UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NEOCHORD, INC.
`
`Petitioner,
`v.
`UNIVERSITY OF MARLY AND, BALTIMORE
`
`Patent Owner.
`
`Case No.: IPR2016-00208
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 7,635,386
`
`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
`
`Table of Contents
`
`Table of Contents ....................................................................................................... i
`
`'fi
`...
`.
`fS
`ertJ 1cate o
`erviCe ................................................................................................ 111
`C
`
`List of Evidence and Exhibits Relied Upon in the Petition ..................................... iv
`
`I.
`
`II.
`
`III.
`
`IV.
`
`v.
`
`INTRODUCTION .................................................................................... 1
`
`MANDATORY NOTICES UNDER37 C.P.R. §42.8(a)(1) ................... 2
`
`A. Real Party-In-Interest Under 37 C.F.R. §42.8(b)(l) ........................... 2
`
`B. Related Matters Under 37 C.F.R. §42.8(b)(2) ..................................... 2
`c. Lead and Back-Up Counsel Under 37 C.F.R. §42.8(b)(3) .................. 2
`
`D. Service Information Under 37 C.F.R. §42.8(b)(4) ............................... 3
`
`PAYMENT OF FEES REQUIRED BY 37 CFR §42.15(a) .................... 3
`
`SUMMARY OF THE '386 PATENT.. .................................................... 3
`
`A. Description of the Claimed Invention of the '386 Patent ................... 3
`
`B. Summary of the Prosecution History of the '386 Patent .................... 4
`
`REQUIREMENTS UNDER 37 C.F.R. §42.104 ..................................... 6
`
`A. Grounds for Standing Pursuant to 37 C.F.R. §41.104(a) ................... 7
`
`B. Identification of Challenged Claims and Relief Requested
`Pursuant to 37 C.F.R. §41.104(b)(l) ..................................................... 7
`
`C. The Specific Art and Statutory Ground(s) on Which the
`Challenge Is Based Pursuant to 37 C.F.R. §41.104(b)(2) ................... 7
`
`I
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`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
`
`D. How the Challenged Claims Are Construed Pursuant to
`37 C.F.R. §41.204(b)(3) .......................................................................... 8
`1.
`Medical/physiological terms ...................................................... 9
`"
`I
`.
`f h
`9
`rt"
`t"
`.
`.
`2
`.
`crea mg an access m an ap1ca reg10n o . a ea
`................... ..
`3.
`"percutaneously accessing an apical region of a heart" ........... 11
`4.
`"replacing ... chordae tendinae" .............................................. 12
`5.
`"a suture with one or more leaflets of the heart" ..................... 13
`6.
`"endovascularly via [an antegrade/a retrograde] approach" .... 15
`
`VI.
`
`DETAILED EXPLANATION OF PERTINENCE AND MANNER
`OF APPLYING CITED PRIOR ART TO EVERY CLAIM FOR
`WHICH REVIEW IS REQUESTED ..................................................... 17
`
`A. Person of Ordinary Skill in the Art .................................................... 17
`
`B. Applicable Law ..................................................................................... 18
`
`C. U.S. Patent No. 8,465,500 to Speziali .................................................. 20
`1.
`Claims 1, 3, 7-17, 19 and 22-23 are anticipated by Speziali .... 20
`2.
`Claims 2 and 4 are obvious over Speziali ................................ 26
`Claims 5-6, 18 and 20-21 are obvious over Speziali in
`3.
`view ofBachman ...................................................................... 27
`
`D. U.S. Patent No. 6,978,176 to Lattouf (Lattouf I) ............................... 30
`1.
`Obviousness over Lattoufl in view of Carpentier ................... 31
`2.
`Obviousness over Lattouf I in view of
`Carpentier and Downing .......................................................... 38
`Obviousness over Lattoufl in view of Bachman ..................... 40
`Obviousness over Lattoufl in view of Downing ..................... 43
`
`3.
`4.
`
`E. U.S. Patent No. 7,871,433 to Lattouf (Lattouf 11) .............................. 47
`1.
`Claims 1, 3, 5-9, 11-15, 17-19 and 22-23 are anticipated by
`Lattouf II ................................................................................... 48
`Remaining dependent claims are obvious over Lattoufii in
`view of Downing ...................................................................... 51
`
`2.
`
`F. U.S. Patent No. 6,840,246 to Downing ................................................ 52
`1.
`Obviousness over Downing in view of U.S. Patent No.
`6,269,819 to Oz ........................................................................ 53
`
`VII.
`
`Conclusion .............................................................................................. 60
`
`11
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`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
`
`Certificate of Service
`
`I hereby certify that on November 18, 2015, a copy of this Petition and
`
`Exhibits 1001-1011 were served by Federal Express on the following counsel of
`
`record for the Patent Owner:
`
`Squire PB (NV A/DC Office)
`8000 Towers Crescent Drive
`14th Floor
`Vienna, VA 22182-6212
`
`Dated: November 18, 2015
`
`Respectfully submitted,
`
`Brad D. Pedersen
`Reg. No. 32,432
`
`Attorney for Petitioner
`
`l1I
`
`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
`
`List of Evidence and Exhibits Relied Upon in the Petition
`
`Exhibit#
`
`Name
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`U.S. Patent No. 7,635,386 (the '386 Patent)
`
`Power of Attorney for Petitioner NeoChord, Inc.
`
`Prosecution History for the '386 Patent
`
`U.S. Patent No. 6,978,176 (Lattouf I)
`
`U.S. Patent No. 6,840,246 (Downing)
`
`U.S. Patent No. 8,465,500 (Speziali)
`
`U.S. Patent No. 7,871,433 to (Lattoufll)
`
`U.S. Publ. No. 2004/0044365 (Bachman)
`
`Cardiac valve surgery - the "French Correction " by Alain
`Carpentier, M.D., The Journal of Thoracic and
`Cardiovascular Surgery, Vol. 86, No.3, September 1983
`(Carpentier)
`
`U.S. Patent No. 6,269,819 (Oz)
`
`Declaration of Dr. Lishan Aklog
`
`IV
`
`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
`
`I.
`
`INTRODUCTION
`
`U.S. Patent No. 7,635,386 (the '386 Patent) is directed to a cardiac
`
`procedure that creates an access in an apical region of a heart through which
`
`instruments may be inserted to repair a cardiac valve. Ex.1 001, Abstract. The
`
`independent claims of the '386 Patent are directed to implantation of artificial heart
`
`valve chordae tendineae into malfunctioning valve leaflets to restore proper leaflet
`
`function.
`
`As of the earliest priority date ofthe '386 Patent in 2006, minimally invasive
`
`procedures were already known for implantation of artificial chordae to repair a
`
`heart valve through an apical access of a beating heart. The '386 Patent was
`
`improperly allowed by the Examiner only after the independent claims were
`
`amended to recite using sutures with the leaflet as the artificial chordae to repair
`
`the malfunctioning valve and incorrect arguments were made as to the teachings of
`
`the cited prior art relative to these amendments.
`
`Not only does the cited art actually teach what was incorrectly argued by
`
`Patent Owner as missing, other unapplied and/or uncited prior art also establishes
`
`that Petitioner has a reasonable likelihood of prevailing on the grounds presented
`
`in this Petition that at least one of the claims of the '386 Patent is invalid as
`
`anticipated and/or obvious. Petitioner therefore respectfully requests that an Inter
`
`Partes Review (IPR) of the '386 Patent be instituted.
`
`1
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`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. §42.8(a)(l)
`
`The following mandatory notices under the Rules are provided.
`
`A.
`
`Real Party-In-Interest Under 37 C.F.R. §42.8(b)(l)
`
`Petitioner certifies and submits that the real party-in-interest for this Petition
`
`is NeoChord, Inc., a Minnesota corporation. Ex.l 002.
`
`B.
`
`Related Matters Under 37 C.F.R. §42.8(b)(2)
`
`Petitioner is unaware of any other judicial or administrative matter that
`
`would affect, or be affected by, a decision in this proceeding.
`
`C.
`
`Lead and Back-Up Counsel Under 37 C.F.R. §42.8(b)(3)
`
`Petitioner designates lead and backup counsel as:
`
`Lead Counsel
`
`Brad D. Pedersen
`
`Reg. No. 32,432
`
`Backup Counsel
`
`Eric H. Chadwick, Chad J. Wickman
`
`Reg. No. 41,664, Reg. No. 58,356
`
`Patterson Thuente Pedersen, P .A.
`
`Patterson Thuente Pedersen, P.A.
`
`
`
`80 South 81h Street, Suite 4800
`
`
`
`80 South 81h Street, Suite 4800
`
`Minneapolis, MN 55402
`
`Minneapolis, MN 55402
`
`Phone: 612.349.5774
`
`Phone: 612.349.5740
`
`Fax: 612.349.9266
`
`chadwick@ptslaw.com,
`
`pedersen@ptslaw.com
`
`wickman@ptslaw.com
`
`2
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`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
`
`D.
`
`Service Information Under 37 C.F.R. §42.8(b)(4)
`
`Papers concerning this matter should be served on lead and backup counsel
`
`as designated in Section II( C), with a courtesy e-mail copy to: prps@ptslaw.com.
`
`Petitioner hereby consents to email service of any papers in this proceeding.
`
`III. PAYMENT OF FEES REQUIRED BY 37 CFR §42.15(a)
`
`Payment of the fees is made concurrently with the filing of this Petition via
`
`the USPTO EFS payment system. The Director is authorized to charge any
`
`additional fees that might be due in connection with this Petition to Deposit
`
`Account No. 16-0631.
`
`IV. SUMMARY OF THE '386 PATENT
`
`A.
`
`Description of the Claimed Invention of the '386 Patent
`
`The two independent claims (1 and 19) of the '386 Patent are each directed
`
`to a method of repairing heart valves. The claims recite: (i) creating an access in an
`
`apical region of the heart through which a device is inserted, and (ii) using that
`
`device to repair the heart valve by replacing chordae tendineae and implanting
`
`artificial chordae tendineae that comprise a suture with one or more leaflets of the
`
`heart. Ex.lOOl, 20:41-52,22:6-14.
`
`The result of this method is shown in Figure 9 of the '386 Patent, which
`
`depicts a suture (990) inserted through a leaflet (980) and anchored adjacent the
`
`apical region (902) at the apex of the heart (900). !d., 13:60-62.
`
`3
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`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
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`VA"'-990
`
`900~
`
`FIG. 9
`
`B.
`
`Summary of the Prosecution History of the '386 Patent
`
`The '386 Patent issued from U.S. Application No. 11/683,282, filed as a
`
`non-provisional patent application on March 7, 2007, and claiming priority to U.S.
`
`Provisional Application No. 60/780,521, filed March 7, 2006. Ex.lOOl. The '386
`
`Patent is governed by U.S. patent laws prior to the America Invents Act (pre-AlA).
`
`The prosecution of the '386 Patent included only a single Office Action.
`
`Ex.1003, pp.21-26. The independent claims and some dependent claims were
`
`initially rejected as being anticipated by U.S. Patent No. 6,978,176 (Lattouf I). The
`
`remaining dependent claims were rejected as being obvious over Lattouf I in view
`
`of U.S. Patent No. 6,840,246 (Downing) or U.S. Patent No. 7,291,168 to Macoviak
`
`et al.
`
`4
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`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
`
`Patent Owner responded with an Amendment cancelling dependent claims 2
`
`and 25 and amending independent claim 1 and independent claim 21 (issued as
`
`independent claim 19). Ex.1003, pp.6-10. Language was added to the independent
`
`claims to recite that repairing the valve comprises replacing chordae and
`
`implanting artificial chordae that comprise a suture with leaflets of the heart. Claim
`
`1 as amended reads:
`
`I. (Currently Amended) A method for repairing a defective mitral or
`
`tricuspid valve, comprising:
`
`creating an access in anthe ap6* apical region of a heart through
`
`which a defective cardiac valve is accessed;
`
`introducing a device through said access; and
`
`repairing said cardiac valve by use of said device,
`
`wherein the repairing comprises
`
`replacing one or more chordae tendineae, and
`
`using said device to implant one or more artificial
`
`chordae tendineae, and
`
`wherein the one or more artificial chordae comprises a suture with
`
`one or more leaflets of the heart.
`
`!d., p.6.
`
`Patent Owner argued that the distinguishing feature of the amended claims
`
`over the cited art was the use of a suture with a valve leaflet:
`
`Lattouf fails to disclose or suggest that the strand includes a suture in
`
`the leaflets. Accordingly, Lattouf fails to disclose or suggest, at least,
`
`"wherein the one or more artificial chordae comprises a suture with
`
`5
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`

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`Petition for Inter Partes Review of U.S. Patent 7,635,386
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`one or more leaflets of the heart," as recited in independent claim I
`
`and similarly recited in independent claim 21. In contrast, Lattouf
`
`refers to the strand having one end secured to the clip, as discussed
`
`above. Lattouf refers to suturing the strand with only the pledget, as
`
`mentioned above, not the leaflets.
`
`!d., pp.l3-I4.
`
`With respect to the secondary reference Downing, Patent Owner cited solely
`
`to an embodiment for repair "of a mitral valve uses staples which may be banded
`
`together with a strip of material," and argued that Downing also did not teach the
`
`limitations urged as missing from Lattouf. !d., pp.l6-I7. Patent Owner concluded
`
`that, "Downing is silent as to teaching the particular features associated with the
`
`artificial chordae of independent claims I and 21." !d., p.17.
`
`Patent Owner did not separately argue for the patentability of any dependent
`
`claims. Id., p.I6. A Notice of Allowance was mailed in response to the
`
`Amendment, but no Reasons for Allowance were provided. !d., pp.l-4.
`
`The entire basis of Patent Owner's argument for patentability that resulted in
`
`allowance of the claims of the '386 Patent was that neither Lattouf I nor Downing
`
`taught using a suture with the valve leaflet as an artificial chordae.
`
`V.
`
`REQUIREMENTS UNDER 37 C.F.R. §42.104
`
`As set forth below, Petitioner submits that each requirement for institution of
`
`an IPR of the '386 Patent is satisfied.
`
`6
`
`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
`
`A.
`
`Grounds for Standing Pursuant to 37 C.F.R. §41.104(a)
`
`Petitioner certifies and submits that the '386 Patent is available for IPR, and
`
`that Petitioner is not barred or estopped from filing this Petition. Ex.1 002.
`
`B.
`
`Identification of Challenged Claims and Relief Requested
`Pursuant to 37 C.F.R. §41.104(b)(l)
`
`The precise relief requested by Petitioner is that claims 1-23 of the '386
`
`Patent be found unpatentable.
`
`C.
`
`The Specific Art and Statutory Ground(s) on Which the
`Challenge Is Based Pursuant to 37 C.F.R. §41.104(b)(2)
`
`Petitioner requests an IPR of the '386 Patent be instituted for any/all of the
`
`following grounds ofunpatentability under pre-AlA 35 U.S.C. §102 (anticipation)
`
`and pre-AlA 35 U.S.C. § 103 (obviousness):
`
`Ground 1- U.S. Patent No. 8,465,500 (Speziali)
`
`lA. Claims 1, 3, 7-17, 19 and 22-23 are anticipated by Speziali
`
`lB. Claims 2 and 4 are obvious over Speziali
`
`lC. Claims 5-6, 18 and 20-21 are obvious over Speziali in view of
`
`U.S. Publ. No. 2004/0044365 (Bachman).
`
`Ground 2- U.S Patent No. 6,978,176 (Lattoufl)
`
`2A. Claims 1-9, 11-15, 17-19 and 22-23 are obvious over Lattoufl
`
`in view of Cardiac valve surgery- the "French Correction" by
`
`Alain Carpentier, M.D., The Journal of Thoracic and
`
`7
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`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
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`Cardiovascular Surgery, Vol. 86, No. 3, September 1983
`
`(Carpentier)
`
`2B. Claims 10, 16 and 20-21 are obvious over Lattoufl in view of
`
`Carpentier and further in view of US Patent No. 6,840,246
`
`(Downing)
`
`2C. Claims 1, 2-9, 11, 14-15 and 17-23 are obvious over Lattoufl
`
`in view of U.S. Pub!. No. 2004/0044365 (Bachman)
`
`2D. Claims 1-23 are obvious over Lattoufl in view of Downing
`
`Ground 3- U.S. Patent No. 7,871,433 (Lattoufll)
`
`3A. Claims 1, 3, 6-9, 11-15, 17-19 and 22-23 are anticipated by
`
`Lattoufll
`
`3B. Claims 2, 4, 10, 16 and 20-21 are obvious over Lattouf II in
`
`view of Downing
`
`Ground 4- U.S Patent No. 6,840,246 (Downing)
`
`4A. Claims 1-13 and 19-23 are obvious over Downing in view of
`
`U.S. Patent No. 6,269,819 (Oz)
`
`4B. Claims 14-18 are obvious over Downing in view of Oz and
`
`further in view ofLattoufi
`
`D.
`
`How the Challenged Claims Are Construed Pursuant to 37 C.F.R.
`§41.204(b )(3)
`
`A claim in IPR is given the "broadest reasonable construction in light of the
`
`8
`
`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
`
`specification." 37 C.F.R. §41.200(b); In re Cuozzo Speed Techs., 778 F.3d 1271,
`
`1279 (Fed. Cir. 2015). To the extent that may be necessary under this standard,
`
`Petitioner has set forth the broadest reasonable interpretation (BRI construction) of
`
`certain of the claim terms below. 1
`
`1. Medical/physiological terms
`
`Various claims of the
`
`'386 Patent recite a number of medical and
`
`physiological
`
`terminology
`
`that Petitioner submits need no specific BRI
`
`construction because such terms would be readily understood and given their plain
`
`and ordinary meaning. Such terms have been defined in the Aklog Declaration for
`
`the purpose of setting forth an understanding of the technical background of the
`
`'386 Patent. Ex.1011, ~15-29.
`
`2.
`
`"creating an access in an apical region of a heart"
`
`Claim 1 of the '386 Patent recites "creating an access in an apical region of
`
`a heart through which a defective cardiac valve is accessed." For BRI construction
`
`an "apical region of a heart" encompasses a region of the heart near its apex, but
`
`this terminology does specify any particular anatomical parts or features of this
`
`region of the heart. Ex.1 011, ~~16 and 40. For BRI construction, the term "access"
`
`in this claim limitation is used as a noun that defines an opening in the apical
`
`1All discussions in the Petition of BRI construction are presumed to be as
`
`understood by a person of ordinary skill in the art at the time of invention.
`
`9
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`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
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`region of the heart "through which a defective cardiac valve is accessed" as
`
`claimed later in the claim. Ex. lOll, ~17. Fig. 5 of the '386 Patent is identified as
`
`illustrating "an access created in the apex region of the heart." Ex.1 001, 10:8-17.
`
`As shown below, Fig. 5 depicts the "access" of claim 1 as an entry (504). The entry
`
`(504) is described as being made by "an incision into the apical region of the
`
`appropriate ventricle (e.g., 520) of the heart." !d.
`
`520
`
`\~504
`J:1"552
`'\..550
`
`FIG. 5
`
`While there are natural openmgs m the supenor regions of the heart
`
`constituting the four heart valves and great vessels, there are no natural openings in
`
`the apical region of the heart. Ex. lOll, ~42. Therefore, the use of the term "access"
`
`in claim 1 must be construed consistent with the specification of the '386 Patent to
`
`be an entry surgically created by an incision or puncture in the wall of the heart.
`
`Ex. lOll, ~43. Accordingly, the BRI construction of "creating an access in an
`
`10
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`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
`
`apical region of a heart" in claim 1 is "creating an incision or puncture in a wall of
`
`the heart in the region near the apex of the heart." Ex.1 011, ~44.
`
`3.
`
`"percutaneously accessing an apical region of a heart"
`
`Claim 19 of the '386 Patent recites "percutaneously accessing an apical
`
`region of a heart with a catheter-based device." For BRI construction, the
`
`terminology "percutaneously accessing" is used as a verb phrase that defines,
`
`consistent with the remainder of claim 19, the process of obtaining access through
`
`the skin to a chamber of the heart with a catheter-based device for "repairing a
`
`cardiac valve by use of said device" as claimed later in the claim. Ex.l 011, ~45.
`
`The '386 Patent discusses several embodiments that are referred to as
`
`percutaneous, including a direct needle access method. Ex.1001, 6:54-7:50. There
`
`is also a brief discussion of a "completely percutaneous" embodiment in which
`
`"[t]hese methods may also be performed in a completely percutaneous manner; for
`
`instance via the femoral or internal jugular veins, via the inter-atrial septum (trans(cid:173)
`
`septal) and then into the left atrium, or via a retrograde approach (femoral artery,
`
`across aortic valve)." Ex.1001, 6:27-31. This passage, and dependent claims 20
`
`and 21, seem to describe an endovascular technique in which access is primarily
`
`obtained by routing the catheter through the vascular system instead of by direct
`
`needle access to the heart; however, there are no figures in the '386 Patent showing
`
`this "completely percutaneous" embodiment. Ex.1011, ~46.
`
`11
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`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
`
`Unlike the construction of claim 1, there is nothing in claim 19 that requires
`
`the accessing method to be limited to creating an incision in a wall of the heart.
`
`There is nothing in the claim language of claim 19 that restricts the accessing
`
`method to a particular embodiment of the method of accessing to either direct or
`
`endovascular percutaneous accessing of the heart, let alone restricting the
`
`accessing method to a method of direct percutaneous access through a wall of the
`
`heart in the apical region. Ex.1 011, ~46. Accordingly, the BRI construction of
`
`"percutaneously accessing an apical region of a heart" in claim 19 as properly
`
`construed and understood by a person skilled in the art is "the process of obtaining
`
`access through the skin to a region of a ventricular chamber of the heart near the
`
`apex of the heart." Id.
`
`4.
`
`"replacing ... chordae tendinae"
`
`Independent claim 1 recites "replacing one or more chordae tendinae" and
`
`independent claim 19 recites "replacing at least one chordae tendinae." The '386
`
`Patent describes that a damaged chordae tendinae is "replaced" by inserting a
`
`suture as a replacement chordae. Jd., 13:42-45 ("Once fully implanted, the
`
`suture(s) acts as a neo-cord, replacing damaged and ruptured chordae tendinae and
`
`restoring proper leaflet function.")
`
`There is no express teaching in the '386 Patent that the "replaced" native
`
`chordae is physically removed from the valve. Id., 10:60-67 ("[I]f one or more of
`
`12
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`

`
`Petition for Inter Partes Review of U.S. Patent 7,635,386
`
`the chordae tendinae are ruptured, elongated or fused, they can be replaced in
`
`accordance with the methods disclosed herein, with one or more artificial cords or
`
`by transferring redundant cords from another leaflet section. Shrunken or fused
`
`cords can be released or split by precisely cutting the affected cords, and even the
`
`papillary muscles, themselves, can be shortened to correct prolapse from multiple
`
`elongated cords."). Rather, for purposes of the BRI construction, it is not the
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`physical structure, but the function of the pathologic chordae that is replaced.
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`Ex.1 011, IJIJ47-48. Accordingly, to the extent it can be understood under the claim
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`construction standard used for this Petition, the BRI construction of the
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`terminology "replacing ... chordae tendinae" as used in the claims of the '386
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`Patent means "replacing the function of the native chordae tendineae with an
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`artificial chordae tendineae. " 2 Ex.1 011, IJ49.
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`5.
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`"a suture with one or more leaflets of the heart"
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`2Petitioner notes that claim 1 recites both "replacing one or more chordae
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`tendineae, and using said device to implant one or more artificial chordae
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`tendineae" (emphasis added). Although not at issue in this proceeding, the
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`presence of the word "and" presents 35 U.S.C. § 112 issues in view of the seeming
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`redundancy of the limitations. For purposes of this Petition, these limitations have
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`been construed as indicated without waiving any right to challenge the validity of
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`the claims on this basis in any subsequent proceeding.
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`Petition for Inter Partes Review of U.S. Patent 7,635,386
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`Both independent claims 1 and 19 of the
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`'386 Patent recite that the
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`implanted artificial/replacement chordae "comprises a suture with one or more
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`leaflets of the heart." The specification of the '3 86 Patent does not define or even
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`use the phrase "a suture with one or more leaflets."3 However, Patent Owner
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`argued extensively regarding this limitation in the one Office Action response
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`submitted during prosecution of the '386 Patent.
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`Patent Owner relied on this limitation as the only basis for patentability of
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`the claims during prosecution. Patent Owner distinguished this limitation from
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`Lattouf I by arguing that Lattouf I only taught connecting a suture to a leaflet clip
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`that is connected to a leaflet or to a pledget. Patent Owner further argued that
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`neither of these types of connections in Lattouf I meet this limitation. Ex.1 003,
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`pp.l3-14. Patent Owner therefore is presumed, solely for purposes of this Petition,
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`3 Petitioner notes that this limitation is ambiguous and unclear in that the use of
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`the word "with" implies that the artificial chordae comprises both the suture and
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`the leaflet. Although not at issue in this proceeding, the use of the word "with"
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`presents 35 U.S.C. § 112 issues in view of the plain reading of the limitation. For
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`purposes of this Petition, this limitation has been construed as indicated without
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`waiving any right to challenge the validity of the claims on this basis in any
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`subsequent proceeding.
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`Petition for Inter Partes Review of U.S. Patent 7,635,386
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`to have defined "a suture with one or more leaflets" as requiring the suture to be
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`inserted directly through the leaflet tissue, rather than to another structure that was
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`connected directly to a
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`leaflet. This interpretation is consistent with the
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`specification of the '386 Patent, which describes grasping a leaflet and inserting a
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`needle through the leaflet to implant a suture through the leaflet tissue. Ex.lOOl,
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`12:2-13:46 and Fig. 9.
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`Accordingly, the BRI construction of the phrase "a suture with one or more
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`leaflets of the heart" as used in the claims of the '386 Patent means "a suture
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`inserted directly through the tissue of a native leaflet of a heart and not indirectly
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`through a clip or other device that is in turn attached to the native leaflet."
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`Ex.1011,~50.
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`6.
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`"endovascularly via [an antegrade/a retrograde] approach"
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`Claims 20 and 21 of the '386 Patent recite that the step of accessing in claim
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`19 is performed "endovascularly." 4 One of ordinary skill in the art would
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`4 Petitioner notes that this limitation in both claims 20 and 21 may be indefinite
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`and/or not enabled because it is not feasible to endovascularly access the heart
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`through the apical region if the term "accessing" is construed consistent with the
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`interpretation of the term "access" in claim 1. Ex. 1011, ~51. Although not at issue
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`in this proceeding, the use of the word "endovascularly" presents 35 U.S.C. § 112
`
`issues for these reasons. For purposes of this Petition, this limitation has been
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`Petition for Inter Partes Review of U.S. Patent 7,635,386
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`understand "endovascular" in this context as referring to using a catheter based
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`device routed through a vascular access path for accessing a target within the
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`patient. Ex.1 011, ~23.
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`Claim 20 of the '386 Patent recites that the endovascular access is "via an
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`antegrade approach." Antegrade means along a direction of blood flow as the
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`catheter approaches the target anatomical structure. Ex. lOll, ~52. The tricuspid
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`valve can be repaired via antegrade access from the femoral vein, through the vena
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`cava and into the right atrium. !d. The only discussion of an antegrade approach in
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`the '386 Patent describes subsequent trans-septal access into the left atrium for
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`repair of the mitral valve. Id.; Ex. 1001, 11:43-49. Accordingly, the BRl
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`construction of "endovascularly via an antegrade approach" means "using a
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`catheter based device that approaches the valve from the atrial side." Ex.l 011, ~52.
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`Claim 21 of the '386 Patent recites that the endovascular access is "via a
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`retrograde approach." Retrograde means opposite of a direction of blood flow as
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`the catheter approaches the target anatomical structure. Ex.1011, ~53. The only
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`discussion of a retrograde approach in the '386 Patent describes an atrial access
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`path through the aorta and across the aortic valve to the left chambers of the heart
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`for repair of the mitral valve. !d.; Ex. 1001, 11:49-53. Repair of the tricuspid valve
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`construed as indicated without waiving any right to challenge the validity of the
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`claims on this basis in any subsequent proceeding.
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`Petition for Inter Partes Review of U.S. Patent 7,635,386
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`via retrograde access is not performed because direct percutaneous access to the
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`pulmonary arterial system is not practical. Ex.1011, ~53. Accordingly, the BRI
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`construction of "endovascularly via a retrograde approach" means "using a
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`catheter based device that approaches the valve from the ventricular side." Ex.
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`1011, ~53.
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`VI. DETAILED EXPLANATION OF PERTINENCE AND MANNER OF
`APPLYING CITED PRIOR ART TO EVERY CLAIM FOR WHICH
`REVIEW IS REQUESTED
`
`Patent Owner essentially conceded in the original prosecution of the '386
`
`Patent that Lattoufl teaches all limitations of the independent claims except that
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`repairing the cardiac valve comprises replacing one or more chordae tendineae by
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`implanting one or more artificial chordae tendineae as a suture "with" or through
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`one or more leaflets of the heart. Ex. 1003, pp. 11-20. However, Patent Owner
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`incorrectly interpreted Lattouf I because the Lattouf references clearly and
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`expressly disclose that sutures can be inserted into a leaflet as artificial chordae.
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`Ex. lOll, ~50 and 65; Ex.1004, 3:51-62; Ex.1007, 4:5-15. In addition, Speziali,
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`Downing, Bachman and Carpentier discussed herein are all prior art references that
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`teach repairing a heart valve leaflet with an artificial chordae that comprises a
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`suture onto one or more leaflets of the heart. Ex. 1011, ~55, 66, 72 and 75.
`
`A.
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`Person of Ordinary Skill in the Art
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`Petition for Inter Partes Review of U.S. Patent 7,635,386
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`Petitioner proposes that a person of ordinary skill in the art in the field of the
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`'386 Patent at the time of invention would be a cardiac surgeon having substantial
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`experience performing mitral valve repair procedures. Ex.1 011, IJ12-14.
`
`B.
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`Applicable Law
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`1.
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`Anticipation (pre-AlA 35 U.S.C. §102)
`
`Under pre-AlA Section 102, each and every element of a claim, as properly
`
`construed, must be found, either explicitly or inherently in a single prior art
`
`reference, as arranged in the claim. To anticipate a claim, the single reference also
`
`must provide an enabling disclosure, with enough information to enable a person
`
`having ordinary skill in the art at the time of invention to reproduce the claimed
`
`invention without undue experimentation. Bristol-Myers Squibb Co. v. Ben Venue
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`Labs., Inc., 246 F.3d 1368, 1374 (Fed. Cir. 2001).
`
`2.
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`Obviousness (pre-AlA 35 U.S.C. §103)
`
`A patent claim is invalid under pre-AlA 35 U.S.C. §103 if the differences
`
`between the claimed invention and the prior art are such that the subject matter as a
`
`whole would have been obvious at the time the invention was made to a person
`
`having ordinary skill in the art to which the subject matter pertains. 5 Graham v.
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`5 All discussions in the Petition of "one skilled in the art" in the context of
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`anticipation or obviousness are presumed to be as understood by a person of
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`Petition for Inter Partes Review ofU.S. Patent 7,635,386
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`John Deere, 383 U.S. 1, 17-18 (1966). The determination of obviousness is based
`
`on the scope and content of the prior art, the differences between the prior art and
`
`the claim, the level of ordinary skill in the art at the relevant time, and any
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`objective evidence (secondary indicia) of non-obviousness, to the extent such
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`evidence exists. !d. at 13.
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`"[R]ejections on obviousness grounds cannot be sustained by mere
`
`conclusory statements; instead, there must be some articulated reasoning with
`
`some rational underpinning to support the legal conclusion of obviousness." In re
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`Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). "[O]bviousness concerns whether a
`
`skilled artisan not only could have made but would have been motivated to make
`
`the combinations or modifications of prior art to arrive at the claimed invention."
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`Belden Inc. v. Berk-Tek LLC, Nos. 2014-1575, -1576. Slip. Op. at 13 (Fed. Cir.
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`Nov. 5, 2015) (emphasis in original). As the Supreme Court has set forth, this
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`articulated reasoning can include the application of routine skill b