2017.
We REVERSE.
1 The Appeal Brief identifies the real parties in interest as CardioPolymers,
Inc. (a subsidiary of LoneStar Heart Inc.); The Regents of the University of
California; and Henry Ford Health System. Br. 5.
Appeal 2015-000681
Application 11/900,005
CLAIMED SUBJECT MATTER
Claims 1, 29, and 43 are independent. Claim 1 illustrates the claimed
subject matter, and it recites:
1. A method of treating a dilated chamber in a heart of a
patient suffering chronic heart failure, comprising:
introducing a biocompatible space-occupying agent into a
plurality of sites within a free myocardial wall of the dilated
chamber to provide a therapeutic internal structure at each of the
sites;
the therapeutic internal structures at the sites being non-
contractile and distributed within the free myocardial wall with
essentially no linkage with one another,
and further being distributed in a pattern generally
throughout a region of the free myocardial wall along a
circumference of the dilated chamber near a widest part of the
dilated chamber between an apex and a base of the dilated
chamber for globally reducing stress in the free myocardial wall
of the dilated chamber, and shrinking the dilated chamber at the
widest part thereof.
Br. 35 (Claims App.) (emphases added).
ANALYSIS
Claims 1—6, 13—16, and 45
In rejecting claim 1, the Examiner finds Taylor discloses a method of
treating a dilated heart chamber, comprising the provision of internal
therapeutic structures into a plurality of sites within a myocardial wall of the
chamber. Final Act. 3 (citing Taylor, Fig. 10, Tflf 4, 23, 24, 76—78). The
Examiner determines Taylor “fails to explicitly disclose wherein there is no
linkage amongst the therapeutic internal structure^]” as required by claim 1.
Id.
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Application 11/900,005
The Examiner cites Jayaraman as disclosing internal therapeutic
structures distributed within a myocardial wall, “with essentially no linkage
with one another.” Id. (citing Jayaraman, Abstract, Figs. 6B and 7B, || 60,
66). The Examiner determines it would have been obvious to utilize a
pattern of essentially unlinked internal reinforcing structures in Taylor, in
light of Jayaraman, “to provide a specific pattern that is known in the art to
provide an efficacious reinforcing structure to reduce the volume of a dilated
left ventricle and reduce stress in the free myocardial wall of the dilated left
ventricle and shrink the chamber at the widest part thereof.” Id. at 3^4.
Appellants argue, in part, that a preponderance of the evidence fails to
support the Examiner’s finding that the prior art discloses essentially no
linkage between therapeutic internal structures. Br. 19-20 (discussing
Taylor || 76—78, and Jayaraman, Abstract, Figs. 6B, 7B, and 7C, Tflf 66, 95,
96). As to Taylor, Appellants contend the disclosure at paragraphs 76—78
“relate [s] to integrated grid patterns for purposes of ‘reinforcing] the heart
tissue to limited atrial or ventricular expansion.’” Id. at 19 (emphasis added,
quoting Taylor 176). As to Jayaraman’s Figures 6B and 7B, Appellants
contend elastic bands 20 and 27 respectively illustrated therein are each
“fully interlinked structure[s],” which are “the opposite of’ the invention of
claim 1. Id.
The Examiner answers that Taylor at “paragraph [0077] in the last
sentence specifically states that the material can also be injected into a
series of separate holes.'1'’ Ans. 5 (emphasis added). The Examiner further
cites Jayaraman paragraphs 31 and 66 as disclosing “the direct injection of
biocompatible materials into the ventricular wall. . . with a plurality of
needles or needle-like elements to allow a wider area of the wall of the
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Appeal 2015-000681
Application 11/900,005
ventricle to be treated at one time'1'’ as well as “a radial dispersion” of filler
material to be injected. Id. (emphasis added).
We have reviewed the respective disclosures of Taylor and Jayaraman
cited by the Examiner. We agree with Appellants that the Examiner errs in
finding the prior art discloses the claimed “essentially no linkage” between
therapeutic internal structures within a cardiac wall. The cited Taylor
disclosure provides: “The [internal therapeutic structure] material may also
be injected into a series of hypodermic needle holes and allowed to harden.”
Taylor 177 (last sentence). The cited Jayaraman disclosure pertinently
provides:
The application catheter of this invention will also
comprise means by which the biocompatible filler material will
be . . . inserted within the wall of the ventricle. These means can
include any tube or conduit which can direct the filler material to
the heart. In addition, filler material distribution elements can
be used to direct the filler material to the proper location. . . .
[T]he catheter can include components for the injection of
biocompatible filler material directly into the wall. These
components are preferably needles or include needle-like tubular
elements for injection of materials. . . allowing a radial
dispersion of the biocompatible filler material within the cardiac
muscle.
Jayaraman | 66 (emphases added). Thus, both Taylor and Jayaraman
disclose that their respective therapeutic internal structures may be injected
into the heart wall at multiple injection points. However, such disclosure
does not establish that after the multiple injections, there will be essentially
no linkage between the therapeutic internal structures. Indeed, the cited
Taylor disclosure relates to the formation of reinforcing grid 105 illustrated
in Figure 10, which is a linked structure. See Taylor 177, Fig. 10.
Similarly, the only figures in Jayaraman cited by the Examiner —
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Appeal 2015-000681
Application 11/900,005
Figures 6B and 7B — fail to illustrate any lack of linkages within the
reinforcing structures. See Jayaraman, Figs. 6B and 7B, || 80, 95—96
(showing and describing elastic bands 20 and 27). The remainder of the
cited prior art disclosure — Jayaraman’s Abstract and paragraph 31 — has
very little or nothing to do with there being essentially no linkage between
therapeutic internal structures within a cardiac wall.
For the foregoing reasons, a preponderance of the evidence does not
support the Examiner’s finding that the prior art discloses essentially no
linkage between therapeutic internal structures within a cardiac wall, as
required by claim 1. The Examiner’s obviousness analysis fails to make up
for that deficiency in the prior art disclosure. See Final Act. 3—4. Therefore,
we do not sustain the rejection of claim 1 and its dependent claims 2—6, 13—
16, and 45 as unpatentable over Taylor and Jayaraman.
Claims 29 and 46
Independent claim 29 recites forming therapeutic internal structures in
a cardiac wall, in a distribution “with essentially no linkage with one
another.” Br. 37 (Claims App.). The Examiner’s rejection of claim 29
pertinently relies on the same findings and analysis discussed above in
connection with claim 1, and is in error for the reasons already provided.
See Final Act. 2—4. Therefore, we do not sustain the rejection of claim 29
and its dependent claim 46 as unpatentable over Taylor and Jayaraman.
Claim 43
Independent claim 43 recites providing therapeutic internal structures
in a cardiac wall, in a distribution “with essentially no linkage with one
another.” Br. 38 (Claims App.). The Examiner’s rejection of claim 43
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Application 11/900,005
pertinently relies on the same findings and analysis discussed above in
connection with claim 1, and is in error for the reasons already provided.
See Final Act. 3^4. Therefore, we do not sustain the rejection of claim 43 as
unpatentable over Taylor and Jayaraman.
DECISION
The rejection of claims 1—6, 13—16, 29, 43, 45, and 46 as unpatentable
over Taylor and Jayaraman is reversed.
REVERSED
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