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
2. Applicant’s election without traverse of Group II (claims 21-26) in the reply filed on 3/17/26 is acknowledged.
Claim Rejections - 35 USC § 103
3. 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.
4. Claims 21-22 are rejected under 35 U.S.C. 103 as being obvious over Greenan et al. (hereafter Greenan) 2021/0052387 in view of Metcalf et al. (hereafter Metcalf) 2020/0188092.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Noting figures 41-44 below,
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Greenan discloses a method of implementing annuloplasty, the method comprising: connecting a guide to a guide-engaging element of a shaping ring (see fig. 41 supra); folding the entire shaping ring into a catheter (see 0025 and 0072) introducing the shaping ring and surgical apparatuses through the catheter (see for example catheter 514) into a body of a patient; anchoring a bar member (see [0068 which states that two structures or bars are utilized) of the shaping ring to annulus tissue by a tissue anchoring element (see anchoring elements 212-214 which are used in fig. 41); contracting (this is interpreted as the “cinching” step as noted in [0068]) the annulus to a proper size by adjusting an adjustment mechanism wire (these is interpreted as tissue anchor guides (518) as discussed throughout the Greenan) and locking the adjustment wire to keep the annulus properly sized (this is interpreted because element 518 is attached to the anchors (212-214) which anchor/lock the device to keep the annulus properly sized) and withdrawing the catheter and the surgical apparatuses (because delivery apparatuses are not left within patients after implant is deployed).
However, Greenan et al. does not disclose that the adjustment mechanism is a wire. Metcalf et al. teaches an annuloplasty heart valve repair which utilizes a delivery device 9200) and control wires [0027]. It would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize a wire for the adjustment mechanism because wire are known for superior strength, flexibility and durability in the field of prosthetics.
5. Regarding claim 22, Greenan does not specifically state “…adjusting the angle and/or orientation of the bar member by engaging a torque drive device with a position adjustment structure on the bar member before anchoring the shaping ring to the annulus tissue. Metcalf et al. teaches that the wires of delivery device improve transfer for a force, such as a push or pull force along longitudinal axis 214 or a torque about longitudinal axis. It would have been obvious to one having ordinary skill in the art to modify the invention of Greenan and utilize a delivery devices adjustment mechanisms (518) to adjust the orientation of the bars because Greenan states in [0075]:
“…The systems and methods also allow for a high level of customization to suit a particular anatomy. This relates to there being distinct components that are placed separately, and the ability to adjust the medial and lateral sides separately….. The systems and methods allow for in vivo adjustability, allow for reduced accuracy needed to place the components and simplify the implantation procedure…”.
Allowable Subject Matter
6. Claims 23-26 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.
7. The following is a statement of reasons for the indication of allowable subject matter: The prior art of Greenan et al. 2021/0052387 and Metcalf et al. 2020/0188092 have been disclose supra however the prior art fails to teach or disclose that wherein the bar member includes a first bar member, a second bar member and a third bar member, the method is used to repair a mitral valve and further comprises: fixing the first bar member to or near region P2 of a posterior leaflet of the annulus tissue by a tissue anchoring element; anchoring the second bar member to a vicinity of a medial trigone region of the annulus tissue by a tissue anchoring element; anchoring the third bar member to a vicinity of a lateral trigone region of the annulus tissue by a tissue anchoring element; and adjusting an adjustment wire by a cinching device rotatably provided on at least one of the first bar member, the second bar member, and the third bar member.
The prior art of Greenan et al. and Metcalf et al. further do not disclose the step of assembling the bar member, an extendable and compressible element, the adjustment wire and a cinching device of the shaping ring before loading the shaping ring into the catheter.
Conclusion
8. 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.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 April 15, 2026
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