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`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 WEARABLE ELECTRONIC
`DEVICES WITH ECG FUNCTIONALITY
`AND COMPONENTS THEREOF
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`Inv. No. 337-TA-1266
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`ORDER NO. 21:
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`REGARDING COMPLAINANT ALIVECOR’S MOTIONS IN
`LIMINE NOS. 3, 4, AND 5
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`(March 21, 2022)
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`Complainant AliveCor, Inc. (“AliveCor”) filed motions in limine nos. 3 (“MIL 3” (Mot.
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`1266-019)), 4 (“MIL 4” (Mot. 1266-014)), and 5 (“MIL 5” (Mot. 1266-016)) on March 7, 2022.
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`Respondent Apple, Inc. (“Apple”) timely filed oppositions (“MIL 3 Oppo.,” “MIL 4 Oppo.,” and
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`“MIL 5 Oppo.,” respectively), and the Commission’s Office of Unfair Import Investigations
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`(“Staff”) filed an omnibus response (“Staff Resp.”). AliveCor thereafter filed a motion for leave
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`to file a reply in support of MIL 4 (Mot. 1266-027).
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`A. MIL 3
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`In its Prehearing Brief (“RPB”), Apple asserts that U.S. Patent Nos. 10,595,731 (“731
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`patent”) and 9,572,499 (“499 patent”) are prior art to U.S. Patent No. 10,638,941 (“941 patent”),
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`and that either the 731 patent or the 499 patent, “independently,” anticipate all asserted claims of
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`the 941 patent. RPB at 69-73. AliveCor moves to preclude Apple from asserting that the 731
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`patent and 499 patent are prior art to the 941 patent, on the basis that the assertion was not included
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`in Apple’s contention interrogatory responses. See MIL 3 at 1, 8. The Staff supports the motion
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`on the same basis. See Staff Resp. at 3-4. Apple does not deny that it failed to timely identify
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`these references as prior art. See MIL 3 Oppo. Therefore, MIL 3 (Mot. 1266-019) is granted.
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`1
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`B. MIL 4
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`In its Prehearing Brief (“CPB”), AliveCor asserts that one of its domestic industry products
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`is the
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` “a smart watch being developed by Pegatron in
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`conjunction with AliveCor.” CPB at 19. In September, 2021, Apple requested and received a
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`subpoena directed to Pegatron Corporation in Taiwan, seeking the testimony of a Pegatron
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`corporate witness (following the model of Fed. R. Civ. P. 30(b)(6)), generally on the topic of
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`products Pegatron works on with AliveCor, including the
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` See MIL 4, Ex. B. In lieu of a
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`deposition, Apple agreed to accept the declaration of Ms. Jessica Ho (“Ho Declaration”), a
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`Pegatron account manager. See MIL 4, Ex. C; RX-0295C.
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`Apple seeks the admission of the Ho Declaration to support its argument that the
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` has
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`been “abandoned.” RPB at 172-74. AliveCor moves to exclude the Ho Declaration because,
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`among other things, its admission violates Ground Rule 10.2, which requires “[a]ll witness
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`testimony [to] be made orally.” See MIL 4 at 1, 6-8; Order No. 2. The Staff supports the motion
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`on the same basis. See Staff Resp. at 5. In opposition, Apple asserts that Ground Rule 10.2 has
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`not been violated, and requests that its experts be permitted to rely on and testify about the Ho
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`Declaration. See MIL 4 Oppo. at 5-10.
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`In substance the Ho Declaration is a witness statement, and witness statements are not
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`being used in this investigation, as Ground Rule 10.2 establishes. Moreover, there is no clear
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`prejudice to Apple from exclusion. Ms. Ho acknowledges in her declaration that AliveCor and
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`Pegatron executed a license agreement, but she never mentions the
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` See RX-0295C at ¶ 15.
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`And Apple’s Prehearing Brief states both that a Pegatron project called
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` “represents the
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` asserted in this Investigation,” and that “AliveCor has no knowledge of” that project. RPB
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`2
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`at 173. Apple’s position is sufficiently confusing that it is impossible to assign any probative value
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`at all to the Ho Declaration.
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`Nonetheless, it is the sort of evidence reasonably relied on by expert witnesses. See, e.g.,
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`Certain Mobile Electronic Devices and Radio Frequency and Processing Components Thereof,
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`Inv. No. 337-TA-1065, Order No. 42 at 3, 7 (EDIS Doc. ID 647537) (“Mobile Electronic
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`Devices”). It is therefore inappropriate to “preclude any [expert] testimony about or based on the
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`Ho Declaration,” as AliveCor requests. MIL 4 at 1. And whether and to what extent the Ho
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`Declaration may be used for impeachment purposes, and whether Ms. Ho will be allowed to testify
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`orally, are questions that are not yet ripe. See Mobile Electronic Devices at 3; Motion for Leave
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`to Amend Pre-Hearing Statement (Mot. 1266-028).
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`In sum, MIL 4 (Mot. 1266-014) is granted-in-part, in that the Ho Declaration (RX-0295C)
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`is excluded from evidence, and otherwise denied. AliveCor’s motion for leave to file a reply in
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`support of MIL 4 (Mot. 1266-027) is granted.
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`C. MIL 5
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`The articles accused of infringement are certain models of Apple Watch. See CPB at 7.
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`Apple received clearance from the U.S. Food and Drug Administration (“FDA”) to market the
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`accused products, subject to certain limitations, on September 11, 2018. See MIL 5 Oppo., Ex. 2
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`at RX-0004C.4. Apple intends to call Professor Erika Lietzan, an expert in FDA regulatory affairs,
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`to explain certain aspects of FDA practice and regulation. See MIL 5 Oppo.; RPB at 4. In its
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`Prehearing Brief Apple lists various specific testimony subjects, including that a particular feature
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`of the Apple Watch “cannot
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` without further FDA clearance,” and that configuring the Apple Watch such that the “ECG
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`App could confirm” another feature’s arrhythmia indication “would likely require new FDA
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`3
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`clearance.” RPB at 4, 53. The first subject appears to be an infringement opinion related to, for
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`example, the requirement of claims 16 and 17 of the 499 patent that the system “alert” the user to
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`record an ECG, and therefore likely outside the scope of Prof. Lietzan’s expertise, and the second
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`subject appears to be an inadmissible legal opinion.
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`In its response to MIL 5, however, Apple lists her testimony as covering three subjects that
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`are not so facially improper: (1) “the scope of the FDA clearances . . . [and] the content of the
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`underlying applications” (MIL 5 Oppo. at 4); (2) “why” certain Apple Watch features relevant to
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`infringement “are designed the way they are,” that is, “why the scope of the FDA’s clearances led
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`Apple to design the products the way that it did” (id. at 1, 6); and (3) “other topics,” apparently
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`including the FDA approval process and research related to that approval process (id. at 2 n.1).
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`AliveCor moves to exclude Prof. Leitzan’s testimony as irrelevant. See MIL 5 at 3-5. The Staff
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`supports the motion to the extent it concerns “Apple’s FDA clearances.” See Staff Resp. at 6-7.
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`In opposition, Apple contends that AliveCor’s motion is limited only to testimony on the
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`first two topics above. See MIL 5 Oppo. at 2 n.1. Admittedly, the first two topics are the focus of
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`AliveCor’s motion, but the relief requested is clear and unqualified: AliveCor “requests that Ms.
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`Lietzan’s testimony be excluded as not relevant.” MIL 5 at 9. And although there are
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`unquestionably situations where the testimony of an FDA regulatory expert might be relevant and
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`otherwise admissible, this is not such a situation. The first topic, regarding the scope of clearance
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`and the applications underlying it, could seemingly be adequately ascertained by reviewing the
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`FDA administrative record; certainly Apple has not shown why an expert’s opinion would be
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`helpful for that purpose. The second topic pertains to Apple’s decision-making process in
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`designing the accused products. This would be relevant if subjective intent were at issue, as with
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`indirect infringement, but Apple identifies no such pertinent issue, and it is not clear why Prof.
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`4
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`Lietzan would understand the subjective intent of the people who actually designed the product.
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`The third topic is wide-ranging, and thus potentially relevant, but Apple does not address it in its
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`opposition, other than simply to observe that it intends to offer Prof. Leitzan’s testimony on “other
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`topics.” MIL 5 Oppo. at 2 n.1.
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`In short, the Staff is correct that Prof. Lietzan’s proposed testimony, to the extent it is
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`limited to non-legal opinions on FDA practice, “has no logical bearing whatsoever as to whether
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`or not Apple infringes any asserted claim.” Staff Resp. at 6. MIL 5 (Mot. 1266-016) is therefore
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`granted. I note, however, that the admissibility of related evidence (such as excerpts of the FDA
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`administrative record), and the propriety of arguments based on such evidence, are questions that
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`have not been presented and so are not decided.
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`Within seven days of the date of this document, the parties shall submit to the Office of the
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`Administrative Law Judges a joint statement as to whether or not they seek to have any portion of
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`this document deleted from the public version. If the parties do seek to have portions of this
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`document deleted from the public version, they must submit to this office a copy of this document
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`with red brackets indicating the portion or portions asserted to contain confidential business
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`information. The submission may be made by email and/or hard copy by the aforementioned date
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`and need not be filed with the Commission Secretary.
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`SO ORDERED.
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`_____________________________
`Cameron Elliot
`Administrative Law Judge
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`5
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