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 .
Election/Restrictions
The Election/Restriction, dated 4/10/2026, has been withdrawn.
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 particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action. There is no requirement that applicants explain the materiality of English language references, however the cloaking of a clearly relevant reference in a long list of references may not comply with applicants’ duty to disclose; see Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, aff’d 479 F. 2d. 1338.
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,722,352. Although the claims at issue are not identical, they are not patentably distinct from each other because the current claims are broader than the patented claims comprising the same limitations. Referring to current claim 1, most of the claim is the same. The “outer skirt” has been named “outer sealing member”. The patented claim 1 continues: “and a plurality of tethers, wherein each tether is secured to the first edge portion of a skirt segment at a first end of the tether, extends across the second edge portion of the same skirt segment, and is secured to the frame or an adjacent skirt segment at a second end of the tether such that when the frame is expanded to the radially expanded configuration, the first edge portion is pulled in a circumferential direction toward the second edge portion by the tether”.
Current claim 1 continues: wherein at least one of the first and second opposing edge portions of each of the plurality of sealing segments are secured to the frame and/or to other sealing segments so as to produce circumferential [and/or twisting movement of the sealing segments upon radial expansion of the frame (not needed to fulfill the claim)]. The language is clearly broader claiming only one edge portion is secured to the frame and/or to other sealing segments and without claiming a tether.
It is noted that the patent does not claim adhesive or ultrasonic welding, however, these are part of a Markush group fulfilled by a tether of claim 1 of the patent. Claim 16 only claims an adhesive and is not rejected.
Claim 10 is much broader than patented claim 1, a comparison of limitations is self-evident. All other claims are self-evident.
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 10 and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen-Thien-Nhon et al (2017/0014229, NTN hereafter).
Referring to at least figures 26-27, NTN teaches an implantable prosthetic valve comprising:
an annular frame 12 comprising an inflow end 15 and an outflow end 19 and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end (all self-evident);
a leaflet structure 14 positioned within the frame and secured thereto;
and an outer sealing member 300 positioned around an outer surface of the frame, wherein the outer sealing member comprises a plurality of sealing segments (308 or the segments between openings 314),
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wherein each sealing segment is coupled to the frame (see at least par. 0107) and/or another sealing segment (at least adjacent sealing elements are coupled to one another at the top or bottom thereof) so as to produce circumferential, and/or twisting movement of the sealing segments upon radial expansion of the frame. It is inherent that the depicted sealing elements increases at least circumferentially from a compressed configuration.
Claim 15, see par. 0107 teaching the skirt segments are secured to the frame or an adjacent skirt segment with tethers, adhesive and/or ultrasonic welding.
Claims 16, see par. 0107 teaching the skirt segments are secured to the frame or an adjacent skirt segment with tethers (sutures).
Claim 17, see par. 0107 teaching the skirt segments are secured to the frame or an adjacent skirt segment with adhesive.
Allowable Subject Matter
Upon submission of a proper terminal disclaimer, claims 1-9 are allowable. Similarly, claims 11-14 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 an examiner’s statement of reasons for allowance:
Claim 1: The closes prior art of record is considered to be NTN as described above, however, fails to teach an outer sealing member comprises: an inflow edge portion secured to the frame at a first location; an outflow edge portion secured to the frame at a second location; and an intermediate portion between the inflow edge portion and the outflow edge portion, wherein the intermediate portion comprises a plurality of circumferentially spaced, axially extending slits that define a plurality of sealing segments between each pair of slits, wherein each sealing segment comprises first and second opposing edge portions, wherein at least one of the first and second opposing edge portions of each of the plurality of sealing segments are secured to the frame and/or to other sealing segments so as to produce circumferential and/or twisting movement of the skirt sealing segments upon radial expansion of the frame.
Claim 11: The closes prior art of record is considered to be NTN as described above, however, fails to teach each sealing segment has upper and lower portions connected to the frame at axially spaced apart locations on the frame that move toward each other upon radial expansion of the frame and cause a portion of the sealing segment to move radially outwardly away from the frame.
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.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yohanan et al (2014/0343671) – see at least the cover page.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/ Primary Examiner, Art Unit 3774
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