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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`ZIMMER BIOMET HOLDINGS, INC.
`Petitioner
`
`v.
`
`FOUR MILE BAY, LLC
`Patent Owner
`____________________
`
`U.S. Patent No. 9,308,093
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`____________________
`DECLARATION OF TIMOTHY P. HARRIGAN, SCD, MBA, PE
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`
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`ZIMMER EXHIBIT 1002
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`TABLE OF CONTENTS
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`Page
`I. 
`INTRODUCTION .......................................................................................... 1 
`QUALIFICATIONS ....................................................................................... 1 
`II. 
`SUMMARY OF OPINIONS .......................................................................... 4 
`III. 
`IV.  LEVEL OF ORDINARY SKILL IN THE ART ............................................ 5 
`V. 
`BACKGROUND OF THE ’093 PATENT .................................................... 6 
`VI.  CLAIM CONSTRUCTION ......................................................................... 11 
`A. 
`“Porous-Metal-Structure” Claim Term .............................................. 11 
`B. 
`“Separate Fabrication” Claim Terms ................................................. 12 
`C. 
`Attaching or Connecting the Bone Fixation Body “After”
`Separately Fabricating It .................................................................... 12 
`VII.  OVERVIEW OF THE PRIOR ART ............................................................ 13 
`A. 
`Zolman ................................................................................................ 13 
`B. 
`Rostoker .............................................................................................. 16 
`C. 
`Bobyn .................................................................................................. 18 
`D. 
`Averill ................................................................................................. 20 
`VIII.  CERTAIN REFERENCES TEACH OR SUGGEST ALL OF THE
`CLAIMED FEATURES OF CLAIMS 1-12 OF THE ’093 PATENT ........ 22 
`A.  Ground 1: Zolman and Rostoker Teach or Suggest All of the
`Features of Claims 1-12 ..................................................................... 22 
`1. 
`Claim 1 ..................................................................................... 22 
`2. 
`Claim 2 ..................................................................................... 43 
`3. 
`Claim 3 ..................................................................................... 45 
`4. 
`Claim 4 ..................................................................................... 46 
`5. 
`Claim 5 ..................................................................................... 47 
`6. 
`Claim 6 ..................................................................................... 48 
`7. 
`Claim 7 ..................................................................................... 49 
`8. 
`Claim 8 ..................................................................................... 54 
`9. 
`Claim 9 ..................................................................................... 54 
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`B. 
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`10.  Claim 10 ................................................................................... 55 
`11.  Claim 11 ................................................................................... 55 
`12.  Claim 12 ................................................................................... 56 
`Ground 2: Zolman, Rostoker, and Averill Teach or Suggest All
`of the Features of Claims 6 and 12 ..................................................... 56 
`Ground 3: Zolman and Bobyn Teach or Suggest All of the
`Features of Claims 1-12 ..................................................................... 58 
`1. 
`Claim 1 ..................................................................................... 58 
`2. 
`Claim 2 ..................................................................................... 69 
`3. 
`Claim 3 ..................................................................................... 70 
`4. 
`Claim 4 ..................................................................................... 71 
`5. 
`Claim 5 ..................................................................................... 71 
`6. 
`Claim 6 ..................................................................................... 72 
`7. 
`Claim 7 ..................................................................................... 72 
`8. 
`Claim 8 ..................................................................................... 76 
`9. 
`Claim 9 ..................................................................................... 77 
`10.  Claim 10 ................................................................................... 77 
`11.  Claim 11 ................................................................................... 78 
`12.  Claim 12 ................................................................................... 78 
`D.  Ground 4: Zolman, Bobyn, and Averill Teach or Suggest All of
`the Features of Claims 6 and 12 ......................................................... 79 
`IX.  CONCLUSION ............................................................................................. 80 
`
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`C. 
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`I, Timothy Patrick Harrigan, declare as follows:
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`I.
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`INTRODUCTION
`1.
`I have been retained by Zimmer Biomet Holdings, Inc. (“Petitioner”)
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`as an independent expert consultant in this proceeding before the United States
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`Patent and Trademark Office regarding U.S. Patent No. 9,308,093 (“the ’093
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`patent”), which I understand is labeled as Ex. 1001 in this proceeding. I have
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`been asked to consider, among other things, whether certain references teach or
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`suggest the features recited in claims 1-12 of the ’093 patent. My opinions are
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`set forth below. My opinions are my own and do not express the views or
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`opinions of my employer, Johns Hopkins University Applied Physics
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`Laboratories.
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`2.
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`I am being compensated at my normal consulting rate for the time I
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`spend on this matter. No part of my compensation is dependent on the outcome
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`of this proceeding or any other proceeding involving the ’093 patent. I have no
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`other interest in this proceeding.
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`II. QUALIFICATIONS
`3.
`I received a B.S. in Mechanical Engineering from Massachusetts
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`Institute of Technology (MIT) in June 1980, a Doctorate in the Sciences (Sc.D)
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`in Mechanical Engineering from MIT in April 1985, and a Master of Business
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`Administration (MBA) from University of Houston in December 1998. I wrote
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`my doctoral thesis on bone compliance and its influence in human hip joints,
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`which was sponsored by a Whitaker Health Sciences Fund fellowship.
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`4.
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`Between 1985 and 1990, I was an assistant in orthopedics
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`(biomechanics) at Massachusetts General Hospital where I conducted research on
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`cemented and un-cemented total hip replacements, researched bone cement
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`porosity, and developed experimental capabilities to characterize cancellous bone
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`around implants. Between 1990 and 1993, I was a director of research in the
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`Department of Orthopedics at the University of Missouri-Kansas City Medical
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`School where I supervised orthopedic resident research projects, developed
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`experimental models for bone machining processes for orthopedic implants, and
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`developed computational bone remodeling simulations. From 1994 to 1999, I
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`was an adjunct associate professor in the Department of Mechanical Engineering
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`at Cullen College of Engineering at the University of Houston, and from 1993 to
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`1999, I was an associate professor in the Department of Mechanical Engineering
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`at Rice University. Between 1993 and 1999, I was the Director of Research in
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`the Department of Orthopedic Surgery at the University of Texas at Houston
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`Medical School, where I supervised orthopedic resident research projects,
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`developed experimental and computational models for orthopedic implants,
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`developed mathematical and experimental models for circulation in and around
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`bone, and researched cement pressurization around total hip implants.
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`5.
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`In addition to my extensive academic experience, I have industry
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`experience with medical devices at Resmed, Inc. (1999), Exponent Failure
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`Analysis Associates (2000-2005), and Foster-Miller (2005-2009). I am presently
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`a senior research engineer at Johns Hopkins University Applied Physics
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`Laboratory.
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`6.
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`I have extensive experience in the biomaterials and biomechanics of
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`orthopedic implants.
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` In my academic career I have taught numerous
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`biomechanics courses, including biomechanics summary courses for orthopedic
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`residents at the University of Missouri-Kansas City; University of Kansas
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`Medical School; and University of Texas medical School at Houston. I have also
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`published extensively in the field with more than 30 scientific articles and 60
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`presentations.
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` Examples of my publications
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`include
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`the
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`articles
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`“Characterization of Microstructural Anisotropy in Orthotropic Materials Using a
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`Second Rank Tensor” (T.P. Harrigan & R. W. Mann, J. of Materials Science,
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`Vol. 19, pp. 761-767 (1984)) and “Limitations of the Continuum Assumption in
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`Cancellous Bone” (Timothy P. Harrigan et al., J. Biomechanics, Vol. 21, No. 4,
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`pp. 269-275 (1988)). My work has been cited in the scientific literature over
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`1200 times. I understand that a copy of my curriculum vitae is labeled as Ex.
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`1003.
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`7.
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`I am a registered professional engineer and a registered patent agent.
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`III. SUMMARY OF OPINIONS
`8.
`All of the opinions contained in this Declaration are based on the
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`documents I reviewed and my knowledge and professional judgment. In forming
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`the opinions expressed in this Declaration, I reviewed the documents mentioned
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`in this declaration, including the ’093 patent (Ex. 1001), U.S. Patent No.
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`5,018,285 to Zolman et al. (“Zolman”) (Ex. 1009), U.S. Patent No. 3,906,550 to
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`Rostoker et al. (“Rostoker”) (Ex. 1010), an article by J.D. Bobyn et al., titled
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`“Characteristics of Bone Ingrowth and Interface Mechanics of a New Porous
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`Tantalum Biomaterial,” J. of Bone and Joint Surgery, Vol. 81-B, No. 5, pp. 907-
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`14 (Sept. 1999) (“Bobyn”) (Ex. 1011), U.S. Patent No. 5,863,295 to Averill et al.
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`(“Averill”) (Ex. 1012), M. Martens et al., “The Mechanical Characteristics of
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`Cancellous Bone at the Upper Femoral Region,” J. Biomechanics, Vol. 16, No.
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`12, pp. 971-983 (1983) (Ex. 1015), D. Carter et al., “The Compressive Behavior
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`of Bone as a Two-Phase Porous Structure,” J. of Bone and Joint Surgery, Vol.
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`59-A, No. 7, pp. 954-962 (Oct. 1977) (Ex. 1016), U.S. Patent No. 4,570,271 to
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`Sump (“Sump”) (Ex. 1017), U.S. Patent No. 5,282,861 to Kaplan (“Kaplan”) (Ex.
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`1020), U.S. Patent No. 6,063,442 to Cohen et al. (“Cohen”) (Ex. 1021), J.D.
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`Bobyn et al., “Characterization of a New Porous Tantalum Biomaterial for
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`Reconstructive Orthopedics,” Scientific Exhibit at 1999 Annual Meeting of the
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`American Academy of Orthopedic Surgeons (1999) (“Bobyn II”) (Ex. 1022),
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`Campbell’s Operative Orthopedics, Vol. 1 (S. Terry Canale, MD. ed., Mosby,
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`10th ed. 2003) (Ex. 1023), U.S. Patent No. 8,821,582 (“the ’582 patent”) (Ex.
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`1024), which I understand is related to the ’093 patent, and the Final Written
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`Decision in an IPR proceeding involving the ’582 patent (“’582 IPR”), IPR2016-
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`00012, Paper No. 34 (March 10, 2017) (Ex. 1008), while drawing on my
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`experience in the biomaterials and biomechanics of hip implants. My opinions
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`are additionally guided by my appreciation of how a person of ordinary skill in
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`the art would have understood the claims of the ’093 patent at the time of the
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`alleged invention, which I have been asked to assume is May 27, 2003.
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`9.
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`Based on my experience and expertise, it is my opinion that certain
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`references teach or suggest all the features recited in these claims.
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`IV. LEVEL OF ORDINARY SKILL IN THE ART
`10. At the time of the alleged invention, in May 2003, a person of
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`ordinary skill in the art would have had an undergraduate degree in a relevant
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`engineering field (e.g., Mechanical Engineering, Materials Science Engineering,
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`Biomedical Engineering) with 3-5 years of experience with hip implants or
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`similar implants. Alternatively, a person of ordinary skill in the art would have
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`had a graduate degree in a relevant engineering field with 1-3 years of experience
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`with hip implants or similar implants. More education can supplement relevant
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`experience and vice versa.
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`11.
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`In determining the level of ordinary skill, I have been asked to
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`consider, for example, the types of problems encountered in the art, prior
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`solutions to those problems, the rapidity with which innovations are made, the
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`sophistication of the technology, and the educational level of active workers in
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`the field. Active workers in the field would have had at least an undergraduate or
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`graduate degree in a relevant engineering specialty, as noted above. Depending
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`on the level of education, it would have taken between 1-5 years for a person to
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`become familiar with the problems encountered in the art and to become familiar
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`with the prior and current solutions to those problems, including the biomaterials
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`and biomechanics used to promote osseointegration, meaning the formation of a
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`direct functional and structural connection between a person’s bone and an
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`artificial implant.
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`V. BACKGROUND OF THE ’093 PATENT
`12. The ’093 patent relates to hip implants. See, e.g., Ex. 1001 at Title,
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`Abstract, 1:7-9, 2:43-46, 2:64-65. The disclosed hip implant includes two
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`components or bodies: a neck body 14 and a bone fixation body 16. See, e.g., id.
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`at Abstract, 1:46-49, 3:1-3, Figs. 1-2. Figure 1 illustrates an example of hip
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`implant 10, and Figure 2 illustrates the implant embedded in an intramedullary
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`canal 52 of a patient’s femur 50:
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`See id. at 2:43-46, 2:64-65, 3:35-37. As shown in Figure 2, bone fixation body 16
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`extends into the intramedullary canal, and the neck body 14 extends outwardly
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`from the resected end of the intramedullary canal. Id. at 3:41-44.
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`13. The ’093 patent states that neck body 14 “is located at the proximal
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`end 18 of the hip implant 10 and functions to connect the hip implant 10 to a
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`spherically shaped femoral ball 19 and acetabular component (not shown).” Id.
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`at 3:4-7. Neck body 14 has a base portion 22 that, in one example, includes a
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`collar 22 adapted to seat against a resected end portion of a femur. Id. at 3:7-10.
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`A neck portion 24 extends from base portion 20 and is configured to connect to a
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`femoral ball 19, which is received by an acetabular component (not shown). Id.
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`at 3:12-17, Figs. 1-2. A distal end surface 21 of neck body 14 is connected or
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`fused
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`to a proximmal end suurface 40 oof bone fixaation bodyy 16 at juncction 44. IId. at
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`permeated urface is punder the sual at and uthe materiameant that t‘porouus,’ it is m
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`does
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`with
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`3:26-228. Bone
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`fixation boody 16 “haas a comppletely poroous structuure” and “
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`clude a so
`not in
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`lid metal ssubstrate.”
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` Id. at 3:229-34; see
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`also id. att 1:62-67.
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`“By
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`intercoonnected interstitial ppores that
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`51.
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`communiccate with tthe surfacee.” Id. at 33:49-
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`14. Thee ’093 pateent also inccludes an eexample off a hip impplant (showwn in
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`Figure 55 to the left) in whicch a protruusion 74 exxtends outwward
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`from thhe base porrtion of thee neck boddy into thee bone fixaation
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`body.
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`Id. at 5:13-16, 5:200-29. Prootrusion 744 can parttially
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`extend iinto the boone fixationn body or
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`protrusionn 74 can exxtend
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`farther
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`toward thee distal ennd surface
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`82 of thee bone fixaation
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`body. IId. at 5:266-28. In thhe latter exxample, “[tt]he protruusion
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`gradually tapers aas it extennds towardd the distall end surfaace.”
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`Id. at 5
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`:28-29. AAccording tto the ’09
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`3 patent, ““the protruusion
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`can be
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`sized annd shaped
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`to providde a stronng connecction
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`betweenn the neckk body andd bone fixaation body”” and “proovide
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`e between al interfacean antti-rotationa
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`the neck bbody and bbone fixatiion body.”” Id.
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`at 5:377-41.
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`15. The porous structure of the ’093 patent can be fabricated by known
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`techniques, e.g., “sintering” and made from conventional porous materials,
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`including “titanium, titanium alloy powder, metal beads, metal wire mesh, or
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`other suitable materials, metals, or alloys known in the art.” Id. at 3:52-54; see
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`also Ex. 1011 at 907 (“In the last 20 years a variety of porous surfaces and
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`materials has been used to obtain fixation of bone ingrowth in total hip and knee
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`prostheses. The most common include titanium and cobalt-chrome-alloy sintered
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`beads, diffusion-bonded titanium, fibre metal, and titanium plasma spray”). The
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`neck body is also made by conventional and known machining techniques. Ex.
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`1001 at 3:20-23, 4:8-10. In one example, bone fixation body 16 “simultaneously
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`forms and attaches to the neck body.” Id. at 4:40-41. In another example, neck
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`body 14 and bone fixation body 16 are made separately and then “attached or
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`fused together using known welding or brazing techniques.” Id. at 4:44-46.
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`16. The porous structure of the bone fixation body engages the femoral
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`bone, which includes cortical and cancellous (trabecular) bone, when the hip
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`implant is positioned in the intramedullary canal of the femur. Id. at 2:7-9, 3:41-
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`46. See also Ex. 1015 at 971, 973; Ex. 1016 at 954. According to the ’093
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`patent, the porous structure is “adapted for the ingrowth of cancellous and
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`cortical bone spicules.” Ex. 1001 at 3:55-56. The ’093 patent states that the
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`geometric configuration of “the porous structure should encourage natural bone
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`to migrate and grow into and throughout the entire body 16,” (id. at 3:62-65) and
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`teaches that “[i]n the exemplary embodiment, the size and shape of the porous
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`structure emulates the size and shape of the porous structure of natural bone” (id.
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`at 3:56-59). In certain disclosed examples, “the average pore diameter of body
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`16 is about 40 µm to about 800 µm with a porosity from about 45% to 65%.
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`Further, the interconnections between pores can have a diameter larger than 50-
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`60 microns.” Id.at 3:59-621. The ’093 patent explains, however, that “[a]though
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`specific ranges are given for pore diameters, porosity, and interconnection
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`diameters, these ranges are exemplary and are applicable to one exemplary
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`embodiment” and “could be modified, and the resulting hip implant still within
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`the scope of the invention.” Id. at 3:66-4:4.
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`17. The ’093 patent includes 15 claims. I have been asked to consider
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`claims 1-12. Independent claims 1 and 7 are directed to a method and recite,
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`among other things, a “bone fixation body” formed of a “porous metal structure”
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`that “has a size and shape that emulate a size and a shape of a porous structure of
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`1 A person of ordinary skill in the art would have understood that the disclosed
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`range of pore diameters and porosities overlap with known pore diameters and
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`porosities of cancellous bone. See Ex. 1016 at p. 954 (“trabecular-bone porosity
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`may range from approximately 30 to more than 90 per cent [sic]”).
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`natural human bone.” See id. at 6:30-35 (claim 1), 7:4-8 (claim 7). I refer to this
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`phrase below as the “porous-metal-structure claim term.”
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`VI. CLAIM CONSTRUCTION
`18.
`I understand that in this proceeding, a claim receives the broadest
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`reasonable construction in light of the specification of the patent in which it
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`appears. I also understand that in this proceeding, any term that is not construed
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`should be given its plain and ordinary meaning under the broadest reasonable
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`construction. I have followed these principles in my analysis below.
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`A. “Porous-Metal-Structure” Claim Term
`Claims 1 and 7 recite the porous-metal-structure claim term. Ex. 1001 at
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`6:30-37, 7:4-10. I understand that Petitioner has offered that the broadest
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`reasonable interpretation of the porous-metal-structure claim term “requires
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`emulating the size and shape of a porous structure of natural human bone as
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`measured, for example, by pore diameter, porosity, and intersection diameter, but
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`they do not require emulating the size and shape of the interconnected plates and
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`rods that form trabecular bone.” I understand that the Board adopted this
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`construction for a similar term in the ’582 IPR. I have used this construction
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`unless otherwise noted, and agree that this construction is consistent with the ’093
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`patent’s disclosure.
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`B. “Separate Fabrication” Claim Terms
`19. Claim 1 recites “fabricating, separately from the neck body, a bone
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`fixation body,” and claim 7 recites “making, separately from the neck body, a
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`bone fixation body.” Ex. 1001 at 6:30-33, 7:4-5. I understand that Petitioner has
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`offered that the broadest reasonable interpretation of these claim terms is that
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`“fabrication of the bone fixation body and the neck body must be performed
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`independently from each other.” I understand that the Board adopted this
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`construction for similar phrases in the ’582 IPR. I have used this construction
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`unless otherwise noted, and agree that this construction is consistent with the
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`’093 patent’s disclosure.
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`C. Attaching or Connecting the Bone Fixation Body “After”
`Separately Fabricating It
`20. Claim 1 recites “permanently connecting, after the bone fixation
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`body is separately fabricated from the neck body, the bone fixation body to the
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`neck body,” and claim 7 recites “permanently attaching, after the bone fixation
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`body is separately made from the neck body, the bone fixation body to the neck
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`body.” Ex. 1001 at 6:38-39, 7:11-13. I understand that Petitioner has offered
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`that the broadest reasonable interpretation of these claim terms requires that
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`fabrication of the bone fixation body and the neck body must be performed
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`independently from each other. I understand that the Board adopted this
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`construction for similar phrases in the ’582 IPR. I have used this construction
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`unless otherwise noted, and agree that this construction is consistent with the
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`’093 patent’s disclosure.
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`VII. OVERVIEW OF THE PRIOR ART
`A.
`Zolman
`21. Zolman teaches a method of constructing a prosthetic implant
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`“suitable for use as a femoral component for a hip prosthesis.” Ex. 1009 at Title,
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`1:11-15. In one example, a porous pad 26 is circumferentially wrapped around a
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`stem portion 20 of a femoral component 10 to form the implant. See, e.g., id. at
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`Abstract, Figs. 1-6, 1:11-15, 2:23-26, 4:5-8, 4:33-36. The implant is “intended to
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`fit within the intramedullary canal of a femur (not shown) such that the proximal
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`end extends outwardly from the intramedullary canal of the femur to cooperate
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`with an acetabulum or acetabular prosthetic member via a ball or the like carried at
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`the proximal end 14.” Id. at 3:45-51. An example of Zolman’s implant and its
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`porous pad are shown in Figures 1 and 11, reproduced below:
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`Id. at Fig 1, Fig.11, 2:58-59, 3:13-14.
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`22. Zolman states that implants with porous surfaces are in “direct contact
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`with the bone surface” and that “[a]fter a period of time, bony ingrowth occurs in .
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`. . the porous surface” to “biologically affix or further secure the implant in the
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`bone.” Id. at 1:16-24. Zolman states that porous pad 26 can be made from “any
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`suitable porous material” and “particularly fibrous (wire-type) porous structures.”
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`Id. at 4:21-24. Zolman states that “one such suitable material is the fiber metal
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`structure disclosed in U.S. Patent No. 3,906,550 to Rostoker.” Id. at 4:12-21.
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`23. Zolman states that porous pad 26 is formed “separate[ly] from the
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`stem portion 20.” See, e.g., id. at 4:33-34. Porous pad 26 “is first formed in or
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`pressed into a substantially flat sheet 126.” Id. at 4:29-32. In a preferred example,
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`“[t]he porous material, such as a kinked titanium fiber metal, is press formed into a
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`sheet 126 of porous material” having “any desired thickness or dimensions.” Id. at
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`4:46-49. The outer contour of porous pad 26 is then cut from the metal sheet. Id.
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`at 4:56-58. The pad is subsequently wrapped and/or formed about stem portion 20
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`into a second shape corresponding to the shape of stem portion 20 as shown in
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`Figs. 1-4. Id. at 4:36-41. Porous pad 26 is positioned in a recess 74 “which
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`corresponds to the wrapped shape of the pad 26.” Id. at 5:13-16, 6:44-46, Fig. 6.
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`The porous pad is subsequently bonded to stem portion 20 by diffusion bonding,
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`sintering, or any “other suitable bonding methods” to form the hip implant. Id. at
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`6:46-54.
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`24.
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`In another example, Zolman teaches forming porous pad 26 into its
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`final shape on a mandrel, removing porous pad 26 from the mandrel, and then
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`placing porous pad 26 onto the stem portion of the implant and bonding the porous
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`pad to the stem portion. Id. at 7:1-14.
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`25. Zolman states that porous pad 26 “can be shaped to conform to any
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`desirable and suitable implant stem or fixation surface configuration.” Id. at 5:16-
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`18. In one example, Zolman teaches that a proximal portion 24 of stem portion 20
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`has a non-circular cross-section as shown in Figures 5 and 6. Id. at 5:19-21, Figs.
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`5 and 6. In my opinion, one skilled in the art at the time of the alleged invention
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`would have recognized that stem portion 20 has a trapezoidal shape in the cross-
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`section of Figure 5.
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`B.
`Rostoker
`26. Rostoker describes a prosthetic device having a porous fiber metal
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`structure. Ex. 1010 at Title. “The fiber metal structure is sintered and open-pored
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`so that the bone and tissue into which the prosthetic device is implanted will grow
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`into such fiber metal structure.” Id. at Abstract. Rostoker explains that “open-pore
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`material into which bone could grow should provide ideal skeletal fixation.” Id. at
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`1:51-52.
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`27. Rostoker teaches that its porous structure is “produced by molding and
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`sintering short metal fibers.” Id. at 2:21-23. In the molded and sintered fiber metal
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`aggregate, the metal fibers are completely interconnected. Id. at 5:16-18. Rostoker
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`teaches that “[t]he sintering process creates metallurgical bonds at the points of
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`contact of the fibers.” Id. at 2:23-25. Rostoker also teaches that “[t]he degree of
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`interlock . . . is substantially increased if the original wire is prekinked prior to
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`cutting the wire into the short fibers.” Id. at 4:42-45. An example of the porous
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`structure, with its interlocked fibers, is show in Figure 4, reproduced below:
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`Id. at Fig. 4, 2:67-68.
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`28. Rostoker
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`teaches
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`that by forming
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`its porous structure with
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`interconnected metal fibers, “the range of pore sizes can be readily controlled” and
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`“the pores are interconnecting and remain so after sintering.” Id. at 2:35-41; see
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`also id. at 2:17-18 (teaching that the porous structure “has a broad range of readily
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`controllable pore sizes”). “Thus, bone growth can penetrate for a substantial
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`distance into the fiber metal structure and thereby provide a very secure
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`connection.” Id. at 2:42-44. Further, “[s]ince the pore size can be readily
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`controlled . . . the density of the sintered composite can approximate the density of
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`the bone to which the prosthetic device is implanted.” Id. at 2:48-52.
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`29. Rostoker states that “[t]he largest principal dimension of the pores is
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`approximately equal to the wire diameter when the void content is about 50
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`percent.” Id. at 5:21-24. Rostoker teaches using wire with a range of diameters
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`from 0.013 centimeters (130 µm) to 0.030 centimeters (300 µm). Id. at 5:14-16.
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`Moreover, the porous structure “may be molded having void or a porosity of 40 to
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`50 percent per unit area.” Id. at 5:6-8. Rostoker describes its disclosed structure as
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`having “considerable mechanical strength due to the sintered bonds and the
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`mechanical interlocks.” Id. at 4:28-31; see also id. at 2:25-27.
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`C. Bobyn
`30. Bobyn studies bone ingrowth in a porous tantalum biomaterial. Ex.
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`1011 at 907. The porous tantalum material is fabricated by coating a vitreous
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`carbon skeleton with tantalum. Id. at 907-8.
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`31. Bobyn’s states that the porous tantalum biomaterial was “75% to 80%
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`porous by volume” and had “a repeating arrangement of slender interconnecting
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`struts which form[] a regular array of dodecahedron-shaped pores.” Id. at 907.
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`Bobyn also states that “[b]ecause of its high porosity, its structural stiffness is . . .
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`similar to subchondral bone.” Id. at 913. A person of ordinary skill in the art
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`would have understood that subchondral bone (i.e., the bone below cartilage layers
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`in joints such as the hip) was composed of cancellous (trabecular) bone. See, e.g.,
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`Ex. 1015 at 973 (showing the cancellous or trabecular bone in an upper femoral
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`region). Based on animal studies, Bobyn determined that “[t]his porous tantalum
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`material has desirable characteristics for bone ingrowth.” Ex. 1011 at 907.
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`32. Bobyn included a scanning electron microscope image (reproduced
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`below) of its disclosed porous tantalum material showing the structure formed by
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`the tantalum struts. Ex. 1011 at 908 (Fig. 1a); see also id. at 907 (describing the
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`structurre as a “rrepeating aarrangemeent of slennder intercconnectingg struts wwhich
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`form[] aa regular arrray of doddecahedronn-shaped ppores.”)
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`33. The
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`cancelloous bone
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`image beelow is aa scanningg electronn microscoope imagee of
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`from an uupper regioon of a feemur showwing the nnatural cel
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`lular
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`structurre of the boone having interconneected platees and coluumns of boone.
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`Ex. 1015 at 976 (FFig. 7).
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`3
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`4. Based on a commparison oof these immages and tthe knowleedge of onne of
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`ordinaryy skill in thhe art, a peerson of orrdinary skiill in the aart, in my oopinion, wwould
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`have understood that the porous tantalum biomaterial described in Bobyn has a
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`three-dimensional structure similar to cancellous (trabecular) bone. By, 2003 it
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`was understood by persons skilled in the art that the porous tantalum mimics the
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`open cell structure of cancellous bone. See, e.g., Ex. 1022 at 1 (stating that the
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`porous tantalum material is similar to tabecular bone); Ex. 1020 at Abstract, 6:1-4.
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`35. Bobyn states that tantalum “is a strong, ductile metal” that was “used
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`for a wide variety of implants.” Ex. 1011 at 913. Bobyn also states that its porous
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`tantalum biomaterial can “be made into complex shapes and used either as a bulk
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`implant or as a surface coating.” Id. at 907. In addition, Bobyn states that its
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`material can be made into “standard or customised [sic] shapes and sizes of the
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`implant.” Id. at 913. As examples, Bobyn states that “[t]he material could be used
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`as a backing for direct compression moulding of polyethylene-bearing components
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`or as a fixation surface on an implant substrate.” Id. Bobyn concludes that the
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`material “offers interesting potential for orthopedic reconstructive procedures.” Id.
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`D. Averill
`36. Averill describes a femoral component of a hip prosthesis 10. Ex.
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`1012 at 4:64-67, Fig. 1. The prosthesis generally includes a stem 12 having a
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`proximal end 16 and a distal end 18, and a neck 36. Id. at 5:8-10. An example of
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`Averill’s prosthesis is reproduced below:
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`37. Averill teaches that stem 12 includes a tapered portion 22 that merges
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`into a cylindrical portion 26. Id. at 5:21-27. FIGS. 2 and 3 illustrate the changing
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`cross-sectional shape of the tapered portion 22 at lines 2—2 and 3—3. Id. at 5:30-
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`32, Figs. 2, 3. The free end of the cylindrical portion 26 forms the distal