throbber
Trials@uspto.gov
`571-272-7822
`
`Paper 10
`Date: December8, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APPLE,INC.,
`Petitioner,
`
`V.
`
`ALIVECOR,INC.,
`Patent Owner.
`
`IPR2021-00971
`Patent 10,595,731 B2
`
`Before ROBERT A. POLLOCK, ERIC C. JESCHKE,and
`DAVID COTTA,Administrative Patent Judges.
`
`POLLOCK,Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`A. Background
`
`I.
`
`INTRODUCTION
`
`Apple, Inc. (‘Petitioner’) filed a Petition for an inter partes review of
`
`claims 1-15 of U.S. Patent No. 10,595,731 B2 (“the ’731 patent,” Ex. 1001).
`
`Paper2 (‘“Pet.”). AliveCor, Inc. (“Patent Owner’’) timely filed a Preliminary
`
`Response. Paper6. (“Prelim. Resp.”). Petitioner further filed an authorized
`
`Reply to the Preliminary Response (Paper7, “Prelim. Reply’’); Patent Owner
`
`filed a responsive Sur-reply (Paper8, “Prelim. Sur-reply”).
`
`B. Summary ofthe Institution Decision
`
`For the reasons provided below,Petitioner has satisfied the threshold
`
`requirementset forth in 35 U.S.C. § 314(a). Because Petitioner has
`
`demonstrated a reasonable likelihood that at least one claim of the ’731
`
`patent is unpatentable, we institute an inter partes review ofall challenged
`
`claims on each of the Groundsraisedin the Petition. See 37 C.F.R.
`
`§ 42.108(a) (2021) (“Wheninstituting inter partes review, the Board will
`
`authorize the review to proceed onall of the challenged claims and onall
`
`grounds of unpatentability asserted for each claim.”).
`
`C. Real Parties-in-Interest
`
`Petitioner identifies itself, Apple Inc., as the real party-in-interest. Pet.
`
`88. Patent Owner, identifies itself, AliveCor, Inc., as the real party-in-
`
`interest. Paper4, 2.
`
`D. Related Matters
`
`According to Patent Owner:
`
`U.S. Patent No. 10,595,731 has been asserted by Patent
`Owneragainst Petitioner in AliveCor, Inc. v. Apple, Inc., Case
`No. 6:20-cv-01112-ADA,filed in the United States District
`
`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`Court for the Western District of Texas, and in Investigation
`No. 337-TA-1266 before the International Trade Commission,
`In the Matter ofCertain Wearable Electronic Devices with
`ECG Functionality and Components Thereof. Apple also filed
`IPR petitions against the other patents asserted in those actions:
`IPR2021-00970 (USP 9,572,499) and IPR2021-00972 (USP
`10,638,941).
`Paper4, 2; see Pet. 88. We refer to the abovelitigations as the “Texas
`
`Litigation” and the “ITC Investigation,” respectively. See Pet. 81-82. We
`
`further note that the ’731 patent at issue here is related by a chain of
`
`continuation applications to Application No. 14/730,122, which issued as
`
`U:S. Patent No. 9,572,499 (“the ’499 patent), challenged in IPR2021-00970.
`
`See Ex. 1001, code (63); Prelim. Resp. 4. As such, the ’731 and ’499 patents
`
`share substantially the same specification.
`
`The ’731 patent claimspriority to, inter alia, a series of provisional
`
`applications filed between December 12, 2013, and June 19, 2014. Ex. 1001,
`
`code (60); see Prelim. Resp. 4; Pet. 2 & nn. 1-3. Petitioner contends, and
`
`Patent Ownerdoes not presently contest, that the claims of the ’731 patent
`
`are not entitled the benefit of the earliest of those applications such that the
`
`critical date is March 14, 2014,the filing date of provisional application No.
`
`61/953,616. Pet. 2-3; Prelim. Resp. 4. For the purposeof institution, we
`
`need not determine whether the challenged claimsare entitled to the benefit
`
`of the earliest filed provisional application. Accordingly, and solely for
`
`purposesof this decision we apply March 14, 2014,as the critical date.
`
`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`E. Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds of unpatentability (Pet. 1):
`
`ClaimsChallenged_|35 U.S.C §
`1, 7, 12, 13, 16, 17,
`§ 103 -
`
`
`In support ofits patentability challenge, Petitionerrelies on, inter alia,
`the Declaration of Dr. Bernard R. Chaitman, M.D. Ex. 1003. Patent Owner
`similarly relies on the Declaration of Dr. Igor Efimov, Ph.D. Ex. 2001.
`
`
`
`1
`
`7
`
`3
`
`1,2, 4, 7, 12-14, 16-18,
`20, 23-26, 30
`3, 5, 6, 19, 21, 22
`
`4
`5
`
`8-11, 27-29
`
`15
`
`§ 103
`
`§ 103
`.
`§ 103
`
`§ 103
`
`Shmueli, Osorio?
`
`Shmueli, Osorio,
`Li
`Shmueli, Osorio,
`ard
`Kleiger
`Shmueli, Osorio,
`Chan?
`
`
`
`
`
`
`
`
`F. The ’731 Patent and Relevant Background
`
`The ’731 patent relates to medical devices, systems, and methods for
`
`detecting cardiac conditions, including cardiac arrhythmias. Ex. 1001, 1:29-
`
`33, 2:17—25. In general:
`
`In response to the continuous measurement andrecordation of
`the heart rate of the user, parameters such as heart rate (HR),
`‘ heart rate variability (R-R variability or HRV), and heart rate
`
`1WO2012/140559, publ. Oct. 18, 2012. Ex. 1004.
`2 U.S. 2014/0275840, publ. Sept. 18, 2014. Ex. 1005.
`3 Li Q, Clifford GD, “Signal quality and datafusionforfalse alarm
`reduction in the intensive care unit,” 45(6) J Electrocardiol. 596-603 (2012).
`(“Li” or “Li-2005”) Ex. 1006.
`* Kleiger RE, Stein PK, “Bigger JT Jr. Heart rate variability: measurement
`andclinical utility.” 10(1) Ann Noninvasive Electrocardiol. 88-101 (2005).
`(“Kleiger” or “Kleiger-2005”) Ex. 1033. -
`> U.S. Pat. No. 7,894,888, publ. Feb. 22, 2011. Ex. 1048.
`
`4
`
`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`turbulence (HRT) may be determined. These parameters and
`further parameters may be analyzed to detect and/or predict one
`or moreofatrial fibrillation, tachycardia, bradycardia,
`bigeminy, trigeminy, or other cardiac conditions.
`Id. at 2:57-64; see id. at 18:52-63 (Table2, listing atrial fibrillation, sinus
`
`and supraventricular tachycardias, bradycardia, bigeminy, and trigemini
`
`amongthe types of arrhythmias).
`
`According to Dr. Chaitman, “HRV analysis is an important tool in
`
`cardiology to help diagnose various types of arrhythmia.” Ex. 1003 435.
`
`“HRV is defined as the variation of RR intervals with respect to time and
`
`reflects beat-to-beat heart rate (HR) variability,” and “can be accurately
`
`determined based on either ECG data or PPG data.” Id. J] 35-36. With
`
`respect to the former, this involves measuring RR intervals. Jd. J 29. “An R-
`
`R interval represents a time elapsed between successive R-waves of a QRS
`
`complex of the ECG that occur between successive heart beats.” Jd. “If the
`
`RR intervals over a time period are close to each other in value, then
`
`ventricular rhythm is understoodto be ‘regular.’ In contrast, if there are
`
`significant variations in the RR intervals over a time period, then the
`
`ventricular rhythm is understood to be ‘irregular.’” Jd. § 37 (citations
`
`omitted).
`
`The Specification explains that during cardiac arrhythmia, “the
`
`electrical activity of the heart is irregular or is faster (tachycardia) or slower
`
`(bradycardia) than normal,” and in some forms, “can cause cardiac arrest
`
`and even suddencardiac death.” Ex. 1001, 1:40-44. According to the
`
`Specification, although the most commoncardiac arrhythmia,atrial
`fibrillation, may cause no symptoms,it is associated with palpitations,
`shortness of breath, fainting, chest pain, congestive heart failure, as well as
`
`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`atrial clot formation, which can lead to clot migration andstroke.Jd. at
`
`1:44-51.
`
`The Specification discloses body-worn devices for detecting the
`occurrence of arrhythmia’s using a combination ofPPG and ECGelectrodes.
`See, e.g., claim 1. PPG, or photoplethysmography, uses an optical sensor to
`
`detect the fluctuation of blood flow, and can provide a measureofheart rate.
`
`Id. at 25:21-24. According to the Specification, fluctuations in heart rate not
`
`explained by changing activity levels may be interpreted as an advisory
`condition for recordingan ECG,or electrocardiogram, whichis a typical
`method for diagnosing episodes of arrhythmia. Jd. at 1:52—-54, 1:60—65,
`
`25:1-35. The collected data may also be analyzed using machinelearning
`
`algorithms to, for example, determine appropriate trigger thresholds, detect
`
`and predict health conditions, or provide a heart health score. See, e.g., id. at
`
`3:43-4:16, 8:38-41, 9:8-11, 12:44-64.
`
`Figure 14, reproduced below, shows one embodimentof a body-worn
`
`device. Jd. at 6:21-23.
`
`7 4800
`
`
`
`Figure 14, shows “smart watch 1400 whichincludesat least one heart rate
`
`monitor 1402 and at least one activity monitor 1404,” such as an
`
`accelerometer. Jd. at 24:66—25:1, 25:13-30. Analysis of signals from these
`
`monitors can be used to “determineif heart rate and activity measurements
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`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`represent an advisory condition for recording an ECG,”andtrigger signals
`
`for recording an ECGif an advisory condition is detected. Jd. at 25:1-12.
`
`Figure 10,illustrated below, shows another embodiment involving a
`
`body-worn device. Jd. at 6:3-5.
`
`1012
`
`at
`if
`
`
`
`Alert Ho
`—p» Bi Record
`
`maniterdne
`kfonnation
`| Processor renees
` 1
`Continuous HR
`and examines MR
`POG ett atnbulatory 3
`wf
`bregutarity,tigger:
`-taaniior
`
`|
`|
`|
`-
`1062
`1004
`1008
`
`L
`1008
`
`Figure 10 illustrates “a method for monitoring a subject to determine when
`
`to record an electrocardiogram (ECG).” Jd. at 23:20—22. According to the
`
`Specification:
`
`In FIG.10, a subject is wearing a continuousheart rate monitor
`(configured as a watch 1010, including electrodes 1016), shown
`in step 1002. The heart rate monitor transmits (wirelessly 1012)
`heart rate information that is received by the smartphone 1018,
`as shownin step 1004. The smartphoneincludesa processor
`that may analyze the heart rate information 1004, and when an
`irregularity is determined, may indicate 1006 to the subject that
`an ECGshould be recorded.
`
`Id. at 23:22-30. In some embodiments, the ECG deviceis “present in
`
`a smart watch band or a smart phone.” Jd. at 25:36—37. “The ECG,
`
`heart rate, and rhythm information can be displayed on the computer
`
`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`or smartphone,stored locally for later retrieval, and/or transmitted in
`
`real-time to a web server.” Jd. at 25:48—50.
`
`G. Challenged Claims
`Petitioner challenges claims 1-30, of which claims 1, 17, and 25 are
`
`independent. Ofthese, claim 1 recites:
`
`1. A smart watchto detect the presence of an arrhythmia of a
`user, Comprising:
`
`a processing device;
`a photoplethysmography (“PPG”) sensor operatively coupled to
`the processing device;
`an ECGsensor, comprising two or more ECGelectrodes, the
`ECGsensoroperatively coupled to the processing device;
`a display operatively coupled to the processing device; and
`a memory, operatively coupled to the processing device,the
`memory havinginstructions stored thereon that, when executed
`by the processing device, cause the processing deviceto:
`receive PPG data from the PPG sensor;
`
`detect, based on the PPG data, the presence of an
`arrhythmia;
`receive ECG data from the ECG sensor; and
`
`confirm the presenceof the arrhythmia based on the ECG
`data.
`
`Independent claims 17 and 25recite similar limitations but are drawnto “[a]
`methodto detect the presence of an arrhythmia of a user on a smart watch,”
`and “non-transitory computer-readable storage medium including
`
`instructions,” respectively.
`Amongthe dependent claims, claims 2, 14, and 18 relate to the use of
`motion sensor(inertial) data; claims 4 and 20 relate to “determin[ing]
`heartrate variability (‘HRV’’) data from the PPG data, and detect[ing], based
`
`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`on the HRV data, the presence of the arrhythmia;” claims 3, 5, 6, 19, 21, and
`
`22 recite “‘a machinelearning algorithm trained to detect arrhythmias;” and
`
`claim 15 recites a device “configured to display an ECG rhythm strip for the
`
`ECG data.”
`
`I.
`
`DISCRETIONARY DENIAL UNDER35 U.S.C. § 314(A)
`
`Under§ 314(a), the Director possesses “broad discretion” in deciding
`
`whetherto institute an inter partes review. See 35 U.S.C. § 314(a) (2018);
`
`Saint Regis MohawkTribe v. Mylan Pharm.Inc., 896 F.3d 1322, 1327 (Fed.
`
`Cir. 2018); HarmonicInc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed.
`
`Cir. 2016) (“[Tjhe PTO is permitted, but never compelled, to institute an
`
`[inter partes review (IPR)] proceeding.”’). The Board decides whether to
`
`institute an inter partes review onthe Director’s behalf. 37 C.F.R. § 42.4(a)
`
`(2021).
`
`Patent Owner argues that we should exercise our discretion to deny
`the Petition in view of the copending ITC Investigation. Prelim. Resp. 15—
`30; Prelim. Sur-reply 1-5. According to Patent Owner,instituting an inter
`
`partes review in this proceeding would result in a duplication of efforts that
`
`“would not be an efficient use of the Board’s resources and would not serve
`
`the primary purpose of AIA proceedings: to provide an effective and
`
`efficient alternative to litigation.” Prelim. Resp. 16. Petitioner argues that
`
`weshould decline to exercise our discretion under § 314(a) to deny
`
`institution. See Pet. 81-87; Prelim. Reply 1-5.
`
`The Board has held that the advancedstate of a parallel district court
`
`action is a factor that may weigh in favor of denying a petition under
`
`§ 314(a). See NHK Spring Co. v. Intri-Plex Techs., Inc., [PR2018-00752,
`
`Paper 8 at 20 (PTAB Sept. 12, 2018) (precedential) (“NHK”); Patent Trial
`
`9
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`

`IPR2021-00971
`Patent 10,595,731 B2
`
`and Appeal Board Consolidated Trial Practice Guide (Nov. 2019), 58 & n.2,
`(“Trial Practice Guide”).° We consider the following factors to assess
`“whetherefficiency, fairness, and the merits support the exercise of
`
`authority to deny institution in view ofan earlier trial date in the parallel
`
`proceeding”:
`
`1. whether the court granted a stay or evidence exists that one
`maybegranted if a proceedingisinstituted;
`2. proximity of the court’s trial date to the Board’s projected
`statutory deadline for a final written decision;
`3. investmentin the parallel proceeding by the court and the
`parties;
`4. overlap betweenissues raised in the petition and in the
`parallel proceeding;
`5. whetherthe petitioner and the defendantin theparallel
`proceeding are the same party; and
`6. other circumstances that impact the Board’s exercise of
`discretion, including the merits.
`
`Apple Inc. v. Fintiv, Inc., 1PR2020-00019, Paper 11 at 5-6 (PTAB Mar.20,
`2020) (precedential) (“Fintiv”). In cvaluating these factors, we “take[] a
`holistic view of whether efficiency and integrity of the system are best
`
`served by denyingorinstituting review.” Id. at 6. Upon consideration of
`these factors, we decline to exercise our discretion to deny the Petition.
`
`A. Whether the Court Granted a Stay or Evidence Exists That One May Be
`Granted if a Proceedingis Instituted
`Fintiv factor 1 recognizesthat a stay of litigation pending resolution
`
`of the PTAB trial allays concerns about inefficiency and duplication of
`
`6 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
`
`10
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`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`efforts, which strongly weighs against exercising the authority to deny
`
`institution. Fintiv, Paper 11 at 6.
`Here, the ’731 patent is involved in two parallel proceedings. One of
`
`those proceedings, the Texas Litigation, has been stayed. Pet. 82; Ex. 1053.
`Asto the other proceeding, Petitioner asserts thatit “intends to movefor a
`stay at the ITC uponinstitution.” Prelim. Reply 5. Accordingly, Petitioner
`
`asserts that Fintiv factor 1 is “at worst, neutral.”Jd.
`
`Patent Ownerarguesthat “[a] stay of the ITC proceedingsis
`extremely unlikely” given the Commission’s “statutory mandate to conclude
`
`its investigation at ‘the earliest practicable time.’” Prelim. Resp. 16.
`According to Patent Owner, the ITC has “refused requests, in essentially all
`
`instances, to stay Investigations pending instituted IPRs.” Jd.
`Wedecline to speculate about the likelihood of a stay. Accordingly,
`
`wefind that this factor is neutral.
`
`B. Proximity of the Court’s Trial Date to the Board’s Projected Statutory
`Deadline for a Final Written Decision
`
`Fintiv factor 2 looks to the “proximity of the court’s trial date to the
`
`Board’s projected statutory deadline.” Fintiv, Paper 11 at 9. “If the court’s
`trial date is earlier than the projected statutory deadline, the Board generally
`
`has weighedthis fact in favor of exercising authority to deny institution
`
`under NHK.” Id.
`
`The Administrative Law Judge (ALJ) in the ITC Investigation set
`
`October 26, 2022 as the target date for completion of the Investigation. Ex.
`
`11
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`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`2006, 5. This date falls approximately seven weeks before our deadline for
`
`submitting a final written decision (“FWD”).
`
`Petitioner argues that the Order Setting the Procedural Schedule for
`
`the ITC Investigation states that “dates .
`
`.
`
`. for the scheduled hearings. .
`
`. are
`
`subject to change becauseofrestrictions and uncertainty due to the COVID-
`
`19 pandemic.” Prelim. Reply 1 (alterations in original). Petitioner contends
`
`that the possibility that the ITC schedule may slip makesit “morelikely that
`
`the FWD precedes ITC resolution.” Jd. In addition, Petitioner offers to
`
`truncate the typical 3-month period for the Petitioner Reply by “up to 7
`
`weeks.” Jd. According to Petitioner, “[w]ith this adjustment in schedule, the
`
`FWD date would be able to precede the ITC’s target date.” Jd. at 1-2.
`
`Patent Ownerarguesthat “[i]n other cases where the conclusion of a
`
`parallel ITC investigation proceeding pre-dates the FWD bya similar length
`
`of time, the Board has found this factor weights against institution.” Prelim.
`
`Resp. 19 (citing Regeneron Pharmaceuticals, Inc. v. Novartis Pharma AG,
`
`et al., IPR2020-01317, Paper 15 at 15 (PTAB Jan. 15, 2021); Philip Morris
`
`Products, S.A. v. RAI Strategic Holdings, Inc., IPR2020-00919, Paper 9 at 9
`
`(PTAB Nov. 16, 2020), and Stanley Black & Decker, Inc., et al. v. Zircon
`
`Corporation, IPR2020-01572, Paper 10 at 13 (PTAB Apr. 19, 2021)). Asto
`
`Petitioner’s offer to shorten the period for the Petitioner Reply, Patent
`
`Ownerarguesthat Petitioner’s offer should have been, but was not, made
`
`whenit filed the Petition, and that shortening the schedule would prejudice
`
`Patent Owner becauseit “shortens the deposition window.” Prelim. Sur-
`
`reply 3.
`
`Wetypically take courts’ trial schedules at “face value,” and decline
`
`Petitioner’s invitation to speculate that the target date for completion ofthe
`
`12
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`IPR2021-00971
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`ITC Investigation will slip as a result of the COVID-19 pandemic. Fintiv,
`
`IPR2020-00019, Paper 15 at 13 (informative). Accordingly, for purposes of
`
`analyzing this factor, we assume that the ITC Investigation will conclude on
`
`October 26, 2022.
`
`Wealso decline Petitioner’s invitation to assume an earlier issuance
`
`date for our FWD. Although weappreciate Petitioner’s willingness to
`
`expedite resolution of this case, Patent Ownerraises valid concernsthat
`
`compressing the reply period will also compress the window for taking
`
`depositions. Moreover, the statutory due date for our FWD istriggered by
`
`the date of our institution decision and is unaffected by the date on which
`
`Petitionerfiles its reply. See 35 U.S.C. § 316(a)(11).
`
`Given that our FWD inthis case is due seven weeksafter the targeted
`
`completion of the ITC Investigation, this factor weighs marginally in favor
`
`of exercising our discretion to deny institution.
`
`C. Investmentin the Parallel Proceeding by the Court and the Parties
`
`Fintiv factor 3 considers the “investmentin the parallel proceeding by
`
`the court and parties,” including “the amount and type of work already
`
`completed in the parallel litigation by the court and the parties at the time of
`
`the institution decision.” Fintiv, Paper 11 at 9. For example,if, at the time of
`
`institution, the court in the parallel proceeding has issued “substantive orders
`
`related to the patentat issue in the petition” or “claim construction orders,”
`
`this favors denial. Jd. at 9-10.
`
`Petitioner argues that “[nJothing of substance has occurredin the
`
`Texas [Litigation] because it was stayed in favor of the ITC case before
`
`Apple’s deadline to answer.” Prelim. Reply 3. As to the ITC Investigation,
`
`Petitioner argues that many significant events remain, includinge.g., “expert
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`reports, summary determination motions,pre-trial briefs, hearing, etc.” Jd. at
`
`2. Petitioner also asserts that its diligence weighs against exercising our
`
`discretion to deny institution. According to Petitioner, it filed the Petition
`
`“less than three weeks after the ITC instituted the investigation. .
`
`. and
`
`before filing its response to the ITC Complaint” or an answerto the
`
`complaint in the Texas Litigation. Jd. Petitioner argues that becauseit filed
`
`its Petition so early, any duplicative investment in the ITC Investigation
`
`cannotbe attributed to Petitioner’s delay. Jd.
`
`Patent Ownerarguesthat “significant resources have been, and will
`
`continue to be, invested before the Board makesits institution decision.”
`
`Prelim. Sur-reply 4. As an example, Patent Owneridentifies the Markman
`
`Orderrecently issued in the ITC Investigation. Jd. Patent Owneralso points
`
`out that, according to the Procedural Schedule in the ITC Investigation (Ex.
`
`2006),
`
`by theDecember 16, 2021 institution decision deadline... ,
`Apple will have filed notices of prior art, the parties’ positions
`on invalidity will be finalized, the parties will havefiled
`witnesslists for the evidentiary hearing, the parties will have
`completed all fact discovery in the case, and the parties will be
`less than a week awayfrom theinitial exchange of expert
`reports.
`
`Prelim. Resp. 20.
`Based on the ITC’s Order Setting Procedural Schedule, the parties
`
`have completed Markman proceedings, completed fact discovery and
`
`negotiated to reduce the numberofasserted claims andinvalidity theories.
`
`Ex. 2006, 3-4. The parties have yet to exchange expert reports,file
`
`dispositive motions,orfile pre-trial pleadings. Jd. at 4-5. We find the
`
`investment in the ITC Investigation to date to be significant, but note that
`
`much remains to be doneandthat, of the work that has been done, much
`
`14
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`IPR2021-00971
`Patent 10,595,731 B2
`
`appears unrelatedto the validity issues raised in the Petition. In this regard,
`
`we note that Patent Ownerdid not identify any claim terms in need of
`
`construction in its Preliminary Response and wedid notfind it necessary to
`construe any claim termstoissue this decision.’ See SectionIII.C, below;
`see also generally Prelim. Resp. On the current record, it thus does not
`
`appearlikely that claim construction will play a significant role in
`addressing Petitioner’s unpatentability arguments. In sum, wefind that the
`
`investmentin the ITC Investigation weighs modestly. in favor of
`
`discretionary denial.
`
`Turning now to Petitioner’s diligence, we are not persuaded by Patent
`Owner’s argumentthat Petitioner failed to exercise diligence becauseit
`
`waited until six months after the Texas Litigation was filed. Prelim. Resp.
`
`21. The Board has previously explainedthat, “[i]f the evidence showsthat
`the petitioner filed expeditiously, such as promptly after becoming aware of
`
`the claims being asserted, this fact has weighed against” discretionary
`
`denial. Fintiv, Paper 11 at 11-12 (noting that filing at or around the time of a
`
`patent owner’s responseto invalidity contentions may reveala lack of
`diligence). Here, Petitioner filed this challenge even before its deadline to
`
`file an answerin the Texas Litigation (which was stayed in view of the ITC
`
`Investigation before an answer was due) and beforeit filed a response to
`
`Patent Owner’s ITC complaint. Accordingly, we find that Petitioner’s
`
`7 Patent Ownerarguesthat “the Markman Orderthat issued in the ITC
`conflicts with [Petitioner’s] positions in this proceeding.” Prelim. Sur-reply
`5. Although Patent Ownerappears to refer to the definition of one of
`ordinary skill in the art, it identifies no claim term dependent on that
`definition.
`
`15
`
`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`diligence in filing weighs against exercise of our discretion to deny
`
`institution.
`
`Overall, considering both investment and diligence, we determinethis
`
`factor weighs against discretionary denial of the Petition.
`
`D. Overlap between Issues Raised in the Petition and in the Parallel
`Proceeding
`
`Fintiv Factor 4 considers whether“the petition includes the same or
`
`substantially the same claims, grounds, arguments, and evidence as
`
`presentedin the parallel proceeding.” Fintiv, Paper 11 at 12. If the issues in
`the Petition overlap substantially with those raised in the parallel proceeding,
`“this fact has favored denial.” Jd. “Conversely, if the petition includes
`
`materially different grounds, arguments, and/or evidence. .
`
`. this fact has
`
`tended to weigh against exercising discretion to deny institution.” Jd. at 12—
`
`13.
`
`Petitioner argues that it has not “advanced the IPR prior art in the ITC
`
`at all, making clearin its invalidity contentions that ‘[Petitioner] is not
`
`relying on the art cited in its petitions at this time .
`
`.
`
`. and only ‘intends to
`
`rely on suchart in the future in the event that the PTAB denies institution.”
`
`Prelim. Reply 3 (quoting Ex. 2004,3). In addition, on the deadline set forth
`in the ITC’s Order Setting Procedural Schedule for “reduc[ing] the number
`of asserted invalidity theories for each asserted patent (including narrowing
`
`the numberofprior art references and combination(s) thereof” (Ex. 2006, 3
`
`(ITC Order No. 6: Setting Procedural Schedule)), Petitioner notified Patent
`
`Ownerthat it “intends to no longer pursuein this investigation theprior art
`
`asserted in [Petitioner’s] IPRs” (Ex. 1057). Further, Petitioner asserts that
`
`“to eliminate any doubt as to the absence of meaningful overlap between the
`
`16
`
`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`proceedings,”Petitioner stipulates that it “will not seek resolution in the
`parallel proceedingsofinvalidity based on any groundthatutilizes Shmueli,
`Osorio, Lee-2012, Kleiger-2005, or Chan.”Pet. 85 (citing Ex. 1051).
`
`Finally, Petitioner argues that inter partes review of the ’731 patent would
`include all of the claims of the ’731 patent and would thus include claims
`
`not addressed in the ITC Investigation because the ITC’s OrderSetting
`
`Procedural Schedule requires Patent Ownerto reduce the numberofasserted
`
`claims. Prelim. Reply 4 (citing Ex. 2006).
`Patent Ownerarguesthat Petitioner’s stipulationcarrieslittle weight
`
`becauseit is not a Sotera stipulation,i.e., a stipulation precluding Petitioner
`
`from pursuing any ground that was raised or could reasonably have been
`raised in the IPR proceeding. Prelim. Resp. 23-27; see Sotera Wireless, Inc.
`v. Masimo Corp., IPR2020-01019, Paper 12 at 18-19 (PTAB Dec.1, 2020)
`(precedential as to § II.A) (“Sotera’”) (finding the stipulation that petitioner
`would not pursue the specific ground asserted as well as any other ground
`99 66.
`
`“that was raised or could have been reasonably raised in an IPR”
`
`“weighs
`
`strongly in favor of not exercising discretion to denyinstitution”). According
`
`to Patent Owner, the “only effect” of Petitioner’s narrow stipulation is “to
`
`create the possibility of inconsistent judgments, where the ITC will rule on
`
`validity issues months before the PTAB.” Prelim. Resp. 24. Indeed, Patent
`
`Ownerarguesthatthe prior art cited in the Petition has “already entered the
`
`ITC case.” Prelim. Sur-reply 1 n.1. Finally, Patent Owner dismisses
`
`Petitioner’s argumentthat the ITC Investigation will address only a subset of
`the claims challenged in this proceeding because Petitioner has not provided
`
`“any indication the narrowedset of claims would be substantially different
`
`than those challenged in the IPR petition.” Jd. at 2.
`
`17
`
`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`Weagree with Petitioner that the Petition includes materially different
`
`grounds, arguments, and/or evidence than the ITC Investigation. Although
`
`Patent Ownerarguesthatthe prior art cited in the Petition has “already
`
`entered the ITC case,” that argument was made before Petitioner narrowed
`
`the numberofprior art referencesit intended to rely upon, as required by the
`
`ITC’s Order Setting Procedural Schedule. Ex. 2006; Ex. 1057. Currently
`
`there does not appear to be any overlap in arguments or evidence between
`
`the two proceedings. Moreover, we agree with Petitioner thatits stipulation
`mitigates to some degree concerns of duplicative efforts and possibly
`
`conflicting decisions between the Board and the ITC. Indeed, Petitioner’s
`
`stipulation echoes the one cited in Sand Revolution II, LLC v. Continental
`
`Intermodal Group-Trucking LLC, which the Board determined weighed
`
`“marginally in favor of not exercising discretion to deny institution.”
`
`IPR2019-01393, Paper 24 at 16 (PTAB June 16, 2020) (informative).
`
`Finally, we agree with Petitioner that this proceeding will likely include
`
`claims that are not at issue in the ITC Investigation. We are not persuaded by
`
`Patent Owner’s argumentthat Petitioner has failed to explain why the
`|
`narrowedset of claims would be substantially different than those
`challenged in the IPR petition because, based on the ITC’s OrderSetting
`
`Procedural Schedule, Patent Ownerhad yet to narrow the numberofasserted
`claimsas of the deadline for Petitioner to brief this issue. See Ex. 3001
`
`(email from the Board authorizing the parties to brief discretionary denial
`
`issues, setting a deadline of October 25, 2021 for Petitioner tofile its
`
`responsive brief); Ex. 2006 (setting a deadline of November 12, 2021 for
`
`Patent Ownerto reduce the numberofasserted claims).
`
`18
`
`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`Considering the absence of overlap in issues, claims, and evidence,
`
`further supported by Petitioner’s stipulation, this factor weighs against
`
`discretionary denial.
`
`E. Whetherthe Petitioner and the Defendant in the Parallel Proceeding Are
`the Same Party
`
`Fintiv Factor 5 looks to “whether the petitioner and the defendantin
`
`the parallel proceeding are the sameparty.” Fintiv, Paper 11 at 14. “Ifa
`
`petitioner is unrelated to a defendant, the Board has weighed this fact against
`
`exercising discretion to deny institution under NHK.” Jd. at 13.
`
`Petitioner is the defendant in the Texas Litigation and the ITC
`
`Investigation. This fact weighs in favor of the Board exercising its discretion
`
`to deny institution under § 314(a). Jd. at 15.
`
`F. Other Circumstances That Impact the Board’s Exercise of Discretion,
`Including the Merits
`
`Fintiv factor 6 looks to whether“other circumstances” exist that might
`
`“impact the Board’s exercise of discretion, including the merits.” Fintiv,
`
`Paper 11 at 14.
`
`Petitioner argues that we should considerthat the ITC “does not have
`
`the authority to invalidate patent claims in a mannerthat is binding upon the
`
`Boardordistrict courts.” Pet. 87; Prelim. Reply 5. Petitioner also argues that
`
`the merits of its “patentability challenges are strong, which favors
`
`institution.” Pet. 87; Prelim. Reply 5.
`
`Patent Ownerarguesthat“the disputes between the petitioner and the
`_
`patent ownerare far ranging, including complex antitrust claims” and thus
`
`“instituting this IPR would dolittle to efficiently resolve the disputes
`
`betweenthe parties.” Prelim. Resp. 27. Patent Owneralso contendsthat
`
`19
`
`

`

`IPR2021-00971
`Patent 10,595,731 B2
`
`Petitioner “raised claim construction disputes at the ITC that it did not
`
`includein its Petition,” including identifying “confirm[ing] the presence of
`
`the arrhythmia based on the ECG data”and “receiv[ing] ECG data from the
`
`ECGsensor.” Jd. at 28-29. According to Patent Owner, this creates a “very
`
`high likelihood of confusion and inconsistent rulings.” /d. at 29. Finally,
`
`Patent Owner argues that the ALJ in the ITC Investigation “rejected Apple’s
`
`arguments regarding the properlevelof ordinary skill,” applying a definition
`that “excludes [Petitioner’s] expert.” Prelim. Sur-reply 5. Patent Owner
`
`asserts that this creates the potential for inconsistent decisions if we credit
`
`Petitioner’s expert’s arguments “when he may not constitute a person of
`
`ordinary skill” under the ITC’s definition. /d.
`
`Asan initial matter, we are not persuaded by Petitioner’s argument
`
`that our Fintiv analysis should accountfor the fact that the ITC lacks the
`
`authority to invalidate patents (Pet. 83; Prelim. Reply 5) because Fintiv
`
`contemplates application of the enumerated factors to ITC proceedings
`
`notwithstanding that the ITC cannot invalidate patents. Fintiv, Paper 11 at 8—
`
`9 (“Werecognize that ITC final invalidity determinations do not have
`
`preclusive effect, but, as a practical matter, it is difficult to maintain a
`
`district court proceeding on patent claims determinedto be invalid at the
`
`ITC. Accordingly, the parties should also indicate whether the.patentability
`
`disputes before the ITC will resolveall or substantially all of the
`
`patentability disputes between theparties, regardless of the stay.”).
`
`With respect to the merits, Petitioner has met its institution burden as
`

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