UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`Case IPR2020-00135
`Patent RE 45,776
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`SECOND DECLARATION OF PETER T. KEITH
`IN SUPPORT OF MOTIONS TO AMEND
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`Page 1
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`Teleflex Ex. 2243
`Medtronic v. Teleflex
`IPR2020-00135
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`II. WRITTEN DESCRIPTION AND INDEFINITENESS ................................. 4
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`TABLE OF CONTENTS
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`LEGAL STANDARDS ................................................................................... 2
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`A.
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`Indefiniteness ......................................................................................... 2
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`B. Anticipation ........................................................................................... 2
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`C. Obviousness ........................................................................................... 3
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`A. The Disclosed Invention Is Not Limited to Embodiments with a Side
`Opening In the Substantially Rigid Portion .......................................... 4
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`1.
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`2.
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`3.
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`The Challenged Claims ............................................................... 5
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`The specification does not require a side opening .................... 12
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`To the extent the claimed invention includes the optional side
`opening, the specification does not require that side opening to
`be in the substantially rigid portion or segment ........................ 16
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`I.
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`B. The Substitute Claims Properly Inform a POSITA About the Scope of
`the Invention ........................................................................................ 21
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`III. THE SUBSTITUTE CLAIMS ARE WITHIN THE SCOPE OF THE
`ORIGINAL CLAIMS .................................................................................... 23
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`IV. NOVELTY OF THE PROPOSED SUBSTITUTE CLAIMS ....................... 25
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`A.
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`Itou ....................................................................................................... 25
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`1.
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`Itou does not teach a structure through which “interventional
`cardiology devices,” “stents,” or “stent catheters” are insertable
`(all substitute claims) ................................................................ 25
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`Medtronic v. Teleflex
`IPR2020-00135
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`2.
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`Itou in view of Ressemann (substitute claims 23-25 of the ʼ032
`patent, 43 and 44 of the ʼ380 patent, 56-58 of the ʼ760 patent,
`58-65 of the ʼ776 patent, and 46-48 and 50-51 of the ʼ379
`patent) ........................................................................................ 27
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`i.
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`Neither Itou nor Ressemann teach or suggest the recited
`complex side opening (substitute claims 23-25 of the
`ʼ032 patent, 44 of the ʼ380 patent, 56-58 of the ʼ760
`patent, 56-58 of the ʼ760 patent, 58-62 and 64-65 of the
`ʼ776 patent, and 46-48 and 50-51 of the ʼ379 patent) .... 27
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`ii. A POSITA would not be motivation to replace Itou’s
`proximal opening with Ressemann’s support collar, and
`would not expect such a combination to be successful
`(substitute claim 23-25 of the ʼ032 patent, 44 of the ʼ380
`patent, 56-58 of the ʼ760 patent, 56-58 of the ʼ760 patent,
`58-62 and 64-65 of the ʼ776 patent, and 46-48 and 50-51
`of the ʼ379 patent) ........................................................... 29
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`3.
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`Itou in view of Kataishi (substitute claims 23-25 of the ʼ032
`patent, 43 and 44 of the ʼ380 patent, 58-65 of the ʼ776 patent,
`and 46-51 of the ʼ379 patent) .................................................... 34
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`i.
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`ii.
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`Kataishi does not disclose a complex side opening
`(substitute claim 23-25 of the ʼ032 patent, 44 of the ʼ380
`patent, 56-58 of the ʼ760 patent, 58-62 and 64-65 of the
`ʼ776 patent, and 46-48 and 50-51 of the ʼ379 patent) .... 34
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`A POSITA would not be motivated to replace Itou’s
`proximal opening with Kataishi’s distal opening, and
`would not expect such a combination to be successful
`(substitute claim 23-25 of the ʼ032 patent, 44 of the ʼ380
`patent, 56-58 of the ʼ760 patent, 58-62 and 64-65 of the
`ʼ776 patent, 46-48 and 50-51 of the ʼ379 patent) ........... 37
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`B. Kontos in View of Ressemann and Takahashi Does Not Render
`Obvious the Substitute Claims (Substitute Claims 23-25 of the ʼ032
`Patent, 43 and 44 of the ʼ380 Patent, 54-58 of the ʼ760 Patent, 58-65
`of the ʼ776 Patent, and 46-51 of the ʼ379 Patent) ............................... 42
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`ii
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`Page 3
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`Teleflex Ex. 2243
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`IPR2020-00135
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`1. Kontos does not teach a structure through which “interventional
`cardiology devices,” “stents,” or “stent catheters” are insertable
`(all substitute claims) ................................................................ 43
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`2.
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`The evidence does not show that a POSITA would be
`motivated to replace Kontos’s proximal opening with
`Ressemann’s support collar (substitute claims 23-25 of the ʼ032
`patent, 44 of the ʼ380 patent, 56-58 of the ʼ760 patent, 58-62
`and 64-65 of the ʼ776 patent, and 46-48 and 50-51 of the ʼ379
`patent) ........................................................................................ 44
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`i.
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`ii.
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`A POSITA would not be motivated to remove Kontos’s
`proximal funnel and replace it with Ressemann’s support
`collar (substitute claims 23-25 of the ʼ032 patent, 43 and
`44 of the ʼ380 patent) ...................................................... 48
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`There is no motivation for a POSITA to make the
`extensive modifications advanced in the new Kontos-
`Ressemann device (substitute claims 23-25 of the ʼ032
`patent, 43 and 44 of the ʼ380 patent) .............................. 49
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`iii. A POSITA would not expect the new Kontos-Ressemann
`combination to be successful (substitute claims 23-25 of
`the ʼ032 patent, 43 and 44 of the ʼ380 patent) ................ 54
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`There is no motivation to modify the teachings of Kontos and
`Ressemann to arrive at the claimed size limitations (substitute
`claims 23, 25 of the ʼ032 patent, 43 and 44 of the ʼ380 patent,
`54-58 of the ʼ760 patent, 63-65 of the ʼ776 patent, and 46-51 of
`the ʼ379 patent) ......................................................................... 57
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`The new Kontos-Ressemann device cannot satisfy the
`“reinforced portion” limitation (substitute claims 25 of the ʼ032
`patent, 57 of the ʼ760 patent, 63 of the ʼ776 patent, and 46-48
`of the ʼ379 patent) ..................................................................... 59
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`3.
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`4.
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`C. Kontos in View of Ressemann, Takahashi, Kataishi, and/or the
`Knowledge of a POSITA Does Not Render Obvious the Substitute
`Claims (Substitute Claims 23-25 of the ʼ032 Patent, 44 of the ʼ380
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`iii
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`IPR2020-00135
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`Patent, 56-58 of the ʼ760 Patent, and 46-48 and 50-51 of the ʼ379
`Patent) .................................................................................................. 60
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`iv
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`Page 5
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`Teleflex Ex. 2243
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`IPR2020-00135
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`I, Peter Keith, hereby declare and state as follows:
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`I have been retained by the owner of U.S. Patent Nos. 8,048,032 (“the
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`ʼ032 patent”), RE45,380 (“the ʼ380 patent”), RE45,760 (“the ʼ760 patent”),
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`RE45,776 (“the ’776 patent”), and RE47,379 (“the ʼ379 patent”), whom I refer to
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`in this declaration as “Teleflex,” to provide my independent expert opinions in
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`IPR2020-00126, IPR2020-00127, IPR202000128, IPR2020-00129, IPR2020-
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`00130, IPR2020-00132, IPR2020-00134, IPR2020-00135, IPR2020-00136,
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`IPR2020-00137, and IPR2020-00138.1
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`I submit this declaration as a supplement to my original declaration in
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`support of Teleflex’s motions to amend, as Petitioner raised new issues in their
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`Opposition to Patent Owner’s Motion to Amend to which I had not previously
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`been given an opportunity to offer testimony. Having considered Petitioner’s
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`1 Unless otherwise indicated, citations to exhibits correspond to the exhibits filed in
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`IPR2020-00126. I understand that most of Patent Owner’s and Petitioner’s
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`exhibits are numbered consistently across IPRs, with Petitioner’s exhibits having
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`the form “Ex-X_XX.” For example, Dr. Brecker’s declarations in support of the
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`Petitions were labeled with an exhibit number having the form “Ex. 1_05”, and Dr.
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`Hillstead’s declarations in support of the Petitions were labeled with an exhibit
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`number having the form “Ex. 1_42.”
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`1
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`IPR2020-00135
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`briefs in opposition to Teleflex’s motions to amend, the testimony of Petitioner’s
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`declarants, and the evidence filed by Petitioner, the opinions set forth in my
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`original declaration, as well as in my declarations filed in connection with
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`Teleflex’s Response to Petitions (Ex-2138), remain unchanged.
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`I.
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`LEGAL STANDARDS
`I am not an attorney and I have not independently researched the law
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`on patentability. I have been informed by counsel of the additional legal standards
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`set forth below.
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`Indefiniteness
`I have been informed that a patent claim, read in light of the
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`specification and prosecution history, must inform, with reasonable certainty, those
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`skilled in the art about the scope of the invention.
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` Anticipation
`I understand that a claim is invalid as anticipated if a single prior art
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`reference discloses each and every limitation of the claimed invention.
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`I understand that a reference may be anticipatory regardless of
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`whether the prior art and the claimed invention are directed to achieving the same
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`purpose, if it contains the claim elements as claimed and would inherently provide
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`any claimed function.
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`2
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`IPR2020-00135
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`I understand that a prior art reference may anticipate a claim without
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`expressly disclosing a feature of the claimed invention if that missing feature is
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`necessarily present, or inherent, in a single anticipating reference.
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`I understand that inherency requires more than a probability or
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`possibility that a claimed feature is present in the prior art, but rather that the
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`feature or characteristic is a necessary part of the prior art. I also understand that a
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`POSITA does not necessarily need to recognize the inherency at the time of the
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`purported invention.
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` Obviousness
`I understand that obviousness is determined based on (1) the scope
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`and content of the prior art; (2) the difference between the claims and the prior art;
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`(3) the level of ordinary skill in the art; and (4) objective indicia of non-
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`obviousness.
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`I understand that there must be a reason to modify a single prior art
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`reference, or to combine multiple references, to achieve the claimed invention. I
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`understand that this motivation may come from a teaching, suggestion, or
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`motivation to combine. I also understand that a specific teaching, suggestion, or
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`motivation is not required.
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`I also understand that the objective indicators of non-obviousness
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`(sometimes referred to as “secondary considerations”) must be considered in
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`3
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`IPR2020-00135
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`evaluating obviousness, including commercial success of the claimed invention,
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`whether others copied the invention, a long-felt but unmet need in a particular
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`industry and whether others in the field praised the invention. I understand that
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`secondary considerations of non-obviousness support a finding of non-obviousness
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`if the evidence is sufficiently tied to the patented features. Where a patent claims a
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`combination of features, I understand that the evidence of secondary considerations
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`may be tied to the claimed combination as a whole.
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`I understand that, after consideration of all of these factors, a patent is
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`not obvious unless the difference between the subject matter sought to be patented
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`and the prior art are such that the subject matter as a whole would have been
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`obvious at the time the invention was made to a person having ordinary skill in the
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`art to which said subject matter pertains.
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`II. WRITTEN DESCRIPTION AND INDEFINITENESS
` The Disclosed Invention Is Not Limited to Embodiments with a
`Side Opening In the Substantially Rigid Portion
`I understand that neither Petitioner nor Petitioner’s expert, Dr.
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`Zalesky, dispute that the Teleflex patents disclose and provide written description
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`support for claims to a side opening. However, I understand that Petitioner,
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`relying on Dr. Zalesky’s opinions, asserts that the specification of the Teleflex
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`patents does not support claims that “recit[e] a side opening outside of the
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`4
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`substantially rigid portion.” See, e.g., Petitioner’s Opposition to Patent Owner’s
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`Contingent Motion to Amend U.S. Patent 8.048,032 (“ʼ032 MTA Opp.”), 1.
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` As set forth in my original declaration in support of Teleflex’s
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`contingent motions to amend, I believe that the specification of the Teleflex patents
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`conveys to a POSITA that the inventors were in possession of a device where the
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`side opening was not limited to being in the substantially rigid portion or segment.
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`See generally, Ex-2124. In addition to the materials I considered in writing my
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`original declaration, (Ex-2124, ¶¶10-14), I have reviewed the Petitioner’s briefs in
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`opposition to Teleflex’s contingent motions to amend, the declaration of Paul
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`Zalesky submitted in support of Petitioner’s oppositions to Teleflex’s motions to
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`amend (Ex-1919), and the deposition transcripts of Dr. Zalesky, Mr. Jones, and Dr.
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`Brecker (Ex-2238, Ex-2240, Ex-2242; Ex-2239; Ex-2241). My opinion has not
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`changed.
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`The Challenged Claims
`1.
` Based on my review of Dr. Zalesky’s declaration and Petitioner’s
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`briefs in opposition to Teleflex’s contingent motions to amend, I understand that
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`Petitioner asserts that the following claims lack written description support because
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`they “recit[e] a side opening outside of the substantially rigid portion.” See, e.g.,
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`Patent Owner’s Corrected Contingent Motion to Amend U.S. Patent 8,048,032
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`(“ʼ032 MTA”), 1-2.
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`5
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`ʼ032 Patent: Substitute Claim 23 (Replaces Claim 1). Substitute
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`claim 23 claims a device for use with a standard 6 French guide catheter
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`comprising, in distal-to-proximal direction, “a flexible tip portion,” “a substantially
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`rigid side opening,” and “a substantially rigid portion.” ʼ032 MTA, Appx. A, 1-2.
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`The “substantially rigid side opening” includes “a first inclined region, a second
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`inclined region, and a non-inclined concave track between the first and second
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`inclined regions.” Id. at 1.
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`ʼ032 Patent, Substitute Claim 24 (Replaces Claim 11). Substitute
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`claim 24 claims a device for use with a standard guide catheter comprising an
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`elongate structure that includes “a flexible tip portion,” “a reinforced portion,” “a
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`substantially rigid portion,” and “a side opening positioned between a proximal
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`end of the reinforced portion and a distal end of the substantially rigid portion.”
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`ʼ032 MTA, Appx. A, 3-4. The side opening includes “a first inclined sidewall that
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`tapers into a non-inclined concave track that is proximate a second inclined
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`sidewall.” Id. at 4.
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`ʼ760 Patent: Substitute Claims 54-56 (Replaces Claims 37-39).
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`Substitute claims 54-56 depend from original claim 25. ʼ760 MTA, Appx. A, 1.
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`Original claim 25 claims a system comprising a guide catheter and a guide
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`extension catheter. Ex-1001 (IPR2020-00132), 13:36-14:7. The guide extension
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`catheter includes, in proximal-to-distal direction, “a substantially rigid segment,”
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`6
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`“a segment defining a side opening,” and “a tubular structure.” Id. 13:53-55. The
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`“segment defining a side opening” is formed from a material “more rigid than the
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`tubular structure.” Id. at 13:41-49. Claim 32, from which substitute claim 56
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`depends, also depends from claim 25, and additionally requires that “the segment
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`defining the side opening includes at least two inclined slopes.” Id. at 14:27-28.
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`Substitute claim 56 further requires that “the two inclined slopes are separated by a
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`non-inclined concave track.” Appendix A to Patent Owner’s Corrected Contingent
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`Motion to Amend U.S. Patent RE45,760 (“ʼ760 MTA, Appx. A”), 1.
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`ʼ760 Patent: Substitute Claim 58 (Replaces Claim 51). Substitute
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`claim 58 claims a system comprising a standard 6 French guide catheter and a
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`guide extension catheter. ʼ760 MTA, Appx. A, 5. The guide extension catheter
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`includes, in proximal-to-distal direction, “a substantially rigid rail structure
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`segment,” “a segment defining a side opening,” and “a tubular structure
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`comprising a reinforced portion and a cylindrical distal tip portion,” where “the
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`segment defining the side opening and the rail structure segment are more rigid
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`than the tubular structure.” Id. at 5, 6. The “segment defining the side opening”
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`includes “a first inclined sidewall proximate to a non-inclined region that is
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`proximate to a second inclined sidewall.” Id. at 6.
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`ʼ776 Patent: Substitute Claims 58-60 (Replaces Claims 27, 33, 37).
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`Substitute claims 58-60 depend from original claim 25. Appendix A to Patent
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`7
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`IPR2020-00135
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`Owner’s Contingent Motion to Amend U.S. Patent RE45,776 (“ʼ776 MTA, Appx.
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`A”), 1. Original claim 25 claims a guide extension catheter for use with a guide
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`catheter, comprising “a substantially rigid segment,” “a tubular structure,” and “a
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`segment defining a partially cylindrical opening.” Ex-1001 (IPR2020-00135),
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`13:36-52. The “segment defining a partially cylindrical opening” has “an angled
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`proximal end” and is “formed from a material more rigid than a material or
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`material combination forming the tubular structure.” Id. at 13:44-47. Substitute
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`claim 58 further requires that “the segment defining the partially cylindrical
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`opening” includes “a portion having an arcuate cross-sectional shape” and “a
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`portion having a non-inclined track.” ʼ776 MTA, Appx. A, 1. Substitute claim 59
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`further requires that the “segment defining the partially cylindrical opening”
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`includes “two inclined slopes separate by the non-inclined track,” and that the
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`“non-inclined track” has a “hemicylindrical cross-sectional shape.” Id. Claim 36,
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`which depends from claim 25 and from which claim 60 depends, requires that the
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`“segment defining the angled proximal end of the partially cylindrical opening
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`includes at least one inclined region that tapers into a non-inclined region.” Ex-
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`1001 (IPR2020-00135), 14:22-25. Substitute claim 60 further requires that the
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`“non-inclined region” of the “partially cylindrical opening” defines “a concave
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`track.” ʼ776 MTA, Appx. A, 1.
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`8
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`ʼ776 Patent: Substitute Claims 61-62 (Replaces Claims 42-43).
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`Substitute claim 61 claims a guide extension catheter for use with a guide catheter
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`comprising “a substantially rigid segment,” “a tubular structure defining a lumen,”
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`and “a segment defining a partially cylindrical opening.” ʼ776 MTA, Appx. A, 1-
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`2. The “partially cylindrical opening” has “an angled proximal end with an
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`inclined region” that “taper[s] into” a “non-inclined region.” Id. at 2. The
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`“partially cylindrical opening” is “formed from a material more rigid than a
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`material or material combination forming the tubular structure.” Id. The “segment
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`defining the partially cylindrical opening” comprises “a continuation of the metal
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`rail structure,” which is “processed to increase the flexibility of the segment
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`defining the partially cylindrical opening.” Id. at 3. Substitute claim 62 further
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`requires that the flexibility increase is achieved by “forming transverse relief cuts
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`in the segment defining the partially cylindrical opening.” Id.
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`ʼ776 Patent: Substitute Claim 65 (Replaces Claim 56). Substitute
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`claim 65 depends from original claim 52. ʼ776 MTA, Appx. A, 5. Original claim
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`52 claims a guide extension catheter for use with a guide catheter comprising “a
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`substantially rigid segment,” a “tubular structure,” and “a segment defining a
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`partially cylindrical opening.” Ex-1001 (IPR2020-00135), 15:15-34. The
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`“segment defining the partially cylindrical opening” has “an angled proximal end,
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`formed from a material having a greater flexural modulus than a flexural modulus
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`of the tubular structure.” Id. at 15:22-26. The “segment defining the angled
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`proximal end of the partially cylindrical opening” includes “at least two inclined
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`regions.” Id. at 32-34.
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`ʼ379 Patent: Substitute Claims 46-47 (Replaces Claims 25, 29).
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`Substitute claim 46 claims a method of forming a device adapted for use with a
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`standard 6 French guide catheter, the method comprising “providing a flexible tip
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`segment,” “providing a reinforced segment,” “providing a substantially rigid
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`segment,” and “defining a side opening portion.” Appendix A to Patent Owner’s
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`Corrected Contingent Motion to Amend U.S. Patent RE47,379 (“ʼ379 MTA Opp.,
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`Appx. A”), 1. The “side opening portion” comprises a “first inclined region that
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`transitions to a uniform non-inclined region that forms a concave track that
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`transitions to a second inclined region,” and defining the “side opening portion”
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`includes forming in proximal-to-distal direction “an arcuate cross-sectional shape
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`and a hemicylindrical cross-sectional shape.” Id. Substitute claim 47 depends
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`from substitute claim 46 and incorporate the same “side opening portion” set forth
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`therein. Id. at 2.
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`ʼ379 Patent: Substitute Claims 49-51 (Replaces Claims 38, 43, 45).
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`Substitute claim 49 claims a method of forming a device adapted for use with a
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`standard guide catheter, the method comprising “providing a flexible tip segment,”
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`“providing a reinforced segment,” “providing a substantially rigid segment,” and
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`“defining a side opening portion.” ʼ379 MTA Opp., Appx. A, 3-4. Defining the
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`“side opening portion” includes forming in proximal-to-distal direction “an arcuate
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`cross-sectional shape and a hemicylindrical cross-sectional shape.” Id. at 4.
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`Substitute claim 50 incorporates the limitations of substitute claim 49 and further
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`requires that defining the “side opening portion” includes “forming an inclined
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`region that tapers into a non-inclined concave track in the side opening portion.”
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`Id. at 5. Substitute claim 51 incorporates the limitations of substitute claim 49 and
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`further requires that “defining the side opening portion” includes “forming a first
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`inclined sidewall, forming a second inclined sidewall, and separating the first
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`inclined sidewall and the second inclined sidewall by a non-inclined concave
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`track.” Id. at 5.
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`In short, I understand that Petitioner contests the written description
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`support for all substitute claims that require a side opening that is not limited to
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`being in the claimed substantially rigid portion.
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`I further understand that Petitioner does not contest that substitute
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`claim 43 of the ʼ380 patent, which does not claim a side opening, but rather claims,
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`among other things, a tubular structure with a lumen, has sufficient written
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`description support. See generally Patent Owner’s Contingent Motion to Amend
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`U.S. Patent RE45,380 (“ʼ380 MTA Opp.”); Ex.-2242, 45:18-46:7, 46:22-47:4,
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`47:21-48:10.
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`The specification does not require a side opening
`2.
` The ʼ629 application does not indicate that a side opening is a critical
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`feature of the invention. The “Summary of the Invention” describes the invention
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`broadly, and indicates that the rigid portion only “preferably” has a cutout portion
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`constituting a side opening. Ex-1003, 8:17-18.2 Dr. Zalesky identifies the
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`Summary of the Invention as requiring a side opening in the substantially rigid
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`portion (Ex-1919, ¶30), but I understand that the terms “preferably” and “may” to
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`indicate that the disclosed configuration is just a possible configuration, not a
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`required configuration.
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` According to the ʼ629 application, the proximal opening can take
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`more than one form. For example, the ʼ629 application teaches that the proximal
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`opening can take the form of an “end” or “perpendicular” opening, as shown, for
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`example, in Figures 20 and 21:
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`
`2 Exhibit 1003 is the original application for the ʼ032 patent, filed in IPR2020-
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`00126. Citations are to the exhibit page number indicated in the exhibit footer, and
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`not the actual page number of the application as filed with the USPTO.
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`Ex-1003, 44 (Figs. 20, 21). Petitioner’s expert, Dr. Zalesky, agrees. Ex-1919, ¶25;
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`Ex-2242, 41:15-42:7. The perpendicular opening in this embodiment is fairly
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`described as being in the tubular structure. The specification does not indicate
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`whether the proximal end of that tubular structure is particularly rigid or flexible,
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`thus confirming that the relative rigidity of the opening is not critical to the
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`invention.
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` Alternatively, the ʼ629 application shows that the opening could be an
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`“angled” or “side” opening. For example, the angled opening is shown in Figures
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`4 and 12-16:
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`Ex-1003, 35, 41 (Figs. 4, 12-16). Dr. Zalesky agrees that the application teaches
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`that the proximal opening can be an “angled” or “side” opening. Ex-2242, 42:10-
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`
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`20.
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` Nothing in the specification states that either type of opening is
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`critical to the invention. In his deposition, Dr. Zalesky agreed. Ex-2242, 63:17-
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`22; 64:9-65:6; 75:21-24; 79:19-82:1. I also understand that Petitioner and its
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`expert both agree that claims that do not specify that the opening at the proximal
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`end of the tubular structure be a side opening do not have a written description
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`problem. See ʼ380 MTA Opp. (no written description challenge for substitute
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`claim 43, which does not require a side opening); see also Ex-2242, 44:14-45:17,
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`45:18-46:7, 46:22-47:4; 47:21-48:10. Accordingly, if the claim need not recite that
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`the opening is a side opening, it is my opinion that it does not make sense to assert
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`that a claim that does recite that the opening is a side opening must place the side
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`opening in a particular claimed segment or portion (or, as Petitioner asserts, a
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`particular “location”) to have adequate written description support.
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`
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`I note that, for other features of the invention, Dr. Zalesky does not
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`believe that a particular type of feature is required even when certain types are
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`disclosed in the ʼ629 application. For example, Dr. Zalesky agrees that, although
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`the ʼ629 application says that the reinforced portion could be made of a braid or a
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`coil (Ex-1003, 8:12-14), there is no written description problem if the claims just
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`require a “reinforced portion” without requiring either one of a braid or a coil. Ex-
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`2242, 137:2-138:14.
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`
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`I do not believe that a POSITA would understand the written
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`description support provided by the ʼ629 application as indicating the criticality of
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`a particular type of proximal opening. Because the ʼ629 application does not
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`require a particular type of proximal opening, I understand that it also does not
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`require that a side opening, when claimed, must reside in the substantially rigid
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`portion.
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`3.
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`To the extent the claimed invention includes the optional
`side opening, the specification does not require that side
`opening to be in the substantially rigid portion or segment
` As set forth in my opening declaration, the specification provides
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`support for an opening located outside of the substantially rigid portion. For
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`example, Figures 20 and 21 of the ʼ629 application teach that the proximal opening
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`is part of a tubular portion made of polymer, not the substantially rigid portion.
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`Petitioner’s expert, Dr. Zalesky, agrees. Ex-2242, 41:15-42:7; Ex-1919, ¶25.
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`Figure 1 also shows an opening that is located in the reinforced portion 18, which
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`is made of polymer and may include a braid or coil. Ex-1003, 14:17-20. Figure 1
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`is shown below:
`
`Ex-1003, 32. Based on the lead lines, the proximal opening of Figure 1 is not
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`shown to be in the rigid portion 20. Alternatively, as shown by Figures 4 and 12-
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`16, the opening could also be located in the rigid portion. Nothing in the
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`specification states or implies that the specific claimed portion segment the
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`proximal opening is located in is critical to the invention.
`
` Dr. Zalesky points to the fact that the specification shows examples of
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`a side opening in the portion that is identified as the rigid portion. Ex-1919, ¶¶31-
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`46 (citing Ex-1003, 15:8-17, Figs. 4, 12-16, 19:12-18). These disclosures,
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`however, simply show exemplary embodiments of the invention, which, as Dr.
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`Zalesky concedes, do not amount to statements of criticality. Ex-2242, 79:19-82:1;
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`82:12-83:10.
`
` Dr. Zalesky also opines that the specification requires the side
`
`opening to be located in the substantially rigid portion because the substantially
`
`rigid portion and the side opening must be part of the same “monolithic metal
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`tube.” Ex-1919, ¶49. I disagree. Nothing in the specification indicates that the
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`substantially rigid portion alone (much less the substantially rigid portion and the
`
`side opening) must be a single “monolithic metal tube.”
`
`
`
`Indeed, the ‘629 application expressly teaches that, while the rigid
`
`portion “may” be formed from a hypotube (which could be a monolithic metal
`
`tube), the substantially rigid portion can be made out of “other substantially rigid
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`materials,” which would include polymers that were available in 2005. Ex-1003,
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`15:5, 16:18-19. I understand that Dr. Zalesky agrees. Ex-2242, 59:9-60:17, 61:5-
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`12. The ‘629 application also teaches that the substantially rigid portion could be
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`made of nitinol, which is significantly more flexible than stainless steel, and
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`teaches the use of relief cuts that could be used to significantly increase the
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`flexibility of certain portions of the device. Ex-1003, 15:5, 18:15-19:11. Here,
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`too, I understand that Dr. Zalesky agrees. Ex-2242, 58:1-7, 54:7-14, 57:1-25.
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` Regardless of whether the side opening was formed out of the exact
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`substantially rigid materials described in the specification or other materials that
`
`are compatible with the intended purpose of the proximal opening, a POSITA
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`would understand that the principal function of the side opening—facilitating the
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`entry of interventional cardiology devices into the proximal portion of the tubular
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`structure while the guide extension catheter is disposed within the guide catheter—
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`would still be served. A POSITA reading Teleflex’s disclosure in 2005 would
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`have known that the side opening could be made out of metal or polymer, that
`
`relief cuts could be used to increase flexibility, and/or that different types of
`
`material and thickness of the material could be used. Petitioner’s experts, Dr.
`
`Zalesky and Mr. Jones both agree. Ex-2242, 62:6-63:16, 89:23-90:3; Ex-2241,
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`150:3-155:1. Moreover, assigning clear rigidity-based demarcations to the
`
`invention would be inconsistent with the understanding of a POSITA, particularly
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`when the ʼ629 application discloses a variety of suitable materials for any given
`
`portion. Ex-2124, ¶33.
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` Taking together the disclosure of the ʼ629 application and the
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`knowledge of a POSITA, a POSITA would understand that the side opening could
`
`be, in different embodiments, part of various segments or formed of v