Ex Parte GOLDFARB et al

Patent Trial and Appeal Board

Dec 18, 2018

14070936 (P.T.A.B. Dec. 18, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/070,936 11/04/2013
76081 7590 12/18/2018
Sughrue Mion - Abbott (Legacy Evalve)
2100 Pennsylvania Ave, N.W., Suite 800
Washington, DC 20037
FIRST NAMED INVENTOR
Eric A. GOLDFARB
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.
A207853 6477
EXAMINER
WOZNICKI, JACQUELINE
ART UNIT PAPER NUMBER
3774
MAIL DATE DELIVERY MODE
12/18/2018 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 ERIC A. GOLDFARB, TROY L. THORNTON,
ALFRED H. RASCHDORF, JAIMEE. SARABIA, JOHN P. MADDEN,
FEROL YN T. POWELL, BRIAN B. MARTIN,
SYLVIA ERICKSON, JAN KOMTEBEDDE, and YEN C. LIA0 1
Appeal2017-009912
Application 14/070,936
Technology Center 3700
Before JEFFREY N. FRED MAN, JOHN E. SCHNEIDER, and
RYAN H. FLAX, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal2 under 35 U.S.C. § 134 of the Examiner's rejection
of claims to a method for stabilizing and fixating tissue for failure to comply
with the written description requirement and as obvious. We have
jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants identify the Real Party in Interest as "EVALVE, INC." Appeal
Br. 2.
2 We have considered and herein refer to the Specification of Nov. 4, 2013
("Spec."); Final Office Action of Aug. 8, 2016 ("Final Act."); Appeal Brief
of Apr. 10, 2017 ("Appeal Br."); Examiner's Answer of May 16, 2017
("Ans."); and Reply Brief of July 14, 2017 ("Reply Br.").
Appeal2017-009912
Application 14/070,936
STATEMENT OF THE CASE
Surgical repair of bodily tissues often involves tissue
approximation and fastening of such tissues in the
approximated arrangement. When repairing valves, tissue
approximation includes coapting the leaflets of the valves in a
therapeutic arrangement which may then be maintained by
fastening or fixing the leaflets. Such coaptation can be used to
treat regurgitation which most commonly occurs in the mitral
valve.
Spec. ,r 3. The Specification describes "a variety of devices, systems and
methods for stabilizing, grasping, assessing and fixating tissues, particularly
valve leaflets in the treatment of cardiac valve regurgitation, more
particularly mitral valve regurgitation." Spec. ,r 10.
Claims 1--4 and 7 are on appeal. Claim 1 is the sole independent
claim and reads as follows:
1. A method comprising:
a first step of advancing a fixation device into a left
ventricle of a heart, the fixation device comprising distal
elements configured to be attached to a ventricular side of a
mitral valve and proximal elements configured to be attached to
an atrial side of the mitral valve;
a second step of advancing a minimally invasive device
into a chamber of the heart having the mitral valve with valve
leaflets, wherein the device comprises a stabilizer; temporarily
stabilizing the valve leaflets by reducing movement of the valve
leaflets by positioning the stabilizer against the atrial side of the
leaflets so as to reduce flail of the leaflets;
a third step of fixing the fixation device to the valve
leaflets after temporarily stabilizing the leaflets,
wherein each step of the method is performed in
sequence.
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Application 14/070,936
The claims stand rejected as follows:
Claims 1--4 and 7 have been rejected under 35 U.S.C. § 112, first
paragraph, for failure to comply with the written description requirement.
Claims 1--4 and 7 have been rejected under 35 U.S.C. § I03(a) as
unpatentable over Goldfarb. 3
WRITTEN DESCRIPTION
Issue
The issue with respect to this rejection is whether the Examiner
properly determined that the amended claims contain new matter not
described in the Specification as filed.
The Examiner finds that the claims at issue call for the steps of the
claimed method to be performed in a particular sequence. Final Act. 3. The
Examiner finds that the Specification does not contain a teaching that the
steps recited in the claims are to be performed in any particular sequence.
Id. at 3--4.
Appellants contend that the Specification does teach that the steps
should be performed in the sequence recited in claim 1. Appeal Br. 5.
Appellants argue that paragraphs 84 and 84 of the Specification teach that
the steps should be performed in sequence. Id. at 5-7.
Principles of Law
A description adequate to satisfy 35 U.S.C. § 112, first paragraph,
must "clearly allow persons of ordinary skill in the art to
recognize that [the inventor] invented what is claimed." In
other words, the test for sufficiency is whether the disclosure of
3 Goldfarb et al., US 2002/0013571 Al, published Jan. 31, 2002
("Goldfarb").
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Appeal2017-009912
Application 14/070,936
the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject
matter as of the filing date.
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
( en bane) ( alteration in original) ( citation omitted).
Id.
[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. Based on that inquiry, the specification must
describe an invention understandable to that skilled artisan and
show that the inventor actually invented the invention claimed.
Analysis
We agree with Appellants that the Specification describes the claimed
method in a manner that one skilled in the art would understand that the
steps are to be performed in sequence. As described in paragraph 84 of the
Specification and as shown in Figure 8A, the fixation device is placed below
the mitral valve into the ventricle. Spec. ,r 84. The Specification goes on to
teach that the stabilizer is placed on the atrial side of the valve. Spec. ,r 85.
The Specification next teaches that the fixation device is fixed to the valve
leaflets. See Spec. ,r 85 (stabilizing loops control the manner and movement
of the leaflets to optimize grasping by the fixation device). The sequence of
the paragraphs would lead one skilled in the art to understand that the steps
are performed in order.
The Examiner contends that the Specification does not specifically
mention the order of the steps or that they are critical. Ans. 8. We are not
persuaded. The Specification need not describe the invention in ipsis verb is.
In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996). Rather, the test is whether
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Appeal2017-009912
Application 14/070,936
the specification describes the invention in a manner that is understandable
to a skilled artisan and shows that the inventor actually invented the
invention claimed. Ariad, 598 F.3d at 1351. As discussed above, we find
that the Specification describes a method where the steps are to be
performed in a particular sequence.
Conclusion of Law
We conclude that the recitation that the steps of claim 1 be performed
in sequence is adequately described in the Specification and does not
constitute new matter.
OBVIOUSNESS
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that the subject matter of
the claims would have been obvious over Goldfarb.
The Examiner finds that Goldfarb teaches a method comprising
advancing a fixation device into a left ventricle, the fixation device
comprising distal elements configured to attach to the ventricular side of the
mitral valve and proximal element configured to attach to the atrial side of
the valve. Final Act. 5. The Examiner finds that the method of Goldfarb
includes the step of advancing a stabilizer into the atrium so as to stabilize
the valve leaflets by reducing the movements of the leaflets. Id. The
Examiner finds that Goldfarb teaches the step of fixing the fixation device to
the leaflets. Id. at 6. The Examiner finds that, although Goldfarb is silent as
to the sequence in which the fixation device and stabilizer are to be inserted,
nevertheless
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Application 14/070,936
Id.
[i]t would have been obvious to one of ordinary skill in the art
at the time the invention was made to modify the method of
Goldfarb by inserting both the stabilizer and the fixation device
in any order the surgeon deemed appropriate, since it has been
held by the courts that reversal or rearrangement of the order of
prior art process steps, if so is desired, would require only
ordinary skill.
Appellants argue that Goldfarb does not teach or suggest the claimed
method. Appeal Br. 9. Appellants argue that Goldfarb does not teach or
suggest a separate stabilizer or the step of advancing a separate stabilizer
after inserting the fixation element. Id. at 8-9.
Findings of Fact
We adopt the Examiner's rationale and findings as our own, including
findings regarding the scope and content of, and motivation to modify or
combine, the prior art. Final Act. 4---6. The following findings are included
for emphasis and reference purposes.
FFI. Goldfarb discloses "methods and devices for grasping, and
optional repositioning and fixation of the valve leaflets to treat cardiac valve
regurgitation." Goldfarb Abstract.
FF2. Goldfarb discloses the use of a leaflet capture device to capture
or hold the valve leaflets. Goldfarb ,r 89.
FF3. Goldfarb discloses a leaflet fixation tool to fix the leaflets
together to maintain a desire orientation. Goldfarb ,r 104.
FF4. Goldfarb teaches that the fixation tool may be the same as the
capture tool or may be a separate device used in conjunction with the capture
tool. Goldfarb ,r,r 104 and 107.
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Appeal2017-009912
Application 14/070,936
Principles of Law
[T]he examiner bears the initial burden, on review of the prior
art or on any other ground, of presenting a prima facie case of
unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant.
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Analysis
We find the Examiner has established that the matter of the claims
would have been obvious over Goldfarb to one of ordinary skill in the art at
the time the invention was made. Appellants have not produced evidence
showing, or persuasively argued, that the Examiner's determinations on
obviousness are incorrect. Only those arguments made by Appellants in the
Briefs have been considered in this Decision. Arguments not presented in
the Briefs are waived. See 37 C.F.R. § 4I.37(c)(l)(iv) (2015). We have
identified claim 1 as representative; therefore, all claims fall with claim 1.
We address Appellants' arguments below.
Appellants contend that Goldfarb does not teach a separate stabilizing
device. Appeal Br. 8. Appellants contend that the Examiner is improperly
pointing to the same device in Goldfarb to perform both the stabilizing
function and the fixation function, whereas the claims call for two separate
devices. Appeal Br. 8; Reply Br. 8.
We have considered Appellants' arguments and are not persuaded.
Goldfarb teaches the use of a capture device that performs the same function
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Application 14/070,936
as the stabilizer of the instant claims - reducing the movement of the valve
leaflets. FF2. Goldfarb separately teaches the use of a fixation tool to fix
the leaflets together to maintain a desired orientation. FF3. While Goldfarb
teaches that the fixation tool and the capture device can be the same device,
Goldfarb also teaches that they can be separate devices. FF4.
Appellants also contend that Goldfarb does not teach or suggest the
insertion of a capture device after the insertion of the fixation tool as
required by the claims. Appeal Br. 9.
We find that the reasoning in Burhans, a case in which there were four
process steps, and each of the steps was disclosed in the prior art, differing
only in the specific order of the steps, to be applicable here. In re Burhans,
154 F.2d 690, 692 (CCPA 1946). The Burhans court was unpersuaded of
patentability, finding that "[ t ]here is no merit in the point here in the absence
of any proof in the record that the order of performing the steps produces
any new and unexpected results." Id. We conclude that the same reasoning
applies in the instant case because there is no indication in either Appellants'
arguments or the Specification that the order of performance of these known
steps results in any unexpected improvement in treating mitral valve
dysfunction.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner's conclusion that the subject matter of claim 1 would have been
obvious over Goldfarb.
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Application 14/070,936
Claims 2--4 and 7 have not been argued separately and therefore fall
with claim 1. 4 37 C.F.R. § 4I.37(c)(l)(iv).
SUMMARY
We reverse the rejection under 35 U.S.C. § 112, first paragraph.
We affirm the rejection under 35 U.S.C. § 103(a).
TIME PERIOD FOR RESPONSE
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
4 Appellants offer separate arguments relating to claims 2--4 and 7 in their
Reply Brief. Reply Br. 9. Because these arguments were not first presented
in the Appeal Brief and are not in response to a new argument made by the
Examiner, we decline to consider these arguments. 37 C.F .R. § 41.41 (b )(2).
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