Ex Parte Bardy

Patent Trial and Appeal Board

Jun 27, 2016

11894281 (P.T.A.B. Jun. 27, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111894,281 08/20/2007
62058 7590 06/29/2016
PAULY, DEVRIES SMITH & DEFFNER, L.L.C.
TCF Tower-Suite 900
121 South 8th Street
MINNEAPOLIS, MN 55402-2481
Gust H. Bardy
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.
l 15.0090USC3/03406APM-CON 9300
EXAMINER
LEVICKY, WILLIAM J
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
06/29/2016 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):
docketing@pdsdlaw.com
kds@pdsdlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GUST H. BARDY 1
Appeal2013-004296
Application 11/894,281
Technology Center 3700
Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
Opinion for the Board filed by
MAJORS, Administrative Patent Judge.
Opinion Dissenting filed by
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to systems
and methods for assessment of heart failure, which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 Appellant identifies the Real Party in Interest as Cardiac Pacemakers, Inc.
(Appeal Br. 2.)
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Application 11/894,281
STATEMENT OF THE CASE
According to the Specification, "there is a need for a system and
method of providing continuous retrieval, transferal, and automated analysis
of retrieved medical device information, such as telemetered signals,
retrieved in general from a broad class of implantable and external medical
devices." (Spec. 4, 11. 24--27.)
The present invention provides a system and method for
automated collection and analysis of patient information
retrieved from an implantable medical device for remote patient
care. The patient device information relates to individual
measures recorded by and retrieved from implantable medical
devices, such as IPGs [implantable pulse generators] and
monitors. . . . The information can be analyzed in any
automated fashion and feedback provided to the patient at any
time and in any location.
(Id. at 5, 11. 12-20.)
Claims 1, 3, 7-14, 16, and 20-32 are appealed. Claim l is illustrative:
1. A computer-implemented system for evaluating a patient
status for use in heart failure assessment, comprising:
a data module configured to assemble physiological
measures which were electronically stored in a memory and
directly recorded as data on a substantially continuous basis by
medical device for a patient or indirectly derived from the data,
wherein the physiological measures comprise measures for the
patient and one or more of measures for a peer group of disease
specific patients and measures for an overall patient population;
a status module configured to sample the physiological
measures over a plurality of data assembly points;
an evaluation module configured to evaluate and match
at each data assembly point the sampled physiological measures
to determine a patient status indicator;
a diagnosis module configured to determine one of a
status quo and a change in cardiac performance of the patient
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and compare the change in the cardiac performance to
worsening heart failure indications;
a quality of life module configured to query the patient
on a regular basis and collect quality of life measures and to
chronicle the quality of life measures with the physiological
measures; and
a feedback module configured to provide tiered feedback
based on the patient status indicator comprising:
a first level module configured to communicate, at
a first level, an interpretation of the change in the cardiac
performance;
a second level module configured to communicate,
at a second level, a notification of potential medical
concern based on the change in the cardiac performance
to the patient;
a third level module configured to communicate, at
a third level, a notification of potential medical concern
based on the change in the cardiac performance to
medical personnel; and
a fourth level module configured to communicate
to a patient medical device of the patient, at a fourth
level, a set of reprogramming instructions based on the
change in the cardiac performance;
wherein the tiered feedback has increasing levels
of patient involvement and medical care intervention.
(Appeal Br. 19-20 (Claims App'x).)
The claims stand rejected as follows:
Claims 1, 3, 8-10, 13, 14, 16, 21-23, 26-28, 30, and 31 stand rejected
as unpatentable under 35 U.S.C. § 103(a) over Finkelstein et al., (US
4,899,758, issued Feb. 13, 1990) ("Finkelstein") in view ofNappholz et al.,
(US 5,720,770, issued Feb. 24, 1998) ("Nappholz"), Surwit et al., (US
6,024,699, issued Feb. 15, 2000) ("Surwit"), and Treatch (US 4,830,018,
issued May 16, 1989) ("Treatch").
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Claims 7, 11, 12, 20, 24, 25, 29, and 32 stand rejected as unpatentable
under 35 U.S.C. § 103(a) over Finkelstein and Nappholz.
On appeal, we determine whether the Examiner established by a
preponderance of the evidence that the claims would have been obvious
based on the rejections described above.
DISCUSSION
The Examiner's rejection of independent claims 1, 14, 27, and 30 are
based on the same or substantially similar factual findings and rationale.
(Final Act. 2-5.) For purposes of appeal, Appellant and the Examiner
further argue the patentability of these claims as a group. (Appeal Br. 12-
16; Ans. 4--5.) Accordingly, in this discussion, we focus on the rejection of
claim 1, which is representative.
The Examiner finds that Finkelstein teaches all but a handful of the
elements of claim 1. More specifically, the Examiner finds
Finkelstein discloses a monitoring system comprising a
data module means for measuring and storing physiological
measures, e.g. vascular impedance, a status module configured
to sample the physiological measures over a plurality of data
points, e.g. AID converter for sampling and digitizing the
measures, an evaluation module for forming a patient status
from the sampled measures, e.g. distal compliance calculations,
and forming a diagnosis of CHF based on the patient status
through determining a trend of the distal compliance
measurements (e.g. Col. 1, line 50----Col. 2, line 11 ).
(Final Act. 2.) Missing from Finkelstein, according to the Examiner, is
disclosure of a "quality of life module configured to query the patient on a
regular basis," "tiered feedback, reprogramming a medical device based on
worsening heart failure indications" and "assembly of peer group/patient
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population physiological measures." (Id. at 2-3.) The Examiner turns to
Surwit, Treatch, and Nappholz for these disclosures. (Id.)
Particularly relevant for this appeal is the Examiner's finding that
Nappholz teaches "tiered feedback" that includes "reprogramming
instructions of a medical therapy device," i.e., the limitation of claim 1 of "a
fourth level module configured to communicate to a patient medical device
of the patient, at a fourth level, a set of reprogramming instructions based on
the change in the cardiac performance." (Id. at 3.) The Examiner finds
Nappholz teaches ... tiered feedback based on a change
in performance comprising; indicating a change in cardiac
performance, notification of potential medical concern to
medical personnel, and reprogramming instructions of a
medical therapy device, which is [an] increasing level of patient
involvement and medical intervention (e.g. Col. 9, lines 19-
Col. 10, line 28) for providing the predictable results of
assembling data for facilitating diagnosis of a compromising
cardiac condition, and delivering the appropriate therapy to
terminate the compromising condition.
(Id.) Further, according to the Examiner, it would have been obvious to
modify the system as taught by Finkelstein with these aspects ofNappholz
"to provide the predictable results of assembling data for facilitating
diagnosis of a compromising cardiac condition, and delivering the
appropriate therapy to terminate the compromising condition and adjusting
the patient medication dosage." (Id. at 4.)
Appellant argues it would have been nonobvious to "make such a
modification to the technology taught in Finkelstein based on Nappholz as
suggested by the examiner." (Appeal Br. 12.) According to Appellant,
"[ m ]odification of Finkelstein to include 'reprogramming instructions of a
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medical therapy device' ofNappholz would require inclusion of an
implanted medical therapy device, which is contrary to the principle of
operation of Finkelstein." (Id.) That is so, Appellant contends, because
Finkelstein's monitoring system is wholly related to minimally invasive or
noninvasive techniques, and Finkelstein eschews devices involving
"significant system invasion." (Id. at 13, (quoting Finkelstein.)2 On the
other hand, Nappholz discloses an implanted "cardiac stimulation device"
(e.g., pacemaker) and an external monitor that is capable of communicating
with and controlling the cardiac device. (Id. at 14.) Thus, Appellant's
argument goes, the modification proposed by the Examiner is "precisely the
level of invasiveness that Finkelstein is trying to avoid ... [and] renders the
relatively non-invasive analysis taught in Finkelstein unnecessary, at best,
and the implanted device changes Finkelstein's principle of operation."
(Appeal Br. 15; see also Reply Br. 5---6.)
We are not persuaded the Examiner has established by a
preponderance of the evidence that claim 1 would have been obvious. As an
initial matter, the modification of Finkelstein proposed by the Examiner in
the 3/15/12 Final Rejection is unclear. Reading that rejection alone, the
Examiner may merely be proposing that the functionality taught in Nappholz
2 The cited portion of Finkelstein reads: "Heretofore, pressure and
waveforms have typically been measured at the ascending aorta, requiring
significant system invasion, and thus limiting the usefulness of the procedure
as a diagnostic and monitoring tool." (Finkelstein, col. 1, 11. 30-34.) The
"minimally invasive" approach of Finkelstein uses an external monitoring
device and measurements of arterial pulse waveforms "requiring only
brachial artery puncture." (Id. at col. 1, 11. 35--47; see also Appeal Br. 13.)
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- providing tiered feedback including reprogramming instructions to a
medical device - should be applied to the medical device described in
Finkelstein. Yet one could also read the Examiner's rejection as proposing
that the structure of Finkelstein's system be modified to include the
implanted medical device (e.g., pacemaker) capable of receiving
reprogramming instructions that is described in Nappholz. Appellant
interpreted the rejection as proposing the latter structural combination.
(Appeal Br. 12; Remarks dated 5/15/12 at 10.) And, ifthe Examiner did not
intend that meaning, the Examiner never clarified the record. To the
contrary, the Examiner seems to have embraced Appellant's interpretation.
(See, e.g., Adv. Act. 2 ("the modification of including an implanted medical
therapy device does nothing to destroy the principle of operation of the
monitoring means."); Ans. 4--5 ("Finkelstein expressly discloses the system
as 'minimally invasive' but does not teach away from a more invasive
system.").) 3
We find that the Examiner has not provided an adequate and reasoned
explanation for the change - whether it be the structural modification of
3 Elsewhere the Examiner writes, "[i]n the current case, nothing of
Finkelstein is changed/replaced/ deleted by inclusion of the select features
disclosed by Nappholz." (Ans. 4.) As Appellant points out, if the
pacemaker device like described in Nappholz is simply added with no
change whatsoever to Finkelstein, it would seem to render Finkelstein's
monitoring device unnecessary or redundant. (Reply Br. 5.) The Examiner,
however, has offered no persuasive rationale why the teachings would be
combined in this way, particularly where the device described in Finkelstein
is directed towards minimally-invasive cardiac monitoring. (Finkelstein col.
1, 11. 30-47; see also Appeal Br. 13.)
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Finkelstein discussed above, or some other modification of the art. KSR
Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) ("there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness.") (quoting In re Kahn, 441 F.3d 977, 988 (Fed.
Cir. 2006). 4 The reasons presently offered lack necessary detail and fail to
persuade us that the claims would have been obvious. (See Final Act. 4;
Adv. Act. 2; Ans. 2-3.) At bottom, there is no adequate explanation from
the Examiner in the record showing how and why Finkelstein's and
Nappholz's teachings would have been predictably combined by the skilled
artisan to create a system within the scope of claim 1.
For these reasons, we conclude that the Examiner has not established
by a preponderance of the evidence that claim 1 would have been obvious.
For the same reasons, we conclude that the Examiner has not established by
a preponderance of the evidence that independent claims 14, 27, or 30 would
have been obvious. The rejection of claims 1, 14, 27, and 30 under§ 103(a)
is, therefore, reversed. So too, we reverse the rejection of claims 3, 7-13,
16, 20-26, 28, 29, 31, and 32 because of their dependency from claims 1, 14,
27 and 30.
4 Although "[t]he test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the structure of the
primary reference" In re Keller, 642 F.2d 413, 425 (CCPA 1981), the
totality of the record does suggest the Examiner's proposed modification
does just that: to incorporate a pacemaker device like disclosed in Nappholz
into Finkelstein's system. A detailed rationale explaining that combination
is thus required.
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SUMMARY
We reverse the rejection of claims 1, 3, 8-10, 13, 14, 16, 21-23, 26-
28, 30, and 31 under 35 U.S.C. § 103(a) over Finkelstein in view of
Nappholz, Surwit, and Treatch.
We also reverse the rejection of claims 7, 11, 12, 20, 24, 25, 29, and
32 under 35 U.S.C. § 103(a) over Finkelstein in view ofNappholz.
REVERSED
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LEBOVITZ, dissenting
I would affirm the rejection. Appellant did not find the basis of the
rejection "unclear" as stated in the majority opinion. Appellant understood
that the Examiner's proposed rejection was based on "inclusion of an
implanted medical therapy device" as described in Nappholz in Finkelstein's
system. Appeal Br. 12, 16. Appellant argued that the modification was not
obvious because it "is contrary to the principle of operation of Finkelstein."
Id. at 12. Appellant also argued:
Finkelstein directly discourages the use of invasive procedures
associated with the implanted devices taught in Nappholz by
offering an alternative method to obtain useful vascular
impedance measurements. Finkelstein teaches benefits from
avoiding such invasive procedures. (See Col. 1, 11. 30-47; and
Summary of Finkelstein in Appeal Brief dated August 13,
2012). The presence of an implantable device such as that
taught in Nappholz, which is already capable of taking
impedance measurements, would render such a non-invasive
technique for system measurements redundant, at best.
Reply Br. 5.
Thus, Appellant clearly understood the Examiner's rejection and
distinguished it by arguing that the skilled worker would have avoided the
type of invasive procedure described by Nappholz. The majority decision
did not address Appellant's concerns with the Examiner's rejection as
summarized above, but rather took the position - that Appellant did not -
that the basis of the rejection could not be understood.
I do not agree with Appellant that the Examiner erred in finding it
obvious to use Nappholz's device in Finkelstein. As noted by the Examiner,
the principle of operation of Finkelstein is not changed "by inclusion of the
select features disclosed by Nappholz." Answer 4. Finkelstein is drawn to a
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monitoring for cardiac output as "indicators for disease and therapeutic
response based on measurements that are obtained in a relatively non-
invasive manner, from a brachial artery puncture." Appeal Br. 13-14. It is
logical that once disease and therapeutic responses are collected by
Finkelstein, a physician would have sought to "deliver[ ] the appropriate
therapy to terminate the compromising condition" as found by the Examiner.
Answer 3. It is true that cardiac stimulatory devices described in Nappholtz,
such as a pacemaker, are invasive to the body, but Appellant has not pointed
to a persuasive teaching in Finkelstein, or any other fact-based reason, that a
device such as pacemaker would not be used in its conventional way to
stimulate the heart once measurements made using Finkelstein's system
indicate that intervention is necessary.
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