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`
`Attorney Docket No.: 50095-0013IP1
`
`Jeroen Poeze et al.
`In re Patent of:
`U.S. Patent No.: 10,588,554
`Issue Date:
`March 17, 2020
`Appl. Serial No.: 16/544,713
`Filing Date:
`August 19, 2019
`Title:
`MULTI-STREAM DATA COLLECTION SYSTEM FOR
`NONINVASIVE MEASUREMENT OF BLOOD
`CONSTITUENTS
`
`
`
`SECOND DECLARATION OF DR. THOMAS W. KENNY
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`I hereby declare that all statements made of my own knowledge are true and
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`that all statements made on information and belief are believed to be true. I further
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`declare that these statements were made with the knowledge that willful false
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`statements and the like so made are punishable by fine or imprisonment, or both,
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`under Section 1001 of the Title 18 of the United States Code.
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`Dated: August 30, 2021
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`By:
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`Thomas W. Kenny, Ph.D.
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`APPLE 1047
`Apple v. Masimo
`IPR2020-01538
`
`1
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`
`
`I.
`II.
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`TABLE OF CONTENTS
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`INTRODUCTION ........................................................................................... 1
`GROUND 1 ..................................................................................................... 3
`A. Ohsaki does not describe, much less require, its convex translucent
`board 8 to be “rectangular” in shape. ...................................................... 10
`B. A POSITA would have recognized the benefits of Ohsaki’s teachings
`when applied to Mendelson-799’s sensor, at virtually any measurement
`location. ................................................................................................... 13
`C. Adding a convex cover to Mendelson-799 as taught by Ohsaki enhances
`the sensor’s light-gathering ability. ........................................................ 16
`1.
`Patent Owner ignores the behavior of scattered light in relation to
`reflectance-type pulse sensors and oximeters. .............................. 16
`2. A POSITA would have implemented the sensor resulting from the
`combination of Mendelson-799 and Ohsaki to prevent air gaps
`between the skin and the detectors ................................................ 21
`D. A POSITA would have found the advantages of using a convex cover to
`outweigh the slight possibility of scratching the cover .......................... 22
`E. A POSITA would have added an opaque layer to the combined sensor of
`Mendelson-799 and Ohsaki based on the teachings of Schulz ............... 23
`1. A POSITA would have modified the combined sensor of
`Mendelson-799 and Ohsaki to guard against saturation based on
`Schulz’s teachings ......................................................................... 23
`Schulz’s teachings are applicable to the combined sensor of
`Mendelson-799 and Ohsaki ........................................................... 25
`3. A POSITA would have understood Schulz’s teachings to render
`obvious a corresponding window for each of at least four
`detectors. ........................................................................................ 27
`4. A POSITA would have understood Schulz’s window to restrict the
`amount of ambient light reaching its photodetectors .................... 28
`F. A POSITA would have enabled the combined sensor of Mendelson-799,
`Ohsaki, and Schulz to commnunicate wirelessly with a handheld
`computing device, based on the teachings of Mendelson-2006 ............. 30
`G. A POSITA would have expected success in performing the combination
` ................................................................................................................. 32
`H. The challenged dependent claims are rendered obvious by Mendelson-
`799, Ohsaki, Schulz, and Mendelson-2006. ........................................... 33
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`2.
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`ii
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`2
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`III. CONCLUSION .............................................................................................. 35
`TH.
`CONCLUSION(0c eeeeeeseeeseeeseeeseeeeaeeeaeeeseeesaeeeaeecsaecsaessaeseseeeseeeeaees 35
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`
`iii
`ill
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`3
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`I.
`Introduction
`I have been retained on behalf of Apple Inc. to offer technical opinions
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`1.
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`relating to U.S. Patent No. 10,588,554 (“the ’554 Patent”) in the present case
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`(IPR2020-01538). In this Second Declaration, I provide opinions related to Patent
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`Owner’s Response (Paper 24) and Dr. Madisetti’s supporting declaration (Ex.
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`2004).
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`2.
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`In addition to the materials listed in my First Declaration (APPLE-1003), I
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`have also reviewed the following materials:
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` Paper 8: Institution Decision;
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` Paper 23: Patent Owner’s Response (“POR”);
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` Ex. 2004: Declaration of Dr. Madisetti;
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` Ex. 2006-2009: Transcripts of my prior depositions;
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` APPLE-1039: Excerpts of Eugene Hecht, Optics (2nd Ed. 1990), pages
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`79-143, 211-220;
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` APPLE-1040: Eugene Hecht, Optics (2nd Ed. 1990);
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` APPLE-1041: Deposition Transcript of Dr. Vijay Madisetti in IPR2020-
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`01520, IPR2020-01537, IPR2020-01539, Day 1 (August 1, 2021);
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` APPLE-1042: Deposition Transcript of Dr. Vijay Madisetti in IPR2020-
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`01520, IPR2020-01537, IPR2020-01539, Day 2 (August 2, 2021);
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`4
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` APPLE-1043: Deposition Transcript of Dr. Vijay Madisetti in IPR2020-
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`01536, IPR2020-01538 (August 3, 2021);
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` APPLE-1044: “Refractive Indices of Human Skin Tissues at Eight
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`Wavelengths and Estimated Dispersion Relations between 300 and 1600
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`nm,” H. Ding, et al.; Phys. Med. Biol. 51 (2006); pp. 1479-1489
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`(“Ding”);
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` APPLE-1045: “Analysis of the Dispersion of Optical Plastic Materials,”
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`S. Kasarova, et al.; Optical Materials 29 (2007); pp. 1481-1490
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`(“Kararova”);
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` APPLE-1046: “Noninvasive Pulse Oximetry Utilizing Skin Reflectance
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`Photoplethysmography,” Y. Mendelson, et al.; IEEE Transactions on
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`Biomedical Engineering, Vol. 35, No. 10, October 1988; pp. 798-805
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`(“Mendelson-IEEE-1988”);
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` APPLE-1049: Eugene Hecht, Optics (4th Ed. 2002).
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`3.
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`Counsel has informed me that I should consider these materials through the
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`lens of one of ordinary skill in the art related to the '554 Patent at the time of the
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`earliest possible priority date of the '554 Patent (July 3, 2008, hereinafter the
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`“Critical Date”) and I have done so during my review of these materials. I have
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`applied the same level of ordinary skill in the art described in my prior declaration,
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`5
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`which I have been informed was also adopted by the Board in the Institution
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`Decision. APPLE-1003, [0020]-[0021]; Institution Decision, 11.
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`4.
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`I have no financial interest in the party or in the outcome of this proceeding.
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`I am being compensated for my work as an expert on an hourly basis. My
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`compensation is not dependent on the outcome of these proceedings or the content
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`of my opinions.
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`5.
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`In writing this declaration, I have considered the following: my own
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`knowledge and experience, including my work experience in the fields of
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`mechanical engineering, computer science, biomedical engineering, and electrical
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`engineer; my experience in teaching those subjects; and my experience in working
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`with others involved in those fields. In addition, I have analyzed various
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`publications and materials, in addition to other materials I cite in my declaration.
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`6. My opinions, as explained below, are based on my education, experience,
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`and expertise in the fields relating to the '554 Patent. Unless otherwise stated, my
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`testimony below refers to the knowledge of one of ordinary skill in the fields as of
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`the Critical Date, or before.
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`II. Ground 1
`In its POR, Masimo first addresses the “Mendelson ’799 and Ohsaki”
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`7.
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`portion of the full Mendelson ’799-Ohsaki-Schulz-Mendelson 2006 combination
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`advanced in Ground 1. As I explained at length in my first declaration, “Ohsaki
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`6
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`would have motivated one of ordinary skill to add a light permeable protruding
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`convex cover to Mendelson ’799’s sensor, to [1] improve adhesion between the
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`sensor and the user’s tissue, to [2] improve detection efficiency, and to [3] provide
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`additional protection to the elements accommodated within sensor housing 17.”
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`APPLE-1003, [0146] (citing APPLE-1009, [0015], [0017], [0025], FIGS. 1, 2, 4A,
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`4B). Rather than attempting to rebut my previous testimony on these points,
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`Masimo offers, through its witness Dr. Madisetti, arguments that are factually
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`flawed and legally irrelevant.
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`8.
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`Specifically, Masimo contends that the Mendelson-799 and Ohsaki
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`references “employ (1) different sensor structures (rectangular versus circular), (2)
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`for different measurements (pulse rate versus oxygen saturation)…(3) in different
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`measurement locations,” and from this concludes that “[a] POSITA would not
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`have been motivated to combine the references,” and would not have “reasonably
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`expected such a combination to be successful.” POR, 1-4.
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`9.
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`In this way, the POR avoids addressing the merits of the combinations
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`advanced in Apple’s Petition, and ignores the “inferences and creative steps” that a
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`POSITA would have taken when modifying Mendelson-799’s sensor to achieve
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`the benefits taught by Ohsaki. KSR Intern. Co. v. Teleflex Inc., 550 U.S. 398, 418
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`(2007).
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`7
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`10. Contrary to Masimo’s contentions, Ohsaki nowhere describes its benefits as
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`being limited to a rectangular pulse rate sensor applied to a particular body
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`location, and a POSITA would not have understood those benefits as being so
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`limited. Instead, and as shown in Ohsaki’s FIG. 2 (reproduced below), Ohsaki
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`attributes the reduction of slippage afforded by use of translucent board 8 (and
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`related improvements in signal quality) to the fact that “the convex surface of the
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`translucent board…is in intimate contact with the surface of the user’s skin”1
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`when the sensor is worn. APPLE-1003, [0148]; APPLE-1009, [0015], [0017]-
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`[0018], [0025], FIGS. 1, 2, 4A, 4B.
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`APPLE-1009, FIG. 2 (annotated).
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`1 Unless otherwise noted, emphases in quotations throughout this Reply are added.
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`8
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`11. Notably absent from Ohsaki’s discussion of these benefits is any mention or
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`suggestion that they relate to a shape of the exterior edge of translucent board 8
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`(whether circular, rectangular, ovoid, or other). Rather, when describing the
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`advantages associated with translucent board 8, Ohsaki contrasts a “convex
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`detecting surface” from a “flat detecting surface,” and explains that “if the
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`translucent board 8 has a flat surface, the detected pulse wave is adversely affected
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`by the movement of the user’s wrist,” but that if the board “has a convex
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`surface…variation of the amount of the reflected light…that reaches the light
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`receiving element 7 is suppressed.” APPLE-1003, [0149]; APPLE-1008, [0015],
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`[0025].
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`12. From this and related description, a POSITA would have understood that a
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`light permeable protruding convex cover would reduce the adverse effects of user
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`movement on signals obtainable by the detectors within Mendelson-799’s sensor,
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`which like Ohsaki’s light receiving elements, detect light reflected from user
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`tissue. APPLE-1009, [0025]; FIGS. 4A, 4B; APPLE-1012, 3:5-14, 6:16-35, 8:27-
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`29, 1:41-60; APPLE-1019, 36-37, 87-88, 91, 124. Indeed, the POSITA would
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`have found it obvious to improve Mendelson-799’s pulse oximeter based on
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`Ohsaki’s teachings, and would have been fully capable of making any inferences
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`and creative steps necessary to achieve the benefits obtainable by attaching a light
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`9
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`permeable protruding convex cover to Mendelson-799’s housing.2 KSR Intern. Co.
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`v. Teleflex Inc., 550 U.S. 398, 418 (2007); see also APPLE-1008, [0058], FIG. 2;
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`APPLE-1026, [0022], [0032], [0035], FIG. 6. The following annotated FIG. 7
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`from Mendelson-799 shows the results of the proposed combination:
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`2 Notably, Ohsaki nowhere depicts or describes its cover as rectangular. APPLE-
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`1049, ¶19; APPLE-1009, [0001]-[0030]; FIGS. 1, 2, 3A, 3B, 4A, 4B. Even if
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`Ohsaki’s cover were understood to be rectangular, “[t]he test for obviousness is not
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`whether the features of a secondary reference may be bodily incorporated into the
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`structure of the primary reference….” Allied Erecting v. Genesis Attachments, 825
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`F.3d 1373, 1381 (Fed. Cir. 2016).
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`10
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`APPLE-1012, FIG. 7 (annotated, with additional section view).
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`13. And, contrary to Masimo’s contentions, the POSITA would have in no way
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`been dissuaded from achieving those benefits by a specific body location
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`associated with Ohsaki’s sensor. POR, 32-38. Indeed, it has been well understood
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`for decades that reflective pulse oximetry sensors like Mendelson-799’s can be
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`placed “on virtually any place on the body where we can expect light reflection
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`due to tissue.” APPLE-1019, 91. And a POSITA would have understood that a
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`light permeable convex cover would have provided the benefits described by
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`Ohsaki in a sensor placed, for example, on the palm side of the wrist or forearm.
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`see also APPLE-1009, [0025], Claims 4-8; FIGS. 4A, 4B.
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`11
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`14. Masimo continues this pattern of mischaracterizing the references and
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`misapplying the law of obviousness in its arguments addressing the addition of the
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`Schulz and Mendelson 2006 references to the proposed combination. See POR, 4-
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`5.
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`15. For these and other reasons explained below, Apple respectfully submits that
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`the Board should reject Masimo’s arguments, which avoid addressing the merits of
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`the combinations advanced in Apple’s Petition, and which are grounded in
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`disregard for well-established principles of patent law. For example, that “[a]
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`person of ordinary skill is also a person of ordinary creativity, not an
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`automaton,” and that “[t]he test for obviousness is not whether the features of a
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`secondary reference may be bodily incorporated into the structure of the primary
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`reference,” but is instead “what the combined teachings of those references would
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`have suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413
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`(C.C.P.A. 1981); Facebook, Inc. v. Windy City Innovations, LLC, 953 F.3d 1313,
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`1333 (Fed. Cir. 2020); KSR, 550 U.S. at 418.
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`16. The sections below address the arguments with respect to Ground 1
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`presented in Masimo’s POR against the backdrop of the description above. As
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`explained below, these arguments fail.
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`12
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`A. Ohsaki does not describe, much less require, its convex
`translucent board 8 to be “rectangular” in shape.
`17. As noted above, the Petition demonstrates that “Ohsaki would have
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`motivated a POSITA to add a light permeable protruding convex cover to
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`Mendelson ’799’s sensor” at least “to improve adhesion between the sensor and
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`the user’s tissue[.]” Petition, 30 (citing APPLE-1003, [0084]-[0092]; APPLE-
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`1009, [0015], [0017], [0025], FIGS. 1, 2, 4A, 4B). As also described above,
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`Ohsaki (at [25]) describes that the “convex surface of the translucent board 8” is
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`responsible for this improved adhesion. See id.
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`18. Masimo argues that it is not the “convex surface” that improves adhesion
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`(i.e., reduces slippage) in Ohsaki, but instead a supposed “longitudinal shape” of
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`“Ohsaki’s translucent board [8].” See POR, 23-28 (citing APPLE-1009, [0019]).
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`But the portions of Ohsaki cited to support this characterization do not include any
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`reference to translucent board 8. See APPLE-1009, [0019]. Instead, the cited
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`portion of Ohsaki ascribes this “longitudinal” shape to a different component:
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`“detecting element 2.” See id. (“it is desirable that the detecting element 2 is
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`arranged so that its longitudinal direction agrees with the longitudinal direction of
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`the user's arm”). Ohsaki never describes the “translucent board 8” as
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`“longitudinal,” and nowhere does Ohsaki describe the “translucent board 8” and
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`“detecting element 2” as having the same shape. See generally APPLE-1009. In
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`fact, as illustrated in Ohsaki’s FIG. 2 (reproduced below), the translucent board 8
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`13
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`
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`(annotated yellow) is not coextensive with the entire tissue-facing side of detecting
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`element 2 (annotated green):
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`19.
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`20. APPLE-1009, FIG. 2 (annotated)
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`21. Based on its unsupported contention that translucent board 8 must have a
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`“very pronounced longitudinal directionality”, Masimo then concludes, without
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`explanation or citation to any disclosure in Ohsaki, that the translucent board 8 has
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`a “rectangular” shape that is allegedly incompatible with Mendelson-799. See
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`POR, 17-19. But Ohsaki never describes translucent board 8, or any other
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`component, as “rectangular”; in fact, the words “rectangular” and “rectangle” do
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`14
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`not appear in Ohsaki’s disclosure. See generally APPLE-1009. Attempting to
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`confirm its false conclusion, Masimo asserts that “Ohsaki illustrates two cross-
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`sectional views of the board that confirm it is rectangular.” POR, 17 (citing Ex.
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`2004, [39]-[42]).3 Masimo identifies these “two cross-sectional views” as FIGS. 1
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`and 2, and infers the supposed “rectangular shape” of the translucent board 8 based
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`on FIG. 1 showing the “short” side of the device, and FIG. 2 showing the “long”
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`side of the same device. See POR, 17-18. But, according to Ohsaki, FIG. 2 is “a
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`schematic diagram,” not a cross-sectional view, and Ohsaki never specifies that
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`FIGS. 1 and 2 are different views of the same device. APPLE-1009, [0013].
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`Accordingly, nothing in Ohsaki supports Masimo’s inference that the “translucent
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`board 8” must be “rectangular” in shape. See, e.g., APPLE-1009, [0013], [0019],
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`[0025], FIG. 2; Hockerson-Halberstadt v. Avia, 222 F.3d 951, 956 (Fed. Cir.
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`2000). Further, even if it is possible for the translucent board 8 to be
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`“rectangular,” Ohsaki certainly does not include any disclosure “requiring” this
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`particular shape. See id.
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`3 As with most of Dr. Madisetti’s declaration, these paragraphs parrot the POR
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`arguments verbatim, without additional analysis or corroboration.
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`15
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`22. Section B.1 of the POR presents several arguments premised on Ohsaki
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`requiring the translucent board 8 to be “rectangular.” See POR, 22-31. Because
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`Ohsaki requires no such shape for the translucent board 8, these arguments fail.
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`23.
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`In addition, as discussed above (supra, 6-7), even if Ohsaki’s translucent
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`board 8 were somehow understood to be rectangular, obviousness does not require
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`“bodily incorporation” of features from one reference into another, and a POSITA,
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`being “a person of ordinary creativity, not an automaton,” would have been fully
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`capable of attaching a light permeable protruding convex cover to Mednelson-
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`799’s housing to obtain the benefits attributed to such a cover by Ohsaki.
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`Facebook, 953 F.3d at 1333; KSR, 550 U.S. at 418.
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`B. A POSITA would have recognized the benefits of Ohsaki’s
`teachings when applied to Mendelson-799’s sensor, at
`virtually any measurement location.
`24. Masimo contends that Ohsaki’s benefits are specific to “the backhand side of
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`the wrist.” POR, 32. But Ohsaki does not describe that its sensor can only be used
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`at backside of the wrist. Instead, at most, Ohsaki describes such an arrangement
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`with respect to a preferred embodiment. APPLE-1009, [0019].
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`25.
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`Indeed, Ohsaki’s claim language reinforces that Ohsaki’s description would
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`not have been understood as so limited. For example, Ohsaki’s independent claim
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`1 states that “the detecting element is constructed to be worn on a back side of a
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`user’s wrist or a user’s forearm.” See also APPLE-1009, Claim 2. As another
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`16
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`
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`example, Ohsaki’s independent claim 3 states that “the detecting element is
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`constructed to be worn on a user’s wrist or a user’s forearm,” without even
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`mentioning a backside of the wrist or forearm. See also APPLE-1019, Claims 4-
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`8. From this and related description, a POSITA would have understood that
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`Ohsaki’s benefits are provided when the sensor is placed, for example, on either
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`side of the user’s wrist or forearm. APPLE-1009, [0025], FIGS. 4A, 4B.
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`26. Moreover, even if a POSITA would have somehow misunderstood Ohsaki’s
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`sensor as limited to placement on the backside of the wrist, and even if the
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`difficulty that Masimo alleges with respect to obtaining pulse oximetry
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`measurements from that location were true, that would have further motivated the
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`POSITA to implement a light permeable convex cover in Mendelson-799’s sensor,
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`to improve detection efficiency. POR, 32-38; APPLE-1009, [0015], [0017],
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`[0025], FIGS. 1, 2, 4A, 4B.
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`27.
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`Indeed, when describing advantages associated with its translucent board,
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`Ohsaki explains with reference to FIGS. 4A and 4B (reproduced below) that “if the
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`translucent board 8 has a flat surface, the detected pulse wave is adversely affected
`
`by the movement of the user’s wrist,” but that if the board “has a convex
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`surface…variation of the amount of the reflected light…that reaches the light
`
`receiving element 7 is suppressed.” APPLE-1003, [0149]; APPLE-1009, [0015],
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`[0017], [0025].
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`17
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`28.
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`29. APPLE-1009, FIGS. 4A, 4B.
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`
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`30. As discussed above (supra 6), a POSITA would have understood that
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`reflectance pulse oximetry sensors like Mendelson-799’s can be placed “on
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`virtually any place on the body where we can expect light reflection due to tissue,”
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`and would have further understood from Ohsaki that, by promoting “intimate
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`contact with the surface of the user’s skin,” a light permeable convex cover would
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`have prevented slippage of Mendelson-799’s sensor when placed, for example, on
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`either side of a user’s wrist or forearm, with associated improvements in signal
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`quality. APPLE-1019, 91; APPLE-1009, [0015], [0017], [0025], FIGS. 4A, 4B,
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`Claims 4-8.
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`18
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`
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`C. Adding a convex cover to Mendelson-799 as taught by
`Ohsaki enhances the sensor’s light-gathering ability.
`In defiance of fundamental principles of elementary optics, Masimo argues
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`31.
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`that a POSITA would not have combined Mendelson-799 and Ohsaki as proposed
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`because the combined sensor “would direct light away from the detectors.” See,
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`e.g., POR, 38. As explained in more detail below, a POSITA would have
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`understood the opposite to be true: that Ohsaki’s cover would improve Mendelson-
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`799’s signal-to-noise ratio by causing more light backscattered from tissue to strike
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`Mendelson-799’s detectors than would have absent the cover. APPLE-1019, 52,
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`86, 90; APPLE-1040, 84, 87-92, 135-141; APPLE-1046, 803-805; APPLE-1012,
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`FIG. 7
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`1.
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`Patent Owner ignores the behavior of scattered light in
`relation to reflectance-type pulse sensors and
`oximeters.
`32. Masimo relies heavily on FIG. 14B from the ’554 patent (reproduced below)
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`to support its contention that a convex cover would direct light to a point in the
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`center of the combined sensor:
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`19
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`APPLE-1001, FIG. 14B (as annotated at POR, 40)
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`
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`33. Masimo and Dr. Madisetti treat this figure as an illustration of the behavior
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`of a convex surface with respect to “all types of light,” regardless of the angle of
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`incidence, and conclude that “the convex shape directs light from the periphery
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`toward the center” as shown in FIG. 14B. POR, 39-40; APPLE-1041, 56:9-60:2.
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`34. But FIG. 14B is not an accurate representation of light that has been
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`reflected from a tissue measurement site. For example, the light rays (1420) shown
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`in FIG. 14B are collimated (i.e., travelling paths parallel to one another), and each
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`light ray’s path is perpendicular to the detecting surface.
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`20
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`35. Even for the collimated light shown in FIG. 14B, the focusing of light at the
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`center only occurs if the light beam happens to be perfectly aligned with the axis of
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`symmetry of the lens. See Ex. 2007, 298:11-299:1. If the collimated light enters
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`the lens at any other angle, as shown below, the light will focus at a different point:
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`APPLE-1040, 141 (annotated)
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`36.
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`In this regard, Dr. Madisetti’s overly-simplistic statements (“My
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`testimony...to avoid any doubt, is that a POSA viewing the teachings of Inokawa
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`Figure 2 would understand that the convex lens 27 of Figure 2 would redirect,
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`condense, and focus light toward the center from the measurement site.”) only
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`apply to a special narrow case of collimated light incident on a convex lens along
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`the axis of symmetry. APPLE-1042, 166:12-182:3. A POSITA would have
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`21
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`understood that Dr. Madisetti’s statements do not reflect the behavior of diffuse
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`light incident on a convex lens-like surface, such as the light incident on the
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`convex cover of the combined sensor of Mendelson-799 and Ohsaki.
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`37. The detector(s) of reflectance type pulse detectors and oximeters (like the
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`devices disclosed by Mendelson-799 and Ohsaki) detect light that has been
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`“partially reflected, transmitted, absorbed, and scattered by the skin and other
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`tissues and the blood before it reaches the detector.” APPLE-1019, 86. In other
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`words, and as a POSITA would have understood from Mendelson-799’s FIG. 7,
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`the light that backscatters from the measurement site after diffusing through tissue
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`reaches the circular active detection area provided by Mendelson-799’s detectors
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`from various random directions and angles, as opposed to all light entering from
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`the same direction and at the same angle as shown in FIG. 14B. APPLE-1019, 52,
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`86, 90.
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`38.
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`Indeed, the POSITA would have understood that Mendelson-799’s sensor,
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`which includes multiple photodiodes placed symmetrically with respect to a central
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`light source, offers the advantage of enabling a large fraction of light randomly
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`backscattered from tissue to be detected within the circular active detection area
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`surrounding that source. APPLE-1019, 86, 90; APPLE-1046, 803-805; see also
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`APPLE-1012, FIG. 7.
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`22
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`39. Further, far from focusing light to the center as Patent Owner contends, a
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`POSITA would have understood that Ohsaki’s cover provides a refracting effect,
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`such that light rays that otherwise would have missed the detection area are instead
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`directed toward that area as they pass through the interface provided by the cover.4
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`APPLE-1019, 52; APPLE-1007, [0015]; APPLE-1040, 87-92, 135-141; APPLE-
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`1041, 60:7-61:6, 70:8-18 (“a lens...would condense incoming light onto the
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`detectors, thus increasing the signal to noise ratio as well as the signal strength per
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`area of the detectors (since each detector area will receive more incoming light
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`signals)”).
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`40. More specifically, because covers used in pulse detection and pulse oximetry
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`tend to have indices of refraction that differ slightly from the index of refraction of
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`human tissue , a cover like Ohsaki’s would have been understood to increase
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`Mendelson-799’s light-gathering ability by causing light to refract towards the
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`circular active detection area as it crosses the interface provided by the cover such
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`that, overall, more of the partially reflected, transmitted, absorbed, and ultimately
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`4 During deposition, Dr. Madisetti contrasted the phrase “to the center” from
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`“towards the center,” and explained his view that a convex cover would redirect
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`light “toward the center,” which he further clarified to be “a general area.”
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`APPLE-1041, 133:19-135:11.
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`23
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`back scattered light strikes the detectors than otherwise would have absent the
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`cover. APPLE-1040, 84; APPLE-1044, 1486; APPLE-1045, 1484; APPLE-1019,
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`52, 86, 90.
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`2.
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`A POSITA would have implemented the sensor
`resulting from the combination of Mendelson-799 and
`Ohsaki to prevent air gaps between the skin and the
`detectors
`41. Masimo argues that the addition of a convex cover “contradicts
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`Mendelson ’799’s warning against ‘the potential for specular reflection…when an
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`air gap exists between the sensor and the skin.” POR, 43-44. But this argument
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`ignores Ohsaki’s teachings that “the convex surface of the translucent member is
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`in intimate contact with the surface of the user's skin,” and thereby improves
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`adhesion of the sensor to the skin. APPLE-1009, [0025]. Masimo infers the
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`presence of alleged “air gaps” based on un-labeled portions of Ohsaki’s FIG. 1.
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`See POR, 44.
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`42. Yet, it is well established that patent figures should not be interpreted as
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`precise and drawn to scale unless otherwise stated. Hockerson-Halberstadt, 222
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`F.3d at 956. Moreover, myself and Dr. Madisetti have both repeatedly indicated
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`that a POSITA would not have interpreted reference figures as precise drawings.
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`See, e.g., Ex. 2006, 73:19-21; APPLE-1041, 79:19-80:2 (“I believe that to a POSA,
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`these figures are not detailed optical diagrams”).
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`24
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`43. Even assuming for the sake of argument alone that the introduction of air
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`gaps could arise through the incorporation of a convex cover into Mendelson-799’s
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`sensor, it would have been well within a POSITA’s capability to apply “inferences
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`and creative steps” when adapting Ohsaki’s teachings to obviate such air gaps.
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`KSR Intern. Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Moreover, the very
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`teachings of Mendelson-799 cited by the POR would have motivated the POSITA
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`to adapt Ohsaki’s teachings in that manner. APPLE-1012, 2:58-61, 5:60-63; Ex.
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`2008, 229-7-13.
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`44. Finally, even if some minor air gaps would have remained, it is well
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`established that “[a] given course of action often has simultaneous advantages and
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`disadvantages, and this does not necessarily obviate motivation to combine.”
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`Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006).
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`D. A POSITA would have found the advantages of using a
`convex cover to outweigh the slight possibility of scratching
`the cover
`45. Masimo claims that “a POSITA would have understood that a flat cover
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`would provide better protection than a convex surface because…it would be less
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`prone to scratches.” POR, 45-47. Even assuming this to be true, one possible
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`disadvantage that competes with the known advantages of applying Ohsaki’s
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`teachings to Mendelson-799’s sensor would not have negated a POSITA’s
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`motivation to combine. In re Fulton, 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir.
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`25
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`2004). In that regard, the POSITA would have understood the multiple advantages
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`of a convex cover described in the Petition to outweigh any possibility of
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`scratching. Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349, n. 8 (Fed.
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`Cir. 2000); see also Medichem, 437 F.3d at 1165.
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`E. A POSITA would have added an opaque layer to the
`combined sensor of Mendelson-799 and Ohsaki based on the
`teachings of Schulz
`46. Masimo also argues that “a POSITA would not have been motivated to
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`combine Schulz with Mendelson ’799, Ohsaki, and Mendelson 2006.” See POR,
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`47-52. But, similar to its treatment of the Mendelson ’799-Ohsaki portion of the
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`combination, Masimo mischaracterizes and, at times, completely fails to address
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`the justifications provided in the Petition for modifying the combined sensor of
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`Mendelson ’799 and Ohsaki based on Schulz. Compare POR, 47-52 to Petition,
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`25-43. Thus, Masimo’s arguments fail.
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`1.
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`A POSITA would have modified the combined sensor
`of Mendelson-799 and Ohsaki to guard against
`saturation based on Schulz’s teachings
`47. Masimo argues that a POSITA would not have been motivated to perform
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`the Mendelson-799-Ohsaki-Schulz combination because “there is no evidence that
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`detector saturation—an issue associated with high signal strength—was a problem
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`for the Ohsaki or Mendelson ’799 sensors.” POR, 47. This argument ignores the
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`Petition’s explanation of Schulz’s disclosure of the benefits of avoiding detector
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`26
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`saturation in pulse oximetry sensors, and the corroborating disclosures from
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`Webster and Yao regarding the desirability of blocking ambient light to improve
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`detection in such sensors. See Petition, 32-37; APPLE-1003, [0093]-[0101]. As
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`the Petition explains at length, these disclosures show that over-saturation (such as
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`that caused by leakage of ambient light into the sensor) was a well-known problem
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`in pulse oximetry sensors by the Critical Date. See id. Thus, the Petition
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`concludes, a POSITA would have been motivated to address this well-known
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`problem in the Mendelson-Ohsaki sensor by implementing the solution described
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`in Schulz. See id.
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`48. Also contrary to Masimo’s argument, there is no re