Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 1 of 18 PageID #: 1357
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 14-1473 (LPS)(CJB)
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`
`Kenneth L. Dorsney (#3726)
`MORRIS JAMES LLP
`500 Delaware Ave., Suite 1500
`Wilmington, DE 19801-1494
`(302) 888-6800
`kdorsney@morrisjames.com
`
`Attorneys for Plaintiffs Endoheart AG
`
`ENDOHEART AG
`
` Plaintiff,
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`
`
`
`
`
`
`v.
`
`EDWARDS LIFESCIENCES
`CORPORATION,
`
` Defendant
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`.
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`
`
`
`
`OF COUNSEL:
`
`Mark H. Bloomberg
`Zuber Lawler and Del Duca LLP
`1325 Avenue of the Americas
`28th Floor
`New York, New York 10019
`(212) 763-8610
`mbloomberg@zuberlaw.com
`
`
`
`
`
`
`Dated: November 20, 2015
`
`ENDOHEART AG’S RESPONSIVE CLAIM CONSTRUCTION BRIEF
`
`Edwards Exhibit 1027, pg. 1
`
`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 2 of 18 PageID #: 1358
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION .................................................................................................................. 1
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`I. 
`
`II.  ENDOHEART'S PROPOSED CONSTRUCTIONS SHOULD BE ADOPTED ................... 1
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`
`
`
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`1. "Elongated wire configured" and "Elongated wire having a length along
` which the wire is configured". .................................................................................. 1
`
`
`
`
`
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`
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`2. "Configured to conform to a direction of blood flow". ............................................. 3
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`3. "Installing". ................................................................................................................ 7
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`4. "Access device having means for preventing bleeding
` through the access device". ........................................................................................ 9
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`
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`III. 
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`5. "The feeding directed by the blood flow". ............................................................... 12
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`CONCLUSION ................................................................................................................. 14 
`
`i
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`Edwards Exhibit 1027, pg. 2
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`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 3 of 18 PageID #: 1359
`
`TABLE OF AUTHORITIES
`
`Page
`
`FEDERAL CASES
`
`Apple Inc. v. Samsung Elecs. Co.,
` 786 F.3d 983 (Fed. Cir. 2015) .................................................................................................... 7
`
`Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
` 246 F.3d 1368 (Fed. Cir. 2001) ................................................................................................ 14
`
`DDR Holdings, LLC v. Hotels.com, L.P.,
` 773 F.3d 1245 (Fed. Cir. 2014) .................................................................................................. 7
`
`Deere & Co. v. Bush Hog. LLC,
` 703 F.3d 1349 (Fed. Cir. 2012) .................................................................................................. 8
`
`Dragon Intellectual Prop., LLC v. Apple, Inc.,
` No. CV 13-2058-RGA, 2015 WL 5298938, at *5 (D. Del. Sept. 9, 2015) .............................. 11
`
`Hoganas AB v. Dresser Indus., Inc.,
` 9 F.3d 948 (Fed. Cir. 1993) ........................................................................................................ 2
`
`Invitrogen Corp. v. Biocrest Mfg., L.P.,
` 424 F.3d 1374 (Fed. Cir. 2005) .................................................................................................. 7
`
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`
` __ U.S. __ , 134 S. Ct. 2120 (2014) ........................................................................................... 7
`
`Nystrom v. TREX Co.,
` 424 F.3d 1136 (Fed. Cir. 2005) .................................................................................................. 2
`
`Philips v. AWN Corp.,
` 415 F.3d 1303 (Fed. Cir. 2005) .................................................................................................. 9
`
`S3 Inc. v. NVIDIA Corp.,
` 259 F.3d 1364 (Fed. Cir. 2001) ................................................................................................ 11
`
`Sarif Biomedical LLC v. Brainlab, Inc.,
` No. CV 13-846-LPS, 2015 WL 5072085, at *2 (D. Del. Aug. 26, 2015) .................................. 3
`
`Seachange Int'l, Inc. v. C-COR, Inc.,
` 413 F.3d 1361 (Fed. Cir. 2005) ............................................................................................ 9, 14
`
`Tarkus Imaging, Inc. v. Adobe Sys., Inc.,
` No. CA 10-63-LPS, 2012 WL 16669598, at *5 (D. Del. May 1 2012) ...................................... 3
`
`ii
`
`Edwards Exhibit 1027, pg. 3
`
`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 4 of 18 PageID #: 1360
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`
`Telcordia Techs., Inc. v. Cisco Sys., Inc.,
` 612 F.3d 1365 (Fed. Cir. 2010) ................................................................................................ 11
`
`STATUTES
`
`35 U.S.C. §112(f) .................................................................................................................... 10, 11
`
`
`
`iii
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`Edwards Exhibit 1027, pg. 4
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`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 5 of 18 PageID #: 1361
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`I. INTRODUCTION
`
`Plaintiff Endoheart AG
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`(“Endoheart”) submits
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`this Responsive Claim
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`Construction Brief in accordance with the March 27, 2015 Scheduling Order (D.I. 19).
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`Endoheart’s opening brief demonstrates that its proposed claim constructions are fully supported
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`by the proper legal analysis and by the intrinsic record. They should therefore be adopted.
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`In contrast, for the reasons set forth below, Defendant Edwards Lifesciences
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`Corporation’s
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`(“Edwards”) proposed constructions should be
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`rejected because
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`they
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`impermissibly add limitations to the claims, while ignoring and mischaracterizing the intrinsic
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`evidence.
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`II. ENDOHEART’S PROPOSED CONSTRUCTIONS SHOULD BE ADOPTED
`
`1.
`
`“Elongated wire configured” and “Elongated wire
`having a length along which the wire is configured”
`
`The parties have proposed that the phrase “elongated wire configured,” which
`
`appears in claim 1 of the ‘530 patent, should be construed as follows:
`
`Endoheart Proposed Construction
`
`Edwards Proposed Construction
`
`a long and thin guidewire having a property or
`structure for achieving something
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`a guidewire having its entire length configured
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`The parties have proposed that the phrase “elongated wire having a length along which the wire
`
`is configured,” which appears in claim 6, be construed as follows:
`
`Endoheart Proposed Construction
`
`Edwards Proposed Construction
`
`a long and thin guidewire having a length
`along which the guidewire has a property or
`structure for achieving something
`
`a guidewire having a portion of its length
`configured
`
` The basic dispute between the parties is that Edwards improperly attempts to read
`
`limitations into the claims to require that the entire length of the guidewire be configured to
`
`1
`
`Edwards Exhibit 1027, pg. 5
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`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 6 of 18 PageID #: 1362
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`conform to the direction of blood flow for the purposes of claim 1, and that only a portion of the
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`guidewire be configured to conform to the direction of blood flow for the purposes of claim 6.
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`There is no support anywhere in the claims, the specification or the prosecution history of the
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`‘530 patent to support Edwards’ constructions. Edwards improperly seeks to add limitations to
`
`the claims. Hoganas AB v. Dresser Indus., Inc., 9 F.3d 948, 950 (Fed. Cir. 1993).
`
`As Endoheart explained in its Opening Brief, neither claim 1 nor claim 6 says
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`anything about what portion of, or whether the entire length of, the guidewire is configured to
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`conform to the direction of blood flow, as long as the guidewire is configured to conform to the
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`direction of blood flow (D.I. 65: pp.9, 17-18).1 Claim 1 simply describes the guidewire as a
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`whole, which contains at least some portion that is configured to conform to the direction of
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`blood flow.
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`In the absence of any support in the intrinsic record for the construction Edwards
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`seeks, Edwards only relies on a presumption that different claim terms have different meanings
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`(D.I. 63: pp.4). However, simply noting differences in claim language does not end the matter.
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`Differences in claim language may be construed to cover the same thing where the specification
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`and prosecution history indicate that such a construction is appropriate, as is the case here.
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`Nystrom v. TREX Co., 424 F.3d 1136, 1143 (Fed. Cir. 2005). Nothing in the specification or in
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`the prosecution history suggests that those phrases in claim 1 and in claim 6 describe different
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`things (i.e., they both describe a guide wire having at least some portion that is configured to
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`conform to the direction of blood flow), and there is nothing in the intrinsic record that supports
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`Edwards’ construction.
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`
`1
`In this sense, the guidewire is no different from an ordinary kitchen knife, which has a
`handle and a blade, and is configured to cut food. Analogous to the guidewire of claim 1, the
`knife itself is configured to cut food because it has a blade; analogous to the guidewire of claim
`6, the knife has a length along which it is configured to cut food (i.e., its blade).
`
`2
`
`Edwards Exhibit 1027, pg. 6
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`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 7 of 18 PageID #: 1363
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`Edwards’ authorities are inapposite. In Tarkus Imaging, Inc. v. Adobe Sys., Inc.,
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`No. CA 10-63-LPS, 2012 WL 16669598, at *5 (D. Del. May 1 2012), the specification – and not
`
`just the difference in language between an independent claim and a dependent claim – confirmed
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`that “image file” and “original image” are different things. There is no such distinction between
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`the guidewire language in independent claim 1 and independent claim 6, contrary to what
`
`Edwards suggests. Sarif Biomedical LLC v. Brainlab, Inc., No. CV 13-846-LPS, 2015 WL
`
`5072085, at *2 (D. Del. Aug. 26, 2015), simply quotes propositions of law about presumptions
`
`that are not applicable to independent claims 1 and 6 here (i.e., “the presence of a dependent
`
`claim that adds a particular limitation gives rise to a presumption that the limitation in question is
`
`not present in the independent claim” and that the presumption is “especially strong when the
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`limitation in dispute is the only meaningful difference between an independent claim and
`
`dependent claim”).
`
`There is no basis in the claims, or elsewhere in the intrinsic record, for Edwards’
`
`proposed constructions. The Court should therefore adopt Endoheart’s proposed constructions.
`
`2.
`
`“Configured to conform to a direction of blood flow”
`
`This phrase appears in claim 1 and claim 6 of the ‘530 patent.
`
`Endoheart Proposed Construction
`
`Edwards Proposed Construction
`
`having the property or structure for adapting to
`the direction of blood flow
`
`adapted to be carried along with the antegrade
`flow of blood
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`Endoheart explained in its opening brief why its proposed construction of this
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`phrase is consistent with the plain and ordinary meaning of the language of “configured” and of
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`“conform to.” The intrinsic record confirms that both of these meanings are correct. The
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`specification explains that guidewire 44 is “relatively thin and flexible,” enabling it to have the
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`property or structure for adapting to the direction of blood flow (D.I. 65: p.10), and the Examiner
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`3
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`Edwards Exhibit 1027, pg. 7
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`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 8 of 18 PageID #: 1364
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`recognized that “[a] guide wire is known to be floppy and would be capable of conforming to
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`blood flow” (D.I. 60-4: p.5). Moreover, Dr. Huber demonstrated at the September 16, 2011
`
`Interview2 that a floppy guidewire is configured to conform to the direction of blood flow (D.I.
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`65: pp.10-11).
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`Endoheart’s opening brief also confirms the plain and ordinary meaning of
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`“configured” and that Endoheart’s construction is correct. Edwards cites to descriptions of
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`“annular wire” and “dissection repair device” as examples of things that are “configured” (D.I.
`
`63: pp.5-6). Those descriptions confirm that the “annular wire” and the “dissection repair
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`device” have a “property or structure for achieving something,” as in Endoheart’s proposed
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`construction (i.e., the annular wire is configured to track an already placed guidewire, and the
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`dissection repair device is configured to be inserted into the patient’s aorta).
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`Edwards’ dictionary citation likewise confirms that Endoheart’s proposed
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`construction is correct: “To design or adapt to form a specific configuration or for some
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`specific purpose” (D.I. 64-1: p.44; emphasis supplied). Notably, Edwards truncates its own
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`dictionary definition to say that “configured” just means “adapted.” The full definition in
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`Edwards’ dictionary proves that Endoheart’s proposed construction is correct – and that
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`Edwards’ proposed construction is incorrect.
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`As Endoheart explained in its opening brief, it disagrees with the inclusion of
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`“antegrade” in Edwards’ proposed construction because Edwards’ proposed construction
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`replaces the language that appears in the claim (i.e., “in the direction of blood flow”), which is
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`
`2
`Endoheart’s opening brief refers to this Interview as “the October 12, 2011 Interview.”
`The Interview occurred on September 16, and the Interview Summary was provided in an Office
`communication dated October 12, 2011.
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`4
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`Edwards Exhibit 1027, pg. 8
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`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 9 of 18 PageID #: 1365
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`easily understood by the jury, with “antegrade,” which would be more difficult to understand,
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`and could easily confuse the jury (D.I.: 65, 11).
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`Endoheart also disagrees with Edwards’ proposed construction that the guidewire
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`be “carried along with” blood flow because that construction introduces potential ambiguity and
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`confusion into the claim construction. As explained in Section 5, infra, the full context of this
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`step of claims 1 and 6 demonstrates that two separate operations are performed – (1) feeding the
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`guidewire through a needle into the ventricle, and (2) directing the guidewire from the ventricle
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`into the aorta following blood flow. Edwards’ proposed construction in Section 5 of “the feeding
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`directed by the blood flow” improperly conflates these two operations. The same is true for this
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`Section 2 construction. Claim 1 recites:
`
`feeding through the cannulated needle an elongated wire configured to conform
`to a direction of blood flow, the feeding continuing such that the wire follows the
`blood flow until a length of the wire extends at least from a ventricular apex of the
`heart through an aortic valve of the heart
`
`and claim 6 recites:
`
`feeding through the cannulated needle an elongated wire having a length along
`which the wire is configured to conform to a direction of blood flow, the feeding
`directed by the blood flow such that the wire follows the blood flow, the feeding
`continuing until the length extends at least from the ventricular apex to an aorta
`
`In both claims, the “configured to conform to a direction of blood flow” limitation
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`relates to following blood flow, not to how feeding is performed. Edwards’ proposed language
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`imposes the same ambiguity discussed below in Section 5, namely that by construing this
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`limitation “to be carried along with” the flow of blood, the jury may be misled into believing that
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`the guidewire must be adapted to perform both operations by the blood flow. Endoheart’s
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`construction “adapting to the direction of blood flow” avoids this potential ambiguity.
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`Edwards’ arguments about the prosecution history (D.I. 65: pp.9-11) fail because
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`Edwards ignores that the claims of the ‘530 patent are directed to methods, and to the unique use
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`5
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`Edwards Exhibit 1027, pg. 9
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`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 10 of 18 PageID #: 1366
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`of guidewires, not any novel structure of guidewires themselves. Edwards’ argument that Dr.
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`Huber stated that “his guidewire was different than the guidewire used in Lattouf” (D.I. 65: p.9)
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`is inapposite. In the Request for Continued Examination, Lattouf (which discloses feeding a
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`guidewire against blood flow from the ventricular apex to the mitral valve) was distinguished
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`because the claims required feeding from the ventricular apex to the aorta in the direction of
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`blood flow (D.I. 60-5: pp.50-52). Contrary to what Edwards suggests, nothing was said about
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`the structure of the guidewire itself. Indeed, the Examiner recognized that the guidewire in the
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`claim was the same as the Lattouf guidewire: “A guide wire is known to be floppy and would be
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`capable of conforming to blood flow” (D.I. 60-4: p.5). Dr. Huber did not disagree with that
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`statement because the Examiner was correct. But he did disagree with the Examiner because the
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`use of the guidewire is different, as he demonstrated at the Interview and described in the
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`October 12, 2011 Reply To Office Action, in which he distinguished the disclosure in Lattouf of
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`using guidewires “for advancement against the direction of blood flow through the left ventricle
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`and further advanced through the mitral valve into the left atrium” (D.I. 60-5: pp.14-15;
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`emphasis supplied). He said nothing about the structure of the guidewires themselves because it
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`is not different.
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`Thus, there is no basis for Edwards’ argument that the structure of the guidewire
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`itself is different, or that Dr. Huber distinguished the structure of the guidewire used in Lattouf
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`from the structure of the guidewire used in his invention during prosecution of the ‘530 patent
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`(D.I. 63: p.11). To the contrary, the intrinsic record makes plain that the invention is for a new
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`use of a floppy guidewire, not for a new type of floppy guidewire.
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`The Court should therefore adopt Endoheart’s proposed construction.
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`6
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`Edwards Exhibit 1027, pg. 10
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`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 11 of 18 PageID #: 1367
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`Edwards has also raised the argument that a guidewire configured to conform to a
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`direction is blood flow is indefinite (D.I. 63: pp.6-8). However, “a patentee need not define his
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`invention with mathematical precision in order to comply with the definiteness requirement.”
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`Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1384 (Fed. Cir. 2005). A claim is
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`definite if it allows a person skilled in the art to know the scope of the claim with “reasonable
`
`certainty.” Nautilus, Inc. v. Biosig Instruments, Inc., __ U.S. __ , 134 S. Ct. 2120, 2124 (2014).
`
`Even where the meaning of a claim term contains some flexibility, the claim term is nonetheless
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`definite if it has an “established meaning” to a person skilled in the art. DDR Holdings, LLC v.
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`Hotels.com, L.P., 773 F.3d 1245, 1261 (Fed. Cir. 2014); Apple Inc. v. Samsung Elecs. Co., 786
`
`F.3d 983, 1003 (Fed. Cir. 2015).
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`One needs to look no further than the prosecution history to see that Edwards’
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`argument is meritless. The Examiner plainly understood that a floppy guidewire is configured to
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`conform to the direction of blood flow: “A guide wire is known to be floppy and would be
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`capable of conforming to blood flow” (D.I. 60-4: p.5). Moreover, the specification describes that
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`a floppy guidewire is used (“a relatively thin and flexible guidewire” that may be replaced by a
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`“stiffer guidewire”) (col. 9, lines 10-14) and the prosecution history confirms that the guidewire
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`is a floppy guidewire, including Dr. Huber’s demonstration before the Examiners (D.I 60-5:
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`p.70) and the Examiners’ agreement that the demonstrated steps were supported by the
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`specification. As above, Edwards’ argument that Dr. Huber distinguished the art based “on the
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`basis that his guidewire was not the same” (D.I. 63: p.8) mischaracterizes the record. Dr. Huber
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`never distinguished the structure of any prior art guidewire; rather he distinguished the prior art
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`guidewires based on the novel use of those guidewires in his claimed method invention.
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`3.
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`“Installing”
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`This term appears in claim 1 and claim 6 of the ‘530 patent.
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`7
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`Edwards Exhibit 1027, pg. 11
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`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 12 of 18 PageID #: 1368
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`Endoheart Proposed Construction
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`Edwards Proposed Construction
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`putting into place
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`anchoring in place
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`Endoheart explained in its opening brief why its proposed construction of
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`“installing” is consistent with the plain and ordinary meaning of the language and with the
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`intrinsic record, including the prosecution history, which distinguished “anchoring” from
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`“installing.” Endoheart’s opening brief further explained that Edwards, in contrast, seeks to
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`rewrite the claims by adding a limitation (“anchoring”) that is not present in the claims and that
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`conflates two separate operations (i.e., installing and anchoring) (D.I. 65: pp.12-14). The
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`specification of the ‘530 patent describes that a heart valve is installed and anchored, and that an
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`access device is installed and may be anchored. But anchoring is not claimed for either the heart
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`valve or for the access device, and it improper for Edwards to add an unclaimed anchoring
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`limitation to the claims. Deere & Co. v. Bush Hog. LLC, 703 F.3d 1349, 1354 (Fed. Cir. 2012).
`
`None of the citations to the specification of the ‘530 patent that Edwards quotes at
`
`page 12 of its opening brief supports its argument that “installing” means “anchoring:”
`
`
`
`
`
`
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`Edwards’ first point, which does not relate to access devices, describes the
`approach by which a new heart valve is installed (i.e., “installing the new
`heart transapically”), and says nothing about anchoring the heart valve.
`
`Edwards’ second point, which does not relate to access devices, says
`nothing about anchoring. Contrary to Edwards argument that the “heart
`valves discussed in these passages are unquestionably implanted” (D.I. 63:
`p.12), this portion of the specification of the ‘530 patent uses the word
`“installing” and the word “implanting” to mean different things (compare
`“installing the new heart valve transapically” (col. 4, line 15) with
`“implantation could be performed transapically. The new heart valve is
`preferably implanted by radially expanding the heart valve” (col. 4, lines
`18-20) (emphasis supplied to both).
`
`Edwards’ third point, which does not relate to access devices, describes
`the approach by which a new heart valve is installed (i.e., “being installed
`in a retrograde approach”), and says nothing about anchoring the heart
`valve.
`
`8
`
`Edwards Exhibit 1027, pg. 12
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`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 13 of 18 PageID #: 1369
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`
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`Edwards’s fourth point, which cites to claim 1, says nothing about
`anchoring – and there is nothing anywhere in claim 1 or in claim 6 about
`anchoring.
`
`Finally, the fact that the preamble of claim 1 may recite a “method of implanting a heart valve”
`
`(D.I. 63: p.12) does not mean that “anchoring” is recited or required anywhere in the claim. It
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`isn’t – not even in the preamble.
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`Edwards’ argument that the access device “must” be anchored is also incorrect.
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`The specification says only that an access device “may” be anchored (D.I. 65: p.14). It is
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`impermissible to read preferred embodiments described in the specification into the claims.
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`Seachange Int'l, Inc. v. C-COR, Inc., 413 F.3d 1361, 1377 (Fed. Cir. 2005). Moreover, the
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`prosecution history (which Edwards ignores) confirms that anchoring is distinct from installing
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`because prior art that the Examiner cited as disclosing anchoring of an access device was
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`specifically distinguished from the claimed access device because anchoring of the access device
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`would be harmful to a patient (D.I. 65: pp.13-14; D.I. 60-3: pp.31-32).
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`Finally, Edwards’ argument based on “installing” having the same meaning in
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`both places in the claim where it appears is misplaced. Edwards is correct that “install” is used
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`in the claims in connection with both the access device and the heart valve. However, Edwards
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`is wrong in concluding that both limitations require anchoring. To the contrary, anchoring is not
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`required by either claim limitation. Thus, Endoheart’s proposed construction is perfectly
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`consistent with Philips v. AWN Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005).
`
`The Court should therefore adopt Endoheart’s proposed construction, which
`
`appears in claim 1 and in claim 6.
`
`4.
`
`“Access device having means for preventing
`bleeding through the access device”
`
`The parties have proposed the following constructions of this phrase:
`
`9
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`Edwards Exhibit 1027, pg. 13
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`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 14 of 18 PageID #: 1370
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`Endoheart Proposed Construction
`
`Edwards Proposed Construction
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`is
`that
`includes a valve
`that
`catheter
`mechanically operable as an iris diaphragm
`or constructed of an elastic material with a
`small central opening that is dilated by
`equipment inserted therethrough and always
`maintains a fluid-tight seal with the inserted
`equipment
`
`a device that provides an access port having
`means for preventing bleeding through the
`device
`The “means for preventing bleeding” (1) may
`be mechanically operable as an iris (like the
`aperture of a lens), (2) may be constructed of
`an elastic material with a small central opening
`that is dilated by whatever equipment is
`inserted therethrough, but always maintains a
`fluid-tight seal with the inserted equipment, (3)
`may compose any fluid-tight valve structure, or
`(4) may be equivalent to any of those disclosed
`structures
`
`
`
`Endoheart explained in its opening brief why the claim term “access device”
`
`means “a device that provides an access port,” consistent with plain and ordinary meaning, as
`
`confirmed by the specification. Endoheart further explained why Edwards’ construction that an
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`“access device” is a “catheter” should be rejected because Edwards improperly rewrites claims 1
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`and 6 to add that limitation, contrary to the specification and the prosecution history (D.I. 65:
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`p.15). Edwards’ opening brief does not even address what “access device” means, much less
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`provide any support for its improper construction. Accordingly, Endoheart’s construction that
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`“access device” means “a device that provides an access port” should be adopted.
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`The parties agree that the “means for preventing bleeding through the access
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`device” is a mean-plus-function element, the construction of which is governed by 35 U.S.C.
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`§112(f) to be the structure defined in the specification and equivalents thereof:
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`An element in a claim for a combination may be expressed as a means or step for
`performing a specified function . . . and such claim shall be construed to cover the
`corresponding structure, material, or acts described in the specification and
`equivalents thereof.
`
`10
`
`Edwards Exhibit 1027, pg. 14
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`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 15 of 18 PageID #: 1371
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`The parties further agree that the structure described in the specification for performing this
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`function is found at col. 10, lines 8-16 of the ‘530 patent. Where they disagree – and where
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`Edwards’ proposed construction fails – is that Edwards makes two fundamental errors in
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`construing this element.
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`First, Edwards leaves one of the structures disclosed in the specification out of its
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`construction (i.e., “Valve 63 may compose any fluid-tight valve structure”). Edwards’ reliance
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`on Dragon Intellectual Prop., LLC v. Apple, Inc., No. CV 13-2058-RGA, 2015 WL 5298938, at
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`*5 (D. Del. Sept. 9, 2015), is misplaced. In Dragon, the specification said nothing more than
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`“alternative power sources may be applied to the instant invention,” without saying what those
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`alternative sources might be, and the Court found “[w]here a patent says alternative structures
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`may be used but does not identify them, the structure is limited to the examples disclosed.” Id.
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`That is plainly not the case here, where the ‘530 patent specifically discloses “any fluid tight
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`valve structure” as an example of a structure for performing the claimed function. Furthermore,
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`the structure corresponding to the claimed “preventing bleeding” function is adequately
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`disclosed. See, e.g., S3 Inc. v. NVIDIA Corp., 259 F.3d 1364, 1370 (Fed. Cir. 2001); Telcordia
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`Techs., Inc. v. Cisco Sys., Inc., 612 F.3d 1365, 1377 (Fed. Cir. 2010). Accordingly, the third
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`structure disclosed in the ‘530 patent for performing this function (“any fluid-tight seal
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`structure”) must be included in the construction, as Endoheart has done – and as Edwards has
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`failed to do.
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`Second, Edwards ignores the requirement of 35 U.S.C. §112(f) that this element
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`include “equivalents thereof.” Indeed, Edwards says “this claim term should be limited in the
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`manner Edwards proposes, to the two specific examples” described in the specification (D.I. 63
`
`p.14; emphasis supplied). Thus, as a matter of law, Edwards’ proposed construction fails.
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`11
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`Edwards Exhibit 1027, pg. 15
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`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 16 of 18 PageID #: 1372
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`Accordingly, the Court should adopt Endoheart’s proposed construction.
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`5.
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`“The feeding directed by the blood flow”
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`The parties have proposed the following constructions of this phrase:
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`Endoheart Proposed Construction
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`Edwards Proposed Construction
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`the supplying of the guidewire is guided by the
`blood flow
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`the flow of blood controlling the advancement
`of the guidewire
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`Endoheart explained in its opening brief why its proposed construction of this
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`phrase is consistent with the plain and ordinary meaning of “directed by” and with the
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`prosecution history. Endoheart further explained that Edwards, in contrast, seeks to rewrite
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`claim 6 by adding limitations that are not present in claim 6, and that Edwards’ proposed
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`construction conflates the two separate operations described in claim 6 (i.e., feeding the
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`guidewire through a needle into the ventricle, and directing the guidewire into the aorta
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`following blood flow) (D.I. 65: pp. 18-19).
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`Edwards’ opening brief indeed conflates these two separate operations by
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`mischaracterizing the prosecution history and reading the language of claims 1 and 6 out of
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`context. Moreover, Edwards provides no basis for the “controlling” limitation that it seeks to
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`add to claim 6, which has no support in the intrinsic record and is contrary to the claim language.
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`At the September 16, 2011 Interview, the Examiners discussed two equivalent
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`phrases to overcome the prior art, both of which included the language “such that the wire
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`follows the blood flow:”
`
`Applicants and Examiners discussed possible claim language including either
`“the feeding continuing such that the wire follows the blood flow until . . .” or
`“the feeding is directed by the blood flow such that the wire follows the blood
`flow, the feeding continuing . . .”
`
`(D.I. 60-5: p.2; emphasis supplied). The first alternative was added to claim 1:
`
`12
`
`Edwards Exhibit 1027, pg. 16
`
`

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`Case 1:14-cv-01473-LPS Document 81 Filed 11/20/15 Page 17 of 18 PageID #: 1373
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`feeding through the cannulated needle an elongated wire configured to conform to
`a direction of blood flow, the feeding continuing such that the wire follows the
`blood flow until a length of the wire extends at least from a ventricular apex of
`the heart through an aortic valve of the heart;
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`and the second alternative was added to claim 6:
`
`feeding through the cannulated needle an elongated wire having a length along
`which the wire is configured to conform to a direction of blood flow, the feeding
`directed by the blood flow such that the wire follows the blood flow, the feeding
`continuing until the length extends at least from the ventricular apex to an aorta;
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`The purpose of these alternatives was the same – overcoming the prior art based on the
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`guidewire following blood flow in the inventions of the ‘530 patent, as Dr. Huber demonstrated
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`during the Interview (D.I. 65: p. 19).
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`The full context of the claim steps cited above, plainly demonstrates that two
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`separate operations are performed in claim 1 and claim 6 – (1) the guidewire is fed through the
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`cannulated needle into the ventricle and (2) the guidewire is directed by blood flow such that it
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`follows the b