UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`NEOCHORD, INC.
`Petitioner
`
`v.
`
`UNIVERSITY OF MARYLAND, BALTIMORE
`
`Patent Owner
`______________
`
`Case No. IPR2016-00208
`Patent No. 7,635,386
`______________
`
`
`
`PATENT OWNER’S RESPONSE
`UNDER 37 C.F.R. § 42.120
`
`
`
`
`

`
`Table of Contents
`
`
`
`I.
`II.
`
`INTRODUCTION .......................................................................................... 1
`BACKGROUND AND SUMMARY OF ARGUMENTS ............................ 1
`A.
`Background on the Invention of the ‘386 Patent ................................. 1
`III. CONSTRUCTION OF AND SUPPORT FOR THE CHALLENGED
`CLAIMS ......................................................................................................... 2
`A.
`The Standard for Claim Construction in These Proceedings ............... 2
`B.
`PO’s Proposed Claim Constructions .................................................... 2
`1.
`“Percutaneously accessing an apical region of the heart”
`(claim 19) ................................................................................... 2
`IV. CHALLENGED CLAIMS 1-23 ARE PATENTABLE OVER THE
`INSTITUTED GROUNDS ........................................................................... 10
`A.
`Challenged Claims 1, 3, 7-14, 19, 22 and 23 Are Patentable
`Under 35 U.S.C. § 102 ....................................................................... 11
`1.
`Ground 1: Claims 19, 22, and 23 are Not Anticipated by
`Speziali. .................................................................................... 11
`Ground 1: Claims 1, 3, and 7-14 are Not Anticipated by
`Speziali. .................................................................................... 16
`The Challenged Claims Are Patentable Under 35 U.S.C. § 103 ....... 16
`1.
`Petition Fails to Provide Sufficient Motivation to
`Combine (MTC) Arguments .................................................... 16
`Ground 2: Claims 20 and 21 are Not Rendered Obvious
`by Speziali in view of Bachman .............................................. 19
`Ground 3: Claims 19, 22 and 23 are Not Rendered
`Obvious by Lattouf I in view of Carpentier. ............................ 26
`Ground 4: Claim 19 is Not Rendered Obvious by Lattouf
`I in View of Bachman. ............................................................. 33
`Ground 4: Claims 20 and 21 are Not Rendered Obvious
`by Lattouf I in view of Bachman. ............................................ 35
`Ground 5: Claim 19 is Not Rendered Obvious by Lattouf
`I in view of Downing. .............................................................. 41
`
`2.
`
`B.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`
`
`
`
`
`-i-
`
`
`
`

`
`Table of Contents
`(continued)
`
`Page
`
`7.
`
`8.
`
`9.
`
`Ground 2: Claims 5, 6 and 18 are Not Rendered Obvious
`by Speziali in view of Bachman .............................................. 44
`Ground 3: Claims 1-9, 11-15, 17 and 18 are Not
`Rendered Obvious by Lattouf I in view of Carpentier. ........... 46
`Ground 4: Claims 1 and 4-6 are Not Rendered Obvious
`by Lattouf I in view of Bachman. ............................................ 47
`10. Ground 5: Claims 1, 2, 4 and 5 are Not Rendered
`Obvious by Lattouf I in view of Downing. .............................. 48
`11. Ground 6: Claims 2 and 4 are Not Rendered Obvious
`over Speziali. ............................................................................ 49
`12. Ground 7: Claims 10 and 16 are Not Rendered Obvious
`over Lattouf I in view of Carpentier and Downing. ................ 49
`CONCLUSION ............................................................................................. 50
`
`
`
`V.
`
`
`
`
`
`
`
`-ii-
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`

`
`List of Exhibits
`
`Description of Document
`
`Declaration of John Richard Garrett, M.D.
`
`Curriculum Vitae of John Richard Garrett, M.D.
`
`Excerpts from The American Heritage Stedman’s Medical
`Dictionary (1995)
`
`Transcript of Deposition of Dr. Lishan Aklog, M.D. dated August
`26, 2016 (“Aklog Trans.”)
`
`Ex. No.
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005 WO 2006/078694 to Speziali
`
`2006
`
`2007
`
`U.S. Patent No. 8,075,510 to Aklog et al.
`
`Excerpts from Stedman’s Medical Dictionary, Illustrated in Color
`(28th ed. 2006)
`
`2008 Wikipedia, “Percutaneous” (retrieved Sept. 2016)
`
`2009
`
`2010
`
`2011
`
`
`
`
`
`
`
`“Seldinger Technique for Introducing Catheters” (retrieved Sept.
`2016)
`
`T. Doby, “A Tribute to Sven-Ivar Seldinger,” American Roentgen
`Ray Society, 142:1-3 (Jan. 1984)
`
`I. Mohiuddin, et al., “Chapter 1: General principles of endovascular
`therapy,” Endovascular Therapy, Blackwell Publishing (2006)
`
`
`
`-iii-
`
`

`
`
`
`I.
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.120, the patent owner, University of Maryland,
`
`Baltimore (“PO”), hereby submits this Patent Owner Response to the Petition for
`
`Inter Partes Review of U.S. Patent No. 7,635,386 (“the ‘386 Patent”) (“Petition”)
`
`filed by NeoChord, Inc. (“Petitioner”) on November 18, 2015. Claims 1-23 are
`
`currently pending and have been instituted under multiple grounds.
`
`This filing is timely as it is being filed on September 12, 2016, pursuant to
`
`the Notice to Modify Due Dates 1 & 2 filed jointly by the parties (see Paper 9).
`
`Petitioner did not submit statements of material facts in the Petition, thus no
`
`response is due pursuant to 37 C.F.R. § 42.23(a) and no facts are admitted.
`
`It is Petitioner’s burden to show by a preponderance of evidence that the
`
`challenged claims are unpatentable. 35 U.S.C. § 316(e). As set forth herein,
`
`Petitioner fails to meet its burden of proof for at least claims 1-23. Accordingly,
`
`PO requests that the Board issue a Final Decision confirming the patentability of
`
`challenged claims 1-23 of the ‘386 Patent.
`
`II. BACKGROUND AND SUMMARY OF ARGUMENTS
`A. Background on the Invention of the ‘386 Patent
`The ‘386 Patent claims priority to U.S. Patent Application No. 60/780,521,
`
`
`
`and is therefore entitled to a priority filing date of March 7, 2006.
`
`1
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`
`
`

`
`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
`III. CONSTRUCTION OF AND SUPPORT FOR THE CHALLENGED CLAIMS
`A. The Standard for Claim Construction in These Proceedings
`The claims are to be given their broadest reasonable interpretation in light of
`
`
`
`the specification. See 37 C.F.R. § 42.100(b).
`
`PO’s Proposed Claim Constructions
`
`B.
`PO’s proposed claim constructions for selected claim terms and clauses are
`
`provided below. Any claim terms or clauses not expressly construed herein should
`
`be given their plain and ordinary meaning as understood by a person of ordinary
`
`skill in the art (“POSITA”). (See Ex. 2001, ¶¶ 26, 29.)
`
`1.
`
`“Percutaneously accessing an apical region of the heart”
`(claim 19)
`
`Petitioner’s proposed construction for the above limitation reads: “the
`
`process of obtaining access through the skin to a region of a ventricular chamber of
`
`the heart near the apex of the heart.” Pet. 12. This construction, however, is
`
`unreasonably broad, inconsistent with the specification, inconsistent with what a
`
`POSITA would understand the term to mean, completely reads out the term
`
`“percutaneously,” and fails to consider the recitations of claims 20 and 21.
`
`Accordingly, PO proposes that “percutaneously accessing an apical region of the
`
`heart” should be construed as “direct transmyocardial puncture through
`
`unbroken skin or endovascularly accessing an apical region of a heart.” (See
`
`Ex. 2001, ¶¶ 29-43.)
`
`2
`
`

`
`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
`a.
`
`The ‘386 Patent’s Disclosure of “Percutaneously
`accessing an apical region of the heart”
`
`
`
`The specification describes two techniques for percutaneously accessing the
`
`apical region of the heart. The apical region of the heart can be accessed, for
`
`example, for repair of a mitral valve, between the left atrium and the left ventricle,
`
`or for a tricuspid valve, between the right atrium and the right ventricle. The first
`
`technique is an “endovascular” approach, and the second is a “direct needle
`
`puncture.” (See, e.g., Ex. 1001, 11:35-52 (“although the following describes
`
`accessing the heart via an apical incision, percutaneous access through direct
`
`puncture of the heart (transmyocardial) may also be used … [s]till yet, other
`
`percutaneous
`
`approaches may be
`
`employed where
`
`access
`
`is made
`
`endovascularly”).)
`
`The endovascular approach is a technique that involves feeding a device
`
`through the patient’s vasculature to the apical region of the heart in the appropriate
`
`ventricle (the left ventricle for repair of a mitral valve or the right ventricle for
`
`repair of a tricuspid valve). In the antegrade approach, the device is fed through
`
`“femoral or internal jugular veins” and then the heart is accessed “via the inter-
`
`atrial septum (trans-septal) and then into the left atrium.” (Ex. 1001, 6:27-31.) In
`
`the retrograde approach, the device is fed through “the femoral artery … the aorta,
`
`across the aortic valve into the left side of the heart.” (Ex. 1001, 11:50-52.) This
`
`3
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`

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`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
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`
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`“endovascular” technique does not require any cuts or openings because the device
`
`is able to access the apical region of the heart entirely through the patient’s
`
`vasculature. (Ex. 2001, ¶ 32.) This technique is consistent with claims 20 and 21,
`
`which recite “wherein said accessing is done endovascularly via an antegrade
`
`approach” (claim 20) or “via a retrograde approach” (claim 21).
`
`The second technique is via “direct needle puncture”. The specification
`
`explains that “[w]hen a percutaneous approach is sought, no incision into the apex
`
`region of the heart need be made, rather access into the apical region may be
`
`gained by direct needle puncture, for instance by an 18 gauge needle.” (Ex. 1001,
`
`10:2-7 (emphasis added); see also, id., 6:65-7:1 (“access to the heart may be
`
`gained by direct puncture (i.e., via an appropriately sized needle, for instance an 18
`
`gauge needle) of the heart from the xyphoid region”), 11:35-52 (“although the
`
`following describes accessing the heart via an apical incision, percutaneous access
`
`through direct puncture of the heart (transmyocardial) may also be used, via the
`
`insertion of an appropriate grade needle (e.g., an 18 gauge needle) into the apical
`
`region of the heart”).) This technique is consistent with claim 22, which recites
`
`“wherein said accessing is done via direct access through a transmyocardial
`
`approach.”
`
`The ‘386 patent specification makes clear that a percutaneous access is
`
`distinct from a minimally invasive access, where “one or more incisions are made
`
`4
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`

`
`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
`
`
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`proximate to the thoracic cavity so as to provide a surgical field of access.” (Ex.
`
`1001, 7:26-27.) The specification unequivocally states that “percutaneously”
`
`means “without the need for an incision.” (Ex. 1001, 7:40-44.) Any suggestion
`
`that percutaneously can include an incision is inconsistent with the clear disclosure
`
`of the ‘386 patent.
`
`During Dr. Aklog’s deposition, he confirmed that an “incision” (for
`
`purposes of this proceeding) is a cut made by a knife or scalpel having a length of
`
`“[a]s little as a millimeter or 2.” (Ex. 2004, 41:1-4.) This is consistent with the ‘386
`
`patent’s disclosure of “incision.” For example, the specification states that “smaller
`
`incisions” can be used, such as “an incision of about 1 mm to about 8mm.” (Ex.
`
`1001, 7:40-44.) These particular incisions are explicitly differentiated from
`
`percutaneous techniques, which are “without the need for an incision.” (Id.)
`
`Thus, the specification indicates that “percutaneously accessing the apical
`
`region of the heart”: (1) can be accomplished by puncturing the wall of the heart
`
`with a needle, (2) does not involve an incision into the patient’s heart or chest, and
`
`(3) can be accomplished by an endovascular approach (antegrade or retrograde).
`
`Any claim construction for this claim 19 limitation must take these attributes into
`
`consideration. Petitioner’s proposed construction, however, does not. Petitioner’s
`
`construction is broad enough to include the insertion of a device through any
`
`incision. This is in direct contradiction to the disclosure of the ‘386 patent
`
`5
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`

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`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
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`
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`specification. (Ex. 2001, ¶¶ 30-36.)
`
`b.
`
`The POSITA’s Understanding of “Percutaneously
`accessing an apical region of the heart”
`
`A POSITA would understand that the term “percutaneous” does not include
`
`an incision or any other cut created by a knife or scalpel. (Ex. 2001, ¶ 37.) This is
`
`confirmed by the passages in the ‘386 patent discussed above. Also, Dr. Garrett
`
`references several medical dictionaries in his declaration that define the term
`
`“percutaneous” consistent with this understanding. (Ex. 2001, ¶¶ 37-38.) For
`
`example, the 1995 Stedman’s Medical Dictionary defines “percutaneous” as
`
`“[p]assed, done, or effected through the unbroken skin.” (Ex. 2003.) A later
`
`version of the same dictionary provides more context and defines the term as
`
`“passage through the skin by needle puncture, including introduction of wires and
`
`catheters by Seldinger technique.” (Ex. 2007, (emphasis in original).) Both
`
`dictionary definitions make clear that a percutaneous access does not include an
`
`incision. (Ex. 2001, ¶¶ 37-38 (also citing to Ex. 2008 for additional support).) Dr.
`
`Garrett confirms that this is also his understanding of the meaning of
`
`“percutaneously”. (Id.)
`
`Dr. Aklog was questioned about the term “percutaneously” during his
`
`deposition and took the position that it simply means “through the skin.” (Ex.
`
`2004, 24:4-26:5, 29:6-32:4; see also, Ex. 2001, ¶¶ 39-41 for Dr. Garrett’s opinions
`
`6
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`

`
`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
`
`
`
`on Dr. Aklog’s testimony.) According to Dr. Aklog, there is no “bright line”
`
`definition as to when a percutaneous procedure becomes a procedure requiring an
`
`incision.1 (Ex. 2004, 29:19-22.) These positions, however, are untenable. First, as
`
`discussed, the ‘386 patent includes clear examples of what constitutes a
`
`percutaneous procedure versus what constitutes an incision. Dr. Aklog should have
`
`been informed by Petitioner that the definitions and examples provided in the ‘386
`
`patent are controlling for claim construction purposes in IPR proceedings. 37
`
`C.F.R. § 42.100 (“A claim in an unexpired patent that will not expire before a final
`
`written decision is issued shall be given its broadest reasonable construction in
`
`light of the specification of the patent in which it appears”) (emphasis added);
`
`CBM2014-00115 at 6 (Paper 8) (PTAB May 1, 2014) (“Under the broadest
`
`reasonable construction standard, claim terms are given their ordinary and
`
`customary meaning, as would be understood by one of ordinary skill in the art in
`
`the context of the entire disclosure”) (emphasis added) (citing to In re Translogic
`
`Tech, Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007)); CBM2013-00005 at 14 (Paper
`
`18) (PTAB March 29, 2013) (“There is a ‘heavy presumption’ that a claim term
`
`carries its ordinary and customary meaning … However, claims must be read in
`
`
` 1
`
` Although he eventually placed a size of 1 millimeter as a minimum cut for an
`
`“incision”. (Ex. 2004, 41:1-4.)
`
`7
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`

`
`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
`
`
`
`view of the specification … [T]he specification is always highly relevant to the
`
`claim construction analysis. Usually, it is dispositive; it is the single best guide
`
`to the meaning of a disputed term”) (emphasis added) (internal quotes omitted)
`
`(citing to CCS Fitness, Inc. v. Brunswick Corp., 228 F.3d 1359, 1366 (Fed. Cir.
`
`2002); and Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Circ. 2005) (en
`
`banc)). Second, Dr. Aklog’s positions are inconsistent with definitions provided by
`
`established medical dictionaries as well as with Dr. Garrett’s understanding of the
`
`term. (Ex. 2001, ¶¶ 37-41.) And, lastly, Dr. Aklog’s positions are inconsistent with
`
`his own past use of the term “percutaneous”.
`
`Regarding this last point, PO directs the Board’s attention to U.S. Patent No.
`
`8,075,510 (“the ‘510 patent”, Ex. 2006) (a patent on which Dr. Aklog is a co-
`
`inventor) at column 15, lines 19-26 and lines 46-48. In the ‘510 patent, Dr. Aklog
`
`distinguishes between “surgical dissection” (i.e., incisions) and percutaneous
`
`procedures. The ‘510 patent describes “percutaneously” as “with, for instance, a
`
`needle”. (Ex. 2006, 15:19-26.) Nowhere does Dr. Aklog state that percutaneously
`
`includes anything but a needle puncture. All incisions are described as “surgical
`
`dissection[s]”. Thus, despite the position Dr. Aklog took during his deposition, Dr.
`
`Aklog has, in the past, referred to percutaneous procedures as those involving only
`
`a needle puncture. Dr. Aklog now conveniently adopts an unreasonably broad
`
`8
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`

`
`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
`
`
`
`construction of the term to apply prior art references that are wholly inconsistent
`
`with Dr. Aklog’s previous use of the term. (Ex. 2001, ¶¶ 42-43.)
`
`c.
`
`The Claim Construction Cannot Read Out the Term
`“Percutaneously”
`
`It is a well-established rule that “claims are interpreted with an eye toward
`
`giving effect to all terms in the claim.” Digital-Vending Svcs. Int’l LLC v. Univ. of
`
`Phoenix, Inc., 672 F. 3d 1270, 1275 (Fed. Cir. 2012) (citing Bicon, Inc. v.
`
`Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006)). Contrary to this rule,
`
`however, Petitioner is attempting to read out the term “percutaneously” from claim
`
`19.
`
`In claim 19, the term “percutaneously” modifies the term “accessing” and
`
`specifically distinguishes it from other types of accessing. For example, claim 1
`
`recites “creating an access in an apical region of a heart” and does not specify the
`
`type of access created. Claim 19 is distinguishable from the generic “accessing”
`
`recited in claim 1 because it requires that such “accessing” be “percutaneous[].”
`
`The use of the term “percutaneously” in claim 19 is intentional, has meaning
`
`and should be given effect. The drafter of the claim would not have otherwise
`
`included it. If the term “percutaneously” was meant to include any and all
`
`incisions, then the term becomes meaningless in claim 19 because there would be
`
`no difference between “percutaneously accessing” and “accessing.” Because the
`
`9
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`

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`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
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`
`
`drafter clearly
`
`intended for
`
`the “accessing” recited
`
`in claim 19
`
`to be
`
`“percutaneous[]” and reading out this term out of claim 19 would be in clear
`
`violation of well-established claim construction rules, the Board must adopt a
`
`claim construction that incorporates the term “percutaneously.”
`
`Thus, the broadest reasonable interpretation of “percutaneously accessing an
`
`apical region of a heart” is “direct transmyocardial puncture through unbroken
`
`skin or endovascularly accessing an apical region of a heart.” (Ex. 2001, ¶ 43.)
`
`IV. CHALLENGED CLAIMS 1-23 ARE PATENTABLE OVER THE INSTITUTED
`GROUNDS
`
`
`
`It is Petitioner’s burden to show by a preponderance of the evidence that the
`
`challenged claims are unpatentable. 35 U.S.C. § 316(e). Petitioner has failed to
`
`meets its burden of proof for any of the alleged grounds of unpatentability that it
`
`has asserted, i.e. 35 U.S.C. §§ 102 and 103, for claims 1-23.
`
`
`
`The instituted grounds are identified in the chart below and have been
`
`renumbered for ease of reference. PO adheres to these ground numbers in this
`
`Response.
`
`Ground
`No.
`1
`
`2
`
`3
`
`Instituted
`Claims
`1, 3, 7-14,
`19, 22, 23
`5, 6, 18, 20,
`21
`1-9, 11-15,
`17-19, 22, 23
`
`Prior Art Basis
`
`Anticipated by Speziali under 35 U.S.C. § 102
`
`Obvious over Speziali in view of Bachman under 35
`U.S.C. § 103
`Obvious over Lattouf I in view of Carpentier under 35
`U.S.C. § 103
`
`10
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`

`
`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
`
`
`
`4
`
`5
`
`6
`7
`
`
`
`Obvious over Lattouf I in view of Bachman under 35
`1, 4-6, 19,
`20, 21
`U.S.C. § 103
`1, 2, 4, 5, 19 Obvious over Lattouf I in view of Downing under 35
`U.S.C. § 103
`Obvious over Speziali under 35 U.S.C. § 103
`Obvious over Lattouf I in view of Carpentier and
`Downing under 35 U.S.C. § 103
`
`2, 4
`10, 16
`
`A. Challenged Claims 1, 3, 7-14, 19, 22 and 23 Are Patentable Under
`35 U.S.C. § 102
`
`Under 35 U.S.C. § 102, “[a]nticipation requires that every limitation of the
`
`claim in issue be disclosed, either expressly or under principles of inherency, in a
`
`single prior art reference.” Corning Glass Works v. Sumitomo Elec. U.S.A., Inc.,
`
`868 F.2d 1251, 1255-56 (Fed. Cir. 1989) (emphasis added).
`
`1. Ground 1: Claims 19, 22, and 23 are Not Anticipated by
`Speziali.
`
`
`
`Petitioner asserts that Speziali anticipates claims 19, 22 and 23 of Speziali.
`
`Pet. 22-24, 26. Petitioner, however, has failed to prove that Speziali is prior art to
`
`the '386 patent. And, even if it is determined that Speziali is prior art to the '386
`
`patent, Speziali fails to anticipate these claims for at least the reason that it does
`
`not disclose “percutaneously accessing an apical region of a heart” as properly
`
`construed by PO. See § III.B.1 above.
`
`11
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`

`
`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
`a.
`
`Petitioner Has Failed to Show that Speziali is Prior
`Art.
`
`
`
`The '386 patent was filed on March 7, 2007 and claims priority to a
`
`provisional application that was filed on March 7, 2006. (Ex. 1001.) Speziali has a
`
`filing date of July 11, 2007, which is more than 4 months after the '386 patent's
`
`filing date and more than a year after the '386 patent's priority date. Speziali claims
`
`priority to PCT Appl. No. PCT/US2006/001699 and U.S. Provisional Appl. No.
`
`60/645,677 – each of which have a filing date before the March 7, 2006 priority
`
`date of the '386 patent. Petitioner appears to rely on the priority dates of the PCT
`
`and provisional applications in the Petition to support its assertion that Speziali is
`
`prior art to the '386 patent under 102(e). See Pet. 20.
`
`According to Federal Circuit precedent in Dynamic Drinkware LLC v.
`
`National Graphics, Inc., however, the Petitioner had the burden of showing in its
`
`Petition that the claims in Speziali are supported by the disclosures in the PCT and
`
`provisional applications, and are thus entitled to the priority dates of those
`
`applications. 800 F.3d 1375, 1378-82 (Fed. Cir. 2015) (IPR2014-01305 at 11, 15
`
`(Paper 34)) (PTAB January 7, 2016) (“Petitioner”), however, does not explain how
`
`the Patterson provisional application or the Aziz nonprovisional application
`
`[incorporated by reference into Patterson] provides adequate written description
`
`support for the claims of the Patterson patent in compliance with § 112, ¶ 1 …
`
`12
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`

`
`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
`
`
`
`Therefore, [Petitioner] fails to demonstrate that the Patterson patent is entitled to
`
`the benefit of the filing date of the Patterson provisional application or the Aziz
`
`nonprovisional application. Consequently, [Petitioner] has not established that the
`
`Patterson patent is prior art to the [challenged] patent.”). Petitioner provided no
`
`such claim analysis in its Petition.2 Petitioner has therefore failed to meet its
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`burden of proof showing that Speziali is prior art under the Dynamic Drinkware
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`standard. The Board should find claims 19, 22 and 23 patentable over Ground 1
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`for at least this reason.
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`b.
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`Petitioner Has Failed to Show that Speziali Discloses
`the “Percutaneously Accessing” Limitation of Claim
`19.
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`The Petitioner has failed to show that Speziali discloses “percutaneously
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`accessing an apical region of a heart with a catheter-based device,” as recited in
`
`claim 19. As discussed above in Part III.B.1, “percutaneously accessing an apical
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` 2
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` The patented claims in Speziali are very different from its originally-filed claims
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`and the claims filed and published in the corresponding PCT application. (See Ex.
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`1001, 8:7-10:44; compare to Ex. 2005, 11-13.) Thus, Petitioner cannot simply rely
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`on a mere statement that Speziali claims priority to its corresponding PCT
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`application. Here, a detailed analysis of Speziali's claims was warranted and should
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`have been included in the Petition.
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`13
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`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
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`region of a heart” should be construed as “direct transmyocardial puncture through
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`unbroken skin or endovascularly accessing an apical region of a heart.”
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`
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`Petitioner relies on the following single passage from Speziali for disclosure
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`of “percutaneously accessing an apical region of the heart”: “[a] double-pledgeted
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`purse-string suture is placed on the apex of the left ventricle 12 and a stab incision
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`in made at that location. The surgical instrument 10 is inserted through this
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`incision, into the left ventricular chamber 14 of the beating heart.” Pet. 23 (citing
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`to Ex. 1006, 5:14-18). Speziali thus explicitly discloses making a stab incision in
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`the apex of the left ventricle. A stab incision is not a direct transmyocardial
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`puncture, nor does it involve an endovascular procedure. (Ex. 2001, ¶¶ 45-46.)
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`
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`Speziali does not provide a detailed description regarding how its
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`instruments are inserted through the patient’s chest wall to access the heart. But, its
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`specification suggests that an incision – i.e., a 1-2mm+ cut in the skin using a
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`scalpel or knife – is created in the chest wall. (Ex. 2004, 41:1-12 (testimony of Dr.
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`Aklog indicating that an “incision” is defined as a cut through the skin “as little as
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`a millimeter or 2”).) For example, Speziali states that “the pericardium overlying
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`the apex 12 of the left ventricle 14 is opened and its edges are suspended to the
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`skin incision line.” (Ex. 1006, 5:6-8 (emphasis added); see also, Ex. 2004, 21:4-
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`23:15.) A POSITA would understand a “skin incision line” to necessarily require a
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`cut by a scalpel or knife because a puncture, such as from a needle, would not
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`14
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`Patent Owner’s Response
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`create an “incision line”. (Ex. 2001, ¶¶ 47-49.) A knife, scalpel, or other like tool
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`would create an “incision line”. (Id.)
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`
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`Speziali does not use the term “percutaneous” in its specification and the
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`single relied-on passage above for this limitation does not include the term. Dr.
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`Aklog admits this during his deposition. (Ex. 2004, 19:14-20:7.) At the same time,
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`however, he also attempted to argue that the “percutaneous” procedures described
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`and claimed in the ‘386 patent are “incorporate[d]” in Speziali but Dr. Aklog could
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`not point to any particular passage in Speziali’s specification to support his
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`position. (Ex. 2004, 23:16-24:1.) The Petition also did not provide any back-up
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`arguments as to what types of incisions, procedures, etc. from Speziali are
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`considered “percutaneous”.
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`
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`For at least these reasons, Petitioner has failed to show that Speziali alone
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`discloses “percutaneously accessing the apical region of the heart” as recited in
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`claim 19. Thus, Speziali does not anticipate claim 19.
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`
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`The Board should therefore find claim 19 valid under Ground 1. Claims 22
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`and 23 depend from claim 19, and are valid under Ground 1 for at least the reason
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`claim 19 is valid.
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`15
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`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
`2. Ground 1: Claims 1, 3, and 7-14 are Not Anticipated by
`Speziali.
`For the same reasons discussed above in Part IV.A.1.a, Petitioner has failed
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`
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`to meet its burden of proof showing that Speziali is prior art under the Dynamic
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`Drinkware standard. The Board should find claims 1, 3, and 7-14 patentable over
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`Ground 1 for at least this reason.
`
`B.
`
`The Challenged Claims Are Patentable Under 35 U.S.C. § 103
`1.
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`Petition Fails to Provide Sufficient Motivation to Combine
`(MTC) Arguments
`
`Petitioner’s MTC arguments generally lack the specificity, substantive
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`analysis and corroborative evidence required to support a showing of obviousness.
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`These three critical issues are outlined below and then discussed in more detail
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`with respect to the specific proposed grounds of rejections set forth in the sections
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`that follow.
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`Issue 1: Petitioner’s rationale for combining Speziali or Lattouf I with one
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`or more secondary references is not sufficiently specific. As a general rule, “there
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`must be some articulated reasoning with some rational underpinning to support the
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`legal conclusion of obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418
`
`(2007) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)) (“KSR”).
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`Arguments that simply demonstrate that prior art references are analogous art to
`
`each other are not “sufficiently specific.” IPR2013-00220 at 22 (Paper 8) (PTAB
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`16
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`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
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`Aug. 15, 2013) (“IPR2013-00220”) (“[Petitioner’s] stated rationale is not
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`sufficiently specific and indicates, at best, that the prior art references are each
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`analogous art to the invention … and perhaps also to each other. That does not
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`suffice as an articulated reason with a rational underpinning to combine specific
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`teachings in the references”). Similarly, arguments that simply indicate that prior
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`art references relate to the same field of endeavor are also not “sufficiently
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`specific.” IPR2013-00183 at 9 (Paper 12) (PTAB July 31, 2013) (“That the
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`references relied upon all relate to human heart repair does not amount to ‘some
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`articulated reasoning with some rational underpinning to support the legal
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`conclusion of obviousness.’”) (quoting KSR, 550 U.S. at 418). Viewed in light of
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`these standards, Petitioner’s MTC arguments are less specific than the rationales
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`presented in the rejected petition arguments cited above.
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`
`
`Issue 2: Petitioner fails to provide a sufficient explanation of how and why a
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`POSITA would be motivated to incorporate an element(s) from one or more
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`secondary references into Speziali’s or Lattouf I’s cardiac procedure (referred to
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`herein as the “how and why analysis”). See, IPR2013-00145 at 17 (Paper 12)
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`(PTAB August 7, 2013). For example, Petitioner makes little, if any, attempt to
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`explain what hypothetical cardiac procedure would have resulted from the
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`combination of Speziali or Lattouf I and one or more other references, and why
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`such a hypothetical procedure would have met each limitation of a particular claim.
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`17
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`Patent Owner’s Response
`Case No.: IPR2016-00208 - Atty Docket: HARP-001/02US
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`See, e.g., IPR2013-00220 at 22. This is an issue common to almost all of the
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`purported grounds of obviousness for the challenged claims.
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`
`
` Issue 3: Petitioner’s MTC arguments are neither supported by, nor are the
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`identified deficiencies cured by, the Declaration. The Declaration fails to support
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`or remedy the Petition because: (1) the MTC arguments in the Declaration
`
`constitute conclusory statements without any corroborated or supportive evidence,
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`and/or (2) the Declaration simply reiterates (almost verbatim) the MTC arguments
`
`in the Petition.
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`
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`With respect to point (1), the Declaration should be entitled little or no
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`weight. In particular, 37 CFR § 42.65 mandates that expert testimony “disclose the
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`underlying facts or data on which the opinion is based” otherwise it is “entitled to
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`little or no weight.” Throughout the Declaration Dr. Aklog purports to analyze a
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`claim but fails to cite to even one reference to support his assertions. For at least
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`these claims, the Declaration provides no supporting facts or corroboration and
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`thus does nothing to support or remedy arguments set forth in the Petition.
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`Petitioner’s arguments are therefore based solely on unsupported attorney
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`argument and should be disregarded.
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`
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`With respect to point (2), the Board has made clear that arguments in a
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`declaration have minimal value and are not persuasive when they simply reiterate
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`arguments raised in the petition rather