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
`______________
`
`
`REPLY TO PATENT OWNER’S RESPONSE
`
`
`
`
`
`

`
`
`
`Table of Contents
`
`A. 
`
`Table of Contents ............................................................................................. i 
`Table of Authorities ....................................................................................... iii 
`Petitioner’s Updated Exhibit List as of November 28, 2016 ......................... iv 
`I. 
`INTRODUCTION ................................................................................... 1 
`II.  ALL CLAIMS OF THE ‘386 PATENT SHOULD BE FOUND
`UNPATENTABLE .................................................................................. 2 
`Patentee’s Claim Construction of “Percutaneously” is wrong .......... 3 
`1.  A narrow construction of “percutaneously” is contrary to the
`specification of the ‘386 Patent ......................................................... 4 
`2.  The addition of “through unbroken skin” to the definition of
`“percutaneous” is contrary to Patentee’s dictionary definition ......... 5 
`3.  Both experts agree on the ordinary meaning of “percutaneously” .... 7 
`4.  Patentee’s proposed construction improperly imports
`limitations into the claim limitation ................................................... 7 
`The Grounds Based on Speziali Should Be Maintained .................... 8 
`1.  Patentee has effectively conceded that claims 1, 3 and 7-14 are
`anticipated by Speziali by only arguing, incorrectly, that Speziali is
`not prior art ........................................................................................ 8 
`a.  Patentee is misreading the burdens imposed by Dynamic
`Drinkware ........................................................................................ 8 
`b.  Dynamic Drinkware is not applicable to Speziali because Speziali
`is a PCT National Stage application ................................................ 9 
`c.  The disclosure of Speziali is effectively identical in all priority
`documents ...................................................................................... 10 
`2.  Speziali anticipates claims 19, 22 and 23 because Patentee’s
`arguments are entirely premised on Patentee’s incorrect construction
`of “percutaneous” ............................................................................. 13 
`3.  Claims 5, 6, 18, 20 and 21 are obvious over the combination of
`Speziali and Bachman ...................................................................... 13 
`
`B. 
`
`
`
`i
`
`

`
`C. 
`
`a.  Patentee has presented no evidence for why one skilled in the art
`would not be motivated to combine Speziali and Bachman
`regarding claims 5, 6 and 18 ......................................................... 14 
`b.  Claims 20 and 21 are unpatentable because Bachman teaches how
`the Speziali device could be modified to be used endovascularly 15 
`The Grounds based on Lattouf I and Bachman Should Be
`Maintained. ...................................................................................... 18 
`1.  Claims 1 and 4-6 are unpatentable because Patentee’s arguments
`ignore the teachings of both references ........................................... 18 
`2.  Claims 19-21 are unpatentable over Lattouf I and Bachman .......... 19 
`a.  Claim 19 is unpatentable because both Lattouf I and Bachman
`teach percutaneous procedures ...................................................... 20 
`b.  Claims 20 and 21 are obvious because Bachman teaches how a
`device similar to that of Speziali could be used endovascularly .. 21 
`The Grounds Based on Lattouf I and Carpentier Should Be
`Maintained ....................................................................................... 22 
`1.  Claims 1-9, 10-18 are unpatentable over the cited combinations .... 22 
`2.  Claims 19, 22 and 23 are unpatentable over Lattouf I and
`Carpentier ......................................................................................... 24 
`The Grounds Based on Lattouf I and Downing Should Be
`Maintained ....................................................................................... 25 
`1.  Claims 1, 2, 4 and 5 are unpatentable over Lattouf
`I and Downing .................................................................................. 25 
`2.  Claims 19 is unpatentable over Lattouf I and Downing .................. 25 
`III.  CONCLUSION ...................................................................................... 26 
`Certificate of Compliance with Word Limitations ....................................... 27 
`Certificate of Service .................................................................................... 28 
`
`D. 
`
`E. 
`
`ii
`
`
`
`
`
`

`
`Table of Authorities
`
`
`
`Cases
`
`Page
`
`Dynamic Drinkware LLC v. National Graphics, Inc.
`
`800 F.3d 1375 (Fed. Cir. 2015) ............................................................ 8
`
`Glob. Tel Link. Corp. V. Securus Techs, Inc., IPR2014-00824
`
`Final Written Decision at *10-12 (PTAB December 2, 2015) ............. 9
`
`In re Merch & Co, Inc. 800 F.2d 1091 (Fed. Cir. 1986) .............................. 16
`
`Superguide Corp. v. DirecTV Enterprises, Inc.
`
`358 F.3d 870 (Fed. Cir. 2004) ........................................................... 7,8
`
`
`
`
`
`Statutes & Rules
`MPEP § 211.01 ............................................................................................... 7
`
`MPEP § 2145 .......................................................................................... 14, 16
`
`
`
`iii
`
`

`
`Petitioner’s Updated Exhibit List as of November 28, 2016
`Exhibit #
`Name
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`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 (Lattouf II)
`
`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
`
`Dictionary definition for “inunction”
`
`PCT Publication No. WO 2006/078694 (Speziali)
`
`Provisional Application No. 60/645,677 (Speziali)
`
`File history for US 8,465,500 (Speziali)
`
`iv
`
`
`
`
`
`
`
`

`
`I.
`
`INTRODUCTION
`
`
`
`The arguments presented by Patentee in the Patent Owner’s Response
`
`(“Response”) fail to overcome the evidence presented by Petitioner that claims 1-
`
`23 of the ’386 Patent should be found unpatentable on the grounds adopted in the
`
`Decision to Institute (“Decision”) based on Speziali1 and Lattouf I2 as primary
`
`references.
`
`As to claims 19, 22 and 23, the Patentee’s claim construction arguments
`
`regarding “percutaneously” are wrong because they do not apply a broadest
`
`reasonable interpretation (“BRI”) construction. In addition, the arguments are
`
`contrary to the specification of the ‘386 Patent, and improperly attempt to read
`
`limitations into the claims.
`
`With respect to Speziali, Patentee’s only argument for claims 1, 3, and 7-14
`
`that Speziali is not prior art is unsupported. Patentee’s arguments for claims 2, 4,
`
`5-6, 18, 20 and 21 for why Speziali would not be combined with Bachman3 are
`
`unpersuasive and do not rebut the testimony of Petitioner’s expert.
`
`With respect to Lattouf I, Patentee’s arguments for patentability fail to
`
`account for the teachings acknowledged by the Board to be present in the cited
`
`
`1 U.S. Patent No. 8,465,500 (Ex.1006).
`2 U.S. Patent No. 6,978,176 (Ex.1004).
`3 U.S. Patent Publication No. 2004/0044365 (Ex.1008).
`1
`
`
`
`

`
`references. In addition, Patentee’s arguments are only attorney argument that
`
`cannot overcome the evidence presented by Petitioner.
`
`Petitioner therefore requests that the grounds adopted in the Decision be
`
`maintained and the claims of the ‘386 Patent be found unpatentable.
`
`II. ALL CLAIMS OF THE ‘386 PATENT SHOULD BE FOUND
`UNPATENTABLE
`
`The Decision instituted rejections of all of the claims of the ‘386 Patent as
`
`
`
`
`
`follows:
`
`References
`
`Basis
`
`Claims
`
`Speziali
`Speziali
`Speziali and Bachman
`Lattouf I and Carpentier4
`Lattouf I, Carpentier, and
`Downing5
`Lattouf I and Bachman
`Lattouf I and Downing
`
`§ 102
`§ 102
`§ 103
`§ 103
`§ 103
`
`§ 103
`§ 103
`
`1, 3, 7-14, 19, 22, 23
`2, 4
`5, 6, 18, 20, 21
`1-9, 11-15, 17-19, 22, 23
`10 and 16
`
`1, 4-6, 19, 20, 21
`1, 2, 4, 5, 19
`
`Each of these findings should be maintained and, accordingly, all claims of
`
`the ‘386 Patent found unpatentable.
`
`
`
`
`
`
`4 Cardiac Valve Surgery – the “French Correction” by Alain Carpentier, M.D.,
`The Journal of Thoracic and Cardiovascular Surgery, Vol. 86, No. 3, September
`1983 (Ex.1009).
`5 U.S. Patent No. 6,840,246 to Downing (Ex.1005).
`2
`
`

`
`A.
`
`Patentee’s Claim Construction of “Percutaneously” is wrong
`
`
`
`Patentee urges on overly narrow definition of “percutaneously” that excludes
`
`the creation of any incisions in the claimed accessing step. Patentee’s proposed
`
`construction of this term is not a BRI construction and is directly contradicted by
`
`Patentee’s own specification.
`
`
`
`In the Petition, Petitioner proposed a BRI construction of the limitation
`
`“percutaneously accessing an apical region of the heart” as “the process of
`
`obtaining access through the skin to a region of a ventricular chamber of the heart
`
`near the apex of the heart.” Petitioner based this BRI construction on the plain and
`
`ordinary meaning of the term “percutaneous” being “through the skin.” (Petition,
`
`pp.11-12.) Petitioner’s expert, Dr. Aklog, testified that one skilled in the art would
`
`understand the term percutaneous to refer to performing a procedure through the
`
`skin. (Ex.2004, 24:4-6, 53:22-54:3 and 92:16-93:6.) In the Decision, the Board
`
`declined to construe the term percutaneous, presumably applying the plain
`
`meaning of the term. (Decision, p.8.)
`
`
`
`Patentee argues in the Response for a narrower construction of this
`
`limitation than was proposed by Petitioner. Patentee proposes that the limitation
`
`“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.” (Response, p.2.) Patentee’s proposed
`
`
`
`3
`
`

`
`construction encompasses two alternative techniques, both of which must be
`
`covered by “percutaneously accessing” – (i) direct needle puncture, or (ii)
`
`endovascular. (Response, p.3).
`
`
`
`1.
`
`A narrow construction of “percutaneously” is contrary to the
`specification of the ‘386 Patent
`
`
`Patentee's argument for a narrower construction of “percutaneously” hinges
`
`on an analysis that concludes as follows:
`
`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.
`(Response, p.5. (emphasis added)).
`
`
`
`Patentee is simply wrong in reaching for this conclusion, and the citation
`
`above misrepresents the actual teaching of the ‘386 Patent. The full sentence from
`
`the ‘386 Patent for this citation reads as follows:
`
`Additionally, where direct needle access to the heart is sought, the
`methods of the invention may be performed with even smaller
`incisions, for instance, an incision of about 1 mm to about 8 mm, from
`about 3 mm to about 5 mm, or even percutaneously, that is without the
`need for an incision.
`(Ex.1001, 7:40-44.)
`
`
`
`
`
`4
`
`

`
`
`
`Despite the express teaching of the specification of the ‘386 Patent that
`
`“where direct needle access to the heart is sought, the methods of the invention
`
`may be performed with even smaller incisions,” Patentee argues that its proposed
`
`construction of “direct transmyocardial puncture” must be interpreted as excluding
`
`any incision. Even the single phrase “without the need for an incision” on which
`
`Patentee places the weight of its entire argument cannot support the conclusion that
`
`Patentee asserts. Setting aside that the claim limitation encompasses two
`
`techniques, not just one, and that the ‘386 Patent expressly teaches the use of an
`
`incision for one of those techniques, the fact that there may not be a need for an
`
`incision in the other technique does not logically equate to an express prohibition
`
`against use of any incision for both techniques.
`
`2.
`
`The addition of “through unbroken skin” to the definition of
`“percutaneous” is contrary to Patentee’s dictionary definition
`
`
`In an effort to support Patentee’s unfounded conclusion, the proposed
`
`
`
`
`
`construction adds the phrase “through unbroken skin” to the direct needle puncture
`
`approach. As support, Patentee cites to a medical dictionary that purports to add
`
`the requirement that the skin be “unbroken” in order to satisfy the definition of
`
`percutaneous. (Response, p.6).
`
`
`
`5
`
`

`
`Again, Patentee’s own evidence does not support its restrictive definition.
`
`The full definition of the term “percutaneous” in the 2006 Stedman’s Medical
`
`Dictionary cited by Patentee is:
`
`Denoting the passage of substances through unbroken skin, as in
`absorption by inunction; also passage through the skin by needle
`puncture, including introduction of wires and catheters by Seldinger
`technique.
`(Ex.2007, p. 8.) (emphasis added).
`
`Patentee omits the final words of the first portion of the definition from the
`
`
`
`2006 Dictionary that the reference to “unbroken skin” relates to procedures such as
`
`“absorption by inunction.” (Response, p.6). “Inunction” refers to the “act of
`
`applying oil or ointment” to the skin. (Ex.1012). It is apparent from the entire
`
`definition that the reference to “unbroken skin” in the first portion is not applied to
`
`the second portion of the definition that is separated by a semicolon. In fact, the
`
`second portion of this definition is defining the type of heart valve repair procedure
`
`that requires insertion of a catheter-based device through the skin and into the body
`
`that is the subject of the ‘386 Patent.
`
`Accordingly, if one were to refer to a dictionary to understand the ordinary
`
`meaning of this term, it is the second portion of the definition from the 2006
`
`dictionary that is actually relevant to construction of the term “percutaneous” for
`
`purposes of this proceeding. Under this second portion, the definition of the term
`
`
`
`6
`
`

`
`“percutaneous” is consistent with Petitioner’s proposed construction of “passage
`
`through the skin.”
`
`
`
`Both experts agree on the ordinary meaning of “percutaneously”
`
`3.
`
`The Patentee attacks the testimony of Petitioner's expert, Dr. Aklog, with
`
`respect to the understanding of the term “percutaneously” by a skilled person.
`
`(Response, p.7-8). Patentee cites to and criticizes one of Dr. Aklog’s patents for
`
`not expressly defining the term “percutaneous.” Even if this were accurate, which
`
`it is not, it is the definition and limitation of the term “percutaneous” in the ‘386
`
`Patent that matters. Even Patentee’s own expert effectively admits that the literal
`
`meaning of the term “percutaneous” is simply “through the skin.” (Ex.2001, ¶39.).
`
`This definition is consistent with Dr. Aklog’s expert declaration and testimony.
`
`
`
`4.
`
`Patentee’s proposed construction improperly imports limitations into
`the claim limitation
`
`
`It is respectfully submitted that the Board has properly applied the BRI
`
`
`
`construction standard in the Decision with respect to the term “percutaneously.”
`
`Under this standard, it is improper to import a limitation in from the specification
`
`when the plain meaning of the term is more broadly defined. (MPEP § 2111.01(II),
`
`quoting Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed.
`
`
`
`7
`
`

`
`Cir. 2004) Accordingly, the Board is correct to use the “plain meaning” of
`
`percutaneous as “through the skin.”
`
`
`
`
`
`B.
`
`The Grounds Based on Speziali Should Be Maintained
`
`1.
`
`Patentee has effectively conceded that claims 1, 3 and 7-14 are
`anticipated by Speziali by only arguing, incorrectly, that Speziali is
`not prior art
`
`The only argument Patentee has mustered for why Speziali does not
`
`
`
`
`
`anticipate claims 1, 3 and 7-14 of the ‘386 Patent is that Speziali is not prior art to
`
`the ‘386 Patent. (Response, p.12-13). The argument, however, is based on a
`
`misreading of the Dynamic Drinkware case. This case provides no support
`
`whatsoever for Patentee’s position.
`
`
`
`
`
`a.
`
`Patentee is misreading the burdens imposed by Dynamic
`Drinkware
`
`
`In Dynamic Drinkware, the issue was whether a patent asserted in an IPR
`
`proceeding was entitled to the priority date of a provisional application to which it
`
`claimed priority. Dynamic Drinkware LLC v. National Graphics, Inc., 800 F.3d
`
`1375, 1377 (Fed. Cir. 2015). The conclusion of the court was that, while the
`
`petitioner had the ultimate burden of persuasion of demonstrating that the patent
`
`was entitled to the priority claim, the petitioner’s initial burden of production was
`
`
`
`8
`
`

`
`satisfied by simply alleging that the patent was entitled to priority. Id. at 1380.
`
`Only after the patent owner challenged the priority claim by presenting evidence of
`
`a reduction to practice prior to its filing date was the petitioner required to set forth
`
`evidence supporting the priority claim. Id.
`
`Contrary to the misleading arguments presented by Patentee, Dynamic
`
`Drinkware imposed no requirements regarding establishing that a priority claim in
`
`the provisional must be definitely proven in a petition. In reviewing Dynamic
`
`Drinkware to determine whether a cited reference was prior art, this Board has
`
`found that:
`
`Petitioner satisfied its burden of production by arguing in its Petition
`that Spadaro was prior art under §102(e) and, in combination with
`one or more other prior art references, would have rendered claims 1–
`20 obvious at the time the invention was made under § 103(a).
`Glob. Tel. Link. Corp. v. Securus Techs, Inc., IPR 2014-00824, Final
`Written Decision at *10-12 (PTAB December 2, 2015). (emphasis
`added).
`
`
`
`
`
`b.
`
`Dynamic Drinkware is not applicable to Speziali because
`Speziali is a PCT National Stage application
`
`
`Speziali claims priority to a PCT application filed January 19, 2006, which is
`
`before the earliest claimed priority date of the ‘386 Patent. (Ex.1006, p.1.) The
`
`Dynamic Drinkware case is inapposite because PCT national stage applications are
`
`
`
`9
`
`

`
`statutorily entitled to the priority date of the PCT application upon which they are
`
`based. 35 U.S.C. § 363.
`
`
`
`c.
`
`The disclosure of Speziali is effectively identical in all priority
`documents
`
`
`Even if relevant, Speziali has a disclosure that is identical in subject matter6
`
`to that of the priority PCT application7. (Cf. Ex.1001 and Ex.1013 (PCT
`
`publication).) Patentee has presented no evidence to challenge this conclusion.
`
`Even if Speziali were only entitled to the priority date of the PCT application, it
`
`would still be prior art to the ‘386 Patent.
`
`
`
`Moreover, even if it were necessary for Petitioner to prove that Speziali is
`
`entitled to the priority date of the provisional application that “burden” is merely a
`
`formality in the present case as the provisional application includes identical
`
`support to the utility application for the claims of Speziali. (Cf. Ex. Ex.1014,
`
`
`6 There is a brief description of the drawings in Speziali that is not present in the
`priority PCT application, but because no new matter could be added and the claims
`of Speziali were already allowed prior to this addition, this description cannot have
`formed any independent basis of support for any of the claims of Speziali.
`(Ex.1015, pp.9)
`7 While not relevant because Speziali is statutorily entitled to the priority date of
`the PCT application, with regard to Petitioner’s comment that the originally filed
`PCT claims are different from the issued claims of Speziali, it is the result of the
`Speziali claims in the U.S. being rejected over the same Lattouf I and Bachman
`references applied in this proceeding against the ‘386 Patent. (See, e.g., Ex. 1015,
`pp. 276-281)
`
`
`
`10
`
`

`
`¶¶[0011]-[0016], [0018]-[0019] and [0021]-[0025] with Ex.1001, 2:66-3:22, 4:63-
`
`5:42, 5:54-6:15, 6:23-50 and 7:35-61 and Ex.1013, ¶¶[0011]-[0012], [0014]-
`
`[0016], [0018]-[0020], [0022]-[0023] and [0029]-[0030].) For example, the chart
`
`below provides corresponding exemplary support in each application for
`
`independent claim 1 of Speziali:
`
`Claim limitation
`
`1. A method of repairing a heart
`valve in a patient with an instrument
`having a distal end and a movable
`element, the method comprising:
`inserting the instrument through the
`patient's chest wall and into the
`patient's chest cavity;
`the
`inserting
`the distal end and
`movable element of the instrument
`through an exterior heart wall;
`grasping a single leaflet on the heart
`valve between the movable element
`and the distal end of the instrument;
`
`proper
`and
`capture
`confirming
`positioning of the leaflet between the
`movable element and the distal end
`using a fiber optic visualization
`system . . .
`puncturing the leaflet with a needle
`disposed on the distal end of the
`instrument after confirming proper
`positioning of the leaflet to form a
`puncture opening and drawing the
`suture through the puncture opening
`to connect the suture to the leaflet;
`
`Support in
`provisional
`application
`[0011],
`[0018]
`
`Support in
`PCT
`application
`[0011],
`[0018]
`
`[0011],
`[0013]
`
`[0011],
`[0014]
`
`[0011],
`[0015],
`[0021]
`
`[0012],
`[0023]-
`[0024]
`
`[0011],
`[0014]
`
`[0011],
`[0014]
`
`[0011],
`[0015],
`[0022]
`
`[0012],
`[0029]-
`[0030]
`
`[0011],
`[0021]
`
`[0011],
`[0022]
`
`Support in
`Speziali
`patent
`2:66-3:10
`and 5:54-
`65
`
`2:66-3:10
`and 4:63-
`5:9
`2:66-3:10
`and 5:9-18
`
`2:66-3:10,
`5:19-35
`and 6:23-
`43
`3:11-22
`and 7:35-
`61
`
`2:66-3:10
`and 6:23-
`43
`
`
`
`11
`
`

`
`
`
`capturing the suture with the needle;
`anchoring
`the suture
`to another
`structure in the heart;
`
`[0021]
`[0011],
`[0015]
`
`withdrawing the instrument through
`the heart wall; and
`
`withdrawing the instrument from the
`chest cavity.
`
`[0011],
`[0015],
`[0025]
`
`[0011],
`[0015],
`[0025]
`
`
`
`
`
`[0022]
`[0011],
`[0015]
`
`[0011],
`[0015],
`[0023]
`
`[0011],
`[0015],
`[0023]
`
`6:23-43
`2:66-3:10
`and 5:19-
`35
`2:66-3:10,
`5:19-35
`and 6:44-
`50
`2:66-3:10,
`5:19-35
`and 6:44-
`50
`
`Even if Patentee had made a sufficient evidentiary showing requiring
`
`Petitioner to prove that Speziali is entitled to the priority date of the provisional
`
`application, which is not the case, Petitioner has proven that Speziali is so entitled.
`
`
`
`Speziali is clearly prior art to the ‘386 Patent, and this negates the only
`
`argument Patentee has presented for why Speziali does not anticipate claims 1, 3
`
`and 7-14 of the ‘386 Patent. (Response, p.16.) Likewise, the only meaningful
`
`arguments offered against the obviousness of claims 2 and 4 are based on the same
`
`arguments with respect to Speziali not being prior art. (Response, p.49.)
`
`Accordingly, the Board should confirm the rejections of these claims as
`
`unpatentable.
`
`
`
`
`
`12
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`

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`2.
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`Speziali anticipates claims 19, 22 and 23 because Patentee’s
`arguments are entirely premised on Patentee’s incorrect construction
`of “percutaneous”
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`Patentee’s only argument for why Speziali does not anticipate claims 19, 22
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`and 23 relies entirely upon its overly narrow construction of the term
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`“percutaneous” as requiring “unbroken skin” without “any incisions.” As
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`discussed in Section II.A, and as previously found by the Board, a BRI
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`construction of the term “percutaneous” can include procedures that utilize a direct
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`needle puncture and/or a small incision to obtain access “through the skin.”
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`(Ex.2004, 23:16-24:16.) When this proper BRI construction is applied, Speziali
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`anticipates claims 19, 22 and 23 because it performs the procedure “through the
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`skin.” Claims 19, 22 and 23 are therefore anticipated by Speziali.
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`3.
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`Claims 5, 6, 18, 20 and 21 are obvious over the combination of
`Speziali and Bachman
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`The Board found claims 5, 6, 18, 20 and 21 likely to be unpatentable over
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`Speziali in view of Bachman based “on our own independent review of the
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`evidence” as well as the evidence presented in “the supporting declaration of Dr.
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`Aklog.”8 Patentee has not presented sufficient technical reasoning or evidence to
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`8 Patentee’s repeated arguments that Dr. Aklog’s testimony is somehow not
`evidence are not plausible. The “underlying facts or data” behind Dr. Aklog’s
`testimony are his decades of experience in the valve repair field and the hundreds
`of valve repair procedures he has performed.
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`contradict the evidence presented by Petitioner, and therefore Petitioner has shown
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`by a preponderance of the evidence that these claims are obvious.
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`a.
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`Patentee has presented no evidence for why one skilled in the
`art would not be motivated to combine Speziali and Bachman
`regarding claims 5, 6 and 18
`
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`With regard to claims 5, 6 and 18, Patentee’s only response for why the
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`claims are not unpatentable over Speziali and Bachman is to attack the “motivation
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`to combine” presented by Petitioner with attorney argument. (Response, pp.44-45.)
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`Whereas the motivation to combine presented by Petitioner is based upon expert
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`declaration evidence and has already been cited with approval by the Board,
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`Patentee’s argument has no evidentiary basis. See MPEP 2145(I) (“Attorney
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`argument is not evidence.”)
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`
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`As stated by Dr. Aklog, claim 5 relating to an “annuloplasty effect,” claim 6
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`relating to a “bow-tie Alfieri” procedure and claim 18 relating to utilizing a
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`vacuum to grasp a leaflet all relate to procedures that are well known to one skilled
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`in the art of heart valve repair and are all expressly disclosed in Bachman. The
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`Board agreed with Petitioner that “a person of ordinary skill in the art would have
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`used professional judgment to combine the teachings of Bachman relating to ‘well
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`known’ additional repair techniques with the teachings of Speziali in order to
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`effectuate a repair that mimics the techniques employed in open procedures, and as
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`selected from a finite set of options.” (Decision, p.17; Ex.2004, 84:1-9 and 85:1-
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`5.) Patentee has presented no evidence to rebut these conclusions.
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`Whether access to the valve is gained transapically, as disclosed in Speziali,
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`or endovascularly, as disclosed in Bachman, the evidence provided by Petitioner
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`relates to techniques for repairing the valve after access is gained, regardless of
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`how access is initially obtained. As found by Petitioner’s expert, it would have
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`been obvious to one skilled in the art, once access to the heart as been gained, to
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`use appropriate professional judgment to determine which of these known
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`procedures should be utilized. (Ex.1011, ¶¶ 60-61.) Patentee has presented no
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`evidence to rebut the conclusion of obviousness of claims 5, 6 and 18, and
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`therefore the claims should be found unpatentable.
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`
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`b.
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`Claims 20 and 21 are unpatentable because Bachman teaches
`how the Speziali device could be modified to be used
`endovascularly
`
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`Patentee’s primary basis for arguing that claims 20 and 21 are not obvious
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`
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`over the combination of Speziali and Bachman is that Speziali discloses a rigid
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`device that could not be used endovascularly. (Response, pp.20-26.) However,
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`this argument improperly overlooks the teachings of Bachman regarding a
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`substantially similar working end of the device as disclosed by Speziali and how
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`the Bachman device can be utilized for endovascularly inserting a suture into a
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`heart valve leaflet.
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`
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`It is canon in patent law that “[o]ne cannot show nonobviousness by
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`attacking references individually where the rejections are based on combinations of
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`references.” (MPEP § 2145(IV), citing In re Keller, 642 F.2d 413 (CCPA 1981)
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`and In re Merck & Co, Inc., 800 F.2d 1091 (Fed. Cir. 1986).) Yet, Patentee’s
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`argument as to why one skilled in the art would not be motivated to combine
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`Speziali and Bachman relies entirely upon alleged deficiencies in Speziali with no
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`mention whatsoever of the teachings of Bachman. Such an argument is a red
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`herring that is insufficient, as a matter of law, to counteract Petitioner’s evidence of
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`obviousness.
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`
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`When one properly evaluates the teachings of Speziali in view of the
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`teachings in Bachman with respect to claims 20 and 21, a clear finding of
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`obviousness is established. Both devices use slideable grasping jaws to retain
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`leaflets for insertion of a rigid needle into the leaflet to deposit a suture into the
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`leaflet. (Cf, e.g., Ex.1006, Abstract and Ex.1008, Abstract.) The primary
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`difference between the devices is based on how they access the valves – Speziali
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`has a rigid body to access the valve transapically and Bachman has a non-rigid
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`body to access the valve endovascularly. (Cf., e.g., Ex.1006, 5:14-18 and Ex.1008,
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`¶[0041].) The working portions of the device once the valve is accessed are
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`generally identical – grasping jaws, a needle and a suture. (Ex.2004, 96:5-14.) In
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`fact, figures in each reference appear almost identical with respect to use of the
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`corresponding devices to insert a suture into a valve leaflet after access to the heart
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`has been gained.
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`
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`Figure 8D of Speziali
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`
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`Figure 10 of Bachman
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`Bachman does not include figures showing how the device is routed through
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`the vasculature to the heart, presumably because the inventor knew that one skilled
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`in the art would understand how such access could be gained. Bachman provides a
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`teaching and motivation for how the device of Speziali could be modified such that
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`the working end of Speziali could be used according to the known endovascular
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`approach with a non-rigid shaft to insert a suture into a leaflet if, based on the
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`professional judgment of the surgeon, an endovascular approach to a particular
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`patient would be more desirable than a transapical approach. (Ex.1011, ¶ 61;
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`Ex.2004, 73:13-19 and 95:18-96:14.)
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`
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`Petitioner respectfully requests that claims 20 and 21 be found unpatentable
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`over the combination of Speziali and Bachman.
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`
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`C.
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`The Grounds based on Lattouf I and Bachman Should Be Maintained.
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`1.
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`Claims 1 and 4-6 are unpatentable because Patentee’s arguments
`ignore the teachings of both references
`
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`Patentee attempts to confuse the obviousness analysis of claims 1 and 4-6
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`over Lattouf I and Bachman by focusing on aspects of the references not related to
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`the obviousness conclusion and on alleged deficiencies in only a single reference.
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`(Response, p.47-48). When the teachings of both references are properly
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`evaluated, claims 1 and 4-6 are unpatentable over the combination.
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`
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`Patentee’s arguments focus on alleged differences between the transapical
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`procedure of Lattouf I and the endovascular approach of Bachman and on alleged
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`deficiencies only in Bachman. The endovascular nature of the approach of
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`Bachman is not at issue in the analysis of independent claim 1, which is admittedly
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`read on by transapical access. Bachman is simply being relied upon as teaching
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`the known alternative of inserting a suture directly through the leaflets in place of
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`the combination of the clip and suture taught in Lattouf I9 after access to the heart
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`is achieved, regardless of the method used to obtain access.
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`The fact that Bachman may not teach anchoring the suture to the heart wall
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`is irrelevant given that Lattouf I teaches inserting “an artificial chordae tendonae
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`such as a strand extending between the valve leaflets and the heart wall.” (Ex.1004,
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`3:46-58.) Bachman is not being relied upon for teaching anchoring a suture to the
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`heart wall, only for inserting