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 .
Response to Amendment
This action is in response to the amendment filed on 9/29/2026. In the amendment, claims 1, 6, and 15 have been amended and claim 17 has been cancelled.
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 1-5 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. In the amendment to claim 1 filed on 7/21/2026, the language ‘a closed position to engage the second portion of the elongated member with the pair of arms’ has been added. There is no support for such an ‘engagement’ in applicant’s specification. The only support found regarding the interaction of the pair of arms with the elongated member is in the original claim language ‘wherein the pair of arms are movable from the open position to a closed position to pinch each of the leaflets between one of the arms and the elongated member’. This is not the same as saying that the pair of arms engages the second portion of the elongated member since the leaflet is preventing the engagement of the two elements, which is what is also seen by the prior art being argued in view of the amendment.
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.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11,690,621. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 11 of ‘621 discloses a valve repair system, comprising: a clip for attachment to two leaflets of a heart valve, the clip comprising: an elongated member configured to be positioned between the two leaflets of the heart valve, wherein the elongated member has a first portion and a second portion that extends from the first portion, and wherein a width of the second portion is greater than a width of the first portion; a pair of arms that are coupled to the first portion of the elongated member; wherein the pair of arms extend radially away from the elongated member as the pair of arms extend away from the first portion toward the second portion when the arms are in an open position; a delivery system comprising: an actuator member that extends into the second portion of the elongated member and through the elongated member such that a distal end of the actuator member is past the second portion of the elongated member; a conduit releasably coupled to the second portion of the elongated member; wherein movement of the distal end of the actuator member toward the conduit moves the pair of arms from an open position to a closed position.
Claim 11 of ‘621 does not explicitly recite that the second portion of the elongated member extends proximally from the first portion or wherein the pair of arms extend proximally away from the first portion toward the second portion. However, by claiming that the second portion is proximal of the first portion and the pair of arms extend away from the first portion toward the second portion, the ‘extend proximally’ is inherent in this language since we know that the second portion is proximal of the first portion. Even before the addition of the ‘proximal’ language, we knew that the second portion extends from the first portion and the pair of arms extend away from the first portion toward the second portion, the pair of arms still extending in the same relative direction with respect to the first portion. Designating what is considered proximal and distal when it does not change the relationship of the pair of arms with respect to the elongated member portions does not define claim 6 over claim 11 of ‘621. Since application claim 6 is anticipated by claim 11 of ‘621, the claims are not patentably distinct.
Claims 15 & 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, & 9 of U.S. Patent No. 10,524,792. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 1, 8, & 9 of ‘792 disclose a clip for attachment to two leaflets of a heart valve, the clip comprising: an elongated member configured to be positioned between the two leaflets of the heart valve; first and second clipping arms that are coupled to a first portion of the elongated member and extend toward a second portion of the elongated member; wherein the first clipping arm extends radially away from the elongated member as the first clipping arm extends from the first portion toward the second portion to form a first leaflet receiving region when the first clipping arm is in an open position; wherein the second clipping arm extends radially away from the elongated member as the second clipping arm extends from the first portion toward the second portion to form a second leaflet receiving region when the second clipping arm is in the open position; and a passive leaflet engaging mechanism comprising a covering having a textured surface (‘fabric covering’ - claim 1; ‘protuberances’ - claim 8; ‘polymeric or fabric covering’ - claim 9) disposed on the elongated member.
Claims 1, 8, & 9 of ‘792 do not explicitly recite that the second portion of the elongated member extends proximally from the first portion or wherein the pair of arms extend proximally away from the first portion toward the second portion. However, by claiming that the second portion is proximal of the first portion and the pair of arms extend away from the first portion toward the second portion, the ‘extend proximally’ is inherent in this language since we know that the second portion is proximal of the first portion. Even before the addition of the ‘proximal’ language, we knew that the second portion extends from the first portion and the pair of arms extend away from the first portion toward the second portion, the pair of arms still extending in the same relative direction with respect to the first portion. Designating what is considered proximal and distal when it does not change the relationship of the pair of arms with respect to the elongated member portions does not define claims 15 & 16 over claims 1, 8, & 9 of ‘792. Since application claims 15 & 16 are anticipated by claims 1, 8, and 9 of ‘792, the claims are not patentably distinct.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, & 9 of U.S. Patent No. 10,524,792 in view of Roschak et al. (US Pub. No. 2002/0087153 A1).
Regarding claim 18, claims 1, 8, & 9 of ‘792 fail to explicitly disclose wherein the covering is made from polyethylene terephthalate, foam, or suture material. However, Roschak et al. teach a balloon to be used within the body to be made of common materials known in the art to include polyethylene terephthalate (paragraph [0153]). It is considered that one of ordinary skill in the art would have found it obvious to use polyethylene terephthalate to make the balloon/’covering’ in ‘792 since such a material was well known in the art before the effective filing date of the claimed invention.
Allowable Subject Matter
Claims 6-14 are allowable over the prior art, however, the double patenting rejection of claim 6 must be properly overcome before allowance of the claims can be made. In the alternative, claims 7-14 are not rejected under double patenting, therefore are objected to, and could be rewritten in independent form to proceed with allowance thereof.
The following is an examiner’s statement of reasons for allowance: the closest prior art is found to be Takahashi (US Pub. No. 2015/0057704 A1) as used to reject claim 1 above. Regarding claim 6, Takahashi fails to further disclose, teach, or suggest an actuator member that extends into the second end portion of the elongated member and through the elongated member such that a distal end of the actuator is past the second end portion of the elongated member and a conduit releasably coupled to the second end portion of the elongated member wherein movement of the distal end of the actuator member toward the conduit moves the pair of arms from an open position to a closed position, in combination with the remaining structural elements of the claim which are anticipated by Takahashi (see rejection of claim 1 above).
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 19 & 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 patent ‘792 used to reject claims 15,16, & 18 above under Double Patenting fails to disclose, teach, or suggest wherein the first and second clipping arms are hinged [claim 19] and wherein a width of the second portion is greater than a width of the first portion [claim 20].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 September 29, 2026
Prosecution Insights