UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`DEXCOM, INC.,
`Petitioner,
`
`v.
`
`
`
`ABBOTT DIABETES CARE INC.,
`Patent Owner.
`
`IPR2023-01409
`U.S. Patent No.: 11,202,591
`Issued: December 21, 2021
`Application No.: 17/221,154
`Filed: April 2, 2021
`
`Title: ANALYTE SENSOR AND
`APPARATUS FOR INSERTION OF THE SENSOR
`_________________
`
`PETITION FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 11,202,591
`
`

`

`TABLE OF CONTENTS
`
`
`
`IPR2023-01409
`Patent 11,202,591
`
`Page(s)
`
`TABLE OF AUTHORITIES ..................................................................................... v
`LIST OF EXHIBITS ............................................................................................... vii
`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) ............................. 4
`III.
`IDENTIFICATION OF CHALLENGE .......................................................... 4
`A.
`Statement Of The Precise Relief Requested / Statutory Grounds ......... 4
`B. No Examiner Addressed These Unpatentability Grounds .................... 5
`C.
`Parallel Proceeding ................................................................................ 6
`IV. THE ’591 PATENT ......................................................................................... 6
`A.
`The ’591 Patent’s Specification ............................................................ 6
`B.
`The Prosecution History ........................................................................ 7
`C.
`Claims Listing ....................................................................................... 8
`LEVEL OF SKILL IN THE ART, AND STATE OF THE ART .................10
`A.
`Person Of Ordinary Skill In The Art ...................................................10
`B.
`State Of The Art ..................................................................................11
`1.
`Inserters With Auto-Retracting Needles Were Known ............11
`
`V.
`
`Page i
`
`

`

`2.
`3.
`
`4.
`5.
`6.
`
`IPR2023-01409
`Patent 11,202,591
`Inserters Reduce Subject Pain And Anxiety .............................11
`Inserter Designs Were Interchangeably Used
`For Insertion Of Different Types Of Subcutaneous Devices ...12
`Low-Profile On-Body Devices Were Known ...........................13
`It Was Known To Protect Needles And Avoid Needle Sticks .13
`It Was Known To Couple The On-Body Unit
`To The Inserter By Using Peripheral Apertures On
`The Unit That Engaged With Projections On The Inserter ......17
`VI. CLAIM CONSTRUCTION ..........................................................................19
`VII. GROUND 1: CLAIMS 1-6, 9-14, 16-24, 27, 29-30
`
`ARE UNPATENTABLE OVER STAFFORD IN VIEW OF COTE ...........20
`A.
`Stafford ................................................................................................20
`B.
`Cote ......................................................................................................23
`C.
`Combining The Teachings Of Stafford And Cote ..............................28
`1.
`Claims 1/19 ...............................................................................33
`2.
`Claims 2/20 ...............................................................................50
`3.
`Claims 3/19 ...............................................................................52
`4.
`Claims 4/19 ...............................................................................59
`5.
`Claims 5/19 ...............................................................................60
`6.
`Claims 6/27 ...............................................................................62
`7.
`Claims 9/22 ...............................................................................63
`8.
`Claims 10/24 .............................................................................66
`9.
`Claims 11/24 .............................................................................68
`10. Claims 12/29 .............................................................................70
`
`Page ii
`
`

`

`IPR2023-01409
`Patent 11,202,591
`11. Claims 13/30 .............................................................................71
`12. Claims 14/19 .............................................................................72
`13. Claims 16/23 .............................................................................73
`14. Claim 17 ....................................................................................75
`15. Claims 18/21 .............................................................................76
`16. Claim 19, 20-24, 27, 29-30 .......................................................84
`VIII. GROUND 2:
`
`STAFFORD+COTE+SAY (CLAIMS 4, 7-8, 14-15, 19-30) ........................84
`A.
`Say .......................................................................................................84
`B.
`Combining The Teachings Of Stafford+Cote+Say .............................85
`1.
`Claims 4/19, 14/19 ....................................................................86
`2.
`Claims 7/25 ...............................................................................87
`3.
`Claims 8/26 ...............................................................................88
`4.
`Claims 15/28 .............................................................................89
`5.
`Claims 20-30 .............................................................................94
`IX. GROUND 3:
`
`STAFFORD+COTE+BRENNEMAN (CLAIMS 18, 21-24, 27, 29-30) ......95
`A.
`Brenneman ...........................................................................................95
`B.
`Combining The Teachings Of Stafford+Cote+Brenneman ................96
`1.
`Claims 18, 21-24, 27, 29-30 ......................................................97
`X. GROUND 4:
`
`STAFFORD+COTE+SHAH (CLAIMS 9, 22-24, 27, 29-30) ......................98
`A.
`Shah .....................................................................................................98
`B.
`Combining The Teachings Of Stafford+Cote+Shah ...........................99
`
`Page iii
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`

`

`IPR2023-01409
`Patent 11,202,591
`Claims 9, 22, 23-24, 27, 29-30................................................100
`1.
`XI. GROUNDS 5-8 (CLAIMS 21-30) ..............................................................102
`A. Ground 5: +Brenneman To Ground 2 (Claims 21-30) ......................103
`B. Grounds 6-8: +Shah To Grounds 2, 3, And 5 (Claims 22-30) ..........104
`1.
`Ground 6: Stafford+Cote+Say+Shah (Claims 25-26, 28) ......104
`2.
`Ground 7:
`Stafford+Cote+Brenneman+Shah
`(Claims 22-24, 27, 29-30) .......................................................105
`Ground 8:
`Stafford+Cote+Say+Brenneman+Shah (Claims 25-26, 28) ...105
`XII. NO OBJECTIVE INDICIA OF NON-OBVIOUSNESS ............................105
`XIII. CONCLUSION ............................................................................................106
`CERTIFICATE OF COMPLIANCE .....................................................................107
`CERTIFICATE OF SERVICE ..............................................................................108
`
`3.
`
`
`
`
`
`
`
`
`
`Page iv
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`

`

`TABLE OF AUTHORITIES
`
`IPR2023-01409
`Patent 11,202,591
`
`Page(s)
`
`Cases
`Cummins-Allison Corp. v. SBM Co., Ltd.,
`484 F. App’x 499 (Fed. Cir. 2012) .......................................................................57
`Gardner v. TEC Syst., Inc.,
`725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984) ........................................... 58, 82
`In re Aslanian,
`590 F.2d 911 (CCPA 1979) ..................................................................................54
`In re Baum,
`374 F.2d 1004 (CCPA 1967) ................................................................................54
`In re Epstein,
`32 F.3d 1559 (Fed. Cir. 1994) ..............................................................................58
`In re Fox,
`471 F.2d 1405 (CCPA 1973) ................................................................................58
`In re Preda,
`401 F.2d 825 (CCPA 1968) ..................................................................................57
`In re Woodruff,
`919 F.2d 1575 (Fed. Cir. 1990) ..................................................................... 58, 73
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ............................................................................19
`Board Decisions
`Dexcom, Inc. v. Abbott Diabetes Care Inc.,
`IPR2022-00605, Paper 29 (PTAB July 10, 2023) ......................................... 13, 30
`First Quality Baby Prod., LLC v. Kimberly-Clark Worldwide, Inc.,
`IPR2014-01021, Paper 57 (PTAB Dec. 10, 2015) ........................................ 58, 73
`Intex Rec. Corp. v. Team Worldwide Corp.,
`IPR2018-00871, 2018 WL 4404107, Paper 14 (PTAB Sept. 14, 2018) ................ 5
`
`Page v
`
`

`

`IPR2023-01409
`Patent 11,202,591
`
`Statutes
`35 U.S.C. § 103 .......................................................................................................... 4
`Rules
`37 C.F.R. § 42.1 ......................................................................................................... 5
`37 C.F.R. § 42.24 ...................................................................................................107
`37 C.F.R. § 42.6 .....................................................................................................108
`Regulations
`83 Fed. Reg. 51340 ..................................................................................................19
`
`
`
`
`
`Page vi
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`

`

`IPR2023-01409
`Patent 11,202,591
`
`LIST OF EXHIBITS
`
`Description
` U.S. Patent No. 11,202,591 (“’591 patent”)
` File History of U.S. Patent No. 11,202,591
` Declaration of Dr. Gary D. Fletcher, dated October 10, 2023
`(“Fletcher Decl.”)
` U.S. Publication No. 2008/0097246 (“Stafford”)
` U.S. Publication No. 2005/0101932 (“Cote”)
` U.S. Publication No. 2007/0073129 (“Shah”)
` U.S. Publication No. 2007/0135774 (“Turner”)
` U.S. Patent No. 6,175,752 (“Say”)
` U.S. Publication No. 2009/0124979 (“Raymond”)
` U.S. Publication No. 2006/0095014 (“Ethelfeld”)
` PCT Publication No. WO2008/155377 (“Hasted”)
` U.S. Publication No. 2009/0076360 (“Brister-360”)
` U.S. Publication No. 2006/0155180 (“Brister-180”)
` U.S. Publication No. 2004/0133164 (“Funderburk-164”)
` U.S. Patent No. 6,560,471 (“Heller”)
` U.S. Patent No. 6,579,690 (“Bonnecaze”)
` U.S. Publication No. 2003/0225373 (“Bobroff-373”)
` U.S. Publication No. 2009/0240121 (“Bickoff”)
` PCT Publication No. WO2008/114223 (“Pesach”)
` U.S. Publication No. 2004/0002682 (“Kovelman”)
` U.S. Patent No. 7,381,184 (“Funderburk”)
` intentionally left blank
`
`No.
`1001
`1002
`1003
`
`1004
`1005
`1006
`1007
`1008
`1009
`1010
`1011
`1012
`1013
`1014
`1015
`1016
`1017
`1018
`1019
`1020
`1021
`1022
`
`Page vii
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`

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`IPR2023-01409
`Patent 11,202,591
`
`Description
`
` intentionally left blank
` intentionally left blank
` U.S. Publication No. 2008/0319414 (“Yodfat-414”)
` U.S. Patent No. 7,207,974 (“Safabash”)
` U.S. Publication No. 2004/0204687 (“Mogensen-687”)
` U.S. Publication No. 2002/0022855 (“Bobroff-855”)
` U.S. Patent No. 9,566,384 (“Gyrn”)
` U.S. Patent No. 8,747,363 (“Nielsen”)
` U.S. Publication No. 2007/0093754 (“Mogensen-754”)
` intentionally left blank
` intentionally left blank
` Steven W. Smith, The Scientist and Engineer’s Guide to Digital
`Signal Processing (2nd ed. 1999) (excerpted)
` B.A. Shenoi, Introduction to Digital Signal Processing and Filter
`Design (2006) (excerpted)
` U.S. Publication No. 2009/0099521 (“Gravesen”)
` U.S. Publication No. 2009/0216215 (“Thalmann”)
` U.S. Publication No. 2008/0255440 (“Eilersen”)
` Scheduling Order, Abbott Diabetes Care Inc. v. DexCom Inc.,
`No. 1-23-cv-00239 (D. Del. filed Mar. 3, 2023)
` PCT Publication No. WO2008/115409 (“Brenneman”)
` Statement of Defense (Counterclaim), Dexcom Inc. v. Abbott
`Diabetes Care Inc., Case No. 21 O 6562/23 (Munich D. Ct. I),
`Sept. 1, 2023
` U.S. Publication No. 2008/0114280 (“Stafford-280”)
`
`No.
`1023
`1024
`1025
`1026
`1027
`1028
`1029
`1030
`1031
`1032
`1033
`1034
`
`1035
`
`1036
`1037
`1038
`1039
`
`1040
`1041
`
`1042
`
`
`
`Page viii
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`

`

`IPR2023-01409
`Patent 11,202,591
`
`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 ’591 patent (EX1001) has been asserted in the following litigations:
`
`• Abbott Diabetes Care Inc. et al. v. DexCom, Inc., Case No. 1:23-cv-
`
`00239 (DED), filed March 3, 2023.
`
`3.
`
`Lead And Back-Up Counsel, And Service Information
`
`Lead Counsel
`Andrew M. Mason, Reg. No. 64,034
`andrew.mason@klarquist.com
`
`
`
`
`Back-up Counsel
`Alexa M. Johnston, Ref. No. 77,415
`alexa.johnston@klarquist.com
`
`Michael J. Loy, Reg. No. 78,505
`michael.loy@klarquist.com
`
`Derrick W. Toddy, Reg. No. 74,591
`derrick.toddy@klarquist.com
`
`John D. Vandenberg, Reg. No. 31,312
`john.vandenberg@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.
`
`Page ix
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`

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`IPR2023-01409
`Patent 11,202,591
`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 x
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`

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`IPR2023-01409
`Patent 11,202,591
`
`I.
`
`INTRODUCTION
`
`Dexcom, Inc. (“Petitioner”) respectfully requests inter partes review (“IPR”)
`
`of claims 1-30 of U.S. Patent No. 11,202,591 (“’591 patent”) (EX1001), allegedly
`
`owned by Abbott Diabetes Care Inc. (“Patent Owner”). As discussed below, these
`
`claims should be found unpatentable and cancelled.
`
`The ’591 patent relates to on-body medical devices with a sensor placed
`
`partially under the skin to allow for monitoring of blood glucose levels. The
`
`challenged claims relate to an insertion assembly that includes (i) an on-body unit
`
`having electronics and a glucose sensor and (ii) an inserter with a sharp (e.g., a
`
`needle) for inserting the sensor under the user’s skin and leaving the on-body unit
`
`secured to the user’s skin. E.g., EX1001 (claim 1).
`
`The supposed distinction over the prior art is the on-body unit comprising
`
`respective openings in top and bottom surfaces through which the sharp extends, and
`
`the inserter being configured to advance the on-body unit and sharp from a first
`
`position to a second position to pierce the skin of the user with the sharp and secure
`
`the on-body unit to the skin. EX1002, 977.1
`
`
`1 Unless otherwise noted, file history cites are to the page numbers added by
`
`Petitioner.
`
`Petition for Inter Partes Review of USP 11,202,591
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`Page 1
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`IPR2023-01409
`Patent 11,202,591
`Yet, known glucose sensing devices, such as that taught by Stafford
`
`(EX1004), included on-body electronics units with glucose sensors inserted using a
`
`sharp that extends through openings in the top and bottom surfaces, as shown in FIG.
`
`4A below.
`
`Stafford, FIG. 4A (annotated)
`
`
`
`And inserters known to be useable for insertion of glucose sensors advanced
`
`an on-body unit and sharp from a first position to a second position to pierce the skin
`
`of the user with the sharp and secure the on-body unit to the skin. For example, Cote
`
`(EX1005) teaches an inserter with a needle that extends through openings in the top
`
`and bottom surfaces of an on-body unit (“site”), as shown below, and is used for
`
`inserting a portion of the device (“cannula”) below the skin while leaving the on-
`
`body unit on the user’s skin. EX1005, [0204]-[0213].
`
`Petition for Inter Partes Review of USP 11,202,591
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`Page 2
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`IPR2023-01409
`Patent 11,202,591
`
`Cote, FIG. 80A, “delivery state” (annotated)
`
`
`
`As explained below, a POSITA would have naturally combined the teachings
`
`of Stafford and Cote to create an insertion assembly that renders many challenged
`
`claims obvious. Infra Section VII. Other secondary references teach additional
`
`features that, when combined with Cote and Stafford, render obvious every other
`
`challenged claim. Infra Sections VIII-XI.
`
`
`
`Petition for Inter Partes Review of USP 11,202,591
`
`Page 3
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`IPR2023-01409
`Patent 11,202,591
`II. GROUNDS FOR STANDING PER SECTION 42.104(a)
`
`Petitioner certifies that the ’591 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 claims 1-30 (the “Challenged
`
`Claims”) of the ’591 patent, on the following statutory grounds:
`
`
`
`Reference(s)
`
`35 U.S.C. § Claims
`
`Ground 1 Stafford (EX1004) and
`Cote (EX1005)
`
`Ground 2 Stafford, Cote, and Say (EX1008)
`
`103
`
`103
`
`103
`
`Ground 3 Stafford, Cote, and Brenneman
`(EX1040)
`Ground 4 Stafford, Cote, and Shah (EX1006)
`
`103
`
`Ground 5 Stafford, Cote, Say, and Brenneman
`103
`Ground 6 Stafford, Cote, Say, and Shah
`103
`Ground 7 Stafford, Cote, Brenneman, and Shah 103
`
`Ground 8 Stafford, Cote, Say, Brenneman, and
`Shah
`
`103
`
`1-6, 9-14,
`16-24, 27,
`29-30
`4, 7-8, 15,
`19-30
`18, 21-24,
`27, 29-30
`9, 22-24,
`27, 29-30
`21-30
`25-26, 28
`22-24, 27,
`29-30
`25-26, 28
`
`Petition for Inter Partes Review of USP 11,202,591
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`Page 4
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`IPR2023-01409
`Patent 11,202,591
`For each ground, in Sections VII-XI below, the Petition presents evidence of
`
`unpatentability establishing a reasonable likelihood that the Petitioner will prevail in
`
`showing that each Challenged Claim is unpatentable.
`
`With the filing of this Petition an electronic payment of $52,750.00 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 that deposit account.
`
`B. No Examiner Addressed These Unpatentability Grounds
`
`Cote (EX1005) and Brenneman (EX1040) were neither cited nor discussed
`
`during prosecution of the ’591 patent. Each provides express teachings on inserters
`
`for on-body units that were not considered by the Examiner.
`
`While prior art references Stafford (EX1004), Shah (EX1006), and Say
`
`(EX1008), PCT publication WO2005/046780 to Cote, and US Publication No.
`
`2010/0113897 to Brenneman were each identified on an IDS, nothing suggests the
`
`Examiner gave any of them more than a “[c]ursory consideration.” See, e.g., Intex
`
`Rec. Corp. v. Team Worldwide Corp., IPR2018-00871, 2018 WL 4404107 at *5,
`
`Paper 14 at 13 (PTAB Sept. 14, 2018). Such minimal review “weighs against
`
`exercising discretion to deny under § 325(d).” Id.
`
`
`
`
`
`Petition for Inter Partes Review of USP 11,202,591
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`Page 5
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`IPR2023-01409
`Patent 11,202,591
`
`C.
`
`Parallel Proceeding
`
`Patent Owner asserts the ’591 patent against Petitioner in district court, with
`
`trial set for March 2026. EX1039, 14. Any IPR based on this Petition would conclude
`
`well in advance of this date and thus the Board should not discretionarily deny
`
`institution in view of the district court case.
`
`IV. THE ’591 PATENT
`
`The ’591 patent, titled “Analyte Sensor And Apparatus For Insertion Of The
`
`Sensor” issued December 21, 2021, from an application filed April 2, 2021, and
`
`claims priority through a series of continuing applications to a provisional
`
`application filed February 3, 2009.
`
`A. The ’591 Patent’s Specification
`
`The ’591 patent describes an inserter that inserts part of an on-body medical
`
`device (e.g., a cannula or an analyte sensor) into a subject using an automatically
`
`retractable sharp. E.g., EX1001, 2:13-36, 14:57-59, 16:20-28, FIGS. 8, 10, 28-31.
`
`The ’591 patent describes an on-body unit that includes a data processing unit and
`
`an analyte sensor “constructed to be maintained ‘on the body’ of the subject for a
`
`period of time.” Id., 9:31-41, FIGS. 1-9.
`
`Petition for Inter Partes Review of USP 11,202,591
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`IPR2023-01409
`Patent 11,202,591
`
`
`
`’591 patent, FIG. 30
`
`B.
`
`The Prosecution History
`
`The application was filed April 2, 2021, along with a preliminary amendment
`
`canceling original claims 1-20 and adding claims 21-50. EX1002, 13-19, 124-125.
`
`Another preliminary amendment filed August 30, 2021, amended certain dependent
`
`claims. Id., 174-184. Following an interview on November 2, 2021, the Examiner
`
`Petition for Inter Partes Review of USP 11,202,591
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`Page 7
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`IPR2023-01409
`Patent 11,202,591
`entered minor amendments and applicant filed terminal disclaimers as to two patents
`
`and a then-co-pending application. Id., 963, 876-885, 976 (indicating Examiner
`
`amendments to claim 21, which issued as claim 1). A Notice of Allowance issued
`
`November 12, 2021. Id., 971-978.
`
`C. Claims Listing
`
`Claim 1 is exemplary and recites:
`
`[1.4]
`[1.5]
`
`[1.6]
`[1.7]
`[1.8]
`[1.9]
`
`[1.1]2 An insertion assembly, comprising:
`[1.2]
`(a) an on-body unit, comprising:
`[1.3]
`
`a housing comprising a top surface and a bottom surface, wherein the
`top surface comprises an opening of the top surface, wherein the bottom
`surface comprises an opening of the bottom surface, and wherein a
`longitudinal axis extends through the opening of the top surface and the
`opening of the bottom surface;
`a glucose sensor; and
`sensor electronics disposed within the housing and coupled with the
`glucose sensor; and
`(b) an inserter, comprising:
`a proximal end, a distal end, and an interior; and
`a sharp,
`wherein the on-body unit and the sharp are entirely disposed in the
`interior of the inserter,
`wherein at least a portion of the glucose sensor is disposed in the sharp,
`wherein the sharp extends through the opening of the top surface and
`the opening of the bottom surface along the longitudinal axis when the on-
`body unit is in a first position,
`wherein the inserter is configured to advance the on-body unit and the
`sharp in a linear direction from the first position to a second position such
`that the sharp pierces skin of a user and the housing of the on-body unit is
`secured to the skin of the user in the second position,
`
`[1.10]
`[1.11]
`
`[1.12]
`
`
`2 Numbering in left-hand column added by Petitioner.
`
`Petition for Inter Partes Review of USP 11,202,591
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`Page 8
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`IPR2023-01409
`Patent 11,202,591
`
`[1.13]
`
`[1.14]
`
`[1.15]
`
`wherein the distal end of the inserter is configured to be positioned on
`the skin of the user before advancement of the on-body unit and the sharp,
`wherein the inserter is further configured to automatically retract the
`sharp from within the user and entirely into the interior of the inserter and
`leave a part of the glucose sensor in the skin of the user, and
`wherein the distal end of the inserter is further configured to be
`removed from the skin of the user after automatic retraction of the sharp from
`within the user.
`
`EX1001, 23:5-46 (claim 1).
`
`The only other independent claim, claim 19, includes features from claim 1
`
`along with limitations from certain claims that depend from claim 1:
`
`[19.1] An insertion assembly, comprising:
`[19.2]
`(a) an on-body unit, comprising:
`[19.3]
`
`a housing comprising a top surface and a bottom surface, wherein
`the top surface comprises an opening of the top surface, wherein the bottom
`surface comprises an opening of the bottom surface, and wherein a
`longitudinal axis extends through the opening of the top surface and the
`opening of the bottom surface;
`a glucose sensor; and
`sensor electronics disposed within the housing and coupled with the
`glucose sensor,
`wherein the sensor electronics comprise a processor, a power source,
`an analog interface, a data storage unit, and wireless communication
`circuitry configured to communicate data indicative of a glucose level; and
`(b) an inserter, comprising:
`a proximal end, a distal end, and an interior; and
`a sharp,
`wherein the on-body unit and the sharp are entirely disposed in the
`interior of the inserter,
`wherein at least a portion of the glucose sensor is disposed in the
`sharp,
`wherein the inserter is configured to advance the on-body unit and
`the sharp in a linear direction from a first position to a second position such
`
`[19.4]
`[19.5]
`
`[19.6]
`
`[19.7]
`[19.8]
`[19.9]
`[19.10]
`
`[19.11]
`
`[19.12]
`
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`IPR2023-01409
`Patent 11,202,591
`
`[19.13]
`
`[19.14]
`
`[19.15]
`
`[19.16]
`
`[19.17]
`
`[19.18]
`
`[19.19]
`
`that the sharp pierces skin of a user and the housing of the on-body unit is
`secured to the skin of the user in the second position,
`wherein a distance between the housing when the on-body unit is in
`the first position and the housing when the on-body unit is in the second
`position is greater than a maximum height of the housing,
`wherein a height profile of the housing is less than or equal to
`approximately 10 millimeters,
`wherein the sharp is configured to pierce the skin of the user at an
`angle substantially perpendicular to the skin of the user,
`wherein the sharp extends through the opening of the top surface and
`the opening of the bottom surface along the longitudinal axis when the on-
`body unit is in the first position,
`wherein the distal end of the inserter is configured to be positioned
`on the skin of the user before advancement of the on-body unit and the
`sharp,
`wherein the inserter is further configured to automatically retract the
`sharp from within the user and entirely into the interior of the inserter and
`leave a part of the glucose sensor in the skin of the user, and
`wherein the distal end of the inserter is further configured to be
`removed from the skin of the user after automatic retraction of the sharp
`from within the user.
`
`Id., 24:62-25:48 (claim 19).
`
`Each of the remaining challenged claims depends directly or indirectly either
`
`from claim 1, or claim 19, and their text is set forth in the specific Grounds in
`
`Sections VII-XI, below.
`
`V. LEVEL OF SKILL IN THE ART, AND STATE OF THE ART
`
`A.
`
`Person Of Ordinary Skill In The Art
`
`The POSITA had a bachelor’s degree in bioengineering, mechanical
`
`engineering, electrical engineering, or a related subject, and one or more years of
`
`experience researching, developing, and/or designing insertable medical devices,
`
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`IPR2023-01409
`Patent 11,202,591
`including, e.g., systems for implanting wearable medical devices such as cannulas,
`
`infusion sets, and analyte sensors, or equivalent experience. Less work experience
`
`may be compensated by a higher level of education, such as a master’s degree, and
`
`vice versa. EX1003, ¶28.
`
`B.
`
`State Of The Art
`
`1.
`
`Inserters With Auto-Retracting Needles Were Known
`
`Inserters using automatically retractable sharps to insert part of an on-body
`
`unit (e.g., a cannula or glucose sensor) into a subject were well-known before 2009.
`
`For example, Cote describes a device comprising an automatically retractable needle
`
`for inserting part of a cannula into a subject. See, e.g., EX1005, [0207], [0211].
`
`Likewise, Raymond (EX1009) describes an insertion device including a needle with
`
`an “automatic retraction feature.” See also EX1009, [0127]; EX1014, [0108],
`
`[0110]; EX1003, ¶29.
`
`2.
`
`Inserters Reduce Subject Pain And Anxiety
`
`It was known that manual use of a needle to insert a device through the skin
`
`causes a patient pain and anxiety. See, e.g., EX1036, [0004]-[0005] (“When
`
`performed manually, the penetration of the catheter-carrying needle into the body,
`
`however, may be considered uncomfortable for a patient, or may cause some other
`
`anxiety.”); EX1037, [0005].
`
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`IPR2023-01409
`Patent 11,202,591
`It was also known that more automatic inserters reduced the amount of pain
`
`and anxiety felt by subjects, e.g., by providing for faster needle puncturing and/or
`
`retraction. See, e.g., EX1036, [0007] (“[O]ne advantage of the invention is to
`
`increase the comfort of a patient during the insertion [by using an inserter in which]
`
`the needle, after reaching its extended state, can be withdrawn quickly and
`
`automatically by a retraction apparatus.”); EX1037, [0005]. Indeed, by 2007, other
`
`patents had recognized that “many manufacturers” had designed inserters to reduce
`
`the amount of pain felt by subjects during transcutaneous device insertion. Id.;
`
`EX1036, [0007]; EX1003, ¶¶30-32.
`
`3.
`
`Inserter Designs Were Interchangeably Used
`For Insertion Of Different Types Of Subcutaneous Devices
`
`It was well-known in the art that various inserters were interchangeably used
`
`for inserting analyte (e.g., glucose) sensors or cannulas or other transcutaneous
`
`devices. See, e.g., EX1010, [0015]–[0016], [0020]–[0023] (teaching an inserter for
`
`either a cannula or a glucose sensor), and EX1011, 4:20-5:2 (teaching an inserter
`
`used to deliver either an infusion device or a sensor device); see also EX1025,
`
`[0070]; EX1026, 1:33-40; EX1027, [0079]; EX1028, [0019]; EX1029, 2:23-26;
`
`EX1030, 13:12-16. In an IPR involving similar technology, the Board recently found
`
`a POSITA in March 2010 “would [be] aware of the interchangeability of sensors and
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`cannulas in inserter devices.” Dexcom, Inc. v. Abbott Diabetes Care Inc., IPR2022-
`
`00605, Paper 29 at 32-34 (PTAB July 10, 2023).
`
`Indeed, the ’591 patent states that its “inserter can be configured to insert
`
`various medical devices to the subject, such as for example, an analyte sensor, an
`
`infusion set, a cannula, or a lancet” (EX1001, 14:54-59), yet provides no meaningful
`
`guidance on how to configure or adapt the inserter for the various types of devices.
`
`See also id., 1:21-31 (“an inserter device, for example, to insert an analyte sensor
`
`and/or an infusion set”), 2:13-20. This reflects the known interchangeability of
`
`inserter devices between infusion sets and analyte sensors and similar devices.
`
`EX1003, ¶¶33-34.
`
`4.
`
`Low-Profile On-Body Devices Were Known
`
`The desirability of “low profile,” “unobtrusive” on-body units was well
`
`known. E.g., EX1005, [0228]; see also EX1004, [0045] (describing benefits of
`
`“smaller profile” on-body unit). Specifically, on-body-units were known to have a
`
`height profile of 10 mm or below. See, e.g., EX1012, [0334]; EX1013, [0425];
`
`EX1014, [0074]; EX1015, 29:63-64; EX1016, 30:33-34; EX1003, ¶35.
`
`5.
`
`It Was Known To Protect Needles And Avoid Needle Sticks
`
`Designing inserters to conceal the needle and prevent needle sticks was also
`
`well-known. See, e.g., EX1009, [0127]. It was known to implement a needle/sharp
`
`extending past the distal tip of a transcutaneous device to protect the transcutaneous
`
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`device (see e.g., EX1004, FIG. 2; EX1005, FIG. 6A) and to shroud the needle within
`
`the inserter prior to and after insertion to minimize anxiety and avoid inadvertent
`
`needle-sticks. EX1005, [0005], [0235].
`
`It was well-known that, to insert a transcutaneous device using an inserter, the
`
`needle and the on-body unit must travel a distance (“distance of travel”) at least equal
`
`to an implantable length of the transcutaneous device in order for the transcutaneous
`
`device to be fully inserted into the skin. See, e.g., EX1017, [0027].
`
`It was routine for this distance of travel (“H1”) to be greater than a height of
`
`the housing of the on-body unit (“H2”), to prevent the needle from being exposed at
`
`the distal end of the inserter for the reasons mentioned above. As shown below,
`
`Hasted (EX1011), Raymond (EX1009), Kovelman (EX1020), and Cote (EX1005)
`
`disclose on-body medical devices (e.g., glucose sensors, infusion sets, etc.) with
`
`travel distances greater than the heights of their housings.
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`Hasted, FIG. 1 (partial, annotated)3
`
`
`
`Raymond, FIG. 29 (partial, annotated)
`
`
`
`
`3 Unless otherwise noted, all color annotations to the FIGS. througho