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 3-7 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 3 recites the limitation "the proximal apices and the distal apices". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
4. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
5. Claim(s) 1, 2, 8-9, 15, 17, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Quadri et al. 2017/0035562 (hereafter Quadri). Regarding claims 1 and 9, Quadri discloses the invention as claimed comprising:
PNG
media_image1.png
214
302
media_image1.png
Greyscale
PNG
media_image2.png
87
327
media_image2.png
Greyscale
an implant device for reshaping heart tissue (see figures 2A-2B and figures 9A-9E), the implant device comprising: a frame (e.g. 40; 140b) having a proximal end and a distal end, the frame comprised of a plurality of interconnected struts (see figures supra) and an anti-backout feature (these may be considered 80; 190c) configured to resist movement of the frame within a valve annulus; and a plurality of anchors (90A-90E) coupled to the anti-backout feature of the frame.
However Quadri does not specifically state that the anchors haver distal ends extending distally away from the distal most end of the frame in a distal direction and configured to engage tissue. Noting for example fig. 9E (see mark-up below)
PNG
media_image3.png
183
190
media_image3.png
Greyscale
the anchor of Quadri does in fact extend distally away from the distal (see e.g. 2nd end 44 and 144). It is obvious to one having ordinary skill in the art that this meets the limitation of the claim. Further, it would have been obvious to modify the shape of the anchors of Quadri because para [0120] of Quadri discloses “…It should be understood that a plurality of anchor shapes may be employed as desired…”.
6. Regarding claim 2, 15, 19, the anti-backout feature is formed on the distal end of the frame and extends distally and outwardly. Regarding claim 8, see [0124] which disclose a stent that expands.
7. Regarding claim 17 it is obvious to one having ordinary skill in the art that because the device of Quadri is compacted and then expanded (see [0124]; this is interpreted to be synonymous with retractable and extendable) into a delivery device (see for example fig. 12-12I) including the anchors.
Double Patenting
8. 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.
9. Claims 1-14, 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,918,462 (hereafter ‘462). Although the claims at issue are not identical, they are not patentably distinct from each other. For example regarding claims 1, 9 and 17:
current claim 1 recites:
“1. An implant device for reshaping heart tissue, the implant device comprising:
a frame having a proximal end and a distal end, the frame comprised of a plurality of
interconnected struts and an anti-backout feature configured to resist movement of the frame within a valve annulus; and a plurality of anchors coupled to the anti-backout feature of the frame and having distal ends extending distally away from the distalmost end of the frame in a distal direction and configured to engage tissue.”
Pat. ‘462 claim 12 recites:
“12. An implant device comprising: a frame having a proximal end and a distal end, the frame comprised of a plurality of adjacent struts joined to provide proximal apices and distal apices, the frame including an anti-backout feature configured to resist movement of the frame within a valve annulus; and a plurality of anchors coupled to the anti-backout feature of the frame and having distal ends extending distally away from the distalmost end of the frame in a distal direction and configured to engage tissue.
It is obvious to one having ordinary skill in the art that “a plurality of interconnected struts is synonymous with a plurality of adjacent struts joined.
10. Regarding claims 2 and 10, see pat. ‘462 claim 13.
11. Regarding claims 3 and 11, see pat. ‘462 claim 14.
12. Regarding claims 4 and 12, see pat. ‘462 claim 15.
13. Regarding claim 5 and 14, see pat. ‘462 claim 16.
14. Regarding claim 6 and 13, see pat. ‘462 claim 17.
15. Regarding claim 7, see pat. ‘462 claim 18.
16. Regarding claims 8 and 19, see pat. ‘462 claim 19.
17. Regarding claim 18, pat. ‘462 does not recite that the frame is disposed about a central axis, and the anti-backout feature is angled relative to the central axis.
However pat. ‘462 claim 4 recites that the frame is disposed about a central axis, and the skirt is angled relative to the central axis of the frame. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the claims of ‘462 and provide the anti-backout feature is angled relative to the central axis because the struts carry the skirt and the anti-backout feature.
17. Claims 16 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,918,462 (hereafter ‘462) in view of U.S. Patent No. 10,258,466 (claims 1-16, hereafter ‘466).
Pat. ‘462 has been disclosed supra however does not claim that at least one of the plurality of anchors is rotatably carried by the frame. Pat. ‘466 claim 14 recites that the anchors are rotatably carried by the frame. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify pat. ‘462 and provide anchors that are rotatable carried by the frame in order to embed and secure into the surrounding tissue upon implantation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. 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:/Awww.uspto.gov/patents/apply/patent- center for more information about Patent Center and https:/Awww.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197.
/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 July 1, 2026
Prosecution Insights