Paper No. 9
`Trials@uspto.gov
`571.272.7822 Filed: April 27, 2016
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MEDTRONIC PLC,
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2016-00058
`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
`
`
`Trials@uspto.gov
`571.272.7822 Filed: April 27, 2016
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MEDTRONIC PLC,
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2016-00058
`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
`
`
`
`IPR2016-00058
`Patent 8,560,034 B1
`
`
`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 claim 1 of the ’034
`patent on the grounds of anticipation under 35 U.S.C. § 102 and obviousness
`under 35 U.S.C. § 103. Masimo Corporation (Patent Owner) filed a
`Preliminary Response to the Petition. Paper 8 (“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 the claim challenged in the Petition.
`Accordingly, we do not authorize an inter partes review to be instituted as to
`the 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 IPR2016-00057 (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 6, 3; see, e.g., Prelim. Resp. 1.
`
`Additionally, Patent Owner identifies several judicial and
`administrative matters concerning related patents. See Paper 6, 1–4.
`
`2
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`IPR2016-00058
`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, ll. 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, ll. 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
`
`3
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`IPR2016-00058
`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
`Claim 1 is reproduced below:
`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
`manipulating said first and second intensity signals without
`
`4
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`IPR2016-00058
`Patent 8,560,034 B1
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`
`subtracting said motion components and with the assumptions
`that
`
`i) an amount of motion is the same at the same
`
`time for each of said intensity signals, and
`
`ii) the motion components of said intensity signals
`are proportional to one another.
`Ex. 1001, col. 64, ll. 31–46.
`
`D. Applied References
`
`Reference
`Prosser
`Diab
`
`US 5,246,002
`WO 92/15955
`
`Sept. 21, 1993
`Sept. 17, 1992
`
`Exhibit No.
`Ex. 1003
`Ex. 1004
`
`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 Grounds of Unpatentability
`Petitioner asserts the following grounds of unpatentability:
`
`
`
`Reference(s)
`Prosser
`Prosser and Diab
`
`Basis
`§ 102(a), (b), and (e)
`§ 103(a)
`
`Claim
`1
`1
`
`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
`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
`
`5
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`IPR2016-00058
`Patent 8,560,034 B1
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`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 requires an express construction to resolve the
`dispositive issues discussed below.
`
`B. Ground 1: Alleged Anticipation by Prosser
`Petitioner asserts that claim 1 is anticipated by Prosser (Ex. 1003).
`
`Pet. 21–37. Patent Owner opposes. Prelim. Resp. 43–56.
`
`Prosser pertains to a “noise insensitive pulse transmittance oximeter.”
`Ex. 1003, Abstr., col. 9, ll. 34–36. Prosser teaches to adjust “the intensity of
`the LEDs until the differences between the peak and valley values of the red
`transmittance pulses [(ΔR)] and infrared transmittance pulses [(ΔIR)] are
`substantially equal.” Id. at Abstr., col. 8, ll. 47–53. Figure 2 of Prosser is
`reproduced below:
`
`
`Figure 2 is “a graphical plot as a function of time of the transmittance of
`light at the red and infrared wavelengths through the finger.” Id. at col. 2,
`
`6
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`IPR2016-00058
`Patent 8,560,034 B1
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`ll. 48–50. Prosser calculates an oxygen saturation ratio in accordance with a
`known equation, shown below.
`
`
`Id. at col. 1, ll. 36–51, col. 8, ll. 43–45, col. 9, ll. 20–23, Fig. 3 (box 67).
`Prosser includes a mathematical proof (id. at col. 9, l. 36–col. 11, l. 8)
`which, according to Prosser, proves that “by controlling [the red and infrared
`LEDs] such that ΔR=ΔIR, the oxygen saturation ratio calculation is
`insensitive to noise.” Id. at col. 11, ll. 9–13.1
`
`Petitioner’s argument that Prosser discloses the claimed assumptions
`is premised on the assertion that “the noise in Prosser’s signal model
`includes motion components.” Pet. 28; Ex. 1002 ¶ 41 (Dr. van der Weide
`stating the same with the inclusion of the assertion that the conclusion is
`“clear”); see also Pet. 18 (“with Prosser discussing the movement of a
`patient’s finger as a noise source”); Ex. 1002 ¶ 27 (Dr. van der Weide stating
`the same). Petitioner has not persuaded us that this assertion is correct.
`
`In support of the assertion, Petitioner points to Prosser’s statement
`that movement of the patient’s finger is an activity that may trigger the
`adjustment of LED intensity. Pet. 28 (citing Ex. 1003, col. 6, ll. 64–67); id.
`
`
`1 Prosser, in the proof, assumes that the respective light transmittance values
`at systolic pressure are much larger than the corresponding noises at systolic
`pressure such that the noise is negligible, and Prosser concludes that the
`oxygen saturation ratio calculation is insensitive to noise. Ex. 1003, col. 10,
`l. 61–col. 11, l. 13; compare id. at col. 10, ll. 45–47 (Equation 10 containing
`noise components ϵ) with id. at col. 11, ll. 5–8 (Equation 12 lacking the
`noise components after assuming R>>ϵ).
`
`7
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`IPR2016-00058
`Patent 8,560,034 B1
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`at 18; see Ex. 1002 ¶¶ 27, 41; Ex. 1003, col. 6, ll. 64–67 (the cited portion
`stating: “For example, movement of the patient’s finger 15 is one common
`activity that triggers the method of the present invention to adjust the LED
`intensity levels”). We fail to see, and Petitioner does not explain adequately,
`how this portion of Prosser—which does not mention explicitly “noise”—
`ties together the concepts of motion and noise.
`Petitioner next states that “Prosser’s disclosure is no different from
`
`the ’034 patent in this regard, given that the ’034 patent does not separately
`account for noise caused by motion and noise originating from other
`sources,” and states that the ’034 patent labels the secondary signal
`component as “noise.” Pet. 28; see Ex. 1002 ¶ 41. We do not find this
`persuasive because it does not follow necessarily that Prosser is using the
`term “noise” and accounting for motion and noise exactly as in the ’034
`patent.
`
`Prosser, rather than offering a clear indication that Prosser’s “noise”
`includes motion, distinguishes the two concepts. Prosser explains that
`“[n]oise may originate from several sources including, but not limited to:
`preamplifier noise, induced noise from inside the oximeter, induced noise
`from outside the oximeter, and ambient light noise.” Ex. 1003, col. 1, l. 66–
`col. 2, l. 2, see id. at col. 13, ll. 8–11, 20–24 (describing an alternative
`embodiment where the pulses are processed using separate circuitry and
`where “noise” is induced by the use of an electrical cable carrying a
`repeating square wave to determine the “noise ratio”). Notably absent from
`the Prosser’s list of “noise” is an explicit reference to motion. Prosser then,
`in the portion relied upon by Petitioner as mentioned above, discusses
`patient movement, stating:
`
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`IPR2016-00058
`Patent 8,560,034 B1
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`
`[M]ovement of the patient’s finger 15 is one common activity
`that triggers the method of the present invention to adjust the
`LED intensity levels. During movement of the finger 15, the
`blood volume and thickness of the finger varies and therefore,
`the [light transmittance] values of RH, RL, IRH, and IRL will vary.
`Ex. 1003, col. 6, l. 64–col. 7, l. 2; see also Ex. 1003, col. 1, ll. 45–51
`(explaining that RH, RL, IRH, and IRL refer to the light transmittance of the
`red (R) and infrared (IR) wavelengths and at systolic pressure (L) and
`diastolic pressure (H)). Thus, Prosser is discussing motion in the context of
`the effect on the light transmittance values of R and IR, values that are used
`in the oxygen saturation ratio formula, and does not mention explicitly noise
`in this context. In contrast, Prosser, at a latter part of the specification and in
`explaining why the disclosed method is insensitive to noise, identifies
`“noise” as a component separate from and added to the light transmittance
`values R and IR. Id. at col. 10, ll. 16–19 (“To account for noise, we assume
`that an arbitrary amount of noise is added to RH, RL, IRH, and IRL, denoted as
`ϵRH, ϵRL, ϵIRH, and ϵIRL, respectively”). Accordingly, we are not persuaded by
`Petitioner’s arguments and testimony from its declarant that Prosser’s
`“noise” includes motion components.
`
`Furthermore, even accepting as true Petitioner’s argument that “the
`noise in Prosser’s signal model includes motion components” (Pet. 28), we
`are not persuaded that Petitioner has carried its burden. In this regard,
`Petitioner makes the conclusory argument that, “[b]ecause Prosser measures
`the signals at substantially the same time and assumes the amount of noise is
`the same for such measurements, Prosser assumes that an amount of motion
`is the same at the same time for each intensity signal (i.e., assumption (i) in
`claim 1 of the ’034 patent).” Pet. 27 (emphasis added, italicizing in original
`
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`Patent 8,560,034 B1
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`omitted); see also Ex. 1002 ¶ 39 (Dr. van der Weide making the same
`conclusory assertion). For the second claimed assumption, Petitioner
`similarly asserts “that the motion components are proportional” because “the
`noise components (including patent motion) are equivalent.” Pet. 27–28; see
`also Ex. 1002 ¶ 40 (Dr. van der Weide immediately following a recitation of
`Prosser’s noise component (ϵ) equality equations with the opinion that “the
`motion components are equivalent”). Petitioner, however, does not explain
`adequately how the claimed motion assumptions are shown by disclosure of
`noise assumptions where motion forms only portion of that total noise.
`Petitioner suggests that there might be a situation where the only component
`in the “noise” is motion. See Pet. 28 (“Prosser also indicates that, in some
`instances, the non-motion noise components may be so insignificant that
`they do not trigger its noise compensation mechanism.”). Petitioner does not
`direct us to evidence that Prosser discloses, either expressly or inherently,
`the occurrence of that hypothetical situation where the total noise is
`composed solely of motion components. Cf. Ex. 1002 ¶ 41 (Dr. van der
`Weide making the same assertion without any supporting citation and
`without elaboration).
`
`Because Petitioner’s theory of anticipation as to the claimed
`assumptions pertaining to motion is based on the unpersuasive arguments
`regarding Prosser’s “noise” (see, e.g., Pet. 36–37), Petitioner has not
`established a reasonable likelihood that it would prevail in demonstrating
`anticipation of claim 1 of the ’034 patent.
`
`Lastly, we find persuasive Patent Owner’s argument that Petitioner is
`relying on an incorrect oxygen saturation ratio equation, which, according to
`Patent Owner, is an equation used in a mathematical proof not in the actual
`
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`IPR2016-00058
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`determination of the oxygen saturation ratio. Prelim. Resp. 55–56.
`Petitioner, in its claim chart, points to, inter alia, the following equation for
`the disclosure of the claimed recitation of “determining said saturation by
`mathematically manipulating said first and second intensity signals without
`subtracting said motion components”:
`
`
`Pet. 35–36 (citing “Ex. 1003 at 11:5-8; see also id. at 9:40-11:13, deriving
`this equation.”); see also id. at 29 (“This final equation is used to determine
`the oxygen saturation of a patient’s blood” (emphasis omitted)). As
`mentioned above, Prosser’s method utilizes the following equation to
`determine oxygen saturation ratio:
`
`
`Id. at col. 8, ll 43–45, col. 9, ll. 20–23, 36–45, Fig. 3 (box 67). We
`recognize Petitioner also refers to the correct equation, but that is in the
`context of beginning the mathematical proof. Pet. 25. Nonetheless, even if
`Petitioner is relying on the disclosure of the proper equation, Petitioner’s
`reference to two equations without a reconciling explanation creates
`confusion rather than clarity. Thus, Petitioner has not met its burden.
`
`For the reasons set forth above, we are not persuaded that Petitioner
`has shown a reasonable likelihood of prevailing in its challenge that claim 1
`is anticipated by Prosser.
`
`C. Ground 2: Alleged Obviousness over Prosser and Diab
`Petitioner argues that claim 1 would have been obvious in light of
`
`Prosser (Ex. 1003) and Diab (Ex. 1004). Pet. 37 (section heading).
`
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`Petitioner relies on Diab for the disclosure of the claimed assumptions. Id.
`Patent Owner responds by arguing that Petitioner “provides no explanation
`about how any assumptions specified in Diab would apply to Prosser’s
`teachings.” Prelim. Resp. 56. Patent Owner’s argument is persuasive.
`Prosser has been discussed above. See Section II.B. Diab discloses a
`
`pulse oximeter that uses “an adaptive noise canceler that removes erratic
`motion-induced undesired signal portions in a pulse oximeter.” Ex. 1004,
`64–65.2 Figure 10 of Diab is reproduced below:
`
`
`
`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
`
`
`2 Citations are to the page numbers of the underlying Diab reference rather
`than the page numbers of the Exhibit.
`
`12
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`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.
`
`We have reviewed all of Petitioner’s arguments and cited support but
`find no persuasive articulation of a reason with rational underpinnings as to
`why one would have found it obvious to combine the references’ teachings
`to arrive at the claimed subject matter. See, e.g., Pet. 42–45.
`
`Petitioner’s initial argument is that the two references are similar and
`have “complimentary” disclosures. See Pet. 42. Similarity might support a
`finding of analogous art, but does not explain why one would have
`combined the references’ teachings. Moreover, Petitioner does not explain
`adequately how the two references are “complimentary” or why that would
`have led a person of ordinary skill in the art to combine them.
`
`Petitioner then argues that the references similarly disclose the
`assumptions and, therefore, “the claimed assumptions were obvious when
`viewing Prosser in light of Diab.” Pet. 42–43. First, the test for
`obviousness is whether the claimed invention as a whole would have been
`obvious to a person of ordinary skill, not whether particular features, i.e., the
`assumptions, would have been obvious. See 35 U.S.C. § 103. Second,
`Petitioner’s implied position that Prosser discloses the assumptions (see
`Pet. 43) is inconsistent with Petitioner’s earlier position that the differences
`between Prosser’s disclosure and the claimed invention are the claimed
`assumptions. See Pet. 37 (in articulating the basis of the obviousness
`
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`ground, stating: “[T]o the extent there is any doubt about whether Prosser
`addresses the claimed assumptions, that doubt can be readily resolved by
`viewing Prosser in light of Diab”). If Prosser already discloses the claimed
`assumptions, we fail to see why one would modify Prosser in view of Diab
`to have those assumptions; and if Prosser lacks the assumptions, we fail to
`see how any similarity between Prosser’s assumptions and Diab’s provides
`rational underpinning for a conclusion of obviousness.
`Petitioner quotes from KSR Int’l. Co. v. Teleflex Inc., 550 U.S. 398,
`
`419–20 (2007), for the proposition that a known problem can provide a
`reason for combining elements. Pet. 43. Petitioner, however, does not
`articulate adequately an application of this proposition. Petitioner merely
`asserts that the two references are focused on and attempting to solve the
`same problem, and argues that it would have been obvious to have “viewed”
`Diab’s assumptions in light of Prosser’s system. Id. at 43–44; see Ex. 1002
`¶¶ 55–56. Absent is an explanation as to why any problem would have
`prompted a modification of Prosser. See Pet. 43–44.
`Petitioner also quotes from KSR regarding the proposition involving
`
`the use of a known technique that improves one device to improve a similar
`device. Id. at 44. Petitioner, however, does not argue affirmatively that the
`assumptions constitute a technique that improved Diab. See id. (“To the
`extent that those assumptions improved Diab’s techniques . . . .”); see
`Ex. 1002 ¶ 56 (same).
`
`Lastly, Petitioner argues that Prosser would not be modified in any
`significant way, its principle of operation would not fundamentally change,
`and implementation of the modification would not require undue
`experimentation. Pet. 44–45. These arguments, again, do not explain why
`
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`one would have made the proposed modification.
`
`Accordingly, we find Petitioner has not demonstrated that there is a
`reasonable likelihood that it would prevail in showing that the subject matter
`of the challenged claim 1 would have been obvious over Diab and
`Weinstein.
`
`III. CONCLUSION
`We determine Petitioner has not demonstrated there is a reasonable
`
`likelihood of establishing the unpatentability of claim 1 of the ’034 patent.
`
`IV. ORDER
`For the foregoing reasons, it is
`
`ORDERED that the Petition is denied as to all challenged claims, and
`
`no trial is instituted.
`
`
`
`
`
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`IPR2016-00058
`Patent 8,560,034 B1
`
`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:
`
`Stephen Jensen
`Jarom D. Kesler
`Brenton R. Babcock
`KNOBBE, MARTENS, OLSON & BEAR LLP
`2scj@knobbe.com
`2jzk@knobbe.com
`2brb@knobbe.com
`
`
`16
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