UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`MEDTRONIC, INC.,
`Petitioner
`
`v.
`
`MARK A. BARRY,
`Patent Owner
`
`
`
`
`Case IPR2015-00780
`Patent No. 7,670,358
`
`
`PATENT OWNER’S OBJECTIONS TO PETITIONER’S EVIDENCE
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`MEDTRONIC, INC.,
`Petitioner
`
`v.
`
`MARK A. BARRY,
`Patent Owner
`
`
`
`
`Case IPR2015-00780
`Patent No. 7,670,358
`
`
`PATENT OWNER’S OBJECTIONS TO PETITIONER’S EVIDENCE
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b), Patent Owner objects as follows to the
`
`admissibility of evidence served with Petitioner’s Petition for Inter Partes Review
`
`of U.S. Patent No. 7,760,358 filed February 20, 2015.
`
`Evidence
`
`Objection
`
`MSD 1001 – Declaration of
`Lawrence G. Lenke, M.D.
`Regarding U.S. Patent No.
`7,670,358
`
`FRE 402: The declaration of Dr. Lenke is not
`relevant to any statutory ground upon which trial
`was instituted at least because Dr. Lenke’s
`testimony relies on: the “Video” (MSD 1002) (e.g.,
`¶¶ 35-39), the “Slides” (MSD 1003) (e.g., ¶¶ 40-
`43), and the comparison of the materials considered
`to the claimed invention (e.g., ¶¶ 75-104) are based
`at least in part on materials that are not a patent or
`printed publication as required by 35 U.S.C. §
`311(b).
`
`FRE 403: The declaration of Dr. Lenke includes
`information whose probative value to any ground
`upon which trial was instituted is substantially
`outweighed by the danger of unfair prejudice,
`confusing the issues, undue delay, wasting time, or
`needlessly presenting cumulative evidence. For
`example, Dr. Lenke’s testimony relies on: the
`“Video” (MSD 1002) (e.g., ¶¶ 35-39), the “Slides”
`(MSD 1003) (e.g., ¶¶ 40-43), and the comparison
`of the materials considered to the claimed invention
`(e.g., ¶¶ 75-104) are based at least in part on
`materials that are not a patent or printed publication
`as required by 35 U.S.C. § 311(b).
`
`FRE 702: Dr. Lenke’s declaration is improper
`expert testimony at least because Dr. Lenke’s
`testimony on: the “Video” (MSD 1002) (e.g., ¶¶
`35-39), the “Slides” (MSD 1003) (e.g., ¶¶ 40-43),
`and the comparison of the materials considered to
`
`
`
`
`-1-
`
`
`
`
`
`MSD 1002 – Thoracic
`Pedicle Screws for
`Idiopathic Scoliosis Video
`(2001)
`
`
`
`
`the claimed invention (e.g., ¶¶ 75-104) are based at
`least in part on materials that are not a patent or
`printed publication as required by 35 U.S.C. §
`311(b). Further, Dr. Lenke’s testimony that certain
`practices or technology were merely conventional,
`well-known, or routine is based on insufficient
`facts or data, and is not the product of reliable
`principles and methods reliably applied by Dr.
`Lenke.
`
`FRE 703: Dr. Lenke’s declaration is improper
`expert testimony at least because Dr. Lenke’s
`testimony on: the “Video” (MSD 1002) (e.g., ¶¶
`35-39), the “Slides” (MSD 1003) (e.g., ¶¶ 40-43),
`and the comparison of the materials considered to
`the claimed invention (e.g., ¶¶ 75-104) are not
`based upon data on which experts in this field
`would reasonably rely.
`
`FRE 802: The exhibit and all appendices thereto,
`including at least ¶ 39 and Appendices A-G, are
`inadmissible hearsay if offered to prove the truth of
`any matter allegedly asserted therein.
`
`
`Reservation of Right to Cross-examination:
`Patent Owner reserves the right to cross-examine
`the declarant regarding any subject that is within
`the scope of his declaration testimony.
`FRE 402: The exhibit is not relevant to any ground
`upon which trial was instituted. For example, the
`exhibit is neither a patent nor a printed publication
`as required by 35 U.S.C. § 311(b) and is irrelevant
`to the grounds available for inter partes review.
`
`FRE 403: The exhibit includes information whose
`probative value to any ground upon which trial was
`instituted is substantially outweighed by the danger
`of unfair prejudice, confusing the issues, undue
`delay, wasting time, or needlessly presenting
`cumulative evidence.
`-2-
`
`
`
`
`
`MSD 1003 – Free Hand
`Thoracic Screw Placement
`and Clinical Use in
`Scoliosis and Kyphosis
`Surgery slide presentation
`handout (2003)
`
`MSD 1012 – Masters
`Techniques in Orthopaedic
`Surgery: The Spine, 2nd
`Edition, Chapter 17:
`“Posterior Spinal
`Instrumentation
`Techniques for Spinal
`Deformity”
`
`MSD 1013 – Krag et al.,
`An Internal Fixator for
`Posterior Application to
`Short Segments of the
`Thoracic, Lumbar, or
`Lumbosacral Spine,
`CLINICAL
`ORTHOPAEDICS AND
`
`
`
`
`FRE 802: The exhibit is inadmissible hearsay if
`offered to prove the truth of any matter allegedly
`asserted therein.
`FRE 402: The exhibit is not relevant to any ground
`upon which trial was instituted. For example, the
`exhibit is neither a patent nor a printed publication
`as required by 35 U.S.C. § 311(b) and is irrelevant
`to the grounds available for inter partes review.
`
`FRE 403: The exhibit includes information whose
`probative value to any ground upon which trial was
`instituted is substantially outweighed by the danger
`of unfair prejudice, confusing the issues, undue
`delay, wasting time, or needlessly presenting
`cumulative evidence.
`
`FRE 802: The exhibit is inadmissible hearsay if
`offered to prove the truth of any matter allegedly
`asserted therein.
`FRE 802: The exhibit is inadmissible hearsay if
`offered to prove the truth of any matter allegedly
`asserted therein.
`
`FRE 901: The exhibit is inadmissible because
`Petitioner has not submitted evidence sufficient to
`support a finding that the item is what Petitioner
`claims it is.
`
`FRE 1002 / 1006: The exhibit is inadmissible
`because Petitioner has not submitted a complete
`copy of the original document.
`FRE 403: The exhibit includes information whose
`probative value to any ground upon which trial was
`instituted is substantially outweighed by the danger
`of unfair prejudice, confusing the issues, undue
`delay, wasting time, or needlessly presenting
`cumulative evidence.
`
`FRE 802: The exhibit is inadmissible hearsay if
`-3-
`
`
`
`
`
`RELATED RESEARCH,
`203: 75-98 (February 1986)
`
`MSD 1014 – W. Dick, The
`"fixateur interne" As a
`Versatile Implant for Spine
`Surgery, SPINE 12:882-
`900, 1987;
`
`MSD 1015 – Olerud et al.,
`Transpedicular Fixation of
`Thoracolumbar Vertebral
`Fractures, CLINICAL
`ORTHOPAEDICS AND
`RELATED RESEARCH
`227:44-51, 1988
`
`
`
`
`offered to prove the truth of any matter allegedly
`asserted therein.
`
`FRE 901: The exhibit is inadmissible because
`Petitioner has not submitted evidence sufficient to
`support a finding that the item is what Petitioner
`claims it is.
`
`FRE 1002 / 1006: The exhibit is inadmissible
`because Petitioner has not submitted a complete
`copy of the original document.
`FRE 403: The exhibit includes information whose
`probative value to any ground upon which trial was
`instituted is substantially outweighed by the danger
`of unfair prejudice, confusing the issues, undue
`delay, wasting time, or needlessly presenting
`cumulative evidence.
`
`FRE 802: The exhibit is inadmissible hearsay if
`offered to prove the truth of any matter allegedly
`asserted therein.
`
`FRE 901: The exhibit is inadmissible because
`Petitioner has not submitted evidence sufficient to
`support a finding that the item is what Petitioner
`claims it is.
`
`FRE 1002 / 1006: The exhibit is inadmissible
`because Petitioner has not submitted a complete
`copy of the original document.
`FRE 403: The exhibit includes information whose
`probative value to any ground upon which trial was
`instituted is substantially outweighed by the danger
`of unfair prejudice, confusing the issues, undue
`delay, wasting time, or needlessly presenting
`cumulative evidence.
`
`FRE 802: The exhibit is inadmissible hearsay if
`offered to prove the truth of any matter allegedly
`asserted therein.
`-4-
`
`
`
`
`
`MSD 1016 – Guyer et al.,
`The Wiltse Pedicle Screw
`Fixation System,
`ORTHOPAEDICS
`11:1455- 1460, 1988.
`
`MSD 1023 – Declaration of
`David Poley
`
`
`
`
`
`FRE 901: The exhibit is inadmissible because
`Petitioner has not submitted evidence sufficient to
`support a finding that the item is what Petitioner
`claims it is.
`
`FRE 1002 / 1006: The exhibit is inadmissible
`because Petitioner has not submitted a complete
`copy of the original document.
`FRE 403: The exhibit includes information whose
`probative value to any ground upon which trial was
`instituted is substantially outweighed by the danger
`of unfair prejudice, confusing the issues, undue
`delay, wasting time, or needlessly presenting
`cumulative evidence.
`
`FRE 802: The exhibit is inadmissible hearsay if
`offered to prove the truth of any matter allegedly
`asserted therein.
`
`FRE 901: The exhibit is inadmissible because
`Petitioner has not submitted evidence sufficient to
`support a finding that the item is what Petitioner
`claims it is.
`
`FRE 1002 / 1006: The exhibit is inadmissible
`because Petitioner has not submitted a complete
`copy of the original document.
`FRE 402: The declaration of Mr. Poley is not
`relevant to any statutory ground upon which trial
`was instituted at least because the “Video” (MSD
`1002), as testified to by Mr. Poley (e.g., ¶¶ 2-3), is
`not a patent or printed publication as required by 35
`U.S.C. § 311(b).
`
`FRE 403: The declaration of Mr. Poley includes
`information whose probative value to any ground
`upon which trial was instituted is substantially
`outweighed by the danger of unfair prejudice,
`confusing the issues, undue delay, wasting time, or
`-5-
`
`
`
`
`
`MSD 1024 – Declaration of
`Ashley Owens
`
`
`
`
`needlessly presenting cumulative evidence. For
`example, the “Video” (MSD 1002), as testified to
`by Mr. Poley (e.g., ¶¶ 2-3), is not a patent or
`printed publication as required by 35 U.S.C. §
`311(b).
`
`FRE 802: The exhibit and all appendices thereto,
`including at least Appendices A-B, are
`inadmissible hearsay if offered to prove the truth of
`any matter allegedly asserted therein.
`
`FRE 901: The exhibit is inadmissible because
`Petitioner has not submitted evidence sufficient to
`support a finding that the item is what Petitioner
`claims it is.
`
`FRE 1002 / 1006: The exhibit and the appendices
`thereto are inadmissible because Petitioner has not
`submitted a complete copy of the original
`document, including at least Exhibit A.
`
`Reservation of Right to Cross-examination:
`Patent Owner reserves the right to cross-examine
`the declarant regarding any subject that is within
`the scope of his declaration testimony.
`FRE 402: The declaration of Ms. Owens is not
`relevant to any statutory ground upon which trial
`was instituted at least because the “Video” (MSD
`1002) and “Slides” (MSD 1003), as testified to by
`Ms. Owens(e.g., ¶¶ 2-7), are not a patent or printed
`publication as required by 35 U.S.C. § 311(b).
`
`FRE 403: The declaration of Ms. Owens includes
`information whose probative value to any ground
`upon which trial was instituted is substantially
`outweighed by the danger of unfair prejudice,
`confusing the issues, undue delay, wasting time, or
`needlessly presenting cumulative evidence. For
`example, the “Video” (MSD 1002) and “Slides”
`(MSD 1003), as testified to by Ms. Owens(e.g., ¶¶
`-6-
`
`
`
`
`
`MSD 1025 – Transcript of
`Thoracic Pedicle Screws
`for Idiopathic Scoliosis
`Video (2001)
`
`
`
`
`2-7), are not a patent or printed publication as
`required by 35 U.S.C. § 311(b).
`
`FRE 802: The exhibit and all appendices thereto,
`including at least Appendices A-J, are inadmissible
`hearsay if offered to prove the truth of any matter
`allegedly asserted therein.
`
`FRE 901: The exhibit is inadmissible because
`Petitioner has not submitted evidence sufficient to
`support a finding that the item is what Petitioner
`claims it is.
`
`FRE 1002 / 1006: The exhibit and the appendices
`thereto are inadmissible because Petitioner has not
`submitted a complete copy of the original
`document, including at least Exhibits A-E.
`
`Reservation of Right to Cross-examination:
`Patent Owner reserves the right to cross-examine
`the declarant regarding any subject that is within
`the scope of his declaration testimony.
`FRE 402: The exhibit is not relevant to any ground
`upon which trial was instituted. For example,
`Petitioner has not cited to this exhibit in its
`Petition.
`
`FRE 403: The exhibit includes information whose
`probative value to any ground upon which trial was
`instituted is substantially outweighed by the danger
`of unfair prejudice, confusing the issues, undue
`delay, wasting time, or needlessly presenting
`cumulative evidence.
`
`FRE 802: The exhibit is inadmissible hearsay if
`offered to prove the truth of any matter allegedly
`asserted therein.
`
`FRE 901: The exhibit is inadmissible because
`Petitioner has not submitted evidence sufficient to
`-7-
`
`
`
`support a finding that the item is what Petitioner
`claims it is.
`FRE 802: The exhibit, including at least ¶ 4, is
`inadmissible hearsay if offered to prove the truth of
`any matter allegedly asserted therein.
`
`
`
`FRE 402: The exhibit is not relevant to any ground
`upon which trial was instituted. For example, the
`claim construction standard used in U.S. District
`Court is narrower than the broadest reasonable
`construction employed by the Board and is not
`relevant to the proper construction of claims in this
`proceeding.
`
`FRE 403: The exhibit includes information whose
`probative value to any ground upon which trial was
`instituted is substantially outweighed by the danger
`of unfair prejudice, confusing the issues, undue
`delay, wasting time, or needlessly presenting
`cumulative evidence.
`FRE 402: The exhibit is not relevant to any ground
`upon which trial was instituted. For example, the
`claim construction standard used in U.S. District
`Court is narrower than the broadest reasonable
`construction employed by the Board and is not
`relevant to the proper construction of claims in this
`proceeding.
`
`FRE 403: The exhibit includes information whose
`probative value to any ground upon which trial was
`instituted is substantially outweighed by the danger
`of unfair prejudice, confusing the issues, undue
`delay, wasting time, or needlessly presenting
`cumulative evidence.
`FRE 402: The exhibit is not relevant to any ground
`upon which trial was instituted. For example,
`Petitioner has not cited to this exhibit in its
`Petition.
`
`
`-8-
`
`
`
`MSD 1026 – Declaration of
`Seth A. Kramer
`
`MSD 1029 – Stryker Corp.
`v. Zimmer, Inc., 774 F.3d
`1349 (Fed. Cir. 2014)
`
`MSD 1030 – NuVasive
`Inc. v. Globus Med., Inc.,
`2013 WL 3705731 (D. Del.
`July 12, 2013)
`
`MSD 1031 – Suk, et al.,
`Direct Vertebral Rotation:
`A New Technique of
`Three-Dimensional
`Deformity Correction with
`
`
`
`
`
`
`
`Segmental Pedicle Screw
`Fixation in Adolescent
`Idiopathic Scoliosis,, 29:3
`SPINE 343 (2004)
`
`
`
`Respectfully submitted,
`
`FRE 403: The exhibit includes information whose
`probative value to any ground upon which trial was
`instituted is substantially outweighed by the danger
`of unfair prejudice, confusing the issues, undue
`delay, wasting time, or needlessly presenting
`cumulative evidence.
`
`FRE 802: The exhibit is inadmissible hearsay if
`offered to prove the truth of any matter allegedly
`asserted therein.
`
`FRE 901: The exhibit is inadmissible because
`Petitioner has not submitted evidence sufficient to
`support a finding that the item is what Petitioner
`claims it is.
`
`
`
`By:
`John Alemanni
`Registration No. 47,384
`Lead Counsel for Patent Owner
`
`
`
`
`
`
`-9-
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that on September 23, 2015, the foregoing
`
`PATENT OWNER’S OBJECTIONS TO PETITIONER’S EVIDENCE was
`
`served via electronic mail, upon the following:
`
`
`
`By:
`John Alemanni
`Registration No. 47,384
`Lead Counsel for Patent Owner
`
`-10-
`
`
`Jeff E. Schwartz
`Fox Rothschild LLP
`1030 15th Street, N.W.
`Washington, D.C. 2005
`jeschwartz@foxrothschild.com
`
`Seth A. Kramer
`Fox Rothschild LLP
`2000 Market Street, 20th Floor
`Philadelphia, PA 19103
`skramer@foxrothschild.com
`
`
`
`Dated: September 23, 2015
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