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. IPR2024-00860
`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 ................................................................................................ 4
`
`A. Overview Of The ’625 Patent ............................................................... 4
`
`B.
`
`C.
`
`Prosecution History ............................................................................... 6
`
`Claim Listing ......................................................................................... 7
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`Claim 1 ........................................................................................ 7
`
`Claim 2 ........................................................................................ 7
`
`Claim 3 ........................................................................................ 7
`
`Claim 4 ........................................................................................ 8
`
`Claim 5 ........................................................................................ 8
`
`Claim 6 ........................................................................................ 8
`
`Claim 7 ........................................................................................ 8
`
`Claim 8 ........................................................................................ 8
`
`- i -
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`

`

`
`
`9.
`
`Claim 9 ........................................................................................ 8
`
`10. Claim 13 ...................................................................................... 9
`
`11. Claim 14 ...................................................................................... 9
`
`12. Claim 15 ...................................................................................... 9
`
`13. Claim 16 ....................................................................................10
`
`14. Claim 17 ....................................................................................10
`
`15. Claim 18 ....................................................................................10
`
`16. Claim 19 ....................................................................................10
`
`17. Claim 22 ....................................................................................10
`
`18. Claim 23 ....................................................................................11
`
`19. Claim 24 ....................................................................................11
`
`20. Claim 25 ....................................................................................11
`
`21. Claim 26 ....................................................................................11
`
`22. Claim 27 ....................................................................................11
`
`23. Claim 28 ....................................................................................11
`
`24. Claim 29 ....................................................................................12
`
`25. Claim 30 ....................................................................................12
`
`D.
`
`Effective Filing Date Of The ’625 Patent ...........................................13
`
`1.
`
`The ’625 Patent Is Not Entitled To The Filing Date Of The ’247
`Provisional ................................................................................13
`
`V.
`
`Level Of Ordinary Skill In The Art ...............................................................15
`
`VI. Claim Construction ........................................................................................15
`
`- ii -
`
`

`

`
`
`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) ................................................................................16
`
`VII. Overview Of The Prior Art ............................................................................17
`
`A.
`
`B.
`
`Rao (Ex-1012) .....................................................................................17
`
`Lundquist (Ex-1011) ...........................................................................21
`
`VIII. The Asserted Grounds Of Unpatentability ....................................................22
`
`A. Ground 1: Rao Renders Obvious The Challenged Claims .................22
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`Independent Claim 1 .................................................................22
`
`Independent Claim 13 ...............................................................35
`
`Independent Claim 22 ...............................................................36
`
`Independent Claim 28 ...............................................................42
`
`Claims 2 & 25 ...........................................................................50
`
`Claim 3 ......................................................................................51
`
`Claims 4, 14, 26, & 30 ..............................................................52
`
`Claims 5, 15, & 27 ....................................................................53
`
`Claims 6 & 16 ...........................................................................55
`
`10. Claims 7, 17, & 29 ....................................................................56
`
`11. Claims 8 & 18 ...........................................................................58
`
`12. Claim 9 ......................................................................................58
`
`13. Claim 19 ....................................................................................59
`
`14. Claim 23 ....................................................................................60
`
`15. Claim 24 ....................................................................................60
`
`- iii -
`
`

`

`
`
`B.
`
`Ground 2: The Combination Of Rao And Lundquist Renders
`Obvious Claims 4-5, 14-15, 26-27, And 30 ........................................61
`
`1.
`
`2.
`
`3.
`
`A POSITA Would Have Been Motivated To Combine Rao And
`Lundquist And Would Have Reasonably Expected Success ....61
`
`Claims 4, 14, 26, & 30 ..............................................................63
`
`Claims 5, 15, & 27 ....................................................................64
`
`IX. The Board Should Not Use Its Discretion To Deny Institution ....................67
`
`A.
`
`B.
`
`314(a) ...................................................................................................67
`
`325(d) ..................................................................................................68
`
`X.
`
`Conclusion .....................................................................................................68
`
`
`
`
`
`
`- iv -
`
`

`

`
`
`Exhibit
`1001
`1002
`1003
`
`1004
`1005
`1006
`1007
`1008
`1009
`1010
`1011
`1012
`1013
`1014
`1015
`
`1016
`
`1017
`
`1018
`
`
`
`LIST OF EXHIBITS
`
`Description
`U.S. Patent No. 11,510,625 (the “’625 patent”)
`File History for U.S. Patent No. 11,510,625
`U.S. Provisional Patent App. No. 62/524,247 (the “’247
`Provisional”)
`Declaration of Cameron Riviere, Ph.D.
`Curriculum Vitae of Cameron Riviere, Ph.D.
`Blank
`Blank
`Blank
`Blank
`Blank
`U.S. Patent Publication No. 2014/0188053 (Lundquist)
`U.S. Patent Publication No. 2018/0235520 (Rao)
`Blank
`Blank
`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)
`
`- v -
`
`

`

`
`
`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:
`
`- 2 -
`
`

`

`
`
`Lead Counsel
`Scott C. Weidenfeller (Reg. No.
`54,531)
` sweidenfeller@cov.com
`Postal and Hand-Delivery Address:
`Covington & Burling LLP
`One CityCenter, 850 Tenth Street NW
`Washington, DC 20001
`Telephone: (202) 662-5923
`Facsimile: (202) 778-5923
`
`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
`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
`
`- 3 -
`
`

`

`
`
`Petitioner.
`
`III. SUMMARY OF CHALLENGE
`
`Petitioner challenges claims 1-9, 13-19, 22-30 of the ’625 patent and requests
`
`that these claims be found unpatentable in view of the following references:
`
`(1) U.S. Patent App. Pub. No. 2018/0235520 (“Rao”) (Ex-1012)
`
`(2) U.S. Patent App. Pub. No. 2014/0188053 (“Lundquist”) (Ex-1011)
`
`
`
`Petitioner assert the following grounds of unpatentability under 35 U.S.C.
`
`§103 (AIA):
`
`Ground
`
`Reference(s)
`
`Statutory Basis
`
`Challenged Claims
`
`1
`
`2
`
`Rao
`
`Rao & Lundquist
`
`§103
`
`§103
`
`1-9, 13-19, 22-30
`
`4-5, 14-15, 26-27, 30
`
`This Petition is accompanied by the declaration of Cameron Riviere, Ph.D.,
`
`an expert in orienting needles in medical devices. Ex-1004.
`
`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
`
`- 4 -
`
`

`

`
`
`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
`
`
`
`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:
`
`
`1 Color annotations in Figures added throughout unless otherwise noted.
`
`- 5 -
`
`

`

`
`
`
`
`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
`
`(“the ’170 Application”) 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, 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 applications filed by DexCom. 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
`
`- 6 -
`
`

`

`
`
`month later, on June 2, 2022, the Examiner allowed all pending claims. Id., 522-536.
`
`C. Claim Listing
`
`1.
`
`Claim 1
`
`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
`
`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.
`
`- 7 -
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`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.
`
`- 8 -
`
`

`

`
`
`
`
`
`
`
`
`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.
`
`- 9 -
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`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.
`
`- 10 -
`
`

`

`
`
`
`
`
`
`
`
`
`
`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
`
`- 11 -
`
`

`

`28.4
`28.5
`
`28.6
`28.7
`
`28.8
`
`28.9
`
`28.10
`
`28.11
`
`28.12
`
`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.
`
`
`
`- 12 -
`
`

`

`
`
`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 (the “247 provisional”), filed
`
`on June 23, 2017. Ex-1001, 1-2. As discussed below, the ’625 patent is not entitled
`
`to the filing date of the ’247 Provisional, and thus the Challenged Claims of the ’625
`
`patent are not entitled to an effective filing date any earlier than April 16, 2018.2
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`1.
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`The ’625 Patent Is Not Entitled To The Filing Date Of The
`’247 Provisional
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`For the Challenged Claims of the ’625 patent to be entitled to the ’247
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`Provisional’s June 23, 2017 filing date, the ’247 provisional must provide written
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`description support under 35 U.S.C. § 112(a) for the Challenged Claims. In other
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`words, “the disclosure of the earlier [’247 Provisional]…must reasonably convey to
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`one of skill in the art that the inventor possessed the later-claimed subject matter [in
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`the ’625 patent] at the time the [earlier] application was filed.” Tronzo v. Biomet,
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`Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998).
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`The ’247 provisional does not disclose, either expressly or inherently, the full
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`scope of the invention now claimed in the ’625 patent, because, among other reasons,
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`2 For purposes of this Petition, Petitioner does not take a position as to whether the
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`’625 patent is entitled to the priority date of U.S. Provisional Application No.
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`62/658,486.
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`the ’247 provisional does not contain any disclosure of any “anti-rotation feature”
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`or “anti-rotation key.” All independent claims of the ’625 patent require a “needle
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`hub” comprising a “base” with an “anti-rotation feature” or “anti-rotation key,” with
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`the anti-rotation “feature” or “key” being “at least partially disposed in [the / an]
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`aperture” of an on-skin sensor assembly. See, supra Section IV.C (claims 1, 13, 22,
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`and 18). However, the ’247 provisional does not contain a single reference to any
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`“anti-rotation feature,” any “anti-rotation key,” or indeed any anti-rotation function
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`at all. Ex-1003.
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`Furthermore, the ’247 provisional only contains Figures 1 through 70 from
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`the ’625 patent and does not include Figures 78 and 91 from the ’625 patent
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`discussed above in Section IV.A, as well as the corresponding description of those
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`figures from the ’625 patent specification. Compare Ex-1001 and Ex-1003. 3 A
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`3 Petitioner does not concede that Figures 78 and 91, and the accompanying
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`description provides adequate written description support for the full scope of the
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`claims of the ‘625 patent under 35 U.S.C. § 112(a) and reserves the right to
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`challenge this in other forums. At minimum however, the ’247 Provisional cannot
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`provide adequate written description support for the ‘625 patent claims without
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`these Figures (and accompanying description), or indeed any description of anti-
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`rotation features or functions at all.
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`POSITA would not understand any of the figures disclosed in the ’247 provisional
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`to disclose an “anti-rotation feature” or “anti-rotation key” of, or extending from, a
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`needle hub, with the “anti-rotation feature” or “anti-rotation key” at least partially
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`disposed in an aperture of an on-skin sensor assembly. Ex-1004, ¶¶33-37.
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`Accordingly, the Challenged Claims of the ’625 patent are not entitled to the
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`June 23, 2017 filing date of the ’247 provisional. For purposes of this Petition only,
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`Petitioner applies April 16, 2018 as the effective filing date of the Challenged Claims.
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`V. LEVEL OF ORDINARY SKILL IN THE ART
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`A POSITA as of the claimed priority date would have had a Bachelor’s degree
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`in mechanical or biomedical engineering (or a related or equivalent field) and two
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`or more years of experience researching, developing, designing and/or evaluating
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`medical devices utilizing needles or sharps or equivalent experience. A person with
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`less or different education but more relevant practical experience, or vice versa, may
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`also meet this standard. The prior art also evidences the level of skill in the art. Ex-
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`1004, ¶39.
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`VI. CLAIM CONSTRUCTION
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`In IPR proceedings, claims are construed in accordance with their “ordinary
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`and customary meaning” in light of the specification. 37 C.F.R. § 42.100(b); see
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`Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005). For purposes of
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`this petition, other than as discussed below, Petitioner does not believe that any
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`specialized constructions are necessary. Petitioner reserves the right to dispute in a
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`different forum whether the Challenged Claims meet the requirements under 35
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`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)
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`Claims 4, 14, 26, and 30 each recite that “the needle hub is coupled to the
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`[insertion element/needle] by heat staking, snap-fit, friction-fit, clamshell[,] or insert
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`molding.” In addition, claims 5, 15, and 27 each further require a “locking element”
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`configured to couple the needle to the needle hub “by insert molding.” The recited
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`alternatives merely describe different methods by which
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`the
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`insertion
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`element/needle or “locking element” thereof is physically coupled to the needle hub,
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`not any significant structural differences. Accordingly, the phrases “by heat staking,
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`snap-fit, friction-fit, clamshell[,] or insert molding” and “by insert molding” should
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`be construed as product-by-process limitations.
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`“If the product in the product-by-process claim is the same as or obvious from
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`a product of the prior art, the claim is unpatentable even though the prior product
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`was made by a different process.” In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985).
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`Notably, the ’625 patent does not suggest that the claimed molding methods are
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`novel or non-obvious. Indeed, these alternatives are only mentioned in passing (Ex-
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`1001, 69:17-32), presuming a POSITA was familiar with these well-known methods.
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`Furthermore, there is no indication that the different methods of coupling the needle
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`to the needle hub recited in the claim would result in any structural differences.
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`VII. OVERVIEW OF THE PRIOR ART
`
`A. Rao (Ex-1012)
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`U.S. Patent Publication No. 2018/0235520, titled “Systems, Devices, and
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`Methods for Analyte Sensor Insertion,” to Rao et al. (“Rao”) was filed on January
`
`22, 2018, and published on August 23, 2018. Ex-1012, Cover. Accordingly, applying
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`an effective filing date for the Challenged Claims of the ’625 patent no earlier than
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`April 16, 2018, see supra Section IV.D, Rao qualifies as prior art to the ’625 patent
`
`under at least 35 U.S.C. § 102(a)(2) (AIA). Rao was not of record during prosecution
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`of the ’625 patent.
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`Rao discloses multiple applicators for use in CGM systems, including an
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`applicator comprising a “[s]harp module 2600” (i.e., a needle hub) with a base and
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`a “bend fin guide 2620 [i.e., an anti-rotation feature] for maintaining ‘pre-bent’ sharp
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`2602, ... including sharp shaft 2604 and sharp tip 2606, ... in position during
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`assembly and/or use.” Ex-1012, [0143].
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`Ex-1012, 11H.
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`Further, the sharp module 2600 engages with a sensor module 504, as seen in
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`Figure 11J below. The sharp module 2600 and sensor module 504 can be provided
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`in a sterile package, separate from the applicator and electronics housing. Id., [0008];
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`see also id. Fig. 3C, [0083]-[0084]. Prior to use of the applicator, the user couples
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`the sharp module 2600 and sensor module 504 with the electronics inside the
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`applicator housing, to form the complete sensor control device 102 (i.e., an on-skin
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`sensor assembly), as shown below in Figures 12A and 11J (annotated call-out).
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`Id., Figs. 12A and 11J; see also id., Fig. 3C, [0083]-[0084]. Rao discloses that bend
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`fin guide 2620 “can prevent lateral or rotational movement of sharp 2602 relative to
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`hub components.” Id., [0143]. As seen in Figure 11J, the hub 2600 cannot rotate
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`relative to the sensor module 504, which is part of the on-skin sensor assembly as
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`seen in Figure 12A, as the bend fin guide (i.e., the anti-rotation feature comprising a
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`key) is prevented from rotating by the sensor module 504. Accordingly the needle
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`2602 and hub 2600 are prevented from rotating with respect to the on-skin sensor
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`assembly.
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`Rao is analogous art, as Rao discloses CGM applicators and is thus from the
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`same field of endeavor. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004).
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`B.
`
`Lundquist (Ex-1011)
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`U.S. Patent Publication No. 2014/0188053, titled “Syringe With Co-Molded
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`Hub And Can