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 .
Response to Arguments
Applicant's arguments filed 5/8/2026 have been fully considered but they are not persuasive. Applicant argues that Chao lacks a non-constant direction of winding, however, this is not persuasive as Chao figure 11 depicts a non-constant direction of winding. Chao, however, does not fairly teach or suggest a third ring shaped structure and second interconnect portion, claims referencing these features have been selected as containing allowable subject matter as detailed below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites the limitation "the first interconnect portion" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 12-13, 15-16, 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chao et al. (Pub. No.: US 2015/0257908).
Chao et al. (hereinafter, Chao) discloses an implant for placement in a prostatic urethra lumen (e.g., abstract), comprising:
a body made from a single elastic wire 154 adapted to laterally expand from a delivery configuration constrained in a lumen of a delivery device (e.g., fig. 16, para. 83-84) to an at-rest configuration (e.g., fig. 11) upon exiting the delivery device, wherein the body is biased towards the at-rest configuration (e.g., para. 84), the at-rest configuration configured to maintain the prostatic urethra lumen in an at least partially open state (e.g., abstract),
wherein the body in the at-rest configuration has a plurality of ring-shaped structures 150A, 150B that are non-coplanar (e.g., fig. 11), the plurality of ring-shaped structures located about a longitudinal axis of the implant and define a lumen therethrough (e.g., fig. 11),
wherein the plurality of ring-shaped structures includes a first ring-shaped structure 150A and a second ring-shaped structure 150B that is coupled with the first ring-shaped structure 150A by an interconnect portion 152 of the body, the interconnect portion extending longitudinally such that the first and second ring- shaped structures are spaced apart (e.g., fig. 11),
the implant having a non-constant direction of winding that, when viewed as commencing at a start of the first ring-shaped structure, proceeds clockwise along the first ring- shaped structure, then reverses along the interconnect portion to a counterclockwise direction for the second ring-shaped structure (e.g., fig. 11),
For claim 13, Chao discloses the implant of claim 12, wherein the body has a greater lateral width and shorter longitudinal length in the at-rest configuration as compared to the delivery configuration (e.g., fig. 11, para. 84).
For claim 15, Chao discloses the implant of claim 12, wherein the distal engagement member 156 has an enlarged terminus and the proximal engagement member 156 has an enlarged terminus (e.g., fig. 11).
For claim 16, Chao discloses the implant of claim 15, wherein each enlarged terminus is ball-shaped (e.g., fig. 11).
For claim 18, Chao discloses the implant of claim 12, wherein the first interconnect portion is curved and perpendicular to both the first ring-shaped structure and the second ring-shaped structure, when the body is in the at-rest configuration (fig. 11, interconnect portion is defined to include a curve at each end).
For claim 19, Chao discloses an implant for placement in a prostatic urethra lumen, comprising:
a body 154 configured to laterally expand from a delivery configuration constrained in a lumen of a delivery device (e.g., fig. 16, para. 83-84) to an at-rest configuration (e.g., fig. 11) upon exiting the delivery device, wherein the body is biased towards the at-rest configuration (e.g., para. 84), the at-rest configuration configured to maintain the prostatic urethra lumen in an at least partially open state (e.g., abstract),
wherein the body in the at-rest configuration has a plurality of ring-shaped structures 150A, 150B that are non-coplanar (e.g., fig. 11), the plurality of ring-shaped structures located about a longitudinal axis of the implant and define a lumen therethrough (e.g., fig. 11),
wherein each of the plurality of ring-shaped structures is coupled with another of the plurality of ring-shaped structures by an interconnect portion 152 of the body, each interconnect portion (1) extending longitudinally such that the plurality of ring-shaped structures are spaced apart, and (2) being curved and perpendicular to the plurality of ring-shaped structures, when the body is in the at-rest configuration (fig. 11, interconnect portion is defined to include a curve at each end).
For claim 24, Chao discloses the implant of claim 19, wherein the body has a greater lateral width and a shorter longitudinal length in the at-rest configuration as compared to the delivery configuration (e.g., fig. 11, para. 84).
For claim 25, Chao discloses the implant of claim 19, wherein the body is made from a single elastic wire (e.g., fig. 11).
Allowable Subject Matter
Claims 1-8, 10, 27-30 are allowed.
The following is an examiner’s statement of reasons for allowance: the closest prior art is Chao et al. (Pub. No.: US 2015/0257908). Chao et al. discloses an implant for placement in a prostatic urethra lumen (e.g., abstract), comprising:
a body made from a single elastic wire 100 (e.g., fig. 1, 10) adapted to laterally expand and longitudinally contract from a lineated configuration in a lumen of a delivery device (e.g., fig. 16, para. 83) to an at-rest configuration upon exiting the delivery device (e.g., fig. 11), wherein the body has a greater lateral width and shorter longitudinal length in the at-rest configuration (e.g., fig. 11, para. 83-84) as compared to the lineated configuration (e.g., fig. 16, para. 83-84), wherein the body is biased towards the at-rest configuration, the at-rest configuration configured to maintain the prostatic urethra lumen in an at least partially open state (e.g., para. 84),
wherein the body in the at-rest configuration has a plurality of ring-shaped structures150a, 150b that are non-coplanar (e.g., fig. 11), the plurality of ring-shaped structures located about a longitudinal axis of the implant (e.g., fig. 11),
wherein each of the plurality of ring-shaped structures is coupled with another of the plurality of ring-shaped structures by an interconnect portion 152 of the body, the interconnect portion extending longitudinally such that the plurality of ring-shaped structures are spaced apart (e.g., fig. 11),
wherein the plurality of ring-shaped structures includes a proximal-most ring-shaped structure and a distal-most ring-shaped structure (e.g., fig. 11),
wherein the body includes a distal engagement member extending from the distal-most ring-shaped structure 150A and a proximal engagement member extending from the proximal-most ring-shaped structure, the proximal engagement member configured to assume a lineated orientation when the body is in the lineated configuration, and a curved orientation when the body is in the at rest configuration, and
wherein the distal engagement member is longitudinally offset from a plane defined by the distal-most ring-shaped structure when the body is in the at rest configuration (not disclosed).
As provided in italicized text above, Chao et al. lacks a proximal engagement member configured to assume a lineated configuration and a curved orientation at rest, and a distal engagement member which is longitudinally offset from a plane defined by the distal-most ring-shaped structure when the body is at rest.
For claims 27-30, Chao lacks a third ring shaped structure and second interconnect portion.
Claims 17, 20-23, 26 are 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: For claims 17, 20-23, 26, Chao lacks a third ring shaped structure and second interconnect portion.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
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.
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
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