`
`
`
`
`
`
`
`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
`
`__________________________
`
`
`DECLARATION OF T. WADE FALLIN, M.S., IN SUPPORT OF PETITION
`FOR POST-GRANT REVIEW OF U.S. PATENT NO. 12,023,254
`
`
`
`
`
`
`
`
`CATALYST, EX-1002
`PAGE 1
`
`

`

`
`
`I.
`
`II.
`III.
`IV.
`
`V.
`
`VI.
`
`
`
`TABLE OF CONTENTS
`INTRODUCTION AND SUMMARY OF TESTIMONY .......................................................... 9
`A.
`Qualifications .................................................................................................................... 10
`B.
`Materials Considered ........................................................................................................ 12
`C.
`Additional Considerations ................................................................................................ 12
`LEGAL PRINCIPLES ................................................................................................................. 13
`OVERVIEW OF OPINIONS ...................................................................................................... 17
`BACKGROUND OF THE '254 PATENT AND APPLIED PRIOR ART ............................... 18
`A.
`Background of the Art ....................................................................................................... 18
`B.
`The '254 Patent .................................................................................................................. 22
`C.
`Orphanos ........................................................................................................................... 23
`D.
`Lefebvre ............................................................................................................................ 26
`E.
`Hopkins ............................................................................................................................. 28
`F.
`Perego ............................................................................................................................... 29
`G.
`Roche ................................................................................................................................ 31
`H.
`Gargac ............................................................................................................................... 33
`I.
`Hale ................................................................................................................................... 34
`J.
`Grainger ............................................................................................................................ 35
`K.
`Level of Skill of a POSITA ............................................................................................... 35
`DETAILED EXPLANATION OF OPINIONS .......................................................................... 37
`A.
`Ground 1: Claims 1-7, 9-18, and 20-22 are obvious over Orphanos in view of Hopkins,
`Perego, Roche, and the knowledge and skill of a POSITA ............................................... 37
`Ground 2: Claims 8 and 19 are obvious over Orphanos in view of Hopkins, Perego,
`Roche, the knowledge and skill of a POSITA, and further in view of Gargac ................. 77
`Ground 3: Claims 1-7, 9-18, and 20-22 are obvious over Lefebvre in view of Orphanos,
`Hopkins, Perego, and Roche ............................................................................................. 79
`Ground 4: Claims 8 and 19 are obvious over Lefebvre in view of Orphanos, Hopkins,
`Perego, and Roche, and in further view of Gargac ......................................................... 106
`Ground 5: Claims 1-22 are unpatentable because the term "baseplate central channel"
`renders the claims indefinite ........................................................................................... 108
`Ground 6: Claims 1-22 are unpatentable because the term "central channel . . . configured
`to interface with the baseplate" is indefinite .................................................................... 111
`CONCLUSION ........................................................................................................................... 115
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`
`
`
`
`CATALYST, EX-1002
`PAGE 2
`
`

`

`EX. NO.
`
`TABLE OF MATERIALS CONSIDERED
`DESCRIPTION
`
`EX-1001 U.S. Patent No. 12,023,254 ("the '254 Patent")
`
`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-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")
`
`
`
`
`
`U.S. Patent No. 10,631,992
`
`U.S. Patent No. 10,143,558
`
`
`
`
`
`CATALYST, EX-1002
`PAGE 3
`
`

`

`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.
`
`
`
`
`
`CATALYST, EX-1002
`PAGE 4
`
`

`

`[2]
`
`[3]
`
`[4]
`
`[5]
`
`[6]
`
`[7]
`
`[8]
`
`[9]
`
`[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-PRE] The reverse shoulder implant of claim 1,
`[3-1] wherein the baseplate has a circular shape.
`[4-PRE] The reverse shoulder implant of claim 1,
`[4-1] wherein the glenosphere is configured to surround the
`baseplate.
`[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-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-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-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-PRE] The reverse shoulder implant of claim 1,
`[9-1] wherein the central channel defines a surface integral with the
`central post.
`
`
`
`
`
`CATALYST, EX-1002
`PAGE 5
`
`

`

`[10]
`
`[11]
`
`[12]
`
`[10-PRE] The reverse shoulder implant of claim 1,
`[10-1] wherein the central post includes a rotational control feature.
`[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-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
`
`
`
`
`
`CATALYST, EX-1002
`PAGE 6
`
`

`

`
`
`[13]
`
`[14]
`
`[15]
`
`[16]
`
`[17]
`
`[18]
`
`[19]
`
`[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-PRE] The reverse shoulder implant of claim 9,
`[13-1] wherein the glenosphere is configured to at least partially
`surround an external surface of the baseplate.
`[14-PRE] The reverse shoulder implant of claim 9,
`[14-1] wherein the baseplate has a circular shape.
`[15-PRE] The reverse shoulder implant of claim 9,
`[15-1] wherein the glenosphere is configured to surround the
`baseplate.
`[16-PRE] The reverse shoulder implant of claim 9,
`[16-1] wherein the glenosphere is configured to be secured to the
`baseplate with a Morse taper.
`[17-PRE] The reverse shoulder implant of claim 9,
`[17-1] wherein a diameter of the locking nut is greater than a length
`of the locking nut.
`[18-PRE] The reverse shoulder implant of claim 9,
`[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.
`[19-PRE] The reverse shoulder implant of claim 9,
`[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.
`
`
`
`
`
`CATALYST, EX-1002
`PAGE 7
`
`

`

`[20]
`
`[21]
`
`[22]
`
`[20-PRE] The reverse shoulder implant of claim 12,
`[20-1] wherein the central channel defines a surface integral with
`the central post.
`[21-PRE] The reverse shoulder implant of claim 12,
`[21-1] wherein the central post includes a rotational control feature.
`[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.
`
`
`
`
`
`
`
`
`
`
`CATALYST, EX-1002
`PAGE 8
`
`

`

`
`
`I.
`
`INTRODUCTION AND SUMMARY OF TESTIMONY
`1. My name is T. Wade Fallin. I am at least 18 years of age and I reside in
`
`Hyde Park, Utah.
`
`2.
`
`Catalyst OrthoScience Inc. ("Petitioner") has retained me to evaluate
`
`the patentability of claims 1-22 ("Challenged Claims") of United States Patent No.
`
`12,023,254 ("the '254 Patent" or "Challenged Patent") in view of certain prior art
`
`references and in further view of the knowledge, skill, and perspective of a person
`
`of ordinary skill in the art ("POSITA") at the time of the alleged invention of the '254
`
`Patent.
`
`3.
`
`In connection with my evaluation, I have been asked to provide expert
`
`opinions in support of a petition for post-grant review ("PGR") of the '254 Patent
`
`that Petitioner is filing with the United States Patent and Trademark Office, Patent
`
`Trial and Appeal Board ("Board"). More particularly, I have been asked to provide
`
`opinions related to, among other things, the background and understanding of the
`
`state of the art pertaining to the '254 Patent, the knowledge, skill, and perspective of
`
`a POSITA at the time of the alleged invention of the '254 Patent, and the patentability
`
`of the Challenged Claims under U.S. patent law.
`
`4.
`
`I am being compensated at my normal consulting rate of $600/hour for
`
`my work on this matter. My compensation does not depend on the outcome of this
`
`or any other proceeding or matter either before the Board or in litigation in court
`
`
`
`CATALYST, EX-1002
`PAGE 9
`
`

`

`
`
`involving the '254 Patent.
`
`5.
`
`As explained below, it is my opinion that each of the Challenged Claims
`
`is unpatentable as obvious in view of certain prior art references and the knowledge
`
`and skill of a POSITA at the time of the alleged invention. It is also my opinion that
`
`each of the Challenged Claims is unpatentable for failing to point out and distinctly
`
`claim with reasonable certainty the alleged invention from the perspective of a
`
`POSITA. I am prepared to testify about these opinions and other subsidiary opinions
`
`expressed within this declaration.
`
`A. Qualifications
`6.
`In my opinion, I possess the requisite knowledge, skill, experience,
`
`training, and education to qualify as an expert in this proceeding, form an expert
`
`opinion on the technological subject matter at issue in this proceeding, and testify as
`
`an expert to aid the Board in reaching conclusions regarding the issues presented in
`
`this proceeding.
`
`7.
`
`In 1984, I earned a B.M.E. in Mechanical Engineering from Georgia
`
`Institute of Technology. In 1995, I earned an M.S. in Mechanical Engineering from
`
`the University of Illinois at Champaign-Urbana.
`
`8.
`
`Since February 2021, I have been a Research Professor in the
`
`Department of Orthopaedics at the University of Utah. I was an adjunct professor in
`
`the same department from October 2019 to February 2021. In addition, since January
`
`
`
`CATALYST, EX-1002
`PAGE 10
`
`

`

`
`
`2021, I have been a Special Content Editor of Foot and Ankle International and a
`
`Special Content Editor of Foot and Ankle Orthopaedics. Since February 2020, I have
`
`been a member of the Health Sciences Research Subcommittee on Innovation and
`
`Entrepreneurship at the University of Utah. Since October 2019, I have served as the
`
`Executive Director of the Orthopaedic Innovation Center at the University of Utah.
`
`9.
`
`Throughout my professional career spanning four decades, I have spent
`
`34 years engaged full time in the field of orthopaedics. In the first decade, I worked
`
`at increasing levels of responsibility in engineering at two of the largest orthopaedic
`
`companies, Zimmer and Smith and Nephew. Since then, I have founded and directed
`
`numerous organizations in the field of orthopaedics, including serving as the
`
`founder, director, and chief executive officer of Surgical Frontiers, LLC, Mortise
`
`Medical, LLC, Intrafuse, LLC, First Ray, LLC, KATOR, LLC, VentureMD, LLC,
`
`MTP Solutions, LLC, IMDS, Inc., Facet Solutions, Inc., and MedicineLodge, Inc.,
`
`all of Logan Utah.
`
`10.
`
`I have decades of experience working directly with joint replacement
`
`systems, including hip joint replacement systems, knee replacement systems, and
`
`facet joint replacement systems. My work on these joint replacement systems
`
`included my direct engagement or supervision of professionals in the inventing,
`
`designing, fabricating, testing, obtaining regulatory approvals, ensuring regulatory
`
`compliance, commercializing, and patenting of these systems.
`
`
`
`CATALYST, EX-1002
`PAGE 11
`
`

`

`
`
`11. My additional relevant experience, including listings of awards I have
`
`received, commercial products I have helped design, and patents for which I am a
`
`named inventor are included in my curriculum vitae, included as EX-1003 to the
`
`petition, which is incorporated-by-reference herein.
`
`B. Materials Considered
`12.
`In formulating my opinions expressed in this declaration, I reviewed
`
`the materials listed in the Table of Materials Considered above.
`
`C. Additional Considerations
`13.
`If asked to provide live testimony in this proceeding, I may use as
`
`exhibits or demonstratives various documents that refer or relate to the matters
`
`contained within this declaration or that are derived from the opinions and analyses
`
`discussed within this declaration. Additionally, I may create or supervise the creation
`
`of demonstratives to assist in understanding my testimony.
`
`14. This declaration summarizes the entirety of the analysis I conducted
`
`and opinions I have reached in relation to the subject matter of this petition. I
`
`understand that Shoulder Innovations, Inc., ("SI") is the patent owner of the '254
`
`Patent and may submit an opinion from another expert. If offered, I intend to respond
`
`to the opinion SI's expert provides and may, based on the opinions and analysis
`
`offered by SI's expert, modify, amend, or supplement my analysis and opinions
`
`explained in this declaration.
`
`
`
`CATALYST, EX-1002
`PAGE 12
`
`

`

`
`
`II. LEGAL PRINCIPLES
`15.
`I am not a lawyer, but my opinions here necessarily involve
`
`understanding and following legal principles. Accordingly, I have been informed of
`
`certain legal principles and asked to apply them when forming my opinions and
`
`preparing this declaration.
`
`16.
`
`I have been informed and understand that the Board construes patent
`
`claim terms during a PGR proceeding under their plain and ordinary meaning as
`
`understood by a POSITA at the time of the invention claimed in the patent. The plain
`
`and ordinary meaning of a term is generally derived from how it is used in the patent,
`
`in accordance with the context of the claims in which the term is recited, the
`
`description of a claimed invention in the patent and its prosecution history, as well
`
`as other evidence, including evidence of the knowledge and understanding of a
`
`POSITA.
`
`17.
`
`I have been informed and understand that, under 35 U.S.C. § 103, a
`
`claimed invention is unpatentable if the differences between the claimed invention
`
`and the prior art are such that the claimed invention, as a whole, would have been
`
`obvious to a POSITA before the effective filing date of the claimed invention.
`
`18.
`
`I also understand that determining whether a claimed invention is
`
`obvious requires an understanding of the scope and content of the prior art, any
`
`differences between the claimed invention and the prior art, the level of skill of the
`
`
`
`CATALYST, EX-1002
`PAGE 13
`
`

`

`
`
`POSITA in the art to which the claimed invention is directed, and any objective
`
`indicia of non-obviousness that is present.
`
`19.
`
`I have been informed and understand that a patent or printed publication
`
`constitutes prior art to a claimed invention if, among other things, it predates the
`
`effective filing date of the claimed invention or if the application that results in an
`
`issued patent or published patent application was effectively filed before the
`
`effective filing date of the claimed invention.
`
`20.
`
`I have been informed and understand that prior art references
`
`considered for purpose of an obviousness determination must be analogous to the
`
`claimed invention, meaning that the prior art references must either come from the
`
`same field of endeavor as the claimed invention or be reasonably pertinent to the
`
`problem the inventor of the claimed invention was attempting to address.
`
`21.
`
`I have been informed and understand that, when determining the
`
`appropriate level of skill of a POSITA at the effective filing date of the claimed
`
`invention, the following factors are often considered: (a) the types of problems
`
`encountered by those working in the field and prior art solutions to those problems;
`
`(b) the sophistication of the technology in question and the rapidity with which
`
`innovations occur in the field; (c) the education level of active workers in the field;
`
`and (d) the education level of the inventor.
`
`22.
`
`I also have been informed and understand that objective indicia of non-
`
`
`
`CATALYST, EX-1002
`PAGE 14
`
`

`

`
`
`obviousness (also referred to as secondary considerations) may include: praise in the
`
`industry for the claimed invention; a long felt but unresolved need for the claimed
`
`invention; commercial success of products that practice the claimed invention;
`
`unexpected results of the claimed invention; and any copying of the claimed
`
`invention by others.
`
`23.
`
`I further understand that the patent owner has the burden of coming
`
`forward with objective evidence of non-obviousness and that the patent owner has
`
`the additional burden of showing a nexus between the objective evidence of non-
`
`obviousness and the claimed invention.
`
`24.
`
`I have been informed and understand that a claim can be obvious in
`
`light of a single prior art reference or multiple prior art references, where there is a
`
`reason or motivation to modify the single prior art reference or combine two or more
`
`references in order to achieve the claimed invention and that a POSITA would have
`
`had a reasonable expectation of success in doing so.
`
`25.
`
`I have been informed and understand that a reason or motivation to
`
`modify a single prior art reference or combine multiple prior art references may
`
`come from common sense or the knowledge and skill of a POSITA. A POSITA may
`
`also have reason or be motivated to modify or combine references where: the
`
`modification or combination is made according to known methods that yield
`
`predictable results; the modification would have been made according to known and
`
`
`
`CATALYST, EX-1002
`PAGE 15
`
`

`

`
`
`predictable techniques or methods to improve similar devices to solve a known
`
`problem; the modification or combination is a substitution of one known element for
`
`another to obtain predictable results; the modification or combination would have
`
`been "obvious to try"—i.e., it would have involved a choice from a finite number of
`
`identifiable, predictable solutions, with a reasonable expectation of success; or
`
`known work in the field of endeavor would have prompted a modification or
`
`combination for use in the field based on design incentives and market forces with a
`
`reasonable expectation of success.
`
`26.
`
`I have been informed and understand that under 35 U.S.C. § 112, a
`
`claimed invention is unpatentable unless it is particularly pointed out and distinctly
`
`claimed in a patent claim that, when read in light of the specification and prosecution
`
`history, informs a POSITA with reasonable certainty about the scope of the
`
`invention. I further understand that a patent must provide objective guidance as to
`
`the scope of the invention and enable a POSITA to determine what falls within that
`
`scope.
`
`27.
`
`I have been informed and understand that, under § 112, a claimed
`
`invention is unpatentable unless there is an adequate written description of the
`
`claimed invention such that a POSITA, reading the patent application directed to the
`
`claimed invention as originally filed, would recognize that the inventor in possession
`
`of the claimed invention as of the effective filing date. I further understand a claimed
`
`
`
`CATALYST, EX-1002
`PAGE 16
`
`

`

`
`
`invention that is not expressly described fails the written description requirement
`
`even if it is an obvious variant of a disclosed embodiment.
`
`28.
`
`I have been informed and understand that, under § 112, a claimed
`
`invention is unpatentable unless it is described in a patent in such full, clear, concise,
`
`and exact terms as to enable a POSITA to make and use the full scope of the claimed
`
`invention without undue experimentation. I further understand whether the
`
`experimentation is undue is determined in light of the level of skill possesses by a
`
`POSITA in consideration of (1) the quantity of experimentation; (2) the amount of
`
`direction or guidance present; (3) the presence or absence of working examples; (4)
`
`the nature of the invention; (5) the state of the prior art; (6) the relative skill of those
`
`in the art; (7) the predictability or unpredictability of the art; and (8) the breadth of
`
`the claims.
`
`29.
`
`I note other legal principles below where appropriate.
`
`III. OVERVIEW OF OPINIONS
`30. This declaration includes an explanation of opinions I have formed
`
`based on my independent analysis of the materials noted above. Based on my
`
`knowledge and experience—including my understanding of the knowledge, skills,
`
`experience, and perspective of a POSITA as of the effective filing date of the claimed
`
`invention—and my review of the materials listed above, it is my opinion that:
`
`31.
`
`Claims 1-7, 9-18, and 20-22 are unpatentable under § 103 as obvious
`
`
`
`CATALYST, EX-1002
`PAGE 17
`
`

`

`
`
`over Orphanos in view of Hopkins, Perego, Roche, and the knowledge and skill of
`
`a POSITA.
`
`32.
`
`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.
`
`33.
`
`Claims 1-7, 9-18, and 20-22 are unpatentable under § 103 as obvious
`
`over Lefebvre in view of Hopkins, Perego, Orphanos and Roche.
`
`34.
`
`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.
`
`35.
`
`Claims 1-22 are unpatentable under § 112 because the term "baseplate
`
`central channel" renders the claims indefinite.
`
`36.
`
`Claims 1-22 are unpatentable under § 112 because the terms
`
`"glenosphere central channel," in claim 1, and "central channel" of the glenosphere,
`
`in claim 12, "configured to interface with the baseplate" render the claims indefinite.
`
`IV. BACKGROUND OF THE '254 PATENT AND APPLIED PRIOR ART
`A. Background of the Art
`37. The shoulder joint, or glenohumeral joint, is formed by a ball and socket
`
`relationship between the head of the humerus, or upper arm bone, and the glenoid
`
`cavity of the shoulder blade, or scapula. The head of the humerus is the "ball" of the
`
`"ball and socket," and the glenoid cavity is the "socket" of the "ball and socket."
`
`
`
`CATALYST, EX-1002
`PAGE 18
`
`

`

`
`
`38. The shoulder joint can deteriorate over time or be damaged due to
`
`injury. Problems associated with the shoulder joint include fractures, rotator cuff
`
`injuries, rheumatoid arthritis, osteoarthritis, cartilage loss, or bone loss.
`
`39. To alleviate prolonged pain associated with a damaged or deteriorated
`
`glenohumeral joint, a patient may undergo a total shoulder replacement surgery,
`
`where the glenohumeral joint is modified with implanted artificial parts.
`
`40. There are two types of total shoulder replacement surgeries. First, there
`
`is what is called an "anatomic total shoulder replacement," where the head of the
`
`humerus is modified or reconstructed with a "ball" implant while the glenoid cavity
`
`is modified or reconstructed with a "socket" implant. This mimics the natural
`
`anatomic structure of the shoulder joint. Second, there is what is referred to as a
`
`"reverse total shoulder replacement," where the glenoid fossa is modified or
`
`reconstructed with the "ball" implant and the head of the humerus is modified with
`
`the "socket" implant. This provides a joint structure that is "reversed" from the
`
`natural anatomic structure of the shoulder joint. Prior to the 1970s, all shoulder
`
`replacement surgeries were of the first, anatomic, type; reverse total replacement
`
`surgeries began in the 1970s.
`
`41. Many prior art reverse shoulder systems disclose a round baseplate and
`
`a glenosphere having a convex joint surface. See, e.g., Hodorek, ¶ [0011], FIGS. 7-
`
`9; Lefebvre, FIGS. 18-23; Orphanos, Abstract, FIGS. 2B, 3, 7-8.
`
`
`
`CATALYST, EX-1002
`PAGE 19
`
`

`

`
`
`42.
`
`In such systems, the baseplate is fixed to the glenoid cavity of the
`
`scapula via an anchoring element, while the glenosphere is fixed to the baseplate.
`
`See, e.g., Hodorek, ¶ [0011].
`
`43. 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. See, e.g., Hodorek, ¶ [0011]; Perego, 12:3-15, 12:52-56; Hopkins, ¶ [0037]-
`
`[0038], [0040]-[0041], [0051], [0068]-[0070]. Those skilled in the art also
`
`appreciated at the time of the invention of the '254 Patent the possibility of using
`
`various structures to couple the glenosphere with the baseplate, e.g., threaded
`
`couplings and/or taper couplings (e.g., Morse taper). See, e.g., Hodorek, ¶ [0011].
`
`44.
`
`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, an anchoring element (e.g., compression screw, post, etc.) to be received
`
`through the central channel to thereby anchor the baseplate with the scapula, 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. Orphanos, Abstract, FIGS. 2B, 3, 7-
`
`8.
`
`45. Additionally, those skilled in the art recognized both the importance of
`
`keeping the baseplate fastened to the scapula, see, e.g., Roche, 7:26-55, as well as
`
`
`
`CATALYST, EX-1002
`PAGE 20
`
`

`

`
`
`the problem that, after implantation, the interface between the glenosphere and the
`
`baseplate may become loose, leading to misalignment between the glenosphere and
`
`the baseplate, see, e.g., Hodorek, ¶ [0012].
`
`46. Prior to the invention of the '254 Patent, various types of anchoring
`
`elements were used in order to anchor the baseplate with the glenoid. See
`
`Orphanos,1:43-2:8, 7:26-30, 8:4-30, 18:9-22; Lefebvre, 6:65-7:35; Perego, 12:3-15,
`
`12:52-56; Hopkins, ¶ [0037]-[0038], [0040]-[0041], [0051], [0068]-[0070]. Prior to
`
`the invention of the '254 Patent, such various anchoring elements were used together,
`
`or as an alternative to one another (i.e., substitutes for one another) to anchor the
`
`baseplate with the glenoid. See Orphanos, 1:43-2:8; Perego, 12:3-15, 12:52-56;
`
`Hopkins, ¶ [0039].)
`
`47. Prior to the invention of the '254 Patent, anchoring elements (e.g.,
`
`compressions screws, posts, etc.) and locking cap screws were 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 in a desired angular orientation
`
`and/or prevent the anchoring element from backing out of the scapula. See, e.g.,
`
`Roche, 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.")
`
`
`
`CATALYST, EX-1002
`PAGE 21
`
`

`

`
`
`48.
`
`It was readily known at the time of the invention of the '254 Patent to
`
`provide a baseplate with through holes (e.g., central and peripheral channels)
`
`dimensioned to receive an anchoring element, 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. See, e.g., Roche, 7:33-38, 14:11-17.
`
`49. Prior to the invention of the '254 Patent, adapters interposed between
`
`portions of the glenosphere and baseplate, in conjunction with fixing screws, had
`
`been used to fixedly couple the glenosphere relative to the baseplate. See, e.g.,
`
`Perego, 12:37-63, FIGS. 7A-7D (adapter 24, fixing screw 25).
`
`B.
`The '254 Patent
`50. The '254 Patent, titled "Total Reverse Shoulder Systems and Methods,"
`
`generally relates to a total reverse shoulder system including a glenoid baseplate
`
`(purple), a central post (e.g., a first embodiment shown in