`571-272-7822
`
`Paper 7
`Entered: May 5, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APPLEINC.,
`Petitioner,
`
`Vv.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`IPR2020-01713
`Patent 10,624,564 Bl
`
`Before JOSIAH C. COCKS, ROBERT L. KINDER,and
`AMANDAF. WIEKER,Administrative Patent Judges.
`
`KINDER,Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 US.C. § 314
`
`
`
`IPR2020-01713
`Patent 10,624,564 Bl
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`I.
`
`INTRODUCTION
`
`A. Background
`
`AppleInc. (‘Petitioner’) filed a Petition requesting an inter partes
`
`review of claims 1—30 (“challenged claims”) of U.S. Patent No. 10,624,564
`
`B1 (Ex. 1001, “the °564 patent”). Paper 2 (‘“Pet.”). Masimo Corporation
`
`(“Patent Owner”) waivedfiling a preliminary response. Paper 6 (“PO
`
`Waiver”).
`
`Wehaveauthority to determine whetherto institute an inter partes
`
`review, under 35 U.S.C. § 314 and 37 C.F.R. § 42.4. An inter partes review
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`may notbeinstituted unless it is determined that “the information presented
`
`in the petition filed under section 311 and anyresponsefiled under section
`
`313 showsthat there is a reasonable likelihood that the petitioner would
`
`prevail with respect to at least 1 of the claims challenged in the petition.”
`
`35 U.S.C. § 314 (2018); see also 37 C.F.R. § 42.4(a) (2020) (“The Board
`
`institutes the trial on behalf of the Director.”).
`
`For the reasons provided below and based on the record before us, we
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`determine that Petitioner has demonstrated a reasonable likelihood that
`
`Petitioner would prevail in showing the unpatentability of at least one of the
`
`challenged claims. Accordingly, we institute an inter partes review onall
`
`groundsset forth in the Petition.
`
`B. Related Matters
`
`The parties identify the following matters related to the °564 patent:
`
`Masimo Corporation v. Apple Inc., Civil Action No. 8:20-cv-00048
`
`(C.D. Cal.);
`
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`Apple Inc. v. Masimo Corporation, IPR2020-01520 (PTAB Aug.31,
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`2020) (challenging claims of U.S. Patent No. 10,258,265 B1);
`
`Apple Inc. v. Masimo Corporation, IPR2020-01521 (PTAB Sept. 2,
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`2020) (challenging claims of U.S. Patent No. 10,292,628 B1);
`
`Apple Inc. v. Masimo Corporation, IPR2020-01523 (PTAB Sept.9,
`
`2020) (challenging claims of U.S. Patent No. 8,457,703 B2);
`
`Apple Inc. v. Masimo Corporation, IPR2020-01524 (PTAB Aug. 31,
`
`2020) (challenging claims of U.S. Patent No. 10,433,776 B2);
`
`Apple Inc. v. Masimo Corporation, IPR2020-01526 (PTAB Aug. 31,
`2020) (challenging claims of U.S. Patent No. 6,771,994 B2);
`|
`Apple Inc. v. Masimo Corporation, IPR2020-01536 (PTAB Aug. 31,
`
`2020) (challenging claims of U.S. Patent No. 10,588,553 B2);
`
`Apple Inc. v. Masimo Corporation, IPR2020-01537 (PTAB Aug.31,
`
`~ 2020) (challenging claims of U.S. Patent No. 10,588,553 B2);
`
`Apple Inc. v. Masimo Corporation, [PR2020-01538 (PTAB Sept. 2,
`
`2020) (challenging claims of U.S. Patent No. 10,588,554 B2);
`
`Apple Inc. v. Masimo Corporation, IPR2020-01539 (PTAB Sept. 2,
`
`2020) (challenging claims of U.S. Patent No. 10,588,554 B2);
`
`Apple Inc. v. Masimo Corporation, IPR2020-01714 (PTAB Sept. 30,
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`2020) (challenging claims of U.S. Patent No. 10,631,765 B1);
`
`Apple Inc. v. Masimo Corporation, IPR2020-01715 (PTAB Sept. 30,
`
`2020) (challenging claims of U.S. Patent No. 10,631,765 B1);
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`Apple Inc. v. Masimo Corporation, IPR2020-01716 (PTAB Sept. 30,
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`2020) (challenging claims of U.S. Patent No. 10,702,194 B1);
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`Apple Inc. v. Masimo Corporation, IPR2020-01722 (PTAB Oct.2,
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`2020) (challenging claims of U.S. Patent No. 10,470,695 B2);
`
`Apple Inc. v. Masimo Corporation, IPR2020-01723 (PTAB Oct. 2,
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`2020) (challenging claims of U.S. Patent No. 10,470,695 B2);
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`Apple Inc. v. Masimo Corporation, IPR2020-01733 (PTAB Sept. 30,
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`2020) (challenging claims of U.S. Patent No. 10,702,195 B1); and
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`Apple Inc. v. Masimo Corporation, IPR2020-01737 (PTAB Sept. 30,
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`2020) (challenging claims of U.S. Patent No. 10,709,366 B1).
`
`Pet. 3; Paper 3, at 1, 3-4.
`
`Patent Ownerfurther identifies certain issued patent applications, as
`
`well as other pending and abandoned applications, that claim priority to, or
`
`share a priority claim with, the °564 patent. Paper 3, at 1-2.
`
`C. The ’564 Patent
`
`The °564 patentis titled “Multi-Stream Data Collection System for
`
`Noninvasive Measurement of Blood Constituents,” and issued on April 21,
`
`2020, from U.S. Patent Application No. 16/725,292, filed December23,
`
`2019. Ex. 1001, codes (21), (22), (45), (54). The 564 patent claimspriority
`
`througha series of continuation and continuation-in-part applicationsto
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`Provisional Application Nos. 61/086,060, 61/086,108, 61/086,063, and
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`61/086,057, each filed on August 4, 2008, as well as 61/091,732 filed on
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`August 25, 2008, and 61/078,228 and 61/078,207 both filed on July 3,
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`2008.' Id. at codes (60), (63).
`
`The *564 patent discloses a two-part data collection system including
`
`a noninvasive sensor that communicates with a patient monitor. Id. at 2:47—
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`51. The sensor includes a sensor housing, an optical source, and several
`
`photodetectors, and is used to measure a blood constituent or analyte, e.g.,
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`oxygen or glucose.
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`/d. at 2:38-46, 3:4-6. Thepatient monitor includes a
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`display and a network interface for communicating with a handheld
`
`computing device. Jd. at 2:54—57.
`
`' The Office has madethe prior determination that the application leading to
`the 564 patent is not designated as an “AIA (FITF)” application. See
`Ex. 1002 at 102 (Notice of Allowability of March 3, 2020). We determine
`that based onthis prior determination, and the lack of any contrary evidence
`before us, the Petition was not required to be filed more than nine months
`after the date of the grant of the patent. See 37 C.F.R. § 42.102(a)(1).
`Instead, based on the record before us, 37 C.F.R. § 42.102(a)(2) should
`apply, which allowsa petition to befiled after “the date of the grant of the
`patent.”
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`Figure | of the °564 patent is reproduced below.
`
`100
`
`SENSOR 104
`
`MONITOR 109
`
`
`EMITTER
`~ DETECTORS
`INPUT OATA
`
` 104 Yo”
`108
`oO
`
`2
`
` SIGNAL
`
`PROCESSOR
`
`
`OPTIONAL OPTIONAL
`NOISE
`TISSUE
`SHIELD
`SHAPER
`NETWORK
`
`
`INTERFACE
`(
`7
`|
`
`3
`rs
`FIG. 1
`
`MEASUREMENT
`DATA
`
`‘
`114
`
`Figure 1 illustrates a block diagram of data collection system 100 including
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`sensor 101 and monitor 109. /d. at 11:56-67. Sensor 101 includes emitter
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`104 and detectors 106. Jd. at 12:1-5. Emitter 104 emits light that is
`
`attenuated or reflected by the patient’s tissue at measurementsite 102. Id. at
`
`14:11-16. Detectors 106 capture and measurethelight attenuated or
`
`reflected from the tissue.
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`/d. In response to the measured light,
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`detectors 106 output detector signal 107 to monitor 109 through front-end
`
`interface 108. Jd. at 14:16-19, 36-42. Sensor 101 also mayincludetissue
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`shaper 105, which maybe in the form of a convex surface that: (1) reduces
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`the thickness of the patient’s measurementsite; and (2) provides more
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`surface area from whichlight can be detected. Jd. at 11:7-23.
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`Monitor 109 includes signal processor 110 and user interface 112. Id.
`
`at 15:27-29. “[S]ignal processor 110 includes processing logic that
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`determines measurements for desired analytes .
`
`.
`
`. based on the signals
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`received from the detectors 106.” Jd. at 15:32-35. User interface 112
`
`presents the measurementsto a user on a display, e.g., a touch-screen
`
`display.
`
`/d. at 15:57-61. In responseto user input or device orientation,
`
`user interface 112 can “reorient its display indicia.” Jd. at 15:63-67. The
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`monitor may be connected to storage device 114 and network interface 116.
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`Id. at 16:4—22. In some embodiments, the monitor, including the display,is
`
`attached to the patient by a strap. Jd. at 17:56-59, 18:16-19.
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`The *564 patent describes various examples of sensor devices.
`
`Figures 14D and 14F, reproduced below,illustrate sensor devices.
`
`FIG. 14D
`
`FIG. 14F
`
`Figure 14D illustrates a detector submount and Figure 14F illustrates
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`portions of a detector shell. Jd. at 6:54-57. As shownin Figure 14D,
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`multiple detectors 1410c are located within housing 1430 and under
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`transparent cover 1432, on which protrusion 605b is disposed. Jd. at 36:40-
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`47. Figure 14F illustrates detector shell 306f including detectors 1410c on
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`substrate 1400c. Jd. at 37:20-21. In some embodiments, the detector shell
`
`includes walls to separate individual photodiode arrays andto “prevent or
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`reduce mixingoflight signals.” Jd. at 22:46-53. Substrate 1400cis
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`enclosed by shielding enclosure 1490 and noise shield 1403, which include
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`window 1492a and window 1492b,respectively, placed above detectors
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`1410c. Id. at 22:20-36.
`
`Figures 4A and 4B, reproducedbelow,illustrate an alternative
`
`exampleof a tissue contact area of a sensor device.
`
`FIG. 4A
`
`FIG. 4B
`
`Figures 4A and 4Billustrate arrangements of protrusion 405 including
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`measurementsite contact area 470. Jd. at 23:30-36. “[M]easurementsite
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`contact area 470 can include a surface that molds bodytissue of a
`
`measurementsite.” Jd. “For example, the measurementsite contact area
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`470 can be generally curved and/or convex with respect to the measurement
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`site.” Jd. at 23:53-55. The measurementsite contact area includes windows
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`420-423 that “mimic or approximately mimic a configuration of, or even
`
`house,a plurality of detectors.” Jd. at 23:61-24:8.
`
`D.
`
`Illustrative Claim
`
`Ofthe challenged claims, claim 1 is independent. Claim 1 is
`
`illustrative and is reproduced below.
`
`1. A_user-worn physiological measurement device
`
`comprising:
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`[a] one or more emitters configured to emitlight into tissue
`of a user;
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`[b] at least four detectors arranged on a substrate;
`
`[c] a cover comprising a protruding convex surface,
`wherein the protruding convex surface extends overall of the at
`least four detectors arranged on the substrate, wherein at least a
`portion of the protruding convex surface isrigid;
`
`[d] one or more processors configured to: receive one or
`more signals from at least one of the at least four detectors, the
`one or more signals responsive to at
`least a physiological
`parameter of the user; and process the one or more signals to
`determine measurements of the physiological parameter;
`
`[e] a network interface configured to communicate with a
`mobile phone;
`
`[f] a touch-screen display configured to provide a user
`interface,
`
`{g] wherein: the user interface is configured to display
`indicia responsive to the measurements of the physiological
`parameter, and
`
`{h] an orientation of the user interface is configurable
`responsiveto a user input;
`
`[i] a wall that surroundsat least the at least four detectors,
`wherein the wall operably connects to the substrate and the
`cover;
`
`[j] a storage device configuredto at least temporarily store
`at least the measurements of the physiological parameter; and
`
`[k] a strap configured to position the physiological
`measurementdevice ontheuser.
`
`Ex. 1001, 44:63-45:29 (bracketed lettering [a]—[k] added).
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`E. Applied References
`
`Petitioner relies upon the following references:
`
`Shermanetal., U.S. Patent No. 4,941,236, filed July 6, 1989,
`issued July 17, 1990 (Ex. 1013, “Sherman”);
`
`Ali et al., U.S. Patent No. 6,584,336 B1, filed March 1, 2000,
`issued June 24, 2003 (Ex. 1019, “Ali”’);
`
`Ohsakiet al., U.S. Patent Application Publication No.
`2001/0056243 A1, filed May 11, 2001, published December 27, 2001
`(Ex. 1009, “Ohsak1’’);
`
`Aizawa, U.S. Patent Application Publication No.
`2002/0188210 Al, filed May 23, 2002, published December 12, 2002
`(Ex. 1006, “Aizawa’’);
`
`Rantala et al., U.S. Patent No. 6,912,413 B2, filed
`September 12, 2003, issued June 28, 2005 (Ex. 1022, “Rantala”); and
`
`Goldsmith et al., U.S. Patent Application Publication No.
`2007/0093786 A1, filed July 31, 2006, published April 26, 2007
`(Ex. 1011, “Goldsmith).
`
`Pet. 10.
`
`Petitioner also submits, inter alia, the Declaration of Thomas W.
`
`Kenny, Ph.D. (Ex. 1003).
`
`F. Asserted Grounds
`
`Petitioner asserts that claims 1-30 are unpatentable based upon the
`
`following grounds(Pet. 9):
`
`
`Claim(s) Challenged|35 U.S.C.§
`
`1-10 and 13-30
`Aizawa, Ohsaki, and Goldsmith
`
`Aizawa, Ohsaki, Goldsmith,
`and Sherman
`Aizawa, Ohsaki, Goldsmith,
`
`
`
`
`
`11
`
`103
`
`
`
`1-10 and 13-30
`
`103
`
`03
`
`Aizawa, Ohsaki, Goldsmith,
`and Ali
`/
`Aizawa, Ohsaki, Goldsmith,
`
`10
`
`
`
`
`
`
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`Claim(s) Challenged|_35 U.S.C. §
`
`|Ss Ai, and Sherman 103
`
`Aizawa, Ohsaki, Goldsmith,
`Ali, and Rantala
`
`II. DISCUSSION
`
`A. Claim Construction
`
`Forpetitions filed on or after November 13, 2018, a claim shall be
`
`construed using the same claim construction standard that would be used to
`
`construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R.
`
`§ 42.100(b) (2020). Accordingly, we construe the claims according to the
`
`standard set forth in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005).
`
`Based on ouranalysis of Petitioner’s challenges presented at this stage of the
`
`proceeding, wefind that one claim term requires express construction.
`
`Petitioner raises the issue of the proper scope of the claim term
`
`“processor” to a person ofordinary skill in the art. Pet. 51. Petitioner
`
`submits “[t]he °564 patent does not define ‘processor,’” but argues that a
`
`person of ordinary skill in the art would understand the term to mean “part
`
`of a computer system that operates on data,” consistent with the definition
`provided in Merriam-Webster’s Collegiate Dictionary.” Id.; Ex. 1012, 5.
`
`First, we observe that the claim language provides an understanding
`
`of the functions of the claimed one or more processers, which are
`39
`66
`
`“configured to:”
`
`“receive one or more signals” and “process the one or more
`
`signals to determine measurements of the physiological parameter.”
`
`? Petitioner adds page numbers 1-6 to Exhibit 1012. We refer to the added
`page numbers whenciting to Exhibit 1012 in this Decision.
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`Ex. 1001, 45:6-12. The Specification describes several distinct processors,
`
`but it also describes a “signal processor” as the device used for processing
`
`signals. See, e.g., id. at 9:50-—55, 14:36—-42, 15:27-56, 33:36-47. Based on
`
`the current record before us, we adopt Petitioner’s definition of the term
`“processor.” See Ex. 1012, 5. This definition is consistent with the general
`
`operation of the signal processorin the ’564 patent, where the signal
`
`processoris described to include “processing logic that determines
`
`measurements .
`
`.
`
`. based on the signals received from the detectors.”
`
`Ex. 1001, 15:31-35; 15:35-39 (“signal processor 110 can be implemented
`
`using one or more microprocessors or subprocessors. .
`
`., digital signal
`
`processors, application specific integrated circuits (ASICs), field
`
`programmable gate arrays (FPGAs), combinations of the same”’).
`
`Wealso offer guidance as to the meaning of“an orientation of the
`
`user interface is configurable responsive to a user input” also found in
`
`claim 1. To determine the meaningof the claim limitation “an orientation of
`
`the user interface is configurable responsive to a user input,” we look to the
`
`Specification of the °564 patent. The Specification states “the user
`
`interface 112 can include a flip screen, a screen that can be moved from one
`
`side to another on the monitor 109, or can include an ability to reorientits
`
`display indicia responsive to user input or device orientation.” Ex. 1001,
`
`15:63-67. Based on the evidence before us, and based on limited discussion
`
`of “orientation” in the °564 patent, we understand the claim limitation “an
`
`orientation of the user interface is configurable responsive to a user input” to
`
`at least encompassreorienting the display indicia responsive to user input.
`
`Based on ouranalysis of the issues in dispute at this stage of the
`
`proceeding, we conclude that no further claim terms require express
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`construction at this time. Nidec Motor Corp. v. Zhongshan Broad Ocean
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`Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017).
`
`B. Principles ofLaw
`
`A claim is unpatentable under 35 U.S.C. § 103 if “the differences
`
`between the subject matter sought to be patented andthe prior art are such
`
`that the subject matter as a whole would have been obviousat the time the
`
`invention was made to a person having ordinary skill in the art to which said
`
`subject matter pertains.”” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`
`(2007). The question of obviousnessis resolved on the basis of underlying
`
`factual determinations, including (1) the scope and contentofthe priorart;
`
`(2) any differences between the claimed subject matter and the priorart;
`
`(3) the level of skill in the art; and (4) objective evidence of non-
`
`obviousness.? Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). When
`
`evaluating a combination of teachings, we must also “determine whether
`
`there was an apparent reason to combine the known elements in the fashion
`
`claimed bythe patentat issue.” KSR, 550 U.S. at 418 (citing In re Kahn,
`
`441 F.3d 977, 988 (Fed. Cir. 2006)). Whether a combination ofpriorart
`
`elements would have produceda predictable result weighs in the ultimate
`
`determination of obviousness. Id. at 416-417,
`
`In an inter partes review, the petitioner must show with particularity
`
`why each challenged claim is unpatentable. Harmonic Inc. v. Avid Tech.,
`
`Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016); 37 C.F.R. § 42.104(b). The
`
`3 Patent Ownerdoesnot present objective evidence of non-obviousnessat
`this stage.
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`burden of persuasion nevershifts to Patent Owner. Dynamic Drinkware,
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`LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
`
`Weanalyze the challenges presented in the Petition in accordance
`
`with the above-stated principles.
`
`C. Level of Ordinary Skill in the Art
`
`Petitioner identifies the appropriate level of skill in the art as that
`
`possessed by a person having “‘a Bachelor of Science degree in an academic
`
`discipline emphasizing the design of electrical, computer, or software
`
`technologies, in combination with training or at least one to two years of
`
`related work experience with capture and processing of data or information.”
`
`Pet. 8 (citing Ex. 1003 J§ 21-22). Petitioner also notes that “[a]dditional
`
`education in a relevant field or industry experience may compensate for one
`
`of the other aspects of the [person of ordinary skill in the art]described
`
`above. Id.
`
`For purposes of this Decision, we generally adopt Petitioner’s
`
`assessmentas set forth above, which appears consistent with the level of
`
`skill reflected in the Specification andpriorart.
`
`D. Obviousness over the Combined Teachings of
`Aizawa, Ohsaki, and Goldsmith
`
`Petitioner presents undisputed contentions that claims 1-10 and 13-30
`
`of the °564 patent would have been obvious over the combined teachings of
`
`Aizawa, Ohsaki, and Goldsmith. Pet. 10-91.
`
`I. Overview ofAizawa (Ex. 1006)
`Aizawais a U.S. patent application publication titled “Pulse Wave
`
`Sensor and Pulse Rate Detector,” and discloses a pulse wave sensorthat
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`detects light output from a light emitting diode and reflected from a patient’s
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`artery. Ex. 1006, codes (54), (57).
`
`Figure 1(a) of Aizawa is reproduced below.
`
`FIG.
`
`1 (a)
`
`1
`
`Figure 1(a) is a plan view of a pulse wave sensor. Jd. | 23. As shown in
`
`Figure 1(a), pulse wave sensor2 includes light emitting diode (“LED”) 21,
`
`four photodetectors 22 symmetrically disposed around LED 21, and
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`holder 23 for storing LED 21 and photodetectors 22. Jd. Aizawa discloses
`
`that, “to further improve detection efficiency, ... the numberof the
`
`photodetectors 22 may be increased.” Jd. | 32, Fig. 4(a). “The sameeffect
`
`can be obtained when the numberof photodetectors 22 is 1 and a plurality of
`
`light emitting diodes 21 are disposed around the photodetector 22.” Id. ¥ 33.
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`Figure 1(b) of Aizawa is reproduced below.
`
`FIG.
`
`1 (b)
`
`Figure 1(b) is a sectional view of the pulse wave sensor. Jd. 7 23. As shown
`
`in Figure 1(b), pulse wave sensor 2 includes drive detection circuit 24 for
`
`detecting a pulse wave by amplifying the outputs of photodetectors 22. Id.
`
`4 23. Arithmetic circuit 3 computes a pulse rate from the detected pulse
`
`wave and transmitter 4 transmits the pulse rate data to an “unshown
`
`display.” Jd. The pulse rate detector further includes outer casing 5 for
`
`storing pulse wave sensor2, acrylic transparent plate 6 mountedto detection
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`face 23a of holder 23, and attachmentbelt 7. Jd.
`
`Aizawadiscloses LED 21 and photodetectors 22 “are stored in
`
`cavities 23b and 23c formedin the detection face 23a” of the pulse wave
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`sensor. Jd. 24. Detection face 23a “is a contact side between the holder 23
`
`and a wrist 10, respectively, at positions where the light emitting face 21s of
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`the light emitting diode 21 andthe light receiving faces 22s of the
`
`photodetectors 22 are set back from the above detection face 23a.” Id.
`
`Aizawafurther discloses that “‘a subject carries the above pulse rate detector
`
`1 on the innerside of his/her wrist 10 with a belt in such a mannerthat the
`
`light emitting face 21s of the light emitting diode 21 faces down (on the
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`wrist 10 side).” Jd. § 26. Furthermore,“the above belt 7 is fastened such
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`that the acrylic transparent plate 6 becomesclose to the artery 11 of the wrist
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`10. Thereby, adhesion between the wrist 10 and the pulse rate detector 1 is
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`improved.” Jd. J 26, 34.
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`2. Overviewof Ohsaki (Ex. 1009)
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`Ohsakiis a U.S. patent application publication titled “Wristwatch-type
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`Human Pulse Wave Sensor Attached on Back Side of User’s Wrist,” and
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`discloses an optical sensor for detecting a pulse wave of a humanbody.
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`Ex. 1009, code (54), 73. Figure 1 of Ohsaki is reproduced below.
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`FIG.
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`|
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`(BACK SIDE)
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`2
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`SKS?
`SSSIOTRSS
`KS
`SS
`57
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`S
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`‘SS —§
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`
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`Figure 1 illustrates a cross-sectional view of pulse wavesensor 1 attached on
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`the back side of user’s wrist 4. Jd. J§ 12, 16. Pulse wave sensor| includes
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`detecting element 2 and sensor body 3. Id. { 16.
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`Figure 2 of Ohsaki, reproduced below,illustrates further detail of
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`detecting element2.
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`FIG. 2
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`!
`proce rererrny
`{DRIVE
`{CMCtg gg
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`15 7
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`MICRO-
`COMPUTER
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`!
`}
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`+
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`1
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`16
`REFLECTED LIGHT
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`Figure 2 illustrates a mechanism for detecting a pulse wave. Id. { 13.
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`Detecting element 2 includes package5, light emitting element6, light
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`receiving element 7, and translucent board 8. Jd. 17. Light emitting
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`element 6 and light receiving element 7 are arranged on circuit board 9
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`inside package 5. Id.
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`“[T]ranslucent board 8 is a glass board whichis transparentto light,
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`and attached to the opening of the package 5. A convex surface is formed
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`on the top of the translucent board 8.” Jd. “[T]he convex surface of the
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`translucent board8 is in intimate contact with the surface of the user’s skin,”
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`preventing detecting element 2 from slipping off the detecting position of the
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`user’s wrist. Jd. § 25. Ohsaki describes that when a translucent board has a
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`flat surface, the detected pulse wave maybe adversely affected by
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`movementofthe user’s wrist. Jd. By preventing the detecting element from
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`slipping, the convex surface suppresses “variation of the amountof the
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`reflected light which is emitted from the light emitting element 6 and
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`reachesthe light receiving element 7 by being reflected by the surface ofthe
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`18
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`user’s skin.” Jd. Additionally, the convex surface prevents penetration by
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`“noise such as disturbancelight from the outside.” Jd.
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`Sensor body 3 is connected to detecting element 2 by signalline 13.
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`Id. § 20. Signal line 13 connects detecting element2 to drivecircuit 11,
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`microcomputer 12, and a monitor display (not shown). Jd. Drive circuit 11
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`drives light emitting element 6 to emit light toward wrist 4. Jd. Detecting
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`element 2 receives reflected light which is used by microcomputer 12 to
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`calculate pulse rate. Jd. “The monitor display showsthe calculated pulse
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`rate.” Id.
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`3. Overview of Goldsmith (Ex. 1011)
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`Goldsmith is a U.S. patent application publication titled “Watch
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`Controller for a Medical Device,” and discloses a watch controller device
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`that communicates with an infusion device to “provid[e] convenient
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`monitoring and control of the infusion pump device.” Ex. 1011, codes (54),
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`(57).
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`Goldsmith’s Figure 9A and 9Bare reproduced below.
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`FIG.TA
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`FIG 16
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`Figure 9A and Figure 9A are respective front and rear views of a combined
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`watch and controller device. Jd. J] 30-31. As shown in Figure 9A, watch
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`controller 900 includes housing 905, transparent member 950, display 910,
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`input devices 92Sa—c, scroll wheel 930, and wrist band 940. Jd. 4] 85-86.
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`Figure 9B showsrear-side cover 960, and a rear view of housing 905, scroll
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`wheel930, and wrist band 940. Jd.
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`Goldsmith discloses the watch controller may interact with one or
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`more devices, such as infusion pumpsor analyte monitors. Id. | 85; see also
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`id. | 88 (‘The analyte sensing device 1060 may be adaptedto receive data
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`from a sensor, such as a transcutaneous sensor.”). Display 910 “may display
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`at least a portion of whatever information and/or graph is being displayed on
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`the infusion device display or on the analyte monitor display,” such as,e.g.,
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`levels of glucose. Jd. § 86. The display is customizable in a variety of
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`configurations including user-customizable backgrounds, languages, sounds,
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`font (including font size), and wall papers. Jd. Jf 102, 104. Additionally,
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`the watch controller may communicate with a remotestation, e.g., a
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`computer, to allow data downloading. Jd. { 89 (including wireless). The
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`remote station mayalso include a cellular telephone to be “used as a conduit
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`for remote monitoring and programming.” Jd.
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`4.
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`Independent Claim 1 (Aizawa, Ohsaki, and Goldsmith)
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`Petitioner presents undisputed contentions that claim 1 would have
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`been obvious over the combined teachings of Aizawa, Ohsaki, and
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`Goldsmith. Pet. 10-63.
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`20
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`i. “[pre] A user-worn physiological measurement device
`comprising ”’
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`Onthis record, the cited evidence supports Petitioner’s undisputed
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`contentions that Aizawadiscloses this limitation. Pet. 41-42.
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`Figure 2 of Aizawa showsa user wearing a pulse wave sensoron the
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`innerside of his/her wrist. Ex. 1006 4 0026. Accordingly, Petitioner’s
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`reliance on Figure 2 of Aizawa and the corresponding disclosure sufficiently
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`disclose the subject matter of the preamble.* See Pet. 42.
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`At this stage of the proceeding, Petitioner’s stated reasoningis
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`sufficiently supported.°
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`ii. ““[a] one or more emitters configured to emit light into
`tissue ofa user”
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`Onthis record, the cited evidence supports Petitioner’s undisputed
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`contentions that Aizawa discloses a pulse wave sensorincluding LED 21
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`that emits light into a user’s tissue. Pet. 42-43; Ex. 1006 § 23 (SLED 21...
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`for emitting light having a wavelength of a near infrared range’’), {27
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`(explaining that light is emitted toward the wrist), Fig. 1(b) (depicting
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`4 Whether the preambleis limiting need not be resolvedat this stage of the
`proceeding, because Petitioner showssufficiently for purposesofinstitution
`that the recitation in the preamble is satisfied by the priorart.
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`> Petitioner further contends that the subject matter of the preambleis taught
`by the combination of Aizawa, Ohsaki, and Goldsmith. Pet. 41-42 (arguing
`that it would have been obviousto incorporate the pulse wave sensor of
`Aizawa (as modified by Ohsaki) into the wrist-worn watch controller device
`in Figures 9A and 9B of Goldsmith, to realize a user-worn physiological
`measurement device). Because Figure 2 of Aizawa teaches a user-wom
`physiological measurement device, further analysis of the combination of
`Aizawa, Ohsaki, and Goldsmith is not necessary for this particular claim
`limitation.
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`21
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`LED 21 facing user wrist 10), Fig. 2 (depicting a pulse wave sensor worn on
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`a user’s wrist).
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`At this stage of the proceeding, Petitioner’s stated reasoningis
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`sufficiently supported.
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`ili. “[b] at leastfour detectors arranged on a substrate”
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`Onthis record, the cited evidence supports Petitioner’s undisputed
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`contentions regarding this limitation. Pet. 44-46.
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`Petitioner contends that pulse wave sensor depicted in Figure 1(a) of
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`Aizawa discloses four photodetectors 22. Pet. 44; see e.g., Ex. 1006 § 27
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`(“[FJour photodetectors 22 are disposed around the light emitting diode
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`21.”).
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`Relying on the cross-section view of Figure 1(b) of the pulse wave
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`detector of Aizawa, Petitioner further contends photodetectors 22 are
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`secured on a substrate illustrated in Petitioner’s annotated Figure 1(b).
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`Pet. 24, 45. Petitioner’s annotated Figure 1(b) of Aizawa is reproduced
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`below.
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`FIG.
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`1 (b)
`Drive Detection Circuit 24 1
`2
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`= First
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`surface of eetenhinaN son
`5,
`“
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`substrate
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`Photodetector 22
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`Annotated Figure 1(b) depicts a structure, identified by Petitioner with
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`brown highlight and the added label “Substrate,” arranged in proximity to
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`photodetectors 22. Pet. 45. Petitioner concedes that Aizawa“doesnotlabel
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`22
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`or describe” a substrate, but contends a person of ordinary skill in the art
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`(‘“POSITA”) would have understoodthat “Aizawa’s photodetectors are
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`secured to the [physiological measure device] .
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`.
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`. through such [as] a
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`substrate” depicted in annotated Figure 1(b). Pet. 24. Dr. Thomas W.
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`Kennytestifies that “[a] POSITA would have understood that the substrate
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`provides physical support and electrical connectivity and is connected to the
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`holder 23.” Ex. 1003 J 71; see also Pet. 24 (citing to testimony of Dr.
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`Kenny). Onthe current record, Petitioner has sufficiently shown that the
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`structure identified in annotated Figure 1(b) of Aizawais a substrate, and
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`that photodetectors 22 are arranged on the substrate.
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`Petitioner further contends that if Aizawa is found notto disclose a
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`substrate, then Ohsaki teachesthis feature. Pet. 25. Similar to the device of
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`Aizawa, Ohsaki teaches a pulse wave sensor comprising a light emitting
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`element6 (e.g., a LED) andalight receiving element(e.g., a photodetector).
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`Ex. 1009 9 17. “The light emitting element 6 and light receiving element 7
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`are... arranged onthe circuit board 9.” Jd. Relying on the testimony of
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`Dr. Kenny, Petitioner contends a POSITA would have modified the pulse
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`wave sensor of Aizawato include a substrate, such as circuit board 9 of
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`Ohsaki, to secure the photodetectors of Aizawa and enable the detectors to
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`send signals to other elements in the device. Pet. 25 (citing Ex. 1003 4 72-
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`73; Ex. 1006 JJ 2-5, 8-16, 23, 27-29, 32-33, Figs. 1, 2, 3, 4(a); Ex. 1009
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`q 17, Fig. 2).
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`Atthis stage of the proceeding, Petitioner’s stated reasoningis
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`sufficiently supported, including by the unrebutted testimony of Dr. Kenny.
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`23
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`iv. “[c] a cover comprising a protruding convex surface,
`wherein the protruding convex surface extends overall
`ofthe at leastfour detectors arranged on the substrate,
`wherein at least a portion ofthe protruding convex
`surface is rigid”
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`Onthis record, the cited evidence supports Petitioner’s undisputed
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`contentions regarding these limitations. Pet. 19-23, 47-49.
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`Petitioner contends the pulse wave sensor depicted in Figure 1(b) of
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`Aizawa comprises “a flat transparent plate 6 that contacts the user’s wrist.”
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`Pet. 19; see, e.g., Ex. 1006 J 26 (“[T]he acrylic transparent plate 6 becomes
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`close to the artery 11 of the wrist 10.’’). In Petitioner’s view,the flat plate of
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`Aizawais unfavorable, in that it “would have slipped along the user’s wrist,
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`resulting in variations in the light detected by the photodetectors.” Pet. 20.
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`Petitioner proposes modifyingthe flat acrylic plate of Aizawa, with
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`the convex translucent board 8 depicted in Figure 2 of Ohsaki. Specifically,
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`Petitioner relies on Ohsaki’s teaching:
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`Ohsaki explains that “if the translucent board 8 hasa flat
`surface, the detected pulse wave is adversely affected by the
`movementof the user’s wrist as shown in FIG. 4B,” but that if
`“the translucent board 8 has a convex surface...variation of the
`amountof the reflected light...that reaches the light receiving
`element 7 is suppressed,” APPLE-1009, 9[0025]. Thus, when a
`protruding convex coveris used, “the pulse wave can be detected
`without being affected by the movementofthe user’s wrist 4 as
`shownin FIG. 4A.” Id.
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`Pet. 21-22