UNITED STATES INTERNATIONAL TRADE COMMISSION
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`Washington, D.C.
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`In the Matter of
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`CERTAIN LIGHT-BASED
`PHYSIOLOGICAL MEASUREMENT
`DEVICES AND COMPONENTS THEREOF
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` Inv. No. 337-TA-1276
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`FINAL INITIAL DETERMINATION ON VIOLATION OF SECTION 337
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`Administrative Law Judge Monica Bhattacharyya
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`(January 10, 2023)
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`Appearances:
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`For Complainants Masimo Corporation and Cercacor Laboratories, Inc.:
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`Stephen C. Jensen, Joseph R. Re, Irfan A. Lateef, Sheila N. Swaroop, Ted M. Cannon, Brian C.
`Claassen, Alan G. Laquer, Kendall M. Loebbaka, Daniel C. Kiang, and Douglas B. Wentzel of
`Knobbe, Martens, Olson & Bear, LLP in Irvine, CA; William R. Zimmerman and Jonathan E.
`Bachand of Knobbe, Martens, Olson & Bear, LLP in Washington, DC; Carol Pitzel Cruz of
`Knobbe, Martens, Olson & Bear, LLP in Seattle, WA; and Karl W. Kowallis and Matthew S.
`Friedrichs of Knobbe, Martens, Olson & Bear in New York, NY.
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`For Respondent Apple Inc.:
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`Mark D. Selwyn of Wilmer Cutler Pickering Hale and Dorr LLP in Palo Alto, CA; Joseph J.
`Mueller, Richard Goldenberg, and Sarah R. Frazier of Wilmer Cutler Pickering Hale and Dorr
`LLP in Boston, MA; and Michael D. Esch and David Cavanaugh of Wilmer Cutler Pickering
`Hale and Dorr LLP in Washington, DC.
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`PUBLIC VERSION
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`APPLE 1033
`Apple v. Masimo
`IPR2022-01291
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`Pursuant to the Notice of Investigation (EDIS Doc. ID 749538), 86 Fed. Reg. 46275-76
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`(Aug. 18, 2021), and Commission Rule 210.42, this is the administrative law judge’s final initial
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`determination on violation in the matter of Certain Light-Based Physiological Measurement
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`Devices and Components Thereof, Commission Investigation No. 337-TA-1276. 19 C.F.R.
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`§ 210.42(a)(1)(i).
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`For the reasons discussed herein, it is the undersigned’s final initial determination that
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`there has been a violation of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C.
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`§ 1337, in the importation into the United States, the sale for importation, and/or the sale within
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`the United States after importation of certain wearable electronic devices with light-based pulse
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`oximetry functionality and components thereof by reason of infringement of certain claims of
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`U.S. Patent No. 10,945,648.
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`It is also the undersigned’s final initial determination that there has been no violation of
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`section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337, in the importation into the
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`United States, the sale for importation, and/or the sale within the United States after importation
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`of certain wearable electronic devices with light-based pulse oximetry functionality and
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`components thereof with respect to U.S. Patent Nos. 10,912,501, U.S. Patent No. 10,912,502,
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`U.S. Patent No. 10,687,745, and U.S. Patent No. 7,761,127.
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`I.
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`TABLE OF CONTENTS
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`BACKGROUND ................................................................................................................. 1
`A. Procedural History .............................................................................................................. 1
`B. The Parties .......................................................................................................................... 3
`C. Asserted Patents .................................................................................................................. 4
`D. Products at Issue ................................................................................................................. 4
`E. Witness Testimony.............................................................................................................. 5
`II.
`JURISDICTION AND IMPORTATION ......................................................................... 8
`A. Personal Jurisdiction ........................................................................................................... 8
`B.
`In Rem Jurisdiction and Importation ................................................................................... 8
`III. LEGAL STANDARDS ....................................................................................................... 8
`A.
`Infringement ........................................................................................................................ 8
`B.
`Invalidity ........................................................................................................................... 11
`C.
`Inequitable Conduct .......................................................................................................... 16
`D. Domestic Industry ............................................................................................................. 17
`IV. POEZE PATENTS ........................................................................................................... 19
`A. Specification ..................................................................................................................... 20
`B. Asserted claims ................................................................................................................. 21
`C. Level of Ordinary Skill in the Art ..................................................................................... 25
`D. Claim Construction ........................................................................................................... 26
`E.
`Infringement ...................................................................................................................... 33
`F. Domestic Industry—Technical prong ............................................................................... 55
`G.
`Invalidity – Anticipation/Obviousness ............................................................................. 88
`H.
`Invalidity – Written Description and Enablement .......................................................... 156
`I.
`Prosecution Laches and Unclean Hands ......................................................................... 170
`V.
`U.S. PATENT NO. 10,687,745 ....................................................................................... 174
`A. Specification ................................................................................................................... 174
`B. Claims ............................................................................................................................. 176
`C. Level of Ordinary Skill in the Art ................................................................................... 179
`D. Claim Construction ......................................................................................................... 179
`E.
`Infringement .................................................................................................................... 180
`F. Domestic Industry—Technical Prong ............................................................................. 199
`G.
`Invalidity – Obviousness................................................................................................. 209
`H.
`Invalidity – Written Description and Enablement .......................................................... 241
`I.
`Prosecution Laches ......................................................................................................... 245
`VI. U.S. PATENT NO. 7,761,127 ......................................................................................... 246
`A. Specification ................................................................................................................... 247
`B. Claims ............................................................................................................................. 248
`C. Level of Ordinary Skill in the Art ................................................................................... 249
`D. Claim Construction ......................................................................................................... 250
`E.
`Infringement .................................................................................................................... 259
`F. Domestic Industry—Technical Prong ............................................................................. 273
`G.
`Invalidity ......................................................................................................................... 283
`VII. DOMESTIC INDUSTRY – ECONOMIC PRONG (MASIMO WATCH) .............. 301
`A. The “Masimo Watch” Articles........................................................................................ 301
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`B. Disputed Background Issues Regarding Domestic Industry Investments ...................... 302
`C. Domestic Industry Existing at the Time of the Complaint ............................................. 305
`D. Domestic Industry in the Process of Being Established ................................................. 319
`VIII. DOMESTIC INDUSTRY – ECONOMIC PRONG (’127 PATENT) ........................ 324
`A. Domestic Industry Existing at the Time of the Complaint ............................................. 324
`B. Domestic Industry in the Process of Being Established ................................................. 326
`C. Asserted Domestic Industry Expenditures ...................................................................... 327
`IX. CONCLUSIONS OF LAW ............................................................................................ 335
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`The following abbreviations may be used in this Initial Determination:
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`Tr.
`Dep. Tr.
`JX
`CX
`CPX
`CDX
`RX
`RPX
`RDX
`CPHB
`CIB
`CRB
`RPHB
`RIB
`RRB
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`Hearing Transcript
`Deposition Transcript
`Joint Exhibit
`Complainants’ exhibit
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`Complainants’ physical exhibit
`Complainants’ demonstrative exhibit
`Respondents’ exhibit
`Respondents’ physical exhibit
`Respondents’ demonstrative exhibit
`Complainants’ pre-hearing brief (EDIS Doc. ID 770786)
`Complainants’ corrected initial post-hearing brief (EDIS Doc. ID 775422)
`Complainants’ post-hearing reply brief (EDIS Doc. ID 775058)
`Respondents’ corrected pre-hearing brief (EDIS Doc. ID 770874)
`Respondents’ second corrected initial post-hearing brief (EDIS Doc. ID 779376)
`Respondents’ corrected post-hearing reply brief (EDIS Doc. ID 779379)
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`I.
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`BACKGROUND
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`A.
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`Procedural History
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`The Commission instituted this investigation in response to a complaint filed by
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`Complainants Masimo Corporation and Cercacor Laboratories, Inc. on June 30, 2021, with an
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`amended complaint filed on July 12, 2021 (the “Amended Complaint,” EDIS Doc. ID 746186),
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`and supplemented on July 19, 2021. Notice of Investigation at 1, EDIS Doc. No. 749538 (Aug.
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`13, 2021); 86 Fed. Reg. 46275-76 (Aug. 18, 2021). The complaint, as amended, alleges
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`violations of section 337 of the Tariff Act of 1930, as amended, by reason of infringement of
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`certain claims of U.S. Patent No. 10,912,501 (“the ’501 patent”), U.S. Patent No. 10,912,502
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`(“the ’502 patent”), U.S. Patent 10,945,648 (“the ’648 patent”), U.S. Patent No. 10,687,745 (“the
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`’745 patent”), and U.S. Patent No. 7,761,127 (“the ’127 patent”). Id. The Commission ordered
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`institution of this investigation to determine “whether there is a violation of subsection (a)(1)(B)
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`of section 337 in the importation into the United States, the sale for importation, or the sale
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`within the United States after importation of certain products . . . by reason of infringement of
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`one or more of claims 1-9 and 11-30 of the ’501 patent; claims 1-2, 4-6, 8-12, 14-22, 24-26, and
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`28-30 of the ’502 patent; claims 1-17 and 19-30 of the ’648 patent; claims 1-6, 8-9, 11, 14, 20-
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`24, and 26-27 of the ’745 patent; and claims 7-9 of the ’127 patent; and whether an industry in
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`the United States exists as required by subsection (a)(2) of section 337.” Id. at 2. The
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`investigation was instituted upon publication of the Notice of Investigation in the Federal
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`Register on Monday, August 18, 2021. 86 Fed. Reg. 46275-76.
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`Respondent Apple Inc. filed a response to the Amended Complaint and Notice of
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`Investigation on September 7, 2021 (the “Response to Complaint”), disputing Complainants’
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`allegations with respect to infringement and domestic industry and asserting affirmative defenses
`of invalidity and unenforceability. See EDIS Doc. ID 752521.1
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`Pursuant to Order No. 3 (Sept. 1, 2021), the target date of this investigation was set to be
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`December 16, 2022. On September 13, 2021, the investigation was assigned by then Chief
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`Administrative Law Judge Bullock to the undersigned. See Notice to the Parties, EDIS Doc. ID
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`751531 (Sept. 13, 2021). Pursuant to Order No. 5 (Sept. 22, 2021), the target date was extended
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`to January 16, 2023. See Comm’n Notice (Oct. 12, 2021), EDIS Doc. ID 754020.
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`A technology tutorial and Markman hearing was held on February 17, 2022. See
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`Markman Tr., EDIS Doc. ID 763489.2
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`Pursuant to Order No. 25 (Mar. 23, 2022), Complainants withdrew their allegations of
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`infringement with respect to claims 2, 4, 5, 7, 11, 16, 19, 20, and 22-30 of the ’501 patent, claims
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`1-2, 4-6, 8-12, 14-18, 20, 25, and 26 of the ’502 patent, claims 3, 4, 6, 7, 9, 10, 13-17, 19, 22, and
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`25-28 of the ’648, and claims 1, 3-6, 8, 11, 14, 20-24, and 26 of the ’745 patent. See Comm’n
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`Notice, EDIS Doc. ID 768023 (Apr. 12, 2022). Pursuant to Order No. 33 (May 20, 2022),
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`Complainants withdrew their allegations of infringement with respect to claims 1, 3, 6, 8, 9, 13-
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`15, 17, 18, and 21 of the ’501 patent, claims 19, 21, 24, 29, and 30 of the ’502 patent, claims 1,
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`2, 5, 8, 11, 20, 21, 23, and 29 of the ’648, and claim 2 of the ’745 patent. See Comm’n Notice,
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`EDIS Doc. ID 772826 (Jun. 10, 2022).
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`1 The affirmative defenses based on inequitable conduct were stricken pursuant to Order No. 9 (Dec. 20,
`2021), and Respondent was subsequently granted leave to add certain inequitable conduct defenses
`pursuant to Order No. 23 (Mar. 23, 2022).
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`2 All of the claim construction disputes raised at the Markman hearing were subsequently mooted by the
`withdrawal of asserted claims or by agreement of the parties. See infra.
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`An evidentiary hearing was held on June 6-10, 2022. The parties filed initial post-
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`hearing briefs on June 27, 2022, and filed post-hearing reply briefs on July 11, 2022. Additional
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`exhibits were admitted pursuant to Order No. 50 (Jun. 16, 2022) and Order No. 56 (Aug. 31,
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`2022). The hearing transcript was amended pursuant to Order No. 51 (Jun. 23, 2022) and Order
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`No. 52 (Jun. 27, 2022). The parties’ post-hearing briefs were amended pursuant to Order No. 54
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`(Jul. 14, 2022), Order No. 55 (Jul. 14, 2022), and Order No. 57 (Aug. 31, 2022).
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`Pursuant to Order No. 58 (Sept. 12, 2022), Order No. 59 (Oct. 24, 2022), and Order
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`No. 61 (Dec. 9, 2022), the target date was extended to May 10, 2023. See Comm’n Notice,
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`EDIS Doc. ID 787448 (Jan. 6, 2023).
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`B.
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`The Parties
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`1.
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`Complainants
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`The Complainants are Masimo Corporation (“Masimo”) and Cercacor Laboratories, Inc.
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`(“Cercacor”) (collectively, “Complainants”). Notice of Investigation at 2. Masimo and Cercacor
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`are both Delaware corporations having their principal places of business in Irvine, California.
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`Complaint ¶ 9. Masimo is the owner of the ’501 patent (JX-0001), ’502 patent (JX-0002), ’648
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`patent (JX-0003), and ’745 patent (JX-0009). Id. ¶ 4. Cercacor is the owner of the ’127 patent
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`(JX-0007). Id. Masimo and Cercacor have rights to each of the asserted patents through a cross-
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`licensing agreement. Id. ¶¶ 4, 77; CX-1612C.
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`2.
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`Respondent
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`The Respondent is Apple Inc. (“Apple”). Notice of Investigation at 2. Apple is a
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`California corporation having its principal place of business in Cupertino, California. Response
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`to Complaint ¶ 21.
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`C.
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`Asserted Patents
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`The ’501 patent, ’502 patent, and ’648 patent share a common specification, claiming
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`priority to an application filed on July 3, 2008. JX-0001; JX-0002; JX-0003. These patents are
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`entitled “User-Worn Device for Noninvasively Measuring a Physiological Parameter of a User,”
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`naming inventors Jeroen Poeze et al., and are referenced herein as the “Poeze patents.” Id.
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`The ’745 patent is entitled “Physiological Monitoring Devices, Systems, and Methods,”
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`and claims priority to an application filed on June 28, 2016, naming inventor Ammar Al-Ali.
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`JX-0009.
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`The ’127 patent is entitled “Multiple Wavelength Sensor Substrate” and issued from an
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`application filed on March 1, 2006, naming inventors Ammar Al-Ali et al. JX-0007.
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`D.
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`Products at Issue
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`The products at issue are “wearable electronic devices with light-based pulse oximetry
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`functionality and components thereof.” Notice of Investigation at 2.
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`1.
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`Accused Products
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`Complainants accuse Apple Watch products of infringing the asserted patents, including
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`the Apple Watch Series 6, the Apple Watch Series 7, and certain prototype Apple Watch
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`products
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` (“Next Generation Apple Watches”). CIB
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`at 37-39. Apple has stipulated to the importation of the Apple Watch Series 6, Apple Watch
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`Series 7, and Next Generation Apple Watches (collectively, the “Accused Products”). See CX-
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`0128C (Stipulation Regarding Importation and Inventory) at ¶¶ 2-4; CX-1259C (Stipulation
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`Relating to Next-Generation Watches) at ¶¶ 5-6. The parties have stipulated that the Accused
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`Products are materially identical for the purposes of infringement in this investigation. See Joint
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`Stipulation of Facts at ¶¶ 11-13, EDIS Doc. ID 770692 (May 13, 2022); CX-1259C at ¶¶ 7-8.
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`2.
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`Domestic Industry Products
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`With respect to the ’501, ’502, ’648, and ’745 patents, Complainants rely on certain
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`“Masimo Watch” products. CIB at 26-35. These Masimo Watch products include certain
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`prototypes identified as the “Circle Sensor” (CPX-0021C), the “Wings Sensor” (CPX-0029C),
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`the “RevA sensor” (CPX-0052C), the “RevD sensor” (CPX-0058C), the “RevE sensors” (CPX-
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`0019C, CPX-0020C, CPX-0065C), and a product identified as the Masimo W1 Watch (CPX-
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`0146C). CIB at 30-35. With respect to the ’127 patent, Complainants rely on certain of
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`Masimo’s rainbow® sensors. Id. at 36.
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`E. Witness Testimony
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`The undersigned received testimonial evidence in this investigation in the form of live
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`testimony and deposition designations.
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`1.
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`Fact Witnesses
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`The first witness at the hearing was Joe Kiani, the chairman and chief executive officer of
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`Masimo and Cercacor. Tr. at 79-189. Complainants also presented testimony from Mohamed
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`Diab, an engineer at Masimo, id. at 190-246; Ammar Al-Ali, who oversees technology
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`development at Masimo, id. at 247-340; and Bilal Muhsin, who is the chief operating officer of
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`Masimo. Id. at 341-89. Complainants further presented testimony from Stephen Scruggs, the
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`director of sensor design at Masimo, id. at 390-479; Micah Young, who is Masimo’s chief
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`financial officer and executive vice president, id. at 481-520; and Jeroen Hammarth, the chief
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`financial officer of Cercacor. Id. at 521-33.
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`Apple presented testimony from several of its employees, including Vivek Venugopal, an
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`optical engineer, id. at 816-49; Saahil Mehra, who manages product design for the Apple Watch
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`health sensors, id. at 850-94; Ueyn Block, who worked on the optical architecture for the Apple
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`Watch health sensors, id. at 895-917; Stephen Waydo, who is the director of a human interface
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`device (HID) health group at Apple, id. at 918-51; Brian Land, who leads a health sensing
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`hardware group at Apple, id. at 952-92; and Paul Mannheimer, a sensor architect and scientist at
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`Apple, id. at 993-1025. Apple’s counsel also examined Scott Cromar, the prosecuting attorney
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`for the ’501 patent, ’502 patent, and ’648 patent. Id. at 1026-41. Apple further presented
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`testimony from Robert Rowe, who was the named inventor of certain asserted prior art. Id. at
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`1141-53; see id. at 1174:3-1175:7 (no cross-examination for Mr. Rowe).
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`2.
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`Expert Witnesses
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`Complainants rely on the testimony of Daniel McGavock, who was admitted as an expert
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`in financial matters, offering testimony regarding economic domestic industry, bond, and
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`commercial success. Tr. at 533-76 (expert qualification at 534:25-535:6), 1416-42. With respect
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`to the ’127 patent, Complainants rely on the testimony of Jack Goldberg, who was admitted as an
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`expert in the field of physiological monitoring technologies. Id. at 612-63 (expert qualification
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`at 614:3-11), 1391-1408. With respect to the ’501 patent, ’502 patent, ’648 patent, and ’745
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`patent, Complainants rely on the testimony of Vijay Madisetti, who was admitted as an expert in
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`the field of physiological monitoring technologies. Id. at 664-813 (voir dire and expert
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`qualification at 666:10-674:12). Complainants also rely on the testimony of Robert Stoll, who
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`was admitted as an expert on Patent Office practice and procedure. Id. at 1409-15 (expert
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`qualification at 1409:23-1410:4).
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`Apple relies on the testimony of Majid Sarrafzadeh, who was admitted as an expert in
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`physiological monitoring technologies including the design of pulse oximetry sensors, with
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`respect to the ’745 patent and ’127 patent. Id. at 1042-1138 (expert qualification at 1046:5-12).
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`With respect to the ’501 patent, ’502 patent, and ’648 patent, Apple relies on the testimony of
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`Steven Warren, who was admitted as an expert in biomedical engineering, medical monitoring
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`systems, biomedical instrumentation, biomedical optics, light issue interaction, diagnostic
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`systems, wearable sensors, and biomedical signal processing. Id. at 1181-1282 (expert
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`qualification at 1187:20-1188:11). Apple also relies on the testimony of Vincent Thomas, who
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`was admitted as an expert in the field of economics and financial analysis, with respect to the
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`economic prong of the domestic industry requirement. Id. at 1282-1389 (expert qualification at
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`1283:11-17).
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`3.
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`Deposition Designations
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`Complainants submitted several designated deposition transcripts that were received into
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`evidence without a sponsoring witness: CX-0273C (Amor Dep. Tr.); CX-0281C (Block Dep.
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`Tr.); CX-0275C (Caldbeck Dep. Tr.); CX-0283C (Charbonneau-Lefort Dep. Tr.); CX-0285C
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`(Dua Dep. Tr.); CX-0287C (Land Dep. Tr.); CX-0289C (Mannheimer Dep. Tr.); CX-0291C
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`(Mehra Dep. Tr.); CX-0293C (Rollins Dep. Tr.); CX-0279C (Rowe Dep. Tr.); CX-0295C (Shui
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`Dep. Tr.); CX-0297C (Venugopal Dep. Tr.); CX-0299C (Waydo Dep. Tr.). See Tr. at 291:22-
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`299:5. Apple also submitted several designated deposition transcripts that were received into
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`evidence without a sponsoring witness: RX-1195C (Abdul-Hafiz Dep. Tr.); RX-1296C (Al-Ali
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`Dep. Tr.); RX-1200C (Diab Dep. Tr.); RX-1201C (Hammarth Dep. Tr.); RX-1202C (Kaufman
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`Dep. Tr.); RX-1204C (Kiani Dep. Tr.); RX-1206C (Muhsin Dep. Tr.); RX-1209C (Scruggs Dep.
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`Tr.); RX-1210C (Scruggs 2nd Dep. Tr.); RX-1211C (Young Dep. Tr.). See Tr. at 1323:24-
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`1324:20.
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`II.
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`JURISDICTION AND IMPORTATION
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`A.
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`Personal Jurisdiction
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`Apple has submitted to the personal jurisdiction of the Commission by answering the
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`Complaint and Notice of Investigation, participating in discovery, appearing at hearings, and
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`filing motions and briefs. See Certain Miniature Hacksaws, Inv. No. 337-TA-237, USITC Pub.
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`No. 1948, Initial Determination at 4, 1986 WL 379287, *1 (Oct. 15, 1986), not reviewed in
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`relevant part by Comm’n Action and Order, 1987 WL 450871 (Jan. 15, 1987). Apple does not
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`dispute the Commission’s jurisdiction in this investigation. See RIB at 18.
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`B.
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`In Rem Jurisdiction and Importation
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`The Commission has in rem jurisdiction over the accused products by virtue of their
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`importation into the United States. See Sealed Air Corp. v. U.S. Int’l Trade Comm’n, 645 F.2d
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`976, 985-86 (C.C.P.A. 1981) (holding that the ITC’s jurisdiction over imported articles is
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`sufficient to exclude such articles). Apple has stipulated to the importation of the Accused
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`Products. CX-0128C at 1-2; CX-1259C ¶¶ 5-6. Apple does not dispute the Commission’s
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`jurisdiction in this investigation. See RIB at 18.
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`III. LEGAL STANDARDS
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`A.
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`Infringement
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`Section 337(a)(1)(B)(i) prohibits “the importation into the United States, the sale for
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`importation, or the sale within the United States after importation by the owner, importer, or
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`consignee, of articles that – (i) infringe a valid and enforceable United States patent or a valid
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`and enforceable United States copyright registered under title 17.” 19 U.S.C. §1337(a)(1)(B)(i).
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`The Commission has held that the word “infringe” in Section 337(a)(1)(B)(i) “derives its legal
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`meaning from 35 U.S.C. § 271, the section of the Patent Act that defines patent infringement.”
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`Certain Elec. Devices with Image Processing Sys., Components Thereof, and Associated
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`Software, Inv. No. 337-TA-724, Comm’n Op. at 13-14, EDIS Doc. ID 467105 (Dec. 21, 2011).
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`Infringement must be proven by a preponderance of the evidence. SmithKline
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`Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988). The preponderance
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`of the evidence standard “requires proving that infringement was more likely than not to have
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`occurred.” Warner-Lambert Co. v. Teva Pharm. USA, Inc., 418 F.3d 1326, 1341 n.15 (Fed. Cir.
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`2005).
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`1.
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`Claim Construction
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`“An infringement analysis entails two steps. The first step is determining the meaning
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`and scope of the patent claims asserted to be infringed. The second step is comparing the
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`properly construed claims to the device accused of infringing.” Markman v. Westview
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`Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996)
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`(citation omitted). “[T]he construction of claims is simply a way of elaborating the normally
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`terse claim language[] in order to understand and explain, but not to change, the scope of the
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`claims.” Embrex, Inc. v. Serv. Eng’g Corp., 216 F.3d 1343, 1347 (Fed. Cir. 2000) (alterations in
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`original) (quoting Scripps Clinic v. Genentech, Inc., 927 F.2d 1565, 1580 (Fed. Cir. 1991)).
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`“[O]nly those [claim] terms need be construed that are in controversy, and only to the extent
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`necessary to resolve the controversy.” Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795,
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`803 (Fed. Cir. 1999). The words of a claim “‘are generally given their ordinary and customary
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`meaning,’” which is “the meaning that the term would have to a person of ordinary skill in art”
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`as of the date that the patent application was filed. Phillips v. AWH Corp., 415 F.3d 1303, 1312-
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`13 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582
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`(Fed. Cir. 1996)).
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`2.
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`Direct and Indirect Infringement
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`A patent claim is directly infringed when a respondent “makes, uses, offers to sell, or
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`sells any patented invention, within the United States, or imports into the United States any
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`patented invention” without consent of the patent owner. 35 U.S.C. § 271(a)
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`In addition to direct infringement, a respondent may be liable for indirect infringement,
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`including induced infringement, which is defined in section 271(b) of the Patent Act: “Whoever
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`actively induces infringement of a patent shall be liable as an infringer.” 35 U.S.C. § 271(b).
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`See DSU Med. Corp. v. JMS Co., Ltd., 471 F.3d 1293, 1305 (Fed. Cir. 2006) (en banc) (“To
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`establish liability under section 271(b), a patent holder must prove that once the defendants knew
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`of the patent, they actively and knowingly aided and abetted another’s direct infringement.”)
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`(citations omitted). “The mere knowledge of possible infringement by others does not amount to
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`inducement; specific intent and action to induce infringement must be proven.” Id. (citations
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`omitted). The Supreme Court has held that induced infringement “requires knowledge that the
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`induced acts constitute patent infringement.” Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S.
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`754, 766 (2011). In Suprema, Inc. v. Int’l Trade Comm’n, the Federal Circuit upheld the
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`Commission’s interpretation of the section 337 language “articles that infringe” in the context of
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`induced infringement, holding that the statute “covers goods that were used by an importer to
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`directly infringe post-importation as a result of the seller’s inducement.” 796 F.3d 1338, 1352-
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`53 (Fed. Cir. 2015).
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`Another form of indirect infringement is contributory infringement, defined in section
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`271(c) of the Patent Act: “Whoever offers to sell . . . or imports into the United States a
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`component of a patented machine, . . . or a material or apparatus for use in practicing a patented
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`process, constituting a material part of the invention, knowing the same to be especially made or
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`especially adapted for use in an infringement of such patent, and not a staple article or
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`commodity of commerce suitable for substantial noninfringing use, shall be liable as a
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`contributory infringer.” 35 U.S.C. § 271(c). The intent requirement for contributory
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`infringement requires that respondent knows “that the combination for which [the] component
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`was especially designed was both patented and infringing.” Global-Tech, 563 U.S. at 763. A
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`violation of section 337 based on contributory infringement requires that “the accused infringer
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`imported, sold for importation, or sold after importation within the United States, the accused
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`components that contributed to another’s direct infringement.” Spansion, Inc. v. Int’l Trade
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`Comm’n, 629 F.3d 1331, 1353 (Fed. Cir. 2010).
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`3.
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`Literal Infringement and the Doctrine of Equivalents
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`A complainant must prove either literal infringement or infringement under the doctrine
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`of equivalents. Literal infringement requires the patentee to prove that the accused device meets
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`each and every limitation of the asserted claim(s). Frank’s Casing Crew & Rental Tools, Inc. v.
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`Weatherford Int’l, Inc., 389 F.3d 1370, 1378 (Fed. Cir. 2004). “If even one limitation is missing
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`or not met as claimed, there is no literal infringement.” Elkay Mfg. Co. v. EBCO Mfg. Co., 192
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`F.3d 973, 980 (Fed. Cir. 1999). Literal infringement is a question of fact. Finisar Corp. v.
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`DirecTV Grp., Inc., 523 F.3d 1323, 1332 (Fed. Cir. 2008). Under the doctrine of equivalents, “a
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`product or process that does not literally infringe upon the express terms of a patent claim may
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`nonetheless be found to infringe if there is ‘equivalence’ between the elements of the accused
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`product or process and the claimed elements of the patented invention.” Warner-Jenkinson Co.
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`v. Hilton Davis Chem. Co., 520 U.S. 17, 21 (1997).
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`B.
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`Invalidity
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`It is the respondents’ burden to prove invalidity, and the burden of proof never shifts to
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`the patentee to prove validity. Scanner Techs. Corp. v. ICOS Vision Sys. Corp. N.V., 528 F.3d
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`1365, 1380 (Fed. Cir. 2008). “Under the patent statutes, a patent enjoys a presumption of
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`validity, see 35 U.S.C. § 282, which can be overcome only through facts supported by clear and
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`convincing evidence . . . .” SRAM Corp. v. AD-II Eng’g, Inc., 465 F.3d 1351, 1357 (Fed. Cir.
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`2006); see also Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91, 100-114 (2011) (upholding the
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`“clear and convincing” standard for invalidity).
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`The clear and convincing evidence standard placed on the party asserting an invalidity
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`defense requires a level of proof beyond the preponderance of the evidence. Although not
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`susceptible to precise definition, “clear and convincing” evidence has been described as evidence
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`that produces in the mind of the trier of fact “an abiding conviction that the truth of a factual
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`contention is ‘highly probable.’” Price v. Symsek, 988 F.2d 1187, 1191 (Fed. Cir. 1993) (quoting
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`Buildex, Inc. v. Kason Indus., Inc., 849 F.2d 1461, 1463 (Fed. Cir. 1988)).
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`1.
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`Anticipation
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`Pursuant to 35 U.S.C. § 102, a patent claim is invalid as anticipated if:
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`(1) the claimed invention was patented, described in a printed publication,
`or in public use, on sale, or otherwise available to the public before the
`effective filing date of the claimed invention; or
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`(2) the claimed invention was described in a patent issued under section
`151, or in an application for patent published or deemed published under
`section 122(b), in which the pa