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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/30/2026 has been entered.
Response to Amendment
The amendment filed 01/30/2026 has been entered. Claims 1-2, 4-5, and 7-8 remain pending in the application, claims 3 and 6 have been cancelled, and claim 9 is added. Applicant’s amendments to the claims have the 112(b) rejections and claim objections, however has not overcome the interpretation of the prior art rejection previously set forth in the Final Office Action mailed 10/31/2025 with respect to claims 1-2, 4-5, and 7-8.
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive.
Applicant argues on page 4 that Jen fails to disclose that the wires 74 extend through the struts 72 themselves, rather they pass through the apertures 70 within the struts 72. The Office respectfully disagrees. The broadest reasonable interpretation of “extend through” is being shown in Jen’s figure 9A as the wires 74 pass through the apertures 70 of the struts 72. The wires passing through the apertures of the struts is another way of saying the wires extending through the struts, and therefore the rejection is maintained.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 line 16 “the net wires” is suggested to read “the at least two net wires” for claim language consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-2, 4-5, and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jen et al. (US PGPub 2021/0022594), hereinafter known as “Jen.”
With regards to claim 1, Jen discloses (Figures 1-9A) an implant 5 for treatment of a urinary tract of a patient by applying a local ischemic pressure to tissue of a median lobe by means of a wire structure 72/74 (paragraph 74; figure 9A), wherein the implant 5 is configured to be introduced into a urethra in a folded state (figure 7A; paragraph 72) with a distal end in a lead and unfolds into the urethra (figure 1) to treat the tissue, wherein:
the wire structure 72/74 includes a loop wire (top and bottom struts 72) configured to form a loop, and at least two net wires 74 configured to stretch in the loop (paragraph 74; net wires 74 stretch through the apertures 70 in the loop);
the wire structure 72/74 is configured to be placed around the median lobe (paragraph 54, functional limitation – wire structure 72/74 is capable of being placed around the median lobe); and
a first end of the wire structure 72 is fixed to a handling device 10 of the implant 5 (paragraphs 59, 72 and 74 – proximal end is fixed via pusher tube 40);
a second end of the wire structure 72 is configured to lock and release from the handling device 10 of the implant 5 (paragraphs 59 and 71-72 – distal end released by pusher tube 40);
the handling device 10 is configured to pull the second end to decrease a circumference of the loop and tighten the at least two net wires 74 (paragraph 74 – “Wires 74 may also assist controlled deployment and/or repositioning of implant 5 at the target site, as desired, by pulling the wires 74 and recollapsing a partially-deployed and wire-engaged implant 5 into delivery system 10… When tension is applied to wires 74 or loop 76, they compress implant struts 72 and constrain (or collapse) it into a low profile (small diameter) configuration. While the wires 74 or loop 76 are in tension, the implant 5 stays compressed”);
one or more connecting springs are provided on at least a portion of the loop wire (see annotated figure 9A below; connecting springs are interpreted as the other two struts 72 that extend into and out of the page; paragraph 55 discloses the implant 5 as being fabricated from spring materials, spring steels, and spring stainless steels),
the at least two net wires 74 extend through the one or more connecting springs in order to maintain a position of the net wire 74 (paragraph 74; net wires 74 extend through the apertures 70 of the connecting springs 72).
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With regards to claim 2, Jen discloses the at least two net wires 74 are configured to stretch within the loop (paragraph 74; net wires 74 stretch through the apertures 70 in the loop), and
the at least two net wires 74 are configured to switch between being in a parallel state and a transverse state (figure 9A; paragraph 74 – when wires 74 are pulled to collapse the implant 5, it is interpreted that the wires 74 will assume a “parallel state” by way of the pulled wires, and the configuration shown in figure 9A is the “transverse state” where portions of the wires 74 run perpendicular to the longitudinal axis of the strut 72 through the aperture 70).
With regards to claim 4, Jen discloses wherein the handling device 10 is configured to be one of a shaft, a wire, and a thread (figure 2A-2B – delivery sheath 12 is part of the handling device 10 which shaped like a shaft or tube as disclosed in paragraph 59).
With regards to claim 5, Jen discloses wherein the length of the loop wire (top and bottom struts of 72) and a length of the net wires 74 are adjustable to apply pressure and denature the tissue (paragraph 74 – controlled deployment by pulling the wires 74 and collapsing the implant 5).
With regards to claim 7, Jen discloses wherein:
at least a portion of the loop wire (top and bottom struts of 72) is configured to be the one or more connecting springs (paragraph 55 discloses the implant 5 as being fabricated from spring materials, spring steels, and spring stainless steels), and
the net wires 74 extend through the one or more connecting springs (paragraph 74; net wires 74 extend through the apertures 70 of the connecting springs 72).
With regards to claim 8, Jen discloses wherein the handling device 10 is provided at a proximal end of the implant 5 (paragraph 74; figures 2A-2B and 9A), and the second end of the wire structure 72/74 is configured to release from the handling device 10 when the tissue is denatured (paragraphs 59 and 71-72).
Allowable Subject Matter
Claim 9 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.
The following is a statement of reasons for the indication of allowable subject matter:
With regards to claim 9, Jen fails to disclose or make obvious the claimed subject matter of “wherein the one or more connecting springs include a plurality of coils that wind around the loop and the at least two net wires extend through the plurality of coils.” The connecting spring of Jen is not designed as a plurality of coils, and would not be obvious to modify without destroying the use of Jen’s implant 5.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached 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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/MOHAMMED S ADAM/Examiner, Art Unit 3771 03/23/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771