Case: 23-1553 Document: 23 Page: 1 Filed: 04/17/2023
`
`
`
`IN THE
`United States Court of Appeals for the Federal Circuit
`
`No. 23-1553
`
`
`
`
`APPLE INC.,
`
`Appellant,
`
`Appellee.
`
`v.
`
`INTERNATIONAL TRADE COMMISSION
`
`
`
`
`On Appeal from the United States International Trade Commission
`Inv. No. 337-TA-1266
`
`
`
`NON-CONFIDENTIAL OPENING BRIEF OF
`APPELLANT APPLE INC.
`
`
`
`Michael A. Amon
`FISH & RICHARDSON P.C.
`12860 El Camino Real, Suite 400
`San Diego, CA 92130
`
`Betty H. Chen
`FISH & RICHARDSON P.C.
`500 Arguello Street, Suite 400
`Redwood City, CA 94063
`
`Benjamin C. Elacqua
`FISH & RICHARDSON P.C.
`1221 McKinney Street,
` Suite 2800
`Houston, TX 77010
`
`Ruffin B. Cordell
`FISH & RICHARDSON P.C.
`1000 Maine Ave, SW
`Washington, DC 20024
`
`Melanie L. Bostwick
`Mark S. Davies
`Zachary J. Hennessee
`Isaac Park
`ORRICK, HERRINGTON &
` SUTCLIFFE LLP
`1152 15th Street, NW
`Washington, DC 20005
`(202) 339-8400
`
`E. Joshua Rosenkranz
`ORRICK, HERRINGTON &
` SUTCLIFFE LLP
`51 West 52nd Street
`New York, NY 10019
`
`Elizabeth R. Moulton
`ORRICK, HERRINGTON &
` SUTCLIFFE LLP
`405 Howard Street
`San Francisco, CA 94105
`Additional Counsel Listed on Inside Cover
`
`
`
`
`

`

`Case: 23-1553 Document: 23 Page: 2 Filed: 04/17/2023
`
`
`
`
`
`Kristina McKenna
`ORRICK, HERRINGTON &
` SUTCLIFFE LLP
`222 Berkeley Street
`Suite 2000
`Boston, MA 02116
`
`Counsel for Appellant
`
`
`
`

`

`Case: 23-1553 Document: 23 Page: 3 Filed: 04/17/2023
`
`
`
`CLAIM LANGUAGE AT ISSUE
`
`U.S. Patent No. 10,638,941 – Claim 12
`
`12. A smartwatch, comprising
`a processor;
`a first sensor configured to sense an activity level value of a user,
`wherein the first sensor is coupled to the processor;
`a photoplethysmogram (“PPG”) sensor configured to sense a heart
`rate parameter of the user when the activity level value is resting,
`wherein the PPG sensor is coupled to the processor;
`an electrocardiogram (“ECG”) sensor configured to sense electrical
`signals of a heart, wherein the ECG sensor comprises a first
`electrode and a second electrode, and wherein the ECG sensor is
`coupled to the processor; and
`a non-transitory computer readable storage medium encoded with
`a computer program including instructions executable by the
`processor to cause the processor to:
`determine if a discordance is present between the activity level
`value of the user and the heart rate parameter of the user;
`based on the presence of the discordance, indicate to the user a
`possibility of an arrhythmia being present; and
`receive electric signals of the user from the ECG sensor to
`confirm the presence of the arrhythmia.
`U.S. Patent No. 10,595,731 – Claim 1
`
`1.
`
`A smart watch to detect the presence of an arrhythmia of a user,
`comprising:
`a processing device;
`
`i
`
`

`

`Case: 23-1553 Document: 23 Page: 4 Filed: 04/17/2023
`
`
`
`a photoplethysmography (“PPG”) sensor operatively coupled to the
`processing device;
`an ECG sensor, comprising two or more ECG electrodes, the ECG
`sensor operatively coupled to the processing device;
`a display operatively coupled to the processing device; and
`a memory, operatively coupled to the processing device, the
`memory having instructions stored thereon that, when executed
`by the processing device, cause the processing device to:
`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 presence of the arrhythmia based on the ECG data.
`U.S. Patent No. 9,572,499 – Dependent Claim 16
`
`11. A system for determining the presence of an arrhythmia of a first
`user, comprising
`a heart rate sensor coupled to said first user;
`a mobile computing device comprising a processor, wherein said
`mobile computing device is coupled to said heart rate sensor, and
`wherein said mobile computing device is configured to sense an
`electrocardiogram of said first user; and
`a motion sensor
`a non-transitory computer readable medium encoded with a
`computer program including instructions executable by said
`processor to cause said processor to receive a heart rate of said
`first user from said heart rate sensor, sense an activity level of
`said first user from said motion sensor, determine a heart rate
`variability of said first user based on said heart rate of said first
`user, compare and [sic] activity level of said first user to said heart
`
`ii
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`

`

`Case: 23-1553 Document: 23 Page: 5 Filed: 04/17/2023
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`
`
`rate variability of said first user, and alert said first user to record
`an electrocardiogram using said mobile computing device.
`16. The system of claim 11, wherein said mobile computing device
`comprises a smartwatch.
`
`iii
`
`

`

`Case: 23-1553 Document: 23 Page: 6 Filed: 04/17/2023
`
`FORM 9. Certificate of Interest
`
`Form 9 (p. 1)
`March 2023
`
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`CERTIFICATE OF INTEREST
`
`Case Number
`Short Case Caption
`Filing Party/Entity
`
`23-1553
`Apple Inc. v. International Trade Commission
`Apple Inc.
`
`Instructions:
`
`1. Complete each section of the form and select none or N/A if appropriate.
`
`2. Please enter only one item per box; attach additional pages as needed, and
`check the box to indicate such pages are attached.
`
`3. In answering Sections 2 and 3, be specific as to which represented entities
`the answers apply; lack of specificity may result in non-compliance.
`
`4. Please do not duplicate entries within Section 5.
`
`5. Counsel must file an amended Certificate of Interest within seven days after
`any information on this form changes. Fed. Cir. R. 47.4(c).
`
`I certify the following information and any attached sheets are accurate and
`complete to the best of my knowledge.
`
`04/17/2023
`Date: _________________
`
`Signature:
`
`/s/ Melanie L. Bostwick
`
`Name:
`
`Melanie L. Bostwick
`
`iv
`
`

`

`Case: 23-1553 Document: 23 Page: 7 Filed: 04/17/2023
`
`Form 9 (p. 2)
`March 2023
`
`FORM 9. Certificate of Interest
`
`1. Represented
`Entities.
`Fed. Cir. R. 47.4(a)(1).
`Provide the full names of
`all entities represented by
`undersigned counsel
`in
`this case.
`
`Apple Inc.
`
`2. Real Party in
`Interest.
`Fed. Cir. R. 47.4(a)(2).
`Provide the full names of
`all real parties in interest
`for the entities. Do not list
`the real parties if they are
`the same as the entities.
`
`3. Parent Corporations
`and Stockholders.
`Fed. Cir. R. 47.4(a)(3).
`Provide the full names of
`all parent corporations for
`the
`entities and all
`publicly held companies
`that own 10% or more
`stock in the entities.
`(cid:1798) None/Not Applicable (cid:1798) None/Not Applicable
`
`✔
`
`✔
`
`(cid:1798) Additional pages attached
`
`v
`
`

`

`Case: 23-1553 Document: 23 Page: 8 Filed: 04/17/2023
`
`FORM 9. Certificate of Interest
`
`Form 9 (p. 3)
`March 2023
`
`4. Legal Representatives. List all law firms, partners, and associates that (a)
`appeared for the entities in the originating court or agency or (b) are expected to
`appear in this court for the entities. Do not include those who have already entered
`an appearance in this court. Fed. Cir. R. 47.4(a)(4).
`(cid:1798) None/Not Applicable
`(cid:1798) Additional pages attached
`
`✔
`
`✔
`
`5. Related Cases. Other than the originating case(s) for this case, are there
`related or prior cases that meet the criteria under Fed. Cir. R. 47.5(a)?
`(cid:1798) Yes (file separate notice; see below) (cid:1798) No (cid:1798) N/A (amicus/movant)
`If yes, concurrently file a separate Notice of Related Case Information that complies
`with Fed. Cir. R. 47.5(b). Please do not duplicate information. This separate
`Notice must only be filed with the first Certificate of Interest or, subsequently, if
`information changes during the pendency of the appeal. Fed. Cir. R. 47.5(b).
`
`6. Organizational Victims and Bankruptcy Cases. Provide any information
`required under Fed. R. App. P. 26.1(b) (organizational victims in criminal cases)
`and 26.1(c) (bankruptcy case debtors and trustees). Fed. Cir. R. 47.4(a)(6).
`(cid:1798) None/Not Applicable
`(cid:1798) Additional pages attached
`
`✔
`
`vi
`
`

`

`Case: 23-1553 Document: 23 Page: 9 Filed: 04/17/2023
`
`Attachment
`
`4. Legal Representatives. List all law firms, partners, and associates
`that (a) appeared for the entities in the originating court or agency or
`(b) are expected to appear in this court for the entities. Do not include
`those who have already entered an appearance in this court. Fed. Cir.
`R. 47.4(a)(4).
`Orrick, Herrington & Sutcliffe LLP: Jordan L. Coyle; Cesar-Lopez
`Morales; Abigail Colella; Sheila Baynes; Bas de Blank
`Fish & Richardson P.C.: Joseph V. Colaianni Jr.; Katherine H. Reardon;
`Thomas S. Fusco; Raisa Ahmad; Qiuyi Wu
`Covington & Burling LLP: Shara L. Aranoff; Alexander D. Chinoy;
`Brian R. Nester; Amy Bond
`
`vii
`
`

`

`Case: 23-1553 Document: 23 Page: 10 Filed: 04/17/2023
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`CLAIM LANGUAGE AT ISSUE ................................................................ i
`CERTIFICATE OF INTEREST ............................................................... iv
`TABLE OF AUTHORITIES ..................................................................... xi
`STATEMENT OF RELATED CASES ................................................... xvi
`INTRODUCTION ...................................................................................... 1
`STATEMENT OF JURISDICTION .......................................................... 3
`STATEMENT OF THE ISSUES ............................................................... 4
`STATEMENT OF THE CASE .................................................................. 5
`Apple Designs The Apple Watch, Including Several Features
`That Help Users Detect And Manage Potentially Fatal
`Cardiac Conditions. ................................................................. 5
`AliveCor Develops But Then Abandons The KardiaBand, An
`Apple Watch Accessory. ........................................................ 13
`AliveCor Sues Apple For Patent Infringement In District
`Court And The International Trade Commission. ............... 17
`The Administrative Law Judge Finds A Violation With
`Respect To Two Of The Three Asserted Patents. ................. 22
`The Commission Affirms The Finding Of A Violation Despite
`AliveCor’s Patents Being Held Unpatentable By The
`PTO. ....................................................................................... 26
`SUMMARY OF ARGUMENT ................................................................. 29
`STANDARD OF REVIEW....................................................................... 31
`ARGUMENT ........................................................................................... 32
`I.
`There Is No Section 337 Violation Because AliveCor
`Failed To Prove The Existence Of A Domestic Industry. .... 32
`A.
`The Commission erred in crediting expenditures
`unrelated to any “articles protected by the patent.” ... 35
`
`viii
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`Case: 23-1553 Document: 23 Page: 11 Filed: 04/17/2023
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`
`
`B.
`
`C.
`
`The Commission erred in crediting expenditures
`that bore no nexus to the asserted patents. ................ 40
`The Commission erred in finding AliveCor’s
`qualifying expenditures were “substantial.” ............... 42
`II. There Is No Section 337 Violation Because AliveCor
`Has Not Shown Infringement Of Valid Patent Claims. ....... 44
`A. Under the proper claim construction, Apple does
`not infringe. .................................................................. 44
`1.
`The claims require that the processor use
`ECG data to “confirm … the arrhythmia” first
`detected by the PPG sensor. ............................... 46
`2. Under the proper construction of the “confirm”
`terms, Apple cannot infringe. ............................. 52
`The exceedingly weak evidence of secondary
`considerations cannot overcome Apple’s showing of
`obviousness. .................................................................. 55
`1.
`The Commission erred in concluding that
`Apple failed to show prima facie obviousness
`as to a handful of dependent claims. .................. 56
`The Commission erred in concluding that
`extraordinarily weak secondary
`considerations “overcome” Apple’s strong
`prima facie showing of obviousness. ................... 63
`III. Because Exclusion Of The Apple Watch Will Risk Lives
`And Jeopardize Critical Research, The Commission
`Should Not Have Issued A Remedy. ..................................... 71
`A.
`The Commission arbitrarily concluded that other
`products can remedy the serious health harms that
`will result from exclusion. ............................................ 74
`The Commission arbitrarily concluded that
`research studies involving the accused Apple
`Watches will not be jeopardized by exclusion. ............ 80
`CONCLUSION ........................................................................................ 82
`
`2.
`
`B.
`
`B.
`
`ix
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`Case: 23-1553 Document: 23 Page: 12 Filed: 04/17/2023
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`
`
`ADDENDUM
`CERTIFICATE OF COMPLIANCE
`
`Statement Regarding Confidential Material Omitted
`Pursuant to Federal Circuit Rule 25.1(e) and the Protective Order
`
`issued in the ITC on May 26, 2021, and amended on August 18, 2021,
`
`two versions of this brief are being filed with the Court: a confidential
`
`version that notes the material marked confidential, and a non-
`
`confidential version containing appropriate redactions. In the non-
`
`confidential version of this brief, confidential material has been deleted
`
`on pages 16-17, 27, 32-34, and 36-44. The general nature of the deleted
`
`material is confidential business information of AliveCor, Inc.,
`
`regarding its finances, product information, and agreements with a
`
`third party not involved in this litigation.
`
`
`
`x
`
`

`

`Case: 23-1553 Document: 23 Page: 13 Filed: 04/17/2023
`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`CAE Screenplates Inc. v. Heinrich Fiedler GmbH & Co. KG,
`224 F.3d 1308 (Fed. Cir. 2000) ........................................................... 47
`Certain Automatic Crankpin Grinders,
`Inv. No. 337-TA-60, Comm’n Op., 0079 WL 419349 (Dec.
`1979) .................................................................................................... 78
`Certain Fluidized Supporting Apparatus,
`Inv. No. 337-TA-182/188, Comm’n Op., 1984 WL 63741
`(Oct. 1984) ........................................................................................... 71
`Certain Inclined-Field Acceleration Tubes,
`Inv. No. 337-TA-67, Comm'n Op., 0080 WL 594319 (Dec.
`1980) .................................................................................................... 80
`Certain Integrated Circuit Chips,
`Inv. No. 337-TA-859, Comm’n Op., 2014 WL 12796437
`(Aug. 22, 2014) .............................................................................. 35, 42
`Certain Marine Sonar Imaging Devices,
`Inv. No. 337-TA-921, Comm’n Op., 2016 WL 10987364
`(Jan. 6, 2016) ....................................................................................... 37
`Certain Microfluidic Devices,
`Inv. No. 337-TA-1068, Comm’n Op., 2020 WL 225020
`(Jan. 10, 2020) ..................................................................................... 71
`Certain Pers. Data Devices,
`Inv. No. 337-TA-710, Comm’n Op., 2011 WL 12488979
`(Dec. 29, 2011) ..................................................................................... 75
`Cisco Sys., Inc. v. ITC,
`873 F.3d 1354 (Fed. Cir. 2017) ........................................................... 31
`
`xi
`
`

`

`Case: 23-1553 Document: 23 Page: 14 Filed: 04/17/2023
`
`
`
`Colo. Interstate Gas Co. v. FERC,
`850 F.2d 769 (D.C. Cir. 1988) ............................................................. 39
`In re Cree, Inc.,
`818 F.3d 694 (Fed. Cir. 2016) ............................................................. 64
`Ecolochem, Inc. v. S. Cal. Edison Co.,
`227 F.3d 1361 (Fed. Cir. 2000) ........................................................... 70
`Extang Corp. v. Truck Accessories Grp., LLC,
`No. CV 19-923 (KAJ), 2022 WL 607868 (D. Del. Feb. 18, 2022) ........ 67
`Fuji Photo Film Co. v. ITC,
`386 F.3d 1095 (Fed. Cir. 2004) ........................................................... 31
`Gen. Protecht Grp., Inc. v. ITC,
`619 F.3d 1303 (Fed. Cir. 2010) ........................................................... 31
`Hyosung TNS Inc. v. ITC,
`926 F.3d 1353 (Fed. Cir. 2019) ........................................................... 38
`InterDigital Commc’ns, LLC v. ITC,
`707 F.3d 1295 (Fed. Cir. 2013) ........................................................... 35
`John Mezzalingua Assocs., Inc. v. ITC,
`660 F.3d 1322 (Fed. Cir. 2011) ..................................................... 31, 32
`Koninklijke Philips N.V. v. Google LLC,
`948 F.3d 1330 (Fed. Cir. 2020) ........................................................... 60
`Leapfrog Enters., Inc. v. Fisher-Price, Inc.,
`485 F.3d 1157 (Fed. Cir. 2007) ........................................................... 70
`LePage’s 2000, Inc. v. Postal Regulatory Comm’n,
`642 F.3d 225 (D.C. Cir. 2011) ............................................................. 39
`Liqwd, Inc. v. L’Oreal USA, Inc.,
`941 F.3d 1133 (Fed. Cir. 2019) ..................................................... 67, 68
`Microsoft Corp. v. ITC,
`731 F.3d 1354 (Fed. Cir. 2013) ........................................................... 32
`
`xii
`
`

`

`Case: 23-1553 Document: 23 Page: 15 Filed: 04/17/2023
`
`
`
`Motor Vehicle Mfgs. Assoc. v. State Farm Mut. Auto. Ins. Co.,
`463 U.S. 29 (1983) ............................................................................... 73
`Motorola Mobility, LLC v. ITC,
`737 F.3d 1345 (Fed. Cir. 2013) ........................................................... 42
`Motorola, Inc. v. Interdigital Tech. Corp.,
`121 F.3d 1461 (Fed. Cir. 1997) ........................................................... 63
`Qualcomm Inc. v. Apple Inc.,
`24 F.4th 1367 (Fed. Cir. 2022) ............................................................ 62
`S. Ala. Med. Sci. Found. v. Gnosis S.P.A.,
`808 F.3d 823 (Fed. Cir. 2015) ............................................................. 66
`Saad v. S.E.C.,
`718 F.3d 904 (D.C. Cir. 2013) ............................................................. 73
`Sakraida v. Ag Pro, Inc.,
`425 U.S. 273 (1976) ............................................................................. 63
`Spansion, Inc. v. ITC,
`629 F.3d 1331 (Fed. Cir. 2010) ........................................................... 72
`Techtronic Indus. Co. v. ITC,
`944 F.3d 901 (Fed. Cir. 2019) ............................................................. 31
`Vandenberg v. Dairy Equip. Co.,
`740 F.2d 1560 (Fed. Cir. 1984) ........................................................... 69
`In re Vivint, Inc.,
`14 F.4th 1342 (Fed. Cir. 2021) ............................................................ 74
`Wi-Lan, Inc. v. Apple Inc.,
`811 F.3d 455 (Fed. Cir. 2016) ............................................................. 49
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ............................................... 31, 66, 69
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) ........................................................... 69
`
`xiii
`
`

`

`Case: 23-1553 Document: 23 Page: 16 Filed: 04/17/2023
`
`
`
`Statutes
`19 U.S.C. § 1337(a)(1)(B)(i) ..................................................................... 22
`19 U.S.C. § 1337(a)(2) ........................................................................ 32, 40
`19 U.S.C. § 1337(a)(3) ........................................................................ 32, 38
`19 U.S.C. § 1337(a)(3)(A) ................................................................... 33, 40
`19 U.S.C. § 1337(a)(3)(B) ............................................................. 33, 39, 40
`19 U.S.C. § 1337(a)(3)(C) ....................................................... 34, 39, 40, 42
`19 U.S.C. § 1337(b)(1) ................................................................................ 3
`19 U.S.C. § 1337(c) .................................................................................... 3
`19 U.S.C. § 1337(d) .................................................................................. 71
`19 U.S.C. § 1337(f) ................................................................................... 71
`19 U.S.C. § 1337(j)(4) ................................................................................ 3
`28 U.S.C. § 1295(a)(6) ................................................................................ 3
`35 U.S.C. § 103 ........................................................................................ 25
`Rules and Regulations
`19 C.F.R. § 201.9 ..................................................................................... 79
`19 C.F.R. § 210.32 ................................................................................... 79
`21 C.F.R. § 870.2345................................................................................ 77
`21 C.F.R. § 870.2790................................................................................ 77
`Other Authorities
`Colleen V. Chien & Mark A. Lemley, Patent Holdup, The
`ITC, And The Public Interest, 98 Cornell L. Rev. 1 (2012) .......... 72, 73
`
`xiv
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`

`

`Case: 23-1553 Document: 23 Page: 17 Filed: 04/17/2023
`
`
`
`Final Written Decision, Apple Inc. v. AliveCor, Inc.,
`IPR2021-00971, Paper 42 (P.T.A.B. Dec. 6, 2022) ............................. 48
`Jonathan J. Engler et al., Domestic Industry Alive and Well
`at ITC (Feb. 1, 2022), https://tinyurl.com/DIAliveAndWell ............... 33
`S. Rep. No. 93-1298 (1974) ...................................................................... 72
`
`
`xv
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`Case: 23-1553 Document: 23 Page: 18 Filed: 04/17/2023
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`
`
`STATEMENT OF RELATED CASES
`Complainant AliveCor, Inc., has noticed an appeal from the same
`
`underlying proceeding before the International Trade Commission.
`
`That appeal is pending before this Court as No. 23-1509. Both AliveCor
`
`and Apple have sought consolidation of Appeal No. 23-1509 with this
`
`appeal, and Apple has asked for this appeal to be designated as lead in
`
`the consolidated appeal so that Apple can self-expedite its briefing.
`
`Those motions remain unresolved. As Apple explained in its motion,
`
`Dkt. 10 at 7, it is filing this opening brief within one week of the
`
`Commission providing the certified list for this appeal. Should the
`
`Court subsequently grant Apple’s consolidation motion, Apple would file
`
`an identical opening brief in the consolidated appeal.
`
`This appeal may affect or be affected by AliveCor’s pending appeal
`
`from the Patent Trial and Appeal Board’s decisions holding all claims of
`
`AliveCor’s asserted patents unpatentable. See AliveCor, Inc. v. Apple
`
`Inc., Nos. 23-1512, -1513, -1514.
`
`In addition, this appeal may affect the pending district court
`
`litigation in which AliveCor has asserted against Apple the same
`
`patents at issue in this appeal. See AliveCor, Inc. v. Apple Inc., No. 20-
`
`xvi
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`Case: 23-1553 Document: 23 Page: 19 Filed: 04/17/2023
`
`
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`cv-1112 (W.D. Tex.). That litigation is stayed pending resolution of the
`
`Commission Investigation. See id., Order, Dkt. 26 (May 6, 2021).
`
`
`
`
`
`
`
`
`
`xvii
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`Case: 23-1553 Document: 23 Page: 20 Filed: 04/17/2023
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`
`
`INTRODUCTION
`According to Apple’s customers, the Apple Watch has saved
`
`lives—“[l]iterally, not figuratively,” as one customer took pains to point
`
`out. Appx1616-1617. With multiple FDA-cleared cardiac-monitoring
`
`functions—among many other industry-leading health and wellness
`
`features—the Apple Watches at issue are helping users both manage
`
`known conditions and discover potential problems that warrant a doctor
`
`visit. Millions of American consumers have activated these features on
`
`their Apple Watches. And many more stand to benefit, as researchers
`
`at renowned institutions across the country are investigating how Apple
`
`Watch can be used to do even more to improve health.
`
`These benefits to the American public are now in jeopardy,
`
`however, because of the International Trade Commission’s ruling that
`
`these Apple Watches infringe two patents held by a company that long
`
`since stopped offering a product protected by those patents. That ruling
`
`would be bad enough if the Commission’s bases for finding a Section
`
`337 violation were valid. That is because the Commission is meant to
`
`protect American industry and the public interest, not just to serve as
`
`an alternative forum for patent assertion. The Commission wields the
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`1
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`Case: 23-1553 Document: 23 Page: 21 Filed: 04/17/2023
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`
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`extreme authority to exclude products from importation, but only for
`
`the purpose of protecting American innovation—and only after
`
`considering the effects of exclusion on public health, competition, and
`
`consumers.
`
`But the Commission not only abdicated that critical responsibility.
`
`It also found a protectable domestic “industry” based on a product that
`
`AliveCor abandoned years before filing its complaint; the Commission
`
`made this finding despite recognizing that AliveCor submitted
`
`unreliable evidence and intentionally declined to satisfy its burden to
`
`link its expenditures with the patents or protected articles. It found
`
`infringement only by ignoring the plain claim language. And it allowed
`
`admittedly shaky evidence of secondary considerations to outweigh a
`
`strong showing of obviousness. It even issued an exclusion order—
`
`albeit in a suspended state—after the Patent Trial and Appeal Board
`
`held AliveCor’s asserted patents invalid as obvious based on a separate
`
`set of prior art from the one the Commission considered.
`
`The Commission’s exclusionary authority is a powerful remedy
`
`meant to protect American industry from unfair importation practices.
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`That is not this case. One American company is providing
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`groundbreaking products that improve consumers’ lives. Another
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`American company is wielding invalid patents without offering any
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`comparable product of its own. The Court should reverse.
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`STATEMENT OF JURISDICTION
`The Commission had jurisdiction of the underlying Investigation
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`pursuant to 19 U.S.C. § 1337(b)(1). The Commission issued a Final
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`Determination on December 22, 2022, finding a violation of Section 337
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`based on the ’941 and ’731 patents but no violation based on the ’499
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`patent. Appx1-89. The Commission’s decision as to the ’499 patent
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`became final upon issuance; AliveCor timely filed a petition for review
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`of that decision on February 7, 2023. No. 23-1509, Dkt. 1. The
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`Commission’s decision as to the ’941 and ’731 patents became final one
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`day after the presidential review period closed with no action from the
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`President, on February 21, 2023. 19 U.S.C. § 1337(j)(4); see Appx2797-
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`2798. Apple timely filed a petition for review of that decision on
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`February 22, 2023. Dkt. 1. This Court has jurisdiction pursuant to 28
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`U.S.C. § 1295(a)(6) and 19 U.S.C. § 1337(c).
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`STATEMENT OF THE ISSUES
`1. Whether the Commission erred in finding an existing
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`domestic industry in AliveCor’s long-discontinued KardiaBand product
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`based on a modest amount of research and development spending that
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`no witness attempted to link to the asserted patents and which mostly
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`related to products that the Commission found were not part of the
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`domestic industry.
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`2. Whether the Commission erred in concluding that the
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`accused Apple Watches infringe patent claims requiring a smartwatch
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`processor that uses ECG data to “confirm … the arrhythmia” first
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`detected by PPG data, despite the undisputed fact that Apple Watch’s
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`ECG and PPG-based features are wholly separate and do not interact,
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`as required by Apple’s FDA clearances.
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`3. Whether the Commission erred in upholding certain
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`dependent patent claims by ignoring record evidence, and whether the
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`Commission erred in concluding that admittedly weak evidence of
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`secondary considerations outweighed Apple’s strong showing of prima
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`facie obviousness.
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`4. Whether the Commission properly issued sweeping remedial
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`orders directed at a U.S. company’s innovative product that can
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`improve health and save lives, particularly when the complainant offers
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`no competing product.
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`STATEMENT OF THE CASE
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`Apple Designs The Apple Watch, Including Several Features
`That Help Users Detect And Manage Potentially Fatal Cardiac
`Conditions.
`Apple, headquartered in Cupertino, California, designs and
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`markets personal consumer devices. Appx713-714. This case involves
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`the Apple Watch, a “revolutionary product” first announced in 2014 that
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`has “grown to become the world’s most popular smartwatch.”
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`Appx10127; Appx2631. Like every Apple product, Apple Watch is
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`designed with one of Apple’s “core principles” in mind: “a commitment
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`to improve users’ lives by developing the world’s best technology.”
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`Appx1502. Consistent with that goal, since the first model debuted in
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`2015, Apple Watch has offered consumers a suite of “comprehensive
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`health and fitness apps that can help people lead healthier lives.”
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`Appx10126-10127. Among many other features, these apps can help
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`consumers monitor their cardiac health.
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`Even before the first release of Apple Watch, Apple was working
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`on this technology. Appx12005-12006; Appx12206; Appx30738-30741.
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`The earliest Watch models contained a feature known as “Background
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`Heart Rate,” which uses an infrared PPG sensor—short for
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`“photoplethysmogram”—to measure a user’s heart rate throughout the
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`day and, for example, allows users to track heart rate during workouts.
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`Appx30746-30747; Appx30751-30752. PPG sensors shine light into the
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`body and measure the absorption rate of that light as blood flows
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`through the blood vessels. Appx716. This measurement can be used to
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`determine a patient’s pulse and to derive estimates of both heart rate
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`and heart-rate variability. Appx497-498.
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`Beginning with the Series 3 model released in 2017, Apple Watch
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`has also included the “High Heart Rate Notification” feature, or
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`“HHRN.” Appx12206; Appx30744-30745. If the Background Heart
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`Rate measurement exceeds a user-set threshold while the user seems to
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`be inactive (as measured by the Watch’s accelerometer), HHRN triggers
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`a higher-powered green-light PPG sensor to obtain a higher-fidelity
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`measurement of heart rate. Appx722; Appx30752-30753; Appx10824-
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`10826. If this process confirms the high heart rate, the user receives a
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`notification that their heart rate is above the preset threshold even
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`though they appear to be inactive. Appx11734-11737; Appx30753.
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`Appx12056.
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`With the release of Apple Watch Series 4 in 2018, and following
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`“clinical evaluation trials” and a “regulatory clearance process,” Apple
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`accomplished its long-held goal of including ECG (“electrocardiogram”)
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`capability. Appx30739-30745; Appx12016-12028. An electrocardiogram
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`uses electrodes placed on the skin to measure the electrical flow that
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`causes the heart muscle to contract and pump blood through the four
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`chambers in an orderly way. Appx716. The normal process by which
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`this electrical flow (also called “depolarization”) occurs—and the
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`corresponding ECG measurement—is depicted below:
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`Appx12114. The P wave (top left) corresponds to current flow that
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`depolarizes the atria (causing contraction), while the “QRS complex”—
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`reflected in the spike shown in the bottom graphics—corresponds to
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`current flow that depolarizes the ventricles (again causing contraction).
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`Appx31065-31068. An ECG can reveal abnormal electrical activity (or
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`“arrhythmias”) in the heart, such as a fast heart rate (called
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`tachycardia) or an irregular heart rhythm such as atrial flutter or atrial
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`fibrillation. Appx12115; Appx31068-31069; Appx30105. Atrial
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`fibrillation is “the most common serious arrhythmia,” affecting many
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