Andreas Blomqvist et al.

Patent Trials and Appeals Board

Aug 20, 2019

13366106 - (D) (P.T.A.B. Aug. 20, 2019)

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.
13/366,106 02/03/2012 Andreas Blomqvist A12P1012 1035
36802 7590 08/20/2019
PACESETTER, INC.
15900 VALLEY VIEW COURT
SYLMAR, CA 91392-9221
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
08/20/2019 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):
Patent.CRMDSylmar@sjm.com
asjm_Patents@abbott.com
estella.pineiro@abbott.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ANDREAS BLOMQVIST and MICHAEL E. BENSER1
__________

Appeal 2017-010178
Application 13/366,106
Technology Center 3700
__________

Before ERIC B. GRIMES, JOHN E. SCHNEIDER, and
TIMOTHY G. MAJORS, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an Appeal under 35 U.S.C. § 134 involving claims to a method
and apparatus for detecting atrial fibrillation, which have been rejected as
being directed to patent-ineligible subject matter and as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm the rejections for obviousness.

1 Appellants identify the real party in interest as Pacesetter, Inc., dba St. Jude
Medical Crmd. Br. 5.
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STATEMENT OF THE CASE
“A significant risk factor for thrombotic stroke is atrial fibrillation
(AF). . . . Accordingly, it is desirable to detect AF in a patient before the
patient suffers a stroke.” Spec. ¶ 3. “The disclosure relates in some aspects to
detecting AF based on pulmonary artery pressure (PAP) monitoring. . . .
[D]etection of AF is based on identifying cycle-to-cycle variations of one or
more parameters derived from the PAP data.” Id. ¶ 6.
Various morphological characteristics of a PAP signal
may be used individually or in combination to detect or confirm
AF. Many of these characteristics are related to the temporal
cycle-to-cycle stability of various measures, including peak-to-
peak amplitude (Pmax – Pmin over the course of each cardiac
cycle), morphological consistency (correlation of the PAP signal
over each cardiac cycle to the prior cardiac cycle or a running
average or some established template), systolic phase-to-systolic
phase timing, as well as rate changes as assessed from the PAP
signal.
Id. ¶ 7.
“Regarding frequency parameters, irregularities in the ventricular
cycles will lead to changes in the frequency spectra for those cycles. For
example, a shorter cardiac cycle may result in a wider frequency spectrum
than other PAP cycles.” Id. ¶ 51. “Baseline PAP cycle frequency information
may be defined in various ways (e.g., in a similar manner as . . . for the
baseline PAP cycle.” Id. ¶ 52.
Claims 1–23 are on appeal. Claims 1 and 21–23 are illustrative and
read as follows:
1. An apparatus for detecting atrial fibrillation, comprising:
an implantable sensor device implantable proximate to a
pulmonary artery, the sensor device including a sensor circuit
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configured to measure pulmonary artery pressure to generate
pulmonary artery pressure data;
a processing circuit configured to:
process the pulmonary artery pressure data to determine
pulmonary artery pressure parameters of a first type
corresponding to a plurality of cardiac cycles,
determine a stability parameter indicative of variation of
the pulmonary artery pressure parameters of the first type over
the cardiac cycles, wherein the stability parameter represents at
least one of an amplitude-based stability parameter, a
morphology-based stability parameter or a frequency-based
stability parameter,
compare the stability parameter to a threshold, and
generate an indication of atrial fibrillation based on the
comparison.

21. The apparatus of claim 1, wherein the stability parameter
represents an amplitude-based parameter.

22. The apparatus of claim 1, wherein the stability parameter
represents a morphology-based parameter.

23. The apparatus of claim 1, wherein the stability parameter
represents a frequency-based parameter.

Claims 15 and 19 are also independent. Claim 15 is similar to claim 1
but requires the processing circuit to “process the pulmonary artery pressure
data to determine a plurality of different types of pulmonary artery pressure
parameters.” Claim 19 is directed to a method, rather than an apparatus, but
otherwise tracks the limitations of claim 1.
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The claims stand rejected as follows:
Claims 1–23 under 35 U.S.C. § 101 as being directed to patent-
ineligible subject matter (Final Action2 2);
Claims 1–3, 7, 9, 11–15, and 19–21 under 35 U.S.C. § 103(a) as
obvious based on Stahmann ’221,3 Wiesel,4 and Moran5 (Final Action 5);
Claims 1–3, 7, 9, 11–15, 19, 20, and 22 under 35 U.S.C. § 103(a) as
obvious based on Stahmann ’221, Wiesel, and Galen6 (Final Action 10);
Claims 1–3, 7, 9, 11–15, 19, 20, and 23 under 35 U.S.C. § 103(a) as
obvious based on Stahmann ’221, Wiesel, and Chang7 (Final Action 16);
Claims 4–6 under 35 U.S.C. § 103(a) as obvious based on Stahmann
’221, Wiesel, Moran (or Galen or Chang), and Stegemann8 (Final Action 21);
Claim 8 under 35 U.S.C. § 103(a) as obvious based on Stahmann ’221,
Wiesel, Moran (or Galen or Chang), and Muessig9 (Final Action 24);
Claim 10 under 35 U.S.C. § 103(a) as obvious based on Stahmann
’221, Wiesel, Moran (or Galen or Chang), and Stahmann ’07510 (Final Action
25); and

2 Office Action mailed August 25, 2016.
3 Stahmann, US 2007/0088221 A1, Apr. 19, 2007.
4 Wiesel, US 2006/0195037 A1, Aug. 31, 2006.
5 JOHN F. MORAN, in CLINICAL METHODS: THE HISTORY, PHYSICAL, AND
LABORATORY EXAMINATIONS 98–100 (H.K. Walker et al. eds., 3rd ed. 1990).
6 Galen et al., US 2012/0310100 A1, Dec. 6, 2012.
7 Chang, US 2008/0108906 A1, May 8, 2008.
8 Stegemann et al., US 2006/0247702 A1, Nov. 2, 2006.
9 Muessig et al., US 2007/0265667 A1, Nov. 15, 2007.
10 Stahmann et al., US 2011/0004075 A1, Jan. 6, 2011.
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Claims 16–18 under 35 U.S.C. § 103(a) as obvious based on Stahmann
’221, Wiesel, Moran (or Galen or Chang), and Ghanem11 (Final Action 26).
I
The Examiner has rejected all of the claims on appeal on the basis that
“the claimed invention is directed to a judicial exception (i.e., a law of nature,
a natural phenomenon, or an abstract idea) without significantly more.” Final
Action 2.
The Examiner finds that the claims “recite comparing new, measured
PAP parameter variation/stability to predefined, stored thresholds to identify
presence or absence of atrial fibrillation, and are therefore . . . abstract.” Id. at
3. The Examiner also finds that “[t]he additional elements of the claims recite
determining stability of the parameters at a high level of generality which
encompasses any stability/variation metric . . . and a generic computer
structure for identifying the abstract/natural relationship.” Id. The Examiner
concludes that “the claims do not include additional elements that are
sufficient to amount to significantly more than the judicial exception,” and
are ineligible for patenting. Id. at 4.
Appellants argue, among other things, that “claim 1 is not directed to a
law of nature, natural phenomenon, or abstract idea.” Br. 15. More
specifically, Appellants argue that “claim 1 includes a combination of
elements/operations that clearly integrate ‘variation in pulmonary artery
pressure (PAP) parameters’ into claimed inventions that ‘practically apply
the principles’ and ensure that the claims ‘amount to significantly more than
the natural principle itself.’” Id.

11 Ghanem et al., US 2011/0137193 A1, June 9, 2011.
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We agree with Appellants that the Examiner has not shown that the
claimed apparatus and method are ineligible for patenting. An invention is
patent-eligible if it claims a “new and useful process, machine, manufacture,
or composition of matter.” 35 U.S.C. § 101. However, the Supreme Court has
concluded that “[l]aws of nature, natural phenomena, and abstract ideas” are
not patentable under 35 U.S.C. § 101. See, e.g., Alice Corp. v. CLS Bank
Int’l, 573 U.S. 208, 216 (2014).
To determine if a claim falls into an excluded category, we apply a
two-step framework, described in Mayo and Alice. Id. at 217–18 (citing Mayo
Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75–77 (2012)).
We first determine what the claim is “directed to.” See Alice, 573 U.S. at 219
(“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
in petitioners’ application explain the basic concept of hedging.”).
Patent-ineligible abstract ideas include certain methods of organizing
human activity, such as fundamental economic practices (Alice, 573 U.S. at
219–20; Bilski, 561 U.S. at 611), mathematical formulas (Parker v. Flook,
437 U.S. 584, 594–95 (1978)), and mental processes (Gottschalk v. Benson,
409 U.S. 63, 69 (1972)). In contrast, patent-eligible inventions include
physical and chemical processes, such as “molding rubber products”
(Diamond v. Diehr, 450 U.S. 175, 191 (1981)); “tanning, dyeing, making
water-proof cloth, vulcanizing India rubber, smelting ores” (id. at 183 n.7
(quoting Corning v. Burden, 56 U.S. 252, 267–68 (1853))); and
manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v. Deener, 94
U.S. 780, 785 (1876))).
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In Diehr, the claimed method employed a mathematical formula, but
the Supreme Court held that “[a] claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
mathematical formula.” Diehr, 450 U.S. at 176; see also id. at 192 (“We view
respondents’ claims as nothing more than a process for molding rubber
products and not as an attempt to patent a mathematical formula.”). The
Supreme Court noted, however, that a claim “seeking patent protection for
that formula in the abstract . . . is not accorded the protection of our patent
laws, . . . and this principle cannot be circumvented by attempting to limit the
use of the formula to a particular technological environment.” Id. (citing
Benson and Flook); see, e.g., id. at 187 (“It is now commonplace that an
application of a law of nature or mathematical formula to a known structure
or process may well be deserving of patent protection.”).
If the claim is “directed to” an abstract idea, we turn to the second step
of the Alice and Mayo framework, and “examine the elements of the claim to
determine whether it contains an ‘inventive concept’ sufficient to ‘transform’
the claimed abstract idea into a patent-eligible application.” Alice, 573 U.S. at
221 (quotation marks omitted). “A claim that recites an abstract idea must
include ‘additional features’ to ensure ‘that the [claim] is more than a drafting
effort designed to monopolize the [abstract idea].’” Id. (quoting Mayo, 566
U.S. at 77 (alterations in original)). “[M]erely requir[ing] generic computer
implementation[] fail[s] to transform that abstract idea into a patent-eligible
invention.” Id.
The PTO recently published revised guidance on the application of
§ 101. USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance, 84
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Fed. Reg. 50 (Jan. 7, 2019) (“Revised Guidance”). Under that guidance, we
first determine whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract
ideas (i.e., mathematical concepts; certain methods of organizing
human activity such as a fundamental economic practice; or mental
processes); and
(2) additional elements that integrate the judicial exception into a
practical application (see MPEP §§ 2106.05(a)–(c), (e)–(h)).
See 84 Fed. Reg. at 54–55. Only if a claim (1) recites a judicial exception and
(2) does not integrate that exception into a practical application, do we then
determine whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not a
“well-understood, routine, conventional activity” in the field (see
MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of
generality, to the judicial exception.
See 84 Fed. Reg. at 56.
Revised Guidance Step 2(A), Prong 1
Following the Revised Guidance, we first consider whether the claims
recite a judicial exception. Claim 1 recites the processing steps of (a)
“compar[ing] the stability parameter to a threshold,” and (b) “generat[ing] an
indication of atrial fibrillation based on the comparison.” Claim 1.
The Revised Guidance identifies “mental processes—concepts
performed in the human mind (including an observation, evaluation,
judgment, opinion)”—as abstract ideas. 84 Fed. Reg. at 52 (footnote
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omitted); see also Mayo, 566 U.S. at 71 (“[M]ental processes[] and abstract
intellectual concepts are not patentable, as they are the basic tools of
scientific and technological work.”).
Here, the “compare” and “generate” steps of claim 1 can be carried out
by simply observing the value of the determined stability parameter relative to
a predetermined value (“compar[ing]” one value to another) and evaluating
whether the result of the comparison indicates atrial fibrillation (“generat[ing]
an indication of atrial fibrillation”). These steps can be carried out mentally,
and therefore claim 1 recites an abstract idea.
Revised Guidance Step 2(A), Prong 2
Although claim 1 recites an abstract idea, it is still patent-eligible if
“the claim as a whole integrates the recited judicial exception into a practical
application of the exception”; i.e., whether the claim “appl[ies], rel[ies] on, or
use[s] the judicial exception in a manner that imposes a meaningful limit on
the judicial exception.” 84 Fed. Reg. at 54. This analysis includes
“[i]dentifying whether there are any additional elements recited in the claim
beyond the judicial exception(s)” and “evaluating those additional elements
individually and in combination to determine whether they integrate the
exception into a practical application.” Id. at 54–55. An additional element
that uses a judicial exception in conjunction with a particular machine that is
integral to the invention may indicate that a judicial exception is integrated
into a practical application. Id. at 55.
Here, claim 1 uses the recited mental steps—“compar[ing] the stability
parameter to a threshold” and “generat[ing] an indication of atrial fibrillation
based on the comparison”—in conjunction with a particular machine;
specifically, “an implantable sensor device implantable proximate to a
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pulmonary artery, the sensor device including a sensor circuit configured to
measure pulmonary artery pressure.” The implantable sensor is integral to the
claim because it is expressly recited as being used to generate the pulmonary
artery pressure data that are used in the processing steps of the claimed
method. The implantable sensor is therefore a particular machine that is
integral to the invention.
In summary, we conclude that, even though claim 1 recites an abstract
idea, as a whole it integrates that idea into a practical application. The same
analysis applies to the apparatus of independent claim 15 and the method of
independent claim 19. Therefore, the claimed method, as a whole, is not
“directed to . . . [a] patent-ineligible concept.” Alice, 573 U.S. at 217. We
reverse the rejection of claims 1, 15, and 19, and dependent claims 2–14, 16–
18, and 20–23, under 35 U.S.C. § 101.
II
The Examiner has rejected claims 1–3, 7, 9, 11–15, and 19–21 as
obvious based on Stahmann ’221, Wiesel, and Moran. The Examiner finds
that Stahmann ’221 discloses an implantable pulmonary artery pressure
(PAP) sensor and a processing circuit configured to process PAP data to
determine PAP parameters (different types of signals) for diagnostic
purposes. Final Action 5. The Examiner also finds that Stahmann ’221
discloses generating an indication of atrial fibrillation (AF) based on the
processed PAP data, because it discloses that the data can be used to control a
therapy delivery device to administer cardioversion/defibrillation therapy:
“[S]ince defibrillation therapy is provided in response to the data, it is
understood an indication of fibrillation is inherently generated prior to
administration of such therapy.” Id.
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The Examiner finds that Stahmann ’221 does not disclose determining
a stability parameter over a number of cardiac cycles, comparing the stability
parameter to a threshold, and generating an indication of AF based on the
comparison. Id. at 6. The Examiner finds, however, that Wiesel discloses
using arterial pressure to determine cycle-to-cycle timing of pulse beats,
determining a stability parameter based on irregularity of the pulse beat
intervals, and comparing that parameter to a threshold. Id.
The Examiner concludes that it would have been obvious to modify the
method and apparatus of Stahmann ’221
with a processing circuit configured to determine a stability
parameter of arterial (e.g., pulmonary) pressure data, such as
cycle-to-cycle timing, and generating an indication of atrial
fibrillation based on a comparison of the stability parameter to a
threshold as taught/suggested by Wiesel . . . in order to provide
an alternative/additional indicator on which to base generation
of therapy (Stahmann ’221, ¶ [0072]), thereby reducing
complications associated with atrial fibrillation such as
formation of blood clots, stroke, etc. (Wiesel, ¶ [0009]).
Id. at 6–7.
The Examiner finds that Moran discloses that, “during atrial
fibrillation, both an irregularly irregular pressure pulse rate . . . and a variable
pressure pulse amplitude . . . are observed.” Id. at 7. The Examiner concludes
that it would have been obvious to further modify the method and apparatus
of Stahmann ’221 to determine “an amplitude-based stability parameter as
taught and/or suggested by Moran,” in addition to the timing parameter
disclosed by Wiesel, “in order to account for additional arterial (e.g.,
pulmonary) pressure parameters known to be indicative of atrial fibrillation,
thereby providing a more accurate/comprehensive assessment of the
condition on which to, e.g., base the initiation of therapy.” Id.
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We agree with the Examiner that the apparatus of claim 1 would have
been obvious to a person of ordinary skill in the art based on the cited
references. Stahmann ’221 discloses “[a]n implantable medical device [that]
processes a sensed pulmonary artery pressure (PAP) signal to isolate a
plurality of signals from the PAP signal for diagnostic, monitoring, and/or
therapeutic uses.” Stahmann ’221 ¶ 4. “In one embodiment, an implantable
pressure sensor is placed in the pulmonary artery to sense the PAP signal.”
Id.
“[A] sensor signal processing system . . . receives and processes the
PAP signal sensed by implantable PAP sensor 110. The sensor signal
processing system includes a PAP signal processor 120 that isolates a
plurality of signals of substantially different types from the PAP signal for
diagnostic, monitoring, and/or therapy-control uses.” Id. ¶ 42.
In one embodiment, “implantable PAP sensor 110 and implantable
medical device 112 are implanted in a body 102 that has a pulmonary artery
103 connected to a heart 101.” Id. Implantable medical device 112 can
include a “[t]herapy delivery device 1170 [that] delivers one or more
therapies such as pacing therapy, cardioversion/defibrillation therapy,” etc.
Id. ¶ 72. We agree with the Examiner that a skilled artisan would reasonably
understand that delivering defibrillation therapy would include first
generating an indication of atrial fibrillation showing the need for such
therapy.
Stahmann ’221 states that “[c]ontroller 1172 controls the delivery of
the one or more therapies using at least one signal of the plurality of signals
provided by PAP signal processor by isolation from the PAP signal received
from implantable PAP sensor 110.” Id. The signals isolated from the PAP
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signal by the PAP signal processor include various signal components. Id.
¶ 39. The “cardiac, respiratory, . . . signals are each isolated for direct and/or
indirect diagnostic[,] monitoring, and/or therapy-control uses. For example,
the one or more cardiac signals are indicative of cardiac performance
parameters such as stroke volume as well as heart failure (HF)
decompensation.” Id. ¶ 60.
Stahmann ’221 does not describe determining a PAP stability
parameter over multiple cardiac cycles. However, Wiesel discloses
“[d]etermin[ing] the presence of atrial fibrillation by (i) detecting the pulse
beat intervals over a short time period to determine whether the intervals
form a random, irregular pattern; (ii) determining whether this pulse beat
pattern indicates possible atrial fibrillation and then; (iii) communicating this
information to the user.” Wiesel ¶ 31. “One embodiment of the invention
uses pulse beats that are detected using an inflatable cuff device. The
inflatable cuff device may be a known apparatus used to measure blood
pressure.” Id. ¶ 50.
We agree with the Examiner that, based on the disclosures described
above, it would have been obvious to modify the apparatus of Stahmann ’221
to include isolating a signal for pulse beat intervals (over multiple cardiac
cycles) from its implantable PAP sensor. The references provide a reason to
do so, because Wiesel discloses that an irregular pulse beat interval can
indicate atrial fibrillation, and Stahmann ’221 discloses delivering
defibrillation therapy based on signals from its implantable PAP sensor.
Neither Stahmann ’221 nor Wiesel describe determining an amplitude-
based stability parameter based on PAP data. However, Moran discloses that
“[a]trial fibrillation causes an irregularly, irregular pulse. Not only will the
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rate of the pulse be irregular, but the pulse amplitude will also vary.” Moran
100, paragraph bridging the columns. Moran also teaches that pulse is related
to blood pressure: “The peak of th[e] arterial pulse is the systolic blood
pressure.” Id. at 98, left col.
Thus, it would have been obvious to modify the apparatus suggested by
Stahmann ’221 and Wiesel to include monitoring a signal for pulse amplitude
from the implantable PAP sensor of Stahmann ’221, because Moran discloses
that irregular pulse (i.e., blood pressure) amplitude is caused by atrial
fibrillation, and Stahmann ’221 discloses delivering defibrillation therapy
based on signals from its implantable PAP sensor. We agree with the
Examiner’s reasoning (Final Action 7) that a skilled artisan would expect that
using both timing stability and amplitude stability to diagnose atrial fibrillation
would be more accurate and reliable than using either parameter alone.
Appellants argue that “Stahmann [’221] describes an implantable
medical device that collects one type of physiologic data (i.e., pulmonary
artery pressure signals or PAP signals) from a sensor in a pulmonary artery.”
Br. 35. “Wiesel describes an external device that collects a different type of
physiologic data (i.e., blood pressure in an arm or other extremity). . . .
Moran describes general principles of arterial blood flow and discusses an
even further different type of physiologic data (i.e., aortic pressure).” Id.
Appellants argue that
[g]iven the differences, between Stahmann [’221], Wiesel and
Moran, in the types of physiologic data and the differences in
the parameter characteristics, it cannot legitimately be
maintained that the person of ordinary skill would pick and
choose varied combinations of parameter characteristics and
physiologic data types from the prior art.
Id.
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This argument is unpersuasive. As the Examiner found (Ans. 7),
Stahmann ’221 discloses administering defibrillation therapy based on
signals from an implanted PAP sensor, but does not disclose what
parameter(s) in the data are used to indicate a need for defibrillation therapy.
Wiesel and Moran disclose blood pressure parameters that are indicative of
atrial fibrillation (irregular beat intervals and irregular amplitude), and
therefore it would have been obvious to use the parameters disclosed by
Wiesel and Moran in the system of Stahmann ’221 to generate an indication
of atrial fibrillation (and a need for defibrillation therapy).
Appellants argue that “Stahmann [’221] locates the PAP sensor 110 in
the interior wall of the pulmonary artery. The pulmonary blood pressure
differs from the aortic blood pressure which differs from the blood pressure
in the arms and legs.” Br. 36. “Moran concerns aortic pressure pulses which
are a type of physiologic data that differs from the pulmonary artery pressure
data collected by Stahmann [’221]. . . . Moran does not discuss any parameter
characteristics or information that may be derived from pulmonary artery
pressure data, as measured by Stahmann [’221].” Id. at 38–39. “Wiesel’s
device monitors and analyzes physiologic data that is separate and distinct
from the physiologic data analyzed by Stahmann [’221] and Moran.” Id. at
39.
Appellants argue that “[a]rterial pressure data is not the same as
pulmonary artery pressure data.” Id. at 40. “The person of ordinary skill
would further understand that variation in an arterial pressure signal (e.g.
changes in pulse shape, pulse duration, pulse amplitude, etc.) does not dictate
that the same variation with necessarily occur in pulmonary artery pressure
signals.” Id. at 43. Similarly, Appellants argue that
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Moran explains a “cause – effect” relation between atrial
fibrillation (representing the cause) and changes in arterial
pressure pulses (representing the effect). This “cause – effect”
relation between atrial fibrillation (the cause) and arterial
pressure pulses (the effect), does not mean that the reverse is
true as an “effect – cause” relation between pulmonary artery
pressure pulses (representing the effect) and atrial fibrillation
(representing the cause). Specifically, Moran . . . concerns how
atrial fibrillation causes an aortic pressure signal to change. The
person of ordinary skill would understand that Moran[] . . . does
not teach or suggest an “effect – cause” relation between
changes in another type of physiologic signal (PAP signal) and
atrial fibrillation.
Id. With specific reference to claim 21, Appellants argue that,
[g]iven that the lungs and left ventricle are positioned between
the pulmonary artery and the aorta, one of ordinary skill would
recognize that the signals collected downstream from the aorta
would exhibit amplitude changes based on factors (e.g. behavior
of the left ventricle and downstream vascular system) that differ
from the factors that affect the amplitude of a pulmonary arterial
pressure signal.
Id. at 62–63.
These arguments are unpersuasive. As we understand it, Appellants’
position is that, although Wiesel and Moran teach that atrial fibrillation (AF)
causes certain characteristic changes in arterial blood pressure, a skilled
artisan would not have found it obvious to monitor pulmonary artery pressure
for the same characteristic changes, because arterial blood pressure and
pulmonary artery blood pressure are different types of data, and are obtained
from different parts of the vascular system.
However, we agree with the Examiner’s reasoning that “[w]hile . . .
absolute pressure values vary throughout the arterial vasculature, the stability
parameters taught or suggested by the prior art of record are indicative of
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relative variation within an arterial pressure signal obtained from a particular
location.” Ans. 8. That is, the vascular system is a closed system filled with
blood, so that the pressure changes caused by a heartbeat are propagated
through the entire system: “The contraction of the left ventricle ejects blood
from the heart into the aorta and the resulting pressure wave is detected as a
pulse in the arterial system.” Wiesel ¶ 10.
Thus, it is reasonable to expect that irregularities in timing or
amplitude, which are described by Wiesel and Moran as indicative of AF,
would be detectable in different parts of the vascular system as relative
differences in blood pressure, even if the absolute differences (between a
normal heart rhythm and fibrillation) were not the same in all places. This
expectation is supported by Wiesel, which teaches that pulse beats can be
monitored in a variety of ways, in a variety of locations, in order to detect the
irregularity that is diagnostic of AF. See Wiesel ¶ 30 (“Pulse beats may be
monitored by use of an inflatable cuff wrapped around a person’s appendage,
such as an arm.”), ¶ 36 (“Pulse beats may also be monitored through changes
in light transmitted through various body appendages.”), ¶ 37 (“Pulse beats
may be monitored using other plethysmographic devices, ultrasound devices
which measure arterial motion with each pulse beat, ultrasound doppler
devices which detect blood flow within an artery or devices that rely on
localized compression of the artery to detect the presence of a pulse beat.”).
Wiesel thus provides evidence that the same blood pressure-related
parameter can be effectively monitored in different parts of the vascular
system. In summary, the evidence supports the Examiner’s position that a
skilled artisan would have considered it obvious to monitor the types of blood
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pressure parameters disclosed by Wiesel and Moran using the PAP sensor
system of Stahmann ’221 in order to detect atrial fibrillation.
Appellants argue that
there is no indication in the prior art that the blood pressure cuff
of Wiesel could obtain sufficiently detailed information
regarding blood pressure to calculate an irregularity index based
on information other than beat to beat timing intervals. For
example, it would not be practical to attempt to utilize
morphology or amplitude information for blood pressure signals
as both types of information would be highly susceptible to
placement of the blood pressure cuff.
Br. 41.
This argument is unpersuasive, because the rejection is based on using
the PAP sensor system of Stahmann ’221 to monitor beat-to-beat timing,
based on Wiesel’s disclosure that timing can be used to diagnose AF, rather
than using Wiesel’s blood pressure cuff to monitor pulse morphology or
amplitude.
Appellants argue that “Wiesel does not teach or suggest to delivery
therapy based on any physiologic signal, or any parameter characteristic.
Wiesel does not delivery any type of therapy.” Br. 41. However, (a) the
rejection is based on Stahmann ’221, Moran, and Wiesel, not Wiesel alone,
and (b) Wiesel discloses the need “to detect the possible presence of atrial
fibrillation and communicate this condition to the user so that the user is
alerted to consult a medical practitioner for further testing and/or treatment.”
Wiesel ¶ 23 (emphasis added). Thus, Wiesel does suggest administering
defibrillation therapy upon detection of atrial fibrillation.
We affirm the rejection of claims 1 and 21 under 35 U.S.C. § 103(a)
based on Stahmann ’221, Wiesel, and Moran. Claims 7, 9, 11–15, and 19
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were not argued separately and therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(iv).
III
The Examiner has rejected 1–3, 7, 9, 11–15, 19, 20, and 22 as obvious
based on Stahmann ’221, Wiesel, and Galen. The Examiner relies on
Stahmann ’221 and Wiesel for the same teachings discussed above with
respect to the rejection based on Stahmann ’221, Wiesel, and Moran.
The Examiner finds that Galen discloses “process[ing] data indicative/
representative of [blood] pressure . . . to determine parameters comprising
cycle-to-cycle timing parameters . . . and per-cycle morphology parameters
. . . and generate an indication of atrial fibrillation based on stability/variation
(change) of the determined parameters.” Final Action 12–13.
The Examiner concludes that it would have been obvious to modify the
method and apparatus of Stahmann ’221 to determine “a morphology-based
stability parameter as taught and/or suggested by Galen,” in addition to the
timing parameter disclosed by Wiesel, “in order to account for additional
arterial (e.g., pulmonary) pressure parameters known to be indicative of atrial
fibrillation, thereby providing a more accurate/comprehensive assessment of
the condition on which to, e.g., base the initiation of therapy.” Id. at 13.
We agree with the Examiner that claim 1 would have been obvious to a
person of ordinary skill in the art based on the cited references. Galen
discloses that current pulse oximeters are unable to diagnose atrial
fibrillation. Galen ¶ 2. Galen states that an oximeter is typically placed on a
patient’s fingertip and senses absorption of light passing through the blood-
perfused tissue. Id. ¶ 21. “A signal representing light intensity versus time or
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a mathematical manipulation of this signal . . . may be referred to as the
photoplethysmograph (PPG) signal.” Id.
Galen discloses identifying heartbeat irregularities from a
transformation of a PPG signal. Id. ¶ 1. Galen’s Figure 5 is reproduced
below:

“FIG. 5 shows PPG signal 500 that may be analyzed in accordance
with [Galen’s] disclosure.” Id. ¶ 67. “PPG signal 500 is an oscillating signal
having pulses such as pulses 502. Each pulse of PPG signal 500 may
correspond to a cardiac cycle. PPG signal 500 has AC component 504, which
oscillates around baseline 540.” Id. “The size of AC component 504 may
correspond to the change in blood pressure at the sensor location (e.g., the
difference between systolic and diastolic pressure in the arteries).” Id. ¶ 70.
“Atrial fibrillation is characterized by erratic heart QRS intervals and
manifests itself in [a] PPG signal . . . as erratically varying amplitudes and
periods of the pulses.” Id. ¶ 93. “The signal processing system may use
various metrics to detect atrial fibrillation from [a] PPG signal. . . . In some
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embodiments, the signal processing system may characterize the amplitude,
timing, period, morphology, or any combination thereof of a pulse, pulses, or
absence thereof of [a] PPG signal.” Id. (emphasis added).
Thus, Galen suggests that atrial fibrillation can be detected based on
the morphology of a pulse, and discloses that AC component 504
corresponds to a change in blood pressure. The AC component affects the
morphology of a pulse (e.g., pulse 502 in Galen’s Figure 5). In view of these
teachings, it would have been obvious to modify the apparatus suggested by
Stahmann ’221 and Wiesel to include monitoring a signal for pulse
morphology from the implantable PAP sensor of Stahmann ’221, because
Galen discloses that atrial fibrillation can be detected based on pulse (i.e.,
blood pressure) morphology, and Stahmann ’221 discloses delivering
defibrillation therapy based on signals from its implantable PAP sensor.
Galen expressly suggests monitoring a combination of pulse characteristics to
detect atrial fibrillation, and we also agree with the Examiner (Final Action
13) that using both timing stability and morphology stability to diagnose
atrial fibrillation would be expected to be more accurate and reliable than
using either parameter alone.
Appellants “reiterate the arguments set forth above regarding the
deficiencies of Stahmann [’221] and Wiesel.” Br. 46. Those arguments are
unpersuasive for the reasons discussed above with respect to the rejection
based on Stahmann ’221, Wiesel, and Moran.
Appellants also argue that “Galen bases operation on yet another type
of physiologic data, namely photoplesmography [sic] (PPG) signals.” Br. 49.
“Galen analyzes a different type of physiologic data and bases the analysis on
a different parameter characteristic of the physiologic data, as compared to
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Stahmann [’221] and Wiesel. During atrial fibrillation, PPG signals exhibit
different behavior and traits as compared to pulmonary artery pressure (PAP)
signals.” Id.
Similarly, Appellants argue that “[p]ulse oximetry is not the same as
pulmonary artery pressure. The shape and behavior of pulse oximetry signals
are not the same as, and are not coextensive with, the shape and behavior of
pulmonary artery pressure.” Id. at 50. Appellants argue that a skilled artisan
would understand that “variation in a pulse oximetry signal (e.g. changes in
pulse shape, pulse duration, pulse amplitude, etc.) does not dictate that the
same variation will necessarily occur in pulmonary artery pressure signals.”
Id.
Appellants argue that
Galen explains a “cause – effect” relation between atrial
fibrillation (representing the cause) and changes in pulse
oximetry pulses (representing the effect). This “cause – effect”
relation between atrial fibrillation (the cause) and arterial
pressure pulses (the effect), does not mean that the reverse is
true as an “effect – cause” relation between pulmonary artery
pressure pulses (representing the effect) and atrial fibrillation
(representing the cause).
Id. Appellants argue that “[t]he general statements of Galen regarding a result
of atrial fibrillation does not afford any meaningful basis to replace
Stahmann’s particular analysis or Wiesel’s particular analysis with a new
hypothetical analysis.” Id. at 51. With specific reference to claim 22,
Appellants argue that “[o]ne of ordinary skill would recognize that the
signals collected by Galen’s pulse oximeter would exhibit morphology
changes based on factors that differ from the factors that affect the
morphology of a pulmonary arterial pressure signal.” Id. at 63.
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These arguments are unpersuasive because, as discussed above, the
evidence provided by the cited references supports the Examiner’s position
that “[w]hile . . . absolute pressure values vary throughout the arterial
vasculature, the stability parameters taught or suggested by the prior art of
record are indicative of relative variation within an arterial pressure signal
obtained from a particular location.” Ans. 8.
Both Galen and Wiesel disclose that a pulse oximeter can be used to
monitor changes in blood pressure. See Galen ¶ 70 (blood pressure changes
AC component of PPG signal); Wiesel ¶ 10 (ejection of blood from the heart
causes a pressure wave that is detected as a pulse), ¶ 36 (pulse beats can be
monitored by light transmitted through a body appendage). And Galen
discloses that changes in pulse morphology, from a PPG signal, can be used
to detect atrial fibrillation. Galen ¶ 93. Thus, a skilled artisan would have
considered it obvious to modify the PAP sensor system of Stahmann ’221 to
monitor a morphology-based stability parameter in order to detect atrial
fibrillation.
We affirm the rejection of claims 1 and 22 under 35 U.S.C. § 103(a)
based on Stahmann ’221, Wiesel, and Galen. Claims 7, 9, 11–15, and 19
were not argued separately and therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(iv).
IV
The Examiner has rejected claims 1–3, 7, 9, 11–15, 19, 20, and 23 as
obvious based on Stahmann ’221, Wiesel, and Chang. The Examiner relies
on Stahmann ’221 and Wiesel for the same teachings discussed above with
respect to the rejection based on Stahmann ’221, Wiesel, and Moran.
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The Examiner finds that Chang discloses that, “during atrial
fibrillation, a plurality of characteristic frequencies are observed within a
frequency spectrum.” Final Action 18. The Examiner concludes that it would
have been obvious to modify the method and apparatus of Stahmann ’221 to
determine “a frequency-based stability parameter as taught/suggested by
Chang,” in addition to the timing parameter disclosed by Wiesel, “in order to
account for additional arterial (e.g., pulmonary) pressure parameters known
to be indicative of atrial fibrillation, thereby providing a more accurate and/or
comprehensive assessment of the condition on which to, e.g., base the
initiation of therapy.” Id. at 18–19.
We agree with the Examiner that claim 1 would have been obvious to a
person of ordinary skill in the art based on the cited references. Chang
discloses a method of “analyzing the heart rhythm by utilizing a frequency
spectrum calculated by evaluating the electrical heartbeat signals on the basis
of a Fourier transformation.” Chang ¶ 2. One embodiment includes
measuring a plurality of electrical heartbeat signals; evaluating
the electrical heartbeat signals on the basis of a Fourier
transformation to calculate a frequency spectrum of the
electrical heartbeat signals; and counting a number of a
characteristic frequency within a frequency range of the
frequency spectrum to judge whether the heart rhythm is under a
condition of arrhythmia.
Id. ¶ 11.
Thus, it would have been obvious to modify the apparatus suggested
by Stahmann ’221 and Wiesel to include monitoring a signal for pulse
frequency from the implantable PAP sensor of Stahmann ’221, because
(a) Chang discloses that arrhythmia can be detected based on heartbeat
frequency, (b) “[a]trial fibrillation is one of the most common arrhythmias
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requiring medical attention” (Wiesel ¶ 8), and (c) Stahmann ’221 discloses
delivering defibrillation therapy based on signals from its implantable PAP
sensor. We also agree with the Examiner (Final Action 13) that using both
timing stability and morphology stability to diagnose atrial fibrillation would
be expected to be more accurate and reliable than using either parameter
alone.
Appellants “reiterate the arguments set forth above regarding the
deficiencies of Stahmann [’221] and Wiesel.” Br. 54. Those arguments are
unpersuasive for the reasons discussed above with respect to the rejection
based on Stahmann ’221, Wiesel, and Moran.
Appellants argue that
Chang discusses a different type of physiologic data, namely
electrical heart beat signals, and does not discuss pulmonary
artery pressure. Electrical heart beat signals are not the same as
pulmonary artery pressure. The shape and behavior of electrical
heart beat signals are not the same as, and are not coextensive
with, the shape and behavior of pulmonary artery pressure.
Br. 57. Appellants argue that a skilled artisan would understand that
“variation in an electrical heart beat signal (e.g. changes in signal shape,
duration, amplitude, etc.) does not dictate that the same variation will
necessarily occur in pulmonary artery pressure signals.” Id. “Chang does
not discuss ANY ‘cause – effect’ relation between atrial fibrillation
(representing the cause) and changes in electrical heart beat signals
(representing the effect).” Id.
With specific reference to claim 23, Appellants argue that “[o]ne of
ordinary skill would recognize that the signals collected by patient monitor
would exhibit frequency changes based on factors that differ from the factors
that affect the frequency of a pulmonary [sic].” Id. at 63.
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These arguments are unpersuasive because, as discussed above, the
evidence provided by the cited references supports the Examiner’s position
that “[w]hile . . . absolute pressure values vary throughout the arterial
vasculature, the stability parameters taught or suggested by the prior art of
record are indicative of relative variation within an arterial pressure signal
obtained from a particular location.” Ans. 8.
Here, Chang discloses that changes in heartbeat frequency can be used
to detect arrhythmia. Chang ¶ 11. Atrial fibrillation is a common type of
arrhythmia. Wiesel ¶ 8. Wiesel also discloses that a heartbeat causes ejection
of blood from the heart that results in a pressure wave that is detected as a
pulse. Id. ¶ 10.
Thus, a skilled artisan would have reasonably expected that changes in
heartbeat frequency that indicate atrial fibrillation (an arrhythmia) would be
detectable as changes in pressure throughout the vascular system, including
in the pulmonary arteries. It therefore would have been obvious to modify the
PAP sensor system of Stahmann ’221 to monitor a frequency-based stability
parameter, based on Chang, in order to detect atrial fibrillation.
We affirm the rejection of claims 1 and 23 under 35 U.S.C. § 103(a)
based on Stahmann ’221, Wiesel, and Chang. Claims 7, 9, 11–15, and 19
were not argued separately and therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(iv).
V
Appellants present separate arguments for claims 2, 3, and 20. Br. 60–
62. Appellants argue that
[t]he Final Office Action is absolutely silent as to which
limitations of claims 2 and 20 are taught by Stahmann [’221], or
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lacking in Stahmann [’221]. The Final Office Action provides
absolutely no basis or explanation for how or why the person of
ordinary skill would rely on Wiesel, Moran, Galen, and Chang,
individually or in any combination, to modify Stahmann [’221]
in some manner that renders obvious claims 2 and 20.
Br. 61.
Similarly, Appellants argue that
[t]he Final Office Action is absolutely silent as to which
limitations of claim 3 are taught by Stahmann [’221], or lacking
in Stahmann [’221]. The Final Office Action provides absolutely
no basis or explanation for how or why the person of ordinary
skill would rely on Wiesel, Moran, Galen, and Chang,
individually or in any combination, to modify Stahmann [’221]
in some manner that renders obvious claim 3.
Id. at 62.
We agree with the Examiner, however, that the rejection adequately
addresses claims 2, 3, and 20. See Ans. 15:
[T]he proposed modification to Stahmann ’221 is to process the
existing PAP signal to determine a timing-based stability
parameter indicative of cycle-to-cycle timing variation (as
taught/suggested by Wiesel) and at least one of an amplitude-
based stability parameter indicative of per-cycle amplitude
variation (as taught/suggested by Moran and Wiesel), a
morphology-based stability parameter indicative of per-cycle
morphology variation (as taught/suggested by Galen and Wiesel)
and a frequency-based stability parameter indicative of per-cycle
frequency variation (as taught/suggested by Chang and Wiesel);
[and] compare these parameters to respective thresholds to
identify atrial fibrillation (in the manner taught/suggested by
Wiesel), for the reasons noted above. This proposed
modification addresses each limitation of claims 2 and 3 [and
20].
We therefore affirm the rejection of claims 2, 3, and 20.
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VI
The Examiner has rejected claims 4–6 as obvious based on Stahmann
’221, Wiesel, Moran (or Galen or Chang), and Stegemann; claim 8 as
obvious based on Stahmann ’221, Wiesel, Moran (or Galen or Chang), and
Muessig; claim 10 as obvious based on Stahmann ’221, Wiesel, Moran (or
Galen or Chang), and Stahmann ’075; and claims 16–18 as obvious based on
Stahmann ’221, Wiesel, Moran (or Galen or Chang), and Ghanem.
Appellants have waived arguments addressed to Stegemann, Muessig,
Stahmann ’075, or Ghanem. Br. 64–65. We therefore affirm the rejection
under 35 U.S.C. § 103(a) of claims 4–6, 8, 10, and 16–18. 37 C.F.R.
§ 41.37(c)(1)(iv) (The Appeal Brief must contain “[t]he arguments of
appellant with respect to each ground of rejection.”); Hyatt v. Dudas, 551
F.3d 1307, 1314 (Fed. Cir. 2008) (“In the event of such a waiver, the PTO
may affirm the rejection of the group of claims that the examiner rejected on
that ground without considering the merits of those rejections.”).
SUMMARY
We reverse the rejection of claims 1–23 under 35 U.S.C. § 101.
We affirm all of the rejections 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