Trials@uspto.gov
`571-272-7822
`
` Paper No. 53
`Entered: February 28, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DEXCOM, INC.,
`Petitioner,
`
`v.
`
`WAVEFORM TECHNOLOGIES, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01679
`Patent 7,146,202 B2
`____________
`
`Before ERICA A. FRANKLIN, JON B. TORNQUIST, and
`ELIZABETH M. ROESEL, Administrative Patent Judges.1
`
`ROESEL, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318 and 37 C.F.R. § 42.73
`
`1 Administrative Patent Judge Erica A. Franklin replaces former panel
`member Brian P. Murphy, who is no longer with the Patent Trial and Appeal
`Board.
`
`
`571-272-7822
`
` Paper No. 53
`Entered: February 28, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DEXCOM, INC.,
`Petitioner,
`
`v.
`
`WAVEFORM TECHNOLOGIES, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01679
`Patent 7,146,202 B2
`____________
`
`Before ERICA A. FRANKLIN, JON B. TORNQUIST, and
`ELIZABETH M. ROESEL, Administrative Patent Judges.1
`
`ROESEL, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318 and 37 C.F.R. § 42.73
`
`1 Administrative Patent Judge Erica A. Franklin replaces former panel
`member Brian P. Murphy, who is no longer with the Patent Trial and Appeal
`Board.
`
`
`
`IPR2016-01679
`Patent 7,146,202 B2
`
`
`In this inter partes review, instituted pursuant to 35 U.S.C. § 314,
`Dexcom, Inc. (“Petitioner”) challenges patentability of claims 1–3, 5, 6, and
`8–11 of U.S. Patent No. 7,146,202 B2 (Ex. 1001, “the ’202 patent”), owned
`by Waveform Technologies, Inc. (“Patent Owner”).
`We have jurisdiction under 35 U.S.C. § 6. This final written decision
`is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`For the reasons that follow, we determine that Petitioner has shown by
`a preponderance of the evidence that claims 1–3, 6, 8, and 11 of the ’202
`patent are unpatentable. We determine that Petitioner has not shown by a
`preponderance of the evidence that claims 5, 9, and 10 of the ’202 patent are
`unpatentable.
`
`I.
`
`BACKGROUND
`
`A.
`
`Procedural History
`Petitioner filed a Petition seeking inter partes review of claims 1–3, 5,
`6, and 8–11 of the ’202 patent. Paper 1 (“Pet.”). Patent Owner filed a
`Preliminary Response. Paper 7 (“Prelim. Resp.”). We instituted inter partes
`review of all challenged claims. Paper 10 (“Institution Decision” or “Dec.”).
`Patent Owner filed a Response. Paper 29 (“PO Resp.”). Petitioner
`filed a Reply. Paper 37 (“Pet. Reply”).2
`With the Petition, Petitioner filed a Declaration of David Vachon,
`Ph.D. Ex. 1006. Patent Owner cross-examined Dr. Vachon and filed a
`transcript of his deposition testimony as Exhibit 2036.
`
`
`2 We rely on the public, redacted versions of Patent Owner’s Response and
`Petitioner’s Reply.
`
`2
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`With the Preliminary Response, Patent Owner filed declarations of
`John L. Smith, Ph.D. (Ex. 2001) and Matthew J. Schurman, Ph.D. (Ex.
`2003). With the Patent Owner Response, Patent Owner filed declarations of
`Dr. Smith (Ex. 2027),3 Dr. Schurman (Ex. 2029), Ellen M. Anderson (Ex.
`2035), and Serena Morones (Ex. 2053). Petitioner cross-examined each of
`these witnesses and filed transcripts of each witness’s deposition testimony
`as follows: Dr. Smith (Ex. 1037), Dr. Schurman (Ex. 1039), Ms. Anderson
`(Ex. 1041), and Ms. Morones (Ex. 1033).
`Oral argument was held December 7, 2017, and a transcript was
`entered in the record. Paper 52 (“Tr.”).
`As further discussed below, each party filed a motion to exclude
`evidence submitted by the opposing party.
`
`B.
`
`Related Matters
`The parties identify the following district court proceeding involving
`the ’202 patent: WaveForm Technologies, Inc. v. Dexcom, Inc., No. 3:16-
`cv-00536-MO (D. Or.). Pet. 64–65; Paper 14, 2 (Patent Owner’s updated
`mandatory notices).
`In addition, the parties identify the following inter partes review
`proceedings: Dexcom, Inc. v. WaveForm Technologies, Inc., IPR2016-
`01680, involving U.S. Patent No. 8,187,433 B2 (“the ’433 patent”);4 and
`Dexcom, Inc. v. WaveForm Technologies, Inc., IPR2017-01051, involving
`
`
`3 We rely on the public, redacted version of Exhibit 2027.
`4 The ’433 patent (Ex. 2028) was issued from U.S. Application No.
`11/538,340, filed October 3, 2006, which is a division of U.S. Application
`No. 10/869,133, filed June 16, 2004, which issued as the ’202 patent (Ex.
`1001).
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`3
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`U.S. Patent No. 7,529,574. Paper 14, 2; Paper 44, 2 (Petitioner’s updated
`mandatory notices).
`
`C.
`
`Instituted Grounds of Unpatentability
`We instituted inter partes review on the following three grounds of
`unpatentability asserted in the Petition:
`
`Reference[s]
`
`Statutory Basis
`
`Challenged Claims
`
`Wilson5 and Rosenblatt6
`
`§ 103(a)
`
`1–3, 5, 6, and 9–11
`
`Hagiwara7
`
`§ 102(b)
`
`1–3, 6, 8, 10, and 11
`
`Hagiwara and Rosenblatt § 103(a)
`
`5
`
`
`
`C. The ’202 Patent
`The ’202 patent, titled “Compound Material Analyte Sensor,” was
`issued December 5, 2006. Ex. 1001, at (54). The ’202 patent relates to a
`sensing element adapted to be inserted, at least in part, into a mammalian
`body. Id. at Abstract, 1:42–44. The ’202 patent discloses that the sensing
`element includes a core of a structurally robust material and a plated portion
`comprising an electrochemically active metal. Id. at Abstract, 1:44–46. The
`sensing element may be used in a method for continuous sensing of an
`
`
`5 G. S. Wilson et al., Progress toward the Development of an Implantable
`Sensor for Glucose, 38(9) Clin. Chem. 1613–17 (1992). Ex. 1004.
`6 U.S. Patent No. 2,719,797, issued October 4, 1955. Ex. 1005.
`7 Japanese Unexamined Patent Application Publication No. S57-110236,
`published July 9, 1982. Ex. 1007. Exhibit 1007 includes an English
`translation (pages 1–16), a translation certificate (page 17), a certified copy
`of the Japanese publication (pages 19–30), and a cover letter (page 18).
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`analyte, such as glucose, within a mammalian body. Id. at Abstract, 1:47–
`52.
`
`According to the ’202 patent, the disclosed sensing element addresses
`problems with platinum wire sensors, including: (1) platinum is a weak
`metal that is susceptible to sensor fatigue and breakage when subjected to
`flexure caused by bodily movement; and (2) platinum is expensive and can
`strain the budget for sensor production. Id. at 1:12–38.
`An embodiment of a sensing element is depicted in Figure 1, which is
`reproduced below:
`
`
`Figure 1, above, shows sensing element 12 including bimetallic wire
`20, membrane system 22 coated on at least a portion of wire 20, and
`protective layer 23, e.g., polyimide, coated on portions of wire 20 not coated
`with membrane system 22. Ex. 1001, 2:10–23. Wire 20 includes core 24
`and electrochemically active layer 26. Id. at 2:24–28. Membrane system
`22, also referred to as sensing region 22, includes reactive layer 30
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`containing enzyme, permselective layer 32, and interferent reducing layer
`34. Id. at 3:48–4:8.
`The ’202 patent discloses that wire core 24 may be made of any
`structurally robust material, such as tantalum, stainless steel, nitinol (an alloy
`of nickel and titanium), polymeric material, or glass fiber. Id. at 2:33–41.
`Electrochemically active layer 26 may be made of a noble metal, such as
`platinum, palladium, gold, or a combination of one of these with iridium. Id.
`at 2:41–43. The ’202 patent discloses various methods for making plated
`wire 20, including electroplating, foil cladding, plasma vapor deposition, and
`sputtering. Id. at 2:47–3:47.
`In operation, a voltage is placed on wire 20 relative to a reference
`electrode. Glucose and oxygen (or glucose only) reacts with the enzyme in
`layer 30 producing hydrogen peroxide, which permeates layer 34 and causes
`an electric current to be produced in wire 20. The current flow is indicative
`of the concentration of glucose in body fluid. Id. at 2:10–15, 3:48–4:8.
`According to the ’202 patent, sensing element 12 may be inserted into the
`body for a number of days, or it may be used as a single use sensing element
`indwelling for less than three minutes. Id. at 4:32–46.
`D. Illustrative Claim
`The ’202 patent includes 12 claims, of which claims 1 and 12 are
`independent. We instituted inter partes review of claims 1–3, 5, 6, and 8–
`11—all claims challenged in the Petition. Claim 1 is illustrative of the
`challenged claims and is reproduced below:
`1. A method for measuring the concentration of an
`analyte within an animal body having body fluids, comprising:
`(a) providing a sensor having:
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`(i) a structurally flexible core having an outer
`surface; and
`(ii) a layer of electrochemically active metal
`surrounding, covering, and in contact with said outer
`surface of said core;
`(b) placing at least a portion of said sensor into said
`animal body; and
`(c) measuring any electric current produced by said
`sensor and forming a measurement of analyte concentration
`based on said current measurement.
`Ex. 1001, 4:55–67.
`
`II. ANALYSIS
`
`A.
`
`Claim Construction
`In an inter partes review, claim terms in an unexpired patent are given
`their broadest reasonable interpretation in light of the specification of the
`patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Tech.,
`LLC v. Lee, 136 S. Ct. 2131, 2142 (2016). Under that standard, we give
`claim terms their ordinary and customary meaning, as understood by a
`person 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). The Board, however, may not “construe claims during IPR so
`broadly that its constructions are unreasonable under general claim
`construction principles. . . . ‘[T]he protocol of giving claims their broadest
`reasonable interpretation . . . does not include giving claims a legally
`incorrect interpretation.’” Microsoft Corp. v. Proxyconn, Inc., 789 F.3d
`1292, 1298 (Fed. Cir. 2015) (citation omitted). “Even under the broadest
`reasonable interpretation, the Board’s construction ‘cannot be divorced from
`the specification and the record evidence,’” and “[t]he PTO should also
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`consult the patent’s prosecution history in proceedings in which the patent
`has been brought back to the agency for a second review.” Id. (citations
`omitted).
`We address certain claim terms below. No other claim term requires
`express construction for purposes of resolving the patentability disputes on
`this record. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999) (“only those terms need be construed that are in
`controversy, and only to the extent necessary to resolve the controversy”).
`
`“structurally flexible”
`1.
`Claim 1 of the ’202 patent recites: “a sensor having a structurally
`flexible core.” Ex. 1001, 4:57–58. In the Institution Decision, we
`preliminarily construed “a structurally flexible core” to mean “a core that is
`robust and able to be flexed or bent repeatedly.” Dec. 9.
`The “robust” portion of our construction was based on descriptions in
`the Specification of ’202 patent, including the disclosure that “wire core 24
`may be of any structurally robust material” and statements that the sensor
`core is made of a “structurally robust” material. Id. at 7–8 (quoting Ex.
`1001, Abstract, 1:44, 1:52–53, 1:61–62, 2:24–26, 2:33–41, 3:17–18, 3:23–
`24). We also relied upon the Specification’s disclosure that fatigue,
`weakness, and breakage are undesirable characteristics of an indwelling wire
`sensor. Id. at 8 (citing Ex. 1001, 1:12–28).
`The portion of our construction that requires that the core is “able to
`be flexed or bent repeatedly” was based, in part, on a dictionary definition.
`The McGraw Hill Dictionary of Scientific and Technical Terms defines
`“flexibility” as “the quality or state of being able to be flexed or bent
`repeatedly.” Id. at 9 (citing Ex. 3001, 620). As stated in our Institution
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`Decision, this definition is consistent with the description of a “structurally
`flexible” core in the ’202 patent. Id.
`Our Institution Decision invited the parties to indicate whether they
`agree or disagree with our preliminary construction and to present arguments
`and evidence in support of, or in opposition to, our preliminary construction,
`and/or to propose a modification thereof. Id.
`In its Response, Patent Owner states it “does not object to the Board’s
`proposed construction,” asserting that it “reflects the key point that a
`‘structurally flexible core’ must be one that is sufficiently robust to
`withstand repeated bending and flexing.” PO Resp. 5. According to Patent
`Owner, the Specification of the ’202 patent demonstrates that “flexibility
`alone is not enough; the structurally flexible core material must also be
`robust.” Id. (citing Ex. 1001, 1:22).
`Petitioner argues that the Board’s preliminary construction improperly
`reads a “robustness” requirement into “structurally flexible” that the
`prosecution history prohibits. Pet. Reply 3. More particularly, Petitioner
`argues that a “robustness” requirement is impermissible because applicant
`struck “robust” from the claims during prosecution. Id. at 5.
`After reviewing the portion of the prosecution history cited by
`Petitioner, we are persuaded that our preliminary construction was incorrect
`to the extent it imposed a requirement for robustness apart from flexibility.
`Claim 1 of the ’202 patent was prosecuted as claim 35. Ex. 1002, 22. When
`first presented, claim 35 recited: “a sensor having . . . a core of structurally
`robust material.” Id. at 77–78. The Examiner rejected that claim over
`
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`Sohrab8 and Smart,9 asserting that Sohrab taught a sensor having a core wire
`made of structurally robust material. Id. at 70. In response to that rejection,
`Applicants amended the claim to recite, “a sensor having a structurally
`flexible core,” instead of “a sensor having a core of structurally robust
`material.” Id. at 57. In other words, Applicants removed the word “robust”
`and replaced it with the word “flexible.” Id. The claim was allowed without
`the word “robust.” Id. at 20, 28.
`We agree with Petitioner that, in view of this prosecution history, it is
`inappropriate for us to construe the term, “structurally flexible core,” as
`requiring that the core be “robust.” Although the ordinary meaning of
`“flexible” may imply some degree of robustness (see Ex. 3001, 620), the
`prosecution history does not support reading the term “robust” back into the
`claim after it was removed by Applicants during prosecution. Laryngeal
`Mask Co. v. Ambu A/S, 618 F.3d 1367, 1373 (Fed. Cir. 2010) (“it would be
`improper to read a . . . limitation back into” the claim after it was deleted
`from the claim during prosecution).
`Patent Owner argues that Applicants’ claim amendment was made to
`distinguish “rigid piercing elements” as disclosed in Sohrab and Smart.
`Tr. 31:8–21; see also Ex. 1002, 63 (Applicants’ remarks: “Neither Sohrab
`nor Smart provide any teaching of a flexible core, but rather teach the use of
`rigid piercing elements.”).
`Patent Owner’s argument does not persuade us to read a requirement
`for robustness back into the claim after it was removed by Applicants during
`prosecution. The impropriety of reading such limitations back into the claim
`
`8 U.S. Patent No. 6,501,976, issued December 31, 2002.
`9 U.S. Patent Publication No. 20020137998, published September 26, 2002.
`10
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`applies “[r]egardless of why [applicant] amended its claims” to remove the
`limitation. Laryngeal, 618 F.3d at 1373. Patent Owner’s argument does not
`convince us that there is a requirement for robustness beyond what is
`implicit in the ordinary meaning of “flexible.” Applicants’ claim
`amendment (Ex. 1002, 57) demonstrates that there is no requirement for
`robustness separate from a requirement that the core be “flexible,” i.e., that it
`can be flexed or bent repeatedly.
`Alternatively, Patent Owner argues that the claim construction should
`specify that the core is able to be bent or flexed repeatedly “without
`breaking.” Tr. 34:8–12; see also Ex. 2029 ¶¶ 24, 31. After considering
`Patent Owner’s proposal, we determine that it is unnecessary to add the
`words, “without breaking,” to the construction. Although these words are
`not expressly stated, they are implied by our construction, which provides,
`“able to be flexed or bent repeatedly.” Logic dictates that a metal core that
`breaks when flexed or bent cannot be flexed or bent “repeatedly.”
`In view of the foregoing, we revise the claim construction provided in
`the Institution Decision to remove the requirement that the core be “robust.”
`We construe the term, “structurally flexible,” to mean “able to be flexed or
`bent repeatedly.”
`Our construction is consistent with the Specification of the ’202
`patent, which does not define the term, “structurally flexible,” but indicates
`that the use of tantalum or nitinol for the sensor core is “desireable because
`they are both naturally flexible.” Ex. 1001, 2:37–39. The Specification
`indicates that such flexibility “is of particular importance if [the sensor] is to
`be inserted in a patient and worn for a period of days.” Id. at 2:39–40. By
`implication, a sensor that is implanted in a patient for a period of days would
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`need to be able to be flexed or bent repeatedly. See id. at 1:14 (discussing
`“flexure caused by bodily movement”). Our construction is also supported
`by the dictionary definition for “flexibility”: “able to be flexed or bent
`repeatedly.” Ex. 3001, 620.
`
`“in contact with”
`2.
`Claim 1 recites “a layer of electrochemically active metal
`surrounding, covering, and in contact with said outer surface of said core.”
`Ex. 1001, 4:60–62 (emphasis added). In the Institution Decision, we
`directed the parties to provide and justify an express construction for the
`term, “surrounding, covering, and in contact with,” as recited in claim 1.
`Dec. 13. We further directed the parties that, in providing an express
`construction, they should address the ’202 patent specification and
`prosecution history in detail, including whether, and to what extent, any
`relevant subject matter was surrendered by a narrowing claim amendment.
`Id.
`
`The parties agree that the term “surrounding, covering” should be
`construed to mean “entirely surrounding and covering.” PO Resp. 5; Pet.
`Reply 7. As support for reading the word “entirely” into the claim, Patent
`Owner relies on the prosecution history, arguing that incomplete coverage of
`the core’s outer surface was clearly and unmistakably disclaimed. PO Resp.
`12–16 (citing Ex. 1002, 33–34). Petitioner does not respond to Patent
`Owner’s prosecution history disclaimer argument. We determine that, for
`purposes of resolving the patentability disputes presented on this record, it is
`not necessary to determine whether the word “entirely” should be read into
`the claim.
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`The parties agree that the term “in contact with” should be construed
`to mean “touching.” PO Resp. 5; Pet. Reply 6. As support for this
`construction, Patent Owner relies on a dictionary definition for “contact”
`(Ex. 2026), the prosecution history and disclosed embodiments of the ’202
`patent, and claims 7 and 16 of the related ’433 patent. PO Resp. 17–23
`(citing Exs. 1001, 1002, 2026, 2028, 3002). Petitioner, however, asserts that
`Patent Owner’s construction for “in contact with” does not preclude an
`intervening layer. Pet. Reply 6. We address the parties’ arguments and
`evidence below.
`Patent Owner argues that the dictionary definition for “contact” is
`“touching” and that applicants disavowed any broader meaning during
`prosecution. PO Resp. 17–19 (citing Exs. 1002, 2026). As support for a
`prosecution history disawowal, Patent Owner directs us to Applicants’
`remarks distinguishing Macur.10 Id. at 17–18 (citing Ex. 1002, 34). There,
`Applicants argued:
`Macur provides an electrochemically active layer 32/33
`that is not in contact with the core. Macur uses an intervening
`insulating layer 14 that separates the core from the
`electrochemically active layer. Thus, the active layer is not in
`contact with the outer surface of the core, as provided in claim
`35.
`Ex. 1002, 34. Thereafter, the Examiner allowed the claims. Id. at 20.
`Applicants’ claim amendment and remarks persuade us that Applicants
`disavowed a claim construction for “in contact with” that is broad enough to
`encompass an intervening layer between the electrochemically active metal
`and the outer surface of the core.
`
`
`10 U.S. Patent No. 3,957,613, issued May 18, 1976. Ex. 3002.
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`Patent Owner relies on claim 16 of the ’433 patent, arguing that the
`term, “in contact with,” is used in that claim consistent with its ordinary
`meaning, “touching.” PO Resp. 20 (citing Ex. 2028, 6:19–27). Patent
`Owner additionally argues that claim 16 is directed to a three-layer
`embodiment that is not encompassed by claim 1 of the ’202 patent. Id. at
`19, 21. We are persuaded by both of these arguments. Claim 16 of the ’433
`patent describes three metal layers: a stainless steel core, a layer of gold “in
`contact with” the outer surface of the core, and a layer of platinum “in
`contact with” the layer of gold. Ex. 2028, 6:19–27. In each instance, claim
`16 uses the term, “in contact with,” consistent with its ordinary meaning,
`“touching.” Whereas claim 16 of the ’433 patent expressly recites an
`intervening layer of gold between the outer surface of the core and the layer
`of platinum (an electrochemically active metal), no such intervening layer is
`permitted by the language of claim 1 of the ’202 patent, which recites that
`the electrochemically active metal is “in contact with” the outer surface of
`the core.
`Both parties rely on claim 7 of the ’433 patent as relevant to the
`meaning of “in contact with” in claim 1 of the ’202 patent. PO Resp. 22–23;
`Pet. Reply 6. Claim 7 depends from claim 1 of the ’433 patent. Ex. 2028,
`5:7. Similar to claim 1 of the ’202 patent, claim 1 of the ’433 patent recites
`“a continuous layer of electrochemically active metal surrounding, covering,
`and in contact with said outer surface of said core.” Id. at 4:56–58. Claim 7
`recites: “wherein said outer surface of said core comprises a passivated
`oxide surface.” Id. at 5:7–9. Patent Owner argues, “[b]ecause the outer
`surface of the core ‘comprises’ the oxide, the electrochemically active metal
`is ‘in contact with’ the core’s outer surface when it touches the oxide.” PO
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`Resp. 23. Petitioner, on the other hand, argues that claim 7 shows that “[t]he
`core can comprise an intervening layer, such as a passivated oxide layer.”
`Pet. Reply 6.
`We determine that claim 7 of the ’433 patent is consistent with the
`ordinary meaning of “contact” and Applicants’ disavowal of an intervening
`layer between the electrochemically active metal layer and the outer surface
`of the core. According to claim 7, the “passivated oxide surface” is part of
`the outer surface of the core (Ex. 2028, 5:7–9), not an “intervening layer,” as
`disclaimed during prosecution (Ex. 1002, 34).
`Accordingly, we construe the term “in contact with” to mean
`“touching,” as proposed by Patent Owner.
`
`B.
`
`Principles of Law
`Petitioner bears the burden of proving unpatentability of the
`challenged claims, and the burden of persuasion never shifts to Patent
`Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375,
`1378 (Fed. Cir. 2015). To prevail, Petitioner must establish the facts
`supporting its challenge by a preponderance of the evidence. 35 U.S.C.
`§ 316(e); 37 C.F.R. § 42.1(d).
`A patent claim is unpatentable as anticipated under 35 U.S.C. § 102
`“when the same device or method, having all of the elements contained in
`the claim limitations, is described in a single prior art reference.” Crown
`Operations Int’l, Ltd. v. Solutia Inc., 289 F.3d 1367, 1375 (Fed. Cir. 2002).
`To anticipate, the reference must disclose “within the four corners of the
`document not only all of the limitations claimed but also all of the
`limitations arranged or combined in the same way as recited in the claim.”
`Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).
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`A patent claim is unpatentable as obvious under 35 U.S.C. § 103(a) if
`the differences between the subject matter sought to be patented and the
`prior art are such that the subject matter as a whole would have been obvious
`to a person of ordinary skill in the art at the time the invention was made.
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). Obviousness is
`resolved based on underlying factual determinations, including: (1) the
`scope and content of the prior art; (2) any differences between the claimed
`subject matter and the prior art; (3) the level of ordinary skill in the art; and
`(4) objective evidence of nonobviousness, i.e., secondary considerations.
`See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`
`C.
`
`Level of Ordinary Skill in the Art
`For purposes of our Institution Decision, we accepted the definition of
`a person of ordinary skill in the art (“POSA”) provided by Petitioner’s
`declarant, Dr. Vachon. Dec. 14 (citing Ex. 1006 ¶ 22). That definition is: a
`bachelor’s degree or equivalent training or experience in mechanical
`engineering, bioengineering, or a related field and at least three years of
`experience relating to biosensor research and development. Id. Patent
`Owner’s declarants accept and apply this definition of a POSA for purposes
`of their opinions. Ex. 2027 ¶ 34 (Dr. Smith); Ex. 2029 ¶ 18 (Dr. Schurman).
`None of the parties’ declarants indicates that any proffered opinion would
`change depending on the level of ordinary skill in the art. See Ex. 2027 ¶ 35
`(Dr. Smith’s opinions would not change, regardless of which definition is
`adopted).
`Therefore, we adopt Dr. Vachon’s definition of a POSA. Ex. 1006
`¶ 22. We also rely on the cited prior art references as reflecting the level of
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`ordinary skill in the art at the time of the invention. See Okajima v.
`Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).
`After reviewing the qualifications of Drs. Vachon, Smith, and
`Schurman, as set forth in their respective declarations and curriculum vitae,
`we find that each of these declarants is qualified to testify from the
`perspective of a POSA. Regarding Dr. Vachon, we rely in particular on his
`experience as director of glucose sensor research and development at
`MiniMed from 1998 to 2001, where he worked on an implantable
`electrochemical glucose sensor. Ex. 1006 ¶ 8, App. A. Regarding
`Dr. Smith, we rely in particular on his experience relating to blood glucose
`monitoring systems as head of research and development at LifeScan, Inc.
`from 1987 to 1998. Ex. 2027 ¶ 3, App. A. Regarding Dr. Schurman, we
`rely in particular on his experience as a consultant in the field of glucose
`monitoring and insulin delivery and as chief technology officer of
`GlucoLight Corporation from 2002 to 2009, where he worked on
`development of a non-invasive glucose monitor. Ex. 2029 ¶¶ 5, 7, App. A.
`There is no contention that any of these declarants is not qualified to testify
`as an expert in this case.
`
`D.
`
`Prior Art References
`
`1. Wilson (Ex. 1004)
`Wilson is an article published in 1992 entitled, “Progress toward the
`Development of an Implantable Sensor for Glucose.” Ex. 1004. There is no
`dispute that Wilson is prior art to the ’202 patent under 35 U.S.C. § 102(b).
`Pet. 6; Ex. 1009 (declaration of librarian, Morris M. Jackson, attesting to
`facts relating to public accessibility of Wilson as of September 1992).
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`Wilson discusses the development of a needle-shaped glucose sensor
`that is flexible and implanted subcutaneously using a catheter. Ex. 1004,
`1613(1).11 According to Wilson, the device had been used to monitor
`glucose concentrations for as long as ten days in rats. Id.
`Wilson’s glucose sensor is schematically illustrated in Figure 2, which
`is reproduced below:
`
`
`Wilson Figure 2 is a schematic diagram of a multilayered sensing
`element, including an electrode, a pair of inner membranes, an enzyme layer,
`and an outer membrane. Ex. 1004, 1615, Fig. 2. In Figure 2, glucose and
`oxygen are shown flowing through the outer membrane to the enzyme layer,
`where they react to form hydrogen peroxide and reduced glucose (gluconic
`acid). Id.; see also id. at 1614(1) (reaction of glucose with oxygen to form
`gluconic acid and hydrogen peroxide). Hydrogen peroxide is shown
`migrating through the inner membranes to the electrode, where it is oxidized
`to form oxygen. Id. at 1615, Fig. 2.
`A cross-section of Wilson’s glucose sensor is illustrated in Figure 3,
`which is reproduced below:
`
`11 We use parenthetical numbers following the internal page numbers to
`indicate the first and second columns on each page.
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`Wilson Figure 3 is a sectional diagram depicting an implantable
`sensor, including a platinum-iridium (Pt-Ir) wire, a Teflon layer, an enzyme
`layer, a polyurethane (PU) layer, and a silver-silver chloride (Ag/AgCl)
`reference electrode. Ex. 1004, 1615, Fig. 3. Wilson discloses that
`“[b]ecause the sensor is extremely flexible, we can implant it by using a
`short (3 cm) stainless steel catheter (21 gauge), which is removed after the
`sensor is in place.” Id. at 1615 (1–2).
`
`Rosenblatt (Ex. 1005)
`2.
`Rosenblatt is a U.S. patent issued in 1955 entitled, “Platinizing
`Tantalum.” Ex. 1005. There is no dispute that Rosenblatt is prior art to the
`’202 patent under 35 U.S.C. § 102(b). Pet. 6; Ex. 1005.
`Rosenblatt discloses a process for producing platinum-coated
`tantalum for use as non-corroding anodes in electrochemical processes, such
`as the electrolysis of chlorides and the production of chlorine, chlorates, and
`per-compounds. Ex. 1005, 1:15–25, 6:3–9. According to Rosenblatt,
`platinum group metals are the “universal choice” for anodic material due to
`their corrosion resistance, but the high cost of these precious metals has
`prompted a search for substitutes, such as tantalum. Id. at 1:29–40, 1:57–64.
`Rosenblatt explains that tantalum cannot be used as an anode because it
`forms an oxide film and that prior attempts to coat tantalum with platinum
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`were unsatisfactory due to insufficient adherence between the metals. Id. at
`1:64–2:21. Rosenblatt’s process aims to provide a thin, firmly adherent,
`practically inseparable coat of platinum on a tantalum base. Id. at 2:22–25.
`In Rosenblatt’s process, a thin deposit of platinum metal is applied on
`the surface of a tantalum body, either by chemical deposition or
`electroplating. Ex. 1005, 2:40–43, 2:45–50; see also id. at 2:67–3:37
`(chemical deposition); 3:38–3:60 (electroplating). Thereafter, the platinum
`metal deposit is bonded to the tantalum body by heating the whole to a high
`temperature under inert conditions. Id. at 2:43–45, 2:50–53; see also id. at
`3:61–4:13 (bonding).
`Rosenblatt discloses that the bonding treatment causes the platinum
`and tantalum metals to interdiffuse and become alloyed, forming a thin layer
`of platinum-tantalum alloy between the tantalum base and an outer layer of
`unalloyed platinum. Id. at 4:22–25, 4:46–51; see also 6:26–30 (claim 1).
`According to Rosenblatt, the resulting platinized tantalum is not attacked by
`hot aqua regia and behaves like a pure platinum electrode, without flaking
`off of the platinum film, even after extended use as an anode in a chlorine or
`chlorate production cell. Id. at 4:14–25, 4:51–56, 5:20–29.
`
`Hagiwara (Ex. 1007)
`3.
`Hagiwara is a 1982 Japanese patent publication titled, “Polarography
`Sensor.” Ex. 1007. There is no dispute that Hagiwara is prior art to the ’202
`patent under 35 U.S.C § 102(b). Pet. 6; Ex. 1007.
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`Hagiwara discloses an intravenous polarography12 sensor for
`measuring the concentration of blood components, such as oxygen or
`glucose, in animals and humans. Ex. 1007, 1 (Title), 2:46–3:2, 4:1–6, 4:17–
`21.13 Hagiwara’s sensor includes a metal wire having an electrode reaction
`surface made of a precious metal,
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