Filed on behalf of: Zimmer Biomet Holdings, Inc.
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`Paper No. ____
`Filed: October 2, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ZIMMER BIOMET HOLDINGS, INC.
`Petitioner
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`v.
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`FOUR MILE BAY, LLC
`Patent Owner
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`U.S. Patent No. 8,506,642
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`DECLARATION OF TIMOTHY P. HARRIGAN, ScD, MBA, PE
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`Page 1 of 88
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`ZIMMER EXHIBIT 1002
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`TABLE OF CONTENTS
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`Page
`INTRODUCTION .......................................................................................... 1 
`I. 
`QUALIFICATIONS ....................................................................................... 1 
`II. 
`SUMMARY OF OPINIONS .......................................................................... 3 
`III. 
`IV.  LEVEL OF ORDINARY SKILL IN THE ART ............................................ 4 
`V. 
`BACKGROUND OF THE ’642 PATENT .................................................... 5 
`VI.  CLAIM CONSTRUCTION ......................................................................... 10 
`A. 
`“Completely Porous Metal Structure” (Claims 1-3) .......................... 10 
`B. 
`“[A] Porous Structure . . . That Emulate[s] a Size and a Shape
`of a Porous Structure of Natural Human Bone” (Claim 1) / “[A]
`Porous Structure . . . [That] Emulates a Porous Structure of
`Natural Human Bone” (Claim 2 and 3) .............................................. 11 
`VII.  CERTAIN REFERENCES TEACH OR SUGGEST ALL OF THE
`CLAIMED FEATURES OF THE ’642 PATENT ....................................... 12 
`A.  Ground 1: Zolman and Rostoker Teach or Suggest All of the
`Features of Claims 1-4 ....................................................................... 12 
`Overview of Combination of Zolman with Rostoker .............. 12 
`1. 
`2. 
`Claim 1 ..................................................................................... 18 
`3. 
`Claim 2 ..................................................................................... 32 
`4. 
`Claim 3 ..................................................................................... 48 
`5. 
`Claim 4 ..................................................................................... 64 
`Ground 2: Zolman and Bobyn Teach or Suggest All of the
`Features of Claims 1-4 ....................................................................... 65 
`Overview of the Combination of Zolman with Bobyn ............. 65 
`1. 
`2. 
`Claim 1 ..................................................................................... 70 
`3. 
`Claim 2 ..................................................................................... 75 
`4. 
`Claim 3 ..................................................................................... 80 
`5. 
`Claim 4 ..................................................................................... 84 
`VIII.  CONCLUSION ............................................................................................. 86 
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`B. 
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`i
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`I, Timothy Patrick Harrigan, declare as follows:
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`I.
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`INTRODUCTION
`1.
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`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. 8,506,642 (“the ’642
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`patent”), which I understand is labeled as Ex. 1001 in this proceeding. I have been
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`asked to consider, among other things, whether certain references teach or suggest
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`the features recited in claims 1-4 of the ’642 patent. My opinions are set forth
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`below. My opinions are my own and do not express the views or opinions of my
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`employer, Johns Hopkins University Applied Physics Laboratory.
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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 of
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`this proceeding or any other proceeding involving the ’642 patent. I have no other
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`interest in this proceeding.
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`II. QUALIFICATIONS
`3.
`I received a Bachelor of Science (B.S.) in Mechanical Engineering
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`from Massachusetts Institute of Technology (MIT) in June 1980, a Doctorate in the
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`Sciences (Sc.D) in Mechanical Engineering from MIT in April 1985, and a Master
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`of Business Administration (MBA) from University of Houston in December 1998.
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`I wrote my doctoral thesis on bone compliance and its influence in human hip
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`joints, 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
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`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 was
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`an adjunct associate professor in the Department of Mechanical Engineering at
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`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 at
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`Rice University. Between 1993 and 1999, I was the Director of Research in the
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`Department of Orthopedic Surgery at the University of Texas Medical School at
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`Houston, where I supervised orthopedic resident research projects, developed
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`experimental and computational models for orthopedic implants, developed
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`mathematical and experimental models for circulation in and around bone, and
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`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 a
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`senior research engineer at Johns Hopkins University Applied Physics 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. In my academic career I have taught numerous biomechanics
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`courses, including biomechanics summary courses for orthopedic residents at the
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`University of Missouri-Kansas City; University of Kansas Medical School; and
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`University of Texas Medical School at Houston. I have also published extensively
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`in the field with more than 30 scientific articles and 60 presentations. My work
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`has been cited in the scientific literature over 1200 times. A copy of my
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`curriculum vitae is attached as Exhibit A.
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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 in
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`this declaration, including the ’642 patent (Ex. 1001), the prosecution history file
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`of U.S. Patent Application No. 10/446,069 (Ex. 1003), the prosecution history file
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`of the ’642 patent (Ex. 1004), U.S. Patent No. 5,018,285 to Zolman (“Zolman”)
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`(Ex. 1005), U.S. Patent No. 3,906,550 to Rostoker et al. (“Rostoker”) (Ex. 1006),
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`an article by J.D. Bobyn et al. titled “Characteristics of Bone Ingrowth and
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`Interface Mechanics of a New Porous Tantalum Biomaterial,” The Journal of Bone
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`and Joint Surgery, Vol. 81-B, No. 5, pp. 907-14 (Sept. 1999) (“Bobyn”) (Ex.
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`1007), and an article by M. Martens et al. titled “The Mechanical Characteristics of
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`Cancellous Bone at the Upper Femoral Region,” The Journal of Biomechanics,
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`Vol. 16, No. 12, pp. 971-83 (1983) (“Martens”) (Ex. 1009), while drawing on my
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`experience in the biomaterials and biomechanics of hip implants. My opinions are
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`additionally guided by my appreciation of how a person of ordinary skill in the art
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`would have understood the claims of the ’642 patent at the time of the alleged
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`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 similar
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`implants. Alternatively, a person of ordinary skill in the art would have had a
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`graduate degree in a relevant engineering field with 1-3 years of experience with
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`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 solutions
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`to those problems, the rapidity with which innovations are made, the sophistication
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`of the technology, and the educational level of active workers in the field. Active
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`workers in the field would have had at least an undergraduate or graduate degree in
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`a relevant engineering specialty, as noted above. Depending on the level of
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`education, it would have taken between 1-5 years for a person to become familiar
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`with the problems encountered in the art and to become familiar with the prior and
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`current solutions to those problems, including the biomaterials and biomechanics
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`used to promote osseointegration, meaning the formation of a direct functional and
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`structural connection between a person’s bone and an artificial implant.
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`V. BACKGROUND OF THE ’642 PATENT
`12. The ’642 patent relates to hip implants, as shown in figures 1 and 2
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`below. See e.g., Ex. 1001 at Title, 1:9-11, 2:65-66. The disclosed hip implant 10
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`includes two components or bodies: a neck body 14 and a bone fixation body 16.
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`See e.g., id. at Abstract, 3:2-4, Figs. 1-2. Figure 2 shows hip implant 10 embedded
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`in an intramedullary canal 52 of a femur 50 of a patient:
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`Id. at 3:37-39.
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`13. Neck body 14 can be formed from a solid metal piece of titanium,
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`titanium alloy, or other metals or alloys. Id. at 3:20-22. As shown above, a collar
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`22 of neck body 14 is configured to seat against a resected end 56 of the femur
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`about an entrance 57 to intramedullary canal 52. Id. at 3:11-12, 3:41-43. Neck
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`body 14 extends outwardly from the resected end of the intramedullary canal 52
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`and includes a base portion 20 with a neck portion 24 that is configured to connect
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`hip implant 10 to a femoral ball 19 which is received by an acetabular component
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`(not shown). Id. at 3:5-8, 3:14-15, 3:22-25, 3:41-46. A distal end surface 21 of
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`neck body 14 connects or fuses to a proximal end surface 40 of bone fixation body
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`16 at a junction 44. Id. at 3:28-30.
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`14. The ’642 patent describes an example of a hip implant (shown in
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`figure 5 below) in which a protrusion 74 extends from the distal end surface of the
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`neck body into the bone fixation body. Id. at 5:16-18.
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`15. Protrusion 74 can have any shape, for example, “cylindrical or
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`polygonal, such as rectangular or square.” See id. at 5:35-36. Protrusion 74 can
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`partially extend into the bone fixation body or protrusion 74 can extend farther
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`toward the distal end surface 82 of the bone fixation body. Id. at 5:28-30. In the
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`latter example, “[t]he protrusion gradually tapers as it extends toward the distal end
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`surface.” Id. at 5:30-31. According to the ’642 patent, “the protrusion can be sized
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`and shaped to provide a strong connection between the neck body and bone
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`fixation body” and “provide an anti-rotational interface between the neck body and
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`bone fixation body.” Id. at 5:40-44.
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`16. As shown in the figures above, bone fixation body 16 has an
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`elongated tapering shape that extends from proximal end surface 40 or 80 to a
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`rounded distal end surface 42 or 82. Id. at 3:26-28, 5:21-23, Figs. 1-6. The
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`elongated tapering shape of bone fixation body 16 also has “a slight bow.” Id. at
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`4:49-50, Figs. 1-5. The ’642 patent also states that “[t]he bone fixation body . . .
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`may have other configurations and still be within the scope of the invention.” Id.
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`at 5:50-52. In certain examples, the ’642 patent describes the bone fixation body
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`as having “a trapezoidal cross-sectional shape.” See id. at 5:64-66, 6:4-5, Fig. 7.
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`17. Bone fixation body 16 is formed of a porous metal such as, for
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`example, titanium, and “has a completely porous structure that extends throughout
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`the entire body from the proximal surface 40 to distal end surface 42.” Id. at 3:33-
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`35. “By ‘porous,’ it is meant that the material at and under the surface is
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`permeated with interconnected interstitial pores that communicate with the
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`surface.” Id. at 3:51-53. Further, the ’642 patent explains that “body 16 does not
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`include a solid metal substrate.” Id. at 3:35-36.
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`18. The ’642 patent broadly describes the porous structure as being
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`“adapted for the ingrowth of cancellous and cortical bone spicules” and having a
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`size and shape that “emulates the size and shape of the porous structure of natural
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`bone.” Id. at 3:57-61. In certain disclosed examples, “the average pore diameter
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`of body 16 is about 40 µm to about 800 µm with a porosity from about 45% to
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`65%. Further, the interconnections between pores can have a diameter larger than
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`50-60 microns.” Id. at 3:61-64. In my opinion, a person of ordinary skill in the art
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`would have recognized that the disclosed range of pore diameters and porosities
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`overlap with known pore diameters and porosities of cancellous bone. See e.g.,
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`Ex. 1013 at p. 954 (“trabecular-bone porosity may range from approximately 30 to
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`more than 90 per cent”). The ’642 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.” Id. at 4:1-3.
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`19. The generally porous structure can be fabricated by known techniques
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`“sintering titanium, titanium alloy powder”, using known materials e.g., “metal
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`beads, metal wire mesh, or other suitable materials, metals, or alloys known in the
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`art.” Id. at 3:54-56. The ’642 patent does not disclose any processes, materials, or
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`material characteristics specifically for achieving a porous structure that “emulates
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`a size and shape of the porous structure of natural bone.” The neck body can be
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`formed using known machining techniques. See id. at 4:10-12. In certain
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`disclosed examples, these bodies are fabricated independently and subsequently
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`connected or fused together. See id. at 4:39-41, 4:44-48.
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`20. The ’642 patent includes 4 claims, of which claims 1, 2, and 3 are
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`independent. See id. at 6:24-8:27. Independent claims 1, 2, and 3 are all directed
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`to a hip implant including, among other things, “a neck body” and “a bone fixation
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`body” that is formed as “a completely porous metal structure.” Id. at 6:24-8:27.
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`The claims recite that the porous structure “emulate[s] a size and a shape of a
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`porous structure of natural human bone” (claim 1) or “emulates a porous structure
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`of natural human bone” (claims 2 and 3). Id.
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`VI. CLAIM CONSTRUCTION
`21.
`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 these proceedings, 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.
`“Completely Porous Metal Structure” (Claims 1-3)
`22. Each independent claim of the ’642 patent includes a “bone fixation
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`body,” and recites that the bone fixation body is formed as a “completely porous
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`metal structure.” Ex. 1001 at 6:29-34, 6:60-67, 7:25-8:3. I understand that
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`Petitioner has offered that the broadest reasonable construction of the claimed
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`“completely porous metal structure” is “a metal structure that is entirely porous.” I
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`have used this construction unless otherwise noted, and agree that this construction
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`is consistent with the ’642 patent’s disclosure.
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`B.
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`“[A] Porous Structure . . . That Emulate[s] a Size and a Shape of a
`Porous Structure of Natural Human Bone” (Claim 1) / “[A]
`Porous Structure . . . [That] Emulates a Porous Structure of
`Natural Human Bone” (Claim 2 and 3)
`23. Each independent claims of the ’642 patent includes a “bone fixation
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`body.” Ex. 1001 at 6:29, 6:60, 7:25. Claims 2 and 3 recite that “[a] porous
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`structure of the bone fixation body emulates a porous structure of natural human
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`bone” (id. at 7:18-19, 8:22-23), and claim 1 recites that “[a] porous structure of the
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`bone fixation body has a size and shape that emulate a size and a shape of a porous
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`structure of natural human bone” (id. at 5:52-54) (referred to later as “the
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`emulating claim features”). I understand that Petitioner has offered that the
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`broadest reasonable construction of these phrases (to the extent they can be
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`construed) includes “a structure that is sufficiently porous so as to permit bone
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`ingrowth.” I have used this construction unless otherwise noted, and agree that this
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`construction is consistent with the’642 patent’s disclosure.
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`VII. CERTAIN REFERENCES TEACH OR SUGGEST ALL OF THE
`CLAIMED FEATURES OF THE ’642 PATENT
`24.
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`In my opinion, Zolman in view of Rostoker and Zolman in view of
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`Bobyn teach or suggest the features recited in the claims of the ’642 patent.
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`A. Ground 1: Zolman and Rostoker Teach or Suggest All of the
`Features of Claims 1-4
`1. Overview of Combination of Zolman with Rostoker
`25. Zolman discloses a prosthetic implant “suitable for use as a femoral
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`component for a hip prosthesis.” See Ex. 1005 at 1:11-15. In one example,
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`Zolman discloses a femoral component 10 that is “intended to fit within the
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`intramedullary canal of a femur (not shown) such that the proximal end extends
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`outwardly from the intramedullary canal of the femur to cooperate with an
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`acetabulum or acetabular prosthetic member via a ball or the like carried at the
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`proximal end 14.” Id. at 3:46-51.
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`Femoral component 10 is formed of, for example, titanium, and includes a stem
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`portion 20 and a neck 28 extending proximally from stem portion 20. See id. at
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`4:26-27, 3:54-59. As shown in Figures 1, 2, 5, and 6 reproduced above, proximal
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`portion 24 of stem portion 20 of Zolman “has an asymmetric non-circular cross-
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`section.” Id. at 5:19-21.
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`26. A porous pad 26, as shown in the examples of Figures 1-6, is
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`circumferentially wrapped around the proximal portion 24 of stem portion 20. Id.
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`at 3:53-54, 4:5-8, 5:12-16, 6:44-48. Porous pad 26 is positioned in a recess 74
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`having a shape corresponding to porous pad 26 and adapted to receive porous pad
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`26. Id. at 5:13-16. In certain disclosed examples, porous pad 26 conforms to the
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`shape of stem portion 20, and has an asymmetric or symmetric configuration. See
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`id. 5:5-11, 5:16-18, Figs. 1-6. Zolman teaches that “[t]he shape of the porous pad
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`26 may have any desirable configuration” and that “[t]he outer boundary of the pad
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`26 may have any suitable contour.” Id. at 4:29-33.
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`27. Porous pad 26 is formed “separate[ly] from the stem portion 20.” See
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`e.g., id. at 4:33-34. In particular, Zolman discloses that “[t]he porous material,
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`such as a kinked titanium fiber metal, is [first] press formed into a sheet 126 of
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`porous material” and that “[a] porous pad 26 having the desired outer contour is
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`then cut from the sheet . . . .” Id. at 4:46-58. The porous pad 26 is subsequently
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`applied to femoral component 10 by securely positioning porous pad 26 in recess
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`74. See e.g., id. at 6:44-46. Zolman teaches that “[t]he porous pad 26 is then
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`bonded to the stem portion 20 to securely attach it thereto.” Id. at 6:46-48.
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`28. As Zolman explains, the porous pad facilitates “bony ingrowth [] in
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`and around the porous surface to biologically affix or further secure the implant in
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`the bone.” Id. at 1:20-23. Zolman discloses that the porous pad can be made from
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`“any suitable porous material” and “particularly fibrous (wire-type) porous
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`structures which are adaptable to be practiced in accordance with the present
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`invention.” Id. at 4:21-24. Zolman expressly discloses that one such suitable
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`material is the fiber metal structure disclosed in Rostoker. Id. at 4:12-15. In my
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`opinion, a person of ordinary skill in the art would have been motivated to look to
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`Rostoker for the porous material from which to fabricate the porous pad of Zolman
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`based on at least this disclosure of Zolman.
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`29. Rostoker discloses a femur prosthesis 12 having a sintered fiber metal
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`attachment structure 18 composed of a plurality of tubular fiber metal segments
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`28a, 28b, 28c, 28d, and 28e. Ex. 1006 at 3:14-17, 3:21-23. Rostoker discloses that
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`the fiber metal segments 28 are “all porous aggregates produced by molding and
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`sintering short metal fibers.” Id. at 4:22-27. “The sintering process creates
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`metallurgical bonds at the points of contact of the fibers.” Id. at 2:23-25. Like
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`Zolman, Rostoker discloses examples in which the fiber metal structure is formed
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`from kinked metal fibers such as, for example, kinked titanium fiber metal. See
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`Ex. 1005 at 4:46-48; Ex. 1006 at 4:42-62.
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`30. Rostoker further describes its disclosed fiber metal structure as having
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`“considerable mechanical strength due to the sintered bonds and the mechanical
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`interlocks.” Id. at 4:28-31; see also id. at 2:25-27. Additionally, Rostoker
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`discloses that “in view of the use of fiber metals, the pores are interconnecting and
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`remain so after sintering. 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 2:40-44. Given Rostoker’s teachings of the benefits of its
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`disclosed porous fiber metal structure and Zolman’s teaching that porous surfaces
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`may be used to allow bony ingrowth, in my opinion, a person of ordinary skill in
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`the art would have been motivated to use the fiber metal structure of Rostoker in
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`Zolman’s porous pad 26 to facilitate “bony ingrowth to biologically affix or secure
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`the implant to the bone.” Ex. 1005 at 1:20-23.
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`31. Rostoker additionally discloses that “[b]y using fiber metals[,] the
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`range of pore sizes can be readily controlled . . . .” Id. at 2:35-36. Rostoker states
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`that “[s]ince the pore size can be readily controlled by the pressing and forming
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`parameters [of the sintering process], the density of the sintered composite can
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`approximate the density of the bone to which the prosthetic device is implanted.”
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`Id. at 2:48-52 (emphasis added). Rostoker discloses pore diameters and porosities
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`that fall within the range of pore diameters and porosities that are disclosed in the
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`’642 patent as “emulat[ing] the size and shape of the porous structure of natural
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`bone.” Compare Ex. 1006 at 5:6-25 with Ex. 1001 at 3:57-67. Thus, in my
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`opinion, Rostoker discloses the “emulating” claim features recited in the claims.
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`32.
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`In my opinion, one of ordinary skill in the art would have fabricated
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`the porous structure of Zolman’s porous pad 26 from the metal fiber structure of
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`Rostoker with a porous structure that “emulates” the porous structure of natural
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`human bone i.e., “a structure that is sufficiently porous so as to permit bone
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`ingrowth.” Indeed, as noted above, Zolman expressly discloses fabricating porous
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`pad 26 from Rostoker’s fiber metal structure. Ex. 1005 at 4:12-15.
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`33.
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`In my opinion, a person of ordinary skill in the art would have been
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`further motivated to fabricate Zolman’s porous pad 26 to have a porous fiber metal
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`structure that “emulates” natural human bone, as taught in Rostoker, to increase the
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`strength of the attachment of Zolman’s femoral component 10 to the surrounding
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`bone, allowing femoral component 10 to better withstand the load applied to the
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`hip joint. In my opinion, a person of ordinary skill in the art would have
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`understood that a structure that is conducive to bone formation and enables tissue
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`infiltration facilitates a strong attachment and long-term implant stability of the
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`implant.
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`34.
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`In my opinion, fabricating Zolman’s porous pad 26 with a porous
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`structure that “emulates” natural human bone would have been a simple and
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`common sense combination in light of Rostoker’s disclosure that its fiber metal
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`structure can “approximate” the structure of bone and encourage bone growth to
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`firmly secure an implant to the surrounding tissue—the importance of which is
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`recognized in Zolman. See Ex. 1005 at 1:20-23 (recognizing that a porous surface
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`permits bony ingrowth, further securing an implant).
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`35.
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`Indeed, in my opinion, a person of ordinary skill in the art would have
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`recognized that fabricating porous pad 26 with the porous fiber metal structure of
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`Rostoker that “emulates” natural human bone would have amounted to nothing
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`more than a simple substitution of known porous structures, and that
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`the
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`modification would yield nothing more than predictable results i.e., bone ingrowth.
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`36. Additionally, given Rostoker’s and Zolman’s teachings and the
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`knowledge of one of ordinary skill in the art at the relevant timeframe, in my
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`opinion, modifying Zolman’s porous pad 26 to use the fiber metal structure of
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`Rosfoker would have constituted no more than a simple design choice to one
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`skilled in the art.
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`Indeed, in my opinion, it would have been an expected design
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`choice as the metal fiber structure is explicitly referenced in Zolman.
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`37.
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`Thus, in my opinion, Zolman in combination with Rostoker teach or
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`suggest all the features of the challenged claims.
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`2.
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`Claim 1
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`38. As described below,
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`the combination of Zolman and Rostoker
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`discloses the features of claim 1:
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`Claim Language
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`Zolman and Rostoker
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`[1.a] A hip implant,
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`Zolman discloses a hip implant. For example,
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`comprising:
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`Zolman discloses a prosthetic implant “suitable
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`prosthesis and is particularly suitable as such.”)-
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`for use as a femoral component
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`for a hip
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`prosthesis.” Ex- 1005 at 1:11-15. See also id. at
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`3:33-35 (“[t]he invention will be described with
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`reference to a femoral component 10 of a hip
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`Femoral component 10 is shown in Figure 1,
`reproduced below.
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`Femoral component 10 includes a proximal end
`14 and a distal end 12, and is “intended to fit
`within the intramedullary canal of a femur (not
`shown) such that the proximal end extends
`outwardly from the intramedullary canal of the
`femur. . . .” Id. at 3:44-51.
`Zolman discloses a neck body (shaded in grey)
`having a proximal end (i.e., neck 28) that
`connects with an acetabular component. As
`shown below, Zolman discloses a neck 28, an
`adjacent portion with aperture 31, and a stem
`portion 20 (collectively referred to hereinafter as
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`[1.b] a neck body having a
`proximal end that connects
`with an acetabular component,
`having a distal end surface
`with an elongated protrusion
`that extends outwardly
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`therefrom, and being formed
`of solid metal; and
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`“neck body”). Zolman teaches that the neck body
`“is adapted to carry a ball 30 shown in phantom
`lines in Fig. 1.” Ex. 1005 at 3:56-59. Ball 30
`cooperates with an acetabulum or acetabular
`prosthetic member. Id. at 3:45-51.
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`Zolman discloses that the neck body has a distal
`end surface (annotated in red) with an elongated
`protrusion, stem portion 20 (shaded above in
`blue), which extends outwardly therefrom. See
`id. at 3:54-56, Figs. 1-4. The distal end surface of
`the neck body is formed by a recess 74 at the
`interface between the neck body and porous pad
`26, and includes the lip of recess 74 and is where
`porous pad 26 engages the neck body. Id. at
`5:13-16, 6:44-48, Fig. 6; see also id. at Figs. 14
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`and 15 (disclosing another example of the recess).
`Zolman discloses in the example of Figs. 1-4, that
`recess 74 extends around the entire circumference
`of stem portion 20. See id. at 5:12-16.
`Zolman discloses that the neck body is formed
`of a solid metal, i.e., titanium. See id. at 4:26-27
`(“the material for the femoral component may []
`be titanium”).
`Zolman discloses a bone fixation body, i.e.,
`porous surface or pad 26, identified in the
`annotated Figure 2 below. See Ex. 1005 at 3:53-
`54, 4:5-8, Figs. 1-6.
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`
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`[1.c] a bone fixation body
`having an elongated tapering
`shape and being formed as a
`completely porous metal
`structure that extends
`throughout an exterior and an
`interior of the bone fixation
`body and that includes a
`proximal end that engages the
`distal end surface of the neck
`body at an interface,
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`As shown above, porous pad 26 has an elongated
`tapering shape. See id. at Figs. 1-4, 11. As
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`shown in Figure 2, porous pad 26 conforms to the
`shape of stem portion 20, id. at 4:10-12, which
`continues and tapers in a distal direction, see e.g.,
`id. at Fig. 2. In my opinion, porous pad 26 would
`also conform to the shape of stem portion 20 and
`continue and taper in a distal direction towards a
`distal end of porous pad 26. See e.g., id. at Fig. 2.
`Zolman discloses that porous pad 26 can be
`formed of a porous metal structure such as, for
`example, a fibrous (wire-type) porous structure.
`See id. at 4:21-24. In one example, Zolman
`discloses that porous pad 26 is formed of a fiber
`metal structure such as, for example, a “kinked
`titanium fiber metal[] [that] is pressed formed
`into a sheet 126 of porous material.” See id. at
`4:46-48. Zolman teaches that porous pad 26 is
`cut from sheet 126 (id. at 4:56-58) and thus
`discloses that the porous metal structure of porous
`pad 26 is a completely porous metal structure
`(i.e., a metal structure that is entirely porous) that
`extends through an exterior and an interior of
`porous pad 26.
`As shown in Figure 2 above, porous pad 26
`includes a proximal end that engages the distal
`end surface of the neck body at an interface. In
`particular, a proximal end of porous pad 26
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`[1.d] wherein the interface has
`a trapezoidal cross-sectional
`shape in which the trapezoidal
`cross-sectional shape
`continues and tapers in a distal
`direction toward a distal end of
`the bone fixation body,
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`engages the distal end surface of the neck body
`that is formed by recess 74 at an interface
`between the neck body and porous pad 26 when
`porous pad 26 is received in recess 74. Id. at
`5:13-16, 6:44-48, Figs. 1-6; see also id. at 3:61-65
`(disclosing that porous pad 26 is adjacent to the
`smooth surface of the neck body).
`Zolman discloses that the interface between the
`neck body and porous pad 26 has a trapezoidal
`cross-sectional shape, which continues and tapers
`in a distal direction toward a distal end of porous
`pad 26. See e.g. Ex. 1005 at 5:9-11, 5:19-21,
`Figs. 5 and 6. In particular, Zolman teaches that
`proximal portion 24 of stem portion 20, which
`includes recess 74, has a noncircular cross-
`section, and that porous pad 26 has a shape
`corresponding to proximal portion 24. See e.g.,
`id. at 5:13-21. Figure 5 is a cross-sectional view
`of the femoral component 10 along line 5—5 in
`Figure 2, just below the distal end surface of the
`interface and the distal end surface of the neck
`body. In my opinion, a person of ordinary ski