IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Attorney Docket No.: 50095-0024IP1
`
`Jeroen Poeze et al.
`In re Patent of:
`10,631,765
`U.S. Patent No.:
`April 28, 2020
`Issue Date:
`Appl. Serial No.: 16/725,478
`Filing Date:
`December 23, 2019
`Title:
`MULTI-STREAM DATA COLLECTION SYSTEM FOR
`NONINVASIVE MEASUREMENT OF BLOOD
`CONSTITUENTS
`
`SECOND DECLARATION OF DR. THOMAS W. KENNY
`
`I hereby declare that all statements made of my own knowledge are true and
`
`that all statements made on information and belief are believed to be true. I further
`
`declare 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 the Title 18 of the United States Code.
`
`Dated: October 29, 2021
`
`By:
`
`Thomas W. Kenny, Ph.D.
`
`1
`
`APPLE 1047
`Apple v. Masimo
`IPR2020-01714
`
`

`

`I. 
`II. 
`
`TABLE OF CONTENTS
`
`INTRODUCTION ........................................................................................... 4 
`GROUND 1 ESTABLISHES OBVIOUSNESS ............................................. 6 
`A.  Ohsaki does not teach or require its convex translucent board 8 to be
`“rectangular” in shape. ............................................................................ 12 
`B.  A POSITA would have recognized the benefits of Ohsaki’s teachings
`when applied to Mendelson-799’s sensor, at virtually any measurement
`location. ................................................................................................... 17 
`C.  Adding a convex cover to Mendelson-799 as taught by Ohsaki enhances
`the sensor’s light-gathering ability. ........................................................ 20 
`1. 
`Patent Owner ignores the behavior of scattered light in relation to
`reflectance-type pulse sensors and oximeters. .............................. 21 
`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 ................................................ 28 
`D.  A POSITA would have found the advantages of using a convex cover to
`outweigh the slight possibility of scratching the cover .......................... 30 
`E.  A POSITA would have added an opaque layer to the combined sensor of
`Mendelson-799 and Ohsaki based on the teachings of Schulz ............... 31 
`1.  A POSITA would have modified the combined sensor of
`Mendelson-799 and Ohsaki to guard against saturation based on
`Schulz’s teachings ......................................................................... 31 
`Schulz’s teachings are applicable to the combined sensor of
`Mendelson-799 and Ohsaki ........................................................... 33 
`3.  A POSITA would have understood Schulz’s teachings to render
`obvious a corresponding window for each of at least four
`detectors. ........................................................................................ 35 
`4.  A POSITA would have understood Schulz’s window to restrict the
`amount of ambient light reaching its photodetectors .................... 36 
`F.  A POSITA would have enabled the combined sensor of Mendelson-799,
`Ohsaki, and Schulz to communicate wirelessly with a handheld
`computing device, based on the teachings of Mendelson-2006 ............. 39 
`G.  A POSITA would have expected success in performing the combination
` ................................................................................................................. 41 
`H.  The challenged dependent claims are rendered obvious by Mendelson-
`799, Ohsaki, Schulz, and Mendelson-2006. ........................................... 42 
`
`2. 
`
`2
`
`

`

`III.  GROUND 2 ESTABLISHES OBVIOUSNESS ........................................... 44 
`IV.  GROUND 3 ESTABLISHES OBVIOUSNESS ........................................... 44 
`V.  GROUND 4 ESTABLISHES OBVIOUSNESS ........................................... 45 
`VI.  CONCLUSION .............................................................................................. 45 
`
`
`3
`
`

`

`
`
`I.
`Introduction
`I have been retained on behalf of Apple Inc. to offer technical opinions
`
`1.
`
`relating to U.S. Patent No. 10,631,765 (“the ’765 Patent”) in the present case
`
`(IPR2020-01714). In this Second Declaration, I provide opinions related to Patent
`
`Owner’s Response (Paper 16) and Dr. Madisetti’s supporting declaration (Ex.
`
`2004).
`
`2.
`
`In addition to the materials listed in my First Declaration (APPLE-1003), I
`
`have also reviewed the following materials:
`
` Paper 8: Institution Decision;
`
` Paper 16: Patent Owner’s Response (“POR”);
`
` Ex. 2004: Declaration of Dr. Madisetti;
`
` Ex. 2006-2009: Transcripts of my prior depositions;
`
` APPLE-1050: Excerpts of Eugene Hecht, Optics (2nd Ed. 1990), pages
`
`79-143, 211-220;
`
` APPLE-1051: Eugene Hecht, Optics (2nd Ed. 1990);
`
` APPLE-1052: Deposition Transcript of Dr. Vijay Madisetti in IPR2020-
`
`01520, IPR2020-01537, IPR2020-01539, Day 1 (August 1, 2021);
`
` APPLE-1053: Deposition Transcript of Dr. Vijay Madisetti in IPR2020-
`
`01520, IPR2020-01537, IPR2020-01539, Day 2 (August 2, 2021);
`
`4
`
`

`

`
`
` APPLE-1054: Deposition Transcript of Dr. Vijay Madisetti in IPR2020-
`
`01536, IPR2020-01538 (August 3, 2021);
`
` APPLE-1055: “Refractive Indices of Human Skin Tissues at Eight
`
`Wavelengths and Estimated Dispersion Relations between 300 and 1600
`
`nm,” H. Ding, et al.; Phys. Med. Biol. 51 (2006); pp. 1479-1489
`
`(“Ding”);
`
` APPLE-1056: “Analysis of the Dispersion of Optical Plastic Materials,”
`
`S. Kasarova, et al.; Optical Materials 29 (2007); pp. 1481-1490
`
`(“Kararova”);
`
` APPLE-1057: “Noninvasive Pulse Oximetry Utilizing Skin Reflectance
`
`Photoplethysmography,” Y. Mendelson, et al.; IEEE Transactions on
`
`Biomedical Engineering, Vol. 35, No. 10, October 1988; pp. 798-805
`
`(“Mendelson-IEEE-1988”);
`
` APPLE-1049: Eugene Hecht, Optics (4th Ed. 2002).
`
` APPLE-1058: US Patent No. 6,198,951 ("Kosuda")
`
`3.
`
`Counsel has informed me that I should consider these materials through the
`
`lens of one of ordinary skill in the art related to the ’765 Patent at the time of the
`
`earliest possible priority date of the ’765 Patent (July 3, 2008, hereinafter the
`
`“Critical Date”) and I have done so during my review of these materials. I have
`
`applied the same level of ordinary skill in the art described in my prior declaration,
`
`5
`
`

`

`
`
`which I have been informed was also adopted by the Board in the Institution
`
`Decision. APPLE-1003, [0021]-[0022]; Institution Decision, 11-12.
`
`4.
`
`I have no financial interest in the party or in the outcome of this proceeding.
`
`I am being compensated for my work as an expert on an hourly basis. My
`
`compensation is not dependent on the outcome of these proceedings or the content
`
`of my opinions.
`
`5.
`
`In writing this declaration, I have considered the following: my own
`
`knowledge and experience, including my work experience in the fields of
`
`mechanical engineering, computer science, biomedical engineering, and electrical
`
`engineer; my experience in teaching those subjects; and my experience in working
`
`with others involved in those fields. In addition, I have analyzed various
`
`publications and materials, in addition to other materials I cite in my declaration.
`
`6. My opinions, as explained below, are based on my education, experience,
`
`and expertise in the fields relating to the ’765 Patent. Unless otherwise stated, my
`
`testimony below refers to the knowledge of one of ordinary skill in the fields as of
`
`the Critical Date, or before.
`
`II. Ground 1 Establishes Obviousness
`In its POR, Masimo first addresses the “Mendelson ’799 and Ohsaki”
`
`7.
`
`portion of the full Mendelson ’799-Ohsaki-Schulz-Mendelson 2006 combination
`
`advanced in Ground 1. As I explained at length in my first declaration, “Ohsaki
`
`6
`
`

`

`
`
`would have motivated one of ordinary skill to add a light permeable protruding
`
`convex cover to Mendelson ’799’s sensor, to [1] improve adhesion between the
`
`sensor and the user’s tissue, to [2] improve detection efficiency, and to [3] provide
`
`additional protection to the elements accommodated within sensor housing 17.”
`
`APPLE-1003, [0098] (citing APPLE-1009, [0015], [0017], [0025], FIGS. 1, 2, 4A,
`
`4B). Rather than attempting to rebut my previous testimony on these points,
`
`Masimo offers, through its witness Dr. Madisetti, arguments that are factually
`
`flawed and legally irrelevant.
`
`8.
`
`Specifically, Masimo contends that the Mendelson-799 and Ohsaki
`
`references “employ (1) different sensor structures (rectangular versus circular), (2)
`
`for different measurements (pulse rate versus oxygen saturation)…(3) in different
`
`measurement locations,” and from this concludes that “[a] POSITA would not
`
`have been motivated to combine the references,” and would not have “reasonably
`
`expected such a combination to be successful.” POR, 1-4.
`
`9.
`
`In this way, the POR avoids addressing the merits of the combinations
`
`advanced in Apple’s Petition, and ignores the “inferences and creative steps” that a
`
`POSITA would have taken when modifying Mendelson-799’s sensor to achieve
`
`the benefits taught by Ohsaki.
`
`10. Contrary to Masimo’s contentions, Ohsaki nowhere describes its benefits as
`
`being limited to a rectangular pulse rate sensor applied to a particular body
`
`7
`
`

`

`
`
`
`
`location, and a POSITA would not have understood those benefits as being so
`
`limited. Instead, and as shown in Ohsaki’s FIG. 2 (reproduced below), Ohsaki
`
`attributes the reduction of slippage afforded by use of translucent board 8 (and
`
`additional related improvements in signal quality) to the fact that “the convex
`
`surface of the translucent board…is in intimate contact with the surface of the
`
`user’s skin”1 when the sensor is worn. APPLE-1003, [0095]; APPLE-1009,
`
`[0015], [0017]-[0018], [0025], FIGS. 1, 2, 4A, 4B.
`
`APPLE-1009, FIG. 2 (annotated).
`
`
`1 Unless otherwise noted, emphases in quotations throughout this Declaration are
`
`added.
`
`8
`
`

`

`
`
`11. Notably absent from Ohsaki’s discussion of these benefits is any mention or
`
`suggestion that they relate to a shape of the exterior edge of translucent board 8
`
`(whether circular, rectangular, ovoid, or other). Rather, when describing the
`
`advantages associated with translucent board 8, Ohsaki contrasts a “convex
`
`detecting surface” from a “flat detecting surface,” and explains that “if the
`
`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
`
`surface…variation of the amount of the reflected light…that reaches the light
`
`receiving element 7 is suppressed.” APPLE-1003, [0096]; APPLE-1009, [0015],
`
`[0025].
`
`12. From this and related description, a POSITA would have understood that a
`
`light permeable protruding convex cover would reduce slippage of Mendelson-
`
`799’s sensor when worn and, in turn, reduce the adverse effects of user movement
`
`on signals obtainable by the detectors within Mendelson-799’s sensor, which like
`
`Ohsaki’s light receiving elements, detect light reflected from user tissue. APPLE-
`
`1009, [0025]; FIGS. 4A, 4B; APPLE-1012, 3:5-14, 6:16-35, 8:27-29, 1:41-60;
`
`APPLE-1019, 36-37, 87-88, 91, 124. Indeed, the POSITA would have found it
`
`obvious to improve Mendelson-799’s pulse oximeter based on Ohsaki’s teachings,
`
`and would have been fully capable of making any inferences and creative steps
`
`necessary to achieve the benefits obtainable by attaching a light permeable
`
`9
`
`

`

`protruding convex cover to Mendelson-799’s housing.2 APPLE-1008, [0058],
`
`FIG. 2; APPLE-1026, [0022], [0032], [0035], FIG. 6. The following annotated
`
`FIG. 7 from Mendelson-799 shows the results of the proposed combination:
`
`
`
`
`
`
`2 Notably, Ohsaki nowhere depicts or describes its cover as rectangular. APPLE-
`
`1009, [0001]-[0030]; FIGS. 1, 2, 3A, 3B, 4A, 4B. Even if Ohsaki’s cover were
`
`understood to be rectangular, “[t]he test for obviousness is not whether the features
`
`of a secondary reference may be bodily incorporated into the structure of the
`
`primary reference….”
`
`
`
`10
`
`

`

`
`
`APPLE-1003, [0099] (showing APPLE-1012, FIG. 7 (annotated, with additional
`
`section view)).
`
`13. And, contrary to Masimo’s contentions, the POSITA would have in no way
`
`been dissuaded from achieving those benefits by a specific body location
`
`associated with Ohsaki’s sensor. POR, 32-38. Indeed, it has been well understood
`
`for decades that reflective pulse oximetry sensors like Mendelson-799’s can be
`
`placed “on virtually any place on the body where we can expect light reflection
`
`due to tissue.” APPLE-1019, 91. And a POSITA would have understood that a
`
`light permeable convex cover would have provided the benefits described by
`
`Ohsaki in a sensor placed, for example, on the palm side of the wrist or forearm.
`
`See APPLE-1009, [0025], Claims 4-8; FIGS. 4A, 4B.
`
`14. Masimo continues this pattern of mischaracterizing the references in its
`
`arguments addressing the addition of the Schulz and Mendelson 2006 references to
`
`the proposed combination. See POR, 4-5.
`
`15. For these and other reasons explained below, Masimo’s arguments avoid
`
`addressing the merits of the combinations advanced in Apple’s Petition
`
`16. The sections below address the arguments with respect to Ground 1
`
`presented in Masimo’s POR against the backdrop of the description above. As
`
`explained below, these arguments fail.
`
`11
`
`

`

`
`
`A. Ohsaki does not teach or require its convex translucent
`board 8 to be “rectangular” in shape.
`17. As noted above, the Petition demonstrates that “Ohsaki would have
`
`motivated a POSITA to add a light permeable protruding convex cover to
`
`Mendelson ’799’s sensor” at least “to improve adhesion between the sensor and
`
`the user’s tissue[.]” Petition, 24-25 (citing APPLE-1003, [0084]-[0092]; APPLE-
`
`1009, [0015], [0017], [0025], FIGS. 1, 2, 4A, 4B). As also described above,
`
`Ohsaki (at [25]) describes that the “convex surface of the translucent board 8” is
`
`responsible for this improved adhesion. See id.
`
`18. Masimo argues that it is not the “convex surface” that improves adhesion
`
`(i.e., reduces slippage) in Ohsaki, but instead a supposed “longitudinal shape” of
`
`“Ohsaki’s translucent board [8].” See POR, 23-28 (citing APPLE-1009, [0019]).
`
`But the portions of Ohsaki cited to support this characterization do not include any
`
`reference to translucent board 8. See APPLE-1009, [0019]. Instead, the cited
`
`portion of Ohsaki ascribes this “longitudinal” shape to a different component:
`
`“detecting element 2.” See id. (“it is desirable that the detecting element 2 is
`
`arranged so that its longitudinal direction agrees with the longitudinal direction of
`
`the user's arm”). Ohsaki never describes the “translucent board 8” as
`
`“longitudinal,” and nowhere does Ohsaki describe the “translucent board 8” and
`
`“detecting element 2” as having the same shape. See generally APPLE-1009. In
`
`fact, as illustrated in Ohsaki’s FIG. 2 (reproduced below), the translucent board 8
`
`12
`
`

`

`(annotated yellow) is not coextensive with the entire tissue-facing side of detecting
`
`element 2 (annotated green):
`
`
`
`APPLE-1009, FIG. 2 (annotated)
`
`
`
`19. Based on its unsupported contention that translucent board 8 must have a
`
`“very pronounced longitudinal directionality”, Masimo then concludes, without
`
`explanation or citation to any disclosure in Ohsaki, that the translucent board 8 has
`
`a “rectangular” shape that is allegedly incompatible with Mendelson-799. See
`
`POR, 17-19. But Ohsaki never describes translucent board 8, or any other
`
`13
`
`

`

`
`
`component, as “rectangular”; in fact, the words “rectangular” and “rectangle” do
`
`not appear in Ohsaki’s disclosure. See generally APPLE-1009.
`
`20.
`
`Indeed, the POR incorrectly assumes that because Ohsaki’s light emitting
`
`element and the light receiving element are arranged in a longitudinal structure,
`
`Ohsaki’s translucent board must have a rectangular structure. APPLE-1009,
`
`[0009], [0019]; POR, 1-3, 22-28. A POSITA would have known and understood
`
`that an elliptical or circular sensor or board configuration can also have a
`
`longitudinal structure or appearance under a cross-sectional view. An example
`
`illustrating such an understanding, contrary to POR’s flawed assumption, is
`
`shown below in Kosuda’s FIGS. 3 and 4. APPLE-1058, 8:42-56.
`
`14
`
`

`

`
`
`Circular circuit board
`appears rectangular
`in cross view
`
`Circular circuit board
`in plan view
`
`APPLE-1060, FIGS 3 and 4
`
`
`
`21. Attempting to confirm its false conclusion, Masimo asserts that “Ohsaki
`
`illustrates two cross-sectional views of the board that confirm it is rectangular.”
`
`POR, 17 (citing Ex. 2004, [38]-[41]).3 Masimo identifies these “two cross-
`
`sectional views” as FIGS. 1 and 2, and infers the supposed “rectangular shape” of
`
`the translucent board 8 based on FIG. 1 showing the “short” side of the device, and
`
`
`3 As with most of Dr. Madisetti’s declaration, these paragraphs parrot the POR
`
`arguments verbatim, without additional analysis or corroboration.
`
`15
`
`

`

`
`
`FIG. 2 showing the “long” side of the same device. See POR, 17-18. But,
`
`according to Ohsaki, FIG. 2 is “a schematic diagram,” not a cross-sectional view,
`
`and Ohsaki never specifies that FIGS. 1 and 2 are different views of the same
`
`device. APPLE-1009, [0013]. Accordingly, nothing in Ohsaki supports Masimo’s
`
`inference that the “translucent board 8” must be “rectangular” in shape. See, e.g.,
`
`APPLE-1009, [0013], [0019], [0025], FIG. 2. Further, even if it is possible for the
`
`translucent board 8 to be “rectangular,” Ohsaki certainly does not include any
`
`disclosure “requiring” this particular shape. See id.
`
`22. Section B.1 of the POR presents several arguments premised on Ohsaki
`
`requiring the translucent board 8 to be “rectangular.” See POR, 22-31. Because
`
`Ohsaki neither teaches nor requires any shape for the translucent board 8, these
`
`arguments fail.
`
`23.
`
`In addition, as discussed above (supra, 6-7), even if Ohsaki’s translucent
`
`board 8 were somehow understood to be rectangular, obviousness does not require
`
`full incorporation of features from one reference into another, and a POSITA
`
`would have been fully capable of attaching a light permeable protruding convex
`
`cover to Mednelson-799’s housing to obtain the benefits attributed to such a cover
`
`by Ohsaki. For example, a POSITA would have found it obvious to design a
`
`circular light-permeable convex cover based on the teachings of Ohsaki, and take
`
`reasonable steps to make sure that the combination of a circular protruding convex
`
`16
`
`

`

`
`
`cover would function with the other features present in Mendelson so as to provide
`
`the benefits discussed above.
`
`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
`
`the wrist.” POR, 32. But Ohsaki does not describe that its sensor can only be used
`
`at backside of the wrist. Instead, at most, Ohsaki describes such an arrangement
`
`with respect to a preferred embodiment. APPLE-1009, [0019].
`
`25.
`
`Indeed, Ohsaki’s specification and claim language reinforce that Ohsaki’s
`
`description would not have been understood as so limited. For example, Ohsaki
`
`explains that “the detecting element 2…may be worn on the back side of the user's
`
`forearm” as one form of modification. See APPLE-1009, [0030], [0028]
`
`(providing a section titled “[m]odifications”). In fact, the gap between the ulna and
`
`radius bones at the forearm is even greater than the gap between bones at the wrist,
`
`which is already wide enough to easily accommodate a range of sensor shapes,
`
`including circular shapes. Similarly, Ohsaki’s independent claim 1 states that “the
`
`detecting element is constructed to be worn on a back side of a user’s wrist or a
`
`user’s forearm.” See also APPLE-1009, Claims 1-2. As another example,
`
`Ohsaki’s independent claim 5 states that “the detecting element is constructed to be
`
`worn on a user’s wrist or a user’s forearm,” without even mentioning a backside
`
`17
`
`

`

`
`
`of the wrist or forearm. See also APPLE-1019, Claims 6-8. From this and related
`
`description, a POSITA would have understood that Ohsaki’s benefits are provided
`
`when the sensor is placed, for example, on either side of the user’s wrist or
`
`forearm. APPLE-1009, [0025], FIGS. 4A, 4B.
`
`26. Moreover, even if a POSITA would have somehow misunderstood Ohsaki’s
`
`sensor as limited to placement on the backside of the wrist, and even if the
`
`difficulty that Masimo alleges with respect to obtaining pulse oximetry
`
`measurements from that location were true, that would have further motivated the
`
`POSITA to implement a light permeable convex cover in Mendelson-799’s sensor,
`
`to improve detection efficiency. POR, 32-38; APPLE-1009, [0015], [0017],
`
`[0025], FIGS. 1, 2, 4A, 4B.
`
`27.
`
`Indeed, when describing advantages associated with its translucent board,
`
`Ohsaki explains with reference to FIGS. 4A and 4B (reproduced below) that “if the
`
`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
`
`surface…variation of the amount of the reflected light…that reaches the light
`
`receiving element 7 is suppressed.” APPLE-1003, [0096]; APPLE-1009, [0015],
`
`[0017], [0025].
`
`18
`
`

`

`
`
`APPLE-1009, FIGS. 4A, 4B.
`
`
`
`28. As discussed above (supra 6), a POSITA would have understood that
`
`reflectance pulse oximetry sensors like Mendelson-799’s can be placed “on
`
`virtually any place on the body where we can expect light reflection due to tissue,”
`
`and would have further understood from Ohsaki that, by promoting “intimate
`
`contact with the surface of the user’s skin,” a light permeable convex cover would
`
`have reduced slippage of Mendelson-799’s sensor when placed, for example, on
`
`either side of a user’s wrist or forearm, with additional associated improvements in
`
`signal quality. APPLE-1019, 91; APPLE-1009, [0015], [0017], [0025], FIGS. 4A,
`
`4B, Claims 4-8.
`
`19
`
`

`

`
`
`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
`
`29.
`
`that a POSITA would not have combined Mendelson-799 and Ohsaki as proposed
`
`because “A Convex Cover Directs Light To The Center Of The Sensor” and “away
`
`from the detectors.” 4 POR, 38-43; Ex. 2004, ¶¶71-76. As explained in more detail
`
`below, a POSITA would have understood the opposite to be true: that Ohsaki’s
`
`cover would improve Mendelson-799’s signal-to-noise ratio by causing more light
`
`backscattered from tissue to strike Mendelson-799’s detectors than would have
`
`
`4 Masimo and its witness Dr. Madisetti fail to articulate a coherent position; for
`
`example, what is meant by “the center,” and also whether Masimo’s position is that
`
`“all” light or only “some” light is directed “to” or “towards the center.” POR, 38-
`
`43, Ex. 2004, ¶¶71-76. For example, Dr. Madisetti testified during deposition that
`
`“if you have a convex surface…all light reflected or otherwise would be
`
`condensed or directed towards the center.” APPLE-1052, 40:4-11; POR, 38-43,
`
`Ex. 2004, ¶¶71-76. However, Dr. Madisetti further testified that “the center” could
`
`be “a general area at which the convex surface would be redirecting…light” or “a
`
`point,” while contrasting the phrase “to the center” from “towards the center.”
`
`APPLE-1052, 133:19-135:11, 40:4-11, 127:22-128:18; APPLE-1052, 40:4-11.
`
`
`
`20
`
`

`

`
`
`absent the cover. APPLE-1019, 52, 86, 90; APPLE-1051, 84, 87-92, 135-141;
`
`APPLE-1057, 803-805; APPLE-1012, FIG. 7; Ex. 2006, 164:8-16 (a convex cover
`
`improves “light concentration at pretty much all of the locations under the
`
`curvature of the lens”).
`
`1.
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`Patent Owner ignores the behavior of scattered light in
`relation to reflectance-type pulse sensors and
`oximeters.
`30. Masimo relies heavily on FIG. 14B from the ’765 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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`21
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`APPLE-1001, FIG. 14B (as annotated at POR, 40)
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`31. 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-1052, 56:9-60:2,
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`127:22-128:18 (“a POSA viewing [FIG. 14B]…would understand that light, all
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`light, light from the measurement site is being focused towards the center”). Also,
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`as Madisetti also stated “as I describe in my Declaration...if you have a convex
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`surface...all light reflected or otherwise would be condensed or directed towards
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`the center.” APPLE-1052, 40:4-11.
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`32. 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.
`
`33. 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. And, if for example,
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`collimated light were to enter the FIG. 14B lens at any other angle, the light would
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`focus at a different location in the focal plane.
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`22
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`

`
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`34. Further, if the light were not collimated, so that rays enter the lens with a
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`very wide range of incident angles, there would be no focus at all, and many rays
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`will be deflected away from the center.
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`35. Moreover, since “the center” takes up a very small portion of the total area
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`under the lens, the majority of rays associated with diffuse light entering the lens
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`would arrive at locations away from the center.
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`36. Dr. Madisetti’s overly-simplistic statements (“My testimony...to avoid any
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`doubt, is that a POSA viewing the teachings of Inokawa Figure 2 would
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`understand that the convex lens 27 of Figure 2 would redirect, condense, and focus
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`light toward the center from the measurement site.”) only apply to a special narrow
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`case of collimated light incident on a convex lens along the axis of symmetry.
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`APPLE-1053, 166:12-182:3. A POSITA would have understood that Dr.
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`Madisetti’s statements do not reflect the behavior of diffuse light incident on a
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`convex lens-like surface, such as the light incident on the convex cover of the
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`combined sensor of Mendelson-799 and Ohsaki. The light rays from a diffuse
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`light source, such as the LED-illuminated tissue near a pulse wave sensor or a
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`pulse oximeter, include a wide range of angles and directions, and cannot be
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`focused with optical elements such as lenses and more general convex surfaces.
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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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`23
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`
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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
`
`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 large circular active detection
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`area surrounding that source. APPLE-1019, 86, 90; APPLE-1046, 803-805; see
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`also APPLE-1012, FIG. 7.
`
`39. Further, far from focusing light towards the center as Patent Owner
`
`contends, a POSITA would have understood that Ohsaki’s cover provides a slight
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`refracting effect, such that light rays that otherwise would have missed the
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`detection area are instead directed toward that area as they pass through the
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`interface provided by the cover. APPLE-1019, 52; APPLE-1007, [0015]; APPLE-
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`1051, 87-92, 135-141; APPLE-1052, 60:7-61:6, 70:8-18 (“a lens...would condense
`
`24
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`

`

`
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`incoming light onto the detectors, thus increasing the signal to noise ratio as well
`
`as the signal strength per area of the detectors (since each detector area will receive
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`more incoming light 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 have a slight
`
`refracting effect on rays returning towards the system that would not be able to
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`condense rays with a broad range of incoming angles towards a small central
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`location. APPLE-1051, 84; APPLE-1055, 1486; APPLE-1056, 1484; APPLE-
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`1019, 52, 86, 90. A cover like Ohsaki’s would also have been understood to
`
`increase Mendelson-799’s light-gathering ability by causing light to refract
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`towards the larger circular active detection area as it crosses the interface provided
`
`by the cover such that, overall, more of the partially reflected, transmitted,
`
`absorbed, and ultimately back scattered light strikes the detectors than otherwise
`
`would have absent the cover. Because the convex cover provides additional
`
`surface area for intimate contact with the tissue, the cover also provides an
`
`increased area for capture of diffuse light from illuminated tissue regions, leading
`
`to increased light capture at the detectors and improved performance.
`
`41. Furthermore, Masimo and Dr. Madisetti appear to ignore that Ohsaki relies
`
`on a convex board to improve signal quality and performance even though
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`25
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`

`

`
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`Ohsaki’sensor does not have a detector at the center. If, as asserted by Madisetti
`
`and the Patent Owner, such a convex cover condenses, directs, or focuses the light
`
`to the center, the embodiments disclosed by Ohsaki would fail because there is no
`
`detector at the center to detect all of the light that would be directed towards the
`
`center by the convex board. But nothing in Ohsaki discloses or teaches that its
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`convex board directs all light towards the center.
`
`
`
`
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`42.
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`Indeed, as shown above, Figure 2 of Ohsaki shows light paths that are not
`
`redirected, condensed or focused at or towards the center. It would have been
`
`26
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`

`

`
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`obvious and understood by a POSITA that the light rays shown in Ohsaki’s figure
`
`are no more than slightly altered by refraction of the convex cover, consistent with
`
`the near equivalence in the values of index of refraction for the tissue and the
`
`materials used for the cover, and with the modest radius of curvature shown in this
`
`figure from Ohsaki. For this reason, Dr. Madisetti and Masimo’s arguments
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`regarding general characteristic of convex surfaces that supposedly focuses all
`
`light towards or at the center are critically flawed because even Ohsaki does not
`
`place a detector at its center.
`
`43. Moreover, even in Patent Owner and Dr. Madisetti’s illustration (shown
`
`below), which represents their understanding of Ohsaki’s FIGS. 1 and 2, the
`
`detector is positioned away from the center. EX. 2004, ¶38. As shown below,
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`even in Dr. Madisetti’s illustration, the detector is not centered. If Patent Owner
`
`and Dr. Madisetti’s arguments were correct (which they are not), Ohsaki
`
`embodiments in FIGS. 1 and 2 would fail to produce a functioning pulse wave
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`sensor—which is not the case—and Patent Owner has never claimed the same
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`either.
`
`
`
`27
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`EX. 2004, pg. 22
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`
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`
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`44. For