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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any specific references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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 apparatus comprising a fastener a housing and a clamping structure disposed within the housing (claim 1) 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.
Claim Rejections - 35 USC § 112
Claims 1-20 are 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.
Regarding claim 1, which recites the limitation “the lock”, on the 2nd to last line of the claim; there is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear what exactly, structurally, “the lock” is and/or how it relates to the final structure of the claimed apparatus. Additionally, lines 4-5 set forth the parameter of “the fastener comprising a housing, and a clamping structure disposed within the housing”; however, this parameter is found to be confusing since it is not clear if the fastener actually comprises the “clamping structure”, or if the “clamping structure” is a different, separate, structure from the fastener, and if so, it is further unclear what exactly this different, separate, “clamping structure” is and/or how it relates to the final structure of the claimed apparatus. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claims 11 and 12, which recite the limitation “the lock”, on line 4 of claim 11 and line 2 of claim 12; there is insufficient antecedent basis for this limitation in the claims. Additionally, it is unclear what exactly, structurally, “the lock” is and/or how it relates to the final structure of the claimed apparatus.
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, 7-10 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 13, 17, 19 and 20 of U.S. Patent No. 11,123,191, hereinafter ‘191. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose an apparatus comprising an annuloplasty structure comprising a contracting member; a fastener configured receive and surround the contracting member, wherein the fastener comprises a clamping structure, which has an open state in which the contracting member can pass through and move, and is biased toward a closed state to clamp onto the contracting member passed; a stop removably coupled to the fastener, such as to maintain the fastener in the open state; and a tool comprising a static cutting element having a first cutting surface, and a dynamic cutting element having a second cutting surface that opposes the first cutting surface, wherein each of the first and second cutting surfaces are concave; and a grasper coupled to the fastener and the tool, wherein the static and dynamic cutting elements each define a lumen such that a portion of the contracting member passes through the static and dynamic cutting elements, and severing the contracting member by moving the dynamic cutting element with respect to the static cutting element.
Allowable Subject Matter
Independent claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and overcome the Double Patenting rejection by filing an e-Terminal Disclaimer.
The following is a statement of reasons for the indication of allowable subject matter: no prior art, by itself, or in combination with other art, could be found that discloses or fairly teaches all the structural limitations set forth in independent claim 1. The closest related art of Sheps et al. (US PG Pub. 2014/0243963), as disclosed in the IDS dated 12/21/2023, teaches an apparatus comprising an annuloplasty structure (3022) comprising a flexible and elongate contracting member (226); a fastener (40) configured to receive, and surround at least a portion of, the contracting member (226), the fastener comprising a housing (44), and a clamping structure (46) disposed within the housing, wherein the clamping structure has an open state in which the contracting member can pass through the fastener, and a closed state in which the contracting member is clamped; and a tool (80) configured to apply tension to the contracting member (226) by pulling it through the fastener, illustrated in Figures 1A, 1B, 5A and 5B ([0153] – [0155] & [0161] – [0166]). However, Sheps et al. does not teach the apparatus comprising a stop removably coupled to the fastener in a manner that maintains the fastener in the open state, and the tool comprising a static cutting element and a dynamic cutting element, such that the contracting member can be severed by moving the dynamic cutting element with respect to the static cutting element.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774