DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 5 objected to because of the following informalities: In line 2, “spokes the second” should read “spokes to the second”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the first position". There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be interpreted as “a first position”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 6-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rothstein (US 2012/0277853).
Regarding claim 1, an invention relating to tissue closure devices, Rothstein discloses (Figs. 3A-B) a method for treating a heart valve (Abstract), said method comprising: introducing a device (24) capable of capturing chordae tendineae into a ventricle of a heart (Par. 0111), the device comprising a central portion (60) and a plurality of spokes (62 & 64); extending the plurality of spokes outward from the central portion to a first configuration [i.e. undeflected arrangement] (Par. 0082); rotating the device in a first direction to bring at least one of the plurality of spokes into physical contact with one or more cords of chordae tendineae disposed in the ventricle; further rotating the device in the first direction to bring the one or more cords inward towards the central portion; and moving the plurality of spokes to a second configuration (Figs. 16A-B) at least partially over the one or more cords to secure the one or more cords (Par. 0111).
Regarding claim 2, Rothstein discloses the method of claim 1. Rothstein further disclose wherein performing the method improves at least one of prolapse of first and second leaflets of the heart valve and regurgitation of the heart valve (Par. 0108).
Regarding claim 3, Rothstein discloses the method of claim 1. Rothstein further discloses wherein said introducing the device is performed using a transcatheter procedure (Par. 0209).
Regarding claim 4, Rothstein discloses the method of claim 3. Rothstein further discloses wherein said extending the plurality of spokes, said rotating the device in the first direction, said further rotating the device in the first direction, and said moving the plurality of spokes to the second configuration are performed using a delivery catheter (Par. 0111 & 0113).
Regarding claim 6, Rothstein discloses the method of claim 1. Rothstein further discloses wherein the device has a disc-shape in the first position (Fig. 3C).
Regarding claim 7, Rothstein discloses the method of claim 1. Rothstein further discloses wherein the central portion is cylindrical in shape (Par. 0094).
Regarding claim 8, Rothstein discloses the method of claim 7. Rothstein further discloses (Fig. 3B) wherein the plurality of spokes comprises first and second spokes (62 & 64) that are offset from one another with respect to a longitudinal axis (3E) of the central portion.
Regarding claim 9, Rothstein discloses the method of claim 1. Rothstein further discloses wherein the central portion comprises a spool, wherein the plurality of spokes are configured to be at least partially wrapped around the spool (Par. 0091).
Regarding claim 10, Rothstein discloses the method of claim 1. Rothstein further discloses (Figs. 3A-B) wherein the plurality of spokes comprises two spokes (62 & 64).
Regarding claim 11, Rothstein discloses the method of claim 1. Rothstein further discloses wherein the plurality of spokes comprises four spokes (Par. 0088).
Regarding claim 12, Rothstein discloses the method of claim 1. Rothstein further discloses wherein the plurality of spokes comprise memory metal wires (Par. 0085).
Regarding claim 13, Rothstein discloses the method of claim 1. Rothstein discloses further comprising, after said rotating the device in the first direction, rotating the device in a second direction substantially opposite the first direction to release the one or more cords from the plurality of spokes (Par. 0111).
Regarding claim 14, Rothstein discloses the method of claim 1. Rothstein discloses further comprising, after said further rotating the device in the first direction, determining whether performance of the heart valve is satisfactory prior to said moving the plurality of spokes to the second configuration (Par. 0111).
Regarding claim 15, Rothstein discloses the method of claim 14. Rothstein discloses further comprising, when it is determined that the performance of the heart valve is not satisfactory, rotating the device in a second direction substantially opposite the first direction (Par. 0111).
Regarding claim 16, Rothstein discloses the method of claim 1. Rothstein discloses further comprising, after said further rotating the device in the first direction, determining whether a position of the chordae tendineae is satisfactory prior to said moving the plurality of spokes to the second configuration (Par. 0111).
Regarding claim 17, Rothstein discloses the method of claim 16. Rothstein discloses further comprising, when it is determined that the position of the chordae tendineae is not satisfactory, rotating the device in a second direction substantially opposite the first direction (Par. 0111).
Regarding claim 18, Rothstein discloses the method of claim 1. Rothstein discloses further comprising, after said rotating the device in the first direction, determining whether a satisfactory number of cords have been captured by the plurality of spokes prior to said further rotating the device in the first direction (Par. 0111).
Regarding claim 19, an invention relating to tissue closure devices, Rothstein discloses (Figs. 3A-B) a method for treating a heart valve (Abstract), said method comprising: introducing a delivery catheter (22) into a ventricle of a heart (Par. 0108-0110); deploying a device (24) capable of capturing chordae tendineae from the delivery catheter within the ventricle (Par. 0111); contacting one or more cords of chordae tendineae associated with the ventricle with one or more radially-projecting, curved spokes of the device (62 & 64; Par. 0110-0111); and drawing the one or more cords in closer to a center of the device using the one or more spokes and thereby repositioning leaflets of an atrioventricular heart valve connected to the one or more cords (Par. 0108 & 0111).
Regarding claim 20, Rothstein discloses the method of claim 19. Rothstein further discloses wherein said drawing the one or more cords in closer to the center of the device comprises at least one of: rotating the device in a direction of curvature of the one or more spokes; or collapsing the one or more spokes around toward the center of the device (Par. 0111).
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Concerning claim 5, the cited prior art fails to divulge the method step comprising releasing the device from the delivery catheter after said moving the plurality of spokes the second configuration.
Modifying the prior art to include the missing limitations wouldn't have been obvious because the modification would only be motivated by hindsight and would possibly render the device inoperable because the device cannot be moved to the second position before being released from the catheter. Furthermore, a teaching reference with this missing structure could not be found.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 March 24, 2026