`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`Before the Honorable Cameron R. Elliot
`Administrative Law Judge
`
`
`
`
`
`
`In the Matter of
`
`CERTAIN WEARABLE ELECTRONIC
`DEVICES WITH ECG FUNCTIONALITY
`AND COMPONENTS THEREOF
`
`
`
`
`
`
`Inv. No. 337-TA-1266
`
`
`
`APPLE’S DISCLOSURE OF INITIAL INVALIDITY CONTENTIONS
`IN RESPONSE TO INDIVIDUAL INTERROGATORY NOS. 19-21
`OF ALIVECOR’S FIRST SET OF INTERROGATORIES TO APPLE
`
`
`I.
`
`INTRODUCTION
`
`Pursuant to the Procedural Schedule set forth in Order No. 6, Respondent Apple Inc.
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`(“Apple”) hereby provides its initial invalidity contentions to Complainant AliveCor, Inc.
`
`(“AliveCor”) in response to Interrogatory Nos. 15, 19-21.
`
`Apple’s initial invalidity contentions address United States Patent Nos. 10,595,731 (“the ’731
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`patent”), 10,638,941 (“the ’941 patent”), and 9,572,499 (“the ’499 patent”) (collectively, the
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`“Asserted Patents”). AliveCor asserts the following claims are allegedly infringed by Apple: claims
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`1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 of
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`the ’731 patent; claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23;
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`claims 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 17, 18, 19, 20 of the ’499 patent (collectively, “the
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`Asserted Claims”).
`
`These contentions are Apple’s initial responses to AliveCor’s contention interrogatories
`
`regarding invalidity, including at least Interrogatory Nos. 19-21 of AliveCor’s first set of
`
`Interrogatories to Apple. Apple’s supplemental responses to AliveCor’s burden contention
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`interrogatories incorporate and attach these initial invalidity contentions in accordance with Order
`
`No. 6. See Apple’s September 10, 2021 Supplemental Objections and Responses to Complaint’s
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`First Set of Interrogatories (Nos. 15-16, 19-21) (served concurrently).
`
`II.
`
`GENERAL RESERVATIONS
`
`The contentions set forth below are initial contentions and provide notice to AliveCor of
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`Apple’s current invalidity theories, as required by the disclosure schedule in Order No. 6. Apple
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`reserves the right to revise or supplement these contentions in light of party and third-party
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`discovery, AliveCor’s forthcoming infringement contentions, any claim construction order issued by
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`the Administrative Law Judge, review and analysis by expert witnesses, and further investigation and
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`discovery regarding the defenses asserted by Apple. For example, Apple expressly reserves the right
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`to amend these contentions after review of AliveCor’s infringement contentions, after review of
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`AliveCor’s validity contentions, after the exchange of the parties’ claim construction briefing, after
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`issuance of a claim construction order, or in the event AliveCor provides any information that it
`
`failed to provide in its disclosures, including if AliveCor amends its disclosures in any way. Further,
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`because discovery is ongoing and the exchange of final burden contention interrogatory responses is
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`not until November 12, 2021, Apple reserves the right to revise, amend, and/or supplement the
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`information provided herein, including identifying other bases of invalidity based on the identified
`
`and charted references, and also charting and relying on additional references. Further, Apple
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`reserves its right to revise, amend, or supplement when AliveCor provides additional discovery.
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`Further, Apple reserves the right to revise its ultimate contentions concerning the invalidity of the
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`Asserted Claims, which may change depending upon further and ongoing investigation, the
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`construction of the Asserted Claims and/or positions that AliveCor or expert witnesses may take
`
`concerning claim construction, infringement, and/or invalidity issues.
`
`APPLE’S DISCLOSURE OF INITIAL
`INVALIDITY CONTENTIONS
`(337-TA-1266) – PAGE 2
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`Prior art not included in this disclosure, whether known or not known to Apple, may
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`become relevant later in the discovery period. In particular, Apple is currently unaware of the
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`extent, if any, to which AliveCor will contend that limitations of the Asserted Claims are not
`
`disclosed in the prior art identified by Apple. To the extent that such an issue arises, Apple reserves
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`the right to identify other prior art that would anticipate and/or render obvious the allegedly missing
`
`limitations of the claims, alone and/or in combination with identified or additional prior art.
`
`Further, Apple reserves the right to rely on any prior art or item sought or to be sought from third
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`parties that are within those third parties’ possession, custody, or control, and have not yet been
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`produced during discovery. Apple reserves the right to rely on any prior art found in the
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`prosecution histories of the applications leading to the Asserted Patents, identified on the covers of
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`the Asserted Patents, or otherwise identified in connection with this Investigation, including in
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`Apple’ Notice of Prior Art to be filed with the schedule set forth in Order No. 6. Apple also
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`reserves the right to rely on the prior art cited in its petitions for inter partes review of the Asserted
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`Patents (IPR2021-00970; IPR2021-00971; IPR2021-00972). Apple is not relying on the art cited in
`
`its petitions at this time given Apple’s stipulation not to do so, but intends to rely on such art in the
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`future in the event that the PTAB denies institution. See Letter from Amon to Counsel re
`
`Conditional Stipulation dated June 8, 2021.
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`To the extent that the following contentions reflect constructions of claim limitations
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`consistent with or implicit in AliveCor’s infringement allegations as set forth in the Complaint, no
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`inference is intended nor should any be drawn that Apple agrees with AliveCor’s infringement
`
`allegations or claim interpretations, and Apple expressly reserves the right to contest such
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`allegations. Apple intends to offer such contentions in response to AliveCor’s infringement
`
`allegations as set forth in the Complaint and without prejudice to any position that Apple may
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`ultimately take as to any claim construction issues. Nothing herein should be construed or
`
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`INVALIDITY CONTENTIONS
`(337-TA-1266) – PAGE 3
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`represented as evidence of any express or implied agreement with any of AliveCor’s claim
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`construction or infringement positions.
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`Apple intends to rely on admissions concerning the scope of the prior art relevant to the
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`Asserted Patents found in, inter alia: the Asserted Patents, related patents, and/or patent applications;
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`the patent prosecution histories for the Asserted Patents, related patents, and/or patent applications
`
`(including all prior art cited therein); any deposition testimony of the named inventors on the
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`Asserted Patents, related patents, and/or patent applications in this matter or any other matter;
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`evidence and testimony relating to the level of ordinary skill in the art; and the papers filed and any
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`evidence submitted by AliveCor in connection with this matter.
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`Apple’s claim charts cite to particular teachings and disclosures of the prior art as applied to
`
`features of the Asserted Claims. However, persons having ordinary skill in the art generally may
`
`view an item of prior art in the context of other publications, literature, products, and general
`
`understanding. As such, the cited portions are only examples, and Apple reserves the right to rely
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`on uncited portions of the prior art references and on other publications, expert testimony, and
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`evidence as aids in understanding and interpreting the cited portions, as providing context thereto,
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`and as additional evidence that the prior art discloses a claim limitation or any of the Asserted
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`Claims as a whole. Apple further reserves the right to rely on uncited portions of the prior art
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`references, other publications, and testimony, including expert testimony, to establish bases for
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`combinations of certain cited references that render the Asserted Claims obvious.
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`The references discussed in the claim charts may disclose the elements of the Asserted
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`Claims explicitly and/or inherently, and/or they may be relied upon to show the state of the art in
`
`the relevant timeframe. The suggested obviousness combinations are provided in addition to,
`
`and/or in the alternative to, Apple’s anticipation contentions and are not to be construed to suggest
`
`that any reference included in the combinations is not by itself anticipatory. The combinations of
`
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`INVALIDITY CONTENTIONS
`(337-TA-1266) – PAGE 4
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`prior art references referred to in these initial invalidity contentions are exemplary. Apple reserves
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`the right to rely on any combination of prior art references to the extent that such prior art
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`references are identified in Apple’s initial contentions or final contentions to be served in
`
`accordance with Order No. 6. The rationale or motivations to combine the prior art references
`
`identified in these initial invalidity contentions are also exemplary. As discovery is ongoing, Apple
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`reserves the right to amend or supplement the rationale or motivation to combine the prior art
`
`references identified in these initial contentions.
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`The following discussion and appendices provide exemplary prior art citations and
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`obviousness positions. The citations and discussion in the charts are organized by claim (and claim
`
`limitation) for convenience, but each limitation or claim section applies to the larger context of each
`
`claim, to any related dependent or independent claims, as well as all claims containing similar
`
`limitations or elements. For example, citations as to any recited limitation, step, or component in
`
`the claims apply wherever each such limitation, step, or component is repeated elsewhere in the
`
`claim or Asserted Patents. Where Apple cites to a particular drawing or figure in the attached claim
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`charts, the citation encompasses the description of the drawing or figure, as well as any text
`
`associated with the drawing or figure. Similarly, where Apple cites to particular text concerning a
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`drawing or figure, the citation encompasses that drawing or figure as well as any other text
`
`associated with the drawing or figure. Relatedly, certain portions of patent or other prior art
`
`disclosures build upon other disclosures, even if they are referred to as a separate or alternative
`
`embodiment. Thus, Apple’s citations to structures or functions incorporate by reference all
`
`disclosures to related structures or functions, including any additional detail provided as to the
`
`operation or design of those structures or functions.
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`Apple also reserves the right to challenge any of the claim terms herein under 35 U.S.C.
`
`§ 112 beyond the grounds outlined in their responses to interrogatories related to invalidity,
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`APPLE’S DISCLOSURE OF INITIAL
`INVALIDITY CONTENTIONS
`(337-TA-1266) – PAGE 5
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`including by arguing that they are indefinite, not supported by the written description, or not
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`enabled. Nothing stated herein shall be construed as a waiver of any argument available under 35
`
`U.S.C. §§ 101, 102, 103, and/or 112.
`
`III.
`
`PERSON HAVING ORDINARY SKILL IN THE ART
`
`A person having ordinary skill in the art (“PHOSITA”) at the time of the alleged invention
`
`in December 2013 (the alleged priority for the ’499 and ’731 patents) would have at least a bachelor
`
`of science in electrical engineering, mechanical engineering, biomedical engineering, computer
`
`science, or a related discipline, with at least two years of relevant work experience designing wearable
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`devices and/or sensors for measuring physiological signals or parameters of mammals. A greater
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`amount of education, i.e., a doctorate in electrical engineering, mechanical engineering, biomedical
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`engineering, computer science, or a related discipline with a focus on designing wearable devices
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`and/or sensors for measuring physiological signals or parameters of mammals would also qualify for
`
`the hypothetical person of ordinary skill in the art in lieu of fewer years of work experience.
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`Alternatively, a hypothetical person of ordinary skill in the art could also be a person with a medical
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`degree (MD or DO) and with at least two years of work experience using biomedical sensors and/or
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`analyzing their data (in the context of industry, in biomedical academic research, or in practice
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`treating patients). Additional relevant industry experience may compensate for lack of formal
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`education or vice versa. Notably, the definition for a PHOSITA would remain the same through
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`May 2015, the priority date of the ’941 patent.
`
`IV.
`
`IDENTIFICATION OF RELEVANT PRIOR ART
`
`Apple identifies the following prior art references that anticipate and/or render obvious the
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`Asserted Claims of the Asserted Patents. The following patents and publications are prior art under
`
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`INVALIDITY CONTENTIONS
`(337-TA-1266) – PAGE 6
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`at least 35 U.S.C. §§ 102(a) and/or (d).1 Whether a prior art reference anticipates or renders obvious
`
`the Asserted Claims may depend upon claim construction. Apple has identified each prior art patent
`
`by its inventor, title, number, country of origin, date of filing, date of issue, and, where applicable,
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`the relevant priority date. Each prior art publication is identified by its title, date of publication, and,
`
`where feasible, author and publisher.
`
`A.
`
`Priority Dates
`
`’499 patent: AliveCor contends the priority date for the ’499 patent is December 12, 2013.
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`(AliveCor Response to Interrogatory No. 15 (June 7, 2021)). However, none of the provisional
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`applications that the ’499 patent claims priority to contain enabling disclosure for asserted claim 1 or
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`11 of the ’499 patent. U.S. Patent Application No. 14/469,513 first contains disclosure for the
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`asserted patent claims, which was filed on December 12, 2014. AliveCor bears the burden of
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`showing on a claim-by-claim basis that it is entitled to a priority date earlier than December 12,
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`2014. AliveCor has not done so, including in any of its Interrogatory responses served to-date.
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`Nevertheless, Apple has used AliveCor’s alleged priority date of December 12, 2013 for purposes of
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`its initial invalidity contentions. Apple reserves the right to identify additional prior art references
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`which anticipate or make obvious the Asserted Claims of the ’499 patent based on resolution of the
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`priority date dispute.
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`’731 patent: AliveCor contends the priority date for the ’731 patent is December 12, 2013.
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`(AliveCor Response to Interrogatory No. 15 (June 7, 2021)). However, none of the provisional
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`applications that the ’731 patent claims priority to contain enabling disclosure for asserted claims 1
`
`or 25 of the ’731 patent. U.S. Patent Application No. 14/469,513 contains disclosure for the
`
`asserted patent claims, which was filed on December 12, 2014. AliveCor bears the burden of
`
`
`1 Unless otherwise indicated, all citations are to the post-AIA provisions of Title 35 of the U.S. Code.
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`INVALIDITY CONTENTIONS
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`showing on a claim-by-claim basis that it is entitled to a priority date earlier than December 12,
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`2014. AliveCor has not done so, including in any of its Interrogatory responses served to-date.
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`Nevertheless, Apple has used AliveCor’s alleged priority date of December 12, 2013 for purposes of
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`its initial invalidity contentions. Apple reserves the right to identify additional prior art references
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`which anticipate or make obvious the Asserted Claims of the ’499 patent based on resolution of the
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`priority date.
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`’941 patent: Based on the information reasonably available to Apple, the priority date for the
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`’941 patent is May 13, 2015, the filing date of related Application No. 62/161,092. AliveCor bears
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`the burden of showing on a claim-by-claim basis that it is entitled to a priority date earlier than May
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`13, 2015, including the filing date and description of the alleged inventions claimed in the ’941
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`patent in any earlier provisional application. AliveCor has not done so, including in any of its
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`Interrogatory responses served to date. (AliveCor Response to Interrogatory No. 15 (June 7, 2021)).
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`If AliveCor demonstrates that any of the Asserted Claims of the ’941 patent are entitled to a priority
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`date before May 13, 2015, then Apple reserves the right to identify additional prior art references
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`which anticipate or make obvious the Asserted Claims of the ’941 patent.
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`B.
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`Prior Art Patent Publications
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`Apple contends that the Asserted Claims are invalid under 35 U.S.C. §§ 102 and/or 103
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`based on the following prior art patent publications. These patent publications constitute prior art
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`under 35 U.S.C. § 102, and their patent numbers, countries of origin, and dates of publication
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`and/or issue are included on the face of those documents. Apple reserves the right to supplement
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`this list should it learn in the course of discovery of other prior art patent publications that would
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`anticipate and/or render the Asserted Claims obvious.
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`Apple hereby incorporates by reference the patent publications cited in its forthcoming
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`notice of prior art, which will be filed in accordance with the Procedural Schedule (Order No. 6),
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`INVALIDITY CONTENTIONS
`(337-TA-1266) – PAGE 8
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`and all patent publications identified on the face of the Asserted Patents, and any additional patent
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`publications identified herein.
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`C.
`
`Prior Art Non-Patent Publications
`
`Apple contends that the Asserted Claims are invalid under 35 U.S.C. §§ 102 and/or 103
`
`based on the following published works of prior art. These publications constitute prior art under
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`35 U.S.C. § 102, and their titles, authors, publishers, and dates of publication are included on the
`
`face of those documents. In addition to the references listed below, Apple hereby discloses as prior
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`art publications all references disclosed below in Section IV.D (regarding on sale/public use), such
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`as press releases, user manuals, and other related documentation about such prior art products.
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`Apple reserves the right to supplement this list as it learns in the course of discovery of other
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`references, prior art public use, and/or sale, which would anticipate and/or render the Asserted
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`Claims obvious.
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`Apple hereby incorporates by reference the non-patent publications cited in its forthcoming
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`notice of prior art, which will be filed in accordance with the Procedural Schedule (Order No. 6).
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`Apple reserves the right to rely on system art cited in its forthcoming Notice of Prior Art, as well as
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`any systems or documentation received in response to third party subpoenas.
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`C.
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`Prior Art Under 35 U.S.C. §§ 102(a) and 102(d)
`
`Because Apple has not yet completed discovery in this case, including but not limited to
`
`taking depositions of the named inventors of the Asserted Patents, reviewing AliveCor’s
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`productions, and seeking discovery of prior inventions by third parties, Apple reserves the right to
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`supplement this disclosure with facts, documents, or other information learned at a later point
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`through discovery or further investigation.
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`INVALIDITY CONTENTIONS
`(337-TA-1266) – PAGE 9
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`V.
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`STATEMENT OF ANTICIPATION AND OBVIOUSNESS
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`Apple contends that the prior art references identified in Apple’s contentions anticipate or
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`render obvious the Asserted Claims. Apple attaches Appendices A-1 to A-5; B-1 to B-5; and C-1 to
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`C5; which provide exemplary disclosures showing how the prior art anticipates and/or renders
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`obvious the Asserted Claims. The charts identify primary references, and in some cases, secondary
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`references and obviousness contentions.
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`A.
`
`Anticipation
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`Single items of prior art that anticipate the Asserted Claims are cited and described in the
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`claim charts attached hereto as Appendices A-1 to A-5; B-1 to B-5; and C-1 to C-5; each of which
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`describes anticipation of one or more claims of the Asserted Patents by a primary reference. These
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`claim charts provide citations to portions of the above references, illustrating how the prior art
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`explicitly discloses every element of the Asserted Claims. To the extent any element is not provided
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`by an expressly enabling disclosure by the referenced prior art, all elements of the Asserted Claims
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`would still be the inherent result of putting into practice the systems and methods described by the
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`prior art referenced herein.
`
`B.
`
`Obviousness
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`In addition to the discussion above, and to the extent not anticipated, the Asserted Claims
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`are invalid under 35 U.S.C. § 103 as being obvious to a person having ordinary skill in the art of the
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`relevant technology. Items of prior art that render obvious the Asserted Claims are cited to and
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`described in the claim charts attached hereto as Appendices A-1 to A-5; B-1 to B-5; and C-1 to C-5.
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`Apple also identifies exemplary secondary references and obviousness combinations in Appendices
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`A-1 to A-5; B-1 to B-5; and C-1 to C-5. In the event a particular primary reference identified in
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`Appendices A-1 to A-5; B-1 to B-5; and C-1 to C-5 does not anticipate one of the Asserted Claims,
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`the reference, alone or in combination with one or more of the exemplary secondary references
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`identified in any of the Appendices renders the claim obvious. The identification of certain
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`combinations of prior art does not exclude other combinations and is without prejudice to Apple’s
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`right to rely on additional specific combinations as well as to detail and explain such combinations.
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`In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized that
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`inventions arising from ordinary innovation, ordinary skill, or common sense should not be
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`patentable. Id. at 420–21, 427. A patent claim may be obvious if the combination of elements was
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`obvious to try or if there existed at the time of the invention a known problem for which there was
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`an obvious solution encompassed by the patent’s claims. When a work is available in one field of
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`endeavor, design incentives and other market forces can prompt variations of it, either in the same
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`field or a different one. If a person of ordinary skill can implement a predictable variation, Section
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`103 likely bars its patentability. Id. at 417. The Court stated that courts should “look to interrelated
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`teachings of multiple patents; the effects of demands known to the design community or present in
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`the marketplace; and the background knowledge possessed by a person having ordinary skill in the
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`art, all in order to determine whether there was an apparent reason to combine the known elements
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`in the fashion claimed by the patent at issue.” Id. at 418. KSR does not mandate evidence of a
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`motivation or suggestion to combine prior art references. See TGIP, Inc. v. AT&T Corp., 527 F.
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`Supp. 2d 561, 580-81 (E.D. Tex. 2007). “[A] court can take account of the inferences and creative
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`steps that a person of ordinary skill in the art would employ” to resolve the question of obviousness.
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`KSR, 550 U.S. at 418.
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`a. Combinations of References Detailed in Appendices
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`Based on all of these considerations, as further detailed in Appendices A-1 to A-5; B-1 to B-
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`5; and C-1 to C-5, a PHOSITA would have combined the teachings of the prior art references
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`identified and charted in the Appendices. The combinations of these references would have
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`rendered obvious to a PHOSITA the subject matter of the Asserted Claims. The references
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`identified in Appendices A-1 to A-5; B-1 to B-5; and C-1 to C-5 are analogous prior art to the
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`subject matter of the Asserted Claims and, for at least the reasons set forth below, are properly
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`combinable. Because these prior art references exist within a single field of art, particularly one in
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`which individuals in the field often shared and/or collaborated on their work, it would have been
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`obvious for a PHOSITA to look from one piece of prior art to another in order to find any missing
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`functionality they desired to implement. Therefore, these references provide interrelated teachings
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`and a PHOSITA would look to the concepts in any of these references when seeking to solve the
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`problems purportedly addressed by the Asserted Patents. It would have been within the ability of a
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`PHOSITA to combine any of the references identified in Appendices A-1 to A-5; B-1 to B-5; and
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`C-1 to C-5. A PHOSITA would have a reasonable expectation of success combining any of the
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`references identified in A-1 to A-5; B-1 to B-5; and C-1 to C-5 because it only involves the
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`predictable use of prior art elements according to their established functions.
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`In addition, it would have been obvious to combine any of the prior art in Appendices A-1 to
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`A-5; B-1 to B-5; and C-1 to C-5 because all of these references relate to well-known devices and
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`methods for monitoring physiological parameters to identify and diagnose arrhythmias, among other
`
`things.
`
`As an example, U.S. Patent Publication No. 2011/0245633 to Robert Goldberg and
`
`Shailendra Yadav (hereinafter, “Goldberg”) entitled “Devices and Methods for Treating
`
`Psychological Disorders” discloses, “all-in-one” wearable biosensors, systems, and methods for
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`“detecting, diagnosing, monitoring, and treating a psychological condition based on physiological
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`parameters specific to the wearer and detected by the device.” Goldberg at [00002], [0022]. The
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`device, which is “preferably adapted for wearing around a wrist,” “triggers real-time psychological
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`treatments based on personalized estimates of the wearer stored on the biosensor device.”
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`Goldberg at [0035]; Abstract. Moreover, it describes “a therapeutic stimulus” that is “selected from
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`a library based on the data received from the wearable biosensor device and relating to psychological
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`condition(s), and that stimulus is delivered to the wearer via an associated display.” Goldberg at
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`[Abstract]. Such physiological conditions include cardiac conditions of a user, including, among
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`other things, arrhythmia, heart rate, and heart rate variability of a user, through the use of heart rate
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`sensors that measure ECG and PPG. See, e.g., Goldberg at [0056], [0062]-[0063]. The activity level
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`of the user is tracked using a “motion sensor” (Goldberg at [0065]), and through the use of the
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`wearable biosensor device, Goldberg describes “comparing real-time data to the stored personalized
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`profile of the wearer.” Goldberg at [0080]. Goldberg “alerts” a user of an “impending symptomatic
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`event,” based on physiological data in the wearer’s stored profile, and provides instructions to a user
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`to take further action. See, e.g., Goldberg at [0010].
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`As another example, and without limitation, it would have been obvious to a PHOSITA to
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`combine the teachings of Goldberg with U.S. Patent Publication No. 2011/0270048 (hereinafter,
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`“Addison”). Goldberg and Addison are in the same field of endeavor. Addison discloses an
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`invention “for using photoplethysmograph[y] (PPG) and electrocardiographic (EKG)-based
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`readings of a subject to determine one or more physiological characteristics of the
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`subject.” Addison at Abstract. Specifically, Addison discloses a monitoring system that “determines
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`an auxiliary parameter based at least in part on the detected EKG signal,” which “may be an
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`indicator of the presence of an arrhythmia condition in the subject.” Addison at [0004].
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`Thus, a PHOSITA would be motivated to collect and analyze a subject’s physiological data,
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`such as the activity level, ECG and PPG data, using the wearable biosensor device disclosed by
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`Goldberg to confirm the presence of an arrhythmia condition in the subject, as disclosed by
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`Addison. It would have been within the ability of a PHOSITA to combine them. A PHOSITA
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`would have a reasonable expectation of success combining Goldberg with Addison because doing
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`APPLE’S DISCLOSURE OF INITIAL
`INVALIDITY CONTENTIONS
`(337-TA-1266) – PAGE 13
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`so in November 2013 would have only involved the predictable use of prior art elements according
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`to their established functions.
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`As another example, and without limitation, it would have been obvious to a PHOSITA to
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`combine the teachings of Goldberg with U.S. Patent No. 4,802,486 (hereinafter,
`
`“Goodman”). Goldberg and Goodman are in the same field of endeavor. Specifically, Goodman
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`discloses “A method and apparatus for measuring and correlating a patient's heart activity with
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`optical detection of the patient's blood flow.” Goodman at Abstract. Goodman further discloses
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`that an advantage of the invention is the improved oximeter, which “has improved capability to deal
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`with arrhythmias. . . .” Id. at 6:66-7:5.
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`Thus, a PHOSITA would be motivated to use the wearable biosensor device disclosed by
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`Goldberg to collect and correlate a subject’s physiological parameters, such as the activity level,
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`ECG and PPG signals, to sense and confirm the presence of arrhythmia, as disclosed by
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`Goodman. It would have been within the ability of a PHOSITA to combine them. A PHOSITA
`
`would have a reasonable expectation of success combining Goldberg with Goodman because doing
`
`so in November 2013 would have only involved the predictable use of prior art elements according
`
`to their established functions.
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`As another example, and without limitation, it would have been obvious to a PHOSITA to
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`combine the teachings of Goldberg with the teachings of U.S. Patent No. 8,478,418 to Michael
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`Fahey (hereinafter, “Fahey”) entitled “Remote Health Monitoring System.” As an example, Fahey
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`discloses “methods and apparatus” that are “disclosed for locally collecting and locally storing
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`physiologic data from an ambulatory patient, wirelessly sending only a proper subset of the collected
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`data to a remote central server and there automatically analyzing the sent data in real time.” Fahey at
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`6:36-42. Fahey discloses a “two-tiered analysis,” in which the system performs a high-sensitivity but
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`low-specificity analysis, to detect a possible arrhythmia, and then analyzes data retrospectively, to
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`APPLE’S DISCLOSURE OF INITIAL
`INVALIDITY CONTENTIONS
`(337-TA-1266) – PAGE 14
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`confirm the suspected arrhythmia. Id. at 6:43-53. Fahey discloses the use of accelerometers and
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`“ECG data, non-ECG data, or a combination of thereof,” to verify an arrhythmia. Id. at 13:5-10.
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`Thus, a PHOISTA would have been motivated to combine the teachings of Goldberg and
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`Fahey, given that they are in the same field or endeavor: both describe wearable devices and
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`methodologies for collecting physiological data from the user and using such information to
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`diagnose, detect, and/or monitor the user’s physiological characteristics, including, among other
`
`things, cardiac conditions. A PHOSITA would have been motivated to combine Goldberg’s
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`wearable biosensor, capable of measuring a user’s activity level, heart rate variability, and ECG of a
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`user, with the methods and systems described in Fahey, which uses cardiac data such as heart rate
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`variability and ECG data, to confirm the presence of an arrhythmia. It would have been within the
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`ability of a PHOSITA to combine them. A PHOSITA would have a reasonable expectation of
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`success combining Goldberg with Fahey because doing so in November 2013 would have only
`
`involved the predictable use of prior art elements according to their established functions.
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`As another example, U.S. Patent No. 7,974,689 to Shane Volpe, John Macho, Wade Braden,
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`Thomas Kalb, and Marshal Linder (hereinafter, “Volpe”), entitled “Wearable Medical Treatment