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 .
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.
Claims 2 & 12 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.
Claim 2 recites the limitation "the plurality of first openings" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, examiner will read ‘the plurality of first openings’ as the --plurality of tissue anchor openings-- claimed in claim 1.
Claim 12, line 2 recites ‘the sewing skirt’ - it is unclear if the ‘sewing skirt’ is the one first claimed in claim 9 or if it is the sewing skirt of the apical cuff as claimed in claim 12. For the purpose of examination, examiner will read line 2’s ‘sewing skirt’ as the one associated with the apical cuff.
Claim Objections
Claim 12 is objected to because of the following informalities: line 3 - examiner suggests amending ‘the apical cuff axial compression assembly’ to --the axial compression assembly-- since this appears to be a typographical error. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: lines 1-2 - examiner suggests amending ‘the apical cuff axial compression assembly’ to --the axial compression assembly-- since this appears to be a typographical error. Appropriate correction is required.
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 15 & 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,684,770 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 to ‘770 discloses an axial compression assembly configured for affixation of an apical cuff to cardiac tissue, the apical cuff having a substantially annular frame, an upper portion of the substantially annular frame is configured to couple to a pump and a lower portion of the substantially annular frame is configured to couple to a sewing skirt, the sewing skirt is joined to the lower portion of the substantially annular frame and extends radially outward from an outer circumference of the central annular frame, the sewing skirt having an lower surface configured to abut the cardiac tissue and an upper surface opposing the lower, consisting essentially of: a substantially unitary ring member having a central opening, an upper surface, a lower surface, an outer circumference, and a plurality of tissue anchor openings passing axially through and positioned circumferentially about substantially an entire circumference of the substantially unitary ring member, the central opening configured to accommodate the central annular frame to pass there through such that the substantially unitary ring member abuts the upper surface of the sewing skirt, the plurality of tissue anchor openings are in axial alignment with a portion of the upper surface of the sewing skirt and an outer circumference of the sewing skirt projects beyond the outer circumference of the substantially unitary ring member; and a plurality of tissue anchors disposed in the plurality of tissue anchor openings and configured to pass through an upper surface of the sewing skirt and exert an axially compressive force about the substantially entire circumference of the substantially unitary ring member and the sewing skirt and onto the cardiac tissue. Since application claims 15 & 16 are anticipated by claim 1 to ‘770, the claims are not patentably distinct.
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 15 & 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andrus (US Pub. No. 2017/0173236 A1).
Regarding claim 15, Andrus discloses an apical cuff axial compression assembly for affixation of an apical cuff having a sewing skirt to cardiac tissue (it is noted that the preceding italicized language is being considered as an intended use statement, meaning, the ‘apical cuff having a sewing skirt’ is not positively recited as part of the assembly), comprising: at least one member 31 (Figs. 1-3) configured to define an annular ring (Figs. 1-3) having a central opening 33 (Figs. 1-3) and having a plurality of openings 34a,b (Figs. 1-3) positioned in a spaced apart relation about at least a substantial circumferential extent of the annular ring, the at least one member configured to bear against the sewing skirt (NOTE: the sewing skirt is not positively recited as pointed out above, therefore, it is considered that the structure of the at least one member being anticipated by the prior art would be capable of bearing against a sewing skirt as claimed); and a plurality of tissue anchors 61 (Figs. 1-3) configured to pass into and through the plurality of openings 34a,b (Figs. 1-3), the sewing skirt (see NOTES above regarding the positive recitation of the sewing skirt) and into cardiac tissue, and exert an axially compressive force onto the ring member, the sewing skirt, and the cardiac tissue as a primary securement of the apical cuff to the cardiac tissue (since the prior art meets the structural requirements of the claim, it is considered to also be capable of performing the above recited function).
Regarding claim 16, Andrus further discloses wherein the plurality of tissue anchor openings 34a,b are positioned radially inward from an outer perimeter of the sewing skirt (NOTE: this limitation is dependent on the size of sewing skirt that is chosen to be used with the assembly - since the sewing skirt is not positively recited as part of the claimed invention, it is considered that the openings would be capable of being positioned radially inward from an outer perimeter of the sewing skirt if the chosen size of the sewing skirt were to accommodate this arrangement).
Allowable Subject Matter
Claims 1-14* are allowed. (NOTE: claims 2 and 12 have been rejected under 35 USC 112(b) for indefiniteness and claims 12 & 14 have been objected to for minor informalities - these rejections/objections need to be overcome before these claims can be allowed).
The following is an examiner’s statement of reasons for allowance: the following is considered to be the closest prior art to the claimed invention: US Pub. No. 2015/0112120 A1; US Pub. No. 2016/0374674 A1; WO 2014/145811; & US Pat. No. 3,587,115. Regarding claim 1, the prior art fails to disclose teach or suggest the axial compression assembly to incorporate, in combination, a plurality of tissue anchors, a sewing skirt having an annular ring having absorptive and/or hemostatic properties; and at least one compression member defining a central opening and having a plurality of tissue anchor openings. Regarding claim 14, in addition to the elements in combination of claim 1, the prior art fails to further disclose, teach, or suggest a delivery tool with a housing that retains each of the plurality of tissue anchors in a corresponding delivery tool channel.
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.”
Claims 17-20 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: regarding claim 17, the prior art fails to further disclose, teach or suggest wherein the plurality of tissue anchors further comprises a tissue screw having a tissue screw head and a helical coil projecting from the tissue screw head.
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 December 3, 2025