Ex Parte Bardy

Patent Trial and Appeal Board

Jun 29, 2016

12689706 (P.T.A.B. Jun. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/689,706 01119/2010
62058 7590 07/01/2016
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 15.0089USC4/03-405-CON4 6368
EXAMINER
FLORY, CHRISTOPHER A
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
07/01/2016 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
Exparte GUST H. BARDY
Appeal2013-003214
Application 12/689,7061
Technology Center 3700
Before RICHARD M. LEBOVITZ, CHRISTOPHER G. PAULRAJ and
ELIZABETH A. LA VIER, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to methods for determining
patient status and providing automated feedback to an individual patient.
Appellant2 appeals from the Examiner's rejections of claims 2-21. We have
jurisdiction under 35 U.S.C. § 134. The rejections are affirmed.
STATEMENT OF CASE
Appellant appeals from the Examiner's final rejection of claims 2-21.
The claims stand rejected by the Examiner as follows:
1 "The '706 Application."
2 Appellant states the real party in interest is Cardiac Pacemakers, Inc.
Appeal Br. 1.
Appeal2013-003214
Application 12/689,706
1. Claims 2, 7 and 19 under 35 U.S.C. § 102(b) (pre-AIA) as
anticipated by Nikolic (US 5,743,267, issued Apr. 28, 1998). Final Rej. 3.
2. Claims 2--4, 13, 14, 19, and 21under35 U.S.C. § 103(a) (pre-AIA)
as obvious in view of Tacklind (US 5,704,366, issued Jan. 6, 1998) and
Nikolic. Id. at 4.
3. Claims 5, 6, and 15-17 under 35 U.S.C. § 103(a) (pre-AIA) as
obvious in view of Tacklind, Nikolic, and Bui (US 6,398, 727 B 1, issued Jun.
4, 2002). Id. at 5.
4. Claim 7 and 18 under 35 U.S.C. § 103(a) (pre-AIA) as obvious in
view of Tacklind, Nikolic, Bui, and Lavin (US 5,772,585, issued Jun. 30,
1998). Id. at 6.
5. Claims 8-10 and 20 under 35 U.S.C. § 103(a) (pre-AIA) as
obvious in view of Tacklind, Nikolic, and Levine (US 4,852,570, issued
Aug. 1, 1989). Id. at 7.
6. Claim 11 under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view
of Tacklind, Nikolic, Levine, and Bui. Id. at 8.
7. Claim 12 under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view
of Tacklind, Nikolic, Levine, and Lavin. Id. at 9.
8. Claims 2-7 under 35 U.S.C. § 101 as directed to non-statutory
subject matter. Id. at 2.
Claims 2, 8 and 13 are independent claims. The remaining claims
depend from them. Independent claim 2 is representative and reproduced
below. The claim has been annotated by the addition of bracketed numerals
to indicate the steps of the claimed method.
2. A method for determining patient status and providing
feedback to an individual patient for automated remote patient
care, compnsmg:
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[ 1] organizing patient care records in a database, where
each patient care record comprises information identifying an
individual patient;
[2] for a particular patient, receiving collected device
measures to provide raw physiological measures for the patient,
wherein the collected device measures are regularly generated
and recorded by an implanted medical device comprising a
plurality of physiological sensors;
[3] determining derived device measures based on the
collected device measures;
[ 4] determining a patient status indicator based on
analysis of the collected device measures; and
[5] sending automated feedback to the patient based at
least in part on the patient status indicator, wherein the
automated feedback includes an interpretation of the patient
status indicator and related health care information.
GROUND 1. ANTICIPATIONBYNIKOLIC
The method of claim 2 comprises the step of [ 5] "sending automated
feedback to the patient based at least in part on the patient status." The
Examiner found this step met by the teaching in Nikolic at column 7, lines
5-10. The cited disclosure is as follows:
For example, a plot illustrating a steady drop in a patient[']s
maximum systolic pressure over a defined period of time may
indicate a weakening of the patient's heart. A doctor can then
prescribe a medical treatment to correct the problem before the
patient progresses into a more severe condition requiring
admission into a hospital.
Id. at col. 7, 11. 5-10.
Appellant contends that "teaching that a doctor can prescribe a
medical treatment to correct a patient health problem, as in Nikolic is not
analogous to, 'sending automated feedback to the patient' of independent
claim 2 because the broadest reasonable interpretation of the word
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'automated' does not encompass a doctor prescribing medical treatment."
Appeal Br. 11.
To address this argument, we must begin with claim interpretation.
During patent prosecution, claim terms are given their broadest reasonable
interpretation, consistent with the specification, as they would be understood
by one of ordinary skill in the art. In re Buszard, 504 F.3d 1364, 1367 (Fed.
Cir. 2007); In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir.
2004). Neither "automated" nor "automated feedback" is defined in the
'706 Application. We thus adopt the ordinary dictionary definition of
"automated" to mean "to run or operate (something, such as a factory or
system) by using machines, computers, etc., instead of people to do the
work."3 This interpretation is consistent with the Application, which
describes automatic feedback generated by a server. '706 Appl. 13: 6-11;
14: 11-16.
Because Nikolic' s system utilizes a person to send feedback ("doctor
can then prescribe a medical treatment" at col. 7, 11. 7-8), it is not
"automated feedback" as one of ordinary skill in the art would have
understood the term at the time of the invention. Accordingly, we reverse
the anticipation rejection of claim 2, and dependent claims 7 and 19.
GROUND 2. OBVIOUSNESS IN VIEW OF TACKLIND AND NIKOLIC
The Examiner found that Tacklind describes steps [1] through [5] of
the method of claim 2, but does not teach collecting the measurements from
"an implanted medical device" as required by the claim. Final Rej. 4.
3 http://www.merriam-webster.com/dictionary/automate. Accessed June 14,
2016.
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However, the Examiner cited Nikolic for teaching that it was known to use
an implantable medical device for remote monitoring of patients with
chronic cardiac disease. Id. at 4--5. The Examiner concluded that it would
have been obvious to use an implantable medical device in Tacklind's
process "since such a modification would provide the predictable results of
accurately monitoring patients that suffer chronic cardiac disease, where the
chronic nature warrants an implanted/long term monitoring means." Id. at 5.
Appellant contends that the cited publications do not make claims 2
and 13 obvious because they do not teach or suggest "a plurality of
physiological sensors" as recited in the claims. Appeal Br. 12. Appellant
"concedes that Tacklind does reference multiple sensors, however, a mere
reference to multiple sensors does not render obvious a method where a
patient status indicator is determined based on collected device" because
"Tacklind does not provide any information suggesting how one would
combine data from multiple sensors to determine a patient status indicator,
or any reason why one would do it in the first place." Id. at 13. Appellant
argues that Nikolic does not "cure" the deficiency in Tacklind. Id. at 13-14.
Analysis
Again we start with claim interpretation because, before a claim is
properly interpreted, it cannot be compared to the prior art. For this ground
of rejection, the dispute between the Examiner and Appellant involves step
[ 4] of claim 2, which recites "determining a patient status indicator based on
analysis of the collected device measures."
Claims are interpreted in view of the specification of which they are
part. Am. Acad., 367 F.3d at 1364. We have not been directed to a
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definition of "patient status indictor" in the '706 Application nor can we find
an explicit definition in the application. An example is given in the '706
Application of measuring cardiac output as a "health trend" "as to the
particular patient," and comparing the output to a group of patients to
establish whether patient "is trending out of the norm." '706 Appl. 21:23-
22: 1. The '706 Application states that "[f]rom this type of analysis, the
analysis module 53 generates a patient status indicator 54 and other metrics
of patient wellness, as is known in the art." Id. at 22:1-3. The '706
Application also teaches that a "new and improved indicator of impending
heart failure could be derived based on the exemplary cardiac collected
measures set described with reference to FIGURE 5," where Fig. 5 lists
various measurements, such as atrial electrical activity, cardiac output,
oxygen level, etc. Id. at 18:2-7. Based on this description in the '706
Application, we interpret the patient status indicator to mean a module
which provides "health trends" and "metrics of patient wellness." Claim 13
is similarly construed because it recites similar language, i.e., "code for
determining a patient status indicator based on an analysis of the collected
device measure."
While the '706 Application describes embodiments where the metrics
of the patient status indicator is "derived" from measurements obtained from
cardiac sensors (e.g., id. at 18:2-7; 21:23-22:3), the claims do not require
this step. Specifically, step [3] of the claim recites "determining derived
device measures based on the collected device measures." However, in step
[ 4], the patient status indicator is determined "based on the collected device
measures" and therefore the patient status indicator is not necessarily
determined from the "derived device measures" of step [3].
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Next, we tum to Tacklind. Tacklind, as conceded by Appellant,
explicitly discloses "a plurality of physiological sensors" as recited in claim
2. Tacklind teaches:
A sensor device 10 is used to measure the value of a selected
physiological characteristic of a patient such as respiratory
functions, e.g., peak expiratory flow (PEP) and forced
expiratory volume (FEV1), blood glucose levels, blood
pressure, heart rate, body weight, fluid intake and discharge
rates, and caloric intake. Sensors for measuring these values
and providing a digital sensor output encoding the measured
values of the physiological characteristics are commercially
available. A particular sensor for measuring respiratory
functions will be described more fully below.
Tacklind, col. 5, 11. 20-30.
Thus, while Tacklind exemplifies a specific type of sensor, Tacklind
has broader disclosure of utilizing a plurality of sensors to collect
physiological characteristics of a patient.
Tacklind also describes a module that collects "the digital sensor
outputs," displays "interpreted measurements" to the patient (e.g., [ 4] "the
patient status indicator" of claim 1 ), and transferring them to a remote
location:
The intelligence and communications functions are
provided in a monitor module 12 which is used by the patient.
The sensor may be integrated into the monitor module 12 or be
separate with a cable or other means. e.g., an IR beam, used to
transfer the digital sensor output to the monitor module 12. The
monitor module 12 performs the intelligence functions of
collection and interpretation of measured values encoded in the
digital sensor outputs, the memory function of storing multiple
measured values along with time stamps indicating when
measurements were taken, the display function of visually
communicating the interpreted measurements to the patient,
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and the communication function for transferring measured
values and time stamps via the telephone system.
Id. at col. 5, 11. 31--44 (emphases added).
Appellant's argument that Tacklind does not teach "how one would
combine data from multiple sensors to determine a patient status indicator"
reads a limitation into the claim which does not appear in it. Appeal Br. 13.
Appellant appears to be distinguishing Tacklind based on step [ 4] of claim 2
of "determining a patient status indicator based on analysis of the collected
device measures." The properly interpreted step requires only that the
patient status indicator provides "health trends" and "metrics of patient
wellness." See discussion above. Appellant has not explained what
language in the claim or definition in the Application would require data
from multiple sensors to be combined. Consequently, we find that
Appellant's argument is not supported by a preponderance of the evidence.
Because Appellant did not demonstrate error in the Examiner's
rejection, we affirm the obviousness rejection of claims 2 and 13 based on
Tacklind and Nikolic. Claims 3, 4, 14, 19, and 21 fall with claims 2 and 13
because separate reasons for their patentability were not provided. See 37
C.F.R. § 41.37(c)(l)(iv).
GROUND 5. OBVIOUSNESS IN VIEW OF TACKLIND, NIKOLIC,
AND LEVINE
The Examiner further rejected claims 8-10 and 20 based on Levine.
Independent claim 8 is directed to a "system for providing feedback to an
individual patient for automated remote patient care" which, inter alia,
recites "a server periodically receiving the collected measures set from the
medical device" and "analyzing the collected measures set and one or more
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of the plurality of collected measures sets relative to one or more other
collected measures sets stored in the database to determine a patient status
indicator." Claims 9, 10, and 20 depend from claim 8.
The Examiner cited Levine for its teaching of comparing collected
device measurements to previous sets of measurements to determine patient
status. Final Rej. 7. The Examiner reasoned it would have been obvious to
one of ordinary skill in the art to implement Levin in Tacklind's process
because "such a modification would provide the predictable results of
facilitating detection of adverse trends that are indicative of problems and
future problems such that preventative action may be taken." Id.
Appellant contends that Levine focuses on "identifying trends" rather
than teaching or suggesting "determining a patient status indicator." Appeal
Br. 16. Appellant also states there is no indication in Levine "that a server
in Levine analyzes collected measures sets ' ... to determine a patient status
indicator.' Levine does not teach or suggest that data sets are analyzed. The
analysis of the measurements is by a person based on the data presented."
Id. See also Reply Br. 6.
Appellant has not demonstrated error in the Examiner's rejection.
The "trends" described by Levine are obtained from periodically taking
medical tests and storing them on a card. Levine, col. 2, 11. 17-26. The
physician reviews
... results of the periodically made groups of tests. By
comparing like measurements taken of that individual over
many spaced periods of time, the doctor can more readily detect
changes and "trends" that have progressively taken place over
the long term. If such comparisons reveal unexplained,
undesirable changes, the doctor is alerted to more intensively
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investigate the conditions indicated, and take such corrective
measures as appear to be necessary.
Id. at col. 2, 11. 35--45.
The test measurements in Levine constitute patient health metrics and
thus meet the limitation of a "patient status indicator" as we have construed
the term. Indeed, the '706 Application uses the term "health trends" (at
21:23-22:1 ), as does Levine. Appellant has not provided adequate argument
or evidence that the Examiner erred in finding that Levine meets the "patient
status indicator."
Alternatively, the Examiner found that Tacklind meets the limitation
of determining a patient status indicator and relied on Levine for its teaching
of comparing the collected measures to one or more stored collected
measure sets, and found it obvious to perform such comparative analysis in
Tacklind. Answer 4. Appellant did not identify an error in this
determination.
As to the argument that Levine's analysis is performed by a person
and not a server as recited in the claim, the Examiner responded that the
rejection is based on utilizing Levine's analysis in Tacklind's system which
uses a "server/database for analysis of collected measures." Answer 4--5.
The Examiner's reasoning is fact-based and sound. See Final Rej. 7.
Appellant has not identified an error in it.
For the foregoing reasons, we affirm the rejection of claim 8. Claims
9, 10, and 20 were not argued separately and thus fall with claim 8. See 37
C.F.R. § 41.37(c)(l)(iv).
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GROUNDS OF REJECTION 3, 4, 6, AND 7
Appellant's arguments as to Ground 3 (Appeal Br. 14), Ground 4 (id. at
14--15), Ground 6 (id. at 17), and Ground 7 (id.) are the same as the
unpersuasive arguments set forth for the rejections based on Tacklind,
Nikolic, and Levine. Consequently, we affirm these rejections for the
reasons already discussed.
GROUND 8. SECTION 101 REJECTION
The Examiner rejected claims 2-7 under 35 U.S.C. § 101 based on the
determination that the claimed invention is directed to non-statutory subject
matter. Final Rej. 2; see also Answer 3.
A patent may be obtained for "any new and useful process, machine,
manufacture, or composition of matter, or any new and useful improvement
thereof." 35 U.S.C. § 101. But,§ 101 has long been understood as
"contain[ing] an important implicit exception: Laws of nature, natural
phenomena, and abstract ideas are not patentable." Alice Corp. Pty. Ltd. v.
CLS Bank Int'!, 134 S. Ct. 2347, 2354 (2014) (internal citation and quotation
omitted).4 In Alice, the Supreme Court reaffirmed the framework set forth
previously in Mayo Collaborative Services v. Prometheus Laboratories,
Inc., 132 S. Ct. 1289 (2012), "for distinguishing patents that claim laws of
nature, natural phenomena, and abstract ideas from those that claim patent-
eligible applications of these concepts." Alice, 134 S. Ct. at 2355. The first
step in the analysis is to "determine whether the claims at issue are directed
to one of those patent-ineligible concepts." Id. If so, the second step is to
4 Although Alice issued after this appeal was docketed, we find that the
Examiner's analysis is consistent with Alice.
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consider the elements of the claims "individually and 'as an ordered
combination' to determine whether the additional elements 'transform the
nature of the claim' into a patent-eligible application." Id. (quoting Mayo,
132 S. Ct. at 1298, 1297). Put differently, the second step is to "search for
an 'inventive concept' - i.e., an element or combination of elements that is
'sufficient to ensure that the patent in practice amounts to significantly more
than a patent upon the [ineligible concept] itself."' Id. (brackets in original)
(quoting Mayo, 132 S. Ct. at 1294).
Beginning with the first step of the Alice framework, we agree with
the Examiner that claims 2-7 are drawn to an abstract idea, see Answer 3,
namely to a method of data gathering and analysis, and the provision of
feedback based on that analysis. Thus, claims 2-7 fall outside the ambit of
§ 101 unless, pursuant to the second step from Alice, the claims include an
"inventive concept" that amounts to "significantly more" than the abstract
idea itself. We conclude that they do not. The Examiner explained that
claims 2-7 are not tied to a particular apparatus and do not transform a
particular article, thus failing the machine-or-transformation test. See Final
Action 2; Answer 3. The machine-or-transformation test is not dispositive,
but it is a "useful clue" in assessing patent eligibility. Bilski v. Kappas, 561
U.S. 593, 604 (2010). Importantly, a claim drawn to an abstract idea cannot
be rescued merely by "limiting the use of [that] abstract idea 'to a particular
technological environment."' Alice, 134 S. Ct. at 2358 (quoting Bilski, 561
U.S. at 610-11); see also id. at 2359 (applying substantially the same
analysis to method claims). In this case, the steps in the claimed method are
principally directed to data gathering (steps [1] and [2]) and the machine is
only tangentially related to performing the steps [3]-[5] because such steps
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can be performed by a person as evidenced by the discussion of step [5] in
the anticipation rejection based on Nikolic and in the discussion of Levine
where the data analysis and patient indicator of [3] and [4] is performed by a
person. Thus, claim 2 does no more "than simply instruct the practitioner to
implement the abstract idea," Alice, 134 S. Ct. at 2359. Claims 3-7, which
are not argued separately, are similarly deficient, and fall with claim 2.
Accordingly, we affirm the Examiner's rejection of claims 2-7 under§ 101.
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
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