UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`DEXCOM, INC.,
`Petitioner,
`
`v.
`
`ABBOTT DIABETES CARE INC.,
`Patent Owner.
`
`IPR2023-01252
`U.S. Patent No.: 11,298,056
`Issued: April 12, 2022
`Application No.: 17/411,154
`Filed: August 25, 2021
`
`Title: METHODS AND SYSTEMS FOR EARLY SIGNAL ATTENUATION
`DETECTION AND PROCESSING
`_________________
`
`PETITION FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 11,298,056
`
`
`
`

`

`IPR2023-01252
`Patent 11,298,056
`
`TABLE OF CONTENTS
`
`LIST OF EXHIBITS .............................................................................................. viii
`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8 ........................................... ix
`1.
`Real Party-In-Interest ................................................................ ix
`2.
`Related Matters ......................................................................... ix
`3.
`Lead And Back-Up Counsel, And Service Information ........... ix
`INTRODUCTION ........................................................................................... 1
`I.
`II. GROUNDS FOR STANDING PER SECTION 42.104(A) ............................ 3
`III.
`IDENTIFICATION OF CHALLENGE .......................................................... 3
`A.
`Statement Of The Precise Relief Requested / Statutory Grounds ......... 3
`B. No Examiner Addressed These Unpatentability Grounds .................... 4
`IV. THE ’056 PATENT ......................................................................................... 5
`A.
`The ’056 Patent’s Specification ............................................................ 5
`B.
`The Prosecution History ........................................................................ 7
`C.
`The Claims And Their Full Scope......................................................... 8
`1.
`Claim 1 ........................................................................................ 8
`2.
`Full Scope Of Claim 1 ................................................................ 9
`3.
`The Dependent Claims ..............................................................16
`The Grandparent App. As Filed ..........................................................17
`D.
`LEVEL OF SKILL IN THE ART, AND STATE OF THE ART .................26
`V.
`VI. CLAIM CONSTRUCTION ..........................................................................26
`VII. THE CITATION OF INTERVENING PRIOR ART SHIFTS THE
`
`BURDEN OF PRODUCTION TO PATENT OWNER TO SHOW
`
`ENTITLEMENT TO AN EARLIER EFFECTIVE FILING DATE ............28
`
`Page i
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`

`

`2.
`
`3.
`
`4.
`
`B.
`
`VIII. THE GRANDPARENT APP. AS
`
`FILED DID NOT SUPPORT THE CLAIMS ...............................................31
`A.
`The Grandparent App. Lacked Written
`Description Support For The Claims’ Full Scope ...............................31
`The Grandparent App. Lacked
`Enablement Support For The Claims’ Full Scope ..............................35
`IX. THE CLAIMS ARE OBVIOUS....................................................................40
`A.
`This Prior Art Teaches An Embodiment Of Each Claim....................40
`1.
`The Prior Art References Disclose An
`Embodiment Of The Claims’ Components ..............................41
`The Prior Art References Disclose An Embodiment
`Of The Claims’ Components’ Functional Capabilities ............43
`Harper 2019 And Hayter/Taub 2013 Combined Disclose
`An Embodiment Of The Claims’ System Capabilities .............50
`Harper 2019 Discloses An
`Embodiment Of The Claims’ Operation ...................................56
`A POSITA Would Have Been Motivated
`To Combine These Teachings To Arrive At An
`Embodiment Of The Claimed Combination, And
`Had A Reasonable Expectation Of Success In Doing So .........57
`There Are No Known Objective Indicia
`Of Non-Obviousness Having A Nexus To
`The Delta Between Harper 2019 And The Claims ...................62
`THE BOARD, C.C.P.A. AND FEDERAL
`X.
`CIRCUIT HAVE FOUND PATENT CLAIMS
`
`ANTICIPATED OVER PUBLISHED ANCESTOR
`
`DISCLOSURES THAT FAILED TO SUPPORT
`
`AN EFFECTIVE FILING DATE FOR THE CLAIMS ................................62
`
`XI. CONCLUSION ..............................................................................................64
`CERTIFICATE OF COMPLIANCE .......................................................................65
`
`
`IPR2023-01252
`Patent 11,298,056
`
`Page ii
`
`5.
`
`6.
`
`

`

`IPR2023-01252
`Patent 11,298,056
`CERTIFICATE OF SERVICE ................................................................................66
`
`
`
`
`
`Page iii
`
`

`

`TABLE OF AUTHORITIES
`
`IPR2023-01252
`Patent 11,298,056
`
`Page(s)
`
`Board Decisions
`Aquestive Therapeutics, Inc. v. Neurelis, Inc.,
`IPR2019-00451, Paper 44 (P.T.A.B. Aug. 6, 2020) ............................................30
`Inguran LLC v. Premium Genetics (UK) Ltd.,
`PGR2015-00017, Paper 22 (P.T.A.B. Dec. 20, 2016) .........................................31
`MaxLite, Inc. v. Jiaxing Super Lighting Elec. Appliance Co.,
`IPR2020-00208, Paper 40 (P.T.A.B. Apr. 29, 2022) ...........................................30
`Penumbra, Inc. v. RapidPulse, Inc.,
`IPR2021-01466, Paper 34 (P.T.A.B. Mar. 10, 2023) ...........................................30
`Samsung Elecs. Co. v. Hardin,
`IPR2022-01331, Paper 14 (P.T.A.B. Feb. 7, 2023) .............................................30
`Smith & Nephew, Inc. v. Arthrex, Inc.,
`IPR2017-00275, Paper 36 (P.T.A.B. May 2, 2018), aff’d, 35 F.4th 1328 (Fed. Cir.
`2022) .....................................................................................................................63
`The Gillette Co. LLC v. Sphere USA, LLC,
`PGR2022-00030, Paper 8 (P.T.A.B. Sept. 23, 2022) .......................................1, 63
`Cases
`AK Steel Corp. v. Sollac & Ugine,
`344 F.3d 1234 (Fed. Cir. 2003) ........................................................................9, 27
`Amgen Inc. v. Sanofi,
`143 S. Ct. 1243 (2023)..........................................................................................35
`Ariad Pharm., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) ............................................................................31
`Atl. Rsch. Mktg. Sys., Inc. v. Troy,
`659 F.3d 1345 (Fed. Cir. 2011) ............................................................................32
`Chester v. Miller,
`906 F.2d 1574 (Fed. Cir. 1990) ............................................................................62
`
`Page iv
`
`

`

`IPR2023-01252
`Patent 11,298,056
`
`D Three Enters., LLC v. SunModo Corp.,
`890 F.3d 1042 (Fed. Cir. 2018) ............................................................... 29, 32, 33
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) ............................................................................30
`Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.,
`535 U.S. 722 (2002) .............................................................................................31
`Gentry Gallery, Inc. v. Berkline Corp.,
`134 F.3d 1473 (Fed. Cir. 1998) ............................................................................32
`Hyatt v. Boone,
`146 F.3d 1348 (Fed. Cir. 1998) ............................................................................32
`Hyatt v. Dudas,
`492 F.3d 1365 (Fed. Cir. 2007) ............................................................................34
`Idenix Pharms. LLC v. Gilead Scis. Inc.,
`941 F.3d 1149 (Fed. Cir. 2019) ..................................................................... 36, 38
`In re Cuozzo Speed Techs., LLC,
`793 F.3d 1268 (Fed. Cir. 2015) ............................................................................40
`In re Katz,
`639 F.3d 1303 (Fed. Cir. 2011) ............................................................................29
`In re Lukach,
`442 F.2d 967 (C.C.P.A. 1971) ..............................................................................63
`In re Magnum Oil Tools Int’l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) ............................................................................30
`In re NTP, Inc.,
`654 F.3d 1268 (Fed. Cir. 2011) ..................................................................... 28, 30
`In re Ruschig,
`379 F.2d 990 (C.C.P.A. 1967) ....................................................................... 34, 35
`Juno Therapeutics, Inc. v. Kite Pharma, Inc.,
`10 F.4th 1330 (Fed. Cir. 2021) .............................................................................32
`KCJ Corp. v. Kinetic Concepts, Inc.,
`223 F.3d 1351 (Fed. Cir. 2000) ............................................................................11
`
`Page v
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`

`

`IPR2023-01252
`Patent 11,298,056
`
`Lockwood v. Am. Airlines, Inc.,
`107 F.3d 1565 (Fed. Cir. 1995) ............................................................................32
`MagSil Corp. v. Hitachi Glob. Storage Techs., Inc.,
`687 F.3d 1377 (Fed. Cir. 2012) ............................................................................36
`Nat. Alts. Int’l, Inc. v. Iancu,
`904 F.3d 1375 (Fed. Cir. 2018) ............................................................................29
`Nat’l Recovery Techs. v. Magnetic Separation Sys., Inc.,
`166 F.3d 1190 (Fed. Cir. 1999) ............................................................................38
`Novozymes A/S v. DuPont Nutrition Biosciences APS,
`723 F.3d 1336 (Fed. Cir. 2013) ............................................................................34
`Parus Holdings, Inc. v. Google LLC,
`70 F.4th 1365 (Fed. Cir. 2023) .............................................................................29
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ............................................................................28
`Purdue Pharma L.P. v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2000) ..................................................................... 32, 35
`Rsch. Corp. Techs., Inc. v. Microsoft Corp.,
`627 F.3d 859 (Fed. Cir. 2010) ..............................................................................30
`Sitrick v. Dreamworks, LLC,
`516 F.3d 993 (Fed. Cir. 2008) ..............................................................................36
`Synthes USA, LLC v. Spinal Kinetics, Inc.,
`734 F.3d 1332 (Fed. Cir. 2013) ............................................................................32
`Tech. Licensing Corp. v. Videotek, Inc.,
`545 F.3d 1316 (Fed. Cir. 2008) ............................................................................29
`Tronzo v. Biomet, Inc.,
`156 F.3d 1154 (Fed. Cir. 1998) ............................................................................31
`Trustees of Boston Univ. v. Everlight Elecs. Co.,
`896 F.3d 1357 (Fed. Cir. 2018) ..................................................................... 36, 38
`U.S. Endodontics, LLC v. Gold Standard Instruments, LLC,
`PGR2015-00019 54 (P.T.A.B. Dec. 28, 2016) ....................................................63
`
`Page vi
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`

`

`IPR2023-01252
`Patent 11,298,056
`
`Statutes
`35 U.S.C. § 103 ............................................................................................... 3, 4, 40
`35 U.S.C. § 112 ................................................................................................ passim
`35 U.S.C. § 120 ............................................................................................. 9, 28, 40
`35 U.S.C. § 325 ......................................................................................................4, 5
`
`
`Regulations
`37 C.F.R. § 42.104 ..................................................................................................... 3
`37 C.F.R. § 42.15 ....................................................................................................... 4
`37 C.F.R. § 42.24 .....................................................................................................65
`37 C.F.R. § 42.6 .......................................................................................................66
`
`
`
`
`
`
`
`Page vii
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`

`

`IPR2023-01252
`Patent 11,298,056
`
`LIST OF EXHIBITS
`
`No.
`1201
`1202
`
`1203
`1204
`1205
`1206
`1207
`1208
`
`1209
`
`1210
`
`1211
`
`1212
`
`Description
` U.S. Patent No. 11,298,056 (“the ’056 Patent”)
`U.S. Ser. No. 16/228,910, filed Dec. 21, 2018 (“Grandparent
`App.”)
` U.S. Ser. No. 17/245,719, filed Apr. 30, 2021 (“Parent App.”)
` U.S. Ser. No. 17/411,154, filed Aug. 25, 2021 (“’056 App.”)
` Prosecution History of Grandparent App. (“Grandparent FH”)
` Prosecution History of Parent App. (“Parent FH”)
` Prosecution History of ’056 Patent (“’056 Patent FH”)
` U.S. Pat. Appl. Pub. No. US 2019/0216373, published July 18,
`2019 (“Harper 2019”)
` U.S. Pat. Appl. Pub. No. 2012/0108931, published May 3, 2012
`(“Taub/Harper 2012”)
` U.S. Pat. Appl. Pub. No. 2013/0127627, published May 23, 2013
`(“Hayter/Taub 2013”)
` U.S. Pat. Appl. Pub. No. 2014/0176338, published June 26, 2014
`(“He/Taub 2014”)
` Declaration of Morten Jensen, dated July 21, 2023 (“Morten
`Jensen Decl.”)
`
`
`
`
`Page viii
`
`

`

`IPR2023-01252
`Patent 11,298,056
`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`1.
`
`Real Party-In-Interest
`
`Dexcom, Inc. is the sole real party-in-interest.
`
`2.
`
`Related Matters
`
`The ’056 patent (EX1201) has been asserted in the following litigation:
`
`• Abbott Diabetes Care Inc. et al. v. DexCom, Inc., Case No. 1:23-cv-00239
`
`(DED), filed March 3, 2023.
`
`The ’056 patent is also the subject of contemporaneously-filed IPR
`
`proceeding, IPR2023-01251. See Petitioner’s Explanation of Material Differences.
`
`3.
`
`Lead And Back-Up Counsel, And Service Information
`
`
`
`Lead Counsel
`John D. Vandenberg, Reg. No. 31,312
`john.vandenberg@klarquist.com
`
`Back-up Counsel
`Andrew M. Mason, Reg. No. 64,034
`andrew.mason@klarquist.com
`Amy Haspel, Reg. No. 78,385
`Amy.haspel@klarquist.com
`KLARQUIST SPARKMAN, LLP
`121 SW Salmon Street, Suite 1600
`Portland, Oregon, 97204
`503-595-5300 (phone)
`503-595-5301 (fax)
`
`Petitioner consents to service via email at the above email addresses.
`
`Pursuant to 37 C.F.R. § 42.10(b), concurrently filed with this Petition is a
`
`Power of Attorney executed by Petitioner and appointing the above counsel.
`
`Page ix
`
`

`

`IPR2023-01252
`Patent 11,298,056
`Dexcom, Inc. (“Petitioner”) respectfully requests inter partes review (“IPR”)
`
`of claims 1-30 of U.S. Patent No. 11,298,056 B2 (“’056 patent”) (EX1201),
`
`identifying as assignee Abbott Diabetes Care Inc. (“Patent Owner”). For the reasons
`
`set forth below, these claims should be found unpatentable and cancelled.
`
`I.
`
`INTRODUCTION
`
`The ’056 patent’s claims are unpatentable for obviousness primarily over the
`
`2019 publication of its grandparent application. The grandparent application lacked
`
`the required Section 112(a) support for the challenged claims to be entitled to that
`
`application’s filing date, making the application’s publication prior art to the claims.
`
`The law permits patent applicants to daisy-chain patent applications back-to-
`
`back over many years changing the claims as they go along. Sometimes that latitude
`
`results in later-drafted patent claims so untethered to the applications’ disclosure that
`
`they cannot be backdated to an ancestor application’s filing date. This in turn
`
`sometimes makes the publication of an ancestor application prior art to the claims,
`
`rendering them unpatentable for anticipation or obviousness. See, e.g., The Gillette
`
`Co. LLC v. Sphere USA, LLC, PGR2022-00030, Paper 8 (P.T.A.B. Sept. 23, 2022)
`
`(granting Institution based in part on the “continuation” patent’s grandparent
`
`application with the same disclosure as the challenged patent lacking full scope
`
`written description support for certain claims, making the publication of that
`
`Petition for Inter Partes Review of USP 11,298,056
`
`Page 1
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`

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`IPR2023-01252
`Patent 11,298,056
`grandparent application prior art, which prior art disclosed an embodiment of those
`
`claims and thus likely anticipated them). That is the case here.
`
`This patent issued from a series of seven patent applications, starting in 2009.
`
`A decade later, the patent applicant further distanced the claims from the scope of
`
`the ancestor applications’ disclosures. As a consequence, no ’056 patent claim is
`
`entitled to an effective filing date earlier than April 30, 2021, the filing date of the
`
`patent’s immediate parent application. More specifically, no claim has either
`
`sufficient written description or enablement support in the grandparent application,
`
`SN 16/228,910, filed on December 21, 2018 (“the Grandparent App.”) (EX1202),
`
`or any earlier ancestor application.
`
`As explained in Section IV C infra, the claims’ full scope encompasses a
`
`glucose monitoring system capable of continuously monitoring and detecting the
`
`start and stop times of 17 identified categories of malfunctions and other “adverse
`
`conditions” and, when
`
`the adverse condition
`
`is corrected,
`
`immediately
`
`retrospectively displaying on a mobile phone accurate glucose values for that entire
`
`period of malfunction despite having not stored during that period any accurate
`
`glucose values. As explained in Section IV D infra, however, the Grandparent
`
`App.’s disclosure fails to enable that full scope of the claimed invention and also
`
`fails to lead a person of ordinary skill in the art to understand that the applicant
`
`Petition for Inter Partes Review of USP 11,298,056
`
`Page 2
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`

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`IPR2023-01252
`Patent 11,298,056
`possessed that full scope of the alleged invention. For those and other reasons, no
`
`claim is entitled to be backdated before April 30, 2021.
`
`The claims are obvious over the Grandparent App.’s publication, US
`
`2019/0216373, published July 18, 2019 (“Harper 2019”) (EX1208), combined with
`
`other applications of Patent Owner published in 2012 (EX1209), 2013 (EX1210),
`
`and 2014 (EX1211). Each qualifies as Section 102(a)(1) (AIA) prior art because the
`
`claims’ effective filing date is no earlier than the April 30, 2021, filing date of their
`
`Parent App. (EX1203).
`
`II. GROUNDS FOR STANDING PER SECTION 42.104(a)
`
`Petitioner certifies that the ’056 patent is available for IPR and that Petitioner
`
`is not barred or estopped from requesting an IPR challenging the patent claims on
`
`the grounds identified in this petition.
`
`III.
`
`IDENTIFICATION OF CHALLENGE
`
`A.
`
`Statement Of The Precise Relief Requested / Statutory Grounds
`
`Petitioner requests inter partes review of all thirty claims of the ’056 patent,
`
`as follows:
`
`
`
`Reference(s)
`
`Basis
`
`Claims
`
`Ground 1 US 2019/0216373 published July
`18, 2019 (“Harper 2019”)
`(EX1208)
`
`
`35 U.S.C. § 103
`(AIA)
`
`1-21, 23-30
`
`Petition for Inter Partes Review of USP 11,298,056
`
`Page 3
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`

`

`
`
`Reference(s)
`
`Basis
`
`Claims
`
`IPR2023-01252
`Patent 11,298,056
`
`US 2012/0108931 (“Taub/Harper
`2012”) (EX1209)
`
`US 2013/0127627 (“Hayter/Taub
`2013”) (EX1210)
`Ground 2 Harper 2019 (EX1208)
`
`Taub/Harper 2012 (EX1209)
`
`Hayter/Taub 2013 (EX1210)
`
`US 2014/0176338 (“He/Taub
`2014”) (EX1211)
`
`35 U.S.C. § 103
`(AIA)
`
`22
`
`This petition establishes a reasonable likelihood that the Petitioner will prevail
`
`in establishing that each claim is unpatentable.
`
`With the filing of this petition, an electronic payment of $52,750 for the
`
`requisite fees is being charged to deposit account no. 02-4550. 37 C.F.R. § 42.15(a).
`
`Any fee adjustments may be debited/credited to the deposit account.
`
`B. No Examiner Addressed These Unpatentability Grounds
`
`Neither “the same [n]or substantially the same prior art or arguments
`
`previously were presented to the Office.” 35 U.S.C. § 325(d). During ex partes
`
`prosecution, the Office did not address whether the claims lack Section 112(a)
`
`support in the Grandparent App., whether Harper 2019 or the other asserted
`
`references qualify as prior art, or whether the claims are unpatentable for
`
`Petition for Inter Partes Review of USP 11,298,056
`
`Page 4
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`

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`IPR2023-01252
`Patent 11,298,056
`obviousness if Harper 2019 is prior art. (See EX1204, EX1205, EX1206.) Therefore,
`
`this petition should not be denied under Section 325(d).
`
`IV. THE ’056 PATENT
`
`The ’056 patent (EX1201), issued on April 12, 2022, from a series of seven
`
`applications: U.S. Patent Application No. 17/411,154 (the “’056 App.”) (EX1204),
`
`filed on August 25, 2021, identified as a “continuation” of Parent App. No.
`
`17/245,719 (EX1203), filed on April 30, 2021, identified as a “continuation” of
`
`Grandparent App. No. 16/228,910 (EX1202), filed on December 21, 2018, identified
`
`as a “continuation” of Application No. 15/061,774, filed on March 4, 2016,
`
`identified as a “continuation” of Application No. 13/925,694, filed on June 24, 2013,
`
`identified as a “continuation” of Application No. 12/769,635, filed on April 28,
`
`2010, which claims priority from Provisional Application No. 61/173,600, filed on
`
`April 29, 2009. (See EX1201.)
`
`A. The ’056 Patent’s Specification
`
`The ’056 patent describes a glucose monitoring system having in some
`
`embodiments the conventional components depicted in Fig. 1:
`
`Petition for Inter Partes Review of USP 11,298,056
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`Page 5
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`IPR2023-01252
`Patent 11,298,056
`
`
`
`The patent describes that periodic calibration of the sensor may be required to
`
`accurately calculate a user’s analyte level (’056 10:59-66), but that there may be a
`
`“condition unsuitable for a sensor calibration event” (id. 11:6-8). It describes
`
`disabling the display of the glucose sensor values on the receiver’s display “if a
`
`required calibration event is unsuccessful over a permitted time period” (id. 12:26-
`
`28), leading to a gap in the data displayed as depicted in Fig. 7A (id. 12:30-39). Once
`
`successful calibration of the sensor data occurs, the data gap is backfilled as depicted
`
`in Fig. 7B. (Id. 12:62-13:5.)
`
`Petition for Inter Partes Review of USP 11,298,056
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`Page 6
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`

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`IPR2023-01252
`Patent 11,298,056
`
`
`
`
`
`B.
`
`The Prosecution History
`
`The as-filed claims of the December 21, 2018, Grandparent App. (EX1202 at
`
`21-24) were cancelled in favor of a new set of claims by a preliminary amendment
`
`dated April 4, 2019 (EX1205 at 118-125). Those new claims published with Harper
`
`2019 (EX1208 at 16-17). They lacked several features of the later-drafted ’056
`
`patent claims, including the “or both” claim language (’056 16:6) discussed below.
`
`Petition for Inter Partes Review of USP 11,298,056
`
`Page 7
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`

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`IPR2023-01252
`Patent 11,298,056
`The claims of the Parent App. (EX1203) were amended on the application’s
`
`filing date of April 30, 2021 (EX1206 at 156-164), and later allowed as is (id. at 12-
`
`13). Those claims added “or both” language. (See id. at 157.)
`
`The claims of the ’056 App. (EX1204 at 21-24) were amended on the
`
`application’s filing date of August 25, 2021 (EX1207 at 1-8), subjected to further
`
`amendments on December 20, 2021 (id. at 279-285), and then allowed.
`
`C. The Claims And Their Full Scope
`
`1.
`
`Claim 1
`
`Claim 1 (’056 15:24-16:20) concerns a “glucose monitoring system for
`
`backfilling data gaps” that appear in the display of calibrated sensor-measured
`
`glucose values, caused by the system’s detection of a malfunction or other “adverse
`
`condition.” The system has three components. A glucose sensor is configured in part
`
`to provide sensor data. (Id. 15:27-30.) A data processing and transmitter unit coupled
`
`to the glucose sensor comprises a power supply, processor, memory, and an RF
`
`transceiver. (Id. 15:31-36.) This unit’s claim-recited functions (id. 15:37-51) are
`
`discussed later herein. A receiver unit comprises a processor, memory, an RF
`
`transceiver, and a display. (Id. 15:52-54.) Its claim-recited functions (id. 15:55-64,
`
`16:8-12) are discussed later herein. Claim 1 also recites functions of the “system”
`
`itself, including being configured to “detect an adverse condition.” (Id. 15:65-16:3.)
`
`It also recites the operation of the system, in the claim’s second wherein clause with
`
`Petition for Inter Partes Review of USP 11,298,056
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`Page 8
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`IPR2023-01252
`Patent 11,298,056
`the “or both” language added, in part, by the Parent App. (EX1203): “wherein,
`
`during a time period corresponding to the adverse condition, sensor data, processed
`
`sensor data, or both, are stored in the memory of the data processing and transmitter
`
`unit.” (’056 16:4-7.)
`
`2.
`
`Full Scope Of Claim 1
`
`The primary issue presented by this petition is the effective filing date of each
`
`claim. To show entitlement to a filing date of an ancestor application under 35 U.S.C.
`
`§ 120, the patent owner has the initial burden of production to show that the ancestor
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`application provides full scope and other written description support and full scope
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`and other enablement support for the claim under Section 112(a). (See Sections VIII
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`A and B infra.) A threshold issue, therefore, is to identify the full scope of the claims.
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`Patent claim constructions normally identify what a claim term requires. But,
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`often, a construction identifies not what a claim or claim term requires but what it
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`encompasses, i.e., includes. Determining what the claims encompass is the first
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`analytical step when determining whether the “full scope” of a claim is supported by
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`an application’s disclosure. AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1241
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`(Fed. Cir. 2003). When asserting herein that a claim element encompasses
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`something, Petitioner takes no position on whether it also requires that something.
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`The full scope of each challenged claim encompasses processors of the
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`claimed system being programmed to perform the full scope of functions and
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`operations of claim 1’s four wherein clauses (’056 15:65-16:20), for the full scope
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`of 17 “adverse conditions,” including being programmed to: (1) continuously
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`monitor for and detect all of those adverse conditions, and when they start and stop;
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`(2) store throughout a 72-hour or longer time period experiencing an adverse
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`condition, in a memory of the data processing and transmitter unit (“transmitter”),
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`calibrated sensor data generated from data received from the sensor during that time
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`period, but not programmed to store in that memory that received uncalibrated
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`sensor data; and (3) display on a mobile phone or other receiver display, immediately
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`after correction of any detected adverse condition, a line graph of accurate glucose
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`values for the entire adverse-condition time period, despite not having stored
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`accurate glucose values during that time period. We explain this full scope in greater
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`detail below.
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`Full scope of 17 adverse conditions: Claim 1 recites that the “system is
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`configured to detect an adverse condition.” (’056 15:65-66.) The dependent claims
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`and the specification identify the following 17 categories1 of “adverse condition”:
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`(1) a “sensor communication error” (’056 claim 3, 13:65); (2) “a signal error
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`associated with the glucose sensor” (claim 4); (3) “a signal error associated with the
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`1 Petitioner takes no position on the extent to which these categories overlap or are
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`clear.
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`data processing and transmitter unit” (claim 5); (4) “a signal error associated with
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`the receiver unit” (claim 6); (5) “a system malfunction associated with the data
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`processing and transmitter unit” (claim 7); (6) “a system malfunction associated with
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`the receiver unit” (claim 7); (7) “an inability of the receiver unit to display or output
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`at least a portion of [the] first line graph” (claim 8); (8) “a sensor instability
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`condition” (claim 9, 13:61); (9) “a calibration failure condition” (claim 10, 13:61-
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`62); (10) “a monitoring system failure condition” (claim 11, 13:62); (11) a “sensor
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`misposition error” (claim 13, 13:64-65); (12) a “temperature measurement outside a
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`predetermined range” (claim 14, 13:65-66); (13) “an analyte level exceeding a
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`predetermined threshold” (claim 15, 14:2); (14) “a rate of change of an analyte level
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`exceeding a predetermined threshold” (claim 16, 14:2-4); (15) “a data unavailability
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`condition” (claim 17, 14:5); (16) “a signal error associated with the blood glucose
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`reference data” (claim 25, see 14:4); and (17) an “early signal attenuation condition
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`of the sensor” (13:64). Thus, the full scope of claim 1 encompasses having the
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`claimed functions and operation for the full range of these 17 “adverse conditions.”
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`Continuously monitor for and detect all 17 adverse conditions, and when they
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`start and stop: Claim 1 recites that the glucose monitoring system is “configured to
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`detect an adverse condition.” (Id.) (emphasis added). As a rule of claim construction,
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`“an” refers, with rare exceptions, to one or more. KCJ Corp. v. Kinetic Concepts,
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`Inc., 223 F.3d 1351, 1356-57 (Fed. Cir. 2000). The ’056 patent expressly adopts this
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`rule: “as used herein and in the appended claims, the singular forms ‘a’, ‘an’, and
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`‘the’ include plural referents unless the context clearly dictates otherwise.” (’056
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`3:50-52.) Thus, by referring to detecting “an” adverse condition, the full scope of
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`claim 1 encompasses a processor programmed to detect all 17 adverse conditions.
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`Claim 1’s first wherein clause indicates that the claim encompasses a system
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`that detects the “start of the adverse condition” (id. 16:2-3) and its fourth wherein
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`clause indicates that the claim encompasses a system that detects “an end of the
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`adverse condition” (id. 16:19-20). Dependent claim 18 similarly recites displaying
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`data “immediately after the correction of the adverse condition,” which implies
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`“immediately” detecting when the adverse condition stops. Thus, claim 1
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`encompasses detecting exactly when the adverse condition starts and stops, which
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`implies continuously monitoring for such adverse conditions and their correction.
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`Therefore, claim 1 encompasses the processor(s) being programmed to continuously
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`monitor for all 17 of those adverse conditions to detect when they start and stop.
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`Store throughout 72-hour or longer adverse-condition time period: Claim 1’s
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`second wherein clause requires certain data to be stored “during a time period
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`corresponding to the adverse condition,” whose full scope includes during the entire
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`time period(s) of the adverse condition(s). (’056 16:4-7.) The claims do not limit the
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`length of the adverse-condition time period(s). But the specification states that the
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`sensor may be configured for calibration 72 hours after insertion (id. 11:8-13), which
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`implies that the detected adverse condition may be as long as 72 hours, or longer.
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`Store calibrated sensor data derived from sensor data received during the
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`adverse-condition time period but not store that sensor data: Claim 1 recites that the
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`transmitter is configured to “receive the sensor data from the glucose sensor …”
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`(’056 15:39) and to “process the sensor data using calibration data to provide
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`processed sensor data …” (id. 15:42-43). Thus, “sensor data” referenced elsewhere
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`in the claim at least includes uncalibrated sensor data the transmitter receives from
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`the glucose sensor, and “processed sensor data” referenced elsewhere in the claim at
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`least includes this calibrated sensor data generated by the transmitter from that
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`sensor data. And both terms encompass data that is bad (inaccurate) on account of
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`some adverse condition. This is confirmed by claim 1’s second wherein clause,
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`which includes storing “sensor data” and/or “processed sensor data” “during a time
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`period corresponding to the adverse condition.” (Id. 16:4-7.)
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`As noted, the second wherein clause (id.) refers to both “sensor data” and
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`“processed sensor data.” It recites that during the adverse-condition time period,
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`“sensor data, processed sensor data, or both” are stored in the memory of the
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`transmitter. (Id.) (emphasis added). As explained below, this “or both” claim
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`language is critical to the claims’ effective filing date.
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`Per the ordinary meaning of “or both,” the full scope of this claim language
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`encompasses three different modes of operation during the adverse-condition time