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 Arguments
Applicant's arguments filed 8/17/2026 have been fully considered. The information disclosure statement filed 3/06/2024 has been reconsidered and included herewith.
All rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn due to applicant’s amendments.
Claims 55-59, 61-68 are rejected under 35 U.S.C. 103 as being unpatentable over McLean et al (2019/0201191) in view of Khairkhahan (2015/0119981).
Applicant argues:
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This is not a specific argument(s), but rather, a description of the McLean et al. The examiner’s rejection below equates the emphasized features of claims 55 and 63.
Regarding the claim amendment that the “coaptation member is configured to engage cardiac tissue 702 and the bridging portion 702B may include a plurality of frictional engagement portions or cleats 712 which are adapted to frictionally engage the walls of the atrium (cardiac tissue upstream of the valve annulus).
See all valve repair device embodiments of McLean et al, including as figure 2D-1, wherein the atrial fixation member engages cardiac tissue upstream of the valve annulus.
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Claim Rejections - 35 USC § 103
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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 55-59, 61-64, 66 and 68 are rejected under 35 U.S.C. 103 as being unpatentable over McLean et al (2019/0201191) in view of Khairkhahan (2015/0119981).
Referring to all embodiments, for example, McLean et al teaches a valve repair device, comprising:
an atrial fixation member 702 configured to engage cardiac tissue proximate to and/or upstream of a native valve annulus (see at least figure 7C);
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a coaptation member 708 extending away from the atrial fixation member and radially inward from the atrial fixation member (see included figures), the coaptation member comprising an inner portion having a coaptation surface configured to coapt with a first native leaflet (anterior leaflet) during systole and an outer portion configured to displace at least a portion of a second native leaflet (posterior leaflet) (see at least par. 0116),
wherein the coaptation member 708 is substantially stationary during cardiac cycles while being positioned between the first native leaflet a the second native leaflet during the cardiac cycle;
a first clip mechanism 720 and a second clip mechanism 720 extending from the outer portion of the coaptation member, said second clip mechanism spaced laterally apart from the first clip mechanism as shown. Par. 0118 of the specification teaches: The posterior hook 720 is configured to atraumatically engage the ventricular side of the annulus, the posterior ventricular wall, and/or free edge of the posterior leaflet. (See, FIG. 7C.).
However, McLean et al unclear as to specifically teaching said first clip mechanism and said second clip mechanism are configured to extend behind and engage a first portion of the posterior leaflet and wherein they are movable between a first closed position and a first open position.
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Khairkhahan et al also teaches a similar valve repair device comprising
first clip mechanism 496 configured to extend behind and engage a first portion (central) of the second native leaflet (posterior leaflet) and second clip mechanisms 496 configured to extend behind and engage a second portion (lateral) of the second native leaflet (see above),
said first and second clip mechanism having a first closed position (as shown) fully capable of securing the first portion and second portion of the second native leaflet against the outer portion of the coaptation member; said clip mechanisms are movable between a first closed position and a first open position to accept the posterior leaflet; see par. 0105 teaching spring-loaded clips or ribbons 496.
It would have been obvious to one having ordinary skill in the art to have configured the first and second clip mechanism of McLean et al (any embodiment) to extend behind and engage a first portion and second portion of the second native leaflet (posterior leaflet) in the first closed position (as shown) to secure the first portion of the second native leaflet against the outer portion of the coaptation member; said clip mechanisms are movable between a first closed position and a first open position to accept the posterior leaflet, as taught by Khairkhahan et al, to increase securement of the posterior leaflet.
Claims 56 and 64 are addressed in main rejection above.
Claims 57, 66 and 67, at least Khairkhahan et al teaches a third clip mechanism; the remainder of the claim(s) is addressed in the main rejection above and/or is self-evident.
Claim 58, see claim 57, “lateral portion of the second native leaflet” is any portion lateral of the central portion.
Claim 59, clip mechanisms (spring-loaded clips or ribbons) are fully capable of the functional language.
Claims 61-62, wherein the atrial fixation member comprises a plurality of interconnected struts that define rows of open cells (see at least par. 0115 of McLean et al), and wherein the atrial fixation member is configured to engage the cardiac tissue along a circumferential portion (ring segment 702, just a portion not the entire circumference) or a non-circumferential portion (ring segment 702) of a cardiac chamber proximate to and/or upstream of the native valve annulus.
Claim 63 is addressed in claim 55.
Claim 68 is addressed in claim 55 above.
Allowable Subject Matter
Claims 70-74 are allowed.
Claim 69 is 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.
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 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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