DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 21-33 in the reply filed on 12/29/2025 is acknowledged.
Claims 34-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/29/2025.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 21-33 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by WO 2012/123950 A2, inventors Bar-On et al. (hereinafter “Bar-On”) (cited in an IDS dated 10/08/2024).
Regarding claim 21, Bar-On discloses (see abstract; Figs. 1-22 and page 9, line 28 - page 34, line 18) a system for enlarging a lumen of a prostatic urethra (see at least page 9, lines 28-32) comprising: a delivery tool (300) comprising a tubular elongate device (306 and/or "sheath", page 19 line 13) configured to be advanced longitudinally through a urethra of a subject until at least a distal portion of the tubular elongate device reaches a prostatic urethra (see Figs. 3-4 and page 18, line 17 - page 19, line 27); and an implant (318) carried by the tubular elongate device (see Fig. 3 and page 19, lines 10-16), the implant comprising a ring structure (see Figs. 2A-2P and page 15, line 20 - page 18, line 14) configured to be implanted within extra-urethral tissue of a prostate such that the implant at least partially circumscribes the lumen of the prostatic urethra after delivery (see page 3, lines 23-29, page 15, lines 1-15, page 23, lines 19-31; Figs. 8A-C).
Bar-On further discloses (claim 22) wherein the ring structure comprises a C-shaped, partial ring structure (see Figs. 2D-2G); (claim 23) wherein the ring structure comprises blunt ends (Fig. 2G); (claim 24) wherein the ring structure is radially self-expanding (see page 17, lines 19-22); (claim 25) further comprising a dilation balloon (500) configured to force the extra-urethral tissue radially outward, causing the lumen of the prostatic urethra to have an expanded diameter (see page 14, lines 31-32); (claim 26) wherein the ring structure is configured to maintain the expanded diameter of the lumen of the prostatic urethra by holding the extra-urethral tissue radially away from the prostatic urethra (see page 10, lines 19-25; page 18, lines 7-12); (claim 27) wherein the delivery tool has a sharp surface configured to penetrate a urethral wall (see page 15, lines 1-5, page 23, lines 13-31); (claim 28) wherein the delivery tool is configured to cut a deployment path through the extra-urethral tissue for the implant (see page 15, lines 1-5, page 23, lines 13-31); (claim 29) wherein the implant is carried internally to at least a portion of the tubular elongate device (see page 19, lines 13-18); (claim 30) wherein the implant provides a physical barrier inhibiting cell growth capable of narrowing the lumen of the prostatic urethra (see page 18, lines 4-12); (claim 31) wherein the implant is generally coaxial with the lumen of the prostatic urethra after delivery (see page 3, lines 23-29, page 15, lines 1-15, page 23, lines 19-31; Figs. 8A-C); (claim 32) further comprising a transurethral imaging device (see page 18, line 24 - page 19, line 9); (claim 33) wherein the implant has a sharp surface configured to penetrate a urethral wall (see page 16, lines 1-10).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771