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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/04/25 has been entered.
Response to Amendment
The Amendment filed 11/04/25 has been entered. Claim 94 has been amended, and claims 99-103 have been cancelled. Claims 94-98 are addressed in the following office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/04/25 was filed after the mailing date of the Final Rejection on 05/09/25. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 94 and 96-98 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alon et al. (US 2010/0049313), cited in previous office action.
Regarding claim 94, an invention relating to prosthetic heart valve and delivery apparatus, Alon discloses (Figs. 9-14) a delivery and retrieval system (100) for a side-deliverable prosthetic valve (Par. 010, the system comprising: a catheter (102, 104, 106) having a distal end [i.e. open end of element 106] and defining a lumen [i.e. space occupied by valve in element 106] (Par. 0110 & 0114); a capture element (138) disposable in the lumen of the catheter in a closed configuration (Fig. 11) and transitionable to an open configuration (Fig. 10) when advanced beyond the distal end of the catheter (Par. 0116); and a control device (140) disposable in the lumen of the catheter and including a yoke [i.e. element 140] configured to removably attach to a proximal portion of a supra-annular member of the prosthetic valve (Par. 0102, 0105-0107, 0116), the control device operable to (i) exert a distally directed force to advance the prosthetic valve in a delivery configuration through the lumen of the catheter for side delivery of the prosthetic valve into a chamber of the heart, and (ii) after the prosthetic valve has been released from the distal end of the catheter, exert a proximally directed force to pull the prosthetic valve in a deployment configuration back into the distal end of the catheter (Par. 0103-0104 & 0114); and an actuator (110) disposable in the lumen of the catheter (Par. 0102) and configured to removably attach to a proximal subannular anchoring element of the prosthetic valve (Par. 0107 & 0116), the actuator configured to transition the proximal subannular anchoring element from an expanded configuration to a compressed configuration in response to being actuated, the proximal subannular anchoring element configured to be in the compressed configuration when the prosthetic valve is in the deployment configuration (Par. 0102 & 0114), wherein the capture element is configured to transition from the closed configuration (Fig. 11) to the open configuration (Fig. 10) in which the capture element extends distal to the catheter and around at least a portion of the prosthetic valve to facilitate a transition of the prosthetic valve from the deployment configuration to the delivery configuration as the control device pulls the prosthetic valve into the distal end of the catheter (Par. 0111-0114).
Regarding claim 96, Alon discloses the system of claim 94. Alon further discloses (Fig. 11) wherein the catheter is an outer catheter (Par. 0101), the capture element is mounted at a distal end of an inner catheter (110) movably disposed in the lumen of the catheter (Par. 0102 & 0108).
Regarding claim 97, Alon discloses the system of claim 94. Alon further discloses wherein the capture element is mounted within the lumen of the catheter (Fig. 11) and is transitionable to the open configuration by withdrawing the catheter (Fig. 10; Par. 0116).
Regarding claim 98, Alon discloses the system of claim 94. Alon further discloses wherein the capture element is mounted at a distal end portion of the control device (Fig. 14).
Claims 94 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gross et al. (US 2014/0324164), cited in previous office action.
Regarding claim 94, an invention relating to prosthetic heart valve and delivery apparatus, Gross discloses (Figs. 9A-E & 25A-E) a delivery and retrieval system (438) for a side-deliverable prosthetic valve (Par. 0240), the system comprising: a catheter (154) having a distal end (see annotated figure below) and defining a lumen (Par. 0208); a capture element (820) disposable in the lumen of the catheter in a closed configuration and transitionable to an open configuration when advanced beyond the distal end of the catheter (Par. 0289); a control device (140) disposable in the lumen of the catheter and including a yoke (140) configured to removably attach to a proximal portion of a supra-annular member of the prosthetic valve (Par. 0205-0206 & 0208), the control device operable to (i) exert a distally directed force to advance the prosthetic valve in a delivery configuration through the lumen of the catheter for side delivery of the prosthetic valve into a chamber of the heart, and (ii) after the prosthetic valve has been released from the distal end of the catheter, exert a proximally directed force to pull the prosthetic valve in a deployment configuration back into the distal end of the catheter (Par. 0208-0215), and an actuator (490) disposable in the lumen of the catheter and configured to removably attach to a proximal subannular anchoring element of the prosthetic valve, the actuator configured to transition the proximal subannular anchoring element from an expanded configuration to a compressed configuration in response to being actuated, the proximal subannular anchoring element configured to be in the compressed configuration when the prosthetic valve is in the deployment configuration (Par. 0205-0206, 0208, 0215), wherein the capture element configured to transition from the closed configuration to the open configuration in which the capture element extends distal to the catheter and around at least a portion of the prosthetic valve to facilitate a transition of the prosthetic valve from the deployment configuration to the delivery configuration as the control device pulls the prosthetic valve into the distal end of the catheter (Par. 0215 & 0289).
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Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 95 is rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US 2014/0324164) as applied to claim 95 above, and further in view of Paul et al. (US 2010/0121434), cited in previous office action.
Regarding claim 95, Gross discloses the system of claim 94. Gross fails to explicitly disclose wherein the capture element is a self-expanding capture element formed from a shape-memory alloy.
In the same field of endeavor, which is prosthetic heart valve and delivery apparatus, Paul teaches wherein the capture element is a self-expanding capture element formed from a shape-memory alloy (Par. 0051, 0100, 0102).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gross to have wherein the capture element is a self-expanding capture element formed from a shape-memory alloy. Doing so would provide a sheathing assist element that also can act as an embolic filter (Par. 0102), as taught by Paul.
Response to Arguments
Applicant's arguments filed 11/04/25 have been fully considered but they are not persuasive. Applicant argues previously cited prior art references Alon and Gross fail to disclose or reasonably suggest a delivery and retrieval system having a capture element and actuator with the structural and functional features recited in amended independent claim 94. Examiner respectfully disagrees.
Concerning claim 94, previously cited prior art reference Alon et al. (US 2010/0049313) discloses (Figs. 9-14) a capture element (138) disposable in the lumen of the catheter in a closed configuration (Fig. 11) and transitionable to an open configuration (Fig. 10) when advanced beyond the distal end of the catheter (Par. 0116); and an actuator (110) disposable in the lumen of the catheter (Par. 0102) and configured to removably attach to a proximal subannular anchoring element of the prosthetic valve (Par. 0107 & 0116), the actuator configured to transition the proximal subannular anchoring element from an expanded configuration to a compressed configuration in response to being actuated, the proximal subannular anchoring element configured to be in the compressed configuration when the prosthetic valve is in the deployment configuration (Par. 0102 & 0114), wherein the capture element is configured to transition from the closed configuration (Fig. 11) to the open configuration (Fig. 10) in which the capture element extends distal to the catheter and around at least a portion of the prosthetic valve to facilitate a transition of the prosthetic valve from the deployment configuration to the delivery configuration as the control device pulls the prosthetic valve into the distal end of the catheter (Par. 0111-0114).
Also, previously cited prior art reference Gross et al. (US 2014/0324164), cited in previous office action, discloses (Figs. 9A-E & 25A-E) a capture element (820) disposable in the lumen of the catheter in a closed configuration and transitionable to an open configuration when advanced beyond the distal end of the catheter (Par. 0289); and an actuator (490) disposable in the lumen of the catheter and configured to removably attach to a proximal subannular anchoring element of the prosthetic valve, the actuator configured to transition the proximal subannular anchoring element from an expanded configuration to a compressed configuration in response to being actuated, the proximal subannular anchoring element configured to be in the compressed configuration when the prosthetic valve is in the deployment configuration (Par. 0205-0206, 0208, 0215), wherein the capture element configured to transition from the closed configuration to the open configuration in which the capture element extends distal to the catheter and around at least a portion of the prosthetic valve to facilitate a transition of the prosthetic valve from the deployment configuration to the delivery configuration as the control device pulls the prosthetic valve into the distal end of the catheter (Par. 0215 & 0289).
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 November 29, 2025