Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`Paper No. 48
`Entered: Sept. 12, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DEXCOM, INC.,
`Petitioner,
`
`v.
`
`WAVEFORM TECHNOLOGIES, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01051
`Patent 7,529,574 B2
`____________
`
`
`
`Before BENJAMIN D. M. WOOD, JON B. TORNQUIST, and
`ELIZABETH M. ROESEL, Administrative Patent Judges.
`
`ROESEL, Administrative Patent Judge.
`
`
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318 and 37 C.F.R. § 42.73
`
`
`
`Tel: 571-272-7822
`
`
`
`
`
`Paper No. 48
`Entered: Sept. 12, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DEXCOM, INC.,
`Petitioner,
`
`v.
`
`WAVEFORM TECHNOLOGIES, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01051
`Patent 7,529,574 B2
`____________
`
`
`
`Before BENJAMIN D. M. WOOD, JON B. TORNQUIST, and
`ELIZABETH M. ROESEL, Administrative Patent Judges.
`
`ROESEL, Administrative Patent Judge.
`
`
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318 and 37 C.F.R. § 42.73
`
`
`
`
`IPR2017-01051
`Patent 7,529,574 B2
`
`
`In this inter partes review, instituted pursuant to 35 U.S.C. § 314,
`Dexcom, Inc. (“Petitioner”) challenges the patentability of claims 1–19 of
`U.S. Patent No. 7,529,574 B2 (Ex. 1001, “the ’574 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, 4–12, and 15–19 of the ’574
`patent are unpatentable. We determine that Petitioner has not shown by a
`preponderance of the evidence that claims 2, 3, 13, and 14 of the ’574 patent
`are unpatentable. We grant Patent Owner’s Contingent Motion to Amend as
`to claims 21, 24, and 25 (proposed substitutes for claims 10, 13, and 14 of
`the ’574 patent) and deny the motion as to claims 20, 22, 23, and 26–29
`(proposed substitutes for claims 9, 11, 12, 15–17, and 19 of the ’574 patent).
`We dismiss Patent Owner’s Motion to Exclude as moot.
`
`I.
`
`BACKGROUND
`
`A.
`
`Procedural History
`Petitioner filed a Petition seeking inter partes review of claims 1–19
`of the ’574 patent. Paper 1 (“Pet.”). Patent Owner filed a Preliminary
`Response. Paper 5 (“Prelim. Resp.”). We instituted inter partes review of
`all challenged claims, based on only one of the five grounds of
`unpatentability presented in the Petition. Paper 7 (“Institution Decision” or
`“Dec.”), 2, 4, 32.
`Patent Owner filed a Response and a Contingent Motion to Amend.
`Paper 17 (“PO Resp.”); Paper 18 (“Mot.”). Petitioner filed a Reply and a
`Response to the Motion to Amend. Paper 23 (“Pet. Reply”); Paper 22 (“Pet.
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`Opp.”). Patent Owner filed a Reply to Petitioner’s Response to the Motion
`to Amend. Paper 27 (“PO Reply”). With prior authorization of the Board,
`Petitioner filed a Sur-Reply to the Motion to Amend (Paper 29, “Pet. Sur-
`Reply”), and Patent Owner filed Responses to Observations of Dr. Smith’s
`testimony (Paper 36).
`Following the Supreme Court’s decision in SAS Institute Inc. v. Iancu,
`138 S. Ct. 1348 (2018), we modified our Institution Decision to include
`review of all grounds presented in the Petition. Paper 30. With the Board’s
`prior authorization, Petitioner filed a Reply regarding the subsequently
`instituted grounds (Paper 37), and Patent Owner filed a Sur-Reply (Paper
`42).
`
`Patent Owner filed a Motion to Exclude Exhibit 1037 filed with
`Petitioner’s Reply (Paper 37) and portions of the Reply discussing that
`exhibit. Paper 41. Petitioner filed a response (Paper 44), and Patent Owner
`filed a reply (Paper 45) concerning the Motion to Exclude.
`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 2009.
`With the Preliminary Response, Patent Owner filed a declaration of
`John L. Smith, Ph.D. Ex. 2001. With the Patent Owner Response, Patent
`Owner filed a second declaration of Dr. Smith. Ex. 2008. With its Reply to
`Petitioner’s Response to the Motion to Amend, Patent Owner filed a third
`declaration of Dr. Smith. Ex. 2024. Petitioner cross-examined Dr. Smith
`three times and filed transcripts of his deposition testimony as Exhibits
`1021, 1031, and 1032.
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`Oral argument was held July 13, 2018, and a transcript was entered in
`the record. Paper 47 (“Tr.”).
`
`B.
`
`Related Matters
`The parties identify the following district court proceeding involving
`the ’574 patent: WaveForm Technologies, Inc. v. Dexcom, Inc., No. 3:16-
`cv-536-MO (D. Or., filed March 28, 2016). Pet. 88; Paper 3 (Patent Owner
`Mandatory Notices—37 C.F.R. § 42.8).
`In addition, Patent Owner identifies the following inter partes review
`proceedings involving Dexcom, Inc. as Petitioner and WaveForm
`Technologies, Inc. as Patent Owner: IPR2016-01679, involving U.S. Patent
`No. 7,146,202 B2, and IPR2016-01680, involving U.S. Patent No.
`8,187,433 B2. Paper 3, 2.
`
`C.
`
`The ’574 Patent (Ex. 1001)
`The ’574 patent was issued May 5, 2009 from Application No.
`10/640,980, filed August 14, 2003. Ex. 1001, [45], [21], [22].
`The ’574 patent relates to an indwelling analyte sensor, for example, a
`glucose sensor. Ex. 1001, 1:18–19. According to the ’574 patent, the
`problem addressed is that of producing a dip coating of curable viscous
`material to form, e.g., a glucose oxidase enzyme layer, over an
`electrochemically active surface, where the coating has a thickness sufficient
`to produce an adequate response to the presence of glucose. Id. at 1:6–14,
`2:8–10. The solution described by the ’574 patent is to provide at least one
`nub of dielectric material that extends outwardly from the electrochemically
`active surface to allow a greater portion of curable viscous liquid to adhere
`to the electrochemically active surface and provide a supportive structure for
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`the curable liquid before and during the curing and for the resulting
`membrane system. Id. at 1:22–25, 1:29–34, 2:6–10.
`An embodiment is shown in Figures 1 and 2, which are reproduced
`below:
`
`
`
`Figure 1 of the ’574 patent shows a work piece formed as part of the
`construction of a biosensor, and Figure 2 shows a sensor constructed from
`the work piece of Figure 1. Ex. 1001, 1:43–47.
`As shown in Figure 2, analyte (typically glucose) sensor 10, includes
`platinum wire 12, polyimide layer 14, silver wire 16 wrapped about a
`portion of layer 14, and stainless steel retractor lead 18. Id. at 1:53–56.
`Referring to the structures shown in Figures 1 and 2, the ’574 patent
`provides the following disclosure regarding construction of a biosensor:
`Three cavities 20, each 2 mm long, are formed by laser
`ablating polyimide layer 14 to form a work piece 8 (FIG. 1).
`The polyimide between the cavities 20, forms a set of annular
`plates 22, that are supported by the adherence of the polyimide
`14 onto wire 12. In an embodiment, nubs, such as annular
`plates 22, may be spaced longitudinally from the active surface
`of wire 12. After the laser machining operation, the work piece
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`is ready to be dip coated with the material 24 that permits it to
`detect glucose. Typically, material 24 is comprised of a set of
`layers that are constructed through a sequence of dip coating
`operations interspersed with curing operations. These layers
`typically include an interferent excluding layer, a glucose
`oxidase layer and a permselective layer as described in U.S.
`Pat. No. 5,165,407, which is hereby incorporated by reference
`as if fully set forth herein. The surface of each viscous fluid
`tends to form a shape somewhat like a catenary curve between
`plates 22.
`Ex. 1001, 1:57–2:6.
`According to the ’574 patent, plates 22 allow a greater portion of
`viscous fluid to adhere to the electrochemically active surface than would
`adhere without plates 22. Id. at 2:6–8.
`
`D.
`
`Illustrative Claims
`The ’574 patent issued with 19 claims, of which claims 1 and 9 are
`independent. All 19 claims are challenged in the Petition. Claims 1 and 9
`are illustrative of the challenged claims and are reproduced below with
`bracketed numerals added to correspond with Petitioner’s identification of
`the First, Second, Third, and Fourth elements of each claim:
`1.
`An indwelling analyte sensor, comprising:
`[1]
`an electrochemically active surface;
`[2]
`at least two nubs of dielectric material extending
`outwardly from said electrochemically active surface and [3]
`forming a cavity along said electrochemically active surface
`and between said at least two nubs; and
`[4]
`a membrane system comprising an enzyme layer,
`said enzyme layer surrounding said at least two nubs and said
`electrochemically active surface at least along said cavity.
`Ex. 1001, 2:20–29.
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`An indwelling analyte sensor, comprising:
`9.
`an electrochemically active surface defining a
`[1]
`sensing region along a portion of said electrochemically active
`surface;
`a plurality of nubs of dielectric material extending
`[2]
`outwardly from said electrochemically active surface, [3] said
`plurality of nubs spaced along said electrochemically active
`surface; and
`[4]
`a membrane system comprising an enzyme layer,
`said enzyme layer surrounding said sensing region of said
`electrochemically active surface to form an active sensing
`region and surrounding said plurality of nubs.
`Id. at 2:46–57.
`In its Contingent Motion to Amend, Patent Owner proposes to
`substitute claims 20–29 for claims 9–19 of the ’574 patent. Mot. 1, 4–6.
`Claim 20 is illustrative of the proposed substitute claims and is reproduced
`below from Patent Owner’s claim listing:
`An indwelling analyte sensor, comprising:
`an electrochemically active surface defining a sensing
`region along a portion of said electrochemically active surface;
`a plurality of nubs of dielectric material extending
`outwardly from said electrochemically active surface, said
`plurality of nubs spaced along said electrochemically active
`surface; and
`a membrane system comprising an enzyme layer, a
`permselective layer and an interferent excluding layer, said
`enzyme layer surrounding said sensing region of said
`electrochemically active surface to form an active sensing
`region and surrounding said plurality of nubs, wherein the
`enzyme is glucose oxidase, thereby forming an indwelling
`analyte sensor for detecting glucose.
`Mot. 4.1
`
`1 Additions to issued claim 9 are underlined.
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`E.
`
`Petitioner’s References
`Petitioner’s patentability challenges are based on the following
`references:
`Wilson et al., US 5,165,407, issued November 24, 1992, Ex. 1003
`(“Wilson”);
`Hagiwara, JP S57-110236, published July 9, 1982, Ex. 1005
`(“Hagiwara”);2
`Michael R. Ryan et al., Biosensor for Neurotransmitter L-Glutamic
`Acid Designed for Efficient Use of L-Glutamate Oxidase and Effective
`Rejection of Interference, ANALYST, 122, 1419–1424 (1997), Ex. 1008
`(“Ryan”);
`Say et al., US 6,175,752 B1, issued January 16, 2001, Ex. 1022
`(“Say”); and
`Richard F. Taylor and Jerome S. Schultz, eds., Handbook of Chemical
`and Biological Sensors, Institute of Physics Publishing (1996), Ex. 1024
`(“Handbook”).
`Wilson, Hagiwara, Ryan, Say, and the Handbook are each asserted as
`prior art under 35 U.S.C. § 102(b). Pet. 8–9; Pet. Opp. 7 n.7.
`
`F.
`
`Asserted Grounds of Unpatentability
`The Petition asserts five grounds of unpatentability. Pet. 9. Initially,
`we instituted inter partes review based on only the following ground:
`whether claims 1–19 of the ’574 patent are unpatentable under 35 U.S.C.
`§ 103(a) as obvious in view of Hagiwara. Dec. 32. Subsequently
`
`
`2 Exhibit 1005 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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`(Paper 30), we instituted inter partes review of the remaining grounds,
`which are based on Wilson, either under 35 U.S.C. § 102(b) or under
`35 U.S.C. § 103(a) in view of Hagiwara and/or Ryan (hereinafter, the
`“Wilson-Based Grounds”). Pet. 9.
`In its Response to the Motion to Amend, Petitioner asserts that
`proposed substitute claims 20 and 22–29 are unpatentable under 35 U.S.C.
`§ 103(a) as obvious in view of Hagiwara, either alone or in view of the
`Handbook, Wilson, or Say. Pet. Opp. 7–24. Petitioner also asserts that
`proposed substitute claim 26 is unpatentable under 35 U.S.C. § 112, first
`paragraph. Id. at 7, 24–25.
`
`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. Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292,
`1298 (Fed. Cir. 2015). “[G]iving claims their broadest reasonable
`interpretation . . . does not include giving claims a legally incorrect
`interpretation.” Id. (citation omitted). “Even under the broadest reasonable
`interpretation, the Board’s construction ‘cannot be divorced from the
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`specification and the record evidence,’” and “[t]he PTO should also 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”).
`In the Institution Decision, we provided express constructions for the
`terms, “nubs,” “surrounding said at least two nubs,” and “surrounding said
`plurality of nubs.” Dec. 7–11. Neither party challenges those constructions
`(see PO Resp. 12–13), which we adopt for purposes of this decision. For
`completeness, we repeat our discussion of those terms below. We also
`discuss the term, “plate,” which appears in both the issued and proposed
`substitute claims, and the term, “permselective,” which appears in proposed
`substitute claim 20.
`
`“nubs” (claims 1 and 9)
`1.
`Petitioner contends that the term, “nubs,” should be construed as
`“protruding structures” and that this term includes the proximal and distal
`dielectric portions 14 shown in Figures 1 and 2 of the ’574 patent. Pet. 12.
`Patent Owner agrees with Petitioner’s proposed construction. Prelim.
`Resp. 15.
`We adopt the parties’ agreed construction. That construction is
`consistent with and supported by claims 1 and 9, which recite that nubs of
`dielectric material extend outwardly from the electrochemically active
`surface. Ex. 1001, 2:22–23, 2:50–51.
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`
`The parties’ agreed construction is also supported by Figures 1 and 2
`of the ’574 patent, which show areas adjacent to cavities 20 where polyimide
`layer 14 has not been removed and protrudes from the surface of wire 12.
`Id. at 1:57–61, Figs. 1 and 2. The ’574 patent discloses: “[t]he polyimide
`between the cavities 20[] forms a set of annular plates 22 . . .” (id. at 1:59–
`60) and “[i]n an embodiment, nubs, such as annular plates 22, may be
`spaced longitudinally from the active surface of wire 12” (id. at 1:61–63).3
`These disclosures demonstrate that the term “nubs” includes, but is not
`limited to, annular plates 22. In re Am. Acad. Of Sci. Tech Ctr., 367 F.3d
`1359, 1369 (Fed. Cir. 2004) (“We have cautioned against reading limitations
`into a claim from the preferred embodiment described in the specification,
`even if it is the only embodiment described, absent clear disclaimer in the
`specification.”). That conclusion is reinforced by dependent claims 2 and 3,
`which depend from claim 1 and recite nubs in the form of a plate or an
`annular plate. Id. at 2:30–33; see also 3:1–4 (claims 13 and 14 depend from
`claim 9 and recite nubs in the form of a plate or an annular plate).
`The parties note that their agreed construction is the same as that
`proposed by Patent Owner and adopted by the District Court in the related
`litigation. Pet. 11; Prelim. Resp. 15; Ex. 1007, 3. We are not bound by the
`construction given a term by the District Court because the District Court
`applies a different claim construction standard than we are required to apply.
`
`
`3 This sentence was added by amendment to the Specification during
`prosecution (Ex. 1004, 119); however, neither party contends that it
`constitutes new matter that should not be relied upon to construe the
`meaning of “nubs.” See Schering Corp. v. Amgen Inc., 222 F.3d 1347, 1353
`(Fed. Cir. 2000) (the court must determine what the claim term meant at the
`time the patentee filed the application).
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`Power Integrations, Inc. v. Lee, 797 F.3d 1318, 1326 (Fed. Cir. 2015).
`When such a claim construction is made of record, however, we must
`acknowledge it and “assess whether it is consistent with the broadest
`reasonable construction of the term” being construed. Id. Here, for the
`reasons discussed above, we determine that the District Court’s construction
`is consistent with the broadest reasonable construction for “nubs.”
`Accordingly, consistent with the parties’ agreement, we construe the
`term, “nubs,” to mean “protruding structures.”
`
`2.
`
`“surrounding said at least two nubs” (claim 1)
`“surrounding said plurality of nubs” (claim 9)
`Petitioner contends that the phrase, “surrounding said at least two
`nubs . . . at least along said cavity” should be interpreted to mean “encircle
`at least a portion of the nubs (e.g., as the enzyme layer cross-sectionally
`encircles the end cap and proximal insulation portions depicted in Fig. 2 of
`the ’574 patent).” Pet. 13–14.
`Patent Owner agrees with Petitioner that, in the context of the ’574
`patent, the term, “surrounding,” should be construed to mean “encircling.”
`Prelim. Resp. 16. Patent Owner proposes that the phrase, “surrounding said
`at least two nubs and said electrochemically active surface at least along said
`cavity” should be construed to mean: “encircling said at least two nubs and
`said electrochemically active surface at least along said cavity.” Id. at 16–
`17.
`
`Neither party explicitly addresses the meaning of the phrase,
`“surrounding said plurality of nubs,” in claim 9. This phrase is similar to
`claim 1’s recitation, “surrounding said at least two nubs.” Unlike claim 1,
`however, claim 9 does not recite the phrase, “at least along said cavity.” In
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`the context of claim 1, we are not persuaded that the phrase, “at least along
`said cavity,” modifies the phrase, “surrounding said at least two nubs.” We
`therefore construe only the word “surrounding,” as used in the phrases of
`claims 1 and 9 set forth in the heading above.
`We adopt the parties’ agreement that the term “surrounding” means
`“encircling.” The parties’ agreed construction is supported by Figure 2 of
`the ’574 patent, which shows what appears to be a partial cross-section along
`a plane through the central axis of sensor 10, with material 24 encircling the
`portion of the sensor to the left of silver wire 16, including polyimide layer
`14 and annular plates 22.
`The parties’ agreed construction is further supported by the
`prosecution history, where Applicants stated:
`In a general sense, the term “surround” is intended to mean that
`the membrane provides a covering/coating encircling the stated
`underlying element(s). When considering the scope of the
`term, reference to Figure 2 shows that the membrane system
`does not simply cover or abut an end of the device, but rather
`encircles the active surface and the nub(s).
`Ex. 1004, 25–26.
`Patent Owner objects to the phrase, “at least a portion of,” in
`Petitioner’s proposed construction. Pet. 14; Prelim. Resp. 17 n.5. Petitioner
`relies on Patent Owner’s district court claim construction brief as support for
`this portion of its proposed construction. Pet. 12–13. According to Patent
`Owner’s district court brief, Figure 2 of the ’574 patent shows a portion of
`polyimide layer 14 beneath silver wire coil 16 and not surrounded by
`membrane 24. Id. Petitioner does not, however, show that the portion of
`polyimide layer 14 beneath silver wire coil 16 is a “nub.” Therefore, we are
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`not persuaded that the intrinsic evidence supports the phrase, “at least a
`portion of,” in Petitioner’s proposed construction.
`Patent Owner also objects to Petitioner’s proposed parenthetical
`language, “(e.g., as the enzyme layer cross-sectionally encircles the end cap
`and proximal insulation portions depicted in Fig. 2 of the ’574 patent).” Pet.
`14; Prelim. Resp. 17 n.5. Petitioner’s proposed parenthetical provides an
`example of the meaning of the claim term with reference to the embodiment
`shown Figure 2 of the ’574 patent. This example is not necessary to define
`the claim term, and we therefore decline to adopt it as part of the claim
`construction.
`Accordingly, consistent with the parties’ agreement, we construe the
`term, “surrounding,” to mean “encircling.”
`
`“plate” (claims 2, 3, 13, and 14)
`3.
`Claim 2 depends from claim 1 and recites: “wherein at least one of
`said at least two nubs is in the form of a plate.” Ex. 1001, 2:30–31. Claim 3
`likewise depends from claim 1 and recites: “wherein at least one of said at
`least two nubs comprises an annular plate.” Id. at 2:32–33. Dependent
`claims 13 and 14 depend from claim 9 and contain the same recitation as
`claims 2 and 3, respectively. Id. at 3:1–4.
`Petitioner contends that “[a] plate in the context of the ’574 patent is a
`portion of material emanating from a center point.” Pet. 52. Patent Owner
`contends that “plate” should be construed as “a disc-shaped nub.” PO Resp.
`13. The parties agree that “annular” means “ring-shaped” (Pet. 53) or in
`“the form of a ring” (PO Resp. 13).
`We adopt Patent Owner’s proposed construction for the term “plate.”
`That construction—“a disc-shaped nub”—is supported by the Specification
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`and claims of the’574 patent. Independent claims 1 and 9 each recites:
`“nubs of dielectric material extending outwardly from said electrochemically
`active surface.” Ex. 1001, 2:22–23, 2:50–51. Claims 2 and 13 depend from
`claims 1 and 9, respectively, and each recites: “at least one of said at least
`two nubs is in the form of a plate.” Id. at 2:30–31, 3:1–2. The term “plate”
`must be construed as having a narrower meaning than the term “nub”
`because otherwise claims 2 and 13 would not further limit claims 1 and 9, as
`required by statute. 35 U.S.C. § 112, fourth paragraph. The Specification
`describes an “annular plate” as an example of a “nub” (Ex. 1001, 1:61–62),
`thus reinforcing that “plate” has a narrower meaning than “nub.” Petitioner
`agrees that “plate” has a narrower meaning than “nub.” Tr. 7:4–7. Our
`construction is supported by Figures 1 and 2, which show side views of
`annular plates 22, which appear to be disc-shaped objects surrounding wire
`12. Id. at Figs. 1, 2; see also id. at 1:43–47 (brief description of the
`drawings). Our construction is further supported by the description of
`annular plates 22 as being formed between cavities 20 by laser-ablating
`polyimide layer 14 on either side of each plate. Id. at 1:57–61.
`Petitioner does not contest Patent Owner’s assertion that a “plate” is a
`“flat, disc-shaped object.” Compare PO Resp. 13, with Pet. Reply 30; see
`also Tr. 7:8–24. We reject Petitioner’s contention that a “plate” is “a portion
`of material emanating from a center point.” Pet. 52. Petitioner’s definition
`would require a spherical shape, which is not supported by the Specification
`or drawings of the ’574 patent. Even if Petitioner’s construction does not
`require a spherical shape, it would blur the distinction between a “nub” and a
`“plate.”
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`Accordingly, we adopt Patent Owner’s proposed construction and
`construe a “plate” as a “disc-shaped nub.”
`
`“permselective layer” (proposed substitute claim 20)
`4.
`Petitioner contends that “permselective layer” should be construed as
`“a layer that is ‘selectively permeable to certain molecules or ions.’” Pet.
`Opp. 5 (quoting Ex. 1020, a dictionary definition for “permselective”).
`Patent Owner contends that “permselective membrane” means “a
`membrane that regulates the passage of different molecules at different
`rates.” PO Reply 5 (citing Ex. 2008 ¶ 74).4 Patent Owner relies on
`Dr. Smith’s testimony that “a ‘permselective layer’ serves to slow glucose
`diffusion (without significantly slowing oxygen diffusion) sufficient to
`ensure that the glucose and oxygen are in proper balance.” Ex. 2008 ¶ 74.
`Patent Owner’s proposed construction is not, however, limited to a layer that
`regulates diffusion of glucose and oxygen.
`Based on the record before us and for the reasons explained below, we
`construe “permselective layer” as “a layer that regulates the passage of
`different molecules or ions at different rates.” Our construction is similar to
`Patent Owner’s proposed construction, with the addition of “ions” as species
`whose passage can be regulated.
`Our construction is supported by the intrinsic evidence, including the
`Specification of the ’574 patent (Ex. 1001) and Wilson (Ex. 1003), which is
`incorporated by reference in the ’574 patent.
`
`
`4 The term recited in proposed substitute claim 20 is “permselective layer,”
`not “permselective membrane.” We view Patent Owner’s proposed
`construction as applying equally to the term recited in the claim.
`
`16
`
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`IPR2017-01051
`Patent 7,529,574 B2
`
`
`The ’574 patent discloses that, to form a glucose sensor, a work piece
`is coated with “a set of layers,” which “typically include an interferent
`excluding layer, a glucose oxidase layer and a permselective layer.”
`Ex. 1001, 1:52–53, 1:63–2:4. For details regarding these layers, the ’574
`patent refers to Wilson, which is incorporated by reference in the ’574
`patent. Id. at 2:1–4. The layers listed in the ’574 patent—(1) an interferent
`excluding layer, (2) a glucose oxidase layer, and (3) a permselective layer—
`correspond one-to-one with Wilson’s disclosure of: (1) an inner membrane
`made of, e.g., cellulose acetate or Nafion (Ex. 1003, 2:66–3:2, 3:26–30,
`5:34–36, 5:58–61, 6:5–7, 6:22–25, 6:36–38, 7:43–44, 8:41–42); (2) a
`glucose oxidase (GOx) enzyme layer (id. at 2:66–3:2, 5:36–38, 5:61–65,
`6:7–15, 6:34–35, 7:44–45, 8:42–43); and (3) an outer membrane made of
`polyurethane (id. at 3:3–14, 6:64–7:12, 7:45–46, 8:45–47). Petitioner argues
`that each of Wilson’s three layers is a permselective membrane. Pet. Opp. 4.
`We disagree. In view of the one-to-one correspondence of the layers, as
`outlined above, and Wilson’s characterization of the polyurethane layer, as
`discussed below, we agree with Patent Owner (PO Reply 6) that the
`“permselective layer” in the ’574 patent corresponds to Wilson’s outer
`polyurethane layer.
`Wilson’s description of an outer polyurethane layer supports our
`construction for “permselective layer.” According to Wilson, the
`polyurethane layer “provides a diffusional barrier for glucose which slows
`down the flow of glucose and creates a linear sensor response over the
`concentration ranges of interest.” Ex. 1003, 3:11–14. In addition, Wilson
`states that this membrane “regulate[s] the passage of molecules therethrough
`to an extent that the enzymatic reaction between the indicating surface and
`
`17
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`IPR2017-01051
`Patent 7,529,574 B2
`
`these molecules is determined by the rate of diffusion through the
`membrane, and not the enzymatic reaction kinetics.” Id. at 3:17–22. These
`descriptions support our construction, which defines a “permselective layer”
`as “a layer that regulates the passage of different molecules or ions at
`different rates.”
`Our construction is also supported by extrinsic evidence, namely the
`Handbook (Ex. 1024), which Petitioner relies upon as a prior art reference
`and both parties rely upon as support for their respective constructions. PO
`Reply 8; Pet. Sur-Reply 2. The Handbook states:
`Permselectivity is the ability of a membrane to allow a high
`flux of one chemical species (typically the analyte) while
`reducing or eliminating the flux of other species (chemical or
`sensor interferences).
`Ex. 1024, 356.
`The Handbook provides an “extreme example” of a permselective
`membrane, where the rate of diffusion of specific ions through the
`membrane is “vanishingly small.” Id. In contrast to this “extreme
`example,” the Handbook states that “[m]ore commonly, permselective
`membranes create a differential in the transport rate of different species.”
`Id. The Handbook’s definition and description of permselectivity
`demonstrates that a “permselective layer” is a layer that regulates the
`passage of different chemical species at different rates, i.e., high flux versus
`low or no flux. Id. The Handbook’s description also demonstrates that a
`permselective layer may regulate the passage of various chemical species,
`including both molecules and ions. Id.
`Our construction is also supported by the undisputed testimony of
`Dr. Smith that a “permselective layer” in the ’574 patent “refers to a
`
`18
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`IPR2017-01051
`Patent 7,529,574 B2
`
`membrane that regulates the passage of different molecules at different rates,
`and in the preferred embodiment, the two molecules are oxygen and
`glucose.” Ex. 2024 ¶ 11.
`Both Wilson’s description of an outer polyurethane layer and the
`Handbook’s description of permselectivity demonstrate that Petitioner’s
`proposed construction is inaccurate or incomplete to the extent that it omits
`any requirement that a “permselective layer” regulate the passage of
`different molecules or ions at different rates. Ex. 1003, 3:11–14, 3:17–22;
`Ex. 1024, 356.
`Accordingly, we construe “permselective layer” as “a layer that
`regulates the passage of different molecules or ions at different rates.”
`
`B.
`
`Principles of Law
`Regarding the issued claims of the ’574 patent, all of which are
`challenged in the Petition, Petitioner bears the burden of proving
`unpatentability, 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).
`Regarding the proposed substitute claims presented in Patent Owner’s
`Contingent Motion to Amend, Patent Owner does not bear the burden of
`persuasion to demonstrate the patentability of the substitute claims. Aqua
`Products, Inc. v. Matal, 872 F.3d 1290 (Fed. Cir. 2017) (en banc). Rather,
`as a result of the current state of the law and USPTO rules and guidance,5
`
`5 See Aqua Products, 872 F.3d 1290; Memorandum “Guidance on Motions
`to Amend in view of Aqua Products” (Nov. 21, 2017)
`19
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`IPR2017-01051
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`
`the burden of persuasion lies with Petitioner to show that the proposed
`substitute claims are unpatentable by a preponderance of the evidence.
`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
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