`
`
`
`
`
`
`
`
`
`
`
`
`
`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. 9,283,080
`
`____________________
`DECLARATION OF TIMOTHY P. HARRIGAN, SCD, MBA, PE
`
`
`
`ZIMMER EXHIBIT 1002
`
`Page 1 of 98
`
`

`

`TABLE OF CONTENTS
`
`
`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 ’080 PATENT .................................................... 6 
`VI.  CLAIM CONSTRUCTION ......................................................................... 11 
`A. 
`“Porous-Metal-Structure” Claim Term .............................................. 11 
`B. 
`“Separate Fabrication” Claim Terms ................................................. 12 
`C. 
`Terms That Require Connecting the Bone Fixation Body
`“After” Separately Fabricating It ....................................................... 13 
`VII.  OVERVIEW OF THE PRIOR ART ............................................................ 14 
`A. 
`Zolman ................................................................................................ 14 
`B. 
`Rostoker .............................................................................................. 16 
`C. 
`Bobyn .................................................................................................. 18 
`D. 
`Averill ................................................................................................. 21 
`VIII.  CERTAIN REFERENCES TEACH OR SUGGEST ALL OF THE
`CLAIMED FEATURES OF CLAIMS 1-3, 5, 7, AND 9-11 OF THE
`’080 PATENT ............................................................................................... 23 
`A.  Ground 1: Zolman and Rostoker Teach or Suggest All of the
`Features of Claims 1-3, 5, 7, and 9-11 ............................................... 23 
`1. 
`Claim 1 ..................................................................................... 23 
`2. 
`Claim 2 ..................................................................................... 46 
`3. 
`Claim 3 ..................................................................................... 48 
`4. 
`Claim 5 ..................................................................................... 51 
`5. 
`Claim 7 ..................................................................................... 56 
`6. 
`Claim 9 ..................................................................................... 57 
`7. 
`Claim 10 ................................................................................... 59 
`8. 
`Claim 11 ................................................................................... 64 
`
`-i-
`
`Page 2 of 98
`
`

`

`
`
`B. 
`
`C. 
`
`Ground 2: Zolman, Rostoker, and Averill Teach or Suggest All
`of the Features of Claims 1-3, 5, 7, and 9-11 ..................................... 65 
`Ground 3: Zolman, Bobyn, and Averill Teach or Suggest All of
`the Features of Claims 1-3, 5, 7, and 9-11 ......................................... 67 
`1. 
`Claim 1 ..................................................................................... 67 
`2. 
`Claim 2 ..................................................................................... 80 
`3. 
`Claim 3 ..................................................................................... 82 
`4. 
`Claim 5 ..................................................................................... 83 
`5. 
`Claim 7 ..................................................................................... 88 
`6. 
`Claim 9 ..................................................................................... 89 
`7. 
`Claim 10 ................................................................................... 89 
`8. 
`Claim 11 ................................................................................... 94 
`IX.  CONCLUSION ............................................................................................. 95 
`
`
`-ii-
`
`Page 3 of 98
`
`

`

`
`
`I, Timothy Patrick Harrigan, declare as follows:
`
`I.
`
`INTRODUCTION
`1.
`I have been retained by Zimmer Biomet Holdings, Inc. (“Petitioner”)
`
`as an independent expert consultant in this proceeding before the United States
`
`Patent and Trademark Office regarding U.S. Patent No. 9,283,080 (“the ’080
`
`patent”), which I understand is labeled as Ex. 1001 in this proceeding. I have been
`
`asked to consider, among other things, whether certain references teach or suggest
`
`the features recited in claims 1-3, 5, 7, and 9-11 of the ’080 patent. My opinions
`
`are set forth below. My opinions are my own and do not express the views or
`
`opinions of my employer, Johns Hopkins University Applied Physics Laboratories.
`
`2.
`
`I am being compensated at my normal consulting rate for the time I
`
`spend on this matter. No part of my compensation is dependent on the outcome of
`
`this proceeding or any other proceeding involving the ’080 patent. I have no other
`
`interest in this proceeding.
`
`II. QUALIFICATIONS
`3.
`I received a B.S. in Mechanical Engineering from Massachusetts
`
`Institute of Technology (MIT) in June 1980, a Doctorate in the Sciences (Sc.D) in
`
`Mechanical Engineering from MIT in April 1985, and a Master of Business
`
`Administration (MBA) from University of Houston in December 1998. I wrote my
`
`-1-
`
`Page 4 of 98
`
`

`

`
`
`doctoral thesis on bone compliance and its influence in human hip joints, which
`
`was sponsored by a Whitaker Health Sciences Fund fellowship.
`
`4.
`
`Between 1985 and 1990, I was an assistant
`
`in orthopedics
`
`(biomechanics) at Massachusetts General Hospital where I conducted research on
`
`cemented and un-cemented total hip replacements, researched bone cement
`
`porosity, and developed experimental capabilities to characterize cancellous bone
`
`around implants. Between 1990 and 1993, I was a director of research in the
`
`Department of Orthopedics at the University of Missouri-Kansas City Medical
`
`School where I supervised orthopedic resident research projects, developed
`
`experimental models for bone machining processes for orthopedic implants, and
`
`developed computational bone remodeling simulations. From 1994 to 1999, I was
`
`an adjunct associate professor in the Department of Mechanical Engineering at
`
`Cullen College of Engineering at the University of Houston, and from 1993 to
`
`1999, I was an associate professor in the Department of Mechanical Engineering at
`
`Rice University. Between 1993 and 1999, I was the Director of Research in the
`
`Department of Orthopedic Surgery at the University of Texas at Houston Medical
`
`School, where I supervised orthopedic resident research projects, developed
`
`experimental and computational models for orthopedic implants, developed
`
`mathematical and experimental models for circulation in and around bone, and
`
`researched cement pressurization around total hip implants.
`
`-2-
`
`Page 5 of 98
`
`

`

`
`
`5.
`
`In addition to my extensive academic experience, I have industry
`
`experience with medical devices at Resmed, Inc. (1999), Exponent Failure
`
`Analysis Associates (2000-2005), and Foster-Miller (2005-2009). I am presently a
`
`senior research engineer at Johns Hopkins University Applied Physics Laboratory.
`
`6.
`
`I have extensive experience in the biomaterials and biomechanics of
`
`orthopedic implants. In my academic career I have taught numerous biomechanics
`
`courses, including biomechanics summary courses for orthopedic residents at the
`
`University of Missouri-Kansas City; University of Kansas Medical School; and
`
`University of Texas medical School at Houston. I have also published extensively
`
`in the field with more than 30 scientific articles and 60 presentations. My work
`
`has been cited in the scientific literature over 1200 times. Examples of my
`
`publications include the articles “Characterization of Microstructural Anisotropy in
`
`Orthotropic Materials Using a Second Rank Tensor” (T.P. Harrigan & R. W.
`
`Mann, J. of Materials Science, Vol. 19, pp. 761-767 (1984)) and “Limitations of
`
`the Continuum Assumption in Cancellous Bone” (Timothy P. Harrigan et al., J.
`
`Biomechanics, Vol. 21, No. 4, pp. 269-275 (1988)). I understand that a copy of
`
`my curriculum vitae is labeled as Ex. 1003.
`
`7.
`
`I am a registered professional engineer and a registered patent agent.
`
`-3-
`
`Page 6 of 98
`
`

`

`
`
`III. SUMMARY OF OPINIONS
`8.
`All of the opinions contained in this Declaration are based on the
`
`documents I reviewed and my knowledge and professional judgment. In forming
`
`the opinions expressed in this Declaration, I reviewed the documents mentioned in
`
`this declaration, including the ’080 patent (Ex. 1001), U.S. Patent No. 5,018,285 to
`
`Zolman et al. (“Zolman”) (Ex. 1009), U.S. Patent No. 3,906,550 to Rostoker et al.
`
`(“Rostoker”) (Ex. 1010), an article by J.D. Bobyn et al., titled “Characteristics of
`
`Bone Ingrowth and Interface Mechanics of a New Porous Tantalum Biomaterial,”
`
`J. of Bone and Joint Surgery, Vol. 81-B, No. 5, pp. 907-14 (Sept. 1999) (“Bobyn”)
`
`(Ex. 1011), U.S. Patent No. 5,863,295 to Averill et al. (“Averill”) (Ex. 1012), M.
`
`Martens et al., “The Mechanical Characteristics of Cancellous Bone at the Upper
`
`Femoral Region,” J. Biomechanics, Vol. 16, No. 12, pp. 971-983 (1983) (Ex.
`
`1015), D. Carter et al., “The Compressive Behavior of Bone as a Two-Phase
`
`Porous Structure,” J. of Bone and Joint Surgery, Vol. 59-A, No. 7, pp. 954-962
`
`(Oct. 1977) (Ex. 1016), U.S. Patent No. 4,570,271 to Sump (“Sump”) (Ex. 1017),
`
`U.S. Patent No. 5,282,861 to Kaplan (“Kaplan”) (Ex. 1020), U.S. Patent No.
`
`6,063,442
`
`to Cohen et al. (“Cohen”) (Ex. 1021), J.D. Bobyn et al.,
`
`“Characterization of a New Porous Tantalum Biomaterial for Reconstructive
`
`Orthopedics,” Scientific Exhibit at 1999 Annual Meeting of the American
`
`Academy of Orthopedic Surgeons (1999) (“Bobyn II”) (Ex. 1022), Campbell’s
`
`-4-
`
`Page 7 of 98
`
`

`

`
`
`Operative Orthopedics, Vol. 1 (S. Terry Canale, MD. ed., Mosby, 10th ed. 2003)
`
`(Ex. 1023), U.S. Patent No. 8,821,582 (“the ’582 patent”) (Ex. 1024), which I
`
`understand is related to the ’080 patent, and the Final Written Decision in an IPR
`
`proceeding involving the ’582 patent (“’582 IPR”), IPR2016-00012, Paper No. 34
`
`(March 10, 2017) (Ex. 1008), while drawing on my experience in the biomaterials
`
`and biomechanics of hip implants. My opinions are additionally guided by my
`
`appreciation of how a person of ordinary skill in the art would have understood the
`
`claims of the ’080 patent at the time of the alleged invention, which I have been
`
`asked to assume is May 27, 2003.
`
`9.
`
`Based on my experience and expertise, it is my opinion that certain
`
`references teach or suggest all the features recited in these claims.
`
`IV. LEVEL OF ORDINARY SKILL IN THE ART
`10. At the time of the alleged invention, in May 2003, a person of
`
`ordinary skill in the art would have had an undergraduate degree in a relevant
`
`engineering field (e.g., Mechanical Engineering, Materials Science Engineering,
`
`Biomedical Engineering) with 3-5 years of experience with hip implants or similar
`
`implants. Alternatively, a person of ordinary skill in the art would have had a
`
`graduate degree in a relevant engineering field with 1-3 years of experience with
`
`hip implants or similar implants. More education can supplement relevant
`
`experience and vice versa.
`
`-5-
`
`Page 8 of 98
`
`

`

`
`
`11.
`
`In determining the level of ordinary skill, I have been asked to
`
`consider, for example, the types of problems encountered in the art, prior solutions
`
`to those problems, the rapidity with which innovations are made, the sophistication
`
`of the technology, and the educational level of active workers in the field. Active
`
`workers in the field would have had at least an undergraduate or graduate degree in
`
`a relevant engineering specialty, as noted above. Depending on the level of
`
`education, it would have taken between 1-5 years for a person to become familiar
`
`with the problems encountered in the art and to become familiar with the prior and
`
`current solutions to those problems, including the biomaterials and biomechanics
`
`used to promote osseointegration, meaning the formation of a direct functional and
`
`structural connection between a person’s bone and an artificial implant.
`
`V. BACKGROUND OF THE ’080 PATENT
`12. The ’080 patent relates to hip implants. See, e.g., Ex. 1001 at Title,
`
`Abstract, 1:38-41, 3:16-22, 3:30-31. The disclosed hip implant includes two
`
`components or bodies: a neck body 14 and a bone fixation body 16. See, e.g., id.
`
`at Abstract, 2:18-21, 3:34-36, Figs. 1-2. Figure 1 illustrates an example of hip
`
`implant 10, and Figure 2 illustrates the implant embedded in an intramedullary
`
`canal 52 of a patient’s femur 50:
`
`-6-
`
`Page 9 of 98
`
`

`

`
`
`
`
`See id. at 1:38-41, 3:30-31, 4:1-3. As shown in Figure 2, bone fixation body 16
`
`extends into the intramedullary canal, and the neck body 14 extends outwardly
`
`from the resected end of the intramedullary canal. Id. at 4:7-12.
`
`13. The ’080 patent states that neck body 14 “is located at the proximal
`
`end 18 of the hip implant 10 and functions to connect the hip implant 10 to a
`
`spherically shaped femoral ball 19 and acetabular component (not shown).” Id. at
`
`3:37-40. Neck body 14 has a base portion 22 that, in one example, includes a
`
`collar 22 adapted to seat against a resected end portion of a femur. Id. at 4:5-7. A
`
`neck portion 24 extends from base portion 20 and is configured to connect to a
`
`femoral ball 19, which is received by an acetabular component (not shown). Id. at
`
`3:37-50, Figs. 1, 2. A distal end surface 21 of neck body 14 is connected or fused
`
`-7-
`
`Page 10 of 98
`
`

`

`
`
`
`
`
`
`
`
`to a prooximal endd surface 40 of bone
`
`
`
`fixation boody 16 at jjunction 444. Id. at 33:59-
`
`
`
`
`
`
`
`
`
`61. Boone fixatioon body 166 “has a ccompletelyy porous sstructure”
`
`
`
`
`
`
`
`
`
`
`
`include
`
`
`
`a solid mmetal substtrate.” Idd. at 3:62-667; see allso id. at
`
`
`
`
`
`
`
`
`
`
`
`permeated urface is pnder the sul at and unhe materialant that th‘porous,’ it is me
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`and “doess not
`
`2:22-35.
`
`“By
`
`with
`
`
`
`
`
`
`
`
`
`
`
`interconnnected intterstitial poores that ccommunicaate with thhe surface..” Id. at 44:15-
`
`
`
`
`
`
`
`17.
`
`
`1
`
`
`
`4. The ’’080 patennt also inclludes an exxample of f a hip impplant (showwn in
`
`
`
`
`
`
`
`
`
`
`
`
`
`Figure 55 to the left) in whicch a protruusion 74 exxtends outwward
`
`
`
`
`
`
`
`
`
`
`
`
`
`from thhe base porrtion of thee neck boddy into thee bone fixaation
`
`
`
`
`
`
`
`
`
`
`
`body.
`
`
`
`
`
`
`
`
`
`Id. at 5:447-51, 5:566-62. Prootrusion 744 can parttially
`
`
`
`
`
`extend iinto the boone fixationn body or
`
`
`
`
`
`
`
`protrusionn 74 can exxtend
`
`
`
`farther
`
`
`
`toward thee distal ennd surface
`
`
`
`
`
`82 of thee bone fixaation
`
`
`
`
`
`body. IId. at 5:566-60. In thhe latter exxample, “[tt]he protruusion
`
`
`
`
`
`
`
`
`
`
`
`
`
`gradually tapers aas it extennds towardd the distall end surfaace.”
`
`
`
`
`
`
`
`
`
`
`
`
`Id. at 5
`
`
`
`:60-62. AAccording tto the ’08
`
`
`
`0 patent, ““the protruusion
`
`
`
`can be
`
`
`
`sized annd shaped
`
`
`
`to providde a stronng connecction
`
`
`
`
`
`
`
`betweenn the neckk body andd bone fixaation body”” and “proovide
`
`
`
`
`
`
`
`
`
`
`
`
`
`an anti--rotational
`
`6:3-7.
`
`
`
`interface bbetween thhe neck boddy and bonne fixationn body.” IId. at
`
`
`
`
`
`
`
`
`
`
`
`-8-
`
`Page 11 of 98
`
`

`

`
`
`15. The porous structure of the ’080 patent can be fabricated by known
`
`techniques, e.g., “sintering” and made from conventional porous materials,
`
`including “titanium, titanium alloy powder, metal beads, metal wire mesh, or other
`
`suitable materials, metals, or alloys known in the art.” Id. at 4:18-20, 4:39; see
`
`also Ex. 1011 at 907 (“In the last 20 years a variety of porous surfaces and
`
`materials has been used to obtain fixation of bone ingrowth in total hip and knee
`
`prostheses. The most common include titanium and cobalt-chrome-alloy sintered
`
`beads, diffusion-bonded titanium, fibre metal, and titanium plasma spray”). The
`
`neck body is also made by conventional and known machining techniques. Ex.
`
`1001 at 3:53-56, 4:41-44. In one example, bone fixation body 16 “simultaneously
`
`forms and attaches to the neck body.” Id. at 5:7-8. In another example, neck body
`
`14 and bone fixation body 16 are made separately and then “attached or fused
`
`together using known welding or brazing techniques.” Id. at 5:9-13.
`
`16. The porous structure of the bone fixation body engages the femoral
`
`bone, which includes cortical and cancellous (trabecular) bone, when the hip
`
`implant is positioned in the intramedullary canal of the femur. Id. at 4:7-12, 12:22-
`
`23, 15:16-19; see also Ex. 1015 at 971, 973; Ex. 1016 at 954. According to the
`
`’080 patent, the porous structure is “adapted for the ingrowth of cancellous and
`
`cortical bone spicules.” Ex. 1001 at 4:22-23. The ’080 patent states that the
`
`geometric configuration of “the porous structure should encourage natural bone to
`
`-9-
`
`Page 12 of 98
`
`

`

`
`
`migrate and grow into and throughout the entire body 16,” (id. at 4:29-33) and
`
`teaches that “[i]n the exemplary embodiment, the size and shape of the porous
`
`structure emulates the size and shape of the porous structure of natural bone” (id. at
`
`4:22-26). In certain disclosed examples, “the average pore diameter of body 16 is
`
`about 40 µm to about 800 µm with a porosity from about 45% to 65%. Further,
`
`the interconnections between pores can have a diameter larger than 50-60
`
`microns.” Id. at 4:26-301. The ’080 patent explains, however, that “[a]though
`
`specific ranges are given for pore diameters, porosity, and interconnection
`
`diameters, these ranges are exemplary and are applicable to one exemplary
`
`embodiment” and “could be modified and the resulting hip implant still within the
`
`scope of the invention.” Id. at 4:32-38.
`
`17. The ’080 patent includes 13 claims. I have been asked to consider
`
`claims 1-3, 5, 7, and 9-11. Independent claims 1 and 5 are directed to a method
`
`and recite, among other things, a “bone fixation body” having “a porous metal
`
`structure” with “a size and shape that emulate a size and a shape of a porous
`
`1 A person of ordinary skill in the art would have understood that the disclosed
`
`range of pore diameters and porosities overlap with known pore diameters and
`
`porosities of cancellous bone. See Ex. 1016 at 954 (“trabecular-bone porosity may
`
`range from approximately 30 to more than 90 per cent [sic]”).
`
`-10-
`
`Page 13 of 98
`
`

`

`
`
`structure of natural human bone” (claim 1) or “interconnected pores having a
`
`geometric structure that replicates a porous structure of natural human bone;”
`
`(claim 5). See id. at 15:47-54 (claim 1), 16:18-25 (claim 5). Independent claim 10
`
`is directed to a “hip implant” and also recites, among other things, a “bone fixation
`
`body” having “a porous metal structure” with “a size and a shape that emulate a
`
`size and a shape of a porous structure of natural human bone.” See id. at 16:57-64.
`
`I refer to this phrase below as the “porous-metal-structure claim term.”
`
`VI. CLAIM CONSTRUCTION
`18.
`I understand that in this proceeding, a claim receives the broadest
`
`reasonable construction in light of the specification of the patent in which it
`
`appears. I also understand that in this proceeding, any term that is not construed
`
`should be given its plain and ordinary meaning under the broadest reasonable
`
`construction. I have followed these principles in my analysis below.
`
`A. “Porous-Metal-Structure” Claim Term
`19. Claims 1, 5, and 10 recite the porous-metal-structure claim term. Id.
`
`at 15:47-54, 16:18-25, 16:57-64. I understand that Petitioner has offered that the
`
`broadest reasonable interpretation of the porous-metal-structure claim term of
`
`claims 1 and 10 “requires emulating the size and shape of a porous structure of
`
`natural human bone as measured, for example, by pore diameter, porosity, and
`
`intersection diameter, but they do not require emulating the size and shape of the
`
`-11-
`
`Page 14 of 98
`
`

`

`
`
`interconnected plates and rods that form trabecular bone.” I understand that the
`
`Board adopted this construction for similar phrases in the ’582 IPR.
`
`20.
`
`I also understand that Petitioner has offered that the porous-metal-
`
`structure claim term of claim 5 requires “replicating a porous structure of natural
`
`human bone as measured, for example, by pore diameter, porosity, and intersection
`
`diameter, but does not require replicating the interconnected plates and rods that
`
`form trabecular bone.”
`
`21.
`
`I have used these constructions unless otherwise noted, and agree that
`
`these constructions are consistent with the ’080 patent’s disclosure.
`
`B. “Separate Fabrication” Claim Terms
`22. Claim 1 recites “fabricating, separately from the neck body, a bone
`
`fixation body.” Ex. 1001 at 15:47-48. Claims 5 and 10 contain similar
`
`recitations.2 I understand that Petitioner has offered that the broadest reasonable
`
`interpretation of these claim terms is that “fabrication of the bone fixation body
`
`and the neck body must be performed independently from each other.” I
`
`understand that the Board adopted this construction for similar phrases in the ’582
`
`
`2 Claim 5 recites “making, separately from the neck body, a bone fixation body.”
`
`Ex. 1001 at 16:18-19. Claim 10 recites “the bone fixation body and the neck body
`
`are separately formed from each other.” Id. at 16:65-66.
`
`-12-
`
`Page 15 of 98
`
`

`

`
`
`IPR. I have used this construction unless otherwise noted, and agree that this
`
`construction is consistent with the ’080 patent’s disclosure.
`
`C. Terms That Require Connecting the Bone Fixation Body “After”
`Separately Fabricating It
`23. Claim 1 recites “connecting, after the bone fixation body is separately
`
`fabricated from the neck body, the bone fixation body to the neck body.” Ex. 1001
`
`at 15:55-58 (emphasis added). Claim 5 and 10 contain similar recitations.3 I
`
`understand that Petitioner has offered that the broadest reasonable interpretation of
`
`these claim terms requires that attachment of the bone fixation body to the neck
`
`body must take place subsequent to fabrication of the bone fixation body. I
`
`understand that the Board adopted this construction for similar phrases in the ’582
`
`IPR. I have used this construction unless otherwise noted, and agree that this
`
`construction is consistent with the ’080 patent’s disclosure.
`
`
`3 Claim 5 recites “permanently connecting, after the bone fixation body is
`
`separately made from the neck body, the bone fixation body to the neck body.”
`
`Ex. 1001 at 16:26-28. Claim 10 recites “the bone fixation body permanently
`
`connects to an outer surface of the elongated male protrusion . . . after being
`
`separately formed from the neck body.” Id. at 17:1-4.
`
`-13-
`
`Page 16 of 98
`
`

`

`
`
`VII. OVERVIEW OF THE PRIOR ART
`A.
`Zolman
`24. Zolman teaches a method of constructing a prosthetic implant
`
`“suitable for use as a femoral component for a hip prosthesis.” Ex. 1009 at Title,
`
`1:11-15. In one example, a porous pad 26 is circumferentially wrapped around a
`
`stem portion 20 of a component 10 to form the implant. See, e.g., id. at Abstract,
`
`Figs. 1-6, 1:11-15, 2:23-26, 4:5-8, 4:33-36. The implant 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 to cooperate with an
`
`acetabulum or acetabular prosthetic member via a ball or the like carried at the
`
`proximal end 14.” Id. at 3:45-51. An example of Zolman’s implant and its porous
`
`pad are shown in Figures 1 and 11, reproduced below:
`
`
`
`
`
`
`
`Id. at Fig 1, Fig.11, 2:58-59, 3:13-14.
`
`-14-
`
`Page 17 of 98
`
`

`

`
`
`25. Zolman states that implants with porous surfaces are in “direct contact
`
`with the bone surface” and that “[a]fter a period of time, bony ingrowth occurs in .
`
`. . the porous surface” to “biologically affix or further secure the implant in the
`
`bone.” Id. at 1:16-24. Zolman states that porous pad 26 can be made from “any
`
`suitable porous material” and “particularly fibrous (wire-type) porous structures.”
`
`Id. at 4:21-24. Zolman states that “one such suitable material is the fiber metal
`
`structure disclosed in U.S. Patent No. 3,906,550 to Rostoker.” Id. at 4:12-21.
`
`26. Zolman states that porous pad 26 is formed “separate[ly] from the
`
`stem portion 20.” See, e.g., id. at 4:33-34. Porous pad 26 “is first formed in or
`
`pressed into a substantially flat sheet 126.” Id. at 4:29-32. In a preferred example,
`
`“[t]he porous material, such as a kinked titanium fiber metal, is press formed into a
`
`sheet 126 of porous material” having “any desired thickness or dimensions.” Id. at
`
`4:46-49. The outer contour of porous pad 26 is then cut from the metal sheet. Id.
`
`at 4:56-58. The pad is subsequently wrapped and/or formed about stem portion 20
`
`into a second shape corresponding to the shape of stem portion 20 as shown in
`
`Figs. 1-4. Id. at 4:36-41. Porous pad 26 is positioned in a recess 74 “which
`
`corresponds to the wrapped shape of the pad 26.” Id. at 5:13-16, 6:44-46, Fig. 6.
`
`The porous pad is subsequently bonded to stem portion 20 by diffusion bonding,
`
`sintering, or any “other suitable bonding methods” to form the hip implant. Id. at
`
`6:46-54.
`
`-15-
`
`Page 18 of 98
`
`

`

`
`
`27.
`
`In another example, Zolman teaches forming porous pad 26 into its
`
`final shape on a mandrel, removing porous pad 26 from the mandrel, and then
`
`placing porous pad 26 onto the stem portion of the implant and bonding the porous
`
`pad to the stem portion. Id. at 7:1-14.
`
`28. Zolman states that porous pad 26 “can be shaped to conform to any
`
`desirable and suitable implant stem or fixation surface configuration.” Id. at 5:16-
`
`18. In my opinion, Zolman teaches that a proximal portion 24 of stem portion 20
`
`has a non-circular cross-section as shown in Figure 5, reproduced below. Id. at
`
`5:19-21, Figs 5; see also id. at Fig. 6.
`
`
`
`B.
`Rostoker
`29. Rostoker describes a prosthetic device having a porous fiber metal
`
`structure. Ex. 1010 at Title. “The fiber metal structure is sintered and open-pored
`
`so that the bone and tissue into which the prosthetic device is implanted will grow
`
`into such fiber metal structure.” Id. at Abstract. Rostoker explains that “open-pore
`
`material into which bone could grow should provide ideal skeletal fixation.” Id. at
`
`1:51-52.
`
`-16-
`
`Page 19 of 98
`
`

`

`
`
`30. Rostoker teaches that its porous structure is “produced by molding and
`
`sintering short metal fibers.” Id. at 2:21-23. In the molded and sintered fiber metal
`
`aggregate, the metal fibers are completely interconnected. Id. at 5:16-18. Rostoker
`
`teaches that “[t]he sintering process creates metallurgical bonds at the points of
`
`contact of the fibers.” Id. at 2:23-25. Rostoker also teaches that “[t]he degree of
`
`interlock . . . is substantially increased if the original wire is prekinked prior to
`
`cutting the wire into the short fibers.” Id. at 4:42-45. An example of the porous
`
`structure, with its interlocked fibers, is show in Figure 4, reproduced below:
`
`
`
`Id. at Fig. 4, 2:67-68.
`
`31. Rostoker
`
`teaches
`
`that by forming
`
`its porous structure with
`
`interconnected metal fibers, “the range of pore sizes can be readily controlled” and
`
`“the pores are interconnecting and remain so after sintering.” Id. at 2:35-41; see
`
`also id. at 2:17-18 (teaching that the porous structure “has a broad range of readily
`
`controllable pore sizes”). “Thus, bone growth can penetrate for a substantial
`
`distance into the fiber metal structure and thereby provide a very secure
`
`-17-
`
`Page 20 of 98
`
`

`

`
`
`connection.” Id. at 2:42-44. Further, “[s]ince the pore size can be readily
`
`controlled . . . the density of the sintered composite can approximate the density of
`
`the bone to which the prosthetic device is implanted.” Id. at 2:48-52.
`
`32. Rostoker states that “[t]he largest principal dimension of the pores is
`
`approximately equal to the wire diameter when the void content is about 50
`
`percent.” Id. at 5:21-24. Rostoker teaches using wire with a range of diameters
`
`from 0.013 centimeters (130 µm) to 0.030 centimeters (300 µm). Id. at 5:14-16.
`
`Moreover, the porous structure “may be molded having void or a porosity of 40 to
`
`50 percent per unit area.” Id. at 5:6-8. Rostoker describes its disclosed structure as
`
`having “considerable mechanical strength due to the sintered bonds and the
`
`mechanical interlocks.” Id. at 4:28-31; see also id. at 2:25-27.
`
`C. Bobyn
`33. Bobyn studies bone ingrowth in a porous tantalum biomaterial. Ex.
`
`1011 at 907. The porous tantalum material is fabricated by coating a vitreous
`
`carbon skeleton with tantalum. Id. at 907-8.
`
`34. Bobyn’s states that the porous tantalum biomaterial was “75% to 80%
`
`porous by volume” and had “a repeating arrangement of slender interconnecting
`
`struts which form[] a regular array of dodecahedron-shaped pores.” Id. at 907.
`
`Bobyn also states that “[b]ecause of its high porosity, its structural stiffness is . . .
`
`similar to subchondral bone.” Id. at 913. A person of ordinary skill in the art
`
`-18-
`
`Page 21 of 98
`
`

`

`
`
`
`
`would hhave underrstood that
`
`
`
`
`
`
`
`
`
`
`
`subchondrral bone (ii.e., the bonne below ccartilage laayers
`
`
`
`
`
`in joints such as tthe hip) iss composedd of canceellous (trabbecular) boone. See,
`
`
`
`
`
`e.g.,
`
`
`
`upper femmoral
`
`
`
`
`
`
`
`
`
`
`
`Ex. 10115 at 973 ((showing tthe cancellous or traabecular boone in an
`
`
`
`
`
`
`
`
`
`
`
`
`
`region).. Based on animal sstudies, Boobyn determmined thatt “[t]his poorous tantaalum
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`biomateerial has deesirable ch
`
`
`
`
`
`aracteristiccs for bonee ingrowthh.” Ex. 10111 at 907.
`
`
`
`
`
`
`
`
`
`
`
`35. Bobyyn includedd a scanniing electroon microsccope imagge (reproduuced
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`of its discclosed poroous tantaluum materiaal showingg the structture forme
`
`below)
`
`
`
`
`
`
`
`
`
`
`
`d by
`
`
`
`the tanttalum strutts. Ex. 1011 at 908
`
`
`
`
`
`(Fig. 1a);
`
`
`
`see also idd. at 907 ((describingg the
`
`
`
`
`
`
`
`structurre as a “rrepeating aarrangemeent of slennder intercconnectingg struts wwhich
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`form[] aa regular arrray of doddecahedronn-shaped ppores.”)
`
`
`
`
`
`36. The
`
`
`
`cancelloous bone
`
`
`
`
`
`
`
`image beelow is aa scanningg electronn microscoope imagee of
`
`
`
`
`
`
`
`
`
`from an uupper regioon of a feemur showwing the nnatural cel
`
`
`
`
`
`
`
`
`
`lular
`
`
`
`
`
`
`
`
`
`
`
`structurre of the boone having interconneected platees and coluumns of boone.
`
`
`
`
`
`-19-
`
`Page 22 of 98
`
`

`

`
`
`
`
`
`
`Ex. 1015 att 976 (Fig. 7).
`
`
`
`E 3
`
`
`
`
`
`
`
`
`
`7. Based on a commparison oof these immages and t
`
`
`
`
`ne of the knowleedge of on
`
`
`
`ordinaryy skill in thhe art, a peerson of orrdinary skiill in the aart, in my oopinion, wwould
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`have unnderstood
`
`
`
`that the pporous tanttalum biommaterial deescribed inn Bobyn hhas a
`
`
`
`
`
`
`
`
`
`
`
`
`
`three-diimensionall structure
`
`
`
`
`
`
`
`
`
`
`
`similar too cancellouus (trabecuular) bonee. By, 20003 it
`
`
`
`
`
`was undderstood bby persons
`
`
`
`skilled in
`
`the art th
`
`
`
`at the poroous tantaluum mimicss the
`
`
`
`
`
`
`
`open ceell structuree of cancelllous (trabeecular) bonne. See, e.
`
`
`
`
`
`
`
`
`
`g., Ex. 10222 at 1 (staating
`
`
`
`
`
`
`
`that thee porous tantalum mmaterial is
`
`
`
`
`
`
`
`“similar tto trabecuular bone”)); Ex. 10220 at
`
`
`
`
`
`
`
`
`
`Abstracct, 6:1-4.
`
`8. Boby
`3
`
`
`
`
`yn states thhat tantalumm “is a strrong, ducti
`
`
`
`
`
`le metal” tthat was “
`
`used
`
`
`
`for a wiide varietyy of implannts.” Ex. 1011 at 9133. Bobyn aalso states
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`that its poorous
`
`bulk
`
`
`
`tantalumm biomaterrial can “bbe made innto compleex shapes aand used eeither as a
`
`
`
`
`
`
`
`implantt or as a ssurface coaating.” Idd. at 907. In additioon, Bobyn
`
`
`
`
`
`
`
`
`
`
`
`
`
` states thaat its
`
`
`
`material can be mmade into
`
`
`
`“standard
`
`
`
`or custommised [sic]
`
`-20-
`
`
`
`shapes annd sizes off the
`
`
`
`Page 23 of 98
`
`

`

`
`
`implant.” Id. at 913. As examples, Bobyn states that “[t]he material could be used
`
`as a backing for direct compression moulding of polyethylene-bearing components
`
`or as a fixation surfa