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`IPR2021-00971
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`U.S. Patent No. 10,595,731
`PATENT OWNER’S SUR-REPLY
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
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`APPLE, INC.,
`Petitioner,
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`v.
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`ALIVECOR, INC.,
`Patent Owner
`________________
`IPR2021-00971
`U.S. Patent No. 10,595,731
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`PATENT OWNER’S SUR-REPLY
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`IPR2021-00971
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`U.S. Patent No. 10,595,731
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`TABLE OF CONTENTS
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`B.
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`C.
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`Page
`INTRODUCTION ........................................................................................... 1
`I.
`THE BOARD SHOULD REJECT APPLE’S NEW EVIDENCE .................. 2
`II.
`III. THE PRIOR ART DOES NOT RENDER ARRHYTHMIA
`DETECTION OBVIOUS ................................................................................ 5
`A. AliveCor’s Expert Did Not Agree That The Prior Art Teaches
`Or Suggests Arrhythmia Detection ....................................................... 6
`Dr. Chaitman’s Shmueli Admissions Were Not Limited To
`Embodiments ......................................................................................... 7
`Apple Mischaracterizes AliveCor’s Arguments And Shmueli’s
`Disclosures ............................................................................................ 8
`Furthermore, Apple’s Positions Are Driven By Hindsight ................... 9
`Shmueli’s Disclosures Teach A POSITA That Its System Is
`Directed To Heart Attacks, Not Arrhythmias ..................................... 10
`1.
`There Is No Record Evidence To Contradict Dr. Efimov
`That “Irregular Heart Condition” Refers To Heart
`Attacks ...................................................................................... 11
`Apple Mischaracterizes AliveCor’s SpO2 Detection
`Arguments And Argues Against Yet Another Strawman......... 12
`Shmueli’s CO2 Detection Disclosures Plainly indicate to
`a POSITA that it is Directed To Heart Attacks ........................ 13
`Osorio Is Directed To Neurological Conditions, Not
`Arrhythmia .......................................................................................... 14
`IV. A POSITA WOULD NOT HAVE BEEN MOTIVATED TO
`COMBINE SHMUELI AND OSORIO ........................................................ 16
`SHMUELI DOES NOT RENDER OBVIOUS “CONFIRMATION” ......... 17
`V.
`VI. NONE OF THE CITED ART RENDERS OBVIOUS MACHINE
`LEARNING ALONE OR IN COMBINATION ........................................... 19
`1.
`Li 2012 Does Not Teach Using Machine Learning To
`Detect The Presence Of An Arrhythmia ................................... 21
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`D.
`E.
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`F.
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`2.
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`3.
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`2.
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`3.
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`A POSITA Would Not Have Combined Li 2012 With
`Shmueli/Osorio ......................................................................... 22
`Shmueli’s “Detection Parameters” Is Not Machine
`Learning .................................................................................... 24
`VII. ALIVECOR’S POSITA DEFINITION IS SUPPORTED BY THE
`RECORD EVIDENCE AND SHOULD BE ADOPTED ............................. 24
`VIII. CONCLUSION .............................................................................................. 26
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`INTRODUCTION
`Apple’s Reply asks this Board for a second bite at its Petition, abandoning its
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`I.
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`Petition positions by recasting its arguments and improperly submitting new
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`evidence. This new evidence includes both hearsay testimony from Dr. Stultz (its
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`ITC expert), as well as unauthenticated prior art references and other testimony cited
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`for the first time. Importantly, Dr. Stultz did not submit a declaration in this IPR.
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`Yet, Apple nevertheless heavily cites to Dr. Shultz’s out-of-court testimony in an
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`apparent attempt to rehabilitate its IPR expert (Dr. Chaitman), who is barely cited at
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`all in its Reply. Apple’s use of Dr. Stultz’s testimony is not only an improper attempt
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`to submit new evidence, it is impermissible hearsay, and AliveCor was not given an
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`opportunity to cross-examine him in this forum. His testimony, and any argument
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`based on that testimony, should be struck on that basis alone. So too should the other
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`additional new evidence submitted in Reply, which includes almost two dozen newly
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`added prior art references, expert reports from other proceedings, and testimony
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`transcripts, none of which was cited in the Petition. Just like Apple’s new expert
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`testimony, this new evidence was all improperly submitted for the first time on
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`Reply, and the record is devoid of any argument or evidence that any of it is authentic
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`or that they were in fact printed publications. It should all be struck, as should any
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`arguments based on that evidence.
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`Even if that evidence is not struck, it fails to establish unpatentability.
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`Tellingly, in many instances Apple does not address AliveCor’s arguments head on,
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`instead reading in teachings from the prior art’s general disclosures. Apple would
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`have this Board find that Shmueli’s teaching of the broad genus of irregular heart
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`conditions and Osorio’s teaching of the broad genus of pathological conditions are
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`both necessarily teachings of the species of arrhythmia. Yet Apple concludes so
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`without applying the proper legal framework that the prior art disclosures must be
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`viewed in context to ascertain what they teach to a POSITA. And as AliveCor
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`established in its Response, when the references are reviewed by the skilled artisan
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`in their entirety, it is clear that Shmueli is directed to techniques for detecting and
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`preventing heart attacks, while Osorio is directed to neurological conditions such as
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`seizures. The references’ disclosures are all in service of these broader contextual
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`purposes. Indeed, perhaps recognizing that the primary prior art references are
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`directed at non-analogous technical fields, Apple recasts its obviousness argument
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`to rely on Amano, a reference that is not part of the grounds.
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`II. THE BOARD SHOULD REJECT APPLE’S NEW EVIDENCE
`Apple submits almost two dozen new prior-art exhibits in its Reply, including
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`testimony from its ITC expert (Dr. Stultz) and multiple unauthenticated printed
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`publications. Both categories of new evidence should be rejected. With respect to
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`the new Stultz testimony—Exhibits 1081 (ITC expert report), 1082 (ITC
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`deposition), 1083 (ITC demonstratives), and 1072-1073 (ITC hearing testimony)—
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`it is untimely and submitted for the first time on Reply. Even if it was not untimely,
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`it should be rejected, it is hearsay. Yet despite these failings, Apple bases many of
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`its new Reply obviousness arguments on Dr. Stultz’s testimony. While these
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`arguments are substantively incorrect as discussed in more detail below, the Board
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`should give them and Dr. Stultz’s testimony zero weight as based on inadmissible,
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`untimely hearsay evidence. Fundamental fairness likewise demands that the
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`testimony be ignored, as Apple should have included this testimony in the Petition,
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`giving both the Board and Patent Owner the full opportunity to consider and rebut.1
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`Also problematic is Apple’s introduction of new “secondary” references to
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`bolster Shmueli’s lacking disclosure. In Section II.A.3 of the Reply, titled
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`“Secondary Evidence Also Reinforces The Petition,” Apple introduces additional,
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`new secondary references to support the proposition that “irregular activity,” as that
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`phrase is used in Shmueli, must refer to arrhythmia. See Reply at 8 (citing Exs.
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`1061, 1062, 1066, 1067, 1068). This evidence is untimely, should have been
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`1 As Apple is well-aware, the PTAB rules do not permit expert declarations on
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`Surreply.
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`submitted with the Petition, and constitutes a material change in obviousness
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`positions meriting a finding of nonobviousness. Shifting positions in reply is
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`prohibited by both the Trial Practice Guide, statute, and controlling Federal Circuit
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`precedent. See Wasica Finance GmbH v. Continental Automotive Sys., Inc., 853
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`F.3d 1272, 1286-87 (Fed. Cir. 2017) (citing 35 U.S.C. § 312(a)(3) (requiring
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`petitions to identify “with particularity ... the grounds on which the challenge to each
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`claim is based”); Trial Practice Guide, 77 F. Reg. 48,756, 48,767 (Aug. 14, 2012)
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`(prohibiting parties from submitting evidence necessary for a prima facie showing
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`of obviousness in a reply)). This admittedly “secondary” evidence is plainly new
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`and could have been cited in the Petition if necessary to support Apple’s prima facie
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`obviousness positions.
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`In addition to being improperly cited for the first time in Reply, most of
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`Apple’s reply evidence is hearsay—Exhibits 1065-1068, 1074-1080 and 1085 are
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`all alleged printed publications, which are being relied upon for the truth of the
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`matter asserted. They are hearsay, and Apple has not argued that any exceptions
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`apply. Moreover, there is no proof in the record (from, for example, a librarian)
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`establishing that any of these references are printed publications. They should thus
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`be given zero weight, as should the arguments upon which Apple relies on them in
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`support.
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`Apple’s other exhibits are equally problematic. Exhibits 1060-1064 are new
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`patents and patent publications—technical evidence with no substantiating expert
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`testimony. See, e.g., Gemtron Corp. v. Saint-Gobain Corp., 572 F.3d 1371, 1380
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`(Fed. Cir. 2009).
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`III. THE PRIOR ART DOES NOT RENDER ARRHYTHMIA
`DETECTION OBVIOUS
`The crux of Apple’s Reply is that the prior art teaches arrhythmia detection.
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`Apple, however, incorrectly minimizes AliveCor’s arguments and raises various
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`strawmen, all of which fail.
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`Apple primarily relies on Shmueli’s disclosure of irregular heart conditions.
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`Since arrhythmia is an irregular heart condition, Apple argues, Shmueli necessarily
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`discloses arrhythmia. Reply, 3. But it is well-settled that the disclosure of a broad
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`genus does not disclose “every species that is a member of that genus.” Atofina v.
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`Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). Shmueli does not
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`give any direction to a POSITA that would lead to the conclusion that arrhythmia is
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`one of the irregular heart conditions it detects. Resp., 42. Instead, Shmueli is
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`directed to heart attacks. See, e.g., Ex. 2016, ¶ 50. AliveCor submitted post-
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`institution evidence with its Response that the Board did not have the benefit of at
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`the pre-institution stage, plainly establishing that the disclosure of generic “irregular
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`heart conditions” does not disclose any and all conditions that may be considered
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`irregular. Id. Apple has failed to address that evidence or to address the proper legal
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`framework to determine when a genus may render a species obvious.
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`A. AliveCor’s Expert Did Not Agree That The Prior Art Teaches Or
`Suggests Arrhythmia Detection
`Dr. Efimov’s testimony does not “reinforce the Petition” as Apple suggests.
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`Reply, 3. Instead, Dr. Efimov’s testimony merely reinforced the undisputed
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`irregular heart condition/arrhythmia genus/species relationship. See Ex. 1069, 28:3-
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`24 (testifying that arrhythmia is a “subcategory” of irregular heart conditions). See
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`Atofina, 441 F.3d at 999.
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`Apple also claims Dr. Efimov incorrectly testified that “sinus tachycardia” is
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`“an indication of a neurological condition” because that testimony “contradicts
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`undisputed disclosures in the ’731 patent.” Reply, 4 n.1 (citing Ex. 1069, 58:1-2).
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`Apple is wrong. Dr. Efimov was plainly referring to Osorio’s disclosure of
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`“respiratory sinus arrhythmia” (Ex. 1005, [0043]), which he explained in his
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`declaration is not a cardiac arrhythmia, but is indicative of a neurological condition.
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`See Ex. 2016, ¶ 9. Respiratory sinus arrhythmia is not disclosed or discussed in
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`the ’731 patent. See Ex. 1001, Table 2 (discussing tachyarrhythmias and atrial
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`fibrillation).
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`B. Dr. Chaitman’s Shmueli Admissions Were Not Limited To
`Embodiments
`Apple cites to AliveCor’s introduction and claims that AliveCor cites no
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`evidence for its contentions that “Dr. Chaitman admitted that detection in Shmueli
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`is performed based on the SpO2 measurement and the SpO2 measurement only.”
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`Reply, 4. This argument is facially incorrect—AliveCor provided specific citation
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`later in its Response. Response, 51 (citing Ex. 2017, 87:19-88:13). Dr. Chaitman’s
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`testimony was unambiguous—Shmueli teaches “the detection of the irregular heart
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`conditions is using [] SpO2 measurements,” not ECG. Id.
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`Apple then raises a strawman: “[t]o the extent that AliveCor’s position is that
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`Shmueli’s detection of irregular heart conditions is based only on blood gas
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`composition measurements, Shmueli’s disclosure and Dr. Efimov’s testimony refute
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`it.” Reply, 5. That is not AliveCor’s contention. Rather, AliveCor’s position is that
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`Shmueli’s disclosure that PPG measurements include data, such as pulse rate, that
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`can be used to detect arrhythmia, is insufficient. Nothing in Shmueli indicates to a
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`POSITA that its pulse rate data is used to detect arrhythmias. Ex. 2016, ¶ 49.
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`Moreover, Shmueli mentions pulse rate exactly twice—everywhere else it refers
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`instead to SpO2 measurements. See id. As AliveCor established in its Response,
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`based on these scant disclosures, a POSITA would have understood Shmueli’s
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`irregular heart conditions to refer to those traditionally detected using SpO2
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`measurements, such as heart attacks. See id.; see also Response, 31.
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`C. Apple Mischaracterizes AliveCor’s Arguments And Shmueli’s
`Disclosures
`Apple argues that Shmueli’s disclosure of an “irregular heart condition” is
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`“intended to include all such new technologies a priori.” Ex. 1004, 16:3-5. Apple
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`claims AliveCor “tries to avoid this disclosure” which it calls an “expansive
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`definition.” Reply, 6 (citing Resp. 44 n.2). Whether this statement is definitional or
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`“expansive” or not is beside the point. First, this statement is merely aspirational,
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`and without more (i.e., supporting expert testimony or objective evidence), cannot
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`be used to conclude that the claims are obvious. Raytheon Techs. Corp. v. Gen. Elec.
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`Co., 993 F.3d 1374, 1376 (Fed. Cir. 2021) (in reversing a PTAB determination of
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`obviousness, finding “futuristic” or aspirational statements in the prior art without
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`supporting evidence could not support a finding obviousness).
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`Indeed, Apple takes an overbroad and unsubstantiated read of the Shmueli
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`disclosure. A prior art’s disclosure must enable the claimed invention to render a
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`patent’s claims obvious. Id. at 1377 (“[I]f an obviousness case is based on a non-
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`self-enabled reference, and no other prior art reference or evidence would have
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`enabled a skilled artisan to make the claimed invention, then the invention cannot be
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`said to have been obvious.”). Shmueli’s disclosure of the broad genus of detecting
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`“irregular heart conditions” using PPG does not enable the narrow species of
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`arrhythmia detection, which has unique technical challenges. See Ex. 2016, ¶ 69;
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`see also id., ¶¶ 13-18.
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`Moreover, Dr. Efimov’s testimony that a POSITA would never have
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`understood, from Shmueli’s generic and overly inclusive statement of “all such new
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`technologies” that Shmueli’s device could specifically be used for arrhythmia
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`detection, is unrebutted. Ex. 2016, ¶ 69; see also id. n.9 (addressing the “new
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`technologies” disclosure and testifying “[i]n my opinion a POSITA would not read
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`Shmueli this way.”). Here, Apple argues against another strawman, claiming
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`AliveCor interprets Shmueli to exclude arrhythmia. Reply, 9. Shmueli does not
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`expressly exclude arrhythmia, but it also doesn’t include it for the reasons just
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`discussed.
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`D.
`Furthermore, Apple’s Positions Are Driven By Hindsight
`Apple argues that because Shmueli teaches “measuring the ECG signal
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`associated with an intermittent irregular heart-related event,” and because the ’731
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`patent explains that arrhythmias can be intermittent and infrequent, that Shmueli
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`teaches arrhythmia. Reply, 7. In so doing, Apple uses the ‘731 patent disclosures as
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`a roadmap. This is of course impermissible. TQ Delta, LLC v. CISCO Sys., Inc.,
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`942 F.3d 1352, 1361 (Fed. Cir. 2019). Apple’s reasoning—that because the ’731
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`patent and Shmueli use similar language (“intermittent,” “continuously”), the ’731
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`patent and Shmueli must both relate to arrhythmia detection—is plainly hindsight
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`driven. See id. It is a transparent attempt to fit the square peg of Shmueli’s
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`disclosures into the round hole of the ’731 patent’s claims and should be rejected
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`Apple does not address AliveCor’s hindsight allegations in reply, instead
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`claiming AliveCor “simply rehashed generalized arguments from its Preliminary
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`Response.” Reply, 15. This is not the case as is clear from a review of the post-
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`institution record. As AliveCor has explained, Apple and its expert Dr. Chaitman
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`have incorrectly assumed, with no basis in the reference, that Shmueli’s “irregular
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`heart condition” refers to (or “encompasses”) arrhythmia. This is definitionally
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`hindsight—Apple is reading disclosures into the prior art in order to map that art to
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`the claims. See Grain Processing Corp. v. Am. Maize-Prods. Co., 840 F.2d 902, 907
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`(1988).
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`E.
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`Shmueli’s Disclosures Teach A POSITA That Its System Is
`Directed To Heart Attacks, Not Arrhythmias
`In Section II.B.1 of its Reply, Apple again inverts the inquiry. The question
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`is not whether the “irregular heart conditions” in Shmueli exclude arrhythmia—
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`Apple’s strawman—but instead whether Shmueli’s disclosures teach arrhythmia
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`detection to a POSITA. The Board’s decision in the ID that “the present record”
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`evidence “established” that “irregular heart conditions” “encompass[]” arrhythmia
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`is no longer pertinent—AliveCor submitted new evidence, in the form of expert
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`testimony, rebutting Apple’s allegations. See, e.g., Ex. 2016, ¶ 69. AliveCor
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`submits that the record evidence demonstrates Shmueli does not teach or suggest
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`detecting arrhythmias. Instead, it teaches a POSITA detecting heart attacks.
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`The Reply then purports to address AliveCor’s “three key arguments,”
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`claiming each “lacks evidentiary support.” Reply, 9. Apple mischaracterizes
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`AliveCor’s arguments and the record evidence and, furthermore, is wrong on the
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`law.
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`1.
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`There Is No Record Evidence To Contradict Dr. Efimov
`That “Irregular Heart Condition” Refers To Heart Attacks
`The evidence establishes that Shmueli’s broad, non-specific disclosure of a
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`broad category of “irregular heart conditions” does not convey arrhythmia detection
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`to a POSITA. See, e.g., Ex. 2016, ¶¶ 69-73. Instead, a POSITA reading Shmueli
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`would understand that its system is directed at detecting the types of diseases
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`traditionally detected using SpO2 measurements—heart attacks. Id. Apple’s expert
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`Dr. Chaitman has no response and, indeed, Apple has no expert testimony
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`contradicting AliveCor’s expert testimony that a POSITA would understand
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`Shmueli is directed to detecting heart attacks even if Dr. Stultz’s impermissible
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`testimony is considered. See Reply, 9-11.
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`In reply, Apple argues “irregular heart condition” being a genus and
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`arrhythmia a species supports Apple’s argument that Shmueli discloses arrhythmia
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`detection. Reply, 9. Apple gets this backwards. It is well established that the
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`disclosure of a genus in the prior art is not necessarily a disclosure of every species
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`that is a member of that genus. See, e.g., In re Baird, 16 F.3d 380, 382 (Fed. Cir.
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`1994). Thus, “[t]here may be many species encompassed within a genus that are
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`not disclosed by a mere disclosure of the genus.” Ex Parte Roorda, No. 2008-4699,
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`2009 WL 851420, at *3 (B.P.A.I. Mar. 27, 2009) (emphasis added). Here, as Apple
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`highlights in its Reply, AliveCor established “there are numerous other irregular
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`heart conditions,” including heart attacks. Ex. 2016, ¶ 69. Shmueli is not directed
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`to arrhythmias and its disclosure of a broad genus does not change that fact.
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`2.
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`Apple Mischaracterizes AliveCor’s SpO2 Detection
`Arguments And Argues Against Yet Another Strawman
`In Section II.B.1.b, Apple raises yet another strawman, alleging that AliveCor
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`“assumes no possible configuration for using SpO2 (PPG oximetry) measurements
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`for arrhythmia detection exists.” Reply, 10. This wholly mischaracterizes
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`AliveCor’s position, Dr. Efimov’s testimony, and the undisputed evidence. Apple
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`is correct that “PPG was a ‘suboptimal’ tool for measuring arrhythmias”—this was
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`conceded by Apple’s ITC expert and is beyond dispute. Ex. 2018 at 62:9-21.
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`Indeed, “suboptimal replacement” are Apple’s expert’s words. Id. It is indisputable
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`that the ECG P-waves are not present in a PPG measurement. Ex. 2016, ¶ 18. But
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`neither of these facts address the relevant issue—what would a POSITA have
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`understood Shmueli’s SpO2 measurement to be used for? The answer is detection
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`of myocardial infarctions, also known as heart attacks. Ex. 2016, ¶¶ 26-27. Apple
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`offers no rebuttal to this point.
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`More problematic, Apple once again resorts to modifying its prima facie
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`obviousness arguments using new references in a failed attempt to rebut AliveCor’s
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`arguments. Here, Apple expressly shifts its focus to a secondary reference called
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`Amano (Ex. 1020) which it argues “discloses an arrhythmia detecting apparatus with
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`a ‘pulse wave detecting means’” with a “wrist-worn device.” Reply, 10-11. As
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`already discussed above, this reference should be struck and Apple’s arguments
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`based on this reference ignored. But even if Apple’s arguments are considered, they
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`are simply irrelevant.
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`3.
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`Shmueli’s CO2 Detection Disclosures Plainly indicate to a
`POSITA that it is Directed To Heart Attacks
`Apple last argues that , that Shmueli’s CO2 measurements are “limited to
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`specific embodiments” and therefore should be disregarded. Reply, 14. This misses
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`the point. The point, as explained in AliveCor’s Response, is that CO2
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`measurements are understood by POSITAs to be used for heart attack detection and
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`not arrhythmia detection. Ex. 2016, ¶ 72. Whether CO2 is an alternative to SpO2 in
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`Shmueli is irrelevant, because it provides additional context to Shmueli’s
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`disclosures, further establishing that Shmueli is directed to detecting heart attacks.
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`Id.
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`F. Osorio Is Directed To Neurological Conditions, Not Arrhythmia
`Apple raises three flawed arguments in connection with Osorio: (1) Osorio’s
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`embodiments are non-limiting; (2) claim differentiation merits a finding that
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`pathological conditions include arrhythmia; and (3) Osorio describes arrhythmia
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`detection. Reply, 11-13. Apple is incorrect on all counts.
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`First, Apple is correct that Osorio uses illustrative evidence to describe its
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`embodiments. But this, again, misses the mark. Every example described in Osorio
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`as a “pathological condition” is a neurological condition. Ex. 2016, ¶¶ 69-72. And
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`in the one instance where Osorio teaches “cardiac arrhythmias,” it distinguishes
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`those arrhythmias from the pathological state, which it describes as a seizure. Ex.
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`1005, [0071] (“In one embodiment, the severity may be measured by a magnitude
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`and/or duration of a pathological state such as a seizure, a type of autonomic change
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`associated with the pathological state (e.g., changes in heart rate, breathing rate,
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`brain electrical activity, the emergence of one or more cardiac arrhythmias, etc.).”)
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`(emphasis added); Ex. 2016, ¶ 71.
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`Furthermore, as with Shmueli, Apple reads too much into Osorio’s generic
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`disclosure. Osorio’s “pathological conditions” do not enable arrhythmia detection.
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`See Raytheon, 993 F.3d at 1377 (“[I]f an obviousness case is based on a non-self-
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`enabled reference, and no other prior art reference or evidence would have enabled
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`a skilled artisan to make the claimed invention, then the invention cannot be said to
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`have been obvious.”). Osorio’s generic disclosure of “any pathological state” does
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`not enable arrhythmia detection, rather Osorio only addresses neurological, not
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`cardiac, conditions. See Ex. 2016, ¶¶ 74-79.
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`Second, Apple is wrong on the application of claim differentiation. While it
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`is true that “the presence of a dependent claim that adds a particular limitation gives
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`rise to a presumption that the limitation in question is not present in the independent
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`claim,” Phillips v. AWH Corp., 415 F.3d 1303, 1314-15 (Fed. Cir. 2005), Apple is
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`wrong to suggest that claim differentiation changes the outcome here. Osorio claim
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`7 recites that the “pathological body state is an epileptic event.” This does not
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`preclude AliveCor’s reading of Osorio—that the pathological states described in
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`Osorio are neurological, and not cardiological—since the broader independent claim
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`would include other neurological conditions. See Resp., 50-51.
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`Third, Apple is incorrect that Osorio “describes arrhythmia detection”—it
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`does not. AliveCor’s expert Dr. Efimov addressed each instance of Osorio’s
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`references to tachycardia and arrhythmia and explained how in every instance
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`Osorio described the pathological state as an epileptic event. Ex. 2016, ¶¶ 77-79.
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`Apple makes no effort to address Dr. Efimov’s testimony regarding Osorio’s
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`disclosures as being consistent with and teaching a POSITA that its system relates
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`to neurological conditions such as epilepsy and, as such, his opinions are unrebutted.
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`IV. A POSITA WOULD NOT HAVE BEEN MOTIVATED TO COMBINE
`SHMUELI AND OSORIO
`Apple erroneously asserts that AliveCor “does not dispute any of the
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`motivations to combine Shmueli and Osorio identified in the Petition.” Reply, 23.
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`This is untrue. In the Petition, Apple asserted that Osorio “describes the benefits …
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`of using activity level to detect an irregular heart condition.” Pet., 20. Apple asserts
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`that the combination would incorporate pathological events “e.g., arrhythmia” from
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`Osorio. Id. All of the Petition’s alleged motivations are based on the premise that
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`the two references disclose arrhythmias. See id., 20-31. Thus, by arguing that
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`neither Shmueli or Osorio disclose arrhythmia detection, AliveCor undercuts the
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`foundation for all of Apple’s motivations to combine the two references.
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`Despite Apple’s protestations, both Adidas and Nichia are on point. The
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`Shmueli/Osorio combination would “alter[ ] the principles of operation” of both
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`references, neither of which are directed to arrhythmia detection, so that neither
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`would work for its intended purpose, just as in Adidas. See Adidas AG v. Nike Inc.,
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`963 F.3d 1355, 1359 (Fed. Cir. 2020). The two references are fundamentally
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`different and a POSITA would not combine them. Id. And in Nichia, the Court
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`found no motivation to combine where the references disclosed “different structures,
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`resolve[d] dissimilar problems, and propose[d] dissimilar solutions.” Nichia Corp.
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`v. Everlight Ams., Inc., 855 F.3d 1328, 1340 (Fed. Cir. 2017). Shmueli and Osorio
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`resolve dissimilar problems—heart attacks in Shmueli and neurological conditions
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`in Osorio—using different solutions—SpO2 measurement in Shmueli and activity
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`level monitoring in Osorio. Ex. 2016, ¶¶ 47-58, 93-94.
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`V.
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`SHMUELI DOES NOT RENDER OBVIOUS “CONFIRMATION”
`AliveCor’s “confirmation” argument is straightforward and unrebutted:
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`(1) Apple’s expert admitted that irregular heart conditions are detected in Shmueli
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`using a continuous SpO2 measurement, not ECG (Ex. 2017, 87:19-88:13; Ex. 2016,
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`¶ 85); (2) Shmueli’s “detection parameters” are merely used to detect whether there
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`is a valid ECG waveform (Ex. 2017, 81:16-21; Ex. 2016, ¶ 85); and (3) ECG
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`detection following an SpO2 measurement is not confirmation (Ex. 2016, ¶ 83).
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`Apple’s arguments to the contrary are unavailing.
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`First, whether ECG is the gold standard for detecting heart conditions is
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`irrelevant; Shmueli improves on the prior art by providing an ECG that does not
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`have to be continuously wired, using SpO2 as the primary detection mechanism for
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`heart attacks. Ex. 2016, ¶ 85. Shmueli teaches detection using SpO2 even though it
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`is an inferior standard from ECG. Id. There is nothing in Shmueli to indicate
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`Shmueli uses the ECG to detect the same irregular heart condition as the SpO2
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`measurement, or to confirm the condition detected by the SpO2 measurement. Id., ¶
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`86. With no hook in the reference for confirmation, Apple’s continued assertion that
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`“a POSITA would have interpreted Shmueli as suggesting the obviousness of using
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`the gold standard ECG data to confirm the irregular heart condition” falls victim
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`once again to hindsight bias. See TQ Delta, 942 F.3d at 1361.
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`Second, Shmueli’s “correlation” of ECG and SpO2 measurements is used to
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`update detection parameters. Ex. 2016, ¶ 53. And those detection parameters are
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`merely used to detect the presence of an ECG signal. Id., ¶ 85. Apple’s expert
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`admitted as much. Ex. 2017, 81:16-21 (agreeing that “if you have detected that there
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`is a valid ECG waveform using the detection parameters in 44, you move up to the
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`top on the right….”). Here, Apple introduces a newly annotated version of Figure 7
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`of Shmueli found nowhere in the Petition. ’941 Reply, 22(offering the same
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`argument as ’731). AliveCor identified this flaw in Apple’s Petition in its Response.
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`Resp., 53-54. This is merely attorney argument. See Gemtron, 572 F.3d at 1380.
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`Third, Shmueli’s “continued monitoring of SpO2/PPG data after initiation of
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`ECG monitoring” is not “limited to specific embodiments” as Apple argues. Apple
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`18
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`does not identify a single embodiment in Shmueli in which the SpO2 measurement—
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`Shmueli’s focus—is not performed. Instead, Apple speculates, backed by no expert
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`testimony, that “the SpO2 measurement may stop in some embodiments” and that, if
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`it does, “ECG is the only measurement.” Reply, 16 (emphasis added). This is also
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`merely attorney argument. See Gemtron, 572 F.3d at 1380.
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`VI. NONE OF THE CITED ART RENDERS OBVIOUS MACHINE
`LEARNING ALONE OR IN COMBINATION
`Apple first argues that the machine learning dependent claims are “nothing
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`more than generic functional language that adds no inventive concept.” Reply, 18.
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`To the extent Apple is raising a claim construction argument, it has failed to
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`provide the proper legal analysis. Whether a term is functional depends on a rigorous
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`analysis, none of which Apple provides here. See, e.g., Nevro Corp. v. Boston
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`Scientific Corp., 955 F.3d 35, 39 (Fed. Cir. 2020). Apple’s “functional language”
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`attack on the machine learning claims should therefore be rejected. Indeed, these
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`terms are plainly not functional—the claims recite “a machine learning algorithm
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`trained to detect arrhythmias.” The claims themselves thus plainly recite structure,
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`which pl