Joseph Wiesel

Patent Trials and Appeals Board

Aug 12, 2021

IPR2020-01540 (P.T.A.B. Aug. 12, 2021)

Trials@uspto.gov Paper 17
571-272-7822 Date: August 12, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

APPLE INC.,
Petitioner,
v.
JOSEPH WIESEL,
Patent Owner.

IPR2020-01540
Patent 7,020,514 B1

Before JAMES A. TARTAL, FREDERICK C. LANEY, and
ALYSSA A. FINAMORE, Administrative Patent Judges.
FINAMORE, Administrative Patent Judge.
DECISION
Denying Petitioner’s Request on Rehearing of Decision Denying Institution
of Inter Partes Review
37 C.F.R. § 42.71(d)(2)

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I. INTRODUCTION
Apple Inc. (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting
an inter partes review of claims 1–10 and 12–21 of U.S. Patent
No. 7,020,514 B1 (“the ’514 patent”) (Ex. 1001). Pet. 1. Joseph Wiesel
(“Patent Owner”) filed a Preliminary Response (Paper 7). Thereafter, we
issued an Order (Paper 10) authorizing additional briefing addressing the
construction of the claim term “irregular.” Paper 10, 3. Pursuant to this
authorization, Petitioner filed a Reply (Paper 11), and Patent Owner filed a
Sur-reply (Paper 12).
On March 16, 2021, we issued a Decision denying institution of an
inter partes review (“Institution Decision”) (Paper 15, “Inst. Dec.”).1
Particularly, we found:
In view of the Specification’s description that “[w]henever the
term ‘irregular’ is used in this application it refers to this random
pattern of beats found almost exclusively in atrial fibrillation”
(Ex. 1001, 1:48–51), the patentee has acted as a lexicographer
and set out a clear definition of “irregular” as “this random
pattern of beats found almost exclusively in atrial fibrillation.”
Inst. Dec. 12. We applied the lexicographic definition of “irregular” in the
Specification, and construed the claim term “irregular” to mean a random
pattern of beats found almost exclusively in atrial fibrillation. Id. at 14.
With this construction, we found Petitioner failed to sufficiently identify, for
purposes of institution, the recited “irregular pulse rhythms” in either
Forstner or its proposed combination of Amano and Wilkinson, and, thus,
failed to demonstrate a reasonable likelihood that it would prevail with
respect to at least one of the challenged claims. Id. at 14–45.

1 This Decision on rehearing incorporates the Institution Decision, including
any abbreviations defined therein for citations to the record.
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Petitioner filed a Request for Rehearing (Paper 16, “Req. Reh’g”)
seeking reconsideration of the Institution Decision. For the reasons below,
we deny the Request for Rehearing.
II. ANALYSIS
When reconsidering a decision on institution, we review the decision
for an abuse of discretion. 37 C.F.R. § 42.71(c) (2019). An abuse of
discretion occurs if a decision is based on an erroneous interpretation of law,
if a factual finding is not supported by substantial evidence, or if the
decision represents an unreasonable judgment in weighing relevant factors.
Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold
P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203
F.3d 1305, 1315–16 (Fed. Cir. 2000). The party requesting rehearing bears
the burden of showing that the decision should be modified. 37 C.F.R.
§ 42.71(d). The party must identify specifically all matters we
misapprehended or overlooked, and the place where each matter was
previously addressed. Id.
Petitioner requests reconsideration for two reasons. Req. Reh’g 1.
First, Petitioner contends we misapprehended or overlooked its arguments
demonstrating the recited “irregular pulse rhythms” were in the prior art. Id.
(citing Pet. 2, 19–22, 40–42). Second, Petitioner contends we
misapprehended or overlooked its arguments regarding the recited
“determination of possible atrial fibrillation.” Id. (citing Pet. 15, 21, 42).
We address each of Petitioner’s contentions in turn below.
A. “irregular pulse rhythms”
Petitioner argues the Institution Decision “demands that the prior art
teach certain features representing ‘a random pattern of beats associated with
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Patent 7,020,514 B1
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atrial fibrillation’—features that are not even described, much less claimed,
in the ’514 patent.” Req. Reh’g 4. According to Petitioner, by imposing
requirements not described or claimed in the ’514 patent, we overlooked and
misapprehended Petitioner’s explanation of how the recited “irregular pulse
rhythms” are found in Forstner and Petitioner’s proposed combination of
Amano and Wilkinson. Id. (citing Pet. 9–12, 56–59).
1. Forstner
Petitioner maintains “the [Institution] Decision effectively requires
Forstner to have disclosed analysis of ‘the order’ of pulse beats.” Req.
Reh’g 4–5; see also Inst. Dec. 20 (finding Forstner’s distribution of pulse
time differences (“Tp”) represented as a histogram contemplates the number
of instances a pulse has a particular Tp, but not the order in which the
instances occurred). Petitioner argues that neither the plain language of the
claims, nor our construction of the recited “irregular pulse rhythms” as a
random pattern of beats found almost exclusively in atrial fibrillation,
requires analysis of the order of pulse beats. Id. at 5. Petitioner alleges the
Specification describes only one technique for detecting irregular pulse
rhythms, which does not analyze the order of pulse beats, but instead
compares the quotient of the standard deviation of the last ten beats over the
mean of these beats to a threshold value. Id. at 6 (citing Ex. 1001, 6:45–51).
Petitioner similarly alleges claims 2 and 3, which depend from independent
claim 1, embody this technique described in the Specification and therefore
confirm the “irregular pulse rhythms” recited in independent claim 1 do not
require consideration of the order of the pulse beats. Id. at 6–7. Petitioner
also contends we improperly credited Dr. Wiesel’s testimony, which,
according to Petitioner, is from an interested witness and is completely
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unsupported by corroborating evidence. Id. at 7. Furthermore, Petitioner
proffers reasons as to why Forstner’s Tp histogram shown in Figure 6
discloses the recited “irregular pulse rhythms,” including: the distribution
shown in the Tp histogram of Figure 6 is due to a kind of arrhythmia that
might be caused by atrial fibrillation (id. (citing Ex. 1004, 6:27–33));
applying the technique of comparing the quotient of the standard deviation
of the last ten beats over the mean to a threshold value as described in the
’514 patent to Forstner’s Tp histogram of Figure 6 would result in a
determination of possible atrial fibrillation (id. at 8 (citing Ex. 1001,
6:38–64)); and Bootsma, which the ’514 patent cites, describes using
histograms of R-R intervals to identify the randomness of heartbeat patterns
found in atrial fibrillation (id. (citing Ex. 1001, 1:45–48; Ex. 10152,
Summary, Figs. 2–5)).
We have considered Petitioner’s arguments and are unpersuaded that
we should modify our Institution Decision. At the outset, we disagree with
Petitioner that the Specification and claims 2 and 3 suggest a distinction
between the recited “irregular pulse rhythms,” which, in view of the
construction of “irregular,” require a random pattern of beats associated
almost exclusively with atrial fibrillation, and an analysis of the order in
which pulse beats having varying time intervals occur. In alleging such a
distinction, Petitioner confounds the detection and analysis of irregular pulse
rhythms with a definition of the recited “irregular pulse rhythms,” which are
detected and analyzed.

2 Bootsma et al., Analysis of R-R Intervals in Patients with Atrial
Fibrillation at Rest and During Exercise, 41 CIRCULATION 783 (1970)
(“Bootsma”) (Ex. 1015).
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The claimed invention detects and analyzes irregular pulse rhythms to
determine possible atrial fibrillation. Specifically, independent claim 1
recites a method of determining possible atrial fibrillation comprising the
steps of: (a) detecting irregular pulse rhythms from a succession of time
intervals between successive pulse beats; (b) analyzing the detected irregular
pulse rhythms to make a determination of possible atrial fibrillation;
and (c) indicating the possible atrial fibrillation. Id. at 7:30–39. The first
two steps of the claimed method recite “irregular pulse rhythms.” The first
step detects irregular pulse rhythms, and the second step analyzes the
detected irregular pulse rhythms to make a determination of possible atrial
fibrillation. Id. at 7:32–37.
Petitioner’s cited portion of the Specification describes detecting pulse
beats with a sphygmomanometer and analyzing the detected pulse beats by
comparing the quotient of the standard deviation over the mean to a
threshold value of 0.06 to diagnose atrial fibrillation. Ex. 1001, 6:39–64.
Although this portion may be silent as to the order of the pulse beats,
Petitioner fails to show this portion is a description of the recited “irregular
pulse rhythms,” which are detected and analyzed, rather than a description of
the detecting and analyzing steps.
Similarly, claims 2 and 3 further define the analysis of the recited
“irregular pulse rhythms,” not the recited “irregular pulse rhythms”
themselves. Claim 2 depends from independent claim 1, and claim 3
depends from claim 2. Ex. 1001, 7:40–48. Independent claim 1 recites, in
pertinent part, the step of “analyzing the detected irregular pulse rhythms to
make a determination of possible atrial fibrillation.” Id. at 7:36–37
(emphasis added). Claim 2 further defines the analyzing step as “wherein
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the analyzing includes ascertaining a mean and a standard deviation of the
succession of time intervals, the determination being based upon a quotient
formed by dividing said standard deviation by said mean and comparing the
quotient with a threshold value.” Id. at 7:40–44 (emphasis added). Claim 3
further prescribes the determination of the analyzing step as “wherein the
determination includes determining that the sequence of the pulse beats is
irregular in response to the quotient being greater than or equal to the
threshold value.” Id. at 7:45–48 (emphasis added).
The analysis of the detected irregular pulse rhythms recited in
claims 2 and 3 may not contemplate the order of the pulse beats.
Nonetheless, the analysis of the detected irregular pulse rhythms does not
define or otherwise describe the recited “irregular pulse rhythms.”
Regardless of whether there is any distinction between the recited
“irregular pulse rhythms,” which require a random pattern of beats
associated almost exclusively with atrial fibrillation, and an analysis of the
order of pulse beats with varying time intervals, Petitioner has not
demonstrated sufficiently, for purposes of institution, that Forstner’s Tp
histogram of Figure 6 discloses the recited “irregular pulse rhythms.” As we
explained in the Institution Decision, “[a] distribution of Tp, represented as a
histogram, contemplates the number of instances a pulse has a particular Tp.”
Inst. Dec. 20. We also explained Dr. Wiesel testifies that the distribution
of Tp shown in the histogram of Forstner’s Figure 6 can result from multiple
premature beats and do not form a random pattern of beats. Id. (citing
Ex. 2002 ¶ 40). With or without considering Dr. Wiesel’s testimony,
Petitioner has not demonstrated a person of ordinary skill in the art would
understand that Forstner’s Tp histogram discloses something more than a
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Patent 7,020,514 B1
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distribution of instances a pulse has a particular Tp, much less a random
pattern of beats found almost exclusively in atrial fibrillation.
In the Institution Decision, we acknowledged Forstner discloses the
distribution shown in the Tp histogram of Figure 6 is due to a kind of
arrhythmia that might be caused by atrial fibrillation, and we explained why
this affiliation between the distribution of Tp shown in the histogram of
Figure 6 and atrial fibrillation does not equate the Tp distribution to a
random pattern of beats found almost exclusively in atrial fibrillation, as the
recited “irregular pulse rhythms” require. Inst. Dec. 20–21. As we found in
the Institution Decision, “a diagnosis of atrial fibrillation is not the same as
the actual condition.” Id. at 21 (citing Ex. 1001, 2:18–3:32; Ex. 2002 ¶ 25).
Notably, the ’514 patent explains that the method and apparatus for
detecting atrial fibrillation described therein mitigates the misdiagnoses of
atrial fibrillation associated with conventional methods and apparatuses. See
Ex. 1001, 2:18–33 (describing that measuring pulse to determine atrial
fibrillation is inaccurate due to pulse deficit), 3:24–32 (describing that an
algorithm for detecting atrial fibrillation by the irregularity of the pulse beat
intervals may be affected by premature beats), 4:31–35 (“What is also
needed is a method that can differentiate an irregular pulse rate pattern from
a normal pulse rate pattern and from common heart rhythm patterns that are
not of significant risk, such as regular sinus rhythm, sinus arrhythmia, atrial
premature beats and ventricular premature beats.”).
In its Request for Rehearing, Petitioner argues, for the first time, that
Forstner’s Tp histogram shown in Figure 6 discloses the recited “irregular
pulse rhythms” because applying the technique of comparing the quotient of
the standard deviation of the last ten beats over the mean to a threshold value
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Patent 7,020,514 B1
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as described in the ’514 patent to Forstner’s Tp histogram of Figure 6 would
result in a determination of possible atrial fibrillation. This belated analysis
underscores the Petition’s lack of analysis regarding how Forstner’s Tp
histogram of Figure 6 discloses the recited “irregular pulse rhythms,” which
require a random pattern of beats found almost exclusively with atrial
fibrillation. Nonetheless, applying this technique to Forstner’s Tp histogram
of Figure 6 does not demonstrate persuasively, for purposes of institution,
that the Tp distribution shown in the histogram of Figure 6 represents a
random pattern of beats found almost exclusively with atrial fibrillation. As
we explain above, the Specification describes this technique in regard to the
analysis of detected pulse beats, which is not a description of the recited
“irregular pulse rhythms.”
Also for the first time in its Request for Rehearing, Petitioner relies on
Bootsma’s description of using histograms of R-R intervals to identify the
randomness of heartbeat patterns found in atrial fibrillation to support the
argument that Forstner’s Tp histogram shown in Figure 6 discloses a random
pattern of beats found almost exclusively with atrial fibrillation. Bootsma,
however, does not simply use histograms to identify the random nature of
heartbeat rhythms. Rather, Bootsma uses both serial autocorrelation
coefficients and R-R interval histograms. Ex. 1015, Summary (“Serial
autocorrelation functions and histograms of R-R intervals in patients with
atrial fibrillation, with and without digitalis, at rest and during exercise, were
produced by a computer.”), 3 (“From this tape an IBM 7094-II computer
finally produced 50 serial autocorrelation coefficients together with the
histogram of the R-R intervals.”), Figs. 2–5 (depicting both histograms and
autocorrelograms of R-R intervals). Moreover, in the Petition, Petitioner
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does not address, much less show, any correlation between Forstner’s Tp
histogram and Bootsma’s R-R interval histograms.
For these reasons, Petitioner has not persuaded us that, in the
Institution Decision, we misapprehended or overlooked its explanation of
how Forstner’s Tp histogram shown in Figure 6 discloses the recited
“irregular pulse rhythms,” which require a random pattern of beats found
almost exclusively in atrial fibrillation. Consequently, Petitioner has not
persuaded us to modify the Institution Decision, in which we found
Petitioner has not demonstrated sufficiently, for purposes of institution, that
Forstner’s Tp histogram of Figure 6 discloses the recited “irregular pulse
rhythms.”
2. Petitioner’s Proposed Combination of Amano and Wilkinson
Petitioner argues the Institution Decision “separately analyzes the
individual disclosures of Amano and Wilkinson in relation to [the]
construction of the recited ‘irregular pulse rhythms,’ and in doing so,
overlooks Petitioner’s arguments addressing the combination of these
references in demonstrating the recited ‘irregular pulse rhythms.’” Req.
Reh’g 9–10. According to Petitioner, the Institution Decision “strictly
focus[es] on time delays that occur ‘randomly’ and Amano’s alleged lack of
disclosure of this feature” and
overlooks the possibility that a pulse waveform that is irregular
in time and irregular in force (which, as explained in the Petition
would have been detectable by the Amano-Wilkinson
combination) represents “a random pattern of beats” since the
pulse waveform has varying pulse wave signal amplitudes and
varying pulse wave intervals.
Id. at 10.
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At the outset, it is not our purview to consider possibilities
unexplained in the Petition. Rather, in its Petition, Petitioner must identify,
with particularity, the ground on which the challenge to each claim is based.
See 35 U.S.C. § 312(a)(3) (requiring that a petition “identifies, in writing
and with particularity, each claim challenged, the grounds on which the
challenge to each claim is based, and the evidence that supports the grounds
for the challenge to each claim”); see also Harmonic Inc. v. Avid Tech., Inc.,
815 F.3d 1356, 1363 (Fed. Cir. 2016) (“In an [inter partes review], the
petitioner has the burden from the onset to show with particularity why the
patent it challenges is unpatentable.”). That notwithstanding, we disagree
with Petitioner that the Institution Decision does not consider whether a
pulse irregular in force and time represents a random pattern of beats.
Whether characterized as irregular in force and time, or as having a
waveform that varies in amplitude and in the time interval between beats,
such a pulse, without more, does not demonstrate persuasively a random
pattern of beats found almost exclusively in atrial fibrillation. See Inst.
Dec. 42 (“Wilkinson provides no further explanation of these irregularities
to teach or suggest that they are a random pattern of beats.”). Petitioner,
therefore, has not persuaded us that we misapprehended or overlooked its
arguments addressing how the combined teachings of Amano and Wilkinson
would have resulted in the recited “irregular pulse rhythms,” which require a
random pattern of beats found almost exclusively in atrial fibrillation.
B. “determination of possible atrial fibrillation”
Petitioner acknowledges the Institution Decision draws a distinction
between diagnosis of atrial fibrillation and actual atrial fibrillation, and
argues “[u]sing this distinction, the [Institution] Decision appears to reject
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Patent 7,020,514 B1
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the prior art as focusing on diagnosing atrial fibrillation, but not detecting
actual atrial fibrillation in the form of an associated random pattern of
beats.” Req. Reh’g 11–12. According to Petitioner, the Institution Decision
“misapprehends or overlooks Petitioner’s arguments that the independent
claims of the ’514 patent do not require detection of actual atrial
fibrillation.” Id. at 12. Petitioner also acknowledges the Specification draws
a distinction between a diagnosis of atrial fibrillation and actual atrial
fibrillation and describes a technique to mitigate misdiagnoses of atrial
fibrillation. Id. at 12–13. Petitioner maintains that the independent claims
do not recite this technique and instead recite a determination of possible
atrial fibrillation, and that dependent claims 11 and 22 encompass this
technique. Id. at 13. Petitioner further asserts the Specification recognizes
this technique does not always accurately detect atrial fibrillation. Id.
at 13–14 (citing Ex. 1001, 6:57–64).
We agree with the Petitioner that the independent claims recite a
determination of possible atrial fibrillation. As we explain above,
independent claim 1, for example, recites a method of determining possible
atrial fibrillation. Ex. 1001, 7:30–39. In particular, the first step detects
irregular pulse rhythms, and the second step analyzes the detected irregular
pulse rhythms to make a determination of possible atrial fibrillation. Id.
at 7:32–37. The claimed method detects and analyzes irregular pulse
rhythms to determine possible atrial fibrillation, but the patentee expressly
and unequivocally defined “irregular” as a “random pattern of beats found
almost exclusively in atrial fibrillation.” Thus, the claimed method requires
detecting and analyzing pulse rhythms having a random pattern of beats
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found almost exclusively in atrial fibrillation to determine possible atrial
fibrillation.
Although the claims recite possible atrial fibrillation, the recited
“irregular pulse rhythms” nonetheless require a random pattern of beats
found almost exclusively in atrial fibrillation. In the Institution Decision, we
did not reject the prior art for failing to disclose the recited “determination of
possible atrial fibrillation.” Rather, we found Petitioner has not shown
sufficiently, for purposes of institution, that the prior art discloses the recited
“irregular pulse rhythms,” which require a random pattern of beats found
almost exclusively in atrial fibrillation. See, e.g., Inst. Dec. 21 (“Petitioner’s
reliance on Forstner’s disclosure of detecting a wide variation in Tp to
diagnose atrial fibrillation does not establish that Forstner discloses the
recited ‘irregular pulse rhythms,’ which require pulse rhythms having a
random pattern of beats associated with atrial fibrillation.”).
In view of the foregoing, Petitioner has not persuaded us that, in the
Institution Decision, we misapprehended or overlooked its arguments that
the independent claims recite a “determination of possible atrial fibrillation”
and do not require detection of actual atrial fibrillation. Consequently,
Petitioner has not persuaded us to modify the Institution Decision, in which
we found Petitioner has not demonstrated sufficiently, for purposes of
institution, that the prior art discloses the recited “irregular pulse rhythms.”
III. CONCLUSION
After considering Petitioner’s arguments in its Request for Rehearing,
we conclude Petitioner has not demonstrated that we abused our discretion
in determining Petitioner failed to meet its burden to show a reasonable
likelihood that it would prevail with respect to at least one of the claims
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challenged in the Petition. Accordingly, we deny Petitioner’s request to
modify the Institution Decision.
IV. ORDER
In consideration of the foregoing, it is:
ORDERED that Petitioner’s Request for Rehearing is denied.

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For PETITIONER:
Walter Renner
Jeremy Monaldo
FISH & RICHARDSON P.C.
axf-ptab@fr.com
monaldo@fr.com

For PATENT OWNER:

Andrew Bochner
BOCHNER IP
andrew@bochnerip.com