HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY – SOURCE CODE
`
`UNITED STATES DISTRICT COURT
`FOR THE CENTRAL DISTRICT OF CALIFORNIA
`
`Case No. 8:19-cv-02115-DOC-JDE
`
`Judge: Hon. David O. Carter
`
`Magistrate Judge: Hon. John D. Early
`
`
`Complaint Filed: November 4, 2019
`
`MEDTRONIC, INC.; MEDTRONIC
`PUERTO RICO OPERATIONS CO.;
`MEDTRONIC LOGISTICS, LLC;
`MEDTRONIC USA, INC.,
`
`
`Plaintiffs,
`
`
`
`AXONICS MODULATION
`TECHNOLOGIES, INC.,
`
`
`Defendant.
`
`v.
`
`
`SUPPLEMENTAL EXPERT REPORT OF DR. RICHARD T. MIHRAN
`DECEMBER 22, 2022
`
`
`
`
`
`
`EXHIBIT
`Mihran 6
`
`Axonics Exhibit 1023
`Axonics, Inc. v. Medtronic, Inc.
`IPR2020-00712
`
`Page 1 of 8
`
`
`
`UNITED STATES DISTRICT COURT
`FOR THE CENTRAL DISTRICT OF CALIFORNIA
`
`Case No. 8:19-cv-02115-DOC-JDE
`
`Judge: Hon. David O. Carter
`
`Magistrate Judge: Hon. John D. Early
`
`
`Complaint Filed: November 4, 2019
`
`MEDTRONIC, INC.; MEDTRONIC
`PUERTO RICO OPERATIONS CO.;
`MEDTRONIC LOGISTICS, LLC;
`MEDTRONIC USA, INC.,
`
`
`Plaintiffs,
`
`
`
`AXONICS MODULATION
`TECHNOLOGIES, INC.,
`
`
`Defendant.
`
`v.
`
`
`SUPPLEMENTAL EXPERT REPORT OF DR. RICHARD T. MIHRAN
`DECEMBER 22, 2022
`
`
`
`
`
`
`EXHIBIT
`Mihran 6
`
`Axonics Exhibit 1023
`Axonics, Inc. v. Medtronic, Inc.
`IPR2020-00712
`
`Page 1 of 8
`
`
`
`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY – SOURCE CODE
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`AX-SC0000207 (
`057.
`
`3.
`
`a.
`
`SRS 9.8-2: “For an optimally aligned IPG, that is
`, The CD shall
`
`”
`
`207.
`
` SRS section 9.8-2 provides that “[f]or an optimally aligned IPG, that is
`
` at lines 637–658); see also AX1261042 at
`
`
`
`
`
`
`
`
`
`,” as
`
`
`
`, The CD shall
`
`shown below.
`
`AX1305702 (CD SRS Rev. N) at 712.
`
`208.
`
`I understand that if
`
` the CD shall
`
` because the SRS document explicitly notes that
`
` Id. at 706. In other words, the SRS provides that the CD software
`
`
`
`
`
`109
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`Page 2 of 8
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`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY – SOURCE CODE
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`software
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` Id. at 712. Therefore, the CD
`
` prescribed by the SRS.
`
`209. Consistent with the foregoing requirements above, Axonics’ software test protocol
`
`described in AX1308612 (“Test Protocol, Software Verification,
`
`, CD, 1401,” Document 106-0207, AMT – 6060 Test Case 03) shows that
`
` as shown below.
`
`AX1308612 at 644 (annotated).
`
`b.
`
`SRS 9.8-3: “For an optimally aligned IPG, that is
` The CD shall
`.”
`
`
`
`
`
`210. SRS section 9.8-3 provides that “[f]or an optimally aligned IPG, that is
`
`, The CD shall
`
` as shown below.
`
`
`
`
`
`
`
`
`
`
`
`
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`
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`AX1305702 (CD SRS Rev. N) at 712.
`
`211.
`
`I understand that if
`
` the CD shall
`
`110
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`Page 3 of 8
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`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY – SOURCE CODE
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`iv.
`
`Claim 6[c] wherein said external power source
`automatically varies its power output based on a value
`associated with said current passing through said
`internal battery; and
`
`244. As stated in my opening report, I understand that the Special Master has construed
`
`the term “value associated with said current” to have its plain and ordinary meaning and rejected
`
`Axonics’ proposal that this term is indefinite or is limited to meaning “proportional to.” Dkt. No.
`
`163-1 at 72–74. The Special Master also noted that “‘associated with” is broad, such that there
`
`may indeed be many different types of values related to the current.” Id., at 66, 74.
`
`245. The Axonics r-SNM system includes an external power source (i.e.,
`
`
`
`) that automatically varies its power output based on a value associated with said current
`
`passing through said internal battery. As explained further below, the CD automatically varies its
`
`power output based on several different values associated with said current passing through said
`
`internal battery. Examples of “a value associated with said current” which the Axonics system
`
`utilizes to automatically vary the output power of the CD includes at least (1)
`
`
`
`, (2)
`
`, (3)
`
`.
`
`246. As I explained in my opening report (§VII.B.), both the CD and IPG have a
`
`. The IPG
`
`
`
`. See Opening Rpt. at Sections VII.G and
`
`VII.H. As I discussed above,
`
` Therefore, I
`
`incorporate by reference the analysis from my opening report herein. See Opening Rpt. at XII.A.4.
`
`(A)
`
`
`
`247.
`
`I understand that
`
`. In particular,
`
`. Therefore, my analysis regarding
`
`125
`
`
`
`
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`
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`Page 4 of 8
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`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY – SOURCE CODE
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`AX1305702 (CD SRS Rev. N) at 711.
`
`265. See also VIII.A, where I describe different SRS requirements that
`
`.
`
`266. The
`
`For these reasons,
`
`
`
`(C)
`
`
`
`267. As discussed above in Section VIII.A.3,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`documents
`
`, which is, based on my review of Axonics
`
` As discussed in
`
`my opening Report with respect to
`
`, these values are associated with said current
`
`passing through internal battery. See Opening Rpt. at ¶¶ 589–619.
`
`v.
`
`Claim 6[d] wherein said external power source
`automatically varies its power source output based on a
`measured voltage associated with said current passing
`through said internal battery.
`
`268. Axonics external power source (e.g., the
`
`) automatically varies its
`
`132
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`Page 5 of 8
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`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY – SOURCE CODE
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`384. The
`
` As such,
`
`For these reasons,
`
`
`
`385. See also VIII.A, where I describe different SRS requirements
`
`
`
`v.
`
`Claim 1[d]: wherein said external power source
`automatically varies its power output based on a
`measured current associated with said current passing
`through said internal power source.
`
`
`
`
`
`
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`
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`
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`
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`
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`386. Axonics external power source (e.g., the
`
`) automatically varies its
`
`power output based on a measured current associated with said current passing through said
`
`internal power source. Similar to limitation 1[c] above, several values meet this limitation. These
`
`include, for example,
`
`.
`
`(A)
`
`
`
`387. As discussed above in Section VIII.A.3, the
`
`
`
`178
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`Page 6 of 8
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`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY – SOURCE CODE
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`documents
`
` which is, based on my review of Axonics
`
` As
`
`discussed in my opening Report with respect to
`
`, these values associated with said
`
`current passing through internal battery. See Opening Rpt. at ¶¶ 589-619.
`
`b.
`
`’758 Patent, claim 5
`
`i.
`
`Claim 5[pre]: An external power source for use with an
`implantable medical device adapted to be implanted in a
`patient and having componentry for providing a
`therapeutic output, an internal power source and a
`secondary coil operatively coupled to said internal
`power source, comprising:
`
`388. The Axonics r-SNM system includes an external power source (e.g., the
`
`
`
`) for use with an implantable medical device adapted to be implanted in a patient and having
`
`componentry for providing a therapeutic output, an internal battery and a secondary coil
`
`operatively coupled to said internal power source.
`
`389. As with limitation 1[a] discussed above,
`
` do not
`
`affect my analysis for this limitation. Therefore, I incorporate by reference my analysis for the
`
`same limitation from my November 7, 2022 opening expert report herein. See Opening Rpt. at
`
`section XIII.D.1 (discussing limitation 5[pre]).
`
`390.
`
`I also provide additional support below showing how the
`
`this limitation. For example, the
`
` meets
`
`
`
`. As Axonics represented to the FDA in its PMA
`
`Supplement Submission corresponding to Axonics Doc. No. 117-0161-078 Rev. A, the Axonics
`
`r-SNM system includes a “Charger…: a portable device powered by a rechargeable battery,”
`
`which “is used for transcutaneous charging of the neurostimulator [i.e., IPG]
`
`
`
`”
`
`179
`
`Page 7 of 8
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`HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY – SOURCE CODE
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`
`
`Dr. Richard T. Mihran
`
`
`
`
`
`
`
`
`
`
`
`
`
`December 22, 2022
`
`Date
`
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`204
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`Page 8 of 8
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