`
`
`
`
`
`
`
`
`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. 9,265,612
`____________________
`DECLARATION OF TIMOTHY P. HARRIGAN, SCD, MBA, PE
`
`
`
`
`
`ZIMMER EXHIBIT 1002
`
`Page 1 of 96
`
`

`

`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 ’612 PATENT .................................................... 6 
`VI.  CLAIM CONSTRUCTION ......................................................................... 11 
`A. 
`“Porous-Metal-Structure” Claim Term .............................................. 11 
`B. 
`“Separate Fabrication” Claim Terms ................................................. 12 
`VII.  OVERVIEW OF THE PRIOR ART ............................................................ 12 
`A. 
`Zolman ................................................................................................ 12 
`B. 
`Rostoker .............................................................................................. 15 
`C. 
`Bobyn .................................................................................................. 17 
`D. 
`Averill ................................................................................................. 19 
`VIII.  CERTAIN REFERENCES TEACH OR SUGGEST ALL OF THE
`CLAIMED FEATURES OF CLAIMS 12, 13, AND 15-19 OF THE
`’612 PATENT ............................................................................................... 21 
`A.  Ground 1: Zolman and Rostoker Teach or Suggest All of the
`Features of Claims 12, 13, and 15-19 ................................................ 21 
`1. 
`Claim 12 ................................................................................... 21 
`2. 
`Claim 13 ................................................................................... 39 
`3. 
`Claim 15 ................................................................................... 42 
`4. 
`Claim 16 ................................................................................... 46 
`5. 
`Claim 17 ................................................................................... 49 
`6. 
`Claim 18 ................................................................................... 53 
`7. 
`Claim 19 ................................................................................... 56 
`Ground 2: Zolman, Rostoker, and Averill Teach or Suggest All
`of the Features of Claim 18 ................................................................ 66 
`Ground 3: Zolman and Bobyn Teach or Suggest All of the
`Features of Claims 12, 13, and 15-19 ................................................ 68 
`
`C. 
`
`B. 
`
`TABLE OF CONTENTS
`
`
`-i-
`
`Page 2 of 96
`
`

`

`
`
`1. 
`Claim 12 ................................................................................... 68 
`Claim 13 ................................................................................... 79 
`2. 
`Claim 15 ................................................................................... 80 
`3. 
`Claim 16 ................................................................................... 81 
`4. 
`Claim 17 ................................................................................... 82 
`5. 
`Claim 18 ................................................................................... 84 
`6. 
`Claim 19 ................................................................................... 85 
`7. 
`D.  Ground 4: Zolman, Bobyn, and Averill Teach or Suggest All of
`the Features of Claim 18 .................................................................... 91 
`IX.  CONCLUSION ............................................................................................. 93 
`
`
`-ii-
`
`Page 3 of 96
`
`

`

`
`
`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. 9,265,612 (“the ’612
`
`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 12, 13, and 15-19 of the ’612 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 ’612 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 96
`
`

`

`
`
`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 96
`
`

`

`
`
`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 96
`
`

`

`
`
`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 ’612 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 96
`
`

`

`
`
`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 ’612 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 ’612 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 96
`
`

`

`
`
`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 ’612 PATENT
`12. The ’612 patent relates to hip implants. See, e.g., Ex. 1001 at Title,
`
`Abstract, 1:14-16, 2:52-55, 3:6-7. 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, 1:55-58, 3:10-12, 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 96
`
`

`

`
`
`
`
`See id. at 2:52-55, 3:6-7, 3:44-46. 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 3:50-55.
`
`13. The ’612 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
`
`3:13-16. Neck body 14 has a base portion 20 that, in one example, includes a
`
`collar 22 adapted to seat against a resected end portion of a femur. Id. at 3:17-19.
`
`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
`
`3:13-26, Figs. 1-2. A distal end surface 21 of neck body 14 is connected or fused
`
`-7-
`
`Page 10 of 96
`
`

`

`
`
`
`
`
`
`
`
`to a prooximal endd surface 40 of bone
`
`
`
`fixation boody 16 at jjunction 444. Id. at 33:35-
`
`
`
`
`
`
`
`
`
`37. Boone fixatioon body 166 “has a ccompletelyy porous sstructure”
`
`
`
`
`
`
`
`
`
`
`
`
`
`include a solid meetal substraate.” Id. att 3:38-43; ssee also idd. at 2:4-9.
`
`
`
`
`
`
`
`
`
`
`
`
`
`and “doess not
`
`
`
` “By ‘poroous,’
`
`
`
`ermeated face is per the surfand undererial at at the matit is mmeant that
`
`
`
`
`
`
`
`
`
`
`
`
`
`with
`
`
`
`interconnnected intterstitial poores that ccommunicaate with thhe surface..” Id. at 33:58-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`60.
`
`
`1
`
`
`
`4. The ’’612 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 5:224-27, 5:299-38. 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 5:29–38. In thhe latter exxample, “[tt]he protruusion
`
`
`
`
`
`
`
`
`
`
`
`
`
`ace.” l end surfad the distalnds towardas it extengradually tapers a
`
`
`
`
`
`
`
`
`
`
`
`
`Id. at 5
`
`
`
`:37-38. AAccording tto the ’6122 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
`
`
`
`5:46-500.
`
`
`
`interface bbetween thhe neck boddy and bonne fixationn body.” IId. at
`
`
`
`
`
`
`
`
`
`
`
`-8-
`
`Page 11 of 96
`
`

`

`
`
`15. The porous structure of the ’612 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 3:61-63; 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 3:29-32,
`
`4:17-19. In one example, bone fixation body 16 “simultaneously forms and
`
`attaches to the neck body.” Id. at 4:49-50. 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 4:53-55.
`
`16. The porous structure of the bone fixation body engages the femoral
`
`bone, which includes cortical and trabecular (cancellous) bone, when the hip
`
`implant is positioned in the intramedullary canal of the femur. Id. at 2:16-19, 3:50-
`
`55. See also Ex. 1015 at 971, 973; Ex. 1016 at 954. According to the ’612 patent,
`
`the porous structure is “adapted for the ingrowth of cancellous and cortical bone
`
`spicules.” Ex. 1001 at 3:64-65. The ’612 patent states that the geometric
`
`configuration of “the porous structure should encourage natural bone to migrate
`
`-9-
`
`Page 12 of 96
`
`

`

`
`
`and grow into and throughout the entire body 16,” (id. at 4:4-7) 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 3:65-
`
`4:1). 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 4:1-41. The ’612 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 4:8-13.
`
`17. The ’612 patent includes 19 claims. I have been asked to consider
`
`claims 12, 13, and 15-19. Independent claims 12 and 19 are all directed to a “hip
`
`implant” and recite, among other things, a “bone fixation body” formed as “a
`
`porous metal structure” that “has a size and shape that emulate a size and a shape
`
`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 96
`
`

`

`
`
`of a porous structure of natural human bone.” See id. at 7:43-45 (claim 12),8:36-
`
`38 (claim 19). 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 12 and 19 recite the porous-metal-structure claim term. Ex.
`
`1001 at 7:33-34, 7:43-45, 8:24-26, 8:36-38. I understand that Petitioner has
`
`offered that the broadest reasonable interpretation of the porous-metal-structure
`
`claim term “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
`
`interconnected plates and rods that form trabecular bone.” I understand that the
`
`Board adopted this construction for a similar term in the ’582 IPR. I have used this
`
`construction unless otherwise noted, and agree that this construction is consistent
`
`with the ’612 patent’s disclosure.
`
`-11-
`
`Page 14 of 96
`
`

`

`
`
`B. “Separate Fabrication” Claim Terms
`20. Claim 13 recites that “the bone fixation body . . . is bonded to the neck
`
`body after being formed separately from the neck body” and claim 19 recites “the
`
`bone fixation body and the neck body are fabricated separately and subsequently
`
`the bone fixation body is bonded from heat to the neck body.” Ex. 1001 at 7:46-
`
`50, 8:48-52. 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
`
`IPR. I have used this construction unless otherwise noted, and agree that this
`
`construction is consistent with the ’612 patent’s disclosure.
`
`VII. OVERVIEW OF THE PRIOR ART
`A.
`Zolman
`21. 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 femoral 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
`
`-12-
`
`Page 15 of 96
`
`

`

`
`
`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.
`
`22. 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.
`
`23. 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
`
`-13-
`
`Page 16 of 96
`
`

`

`
`
`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.
`
`24.
`
`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.
`
`25. 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 one example, 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, Fig. 5; see also Fig. 6.
`
`-14-
`
`Page 17 of 96
`
`

`

`
`
`
`
`B.
`Rostoker
`26. 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.
`
`27. 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:
`
`-15-
`
`Page 18 of 96
`
`

`

`
`
`
`
`Id. at Fig. 4, 2:67-68.
`
`28. 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
`
`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.
`
`29. 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
`
`-16-
`
`Page 19 of 96
`
`

`

`
`
`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
`30. 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.
`
`31. 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
`
`would have understood that subchondral bone (i.e., the bone below cartilage layers
`
`in joints such as the hip) is composed of cancellous (trabecular) bone. See, e.g.,
`
`Ex. 1015 at 973 (showing the cancellous or trabecular bone in an upper femoral
`
`region). Based on animal studies, Bobyn determined that “[t]his porous tantalum
`
`biomaterial has desirable characteristics for bone ingrowth.” Id. at 907.
`
`32. Bobyn included a scanning electron microscope image (reproduced
`
`below) of its disclosed porous tantalum material showing the structure formed by
`
`the tantalum struts. Ex. 1011 at 908 (Fig. 1a); see also id. at 907 (describing the
`
`-17-
`
`Page 20 of 96
`
`

`

`
`
`
`
`structurre as a “rrepeating aarrangemeent of slennder intercconnectingg struts wwhich
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`form[] aa regular arrray of doddecahedronn-shaped ppores.”)
`
`
`
`
`
`33. 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.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Ex. 1015 at 976 (FFig. 7).
`
`
`
`
`
`
`3
`
`
`
`4. Based on a commparison oof these immages and tthe knowleedge of onne of
`
`
`
`
`
`
`
`
`
`
`
`
`
`ordinaryy skill in thhe art, a peerson of orrdinary skiill in the aart, in my oopinion, wwould
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`-18-
`
`Page 21 of 96
`
`

`

`
`
`have understood that the porous tantalum biomaterial described in Bobyn has a
`
`three-dimensional structure similar to cancellous (trabecular) bone. By, 2003 it
`
`was understood by persons skilled in the art that the porous tantalum mimics the
`
`open cell structure of cancellous bone. See, e.g., 1022 at 1 (stating that the porous
`
`tantalum material is “similar to trabecular bone”); 1020 at Abstract, 6:1-4.
`
`35. Bobyn states that tantalum “is a strong, ductile metal” that was “used
`
`for a wide variety of implants.” Ex. 1011 at 913. Bobyn also states that its porous
`
`tantalum biomaterial can “be made into complex shapes and used either as a bulk
`
`implant or as a surface coating.” Id. at 907. In addition, Bobyn states that its
`
`material can be made into “standard or customised [sic] shapes and sizes of the
`
`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 surface on an implant substrate.” Id. Bobyn concludes that the
`
`material “offers interesting potential for orthopedic reconstructive procedures.” Id.
`
`D. Averill
`36. Averill describes a femoral component of a hip prosthesis 10. Ex.
`
`1012 at 4:64-67, Fig. 1. The prosthesis generally includes a stem 12 having a
`
`proximal end 16 and a distal end 18, and a neck 36. Id. at 5:8-10. An example of
`
`Averill’s prosthesis is reproduced below:
`
`-19-
`
`Page 22 of 96
`
`

`

`
`
`
`
`37. Averill teaches that stem 12 includes a tapered portion 22 that merges
`
`into a cylindrical portion 26. Id. at 5:21-27. FIGS. 2 and 3 illustrate the changing
`
`cross-sectional shape of the tapered portion 22 at lines 2—2 and 3—3. Id. at 5:30-
`
`32, Figs. 2, 3. The free end of the cylindrical portion 26 forms the distal end 18 of
`
`the stem 12 that “tapers down from the cylindrical portion 26 to a generally
`
`spherical tip portion 19.” Id. at 5:26-29, Fig. 1.
`
`-20-
`
`Page 23 of 96
`
`

`

`
`
`38. Averill teaches that its prosthesis can be “manufactured from titanium
`
`alloy” and made by “forging, casting and/or machining operations or any other
`
`well known technique.” Id. at 6:54-58.
`
`VIII. CERTAIN REFERENCES TEACH OR SUGGEST ALL OF THE
`CLAIMED FEATURES OF CLAIMS 12, 13, AND 15-19 OF THE ’612
`PATENT
`39.
`In my opinion, Zolman in view of Rostoker and Zolman in view of
`
`Bobyn teach or suggest the features recited in claims 12, 13, and 15-19 of the ’612
`
`patent. In addition, it is my opinion, that the combination of Zolman, Rostoker,
`
`and Averill and the combination of Zolman, Bobyn, and Averill teach or suggest the
`
`features recited in claim 18 of the ’612 patent.
`
`A. Ground 1: Zolman and Rostoker Teach or Suggest All of the
`Features of Claims 12, 13, and 15-19
`1.
`Claim 12
`In my opinion, the combination of Zolman and Rostoker teaches the
`
`40.
`
`features of claim 12.
`
`41.
`
`I address claim element [12.a] below.
`
`Claim Language
`[12.a] A hip implant,
`comprising:
`
`Zolman and Rostoker
`In my opinion, Zolman teaches a hip implant.
`Zolman teaches a prosthetic implant “suitable for
`use as a femoral component for a hip prosthesis.”
`Ex. 1009 at 1:11-15; see also id. at 2:58-62
`
`-21-
`
`Page 24 of 96
`
`

`

`
`
`(“FIG. 1 is a perspective view of a femoral
`component for a hip prosthesis”), 3:33-35 (“[t]he
`invention will be described with reference to a
`femoral component 10 of a hip prosthesis and is
`particularly suitable as such.”), Figs. 1-6.
`
`42.
`
`I address claim element [12.b] below.
`
`Claim Language
`[12.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
`therefrom, and being formed
`of solid metal; and
`
`Zolman and Rostoker
`In my opinion, Zolman