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 .
Status of Claims
This office action is responsive to the amendment filed on 03/10/2025. As directed by the amendment, claims 1-10 have been cancelled and new claims 11-30 have been added. Therefore, claims 11-30 are presently pending in this application, and currently examined in the Office Action.
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 anchor comprising a distal end, which by rotating the anchor with the anchor catheter, would embed in a heart wall (claims 11, 18 and 25), and the anchor comprising a spring and a movable housing element within the housing such that releasing the spring from the compressed configuration/state to the released configuration/state includes causing the spring to move the movable housing element within the housing (claims 12, 19 and 26) 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
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.
Claims 11-30 are 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. Independent claims 11, 18 and 25, on lines 6-7 of each claim, set forth the parameter of “rotating the anchor with the anchor catheter to embed the distal portion in a heart wall of the beating heart”; however, this parameter was never mentioned before in the originally filed disclosure. Specifically, the originally filed specification never mentions such a parameter, nor do any of the figures even show a distal portion of the anchor which could be rotated by the anchor catheter to embed in a heart wall. It is to be noted that the currently pending claims were newly added in the amendment dated 03/10/2025, and therefore are not considered part of the originally filed disclosure.
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.
Claims 12, 19 and 26 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. Claims 12, 19 and 26 each recite the limitation “the housing”, on the last line of each claim; there is insufficient antecedent basis for this limitation in the claims. Furthermore, it is unclear what exactly the structure of “the housing” is, and/or how exactly is relates to the structure(s) of the anchor and/or anchor catheter.
Examiner’s Note
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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 11-13, 16-20, 23-27 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maisano et al. (US PG Pub. 2010/0161041), as disclosed in the IDS dated 10/29/2024, hereinafter Maisano.
Regarding claims 11, 17, 18, 24 and 25, Maisano discloses a method of anchoring a suture (60/62) attached to a valve leaflet (12) in a beating heart of a patient, illustrated in Figures 5A-5E, comprising intravascularly inserting an anchor catheter (20) containing an anchor (240) attached to the suture (60/62) into the beating heart of the patient, the anchor (240) including an anchor body (40) having an open interior (48, 128 & OI – all together are considered the open interior) and a distal portion (20) configured to be embedded into heart tissue, illustrated in Figures 2-4C, 5A, and modified figure 4A, below; rotating the anchor (20) with the anchor catheter (20) to embed the distal portion (50) in a heart wall such that the suture (60/622) extends from the valve leaflet (12) to the anchor (240), illustrated in Figures 5A-5D ([0303]; [0304]; [0326]; [0328]; [0334] & [0335]); adjusting a tension on the suture (60/62) to achieve proper valve function with a spring (156) disposed within the open interior (OI) of the anchor body (40) in a compressed configuration/state in which the suture (60/62) can slide freely within an open space in the anchor body; releasing the spring (156) from the compressed configuration/state to a released configuration/state in which the spring (156) exerts a force eliminating the open space to clamp the suture at the tension within the anchor body (40), and further comprising compressing the spring (156) from the released configuration and re-tensioning the suture (60/62), illustrated in Figures 3-4C and 5E ([0320]; [0321]; [0325]; [0338]; [0340] – [0344] & [0348]).
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Regarding claims 12, 19 and 26, Maisano discloses the method of claims 11, 18 and 25, wherein releasing the spring (156) from the compressed configuration to the released configuration includes causing the spring to move a movable housing (46) element within the housing, illustrated in Figures 3-4C ([0342]).
Regarding claims 13, 20 and 27, Maisano discloses the method of claims 11, 18 and 25, wherein clamping the suture (60/62) includes causing a suture clamp (260/262 & cylindrical body portion of 46) disposed within the anchor body (40) to clamp the suture (60/62) when the spring (156) is released, illustrated in Figures 4A and 5E ([0313]; [0314]; [0341] & [0342]).
Regarding claims 16, 23 and 30, Maisano discloses the method of claims 11, 18 and 25, wherein the suture (60/62) is clamped adjacent a proximal end (40) of the anchor (240) opposite of the distal portion (50), illustrated in Figure 3.
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 11, 13, 16, 18, 20, 23, 25, 27 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 12,208,007. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims discloses an anchor assembly for a method of anchoring a suture attached to a valve leaflet comprising an anchor including an anchor body having an open interior and a distal portion configured to be embedded into heart tissue, helical rotation of the anchor to embed the distal portion in a heart wall such that the suture extends from the valve leaflet to the anchor, tensioning of the suture to achieve proper valve function with a spring disposed within the anchor body in a compressed configuration in which the suture can slide freely within an open space in the anchor body, releasing the spring from the compressed configuration to a released configuration in which the spring exerts a force eliminating the open space to clamp the suture at the tension within the anchor body.
Claims 11, 14, 17, 18, 21, 24, 25 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 and 15 of U.S. Patent No. 11,173,030, hereinafter ‘030, and claims 1, 5, 6 and 10 of U.S. Patent No. 11,957,584, hereinafter ‘584, in view of Maisano. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims discloses an anchor assembly for a method of anchoring a suture attached to a valve leaflet comprising an anchor including an anchor body having an open interior and a distal portion configured to be embedded into heart tissue, tensioning of the suture to achieve proper valve function with a spring disposed within the anchor body in a compressed configuration in which the suture can slide freely within an open space in the anchor body, releasing the spring from the compressed configuration to a released configuration in which the spring exerts a force eliminating the open space to clamp the suture at the tension within the anchor body; but ‘030 and ‘584 do not specifically disclose rotating the anchor to embed the distal portion in a heart wall. However, Maisano teaches an anchor, and a method of using said anchor, wherein the anchor comprises a distal portion, and the anchor is rotated by an anchor catheter to embed the distal portion in a heart wall, illustrated in Figures 5A-5D (Maisano: [0303]; [0304]; [0326] & [0328]). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for ‘030 and ‘584 to include helical rotation of the anchor to embed the distal portion in a heart wall, since this is well-known way in the art to attach/embed an anchor into a heart wall, as taught by Maisano.
Allowable Subject Matter
Claims 14, 15, 21, 22, 28 and 29 would be allowable if rewritten to include all of the limitations of the base claim and any intervening claims, overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, and overcome the Double Patenting rejection by filing an e-Terminal Disclaimer.
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 06/16/2026
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