UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`
`
`MAKO SURGICAL CORP.,
`Petitioner
`
`v.
`
`BLUE BELT TECHNOLOGIES, INC.,
`Patent Owner
`
`______________________
`
`Case IPR2015-00630
`Patent No. 6,205,411 B1
`_______________________
`
`
`PETITIONER MAKO SURGICAL CORP.’S OPPOSITION
`TO PATENT OWNER’S CONTINGENT MOTION TO AMEND
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`dc-819447
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`REDACTED VERSION
`
`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`
`
`MAKO SURGICAL CORP.,
`Petitioner
`
`v.
`
`BLUE BELT TECHNOLOGIES, INC.,
`Patent Owner
`
`______________________
`
`Case IPR2015-00630
`Patent No. 6,205,411 B1
`_______________________
`
`
`PETITIONER MAKO SURGICAL CORP.’S OPPOSITION
`TO PATENT OWNER’S CONTINGENT MOTION TO AMEND
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`dc-819447
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`REDACTED VERSION
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`Petitioner’s Opp. to Patent Owner’s Contingent Motion to Amend IPR2015-00630
`
`
`TABLE OF CONTENTS
`
`I.
`II.
`III.
`
`INTRODUCTION ........................................................................................... 1
`DIGIOIA IS AT LEAST § 102(A) PRIOR ART ............................................ 2
`PATENT OWNER DOES NOT ESTABLISH THAT THE PROPOSED
`SUBSTITUTE CLAIMS WOULD HAVE BEEN PATENTABLE OVER
`OTHER PRIOR ART OF RECORD ............................................................... 9
`A.
`Patent Owner Failed to Distinguish Material Art of Record .............. 10
`B.
`DiGioia II Alone, or in Combination with Chao and O’Toole,
`Invalidates Patent Owner’s Proposed New Claims ............................. 11
`1. DiGioia II, Chao, and O’Toole References ......................................... 11
`2.
`Pre-operative kinematic biomechanical simulator . . . executing on the
`computer system .......................................................................................... 13
`3.
`Simulate movement of the hip joint with the artificial
`component/implant in a test position ........................................................... 14
`4. Calculate a range of motion based on the simulated movement and
`determine an implant position ...................................................................... 16
`5. Taylor Reference ................................................................................. 17
`C.
`Claim Chart for Patent Owner’s Proposed New Claims ..................... 18
`IV. Conclusion ..................................................................................................... 24
`
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`Petitioner’s Opp. to Patent Owner’s Contingent Motion to Amend IPR2015-00630
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`CASES
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`Table of Authorities
`
`Page(s)
`
`Amgen Inc. v. Hoechst Marion Roussel, Inc.,
`314 F.3d 1313 (Fed. Cir. 2003) .......................................................................................16
`
`Geo M. Martin Co. v. All. Mach. Sys. Int’l LLC,
`618 F.3d 1294 (Fed. Cir. 2010) .......................................................................................15
`
`Idle Free Systems, Inc. v. Bergstrom, Inc.,
`Case IPR2012-00027, 2013 WL 5947697 (PTAB June 11, 2013) .................... 10
`
`In re Katz,
`687 F.2d 450 (C.C.P.A. 1982) .......................................................................................2, 3
`
`MasterImage3D, Inc. v. Reald Inc.,
`Case IPR2015-00040, 2015 WL 4383224 (PTAB July 15, 2015) .........................10
`
`Nike, Inc. v. Adidas AG,
`No. 2014-1719, 2016 WL 537609 (Fed. Cir. Feb. 11, 2016) ..............................9, 10
`
`Toyota Motor Corp. v. Am. Vehicular Scis. LLC,
`Case IPR2013-00422, slip op. (PTAB Mar. 7, 2014) ..................................................9
`
`OTHER AUTHORITIES
`
`M.P.E.P. § 2132.01(I) ................................................................................................................2
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`Petitioner’s Opp. to Patent Owner’s Contingent Motion to Amend IPR2015-00630
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`PETITIONER’S EXHIBIT LIST
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`Exhibit Description
`
`Exhibit #
`
`U.S. Patent No. 6,205,411 (“the ’411 patent”)
`
`Prosecution History of U.S. Patent No. 6,205,411
`
`Prosecution History of U.S. Patent No. 5,880,976
`
`Declaration of Robert D. Howe
`
`A.M. DiGioia et al., “HipNav: Pre-operative Planning and
`Intraoperative Navigational Guidance for Acetabular Implant
`Placement in Total Hip Replacement Surgery,” 2nd CAOS
`Symposium, 1996 (“DiGioia”)
`
`Anthony M. DiGioia III et al., “An Integrated Approach to
`Medical Robotics and Computer Assisted Surgery in
`Orthopaedics,” Proc. 1st Int’l Symposium on Medical Robotics and
`Computer Assisted Surgery, pp. 106-111, 1995 (“DiGioia II”)
`
`E.Y.S. Chao et al., “Simulation and Animation of Musculoskeletal
`Joint System,” Transactactions of the ASME, Vol. 115, pp. 562-
`568, Nov. 1993 (“Chao”)
`
`R.V. O’Toole III et al., “Towards More Capable and Less Invasive
`Robotic Surgery in Orthopaedics,” Computer Vision, Virtual
`Reality and Robotics in Medicine Lecture Notes in Computer
`Science, Vol. 905, pp. 123-130, 1995 (“O’Toole”)
`
`Russell H. Taylor et al., An Image-Directed Robotic System for
`Precise Orthopaedic Surgery, IEEE Transactions on Robotics and
`Automation, Vol. 10, No. 3, June 1994 (“Taylor”)
`
`Deposition Transcript of Dr. Cleary
`
`Deposition Transcript of Dr. Jaramaz – Filed Under Seal
`
`Deposition Transcript of Dr. Jaramaz – Redacted
`
`Declaration of Eric R. Kischell
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`iv
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`1001
`
`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`1013
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`Exhibit Description
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`Exhibit #
`
`Intentionally left blank
`
`Intentionally left blank
`
`U.S. Patent No. 5,880,976 (“the ’976 patent”)
`
`Intentionally left blank
`
`Web page from Carnegie Mellon University for Branislav Jaramaz
`
`A.M. DiGioia et al., “HipNav: Pre-operative Planning and Intra-
`Operative Navigational Guidance for Acetabular Implant
`Placement in Total Hip Replacement Surgery,” Proc. of the CAOS
`Symposium, Nov. 1995.
`
`CAOS Symposium Final Program, 18 November 30 - December 2,
`1995
`
`D.A. Simon et al., “Development and Validation of a Navigational
`Guidance System for Acetabular Implant Placement”
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
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`1020
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`1021
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`v
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`I.
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`INTRODUCTION
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`Patent Owner Blue Belt Technologies attempts to avoid invalidity by filing a
`
`
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`contingent motion to amend. The premise of the motion is that if the claims are
`
`amended as proposed in new claims 18-34, the specification filed on February 21,
`
`1997 would then support the claims such that the primary DiGioia reference would
`
`no longer serve as § 102(b) prior art. However, even if the Patent Owner may
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`reach back to the earlier priority date of February 21, 1997 by limiting the claims
`
`to the hip joint, the DiGioia article remains § 102(a) prior art because the article
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`has a different inventive entity than the ‘411 patent. There are two authors who
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`contributed to the conception of the system in the article that are not listed as
`
`inventors on the patent. There is also one inventor on the ‘411 patent who is not
`
`listed as an author of the article. Patent Owner offers the Jaramaz Declaration in
`
`an attempt to get around this inventorship problem, but his testimony lacks
`
`foundation regarding the inventive entity involved with the article. Indeed, while
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`Patent Owner failed to submit a declaration from anyone who had actual
`
`knowledge about the naming of the authors who contributed to DiGioia, Petitioner
`
`has submitted a declaration from Mr. Eric Kischell, one of the authors who was not
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`named on the ’411 patent, explaining his role in drafting the article and developing
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`the system described therein. Because he clearly belongs to the inventive entity of
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`Petitioner’s Opp. to Patent Owner’s Contingent Motion to Amend IPR2015-00630
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`the DiGioia article, the inventive entity of DiGioia is not the same as that of the
`
`’411 patent, such that DiGioia is at least § 102(a) prior art.
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`Moreover, as argued in the Petition, an earlier 1995 reference, DiGioia II, in
`
`combination with the Chao, O’Toole, and Taylor references invalidates the issued
`
`claims. These same combinations also invalidate the new claims 18-34. The
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`amended claims’ focus on the hip joint does not solve anything for Patent Owner
`
`because these prior art references were explicitly focused on the hip joint. Patent
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`Owner not only failed to distinguish the proposed new claims from these prior art
`
`references, but failed to even address certain prior art of record, as was required.
`
`II. DIGIOIA IS AT LEAST § 102(A) PRIOR ART
`
`Even if Patent Owner is permitted to amend the ’411 patent to substitute
`
`proposed claims 18-34 for claims 1-17, DiGioia still qualifies as prior art against
`
`the proposed substitute claims. When a printed publication is filed that describes
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`the subject matter of the claimed invention and is published before an application,
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`the article may raise a substantial question whether the applicant is the inventor. In
`
`re Katz, 687 F.2d 450, 455 (C.C.P.A. 1982); see also M.P.E.P. § 2132.01(I) (“[a]
`
`prima facie case is made out under pre-AIA 35 U.S.C. 102(a) if, within 1 year of
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`the filing date, the invention, or an obvious variant thereof, is described in a
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`‘printed publication’ whose authorship differs in any way from the inventive entity
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`unless it is stated within the publication itself that the publication is describing the
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`applicant’s work”).
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`A prima facie case that DiGioia is prior art has been made out under §
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`102(a) because DiGioia was published no later than 1996 and the authorship of
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`DiGioia differs from that of the ’411 patent: Dr. Takeo Kanade, who is listed as an
`
`inventor of the ’411 patent, is not listed as an author of DiGioia; and DiGioia lists
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`Mr. Bruce Colgan and Mr. Eric Kischell as authors, neither of whom are listed as
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`inventors of the ’411 patent. (Ex. 1005 at 1; Ex. 1001 at 1.)
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`Because of the different authors of DiGioia, it was incumbent on Patent
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`Owner to provide a showing which would lead to a reasonable conclusion that the
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`inventive entity of DiGioia and the ’411 patent are identical. In re Katz, 687 F.2d
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`at 455. Patent Owner has failed to do so. Patent Owner has submitted only one
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`declaration on the subject, that of Dr. Jaramaz, the founder and CTO of Blue Belt.
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`At his deposition, it became clear that he did not have the factual knowledge
`
`necessary to establish that the inventive entities were identical. Indeed, Dr.
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`Jaramaz appears to have signed a declaration without having actual recollections to
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`support what was written.
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`Dr. Jaramaz states in his declaration that Dr. Kanade, an inventor of the ’411
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`patent, was not listed as an author of the DiGioia article because he was not
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`working day-to-day on the system at the time. (Ex. 2002 at ¶ 11.) Dr. Jaramaz
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`Petitioner’s Opp. to Patent Owner’s Contingent Motion to Amend IPR2015-00630
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`named Dr. Kanade to other articles at the time, but not this one. (Ex. 1012 at
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`23:16-25:13.) Although Dr. Jaramaz’s declaration contains extensive comments
`
`on the contributions to the article, he did not know who decided to omit Dr.
`
`Kanade as an author of the article, and did not ask anyone else how this process
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`occurred:
`
`Q Do you know who decided to not list Dr. Kanade on the
`HipNav article? Do you know who made that decision?
`A No.
`Q Was it you?
`A No. It wasn’t me.
`Q You haven’t spoken with anyone who made the decision to
`determine why they did it, have you?
`A Not that I recall. No.
`Q If you didn’t make the decision yourself and you haven’t
`spoken to anyone who did make the decision and you are not sure
`who made the decision, you can’t really tell us why he was left off.
`Correct?
`
`. . .
`A I can tell you my opinion, if that is worth anything. I cannot tell you the
`
`exact reasons.
`
`(Ex. 1012 at 25:14-26:5 (objection omitted).) Thus, at the end of the day, Patent
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`Owner has not offered any factual testimony explaining Dr. Kanade’s omission
`
`from the article. Without such testimony, his omission from the inventive entity of
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`DiGioia means that there is a different inventive entity pertaining to the system
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`described in the article than the one in the ’411 patent, and DiGioia qualifies as §
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`102(a) prior art.
`
`There are further problems with Patent Owner’s “same inventive entity”
`
`argument. Mr. Kischell is listed as a co-author of DiGioia, but is not listed as an
`
`inventor of the ’411 patent. Because he is part of the inventive entity of the system
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`included in DiGioia, there is an additional hurdle that Patent Owner has not
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`overcome. In Dr. Jaramaz’s declaration, he admitted that Mr. Kischell was
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`involved in developing the HipNav System discussed in DiGioia on a day-to-day
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`basis, and that Mr. Kischell developed a user interface for the HipNav system.
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`(Ex. 2002 at ¶¶ 11, 16.) In his deposition, Dr. Jaramaz further admitted that the
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`software that Mr. Kischell developed made it possible to convert the data from CT
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`scans into 3D geometric models in the HipNav system. (Ex. 1012 at 26:6-29:18.)
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`This software was not commercially available and needed to be created specifically
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`for the HipNav system. (Id. at 27:14-18.) All of these admissions point to Mr.
`
`Kischell being part of the inventive entity of the DiGioia article.
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`Although Dr. Jaramaz’s declaration attempts to minimize Mr. Kischell’s
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`contribution to the system and the article, in his deposition, it became clear that he
`
`did not know what Mr. Kischell’s contribution had been to the article. (Ex. 1012 at
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`47:9-19.) Mr. Kischell did not report to Dr. Jaramaz. (Id. at 29:5-11.) Thus, once
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`Petitioner’s Opp. to Patent Owner’s Contingent Motion to Amend IPR2015-00630
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`again, in describing Mr. Kischell’s role in the article, Dr. Jaramaz was simply
`
`providing his opinion about what might have happened, rather than what did in fact
`
`happen.
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`Fortunately, we do not need to speculate about Mr. Kischell’s contribution
`
`as he has provided a declaration on the subject. (See Ex. 1013.) At the time of his
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`work on the article, Mr. Kischell held a M.S. in Electrical Engineering from Texas
`
`A&M University, and a B.S. in Electrical Engineering from Northeastern
`
`University. (Ex. 1013 at ¶ 1.) His expertise encompasses image processing,
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`pattern recognition, 3D visualization, object oriented architecture, user interface
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`prototyping and code optimization. (Id.) In working on the HipNav system, he
`
`solved the problem of how to integrate the intra-operative tracking and guidance
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`system into a graphical user interface. (Id.at ¶¶ 7-8.) The data had to be integrated
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`and tracked in real time in a capable graphical user interface so that the surgeon
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`could utilize the intra-operative tracking and guidance system to accurately place
`
`the implant in the predetermined optimal position. (Id.at ¶ 8.) He also developed a
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`way to process the CT scans so that they could be utilized in the pre-operative
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`planner. (Id.at ¶ 9.) Both of these solutions were utilized in the HipNav System as
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`represented in the DiGioia article. (Id.at ¶¶ 7-9.) It took approximately 14 months
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`to create the graphical user interface, and approximately 20 months to develop the
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`CT scan pre-processing software. (Id.at ¶ 10.) Mr. Kischell reviewed and edited
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`Petitioner’s Opp. to Patent Owner’s Contingent Motion to Amend IPR2015-00630
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`the DiGioia article before its publication. (Id.at ¶ 11.) Mr. Kischell’s contributions
`
`to solving the software problems in the HipNav system were important to the
`
`project’s success and in any event were not insubstantial. (Id.at ¶ 11.) Because
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`Mr. Kischell was properly a part of the inventive entity in DiGioia and was not an
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`inventor of the ’411 patent, Patent Owner’s “same inventive entity” argument fails.
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`Beyond these problems with his statements on the authors of DiGioia, Dr.
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`Jaramaz made further factual statements in his declaration that, at a minimum,
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`lacked foundation. While stating in his declaration that “[o]n February 22, 1996,
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`we created an initial version of [DiGioia]”, his own publication list dates the article
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`as having been published in 1995. (Ex. 1012 at 17:6-18:7; Ex. 1018 at 8.) He also
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`cites DiGioia as having been published in 1995 in one of his earlier articles and the
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`“pdf” of the article on his website states that it was published in 1995. (Ex. 1012 at
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`20:24-21:20; (A.M. DiGioia et al., “HipNav: Pre-operative Planning and Intra-
`
`Operative Navigational Guidance for Acetabular Implant Placement in Total Hip
`
`Replacement Surgery,” Proc. of the CAOS Symposium, Nov. 1995 ( Ex. 1019 at
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`1); D.A. Simon et al., “Development and Validation of a Navigational Guidance
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`System for Acetabular Implant Placement” (Ex. 1021 at 10.) On cross
`
`examination, he agreed that the article was first published in 1995 and that his
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`dating of the article as being created on February 22, 1996 was incorrect. (Ex.
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`1012 at 21:21-22:11.) However, after meeting with his counsel during a break, he
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`Petitioner’s Opp. to Patent Owner’s Contingent Motion to Amend IPR2015-00630
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`testified on redirect that in fact the article had been published in 1996, blaming the
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`1995 dates in his materials on his secretary. (Ex. 1012 at 59:2-64:25.) Although
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`the testimony is unclear, it is very apparent that Dr. Jaramaz does not know or
`
`recall when the first version of the article had been drafted or published. He
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`simply signed the declaration that had been drafted for him saying that DiGioia had
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`been written on February 22, 1996, conveniently exactly one year before the filing
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`date, without actually knowing when the article had actually been drafted.
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`Dr. Jaramaz’s willingness to help the Patent Owner’s cause may be the
`
`product of bias. He recently received
`
` due to the sale of Blue
`
`Belt to Smith & Nephew for $275 million. (Ex. 1012 at 4:9-6:11.) There is also a
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`holdback amount of around
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` percent of the $275 million in escrow that will be
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`paid out -- or not paid out -- based on subsequent events. (Ex. 1012 at 6:12-6:16.)
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`When asked whether success or failure in this proceeding could affect the amount
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`of the payment of the
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` of funds in escrow, he testified that he
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`did not know. (Ex. 1012 at 6:17-7:10.) It is not credible that the head of
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`technology in a company with only a few patents would not know whether a patent
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`matter involving two of those patents could impact a
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` escrow account
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`or not. It appears more likely than not that it does, and if Patent Owner maintains
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`to the contrary, the terms of that escrow should be produced.
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`Petitioner’s Opp. to Patent Owner’s Contingent Motion to Amend IPR2015-00630
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`Given the weaknesses of Dr. Jaramaz’s declaration, the fact that no
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`disclaiming affidavits were filed by any of the other DiGioia co-authors, and the
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`testimony in the Kischell declaration on his role in the article, the Court must
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`conclude that Patent Owner has failed to meet its burden of demonstrating that
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`DiGioia has the same inventive entity. Thus, DiGioia remains prior art under §
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`102(a). Because DiGioia focuses on the hip joint, the amended claims 18-34 are
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`invalid for obviousness in the same way that DiGioia renders claims 1-17 obvious.
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`See Petition Owner Mako Surgical’s Reply to Patent Owner’s Response at 17-25.
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`In addition, the other minor changes made to the new claims were already present
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`in original claim 17, and are therefore invalid for obviousness in the same way that
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`DiGioia rendered claim 17 obvious. Id.
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`III. PATENT OWNER DOES NOT ESTABLISH THAT THE PROPOSED
`SUBSTITUTE CLAIMS WOULD HAVE BEEN PATENTABLE
`OVER OTHER PRIOR ART OF RECORD
`
`“[T]he burden of establishing the patentability of proposed substitute claims
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`[is] on the patent owner[.]” Nike, Inc. v. Adidas AG, No. 2014-1719, 2016 WL
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`537609, at *5 (Fed. Cir. Feb. 11, 2016); see also Toyota Motor Corp. v. Am.
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`Vehicular Scis. LLC, Case IPR2013-00422, slip op. at 4 (PTAB Mar. 7, 2014)
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`(Paper 25) (noting that a patent owner “bears the burden of proof to establish that it
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`is entitled to the relief requested in the motion to amend”) (citing 37 C.F.R. §
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`42.20(c)). Further, “a motion to amend will be successful only if the patent owner
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`Petitioner’s Opp. to Patent Owner’s Contingent Motion to Amend IPR2015-00630
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`‘persuade[s] the Board that the proposed substitute claim is patentable over the
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`prior art of record, and over prior art not of record but known to the patent
`
`owner.’” Nike, Inc., 2016 WL 537609, at *19 (citing Idle Free Systems, Inc. v.
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`Bergstrom, Inc., Case IPR2012-00027, 2013 WL 5947697 at*4 (PTAB June 11,
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`2013) (Paper 26) (emphasis omitted)). Patent Owner has not only failed to address
`
`prior art of record, but has also failed to show a patentable distinction over prior art
`
`that was outlined in the Petition.
`
`A.
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`Patent Owner Failed to Distinguish Material Art of Record
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`As mentioned above, Patent Owner must show patentable distinction over
`
`the prior art of record. Id. “Prior art of record” includes “a. any material art in the
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`prosecution history of the patent; b. any material art of record in the current
`
`proceeding, including art asserted in grounds on which the Board did not
`
`institute review; and c. any material art of record in any other proceeding before
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`the Office involving the patent.” MasterImage3D, Inc. v. Reald Inc., Case
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`IPR2015-00040, 2015 WL 4383224, at 2 (PTAB July 15, 2015) (Paper 42)
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`(emphasis added). In its Motion, Patent Owner discussed only the DiGioia II
`
`(Ex.1006) and Taylor (Ex. 1009) references, noting that they were the “most
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`relevant” prior art references cited by Petitioner. (Motion to Amend at 14.) But
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`Patent Owner failed to even address the Chao (Ex. 1007) and O’Toole (Ex. 1008)
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`Petitioner’s Opp. to Patent Owner’s Contingent Motion to Amend IPR2015-00630
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`references, which Petitioner also included in the Petition. Thus, Patent Owner has
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`not met its burden to show patentable distinction over the prior art of record.
`
`B. DiGioia II Alone, or in Combination with Chao and O’Toole,
`Invalidates Patent Owner’s Proposed New Claims
`
`Patent Owner unconvincingly argues that the new limitations added to
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`proposed new claims 18, 27, and 34 are not taught by or obvious in light of
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`DiGioia II and Taylor references. (Motion at 15-16.) But as explained below,
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`DiGioia II, either alone or in combination with Chao and O’Toole, teaches these
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`added limitations. Patent Owner failed to address the Chao and O’Toole
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`references in its Motion.
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`DiGioia II, Chao, and O’Toole References
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`1.
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`DiGioia II is an article published at least as early as 1995, 1-2 years prior to
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`the February 21, 1997 date to which the ’411 patent claims priority. (Ex. 1006;
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`http://www.ri.cmu.edu/person.html?type=publications&person_id=65 (listing
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`publication date as 1995).) Thus, DiGioia II qualifies as prior art under § 102(b).
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`DiGioia II describes systems and methods to improve accuracy of joint
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`replacements through the use of pre-operative planning and computer systems.
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`DiGioia II proposes a pre-operative planning component and the use of a simulator
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`to determine optimal implant positioning. It describes that if biomechanics-based
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`preoperative planning is linked with patient and pre-determined implant data, as
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`well as a computer or robot monitoring and assisting the surgery, surgical results
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`could be improved. A main figure in the article, Figure 1, displays the combined
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`system, indicating with arrows communication between the various components.
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`Like the ’411 patent, DiGioia II discloses an approach to improved surgical
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`techniques incorporating pre-operative planning with biomechanical analysis and
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`computer or robot-assisted surgery. (Ex. 1006 at 108.)
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`The O’Toole reference is another article written by several of the same
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`authors that wrote DiGioia II. (Ex. 1004 ¶ 49.) O’Toole is also § 102(b) prior art
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`to the ’411 patent, even with the proposed new claims, as O’Toole was published
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`in 1995. (Id.) A person of ordinary skill would be motivated to combine DiGioia
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`II with O’Toole, as O’Toole also describes a system for planning a hip surgery
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`involving a femoral implant and a femur and shares most of its authors with
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`DiGioia II (including respective lead authors O’Toole and DiGioia along with four
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`other authors). (Id.¶ 33.)
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`The Chao reference is an article published in November of 1993. (Ex. 1007
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`at 1.) Chao was published in 1993, and is therefore also § 102(b) prior art to the
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`’411 patent even with the proposed new claims. A person of ordinary skill in the
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`art would be motivated to combine DiGioia II with Chao, because Chao addressed
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`the same subject matter as DiGioia II. (Ex. 1004 ¶ 32.) Like DiGioia II, Chao
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`addresses simulation and animation of joints. Also like DiGioia II, Chao expresses
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`a desire to allow a user to simulate joint pressure distribution in order to improve
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`joint replacement, including hip replacements.
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`2.
`
`Pre-operative kinematic biomechanical simulator . . .
`executing on the computer system
`
`New claims 18 and 27 include the following limitation: “a pre-operative
`
`kinematic biomechanical simulator . . . executing on the computer system to:[.]”
`
`DiGioia II discloses this limitation. DiGioia II describes the use of a pre-operative
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`biomechanical analysis system: “Biomechanical analyses would provide the
`
`surgeon with feedback concerning the distribution of strain in the bone, and the
`
`amount of bone-implant contact for a given surgical plan.” (Ex. 1006 at 107.)
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`“Biomechanical analyses should consider . . . bone remodeling effects due to joint
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`loading and varying load transfer mechanisms.” (Id.) This biomechanical
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`analysis system relates to movement and is therefore a kinematic biomechanical
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`simulator. Additionally, DiGioia II Figure 1 depicts a pre-operative biomechanical
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`analysis system on a computer system. (Ex. 1006 at Fig. 1 (“Biomechanic-based
`
`Preoperative Planning”; “3-D Templating”; “Biomechanical Analysis”).) In
`
`addition, this limitation is made obvious by DiGioia II in view of Chao. Chao
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`discusses computer-based software for three-dimensional geometric data base of
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`the human musculoskletal system, and discloses biomechanical simulations used in
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`preoperative planning and for selection and planning for total joint replacement.
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`(Ex. 1007 at 2, 4-6.)
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`3.
`
`Simulate movement of the hip joint with the artificial
`component/implant in a test position
`
`New claims 18 and 27 include the following limitation: “simulate
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`movement of the hip joint with the artificial component in a test position using the
`
`geometric model of the hip joint and the component model;” and new claim 34
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`includes the following limitation: “simulating movement of the joint with the
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`artificial implant in a test position[.]” DiGioia II discloses these limitations.
`
`By “provid[ing] the surgeon with feedback concerning the distribution of
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`strain in the bone,” “the amount of bone-implant contact for a given surgical
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`plan[,]” and by recommending that the biomechanical analyses “consider . . . bone
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`remodeling effects due to joint loading and varying load transfer mechanisms[,]”
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`DiGioia II’s biomechanical system is simulating movement of the hip joint with
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`the artificial component/implant in a test position. DiGioia II discloses that
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`software utilizes imaging data to generate 3-D skeleton models. (Ex. 1006 at Fig.
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`1 (“Imaging”; “3-D Skeleton Model”).) These 3-D skeleton models are geometric
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`models of the hip joint. DiGioia II teaches a three-dimensional component model
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`by in Figure 1 by depicting a computer and an “Implant Database” as part of
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`“Patient Data,” which are connected to 3-D Templating on a computer system in
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`the “Biomechanics-based Preoperative Planning” section. DiGioia Figure 2 also
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`depicts a 3-D skeleton or “bony” model and an implant model. (Ex. 1006 at Fig.
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`2.) It is clear that the biomechanical analysis system utilizes both the 3-D skeleton
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`model and the Implant Database with the 3-D Templating by the arrows going
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`from Patient Data to Biomechanical-based Preoperative Planning sections of
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`Figure 1, and additionally by the arrow going from 3-D Templating to
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`Biomechanical Analysis.
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`Patent Owner argues that the statement in DiGioia II that the researchers
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`were “working toward developing of an automatized procedure that will include
`
`biomechanical simulation as a component of a preoperative surgical planner”
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`somehow means that this limitation is not disclosed by DiGioia. (Motion at 16.)
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`But just because a fully automated preoperative surgical planning procedure that
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`included a biomechanical simulation component was not yet entirely developed
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`does not mean that DiGioia II did not disclose this limitation. DiGioia II Figure 1
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`clearly shows the biomechanical analysis system integrated into preoperative
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`planning. Further development to make the system more autonomous is not
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`necessary to satisfy this limitation. See Geo M. Martin Co. v. All. Mach. Sys. Int’l
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`LLC, 618 F.3d 1294, 1302 (Fed. Cir. 2010) (“Under an obviousness analysis, a
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`reference need not work to qualify as prior art. . . . Even if a reference discloses an
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`inoperative device, it is prior art for all that it teaches”) (internal quotations and
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`citations omitted); Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313,
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`1357 (Fed. Cir. 2003) (“Under § 103, however, a reference need not be enabled; it
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`qualifies as a prior art, regardless, for whatever is disclosed therein”), aff’d in part
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`and rev’d in part, on other grounds, 457 F.3d 1293 (Fed. Cir. 2006). Thus, this
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`limitation was disclosed or made obvious in light of DiGioia II.
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`4.
`
`Calculate a range of motion based on the simulated
`movement and determine an implant position
`
`New claims 18 and 27 include the following limitation: “calculate a range
`
`of motion of the artificial component and the hip joint for the test position based on
`
`the simulated movement;” and new claim 34 includes the following limitation:
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`“calculating a range of motion of the artificial implant and the bones comprising
`
`the joint for the test position based on the simulated movement[.]” Additionally,
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`New claims 18 and 27 include the following limitation: “determine a position for
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`implantation for the artificial component based at least in part on the calculated
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`range of motion[,]” and new claim 34 includes the following limitation:
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`“determining an implant position based on a predetermined range of motion and
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`the calculated range of motion.” Patent Owner argues that DiGioia II’s reference
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`to “biomechanical simulation” does not teach or suggest these limitations. But
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`Patent Owner failed to even acknowledge or address the Chao reference. DiGioia
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`II in view of Chao renders these limitations obvious.
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`Chao specifically addresses simulation and animation of joints. (Ex. 1007.)
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`Chao indicates that its simulations may be used for “[s]election and planning in
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`total joint replacement” and discloses examples where “[j]oint pressure and motion
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`were obtained through model simulation.” (Ex. 1007 at 5.) In light of Chao, it
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`would have been obvious to simulate motion of the hip joint/bones comprising the
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`joint with the implant in place and therefore calculate the range of motion of the
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