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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`
`
`APPLE INC.
`
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`
`Patent Owner.
`
`________________
`
`
`
`Case IPR2020-01526
`U.S. Patent 6,771,994
`________________
`
`
`PETITIONER’S REPLY TO PATENT OWNER RESPONSE
`
`
`
`
`
`Case No. IPR2020-01526
`Attorney Docket: 50095-0005IP1
`
`I.
`II.
`
`TABLE OF CONTENTS
`
`INTRODUCTION ........................................................................................... 1
`GROUND 1 ESTABLISHES OBVIOUSNESS ............................................. 1
`A. Diab explicitly discloses removing the scattering medium from its
`photodetector, which is consistent with the proposed combination ......... 1
`B. Adding the light control film over Diab’s photodetector would reduce
`the amount of ambient light reaching the photodetector .......................... 2
`C. Masimo’s argument regarding the results of the Diab-Benjamin-Melby
`combination lacking predictability fails ................................................... 2
`III. GROUND 2 ESTABLISHES OBVIOUSNESS ............................................. 4
`A. Masimo’s arguments mischaracterize Webster’s disclosure of placing a
`light filter over the photodetector to minimize the effects of ambient
`light ........................................................................................................... 4
`IV. GROUND 3 ESTABLISHES OBVIOUSNESS ............................................. 5
`A. Masimo’s arguments regarding the complexity and price of Fine’s
`design are irrelevant .................................................................................. 5
`B. Fine’s bundles of optical fibers teach or suggest the claimed “plurality
`of louvers” ................................................................................................. 6
`V. GROUND 4 ESTABLISHES OBVIOUSNESS ............................................. 8
`A. Masimo mischaracterizes the proposed combination ............................... 8
`VI. CONCLUSION ................................................................................................ 9
`
`
`
`
`
`ii
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`Case No. IPR2020-01526
`Attorney Docket: 50095-0005IP1
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`
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`EXHIBITS
`
`APPLE-1001
`
`U.S. Patent No. 6,771,994
`
`APPLE-1002
`
`File History for U.S. Patent No. 6,771,994
`
`APPLE-1003
`
`Declaration of Dr. Anthony
`
`APPLE-1004
`
`Reserved
`
`APPLE-1005
`
`Masimo Corporation, et al. v. Apple Inc., Complaint, Civil
`Action No. 8:20-cv-00048 (C.D. Cal.)
`
`APPLE-1006
`
`U.S. Patent No. 5,638,818 (“Diab”)
`
`APPLE-1007
`
`U.S. Patent No. 4,015,595 (“Benjamin”)
`
`APPLE-1008
`
`U.S. Patent No. 5,254,388 (“Melby”)
`
`APPLE-1009
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`WO Pub. No. 1996/41566 (“Fine”)
`
`APPLE-1010
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`Excerpts from Design of Pulse Oximeters, J.G. Webster;
`Institution of Physics Publishing, 1997 (“Webster”)
`
`APPLE-1011
`
`Tremper, Pulse Oximetry, Anesthesiology, The Journal of the
`American Society of Anesthesiologists, Inc., Vol. 70, No. 1
`(January 1989) (“APPLE-1011”)
`
`APPLE-1012
`
`Mendelson, Skin Reflectance Pulse Oximetry: In Vivo
`Measurements from the Forearm and Calf, Journal of Clinical
`Monitoring, Vol. 7, No. 1 (January 1991) (“APPLE-1012”)
`
`
`
`APPLE-1013
`
`Excerpts from Bronzino, The Biomedical Engineering
`Handbook, CRC Press, Inc. (1995) (“APPLE-1013”)
`
`APPLE-1014
`
`Konig, Reflectance Pulse Oximetry – Principles and Obstetric
`Application in the Zurich System, Journal of Clinical
`Monitoring, Vol. 14, No. 6 (August 1998) (“APPLE-1014”)
`
`iii
`
`
`
`
`APPLE-1015
`
`Declaration of Jacob Munford
`
`APPLE-1016 to 1030
`
`Reserved
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`Case No. IPR2020-01526
`Attorney Docket: 50095-0005IP1
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`APPLE-1031
`
`Scheduling Order, Masimo v. Apple et al., Case 8:20-cv-00048,
`Paper 37 (April 17, 2020)
`
`APPLE-1032
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`Stipulation by Apple
`
`APPLE-1033
`
`Telephonic Status Conference, Masimo v. Apple et al., Case
`8:20-cv-00048, Paper 78 (July 13, 2020)
`
`APPLE-1034
`
`APPLE-1035
`
`Joseph Guzman, “Fauci says second wave of coronavirus is
`‘inevitable’”, TheHill.com (Apr. 29, 2020), available at:
`https://thehill.com/changing-america/resilience/natural-
`disasters/495211-fauci-says-second-wave-of-coronavirus-is
`
`“Tracking the coronavirus in Los Angeles County,”
`LATimes.com (Aug. 20, 2020), available at
`https://www.latimes.com/projects/california-coronavirus-cases-
`tracking-outbreak/los-angeles-county/
`
`
`APPLE-1036
`
`Reserved
`
`APPLE-1037
`
`Order Regarding Motion to Stay (Redacted) in Masimo
`Corporation et al. v. Apple Inc., Case 8:20-cv-00048, October
`13, 2020
`
`APPLE-1038
`
`Deposition Transcript of Dr. Vijay Madisetti
`
`
`
`iv
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`Case No. IPR2020-01526
`Attorney Docket: 50095-0005IP1
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`
`I.
`
`Introduction
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`Apple Inc. (“Petitioner” or “Apple”) submits this Reply to Patent Owner’s
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`Response (“POR”) to the Petition for Inter Partes Review (“IPR”) of U.S. Patent
`
`No. 6,771,994 (“the ’994 patent”) filed by Masimo Corporation (“Patent Owner”
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`or “Masimo”). As demonstrated below with reference to evidence including Dr.
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`Anthony’s testimony, the POR fails to address, much less rebut, positions
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`advanced in the Petition. Accordingly, Apple respectfully submits that the Board
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`should find claim 15 (“the Challenged Claim”) of the ’994 patent unpatentable.
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`II. Ground 1 Establishes Obviousness
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`A. Diab explicitly discloses removing the scattering medium from its
`photodetector, which is consistent with the proposed combination
`
`Masimo argues that a POSITA would have had no reason to perform the
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`combination of Diab, Benjamin, and Melby. See POR, 28-33. In particular,
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`Masimo argues that “neither Apple nor the Board explains why a POSITA
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`explicitly seeking to scatter light as the critical teaching of Diab would make
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`modifications to eliminate this core feature and cause the light to be uniform in
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`direction.” See id., 30-31. Masimo argues that this purportedly “critical teaching”
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`of Diab is its “scattering medium…interposed between the” user tissue “and the
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`photodetector,” which the Petition proposes replacing in the combination. See id.,
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`29-31; APPLE-1006, 4:8-10. But Diab explicitly discloses examples in which the
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`scattering medium is “interposed” only “between the light source and the” the user
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`1
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`tissue, and describes these examples as “result[ing] in an improved optical signal-
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`to noise ratio.” APPLE-1006, 4:6-12. Accordingly, based on Diab’s explicit
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`Case No. IPR2020-01526
`Attorney Docket: 50095-0005IP1
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`disclosure, Masimo’s argument fails.
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`B. Adding the light control film over Diab’s photodetector would
`reduce the amount of ambient light reaching the photodetector
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`Masimo argues that “the combination of Diab’s absorbing chamber wall and
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`Melby’s light control film would reduce the total light received by the
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`photodetector 426” and “make the signal more difficult to interpret.” POR, 35. As
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`explained in the Petition, in the combination, the light control film blocks ambient
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`light (i.e., light that has not passed through the tissue). Petition, 19-29. This
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`ambient light is noise not signal, because it cannot be used to calculate oxygen
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`saturation. See Petition, 22; APPLE-1006, 17:62-18:22 Thus, even if the “total
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`light received by the photodetector 426” were reduced by the introduction of the
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`light control film, much of the light constituting the reduction would be ambient
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`light, thereby increasing the signal to noise ratio and, contrary to Masimo’s
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`argument, making the signal easier to interpret. See Petition, 28; APPLE-1008,
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`3:65-4:10; APPLE-1003, [0069]-[0073]. Accordingly, Masimo’s argument fails.
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`C. Masimo’s argument regarding the results of the Diab-Benjamin-
`Melby combination lacking predictability fails
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`Masimo argues that the Diab-Melby-Benjamin combination would not have
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`led to predictable results because “the FDA considers introducing a component in
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`2
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`Attorney Docket: 50095-0005IP1
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`the light path a significant modification that should undergo further regulatory
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`review.” POR, 37-38. For support, Masimo and cites to a document (Ex-2005) it
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`refers to as “FDA Guidance,” which is dated “March 4, 2013.” See Ex-2005, 1;
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`POR, Exhibit List (confirming March 2013 date for Ex-2005). As noted in the
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`Petition, the ’994 patent claims an earliest priority date of June 18, 1999 (the
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`“Critical Date”). See APPLE-1001, Face; Petition, 1. Masimo fails to explain
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`what relevance, if any, this purported FDA Guidance document from over a
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`decade after the Critical Date of the ’994 patent has to the present obviousness
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`analysis.
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`Even if the FDA Guidance cited by Masimo were from the relevant
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`timeframe for our present analysis (which they are not), Masimo cites no case law
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`or other authority standing for its proposition that the possibility of burdensome or
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`expensive regulatory processes can dissuade a POSITA from arriving at a claimed
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`invention. See POR, 37-38. Petitioner is similarly unaware of any authority
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`endorsing such an approach. And because obtaining regulatory approval is neither
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`a requirement for patentability, nor recited as an element of the present claims, it
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`seems irrelevant to the issue of whether claim 15 is unpatentable.
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`Accordingly, Masimo’s arguments relating to the predictability of the Diab-
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`Benjamin-Melby combination lack merit.
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`3
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`Attorney Docket: 50095-0005IP1
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`III. Ground 2 Establishes Obviousness
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`A. Masimo’s arguments mischaracterize Webster’s disclosure of
`placing a light filter over the photodetector to minimize the effects
`of ambient light
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`Masimo argues that “Apple conflates Webster’s wavelength filter, one
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`component, with the optical effect of the barrier, a different component,” and that a
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`POSITA would not have been motivated to combine Webster and Melby. POR,
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`42-46 (Sections C.1, C.2). But the Petition merely relies on the explicit disclosure
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`of Webster. See Petition, 39. For example, Webster states that “it is important to
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`minimize the effects from light other than the optical signals of interest.” APPLE-
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`1010, 79. “One way to minimize unwanted light incident upon the detector is to
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`place some type of light filter over the detector.” Id. Webster describes that one
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`type of “unwanted light” that should be minimized is “ambient light”—which is
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`the type of light the light control film of Melby is designed to minimize. See id.;
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`APPLE-1008, Abstract, 3:1-8, 3:46-4:25, FIGS. 1-2; Petition, 39-44; APPLE-1003,
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`[0092]-[0105].
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`Thus, as established in the Petition, Webster recognizes the need to
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`minimize unwanted light reaching the detector, and recognizes that light filters can
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`be used for this purpose. See APPLE-1010, 79; Petition, 39; APPLE-1003, [0092]-
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`[0095]. The Petition further establishes that a POSITA would have been motivated
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`to use Melby’s light control film as such a light filter in Webster’s system, and that
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`4
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`the results of the combination would have been predictable. See Petition, 39-44;
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`Case No. IPR2020-01526
`Attorney Docket: 50095-0005IP1
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`APPLE-1003, [0092]-[0105].
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`Masimo’s arguments appear to characterize Webster as requiring a
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`wavelength filter, when in fact Webster’s disclosure provides this only as one
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`example mechanism for limiting unwanted light. See APPLE-1010, 79. Webster
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`even makes clear that it requires no such thing, stating that such wavelength filters
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`“do not appear to be used much in actual pulse oximetry designs.” Id. Thus,
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`Masimo’s arguments mischaracterize Webster’s disclosure and fail to address the
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`Petition arguments.
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`IV. Ground 3 Establishes Obviousness
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`A. Masimo’s arguments regarding the complexity and price of Fine’s
`design are irrelevant
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`Masimo argues that “Fine’s expensive and complex fetal sensor design
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`would not form the basis for a POSITA looking to design a pulse oximetry sensor.”
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`POR, 47 (Section C.1). But regardless of how “complex” or “expensive” Fine’s
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`invention would be to implement, Fine’s disclosure is nonetheless prior art with
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`respect to the ’994 patent. See Raytheon v. General Electric, 993 F. 3d 1374, 1380
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`(Fed. Cir. 2021) (A reference “is prior art for all that it teaches.”) (quoting
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`Beckman Instruments v. LKB Produkter, 892 F.2d 1547, 1551 (Fed. Cir. 1989)).
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`Masimo does not cite, and Petitioner is not aware of, any authority for
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`disqualifying a prior art reference from an obviousness analysis due to its
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`5
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`complexity or the cost to implement the invention it describes. Accordingly, these
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`Case No. IPR2020-01526
`Attorney Docket: 50095-0005IP1
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`arguments fail.
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`B.
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`Fine’s bundles of optical fibers teach or suggest the claimed
`“plurality of louvers”
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`As explained at length in the Petition, “Fine’s fiber bundles 63 and 64 teach
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`a plurality of louvers positioned over its detector that accept light from the LEDs
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`originating from the LEDs through tissue.” See APPLE-1009, 16:31-17:5;
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`Petition, 54; APPLE-1003, [0126]. The Petition explains that each fiber in the
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`bundles “terminate[s] with an oblique cut.” APPLE-1009, 17:14-18; Petition, 54.
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`Due to the oblique cut on the end of the fiber, “the specular reflection and shunted
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`light which mostly come to the 30 surface 72 from left of the ray 74 will not be
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`perceived by the detector,” while light arriving from the reflective deep layers of
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`the tissue in directions substantially perpendicular to surface 71 in a rather wide
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`area confined between rays 74 and 75” will be perceived by the detector. See
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`APPLE-1009, 17:28-18:1; Petition, 55-56; APPLE-1003, [0128]. This is shown in
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`the following annotated FIG. 5 from Fine included in the Petition:
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`6
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`Case No. IPR2020-01526
`Attorney Docket: 50095-0005IP1
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`APPLE-1009, FIG. 5 (as annotated at Petition, 56)
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`The Petition concludes that “a POSITA would have recognized that each of
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`the separate fibers within the fiber optic bundle 57 acts as a louver positioned over
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`a light detector of Fine’s probe” and “a POSITA would have understood fibers 70
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`and 80 to teach separate louvers because the walls of the fibers serve to direct light
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`and control the scope of vision of the fibers.” Petition, 57; APPLE-103, [0125]-
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`[0130].
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`Masimo’s positions largely ignore the Petition arguments and focus on
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`Fine’s optical fibers “accept light from a three-dimensional acceptance cone” and
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`not being structured like “window shutters…or set of angled slats”—neither of
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`which are requirements of the louvers of claim 15. See POR, 48. None of
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`7
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`Case No. IPR2020-01526
`Attorney Docket: 50095-0005IP1
`
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`Masimo’s arguments address the Petition’s specific analysis of how a “POSITA
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`would have recognized that each of the separate fibers within the fiber optic bundle
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`57 acts as a louver positioned over a light detector of Fine’s probe.” Petition, 57;
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`APPLE-103, [0125]-[0130]. Accordingly, Masimo’s arguments fail.
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`V. Ground 4 Establishes Obviousness
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`A. Masimo mischaracterizes the proposed combination
`
`Masimo argues that the Petition proposes “implement[ing] a light control
`
`film over Fine’s detectors 65 at the termination of the optical fibers 63, 64”, and
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`indicates this supposed location of the light control film with a red arrow in the
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`following annotated FIG. 4 from Fine in the POR. POR, 53; see APPLE-1038,
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`53:5-56-14:
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`8
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`Case No. IPR2020-01526
`Attorney Docket: 50095-0005IP1
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`
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`APPLE-1009, FIG. 4 (as annotated at POR, 53)
`In fact, the Petition proposes incorporating the light control film not at the
`
`“termination” of the fibers as Masimo states, but at the origination side of the fiber
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`(i.e., the green arrow in the above figure). See Petition, 67. Specifically, the
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`Petition states that “a POSITA would have understood that the fibers could thus
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`accept light from the light emission device from a particular direction based on the
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`angle of the louvers within the light control film.” Id. Thus, in the combination,
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`the light control film is implemented at the originating side of the fibers (i.e.,
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`where the fibers “accept” light), not at the “termination” of the fibers near the
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`detector as Masimo argues. Id.
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`Accordingly, Masimo arguments mischaracterize, and thus fail to address,
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`the Fine-Benjamin-Melby combination proposed in the Petition.
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`VI. CONCLUSION
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`Petitioner respectfully submits that the Board should find the Challenged
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`Claim unpatentable.
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`9
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`Dated: October 22, 2021
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`(Control No. IPR2020-01526)
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`Case No. IPR2020-01526
`Attorney Docket: 50095-0005IP1
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`Respectfully submitted,
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`
`/Dan Smith/
`W. Karl Renner, Reg. No. 41,265
`Dan Smith, Reg. No. 71,278
`Fish & Richardson P.C.
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`T: 202-783-5553
`F: 877-769-7945
`
`Attorneys for Petitioner
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`10
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`Case No. IPR2020-01526
`Attorney Docket: 50095-0005IP1
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`CERTIFICATION UNDER 37 CFR § 42.24
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`Under the provisions of 37 CFR § 42.24(d), the undersigned hereby certifies
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`that the word count for the foregoing Petitioner’s Reply to Patent Owner’s
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`Response totals 1,685 words, which is less than the 5,600 allowed under 37 CFR
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`§ 42.24.
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`
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`Dated: October 22, 2021
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`/Dan Smith/
`W. Karl Renner, Reg. No. 41,265
`Dan Smith, Reg. No. 71,278
`Fish & Richardson P.C.
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`T: 202-783-5070
`F: 877-769-7945
`
`Attorneys for Petitioner
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`11
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 CFR §§ 42.6(e)(4)(i) et seq., the undersigned certifies that on
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`October 22, 2021, a complete and entire copy of this Petitioner’s Reply to Patent
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`Owner’s Response was provided by electronic mail to the Patent Owner by serving
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`the correspondence e-mail address of record as follows:
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`Joseph R. Re
`Stephen W. Larson
`Jarom D. Kesler
`Shannon H. Lam
`Benjamin A. Katzenellenbogen
`
`Knobbe, Martens, Olson, & Bear, LLP
`2040 Main St., 14th Floor
`Irvine, CA 92614
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`Email: AppleIPR2020-1526-994@knobbe.com
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`/Crena Pacheco/
`Crena Pacheco
`Fish & Richardson P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`(617) 596-5938
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