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`1.63(d)(2) and 1.33(b).
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`i.
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`7. E] CD-ROM or CD-R in duplicate, large table or
`puter Program (Appendix)
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`(if ap licable, items a. — c. are required)
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`Continuation
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`ofprior application No.:10/829,340................
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`Prior application information:
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`Examiner Ann M. Schillinger
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`Art Unit: 3774
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`19. CORRESPONDENCE ADDRESS
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`_—
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`——
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`Registration No.—
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`Name
`We ,Aem 55.760
`THOMASMZLOGAR
`
`
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`If you need assistance in completing the form, call 1-800—PTO—9199 and select option 2.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 1 of 492
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 1 of 492
`
`

`

`
`
`FILED VIA EFS ON NOVEMBER 12, 2008 j
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Confirmation No.:
`
`Appl. No.
`
`Applicant
`
`Filing Date
`
`Title
`
`Group Art Unit
`
`Examiner
`
`Docket No.
`
`Customer No.
`
`:
`
`:
`
`:
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`:
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`:
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`:
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`:
`
`Amr SALAHIEH et al.
`
`November 12, 2008 (herewith)
`
`Everting Heart Valve
`
`10012-710301
`
`66854
`
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313
`Sir:
`
`COMMUNICATION RE ORDER OF INVENTORS
`
`This communication accompanies a new application, which is a continuation of US
`Application No. 10/870,340. In that application, a petition was filed and granted, changing the
`order of inventors as follows:
`
`Amr SALAHIEH,
`
`Ulrich R. HAUG,
`
`Hans. F. VALENCIA,
`Robert A. GESHLIDER,
`
`Tom SAUL,
`Dwight P. MOREJOHN and
`Kenneth J. MICHLITSCH.
`
`Copies of the granted petition and the corrected filing receipt are attached. It is requested
`that the subject continuation herein retain the same order of inventors.
`
`Respectfully submitted,
`
`By: W.
`
`Thomas Zlogar, Reg. No. 55,760
`
`Date: November 12, 2008
`
`SHAY GLENN LLP
`
`2755 Campus Drive, Suite 210
`San Mateo, CA 94403
`Telephone: 650.212.1700
`Facsimile: 650.212.7562
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 2 of 492
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 2 of 492
`
`

`

`vvxw‘-~\uvav'1
`
`I
`
`\V VV\
`
`Commissioner for Patents
`United States Patent and Trademark Office
`PO. Box 1450
`Alexandria, Vszglflg-‘gfl
`
` .
`
`.
`
`. UNITED S % QTES PATENT AND TRADEMARK OFFICE
`‘
`-- £35 .2." r
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`3
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`e
`
`
`
`
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`%
`
`%
`
`some“?
`A
`WILSgESH & HOSP“ %
`
`WILSON SONSINI GOODRICH &
`ROSATI
`650 PAGE MILL ROAD
`PALO ALTO CA
`94304-1050
`
`E
`
`"
`
`'_
`
`In re Application of
`Arm Salahieh et al
`
`Application No. 10/870,340
`”Filed: June 16, 2004
`
`'
`
`Attorney Docket No. 30207—710.201
`
`:
`
`:
`-
`
`COPY MAILED
`FEB 1 6 2005
`
`OFFICE OF PETITIONS
`
`ON PETITION
`
`This is a decision on the petition under 37 CFR 1.182, filed
`September 29, 2005,
`to change the order_of the names of the
`inventors.
`
`The petition is Granted.
`
`A corrected Filing Receipt with the desired order of the names of
`the inventors accompanies this de01s1on on petition.
`
`Telephone inquiries regarding the above matter should be directed
`to the undersigned at
`(571)272—3208.
`'
`
`This matter is being referred to Technology Center AU 3738.
`
`Karen CreasyW
`
`Petitions Examiner
`Office of Petitions
`Office of the Deputy Commissioner
`for Patent Examination Policy
`
`ATTACHMENTI CORRECTED FILING RECEIPT
`
`EdwardsLifesciences Corporation, et a]. Exhibit 1144, Page 3 of 492'
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 3 of 492
`
`

`

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`ii
`ia5
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`Page 1 of 3
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`_
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`MflcomHESIaoNERaI-f-ok FEE?
`PO. Box 1450
`Namath-in, W3 22313-1450
`
`we
`
`10/870,340
`
`06/16/2004
`
`3738
`
`
`
`FlL FEE REC'D
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`
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`971
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`A'lTY.DOCKET No M TOT CLMS
`63
`67
`30207-710201
`
`
`
`5
`
`021971
`
`WILSON SONSINI GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050
`
`CONFIRMATION NO. 7111
`
`CORRECTED FILING RECEIPT
`
`*OCOOOOOOO18061255*
`*OC00000001 8061255“
`
`Date Mailed: 02/15/2006
`
`It will be considered in its order and you will be
`Receipt is acknowledged of this regular Patent Application.
`notified as to the results of the examination. Be sure to provide the US. APPLICATION NUMBER, FILING DATE,
`NAME OF APPLICANT, and TITLE OF INVENTION when inquiring about this application. Fees transmitted by
`check or draft are subject to collection. Please verify the accuracy of the data presented on this receipt. If an
`error is noted on this Filing Receipt, please 'mail to the Commissioner for Patents P.0. BOX 1450
`Alexandria Va 22313-1450. Please provide a copy of this Filing Receipt with the changes noted thereon. If
`you received a "Notice to File Missing Parts" for this application, please submit any corrections to this
`, Filing Receipt with your reply to the Notice. When the USPTO processes the reply to the Notice, the
`USPTO will generate another Filing Receipt incorporating the reqUested corrections (if appropriate).
`
`Applicant(s)
`
`Amr Salahieh, Saratoga, CA;
`Ulrich R. Haug, Campbell, CA;
`Hans F. Valencia, Berkeley, CA;
`Robert A. Geshlider, San Francisco, CA;
`Tom Saul, El Granada, CA;
`Dwight P. Morejohn, Davis, CA;
`Kenneth J. Michlitsch, Livermore, CA;
`
`Power Of Attorney: The patent practitioners associated with Customer Number 021971.
`
`Domestic PriOrity data as claimed by applicant
`
`*I
`
`Foreign Applications
`
`If Required, Foreign Filing License Granted: 08/03/2004
`
`The country code and number of your priority application, to be used for filing abroad under the Paris
`Convention, is US10/870,340 _
`
`Projected Publication Date: Not Applicable
`
`Non-Publication Request: No
`
`Early Publication Request: No
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 4 of 492
`
`
`
`e: EA! are
`
`4 2008
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`CH & ROSAT
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 4 of 492
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`

`

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`Page 2 of 3
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`** SMALL ENTITY **
`
`Title
`
`Everting heart Valve
`
`Preliminary Class
`623
`
`PROTECTING YOUR INVENTION OUTSIDE THE UNITED STATES
`
`Since the rights granted by a US. patent extend only throughout the territory of the United States and have no
`effect in a foreign country, an inventor who wishes patent protection in another country must apply for a patent in
`a specific country or in regional patent offices. Applicants may wish to consider the filing of an international
`application under the Patent Cooperation Treaty (PCT). An international (PCT) application generally has the same
`effectas a regularnational patent: application in each PCT-member country. The PCT process simplifies the
`filing of patent applications on the Same invention in member countries, but does not result in a grant of "an
`international patent" and does not eliminate the need of applicants to file additional documents and fees in
`countries where patent protection is desired.
`
`Almost every country has its own patent law, and a person desiring a patent in a particular country must make an
`application for patent in that country in accordance with its particular laws. Since the laws of many countries differ
`in various respects from the patent law of the United States, applicants are advised to seek guidance from
`specific foreign countries to ensure that patent rights are not lost prematurely.
`
`Applicants also are advised that in the case of inventions made in the United States, the Director of the USPTO
`must issue a license before applicants can apply for a patent in a foreign country. The filing of a US. patent
`application serves as a request for a foreign filing license. The application's filing receipt contains further
`information and guidance as to the status of applicant's license for foreign filing.
`
`Applicants may wish to consult the USPTO booklet. “General Information Concerning Patents" (specifically. the
`section entitled "Treaties and Foreign Patents") for more information on timeframes and deadlines for filing foreign
`patent applications. The guide is available either by contacting the USPTO Contact Center at 800-786-9199, or it
`. can be viewed on the USPTO website at http://www.uspto.gov/web/officeslpac/doc/general/index.html.
`
`For information on preventing theft of your intellectual property (patents, trademarks and copyrights), you may
`wish to consult the US. Government website, http://www.stopfakes.gov. Part of a Department of Commerce
`initiative, this website includes self-help "toolkits" giving innovators guidance on how to protect intellectual
`. property in specific, countries. suCh as China, Korea and Mexico. .For.qUestions regarding patent enforcement
`’ issues, applicants may call the.U.‘S. Government hotline at 1-866-999‘-HALT (1 -866-999-41 58).
`
`
`
`LICENSE FOR FOREIGN FILING UNDER
`
`Title 35, United States Code, Section 184
`Title 37, Code of Federal Regulations, 5.11 & 5.15
`
`9M9.
`
`The applicant has been granted a license under 35 U.S.C. 184, if the phrase "lF REQUIRED, FOREIGN FlLlNG
`LICENSE GRANTED" followed by a date appears on this form. Such licenses are issued in all applications where
`the conditions for issuance of a license have been met, regardless of whether or not a license may be required as
`set forth in 37 CFR 5.15. The scope and limitations of this license are set forth in 37 CFR 5.15(a) unless an earlier
`license has been issued under 37 CFR 5.15(b). The license is subject to revocation upon written notification. The
`date indicated is the effective date of the license, unless an earlier license of similar scope has been granted
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 5 of 492
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 5 of 492
`
`

`

`Page 3 of 3
`
`under 37 CFR 5.13 or 5.14.
`
`This license is to be retained by the licensee and may be used at any time on or after the effective date thereof
`unless it is revoked. This license is automatically transferred to any related applications(s) filed under 37 CFR
`1.53(d). This license is not retroactive.
`
`The grant of a license does not in any way lessen the responsibility of a licensee for the security of the subject
`matter as imposed by any Government contract or the provisions of existing laws relating to espionage and the
`national security or the export of technical data. Licensees should apprise themselves of current regulations
`especially with respect to certain coUntries, of other agencies, particularly the Office of Defense Trade Controls,
`Department of State (with respect to Arms, Munitions and Implements of War (22 CFR 121-128)); the Bureau of
`Industry and Security, Department of Commerce (15 CFR parts 730-774); the Office of Foreign Assets Control,
`Department of Treasury (31 CFR Parts 500+) and the Department of Energy.
`
`NOT GRANTED
`
`.No license under 35 “U.S.C. 184 has been granted at this time, if’ the phrase "_lF REQUIRED, FOREIGN FILING
`LICENSE GRANTE’D""DOES NOT appear on this form. Applicant may Still-petition'for a license under 37 CFR
`5.12, if a license is desired before the expiration of 6 months from the filing date of the application. If 6 months
`has lapsed from the filing date of this application and the licensee has not received any indication of a secrecy
`order under 35 U.S.C. 181, the licensee‘may foreign file the application pursuant to 37 CFR 5.15(b).
`
`
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 6 of 492
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 6 of 492
`
`

`

`Attorney Docket No. 10012-710301
`
`UNITED STATES PATENT APPLICATION
`
`EVERTING HEART VALVE
`
`lnventor(s):
`
`SALAHIEH, Amr,
`HAUG, Ulrich R.,
`VALENCIA, Hans F.,
`
`GESHLIDER, Robert A.,
`
`SAUL, Tom,
`MOREJOHN, Dwight P.,
`MICHLITSCH, Kenneth J.
`
`Shayigigfifim
`
`2755 Campus Drive, Suite 210
`San Mateo, CA 94403
`(650) 212-1700 Main Phone
`(650) 212-7562 Facsimile
`
`
`
`;
`
`FILED VIA EFS ON NOVEMBER 12, 2008
`
`Edwards Lifesciences Corporation, et 31. Exhibit 1144, Page 7 of 492
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 7 of 492
`
`

`

` , g i z
`
`Attorney Docket No. 10012-710301
`
`EVERTING HEART VALVE
`
`CROSS-REFERENCE TO RELATED APPLICATION
`
`[0001]
`
`This application is a continuation of pending U.S. Application No. 10/870,340,
`
`filed June 16, 2004, entitled “Everting Heart Valve”, the disclosure of which is incorporated by
`
`reference in its entirety as if fully set forth herein.
`
`BACKGROUND OF THE INVENTION
`
`[0002]
`
`The present invention relates to methods and apparatus for endovascularly
`
`replacing a heart valve. More particularly, the present invention relates to methods and
`
`apparatus for endovascularly replacing a heart valve with a replacement valve and an expandable
`
`and retrievable anchor. The replacement valve preferably is not connected to the expandable
`
`anchor and may be wrapped about an end of the anchor, for example, by everting during
`
`endovascular deployment.
`
`[0003]
`
`Heart valve surgery is used to repair or replace diseased heart valves. Valve
`
`surgery is an open-heart procedure conducted under general anesthesia. An incision is made
`
`through the patient’s sternum (stemotomy), and the patient’s heart is stopped while blood flow is
`rerouted through a heart—lung bypass machine.
`I
`
`[0004]
`
`Valve replacement may be indicated when there is a narrowing of the native heart
`
`valve, commonly referred to as stenosis, or when the native valve leaks or regurgitates. When
`
`replacing the valve, the native valve is excised and replaced with either a biologic or a
`
`mechanical valve. Mechanical valves require lifelong anticoagulant medication to prevent blood
`
`clot formation, and clicking of the valve often may be heard through the chest. Biologic tissue
`
`valves typically do not require such medication. Tissue valves may be obtained from cadavers or
`
`may be porcine or bovine, and are commonly attached to synthetic rings that are secured to the
`
`patient’s heart.
`[0005]
`
`Valve replacement surgery is a highly invasive operation with significant
`
`concomitant risk. Risks include bleeding, infection, stroke, heart attack, arrhythmia, renal
`
`- 2 of 35 -
`
`FILED VIA EFS
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 8 of 492
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 8 of 492
`
`

`

`Attorney Docket No. 10012-710301
`
`failure, adverse reactions to the anesthesia medications, as well as sudden death. 2-5% of
`
`patients die during surgery.
`
`[0006]
`
`Post-surgery, patients temporarily may be confused due to emboli and other
`
`factors associated with the heart-lung machine. The first 2-3 days following surgery are spent in
`
`an intensive care unit where heart filnctions can be closely monitored. The average hospital stay
`
`is between 1 to 2 weeks, with several more weeks to months required for complete recovery.
`
`[0007]
`
`In recent years, advancements in minimally invasive surgery and interventional
`
`cardiology have encouraged some investigators to pursue percutaneous replacement of the aortic
`
`heart valve. See, e.g., U.S. Pat. No. 6,168,614. In many of these procedures, the replacement
`
`valve is deployed across the native diseased valve to permanently hold the valve open, thereby
`
`alleviating a need to excise the native valve and to position the replacement valve in place of the
`
`native valve.
`
`[0008]
`
`In the endovascular aortic valve replacement procedure, accurate placement of
`
`aortic valves relative to coronary ostia and the mitral valve is critical. Stande self—expanding
`
`systems have very poor accuracy in deployment, however. Often the proximal end of the stent is
`
`not released from the delivery system until accurate placement is verified by fluoroscopy, and
`
`the stent typically jumps once released. It is therefore often impossible to know where the ends
`
`of the stent will be with respect to the native valve, the coronary ostia and the mitral valve.
`
`[0009]
`
`Also, visualization of the way the new valve is functioning prior to final
`
`deployment is very desirable. Visualization prior to final and irreversible deployment cannot be
`
`done with standard self—expanding systems, however, and the replacement valve is often not
`
`fully functional before final deployment.
`
`[0010]
`
`Another drawback of prior art self—expanding replacement heart valve systems is
`
`their lack of radial strength. In order for self-expanding systems to be easily delivered through a
`
`delivery sheath, the metal needs to flex and bend inside the delivery catheter without being
`
`plastically deformed. In arterial stents, this is not a challenge, and there are many commercial
`
`arterial stent systems that apply adequate radial force against the vessel wall and yet can collapse
`
`to a small enough of a diameter to fit inside a delivery catheter without plastic deformation.
`
`However when the stent has a valve fastened inside it, as is the case in aortic valve replacement,
`
`the anchoring of the stent to vessel walls is significantly challenged during diastole. The force to
`
`hold back arterial pressure and prevent blood from going back inside the ventricle during diastole
`
`— 3 0f 35 -
`
`FILED VIA EFS
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 9 of 492
`
`
`
`
`
`
`
`
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 9 of 492
`
`

`

`Attorney Docket No. 10012-710301
`
`will be directly transferred to the stent/vessel wall interface. Therefore, the amount of radial
`
`force required to keep the self—expanding stent/valve in contact with the vessel wall and not
`
`sliding will be much higher than in stents that do not have valves inside of them. Moreover, a
`
`self-expanding stent without sufficient radial force will end up dilating and contracting with each
`
`heartbeat, thereby distorting the valve, affecting its function and possibly migrating and
`
`dislodging completely. Simply increasing strut thickness of the self—expanding stent is not a
`
`practical solution as it runs the risk of larger profile and/or plastic deformation of the self—
`
`expanding stent.
`
`[0011]
`
`In view of drawbacks associated with previously known techniques for
`
`endovascularly replacing a heart valve, it would be desirable to provide methods and apparatus
`
`that overcome those drawbacks.
`
`SUMMARY OF THE INVENTION
`
`[0012]
`
`One aspect of the present invention provides apparatus for endovascularly
`
`replacing a patient’s heart valve, the apparatus including: a replacement valve; and an
`
`expandable anchor, wherein the replacement valve and expandable anchor are configured for
`
`endovascular delivery to the vicinity of the heart valve, and wherein at least a portion of the
`
`replacement valve is configured to evert about the anchor during endovascular deployment.
`
`[0013]
`
`Another aspect of the invention provides a method for endovascularly replacing a
`
`patient’s heart valve. In some embodiments the method includes the steps of: endovascularly
`
`delivering a replacement valve and an expandable anchor to a vicinity of the heart valve;
`
`everting at least a portion of the replacement valve about the anchor; and expanding the anchor
`
`to a deployed configuration.
`
`[0014]
`
`Yet another aspect of the invention provides apparatus for endovascularly
`
`replacing a patient’s heart valve including: an anchor comprising a lip region and a skirt region;
`
`and a replacement valve, wherein at least a portion of the replacement valve is configured to
`
`evert about the anchor during endovascular deployment, and wherein the lip region and skirt
`
`region are configured for percutaneous expansion to engage the patient’s heart valve.
`
`[0015]
`
`Still another aspect of the present invention provides a method for endovascularly
`
`replacing a patient’s heart valve, the method including: endovascularly delivering a replacement
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`valve and an expandable anchor to a vicinity of the heart valve, endovascularly wrapping at least
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`- 4 of 35 -
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`FILED VIA EFS
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`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 10 of 492
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`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 10 of 492
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`Attorney Docket No. 10012-710.301
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`a portion of the replacement valve about the anchor, and expanding the anchor to a deployed
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`configuration.
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`[0016]
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`Another aspect of the present invention provides apparatus for endovascularly
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`replacing a patient’s heart valve, the apparatus including: a replacement valve, and an
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`expandable anchor, wherein the replacement valve and the anchor are configured for
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`endovascular delivery to a vicinity of the patient’s heart valve, and wherein at least a portion of
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`the replacement valve is wrapped about an end of the anchor in a deployed configuration.
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`INCORPORATION BY REFERENCE
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`[0017]
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`All publications and patent applications mentioned in this specification are herein
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`incorporated by reference to the same extent as if each individual publication or patent
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`application was specifically and individually indicated to be incorporated by reference.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`[0018]
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`The novel features of the invention are set forth with particularity in the appended
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`claims. A better understanding of the features and advantages of the present invention will be
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`obtained by reference to the following detailed description that sets forth illustrative
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`embodiments, in which the principles of the invention are utilized, and the accompanying
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`drawings of which:
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`[0019]
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`Figures lA-B are elevational views of a replacement heart valve and anchor
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`according to one embodiment of the invention.
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`[0020]
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`[0021]
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`Figures 2A—B are sectional views of the anchor and valve of Figures 1.
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`Figures 3A—B show delivery and deployment of a replacement heart valve and
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`anchor, such as the anchor and valve of Figures 1 and 2.
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`[0022]
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`Figures 4A-F also show delivery and deployment of a replacement heart valve
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`and anchor, such as the anchor and valve of Figures 1 and 2.
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`[0023]
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`Figures SA-F show the use of a replacement heart valve and anchor to replace an
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`aortic valve.
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`[0024]
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`Figures 6A—F show the use of a replacement heart valve and anchor with a
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`positive registration feature to replace an aortic valve.
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`[0025]
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`Figure 7 shows the use of a replacement heart valve and anchor with an
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`alternative positive registration feature to replace an aortic valve.
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`- 5 of 35 -
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`FILED VIA EFS
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`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 11 of 492
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`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 11 of 492
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`25
`2iE§
`3s
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`ii233i 3i2iia x
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`Attorney Docket No. 10012-710301
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`[0026]
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`Figures 8A-C show another embodiment of a replacement heart valve and anchor
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`according to the invention.
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`[0027]
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`Figures 9A-H show delivery and deployment of the replacement heart valve and
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`anchor of Figures 8.
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`[0028]
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`Figure 10 is a cross-sectional drawing of the delivery system used with the
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`method and apparatus of Figures 8 and 9.
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`[0029]
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`Figures llA—C show alternative locks for use with replacement heart valves and
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`anchors of this invention.
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`[0030]
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`Figures 12A—C show a vessel wall engaging lock for use with replacement heart
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`valves and anchors of this invention.
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`[0031]
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`Figure 13 demonstrates paravalvular leaking around a replacement heart valve
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`and anchor.
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`[0032]
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`Figure 14 shows a seal for use with a replacement heart valve and anchor of this
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`invention.
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`[0033]
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`Figures ISA-E show alternative arrangements of seals on a replacement heart
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`valve and anchor.
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`[0034]
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`Figures 16A—C show alternative seal designs for use with replacement heart
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`valves and anchors.
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`[0035]
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`Figures 17 show an alternative anchor lock embodiment in an unlocked
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`configuration.
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`[0036]
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`[0037]
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`Figures 18A-B show the anchor lock of Figure 17 in a locked configuration.
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`Figure 19 shows an alternative anchor deployment tool attachment and release
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`mechanism for use with the invention.
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`[0038]
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`Figure 20 shows the attachment and release mechanism of Figure 19 in the
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`process of being released.
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`[0039]
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`Figure 21 shows the attachment and release mechanism of Figures 19 and 20 in a
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`released condition.
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`[0040]
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`Figure 22 shows an alternative embodiment of a replacement heart valve and
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`anchor and a deployment tool according to the invention in an undeployed configuration.
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`[0041]
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`Figure 23 shows the replacement heart valve and anchor of Figure 22 in a
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`partially deployed configuration.
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`- 6 of 35 -
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`FILED VIA EFS
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`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 12 of 492
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`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 12 of 492
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`Attorney Docket No. 10012-710.301
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`[0042]
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`Figure 24 shows the replacement heart valve and anchor of Figures 22 and 23 in a
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`more fully deployed configuration but with the deployment tool still attached.
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`[0043]
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`Figure 25 shows yet another embodiment of the delivery and deployment
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`apparatus of the invention in use with a replacement heart valve and anchor.
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`[0044]
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`Figure 26 shows the delivery and deployment apparatus of Figure 25 in the
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`process of deploying a replacement heart valve and anchor.
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`[0045]
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`Figure 27 shows an embodiment of the invention employing seals at the interface
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`of the replacement heart valve and anchor and the patient’s tissue.
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`[0046]
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`Figure 28 is a longitudinal cross—sectional view of the seal shown in Figure 27 in
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`compressed form.
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`[0047]
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`[0048]
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`Figure 29 is a transverse cross—sectional view of the seal shown in Figure 28.
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`Figure 30 is a longitudinal cross—sectional view of the seal shown in Figure 27 in
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`expanded form.
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`[0049]
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`[0050]
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`Figure 31 is a transverse cross—sectional view of the seal shown in Figure 30.
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`Figure 32 shows yet another embodiment of the replacement heart valve and
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`anchor of this invention in an undeployed configuration.
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`[0051]
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`Figure 33 shows the replacement heart valve and anchor of Figure 32 in a
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`deployed configuration.
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`[0052]
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`Figure 34 shows the replacement heart valve and anchor of Figures 32 and 33
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`deployed in a patient’s heart valve.
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`[0053]
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`Figures 35A-H show yet another embodiment of a replacement heart valve,
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`anchor and deployment system according to this invention.
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`[0054]
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`Figures 36A—E show more detail of the anchor of the embodiment shown in
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`Figures 35A—H.
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`[0055]
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`Figures 37A-B show other embodiments of the replacement heart valve and
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`anchor of the invention.
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`[0056]
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`Figures 38A—C illustrate a method for endovascularly replacing a patient’s
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`diseased heart valve.
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`[0057]
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`Figures 39A-G are side views, partially in section, as well as an isometric view,
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`illustrating a method for endovascularly replacing a patient’s diseased heart valve with an
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`embodiment of the present invention comprising a replacement valve that is not connected to the
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`- 7 of 35 -
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`FILED VIA EFS
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`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 13 of 492
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`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 13 of 492
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`Attorney Docket No. 10012-710301
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`expandable anchor, the replacement valve wrapped about the anchor, illustratively by everting
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`during deployment.
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`[0058]
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`Figures 40A-D are side views, partially in section, illustrating a method for
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`endovascularly replacing a patient’s diseased heart valve with another everting embodiment of
`
`the present invention.
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`[0059]
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`Figures 4lA—E are side views, partially in section, illustrating a method for
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`endovascularly replacing a patient’s diseased heart valve with yet another everting embodiment
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`of the present invention, wherein the replacement valve and the anchor are telescoped relative to
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`one another during endovascular delivery.
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`[0060]
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`Figures 42A—B are side-sectional views of alternative everting apparatus
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`comprising everting valve leaflets.
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`[0061]
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`Figures 43A-B, are side-sectional views of further alternative everting apparatus
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`comprising a locking mechanism coupled to the everting segment.
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`[0062]
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`Figures 44A-B are side-sectional views of telescoping embodiments of the present
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`invention comprising U-shaped valve frames.
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`DETAILED DESCRIPTION OF THE INVENTION
`
`[0063]
`
`While preferred embodiments of the present invention have been shown and
`
`described herein, it will be obvious to those skilled in the art that such embodiments are provided
`
`by way of example only. Numerous variations, changes, and substitutions will now occur to
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`those skilled in the art without departing from the invention. It should be understood that various
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`alternatives to the embodiments of the invention described herein may be employed in practicing
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`the invention. For example, for the two-part locking mechanisms described hereinafter, it will be
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`apparent that the locations of the male and female elements may be reversed. It is intended that
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`the following claims define the scope of the invention and that methods and structures within the
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`scope of these claims and their equivalents be covered thereby.
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`[0064]
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`With reference now to Figures 1-4, a first embodiment of replacement heart valve
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`apparatus in accordance with the present invention is described, including a method of actively
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`foreshortening and expanding the apparatus from a delivery configuration and to a deployed
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`configuration. Apparatus 10 comprises replacement valve 20 disposed within and coupled to
`
`anchor 30. Figures 1 schematically illustrate individual cells of anchor 30 of apparatus 10, and
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`- 8 of 35 -
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`FILED VIA EFS
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`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 14 of 492
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`Edwards Lifesciences Corporation, et al. Exhibit 1144, Page 14 of 492
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`33
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`Attorney Docket No. 10012-710301
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`should be viewed as if the cylindrical anchor has been cut open and laid flat. Figures 2
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`schematically illustrate a detail portion of apparatus 10 in side-section.
`
`[0065]
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`Anchor 30 has a lip region 32, a skirt region 34 and a body region 36. First,
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`second and third posts 38a, 38b and 38c, respectivel