`
`In re Patent of:
`
`Michelson
`
`US. Patent No.:
`Issue Date:
`Appl. Serial No.:
`Filing Date:
`Title:
`
`8,251 ,997
`August 28, 2012
`13r'306,583
`November 29, 201 1
`METHOD FOR INSERTING AN ARTIFICIAL IMPLANT BETWEEN TWO ADJACENT
`
`Attorney Docket No.: 13958-0112IP1
`
`VERTEBRAE ALONG A CORONAL PLANE
`
`DECLARATION OF DR. PAUL McAFEE M.D. M.B.A.
`
`I, Dr. Paul McAfee, MD, MBA, of Sparks Glencoe, Maryland, declare that:
`
`QUALIFICATIONS
`
`1.
`
`I am an orthopaedic surgeon board certified by the American Board of Orthopaedic
`
`Surgery and fellowship trained in spine surgery.
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`I received my medical degree from the State University of
`
`New York at Upstate Medical Center, Syracuse, NY, in 1978.
`
`I performed an internship at the Department
`
`of General Surgery, University of Virginia, Charlottesville, VA, from 1978-1979, a residency in orthopaedic
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`surgery at the State University of New York, Upstate Medical Center, Syracuse, NY, from 1979-1983, and a
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`fellowship in spinal reconstructive surgery at the Case Western Reserve University.I University Hospitals, in
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`Cleveland, OH, from 1983-1984.
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`I am currently the Chief of Spine Surgery, at Towson Orthopaedic
`
`Associates, PA, in Baltimore, MD.
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`I also currently have an academic appointment as Chief, Spinal
`
`Reconstructive Surgery, at University of Maryland St. Josephs Hospital, Towson, MD, a position I have held
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`since 1989, and as Associate Professor, Department of Orthopaedic Surgery, The Johns Hopkins Hospital
`
`and Johns Hopkins University School of Medicine, a position I have held since 1988.
`
`2.
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`With specific regards to spinal surgical procedures using a lateral approach to the spine, I
`
`have the following experience.
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`I have performed over 500 lateral approaches with discectomy, fusion, and
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`instrumentation in the thoracolumbar spine. I have published over 150 peer-reviewed publications
`
`pertaining to spinal fusion. I have over 20 patents pertaining to the subject of spinal implants. I have
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`participated in over 10 clinical studies registered with the United States Food and Drug Administration to
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`Page 1 of 41
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`NUVASIVE 1001
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`
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`investigate the clinical use of spinal implants. l have continuously maintained the clinical practice of spinal
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`surgery caring for over 1000 outpatients per year for the last 28 years.
`
`3.
`
`I am not an employee of NuVasive, lnc., but I have been a clinical and research consultant
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`working with Nuvasive over the past 10 years.
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`I am the inventor of the Porous Coated Motion (POM)
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`cervical disk replacement, and the intellectual property associated with that invention was held by a
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`company named Cervitech Inc., which was acquired by NuVasive in 2009.
`
`l have been engaged in the
`
`present matter to provide my independent analysis of the issues raised in the above-mentioned inter partes
`
`review of US. Patent No. 8,251,997 (“the ‘99? patent’).
`
`I received no compensation for this declaration
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`beyond my normal hourly compensation based on my time actually spent studying the matter, and I will not
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`receive any added compensation based on the outcome of the above-mentioned reexamination of the '99?
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`patent.
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`4.
`
`Based upon my knowledge and experience in this field, I am aware of the needs and the
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`challenges orthopaedic surgeons face in performing spinal surgical procedures.
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`I routinely perform and
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`observe these spinal surgical procedures, and I am familiar with the various types of access systems that
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`are used during spinal surgical procedures, including dilator instruments and retractor assemblies.
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`l was a
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`practicing spine surgeon prior to February 27, 1995 and I am familiar with the state of spinal surgery prior to
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`February 27, 1995.
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`I am also very familiar with what was considered acceptable in terms of lateral access
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`to the spine before and after February 27, 1995.
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`l have formulated my analysis on this matter based on
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`this personal experience and what was considered standard by one skilled in the art prior to February 27,
`
`1995.
`
`5.
`
`I am familiar with the content of the ‘99? patent, and the prosecution history of the ‘997
`
`patent. Additionally, I have reviewed the following documents: (1) U.S. Patent No. 4,545,374 to Jacobson
`
`(“Jacobson”); (2) Leu et al., “Percutaneous fusion of the lumbar spine,” SPINE: State of the Art Reviews,
`
`Vol. 6, No. 3, Sep. 1992 (“Leu”); (3) US. Patent No. 5,192,321 to Brantigan (“Brantigan”); (4) U.S. Patent
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`Page 2 of 41
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`2
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`
`
`No. 4,917,704 to Frey et al. (“Frey”); (5) US. Patent No. 5,015,247 to Michelson (Michelson '247); (6)
`
`European Patent Application No. 0 567 424 A1 to Alacreu (“Alacreu”); (7) “Baulot et al., “Spondylodese
`
`anterieure complementaire par thoracoscopie: Note technique a propos d’une observation ,” Lyon
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`Chirurgical, Vol. 90, No. 5, pp. 347-51 (1994) (“Baulot”); (8) English translation of Balout; (9) Rosenthal et
`
`al., “Removal of a protruded thoracic disc using microsurgical endoscopy,” SPINE, Vol. 19, No. 9, pp. 1087-
`
`1091 (1994) (“Rosenthal”); (10) US. Patent No. 4,573,448 to Kambin (“Kambin”); (11) Patent Cooperation
`
`Treaty (PCT) Intemational Application Publication No. WO 94728824 to Michelson (“Michelson PCT”); (12)
`
`US. Patent No. 5,772,661 to Michelson (Michelson ‘661); (13) US. Patent No. 6,241,770 to Michelson
`
`(“Michelson 770); (14) Crock, “Anterior Lumbar Interbody Fusion: Indications for its Use and Notes on the
`
`Surgical Technique,” in Clinical Orthopaedics and Related Research, No. 165, pp. 157-63, May 1982
`
`(“Crock”) (attached as Exhin A to this Declaration); (15) Affidavit of Dr. Henry Crock (attached as Exhibit B
`
`to this Declaration); (16) Ben‘y et al., “A Morphometric Study of Human Lumbar and Selected Thoracic
`
`Vertebrae,” Spine, Vol. 12, No.4, pp. 362-67, at p. 364, Table 1 (1987) (“Berry”) (attached as Exhibit C to
`
`this Declaration); (17) McAfee et al., “The value of computed tomography in thoracolumbar fractures: An
`
`analysis of one hundred consecutive cases and a new classification,” The Joumal of Bone and Joint
`
`Surgery, Vol. 65-A, No.4, pp. 461-473, April 1983 (attached as Exhibit D to this Declaration).
`
`I also have
`
`reviewed additional references cited in this Declaration but not included in the list above.
`
`6.
`
`My findings, explained below, are based on my education, experience, and background in
`
`the fields discussed above.
`
`BACKGROUND KNOWLEDGE ONE OF SKILL IN THE ART WOULD HAVE HAD PRIOR TO THE
`
`FILING OF THE ‘997 PATENT
`
`7.
`
`The ‘997 patent is entitled “method for inserting an artificial implant between two adjacent
`
`vertebrae along a coronal plane.” Specifically, the '997 patent discloses performing the method using an
`
`approach, or direction, to the spine that is generally lateral (that is, from the patient’s side) or antero-lateral
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`Page 3 of 41
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`3
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`
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`(that is, obliquely from the frontlside of the patient).
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`lot, col. 3, lines 36-37. The ’997 patent describes the
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`access tools for the surgery, or in other words, how the surgeon accesses the spine to perform the
`
`procedure, and in addition, discloses a particular procedure that is called “fusion.” I am an expert in these
`
`areas of technologies and procedures, and was an expert in these areas prior to the filing of the '99? patent
`
`on February 27, 1995.
`
`8.
`
`By way of background, the human spine (shown below) is made up of 33 vertebrae,
`
`including 24 articulating vertebrae and nine fused vertebrae of the sacrum and ooocyx. The articulating
`
`vertebrae are divided into three groups, the cervical group in the neck region (seven vertebrae), the
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`thoracic group in the middle (12 vertebrae), and the lumbar group in the lower back (five vertebrae). These
`
`articulating vertebrae articulate because they have discs positioned between adjacent vertebrae which
`
`allow the articulation. The patent claims of the ‘99? patent are directed to spinal fusion procedures in the
`
`thoracic and lumbar regions of the spine. Also as shown below, the spine is made up of an anterior (front)
`
`column, a middle column, and a posterior portion, with the spinal cord being enclosed between the latter
`
`two.
`
`In the anterior column, adjacent vertebrae are separated by an intervertebral disc. Each disc forms a
`
`joint that allows slight movement of the vertebrae, and acts as a ligament to hold the vertebrae together.
`
`The middle column is comprised by the posterior annulus fibrosis, posterior vertebral body, and posterior
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`longitudinal ligament.
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`Page 4 of 41
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`4
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`
`Bottom figure, above — McAfee et al-, “The value of computed tomography in lhoracolumbar fractures: An
`
`analysis of one hundred conseculive cases and a new classification,” The Journal of Bone and
`
`Joint Surgery, Vol. 65-A, No. 4, pp. 451—473, April 1983 (Exhibit D)
`
`Page 5 of 41
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`
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`9.
`
`Spinal fusion is a surgical procedure, believed to be first reported in 1911, that fuses two or
`
`more parts of the vertebrae together. This is done in some cases to eliminate motion in the spine to
`
`decrease or eliminate back pain created by the motion, and in other cases to correct various spinal
`
`deformities. Fusion procedures may be performed in the spine’s posterior portion or in its anterior column.
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`Fusions in the anterior column in many cases involve removing all or a portion of an intervertebral disc, and
`
`implanting a fusion implant in the disc space to cause bone growth between two adjacent vertebrae. This
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`may involve the fusion of two vertebrae across one disc space (single-level fusion), or three or more
`
`vertebrae across multiple disc spaces (multi-level fusion). A discectomy is another procedure that is
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`sometimes performed in the anterior column of the spine. This is done in some cases to remove disc
`
`material that has been expelled from a ruptured intravertebral disc, and that is impinging on a nerve. A
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`spinal fusion across a disc space also involves a discectomy, to remove a degenerated disc before
`
`implanting a fusion implant in the disc space where the removed disc had resided.
`
`10.
`
`To perform a procedure in the anterior column of the spine — whether it be a fusion
`
`procedure, a discectomy or some other procedure — the spine is surgically accessed. This may be done
`
`from many different directions, or approaches, each approach having benefits and disadvantages or
`
`challenges. As illustrated in the diagram below, the various approaches that may be taken to the anterior
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`column of the spine include posterior, postero-lateral, far or direct lateral, antero-lateral, and anterior.
`
`|n
`
`posterior or postero-lateral approaches, the patient is typically positioned on his or her stomach (prone).
`
`In
`
`anterior and antero-lateral approaches, the patient is positioned on his or her back (supine).
`
`In a direct or
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`far lateral approach, the patient is typically positioned in a so—nlled “lateral decubitus” position, which is on
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`the patient’s side. All of these approaches to the spine were known and used before the filing of the ‘99?
`
`patent.
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`Page 6 of 41
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`
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`Posterior
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`
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`§ Anterior
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`spinal column
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`Posterior
`
`Postero—Lateral
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`Direct Lateral
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`Antero—Lateral
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`Anterior
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`11.
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`The use of a direct or far lateral approach goes back at least to the early 1980’s, as the
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`approach is disclosed in a 1982 paper authored by the well-known and highly regarded spine surgeon, Dr.
`
`Henry Crock of Australia. Crock, “Anterior Lumbar lnterbody Fusion: Indications for its Use and Notes on
`
`the Surgical Technique,” in Clinical Orthopaedics and Related Research, No. 165, pp. 157-63, May 1982
`
`(attached hereto as Exhibit A); see also Affidavit of Dr. Crock (attached hereto as Exhibit B). Dr. Crock
`
`describes that when a fusion procedure is to be performed in the upper lumbar region, the patient is placed
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`in the lateral decubitus position (on the patient’s side), and the anterior column of the upper lumbar spine is
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`approached from a direct or far lateral direction.
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`lot, p. 158-59. Dr. Crock also illustrates two side-by-side
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`openings having been formed in a lateral aspect (the side) of the intervertebral disc area, and describes
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`that fusion-creating grafts in the form of cylindrical bone dowels are inserted into those laterally facing
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`openings.
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`lot, p. 160-61. Also in the early 1980’s, another publication of a direct or far lateral approach to
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`the lumbar spine was provided in US. Patent No. 4,545,374 to Jacobson (“Jacobson”). Dr. Jacobson
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`describes a less invasive “percutaneous” approach to the lumbar spine than the procedure described by Dr.
`
`Crock, but similarly Dr. Jacobson’s access technique involves placing the patient in the lateral decubitus
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`Page 7 of 41
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`7
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`
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`position and advancing instruments to the anterior column of the spine along a direct or far lateral
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`approach. See, e.g., Jacobson, col. 2, line 31; col. 5, line 6; FIG. 3 et seq. Dr. Jacobson disctoses that this
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`direct lateral access technique may be used for discectomy procedures and fusion procedures, among
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`others. See id, col. 1, line 9; col. 6, lines 9-13.
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`In the thoracic spine, direct or far lateral approaches were
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`also known and used before the February 27, 1995 filing of the '99? patent.
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`INTERPRETATIONS OF THE '997 PATENT CLAIMS AT ISSUE
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`12.
`
`I understand that, for purposes of my analysis, the terms appearing in the patent claims
`
`should be interpreted according to their “broadest reasonable construction in light of the specification of the
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`patent in which it appears.” 3? C.F.R. §42.100(b).
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`I further understand that the words of the claims should
`
`be given their plain meaning unless that meaning is inconsistent with the patent specification or the patents
`
`history of examination before the Patent Office.
`
`I also understand that the words of the claims should be
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`interpreted as they would have been interpreted by a person of skill in the art at the time of the invention
`
`was made (not today); because I do not know what the date that the invention as claimed was made by Dr.
`
`Michelson, I have used the filing date of the claimed priority patent application to the ‘99? patent as the
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`point in time for claim interpretation purposes, to the extent it matters. That date was February 27, 1995.
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`I
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`have been asked to provide my interpretation of the following terms and phrases of the ‘997 patent set forth
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`below.
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`13.
`
`Claim 1 recites a “path having an axis lying in a coronal plane passing through a lateral
`
`aspect and a medial aspect of the two adjacent vertebrae and anterior to the transverse processes” (col.
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`22, lines 60-63). First, the term “coronal plane” is illustrated in a diagram from TheFreeDictionary’s medical
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`dictionary that was provided by the patent applicant during the prosecution history, copied below:
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`Page 8 of 41
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`
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`Figme A
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`‘997 patent prosecution history, Reply to Office Action, March 20, 2012, p. 14. Claim 1 also defines that the
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`“coronal plane” must “pass|] through a lateral aspect and a medial aspect of the two adjacent vertebrae.“
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`The phrase “lateral aspect” of vertebrae generally refers to each of the two sides — the left side and the
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`right side — of the vertebrae. Given the curved nature of vertebrae, one of skill in the art would understand
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`that there is no definitive starting point or ending point of a “lateral aspect” of a vertebra, but rather the
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`lateral aspect is an approximate area. A “medial aspect" of two adjacent vertebrae is a phrase that would
`
`not be conventionally used by persons of skill in the art-
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`In addition, I have not found that the phrase
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`“medial aspect” is used or defined in the ‘997 patent specification. As such, and for purposes of my
`
`analysis in this matter only, l have assumed the term “medial aspect” to mean a mid-line of the vertebrae,
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`extending anterior to posterior. Finally, I have assumed that the phrase “anterior to the transverse
`
`processes“ defines the path, and thus it is the “path” that must be “anterior to the transverse processes.” In
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`addition, and although inconsistent with the plain language of the claim, I have also assumed that the
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`clause does not require that the path be entirely anterior of the transverse processes (that is, directly in
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`front of the transverse processes); indeed, if that were the case, then the path would not lie in a coronal
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`Page 9 of 41
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`9
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`plane, but may lie in a sagittal plane. As such, I have assumed that the claim limitation requiring the “path”
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`to be “anterior to the transverse processes” simply requires that the claimed “path” be anterior to a line
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`extending through the right and left transverse processes, and extending to the sides of the transverse
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`processes.
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`14.
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`Claim 1 recites the step of “advancing a second surgical instrument
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`over at least a
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`portion of the length of said first surgical instrument” (col. 23, lines 1-3).
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`In accordance with the claim
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`interpretation principles set forth above, I believe that a person of ordinary skill in the art would recognize
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`the broadest reasonable interpretation of the above phrase in claim 1 to be as follows. The term “over,” as
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`used in this claim phrase, means extemal of an outside periphery of the claimed first surgical instrument, or
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`in other words, surrounding it.
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`In my opinion, this is consistent with the ‘99? patent specification, which
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`shows an elongate bullet-nosed distractor 100 (with a central passageway 10? or lumen) being advanced
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`“over” an elongate guide pin 30. See ‘99? patent, FIGS. 2 and 4.
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`15.
`
`Claim 1 recites the step of “advancing a third surgical instrument
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`over at least a portion
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`of the length of said second surgical instrument” (col. 23, lines 9-11). In accordance with the claim
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`interpretation principles set forth above, I believe that a person of ordinary skill in the art would recognize
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`the broadest reasonable interpretation of the above phrase in claim 1 to be as follows. The term “over,” as
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`used in this claim phrase and similarly to how it was used previously in the claim as discussed above,
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`means external of an outside periphery of the claimed second surgical instrument, or in other words,
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`surrounding it.
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`In my opinion, this is consistent with the ‘99? patent specification, which shows a tubular
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`“extended outer sleeve” 140 being advanced “over” the distractor 100. See ‘99? patent, FIGS. 6 and ?.
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`16.
`
`Claim 1 recites the phrase “non-bone interbody intraspinal implant” (col. 23, line 21). In
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`accordance with the claim interpretation principles set forth above, I believe that a person of ordinary skill in
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`the art would recognize the broadest reasonable interpretation of the above phrase in claim 1 to be as
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`follows. The term “non-bone interbody intraspinal implant” means that at least part of the implant
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`Page 10 of 41
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`10
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`comprises material that is not naturally occurring autogratt (bone taken from the patients body) or atlograft
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`(bone taken from a body other than the patient receiving the implant, such as a cadaver)-
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`1?.
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`Claim 1 further recites the length of said implant “being sized to occupy substantially the
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`full transverse width of the vertebral bodies of the two adjacent vertebrae” and “being greater than the
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`depth of the disc space” (col. 23, lines 27-30). For purposes of my analysis, l have assumed the meaning
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`of "sized to occupy substantially the full transverse width” includes within its scope lengths that are shorter
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`than the full transverse width of the two adjacent vertebrae, because that is what the ‘997 patent discloses,
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`as discussed in the next paragraph.
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`18.
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`In particular, the ‘997 patent describes an implant that is shorter than the full transverse
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`width of the vertebral bodies of the two adjacent vertebrae, and the ‘997 patent describes no implants that
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`are equal to or greater than the full transverse width of the vertebral bodies. The fact that the implant is
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`shorter than the full transverse width is illustrated not only in Figure 30 of the ‘997 patent, but also very
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`clearty in Figure 23 of the ‘997 patent, which provides more anatomical detail than Figure 30. An annotated
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`version of a portion of Figure 23 is copied below:
`
` I
`
`I
`i
`'
`I
`|
`:<—~73%ofwidth—>.
`I
`K- Futl Transverse Width —>l
`
`I:
`
`Contra-lateral annulus
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`As shown in Figure 23 (above), the length of the implant (I) is less than (in fact, about 73% of) the full
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`transverse width of the vertebral bodies of the two adjacent vertebrae.
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`In addition, Figure 23 shows that
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`Page 11 of 41
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`11
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`the portion of the annulus (the outer harder periphery of the disc) that is opposite of the side in which the
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`implant was inserted (the so-called “contra-lateral annulus,” which is on the right side of Figure 23 above)
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`has been left in place.
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`In order for the implant (I) to extend across the full transverse width of the adjacent
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`vertebral bodies, the contra-lateral annulus would have to be “released,” which means to cut through it,
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`which would permit the implant to extend beyond the contra-lateral annulus. With the contra-lateral
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`annulus shown left in place, one of skill in the art would understand that the length of the implant would be
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`less than the full transverse width of the vertebral bodies of the two adjacent vertebrae.
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`I understand that
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`the reference letter “D” in Figure 23 is referenced in the '99? patent specification as being a “disc space,”
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`but I do not view that labeling as being contrary to my opinion that the contra-lateral annulus is shown in
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`Figure 23 as having been left in place. There is in fact a disc space in Figure 23, as well as a contra-lateral
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`annulus.
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`In addition, the ‘99? patent does not describe removing the contra-lateral annulus, and does not
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`describe an implant resting on the ring apophysus. One of skill in the art, in February 1995, would have
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`understood that at that time it was most conventional to not drill through the opposite annulus when drilling
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`a hole in a disc to implant a fusion implant.
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`In addition, the ‘997 patent specification describes mechanisms
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`for ensuring that the drilling of the hole for the implant does not extend too far (col. 13, lines 22-26), and
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`states that the path of drilling is done to a “predetermined and limited depth” (col. 13, lines 60-61).
`
`19.
`
`I also understand that the Patent Owner — in a reissue proceeding for US. Patent No.
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`5,772,661 to Michelson (‘661 patent) that was eventually abandoned — relied on Figure 30 of the ‘661
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`patent (which is the same as Figure 30 of the ‘997 patent) in support of an argument that the specification
`
`discloses “positioning said implant to contact at least a portion of a cortical rim of at least one of the
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`adjacent vertebrae with each of said ends of said implant.” In connection with that, the Examiner rejected
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`the Patent Owner’s contention, and reasoned as follows:
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`Fig. 30 of Applicant's disclosure is a two-dimensional representation of a three dimensional
`structure. The actual points of contact of the ends of the implant with each of the adjacent
`vertebrae are different due to the curvature of the implant in a sagittal plane. Since, the
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`Page 12 of 41
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`12
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`
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`surface of an end of the implant curves away from the cortical rim due to the curvature of
`the implant in a sagittat plane, Applicant‘s argument that ‘The area of contact of the
`implant I with the vertebra L inherently includes the cortical rim thereof" is not persuasive.
`
`U.S. Patent Application Serial No. 12f655,1?8, filed Dec. 23, 2009, Final Rejection, p. 13 (Aug. 11, 2011).
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`In my opinion, the Examiner was correct in this conclusion, for the following reasons. Figure 30 of the ‘99?
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`patent does not illustrate the necessary detail to address the issue.
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`In addition, the figure of the ‘99? patent
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`that does provide the necessary detail — namely, Figure 23 copied and discussed above — shows that the
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`implant (I) does not rest on the vertebral body cortical rim.
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`In addition, the relative dimensions of depth and
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`width of the fourth lumbar (L4) vertebra’s end surface depicted in Figure 30 of the ‘99? patent is
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`anatomically inaccurate.
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`In particular, a typical depth-to-width ratio for the superior (upper) surface of the
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`L4 vertebra is 49.6mmr'33.9mm, or 1.46. See Berry et al., “A Morphometric Study of Human Lumbar and
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`Selected Thoracic Vertebrae,” Spine, Vol. 12, No. 4, pp. 362-6?, at p. 364, Table 1 (198?) (attached hereto
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`as Exhibit C). By contrast, the ratio of depth-to-width of the lumbar vertebra endplate depicted in Figure 30,
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`as measured by me, is approximately 1.60. Given the anatomical inaccuracy of Figure 30, it would be
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`inappropriate in my opinion to rely on it as depicting that the implant (I) is resting on the vertebra‘s cortical
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`rim. Third, a later-filed patent of Dr. Michelson — US. Patent No. 6,241 ,??0 (‘7?0 patent) — explains, in its
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`background section, that the implant (I) shown in the ‘99? patent (and thus in the '661 patent which has the
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`same specification) “prevents the utilization of the apophyseal rim bone [labeled “AR” in FIG. 1 copied
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`below], located at the perimeter of the vertebral body to support the implants at their trailing end.” See ‘7?0
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`patent, col. 3, line 5? to col. 4, line 12. This is illustrated by Figures 1 and 11 of the ‘99? patent copied
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`below:
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`Page 13 of 41
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`13
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`
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`FIG.
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`As such, the characterization of the ‘661 patent (and hence the '99? patent) implant that Dr. Michelson
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`made in his later 770 patent furfl1er illustrates that the Examiner was correct in assessing that the ‘661 and
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`‘997 patent specifications do not disclose “positioning said implant to contact at least a portion of a corfical
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`rim of at least one of the adjacent vertebrae with each of said ends of said implant.”
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`20.
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`Claim 1 recites the phrase “said implant having a maximum height between said bone
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`engaging projections of said opposed surfaces and perpendicular to the length of said implant, the length of
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`said implant being greater than the maximum height of said implant” (col. 23, lines 35-39). In accordance
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`with the claim interpretation principles set forfl1 above, I believe that a person of ordinary skill in the art
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`would recognize the broadest reasonable interpretation of the above phrase in claim 1 to be as follows.
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`The definition in the claim of “maximum height” is unclear, because for the threaded cylindrical implant (I)
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`described in the ‘997 patent, the “height between bone engaging projections of said opposed surfaces” is
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`not “perpendicular to the length of said implant.” This is shown with reference to the implant (I) as shown
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`in Figure 30 of the ‘997 patent, as copied below (with annotations and modified to remove illustration of
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`surrounding vertebrae):
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`Page 14 of 41
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`14
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`21.
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`Major diameter
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`Bone engaging projects are offset
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`.
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`and thus the maximum height is
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`not "between said bone engaging
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`projections“
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`T
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`I _ _
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`As illustrated above, a line perpendicular to the length of the implant would not extend between a bone
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`engaging projection on the top of the implant and a bone engaging projection on the bottom of the implant.
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`As such, for purposes of my analysis, l have assumed the claimed “height” to be a distance between a
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`highest point of the implant and the lowest point of the implant, or in other words for a threaded, cylindrical
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`implant, the outside thread diameter (or in other words, the major diameter).
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`JACOBSON IN VIEW OF LEU AND BRANTIGAN CLAIMS 1 AND 8
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`22-
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`Jacobson discloses a spinal access technique that involves placing the patient in a lateral
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`decubitus position, and advancing to a spinal disc space in the lumbar region via a direct lateral approach.
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`See Jacobson, Figures 3 and 8; col- 2, lines 23-33; col- 5, lines 5-8.
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`In Jacobson, the access technique
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`involves the use of three instruments used in the establishment of an access cannula 11 (e.g., Figure 6),
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`through which a spinal procedure is performed. Jacobson discloses that the access cannula may be used
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`to perform a discectomy procedure (shown in Figures 7-8) and other types of surgical procedures in the
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`spinal column lumbar region, including, among others, a “fusion” procedure (col. 6, lines 9—13).
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`23-
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`Based on my knowledge and experience in this field and my review of the Jacobson
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`reference, I believe that a person having ordinary skill in the art would recognize that this direct lateral
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`Page 15of41
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`15
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`
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`approach to the spine, as disclosed in Jacobson, advances along a “path having an axis lying in a coronal
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`plane passing through a lateral aspect and a medial aspect of the two adjacent vertebrae and anterior to
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`the transverse process,” as recited in claim 1 of the ‘99? patent in accordance with its broadest reasonable
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`interpretation. See Jacobson, Figures 3 and 8; col. 2, lines 23-33. Jacobson also discloses the claimed
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`step of making a laterally-located incision through which the three claimed instruments are inserted.
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`In
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`particular, Jacobson describes the lateral insertion into the patient of a long spinal needle or guide wire 8
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`(Figure 3, and col. 5, lines 28-30 and lines 42-45), which one of skill in the art would understand to require
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`the making of a skin incision (especially for the guide wire embodiment having a diameter of nearly “3-
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`mm”).
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`In addition, and after describing the insertion of the needle or guide wire 8, Jacobson then describes
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`making a one centimeter long incision in the same area as the first, namely above the pelvic crest (col. 5,
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`lines 45—46), which one of skill in the art would understand to be an increase in the incision already formed.
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`24.
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`Jacobson discloses a cannulated second instrument in the form of a speculum 10, which
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`may be advanced over the initial guide needle or wire 8 so as to widen the surgical access path for
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`subsequent insertion of the final working cannula 11 within the speculum 10. Jacobson, col. 5, lines 48-54;
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`FIGS. 4-5. Claim 1 requires, however, “advancing a second surgical instrument
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`over at least a portion of
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`the length of the first surgical instrument,” and “advancing a third surgical instrument
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`over at least a
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`portion of the length of said second surgical instrument.” In other words, claim 1 encompasses a
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`conventional access technique known as sequential dilation, which is the advancement of successively
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`larger tubes over one another to achieve a desired size of working cannula. By the early 1990s, surgeons
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`commonly employed sequential dilators to widen a surgical access path from the width of an initial guide
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`needle to a width that is sufficient for a working cannula of a desired size. See, e.g., Leu at p. 596; U.S.
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`Patent No. 4,449,532 to Storz (sequential dilator access system); US. Patent No. 4,573,448 to Kambin
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`(sequential dilator access system for cannula access to a spinal disc space); US. Patent No. 4,969,888 to
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`Scholten et al. (sequential dilation system for cannula access to vertebral body); U.S. Patent No. 5,015,255
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`Page 16 of 41
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`16
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`
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`to Kuslich, at col. 8, lines 29-32 (initial guide pin, sheath over guide pin, and locating cylinder 104 over
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`sheath to access disc space to perform spinal fusion procedure); US. Patent No. 5,171,279 to Mathews,
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`FIGS. 4A—4C (sequential dilator access system for cannula access to a spinal pedicie); US. Patent No.
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`5,472,426 to Bonati et al. (sequential dilator access system for cannula access to a spinal disc space).
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`25.
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`An example of the use of sequential dilators in the access of a spinal disc space to perform
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`a spinal fusion procedure is disclosed in Leu, which discloses a surgical method for accessing a lumbar
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`disc space via a working cannula to deliver a spinal fusion implant. Leu, p. 594 (describing a technique of
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`“percutaneous lumbar interbody fusion); p. 596 (describing “four cannulas” used for sequential dilation and
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`a “working cannula”); p. 603 (suggesting the use of non-bone fusion implants (“composite grafts”) through
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`the working cannula).
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`In such prior art surgical methods, Leu expressly teaches the general prior art
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`practice in which sequential dilators (for example, “four cannulas of increasing diameter are stepwise
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`overslipped, one upon the other”) are advanced over a “central guide needle” to widen the surgical access
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`path from