DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 04/28/2026.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 21-33 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO 2012/123950 A2, inventors Bar-On et al. (hereinafter “Bar-On”) (previously of record) in view of US 5,531,741 to Barbacci (hereinafter “Barbacci”).
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), wherein the tubular elongate device comprises optical sensors (see page 18, lines 26-28; page 19, lines 7-8 & 26-29; and page 32, line 32 – page 33, line 2); 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).
With respect to claim 21, Bar-On fails to specifically disclose wherein a distal end of the implant is configured to transmit light detectable by the optical sensors of the tubular elongate device. Barbacci discloses, in the same field of endeavor, the known use of light emitting implants used in the urinary system (see abstract), wherein a distal end of the implant is configured to transmit light (see Figs. 14-21, via fiber optic strands 29, Col. 6, lines 4-7 & Col. 8, lines 40-47) for the purpose of enhancing visualization of placement of the implant within the urinary tract which provides a visual signal for use in placement where instrumentation is otherwise limited (see Col. 4, lines 3-28). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Bar-On’s implant with the light emitting capability of Barbacci in order to enhance visualization of placement of the implant within the urinary tract which provides a visual signal for use in placement where instrumentation is otherwise limited. Since Bar-On’s insertion device has optical sensors (see page 18, lines 26-28; page 19, lines 7-8 & 26-29; and page 32, line 32 – page 33, line 2) capable of observing light, they would be capable of detecting the light emitted by the fiber optics placed on the implant.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-33 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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