`Approved for use through 01/31/2007. OMS 0651-0032
`U.S. Patent and Trademark Office. U.S. DEPARTMENT OF COMMERCE
`u d
`n ert e
`h p aoerwork Reduction Act of 1995 no persons are reauired to resPOnd to a collection of information unless it displays a valid OMB control number.
`
`UTILITY
`PATENT APPLICATION
`TRANSMITTAL
`(Only for new nonprovisional applications under 37 CFR 1.53(b))
`
`Attorney Docket No.
`
`10012-710.401
`
`First Inventor
`
`Title
`
`Amr SALAHIEH et al.
`
`Everting Heart Valve
`
`Express Mail Label No. FILED VIA EFS
`
`APPLICATION ELEMENTS
`See MPEP chapter 600 concerning utility patent application contents.
`
`ADDRESS TO:
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria VA 22313-1450
`
`'
`
`"'
`
`..1
`
`2.0
`
`1.0 Fee Transmittal Form (e.g., PTO/SBI17)
`(Submit an original and a duplicate for fee processing)
`Applicant claims small entity status.
`See 37 CFR 1.27.
`(Total Pages
`3.0 Specification
`29
`Both the claims and abstract must start on a new page
`(Forinfonnation on the preferred arrangement, see MPEP 60B.01(a))
`[Total Sheets
`40 Drawing(s) (35 U.S. C. 113)
`63
`
`5. Oath or Declaration
`
`[Total Sheets
`
`4
`
`a. fZj Newly executed (original or copy)
`0or continuation/divisional with Box 18 completed)
`
`b.
`
`A copy from a prior application (37 CFR 1.63(d))
`
`i.
`
`DELETION OF INVENTOR(S)
`Signed statement attached deleting inventor(s)
`name in the prior application, see 37 CFR
`1.63(d)(2) and 1.33(b).
`
`6.0 Application Data Sheet. See 37 CFR 1. 76
`
`7.0 CD-ROM or CD-R in duplicate, large table or
`cr5puter Program (Appendix)
`Landscape Table on CD
`
`8. Nucleotide and/or Amino Acid Sequence Submission
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`Computer Readable Form (CRF)
`a. 0
`b.
`Specification Sequence Listing on:
`
`0
`CD-ROM or CD-R (2 copies); or
`i.
`ii.O Paper
`
`l
`
`I
`l
`
`ACCOMPANYING APPLICATION PARTS
`
`9. 0
`
`Assignment Papers (cover sheet & document(s))
`
`Name of Assignee
`
`10. 0
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`37 CFR 3.73(b) Statement
`(when there is an assignee)
`
`OPowerof
`Attorney
`
`11. 0
`
`English Translation Document (if applicable)
`
`12. 0
`
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`Copies of citations attached
`
`13. 0
`
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`
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`(Should be specifically itemized)
`
`15. 0 Certified Copy of Priority Document(s)
`(if foreign priority is claimed)
`
`16. 0 Nonpublication Request under 35 U.S.C. 122(b)(2)(B)(i).
`Applicant must attach form PTO/SB/35 or equivalent.
`
`17. 0 Other: Communication reOrder of Inventors
`
`Statements verifying identity of above copies
`c. 0
`18. If a CONTINUING APPLICATION, check appropriate box, and supply the requisite information below and in the first sentence of the
`specification following the title, or in an Application Data Sheet under 37 CFR 1. 76:
`D Divisional
`Examiner Ann M. S!;;HILLINGER
`
`0
`
`Continuation-in-part (CIP)
`
`of prior application No :1.2/.269,:U3. ...............
`
`Art Unit: 3774
`
`0
`
`Continuation
`
`Prior application information:
`
`[{] The address associated with Customer Number: I
`
`66854
`
`I OR D Correspondence address below
`
`19. CORRESPONDENCE ADDRESS
`
`Name
`
`Address
`
`City
`
`Country
`
`Signature
`
`Name
`(Print/Type)
`
`I State I
`1 Telephone J
`
`~;---
`THOMAS M. ZLOGAR
`
`1 Zip Code
`I Email
`1 Date JUNE 26, 2009
`Registration No. I
`(Attornev/Aoent\ 55•760
`
`This collection of information is required by 37 CFR 1.53(b). The information is required to obtain or retain a benefit by the public which is to file (and by the
`USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 12 minutes to
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`U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, ca/11-800-PT0-9199 and select option 2.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1002, p. 1 of 442
`
`
`
`FILED VIA EFS ON JUNE 26, 2009
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Confirmation No.:
`
`Appl. No.
`
`Applicant
`
`Filing Date
`
`Title
`
`Group Art Unit
`
`Examiner
`
`Docket No.
`
`Arnr SALAHIEH et al.
`
`June 26, 2009 (herewith)
`
`Everting Heart Valve
`
`10012-710.401
`
`Customer No.
`
`66854
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313
`Sir:
`
`COMMUNICATION REORDER OF INVENTORS
`
`This communication accompanies a new application, which is a divisional of U.S.
`Application No. 12/269,213, which in tum is a continuation ofUS Application No. 10/870,340.
`In that application, a petition was filed and granted, changing the order of inventors as follows:
`
`Arnr SALAHIEH,
`Ulrich R. HAUG,
`Hans. F. VALENCIA,
`Robert A. GESHLIDER,
`Torn 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 divisional application herein retain the same order of inventors.
`
`Respectfully submitted,
`
`~b
`
`Thomas Zlogar, Reg. No. 55,760
`
`Date: June 26, 2009
`
`By:
`
`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 1002, p. 2 of 442
`
`
`
`..._,.......__.--\';·"......,Co''-" . I
`~·
`<$..\'""-~
`
`I
`
`\ "-' v '·'I
`
`UNITED S~TES PATENT AND 'IRADEMARK OFFICE
`
`,v.e .. ·
`
`ft. B 2 .\ 'l.QUG
`. ~oN::.;N't, .
`W\LSON. ~ &. p.QSP..11
`GoooR\Cr\
`
`WILSON SONSINI
`ROSATI
`650 PAGE MILL
`PALO ALTO CA
`
`ROAD
`94304-1050
`
`GOODRICH &: DOCKETED
`
`In re Application of
`Arm Salahieh et al
`Application No. 10/870,340
`·'Filed: June 16, 2004
`Attorney Docket No. 30207-710.201
`
`Commissioner for Patents
`United States Patent and Trademar1< Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`www.IIIPfo.gov
`
`. COPY MAILED
`FEB 1 6 2006
`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 decision on petition.
`Telephone inquiries regarding the above matter should be directed
`to the undersigned at (571) 272-320.8.
`This matter is being referred to Technology Center AU 3738.
`
`!~~
`
`Petitions Examiner
`Office of Petitions
`Office of the Deputy Commissioner
`for Patent Examination Policy
`
`ATTACHMENT: CORRECTED FILING RECEIPT
`
`.f'
`
`.... :·
`
`,.. ~ -•. f··~ .• ·•
`
`·:·
`{
`., ,.
`
`:·. ··-·'
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`
`:
`
`Edwards Lifesciences Corporation, et al. Exhibit 1002, p. 3 of 442
`
`
`
`~--
`
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`
`,.A
`~···' ~
`··· \~i=CF.t'''-=-r:
`4 zoos
`
`UNITED STATES PATENT AND ThADEMARK OFFICE
`
`/
`\
`
`Page 1 of3
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United sw- PateD' auciTI'aclemark OffiCe
`A<l4ren:OOMMISSIONER FOR PATENTS
`P.O.Bol<l4SO
`- . Viqpnla 22313-1450
`......... up~o.p
`
`FILING OR 371
`(c)DATE
`10/870,340 06/16/2004
`
`FIL FEE REC'D
`
`AlTY.DOCKET NO
`
`3738
`
`971
`
`30207-710.201
`
`63
`
`67
`
`5
`
`021971
`WILSON SONSINI GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050
`
`CONFIRMATION NO. 7111
`CORRECTED FILING RECEIPT
`*OC000000018061255*
`*CX)000000018061255*
`
`Date Mailed: 02/15/2006
`
`Receipt. is acknowledged of this regular Patent Application. It will be considered in its order and you will be
`notified as to the results of the examination. Be sure to provide the U.S. 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.O. 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
`
`... 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 US1 0/870,340
`
`Projected Publication Date: Not Applicable
`
`Non-Publication Request: No
`
`Early Publication Request: No
`
`Edwards Lifesciences Corporation, et al. Exhibit 1002, p. 4 of 442
`
`
`
`.., ~i
`
`' . -1
`
`.-·
`
`** SMALL ENTITY**
`
`Title
`
`Everting heart valve
`
`Preliminary Class
`623
`
`Page 2 of3
`
`PROTECTING YOUR INVENTION OUTSIDE THE UNITED STATES
`
`Since the rights granted by a U.S. 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
`effect as a regular national patent appllcatic;m 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 '1an
`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 Dire~or of the USPTO
`must issue a license before applicants can apply for a patent in a foreign country. The filing of a U.S. 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" (specificaUy, 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/offices/pac/doc/general/index.html.
`
`For information on preventing theft of your intellectual property (patents, trademarks and copyrights), you may
`wish to consult the U.S. 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 (1-866-999-4158).
`
`LICENSE FOR FOREIGN FILING UNDER
`Title 35, United States Code, Section 184
`Title 37, Code of Federal Regulations, 5.11 & 5.15
`
`GRANTED
`
`The applicant has been granted a license under 35 U.S.C. 184, if the phrase "IF REQUIRED, FOREIGN FILING
`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 1002, p. 5 of 442
`
`
`
`'·'
`
`'··
`
`under 37 CFR 5.13 or 5.14.
`
`Page 3 of3
`
`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 und~r 35 U.S.C. 184 has been granted at this time, if the phrase ''IF REQUIRED, FOREIGN FILING
`LICENSE GRANTED"'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 1002, p. 6 of 442
`
`
`
`Attorney Docket No. 10012-710.401
`
`UNITED STATES PATENT APPLICATION
`
`EVERTING HEART VALVE
`
`Inventor(s):
`
`SALAHIEH, Amr,
`
`HAUG, Ulrich R.,
`
`VALENCIA, Hans F.,
`
`GESHLIDER, Robert A.,
`
`SAUL, Tom,
`
`MOREJOHN, Dwight P.,
`
`MICHLITSCH, Kenneth J.
`
`2755 Campus Drive, Suite 210
`San Mateo, CA 94403
`(650) 212-1700 Main Phone
`(650) 212-7562 Facsimile
`
`FILED VIA EFS ON JUNE 26, 2009
`
`Edwards Lifesciences Corporation, et al. Exhibit 1002, p. 7 of 442
`
`
`
`Attorney Docket No. 10012-710.401
`
`EVERTING HEART VALVE
`
`CROSS-REFERENCE TO RELATED APPLICATION
`
`[0001]
`
`This application is a divisional of pending U.S. Application No. 12/269,213, filed
`
`November 12, 2008; which application is a continuation of pending U.S. Application No. 10/870,340,
`
`filed June 16, 2004, entitled "Everting Heart Valve", the disclosures of which are incorporated by
`
`reference in their entirety.
`
`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
`
`(sternotomy), and the patient's heart is stopped while blood flow is rerouted through a heart-lung bypass
`
`machine.
`
`[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 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 functions can be closely monitored. The average hospital stay is between I 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.,
`
`-2 of29-
`
`FILED VIA EFS
`
`Edwards Lifesciences Corporation, et al. Exhibit 1002, p. 8 of 442
`
`
`
`Attorney Docket No. 10012-710.401
`
`U.S. Patent 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. Standard 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(cid:173)
`
`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 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(cid:173)
`
`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.
`
`-3 of29-
`
`FILED VIA EFS
`
`Edwards Lifesciences Corporation, et al. Exhibit 1002, p. 9 of 442
`
`
`
`Attorney Docket No. 10012-710.401
`
`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 valve and an
`
`expandable anchor to a vicinity of the heart valve, endovascularly wrapping at least a portion of the
`
`replacement valve about the anchor, and expanding the anchor to a deployed configuration.
`
`[0016] Another 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 the anchor are configured for endovascular delivery to a vicinity of the
`
`patient's heart valve, and wherein at least a portion of the replacement valve is wrapped about an end of
`
`the anchor in a deployed configuration.
`
`INCORPORATION BY REFERENCE
`
`[0017] All publications and patent applications mentioned in this specification are herein incorporated
`
`by reference to the same extent as if each individual publication or patent application was specifically and
`
`individually indicated to be incorporated by reference.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0018]
`
`The novel features of the invention are set forth with particularity in the appended claims. A
`
`better understanding of the features and advantages of the present invention will be obtained by reference
`
`to the following detailed description that sets forth illustrative embodiments, in which the principles of
`
`the invention are utilized, and the accompanying drawings of which:
`
`-4 of29-
`
`FILED VIA EFS
`
`Edwards Lifesciences Corporation, et al. Exhibit 1002, p. 10 of 442
`
`
`
`Attorney Docket No. 10012-710.401
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`[0019]
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`Figures lA-B are elevational views of a replacement heart valve and anchor according to one
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`embodiment of the invention.
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`[0020]
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`Figures 2A-B are sectional views of the anchor and valve of Figures 1.
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`[0021]
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`Figures 3A-B show delivery and deployment of a replacement heart valve and anchor, such as
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`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 and anchor, such
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`as the anchor and valve of Figures 1 and 2.
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`[0023]
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`[0024]
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`Figures 5A-F show the use of a replacement heart valve and anchor to replace an aortic valve.
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`Figures 6A-F show the use of a replacement heart valve and anchor with a positive registration
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`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 alternative positive
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`registration feature to replace an aortic valve.
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`[0026]
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`Figures SA-C show another embodiment of a replacement heart valve and anchor according to
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`the invention.
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`[0027]
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`Figures 9A-H show delivery and deployment of the replacement heart valve and anchor of
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`Figures 8.
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`[0028]
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`Figure 10 is a cross-sectional drawing ofthe delivery system used with the method and
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`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 anchors of this
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`invention.
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`[0030]
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`Figures 12A-C show a vessel wall engaging lock for use with replacement heart valves and
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`anchors of this invention.
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`[0031]
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`[0032]
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`[0033]
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`[0034]
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`[0035]
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`[0036]
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`[0037]
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`Figure 13 demonstrates paravalvular leaking around a replacement heart valve and anchor.
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`Figure 14 shows a seal for use with a replacement heart valve and anchor of this invention.
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`Figures 15A-E show alternative arrangements of seals on a replacement heart valve and anchor.
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`Figures 16A-C show alternative seal designs for use with replacement heart valves and anchors.
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`Figures 17 show an alternative anchor lock embodiment in an unlocked configuration.
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`Figures 18A-B show the anchor Jock of Figure 17 in a locked configuration.
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`Figure 19 shows an alternative anchor deployment tool attachment and release mechanism for
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`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 process of being
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`released.
`[0039]
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`Figure 21 shows the attachment and release mechanism of Figures 19 and 20 in a released
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`condition.
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`- 5 of29-
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`FILED VIA EFS
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`Edwards Lifesciences Corporation, et al. Exhibit 1002, p. 11 of 442
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`
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`Attorney Docket No. 10012-710.401
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`[0040]
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`Figure 22 shows an alternative embodiment of a replacement heart valve and anchor and a
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`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 partially deployed
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`configuration.
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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 more fully
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`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 apparatus of the
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`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 process of
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`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 of the
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`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 compressed
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`form.
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`[0047]
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`Figure 29 is a transverse cross-sectional view of the seal shown in Figure 28.
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`[0048]
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`Figure 30 is a longitudinal cross-sectional view of the seal shown in Figure 27 in expanded
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`form.
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`(0049]
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`Figure 31 is a transverse cross-sectional view of the seal shown in Figure 30.
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`[0050]
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`Figure 32 shows yet another embodiment of the replacement heart valve and anchor of this
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`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 deployed
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`configuration.
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`[0052]
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`Figure 34 shows the replacement heart valve and anchor of Figures 32 and 33 deployed in a
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`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, anchor and
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`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 Figures 35A-H.
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`[0055]
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`Figures 37A-B show other embodiments of the replacement heart valve and anchor of the
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`invention.
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`[0056]
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`Figures 38A-C illustrate a method for endovascularly replacing a patient's 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, illustrating a
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`method for endovascularly replacing a patient's diseased heart valve with an embodiment of the present
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`invention comprising a replacement valve that is not connected to the expandable anchor, the replacement
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`valve wrapped about the anchor, illustratively by everting during deployment.
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`-6of29-
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`FILED VIA EFS
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`Edwards Lifesciences Corporation, et al. Exhibit 1002, p. 12 of 442
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`
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`Attorney Docket No. 10012-710.401
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`[0058)
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`Figures 40A-D are side views, partially in section, illustrating a method for endovascularly
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`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 41A-E are side views, partially in section, illustrating a method for endovascularly
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`replacing a patient's diseased heart valve with yet another everting embodiment ofthe present invention,
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`wherein the replacement valve and the anchor are telescoped relative to one another during endovascular
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`delivery.
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`[0060]
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`Figures 42A-B are side-sectional views of alternative everting apparatus comprising everting
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`valve leaflets.
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`[0061]
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`Figures 43A-B, are side-sectional views of further alternative everting apparatus comprising a
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`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 invention
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`comprising U-shaped valve frames.
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`DETAILED DESCRIPTION OF THE INVENTION
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`[0063] While preferred embodiments of the present invention have been shown and described herein, it
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`will be obvious to those skilled in the art that such embodiments are provided by way of example only.
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`Numerous variations, changes, and substitutions will now occur to those skilled in the art without
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`departing from the invention. It should be understood that various alternatives to the embodiments of the
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`invention described herein may be employed in practicing the invention. For example, for the two-part
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`locking mechanisms described hereinafter, it will be apparent that the locations of the male and female
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`elements may be reversed. It is intended that the following claims define the scope of the invention and
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`that methods and structures within the scope of these claims and their equivalents be covered thereby.
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`[0064] With reference now to Figures 1-4, a first embodiment of replacement heart valve apparatus in
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`accordance with the present invention is described, including a method of actively foreshortening and
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`expanding the apparatus from a delivery configuration and to a deployed configuration. Apparatus I 0
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`comprises replacement valve 20 disposed within and coupled to anchor 30. Figures I schematically
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`illustrate individual cells of anchor 30 of apparatus I 0, and should be viewed as if the cylindrical anchor
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`has been cut open and laid flat. Figures 2 schematically illustrate a detail portion of apparatus I 0 in side(cid:173)
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`section.
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`[0065) Anchor 30 has a lip region 32, a skirt region 34 and a body region 36. First, second and third
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`posts 3 Sa, 3 8b and 3 8c, respectively, are coupled to skirt region 34 and extend within lumen 3I of anchor
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`30. Posts 38 preferably are spaced 120° apart from one another about the circumference of anchor 30.
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`[0066] Anchor 30 preferably is fabricated by using self-expanding patterns (laser cut or chemically
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`milled), braids and materials, such as a stainl