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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “triangular radial shape” (claim 7), the “plurality of ridges that project radially outwards” (claim 8), must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification fails to provide proper antecedent basis for a nitinol single elastic wire (claims 11 and 14).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification fails to describe a ring-shaped structure with a plurality of ridges that project radially outwards.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. (MPEP 2163). Here, Applicant has provided no written description apart from the original claim text of claim 9. While the text of the claim describes a “plurality of ridges that project radially outwards,” no other description of these features is present in the specification or drawings. The particularities of the ridges, including Applicant’s conception of their orientation, length, shape, or even the number of ridges, are all left without written description. Because this aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing, the claimed invention as a whole is not adequately described, despite the claim status as an original 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 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticpated 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 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 150B and a distal-most ring-shaped structure 150A,
wherein the body in the at-rest configuration includes (1) a distal engagement member 156 extending from the distal-most ring-shaped structure and (2) a proximal engagement member 156 extending from the proximal-most ring-shaped structure, the distal and proximal engagement members not extending into the lumen when the body is in the at-rest configuration (e.g., fig. 11),
wherein the distal-most ring-shaped structure defines a distal plane, and wherein the distal engagement member does not extend distally beyond the distal plane when the body is in the at-rest configuration (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 14, Chao discloses the implant of claim 12, wherein the single elastic wire is nitinol (e.g., para. 17).
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).
Allowable Subject Matter
Claims 1-8, 10 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.
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
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/SUBA GANESAN/Primary Examiner, Art Unit 3774