`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`APPLEINC.,
`
`Petitioner,
`
`V.
`
`MASIMO CORPORATION,
`
`Patent Owner.
`
`Case IPR2022-01291, IPR2022-01465
`USS. Patent 10,687,745
`
`DECLARATIONOF R. JAMES DUCKWORTH
`
`IN SUPPORT OF PATENT OWNER’S RESPONSES
`
`I declare that all statements made herein on my own knowledgeare true and
`that all statements made on information and belief are believed to be true, and
`further, that these statements were made with the knowledge that willful false
`statements and the like so made are punishable by fine or imprisonment, or both,
`under Section 1001 of Title 18 of the United States Code.
`I reserve the right to supplement my opinionsin the future to respond to any
`arguments or positions Apple may raise, taking account of new information asit
`
`becomesavailableto me.
`Dated: 5/26/ Zov3
`
`fe
`S.
`
`
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`R. James Duckworth, Ph.D.
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`MASIMO 2070
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`Apple v. Masimo
`IPR2022-01291
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`MASIMO 2070
`Apple v. Masimo
`IPR2022-01291
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`I, R. James Duckworth, declare and state as follows:
`
`I.
`
`INTRODUCTION
`1. My name is R. James Duckworth, Ph.D. I have been retained by
`
`Knobbe, Martens, Olson & Bear, LLP, counsel for Patent Owner Masimo
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`Corporation (“Masimo”). I previously submitted two declarations in IPR2022-
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`01291 and IPR2022-01465, both of which concern the ’745 Patent. Both
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`declarations are labeled Exhibit 2002 in their respective IPRs. I expressly
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`incorporate by reference my original declarations, EX2002 in IPR2022-01291 and
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`EX2002 in IPR2022-01465, as if set forth fully herein.
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`2.
`
`I am providing this supplemental declaration to provide additional
`
`opinions relating to IPR2022-01291 and IPR2022-01465. I may refer to my original
`
`declarations throughout this supplemental declaration. I will refer to my original
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`declaration in IPR2022-01291 as EX2002-1291 and to my original declaration in
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`IPR2022-01465 as EX2002-1465.
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`3.
`
`I have continued to apply the legal standards provided to me by counsel
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`as set forth in my original declarations.
`
`II. MATERIALS CONSIDERED
`In paragraphs 3-6 of Exhibit 2002-1291 and in paragraphs 3-5 of
`4.
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`Exhibit 2002-1465, I listed the materials I considered with respect to my original
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`declarations. In connection with this declaration, I have considered those materials
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`
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`and further considered the following materials:
`
`Exhibit Description
`
`2071
`
`Transcript of March 24, 2023 Deposition of Dr. Brian W. Anthony
`
`2072
`
`Excerpt of Webster’s II New College Dictionary (2001)
`
`2073
`
`2074
`
`2075
`
`2076
`
`2077
`
`2078
`
`2079
`
`2080
`
`Encyclopedia Britannica, Light, the visible spectrum,
`https://www.britannica.com/science/light (last visited May 19, 2023)
`
`Nonconfidential Excerpt of Page 65 from June 6-10, 2022 Hearing
`Transcript, Masimo Corp. et al. v. Apple Inc., ITC Inv. No 337-TA-
`1276
`
`February 13, 2023 Respondent Apple Inc.’s Response to Complainants’
`Petition for Review (Public Version), filed in Masimo Corp. et al. v.
`Apple Inc., ITC Inv. No 337-TA-1276
`
`CONFIDENTIAL – Transcript of Testimony of Brian Land from June
`6-10, 2022 Hearing Transcript, Masimo Corp. et al. v. Apple Inc., ITC
`Inv. No 337-TA-1276
`
`CONFIDENTIAL – Transcript of Testimony of Dr. Paul Mannheimer
`from June 6-10, 2022 Hearing Transcript, Masimo Corp. et al. v. Apple
`Inc., ITC Inv. No 337-TA-1276
`
`CONFIDENTIAL – Transcript of Testimony of Dr. Stephen Waydo
`from June 6-10, 2022 Hearing Transcript, Masimo Corp. et al. v. Apple
`Inc., ITC Inv. No 337-TA-1276
`
`CONFIDENTIAL – Transcript of Testimony of Dr. Vivek Venugopal
`from June 6-10, 2022 Hearing Transcript, Masimo Corp. et al. v. Apple
`Inc., ITC Inv. No 337-TA-1276
`
`CONFIDENTIAL – ITC Exhibit CX-0289C – Designated Portions of
`February 10, 2022 Deposition of Paul Mannheimer
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`2081
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`2082
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`2083
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`2084
`
`CONFIDENTIAL – ITC Exhibit CX-0299C – Designated Portions of
`February 18, 2022 Deposition of Stephen Waydo
`
`CONFIDENTIAL – ITC Exhibit CX-0295C – Designated Portions of
`February 11, 2022 Deposition of Tao Shui
`CONFIDENTIAL – ITC Exhibit CX-0007C – Email from Brian Land
`to Paul Mannheimer et al.
`CONFIDENTIAL – ITC Exhibit CX-0175C – Apple Organization
`Chart
`
`2085
`
`CONFIDENTIAL – ITC Exhibit CX-0177C – Apple Presentation
`
`2086
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`CONFIDENTIAL – ITC Exhibit CX-0185C – Apple Presentation
`
`2087
`
`2088
`
`2089
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`2090
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`2091
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`Kim, Gina, “Masimo Wants $3B From Apple Over Smartwatch IP, Jury
`Told.” Law360, April 5, 2023
`(https://www.law360.com/articles/1593689/masimo-wants-3b-from-
`apple-over-smartwatch-ip-jury-told)
`
`ITC Exhibit CX-1616 – Fowler, Geoffrey, “The new Apple Watch says
`my lungs may be sick. Or perfect. It can’t decide.” Washington Post,
`September 23, 2020 (https://www.washingtonpost.com/technology/202
`0/09/23/apple‐watch‐oximeter/)
`
`CONFIDENTIAL – ITC Exhibit CX-1793C – Apple Presentation
`CONFIDENTIAL – ITC Exhibit CX-1800C – Email from Adrian
`Perica to Steve Hotelling, et al.
`William, Andrews, “Fitbit Update Lets You Quickly Check Your Blood
`Oxygen Saturation.” Forbes, Sept. 9, 2020
`(https://www.forbes.com/sites/andrewwilliams/2020/09/09/fitbit-
`update-lets-you-quickly-check-your-blood-oxygen-
`saturation/?sh=5d6ecb55e76a)
`
`2092
`
`“Track Your SpO2 to Uncover Changes in Your Wellbeing,” Fitbit,
`Sept. 7, 2020 (https://blog.fitbit.com/track-your-spo2/)
`
`2093
`
`CONFIDENTIAL – ITC Final Initial Determination
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`EX1036
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`CONFIDENTIAL – Transcript of Testimony of Ueyn Block from June
`6-10, 2022 Hearing Transcript, Masimo Corp. et al. v. Apple Inc., ITC
`Inv. No 337-TA-1276
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`EX1037
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`CONFIDENTIAL – Transcript of Testimony of Saahil Mehra from
`June 6-10, 2022 Hearing Transcript, Masimo Corp. et al. v. Apple Inc.,
`ITC Inv. No 337-TA-1276
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`EX1038
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`ITC Exhibit RX-0335
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`EX1039
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`ITC Exhibit RX-0504
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`EX1040
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`ITC Exhibit RX-0508
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`EX1041
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`ITC Exhibit RX-0632
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`
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`In addition to the exhibits listed above, I have also considered Masimo’s Patent
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`Owner Preliminary Responses in these IPRs, the Institution Decisions in these IPRs,
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`all other documents that Apple produced in response to Masimo’s Motion for
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`Additional Discovery, the parties’ public Petitions for Review of the Final Initial
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`Determination and the parties’ public Responses to those Petitions in the
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`Investigation, and to the extent not listed here, any other documents that I cite in this
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`declaration.
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`III. LEVEL OF ORDINARY SKILL
`For purposes of this declaration, I have continued to apply the definition
`5.
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`of a person of ordinary skill in the art (“POSITA”) that Apple proposed. See
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`EX2002-1291 at ¶¶ 31-32. I have been informed and understand that obviousness
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`must be evaluated from the perspective of a POSITA as of the effective filing date
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`of the ’745 Patent. I have been informed and understand that the effective filing date
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`of the ’745 Patent is July 2, 2015, based on the earliest priority date of the ’745
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`Patent. My analysis and opinions are based on the perspective of a POSITA as of
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`the effective filing date of the ’745 Patent.
`
`IV. CLAIM CONSTRUCTION
`Independent Claims 1 and 20 both require “a plurality of light-emitting
`6.
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`diodes configured to emit light in a first shape” and a “material configured to change
`
`the first shape into a second shape.” In my opinion, the claim language, the
`
`specification, the prosecution history, and the parties’ agreements in the ITC
`
`Investigation all support a construction of the phrase “change the first shape into a
`
`second shape” that includes that the “second shape” must be a “a shape different
`
`from the first shape.” In other words, the claims require a material that is configured
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`to change the first shape into a shape different from the first shape.
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`7.
`
`First, a POSITA reading the claim’s plain language would have
`
`understood that the phrase requires the material to “change the first shape into a
`
`second shape.”1 The requirement that there be a “change” would indicate to a
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`POSITA that the second shape must be different than the first shape. I note this is
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`1 All emphases are added unless stated otherwise.
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`consistent with the common meaning of the word “change,” which is “[t]o make
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`
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`different.” See EX2072.
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`8.
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`Second, the specification also indicates to a skilled artisan that the claim
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`phrase required that the second shape must be different than the first shape. As I
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`explained previously, the specification contains several examples of a material
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`changing a first shape into a second shape. See EX1001 at 7:63-8:14, 10:65-11:2;
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`EX2002-1291 at ¶ 36; EX2002-1465 at ¶ 36.
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`9.
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`Third, as I explained in my original declarations, I understand that
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`during prosecution Masimo overcame a prior art rejection that included a lens by
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`explaining that an analogous claim limitation required a change in the shape of the
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`emitted light—not just a change in size. See EX2002-1291 at ¶¶ 38-43; EX2002-
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`1465 at ¶¶ 38-43. As I explained previously, the prosecution history shows that the
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`“first shape” and “second shape” limitations were claim amendments that Masimo
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`made to overcome prior art, and that those amendments “reflect a change in shape
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`of emitted light beyond a change in size, defined over the Examiner’s citation of
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`judicial notice of emitted light passing through a lens.” See EX2002-1291 at ¶ 42;
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`EX2002-1465 at ¶ 42. The prosecution history further confirms that the claims
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`require a change in the shape of the light and that a change in size is not considered
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`a change in shape. For example, if the first shape of light were a circle, a smaller
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`circle would not be considered a second shape. But a square would be considered a
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`different shape than a circle.
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`10. Fourth, the ITC also agreed that the “second shape” is “a shape different
`
`from the first shape.” I understand that on January 10, 2023, the ITC issued its Final
`
`Initial Determination on Violation of Section 337 in In the Matter of Certain Light-
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`Based Physiological Measurement Devices and Components Thereof, Inv. No. 337-
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`TA-1276 (“Investigation”). The ITC construed “second shape,” as used in the claim
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`phrase, to have its “plain and ordinary meaning, which the parties agree is ‘a shape
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`different from the first shape.’” EX2093 at 179-180. I understand that after the ITC
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`issued its Final Initial Determination, Apple confirmed that the ITC applied the
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`“correct construction” of “second shape,” which is a shape different from the first
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`shape. EX2075 at 36.
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`11. Thus, in my opinion, the plain language of the claims, the specification,
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`the prosecution history, and the parties’ prior agreed-upon plain meaning
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`construction that was adopted by the ITC, the phrase “change the first shape into a
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`second shape” means that the “second shape” must be “a shape different from the
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`first shape.”
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`12.
`
`I have reviewed the March 24, 2023 deposition transcript for Apple’s
`
`expert, Dr. Brian Anthony. Based on my review, I believe Dr. Anthony and Apple
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`interpreted the “second shape” claim limitation in these IPRs in a way that is
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`materially different than how it was interpreted in the ITC Investigation. Dr.
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`Anthony admitted that Apple never informed him about the prior constructions
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`before he signed his IPR declaration. EX2071 at 76:10-16, 79:8-84:10. However,
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`Dr. Anthony’s testimony shows that he interpreted “second shape” in a way that
`
`differs from the construction Apple previously agreed was the plain meaning. The
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`ITC Initial Determination stated all parties agreed that “second shape” is “a shape
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`different from the first shape.” EX2093 at 179-180. But Dr. Anthony refused to
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`agree that the shapes must be different and instead indicated that he believes the
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`“first shape” and “second shape” can be the same shape:
`
`Q. Would a person of ordinary skill in the art understand that if a first
`shape has to change into a second shape, second shape has to be
`different than the first shape?
`
`A. I think a person skilled in the art reading this would read it in the
`entire context; such that the shape is changed and the person would also
`understand that the shape that is coming out of the – that the first shape
`is a function of the materials, the arrangement of the lights. The second
`shape is a function of materials, the curvature of the human body. And
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`that there is a first shape and a second shape and they are being changed
`from one to the other. It’s a very degenerate solution to have the exact
`same shape. Doesn’t preclude that it could be. But person skilled in
`the art would know a first shape and a second shape.
`
`EX2071 at 108:9-109:5; see also id. at 104:3-113:6 (refusing to confirm the shapes
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`must be different). That is not correct. As I explained above, and as Apple
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`previously agreed, the claims require that the “first shape” and “second shape” be
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`different. Apple’s Petitions and Dr. Anthony’s declarations do not show, for
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`example, that their proposed combination of Sarantos and Shie would result in a
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`“second shape” that is different from the “first shape.”
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`13. Additionally, as I noted in my original declaration, Apple’s attempt to
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`equate the “material configured to change the first shape into a second shape” with
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`a diffuser would eliminate the requirement that the shapes be different. See EX2002-
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`1291 at ¶¶ 45-46; EX2002-1465 at ¶¶ 45-46. Claims 15 and 19 of the ’745 Patent
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`further confirm my opinion. Claim 15 recites “a light diffusing material” but does
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`not require that material to change a first shape into a second shape. Claim 19, which
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`depends from Claim 15, adds the limitation “wherein the light diffusing material is
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`configured to change the first shape into a second shape.” See EX1001 at Claims
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`15, 19. I have been informed and understand that when a dependent claim adds a
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`particular limitation, there is a presumption that the limitation is not present in the
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`independent claim. Thus, the claims confirm that a “light diffusing material” does
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`not necessarily, by itself, change a first shape of light into a second shape of light. I
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`also understand that the ITC similarly agreed that “light diffusion, in itself, does not
`
`necessarily provide changes in ‘shape.’” EX2093 at 190 n.71.
`
`V. DESCRIPTION OF APPLE’S ASSERTED REFERENCES
`Iwamiya (EX1004)
`A.
`14. U.S. Patent No. 8,670,819 to Iwamiya et al. is titled “OPTICAL
`
`BIOLOGICAL INFORMATION DETECTING APPARATUS AND OPTICAL
`
`BIOLOGICAL INFORMATION DETECTING METHOD.” Iwamiya discloses an
`
`optical sensor built into a wristwatch that can measure “biological information.”
`
`EX1004 at 5:54-67. The only example of “biological information” disclosed in
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`Iwamiya is a “pulse wave” which measures pulse rate. EX1004 at 9:4-5. Iwamiya
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`does not mention measurement of oxygen saturation. Iwamiya also identifies a
`
`problem where melanin pigment in the skin can absorb light with a wavelength under
`
`600 nm such that the signal received is too weak to detect a pulse wave. EX1004 at
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`1:53-2:6. To address that problem, Iwamiya uses a single wavelength of light at 940
`
`nm. Id. at 10:34-43. Iwamiya also teaches the use of an optical filter placed over
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`the light detector to filter out light with a wavelength under 900 nm to “alleviate[]
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`an influence from a measurement change due to external light, such as sunlight.” Id.
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`at 8:38-47.
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`Sarantos (EX1005)
`B.
`15. U.S. Patent No. 9,392,946 to Sarantos et al. is titled “HEART RATE
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`SENSOR WITH HIGH-ASPECT-RATIO PHOTODETECTOR ELEMENT.”
`
`EX1005 at Title. Sarantos teaches improvements to heart rate sensors by using so-
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`called “high-aspect-ratio” (HAR) photodetector elements which differ from
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`conventional photodetectors that have a square aspect ratio. Id. at 9:48-10:15.
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`Sarantos explains that the HAR photodetectors are able to improve light collection
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`capabilities while still having substantially the same active area as a conventional
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`square photodetector. See id. at 10:27-50, FIG. 5. Sarantos explains that the
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`concepts discussed in his patent are “discussed primarily with respect to light sources
`
`that emit green light, e.g., wavelengths in the range of 500 nm to 550 nm, although
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`it is contemplated that the photodetector element concepts discussed herein may see
`
`similar performance with light sources that emit light predominantly in the 500 nm
`
`to 600 nm range, which includes yellow light as well as some light orange light.”
`
`Id. at 18:35-41. Sarantos also explains that the invention is “not tailored for use in
`
`other spectrums, such as the red or infrared spectra,” which Sarantos noted would
`
`be the wavelengths used for measuring blood oxygenation levels. Id. at 18:44-51.
`
`C. Venkatraman (EX1006)
`16. U.S. Patent Application Publication 2014/0275854 to Venkatraman et
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`al. is titled “WEARABLE HEART RATE MONITOR” and discloses a pulse rate
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`monitor worn on the wrist. EX1006 at Abstract, FIGS. 2A-2B. I note, however, that
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`
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`Venkatraman uses paragraph numbers, but not columns and line numbers. Apple’s
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`petitions and Dr. Anthony’s declarations cite to Venkatraman using column and line
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`numbers, which are unclear.
`
`Shie (EX1007)
`D.
`17. U.S. Patent No. 6,483,976 to Shie et al. is titled “OPTICAL ELEMENT
`
`HAVING AN INTEGRAL SURFACE DIFFUSER” and was originally assigned to
`
`Physical Optics Corporation. EX1007 at Title. Shie describes over a dozen different
`
`types of optical elements depicted across 22 figures (counting subfigures). Id. at
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`FIGS. 1a-11. Shie explains that these various optical elements have a “plurality of
`
`surface micro-structures.” Id. at Abstract. However, Shie does not mention that any
`
`of the various optical structures have applications in a physiological sensor, let alone
`
`a pulse oximeter. See generally id. Nor does Shie explain any benefits that any of
`
`the optical structures might provide in a physiological sensor. Shie has nothing to
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`do with physiological sensors.
`
`Savant (EX1012)
`E.
`18. U.S. Patent 6,158,245 to Savant is titled “HIGH EFFICIENCY
`
`MONOLITHIC GLASS LIGHT SHAPING DIFFUSER AND METHOD OF
`
`MAKING.” EX1012 at Title. Both Savant (EX1012) and Shie (EX1007) were
`
`originally assigned to Physical Optics Corporation and both list Gajendra Savant as
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`an inventor. The Background of the Invention section in Savant describes a “Light
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`Shaping Diffuser™ (LSD®)” as a “transparent or translucent structure having an
`
`entrance surface, an exit surface, and light shaping structures formed on its entrance
`
`surface and/or in its interior.” EX1012 at 1:16-19.
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`19. However, Savant does not disclose any drawings of any particular
`
`“LSD.” Notably, Savant has no relation to physiological sensors. It does not
`
`describe any physiological sensors, let alone a pulse oximeter, nor does it explain
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`that an LSD would be used in a physiological sensor or any benefits that an LSD
`
`would provide to a physiological sensor. Rather, the disclosure of Savant focuses
`
`on the manufacturing process for an LSD. See generally EX1012.
`
`VI. A POSITA WOULD NOT HAVE HAD A REASONABLE
`EXPECTATION OF SUCCESS IN MEASURING OXYGEN SATURATION
`AT THE WRIST AND OBJECTIVE
`INDICIA CONFIRMS
`NONOBVIOUSNESS
`20. As explained above, I understand that obviousness is to be assessed as
`
`of the July 2, 2015 effective filing date for the ’745 Patent. As I explained previously
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`in my original declaration, Claims 9 and 18 require the measurement of oxygen
`
`saturation at the wrist. EX2002-1291 at ¶ 74. Apple’s obviousness arguments do
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`not demonstrate that a person of ordinary skill in the art would have reasonably
`
`expected success in making a device that can measure oxygen saturation from the
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`wrist as of the effective filing date for the ’745 Patent.
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`In my original declaration, I explained, based on what was publicly
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`
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`21.
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`available in the ITC briefs, that Apple’s engineers expressed skepticism that pulse
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`oximetry could be performed at the wrist and that others, including Apple itself,
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`failed for years to develop such a device. See EX2002-1291 at ¶¶ 86-90, 120-121,
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`177-196. I understand that Apple was ordered to produce certain documents and
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`testimony from the Investigation in this IPR. I have reviewed the produced
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`documents and testimony. The produced documents and testimony confirm that a
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`POSITA would not have had a reasonable expectation of success in measuring
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`oxygen saturation at the wrist as of the ’745 Patent’s July 2, 2015 effective filing
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`date.
`
`A. Apple’s Highly-Skilled Engineers Expressed Skepticism for Pulse
`Oximetry at the Wrist and Revealed that Others Had Failed
`In late 2014, Apple hired Dr. Paul Mannheimer to begin looking into
`22.
`
`pulse oximetry at the wrist for the Apple Watch. EX2077 at 996:9-997:8. Brian
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`Land, who is the chief of Apple’s Health Sensing Hardware Group and who led
`
`development of the health sensor hardware in the Apple Watch, testified that
`
`
`
`
`
` EX2076 at 954:15-955:9, 963:5-15; EX2008
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`at 39:21-25. Mannheimer holds a Ph.D. in biomedical engineering and had spent
`
`over twenty years designing pulse oximeters at one of Masimo’s major competitors,
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`Nellcor, and considered his specialty to be the physio-optics of pulse oximetry. See
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`
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`EX2077 at 994:2-25, 1009:1-8; EX2080 at 180:22-181:4.
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`23. Mannheimer explained that his first assignment at Apple was to
`
`
`
`
`
` EX2080 at 173:9-173:13; see also EX2077 at
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`996:25-997:5, 1012:12-25. Mannheimer testified,
`
`
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`internally to my head rolling my eyes, thinking, as I’d thought of it
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`in the past with other clients, like good luck with that.” EX2080 at 173:14-174:1;
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`see also EX2077 at 1012:12-25.
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`174:2-6.
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`24.
`
` He testified:
`
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`-15-
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` EX2080 at
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`EX2080 at 174:7-18; see also EX2077 at 1013:1-6 (same). Mannheimer also
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`explained that the products he previously worked on “operated on a much more
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`vascularized tissue bed, usually fingers or forehead,
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`but that in contrast, “[t]he wrist is just an incredibly different beast” because
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` EX2077 at 998:21-999:11. It
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`ultimately took Apple six years,
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`to develop the
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`blood oxygen feature. EX2080 at 174:19-175:5.
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`25. Other Apple engineers also shared Mannheimer’s skepticism for pulse
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`oximetry at the wrist. Dr. Stephen Waydo is the director of Apple’s team for health
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`algorithms on the Apple Watch. EX2078 at 919:1-8. Waydo spent four and a half
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`years working at a medical device startup trying to build a noninvasive glucose
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`measuring device before working at Apple. Id. at 920:3-6. Waydo testified that his
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`reaction to receiving the assignment to help develop the blood oxygen feature for
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`the Apple Watch was “both excited and, I’d say, intimidated.” EX2008, 938:3-12.
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`Waydo also explained that it was “extremely challenging” to develop the blood
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`oxygen feature in the Apple Watch and
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`16. He also testified:
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` EX2081 at 165:12-
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`IPR2022-01291
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`A. The wrist is one of the most difficult places on the body to do almost
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`every physiological measurement.
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`EX2081 at 166:4-166:18.
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`26. Waydo also
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`testified
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`that oxygen saturation and pulse rate
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`measurements are “very different,” and that measuring oxygen saturation requires
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`solving “a different set of problems.” EX2008 at 937:2-938:24.
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` EX2078 at 923:24-924:4.
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` Id. at 924:5-11. Waydo
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`also explained that his team of
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` engineers were “just a small piece of the
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`overall puzzle” but that they spent
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` just on developing the
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`algorithm architecture for the oxygen saturation feature, totaling between “20 or
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`30,000 hours of engineering time.” Id. at 925:23-926:6.
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`MASIMO 2070
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`IPR2022-01291
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`27. Another Apple engineer, Dr. Tao Shui, who also helped develop the
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`oxygen saturation feature in the Apple Watch, also testified:
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` The watch is worn on the wrist,
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`and the wrist is well known for its lack of signal.
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`EX2082 at 108:13-21.
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`28. Brian Land also testified that
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`work [] at the wrist, which was unprecedented –
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` “we also had to
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` EX2076 at 963:19-964:6.
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` EX2076 at
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` Land also testified
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`962:25-963:9
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`EX2080 at 174:19-175:5
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`IPR2022-01291
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`that
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` Id. at 984:17-21.
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`29. The testimony from Apple’s experienced engineers, including Apple’s
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`lead engineer on the oxygen saturation sensor project, mirrors my understanding.
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`As of 2015, it was my understanding and experience that pulse oximetry
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`measurements at the wrist were extremely challenging. Indeed, between 2005-2008,
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`I worked on designing a reflectance pulse oximeter for military and first responder
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`applications at a company I formed with my colleague, Professor Yitzhak
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`Mendelson. See EX2002-1291 at ¶¶ 55-58. We ultimately chose the forehead as
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`the intended measurement site for the pulse oximeter. My understanding at the time
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`was that other potential measurement sites like the wrist and the finger were not
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`viable. The finger was not viable because it would have been obtrusive for military
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`personnel and first responders who need to use their hands. The wrist also was not
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`viable due to the poor quality of PPG signals obtained there. Thus, the testimony of
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`Apple’s various engineers is consistent with my own experience and understanding.
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`Apple’s Petition and Dr. Anthony’s declaration are incorrect in stating that “wrist-
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`worn pulse oximetry sensors, such as that described in Sarantos, were well-known
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`in the art.” 1291 Pet. 20; EX1003-1291 at ¶ 48. I further note that Dr. Anthony (and
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`the Petition) do not identify or cite any examples of the allegedly “well-known”
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`wrist-worn pulse oximetry sensors. 1291 Pet. 20; EX1003-1291 at ¶ 48.
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`-19-
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`MASIMO 2070
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`B. Apple’s Internal Development Documents Confirm Their
`Engineers’ Skepticism and the Difficulties of Pulse Oximetry at the Wrist
`as of July 2015
`30. Apple’s internal development documents are also consistent with
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`Apple’s engineers’ testimony during the ITC Investigation. For example, Brian
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`Land testified
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`EX2076 at 962:25-963:4.
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`990:9.
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` See EX2085; EX2076 at 981:19-983:1, 989:21-
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` EX2085 at 6.
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` Id. at 7.
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`EX2085 at 8-9.|
`EX2085 at 8-9.
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`-21-
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`MASIMO 2070
`Apple v. Masimo
`IPR2022-01291
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`MASIMO 2070
`Apple v. Masimo
`IPR2022-01291
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`Id. at 13.
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` “Conventional sensing methods do not result in
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`waveforms that are consistent enough for SpO2 measurements at the wrist.” Id.
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`MASIMO 2070
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`IPR2022-01291
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` Id.
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` These statements show how actual engineers, who have
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`significantly more skill than the ordinary level of skill in the art, viewed pulse
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`oximetry at the wrist
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`. This is also consistent with my understanding at the time
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`that conventional pulse oximetry at the wrist was not feasible and that innovation
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`was needed.
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`32. Apple’s documents show
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` See EX2083.
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` Id.
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` Id. at 7.
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`33. As I noted in paragraphs 188-192 of Exhibit 2002-1291, it was not until
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`Apple redesigned the optical sensor in the Apple Watch to include a new optical
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`material called a microlens array (MLA) that changed the shape of light that Apple
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`was able to achieve pulse oximetry at the wrist.
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`MASIMO 2070
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`IPR2022-01291
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` EX2077 at 1020:8-20.
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`EX2079 at 824:13-23, 826:13-20.
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` EX2085 at 13.
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`34.
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` The testimony of Apple’s engineers Dr. Paul Mannheimer, Brian Land,
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`Dr. Stephen Waydo, Dr. Tao Shui, and Dr. Ueyn Block demonstrate skepticism for
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`measuring oxygen saturation at the wrist due to challenges with the physiology of
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`the wrist as of the effective filing date for the ’745 patent and after.
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`to develop the oxygen saturation sensor for the Apple Watch Series 6. Thus, the
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`evidence also shows that others, including Apple, failed to achieve oxygen saturation
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` it ultimately took Apple years
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`-24-
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`MASIMO 2070
`Apple v. Masimo
`IPR2022-01291
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`measurements at the wrist as of the ’745 Patent’s effective filing date. Given the
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`struggles of Apple’s highly-educated and highly-experienced engineers even after
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`the ’745 Patent’s July 2, 2015 effective filing date, a POSITA with less education
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`and less experience than Apple’s engineers would not have had a reasonable
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`expectation of success in developing a device that measures oxygen saturation at the
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`wrist as of the ’745 Patent effective filing date. That is consistent with my
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`understanding at the time that measuring oxygen saturation at the wrist was not yet
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`feasible. Thus, in my opinion, a POSITA would not have had a reasonable
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`expectation of success in measuring oxygen saturation at the wrist at the time of the
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`’745 Patent.
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`C. Apple’s “Supplemental Information” Does Not Demonstrate a
`Reasonable Expectation of Success for Measuring Oxygen Saturation at
`the Wrist as of July 2015 or Negate the Objective Indicia of
`Nonobviousness
`I understand that Apple has filed “supplemental information” in the
`35.
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`IPRs. I understand that Apple identified the “supplemental information” as
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`testimony from Apple engineers Ueyn Block (EX1036) and Saahil Mehra (EX1037),
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`and testimony from Apple’s expert witness in the ITC, Dr. Steven Warren, (found
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`in EX2008, which is a transcript of the public sessions of the entire ITC hearing),
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`and ITC exhibits RX-0335 (EX1038), RX-0504 (EX1039), RX-0508 (EX1040),
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`RX-0632 (EX1041). However, neither Apple’s Petition nor Dr. Anthony’s
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`declaration referenced or made an argument about any of the “supplemental
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`-25-
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`MASIMO 2070
`Apple v. Masimo
`IPR2022-01291
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`information” and so I do not know how the “supplemental information” relates to
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`either the Petition or Dr. Anthony’s declaration. Regardless, I have reviewed the
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`“supplemental information” and it does not change my opinion that a POSITA would
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`not have had a reasonable expectation of success in measuring oxygen saturation at
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`the wrist as of July 2015 or that the objective indicia also discussed above show that
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`the ’745 Patent claims that require oxygen saturation at the wrist would not have
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`been obvious.
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`36. Dr. Block’s testimony further confirms my opinion that a POSITA
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`would not have had a reasonable expectation of success in measuring oxygen
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`saturation at the wrist as of the earliest effective filing date of the ’745 Patent.
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` EX1036 at 902:13-19.
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`37.
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`I have reviewed Dr. Mehra’s testimony, and it also does not change my
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`opinion.
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`-26-
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`MASIMO 2070
`Apple v. Masimo
`IPR2022-01291
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`6. Thus, in my opinion, Dr. Mehra’s testimony is not relevant to the skepticism or
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`expectation of success as of the earliest effective filing date of the ’745 Patent’s
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` EX2008 at 852:1-
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`invention.
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`38. Dr. Steven Warren’s testimony and ITC exhibits RX-0504, RX-0508,
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`and RX-0632 also do not change my opinion. As an initial matter, I understand that
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`Dr. Warren is not Apple’s expert in these IPRs and also was not Apple’s expert with
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`respect to the ’745 Patent in the ITC Investigation. In the ITC Investigation, Dr.
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`Warren presented opinions regarding U.S. Patent Nos. 10,912,501, 10,912,502, and
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`10,945,648, which are unrelated to the ’745 Patent. I understand, however, that in
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`the ITC, Dr. Warren tes