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`NUVASIVE, INC.,
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
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` Case No.: 3:18-CV-347-CAB-MDD
`
`ORDER ON MOTIONS FOR
`SUMMARY JUDGMENT
`
`[Doc. Nos. 303, 304]
`
`Plaintiff,
`
`v.
`ALPHATEC HOLDINGS, INC. et al.,
`Defendants.
`
`
`Before the Court are the parties’ motions for summary judgment of certain claims
`and defenses relating to United States Patent Nos. 8,361,156 and 8,187,334. Plaintiff
`NuVasive moves for judgment: (1) that Defendants Alphatec Holdings, Inc. and Alphatec
`Spine, Inc.’s (jointly, “Alphatec”) accused devices – the Battalion Lateral Spacers, the
`Transcend LIF PEEK Spacer, and the Titec Coated LLIF Implants – infringe the asserted
`claims of the ‘156 patent and the ‘334 patent; (2) that these two patents are entitled to the
`priority filing date of March 29, 2004 of a related U.S. provisional patent application, No.
`60/557,536: and (3) for dismissal of Alphatec’s invalidity defense of indefiniteness. [Doc.
`No. 303.]
`Alphatec argues that the motions should be denied because there are disputed
`material facts regarding both the alleged infringement of their accused devices and whether
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`NuVasive’s 2004 provisional application provides a sufficient description of later claimed
`subject matter to reasonably convey that the inventor had possession of that subject matter
`as of the 2004 filing date. Alphatec also filed its own motion requesting a judgment of
`invalidity of both patents based on the indefiniteness of three claim terms. [Doc. No. 304.]
`Legal Standard
`I.
`The familiar standard for summary judgment applies to these motions. Where there
`is no genuine issue as to any material fact and the movant is entitled to judgment as a matter
`of law, summary judgment should be granted. Fed. R. Civ. P. 56(a). The nonmoving party
`must come forward with specific facts showing there is a genuine issue for trial. Fed. R.
`Civ. P. 56(e). “Where the record taken as a whole could not lead a rational trier of fact to
`find for the non-moving party, there is no ‘genuine issue for trial.’” Matsushita Elec. Indus.
`Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). It is not for the Court, however, to
`weigh the evidence presented and determine the truth of the matter. Instead, the Court
`must assess only whether there is sufficient evidence favoring the non-moving party, with
`reasonable inferences drawn in the non-movant’s favor, such that a jury could return a
`verdict for that party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986).1
`Infringement of the ‘156 Patent and ‘334 Patent
`II.
`“Patent infringement, whether literal or by equivalence, is an issue of fact, which the
`patentee must prove by a preponderance of the evidence.” Siemens Med. Sols. USA, Inc.
`v. Saint-Gobain Ceramics & Plastics, Inc., 637 F.3d 1269, 1279 (Fed. Cir. 2011). To
`establish literal infringement of an asserted claim, NuVasive must demonstrate that every
`limitation recited in the claim is found in the accused devices.2 Akzo Nobel Coatings, Inc.
`v. Dow Chemical Co., 811 F3d 1334, 1341 (Fed. Cir. 2016). NuVasive argues that there
`
`
`
`1 NuVasive’s objections to declarations Alphatec submitted in support of its opposition to NuVasive’s
`summary judgment motion [Doc. No. 331, at 8] are denied.
`2 NuVasive’s motion does not make an infringement claim based on the doctrine of equivalents, so the
`Court considers the sufficiency of Alphatec’s evidence of a material dispute as to whether all the claim
`limitations are literally met by the accused devices.
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`are no material disputes that the accused Alphatec devices meet all the limitations of the
`asserted claims.3
`Alphatec asserts several factual disputes challenging whether the accused implants
`meet all the limitations of the asserted claims. NuVasive argues that Alphatec’s positions
`are factually incorrect. NuVasive may ultimately be right, but that is for a jury, not the
`Court, to decide. NuVasive’s motion for summary judgment of infringement of the ‘154
`patent and the ‘334 patent is therefore DENIED.
`III. Priority Date
`The ‘156 patent and ‘334 patent are continuations of U.S. Patent No. 7,918,891 with
`a filing date of March 29, 2005. Alphatec asserts an affirmative defense of on-sale bar,
`alleging commercial embodiments of the ‘891 patent were sold more than a year before the
`filing date of the ‘891 patent. 35 U.S.C.§ 102(b) (pre-AIA). NuVasive challenges
`Alphatec’s evidence of prior invalidating sales.4 NuVasive also seeks to establish a claim
`of priority to an earlier provisional application, No. 60/557,536, filed on March 29, 2004.
`NuVasive bears the burden of proving by a preponderance of the evidence that the
`written description of the 2004 application supports and enables the claim limitations of
`the ‘891 patent. See Speedfit LLC v. Woodway USA, Inc., 432 F. Supp. 3d 183, 208
`(E.D.N.Y. 2020) (“[O]nce an accused infringer ‘has established a prima facie case of
`invalidity and its burden is met,’ the patentee bears the burden of coming forward with
`evidence to prove entitlement to claim priority to an earlier filing date.”) (quoting
`
`
`
`3 Alphatec’s opposition to NuVasive’s motion for summary judgment of infringement contends in part
`that the motion must be denied because it broadly represents that all of Alphatec’s implants infringe the
`asserted claims without distinguishing Alphatec’s devices that clearly do not meet certain dimensional
`limitations of the claims. NuVasive however clarified its infringement assertion in its reply submission
`with a comprehensive list of the implants accused on a claim-by-claim basis. [Doc. No. 311-13.]
`4 NuVasive’s Motion to Exclude the portion of Alphatec’s expert report regarding NuVasive’s sales that
`could constitute an on-sale bar [Doc. No. 302-1, at 5] was withdrawn at argument based on subsequently
`considered evidence. [Doc. No. 332, Hrg. Transcript at 61.] The remainder of NuVasive’s motion to
`strike expert testimony [Doc. No. 302] was DENIED at the hearing for the reasons stated on the record.
`[Doc. No. 332, Hrg. Transcript at 60-64.]
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`PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1305 (Fed. Cir. 2008)). To satisfy
`this burden, NuVasive must demonstrate that the 2004 application itself “describe[s] an
`invention ... in sufficient detail that one skilled in the art can clearly conclude that the
`inventor invented the claimed invention as of the filing date sought.” Trading Techs. Int'l,
`Inc. v. eSpeed, Inc., 595 F.3d 1340, 1359 (Fed. Cir. 2010) (quoting Lockwood v. Am.
`Airlines, 107 F.3d 1565, 1572 (Fed. Cir. 1997)). “In other words, the specification of the
`provisional [application] must ‘contain a written description of the invention and the
`manner and process of making and using it, in such full, clear, concise, and exact terms,’
`35 U.S.C. § 112 ¶ 1, to enable an ordinarily skilled artisan to practice the invention claimed
`in the non-provisional application.” Dynamic Drinkware, LLC v. Nat'l Graphics, Inc., 800
`F.3d 1375, 1378 (Fed. Cir. 2015) (quoting New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co.,
`298 F.3d 1290, 1294 (Fed. Cir. 2002) (emphases in original)); see also Star Sci., Inc. v.
`R.J. Reynolds Tobacco Co., 655 F.3d 1364, 1371 (Fed. Cir. 2011) (“Consistent with 35
`U.S.C. § 112 ¶ 1, the written description of the provisional application must enable one of
`ordinary skill in the art to practice the invention claimed in the non-provisional
`application.”).
`Whether the 2004 application discloses all the limitations of the ‘891 patent (and
`therefore the ‘156 patent and ‘334 patent) is contested by the experts. Further, NuVasive
`offers nothing in its motion on this issue to explain the significance (or lack thereof) of the
`addition of new material and multiple new figures to the application for the ‘891 patent,
`that disclose and describe the later claimed radiopaque marker limitation. Again, the Court
`will not weigh the competing opinions of the experts and determine which is more credible.
`These are factual disputes for a jury to decide.
`NuVasive’s motion for summary judgment of the 2004 priority filing date for the
`‘154 patent and the ‘334 patent is therefore DENIED.
`IV. Affirmative Defense of Indefiniteness
` A patent is presumed valid and the burden of establishing the invalidity of a patent
`or any claim thereof is on the party asserting such invalidity by clear and convincing
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`evidence. 35 U.S.C. § 282; Microsoft Corp. v. I4I Ltd. P’ship, 564 U.S. 91, 97 (2011)
`(holding that invalidity defenses must be proved by clear and convincing evidence). The
`patent’s specification shall conclude with one or more claims particularly pointing out and
`distinctly claiming the subject matter which the applicant regards as his invention. 35
`U.S.C. §112. Section 112, ¶ 2 requires that “a patent’s claim language, viewed in light of
`the specification and prosecution history, inform those skilled in the art about the scope of
`the invention with reasonable certainty.” Nautilus, Inc. v. Biosig Instruments, Inc., 572
`U.S. 898, 134 S. Ct. 2120, 2129 (2014).
`The parties agree with the Patent Trial and Appeal Board that a person of ordinary
`skill in the art regarding these patents is someone with a medical degree with two or three
`years of experience performing procedures using interbody spinal fusion implants.
`NuVasive represents that its designated expert, Dr. Jim Youssef, is a person of ordinary
`skill in the art regarding the ‘156 patent and the ‘334 patent. [Doc. No. 332, Hrg. Transcript
`at 9, 14.]
` Based on the intrinsic evidence and the testimony of Dr. Youssef as a person of
`ordinary skill, Alphatec argues that the asserted claims of the ‘156 patent and the ‘334
`patent fail to meet the statutory requirement of definiteness.
`A. The Scope of “Proximate to Said Medial Plane” is Not Reasonably
`Certain.
` The ‘156 patent is directed at a spinal fusion implant with certain features, including
`radiopaque markers positioned in the implant to be readily observable under X-ray or
`fluoroscopy such that a surgeon may track the progress of the implant during implantation
`and/or determine the placement of the implant after implantation. [Doc. No. 110-38, at
`Col. 6:49-56.] The location of certain of these radiopaque markers is set forth in the claims.
`
`Claim 1 of the ‘156 patent claims:
`A spinal fusion implant of non-bone construction positionable within an
`interbody space between a first vertebra and a second vertebra, said implant
`comprising:
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` an upper surface including anti-migration elements to contact said first
`vertebra when said implant is positioned within the interbody space, a lower
`surface including anti-migration elements to contact said second vertebra
`when said implant is positioned within the interbody space, a distal wall, a
`proximal wall, a first sidewall, and a second sidewall generally opposite from
`the first sidewall, wherein said distal wall, proximal wall, first sidewall, and
`second sidewall comprise a radiolucent material;
` wherein said implant has a longitudinal length extending from a proximal
`end of said proximal wall to a distal end of said distal wall, said implant has a
`maximum lateral width extending from said first sidewall to said second
`sidewall along a medial plane that is generally perpendicular to said
`longitudinal length, and said longitudinal length is greater than said maximum
`lateral width;
` at least a first fusion aperture extending through said upper surface and
`lower surface and configured to permit bone growth between the first vertebra
`and the second vertebra when said implant is positioned within the interbody
`space, said first fusion aperture having: a longitudinal aperture length
`extending generally parallel to the longitudinal length of said implant, and a
`lateral aperture width extending between said first sidewall to said second
`sidewall, wherein the longitudinal aperture length is greater than the lateral
`aperture width; and
` at least first and second radiopaque markers oriented generally parallel to a
`height of the implant, where said first radiopaque marker extends into said
`first sidewall at a position proximate to said medial plane, and second
`radiopaque marker extends into said second sidewall at a position
`proximate to said medial plane.
`
`[Id., at Col. 12:32-67.]
` All the asserted claims of the ‘156 patent include the limitation that the first and
`second radiopaque markers extend into the sidewalls of the implant “at a position
`proximate to [the] medial plane.” [Id., at Col. 12:63-67.] The parties agree that the medial
`plane is the midline of the implant and proximate is understood to mean “near.” The
`question presented, therefore, is what a person of ordinary skill in the art would understand
`to be the objective boundary of “near the midline.”
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`The specification makes no reference to “markers.” In the description of the anti-
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`migration features of the implant, the specification discloses the option to include “spike
`elements” that may be disposed in the implant in its proximal, distal and central regions.5
`[Id., at Col. 6:27-35.] The exemplary depictions in the patent’s figures show these spike
`elements positioned at each end and at the midline of the implant. [See e.g., id., Fig. 3 (7),
`(8), and (9).]
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`The specification teaches that when these anti-migration spike elements are made of
`radiodense materials and the implant is manufactured from a radiolucent material, the spike
`elements will be readily observable under X-ray or fluoroscopy such that a surgeon can use
`them to track the progress of the implant during implantation and/or determine the
`placement of the implant after implantation. [Id., at Col. 2:53-Col. 3:10; 6:49-56; Col.
`11:4-Col.12:11; Figs 2, 3, 20 and 21.] The limitation in claim 1 of a “radiopaque marker”
`therefore corresponds to the specification’s disclosure of providing spike elements of
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`5 The specification identifies the proximal end of the implant (22) with spike element 7 described as in
`the “proximal region.” It also identifies the distal end of the implant (16) with spike element 8 described
`as in the “distal region.” Spike element 9 is identified as in the implant’s “central region.” This is the
`extent of the discussion of “regions” of the implant in the specification. [Id., at Col. 6:27-35.]
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`radiodense materials incorporated into a radiolucent implant for purposes of enhancing
`visualization of the implant by the surgeon during or after implantation. [Id., at Col. 2:53-
`62.] Nothing further is disclosed to explain the significance or benefit of positioning the
`spike elements at any particular location within a “region” of the implant. There is nothing
`disclosed identifying what portion of the implant is considered to be proximate to the
`midline.
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`Alphatec does not dispute that spike element (9) in Figs. 2, 3, 20 and 21, illustrates
`a radiopaque marker “proximate to the medial plane,” as it appears to be at the midline of
`the implant. However, in the absence of any intrinsic evidence in the specification and
`prosecution history as to what area constitutes proximate to the midline, Alphatec argues
`that the disclosure does not provide any way for a person of ordinary skill to objectively
`determine whether a marker is proximate to, or near, the medial plane if a marker is located
`farther away from the midline than depicted in the specification. Specifically, the patent
`does not teach how far a marker can be moved from the midline and still be within the
`scope of the claim.
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`Alphatec acknowledges that mathematical precision is not required, but the patent
`must inform those skilled in the art with reasonable certainty of the scope of the claim.
`Nautilus, Inc., 134 S.Ct. at 2129 (“The definiteness requirement mandates clarity, while
`recognizing absolute precision is unattainable.”). It must be precise enough to afford clear
`notice of what is claimed, thereby apprising the public of what is still open to them. Id.
`Otherwise, there would be a “zone of uncertainty which enterprise and experimentation
`may enter only at the risk of infringement claims.” Id. (citing Union Carbon Co. v. Binney
`& Smith Co., 317 U.S. 228, 236 (1942)). The claims must provide objective boundaries
`for those of skill in the art. Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370-71
`(Fed. Cir. 2014). In this case, the specification and prosecution history provide no notice
`of the distance at which a marker could be placed away from the midline and still be
`proximate to the midline.
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`Definiteness is evaluated from the perspective of someone skilled in the relevant art.
`Nautilus, Inc., 134 S.Ct. at 2128. Alphatec argues that the testimony of Dr. Youssef,
`NuVasive’s expert witness, as a person of skill in this art, establishes that the patent does
`not disclose an objective boundary for one to determine whether a marker is near the middle
`or not.
`Dr. Youssef testified that the practical application for the markers described in Claim
`1 is to assist a surgeon in visualizing the location of the implant after insertion. [Doc. No.
`304-23, at 57:1-10.] NuVasive argues that a marker positioned “proximate to the medial
`plane” is intended to provide the surgeon with a visual mark at or near the center of the
`implant. Dr. Youssef testified that such a marker should be “close” to the midline.
`However, when asked how to determine what constitutes “close,” he testified that he could
`only offer an opinion for himself. Despite being designated as a person of ordinary skill,
`he did not feel he could comment for other surgeons as to whether a marker was close to
`the medial plane. [Doc. No. 304-22, at 88:5-23.]
`When asked if there is an objective standard to determine whether a marker is at a
`position proximate to the medial plane, Dr. Youssef replied that “it’s a subjective analysis
`using the claim language, the understanding of the claim language, the agreed-upon terms,
`and for those terms that don’t have a construed definition, using the ordinary meaning of
`those terms.” [Id., at 105:11-19.] He testified that he did not think that there is an objective
`boundary. [Id., at 102:3-12.]
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`At his deposition, Dr. Youssef was shown a series of annotated images of Figure 3
`of the ‘156 patent.
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`IMAGE 1
`Ex. 16 (Dep. Ex. 7)
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`IMAGE 2
`Ex. 17 (Dep. Ex. 8)
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`IMAGE 3
`Ex. 18 (Dep. Ex. 9)
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`IMAGE 4
`Ex. 19 (Dep. Ex. 10)
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`Image 1 is of Fig. 3 as shown in the specification highlighting in red the first and
`second radiopaque markers (9) at the midline. In the subsequent images, those markers
`were moved gradually away from the midline. Dr. Youssef opined that the markers
`depicted in Image 2 fell within the scope of the claim and the markers depicted in Image 3
`were “pretty close” to the medial plane and therefore, in his opinion, were still proximate
`to the medial plane. [Id., 91:12-16; 102:18-103:25.] As to the markers depicted in Image
`4, he concluded that they did not come within the scope of the claim. [Id., at 104:25-106:5.]
`When asked why he concluded the markers in Image 3 were within the scope of the claim
`but those in Image 4 were not, he testified that he came to that conclusion “because one is
`further from the medial plane than the other.” [Id., at 106:6-14.] In response to the follow-
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`up question, “Is there some position between the two that might be the boundary?”, he
`replied, “I think it's subjective.” [Id., at 106:15-18.]
`While some modicum of uncertainty is allowed, a patent must be precise enough to
`afford clear notice of what is claimed, thereby apprising the public of what is still open to
`them. Nautilus, 134 S.Ct. at 2128-29. Claims cannot rely on the “unpredictable vagaries of
`any one person’s opinion.” Interval Licensing LLC, 766 F.3d at 1376.
`When a word of degree is used, the specification must provide some standard for
`measuring that degree that one of ordinary skill would understand. The lone example in
`the specification depicts the markers at the midline and therefore provides no guidance as
`to what constitutes near or close to the midline. Dr. Youssef provided no functional
`explanation or other objective guidance to support his determination of when the distance
`from the midline no longer constitutes near or close, just his subjective opinion. While
`absolute precision is not required, such ambiguity and subjectivity does not provide the
`clarity needed to inform the public as to the scope of this claim.
`Accordingly, based on the specification and prosecution history, and as
`acknowledged by Dr. Youssef, a person of ordinary skill in the art, the claim limitation
`“proximate to the medial plane” is a subjective limitation that fails to inform those skilled
`in the art about the scope of the invention with reasonable certainty.
`Alphatec’s motion for summary judgment of invalidity of the ‘156 patent for failure
`to meet the statutory requirement of definiteness is therefore GRANTED.
`The Scope of a Central Region Positioned Generally Centrally
`B.
`between the Proximal and Distal Walls is Disputed.
` The ‘334 patent, which has the same specification as the ‘156 patent, is also directed
`at a spinal fusion implant with certain features including radiopaque markers positioned in
`the implant to be readily observable under X-ray or fluoroscopy such that a surgeon may
`track the progress of the implant during implantation and/or determine the placement of
`the implant after implantation. [Doc. No. 110-48, at Col. 6:49-56.] The location of certain
`of these radiopaque markers is set forth in the claims.
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`Claim 1 of the ‘334 patent claims:
`A spinal fusion implant of non-bone construction positionable within an
`interbody space between a first vertebra and a second vertebra, said implant
`comprising:
` an upper surface including anti-migration elements to contact said first
`vertebra when said implant is positioned within the interbody space, a lower
`surface including anti-migration elements to contact said second vertebra
`when said implant is positioned within the interbody space, a distal wall, a
`proximal wall, a first sidewall, and a second sidewall, said distal wall,
`proximal wall, first sidewall, and second sidewall comprise a radiolucent
`material;
` wherein said implant has a longitudinal length greater than 40 mm
`extending from a proximal end of said proximal wall to a distal end of said
`distal wall;
` wherein a central region of said implant includes portions of the first
`and second sidewalls positioned generally centrally between the proximal
`wall and the distal wall, at least a portion of the central region defining a
`maximum lateral width of said implant extending from said first sidewall
`to said second sidewall, where said longitudinal length is at least two and
`half times greater than said maximum lateral width;
` at least a first fusion aperture extending through said upper surface and
`lower surface and configured to permit bone growth between the first vertebra
`and the second vertebra when said implant is positioned within the interbody
`space, said first fusion aperture having: a longitudinal aperture length
`extending generally parallel to the longitudinal length of said implant, and a
`lateral aperture width extending between said first sidewall to said second
`sidewall, wherein the longitudinal aperture length is greater than the lateral
`aperture width; and
` at least three radiopaque markers; wherein a first of the at least three
`radiopaque markers is at least partially positioned in said distal wall, a second
`of said at least three radiopaque markers is at least partially positioned in said
`proximal wall, and a third of said at least three radiopaque markers is at
`least partially positioned in said central region.
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`[Id., at Col. 12:32-Col. 13:4.]
` All the asserted claims of the ‘334 patent include the limitation that a third
`radiopaque marker be “at least partially positioned in [the] central region” of the implant.”
`[Id., at Col. 13:2-4.] The claim itself describes the “central region” as the portion of the
`implant “generally centrally” between the proximal and distal walls that includes the width
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`of the implant at its maximum width from side wall to side wall. Alphatec argues that this
`claim language read in light of the specification fails to inform a person of ordinary skill
`as to an objective boundary of what area of the implant is “generally centrally” between
`the proximal and distal walls.
`NuVasive disagrees, arguing that the specification teaches that a purpose of the
`radiopaque markers is to enhance a surgeon’s ability to visualize the position of an implant
`within the interbody space. In that context, NuVasive contends that a person of ordinary
`skill would understand that the portion of the implant that is “generally centrally” between
`the proximal and distal walls comprises that area of the implant in which the positioning
`of the third marker would assist the surgeon’s visualization. According to NuVasive, while
`not mathematically precise, the objective boundaries of the central region are ascertainable
`with reasonable certainty based on the functional purpose. See Biosig Instruments, Inc. v.
`Nautilus, Inc., 783 F.3d 1374, 1382 (Fed. Cir. 2015) (“The degree of precision necessary
`for adequate claims is a function of the nature of the subject matter.”)
`As noted supra, the patent specification identifies the proximal wall (22), distal wall
`(16) and sidewalls (14) of the implant. In his expert report, Dr. Youssef illustrated on an
`accused device, markers that are positioned in the central region of an implant in
`accordance with the claim language. His blue circle encompasses the markers and the
`maximum lateral width of the implant and a region “‘positioned generally centrally
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`between the proximal and distal wall’–so that’s generally center, between those two walls
`somewhere in the center.” [Doc. No. 304-23, at 50:19-51:6; 54:4-7.]
`In response to an inquiry at his deposition as to whether a marker placed outside this
`blue circle would not meet the claim limitation, Dr. Youssef responded that his circle was
`a general example. He testified that “for a marker to fall outside [the central] region, it
`would be necessary for them to be closer to the proximal or distal walls.” [Id., at 52:5-8.]
`[M]y blue circle is just a depiction in static. It could be moved and adjusted
`to still meet the limitations of the claim and still account for the central region.
`So really to get a marker outside the boundary of the central region as defined
`by [the claim] would be pretty tough. I think you’d have to put them closer
`to the proximal and distal walls to get them there.
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`[Id., at 54:18-25.]
` Dr. Youssef testified that the central region, as long as it includes the maximum
`lateral width, could be expanded to include the area to the left or the right up to either the
`distal or proximal wall. [Id., 51:19-53:12.] The claim language allows that “the boundary
`could be fairly substantial.” [Id., at 53:12-14.] However, he also clarified that although
`the general central region has “a lot of real estate,” he did not consider the central region
`to be everything between the proximal and distal walls. [Id., at 64:16-23.]
`Dr. Youssef explained that a person of ordinary skill in the art would understand the
`scope or breadth of the claimed central region in the context of the usefulness of the
`placement of a third radiopaque marker. [Id., at 74-77.] In his opinion, the third marker
`described in the claim is intended to provide a third reference point for the surgeon
`evaluating the placement of the implant. The breadth of the central region would therefore
`be understood in part by the positional purpose of the third marker. In other words, the
`third marker is no longer in the central region when it is positioned too close to the first or
`second marker of the claim limitation (which are positioned at least partially in the
`proximal or distal walls) to be of practical usefulness as a third reference point.
` When asked how close to the proximal and distal walls a marker would need to be
`placed to be out of the central region, he responded, “Well, it’s hard to know. . . . I don’t
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`have an answer for you. I don’t know exactly how far out but much closer to the proximal
`distal wall than the circle that’s shown [in his drawing].” [Id., at 55:11-14.]
`To establish an objective boundary for the central region, that portion of the implant
`“generally centrally” between the proximal and distal walls, Dr. Youssef was shown Figure
`3 from the specification with locations marked in red for placement of the third marker.
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`IMAGE 1
`Ex. 16 (Dep. Ex. 7)
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`IMAGE 4
`Ex. 19 (Dep. Ex. 10)
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`IMAGE 2
`Ex. 17 (Dep. Ex. 8)
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`IMAGE 5
`Ex. 20 (Dep. Ex. 11)
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`IMAGE 3
`Ex. 18 (Dep. Ex. 9)
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`IMAGE 6
`Ex. 21 (Dep. Ex. 12)
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`IMAGE 7
`Ex. 22 (Dep. Ex. 13)
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`He testified that the markers depicted i