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 .
Election/Restrictions
Claims 4 & 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/9/2026.
Applicant's election with traverse of Species A in the reply filed on 7/9/2026 is acknowledged. The traversal is on the ground(s) that ‘the search and examination of the entire application could be made without serious burden. This is not found persuasive because, as also disclosed by the examiner in the species election requirement, ‘the prior art applicable to one species would not likely be applicable to another species’ – meaning the species are distinct enough that they are not obvious variants such that most of the prior art would likely include these variations. Since the variations would not likely be found in one prior art document, it would require a different search query to find another prior art document to read on the alternate species, which is considered a search burden since separate search queries would be needed to properly reject the claims of the other species. NOTE: Claim 14 recites a list of simple closed curve shapes – the only shape applicable to the Species A is a triangle.
The requirement is still deemed proper and is therefore made FINAL.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-9, 13, & 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 9, 10, 12, & 13 of U.S. Patent No. 11,304,724 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims
Claims
Claims
Claims
Claims
Claims
19/051432
1, 13
2, 3
5-7
8
9
14
11,304,724
1, 12
2, 13
3, 4
6
9
10
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 2 of U.S. Patent No. 11,969,183 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because: Claim 1 of the application is anticipated by claims 1 & 2 of US Patent No. 11,969,183 B2.
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 1-3, 5-9, & 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kilemnik (US Pub. No. 2016/0317180 A1).
Regarding claim 1, Kilemnik discloses a prostatic urethra implant (Figs. 1A-1C) for generating incisions in the prostatic urethra of a patient and for compressing the median lobe of the prostate, said implant comprising: at least two closed-shaped incising wires 102A-C (Figs. 1A-1C), each of said incising wires 102A-C having a proximal section, a distal section and two lateral sections extending longitudinally between said proximal section and said distal section (Figs. 1A-1C), each of said lateral sections of each of said incising wires being adjoined with another lateral section of another one of said incising wires (Figs. 1A-1C); and a first closed-shaped anchoring wire 104 (Figs. 1A-1C), said first anchoring wire 104 extending outwardly from at least one of said proximal sections and through one of said incising wires 102A-C (Figs. 1A-1C), said first anchoring wire 104 being sufficiently long to compress said median lobe when said implant is positioned in said prostatic urethra, wherein each of said at least two incising wires 102A-C and said first anchoring wire 104 being elastic and having shape memory thereby having an expanded configuration and also being compressible into a compressed configuration (paragraph [0030]); and wherein in said expanded configuration, said incising wires incising tissue in said prostatic urethra via an outward radial pressure and said first anchoring wire applying outward radial pressure on said median lobe (paragraph [0030]).
Regarding claim 2, Kilemnik further discloses wherein each of said lateral sections of each of said incising wires 102A-C are wound around said another lateral section of said another one of said incising wires 102A-C (Figs. 1A-1C).
Regarding claim 3 Kilemnik further discloses wherein each of said lateral sections of each of said incising wires are adjoined together via a coupling technique (‘twisting’ - Figs. 1A-1C; paragraph [0034]).
Regarding claim 5, Kilemnik further discloses a hollow proximal cap 106 (Figs. 1A-1C) coupled with said proximal section of each of said incising wires 102A-C and with said first anchoring wire 104 (Figs. 1A-1C), said hollow proximal cap 106 configured to hold said incising wires and said first anchoring wire together.
Regarding claim 6, Kilemnik further discloses wherein said hollow proximal cap 106 comprises a proximal non-round niche configured to accept a corresponding mechanism (paragraph [0039]); and wherein said proximal non-round niche is configured to transfer rotational motion of said corresponding mechanism to said implant (paragraph [0039]).
Regarding claim 7, Kilemnik further discloses wherein said corresponding mechanism is selected from the list consisting of: a pin; and a tool (paragraph [0039]; NOTE: the corresponding mechanism is not considered part of the claimed invention as it is not positively recited in claims 6 or 7).
Regarding claim 8, Kilemnik further discloses an extraction string 108 (Figs. 1A-1C) coupled with said implant, said extraction string 108 being arranged to allow pulling said implant out of said patient (Figs. 1A-1C).
Regarding claim 9, Kilemnik further discloses wherein said at least two closed-shaped incising wires 102A-C and said first anchoring wire 104 are made from a material selected from the list consisting of: Nickel Titanium alloy (Nitinol); and a biocompatible material (paragraph [0030]).
Regarding claim 12, Kilemnik further discloses a hollow proximal cap 106 further comprising a plurality of barbs (paragraph [0040] – it is considered that since the cap is part of the proximal ends of the wires 102, barbs would also be considered associated therewith).
Regarding claim 13, Kilemnik further discloses wherein said at least two closed-shaped incising wires diverge at their respective distal sections such that said distal sections form a simple closed curve shape at a terminus of said implant in said expanded configuration (Figs. 1A-1C).
Regarding claim 14, Kilemnik further discloses wherein said simple closed curve shape is selected from the list consisting of: a triangle; a square; a pentagon; and a polygon (paragraph [0048]).
Allowable Subject Matter
Claim 10 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: Regarding claim 10, Kilemnik further includes wire 108 which could read as a ‘second anchoring wire’ but Kilemnik fails to further disclose, teach, or suggest a second wire 108 to be shorter than said first anchoring wire and wire 108 does not have a function of preventing said implant, once implanted, from moving distally in the direction of the bladder neck of said patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 September 28, 2026
