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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/28/26 has been entered.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 7/28/26. The claims 1-23 are pending. The claims 1 and 16 are amended. Claims 3, 5-14, 18-21, and 23 are withdrawn.
Response to Arguments
Applicant’s amendments filed 7/13/26 with have overcome the claim objections.
Applicant’s arguments, filed 7/13/26 with respect to the rejections of claims 1, 2, and 16 under 35 U.S.C. 102(a)(1) as being anticipated by Jen (US2021/0022594) have been fully considered and the amendment overcomes the previous rejection. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection has been made in view of Jen in view of Lorenzo (US2021/0001082).
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 of this title, 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.
Claims 1, 2, 4, 15-17, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Jen (US2021/0022594 – as cited in Applicant’s IDS) in view of Lorenzo (US2021/0001082).
Regarding claim 1, Jen discloses a controlled release mechanism for a prostatic implant delivery and deployment system (see Abstract) comprising:
a catheter (12) having a proximal end (see Fig. 2A) and a distal portion (see Fig. 8C);
a prostatic implant (5) disposed within a distal portion of the catheter ([0059]), a pusher member (40, [0073]) coaxially disposed within the catheter proximal to the prostatic implant ([0062]); and
a control member (puller wire extending through lumen of pusher tube 40, [0073]) retractable within a lumen in the pusher member, the control member being configured to form a disengageable connection between the pusher member and the prostatic implant ([0073]), the control member extending between the disengageable connection located at a distal end of the control member and extends proximally ([0073], see Fig. 8C).
However, Jen does not explicitly disclose wherein the disengageable connection is retractable with the control member within the lumen in the pusher member as the prostatic implant is deployed within a prostatic urethra of a patient, the control member extending between the disengageable connection located at a distal end of the control member and the proximal end of the catheter. In fact, Jen teaches the arms of the disengageable connection splay outward. Lorenzo teaches a disengageable connection between a medical implant and the delivery device, and further having a control member being a pull wire 140 and the disengageable connection being a loop wire 400 that the pull wire 140 is threaded through ([0047]). The loop wire 400 having an opening 405 that is seated in the locking portion 18 of the medical device implant ([0047]). Where the pull wire 140 and the loop wire 400 are retracted within a lumen of a delivery tube 300 (interpreted as the catheter) ([0047], see Fig. 3C-3D). The pull wire 140 extends proximally to proximal tube 100 (interpreted as the proximal end of catheter) and is intended to be manipulated by a physician to deploy the medical device ([0042]-[0043]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the disengageable connection with the control member extending to a proximal end of Lorenzo for the disengageable connection of Jen, since the substitution would have yielded the same predictable result of a release mechanism for releasing a medical implant, while providing the added benefit of having no elements splaying outwardly possibly making contact with a wall of the vessel.
Regarding claim 2, Jen/Lorenzo makes obvious the controlled release mechanism of claim 1, Jen further discloses wherein the pusher member comprises an elongated tubular member (pusher tube 40, [0073] of Jen).
Regarding claim 4, Jen/Lorenzo makes obvious the controlled release mechanism of claim 1, Lorenzo further teaches wherein the disengageable connection comprises a wire latch (wire latch is interpreted as the end of the pull wire 140 that latches onto the implant by the loop wire 400, [0043]) removably disposed in a lumen of the prostatic implant (pull wire 140 extends into the lumen of the implant and is removable by being withdrawn from the implant, as discussed in paragraph [0043] and as shown in Fig. 3A-3B), a suture (loop wire 400, loop wire is interpreted as a suture by being a string of material that is capable of performing the function of a suture) looping from the pusher member around the wire latch ([0047] see Fig. 3A).
Regarding claim 15, Jen/Lorenzo makes obvious the controlled release mechanism of claim 1; Lorenzo further teaches wherein the disengageable connection comprises a suture (loop wire 400, loop wire is interpreted as a suture by being a string of material that is capable of performing the function of a suture) connected to the control member (the loop wire 400 is connected to the control member/pull wire 140 by being locked to hold the medical device, [0047]) and looped through an aperture formed in a proximal portion of the prostatic implant (aperture of the implant would be aperture formed in the locking portion 18, where the loop wire 400 extends through the aperture and is therefore interpreted as being looped through it, see Fig. 3A, [0047]).
Regarding claim 16, Jen discloses a method for deploying and disengaging a prostatic implant (see Abstract) comprising:
providing a catheter (12) having a proximal end (see Fig. 2A), a distal portion (see Fig. 8C) and a prostatic implant (5) disposed within the distal portion of the catheter ([0059]), a pusher member (40, [0073]) coaxially disposed within the catheter proximal to the prostatic implant ([0062]) and a control member (64B) configured to form a disengageable connection between the pusher member and the prostatic implant ([0073]); the control member extending between the disengagable connection located at a distal end of the control member and a proximal end of the catheter ([0073]);
advancing the pusher member distally until the prostatic implant is beyond a distal end of the catheter ([0062]);
actuating a control member (puller wire extending through lumen of pusher tube 40, [0073]) at a proximal end of the catheter to release the prostatic implant, wherein the control member is coupled to the disengageable connection ([0073]).
However, Jen does not explicitly disclose wherein control member retractable within a lumen in the pusher member, the control member being retractable with the disengagable connection within the lumen in the pusher member as the prostatic implant is deployed within a prostatic urethra of a patient, the control member extending between the disengageable connection located at a distal end of the control member and the proximal end of the catheter. In fact, Jen teaches the arms of the disengageable connection splay outward. Lorenzo teaches a disengageable connection between a medical implant and the delivery device, and further having a control member being a pull wire 140 and the disengageable connection being a loop wire 400 that the pull wire 140 is threaded through ([0047]). The loop wire 400 having an opening 405 that is seated in the locking portion 18 of the medical device implant ([0047]). Where the pull wire 140 and the loop wire 400 are retracted within a lumen of a delivery tube 300 (interpreted as the catheter) ([0047], see Fig. 3C-3D). The pull wire 140 extends proximally to proximal tube 100 (interpreted as the proximal end of catheter) and is intended to be manipulated by a physician to deploy the medical device ([0042]-[0043]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the disengageable connection with the control member extending to a proximal end of Lorenzo for the disengageable connection of Jen, since the substitution would have yielded the same predictable result of a release mechanism for releasing a medical implant, while providing the added benefit of having no elements splaying outwardly possibly making contact with a wall of the vessel.
Regarding claim 17, Jen/Lorenzo makes obvious the method of claim 16, Lorenzo further teaches wherein actuating the control member comprises withdrawing a wire latch (wire latch is interpreted as the end of the pull wire 140 that latches onto the implant by the loop wire 400 and is pulled proximally to release implant, [0043], [0047]) from a lumen of the prostatic implant disengaging a suture (loop wire 400, wire is interpreted as a suture by being a string of material that is capable of performing the function of a suture) looping from the pusher member around the wire latch (the loop wire 400 loops around the wire latch/pull wire 140, see Fig. 3A).
Regarding claim 22, Jen/Lorenzo makes obvious the method of claim 16; Lorenzo further teaches wherein actuating the control member comprises withdrawing the control member (the pull wire 140 is locked onto the implant by the loop wire 400 and is pulled proximally to release implant, [0043], [0047]) to disengage a suture (loop wire 400, loop wire is interpreted as a suture by being a string of material that is capable of performing the function of a suture) looped through an aperture formed in a proximal portion of the prostatic implant (aperture of the implant would be aperture formed in the locking portion 18, where the loop wire 400 extends through the aperture and is therefore interpreted as being looped through it, see Fig. 3A, [0047]).
Conclusion
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
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