UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`32294
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`SQUIRE, SANDERS & DEMPSEY L.L.P.
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`
`EXAMINER
`
`GHERBI, SUZETTE JAIME J
`
`ART UNIT
`
`PAPER NUMBER
`
`3738
`DATE MAILED: 08/14/2009
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`11/683,282
`
`James S. Gammie
`03/07/2007
`TITLE OF INVENTION: METHODS AND DEVICES FOR PERFORMING CARDIAC VALVE REP AIR
`
`102541.00002
`
`1605
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisiona1
`
`YES
`
`$755
`
`$0
`
`$0
`
`$755
`
`11116/2009
`
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`PTOL-85 (Rev. 08/07) Approved for use through 08/3112010.
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`Page 1 of 3
`
`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 1 of 33
`
`

`
`PART B- FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
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`
`or Fax
`
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks l through 5 should be completed where
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`indicated unless corrected below or directed otherwise in Block l, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS" for
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`32294
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`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
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`transmitted to the USPTO (571) 273-2885, on the date indicated below.
`
`(Depositor's name)
`
`(Signature)
`
`(Date)
`
`I
`
`APPLICATION NO.
`
`ll/683,282
`
`I
`
`FILING DATE
`
`03/07/2007
`
`I
`
`FIRST NAMED INVENTOR
`
`I ATTORNEY DOCKET NO. I CONFIRMATION NO.
`
`James S. Gammie
`
`l 02541.00002
`
`1605
`
`TITLE OF INVENTION: METHODS AND DEVICES FOR PERFORMING CARDIAC VALVE REP AIR
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`YES
`
`$755
`
`$0
`
`$0
`
`$755
`
`ll/16/2009
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`GHERBI, SUZETTE JAIME J
`
`3738
`
`623-002110
`
`l. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`0 Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/122) attached.
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`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent. If an assignee is identified below, the document has been filed for
`recordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
`(A) NAME OF ASSIGNEE
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`This collection of information is required by 37 CFR 1.311. The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO to process)
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`PTOL-85 (Rev. 08/07) Approved for use through 08/3112010.
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`OMB 0651-0033
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 2 of 33
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`11/683,282
`
`03/07/2007
`
`James S. Gammie
`
`102541.00002
`
`1605
`
`32294
`7590
`08114/2009
`SQUIRE, SANDERS & DEMPSEY L.L.P.
`8000 TOWERS CRESCENT DRIVE
`14TH FLOOR
`VIENNA, VA 22182-6212
`
`EXAMINER
`
`GHERBI, SUZETTE JAIME J
`
`ART UNIT
`
`PAPER NUMBER
`
`3738
`DATE MAILED: 08/14/2009
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment to date is 296 day(s). If the issue fee is paid on the date that is three months after the
`mailing date of this notice and the patent issues on the Tuesday before the date that is 28 weeks (six and a half
`months) after the mailing date of this notice, the Patent Term Adjustment will be 296 day(s).
`
`If a Continued Prosecution Application (CPA) was filed in the above-identified application, the filing date that
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`PTOL-85 (Rev. 08/07) Approved for use through 08/3112010.
`
`Page 3 of 3
`
`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 3 of 33
`
`

`
`Notice of Allowability
`
`11/683,282
`Examiner
`
`GAMMIE, JAMES S.
`Art Unit
`
`Application No.
`
`Applicant(s)
`
`SUZETTE J-J GHERBI
`
`3738
`
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address-(cid:173)
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application. If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOW ABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`1. 1Zl This communication is responsive to the amendment filed 5/21/09.
`
`2.1Z! The allowed claim(s) is/are 1,3-18,20-24 and 26.
`3. D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a) D All
`b) D Some*
`c) D None
`of the:
`1. D Certified copies of the priority documents have been received.
`2. D Certified copies of the priority documents have been received in Application No. __ .
`3. D Copies of the certified copies of the priority documents have been received in this national stage application from the
`International Bureau (PCT Rule 17.2(a)).
`* Certified copies not received: __ .
`
`Applicant has THREE MONTHS FROM THE "MAILING DATE" of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`4. 0 A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER'S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PT0-152) which gives reason(s) why the oath or declaration is deficient.
`5. D CORRECTED DRAWINGS (as "replacement sheets") must be submitted.
`(a) D including changes required by the Notice of Draftsperson's Patent Drawing Review ( PT0-948) attached
`1) D hereto or 2) D to Paper No./Mail Date __ .
`(b) D including changes required by the attached Examiner's Amendment I Comment or in the Office action of
`Paper No./Mail Date __ .
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the front (not the back) of
`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).
`6. 0 DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. D Notice of References Cited (PT0-892)
`2. D Notice of Draftperson's Patent Drawing Review (PT0-948)
`3. D Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date __
`4. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`
`/SUZETTE J-J GHERBI/
`Primary Examiner, Art Unit 3738
`
`5. D Notice of Informal Patent Application
`6. D Interview Summary (PT0-413),
`Paper No./Mail Date __ .
`7. D Examiner's AmendmenUComment
`8. D Examiner's Statement of Reasons for Allowance
`9. D Other __ .
`
`U.S. Patent and Trademark Off1ce
`PTOL-37 (Rev. 08-06)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20090803
`
`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 4 of 33
`
`

`
`PATENT APPLICATION
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re the Application of:
`
`Confirmation No.: 1605
`
`James S. Gammie
`
`Art Unit: 3738
`
`Application No.: 11/683,282
`
`Examiner: Gherbi, Suzette Jaime J.
`
`Filed: March 7, 2007
`
`Attorney Dkt. No.: 102541.00002
`
`For: METHODS AND DEVICES FOR PERFORMING CARDIAC VALVE REPAIR
`
`RESPONSE UNDER 37 CFR § 1.111
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`May 21,2009
`
`In response to the Office Action dated February 27, 2009, please amend the
`
`above-identified application as set forth below.
`
`Amendments to the claims are submitted beginning on page 2.
`
`Remarks are submitted beginning on page 7.
`
`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 5 of 33
`
`

`
`IN THE CLAIMS:
`
`Please AMEND claims 1, 12, 21, and 26; and
`
`Please CANCEL claims 2, 19, and 25, as shown below.
`
`1. (Currently Amended) A method for repairing a defective mitral or tricuspid
`
`valve, comprising:
`
`creating an access in anthe apex apical region of a heart through which a defective
`
`cardiac valve is accessed;
`
`introducing a device through said access; and
`
`repairing said cardiac valve by use of said device.~.
`
`wherein the repairing comprises
`
`replacing one or more chordae tendineae, and
`
`using said device to implant one or more artificial chordae tendineae, and
`
`wherein the one or more artificial chordae comprises a suture with one or more
`
`leaflets of the heart.
`
`2. (Cancelled)
`
`3. (Original) The method of claim 1, wherein the repairing comprises resecting
`
`one or more leaflets.
`
`- 2 -
`
`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 6 of 33
`
`

`
`4. (Original) The method of claim 1, wherein the device is a suturing or stapling
`
`device.
`
`5.
`
`(Original) The method of claim 1, wherein the repairing comprises
`
`annuloplasty.
`
`6. (Original) The method of claim 1, wherein the repairing comprises stapling or
`
`suturing the annulus to create an annuloplasty "effect".
`
`7. (Original) The method of claim 1, wherein the repairing comprises performing
`
`a bow-tie Alfieri procedure.
`
`8. (Original) The method of claim 1, wherein the repair is performed while the
`
`heart is beating.
`
`9. (Original) The method of claim 1, wherein the method is a minimally invasive
`
`procedure.
`
`10. (Original) The method of claim 1, wherein the method comprises the use of
`
`endoscopy.
`
`- 3 -
`
`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 7 of 33
`
`

`
`11. (Original) The method of claim 1, wherein the introduction of the device is
`
`performed in conjunction with sonography or direct transblood visualization.
`
`12. (Currently Amended) The method of claim 1elaim 2, wherein said repairing
`
`comprises:
`
`usiag said deviee to implaat oae or more artifieial ehordae teadiaeae; aad
`
`anchoring the one or more artificial chordae to a tissue in the apical region of the
`
`heart.
`
`heart.
`
`13. (Original) The method of claim 12, wherein the apical tissue is internal to the
`
`14. (Original) The method of claim 12, wherein the apical tissue is a papillary
`
`muscle, a papillary connective tissue or an endocardial tissue in the lower ventricle.
`
`15.
`
`(Original) The method of claim 12, wherein the apical tissue is the
`
`epicardium.
`
`16.
`
`(Original) The method of claim 12, further comprising determining an
`
`optimal configuration of the one or more artificial chordae before anchoring the artificial
`
`chordae.
`
`- 4 -
`
`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 8 of 33
`
`

`
`17. (Original) The method of claim 16, wherein the determining comprises the
`
`use of sonic guidance.
`
`18.
`
`(Original) The method of claim 16, wherein the artificial chordae are
`
`anchored to the apical tissue subsequent to said determination.
`
`19. (Cancelled)
`
`20.
`
`(Original) The method of claim 1, wherein the repairing comprises the
`
`application of a vacuum.
`
`21. (Currently Amended) A method for treating a defective mitral or tricuspid
`
`valve, comprising:
`
`percutaneously accessing an apical region of ~the heart with a catheter-based
`
`device; and
`
`repairing a cardiac valve by use of said device_,_
`
`wherein the repairing comprises replacing at least one chordae tendineae, and
`
`wherein the replaced chordae tendineae comprises a suture with one or ·more
`
`leaflets of the heart.
`
`- 5 -
`
`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 9 of 33
`
`

`
`22.
`
`(Original) The method of claim 21, wherein said accessing is done
`
`endovascularly via an antegrade approach.
`
`23.
`
`(Original) The method of claim 21, wherein said accessing is done
`
`endovascularly via a retrograde approach.
`
`24. (Original) The method of claim 21, wherein said accessing is done via direct
`
`access through a transmyocardial approach.
`
`25. (Cancelled)
`
`26. (Currently Amended) The method of claim 21 claim 25, wherein the replacing
`
`comprises anchoring a neochord to the apical region.
`
`- 6 -
`
`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 10 of 33
`
`

`
`REMARKS
`
`The Office Action dated February 27, 2009, has been received and carefully noted.
`
`The above amendments to the claims, and the following remarks, are submitted as a full
`
`and complete response thereto.
`
`By this Response, claims 1, 12, 21, and 26 have been amended to more
`
`particularly point out and distinctly claim the subject matter of the present invention. No
`
`new matter has been added. Claims 2, 19, and 25 have been cancelled without prejudice
`
`or disclaimer. Accordingly, claims 1, 3~ 18, 20~24, and 26 are currently pending in the
`
`application, of which claims 1 and 21 are independent claims.
`
`In view of the above amendments and the following remarks, Applicant
`
`respectfully requests reconsideration and timely withdrawal of the pending rejections to
`
`the claims for the reasons discussed below.
`
`Claim Rejection- 35 U.S. C. 102
`
`Claims 1~2, 4, 6-11, 20-21, and 24-25 were rejected under 35 U.S.C. 102(b) as
`
`allegedly being anticipated by U.S. Patent No. 6,978,176 of Lattouf ("Lattouf').
`
`Applicant respectfully submits that each of claims 1, 4, 6-11, 20-21, and 24 recites
`
`subject matter that is neither disclosed nor suggested in Lattouf. Claims 2 and 25 have
`
`been cancelled without prejudice or disclaimer. Accordingly, Applicant respectfully
`
`submits that the rejection of claims 2 and 25 is moot in view of the claim cancellations,
`
`and respectfully requests that the rejection of these claims be withdrawn.
`
`- 7 -
`
`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 11 of 33
`
`

`
`As a threshold matter, Applicant respectfully submits that the Office Action is
`
`legally improper because it is incomplete. 3 7 C.F .R. 1.1 04(b) explicitly requires, "The
`
`examiner's action will be complete as to all matters." "In order to provide a complete
`
`application file history and to enhance the clarity of the prosecution history record, an
`
`examiner must provide clear explanations of all actions taken by the examiner during
`
`prosecution of an application" (see MPEP 707.07(t)). However, the Office Action failed
`
`to cite the portions of Lattouf that allegedly teach the features of claims 7-11 and 24 (see
`
`Office Action at page 2). Thus, Applicant respectfully submits that the Office Action is
`
`deficient because it does not provide a clear explanation of the rejection of claims 7-11
`
`and 24, as required by the MPEP. Accordingly, Applicant respectfully requests that, if
`
`the rejection of claims 7-11 and 24 is maintained, citations to the portions ofLattoufthat
`
`allegedly teach the features of these claims be in a new non-final Office Action.
`
`Independent claim 1, upon which claims 3-18 and 20 depend, is directed to a
`
`method for repairing a defective mitral or tricuspid valve, including creating an access in
`
`an apex region of a heart through which a defective cardiac valve is accessed. The
`
`method also includes introducing a device through the access. The method further
`
`includes repairing the cardiac valve by use of the device. The repairing includes
`
`replacing one or more chordae tendineae, and using the device to implant one or· more
`
`artificial chordae ·tendineae. The one or more artificial chordae includes a suture in one
`
`or more leaflets of the heart.
`
`- 8 -
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`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 12 of 33
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`Independent claim 21, upon which claims 22-24 and 26 depend, is directed to a
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`method for treating a defective mitral or tricuspid valve including percutaneously
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`accessing an apical region of a heart with a catheter-based device. The method also
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`includes repairing a cardiac valve by use of the device. The repairing includes replacing
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`at least one chordae tendineae. The replaced chordae tendineae includes a suture in one
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`or more leaflets of the heart.
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`Applicant respectfully submits that Lattouf fails to disclose or suggest all of the
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`features of any of the presently pending claims.
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`Lattouf describes two minimally invasive therapeutic procedures, particularly for
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`patients with congestive heart failure, that may be performed separately or together. One
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`procedure involves providing a valved passageway through the patient's left ventricular
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`wall at the apex of the patient's heart and advancing instruments through the valved
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`passageway to connect the valve leaflets of the patient's heart valve, e.g. the mitral valve.
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`The second procedure involves advancing a pacing lead and a pacing lead implanting
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`device through a trocar in the patient's chest and implanting the pacing lead on an
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`exposed epicardial region of the patient's heart wall. The pacing lead has a penetrating
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`electrode which is secured within the heart wall. Improved devices for these procedures
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`include a minimally invasive grasping device for heart leaflets, a leaflet connector with
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`artificial cordae tendenae and a pacing lead implant instrument (see Lattouf at Abstract).
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`However, Lattouf fails to disclose or suggest, at least, "wherein the one or more
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`artificial chordae comprises a suture with one or more leaflets of the heart," as recited in
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`- 9 -
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`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 13 of 33
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`independent claim 1 and similarly recited in independent claim 21. As shown in Figure
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`27, Lattouf refers to an elongated strand 56 having one end 57 secured to the closed end
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`of a leaflet clip 49, which connects the free edges 21 and 22 of leaflets 14 and 15 in a
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`Bow-Tie connection (see also Lattouf at column 8, lines 36-41). The proximal end 58 of
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`the strand 56 is pulled taut to position the leaflets 14 and 15 in a natural position to ensure
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`proper closure, and is secured to a free ventricular wall 32, preferably to the exterior
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`thereof, such as shown suturing with a pledget 59 (see Lattouf at Figure 27 and column 8,
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`lines 41-46).
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`However, Lattouf does not disclose or suggest that the strand includes a suture in
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`the leaflets. Accordingly, Lattouf fails to disclose or suggest, at least, "wherein the one
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`or more artificial chordae comprises a suture with one or more leaflets of the heart," as
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`recited in independent claim 1 and similarly recited in independent claim 21. In contrast,
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`Lattouf refers to the strand having one end secured to the clip, as discussed above.
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`Lattouf refers to suturing the strand with only the pledget, as mentioned above, not the
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`leaflets.
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`For at least the reasons discussed above, Applicant respectfully submits that
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`Lattouf fails to disclose or suggest all of the elements of independent claims 1 and 21.
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`Accordingly, Applicant respectfully requests that the rejections of independent claims 1
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`and 21 be withdrawn.
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`Claims 4, 6-11, 20, and 24 depend from, and further limit, independent claims 1
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`and 21. Thus, each of 4, 6-11, 20, and 24 recites subject matter that is neither disclosed
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`- 10-
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`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 14 of 33
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`nor suggested in Lattouf. Accordingly, Applicant respectfully requests that the rejection
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`of claims 4, 6-11, 20, and 24 be withdrawn.
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`Reconsideration and allowance of claims 1, 4, 6-11, 20-21, and 24 are, ther~fore,
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`respectfully submitted.
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`Claim Rejections - 3 5 U.S. C. 103
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`Claims 3, 5, 10-19, 23, and 26 were rejected under 35 U.S.C. 103(a) as allegedly
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`being unpatentable over Lattouf in view of U.S. Patent No. 6,840,246 of Downing
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`("Downing"). The Office Action acknowledged that Lattouf fails to disclose or suggest
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`all of the features of claims 3, 5, 10-19, 23, and 26, and cited Downing to remedy .the
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`deficiencies of Lattouf with respect to these rejected claims. Applicant respectfully
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`submits that each of claims 3, 5, 10-11, 13-18, and 23 recites subject matter that is neither
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`disclosed nor suggested in the combination of Lattouf and Downing. Claim 19 has been
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`cancelled without prejudice or disclaimer. Accordingly, Applicant respectfully submits
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`that the rejection of claim 19 is moot in view of the claim cancellations, and respectfully
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`requests that the rejection of this claim be withdrawn.
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`As a threshold matter, Applicant respectfully submits that the Office Action is
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`legally improper because it is incomplete. 3 7 C.F .R. 1.1 04(b) explicitly requires, "The
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`examiner's action will be complete as to all matters." "In order to provide a complete
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`application file history and to enhance the clarity of the prosecution history record, an
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`examiner must provide clear explanations of all actions taken by the examiner during
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`- 11 -
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`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 15 of 33
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`prosecution of an application" (see MPEP 707.07(f)). However, the Office Action failed
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`to cite the portions of Lattouf or Downing that allegedly teach the features of claims 23
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`and 26, such as "wherein said accessing is done endovascularly via a retrograde
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`approach" (see Office Action at pages 3-4). Thus, Applicant respectfully submits that the
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`Office Action is deficient because it does not provide a clear explanation of the rejection
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`of claims 23 and 26, as required by the MPEP. Accordingly, Applicant respectfully
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`requests that, if the rejection of claims 23 and 26 is maintained, citations to the portions
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`of Lattouf or Downing that allegedly teach the features of these claims be in a new non(cid:173)
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`final Office Action.
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`In order for this rejection to be sustainable, the combination of Lattouf and
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`Downing must teach all the recitations of independent claims 1 and 21. Accordingly, the
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`arguments presented above supporting the patentability of independent claims 1 and 21
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`over Lattouf are incorporated herein to support the patentability of dependent claims 3, 5,
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`10-11, 13-18, and 23. Thus, it is respectfully requested that dependent claims 3, 5, 10-11,
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`13-18, and 23 be allowed. Downing does not cure the deficiencies ofLattouf.
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`Downing describes diagnostic and surgical procedures performed on a beating
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`heart using an assembly which includes a port and a fluid transport device. The port has
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`a housing for insertion through a wall of the heart chamber and may include one valve
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`disposed in the housing and an inlet connected to the housing. Methods for repair and
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`diagnosis of the heart are also described. A specific method for repairing a mitral valve
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`- 12-
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`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 16 of 33
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`

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`uses staples which may be banded together with a strip of material (see Downing at
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`Abstract).
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`However, Downing fails to cure the deficiencies of Lattouf. Similarly to Lattouf,
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`Downing does not disclose or suggest, at least, "wherein the one or more artificial
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`chordae comprises a suture with one or more leaflets of the heart," as recited in
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`independent claim 1 and similarly recited in independent claim 21. Downing is silent as
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`to teaching the particular features associated with the artificial chordae of independent
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`claims 1 and 21.
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`Therefore, the combination of Lattouf and Downing would not lead a person of
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`ordinary skill in the art to arrive at the features of the artificial chordae as recited in
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`independent claims 1 and 21. Consequently, Applicant respectfully submits that
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`independent claims 1 and 21 and related dependent claims 3, 5, 10-11, 13-18, and 23 are
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`not obvious over the combination of Lattouf and Downing. Accordingly, Applicant
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`respectfully requests that the rejection of claims 3, 5, 10-11, 13-18, and 23 be withdrawn.
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`Claims 22 and 24 were rejected under 35 U.S.C. 1 03(a) as allegedly being
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`unpatentable over Lattouf in view of U.S. Patent No. 7,291,168 of Macoviak et al.
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`("Macoviak"). The Office Action acknowledged that Lattouf fails to disclose or suggest
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`all of the features of claims 22 and 24, and cited Macoviak to remedy the deficiencies of
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`Lattouf with respect to these rejected claims. Applicant respectfully submits that each of
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`claims 22 and 24 recites subject matter that is neither disclosed nor suggested in the
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`combination ofLattouf and Macoviak.
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`- 13-
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`NeoChord v. Univ of Maryland
`Exhibit 1003
`Page 17 of 33
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`

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`As a threshold matter, Applicant respectfully submits that the Office Action is
`
`legally improper because it is incomplete. 3 7 C.F .R. 1.1 04(b) explicitly requires, "The
`
`examiner's action will be complete as to all matters." "In order to provide a complete
`
`application file history and to enhance the clarity of the prosecution history record, an
`
`examiner must provide clear explanations of all actions taken by the examiner during
`
`prosecution of an application" (see MPEP 707.07(f)). However, the Office Action failed
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`to cite the portions of Lattouf or Macoviak that allegedly teach the features of claim 24,
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`specifically, "wherein said accessing is done via direct access through a transmyocardial
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`approach" (see Office Action at page 4). Therefore, Applicant respectfully submits that
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`the Office Action is deficient because it does not provide a clear explanation of the
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`rejection of claim 24, as required by the MPEP. Accordingly, Applicant respectfully
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`requests that, if the rejection of 24 is maintained, citations to the portions