U.S. Patent No. 12,023,254
`Petition for Post-Grant Review
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`CATALYST ORTHOSCIENCE INC.,
`
`Petitioner,
`
`v.
`
`SHOULDER INNOVATIONS, INC.,
`
`Patent Owner.
`
`____________________________
`
`Case No.: PGR2025-00001
`
`U.S. Patent No. 12,023,254
`
`__________________________
`
`
`
`PETITION FOR POST-GRANT REVIEW
`
`OF U.S. PATENT NO. 12,023,254
`
`
`
`
`
`
`
`
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ......................................................................................... 1
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8 ................................. 1
`
`A.
`
`B.
`
`C.
`
`D.
`
`REAL PARTY-IN-INTEREST ........................................................................................... 1
`
`RELATED MATTERS ....................................................................................................... 1
`
`LEAD AND BACK-UP COUNSEL ................................................................................... 2
`
`SERVICE INFORMATION ................................................................................................ 3
`
`III. FEE AUTHORIZATION .............................................................................. 3
`
`IV. REQUIREMENTS UNDER 37 C.F.R. § 42.204 ......................................... 3
`
`A.
`
`B.
`
`C.
`
`GROUNDS FOR STANDING ........................................................................................... 3
`
`UNPATENTABILITY GROUNDS AND RELIEF REQUESTED .................................... 3
`
`CLAIM CONSTRUCTION ................................................................................................ 4
`
`V.
`
`THE CHALLENGED PATENT ................................................................... 5
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`BACKGROUND OF THE ART ......................................................................................... 5
`
`EFFECTIVE FILING DATE OF THE CHALLENGED CLAIMS.................................... 9
`
`ALLEGED INVENTION OF THE CHALLENGED PATENT ....................................... 10
`
`CHALLENGED CLAIMS................................................................................................ 11
`
`PROSECUTION HISTORY ............................................................................................. 13
`
`VI. THE CHALLENGED CLAIMS ARE UNPATENTABLE ......................16
`
`A.
`
`GROUND 1: CLAIMS 1-7, 9-18, AND 20-22 ARE OBVIOUS OVER ORPHANOS IN
`VIEW OF HOPKINS, PEREGO, ROCHE, AND KNOWLEDGE OF A PERSON
`HAVING ORDINARY SKILL IN THE ART ................................................................... 16
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`Overview of Orphanos ......................................................................................... 16
`
`Overview of Hopkins ........................................................................................... 20
`
`Overview of Perego ............................................................................................. 21
`
`Overview of Roche .............................................................................................. 23
`
`Claim 1 ................................................................................................................. 26
`
`Claims 2-7 and 9-11 ............................................................................................. 54
`
`Claim 12 ............................................................................................................... 57
`
`Claims 13-18 and 20-22 ....................................................................................... 60
`
`B.
`
`GROUND 2: CLAIMS 8 AND 19 ARE OBVIOUS OVER ORPHANOS IN VIEW OF
`HOPKINS, PEREGO, ROCHE, KNOWLEDGE OF A PERSON HAVING ORDINARY
`SKILL IN THE ART, AND FURTHER IN VIEW OF GARGAC ................................... 63
`
`ii
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`Overview of Gargac ............................................................................................. 63
`
`Claim 8 ................................................................................................................. 65
`
`Claim 19 ............................................................................................................... 67
`
`1.
`
`2.
`
`3.
`
`C.
`
`GROUND 3: CLAIMS 1-7. 9-18, and 20-22 ARE OBVIOUS OVER LEFEBVRE IN
`VIEW OF ORPHANOS, HOPKINS, PEREGO, AND ROCHE ...................................... 67
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`Overview of Lefebvre .......................................................................................... 67
`
`Claim 1: ............................................................................................................... 70
`
`Claims 2-7, 9-11 ................................................................................................... 88
`
`Claim 12 ............................................................................................................... 89
`
`Claims 13-18 and 20-21 ....................................................................................... 91
`
`GROUND 4: CLAIMS 8 AND 19 ARE OBVIOUS OVER LEFEBVRE IN VIEW OF
`ORPHANOS, HOPKINS, PEREGO, AND ROCHE, AND IN FURTHER VIEW OF
`GARGAC
`93
`
`9.
`
`Claim 8 ................................................................................................................. 93
`
`10.
`
`Claim 19 ............................................................................................................... 95
`
`GROUND 5: CLAIMS 1-22 ARE UNPATENTABLE BECAUSE THE TERM
`"BASEPLATE CENTRAL CHANNEL" RENDERS THE CLAIMS INDEFINITE ....... 95
`
`GROUND 6: CLAIMS 1-22 ARE UNPATENTABLE BECAUSE THE TERM
`"CENTRAL CHANNEL ... CONFIGURED TO INTERFACE WITH THE
`BASEPLATE" RENDERS THE CLAIMS INDEFINITE................................................ 99
`
`D.
`
`E.
`
`F.
`
`VII. DISCRETIONARY DENIAL UNDER 35 U.S.C. § 314(A) AND 35
`U.S.C. § 325(D) IS NOT WARRANTED .................................................103
`
`A.
`
`B.
`
`THE FINTIV FACTORS WEIGH IN FAVOR OF INSTITUTION ............................... 103
`
`THE ADVANCED BIONICS FRAMEWORK WEIGHS IN FAVOR OF INSTITUTION
`
`105
`
`VIII. CONCLUSION ..........................................................................................107
`
`
`
`
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`
`
`Page(s)
`
`Cases
`
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH,
`IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) .................................................................................. 94
`
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (PTAB March 20, 2020) ...................................................................... 91, 92
`
`In re Bagnall,
`Appeal 2009-013429, 2011 WL 1463378 (B.P.A.I. Apr. 14, 2011) .................................................... 36
`
`In re Bigio,
`381 F.3d 1320 (Fed. Cir. 2004) ................................................................................................ 22, 55, 59
`
`In re Dulberg,
`289 F.2d 522 (CCPA 1961) .................................................................................................................. 70
`
`Dynamic Drinkware, LLC v. Nat'l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) .......................................................................................................... 8, 9
`
`Energizer Holdings, Inc. v. International Trade Comm'n,
`435 F.3d 1366 (Fed. Cir. 2006) .............................................................................................................. 3
`
`Environmental Designs, Ltd. v. Union Oil Co.,
`713 F.2d 693 (Fed. Cir. 1983) .............................................................................................................. 15
`
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ................................................................................................................. 22, 55, 59
`
`Nautilus, Inc. v. Biosign Instruments, Inc.,
`572 U.S. 898 (2014) ............................................................................................................................. 84
`
`Shoulder Innovations, Inc. v. Catalyst OrthoScience Inc.,
`C.A. No. 24-00266-JPM (D. Del.) ................................................................................................... 1, 92
`
`Statutes
`
`35 U.S.C. §102(a)(1) ................................................................................................................................... 21
`
`35 U.S.C. § 102(a)(2) ...................................................................................................................... 18, 55, 58
`
`35 U.S.C. § 103 ............................................................................................................................................. 3
`
`35 U.S.C. § 112(b) ...................................................................................................................................... 84
`
`35 U.S.C. § 112(d) ...................................................................................................................................... 85
`
`iv
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`35 U.S.C. § 314(A) ..................................................................................................................................... 91
`
`35 U.S.C. § 325(D) ......................................................................................................................... 91, 94, 95
`
`35 U.S.C. § 325(e)(2) .................................................................................................................................. 93
`
`Other Authorities
`
`37 C.F.R. § 42.8 ............................................................................................................................................ 1
`
`37 C.F.R. § 42.15(a) and § 42.103(a) ........................................................................................................... 2
`
`37 C.F.R. § 42.204 ........................................................................................................................................ 2
`
`MPEP § 2144.04(V)(C) .............................................................................................................................. 70
`
`MPEP § 2159.01 ........................................................................................................................................... 9
`
`
`
`
`
`
`
`
`
`
`
`v
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`TABLE OF EXHIBITS
`
`EX. NO.
`
`DESCRIPTION
`
`EX-1001
`
`U.S. Patent No. 12,023,254 ("the '254 Patent")
`
`EX-1002
`
`Declaration of T. Wade Fallin, M.S.
`
`EX-1003 Curriculum Vitae for T. Wade Fallin, M.S.
`
`EX-1004
`
`Prosecution History of U.S. Patent No. 12,023,254 (Part I)
`
`EX-1005
`
`Prosecution History of U.S. Patent No. 12,023,254 (Part II)
`
`EX-1006
`
`U.S. Patent No. 10,813,769 ("Orphanos")
`
`EX-1007
`
`U.S. Patent No. 9,233,003 ("Roche")
`
`EX-1008
`
`U.S. Pat. Pub. No. 2022/0125594 ("Frankle")
`
`EX-1009
`
`U.S. Patent No. 11,439,513 ("Lefebvre")
`
`EX-1010
`
`U.S. Patent No. 11,596,520 ("Perego")
`
`EX-1011
`
`U.S. Pat. Pub. No. 2018/0008350 ("Varadarajan")
`
`EX-1012
`
`U.S. Pat. Pub. No. 2020/0368032 ("Hodorek")
`
`EX-1013
`
`U.S. Patent No. 5,429,268 ("Hale")
`
`EX-1014
`
`Key of Limitations for Challenged Claims
`
`EX-1015
`
`EX-1016
`
`Docket Navigator Report: Profile of Judge Jon P. McCalla
`decisions related to motions to stay, dated June 24, 2024
`
`Shoulder Innovations, Inc. v. Catalyst OrthoScience Inc., C.A. No.
`24-266-JMP (D. Del.), Scheduling Order, D.I. 51
`
`EX-1017 Webster's Ninth New Collegiate Dictionary (1987)
`
`EX-1018
`
`Grainger Catalog No. 400, 2009-2010 ("Grainger")
`
`EX-1019
`
`U.S. Pat. Pub. No. 2018/0193074 ("Hopkins")
`
`EX-1020
`
`U.S. Pat. Pub. No. 2015/0305877 ("Gargac")
`
`
`
`
`
`
`
`vi
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`KEY OF LIMITATIONS FOR CHALLENGED CLAIMS1
`
`CLAIM
`
`RECITED LIMITATIONS
`
`[1]
`
`[1-PRE] A reverse shoulder implant, comprising:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[1-1] a baseplate configured to be secured to a glenoid of a scapular
`bone of [a] patient,
`
`[1-2] the baseplate having a lateral end, a medial end, and a
`baseplate central channel extending through the baseplate from the
`lateral end to the medial end;
`
`[1-3] a central post configured to at least partially pass through the
`central channel;
`
`[1-4] a locking nut having a cylindrical shape, an external thread on
`an outside surface of the locking nut and an internal thread on an
`internal surface of the locking nut,
`
`[1-5] the locking nut configured to engage the central post when the
`central post and baseplate are implanted within the medical patient,
`
`[1-6] wherein the external thread is configured to couple the locking
`nut with the baseplate central channel;
`
`[1-7] a glenosphere, having a lateral, convex articular side, a medial
`side, and a glenosphere central channel extending from the convex
`articular side to the medial side and configured to interface with the
`baseplate; and
`
`[1-8] a glenosphere screw, sized to pass at least partially within the
`glenosphere central channel and having external threads sized to
`secure the glenosphere screw to the internal thread on the internal
`surface of the locking nut to secure the glenosphere to the locking
`nut.
`
`
`1 This key of claim limitations is also submitted as EX-1014.
`
`vii
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`CLAIM
`
`RECITED LIMITATIONS
`
`[2]
`
`[2-PRE] The reverse shoulder implant of claim 1,
`
`[2-1] wherein the glenosphere is configured to at least partially
`surround an external surface of the baseplate.
`
`[3]
`
`[3-PRE] The reverse shoulder implant of claim 1,
`
`[3-1] wherein the baseplate has a circular shape.
`
`[4]
`
`[4-PRE] The reverse shoulder implant of claim 1,
`
`[4-1] wherein the glenosphere is configured to surround the
`baseplate.
`
`[5]
`
`[5-PRE] The reverse shoulder implant of claim 1,
`
`[5-1] wherein the glenosphere is configured to be secured to the
`baseplate with a Morse taper.
`
`[6]
`
`[6-PRE] The reverse shoulder implant of claim 1,
`
`[6-1] wherein a diameter of the locking nut is greater than a length
`of the locking nut.
`
`[7]
`
`[7-PRE] The reverse shoulder implant of claim 1,
`
`[7-1] wherein the locking nut comprises a rotational control feature
`configured to receive a tool to enable twisting of the locking nut to
`secure it to the central screw.
`
`[8]
`
`[8-PRE] The reverse shoulder implant of claim 1,
`
`[8-1] wherein the central post has a length of about 5 mm, 5.5 mm,
`6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10
`mm, 10.5 mm, 11 mm, 11.5 mm, 12 mm, 12.5 mm, 13 mm, 13.5
`mm, 14 mm, 14.5 mm, or 15 mm.
`
`[9]
`
`[9-PRE] The reverse shoulder implant of claim 1,
`
`[9-1] wherein the central channel defines a surface integral with the
`central post.
`
`viii
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`CLAIM
`
`RECITED LIMITATIONS
`
`[10]
`
`[10-PRE] The reverse shoulder implant of claim 1,
`
`[10-1] wherein the central post includes a rotational control feature.
`
`[11]
`
`[11-PRE] The reverse shoulder implant of claim 1,
`
`[11-1] wherein the central post comprises a central channel
`configured to house a primary screw.
`
`[12]
`
`[12-PRE] A reverse shoulder implant, comprising:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`[12-1] a baseplate configured to be secured to a glenoid of a
`scapular bone of patient,
`
`[12-2] the baseplate having a lateral end, a medial end, and a
`baseplate central channel extending through the baseplate from the
`lateral end to the medial end;
`
`[12-3] a central post configured to at least partially pass through the
`central channel;
`
`[12-4] a locking nut having a cylindrical shape, an external thread
`on an outside surface of the locking nut and an internal thread on an
`internal surface of the locking nut,
`
`[12-5] the locking nut configured to engage the central post when
`the central post and baseplate are implanted within the medical
`patient,
`
`[12-6] wherein the external thread is configured to engage the
`baseplate central channel; and
`
`[12-7] a glenosphere, having a lateral, convex articular side, a
`medial side, and a central channel extending from the convex
`articular side to the medial side and configured to interface with the
`baseplate; and
`
`ix
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`CLAIM
`
`
`
`RECITED LIMITATIONS
`
`[12-8] a glenosphere screw, sized to pass at least partially within the
`glenosphere central channel and having external threads sized to
`secure the glenosphere screw to the internal thread on the internal
`surface of the locking nut to secure the glenosphere to the locking
`nut.
`
`[13]
`
`[13-PRE] The reverse shoulder implant of claim 12,
`
`[13-1] wherein the glenosphere is configured to at least partially
`surround an external surface of the baseplate.
`
`[14]
`
`[14-PRE] The reverse shoulder implant of claim 12,
`
`[14-1] wherein the baseplate has a circular shape.
`
`[15]
`
`[15-PRE] The reverse shoulder implant of claim 12,
`
`[15-1] wherein the glenosphere is configured to surround the
`baseplate.
`
`[16]
`
`[16-PRE] The reverse shoulder implant of claim 12,
`
`[16-1] wherein the glenosphere is configured to be secured to the
`baseplate with a Morse taper.
`
`[17]
`
`[17-PRE] The reverse shoulder implant of claim 12,
`
`[17-1] wherein a diameter of the locking nut is greater than a length
`of the locking nut.
`
`[18]
`
`[18-PRE] The reverse shoulder implant of claim 12,
`
`[18-1] wherein the locking nut comprises a rotational control feature
`configured to receive a tool to enable twisting of the locking nut to
`secure it to the central screw.
`
`x
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`CLAIM
`
`RECITED LIMITATIONS
`
`[19]
`
`[19-PRE] The reverse shoulder implant of claim 12,
`
`[19-1] wherein the central post has a length of about 5 mm, 5.5 mm,
`6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10
`mm, 10.5 mm, 11 mm, 11.5 mm, 12 mm, 12.5 mm, 13 mm, 13.5
`mm, 14 mm, 14.5 mm, or 15 mm.
`
`[20]
`
`[20-PRE] The reverse shoulder implant of claim 12,
`
`[20-1] wherein the central channel defines a surface integral with
`the central post.
`
`[21]
`
`[21-PRE] The reverse shoulder implant of claim 12,
`
`[21-1] wherein the central post includes a rotational control feature.
`
`[22]
`
`[22-PRE] The reverse shoulder implant of claim 12,
`
`[22-1] wherein the central post comprises a central channel
`configured to house a primary screw.
`
`xi
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`I.
`
`INTRODUCTION
`
`Catalyst OrthoScience Inc. ("Petitioner") requests post-grant review ("PGR")
`
`of claims 1-22 ("Challenged Claims") of U.S. Patent No. 12,023,254 ("the '254
`
`Patent" or "Challenged Patent") (EX-1001), which is assigned to Shoulder
`
`Innovations, Inc. ("Patent Owner").
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`A. REAL PARTY-IN-INTEREST
`
`The real party-in-interest is Petitioner, Catalyst OrthoScience Inc.
`
`B. RELATED MATTERS
`
`Patent Owner has asserted the '254 Patent against Petitioner in Shoulder
`
`Innovations, Inc. v. Catalyst OrthoScience Inc., C.A. No. 24-00266-JPM (D. Del.)
`
`("the Lawsuit"). Petitioner filed counterclaims for non-infringement and invalidity
`
`of the '254 Patent in the Lawsuit. On July 3, 2024, Petitioner filed a PGR petition
`
`challenging the claims of U.S. Patent No. 11,771,561 ("the '561 Patent"), which
`
`Patent Owner has also asserted against Petitioner in the Lawsuit. See Catalyst
`
`OrthoScience Inc. v. Shoulder Innovations, Inc., No. PGR2024-00042 (PTAB) ("the
`
`'561 Petition"). The '254 Patent and the '561 Patent both claim priority to application
`
`serial no. 17/435,333, filed as PCT/US2020/022094 on March 11, 2020, and to
`
`provisional application no. 62/816,708, filed on March 11, 2019. As of the filing of
`
`this petition, PTAB has not made an institution decision regarding the '561 Petition.
`
`1
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`The Challenged Claims in this petition are nearly identical to those in the '561
`
`Petition. The prior art relied on here significantly overlaps the prior art relied on in
`
`the '561 Petition. Petitioner is not aware of any other judicial or administrative
`
`matters that would affect, or be affected by, a decision in this proceeding.
`
`C. LEAD AND BACK-UP COUNSEL
`
`Petitioner designates the counsel below as its representatives for this
`
`proceeding and has filed a power of attorney to this effect:
`
`LEAD COUNSEL
`
`BACK-UP COUNSEL
`
`Paul M. Ulrich (Reg. No. 46,404)
`FROST BROWN TODD LLP
`301 East Fourth Street, Suite 3300
`Cincinnati, Ohio 45202
`Tel: (513) 651-6432
`Fax: (513) 651-6981
`Email: pulrich@fbtlaw.com
`
`
`
`
`Paul J. Linden (Reg. No. 74,058)
`FROST BROWN TODD LLP
`301 East Fourth Street, Suite 3300
`Cincinnati, Ohio 45202
`Tel: (513) 651-6135
`Fax: (513) 651-6981
`Email: plinden@fbtlaw.com
`
`Todd A. Spears (Reg. No. 76,887)
`FROST BROWN TODD LLP
`301 East Fourth Street, Suite 3300
`Cincinnati, Ohio 45202
`Tel: (513) 651-6411
`Fax: (513) 651-6981
`Email: tspears@fbtlaw.com
`
`
`2
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`D.
`
`SERVICE INFORMATION
`
`Petitioner consents to electronic service by email of all documents and
`
`correspondence related to this proceeding. Any information related to this
`
`proceeding should be sent to Petitioner's lead and back-up counsel using the contact
`
`information above.
`
`III. FEE AUTHORIZATION
`
`Under 37 C.F.R. § 42.15(a) and § 42.103(a), Petitioner authorizes the USPTO
`
`to charge any and all fees for this petition to Deposit Account No. 06-2226.
`
`IV. REQUIREMENTS UNDER 37 C.F.R. § 42.204
`
`A. GROUNDS FOR STANDING
`
`Petitioner certifies that the '254 Patent is eligible for PGR and Petitioner is not
`
`barred or estopped from requesting PGR on the grounds identified in this petition.
`
`B. UNPATENTABILITY GROUNDS AND RELIEF REQUESTED
`
`Petitioner requests cancellation of each of the Challenged Claims under AIA2
`
`35 U.S.C. §§ 103 and 112, based on the following grounds, supported by the
`
`declaration of T. Wade Fallin, M.S., who has at least the qualifications of POSITA,
`
`and is qualified to be an expert in this matter. (Fallin Decl., EX-1002 at 10-12, ¶¶6-
`
`11("EX-1002").)
`
`
`2 The earliest possible priority date to which any of the Challenged Claims could be
`entitled is after March 16, 2013 and, thus, the Leahy-Smith America Invents Act
`("AIA") applies to patentability determinations. MPEP § 2159.01.
`
`3
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`SUMMARY OF GROUNDS
`
`1. Claims 1-7, 9-18, and 20-22 are unpatentable under § 103 as obvious over
`Orphanos in view of Hopkins, Perego, Roche, and the knowledge and skill of
`a POSITA
`
`2. Claims 8 and 19 are unpatentable under § 103 as obvious over Orphanos in
`view of Hopkins, Perego, Roche, the knowledge and skill of a POSITA, and
`in further view of Gargac
`
`3. Claims 1-7, 9-18, and 20-22 are unpatentable under § 103 as obvious over
`Lefebvre in view of Hopkins, Perego, Orphanos, and Roche
`
`4. Claims 8 and 19 are unpatentable under § 103 as obvious over Lefebvre in
`view of Hopkins, Perego, Orphanos, and Roche, and in further view of Gargac
`
`5. Claims 1-22 are unpatentable under § 112 because the term "baseplate central
`channel" renders the claims indefinite
`
`6. Claims 1-22 are unpatentable under § 112 because the term "central channel...
`configured to interface with the baseplate" renders the claims indefinite
`
`C. CLAIM CONSTRUCTION
`
`Grounds five and six present arguments of unpatentability based on
`
`indefiniteness under § 112 and may require the Board to engage in claim
`
`construction analysis to resolve them. Energizer Holdings, Inc. v. International
`
`Trade Comm'n, 435 F.3d 1366, 1368 (Fed. Cir. 2006). That analysis is addressed
`
`below. Other than for those grounds, the Board need not construe the Challenged
`
`Claims to grant this petition. Petitioner may present proposed claim constructions
`
`later in this proceeding if necessary to respond to arguments presented by the Patent
`
`Owner or findings of the Board. In the Lawsuit noted above, neither Petitioner nor
`
`Patent Owner identified any terms or phrases recited in the Challenged Claims for
`
`construction.
`
`4
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`V. THE CHALLENGED PATENT
`
`A. BACKGROUND OF THE ART
`
`The glenohumeral joint (i.e., shoulder joint) is formed by a ball and socket
`
`relationship between the head of the humerus (i.e., the upper arm bone), which
`
`represents the "ball," and the glenoid cavity of the scapula (i.e., shoulder blade),
`
`which represents the "socket." (EX-1002 at 18, ¶37.) Over time, a patient may
`
`experience damage to or deterioration of the glenohumeral joint, such as fractures,
`
`rotator cuff injuries, rheumatoid arthritis, osteoarthritis, cartilage loss, or bone loss.
`
`(Id. at 19, ¶38.) To alleviate prolonged pain associated with such damage or
`
`deterioration, a patient may undergo a total shoulder replacement surgery, where the
`
`glenohumeral joint is modified with implanted artificial parts. (Id., ¶39.)
`
`There are two types of total shoulder replacement surgeries: (i) an anatomic
`
`total shoulder replacement and (ii) a reverse total shoulder replacement. Anatomic
`
`shoulder replacement was the norm until the 1970s when reverse shoulder
`
`replacements were conceived. (Id., ¶40; Roche, 1:32-63, EX-1007 at 66 ("EX-
`
`1007").)
`
`An anatomic total shoulder replacement involves modifying: (i) the humeral
`
`head with a ball implant; and (ii) the glenoid cavity with a socket implant; thus, the
`
`implants reflect the natural shape of the bones. (EX-1002 at 19, ¶40.)
`
`A reverse total shoulder replacement, by contrast, involves modifying: (i) the
`
`5
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`glenoid fossa with a ball implant; and (ii) the humeral head with a socket implant;
`
`achieving the reverse of the natural configuration of the joint. (Id.)
`
`Example of Anatomic Total Shoulder Replacement
`Perego, Figure 20, EX-1010 at 17
`
`Example of Reverse Total Shoulder Replacement
`Varadarajan, Figure 1, EX-1011 at 12
`
`
`
`
`
`Many prior art reverse shoulder systems disclose a round baseplate and a
`
`6
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`glenosphere having a convex joint surface. (Hodorek, ¶[0011], FIGS. 7-9, EX-1012
`
`at 5, 6, 27 ("EX-1012"); Lefebvre, FIGS. 18-23, EX-1009 at 10-12 ("EX-1009");
`
`Orphanos, Abstract, FIGS. 2B, 3, 7-8, EX-1006 at 1, 4-5, 10-11 ("EX-1006");EX-
`
`1002 at 19, ¶41.) In such systems, the baseplate is fixed to the glenoid cavity of the
`
`scapula, while the glenosphere is fixed to the baseplate. (EX-1012 at 27, ¶11;EX-
`
`1002 at 20, ¶42.) Those skilled in the art appreciated at the time of the invention of
`
`the '254 Patent the possibility of using various structures to fasten the baseplate to
`
`the scapula, as well as using various structures to couple the glenosphere with the
`
`baseplate, e.g., threaded couplings and/or taper couplings (e.g., Morse taper). (EX-
`
`1002 at 20, ¶43.)
`
`It was well known by a POSITA at the time of the invention of the '254 Patent
`
`that such prior art reverse shoulder systems may include a baseplate, a central
`
`channel, a central anchoring element (e.g., a compression screw, post, etc.) to be
`
`received through the central channel, a coupling member or reducing bushing to be
`
`received within the central channel, a convex glenosphere, and a glenosphere screw
`
`having threading to affix the glenosphere to the baseplate via those threads. (Id.,
`
`¶44.) Additionally, those skilled in the art recognized the importance of keeping the
`
`baseplate fastened to the scapula (see, e.g., EX-1007 at 29, 7:26-55) and the problem
`
`that, after implantation, the interface between the glenosphere and baseplate may
`
`loosen, leading to misalignment between the glenosphere and baseplate (see, e.g.,
`
`7
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`EX-1012 at 27, ¶[0012]). (EX-1002 at 20-21, ¶45.)
`
`It also was well known by a POSITA at the time of the invention of the '254
`
`Patent that various types of anchoring elements may be used to anchor the baseplate
`
`with the glenoid cavity of the scapular. (EX-1006 at 22, 25, 30, 1:43-2:8, 7:26-30,
`
`8:4-30, 18:9-22; EX-1009 at 15-16, 6:65-7:35; Perego, 12:3-15, 12:52-56, EX-1010
`
`at 23 ("EX-1010"); Hopkins, ¶¶[0037]-[0038],[0040]-[0041],[0051],[0068]-[0070],
`
`EX-1019 at 10-12, 14 ("EX-1019"); EX-1002 at 21, ¶46.) Further, it was well known
`
`by a POSITA at the time of the invention of the '254 Patent that the various types of
`
`anchoring elements may be used together, or as an alternative to one another (i.e.,
`
`substitutes for one another), to anchor the baseplate with the glenoid cavity of the
`
`scapula. (EX-1006 at 22, 1:43-2:8; EX-1010 at 23, 12:3-15, 12:52-56; EX-1019 at
`
`10, ¶[0039]; EX-1002 at 21, ¶46.)
`
`Anchoring elements (e.g., compression screws, posts, etc.) and locking cap
`
`screws were, before the '254 Patent, used to fasten the baseplate to the scapula such
`
`that (i) the anchoring element engages the scapula at a suitable angle, and (ii) the
`
`locking cap screw is screwed into the baseplate on top of the anchoring element to
`
`lock the anchoring element at the desired angle or prevent the anchoring element
`
`from backing out of the scapula. (EX-1007 at 69-70, 7:26-55, 10:57-59 ("The
`
`glenoid plate may allow for use of a locking cap screw which can be attached to any
`
`compression screw thereby making each screw a locking/compression screw."); EX-
`
`8
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`1002 at 21, ¶47.)
`
`Therefore, it was known at the time of the '254 Patent to provide a baseplate
`
`with through-holes (e.g., central and peripheral channels) dimensioned to receive an
`
`anchoring element (e.g., a compression screw, post, etc.), where the through-holes
`
`also have internal threading to mate with a locking cap screw such that the locking
`
`cap screw may engage the anchoring element. (EX-1007 at 69, 72, 7:33-38, 14:11-
`
`17;EX-1002 at 22, ¶48.) And it was well known that adapters interposed between
`
`portions of the glenosphere and baseplate, in conjunction with fixing screws, had
`
`been used to fixedly couple the glenosphere to the baseplate. (EX-1010 at 8-9, 23,
`
`12:37-63, FIGS. 7A-7D (adapter 24, fixing screw 25);EX-1002 at 22, ¶49.)
`
`B.
`
`EFFECTIVE FILING DATE OF THE CHALLENGED CLAIMS
`
`The effective filing date of the '254 Patent is March 14, 2024, the date that the
`
`patent application that issued as the '254 Patent was filed. (EX-1001 at 1.) If Patent
`
`Owner claims that the '254 Patent is entitled to an earlier effective filing date, it is
`
`Patent Owner's burden of proving said entitlement. Dynamic Drinkware, LLC v.
`
`Nat'l Graphics, Inc., 800 F.3d 1375, 1379-80 (Fed. Cir. 2015) ("[B]ecause the PTO
`
`does not examine priority claims unless necessary, the Board has no basis to presume
`
`that a [] patent is necessarily entitled to the filing date of its provisional application").
`
`If Patent Owner attempts to prove an earlier effective filing date, then Petitioner may
`
`attempt to prove an earlier effective filing date for any reference that was obviated
`
`9
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`as prior art because of Patent Owner's establishing an earlier effective filing date
`
`than March 14, 2024. Id.3
`
`C. ALLEGED INVENTION OF THE CHALLENGED PATENT
`
`The '254 Patent, titled "Total Reverse Shoulder Systems and Methods,"
`
`generally relates to a total reverse shoulder replacement system, which includes (as
`
`shown below in Figure 8) a glenoid baseplate (purple), a central post (e.g., light
`
`green or dark green), a threaded locking insert (red), a glenosphere (orange), and a
`
`locking screw (blue):
`
`EX-1001 at 12, Figure 8
`
`Color Key:
`glenosphere
`glenosphere screw
`baseplate
`central post (1)
`central post (2)
`locking nut
`
`
`
`(EX-1001 at 27, 3:25-28.) The claimed subject matter of the '254 Patent is primarily
`
`directed toward the embodiment shown in Figure 8 above, which is described in
`
`column 6, lines 34-56.
`
`
`3 Petitioner respectfully reserves the right to rebut any attempt by Patent Owner to
`establish an effective filing date earlier than March 14, 2024.
`
`10
`
`

`

`U.S. Patent No. 12,023,254
`Petition for PGR
`
`
`D. CHALLENGED CLAIMS
`
`Petitioner challenges the patentability of each Challenged Claim, which
`
`includes two independent claims (claims 1 and 12) and 20 dependent claims (claims
`
`2-11 and claims 13-22), of