IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of:
`
`Michelson
`
`US. Patent No.:
`Issue Date:
`Appl. Serial No.:
`Filing Date:
`Trtle:
`
`8,251 ,997
`August 28, 2012
`13,806,583
`November 29, 2011
`METHOD FOR INSERTING AN ARTIFICIAL IMPLANT BETWEEN TWO ADJACENT
`
`Attorney Docket No.: 13958-0112lP2
`
`VERTEBRAE ALONG A CORONAL PLANE
`
`DECLARATION OF DR. PAUL McAFEE NLD. 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.
`
`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
`
`surgery at the State University of New York, Upstate Medical Center, Syracuse, NY, from 1979-1983, and a
`
`fellowship in spinal reconstructive surgery at the Case Western Reserve University.I University Hospitals, in
`
`Cleveland, OH, from 1983-1984.
`
`I am currently the Chief of Spine Surgery, at Towson Orthopaedic
`
`Associates, PA, in Baltimore, MD.
`
`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
`
`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.
`
`With specific regards to spinal surgical procedures using a lateral approach to the spine, l
`
`have the following experience.
`
`l have performed over 500 lateral approaches with discectomy, fusion, and
`
`instrumentation in the thoracolumbar spine. l have published over 150 peer-reviewed publications
`
`pertaining to spinal fusion. l have over 20 patents pertaining to the subject of spinal implants. l have
`
`participated in over 10 clinical studies registered with the United States Food and Drug Administration to
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`Page 1 of 38
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`NUVASIVE 1001
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`investigate the clinical use of spinal implants. l have continuously maintained the clinical practice of spinal
`
`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
`
`working with Nuvasive over the past 10 years.
`
`I am the inventor of the Porous Coated Motion (POM)
`
`cervical disk replacement, and the intellectual property associated with that invention was held by a
`
`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
`
`beyond my normal hourfy compensation based on my time actually spent studying the matter, and I will not
`
`receive any added compensation based on the outcome of the above-mentioned reexamination of the '99?
`
`patent.
`
`4.
`
`Based upon my knowledge and experience in this field, I am aware of the needs and the
`
`challenges orthopaedic surgeons face in performing spinal surgical procedures.
`
`I routinely perform and
`
`observe these spinal surgical procedures, and I am familiar with the various types of access systems that
`
`are used during spinal surgical procedures, including dilator instruments and retractor assemblies.
`
`l was a
`
`practicing spine surgeon prior to February 27, 1995 and I am familiar with the state of spinal surgery prior to
`
`February 27, 1995.
`
`I am also very familiar with what was considered acceptable in terms of lateral access
`
`to the spine before and after February 27, 1995.
`
`l have formulated my analysis on this matter based on
`
`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
`
`Page 2 of 38
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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)
`
`US. Patent No. 5,569,290 to McAfee (“McAfee”); (7) US. Patent No. 5,772,661 to Michelson (“Michelson
`
`'661”); (8) US. Patent No. 6,241,770 to Michelson (“Michelson 770"); (9) 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 Appendix A to this
`
`Declaration); (10) Affidavit of Dr. Henry Crock (attached as Appendix B to this Declaration); and (11) Berry
`
`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 Appendix C to this Declaration).
`
`(12) McAfee et
`
`al., “The value of computed tomography in thoracolumbar fractures: An analysis of one hundred
`
`consecutive cases and a new classification,” The Journal of Bone and Joint Surgery, Vol. 65-A, No. 4, pp.
`
`461-473, April 1983 (attached as Appendix D to this Declaration).
`
`I have also 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 patients side) or antero-Iateral
`
`(that is, obliquely from the frontlside of the patient).
`
`Id., col. 3, lines 36—37. The ’997 patent describes the
`
`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 '997 patent
`
`on February 27, 1995.
`
`Page 3 of 38
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`3
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`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 ooccyx. The articulating
`
`vertebrae are divided into three groups, the cerviul group in the neck region (seven vertebrae), the
`
`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
`
`longitudinal ligament.
`
`Page 4 of 38
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`4
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`Upper-left figure, above — Wikipediaorg, [refrieved on March 20, 2013]
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`:llen.wiki edia.or lwikilFile:lllu vertebral column.'<htt >
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`Upper-right figure, above — Wikipediaorg, [refrieved on March 20, 2013]
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`
`Bottom figure, above — MoAfee et al_, “The value of computed tomography in lhoraoolumbar fractures: An
`
`analysis of one hundred oonseoulive cases and a new classification,” The Journal of Bone and
`
`Joint Surgery, Vol. 65-A, No. 4, pp. 461-473, April 1983 (Exhibit D)
`
`Page 5 of 38
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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 uses 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 oolumn.
`
`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
`
`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
`
`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
`
`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
`
`column of the spine include posterior, postero-lateral, far or direct lateral, antero-lateral, and anterior.
`
`In
`
`posterior or postero-lateral approaches, the patient is typically positioned on his or her stomach (prone).
`
`|n
`
`anterior and antero-lateral approaches, the patient is positioned on his or her back (supine).
`
`In a direct or
`
`far lateral approach, the patient is typically positioned in a so—nlled “lateral decubitus” position, which is on
`
`the patient’s side. All of these approaches to the spine were known and used before the filing of the ‘99?
`
`patent.
`
`Page 6 of 38
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`Posterior
`
`Postem—Lateral
`
`l
`
`Anterior
`
`Direct Lateral
`
`Antero-Lateral
`
`Posterior
`
`7g '
`
`l
`l
`8pm m um"
`
`Anterior
`_
`spinal column
`
`‘
`
`\Q
`
`11.
`
`The use of a direct or far lateral approach goes back at least to the early 1980’s, as the
`
`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 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
`
`(attached hereto as Exhibit A); see also Affidavit of Dr. Crock (attached hereto as Exhin B). Dr. Crock
`
`describes that when a fusion procedure is to be performed in the upper lumbar region, the patient is placed
`
`in the lateral decubitus position (on the patient’s side), and the anterior column of the upper lumbar spine is
`
`approached from a direct or far lateral direction.
`
`lot, p. 158-59. Dr. Crock also describes that two side-by-
`
`side openings have been formed in a lateral aspect (the side) of the intervertebral disc area, and describes
`
`that fusion-creating grafts in the form of cylindrical bone dowels are inserted into those laterally facing
`
`openings.
`
`ld., p. 160-61. Also in the early 1980’s, another publication of a direct or far lateral approach to
`
`the lumbar spine was provided in U.S. Patent No. 4,545,374 to Jacobson (“Jacobson”). Dr. Jacobson
`
`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
`
`position and advancing instruments to the anterior column of the spine along a direct or far lateral
`
`approach. See, e.g., Jacobson, col. 2, line 31; col. 5, line 6; FIG. 3 et seq. Dr. Jacobson discloses that this
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`Page 7 of 38
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`direct lateral access technique may be used for discectomy procedures and fusion procedures, among
`
`others. See id, col. 1, line 9; col. 6, lines 9-13.
`
`In the thoracic spine, direct or far lateral approaches were
`
`also known and used before the February 27, 1995 filing of the '99? patent.
`
`INTERPRETATIONS OF THE '997 PATENT CLAIMS AT ISSUE
`
`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
`
`patent in which it appears.” 3? C.F.R. §42.100(b).
`
`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
`
`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, l have used the filing date of the claimed priority patent application to the ‘99? patent as the
`
`point in time for claim interpretation purposes, to the extent it matters. That date was February 27, 1995.
`
`l
`
`have been asked to provide my interpretation of the following terms and phrases of the ‘997 patent set forth
`
`below.
`
`13.
`
`Claims 9, 17 and 24 recite 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. 24, lines 6-9; col. 25, lines 31-34; col. 25, lines 56-59). First, the term “coronal plane” is
`
`illustrated in a diagram from TheFreeDictionanfs medical dictionary that was provided by the patent
`
`applicant during the prosecution history, copied below:
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`Page 8 of 38
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`
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`Figuare A
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`‘997 patent prosecution history, Reply to Office Action, March 20, 2012, p- 14. The claims also define that
`
`the “coronal plane” must “pass|] through a lateral aspect and a medial aspect of the two adjacent
`
`vertebrae.” The phrase “lateral aspect” of vertebrae generally refers to each of the two sides — the left side
`
`and the right side — of the vertebrae. Given the curved nature of vertebrae, one of skill in the art would
`
`understand that there is no definitive starting point or ending point of a “lateral aspect” of a vertebra, but
`
`rather the 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.
`
`In addition, I have not found that the
`
`phrase “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,
`
`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
`
`addition, and although inconsistent with the plain language of the claim, I have also assumed that the
`
`clause does not require that the path be entirely anterior of the transverse processes (that is, direcfly in
`
`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 38
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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”
`
`to be “anterior to the transverse processes” simply requires that the claimed “path” be anterior to a line
`
`extending through the right and left transverse processes, and extending to the sides of the transverse
`
`processes.
`
`14.
`
`Claims 9, 17 and 24 recite the step of “advancing a second surgical instrument
`
`over at
`
`least a portion of the [or said] length of said first surgical instru ment’ (col. 24, lines 15—17; col. 25, lines 39-
`
`41; col. 26, lines 63-65).
`
`In accordance with the claim interpretation principles set forth above, I believe
`
`that a person of ordinary skill in the art would recognize the broadest reasonable interpretation of the above
`
`phrase in the claims to be as follows. The term “over,” as used in this claim phrase, means extemal of an
`
`outside periphery of the claimed first surgical instrument, or in other words, surrounding it.
`
`In my opinion,
`
`this is consistent with the ‘99? patent specification, which shows an elongate bullet-nosed distractor 100
`
`(with a central passageway 10? or lumen) being advanced “over” an elongate guide pin 30. See '99?
`
`patent, FIGS. 2 and 4.
`
`15.
`
`Claims 9, 17 and 24 recite the step of “advancing a third surgical instrument
`
`over at
`
`least a portion of the length of said second surgical instrument” (col. 24, lines 23-25; col. 25, lines 47-49;
`
`col. 2?, lines 4-6). In accordance with the claim interpretation principles set forth above, I believe that a
`
`person of ordinary skill in the art would recognize the broadest reasonable interpretation of the above
`
`phrase in the claims to be as follows. The term “over,” as used in this claim phrase and similarly to how it
`
`was used previously in the claim as discussed above, means external of an outside periphery of the
`
`claimed second surgical instrument, or in other words, sunounding it.
`
`In my opinion, this is consistent with
`
`the ‘997 patent specification, which shows a tubular “extended outer sleeve” 140 being advanced “over” the
`
`distractor 100. See 997 patent, FIGS. 6 and 7.
`
`16.
`
`Claim 9 recites “a single elongated portion removably attached to said distal end of said
`
`third surgical instrument” (col. 24, lines 30-31).
`
`In accordance with the claim interpretation principles set
`
`Page 10 of 38
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`forth above, I believe that a person of ordinary skill in the art would recognize that the broadest reasonable
`
`interpretation of the above phrase in claim 9 to be as follows. One of skill in the art would interpret the
`
`claimed “single elongated portion” to include a ring with at least one (and not necessarily only one)
`
`elongated portion.
`
`I believe this interpretation to be consistent with the '99? patent specification, in that the
`
`only structure I could find that was removably attachable to a third instrument is the removable anchoring
`
`structure shown in Figure 35, which removably attaches to a distal end 1104 of an outer tubular member
`
`1102. Throughout the entire '99? patent, this removable anchor ring structure is the only structure that is
`
`“removably attached” to any type of instrument (tubular member 1102) that might be considered a third
`
`surgical instrument. The ‘99? patent discloses only methods for using the detachable ring structure 1104 in
`
`which the third surgical instrument (tubular member 1102) is entirely removed from the patient before the
`
`spinal implant is inserted (see col. 21, line 39 to col. 22, line 39), and thus there is no disclosure in the “997
`
`patent of advancing an implant through the tubular member 1102 in this embodiment.
`
`17.
`
`Claims 9 and 17 recite the length of said implant “being sized to occupy substantially the
`
`full transverse width of the vertebral bodies of the two adjacent vertebrae” and “being greater than the
`
`depth of the disc space” (col. 23, lines 27-30). For purposes of my analysis, l have assumed the meaning
`
`of “sized to occupy substantially the full transverse width” includes within its scope lengths that are shorter
`
`than the full transverse width of the two adjacent vertebrae, because that is what the '99? patent discloses,
`
`as discussed in the next paragraph.
`
`18.
`
`In particular, the “997 patent describes an implant that is shorter than the full transverse
`
`width of the vertebral bodies of the two adjacent vertebrae, and the ‘99? patent describes no implants that
`
`are equal to or greater than the full transverse width of the vertebral bodies. The fact that the implant is
`
`shorter than the full transverse width is illustrated not only in Figure 30 of the “997 patent, but also very
`
`clearly in Figure 23 of the “997 patent, which provides more anatomical detail than Figure 30. An annotated
`
`version of a portion of Figure 23 is copied below:
`
`Page 11 of38
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`11
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` I
`
`_
`Contra lateral annulus
`
`I
`:(___73% ofwidth—>{
`|
`K—Futl Transverse Width —)1
`
`'
`
`19.
`
`As shown in Figure 23 (above), the length of the implant (I) is less than (in fact, about 73%
`
`ot) the full transverse width of the vertebral bodies of the two adjacent vertebrae.
`
`In addition, Figure 23
`
`shows that the portion of the annulus (the outer harder periphery of the disc) that is opposite of the side in
`
`which the implant was inserted (the so-called “contra-lateral annulus,” which is on the right side of Figure
`
`23 above) has been left in place.
`
`In order for the implant (I) to extend across the full transverse width of the
`
`adjacent vertebral bodies, the contra-lateral annulus would have to be “released," which means to cut
`
`through it, which would permit the implant to extend beyond the contra-lateral annulus. IMth the contra-
`
`Iateral annulus shown left in place, one of skill in the art would understand that the length of the implant
`
`would be less than the full transverse width of the vertebral bodies of the two adjacent vertebrae.
`
`I
`
`understand that the reference letter “D” in Figure 23 is referenced in the ‘997 patent specification as being a
`
`“disc space," but I do not view that labeling as being contrary to my opinion that the contra-lateral annulus
`
`is shown in Figure 23 as having been left in place. There is in fact a disc space in Figure 23, as well as a
`
`contra-lateral annulus.
`
`In addition, the ‘997 patent does not describe removing the contra-lateral annulus,
`
`and does not describe an implant resting on the ring apophysus. One of skill in the art, in February 1995,
`
`would have understood that at that time it was most conventional to not drill through the opposite annulus
`
`when drilling a hole in a disc to implant a fusion implant.
`
`In addition, the ‘997 patent specification describes
`
`mechanisms for ensuring that the drilling of the hole for the implant does not extend too far (col. 13, lines
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`Page 12 cf 38
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`12
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`22-26), and states that the path of drilling is done to a “predetermined and limited depth” (col. 13, lines 60-
`
`61).
`
`20.
`
`I also understand that the Patent Owner— in a reissue proceeding for US. Patent No.
`
`5,772,661 to Michelson (‘661 patent) that was eventually abandoned — relied on Figure 30 of the '661
`
`patent (which is the same as Figure 30 of the ‘99? 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
`
`adjacent vertebrae with each of said ends of said implant.” In connection with that, the Examiner rejected
`
`the Patent Owner's contention, and reasoned as follows:
`
`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
`surface of an end of the implant curves away from the cortical rim due to the curvature of
`the implant in a sagittal plane, Applicant‘s argument that ‘The area of contact of the
`implant l with the vertebra L inherently includes the cortical rim thereof" is not persuasive.
`
`US. Patent Application Serial No. 12l655,1?8, filed Dec. 23, 2009, Final Rejection, p. 13 (Aug. 11,2011).
`
`In my opinion, the Examiner was correct in this conclusion, for the following reasons. Figure 30 of the ‘99?
`
`patent does not illustrate the necessary detail to address the issue.
`
`In addition, the figure of the ‘99? patent
`
`that does provide the necessary detail — namely, Figure 23 copied and discussed above — shows that the
`
`implant (I) does not rest on the vertebral body cortical rim.
`
`In addition, the relative dimensions of depth and
`
`width of the fourth lumbar (L4) vertebra’s end surface depicted in Figure 30 of the ‘99? patent is
`
`anatomically inaccurate.
`
`In particular, a typical depth-to-width ratio for the superior (upper) surface of the
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`L4 vertebra is 49.6mml33.9mm, or 1.46. See Beny 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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`Page 13 of38
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`n'm. Third, a later-filed patent of Dr. Michelson — US. Patent No. 6,241 ,770 (770 patent) — explains, in its
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`background section, that the implant (I) shown in the ‘997 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 HS. 1 copied
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`below], located at the perimeter of the vertebral body to support the implants at their trailing end.” See 770
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`patent, col. 3, line 57 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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`LC”
`PRIOR ART
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`FIG.
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`7 7
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`As such, the characterization of the ‘661 patent (and hence the ‘997 patent) implant that Dr. Michelson
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`made in his later 770 patent further illustrates that the Examiner was correct in assessing that the '661 and
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`‘99? patent specifications do not disclose “positioning said implant to contact at least a portion of a cortical
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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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`21.
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`Claim 24 recites the length of said implant “being sized to occupy the full transverse width
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`of the vertebral bodies of the two adjacent vertebrae” and “being greater than the depth of the disc space”
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`(col. 23, lines 27-30). Notably, claim 24 does not include the modifier “substantially.” For purposes of my
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`analysis, l have assumed the meaning of “sized to occupy the full transverse width” includes within its
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`scope lengths that are shorter than the full transverse width of the two adjacent vertebrae, because that is
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`what the '99? patent discloses, as discussed above.
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`22.
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`Claims 9, 17 and 24 recite the phrase “said implant having a maximum height between
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`said bone engaging projections of said opposed surfaces and perpendicular to the length of said implant,
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`Page 14 of 38
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`the length of said implant being greater than the maximum height of said implant” (col. 24, lines 60—64; col.
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`26, lines 20-24; col- 28, lines 15-20).
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`In accordance with the claim interpretation principles set forfl1 above,
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`I believe that a person of ordinary skill in the art would recognize the broadest reasonable interpretation of
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`the above phrase in the claims to be as follows- The definition in the claim of “maximum height” is unclear,
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`because for the threaded cylindrical implant (I) described in the ‘997 patent, the “height between bone
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`engaging projections of said opposed surfaces” is not "perpendicular to the length of said implant.” This is
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`shown with reference to the implant (I) as shown in Figure 30 of the ‘997 patent, as copied below (with
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`annotations):
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`Major diameter
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`Bone engaging projects are offset
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`and thus the maximum height is
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`projections”
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`not “between said bone engaging
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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, I 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 McAFEE AND MICHELSON ‘24? CLAIMS 9 AND 16
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`23.
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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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`Page 15 of 38
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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 Y—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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`24.
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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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`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 9 of the ‘997 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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`25.
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`Jacobson discloses a nnnulated 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 9 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 9 encompasses a
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`Page 16 of 38
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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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`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 ac