Paper No. ____
`Filed: April 16, 2015
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`Filed on behalf of: Zimmer Holdings, Inc. and Zimmer Dental Inc.
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`By: Naveen Modi (naveenmodi@paulhastings.com)
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`Srikala P. Atluri (srikalaatluri@paulhastings.com)
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`Paromita Chatterjee (mitachatterjee@paulhastings.com)
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`Paul Hastings LLP
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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 HOLDINGS, INC.
`AND ZIMMER DENTAL 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. 8,684,734
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`DECLARATION OF JAMES EARTHMAN, PH.D
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`Page 1 of 99
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`ZIMMER EXHIBIT 1002
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`TABLE OF CONTENTS
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`Page
`INTRODUCTION .......................................................................................... 1 
`I. 
`II.  QUALIFICATIONS ....................................................................................... 1 
`III.  SUMMARY OF OPINIONS .......................................................................... 3 
`IV.  LEVEL OF ORDINARY SKILL IN THE ART ............................................ 5 
`V. 
`BACKGROUND OF THE ’734 PATENT .................................................... 6 
`VI.  CLAIM CONSTRUCTION ......................................................................... 11 
`VII.  THE EARLIER FILED U.S. APPLICATIONS DO NOT TEACH
`THE UNIFORM POROSITY FEATURES ................................................. 14 
`VIII.  CERTAIN REFERENCES TEACH OR SUGGEST ALL OF THE
`FEATURES OF CLAIMS 1-3, 5-10, 12-15, AND 17-27 ............................ 15 
`Lomicka’s Teachings .......................................................................... 15 
`A. 
`Lomicka Teaches All of the Features of Claims 1-3, 5-10, 12-
`B. 
`15, 17-21, 23, 24, and 27 .................................................................... 17 
`1. 
`Claim 1 ..................................................................................... 17 
`2. 
`Claim 2 ..................................................................................... 23 
`3. 
`Claim 3 ..................................................................................... 24 
`4. 
`Claim 5 ..................................................................................... 25 
`5. 
`Claim 6 ..................................................................................... 25 
`6. 
`Claim 7 ..................................................................................... 26 
`7. 
`Claim 8 ..................................................................................... 26 
`8. 
`Claim 9 ..................................................................................... 29 
`9. 
`Claim 10 ................................................................................... 29 
`10.  Claim 12 ................................................................................... 30 
`11.  Claim 13 ................................................................................... 30 
`12.  Claim 14 ................................................................................... 31 
`13.  Claim 15 ................................................................................... 33 
`14.  Claim 17 ................................................................................... 34 
`15.  Claim 18 ................................................................................... 34 
`16.  Claim 19 ................................................................................... 34 
`17.  Claim 20 ................................................................................... 35 
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`C. 
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`18.  Claim 21 ................................................................................... 38 
`19.  Claim 23 ................................................................................... 38 
`20.  Claim 24 ................................................................................... 38 
`21.  Claim 27 ................................................................................... 39 
`Lomicka Teaches or Suggests All of the Features of Claim 22 ......... 42 
`1. 
`Claim 22 ................................................................................... 42 
`Lomicka and Bhaduri Teach or Suggest All of the Features of
`Claims 25 and 26 ................................................................................ 43 
`1. 
`Claim 25 ................................................................................... 43 
`2. 
`Claim 26 ................................................................................... 46 
`IX.  CONCLUSION ............................................................................................. 46 
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`D. 
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`I, James Earthman, declare as follows:
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`I.
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`INTRODUCTION
`1.
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`I have been retained by Zimmer Holdings, Inc. and Zimmer Dental
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`Inc. (“Petitioner”) as an independent expert consultant in this proceeding before
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`the United States Patent and Trademark Office regarding U.S. Patent No.
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`8,684,734 (“the ’734 patent”), which I understand is labeled as Ex. 1001 in this
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`proceeding. I have been asked to consider, among other things, whether certain
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`references disclose or suggest the features recited in claims 1-3, 5-10, 12-15, and
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`17-27 of the ’734 patent. My opinions are set forth below.
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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 ’734 patent. I have no other
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`interest in this proceeding.
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`II. QUALIFICATIONS
`3.
`I received a B.S. from Rice University in June 1980, a Masters in
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`Materials Science and Engineering from Stanford University in 1982, and a
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`Doctorate of Philosophy (PhD) in Materials Science and Engineering from
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`Stanford University in 1985.
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`4.
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`Between 1985 and 1988, I was a research associate at the Mechanical
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`Metallurgy Laboratory at the Swiss Federal Institute of Technology. In 1988, I
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`joined the faculty at University of California Irvine, where I have advanced to the
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`position of Professor. I am presently a professor in the Department of Chemical
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`Engineering, Materials Science, and Biomedical Engineering at the University of
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`California at Irvine. I served as the Associate Vice Chancellor for Research at the
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`University of California at Irvine from March 2007 to February 2009, and I am
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`currently the Associate Dean for Professional Development at the University of
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`California at Irvine, a position I have held since 2014.
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`5.
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`I have more than 25 years of experience in the biomaterials and
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`biomechanics of dental and orthopedic implants. My research activities have
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`included investigating the integration of dental implant into bone, and in particular,
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`the stability, durability, and osseointegration of the implants in bone. I have
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`published extensively with more than 100 scientific articles and book chapters,
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`including J. C. Earthman, C. G. Sheets, J. M. Paquette, R. M. Kaminishi, W. P.
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`Nordland, R. G. Keim, and J. C. Wu, “Tissue Engineering in Dentistry,” invited
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`chapter, Clinics in Plastic Surgery, Vol. 30 Tissue Engineering, G. R. D. Evans,
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`ed., pp. 621-639 (2003). A copy of my curriculum vitae is attached as App. A.
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`6.
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`Aside from my academic expertise, I have extensive industry
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`experience with dental implants. Specifically, I co-founded Perimetrics in
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`Newport Beach, CA, a dental device company that researches and develops dental
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`diagnostic devices. I have also served as a Member of the Board of Directors of
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`the Newport Coast Oral-Facial Institute from October 1995 to present.
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`7.
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`I have six patents issued to my name including U.S. Patent No.
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`6,630,197, titled “Inhibition of Sulfate-Reducing-Bacteria-mediated Degradation
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`using Bacteria which Secrete Antimicrobials,” issued October 7, 2003, U.S. Patent
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`No. 6,120,466, titled “System and Method for Quantitative Measurements of
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`Energy Damping Capacity,” issued September 19, 2000; U.S. Patent No.
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`6,997,887, titled "Evaluation of Reflected Time-Energy Profile for Determination
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`of Damping Capacity," issued February 14, 2006; US Patent No. 7,008,385, titled
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`"Evaluation of Reflected Time-Energy Profile for Evaluating Osseointegration and
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`Density," issued March 7, 2006; U.S. Patent No. 7,221,445, entitled “Methods and
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`Apparatus For Detecting And Quantifying Surface Characteristics And Material
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`Conditions Using Light Scattering,” issued May 22, 2007; and U.S. Patent No.
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`8,628,599, entitled “Diamondoid Stabilized Fine-Grained Metals,” issued January
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`14, 2014; and two U.S. Patent Application Publications, including U.S. Patent
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`Application Publication Nos. 2013/0174639 and 2011/0311944.
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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 ’734 patent (Ex. 1001), the prosecution history file
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`of the ’734 patent (Ex. 1004), the prosecution history file of U.S. Patent No.
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`8,297,974 (Ex. 1011), the prosecution history file of U.S. Patent No. 8,043,090
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`(Ex. 1012), the prosecution history file of U.S. Patent No. 7,291,012 (Ex. 1003),
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`U.S. Patent Application Publication No. 2011/0123951 to Lomicka (“Lomicka”)
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`(Ex. 1006), U.S. Patent Application Publication No. 2002/0106611 to Bhaduri et
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`al. (“Bhaduri”) (Ex. 1007), U.S. Patent No. 5,049,074 to Otani (“Otani”) (Ex.
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`1008), U.S. Patent No. 6,095,817 to Wagner et al. (“Wagner”) (Ex. 1009), U.S.
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`Patent No. 5,282,861 to Kaplan (“Kaplan”), and excerpts from Merriam-Webster’s
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`Collegiate Dictionary (Ex. 1010) and Webster’s New World College Dictionary
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`(Ex. 1014), while drawing on my experience in the biomaterials and biomechanics
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`of dental implants. My opinions are additionally guided by my appreciation of how
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`a person of ordinary skill in the art would have understood the claims of the ’734
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`patent at the time of the alleged invention, which I have been asked to assume is
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`either August 2012 or February 2003.
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`9.
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`Based on my experience and expertise, it is my opinion that one of
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`ordinary skill would have understood that the applications prior to the ’734 patent
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`application do not disclose certain features recited in claims 1-3, 5-10, 12-15, and
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`17-27 of the ’734 patent. It is also my opinion that certain references disclose or
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`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 either August 2012 or
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`February 2003, a person of ordinary skill in the art would have had an
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`undergraduate degree in a relevant engineering field (e.g., Mechanical
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`Engineering, Materials Science Engineering, Biomedical Engineering) with 3-5
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`years of experience with dental implants or similar implants. Alternatively, a
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`person of ordinary skill in the art would have had a graduate degree in a relevant
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`engineering field with 1-3 years of experience with dental implants or similar
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`implants. More education can supplement relevant 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 ’734 PATENT
`12.
`I understand that the ’734 patent issued from U.S. Patent Application
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`No. 13/571,375, filed August 10, 2012, and that it is listed on the face of the patent
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`as a “continuation-in-part” of U.S. Patent Application No. 13/195,872 (“the ’872
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`application”), now Patent No.8,297,974, which is listed as a “continuation” of U.S.
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`Patent Application No. 11/358,375 (“the ’8,375 application”), filed on February
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`21, 2006, now U.S. Patent No. 8,043,090, which is listed as a “continuation” of
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`U.S. Patent Application No. 10/375,343 (“the ’343 application”), filed on February
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`27, 2003, now Patent No. 7,291,012 (“the ’012 patent”). Ex. 1001 at title page.
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`13. The ’734 patent relates to dental implants. See e.g., id. at 2:33-63.
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`The dental implants include two components or bodies: a coronal body and a bone
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`fixation body. See e.g., id. at 2:34-37, Figs. 1 and 2. Figure 2 shows a dental
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`implant 10 having a coronal body 14 and bone fixation body 16 embedded in a
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`jawbone 34 of a patient:
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`14. The coronal body is formed from a solid metal piece of titanium or
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`titanium alloy, and includes a transgingival section 24, which extends along the
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`gum or gingival tissue 38. See id. at 2:38-41, 2:49-51, Fig. 2. It also includes a
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`dental interface 26 extending upwardly from the transgingival section 24. See id.
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`at 2:38-44, Fig. 2. Dental interface 26 is formed as a male connector (Fig. 2) or a
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`female connector (Fig. 6) having a polygon shape and is provided with a threaded
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`bore 28 adapted to receive a fixation screw for connecting the implant to a dental
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`component such as a prosthesis. See id. at 2:42-49 (disclosing a male hexagon
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`connector), 4:17-19 (disclosing a female connector having a hexagon or polygon
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`shape). In some examples, coronal body 14 can include a first region having a
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`smooth outer surface and a second region having a surface treatment such as, for
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`example, micro-texturing. See id. at 3:60–4:9, Figs. 3 and 4.
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`15. The ’734 patent describes an example in which a distal end surface 84
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`of the coronal body 80 includes an elongated protrusion 86 that extends into the
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`bone fixation body 72. See id. at 4:19-21, Fig. 6.
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`
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`Protrusion 86 can have any shape such as, for example, “cylindrical, square,
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`rectangular, hexagonal, octagonal, polygonal, or other shapes.” Id. at 4:24-27. In
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`the example shown in Fig. 6, the porous structure of the bone fixation body 72
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`connects to the metal coronal body at an interface that has a circular or elliptical
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`cross-section. See id. at 11:40-46. According to the ’734 patent, protrusion 86 is
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`“adapted to increase the interface between the coronal body and bone fixation
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`body.” Id. at 4:21-23.
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`16. The bone fixation body has a generally cylindrical shape (Figs.1 and
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`2) or tapered shape (Figs. 3 and 4) that extends from a proximal end to a rounded
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`distal end. See id. at 2:53-55, 3:62-65, Figs. 1-4. The bone fixation body is
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`formed from titanium and has a “completely porous structure” that “extends
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`throughout the entire body from the proximal to distal ends [sic].” Id. at 2:55-58.
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`“By ‘porous,’ it is meant that the material at and under the surface is permeated
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`with interconnected interstitial pores that communicate with the surface.” Id. at
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`3:3-5. According to the ’734 patent, “the size and shape of the porous structure
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`emulates the size and shape of the porous structure of natural bone.” Id. at 3:10-
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`11. In one example, the ’734 patent explains that the average pore diameter “is
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`about 40µm to about 800µm with a porosity from about 45% to 65%. Further, the
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`interconnections between pores can have a diameter larger than 50-60 microns.”
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`Id. at 3:11-15.
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`17. The ’734 patent describes a new example—not present in the related
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`applications from which the patent stems—in which “the porosity of the porous
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`structure can be constant throughout the porous structure.” Compare id. at 13:16-
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`17 with generally Ex. 1003 at 160-174; Ex. 1011 at 94-107, Ex. 1012 at 238-252.
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`Alternatively, the ’734 patent explains, the porosity may “change within the porous
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`structure.” See Ex. 1001 at 13:17-18.
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`18. The ’734 patent states that the configuration of the porous structure
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`“encourage[s] natural bone to migrate and grow into and throughout the entire
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`body 16.” Id. at 3:16-17. The bone fixation body can also be adapted to induce
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`bone growth through the body. See id. at 4:52-54. For example, the bone fixation
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`body can be doped with biological active substances containing pharmaceutical
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`agents to stimulate bone growth. See id. at 3:53-57.
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`19. The bone fixation body can be fabricated using various techniques
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`including sintering, casting, plasma-spraying, sputter deposition techniques, and
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`metallic deposition techniques. See id. at 12:64-67. The coronal body can be
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`formed using known machining techniques. See id. at 3:21-22. In certain
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`examples, these bodies are fabricated independently and subsequently connected or
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`fused together. See id. at 3:55-59.
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`20. The ’734 patent includes 27 claims, of which claims 1, 8, 14, 20, 25,
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`and 27 are independent. Claims 1, 8, 14, and 20 are directed to a dental implant
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`comprising, among other things, a coronal body and a porous body that is
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`“uniform”/has “uniform porosity.” Claims 25 and 27 are directed to a method
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`comprising, among other things, forming a porous body having “uniform
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`porosity.” Independent claim 1 reads in full:
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`1. A dental implant, comprising:
`a coronal body having a proximal end with a
`connection shaped as a polygon to receive a dental
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`component, having a distal end surface with an elongated
`protrusion that extends outwardly therefrom, and being
`formed of solid metal; and
`an elongated cylindrical porous body formed as a
`porous metal structure that is uniform and that includes a
`proximal end that engages the distal end surface of the
`coronal body at an interface,
`wherein the distal end surface of the coronal body
`has a circular shape, the proximal end of the porous body
`has a circular shape, and the solid metal of the circular
`shape of the coronal body interfaces with the porous
`metal structure of the circular shape of the porous body at
`the interface, and
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`wherein the elongated protrusion of the coronal
`body includes a polygonal shape that extends into an
`opening of the porous body such that the porous metal
`structure completely surrounds and engages an exterior
`surface of the elongated protrusion that extends into the
`porous body.
`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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`22. The independent claims of the ’734 patent all include a “porous”
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`feature that is “uniform,” (hereinafter the “uniform porosity features”).
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`Specifically, claim 1 recites a “porous . . . structure that is uniform.” Ex. 1001 at
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`13:55-56. Claims 8 and 14 recite a “porous body” having “uniform porosity.” Id.
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`at 14:46-47, 15:9-10. And claims 20, 25, and 27 recite “a uniform porous . . .
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`structure.” Id. at 16:5, 32, 58-59. I understand that the Applicant and Patent
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`Owner have described the uniform porosity features of the independent claims
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`similarly. Ex. 1005 at 1; Ex. 1004 at 38-39, 41. I have similarly considered the
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`features together.
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`23.
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`I understand that Petitioner has offered that the broadest reasonable
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`construction of the claimed uniform porosity features is “a porous body or
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`structure having a constant porosity throughout the body or structure.” I have used
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`this construction unless otherwise noted, and agree that this construction is
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`consistent with the ’734 patent’s new disclosure and the plain language of the
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`claims.
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`24. The plain and ordinary meaning of “uniform” is “not varying or
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`changing” or “constant.” See Ex. 1010 at 1368; Ex. 1014 at 1561. Outside of the
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`claims, the term “uniform” is not expressly used in the ’734 patent specification.
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`However, the new disclosure of the ’734 patent includes an example with a porous
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`body or structure having a “constant” porosity throughout. Ex. 1001 at 13:16-18.
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`Like the term “uniform,” “constant” has a plain and ordinary meaning of
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`“unchanging,” “remaining free from variation or change,” or “uniform.” See Ex.
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`1010 at 267; Ex. 1014 at 312.
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`25. The ’734 patent teaches a porous structure that is porous throughout.
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`Ex. 1001 at 2:56-59 (describing a bone fixation body 16 made up of “a completely
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`porous structure that extends through the entire body from the proximal to distal
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`ends”); see also id. at 3:1-2. In the newly added disclosure, the ’734 patent further
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`teaches that “the porosity of the porous structure can be constant throughout the
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`porous structure.” Id. at 13:16-18 (emphasis added).
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`26.
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`In my opinion, consistent with the plain and ordinary meaning of both
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`“uniform” and “constant,” the ’734 patent contrasts the porous structure having
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`“constant” porosity with a porous structure in which the porosity “change[s] within
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`the porous structure.” Id. (reciting that “the porosity of the porous structure can be
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`constant throughout the porous structure or change within the porous structure.”)
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`Unlike the porous structure having “constant” porosity, the ’734 patent explains
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`that a “porous structure can have a gradient porosity in which the porosity changes
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`from the surface of the bone fixation body to the center of the bone fixation bode
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`[sic] (for example, the porosity near the [external] surface of the bone fixation
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`body is different than the porosity [near] the internal [surface of the] cavity).” Id.
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`at 13:18-23. In another example, the ’734 patent discloses a non-constant porous
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`body in which porosity varies from 45% to 65% within the porous structure. Id. at
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`3:11-13.
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`27.
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`I understand that Patent Owner contends that the uniform porosity
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`features should be construed as “a metal structure that is porous throughout.” Ex.
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`2005 at 1. Patent Owner’s construction is incorrect because it is inconsistent with
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`the ’734 patent’s new disclosure of a porous structure having a porosity that is
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`“constant throughout.” Ex. 1001 at 13:16-18.
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`VII. THE EARLIER FILED U.S. APPLICATIONS DO NOT TEACH THE
`UNIFORM POROSITY FEATURES
`28.
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`In my opinion, one of ordinary skill would have understood that the
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`applications prior to the ’734 patent application do not teach the claimed uniform
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`porosity features. See Ex. 1001 at 1:6-11; see also supra Section VII. The new
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`disclosure of the ’734 patent states that “the porosity of the porous structure can be
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`constant throughout the porous structure.” Ex. 1001 at 13:16-18. By contrast, the
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`earlier-filed applications, i.e., the ’343 application, ’375 application, and the ’8,375
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`application, describe a bone fixation body that is “completely porous,” but with
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`varying pore diameter and porosity throughout. See e.g., Ex. 1003 at 165
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`(“Preferably, the average pore diameter of body 16 is about 40µm to about 800µm
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`with a porosity from about 45% to 65%.”); Compare Ex. 1004 at 124, ll. 7-8 with
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`Ex. 1003. These applications do not describe or show a bone fixation body with
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`the “uniform porosity” features. See generally Ex. 1003 at 160-174, Ex. 1011 at
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`94-107, Ex. 1012 at 238-252.
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`VIII. CERTAIN REFERENCES TEACH OR SUGGEST ALL OF THE
`FEATURES OF CLAIMS 1-3, 5-10, 12-15, AND 17-27
`In my opinion, Lomicka and/or Lomicka in view of Bhaduri teach or
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`29.
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`suggest the features recited in claims 1-3, 5-10, 12-15, and 17-27 of the ’734
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`patent.
`
`A.
`Lomicka’s Teachings
`30. Lomicka teaches a dental implant 10 “for insertion into a mandible or
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`maxilla. The implant 10 is used to anchor one or more dental prostheses . . . .” See
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`Ex. 1006 at ¶¶ [0016]-[0017], Figs. 1-4. Implant 10, shown below in Figure 2,
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`includes a coronal head 20 and core 16 extending outwardly from head 20. See
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`e.g., id. at ¶¶ [0016]-[0018], Fig. 2. Core 16 can be integrally formed with head 20
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`and the structure may be formed of a solid metal such as “titanium, titanium alloy,
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`stainless steel, zirconium[], [or] cobalt-chromium molybedenum alloy.” See id. at
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`¶¶ [0017], [0021]. Lomicka teaches that core 16 may have a generally polygonal
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`shape. See id. at Figs. 2, 3; see also id. at ¶¶ [0042], [0047].
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`31. Lomicka further teaches that coronal end 24 of the head 20 is
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`configured with a female engagement structure that receives a corresponding
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`structure from a separate dental component such as an abutment. See id. at
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`¶ [0018]. As shown in Figure 5, the female engagement structure can be shaped as
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`a polygon to receive and retain a dental component. See e.g., id. at Fig. 5.
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`32.
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`Implant 10 of Lomicka includes an exterior portion 12 made of a
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`porous material 14 that surrounds a surface of core 16. See Ex. 1006 at ¶¶ [0016],
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`[0019], [0040], Fig. 2. As shown in Fig. 2, exterior portion 12 forms a cylindrical
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`body, and includes a coronal end 32 that engages an apical end surface 28 of head
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`20 at an interface. See id. at Fig. 2; see also id. at ¶[0016], [0019]. Lomicka
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`discloses that “the porous material 14 forming the exterior portion 12 may include
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`metal, and in one form, is a porous tantalum portion 40 which is a highly porous
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`biomaterial useful as a bone substitute and/or cell and tissue receptive material.”
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`Id. at ¶ [0023]; see also id. at Fig. 4 (depicting the porous tantalum structure 40).
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`The porous tantalum structure 40 “may be fabricated to virtually any desired
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`porosity and pore size, whether uniform or varying, and can thus be matched with
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`the surrounding natural bone in order to provide an improved matrix for bone in-
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`growth and mineralization.” Id. at ¶ [0029].
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`B.
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`33.
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`Lomicka Teaches All of the Features of Claims 1-3, 5-10, 12-15,
`17-21, 23, 24, and 27
`1.
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`Claim 1
`i.
`“A dental implant, comprising:”
`In my opinion, Lomicka teaches a dental implant. See e.g., Ex. 1006
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`at ¶¶ [0004]-[0012], [0016], [0017], Figs. 1-4. For example, Lomicka teaches an
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`implant 10 “for insertion into a mandible or maxilla. The implant 10 is used to
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`anchor one or more dental prostheses . . . .” See id. at ¶¶ [0016]-[0017]; see also
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`infra Sections VIII.B.1.ii-v.
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`ii.
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`“a coronal body having a proximal end with a
`connection shaped as a polygon to receive a dental
`component, having a distal end surface with an
`elongated protrusion that extends outwardly
`therefrom, and being formed of solid metal; and”
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`
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`34.
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`In my opinion, Lomicka teaches the coronal body, as claimed.
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`Implant 10 includes a coronal head portion or head 20, shown in blue in Fig. 2
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`above. See Ex. 1006 at ¶ [0017]. Head 20 has a coronal end 24 and a core 16
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`extending outwardly from an opposite end of head 20. See e.g., id. at ¶¶ [0017]-
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`[0018], Fig. 2. Core 16 can be integrally formed with head 20. See id. at ¶ [0017].
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`Lomicka explains that head 20 and core 16 are formed of a solid metal such as
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`“titanium, titanium alloy, stainless steel, zirconium[], [or]cobalt-chromium
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`molybedenum alloy.” See id. at ¶ [0021].
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`35. Lomicka further teaches that coronal end 24 of the head 20 is
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`configured with a female engagement structure that receives a corresponding
`
`structure from a separate dental component such as an abutment. See id. at ¶
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`[0018]. In my opinion, as shown in Figure 5, the female engagement structure can
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`be shaped as a polygon to receive and retain a dental component. See e.g., id. at
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`Fig. 5.
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`iii.
`
`“an elongated cylindrical porous body formed as a
`porous metal structure that is uniform and that
`includes a proximal end that engages the distal end
`surface of the coronal body at an interface,”
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`
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`36.
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`In my opinion, Lomicka teaches the elongated cylindrical porous
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`body, as claimed. Implant 10 of Lomicka includes an exterior portion 12, shown in
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`green in Fig. 2 above, made of a porous material 14. See Ex. 1006 at ¶ [0016]. As
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`shown in Fig. 2, exterior portion 12 forms a cylindrical body, and includes a
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`coronal end 32 that engages an apical end surface 28 of head 20 at an interface.
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`See id. at Fig. 2; see also id. at ¶ [0016] (“exterior portion 12 may be placed on or
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`around an interior portion [of] core 16”) (emphasis added), id. at ¶ [0019] (“apical
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`end surface 28 forms a shoulder to abut and retain exterior portion 12 on the core
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`16” and “[a] coronal end 32 of the exterior portion 12 faces and/or abuts the apical
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`end surface 28.”).
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`37. Lomicka explains that “the porous material 14 forming the exterior
`
`portion 12 may include metal, and in one form, is a porous tantalum portion 40
`
`which is a highly porous biomaterial useful as a bone substitute and/or cell and
`
`tissue receptive material.” Id. at ¶ [0023]; see also id. at Fig. 4 (depicting the
`
`porous tantalum structure 40). Lomicka teaches that the porous tantalum structure
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`40 “may be fabricated to virtually any desired porosity and pore size, whether
`
`uniform or varying, and can thus be matched with the surrounding natural bone in
`
`order to provide an improved matrix for bone in-growth and mineralization.” Id. at
`
`¶ [0029]. In my opinion, Lomicka thus teaches the uniform porosity feature of
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`claim 1 under the broadest reasonable interpretation of “a porous body or structure
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`having a constant porosity throughout the body or structure.”
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`iv.
`
`“wherein the distal end surface of the coronal body
`has a circular shape, the proximal end of the porous
`body has a circular shape, and the solid metal of the
`circular shape of the coronal body interfaces with the
`porous metal structure of the circular shape of the
`porous body at the interface, and”
`38. As shown in Fig. 2, apical end surface 28 of head 20 has a circular
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`shape. See Ex. 1006 at Fig. 2. Likewise, coronal end 32 of exterior portion 12 has
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`a circular shape. See Ex. 1006 at Fig. 2. The solid metal of the circular shape of
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`head 20 interfaces with the porous metal structure 40 of the circular shape of
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`exterior portion 12, as shown in Fig. 1 reproduced below.
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`
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`See id. at ¶ [0019] (“[a] coronal end 32 of the exterior portion 12 faces and/or abuts
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`the apical end surface 28.”).
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`v.
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`“wherein the elongated protrusion of the coronal
`body includes a polygonal shape that extends into an
`opening of the porous body such that the porous
`metal structure completely surrounds and engages an
`exterior surface of the elongated protrusion that
`extends into the porous body.”
`39. Lomicka teaches that “exterior portion 12 is a sleeve or collar with a
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`bore 30 that receives the core 16” and that core 16 “has a reduced outer diameter
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`compared to the diameter of the outer surface 26 and extends apically from an
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`apical end surface 28 of head 20 so that apical end surface 28 forms a shoulder to
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`abut and retain exterior portion 12 on the core 16.” See Ex. 1006 at ¶ [0019].
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`In my opinion, and as shown in Fig. 3 below, porous material 14 forming exterior
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`portion 12 completely surrounds and engages an exterior surface of core 16. See
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`id. at ¶¶ [0016], [0040].
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`
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`Lomicka teaches that, in some examples, core 16 has a generally polygonal shape
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`with edges 64 that cut into and engage wall 62 of exterior portion 12. See Ex. 1006
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`-22-
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