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 § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 6-7, 17, 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chau et al. 2016/0331523.
PNG
media_image1.png
375
378
media_image1.png
Greyscale
Chau et al. discloses the invention as claimed noting for example fig. 4-5 comprising: An implant for reducing heart valve regurgitation, the implant comprising: a central member (106) having a first end and a second end (inherent); a first arm (110 left) extending from the first end of the central member; a second arm (110 right) extending from the second end of the central member (this is interpreted as elements 706); and a plurality of support members (102) each extending from the first arm to a respective free end.
Regarding claim 2, the central member is tubular thus it is curved; Regarding claim 6 see [0012].
Regarding the limitations of claims 4, the intended use recitation language “..wherein each of the plurality of support members is in an elongated state when the implant is in a delivery configuration” carries no weight in the absence of any distinguishing structure. Chau et al. discloses the structure as claimed and is thus capable of performing the functions. See MPEP 2114.
Regarding claims 6, Chau et al. discloses that the first and second arm are configured to receive a portion of a first native leaflet of a heart valve therebetween to couple the implant to the first native leaflet, the central member forms at least a portion of a coaptation section configured to contact a second native leaflet of the heart valve (see [0012; 0017-0019]).
Regarding claim 7, “configured to bias the first arm towards the second arm is functional language. The first and second arm as disclosed by Chau et al. are capable of performing the functions. See MPEP 2114. Regarding claim 17 see MPEP 2114.
Regarding claims 18 and 21-26, 28, figure 53 discloses: An implant for reducing heart valve regurgitation, the implant comprising: a central member (106) having a first end and a second end (inherent); a first arm (110 left) extending in a distal direction from the first end of the central member;
PNG
media_image1.png
375
378
media_image1.png
Greyscale
a second arm (110 right ) extending in the distal direction from the second end of the central member, the first arm and the second arm configured to receive a portion of a native leaflet of a heart valve therebetween to couple the implant to the native leaflet (functional language); and a plurality of support members (102) each extending in a proximal direction from at least one of the first arm or the central member.
Regarding claims 22-24, 29 these limitations are functional. See MPEP 2114. Regarding claims 28 and noting figure 13 for example, the device along with the support members are placed within a catheter and a delivery sheath and when the sheath is retracted the device is deployed. See figure below..
PNG
media_image2.png
350
221
media_image2.png
Greyscale
Claim Rejections - 35 USC § 103
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.
Claim(s) 3, 25, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Chau et al. Chau et al. 2016/0331523.
Chau et al. has been disclosed above however does not recite the term “coplanar” with a most proximal surface of the central member when the implant is in a deployed configuration. This limitation recites the manner in which the device functions and does not recite structural limitation. Noting figure 13 for example, the device along with the support members are placed within a catheter and a delivery sheath and when the sheath is retracted the device is deployed. It is obvious to one having ordinary skill in the art that the support members are compacted and coplanar upon deployment in order to fit within the catheter/sheath assembly.
Regarding claims 25, 26, 28-29, Chau et al has been disclosed supra including: a central member (e.g. 106 ) having a first end and a second end; a first arm extending from the first end of the central member (110 left); a second arm (110 right) extending from the second end of the central member, the first arm and the second arm configured to receive a portion of a native leaflet of a heart valve therebetween to couple the implant to the native leaflet (see fig 36); and a plurality of support members (102) each extending from at least one of the first arm or the central member; and wherein the support members extends to a respective free end
however Chau et al. does not specify the functional language of claims 26, 28 and 29 e.g. “the plurality of support members configured to transition between an elongated state in which the plurality of support members elongate along a longitudinal axis of the implant to an expanded state in which the plurality of support members shorten along the longitudinal axis and expand along a transverse axis of the implant etc..” It is obvious to one having ordinary skill in the art that because [0085] states “ …The body and the anchor can be compressible to a radially compressed state and can be self-expandable to a radially expanded state when compressive pressure is released” then device as a whole is capable of performing the functions as claimed.
Regarding claim 30 Chau et al. discloses that “…the body 304 of the device 300 can be an integral component of the device 300 formed from a single, unitary piece of self-expandable braided material, such as braided Nitinol”. However, Chau does not specify that the first arm, and the second arm are integrally formed. This is a product by process limitation. See MPEP 2113. It would have been obvious to one having ordinary skill in the art to integrally form the central member and the arms in order to form a seamless device that would not injure surrounding tissues.
Allowable Subject Matter
Claims 5, 8-16, 19-20 and 27 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: The limitations of claims 5, 8-16, 19-20 and 27 in combination with the independently claimed subject matter is novel over prior art.
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.
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 November 18, 2025