UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
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`MEDSHAPE, INC.
`Petitioner
`
`v.
`
`CAYENNE MEDICAL, INC.
`Patent Owner
`_______________
`
`Case No. Unassigned
`
`U.S. Patent 8,435,294
`
`Issue Date: May 7, 2013
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`Title: Devices, Systems and Methods for Material Fixation
`_______________
`
`
`DECLARATION OF GEOFFREY HIGGS, M.D.
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`MEDSHAPE Ex. 1004, p. 1 of 63
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`_______________
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`MEDSHAPE, INC.
`Petitioner
`
`v.
`
`CAYENNE MEDICAL, INC.
`Patent Owner
`_______________
`
`Case No. Unassigned
`
`U.S. Patent 8,435,294
`
`Issue Date: May 7, 2013
`
`Title: Devices, Systems and Methods for Material Fixation
`_______________
`
`
`DECLARATION OF GEOFFREY HIGGS, M.D.
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`MEDSHAPE Ex. 1004, p. 1 of 63
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`Patent No. 8,435,294
`Declaration of Geoffrey Higgs, M.D
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`TABLE OF CONTENTS
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`I.
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`Engagement and Compensation ....................................................................... 1
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`II. Qualifications .................................................................................................... 1
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`III. MATERIALS REVIEWED ............................................................................. 4
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`IV. Understanding of the relevant law .................................................................... 4
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`A.
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`B.
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`C.
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`Claim Construction and Relevant Timeframe...................................... 4
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`Anticipation .......................................................................................... 5
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`Obviousness .......................................................................................... 6
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`V. Level of ordinary skill in the art ....................................................................... 9
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`VI. Technical Introduction ....................................................................................10
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`D.
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`Background ........................................................................................ 10
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`VII. Claim Construction .........................................................................................11
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`VIII. Claim ANALYSIS in view of prior art ..........................................................11
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`A. Analysis of EP 1066 805 A2 .............................................................. 11
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`B.
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`C.
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`Analysis of U.S. Patent No. 6,887,271 to Justin ................................ 24
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`Analysis of WO 02/32345 .................................................................. 34
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`D. Analysis of WO ‘345 in View of Either EP ‘805 or Justin ‘271 ....... 40
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`IX. Oath.................................................................................................................43
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`i
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`Patent No. 8,435,294
`Declaration of Geoffrey Higgs, M.D.
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`I, Geoffrey Higgs, M.D. hereby declare as follows:
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`I.
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`ENGAGEMENT AND COMPENSATION
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`1.
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`I have been retained by MedShape, Inc. to serve as an expert in
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`the inter partes review proceeding identified above. For this service, I am being
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`paid an hourly consulting fee of $500/hour.
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` QUALIFICATIONS
`II.
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`2.
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`3.
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`A copy of my CV is attached as Exhibit A.
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`I received a Bachelor of Science in Systems Engineering from
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`the University of Virginia (1983) and a Doctorate of Medicine (M.D.) degree from
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`Columbia University (1988).
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`4.
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`I completed my residency and internship at Columbia, and
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`earned a fellowship in Orthopaedic Sports Medicine/Shoulder Surgery at
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`Harvard/Massachusetts General Hospital. I received another fellowship in
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`Orthopaedic Surgery Research at University of California San Diego.
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`5.
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`I have extensive background in sports medicine, shoulder
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`surgery and knee surgery. I am Fellowship Trained and Subspeciality Certified in
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`Orthopaedic Sports Medicine by the American Board of Orthopaedic Surgery.
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`6.
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`I served my active duty obligation for a medical school
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`academic scholarship as a Major in the U.S. Army. I served in Seoul, South Korea
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`as the Assistance Chief and Acting Chief of Orthopaedic Surgery at the U.S. Army
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`121 General Hospital; Attending Orthopaedic Surgeon and Assistant Chief of
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`Orthopaedic Surgery at the U.S. Army Hospital in Heidelberg, Germany; and
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`served as The Chief of Orthopaedic Surgery at the 67th U.S. Army Combat
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`Support Hospital (Deployed) in Taszar, Hungary during the Bosnian war.
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`7.
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`I am a subspecialist in the treatment of injuries sustained during
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`athletic activities. Areas of expertise include: complex shoulder reconstruction for
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`rotator cuff surgery, shoulder instability, acute traumatic shoulder injury and
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`shoulder arthritis, knee ligament reconstruction, knee cartilage restoration, knee
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`arthritis in the young adult, traumatic knee injuries, acute treatment of sports
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`medicine injuries and advanced arthroscopic techniques.
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`8.
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`I have served as Team Physician for Harvard University
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`Athletic Teams, the New England Patriots Professional Football Team, the Boston
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`Bruins Professional Hockey Team, and the New England Revolution Professional
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`Soccer Team. During my residency at Columbia University, I served as Chief of
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`Physicians for Yankee Stadium and Madison Square Garden, home to the New
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`York Yankees (MLB), New York Knicks (NBA) and the New York Rangers
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`(NHL).
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`9.
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`Currently, I am Clinical Assistant Professor of Orthopaedic
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`Surgery at the Medical College of Virginia. I am the Chief Team Physician for the
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`Richmond Raiders Professional Arena Football Team, and have been the Chief
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`Team Physician for each Professional Arena Football Team in Richmond including
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`The Richmond Revolution, The Richmond Bandits, and The Richmond Speed.
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`10.
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`I have widely published in medical literature and have lectured
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`at numerous national and international meetings. I am the recipient of the Frank E.
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`Stinchfield Award for Excellence in Orthopaedic Surgery, The Orren D. Baab
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`Award for Excellent in Orthopaedic Surgery, the Columbia University-Residence
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`Clinical Research Award/Grant, and the Pediatric Orthopaedic Society of New
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`York’s Best Resident Research Award. While serving in the army, I received the
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`Meritorious Service Medal and the Army Commendation Medal, and twice
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`received the Overseas Service Medal, among others.
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`11. During the course of my medical practice, I have utilized
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`numerous medical devices designed to assist in the attachment of soft tissue, such
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`as ligaments and cartilage, bone. I have been practicing Orthopaedic Surgery with
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`a subspecialty focus in Sports Medicine for 25 years and have been doing
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`Biomechanical and Biomaterial research throughout that time frame. I perform
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`approximately 500 tendon repairs and ligament reconstructions per year. I have
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`utilized a variety of fixation methods for ligament reconstruction during this past
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`25 years including: interference fixation, suspensory fixation, press fit fixation and
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`virtually all commercially available products that offer adequate fixation of the
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`ligament graft material. I am thoroughly familiar with all Ligament reconstruction
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`products that have been on the market since ligament reconstruction first
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`evolved. I am also thoroughly familiar with the scientific literature related to both
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`the methodologies of ligament reconstruction as well as the various fixation
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`devices and methods.
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` MATERIALS REVIEWED
`III.
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`12. For this declaration I have reviewed and am familiar with U.S.
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`Patent No. 8,435,294.
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`13.
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`I have also reviewed and am familiar with the following prior
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`art documents: U.S. Patent No. 6,887,271; EP 1 066 805 A2; and WO 02/32345
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`A3.
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` UNDERSTANDING OF THE RELEVANT LAW
`IV.
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`A. Claim Construction and Relevant Timeframe
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`14.
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`I understand that a claim term in an inter partes review is to be
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`given its broadest reasonable construction in light of the specification of the patent
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`in which it appears. I understand that the specification may expressly define a term
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`in the claims. If no such definition is present, however, I understand that the
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`broadest reasonable interpretation that a person of ordinary skill in the relevant
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`timeframe would have applied controls the construction.
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`15.
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`I will assume for the purpose of this report that November 18,
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`2004, the date of the earliest application to which the ‘294 patent is entitled to
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`claim priority, is the earliest date the purported invention was made, and that the
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`relevant time period extends through the filing date of the ‘294 patent. (Ex. 1001).
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`I may refer to this time period as the “relevant time frame,” and my testimony is
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`directed to this timeframe, even if I occasionally do not explicitly use a past tense.
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`To the extent that there is a relevant event or difference within this relevant time
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`frame, I will specify that where appropriate.
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`B. Anticipation
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`16.
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`I understand that a claim in an issued patent can be invalid if it
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`is anticipated. In this case, “anticipation” means that there is a single prior art
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`reference that discloses every element of the claim, arranged in the way required
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`by the claim.
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`17.
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`I understand that an anticipating prior art reference must
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`disclose each of the claim elements expressly or inherently. I understand that
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`“inherent” disclosure means that the claim element, although not expressly
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`described by the prior art reference, must necessarily be present based on the
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`disclosure. I understand that a mere probability that the element is present is not
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`sufficient to qualify as “inherent disclosure.”
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`C. Obviousness
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`18.
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`I understand that a claim in an issued patent can be invalid if it
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`is obvious. Unlike anticipation, obviousness does not require that every element of
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`the claim be in a single prior art reference. Instead, it is possible for claim elements
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`to be described in different prior art references, so long as there is motivation or
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`sufficient reasoning to combine the references.
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`19.
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`I understand that a claim is invalid for obviousness if the
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`differences between the claimed subject matter and the prior art are such that the
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`subject matter as a whole would have been obvious at the time the alleged
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`invention was made to a person having ordinary skill in the art to which said
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`subject matter pertains.
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`20.
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`I understand, therefore, that when evaluating obviousness, one
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`must consider obviousness of the claim “as a whole.” This consideration must be
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`from the perspective of the person of ordinary skill in the relevant art, and that
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`such perspective must be considered as of the “time the invention was made.”
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`21.
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`I understand that in considering the obviousness of a claim, one
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`must consider four things. These include the scope and content of the prior art, the
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`level of ordinary skill in the art at the relevant time, the differences between the
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`prior art and the claim, and any “secondary considerations.”
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`22.
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`I understand that “secondary considerations” include real-world
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`evidence that can tend to make a conclusion of obviousness more probable or less
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`probable. For example, the commercial success of a product embodying a claim of
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`the patent could provide evidence tending to show that the claimed invention is not
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`obvious. In order to understand the strength of the evidence, one would want to
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`know whether the commercial success is traceable to a certain aspect of the claim
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`not disclosed in a single prior art reference (i.e., whether there is a causal “nexus”
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`to the claim language).
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`23. One would also want to know how the market reacted to
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`disclosure of the invention, and whether commercial success might be traceable to
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`things other than innovation, for example the market power of the seller, an
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`advertising campaign, or the existence of a complex system having many features
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`beyond the claims that might be desirable to a consumer. One would also want to
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`know how the product compared to similar products not embodying the claim. I
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`understand that commercial success evidence should be reasonably commensurate
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`with the scope of the claim, but that it is not necessary for a commercial product to
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`embody the full scope of the claim.
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`24. Other kinds of secondary considerations are possible. For
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`example, evidence that the relevant field had a long-established, unsolved problem
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`or need that was later provided by the claimed invention could be indicative of
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`non-obviousness. Evidence that others had tried, but failed to make an aspect of
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`the claim might indicate that the art lacked the requisite skill to do so. Evidence of
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`copying of the patent owner’s products might also indicate that its approach to
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`solving a particular problem was not obvious. Evidence that the art recognized the
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`value of products embodying a claim, for example, by praising the named
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`inventors’ work, might tend to show that the claim was non-obvious.
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`25.
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`I further understand that prior art references can be combined
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`where there is an express or implied rationale to do so. Such a rationale might
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`include an expected advantage to be obtained, or might be implied under the
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`circumstances. For example, a claim is likely obvious if design needs or market
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`pressures existing in the prior art make it natural for one or more known
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`components to be combined, where each component continues to function in the
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`expected manner when combined (i.e., when there are no unpredictable results). A
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`claim is also likely invalid where it is the combination of a known base system
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`with a known technique that can be applied to the base system without an
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`unpredictable result. In these cases, the combination must be within the capabilities
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`of a person of ordinary skill in the art.
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`26.
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`I understand that when considering obviousness, it is not
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`appropriate to refer to teachings in the specification of the patent itself for
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`motivation to combine certain prior art. One can, however, refer to portions of the
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`specification admitted to be prior art, including the “BACKGROUND” section.
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`Furthermore, a lack of discussion in the patent specification concerning how to
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`implement a disclosed technique can support an inference that the ability to
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`implement the technique was within the ordinary skill in the prior art.
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` LEVEL OF ORDINARY SKILL IN THE ART
`V.
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`27.
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`I have considered what the level of ordinary skill in the art of
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`the ‘294 patent was in the relevant timeframe. In considering the level of ordinary
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`skill, I have taken into account the levels of education and experience of persons
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`working in the field, the types of problems encountered in the field; and the
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`sophistication of the technology. I understand that a person of ordinary skill in the
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`art is a hypothetical person that is deemed to be aware of the content of all
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`analogous technical literature.
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`28.
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`In the relevant timeframe, one of ordinary skill in the art of the
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`patent in my opinion would be a person with a Bachelor of Science degree in
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`mechanical engineering with at least two years of practical or post-graduate work
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`in the area of medical devices, or a person having graduated with a medical degree
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`from an accredited medical school with experience in using anchor devices for
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`attaching soft tissue to bone.
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` TECHNICAL INTRODUCTION
`VI.
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`D. Background
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`29. This inter partes review relates to medical devices used to
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`assist in surgically attaching soft tissue, such as tendons or cartilage, to bone. Such
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`devices have been well known for many years and generally include utilizing a
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`medical device that engages bone so as to anchor the implant while also holding
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`the soft tissue in place adjacent to the bone to facilitate attachment and healing.
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`30. During the course of my career, I have utilized many such
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`devices. I have utilized a variety of fixation methods for ligament reconstruction
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`during this past 25 years including: interference fixation, suspensory fixation, press
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`fit fixation and virtually all commercially available products that offer adequate
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`fixation of the ligament graft material. I am thoroughly familiar with all Ligament
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`reconstruction products that have been on the market since ligament reconstruction
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`first evolved.
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` CLAIM CONSTRUCTION
`VII.
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`31.
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`I have reviewed the claim constructions applied in the Petitions
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`for inter partes review that this Declaration supports, and I find that the
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`construction would have been reasonable and appropriate for understanding of a
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`person of ordinary skill in the art in the relevant timeframe. I have applied these
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`claim constructions in my analysis in this Declaration.
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` CLAIM ANALYSIS IN VIEW OF PRIOR ART
`VIII.
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`A. Analysis of EP 1066 805 A2
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`32. EP 1 066 805 A2 to Gerke et al. (“EP ‘805”) includes each of
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`the elements in Claims 6-11, 13 and 16-18 and, therefore, those claims are invalid.
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`Claim 6
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`33. Claim 6 is directed to a material fixation system, comprising an
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`implant which is placeable in a space defined by bone. The implant includes a
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`body having a longitudinal axis, a distal end and a proximal end.
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`34. EP ‘805 discloses an implantable bone anchor 2, 76 insertable
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`into a bore hole 70 formed in the bone for attaching a ligament or tendon secured
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`thereto. Fig. 3 (shown annotated above); Col. 2, lines 19-24; Col. 9, lines 9-14.
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`35. The EP ‘805 discloses that the anchor 2 has a longitudinal axis
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`with a proximal end 6 and a distal end 4 as shown in Fig. 1(c) (shown annotated
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`below); Col. 7, lines 14-17.
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`36. Claim 6 further includes a first member on the body which is
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`moveably expandable outwardly.
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`37. This element is found in EP ‘805. With reference to the
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`annotated Fig. 1(c) above, EP ‘805 discloses that the anchor includes a plurality of
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`legs 20, 22, 24 and 26 joined at the distal end 4. Col. 7, lines 11-13. The legs have
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`a portion extending from the proximal end, e.g., 14b, up into a medially disposed
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`notch as shown in Fig. 1(c). This portion of the anchor body forms a first member.
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`The first member is capable of being moved in an outward direction away from the
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`longitudinal axis of the body. See Col. 8, lines 10-12 “this causes the legs 20-26 to
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`splay outwardly. . . ;” Col. 9, lines 27-32 “to cause the proximal end 78 of the bone
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`anchor 76 to expand radially”.
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`38. Claim 6 further recites a second member on the body which is
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`disposed axially from the first member.
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`39. With further reference to the annotated Fig. 1(c) above, EP ‘805
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`discloses a second member including the portion of the legs 20-26 between the
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`medially disposed notch and a distally located second notch formed on the legs.
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`The second member is located at a different position from the first member in a
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`direction defined by the longitudinal axis of the body. Fig. 1(c). Therefore, the
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`second member is disposed axially from the first member. The second member is
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`a separate and distinct portion of the anchor.
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`40. Claim 6 further defines that the second member is moveable
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`expandable outwardly. In EP ‘805, during securement of the bone anchor, the
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`entire portion of the legs would expand outwardly, especially upon insertion of a
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`peg 50. See Col. 4, lines 44-47; Col. 6, lines 21-30; Col. 8, lines 7-18 and Col. 9,
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`lines 27-32. The peg 50 expands the legs outwardly to help retain the anchor
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`within the bone and to keep tension on the soft tissue.
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`41. Claim 6 further requires that the second member is of
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`substantially different construction than the first member.
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`42.
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`In EP ‘805, the proximal portion of the leg which constitutes
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`the first member has a significantly different size and shape than the second
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`member. This is clearly shown in Figs. 1(c)-(f). Specifically, the first member
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`includes a thickened portion 32 and bottom surface 14 which is urged against the
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`inside surface of cortical bone. Fig. 1(d) and Col. 8, lines 11-15. Such a thickened
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`portion is not found on the second member. The first member also has a bottom
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`surface 14 not found in the second member.
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`43. As recited in claim 6, EP ‘805 also discloses a distal end of the
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`body comprising a space for receiving soft tissue therethrough.
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`44. The ‘805 reference includes an empty space, or recess, defined
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`by a portion of the distal end through which soft tissue can be received. See Col. 3,
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`lines 53-57; and Col. 7, lines 38-41. This is shown in Figs. 1(a), 1(c) and 3. Col.
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`7, lines 52-56 states that “due to the shape of the bone anchor, described, two
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`constructive ligaments or tendons may be located crosswise over the distal end 4 of
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`the bone anchor.
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`45. Claim 6 further requires that the space is defined by surfaces of
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`said body which are oriented both generally parallel to the longitudinal axis and
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`generally transverse to the longitudinal axis.
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`46. This claimed feature is shown in EP’ 805 Figs. 1(a) and 1(d)
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`(annotated Figs. of which are set forth above.) The upper end of the walls that
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`form the recess space are generally parallel to the longitudinal axis of the anchor as
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`shown in Fig. 1(d). The top ends of the walls are transverse to the longitudinal
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`axis as shown in Fig. 1(a).
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`47. Claim 6 still further requires a deployment device which is
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`moveable in a generally axially direction to deploy at least one of the first and
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`second members.
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`48. As set forth in EP ‘805, Col. 8, lines 30-34, peg 50 is received
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`within a peg receiving cavity 10. In Col. 8, lines 28-49, the reference discloses that
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`the axially inserting the peg 50 in to the peg receiving cavity 10 forces the legs
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`outwardly to the radially extent to which they are designed. See, also, Col. 8 lines
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`7-18 and Col. 9, lines 27-32. Accordingly, the peg is a deployment device which
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`moves both of the first and second members away from the longitudinal axis of the
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`body.
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`Claim 7
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`49. Therefore, all of the elements of claim 6 are found in EP ‘805.
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`50. Claim 7 adds that the second member is disposed distally of the
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`first member. This feature is clearly shown in EP ‘805 Figs. 1(c) and Fig. 3. The
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`portion of the leg constituting the second member is located closer to the distal end
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`than the first member.
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`Claim 8
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`51. Claim 8 adds that the second member is proximal to the distal
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`end. EP ‘805 in Figs. 1(c) and 3 discloses that the second member is proximal to
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`the second end.
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`Claim 8
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`52. Claim 9 adds that the first member comprises an arm which is
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`pivotable outwardly, the arm having a portion which is adapted to engage bone to
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`anchor the body to the bone.
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`53.
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`In EP ‘805, the first member extends outwardly and has an
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`unsupported terminal end, thereby forming an arm. The proximal end pivots
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`outwardly to engage bone as set forth, for example, in EP ‘805 Col. 8, lines 10-15
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`and 46-49; and Col. 9, lines 27-32.
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`Claim 10
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`54. Claim 10 adds that a distal end of the arm is attached to the
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`body, and comprises the pivoting end, and a proximal end of the arm pivots
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`outwardly and comprises the portion which is adapted to engage bone.
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`
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`55.
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`In EP ‘805, the arm is pivotable outwardly especially upon
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`insertion of the peg 50. The distal end of the arm is attached to the anchor body.
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`The proximal end of the arm includes outwardly thickened portions 32 that engage
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`the bone. Fig. 3; Col. 5, lines 1-5; Col. 8, lines 10-15.
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`
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`- 18 -
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`MEDSHAPE Ex. 1004, p. 20 of 63
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`Patent No. 8,435,294
`Declaration of Geoffrey Higgs, M.D
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`Claim 11
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`56. Claim 11 adds that the first member comprises a plurality of
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`arms. In EP ‘805, the anchor 2 includes plurality of legs 20, 22, 24 and 6. Each
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`leg includes a proximal portion forming a first member. Fig. 1(c); Col. 8 lines 10-
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`12. Each first member is in the form of an arm. Therefore, EP ‘805 discloses a
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`plurality of first arms.
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`Claim 13
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`57. Claim 13 adds that the deployment device deploys both the first
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`and second members.
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`58.
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`In EP ‘805, the peg 50, also referred to as a wedge means or
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`expansion tool, is axially inserted into peg receiving cavity 10, the legs which
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`include the first and second members are pivoted outwardly. Col. 6, lines 22-30;
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`Fig. 3; Col. 8, lines 7-11 and 34-49.
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`Claim 16
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`59. Claim 16 relates to a method of anchoring soft tissue to bone,
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`comprising placing the soft tissue on an implant having a longitudinal axis
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`extending from a distal end of the implant to a proximal end of the implant, and
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`disposing the implant within a space at a desired location within a portion of bone.
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`- 19 -
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`MEDSHAPE Ex. 1004, p. 21 of 63
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`Patent No. 8,435,294
`Declaration of Geoffrey Higgs, M.D
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`60. EP ‘805 is directed to a bone anchor insertable into a bore hole
`
`
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`formed in the bone for attaching a ligament or tendon secure thereto. EP ‘805
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`explicitly discloses a material fixation system comprising bone anchor 2, 76 which
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`is placeable in a hole 70 formed in a bone. Fig. 3; Col. 2, lines 19-26; Col. 7, lines
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`15-18; Col. 9, lines 9-14.
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`61. The bone anchor has a longitudinal axis as shown in Figs. 1(c)
`
`and 3 with a distal end 4 and a proximal end 6. Col. 7, lines 15-18. Soft tissue
`
`such as ligaments or tendons may be positioned cross wise over the distal end of
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`the anchor as described in EP ‘805 Col. 7, lines 52-56.
`
`62. EP ‘805 discloses that the anchor is placed within a bore hole
`
`formed in the bone and mounted on the inside surface of the cortical bone. Col. 6
`
`lines 2-6, Fig. 3.
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`
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`- 20 -
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`MEDSHAPE Ex. 1004, p. 22 of 63
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`
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`Patent No. 8,435,294
`Declaration of Geoffrey Higgs, M.D
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`
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`63. Claim 16 further defines deploying a first member on the
`
`implant outwardly to engage adjacent bone.
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`64. With reference to annotated Fig. 1(c) above, the EP ‘805 anchor
`
`includes a first member including the bottom of legs 20-26 including the thickened
`
`radially outermost portion 32 and bottom surface 14, up to medially disposed
`
`notch. Figs. 1(c), annotated above, and 1(d). EP ‘805 discloses that the legs 20,
`
`22, 24, and -26, which include the first member are splayed outwardly away from
`
`the longitudinal axis to urge the legs into firm engagement against the bone at a
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`first axial location. It also causes the bottom surface of the first member to come
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`
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`- 21 -
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`MEDSHAPE Ex. 1004, p. 23 of 63
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`
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`Patent No. 8,435,294
`Declaration of Geoffrey Higgs, M.D
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`
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`into “the plane of the inside surface of the cortical bone providing a flat base for
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`anchoring against the bone.” Fig. 3; Col. 8, lines 10-18; Col.. 9, lines 30-32.
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`65. The claim also defines the step of deploying a second member,
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`disposed on the implant in axially spaced relationship from the first member,
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`outwardly to engage adjacent bone, wherein the outward deployment of one of the
`
`first and second members compresses the soft tissue between the one of the first
`
`and second members and adjacent bone.
`
`66. With further reference to the annotated Fig. 1(c) above, EP ‘805
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`discloses a second member including the portion of the legs 20-26 between the
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`medially disposed notch and a distally located second notch formed on the
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`legs. The second member is located at a different position from the first member
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`in a direction defined by the longitudinal axis of the body. Fig. 1(c). Therefore,
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`the second member is disposed axially from the first member. The second member
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`is a separate and distinct portion of the anchor.
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`67. The second member is deployed outwardly away from the
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`longitudinal axis of the anchor when the peg 50 is inserted in the peg receiving
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`cavity 10. Col. 6, lines 22-30; Fig. 3; Col. 8, lines 7-11; and Col. 8 lines 34-49.
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`The outermost surface of the second member will engage adjacent bone at an axial
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`- 22 -
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`MEDSHAPE Ex. 1004, p. 24 of 63
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`Patent No. 8,435,294
`Declaration of Geoffrey Higgs, M.D
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`location different from the first axial location contacted by the first portion. Fig. 3;
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`Col. 8, lines 7-11.
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`68. EP ‘805 discloses that it as advantageous to use the anchor to
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`compress the soft tissue and the bone. The references discloses that tendon profile
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`40 may be urged radially outwardly into the bore hole and cortical bone at the
`
`outlet causing a greater likelihood of graft fixation. Col. 4, lines 44-47, and Col. 8,
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`lines 19- 27 and 30-34.
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`69. Therefore, all of the elements of claim 16 are found in EP ‘805.
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`Claim 17
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`70. Claim 17 recites that each of the deploying steps are performed
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`by moving a deployment device in a generally axial direction.
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`71. EP ‘805 discloses using a peg 50 which widens as it extends
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`from the distal to proximal end as shown in Fig. 2(a). The peg is insertable into a
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`cavity 10 which extends along the longitudinal axis of the anchor. Insertion of the
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`peg into the cavity along the axial direction causes the first and second members to
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`move outwardly away from the longitudinal axis of the anchor. The peg forces the
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`legs including the first and second members outwardly to the radial extent to which
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`they were designed. Col. 8, lines 47-49.
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`- 23 -
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`MEDSHAPE Ex. 1004, p. 25 of 63
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`
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`Patent No. 8,435,294
`Declaration of Geoffrey Higgs, M.D
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`Claim 18
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`72. Claim 18 defines that the second member is disposed distally of
`
`the first member. In EP ‘805, the second member is disposed closer to the distal
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`end than the first member, as shown in Fig. 1(c).
`
`73.
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`In my opinion, each of the elements defined in Claims 6-11, 13
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`and 16-18 of the ‘294 patent are found in EP ‘805.
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`B. Analysis of U.S. Patent No. 6,887,271 to Justin
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`U.S. Patent No. 6,887,271 (“Justin ‘271”) discloses each of the elements in
`
`Claims 6-11, 13 and 16-18 of the ‘294 patent.
`
`Claim 6
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`- 24 -
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`MEDSHAPE Ex. 1004, p. 26 of 63
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`Patent No. 8,435,294
`Declaration of Geoffrey Higgs, M.D
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`74. Claim 6 is directed to a material fixation system having a body,
`
`
`
`and a first and second members. Justin ‘271 discloses a fixation member 20 which
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`is inserted within a patient’s body in a space defined by bone as set forth in Col. 2,
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`lines 24-26 and Col. 3, lines 52-55. The fixation member 20 has a longitudinal axis
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`with a proximal end 110 and a distal end 112 as required by claim 6. Fig. 2; Col.
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`3, lines 56-61.
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`75. As shown in the annotated Fig. 2 above, the fixation member of
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`Justin ‘271 has a body which includes a first member thereon. Fig. 2. The first
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`member includes a proximal portion including a flat end surface and fins 11 and 12
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`located on the extremity of the fixation member. The first member is moveable
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`expandably outwardly away from the longitudinal axis of the body. Fig. 2; Col. 4,
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`lines 37-43; Col. 5, lines 1-5.
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`76. With further reference to annotated Fig. 2 shown above, the
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`first member extends axially from the flat end surface and most proximal set of
`
`fins 11/12 of the fixation member to the beginning of the second member. The
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`second member is the portion of the fixation member that begins at the second set
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`of fins 11/12 located distally from the first set o
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