`Trials@uspto.gov
`571.272.7822 Filed: April 27, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MEDTRONIC PLC,
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2016-00057
`Patent 8,560,034 B1
`____________
`
`
`
`Before KEN B. BARRETT, BENJAMIN D. M. WOOD, and
`GEORGIANNA W. BRADEN, Administrative Patent Judges.
`
`BARRETT, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
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`IPR2016-00057
`Patent 8,560,034 B1
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`I.
`INTRODUCTION
`Medtronic PLC (“Petitioner”) filed a Petition requesting inter partes
`
`review of U.S. Patent No. 8,560,034 B1 (“the ’034 patent”). Paper 1
`(“Pet.”). The Petition challenges the patentability of claims 1, 5, and 6 of
`the ’034 patent on the ground of obviousness under 35 U.S.C. § 103.
`Masimo Corporation (Patent Owner) filed a Preliminary Response to the
`Petition. Paper 7 (“Prelim. Resp.”). We have jurisdiction under 35 U.S.C.
`§ 314(a), which provides that an inter partes review may not be instituted
`“unless . . . the information presented in the petition . . . shows that there is a
`reasonable likelihood that the petitioner would prevail with respect to at least
`1 of the claims challenged in the petition.”
`
`After considering the information presented in the Petition, we
`determine that Petitioner has not established a reasonable likelihood that it
`would prevail with respect to any of the claims challenged in the Petition.
`Accordingly, we do not authorize an inter partes review to be instituted as to
`any challenged claim of the ’034 patent.
`
`A. Related Proceedings
`One or both parties identify, as matters involving or related to the
`
`’034 patent, Patent Trial and Appeal Board cases IPR2016-00058 (the ’034
`patent) and IPR2016-00056 (U.S. Patent No. 7,496,393), and Board of
`Patent Appeals and Interferences case Interference No. 105,471. Pet. 1;
`Paper 5, 3; see, e.g., Prelim. Resp. 1.
`
`Additionally, Patent Owner identifies several judicial and
`administrative matters concerning related patents. See Paper 5, 1–4.
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`Patent 8,560,034 B1
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`B. The’034 Patent
`The ’034 patent pertains to the processing of measured signals, in the
`
`context of blood oxygen saturation systems, in a way “which facilitates
`minimizing the correlation between the primary signal portion and the
`secondary signal portion in order to produce a primary and/or secondary
`signal.” Ex. 1001, col. 1, ll. 15–29. “Complications arising in these
`measurements are often due to motion of the patient, both external and
`internal (muscle movement, vessel movement, and probe movement, for
`example), during the measurement process.” Id. at col. 2, ll. 22–26. Motion
`artifacts, introduced by patient movement, distort the measured signal. Id. at
`col. 3, ll. 5–8.
`
`A monitor for pulse oximetry saturation measurement uses two light
`emitting diodes (LEDs) that emit light at different wavelengths, for example,
`red (R) and infrared (IR). Id. at col. 4, l. 46–49, col. 33, ll. 58-65. The light
`passes through a portion of the body where blood flows, such as a finger,
`and is received by a photodetector positioned on the opposite side of the
`finger. Id. at col. 4, ll. 49–52, col. 33, ll. 58–62. The ’034 patent explains
`that “[t]he attenuated signals generally comprise both primary . . . and
`secondary (noise) signal portions.” Id. at col. 4, ll. 52–54. The “noise” of
`the secondary signal includes “venous oxygen saturation and other
`parameters.” Id. at col. 5, ll. 25–26. These other parameters of the
`secondary portion include “artifacts due to patient movement which causes
`the venous blood to flow in an unpredictable manner.” Id. at col. 4, ll. 31–
`38; see also id. at col. 34, l. 7–15 (the ’034 patent also referring to “[e]rratic
`motion induced noise”). According to the ’034 patent, where the two light
`signals are measured substantially simultaneously, the secondary signal
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`Patent 8,560,034 B1
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`components are correlated to each other “because any random or erratic
`functions affect each measurement in nearly the same fashion” and the
`primary signal components are correlated to each other. Id. at col. 12, ll. 4–
`10.
`In the model of the ’034 patent, coefficients relating the two signal
`
`portions may be determined by minimizing the correlation between the
`primary and secondary signal portions. Id. at col. 5, ll. 19–29. In the
`method of claim 1, the two signals (e.g., red and infrared) are
`mathematically manipulated based on two assumptions. First, the model
`assumes that the amount of motion affecting each of the two light signals is
`the same because the two signals are measured so closely together in time.
`Id. at col. 64, ll. 43–44; see id. at col. 12, ll. 4–10 (“any random or erratic
`functions affect each measurement in nearly the same fashion.”). Second,
`the model assumes that the motion components of the two signals are
`proportional to each other. Id. at col. 64, ll. 45–46; see id. at col. 12, ll. 5–25
`(discussing proportionality constants between the secondary signal portions).
`
`C. The Claim
`Claims 1 and 5 are independent claims. Claim 1, reproduced below,
`
`is illustrative:
`1. A method for measuring saturation of a blood constituent
`in a patient comprising the steps of:
`
`irradiating said patient with electromagnetic radiation of
`two discrete, different wavelengths;
`
`sensing an intensity of said radiation for each of said
`wavelengths after it passes through a portion of said patient to
`produce first and second intensity signals including motion
`components; and
`
`determining said saturation by mathematically
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`manipulating said first and second intensity signals without
`subtracting said motion components and with the assumptions
`that
`
`i) an amount of motion is the same at the same
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`time for each of said intensity signals, and
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`ii) the motion components of said intensity signals
`are proportional to one another.
`Ex. 1001, col. 64, ll. 31–46. Independent claim 5 recites an apparatus
`having a “control means for determining said saturation.” Id. at col. 65,
`l. 48–col. 66, l. 11.
`
`D. Applied References
`
`Reference
`WO 92/15955
`Diab
`US 5,208,786
`Weinstein
`Admitted Prior Art in the ’034 patent
`
`Sept. 17, 1992
`May 4, 1993
`
`Exhibit No.
`Ex. 1003
`Ex. 1004
`Ex. 1001
`
`Petitioner relies also on the Declaration of Dr. Daniel van der Weide,
`
`dated October 20, 2015, (Ex. 1002) in support of Petitioner’s arguments.
`
`E. Asserted Ground of Unpatentability
`Petitioner asserts that claims 1, 5, and 6 are unpatentable under 35
`
`U.S.C. § 103(a) as obvious over Diab, Weinstein, and Admitted Prior Art.
`
`II. ANALYSIS
`A. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are given
`their broadest reasonable construction in light of the specification of the
`patent in which they appear. 37 C.F.R. § 42.100(b); see also In re Cuozzo
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`Speed Techs., LLC, 793 F.3d 1268, 1278–79 (Fed. Cir. 2015), cert. granted
`sub nom. Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct. 890 (2016). Under the
`broadest reasonable construction standard, claim terms are given their
`ordinary and customary meaning, as would be understood by one of ordinary
`skill in the art in the context of the entire patent disclosure. In re Translogic
`Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
`
`On this record and for purposes of this Decision, we determine that
`none of the claim terms require an express construction to resolve the
`dispositive issues discussed below.
`
`B. The Ground of Alleged Obviousness over
`Diab, Weinstein, and Admitted Prior Art
`Petitioner asserts that claims 1, 5, and 6 are obvious over Diab
`
`(Ex. 1003), Weinstein (Ex. 1004), and Admitted Prior Art (Ex. 1001).
`Pet. 26–60. Patent Owner opposes. Prelim. Resp. 41–55.
`
`Diab discloses a pulse oximeter that uses “an adaptive noise canceler
`that removes erratic motion-induced undesired signal portions i[n] a pulse
`oximeter.” Ex. 1003, 64–65.1 Figure 10 of Diab is reproduced below:
`
`
`1 Citations are to the page numbers of the underlying Diab reference rather
`than the page numbers of the exhibit.
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`Figure 10 depicts a pulse oximetry monitor incorporating a processor with
`an adaptive noise canceler. Id. at 21. LEDs 300 and 302 emit red and
`infrared wavelengths which pass through finger 310 and are received by
`photodetector 320. Id. at 66, 68. Photodetector 320 produces electronic
`signals corresponding to the attenuated red and infrared light signals. See id.
`at 66–67. After filtering and other processing, the signals are input to
`microprocessor 420 “for calculation of a noise reference signal via the
`processing technique of [Diab] and removal of undesired signal portions via
`an adaptive noise canceler.” Id. at 68–69.
`
`Weinstein pertains to a signal processing system including a plurality
`of detectors receiving a plurality of signals which are subjected to an
`unknown transfer function. Ex. 1004, col. 2, ll. 4–8. The plurality of signals
`received by the detectors contain components of multiple sources, e.g.,
`multiple microphones will have components from both the speaker and
`background noise. Id. at col. 1, ll. 11–19. Figure 7 of Diab is reproduced
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`below:
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`Figure 7 depicts a speech enhancing and noise cancellation system using the
`signal processing circuit of Diab. Id. at col. 4, ll. 1–3. In the embodiment of
`Figure 7, the voice signals from individual 61 are separated from interfering
`noise signals from TV or radio 60. Id. at col. 12, ll. 58–67. The system
`utilizes microphone 54 located near the noise source and microphone 56
`located near the desired signal source from the individual. Id. Due to the
`room acoustics, both microphones pick up signals from both sources, thus
`each detected signal contains desired voice and undesired noise components.
`See id. at col. 12, ll. 67–68. “A processor receives the observed signals and
`estimates the components of the transfer function, which are used to produce
`a filter (for example, but not necessarily, an inverse filter) for reconstructing
`the input source signals.” Id. at col. 2, ll. 8–12. Figures 2 and 3 of Diab are
`reproduced below:
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`Figure 2 illustrates a general two channel system where H11, H12, H21, and
`H22 represent the transfer functions of four single-input single-output
`systems, and Figure 3 represents a schematic representation of H-1, the
`inverse of the estimated system of Figure 2. Id. at col. 3, ll. 56–60. The
`inputs to the system of Figure 2 are the original source signals, sa and sb,
`from the detectors, and the outputs of the inverse of the system (Figure 3)
`are s1 and s2, the reconstructed separated source signals processed by the
`filters. See id. at col. 2, ll. 21–24.
`
`Petitioner argues that Diab discloses the claimed inventions except for
`“mathematically manipulating said first and second intensity signals without
`subtracting said motion components.” Pet. 28. Petitioner relies on
`Weinstein for the missing aspect, arguing “this type of mathematical
`manipulation was already well known in the art for this type of signal
`model.” Id. at 26–27. Petitioner characterizes certain portions of the ’034
`patent specification as Admitted Prior Art and relies on those portions for
`the disclosure that it was well known in the art to determine oxygen
`saturation based on the ratio of the intensity of red and infrared light. See id.
`at 33–34 (citing Ex. 1001, col. 41, ll. 28–32, col. 61, ll. 38–39).
`
`Patent Owner argues that the proposed combination fails to disclose
`the claimed feature of determining saturation without subtraction. Prelim.
`Resp. 43. Specifically, Patent Owner argues that Weinstein discloses the use
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`of subtraction to determine the desired primary signal (id. at 41–42) and that
`Petitioner “endeavors to eliminate the required subtraction or
`‘reconstruction’ step of Weinstein by simply omitting it, arguing ‘there is no
`need to take the steps to reconstruct those signals’” (id. at 46 (quoting Pet.
`at 50)). Patent Owner points to Weinstein’s Figure 3 and the corresponding
`discussion of subtraction. Id. at 45 (quoting Ex. 1004, col. 7, ll. 9–16).
`
`We determine that Petitioner does not explain adequately and with the
`necessary specificity how the references’ teachings are proposed to be
`combined or why one would have combined the references as proposed.
`
`Petitioner initially appears to propose incorporating the entirety of
`Weinstein’s signal processing algorithm into Diab’s processor 420. See
`Pet. 38; id. at 38–39 (The resulting combination is Diab’s “microprocessor
`420 running Weinstein’s signal separation algorithm.”). For example, in
`arguing that Weinstein discloses the “control means” of claim 5, Petitioner
`relies on Weinstein’s disclosure of reconstructed source signals, s1 and s2,
`and a reconstruction filter. Id. at 50; see id. at 49 (arguing that an
`assumption of the ’034 patent is the same as Weinstein’s assumption used to
`produce the reconstruction filter). Petitioner, however, appears to propose
`that only a portion of the Weinstein algorithm be utilized in Diab. Petitioner
`states:
`
`Weinstein iterates through potential values to solve for
`the values in its matrix. ([Ex. 1004] at 5:55-6:15.) These
`values may be used to create in [sic] inverse filter for
`reconstructing the desired signals. (Id.; see also id. at 6:17-21.)
`However, when applied to Diab’s pulse oximeter, there is no
`need to take the steps to reconstruct those signals. Instead,
`solving for the matrix values relates the measured red and
`infrared signals to the arterial pulse signal such that one can
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`directly determine the arterial saturation, just as the ’034 patent
`teaches solving for ra in a matrix and then determining
`saturation from it. (Ex. 1002 at ¶¶ 78-80.)
`Pet. 50 (emphasis added, italicizing in original omitted). Thus, Petitioner
`also is proposing to modify Weinstein’s overall algorithm by omitting the
`steps related to the reconstruction filter. Diab, in describing Figure 3,
`explains that the reconstruction filter uses an inverse filter to reconstruct the
`desired source signals, s1 and s2, and that subtraction is involved in the
`process leading to the reconstructed source signals. Ex. 1004, col. 7, ll. 7–
`16. Petitioner does not explain adequately why one of ordinary skill in the
`art would incorporate only part of Weinstein’s algorithm into Diab’s
`processor. See Pet. 50; Ex. 1002 ¶ 80. Therefore, we are unpersuaded by
`Petitioner’s argument.
`
`Patent Owner further contests Petitioner’s position, arguing that
`Weinstein’s system—utilizing two detectors (e.g., microphones) with one
`primarily for noise and one primarily for the desired signal—is inapplicable
`to Diab’s pulse oximetry system utilizing a single detector. Prelim. Resp.
`42; see id. 49–55.
`
`We determine that Petitioner has not adequately and persuasively
`explained how Weinstein’s algorithm is compatible with Diab’s system such
`that the modification would yield the claimed subject matter—including the
`“manipulating . . . without subtracting” aspect—and that a person of
`ordinary skill in the art would have found it obvious to combine the two
`systems in the manner proposed.
`
`As Patent Owner asserts, Weinstein’s signal processing algorithm
`addresses the situation “where there is a single desired source signal and two
`microphones (or sensors) spaced apart in two different locations to detect the
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`source signal” but Diab applies to the situation where there are two sources
`and a single detector. Prelim. Resp. 51. Weinstein, through its algorithm,
`processes interfering signals detected by the two sensors. See Ex. 1004,
`col. 3, ll. 20–40; id. at col. 3, ll. 18–20 (Weinstein describing one
`embodiment: “The first microphone detects the desired speech signal with
`some noise, and the second microphone detects mainly the noise with some
`speech language.”). That interfering signal situation does not appear to be
`present in Diab’s system with a single detector which, according to
`Petitioner, receives two signals containing desired and undesired
`components correlated respectively across the two signals. See Pet. 28.
`
`Petitioner argues that both references disclose that their respective
`techniques may be used in electrocardiography and one would have been
`motivated to combine their teachings and “would have had a reasonable
`expectation of success.” Id. (citing Ex. 1002 ¶¶55–56).2 Pet. 36. Petitioner,
`however, acknowledges that “pulse oximetry differs somewhat from
`electrocardiography” but does not explain whether that difference is
`insignificant. See id. That the references disclose the common application
`of electrocardiograms does not persuade us that one of ordinary skill in the
`art would recognize that Weinstein’s specific algorithm, as opposed to signal
`processing generally, has applicability in Diab’s single-detector pulse
`oximetry system. Therefore, we are unpersuaded by Petitioner’s argument.
`
`
`2 We note that Petitioner’s declarant’s testimony regarding the applicability
`of signal processing to physiological monitoring contexts, such as pulse
`oximetry, relies on the teachings of the ’034 patent. Ex. 1002 ¶ 56. Such
`reliance suggests the opinion testimony is based on impermissible hindsight.
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`Accordingly, we find Petitioner has not demonstrated that there is a
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`reasonable likelihood that it would prevail in showing that the subject matter
`of the challenged claims 1, 5, and 6 would have been obvious over Diab,
`Weinstein, and Admitted Prior Art.
`
`III. CONCLUSION
`We determine Petitioner has not demonstrated there is a reasonable
`
`likelihood of establishing the unpatentability of claims 1, 5, and 6 of the
`’034 patent.
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`IV. ORDER
`For the foregoing reasons, it is
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`ORDERED that the Petition is denied as to all challenged claims, and
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`no trial is instituted.
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`For PETITIONER:
`Kathleen Daley
`Jason Stach
`Luke McCammon
`Arpita Bhattacharyya
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`kathleen.daley@finnegan.com
`jason.stach@finnegan.com
`luke.mccammon@finnegan.com
`arpita.bhattacharyya@finnegan.com
`
`
`
`For PATENT OWNER:
`
`Brenton R. Babcock
`Jarom D. Kesler
`Ted M. Cannon
`KNOBBE, MARTENS, OLSON & BEAR LLP
`2brb@knobbe.com
`2jzk@knobbe.com
`2tmc@knobbe.com
`
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