UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`_________________
`
`PARAGON 28, INC.,
`Petitioner,
`
`
`v.
`
`
`WRIGHT MEDICAL TECHNOLOGY, INC.,
`Patent Owner.
`
`_________________
`
`Case IPR2019-00894
`
`Patent 9,144,443
`
`_________________
`
`
`
`
`PATENT OWNER’S SUR REPLY TO PETITIONER’S REPLY
`
`
`
`i
`
`
`
`
`
`
`
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`_________________
`
`PARAGON 28, INC.,
`Petitioner,
`
`
`v.
`
`
`WRIGHT MEDICAL TECHNOLOGY, INC.,
`Patent Owner.
`
`_________________
`
`Case IPR2019-00894
`
`Patent 9,144,443
`
`_________________
`
`
`
`
`PATENT OWNER’S SUR REPLY TO PETITIONER’S REPLY
`
`
`
`i
`
`
`
`
`
`
`
`
`
`I.
`II.
`
`2.
`
`Table of Contents
`INTRODUCTION ......................................................................................... 1
`THE TERM PRE-CONTOURED AND ITS RELATION TO THE
`BENDABILITY FEATURE OF THE PLATES ........................................ 5
`A.
`If Pre-Contoured Precludes Reliance on the Bendability
`Feature of the Plate, Ground 1 Fails Because Petitioner
`Relies on Bending the Plate of Kay To “Apply the Shape of
`Heinl” .................................................................................................... 5
`If Pre-Contoured Does Not Preclude Bending, Ground 1
`Fails Because Kay Discloses Molded Plates Embodying the
`S-curve .................................................................................................. 5
`III. THE MEDIAL LINE OF AN X-SHAPED PLATE ................................... 9
`A.
`Petitioner Relies on an Overly Narrow Determination of
`Medial Line in Evaluating Priority ................................................. 11
`1.
`Petitioner Mischaracterizes the Express Disclosure of the
`443 Patent ................................................................................. 11
`Petitioner Mischaracterizes the Testimony of Wright’s
`Expert ....................................................................................... 15
`Petitioner Contradicts Its Petition and Expert .................... 18
`3.
`4. Wright Does Not Rely on Complex Quantitative Analysis . 18
`5.
`Petitioner Mischaracterizes the Prosecution Snippet It Cites
` ................................................................................................... 21
`Petitioner Fails to Carry Its Burden of Proving a POSA
`Would Combine Kay and Heinl or How the Combination
`Embodies the S-Curve Limitation ................................................... 22
`IV. CONCLUSION ............................................................................................ 26
`
`B.
`
`B.
`
`
`
`
`
`
`
`
`ii
`
`
`
`I.
`
`INTRODUCTION
`The Petition challenges the claims on a single ground (Ground 1) relying on
`
`modifying Kay in view of Heinl based on the following assertions by the
`
`Petitioner:
`
` Kay discloses a plate (depicted in Figure 1) embodying each and every
`limitation recited in the Challenged Claims but for the S-curve limitation1
`(Petition, 33-38);
`
` Kay discloses the plate of Figure 1 as having a bendability feature
`including a bendable waist area in its trunk (Petition, 39-41);
`
` Heinl discloses a plate having an S-shape in the lateral plane (Petition, 7,
`39, 41); and
`
` In view of Kay’s bendability feature, a POSA would have been motivated
`to “apply the S-shape of Heinl to the bone plate of Kay” to “bend Kay’s
`plate to form a lateral S-curve, like that shown in Heinl” by bending the
`plate laterally at the waist area of the trunk (Petition, 40-41).
`
`
`Kay, the grand-parent of the 443 Patent, is only available as prior art if the
`
`Challenged Claims are not entitled to its priority. Thus, Petitioner must prevail on
`
`its priority argument or Ground 1 fails.
`
`
`1 Petitioner alleges Kay is prior art solely on the basis that the S-curve limitation is
`
`a novel feature of the Challenged Claims such that the claims are not entitled to the
`
`priority of Kay.
`
`
`
`1
`
`
`
`However, notwithstanding priority, Ground 1 also fails under the proper
`
`construction of the term “pre-contoured” as recited in the Challenged Claims.
`
`Wright contends that the term “pre-contoured” precludes the individualized
`
`bending enabled by the bendability feature of the plate relied upon by Petitioner to
`
`“apply the S-shape of Heinl to the bone plate of Kay” to meet the limitations of the
`
`Challenged Claims in Ground 1. However, Petitioner’s argument that “the same
`
`features that would make a plate suitable for individual contouring would be of
`
`assistance when pre-contouring the plate” (PR, 20) presents a double-edged sword
`
`for the Petitioner. If the Board agrees with Petitioner’s construction that the term
`
`“pre-contoured” does not preclude Petitioner’s reliance on the bendability feature
`
`to modify the plate of Kay “to apply the S-shape of Heinl” in Ground 1, then the
`
`Board must also consider the shape of plates that have been molded to fit small
`
`bones as expressly disclosed by Kay when evaluating the scope of the invention of
`
`Kay for priority purposes. Petitioner agrees that Kay’s pre-contoured plates would
`
`embody the S-curve:
`
`POSITAs would have known that some small bones would require an
`S-shape plate in order for the plate to be molded to the optimal shape
`for those bones. In other words, a POSITA would know that for some
`bones, the pre-contoured plate would require an S-shape in order for
`the plate later be individually contoured ….
`PR, 20 (emphasis in original)
`
`
`
`2
`
`
`
`Importantly, Kay (i.e., the 2006 Application) expressly discloses that its
`
`plates are designed to be contoured to accommodate those very bones that require
`
`an S-curve:
`
`[P]rovides a plate… designed to facilitate three dimensional
`contouring to provide for a variety of applications and to
`accommodate individual variation in bone shape. The plate is
`designed specifically for the small bone market, i.e. for use in bones
`distil to the elbow and knee, including, for example, the ulna, radius,
`tibia, fibula, as well as the metacarpals, carpals, metatarsals, tarsals,
`and phalanges.
`WMT-2001, ¶0006.
`
`Thus, Wright prevails on Ground 1 if the term “pre-contoured” precludes the
`
`bending relied upon by Petitioner in Ground 1 to modify the plate of Kay, or
`
`Wright prevails on the priority issue because the molded plates of Kay “would
`
`require an S-shape” as acknowledged by Petitioner.
`
`With respect to priority, Petitioner complains that “[a]lthough PO asserts
`
`that ‘several portions of the 2006 Application provide sufficient support for the ‘S-
`
`curve’ limitation in either the lateral plane or the longitudinal plane,’ PO only
`
`substantively argues that ‘the embodiments of the orthopedic plates disclosed in
`
`the 2006 Application … possess[] a medial line describing an S-curve in the lateral
`
`plane as recited in the Challenged Claims.’” PR, 4. However, Wright was
`
`responding to Petitioner’s challenge to priority in the Petition which focused
`
`
`
`3
`
`
`
`substantively on the alleged lack of support for the ‘S-curve’ limitation in the
`
`lateral plane and its reliance on Heinl as providing motivation to modify Kay’s
`
`plates. As demonstrated below, Kay provides sufficient support for the ‘S-curve’
`
`limitation in either the lateral plane or the longitudinal plane. Thus, in the event
`
`that the Board accepts Petitioner’s definition of “pre-contoured”, Wright
`
`demonstrates that the embodiments of the orthopedic plates disclosed in the 2006
`
`Application possess a medial line describing an S-curve in the lateral or
`
`longitudinal plane as recited in the Challenged Claims
`
`Additionally, and again notwithstanding priority, Wright prevails on Ground
`
`1 because there is no motivation to combine Kay and Heinl as alleged by Petitioner
`
`and, even if combined, Petitioner has failed to carry its burden of setting forth
`
`Ground 1 in sufficient detail to demonstrate that the result of the proposed
`
`combination meets the limitations recited in the Challenged Claims. Petitioner
`
`offers no detail whatsoever as to how a POSA would “apply the S-shape of Heinl
`
`to the bone plate of Kay” by bending the plate laterally at the waist or how such
`
`bending would transform the X-shaped plate of Kay into the S-shaped plate of
`
`Heinl in the lateral plane – i.e., when viewed from the top.
`
`Finally, the PR is rife with mischaracterizations of the facts which can only
`
`be an attempt to mislead the Board and should be disregarded on this basis alone.
`
`
`
`
`
`4
`
`
`
`II. THE TERM PRE-CONTOURED AND ITS RELATION TO THE
`BENDABILITY FEATURE OF THE PLATES
`A.
`If Pre-Contoured Precludes Reliance on the Bendability Feature of
`the Plate, Ground 1 Fails Because Petitioner Relies on Bending
`the Plate of Kay To “Apply the Shape of Heinl”
`As set forth in the POR (pp. 25-30), Wright contends that the 443 Patent
`
`(and its grand-parent Kay) distinguishes between pre-contouring of the plate and
`
`the individualized contouring of the plate enabled by its bendability feature, such
`
`that the term “pre-contoured” as recited in the Challenged Claims, precludes
`
`reliance on the bendability feature of the plate to obtain a medial line that describes
`
`an S-curve. Petitioner admits that the plate depicted in Figure 1 of Kay is a “pre-
`
`contoured” plate, but argues that the pre-contour lacks the required medial line that
`
`describes an S-curve. Petition, 38. Petitioner also admits that it relies on the
`
`bendability feature of the plate, specifically at the waist, to “apply the S-shape of
`
`Heinl to the bone plate of Kay” by “bend[ing] Kay’s plate to form a lateral S-
`
`curve, like that shown in Heinl ….” Petition, 40-41, PR, 21. Thus, under the
`
`construction of the term “pre-contoured” urged by Wright, Ground 1 fails
`
`notwithstanding the priority of the Challenged Claims.
`
`B.
`
`If Pre-Contoured Does Not Preclude Bending, Ground 1 Fails
`Because Kay Discloses Molded Plates Embodying the S-curve
`If the Board construes the term “pre-contoured” such that the term does not
`
`preclude bending the plate of Kay as relied upon by Petitioner in Ground 1, then
`
`Ground 1 still fails because Kay discloses to a POSA molded plates embodying the
`5
`
`
`
`
`
`S-curve thus affording the Challenged Claims the priority of Kay (i.e., the 2006
`
`Application). In other words, Kay discloses plates embodying the S-curve – not
`
`that such plates are a novel modification of Kay’s plates.
`
`There is no dispute that the 2006 Application discloses bone plates having
`
`the bendability feature discussed above and relied upon by Petitioner in Ground 1.
`
`Petitioner argues that “the same features that would make a plate suitable for
`
`individual contouring would be of assistance when pre-contouring the plate.” PR,
`
`20. In the Petition, Petitioner and its expert acknowledge that Kay itself teaches
`
`molding the plates to fit the bone shape:
`
`Kay states that its orthopedic plate “facilitates three dimensional
`contouring to provide for a variety of applications and to
`accommodate individual variation in bone shape,” Ex. 1006, Abstract,
`and describes that the portion of the trunk of its plate “linking the
`screw holes [through holes 14 in Figure 1] has a decreased width so as
`to define a waist area 26 that will bend laterally (or ‘curve’) relative to
`the longitudinal axis and which will bend longitudinally to form a
`curved area in and out of the plane of the plate,” Id., ¶47. POSITAs
`would have been motivated by this disclosure in Kay to seek out a
`number of different shapes of orthopedic bone plates to accommodate
`the variety of bone shapes of the human body, and would have
`understood that the bone plate of Kay could be bent in a number of
`different ways. Ex. 1001, ¶¶121-122.
`
`Petition, 31-32.
`
`
`
`6
`
`
`
`
`
`If Petitioner’s assertion is correct, this is not a disclosure that Kay could be
`
`“modified” to bend longitudinally to form a curved area in and out of the plane of
`
`the plate. Instead, this is an express disclosure by Kay of a medial line that
`
`describes a curve in a lateral plane or in a longitudinal plane for a variety of bone
`
`shapes of the human body. In fact, in IPR2019-00896 challenging the 278 Patent
`
`(a sister patent to the 443 Patent), Petitioner admits that “Kay discloses a plate with
`
`a medial line that describes a curve in a lateral plane or in a longitudinal plane.”
`
`278 Petition, 47 (citing EX-1001, ¶429). In its Reply, Petitioner now admits that a
`
`POSA understood from the disclosure of Kay itself that molding the plate to
`
`accommodate small bones would require an S-shape –
`
`Petitioner explained that Kay discloses molding the plate to the
`optimal shape, and “POSITAs would have known that some small
`bones would require an S-shape plate in order for the plate to be
`molded to the optimal shape for those bones.” In other words, a
`POSITA would know that for some bones, the pre-contoured plate
`would require an S-shape in order for the plate later be individually
`contoured (molded) to the optimal shape for those bones.
`PR, 20 (emphasis in original)(color added).
`
`
`
`Petitioner’s expert even testified that a POSA knew “to use plates with an S-
`
`curve because the curve better matches the shape or contour of certain bones, for
`
`example the clavicle bone.” Ex. 1001, ¶41.
`
`
`
`7
`
`
`
`
`
`Petitioner’s new evidence even confirms that small bones such as the radius
`
`would require an S-shaped plate as illustrated below by the dorsal plate (Plate #1
`
`highlighted in red) and volar plate (Plate #2 highlighted in blue) positioned on the
`
`radius bone:
`
`
`
`EX-1086, Figure 1 (annotated with color)
`
`
`
`Wright’s experts agree – “A POSA understood that a plate that was
`
`customized by bending longitudinally to form a curved area in and out of the plane
`
`of the plate would have a medial line that described an S-curve in the longitudinal
`
`plane.” POR, 15 (citing WMT-2017, ¶46 and WMT-2018, ¶45).
`
`
`
`It is clear that rather than providing a “motivation” to mold the plates of Kay
`
`to embody a medial line describing an S-curve, Kay expressly discloses such
`
`molding and the well-known shape of the bones that the plates are designed to
`
`
`
`8
`
`
`
`repair such that a POSA understood that the inventors were in possession of plates
`
`embodying the S-curve. Here, Petitioner attempts to cast the argument as one of
`
`obviousness – i.e., molding Kay’s plates to embody an S-curve is a novel but
`
`obvious modification motivated by Heinl. However, a careful review of the
`
`evidence of record demonstrates that Kay necessarily discloses plate embodying
`
`the S-curve and thus Petitioner’s argument that such plates are a novel
`
`modification of Kay’s plates motivated by the teaching of Heinl does not make
`
`sense.
`
`III. THE MEDIAL LINE OF AN X-SHAPED PLATE
`The Challenged Claims are directed to a Y-shaped or an X-shaped plate
`
`
`
`embodying the S-curve limitation. In Ground 1, Petitioner alleges that it would
`
`have been obvious to bend the X-shaped plate of Kay (Figure 1) to apply the S-
`
`shape of Heinl such that the medial line of the plate describes an S-curve in the
`
`lateral plane only:
`
`POSITAs desiring to bend Kay’s plate to form a lateral S-curve, like
`that shown in Heinl, would have understood that the bending should
`be done at the waist section of the trunk of Kay because, as Kay itself
`discloses, the decreased width of the “waist area” facilitates the
`bending or curving of the orthopedic plate.
`
`Petition, 41 (emphasis added).
`
`
`
`9
`
`
`
`
`
`Petitioner does not allege that Heinl discloses an S-curve in the longitudinal
`
`plane or that the plate of Kay could be bent such that the medial line describes an
`
`S-curve in the longitudinal plane. Despite the Petition simply quoting the claim
`
`limitation “S-curve in the lateral plane or in the longitudinal plane” when alleging
`
`that the plate of Kay could be bent in view of Heinl, Petitioner’s expert confirmed
`
`during cross-examination that Heinl discloses only an S-curve in the lateral plane
`
`and that reference to the longitudinal plane in paragraph 121 of his declaration was
`
`an error. WMT-2019, 30:18 – 32:6.
`
`
`
`Notwithstanding priority, and accepting Petitioner’s argument that Kay does
`
`not disclose a plate with a medial line that describes an S-curve in a lateral plane or
`
`in a longitudinal plane, Ground 1 still fails because there is no motivation to
`
`combine Kay and Heinl as alleged by Petitioner, and even if combined, Petitioner
`
`has failed to carry its burden of setting forth Ground 1 in sufficient detail to
`
`demonstrate that the proposed combination meets the limitations recited in the
`
`Challenged Claims. Petitioner offers no detail whatsoever as to how a POSA
`
`would “apply the S-shape of Heinl to the bone plate of Kay” by bending the plate
`
`laterally or how such bending would transform the X-shaped plate of Kay into the
`
`S-shaped plate of Heinl.
`
`
`
`Moreover, Petitioner relies on an overly narrow determination of the medial
`
`line of the X-shaped plates in alleging that Kay fails to discloses plates embodying
`
`
`
`10
`
`
`
`the S-curve limitation, yet Petitioner completely ignores its narrow interpretation in
`
`alleging that the X-shaped plate of Kay is somehow transformed to an S-shaped
`
`plate by bending the plate laterally.
`
`A.
`
`Petitioner Relies on an Overly Narrow Determination of Medial
`Line in Evaluating Priority
`As set forth in the POR, Petitioner relies on an overly narrow interpretation
`
`
`
`of the S-curve limitation in its determination of the medial line of an X-shaped
`
`plate such that only the “main body” or “main portion” of the plate is considered,
`
`thus ignoring the actual shape of the plate. POR, 18-25. In its Reply, Petitioner
`
`does not dispute its reliance on such a narrow interpretation in its evaluation of
`
`priority and, in fact, doubles down on it. Now, for the first time in its Reply,
`
`Petitioner argues that the “medial line” is simply a line that “divides the plate
`
`laterally” and as such, all plates in the 2006 Application contain a straight medial
`
`line. PR, 7-8. As set forth below, Petitioner’s new arguments are contrary to the
`
`disclosure of the 443 Patent and the 2006 Application.
`
`1.
`
`Petitioner Mischaracterizes the Express Disclosure of the
`443 Patent
`In support of its interpretation of medial line, Petitioner mischaracterizes the
`
`
`
`disclosure of the 443 Patent. Petitioner alleges “the ’443 Patent provides a
`
`straightforward explanation of ‘medial line:’ it ‘divides the plate in half laterally.’”
`
`However, Petitioner offers only a partial quote of the actual disclosure and
`
`
`
`11
`
`
`
`conveniently omits the fact that the referenced medial line is the medial line of the
`
`elongated trunk of the plate and not the medial line of the plate in its entirety. The
`
`full unredacted disclosure is below:
`
`the present invention provides answers to the prior art issues by
`providing a variety of plates with varying footprints that share an
`elongate trunk with a medial line (which is intended in this instance to
`include a curving line) that divides the plate in half laterally.
`
`EX-1002, 3:7-11 (emphasis added).
`
`
`
`Petitioner’s interpretation is also contrary to the express disclosure of the
`
`443 Patent. For example, the 443 Patent discloses the plate depicted in Figure 13
`
`as a 4-hole anterior clavicle plate and that such plates include a c-shaped lateral
`
`curve. EX-1002, 5:5-14; 9:3-4. Thus, as shown in annotated Figure 13 below,
`
`while the elongated trunk of the plate has a straight medial line that may divide the
`
`plate in half laterally, the plate is expressly disclosed as including a “c-shaped
`
`lateral curve” when the entirety of the plate is considered in determining the medial
`
`line of the plate.
`
`
`
`12
`
`
`
`
`
`EX-1002, Figure 13 (annotated)
`
`
`
`Further contradicting Petitioner’s interpretation is the express description of
`
`the plate depicted in Figure 43. The 443 Patent describes the plate depicted in
`
`Figure 43 as a lateral clavicle plate having “an S-curve of the medial line in the
`
`direction of the width of the plate” -- i.e., in the lateral plane. Thus, as shown in
`
`annotated Figure 43 below, while the elongated trunk of the plate has a medial line
`
`with a single curvature, the plate is expressly disclosed as including a “an S-curve
`
`of the medial line” in the lateral plane when the entirety of the plate is considered
`
`when determining the medial line.
`
`
`
`13
`
`
`
`
`
` EX-1002, Figure 43 (annotated)
`
`
`
`This is further amplified in that the inflection point of the S-curved medial
`
`line is located near the translation hole proximate the arms 530. EX-1002, 11:27-
`
`35. This location of the inflection point indicating the transition between the two
`
`lobes of the S-curve described by the medial line is only evident if the medial line
`
`is a function of not only the main trunk 510 but also the arms 530 of the plate.
`
`Thus, the narrow interpretation asserted by Petitioner is directly contradicted by
`
`the express description of the plate depicted in Figure 43.
`
`
`
`In a further attempt to justify its overly narrow interpretation, Petitioner also
`
`mischaracterizes the disclosure of the 443 Patent as to the plates depicted in
`
`Figures 19 and 25. Again, Petitioner offers only a partial quote of the actual
`
`disclosure and conveniently omits the fact that the referenced medial line is the
`14
`
`
`
`
`
`medial line of the elongated trunk and not the medial line of the plate in its
`
`entirety. The full unredacted disclosure is below:
`
`However, in both versions, the plate 310, 310’ has a y-shaped
`footprint which comprises an elongate central trunk 312, 312’ having
`a medial line and along that medial line, through holes …. In these
`embodiments, the holes of the central body are aligned with their
`centers along a straight medial line ….
`EX-1002, 9:55-63
`
`
`
`It is clear from the full unredacted version of the disclosure that the
`
`referenced medial line is the medial line of the elongate trunk portion and not the
`
`medial line of the entirety of the plate.
`
`2.
`
`Petitioner Mischaracterizes the Testimony of Wright’s
`Expert
`Petitioner asserts that “there is no dispute that the only plates depicted in the
`
`
`
`2006 Application contain a straight medial line, not an S-curved medial line.” PR,
`
`8 (emphasis in original). In support of its proclamation, Petitioner
`
`mischaracterizes the testimony of Wright’s expert Dr. Harrigan.
`
`
`
`The testimony of Dr. Harrigan is clear – the plate of Figure 1 has a medial
`
`line that describes an S-curve in the lateral plane. WMT-2018, ¶59; EX-1066, 78-
`
`79. Despite Dr. Harrigan’s clear testimony, in an apparent effort to mislead the
`
`Board, Petitioner asserts that “[w]hen PO’s expert was asked to identify ‘the line
`
`that divides the plate in half laterally’ on Figure 1 of the 2006 Application, he drew
`
`
`
`15
`
`
`
`a straight line through the middle of the plate.” In support of this contention,
`
`Petitioner includes an annotated copy of Figure 1 of the 2006 Application
`
`submitted as EX-1071.
`
`
`
`However, a review of the transcript of Dr. Harrigan’s testimony
`
`demonstrates that Petitioner’s assertion is materially false. During cross-
`
`examination, Dr. Harrigan was asked to draw the medial axis (as distinguished
`
`from the medial line in the testimony cite) on Figure 1, he was not asked to “to
`
`identify ‘the line that divides the plate in half laterally’ on Figure 1” as falsely
`
`asserted by Petitioner. In fact, Dr. Harrigan specifically stated that the medial axis
`
`and the medial line are two different things. The specific examination includes:
`
`Q So then can you draw on the Figure 1 that I handed you where you
`believe you would place the medial axis.
`
`* * *
`
`A What it looks like is the medial axis is meant to be the same as the
`longitudinal axis.
`
`Q Okay.
`
`A Based on that, I can draw a medial axis.
`
`Q Please do so.
`
`A As opposed to a medial line, which is -- you know, the two things
`are different. Okay So the longitudinal axis from my -- page 23 of
`my ’443 disclosure is in fact there.
`
`MR. POLINS: Can we mark that as Exhibit 5.
`16
`
`
`
`
`
`(Whereupon, Harrigan Exhibit 5 was marked for identification.)
`
`Q Exhibit 5 is, drawn in red, the medial axis of the plate depicted in
`Figure 1. True?
`
`A Based on my interpretation of the disclosure, that’s the medial
`axis.
`
`EX-1066, 212-213 (emphasis added).
`
`
`
`Counsel further questioned Dr. Harrigan as to whether he believed that the
`
`line he drew on Figure 1 divides the plate in half laterally. After clearly
`
`distinguishing his interpretation of the medial axis from the medial line of the
`
`plate, Dr. Harrigan testified that:
`
`If by dividing the plate in half laterally you mean that half of the
`plate is above and half of the plate is below, then the answer is yes.
`
`EX-1066, 214-220 (emphasis added).
`
`
`
`Thus, Petitioner’s expert only agreed that the line he drew representing the
`
`medial axis of the plate divides the plate laterally so that “half the plate is above
`
`the line and half is below [the line].”
`
`
`
`Clearly, Wright disputes the contention that the plates disclosed in the 2006
`
`Application only have straight medial lines and Petitioner’s blatant
`
`mischaracterization of the testimony of Dr. Harrigan can only be an attempt to
`
`mislead the Board.
`
`
`
`
`
`17
`
`
`
`3.
`Petitioner Contradicts Its Petition and Expert
`In addition to mischaracterizing the testimony of Wright’s expert,
`
`
`
`Petitioner’s newly asserted interpretation directly contradicts its Petition and the
`
`testimony of its common expert in IPR2019-00896 directed to the 278 Patent. In
`
`the 278 Patent, Challenged Claim 5 is directed to an orthopedic plate wherein “the
`
`plate has a medial line that describes a curve in a lateral or in a longitudinal plane.”
`
`(the “Curve Limitation”). Petitioner did not challenge the priority of Claim 5 to
`
`Kay (the 2006 Application) on the basis of the Curve Limitation and affirmatively
`
`argued (citing the supporting testimony of Mr. Castaneda) that “Kay discloses a
`
`plate having a medial line which describes a curve in a lateral plane or in a
`
`longitudinal plane.” 278 Petition, 47 (citing EX-1001, ¶429). Mr. Castaneda bases
`
`his testimony in part on the understanding of the shape described by the medial
`
`line of plates having bilateral asymmetry and transverse mirror symmetry as
`
`disclosed in Kay (and the 2006 Application). EX-1001, ¶429. Petitioner cannot
`
`now contradict its earlier assertions and expert testimony in an attempt to craft an
`
`argument to dispute Wright’s contentions.
`
`4. Wright Does Not Rely on Complex Quantitative Analysis
`Contrary to Petitioner’s assertion, Wright does not rely on complex
`
`
`
`quantitative analysis to determine the medial line. As clearly stated in the POR,
`
`Dr. Harrigan uses a quantitative approximation to confirm a POSA’s understanding
`
`
`
`18
`
`
`
`of the shape described by the medial line of X-shaped plates having bilateral
`
`asymmetry and either mirror symmetry (C-curve) or transverse mirror symmetry
`
`(S-curve). WMT-2018, ¶¶75-77, Appendix A.
`
`
`
`Petitioner’s overly simplistic interpretation that the medial line is a line that
`
`“divides the plate in half laterally” ignores the plain and ordinary meaning of the
`
`term “medial” in the determination of a medial line. As discussed above, Petitioner
`
`asserts “no dispute” with Dr. Harrigan’s testimony regarding the meaning of
`
`dividing the plate in half laterally -- “[i]f by dividing the plate in half laterally you
`
`mean that half of the plate is above and half of the plate is below [the line].”
`
`According to Petitioner’s interpretation, each of the lines shown below (in orange
`
`and blue) on annotated Figure 1 would qualify as a medial line that “divides the
`
`plate in half laterally” such that half of the plate is above the line and half of the
`
`plate is below the line:
`
`WMT-2001, Figure 1 (annotated)
`
`
`
`
`
`19
`
`
`
`
`
`
`
`Wright’s use of the quantitative approximation illustrates the understanding
`
`of a POSA of the meaning of the term “medial” in the determination of the medial
`
`line of a plate. A POSA understands that the “medial line” is not simply any line
`
`where half the plate is above the line and half the plate is below the line but is
`
`defined by the series of points along the plate that represent the midpoint between
`
`the boundaries of the plate along its longitudinal axis.
`
`
`
`Petitioner’s protest regarding the use of the figures for the quantitative
`
`approximation not only misstates what is generally prohibited, but also grossly
`
`misleads the Board with respect to the testimony of Dr. Harrigan. First, while
`
`patent drawings are not presumed to be to scale, they nonetheless form part of the
`
`disclosure especially with respect to the spatial and functional relationships
`
`illustrated in the figures. The prohibition related to reliance on figures not drawn to
`
`scale relates to specific ratios and measurements taken from the drawings, not
`
`relationships. In this instance, for example Figure 1, the figure illustrates a pair of
`
`arms on each end of the plate arranged in transverse mirror symmetry. This
`
`relationship is independent of scale, described in the specification, notes the
`
`general configuration of the plates and thus, the figures disclose the S-curve shape
`
`of the medial line which is independent of scale.
`
`
`
`Petitioner ’s characterization that “As Dr. Harrigan admitted, his analysis
`
`would change if the dimensions of the figures changed” is misleading. PR, 7. To
`
`
`
`20
`
`
`
`the contrary, Dr. Harrigan specifically testified that the medial line would describe
`
`an S-curve to a POSA under any reasonable scale. See EX-1066, 86:16-87:18.
`
`5.
`Petitioner Mischaracterizes the Prosecution Snippet It Cites
`Contrary to Petitioner’s assertion, the prosecution snippet it cites does not
`
`
`
`affirm that Figure 1 did not disclose a medial line describing an S-curve. To the
`
`contrary, the prosecuting attorney asserted that the plates having a medial line
`
`which describes an S-curve in the longitudinal or lateral direction were meant for
`
`the aspect (e.g., the superior aspect) of the clavicle having an S-shape. The 443
`
`Patent expressly discloses the plate depicted in Figure 1 as a plate suitable for use
`
`on a clavicle and having a footprint similar to many of the plates in Figures 30-47
`
`identified by Petitioner. Moreover, on cross-examination, Dr. Neufeld confirmed
`
`that the plate of Figure 1 is a plate that would be used to fit an S-curve of a
`
`clavicle:
`
`It [the plate of Figure 1] looks like it’s following -- this was designed
`for an clavicle, which has an S. So the medial line fits that S curve.
`EX-1072, 94:9-10.
`
`
`
`Thus, contrary to the Petitioner’s allegation, the prosecution snippet cited by
`
`Petitioner actually affirms that the plate of Figure 1 embodies the S-curve
`
`limitation.
`
`
`
`
`
`21
`
`
`
`B.
`
`Petitioner Fails to Carry Its Burden of Proving a POSA Would
`Combine Kay and Heinl or How the Combination Embodies the
`S-Curve Limitation
`Petitioner bears the burden of setting forth Ground 1 in sufficient detail to
`
`
`
`prove the unpatentability of the Challenged Claims. However, Petitioner offers no
`
`more than a discussion of the bendability feature of the plate of Kay and that a
`
`POSA would be motivated to “apply the S-shape of Heinl to the bone plate of
`
`Kay” and that “POSITAs desiring to bend Kay’s plate to form a lateral S-curve,
`
`like that shown in Heinl, would have understood that the bending should be done at
`
`the waist section of the trunk of Kay because, as Kay itself discloses, the decreased
`
`width of the ‘waist area’ facilitates the bending or curving of the orthopedic plate.”
`
`Petition, 40-41.
`
`
`
`In doing so, Petitioner ignores that the plate of Kay covers the same
`
`footprint as the plate of Heinl such that there is no motivation to bend the plate of
`
`Kay in view of Heinl. Petitioner also fails to provide any analysis as to how such a
`
`modified plate embodies the S-curve limitation under any interpretation, let alone
`
`the overly narrow interpretation it urges in evaluating the priority of the X-shaped
`
`plates of Kay. In other words, Petitioner fails to provide any explanation of how
`
`bending the plate of Kay laterally at its waist in view of Heinl somehow transforms
`
`the plate from being X-shaped to being S-shaped in the lateral plane.
`
`
`
`22
`
`
`
`
`
`As set forth in the POR, the plate of Kay covers substantially the same
`
`footprint as the plate of Heinl such that there would be no motivation modify Kay:
`
`Kay
`
`Heinl
`
`
`
`
`
`
`
`
`
`Petitioner also ignores that Kay discloses an embodiment of its plate that is
`
`materially the same shape as Heinl – i.e., having only a single arm at each end of
`
`its trunk. With reference to Figure 1, Kay describes the plate 10
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
