Trials@uspto.gov
`571-272-7822
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`Paper No. 7
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`DEXCOM, INC.
`Petitioner,
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`v.
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`AGAMATRIX, INC.
`Patent Owner
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`IPR2016-01679
`Patent 7,146,202
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`Before Steven M. Amitrani, Trial Paralegal
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`PATENT OWNER’S PRELIMINARY RESPONSE
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`

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`Patent Owner’s Preliminary Response
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`Table of Contents
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`IPR2016-01679
`Patent No. 7,146,202
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`Page
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`I.
`
`
`II.
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`
`INTRODUCTION AND SUMMARY OF ARGUMENT ................... 1
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`STATEMENT OF FACTS .................................................................... 3
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`A. Overview of AgaMatrix’s ’202 Patent ........................................ 3
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`B.
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`C.
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`The Challenged Claims of the ’202 Patent ................................. 6
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`The Prior Art Relied Upon in the Petition .................................. 8
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`1.
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`Hagiwara ........................................................................... 8
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`2. Wilson ............................................................................... 8
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`3.
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`4.
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`Gross ................................................................................. 9
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`Rosenblatt .......................................................................10
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` CLAIM CONSTRUCTION ................................................................10 III.
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`A.
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`B.
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`C.
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`Claim Construction Standard in Inter Partes Review ..............10
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`Person of Ordinary Skill in the Art ...........................................12
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`“Structurally Flexible” ..............................................................12
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`
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` STANDARD FOR GRANTING INTER PARTES REVIEW ............16 IV.
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` DEXCOM’S GROUNDS BASED UPON ANTICIPATION V.
`SHOULD BE DENIED .......................................................................16
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`A.
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`B.
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`The Petition Includes Redundant Grounds ...............................16
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`The Petition Fails to Establish a Reasonable Likelihood
`That Hagiwara Anticipates the Claims of the ’202 Patent .......17
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`1.
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`2.
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`Overview of Hagiwara ....................................................17
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`Hagiwara does not anticipate because it fails to
`disclose a “structurally flexible core” .............................20
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`-i-
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`Patent Owner’s Preliminary Response
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`3.
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`
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`IPR2016-01679
`Patent 7,146,202
`Hagiwara does not anticipate because it fails to
`disclose a “layer of electrochemically active metal
`surrounding, covering and in contact with said
`outer surface of said core” ..............................................23
`
`C.
`
`The Petition Fails to Establish a Reasonable Likelihood
`of Anticipation by Gross At Least Because Gross Lacks a
`Structurally Flexible Core .........................................................27
`
`
` DEXCOM’S GROUNDS BASED UPON OBVIOUSNESS VI.
`SHOULD BE DENIED .......................................................................33
`
`A.
`
`B.
`
`C.
`
`The Petition Includes Redundant Grounds ...............................33
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`The Petition Fails to Identify the Level of Ordinary Skill
`in the Art ..................................................................................34
`
`The Petition Fails to Establish a Reasonable Likelihood
`that Claim 5 is Obvious over Hagiwara in View of
`Rosenblatt ..................................................................................35
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`1.
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`2.
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`3.
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`Overview of Rosenblatt ..................................................36
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`Hagiwara and Rosenblatt do not combine to
`produce the invention of claim 5. ...................................37
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`Rosenblatt’s teaching away from “an
`electrochemically active metal . . . contacting said
`[tantalum] core” defeats Dexcom’s Hagiwara-
`Rosenblatt combination. .................................................41
`
`D.
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`The Wilson–Rosenblatt Combination Also Fails to Show
`a Reasonable Likelihood of Obviousness .................................43
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` 1.
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`Overview of the Wilson article .......................................44
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` 2. Wilson does not disclose a sensing region .....................45
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`3. Wilson-Rosenblatt fail to teach or suggest the
`element of “contact” between the
`electrochemically active metal and a core material ........46
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`-ii-
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`Patent Owner’s Preliminary Response
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`E.
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`IPR2016-01679
`Patent 7,146,202
`The Petition Fails to Provide Particularized Rationales
`for Why The Person of Ordinary Skill Would Have Been
`Motivated to Modify the Prior Art to Achieve the
`Claimed Invention .....................................................................46
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`1.
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`2.
`
`3.
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`Obviousness Factors .......................................................46
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`The Petition Fails to Articulate a Credible
`Rationale for Making the Wilson-Rosenblatt
`Combination ...................................................................48
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`The Petition Fails to Articulate a Credible
`Rationale for the Hagiwara-Rosenblatt
`Combination ...................................................................52
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`F.
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`Tertiary References Not of Record Must Not Be
`Considered in the Obviousness Analysis ..................................54
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`
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` CONCLUSION ...................................................................................55 VII.
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`-iii-
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`Patent Owner’s Preliminary Response
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`
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`TABLE OF AUTHORITIES
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`IPR2016-01679
`Patent 7,146,202
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` Page(s)
`
`Cases
`Akzo Nobel Coatings, Inc. v. Dow Chemical Co.,
`811 F.3d 1334 (Fed. Cir. 2016) .......................................................................... 15
`
`Bettcher Indus. v. Bunzl USA, Inc.,
`661 F.3d 629 (Fed. Cir. 2011) ...................................................................... 22, 32
`
`Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
`246 F.3d 1368 (Fed. Cir. 2001) .......................................................................... 24
`
`Cuozzo Speed Techs., LLC v. Lee,
`579 U.S. ___, 136 S. Ct. 2131 (June 20, 2016) ............................................ 10, 11
`
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) .......................................................................... 42
`
`Eon Corp. IP Holdings LLC v. Silver Spring Networks, Inc.,
`815 F.3d 1314 (Fed. Cir. 2016) .......................................................................... 11
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ...................................................................................... 2, 34, 47
`
`In re Gurley,
`27 F.3d 551 (Fed. Cir. 1994) .............................................................................. 43
`
`In re ICON Health & Fitness, Inc.,
`496 F.3d 1374 (Fed. Cir. 2007) .................................................................... 42, 43
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) ............................................................................ 47
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 47
`
`Liberty Mutual Ins. Co. v. Progressive Casualty Ins. Co.,
`CBM2012–00003, Paper No. 7 (P.T.A.B. Oct. 25, 2012) ............................ 17, 34
`
`Motorola Mobility, LLC v. ITC,
`737 F.3d 1345 (Fed. Cir. 2013) .......................................................................... 22
`
`-iv-
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`Patent Owner’s Preliminary Response
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`IPR2016-01679
`Patent 7,146,202
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`Net Moneyin, Inc. v. Verisign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) .......................................................................... 25
`
`In re Oetiker,
`977 F.2d 1443 (Fed. Cir. 1992) .......................................................................... 51
`
`Oracle Corp. v. Clouding IP, LLC,
`IPR2013–00088, Paper No. 13 (P.T.A.B. June 13, 2013) .................................. 34
`
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) .................................................................... 47, 48
`
`PPC Broadband v. Corning Optical Comms. RF, LLC,
`815 F.3d 734 (Fed. Cir. 2016) ............................................................................ 11
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .......................................................................... 11
`
`R.R. Street & Co., Inc. v. Chemische Fabrik Kreussler & Co., GmbH,
`IPR2015-00289, Paper No. 9 (P.T.A.B. May 26, 2015) .................................... 55
`
`SAS Institute v. ComplementSoft, LLC,
`825 F.3d 1341 (Fed. Cir. 2016) .................................................................... 11, 16
`
`Trs. of Columbia Univ. v. Symantec Corp.,
`811 F.3d 1359 (Fed. Cir. 2016) .......................................................................... 12
`
`UltimatePointer, LLC v. Nintendo Co., Ltd.,
`816 F.3d 816 (Fed. Cir. 2016) ............................................................................ 21
`
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) .......................................................................... 47
`
`United States v. Adams,
`383 U.S. 39 (1966) ........................................................................................ 42, 43
`
`ZTE (USA) Inc. et al. v. Electronics and Telecomm. Research Inst.,
`IPR2015-00029, 2015 Pat. App. LEXIS 2544, Paper No. 12
`(P.T.A.B. Mar. 20, 2015) .............................................................................. 35, 48
`
`Statutes
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`35 U.S.C. § 314(a) ................................................................................................... 16
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`-v-
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`Patent Owner’s Preliminary Response
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`Other Authorities
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`IPR2016-01679
`Patent 7,146,202
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`37 C.F.R. 42.104(b) ................................................................................................. 54
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`37 C.F.R. § 42.6(a)(3) ........................................................................................ 35, 48
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`37 C.F.R. § 42.100(b) .............................................................................................. 10
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`37 C.F.R. § 42.108(c) ............................................................................................... 16
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`M.P.E.P. § 2112(IV) ................................................................................................ 22
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`Office Patent Trial Practice Guide, 77 Fed. Reg. 157 (Aug. 14, 2012)................... 16
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`-vi-
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`Patent Owner’s Preliminary Response
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`IPR2016-01679
`Patent No. 7,146,202
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`I.
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`INTRODUCTION AND SUMMARY OF ARGUMENT
`This case involves an AgaMatrix Patent directed to a method of measuring
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`the concentration of an analyte, such as glucose, within an animal body using an
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`indwelling analyte sensor. These sensors have tiny wires that are inserted into the
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`body for extended periods of time. The sensors convert the analyte concentrations
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`in body fluids into electrical current, which is measured. While inserted, the
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`sensor wires are subjected to repeated flexing resulting from bodily movement.
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`Prior art sensors, typically made from platinum, tended to fracture and break inside
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`the body creating risk to body tissue and sensitive internal organs. AgaMatrix’s
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`inventors solved this problem by inventing a two-layer, structurally flexible sensor
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`wire capable of withstanding repeated flexing without fracturing or breaking inside
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`the wearer’s body.
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`Although Dexcom’s Petition is deficient on several grounds, this
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`Preliminary Response focuses on four issues that are fatal to its assertions.1 First,
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`Dexcom’s overbroad construction of the “structurally flexible” claim term ignores
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`the context provided by the ’202 patent specification, which makes clear that the
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`
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`1 AgaMatrix reserves all rights with respect to arguments not presented in this
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`Preliminary Response.
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`-1-
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`Patent Owner’s Preliminary Response
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`IPR2016-01679
`Patent 7,146,202
`principle problem solved by the ’202 patent was the tendency of prior art platinum
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`
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`wires to fatigue and break inside the body. Thus, Dexcom’s interpretation, which
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`reduces “structurally flexible” to an overbroad dictionary definition of “flexible”
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`fails to reasonably capture the meaning of the term in the context of the patent, and
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`this error carries all the way through its arguments .
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`Second, the anticipation grounds presented by the Petition fail to show a
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`reasonable likelihood of anticipation. The two anticipation grounds are redundant,
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`and the Board should not institute an inter partes review on both. Further, the
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`Hagiwara and Gross references are each missing one or more elements required by
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`the challenged claims. Both references fail to teach a “structurally flexible core,”
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`and Hagiwara further fails to teach at least one additional element of the
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`challenged claims.
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`Third, Dexcom’s obviousness combinations of Hagiwara-Rosenblatt and
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`Wilson-Rosenblatt are redundant, fail to identify the level of skill in the art and fail
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`to present a reasonable likelihood of success because, among other reasons,
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`Rosenblatt teaches away from the claimed invention. Specifically, Rosenblatt
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`disparages contact between a core metal and an electrochemically active metal
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`cladding, as required by each of the challenged patent claims.
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`Fourth, Dexcom’s Petition fails to articulate the rationale required by the
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`Graham factors to support its obviousness argument. The conclusory statements
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`-2-
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`Patent Owner’s Preliminary Response
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`IPR2016-01679
`Patent 7,146,202
`contained in the Petition with respect to these factors are insufficient to establish a
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`
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`reasonable likelihood of success on obviousness grounds.
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`Dexcom cannot overcome these deficiencies. Accordingly, there is no
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`reasonable likelihood that it can prevail, and the Board should deny the Petition
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`with respect to all asserted claims.
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`II.
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`
`STATEMENT OF FACTS
`A. Overview of AgaMatrix’s ’202 Patent
`The ’202 patent, titled “Compound Material Analyte Sensor,” claims priority
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`to a provisional application filed on June 16, 2003. (See ’202 patent (Ex. 1001)2).
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`The ’202 patent is directed to methods for measuring the concentration of an
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`“analyte” within an animal body having body fluids. An analyte is a substance or
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`chemical compound that is undergoing analysis. In a preferred embodiment, the
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`analyte being measured is glucose. (Ex. 1001 at 2:10-15). In another aspect, the
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`’202 patent is directed to methods for continuously monitoring the concentration of
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`an analyte, such as glucose, within a mammalian body over an extended period of
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`time. (Id. at 1:47-52). A portion of the analyte sensor is inserted into the body
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`2 References to exhibits in the “1001” series, e.g., Ex. 1001, Ex. 1002, etc. are to
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`exhibits to Dexcom’s Petition. References to Exhibits in the “2001” series, e.g.,
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`Ex. 2001, Ex. 2002, etc. are exhibits to this Preliminary Response.
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`-3-
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`Patent Owner’s Preliminary Response
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`IPR2016-01679
`Patent 7,146,202
`where it continuously monitors the analyte of interest in bodily fluids for a period
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`
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`of several days. (Id. at 4:32-35).
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`
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`The ’202 patent discloses that the metal typically used for a wire sensor is
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`platinum, which is useful in sensing applications because it is electrochemically
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`active. (Id. at 1:19-21). Unfortunately, while capable of being bent or flexed,
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`platinum “is a weak metal that is easily broken with only a little flexure,” creating
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`a danger to the patient that the “indwelling … cylindrical wire sensor [will] fatigue
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`from the flexure caused by bodily movement and break off inside the body.” (Id.
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`at 1:12-18, 21-23). Efforts to make platinum more flex-resistant by stranding very
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`thin platinum wires together suffered from negative effects on biochemical
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`reactivity due to the more complex platinum surface. (Id. at 1:24-28). The ’202
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`patent further notes that platinum is an expensive metal, though the cost factor is
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`reduced for sensors meant to be worn for multiple days, versus single use sensors.
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`(Id. at 1:29-38).
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`
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`The ’202 inventors solved the problem of sensor wire breakage by
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`developing a more robust, two-layer sensor wire in which a layer of an
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`electrochemically active metal, such as platinum, is plated onto at least a portion of
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`a structurally flexible core, such as tantalum. The ’202 patent describes two
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`naturally flexible metals, tantalum and nitinol, that—though relatively expensive—
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`are especially well-suited for a sensor to be inserted into a patient’s body and worn
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`-4-
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`Patent Owner’s Preliminary Response
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`IPR2016-01679
`Patent 7,146,202
`for a period of days without breaking as a result of repeated flexing from bodily
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`
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`movement. (Id. at 2:33-40).
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`Figure 1 of the ’202 patent, reproduced below, shows a portion of the sensor
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`wire 12 including core 24 and electrochemically active metal layer 26:
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`Figure 1 also shows an enzyme layer 30 that is sandwiched between thin
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`membranes 32 and 34 that may perform various functions to ensure accurate
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`measurement of analyte.
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`The ’202 patent discloses sensor wires that can measure an electrical current
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`corresponding to the quantity of an analyte in body fluid. To measure a substance
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`using such electrochemical techniques, two electrodes (a “working electrode” and
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`-5-
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`Patent Owner’s Preliminary Response
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`IPR2016-01679
`Patent 7,146,202
`a “reference electrode”) must be present in a conductive medium.3 (See Ex. 2001
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`
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`(Declaration of John L. Smith, Ph.D.) at ¶ 21). In operation, an electrical current
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`flows between these electrodes. Id. The “working electrode” has an
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`electrochemically active surface which is where the reaction that leads to
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`measurement of the analyte is carried out; the other electrode is termed the
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`“reference electrode.” Id. Depending upon the analyte to be measured, the
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`working electrode can either be an anode or a cathode. Id. The measured current
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`is then converted into a readable form which is the measurement of analyte
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`concentration. Id.
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`The Challenged Claims of the ’202 Patent
`B.
`Dexcom has challenged one independent claim of the ’202 patent and eight
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`claims depending from that claim. Independent claim 1 is reproduced below:
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`1. A method for measuring the concentration of any analyte within an
`animal body having body fluids, comprising:
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`(a) providing a sensor having:
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`(i) a structurally flexible core having an outer surface; and
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`3 Examples of such media include water with dissolved salts, interstitial fluid, and
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`blood. Interstitial fluid is a fluid similar to blood plasma which surrounds the cells
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`of the body, and through which nutrients such as glucose and oxygen are
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`transported to the cells.
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`-6-
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`Patent Owner’s Preliminary Response
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`IPR2016-01679
`Patent 7,146,202
`(ii) a layer of electrochemically active metal surrounding, covering,
` and in contact with said outer surface of said core;
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`(b) placing at least a portion of said sensor into said animal body; and
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`(c) measuring any electric current produced by said sensor and forming a
`measurement of analyte concentration based on said current measurement.
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`Dependent claim 2 limits the electrochemically active metal of claim 1 to a
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`noble metal.
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`Dependent claim 3 limits the noble metal of claim 2 to at least one of
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`platinum, palladium, and gold.
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`Dependent claim 5 limits the structurally flexible core of claim 1 to
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`tantalum.
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`Dependent claim 6 limits claim 1 by reciting that the electrochemically
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`active metal of claim 1 is adapted to provide at least one sensing surface.
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`Dependent claim 8 limits claim 1 by reciting that at least a portion of the
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`sensor is inserted into the animal body for less than 3 minutes.
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`Dependent claim 9 limits claim 1 by reciting that at least a portion of the
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`sensor is inserted into the animal body for at least 24 hours.
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`Dependent claim 10 limits the analyte of claim 1 to glucose.
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`-7-
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`Patent Owner’s Preliminary Response
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`IPR2016-01679
`Patent 7,146,202
`Dependent claim 11 recites that the core of claim 1 further comprises at least
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`a first end, and wherein said electrochemically active layer further surrounds,
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`covers, and is in contact with said at least a first end of said core.
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`C. The Prior Art Relied Upon in the Petition
`The Petition relies upon four prior art references. These are briefly
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`described below.
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`1.
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`Hagiwara
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`Hagiwara (Ex. 1007) is a Japanese unexamined patent application, titled
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`“Polarography Sensor” and published in 1982. Hagiwara appears to have been
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`written in multiple Japanese character sets and syllabaries such that in original or
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`translated form, it is ambiguous and difficult to read. Hagiwara describes a
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`polarography sensor that can be inserted through blood vessels and into the heart.
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`Structurally, Hagiwara discloses a sensor made of a precious metal with various
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`other membranes, coatings and shells. The Petition asserts that Hagiwara
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`anticipates claims and renders claims obvious in combination with another prior art
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`reference, Rosenblatt.
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`2. Wilson
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`Wilson (Ex. 1004) is an article published in a 1992 edition of Clinical
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`Chemistry, titled “Progress toward the Development of an Implantable Sensor for
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`Glucose.” Wilson discloses a partially implantable glucose sensor wire made of a
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`platinum-iridium alloy. The Wilson sensor lacks a core metal having an
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`-8-
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`IPR2016-01679
`Patent 7,146,202
`electrochemically active metal cladding. A 1992 patent to Wilson, U.S. Patent
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`
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`No. 5,165,407 (Ex. 2002), with a more detailed description of the Wilson sensor,
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`was cited and considered by the Examiner during prosecution of the ’202 patent.
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`The Petition asserts that Wilson renders claims of the ’202 patent obvious in
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`combination with Rosenblatt.
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`3.
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`Gross
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`Gross (Ex. 1003) is U.S. Patent No. 6,275,717, titled “Device and Method of
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`Calibrating and Testing a Sensor for In Vivo Measurement of an Analyte,” and
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`issued in 2001. Gross discloses a short and rigid “sensor needle” configured like a
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`thumbtack that is pressed into the skin:
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`
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`Specifically, Gross discloses pressing the needle against the skin of a subject
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`so that the sensor needle penetrates the skin of the subject and enters the
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`subcutaneous region. The Gross needle is made of an undisclosed type of stainless
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`-9-
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`IPR2016-01679
`Patent 7,146,202
`steel, and there is no indication that it has any flexibility. The Petition asserts that
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`
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`Gross anticipates claims of the ’202 patent.
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`4.
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`Rosenblatt
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`Rosenblatt (Ex. 1005) is U.S. Patent No. 2,719,797, titled “Platinizing
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`Tantalum” and issued in 1955. Rosenblatt discloses making electrodes used for
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`production of chemicals like chlorine and percompounds. Rosenblatt teaches away
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`from plating platinum directly on tantalum, and favors a process that produces
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`three metal layers: a tantalum core covered by an intermediate alloy layer that, in
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`turn, is covered by platinum. As mentioned, Rosenblatt is cited as a secondary
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`reference for obviousness in combination with Hagiwara and Wilson.
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`III.
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`CLAIM CONSTRUCTION
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`A. Claim Construction Standard in Inter Partes Review
`The Board interprets claim terms according to the broadest reasonable
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`interpretation in light of the specification of the patent in which they appear.
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`37 C.F.R. § 42.100(b); see also Cuozzo Speed Techs., LLC v. Lee, 579 U.S. ___,
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`136 S. Ct. 2131, 2136 (June 20, 2016). Importantly, the Board must “take care to
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`not read ‘reasonable’ out of the standard. This is to say that even under the
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`broadest reasonable interpretation, the Board’s construction cannot be divorced
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`from the specification and the record evidence, and must be consistent with the one
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`-10-
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`IPR2016-01679
`Patent 7,146,202
`that those skilled in the art would reach.” SAS Institute v. ComplementSoft, LLC,
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`
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`825 F.3d 1341, 1348 (Fed. Cir. June 10, 2016)(internal quote marks omitted).4
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`To avoid an unreasonable interpretation in an inter partes review, the
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`Federal Circuit follows the claim construction procedure identified in Phillips v.
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`AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). SAS Inst., 825 F.3d. at
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`1348 (quoting Phillips).
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`The Federal Circuit recently has reiterated that “[t]he only meaning that
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`matters in claim construction is the meaning in the context of the patent.” Eon
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`Corp. IP Holdings LLC v. Silver Spring Networks, Inc., 815 F.3d 1314, 1321 (Fed.
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`Cir. 2016) (quoting Trs. of Columbia Univ. v. Symantec Corp., 811 F.3d 1359,
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`1363 (Fed. Cir. 2016)). This is because “[t]he ordinary meaning of a claim term is
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`not the meaning of the term in the abstract. Instead, the ordinary meaning of a
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`4 Patent Owner expressly reserves the right to argue a different claim construction
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`in litigation for any term of the ’202 patent because the standard for claim
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`construction used during U.S. District Court litigation is different than that used
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`during an inter partes review proceeding. See Cuozzo, 136 S. Ct. at 2142; PPC
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`Broadband v. Corning Optical Comms. RF, LLC, 815 F.3d 734, 742 (Fed. Cir.
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`2016).
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`Patent Owner’s Preliminary Response
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`IPR2016-01679
`Patent 7,146,202
`claim term is its meaning to the ordinary artisan after reading the entire patent.”
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`
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`Id. at 1321 (quoting Phillips, 415 F.3d at 1321) (quotes and citation omitted).
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`Person of Ordinary Skill in the Art
`B.
`In determining that level of skill in the art, the following six factors are to be
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`considered: (1) the educational level of the inventor; (2) type of problems
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`encountered in the art; (3) prior art solutions to those problems; (4) rapidity with
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`which innovations are made; (5) sophistication of the technology; and
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`(6) educational level of active workers in the field.
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`Considering all of the relevant factors, a person of ordinary skill in the art of
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`indwelling analyte sensing devices would have at least a bachelor’s degree in
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`mechanical engineering, biomedical engineering, chemical engineering, chemistry,
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`or physics and at least 3 years of experience working with biosensors. (Ex. 1001,
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`Abstract; Ex. 2003, ¶15).5
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`“Structurally Flexible”
`C.
`Each of the challenged claims of the ’202 patent requires the sensor to have
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`a “structurally flexible core.” Dexcom asserts that the term “structurally flexible”
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`should be interpreted without regard to the specification, and relies on a non-
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`5 As discussed infra, Dexcom fails to address or mention the Person of Ordinary
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`Skill in the Relevant Art in its Petition.
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`Patent Owner’s Preliminary Response
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`IPR2016-01679
`Patent 7,146,202
`technical dictionary definition that defines a different term, “flexible,” as “capable
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`
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`of being bent or flexed.” (Petition, pp. 7-8).
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`Dexcom’s proposed construction of “structurally flexible” fails to account
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`for Dexcom’s own admissions regarding a more appropriate definition for this
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`term. For example, Dexcom admits that “both tantalum and nitinol fall within the
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`’202 patent’s definition of structurally flexible.” (Petition, p. 8). Thus, Dexcom
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`concludes, “structurally flexible should be construed … as capable of being bent or
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`flexed, where tantalum and nitinol are two examples of materials that are
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`structurally flexible.” Id. (internal quote marks omitted). Given Dexcom’s
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`explanation, the construction for this term should be expanded at least to include
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`these two exemplary “structurally flexible” materials.
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`
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`Similarly, at page 56 of its Petition, Dexcom states that “[t]he stainless steel
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`core disclosed in Gross is structurally flexible because it is capable of bending
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`without permanently being deformed …” (Petition, p. 56) (emphasis added).
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`While Dexcom’s conclusion regarding Gross is incorrect for reasons stated infra,
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`its defense of Gross reveals Dexcom’s own understanding that, within the context
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`of the ’202 patent, “structurally flexible” connotes more than mere “flexibility.”
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`Based on Dexcom’s foregoing admissions, its construction is overbroad.
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`
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`AgaMatrix respectfully submits that the broadest reasonable interpretation
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`for the “structurally flexible” core term, as it would have been understood by a
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`Patent Owner’s Preliminary Response
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`IPR2016-01679
`Patent 7,146,202
`person of ordinary skill in the art, is “a material such as tantalum or nitinol that is
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`
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`able to be repeatedly flexed without breaking.”
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`The ’202 patent specification provides ample support for AgaMatrix’s
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`proposed construction. The Background of the Invention explains the problem:
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`“[w]ith the advent of indwelling wire sensors has come the danger to the patient of
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`having a cylindrical wire sensor fatigue from the flexure caused by bodily
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`movement and break off inside the body.” (Ex. 1001 at 1:12-15). The patent
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`further explains that “the typical metal used for such a wire sensor is platinum,
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`which is electrochemically active and generally very useful in sensing
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`applications.” (Id. at 1:19-21). “Platinum, however, is a weak metal that is easily
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`broken with only a little flexure.” (Id. at 1:21-23). Thus, the specification is clear
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`that a platinum sensor wire is not “structurally flexible.” (Id.).
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`The ’202 patent explains that the solution to the breakage problem is the use
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`of a robust sensor wire able to withstand repeated flexing without breaking. See
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`Id. at Abstract; Summary at 1:44-46 (“The sensor comprises a core of structurally
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`robust material and a plated portion…”); 1:52-55; 1:59-62; 2:24-28; 2:33-37; 2:59-
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`61; 3:9-12; 3:15-19; 3:19-24; 3:21-24 (all referencing the requirement for a robust
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`sensor wire). The specification further describes two naturally flexible metals that
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`are particularly well-suited for sensors inserted into a patient for a period of days.
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`Specifically, the Detailed Description of the Preferred Embodiment states:
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`Patent Owner’s Preliminary Response
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`IPR2016-01679
`Patent 7,146,202
`[a] wire core . . . of any structurally robust material, such
`as tantalum, stainless steel or nitinol. Tantalum and
`nitinol, although both fairly expensive, are desirable
`because they are both naturally flexible. This is of
`particular importance if sensing element 12 is to be
`inserted in a patient and worn for a period of days.
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`(Id. at 2:33-39) (emphases added).
`
`
`
`Claim 9 of the ’202 patent reinforces that the sensor wires must be designed
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`for extended use by requiring that the sensor is placed in the “body for at least 24
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`hours.” Claim 1, from which claim 9 depends, is inherently broader than claim 9,
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`and thus encompasses sensors that are designed to be implanted for at least a day.
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`Dexcom has improperly construed the “structurally flexible” term in a
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`vacuum, relying on extrinsic evidence (a conventional, non-technical dictionary)
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`for the meaning of the term “flexible,” without regard to the context provided by
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`the ’202 patent. Dexcom’s construction renders the term “structurally”
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`superfluous, and instead relies entirely on the word “flexible.” This approach
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`violates an age-old canon of claim construction, recently reinforced by the Federal
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`Circuit in Akzo Nobel Coatings, Inc. v. Dow Chemical Co., 811 F.3d 1334 (Fed.
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`Cir. 2016): “A claim construction that gives meaning to all the terms of the claim
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`is preferred over one that does not do so.” Id. at 1340 (quoting Merck & Co. v.
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`Teva Pharm. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir.2005)).
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`Patent Owner’s Preliminary Response
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`IPR2016-01679
`Patent 7,146,202
`Dexcom’s approach also violates the Federal Circuit’s mandate in Phillips
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`
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`that extrinsic evidence is to be considered last, after resort to the claims, the
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`specification, and the prosecution history, to guide the meaning of the claim term.
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`The Board should reject Dexcom’s overbroad interpretation of the
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`“structurally flexible” term, and deny institution of an inter partes review of claims
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`1-3, 5, 6 and 8-11 on that basis. Without its overly broad construction of the
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`“structurally flexible” term, Dexcom cannot show that any of the challenged
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`claims read on the prior art.
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` STANDARD FOR GRANTING INTER PARTES REVIEW
`IV.
`The Board may grant