IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Attorney Docket No.: 50095-0007IP1
`
`Poeze et al.
`In re Patent of:
`10,258,266
`U.S. Patent No.:
`April 16, 2019
`Issue Date:
`Appl. Serial No.: 16/212,537
`Filing Date:
`Dec. 6, 2018
`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: December 2, 2021
`
` By: _______________________
`
`Thomas W. Kenny, Ph.D.
`
`APPLE 1047
`Apple v. Masimo
`IPR2021-00208
`
`1
`
`
`
`Attorney Docket No.: 50095-0007IP1
`
`Poeze et al.
`In re Patent of:
`10,258,266
`U.S. Patent No.:
`April 16, 2019
`Issue Date:
`Appl. Serial No.: 16/212,537
`Filing Date:
`Dec. 6, 2018
`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: December 2, 2021
`
` By: _______________________
`
`Thomas W. Kenny, Ph.D.
`
`APPLE 1047
`Apple v. Masimo
`IPR2021-00208
`
`1
`
`
`
`Table of Contents
`
`Introduction ..................................................................................................... 3
`
`II.
`
`Ground 1 Establishes Obviousness .................................................................. 5
`
`A. Inokawa’s lens enhances the light-gathering ability of Aizawa ................... 5
`
`B. A POSITA would have been motivated to add a second LED to Aizawa .. 21
`
`C.A POSITA would have been motivated to modify Aizawa in view of Ohsaki
`to include a convex protrusion ....................................................................... 24
`
`III. Ground 2 Establishes Obviousness ................................................................ 28
`
`A. Inokawa’s lens similarly enhances the light-gathering ability of Mendelson-
`1988 ............................................................................................................... 28
`
`B. Mendelson-1988 in view of Inokawa includes the claimed cover .............. 29
`
`C. Mendelson-1988 in view of Inokawa renders obvious a “circular housing”
`with a “cover” ................................................................................................ 31
`
`D. Nishikawa is a supporting reference .......................................................... 32
`
`IV. CONCLUSION ............................................................................................. 32
`
`2
`
`
`
`
`
`Introduction
`
`1.
`
`I have been retained on behalf of Apple Inc. to offer technical opinions relating
`
`to U.S. Patent No. 10,258,266 (“the ’266 Patent”) in the present case (IPR2021-
`
`00208). In this Second Declaration, I provide opinions related to Patent Owner’s
`
`Response (Paper 15) and Dr. Madisetti’s supporting declaration (Ex. 2004).
`
`2.
`
`In addition to the materials listed in my First Declaration (APPLE-1003), I
`
`have reviewed several additional documents and references including:
`
` Paper 7: Institution Decision;
`
` Paper 15: Patent Owner’s Response (“POR”);
`
` Ex. 2004: Declaration of Dr. Madisetti;
`
` Ex. 2006-2009: Transcripts of my prior depositions;
`
` APPLE-1034: Deposition Transcript of Dr. Vijay Madisetti in
`
`IPR2020- 01520, IPR2020-01537, IPR2020-01539, Day 1 (August
`
`1, 2021);
`
` APPLE-1035: Deposition Transcript of Dr. Vijay Madisetti in
`
`IPR2020- 01520, IPR2020-01537, IPR2020-01539, Day 2 (August
`
`2, 2021);
`
` APPLE-1036: Deposition Transcript of Dr. Vijay Madisetti in
`
`IPR2020- 01536, IPR2020-01538 (August 3, 2021);
`
` APPLE-1044: “Refractive Indices of Human Skin Tissues at Eight
`
`Wavelengths and Estimated Dispersion Relations between 300 and
`
`
`
`3
`
`
`
`1600 nm,” H. Ding, et al.; Phys. Med. Biol. 51 (2006); pp. 1479-
`
`1489 (“Ding”);
`
` APPLE-1045: “Analysis of the Dispersion of Optical Plastic
`
`Materials,” S. Kasarova, et al.; Optical Materials 29 (2007); pp.
`
`1481-1490 (“Kararova”);
`
` APPLE-1046; “Noninvasive Pulse Oximetry Utilizing Skin
`
`Reflectance Photoplethysmography,” Y. Mendelson, et al.; IEEE
`
`Trans-actions on Biomedical Engineering, Vol. 35, No. 10,
`
`October 1988; pp. 798-805 (“Mendelson-IEEE-1988”);
`
` APPLE-1049: Eugene Hecht, Optics (4th Ed. 2002);
`
` APPLE-1050: Excerpt from Merriam-Webster Dictionary
`
` APPLE-1051: Design of Pulse Oximeters, J.G. Webster; Institution
`
`of Physics Publishing, 1997 (“Webster”); and
`
` APPLE-1052: Eugene Hecht, Optics (2nd Ed. 1990).
`
`3.
`
`Counsel has informed me that I should consider these materials through the
`
`lens of a person of ordinary skill in the art (POSITA) related to the ’266 Patent at the
`
`time of the earliest possible priority date of the ’266 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,
`
`which I have been informed was also adopted by the Board in the Institution Decision.
`
`APPLE-1003, [0021]-[0022]; Institution Decision, 12-13.
`
`
`
`4
`
`
`
`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 ’266 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.
`
` Ground 1 Establishes Obviousness
`
`A. Inokawa’s lens enhances the light-gathering ability of Aizawa
`
`7.
`
`As I previously explained in the Original Declaration, Inokawa very generally
`
`describes a “lens [that] makes it possible to increase the light-gathering ability” of a
`
`reflectance type pulse sensor, APPLE-1008, [0015], [0058], FIG. 2, and, based on
`
`this disclosure, a POSITA would have been motivated to incorporate “an Inokawa-
`
`like lens into the cover of Aizawa to increase the light collection efficiency....”
`
`APPLE-1003, ¶¶86-89. In a significant extrapolation from the very simple and
`
`
`
`5
`
`
`
`purely illustrative description in Inokawa, Patent Owner provides two incorrect
`
`arguments. First, Patent Owner claims that Inokawa’s disclosure is narrowly-limited
`
`to a particular lens that somehow is only capable of operation with peripheral
`
`emitters and a central detector. Second, the Patent Owner claims that the lens of
`
`Inokawa directs all incoming light rays “to the center of the sensor” and would
`
`“direct light away from the periphery-located detectors as in Aizawa,” regardless of
`
`the direction of light propagation of each ray, which is a violation of elementary laws
`
`of light propagation that would be familiar to a POSITA. POR, 16, 20; see also
`
`APPLE-1034, 40:4-11 (“...as I describe in my Declaration...if you have a convex
`
`surface...all light reflected or otherwise would be condensed or directed towards the
`
`center.”). Based on these two incorrect claims, the Patent Owner insists that there
`
`would be no motivation to combine.
`
`8.
`
`Patent Owner’s misinformed understanding of Inokawa’s lens as well as lenses
`
`in general is demonstrated by their description of Inokawa’s lens 27 as “focus[ing]
`
`light from LEDs (21, 23)...to a single detector (25) in the center” and “direct[ing]
`
`incoming light to the centrally located detector.” POR, 14; see also APPLE-1034,
`
`40:4-11 (“...as I describe in my Declaration...if you have a convex surface...all light
`
`reflected or otherwise would be condensed or directed towards the center.”).
`
`9.
`
`A correct understanding of Inokawa’s lens as well as of reflectance type pulse
`
`sensors in general (like those disclosed by each of Aizawa, Inokawa, and Mendelson-
`
`1988) readily exposes Patent Owner’s flawed rationale. Indeed, as I noted during
`
`
`
`6
`
`
`
`deposition, a POSITA would understand that Inokawa’s lens generally improves
`
`“light concentration at pretty much all of the locations under the curvature of the
`
`lens,” as opposed to only at a single point at the center as asserted by Patent Owner.
`
`Ex. 2006, 164:8-16. Indeed, as further explained below, a POSITA would have
`
`understood the following to be true—that a cover featuring a convex protrusion
`
`would improve Aizawa’s signal-to-noise ratio by causing more light backscattered
`
`from tissue to strike Aizawa’s photodetectors than would have with a flat cover.
`
`APPLE-1051, 52, 86, 90; APPLE-1052, 84, 87-92, 135-141; APPLE-1046, 803-805;
`
`APPLE-1006, FIGS. 1(a)-1(b). The convex cover enhances the light-gathering
`
`ability of Aizawa’s sensor.
`
`i. Masimo ignores the well-known principle of
`reversibility
`
`10.
`
`The well-known optical principle of reversibility readily dispels Masimo’s
`
`claim that “a convex cover condenses light towards the center of the sensor and away
`
`from the periphery,” when applied to Aizawa. POR, 16; APPLE-1052, 87-92;
`
`APPLE-1049, 106-111. Specifically, according to the principle of reversibility, “a ray
`
`going from P to S will trace the same route as one from S to P.” APPLE-1052, 92, 84;
`
`APPLE-1049, 101, 110; APPLE-1036, 80:20-82:20. Importantly, the principle
`
`dictates that rays that are not completely absorbed by user tissue will propagate in a
`
`reversible manner. In other words, every ray that completes a path through tissue
`
`from an LED to a detector would trace an identical path through that tissue in reverse,
`
`if the positions of the LED emitting the ray and the receiving detector were swapped.
`
`
`
`7
`
`
`
`APPLE-1052, 92. To help explain, I have annotated Inokawa’s FIG. 2 (presented
`
`below) to illustrate the principle of reversibility applied in the context of a reflective
`
`optical physiological monitor. As shown, Inokawa’s FIG. 2, illustrates two example
`
`ray paths from surrounding LEDs (green) to a central detector (red):
`
`APPLE-1008, FIG. 2 (annotated)
`
`As a consequence of the principle of reversibility, a POSITA would have
`
`11.
`
`
`
`understood that if the LED/detector configuration were swapped, as in Aizawa, the
`
`two example rays would travel identical paths in reverse, from a central LED (red) to
`
`surrounding detectors (green). A POSITA would have understood that, for these rays,
`
`any condensing/directing/focusing benefit achieved by Inokawa’s cover (blue) under
`
`the original configuration would be identically achieved under the reversed
`
`configuration:
`
`
`APPLE-1008, FIG. 2 (annotated)
`
`
`12. When factoring in additional scattering that may occur when light is reflected
`
`within human tissue, reversibility holds for each of the rays that are not completely
`
`absorbed; consequently, “if we’re concerned with the impact of the lens on the system,
`8
`
`
`
`
`it’s absolutely reversible.” EX. 2006, 209:19-21, 207:9-209:21 (“one could look at
`
`any particular randomly scattered path…and the reversibility principle applies to all of
`
`the pieces [of that path] and, therefore, applies to the aggregate”).
`
`
`
`13.
`
`An example of reversibility in a situation with diffuse light, such as is present
`
`when LEDs illuminate tissue, is shown below from Hecht’s Figure 4.12.
`
`
`
`14.
`
`In this figure 4.12a, collimated light is incident on a smooth surface, and
`
`exhibits specular reflection, in which parallel light rays encounter and are reflected
`
`from the surface and remain parallel. A POSITA would certainly understand specular
`
`reflection. In the case of the reflection as shown in Figure 4.12b, the random
`
`roughness of the surface scatters the incoming rays into many directions, and the
`
`resulting light would appear to be diffuse. However, even in this circumstance, the
`
`principle of reversibility applies–each individual ray can be reversed such that a ray
`
`travelling to the surface and scattered in a random direction can be followed
`
`backwards along exactly the same path.
`
`15.
`
`In more detail, and as shown with respect to the example paths illustrated
`
`below (which include scattering within tissue), each of the countless photons
`
`
`
`9
`
`
`
`travelling through the system must abide by Fermat’s principle. APPLE-1049, 106-
`
`111. Consequently, even when accounting for various random redirections and partial
`
`absorptions, each photon traveling between a detector and an LED would take the
`
`quickest (and identical) path along the segments between each scattering event, even if
`
`the positions of the detector and LED were swapped.
`
`
`
`
`
`
`To better understand the effect of a convex lens on the propagation of light
`
`
`
`16.
`
`rays towards or away from the different LEDs or detectors, the first and last segment
`
`of the light path may be representative of the light propagation of the various light
`
`rays. In the figures above, starting at the upper left, there is a pink-colored light ray
`
`emerging from the green LED and passing through the convex lens and entering the
`
`tissue. On the lower left, there is a pink-colored light ray leaving the tissue and
`
`entering the convex lens. As drawn, these rays are the same in position and
`
`orientation, except that the direction is exactly reversed. This illustration is consistent
`
`with the Principle of Reversibility as applied to this pair of possible light rays.
`
`According to the principle of reversibility, the upper light path from the LED to the
`
`
`
`10
`
`
`
`first interaction with a corpuscle is exactly reversed. This same behavioral pattern
`
`applies to all of the segments of the many light paths that cross the interface at the
`
`surface of the convex lens. Importantly, in this example, the convex lens does not
`
`refract the incoming ray in a different direction from the outgoing ray, e.g., in a
`
`direction towards the center different from the outgoing ray. As required by the
`
`principle of reversibility, this incoming ray follows the same path as the outgoing ray,
`
`except in the reverse direction. This statement is true for every segment of these light
`
`paths that crosses the interface between the tissue and the convex lens. Any ray of
`
`light that successfully traverses a path from the LED to the detector, that path already
`
`accounts for the random scattering as that scattering is what allowed the ray to go from
`
`the LED to a detector along the path to thereby be subsequently detected by the
`
`detector. A POSITA would have understood that the path is an aggregation of
`
`multiple segments and that the path is reversible as each of its segments would be
`
`reversible, consistent with Fermat’s principle.
`
`17.
`
`The statement about the reversibility of the segments of the light path which
`
`cross the interface between tissue and convex lens is consistent with the well-known
`
`and well-established Snell’s law, which provides a simple algebraic relation between
`
`the angles of incidence and refraction as determined by the two indices of refraction.
`
`And Snell’s law supports the basic understanding that the path of the light rays to/from
`
`a scattering event across the interface to/from the convex lens and on to/from the LED
`
`or photodetector must be reversible.
`
`
`
`11
`
`
`
`18.
`
`Based on this understanding of light rays and Snell’s law, a POSITA would
`
`have understood that the positions of the emitters and detectors can be swapped in the
`
`proposed combination, and that the light paths from the initial situation would be
`
`reversed in the altered situation.
`
`19.
`
` When confronted with this basic principle of reversibility during deposition,
`
`Dr. Madisetti refused to acknowledge it, even going so far as to express ignorance of
`
`“Fermat’s principle, whatever that is.” APPLE-1034, 89:12-19. Yet Fermat’s
`
`principle, which states that a path taken by a light ray between two points is one that
`
`can be traveled in the least time, regardless of the direction of travel, is one of the most
`
`fundamental concepts in optics/physics and plainly requires the basic principle of
`
`reversibility. APPLE-1052, 87-92; APPLE-1049, 106-111. This is in no way a new
`
`theory, as this core concept dates back many years, and is offered in Aizawa itself.
`
`Indeed, Aizawa recognizes this reversibility, stating that while the configurations
`
`depicted include a central emitter surrounded by detectors, the “same effect can be
`
`obtained when…a plurality of light emitting diodes 21 are disposed around the
`
`photodetector 22.” APPLE-1006, [0033]; EX. 2006, 209:19-21.
`
`20. Masimo’s technically and factually flawed argument is exposed by multiple
`
`prior art references, including the Ohsaki and Inokawa references which are the key
`
`elements of our combinations. As shown in the figures below, Ohsaki and Inokawa
`
`both show embodiments which use a convex lens to direct light to detectors that are
`
`not located at the center of a sensor. APPLE-1014, FIG. 2; APPLE-1008, FIG. 3.
`
`
`
`12
`
`
`
`In Inokawa’s Figure 2, an off-center emitter and sensor are configured to send and
`
`receive text messages, and are capable of success, even though the detector is not
`
`positioned at the center.
`
`
`
`APPLE-1014, FIG. 2
`
`13
`
`
`
`
`
`21.
`
`If, as asserted by the Patent Owner, a convex lens is required to condense,
`
`direct, or focus the light to the center, the embodiments disclosed by Ohsaki and
`
`Inokawa would all 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. The Ohsaki and
`
`Inokawa embodiments (reproduced above) do not show or otherwise teach that its
`
`convex board directs all light towards the center.
`
`22.
`
`In short, based at least on the principle of reversibility, a POSITA would have
`
`understood that both configurations of LEDs and detectors—i.e., with the LED at the
`
`center as in Aizawa or with the detector at the center as in Inokawa—would identically
`
`benefit from the enhanced light-gathering ability of a convex lens/protrusion.
`
`
`
`ii. Masimo ignores the behavior of scattered light in
`a reflectance-type pulse sensor
`
`23.
`
`Because Aizawa is a reflectance-type pulse sensor that receives diffuse,
`
`backscattered light from the measurement site, its cover/lens cannot focus all
`
`incoming light toward the sensor’s center. Ex. 2006, 163:12-164:2 (“A lens in
`
`general…doesn’t produce a single focal point”). Indeed, reflectance-type sensors
`
`work by detecting light that has been “partially reflected, transmitted, absorbed, and
`
`scattered by the skin and other tissues and the blood before it reaches the detector.”
`
`APPLE-1051, 86. A POSITA would have understood that light which backscatters
`
`from the measurement site after diffusing through tissue reaches the active detection
`
`area from various random directions and angles. APPLE-1046, 803; APPLE-1051,
`
`90, 52.
`
`
`
`14
`
`
`
`24.
`
`As noted above, basic law of refraction, namely Snell’s law, dictates this
`
`behavior of light. APPLE-1052, 84; APPLE-1049, 101; APPLE-1036, 80:20-82:20;
`
`APPLE-1051, 52, 86, 90. For example, referring to Masimo’s version of Inokawa’s
`
`FIG. 2, further annotated below to show additional rays of light emitted from LED 21,
`
`it is clearly seen how some of the reflected/scattered light from the measurement site
`
`does not reach Inokawa’s centrally located detector:
`
`
`
`
`
`APPLE-1008, FIG. 2 (annotated); POR, 14.
`
`25.
`
`For these and countless other rays that are not shown, there is simply no way
`
`for a cover to focus all light at the center of the sensor device. APPLE-1052, 84;
`
`APPLE-1049, 101; APPLE-1036, 80:20-82:20. The illustration I provide below
`
`shows how Snell’s law determines a direction of a backscattered ray within a convex
`
`cover, thus providing a stark contrast to Masimo’s assertions that all such rays must be
`
`redirected to or towards the center:
`
`
`
`15
`
`
`
`
`
`26.
`
`Indeed, far from focusing light to the center as Masimo contends, Ohsaki’s
`
`convex cover provides a slight refracting effect, such that light rays that may have
`
`otherwise missed the detection area are instead directed toward that area as they pass
`
`through the interface provided by the cover. This is particularly true in configurations
`
`like Aizawa’s in which light detectors are arranged symmetrically about a central light
`
`source, so as to enable backscattered light to be detected within a circular active
`
`detection area surrounding that source. APPLE-1051, 86, 90. The slight refracting
`
`effect is a consequence of the similar indices of refraction between human tissue and a
`
`typical cover material (e.g., acrylic). APPLE-1044, 1486; APPLE-1045, 1484).
`
`27.
`
`To support the misguided notion that a convex cover focuses all incoming light
`
`at the center, Masimo relies heavily on the ’266 Patent’s FIG. 14B (reproduced
`
`below):
`
`
`
`
`
`16
`
`
`
`
`
`
`
`APPLE-1001, FIG. 14B (as annotated at POR, 18-19, 26)
`
`28. Masimo and Dr. Madisetti treat this figure as an illustration of the behavior of
`
`all convex surfaces with respect to all types of light, and conclude that “a convex
`
`surface condenses light away from the periphery and towards the sensor’s center.”
`
`POR, 16; APPLE-1034 (“…a POSA viewing [FIG. 14B]…would understand that
`
`light, all light, light from the measurement site is being focused towards the center”).
`
`29. But the incoming collimated light shown in FIG. 14B is not an accurate
`
`representation of light that has been reflected from a tissue measurement site. The
`
`light rays (1420) shown in FIG. 14B are collimated (i.e., travelling paths parallel to
`
`one another), and each light ray’s path is perpendicular to the detecting surface.
`
`30. While each of Inokawa, Aizawa, and Mendelson-1988 are directed to a
`
`reflectance-type pulse sensor that detects light that has been backscattered from the
`
`
`
`17
`
`
`
`measurement site, the scenario depicted in FIG. 14B shows a transmittance-type
`
`configuration where collimated or nearly-collimated light is “attenuated by body
`
`tissue,” not backscattered by it. APPLE-1001, 35:65-67. Indeed, FIG. 14I of the
`
`’266 Patent puts FIG. 14B in proper context, showing how light from the emitters is
`
`transmitted through the entire finger/tissue before being received by the detectors on
`
`the other side:
`
`
`
`31. By contrast, the detector(s) of reflectance type pulse detectors detect light that
`
`has been “partially reflected, transmitted, absorbed, and scattered by the skin and
`
`other tissues and the blood before it reaches the detector.” APPLE-1051, 86. For
`
`example, a POSITA would have understood from Aizawa’s FIG. 1(a) that light that
`
`backscatters from the measurement site after diffusing through tissue reaches the
`
`circular active detection area provided by Aizawa’s detectors from various random
`
`directions and angles, as opposed to all light entering from the same direction and at
`
`
`
`18
`
`
`
`the same angle as shown above in FIG. 14B. APPLE-1051, 52, 86, 90; APPLE-
`
`1046, 803-805; see also APPLE-1012, FIG. 7. Even for the collimated light shown
`
`in FIG. 14B, the focusing of light at the center only occurs if the light beam also
`
`happens to be perfectly aligned with the axis of symmetry of the lens. If for
`
`example, collimated light were to enter the FIG. 14B lens at any other angle, the light
`
`would focus at a different location in the focal plane. Further, if the light were not
`
`collimated, so that rays enter the lens with a very wide range of incident angles, there
`
`would be no focus at all, and many rays will be deflected away from the center.
`
`Moreover, since “the center” takes up a very small portion of the total area under the
`
`lens, the majority of rays associated with diffuse light entering the lens would arrive
`
`at locations away from the center.
`
`32. The light rays from a diffuse light source, such as the LED-illuminated tissue
`
`near a pulse wave sensor or a pulse oximeter, include a very wide range of angles
`
`and directions, and cannot be focused to a single point/area with optical elements
`
`such as lenses and more general convex surfaces. The example figure below
`
`illustrates light rays backscattered by tissue toward a convex lens; as consequence of
`
`this backscattering, a POSITA would have understood that the backscattered light
`
`will encounter the interface provided by the convex board/lens at all locations from a
`
`wide range of angles. This pattern of incoming light cannot be focused by a convex
`
`lens towards any single location.
`
`
`
`19
`
`
`
`
`
`APPLE-1052, 141 (annotated)
`
`
`
`33. To the extent Masimo contends that only some light is directed “towards the
`
`center” and away from Aizawa’s detectors in a way that discourages combination,
`
`such arguments also fail. Indeed, far from focusing light to a single central point, a
`
`POSITA would have understood that Ohsaki’s cover provides a slight refracting
`
`effect, such that light rays that may have missed the active detection area are instead
`
`directed toward that area as they pass through the interface provided by the lens.
`
`APPLE-1051, 52; APPLE-1007, [0015]; APPLE-1052, 87-92, 135-141; APPLE-
`
`1034, 60:7-61:6, 70:8-18.
`
`34. Patent Owner and Dr. Madisetti’s reliance on drawings provided in paragraphs
`
`119-120 of my Original Declaration filed in IPR2020-01520 for justification of their
`
`understanding of Inokawa’s lens is similarly misplaced. POR, 16-18; APPLE-1041,
`
`41:7-22, 60:7-61:6. Far from demonstrating the false notion that a convex lens
`
`directs all light to the center, these drawings I previously provided are merely
`
`
`
`20
`
`
`
`simplified diagrams included to illustrate, as per dependent claim 12, one example
`
`scenario (based on just one ray and one corpuscle) where a light permeable cover can
`
`“reduce a mean path length of light traveling to the at least four detectors.” Ex.
`
`2020, ¶¶119-120. As previously illustrated, there are many other rays that would
`
`intersect the interface between the tissue and the lens at different locations and with
`
`different angles of incidence, and the effect of the lens on this variety of rays is not
`
`nearly as simple as the statements provided by Dr. Madisetti. There is simply no
`
`possibility of any lens focusing all incoming rays from a diffuse light source toward a
`
`central location.
`
`
`
`B. A POSITA would have been motivated to add a second LED to
`Aizawa
`
`35. As laid out in detail in my Original Declaration, a POSITA would
`
`have been motivated to add a second emitter operating at a different
`
`wavelength to Aizawa in order to allow for a more reliable pulse
`
`measurement that takes into account and corrects for inaccurate readings
`
`stemming from body movement. APPLE-1003, ¶¶69-81.
`
`36. Patent Owner, however, suggests that such motivation is flawed
`
`because “Aizawa...expressly states that it provides a “device for computing
`
`the amount of motion load from the pulse rate.’” POR, 39. But Patent
`
`Owner fails to explain how Aizawa senses and computes motion load.
`
`Indeed, Aizawa is completely silent on this point. Moreover, while Patent
`
`Owner contends that Aizawa “account[s] for” motion, Aizawa does not even
`21
`
`
`
`
`
`say whether it uses the computed motion load to improve the detection
`
`signal. Patent Owner further fails to rebut that adding a second LED having
`
`a second wavelength, as per Inokawa, will “allow for a more reliable”
`
`reading that compensates for body motion. APPLE-1003, ¶72. Like I
`
`explained during my deposition, adding a second LED at a different
`
`wavelength to Aizawa’s single LED design would allow it to obtain a more
`
`reliable pulse measurement by allowing the system to “measur[e] pulse rate
`
`and motion load during the same time” by operating a separate LED
`
`dedicated to sensing motion. Ex. 2007, 401:11-402:4. Moreover, having
`
`two separate signals that are respectively dedicated to measuring pulse and
`
`body motion, as per Inokawa, will allow Aizawa’s system to “take into
`
`account and correct for inaccurate readings related to body movement” by
`
`subtracting the “signal component corresponding to body movement [] from
`
`the pulse signal to help better isolate the desired pulse data.” APPLE-1003,
`
`¶72.
`
`37. By using two wavelengths, it is possible to record two independent
`
`signal waveforms at the same time from the same site. As explained above,
`
`each reflected signal includes some dependence on the physiological
`
`parameter, and on the movement of the sensor relative to the measurement
`
`site. Because it is possible to choose different wavelengths of light so as to
`
`have one signal with strongest dependence on the physiological parameter
`
`
`
`22
`
`
`
`and the second signal with the strongest dependence on the movement of the
`
`sensor, the signals can be processed in a way to compensate for movement
`
`and create a more reliable measurement of the physiological parameter. The
`
`use of two or more separate wavelengths to obtain independent measures of
`
`the physiological parameter and error sources such as body movement, was
`
`well-known at the time of the invention, and it would have been obvious for
`
`a POSITA to consider the use of a second wavelength LED to capture these
`
`benefits.
`
`38.
`
`Inokawa provides a second and independent motivation for adding a
`
`second LED having a different wavelength, namely the ability to “improve
`
`data transmission accuracy by using the second LED...to transmit checksum
`
`information such that ‘the accuracy of data can be increased.” APPLE-1008,
`
`[0111], [0044], [0048]; APPLE-1003, ¶78. The fact that “Inokawa states
`
`that it can accomplish transmission with a single LED” does not take away
`
`from the fact that a POSITA would nevertheless have been motivated to
`
`look to the two-LED implementation of Inokawa to further improve
`
`accuracy. POR, 41; Ex. 2007, 407:7-408:20. Despite Patent Owner’s
`
`contention that I “acknowledged that POSITA wanting to maintain a
`
`wireless data transmission approach [in Aizawa] would not switch to the
`
`base station transmission approach of Inokawa,” POR, 42, a full reading of
`
`transcript reveals that I was simply making it very clear that if “they’ve
`
`
`
`23
`
`
`
`already decided not to use a base station transmission device, then they
`
`probably wouldn’t switch to one.” Ex. 2007, 416:5-15. As for Patent
`
`Owner’s assertion that Aizawa’s goal is “real-time measuring,” I note that
`
`there is no disclosure in Aizawa indicating that such measured data must
`
`also be transmitted externally in real-time. POR, 40. Moreover, a POSITA
`
`would have been capable of balancing potential benefits associated with
`
`different data transmission approaches, for instance improved transmission
`
`accuracy on one hand and quicker transmission on the other.
`
`39. Patent Owner additionally argues that “Petitioner fails to address other
`
`complications that would result from adding an extra LED to a physiological
`
`sensor,” such as the potential for “thermal interference.” POR, 42. But as I
`
`again explained during my deposition and reiterate here, such minor issues
`
`are “part of what I understand someone of ordinary skill in the art would
`
`bring...to the problem and would know how to make the changes needed.”
`
`Ex. 2007, 384:8-388:12.
`
`C. A POSITA would have been motivated to modify Aizawa in view
`of Ohsaki to include a convex protrusion
`
`40. As explained in my Original Declaration, “Ohsaki teaches that adding a
`
`convex surface...can help prevent the device from slipping on the tissue of the wearer
`
`compared to using a flat cover without such protrusion” and that “a POSITA seeking
`
`to achieve improved adhesion between the detector and the skin, as expressly
`
`recognized in Aizawa, would have been motivated and readily able to modify
`
`
`
`24
`
`
`
`Aizawa’s acrylic plate to have a convex shape as in Ohsaki.” APPLE-1003, ¶¶127-
`
`128 (citing to APPLE-1014, [0025]; APPLE-1006, [0026], [0030]).
`
`41. Patent Owner, rather than attempting to directly rebut this rationale, focuses on
`
`arguments that are factually flawed and legally irrelevant. Specifically, Patent
`
`Owner contends that Ohsaki’s “convex surface must have longitudinal
`
`directionality,” and that “Ohsaki indicates that its convex surface only prevents
`
`slipping on the backhand side (i.e., watch-side) of the user’s wrist.” POR, 45.
`
`Patent Owner further asserts that the shape of Oh
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