IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`Abbott Diabetes Care Inc.
`Petitioner,
`
`
`v.
`
`DexCom, Inc.,
`Patent Owner.
`
`
`Case No. IPR2024-00859
`Patent No. 11,510,625
`
`
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO.
`11,510,625
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 et seq.
`
`
`
`
`
`
`
`

`

`
`
`Table of Contents
`
`I.
`
`II.
`
`Introduction ...................................................................................................... 1
`
`Standing, Mandatory Notices, and Fee Authorization .................................... 1
`
`A. Grounds for Standing ............................................................................ 1
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`Real Party In Interest ............................................................................. 2
`
`Related Matters ...................................................................................... 2
`
`Lead And Back-Up Counsel ................................................................. 2
`
`Service Information ............................................................................... 3
`
`Fee Authorization .................................................................................. 3
`
`III.
`
`Summary of Challenge .................................................................................... 4
`
`IV. The ’625 Patent ................................................................................................ 5
`
`A. Overview Of The ’625 Patent ............................................................... 5
`
`B.
`
`C.
`
`Prosecution History ............................................................................... 6
`
`Claim Listing ......................................................................................... 8
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`Claim 1 ........................................................................................ 8
`
`Claim 2 ........................................................................................ 8
`
`Claim 3 ........................................................................................ 8
`
`Claim 4 ........................................................................................ 9
`
`Claim 5 ........................................................................................ 9
`
`Claim 6 ........................................................................................ 9
`
`Claim 7 ........................................................................................ 9
`
`Claim 8 ........................................................................................ 9
`
`Claim 9 ........................................................................................ 9
`
`- i -
`
`

`

`
`
`10. Claim 13 ....................................................................................10
`
`11. Claim 14 ....................................................................................10
`
`12. Claim 15 ....................................................................................10
`
`13. Claim 16 ....................................................................................11
`
`14. Claim 17 ....................................................................................11
`
`15. Claim 18 ....................................................................................11
`
`16. Claim 19 ....................................................................................11
`
`17. Claim 22 ....................................................................................11
`
`18. Claim 23 ....................................................................................12
`
`19. Claim 24 ....................................................................................12
`
`20. Claim 25 ....................................................................................12
`
`21. Claim 26 ....................................................................................12
`
`22. Claim 27 ....................................................................................12
`
`23. Claim 28 ....................................................................................12
`
`24. Claim 29 ....................................................................................13
`
`25. Claim 30 ....................................................................................13
`
`D.
`
`Effective Filing Date Of The ’625 Patent ...........................................14
`
`V.
`
`Level of Ordinary Skill In the Art .................................................................14
`
`VI. Claim Construction ........................................................................................14
`
`A.
`
`“[B]y heat staking, snap-fit, friction-fit, clamshell[,] or insert
`molding” (claims 4, 14, 26, 30) And “[B]y insert molding”
`(Claims 5, 15, 27) ................................................................................15
`
`VII. Overview Of The Prior Art ............................................................................16
`
`A.
`
`Pace (Ex-1006) ....................................................................................16
`
`- ii -
`
`

`

`
`
`B.
`
`C.
`
`Pace 2 (Ex-1007) .................................................................................21
`
`Chae (Ex-1008) ...................................................................................26
`
`1.
`
`2.
`
`Overview Of Chae ....................................................................27
`
`Chae Is Entitled To A June 2, 2017, Effective Filing Date ......31
`
`D.
`
`Lundquist (Ex-1011) ...........................................................................32
`
`VIII. The Asserted Grounds Of UnpatentabIlity ....................................................34
`
`A. Ground 1: Pace Anticipates Or Renders Obvious The
`Challenged Claims ..............................................................................34
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`Independent Claim 1 .................................................................34
`
`Independent Claim 13 ...............................................................50
`
`Independent Claim 22 ...............................................................52
`
`Independent Claim 28 ...............................................................57
`
`Claims 2 & 25 ...........................................................................61
`
`Claim 3 ......................................................................................63
`
`Claims 4, 14, 26, & 30 ..............................................................64
`
`Claims 5, 15, & 27 ....................................................................65
`
`Claims 6 & 16 ...........................................................................66
`
`10. Claims 7, 17, & 29 ....................................................................66
`
`11. Claims 8 & 18 ...........................................................................68
`
`12. Claim 9 ......................................................................................69
`
`13. Claim 19 ....................................................................................69
`
`14. Claim 23 ....................................................................................70
`
`15. Claim 24 ....................................................................................70
`
`- iii -
`
`

`

`
`
`B.
`
`Ground 2: The Combination Of Pace And Lundquist Renders
`Obvious Claims 4-5, 14-15, 26-27, And 30 ........................................71
`
`1.
`
`2.
`
`3.
`
`A POSITA Would Have Been Motivated To Combine Pace
`And Lundquist And Would Have Reasonably Expected Success
` ...................................................................................................71
`
`Claims 4, 14, 26, & 30 ..............................................................72
`
`Claims 5, 15, & 27 ....................................................................74
`
`C.
`
`Ground 3: Pace 2 Renders Obvious Claims 1-3, 6-9, 13, 16-19,
`22-25, And 28-29 ................................................................................76
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`Independent Claim 1 .................................................................76
`
`Independent Claim 13 ...............................................................85
`
`Independent Claim 22 ...............................................................87
`
`Independent Claim 28 ...............................................................91
`
`Claims 2 & 25 ...........................................................................94
`
`Claim 3 ......................................................................................95
`
`Claims 6 & 16 ...........................................................................96
`
`Claims 7, 17, & 29 ....................................................................96
`
`Claims 8 & 18 ...........................................................................97
`
`10. Claim 9 ......................................................................................97
`
`11. Claim 19 ....................................................................................97
`
`12. Claim 23 ....................................................................................98
`
`13. Claim 24 ....................................................................................98
`
`D. Ground 4: The Combination Of Pace 2 And Lundquist Renders
`Obvious Claims 4-5, 14-15, 26-27, and 30 .........................................99
`
`- iv -
`
`

`

`
`
`1.
`
`2.
`
`3.
`
`A POSITA Would Have Been Motivated To Combine Pace 2
`And Lundquist And Would Have Reasonably Expected Success
` ...................................................................................................99
`
`Claims 4, 14, 26, & 30 ............................................................101
`
`Claims 5, 15, & 27 ..................................................................101
`
`E.
`
`Ground 5: Chae Renders Obvious Claims 1-3, 6, 9, 13, 16, And
`22-24 ..................................................................................................102
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`Independent Claim 1 ...............................................................102
`
`Independent Claim 13 .............................................................114
`
`Independent Claim 22 .............................................................115
`
`Claims 2 & 25 .........................................................................117
`
`Claim 3 ....................................................................................118
`
`Claims 6 & 16 .........................................................................119
`
`Claim 9 ....................................................................................119
`
`Claim 23 ..................................................................................120
`
`Claim 24 ..................................................................................121
`
`IX. The Board Should Not Use Its Discretion To Deny Institution ..................121
`
`A.
`
`B.
`
`314(a) .................................................................................................121
`
`325(d) ................................................................................................122
`
`X.
`
`Conclusion ...................................................................................................124
`
`
`
`
`
`
`- v -
`
`

`

`
`
`LIST OF EXHIBITS
`
`Description
`U.S. Patent No. 11,510,625 (the “’625 patent”)
`File History for U.S. Patent No. 11,510,625
`Blank
`Declaration of Cameron Riviere, Ph.D.
`Curriculum Vitae of Cameron Riviere, Ph.D.
`U.S. Patent Publication No. 2013/0150691 (Pace)
`U.S. Patent Publication No. 2016/0331284 (Pace 2)
`U.S. Patent Publication No. 2020/0178899 (Chae)
`Korean Patent Application No. 10-2017-0068964
`Certified English Translation of Korean Patent Application No.
`10-2017-0068964
`U.S. Patent Publication No. 2014/0188053 (Lundquist)
`Blank
`Blank
`U.S. Pat. No. 6,175,752 (Say)
`Neil Sclater and Nicholas P. Chironis, Mechanisms and
`Mechanical Devices Sourcebook (4th ed. McGraw-Hill, 2007)
`M. A. Meltsner, et al., Observations on rotating needle
`insertions using a brachytherapy robot, 52 Physics in Medicine
`and Biology 6027-6037 (2007)
`Ryosuke Tsumura, et al., Histological evaluation of tissue
`damage caused by rotational needle insertion, Proceedings of
`the Annual International Conference of the IEEE Engineering in
`Medicine and Biology Society, 5120-5123 (2016)
`Abbott Diabetes Care Inc. et al. v. DexCom, Inc., No. 1:23-cv-
`00239, Dkt. 54 (D. Del. Sept. 19, 2023)
`
`Exhibit
`1001
`1002
`1003
`1004
`1005
`1006
`1007
`1008
`1009
`1010
`
`1011
`1012
`1013
`1014
`1015
`
`1016
`
`1017
`
`1018
`
`- vi -
`
`

`

`
`
`I.
`
`INTRODUCTION
`
`Since the advent of the first transdermal implantable glucose sensors in 1999,
`
`makers of continuous glucose monitoring (CGM) systems have had to address
`
`numerous engineering challenges relating to these wearable medical devices. One of
`
`those challenges is to limit unwanted rotation of the needle used to partially implant
`
`the glucose sensor in the patient.
`
`The claims of U.S. Patent No. 11,510,625 (the “’625 patent”) purport to
`
`address this challenge. For example, independent claim 1 recites, in pertinent part,
`
`an “anti-rotation feature … configured to prevent rotation of [a] needle hub within
`
`[an] aperture [of an on-skin sensor assembly].” As set forth in detail below, however,
`
`the claimed “anti-rotation feature,” along with all of the other claimed limitations of
`
`the ’625 patent, were disclosed long ago in the prior art, including several of
`
`Petitioner’s patent publications.
`
`Accordingly, Abbott Diabetes Care Inc. (“Petitioner”) petitions for inter
`
`partes review seeking cancellation of claims 1-9, 13-19, and 22-30 (“Challenged
`
`Claims”) of the ’625 patent.
`
`II.
`
`STANDING, MANDATORY NOTICES, AND FEE
`AUTHORIZATION
`
`A. Grounds for Standing
`
`Pursuant to 37 C.F.R. §42.104 (a), Petitioner certifies that the ’625 patent is
`
`available for inter partes review and that Petitioner is not barred or estopped from
`
`- 1 -
`
`

`

`
`
`requesting inter partes review based on the grounds identified in this petition.
`
`B. Real Party In Interest
`
`Petitioner certifies that the real parties-in-interest of this Petition are Abbott
`
`Diabetes Care Inc., Abbott Diabetes Care Sales Corp., and Abbott Laboratories.
`
`Abbott Diabetes Care Inc. is the Petitioner. Abbott Diabetes Care Inc. is directly
`
`owned by Abbott Laboratories. Abbott Diabetes Care Inc. directly owns Abbott
`
`Diabetes Care Sales Corp.
`
`C. Related Matters
`
`The ’625 patent is asserted against Abbott Diabetes Care Inc. and Abbott
`
`Diabetes Care Sales Corp. as a counterclaim for infringement in Abbott Diabetes
`
`Care Inc. et al. v. DexCom, Inc., No. 1:23-cv-00239 (D. Del). DexCom, Inc. (“Patent
`
`Owner” or “DexCom”) asserted the ’625 patent in its Answer, Affirmative Defenses,
`
`and Counterclaims, electronically served on Petitioner Abbott Diabetes Care Inc. on
`
`May 12, 2023, and hand-served on Abbott Diabetes Care Sales Corp. on May 15,
`
`2023. Petitioner asserts that the ’625 patent is not infringed.
`
`D. Lead And Back-Up Counsel
`
`Petitioner designates the following counsel:
`
`Lead Counsel
`Scott C. Weidenfeller (Reg. No.
`54,531)
` sweidenfeller@cov.com
`Postal and Hand-Delivery Address:
`Covington & Burling LLP
`
`Back-Up Counsel
`Peter P. Chen (Reg. No. 39,631)
` pchen@cov.com
`Postal and Hand-Delivery Address:
`Covington & Burling LLP
`3000 El Camino Real
`
`- 2 -
`
`

`

`
`
`One CityCenter, 850 Tenth Street NW
`Washington, DC 20001
`Telephone: (202) 662-5923
`Facsimile: (202) 778-5923
`
`5 Palo Alto Square, 10th Floor
`Palo Alto, CA 94306
`Telephone: (650) 632-4700
`Facsimile: (650) 632-4820
`
`David A. Garr (Reg. No. 74,932)
` dgarr@cov.com
`Postal and Hand-Delivery Address:
`Covington & Burling LLP
`One CityCenter, 850 Tenth Street NW
`Washington, DC 20001
`Telephone: (202) 662-5250
`Facsimile: (202) 778-5250
`
`Pursuant to 37 C.F.R. §42.10 (b), Petitioner has filed a power of attorney with
`
`the above designation of counsel.
`
`
`
`E.
`
`Service Information
`
`Please address correspondence to counsel at the address above. Petitioner
`
`consents to electronic service to: Abbott-IPR@cov.com and the email addresses
`
`listed above. Service information is provided in the designation of counsel above.
`
`F.
`
`Fee Authorization
`
`This Petition is accompanied by the fees set forth in 37 C.F.R. §42.15(a).
`
`Please charge or credit Deposit Account No. 60-3160 with any shortage or
`
`overpayment of fees associated with this Petition and any other fees incurred by
`
`Petitioner.
`
`
`
`- 3 -
`
`

`

`
`
`III. SUMMARY OF CHALLENGE
`
`Petitioner challenges claims 1-9, 13-19, 22-30 of the ’625 patent and requests
`
`these claims be found unpatentable in view of the following references:
`
`(1) U.S. Patent App. Pub. No. US 2013/0150691 (“Pace”) (Ex-1006);
`(2) U.S. Patent App. Pub. No. US 2016/0331284 (“Pace 2”) (Ex-1007);
`(3) U.S. Patent App. Pub. No. US 2020/0178899 (“Chae”) (Ex-1008); and
`(4) U.S. Patent App. Pub. No. US 2014/0188053 (“Lundquist”) (Ex-1011)
`
`Petitioner asserts the following grounds of unpatentability under 35 U.S.C.
`
`§§102 and 103 (AIA):
`
`Ground
`
`Reference(s)
`
`Statutory Basis Challenged Claims
`
`1
`
`2
`
`3
`
`4
`
`5
`
`Pace
`
`§§102, 103
`
`1-9, 13-19, 22-30
`
`Pace & Lundquist
`
`§103
`
`4-5, 14-15, 26-27, 30
`
`Pace 2
`
`Pace 2 & Lundquist
`
`Chae
`
`§103
`
`§103
`
`§103
`
`1-3, 6-9, 13, 16-19, 22-
`
`25, 28-29
`
`4-5, 14-15, 26-27, 30
`
`1-3, 6, 9, 13, 16, 22-24
`
`This Petition is accompanied by the declaration of Cameron Riviere, Ph.D.,
`
`an expert in orienting needles in medical devices. Ex-1004.
`
`
`
`- 4 -
`
`

`

`
`
`IV. THE ’625 PATENT
`
`A. Overview Of The ’625 Patent
`
`The ’625 patent relates to “systems and methods for measuring an analyte in
`
`a host,” including a “transcutaneous analyte measurement system.” Ex-1001, 2:10-
`
`14. The ’625 patent acknowledges that such systems were in the prior art. Id., 19:55-
`
`20:8.
`
`While the ’625 patent describes multiple CGM applicator embodiments for
`
`applying an on-skin sensor assembly, there is scarce disclosure, beyond mere
`
`functional description, of structures constituting an “anti-rotation feature” or “key”
`
`to prevent rotation of a needle hub within an aperture of an on-skin sensor assembly.
`
`For example, for Figure 91, the specification describes an aperture 9294 in the on-
`
`skin sensor assembly that is “configured to” engage with an anti-rotation feature
`
`“such as base 7152 of needle hub 7150”:
`
`aperture 9294
`
`
`
`- 5 -
`
`

`

`
`
`Id., Fig. 91 (annotated1); 25:40-46.
`
`The specification calls “base 7152 of needle hub 7150” in Figure 78 “an anti-
`
`rotational feature,” id., 25:45-46, but does not identify any particular structures that
`
`would prevent rotation. Completely lacking is any explanation of how the base 7152
`
`would interact with the aperture 9294 of Figure 91:
`
`
`
`Id., Fig. 78; see also id., 68:41-56. The ’625 patent therefore offers little guidance
`
`as to what constitutes the claimed “anti-rotation feature” or “anti-rotation key.”
`
`B.
`
`Prosecution History
`
`The ’625 patent was filed with one claim as U.S. Application No. 17/592,170
`
`on February 3, 2022, in a chain of continuation applications first filed on June 22,
`
`2018, claiming priority to two provisional applications. Ex-1001, 1-2. On March 2,
`
`
`1 Color annotations in Figures added throughout unless otherwise noted.
`
`- 6 -
`
`

`

`
`
`2022, DexCom filed three IDSs listing over 500 references. Ex-1002, 289-373. On
`
`April 13, 2022, the Examiner issued an Office Action rejecting the sole claim as
`
`anticipated by U.S. Patent No. 6,248,067, as well as for double-patenting over nine
`
`co-pending DexCom applications. Id., 379-385.
`
`On May 13, 2022, DexCom filed an amendment cancelling original claim 1
`
`and adding 22 new claims. Id., 481-488. Six days later, DexCom filed a
`
`“supplemental” amendment adding 9 more new claims. Id., 512-521. Less than one
`
`month later, on June 2, 2022, the Examiner allowed all pending claims. Id., 522-536.
`
`- 7 -
`
`

`

`
`
`
`
`
`
`
`
`1.P
`
`1.1
`1.2
`
`1.3
`1.4
`1.5
`1.6
`1.7
`
`1.8
`
`1.9
`
`1.10
`
`1.11
`
`2
`
`3
`
`C. Claim Listing
`
`1.
`
`Claim 1
`
`An applicator for applying an on-skin sensor assembly to a skin of a
`host, the applicator comprising:
`an applicator housing having an internal volume;
`a needle hub coupled to an insertion element configured to pierce a
`skin of a host, the needle hub comprising:
`a base, and
`an anti-rotation feature extending from the base,
`the anti-rotation feature comprising a key, the key having a first shape;
`and an on-skin sensor assembly comprising:
`a sensor, the sensor configured to measure a glucose concentration of
`a host, and
`an aperture extending from a top surface of the on-skin sensor
`assembly,
`the aperture having a second shape, the second shape complementary
`to the first shape of the key; and
`wherein the key of the anti-rotation feature is configured to be at least
`partially disposed in the aperture of the on-skin sensor assembly;
`wherein the anti-rotation feature is configured to prevent rotation of
`the needle hub within the aperture.
`
`2.
`
`Claim 2
`
`The applicator of claim 1, wherein the insertion element comprises an
`open side configured to receive the sensor.
`
`3.
`
`Claim 3
`
`The applicator of claim 2, wherein the insertion element has a C-
`shaped, U-shaped, or V-shaped cross section.
`
`- 8 -
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`4.
`
`Claim 4
`
`The applicator of claim 1, wherein the needle hub is coupled to the
`insertion element by heat staking, snap-fit, friction-fit, clamshell, or
`insert molding.
`
`5.
`
`Claim 5
`
`The applicator of claim 4, wherein the insertion element comprises a
`locking element configured to couple the insertion element to the
`needle hub by insert molding.
`
`6.
`
`Claim 6
`
`The applicator of claim 1, wherein the on-skin sensor assembly
`comprises an electronics unit.
`
`7.
`
`Claim 7
`
`The applicator of claim 6, wherein the electronics unit includes a
`power source,
`signal processing components, data
`storage
`components, and a communication module.
`
`
`
`8.
`
`Claim 8
`
`The applicator of claim 7, wherein the sensor is connected to the
`electronics unit in the applicator housing.
`
`9.
`
`Claim 9
`
`The applicator of claim 1, wherein the on-skin sensor assembly
`includes an adhesive patch configured to secure the on-skin sensor
`assembly to the skin of the host.
`
`- 9 -
`
`

`

`
`
`
`
`
`
`
`
`13.P
`
`13.1
`13.2
`13.3
`
`13.4
`13.5
`
`13.6
`13.7
`13.8
`
`13.9
`
`13.10
`
`13.11
`
`14
`
`15
`
`10. Claim 13
`
`An applicator for applying an on-skin sensor assembly to a skin of a
`host, the applicator comprising:
`an applicator housing having an internal volume;
`a needle hub coupled to a needle,
`wherein the needle comprises a portion configured to extend through
`the skin of the host,
`wherein the needle hub comprises a base,
`wherein the base comprises an anti-rotation key, wherein the anti-
`rotation key has a first shape;
`and an on-skin sensor assembly comprising:
`a sensor configured to measure a glucose concentration of a host;
`and an aperture extending from a top surface of the on-skin sensor
`assembly,
`wherein the aperture has a second shape, wherein the second shape is
`complementary to the first shape of the anti-rotation key;
`and wherein the anti-rotation key is configured to be at least partially
`disposed in the aperture of the on-skin assembly;
`and wherein the anti-rotation key is configured to prevent rotation of
`the needle hub with respect to the on-skin sensor assembly.
`
`11. Claim 14
`
`The applicator of claim 13, wherein the needle hub is coupled to the
`needle by heat staking, snap-fit, friction-fit, clamshell or insert
`molding.
`
`12. Claim 15
`
`The applicator of claim 14, wherein the needle comprises a locking
`element configured to couple the needle to the needle hub by insert
`molding.
`
`- 10 -
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`16
`
`17
`
`18
`
`19
`
`22.P
`
`22.1
`22.2
`
`22.3
`
`22.4
`
`13. Claim 16
`
`The applicator of claim 13, wherein the on-skin sensor assembly
`comprises sensor electronics.
`
`14. Claim 17
`
`The applicator of claim 16, wherein the sensor electronics includes a
`power source,
`signal processing components, data
`storage
`components, and a communication module.
`
`15. Claim 18
`
`The applicator of claim 17, wherein the sensor is connected to the
`sensor electronics in the applicator housing.
`
`16. Claim 19
`
`The applicator of claim 16, wherein the needle is configured to be
`inserted through the sensor electronics.
`
`17. Claim 22
`
`A needle hub for applying an on-skin sensor assembly to a skin of a
`host, the needle hub comprising:
`a base comprising an anti-rotation key,
`the anti-rotation key configured to be at least partially disposed in an
`aperture of an on-skin sensor assembly,
`wherein the needle hub is configured to couple with an insertion
`element; and
`wherein the base comprises a flat surface configured to mate with a
`top surface of the on-skin sensor assembly, thereby maintaining the
`insertion element in a substantially perpendicular orientation to the top
`surface of the on-skin sensor assembly.
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`- 11 -
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`

`

`
`
`
`
`
`
`
`
`
`
`23
`
`24
`
`25
`
`26
`
`27
`
`
`
`28.P
`
`28.1
`28.2
`
`28.3
`
`18. Claim 23
`
`The needle hub of claim 22, wherein the anti-rotation key is configured
`to prevent rotation of the base within the aperture.
`
`19. Claim 24
`
`The needle hub of claim 22, wherein the anti-rotation key has a shape
`complementary to at least a portion of the aperture.
`
`20. Claim 25
`
`The needle hub of claim 22, wherein the insertion element comprises
`an open side configured to receive a sensor of the on-skin sensor
`assembly.
`
`21. Claim 26
`
`The needle hub of claim 22, wherein the needle hub is coupled to the
`insertion element by heat staking, snap-fit, friction-fit, clamshell, or
`insert molding.
`
`22. Claim 27
`
`The needle hub of claim 26, wherein the insertion element comprises
`a locking element configured to couple the insertion element to the
`needle hub by insert molding.
`
`23. Claim 28
`
`An applicator for applying an on-skin sensor assembly to a skin of a
`host, the applicator comprising:
`an applicator housing having an internal volume;
`a needle hub coupled to a needle configured to pierce a skin of a host,
`the needle hub comprising:
`a base, and
`
`- 12 -
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`

`

`28.4
`28.5
`
`28.6
`28.7
`
`28.8
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`28.9
`
`28.10
`
`28.11
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`28.12
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`28.13
`
`29
`
`30
`
`
`
`
`
`
`
`
`
`an anti-rotation feature extending from the base,
`the anti-rotation feature comprising a key, the key having a first shape;
`and
`an on-skin sensor assembly comprising:
`a sensor, the sensor configured to measure a glucose concentration of
`a host;
`an aperture extending from a top surface of the on-skin sensor
`assembly,
`the aperture having a second shape, the second shape complementary
`to the first shape of the key, and
`sensor electronics operably connected to the sensor in the applicator
`housing;
`wherein the key of the anti-rotation feature is configured to be at least
`partially disposed in the aperture of the on-skin sensor assembly;
`wherein the anti-rotation feature is configured to prevent rotation of
`the base within the aperture; and
`wherein the needle is configured to be inserted through at least a
`portion of the sensor electronics.
`
`24. Claim 29
`
`The applicator of claim 28, wherein the sensor electronics includes a
`power
`source,
`signal processing components, data
`storage
`components, and a communication module.
`
`25. Claim 30
`
`The applicator of claim 28, wherein the needle hub is coupled to the
`needle by heat staking, snap-fit, friction-fit, clamshell, or insert
`molding.
`
`- 13 -
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`

`
`
`D. Effective Filing Date Of The ’625 Patent
`
`The ’625 patent claims priority to U.S. Provisional Application Nos.
`
`62/658,486, filed on April 16, 2018, and 62/524,247, filed on June 23, 2017. Ex-
`
`1001, 1-2. For this Petition only, and without conceding that the ’625 patent is
`
`entitled to the benefit of the earliest claimed priority date, Petitioner applies June 23,
`
`2017, as the ’625 patent’s effective filing date.2
`
`V. LEVEL OF ORDINARY SKILL IN THE ART
`
`A POSITA as of the claimed priority date would have had a Bachelor’s degree
`
`in mechanical or biomedical engineering (or a related or equivalent field) and two
`
`or more years of experience researching, developing, designing and/or evaluating
`
`medical devices utilizing needles or sharps, or equivalent experience. A person with
`
`less or different education but more relevant practical experience, or vice versa, may
`
`also meet this standard. The prior art also evidences the level of skill in the art. Ex-
`
`1004, ¶35.
`
`VI. CLAIM CONSTRUCTION
`
`In IPR proceedings, claims are construed in accordance with their “ordinary
`
`and customary meaning” in light of the specification. 37 C.F.R. §42.100(b); see
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005). For purposes of
`
`
`2 In concurrently-filed IPR2024-00860, Petitioner asserts that the claims of the
`
`’625 patent are not entitled to the filing date of Application No. 62/524,247.
`
`- 14 -
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`
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`this petition, other than as discussed below, Petitioner does not believe that any
`
`specialized constructions are necessary. Petitioner reserves the right to dispute in a
`
`different forum whether the Challenged Claims meet the requirements under 35
`
`U.S.C. §§101 or 112.
`
`A.
`
`“[B]y heat staking, snap-fit, friction-fit, clamshell[,] or insert
`molding” (claims 4, 14, 26, 30) And “[B]y insert molding” (Claims
`5, 15, 27)
`
`Claims 4, 14, 26, and 30 each recite that “the needle hub is coupled to the
`
`[insertion element/needle] by heat staking, snap-fit, friction-fit, clamshell[,] or insert
`
`molding.” In addition, claims 5, 15, and 27 each further require a “locking element”
`
`configured to couple the needle to the needle hub “by insert molding.” The recited
`
`alternatives merely describe different methods by which
`
`the
`
`insertion
`
`element/needle or “locking element” thereof is physically coupled to the needle hub,
`
`not any significant structural differences. Accordingly, the phrases “by heat staking,
`
`snap-fit, friction-fit, clamshell[,] or insert molding” and “by insert molding” should
`
`be construed as product-by-process limitations.
`
`“If the product in the product-by-process claim is the same as or obvious from
`
`a product of the prior art, the claim is unpatentable even though the prior product
`
`was made by a different process.” In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985).
`
`Notably, the ’625 patent does not suggest that the claimed molding methods are
`
`novel or non-obvious. Indeed, these alternatives are only mentioned in passing (Ex-
`
`- 15 -
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`

`

`
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`1001, 69:17-32), presuming a POSITA was familiar with these well-known methods.
`
`Furthermore, there is no indication that the different methods of coupling the needle
`
`to the needle hub recited in the claim would result in any structural differences.
`
`VII. OVERVIEW OF THE PRIOR ART
`
`A.
`
`Pace (Ex-1006)
`
`U.S. Patent Publication No. 2013/0150691, titled “Analyte Sensor Devices,
`
`Connections and Methods,” to Pace et al. (“Pace”) was filed on December 11, 2012,
`
`and published on June 13, 2013. Ex-1006, Cover. Accordingly, Pace qualifies as
`
`prior art under at least 35 U.S.C. §§102(a)(1) and (a)(2) (AIA). Pace was listed in an
`
`IDS along with hundreds of references during prosecution of the ’625 patent, but the
`
`Examiner never cited or discussed Pace in any rejection.
`
`Pace discloses multiple CGM applicators with on-body devices. In each
`
`embodiment, a glucose sensor mates with an electronics assembly inside the
`
`applicator prior to use, forming a complete on-body device (i.e., the claimed “on-
`
`skin sensor assembly”). A first embodiment (“embodiment A”) is depicted in
`
`Figures 21A-C (below). In this embodiment, “a sensor assembly gripper 2106, with
`
`a light snap fit, grabs and orients the sensor assembly 2104 for connection to the
`
`electronics assembly 2102” as part of the “mating” process to form the on-body
`
`device. Ex-1006,
`
`[0123].The sensor assembly gripper
`
`features may be
`
`“incorporated” in a “sharp hub.” Id. As shown in Figures 21A-21C, the base
`
`- 16 -
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`

`
`
`(annotated in green) of the sharp hub/gripper 2106 (annotated in blue) has an anti-
`
`rotation feature (annotated in yellow) with a key (annotated in purple). Id., Figs.
`
`21A-21C, [0123]. The anti-rotation feature and its corresponding receiving
`
`aperture(s) (annotated in red) in