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 .
Detailed Action
This is in response to the amendment filed 01/22/2026.
Allowable Subject Matter
Claims 2-18, are allowed.
Claim 20 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.
The following is an examiner’s statement of reasons for allowance: claims 2 and 20 recite a first fastening catheter and a first fastener disposed on a distal end portion of the first fastening catheter, the first fastening catheter configured to push the first fastener over a first portion of each of the first guide wire and the second guide wire to couple the first fastener with a first end portion of each of the first tubular brace and the second tubular brace. Claim 15 recites a first fastening catheter and a first fastener, wherein the first fastening catheter is configured to frictionally couple the first fastener with a first end portion of each of the first tubular brace and the second tubular brace; a second fastening catheter and a second fastener, wherein the second fastening catheter is configured to frictionally couple the second fastener with a second end portion of each of the first tubular brace and the second tubular brace.
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.”
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 19, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0245910 (Righini) in view of U.S. Patent Publication Number 2003/0233142 (Morales et al.)
Regarding claim 19, Righini discloses as shown in Figure 1, a delivery assembly comprising: at least one introducer sheath (catheter 10, see paragraph [0052]); a first guide catheter (one of guide catheters 14, see paragraph [0044]) and a first guide wire (one of guide wires 46, see paragraph [0051]) insertable through the first guide catheter; a first snare catheter (small gauge sheath 52, see paragraph [0052]) and a first snare wire (capture device 22, see paragraph [0052]) insertable through the first snare catheter, the first snare wire configured to capture a distal end portion of the first guide wire for forming a posterior guide wire loop around a first leaflet of a native heart valve; a second guide catheter (one of the other guide catheters 14, see paragraph [0044]) and second guide wire (one of the other guide wires 46, see paragraph [0051]) insertable through the second guide catheter;
Righini fails to disclose a second snare catheter and a second snare wire insertable through the second snare catheter, the second snare wire configured to capture a distal end portion of the second guide wire for forming an anterior guide wire loop around a second leaflet of the native heart valve; a first tubular leaflet brace slidable over the posterior guide wire loop; and a second tubular leaflet brace slidable over the anterior guide wire loop.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the assembly disclosed by Righini to include a second snare catheter and a second snare wire insertable through the second snare catheter, the second snare wire configured to capture a distal end portion of the second guide wire for forming an anterior guide wire loop around a second leaflet of the native heart valve because it would only require the duplication of parts without changing the device operates. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)
Morales et al., from the same field of endeavor teaches a similar assembly was shown in Figures 3A-3C where a first tubular leaflet brace (one of clips 34, see paragraph [0091]) slidable over a guide wire loop (tether is disclosed as a wire see paragraph [0035]), for the purpose of tightening the annulus and reducing regurgitation. See paragraph [0094].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the assembly disclosed by Righini to include a first tubular leaflet brace slidable over the posterior guide wire loop; and a second tubular leaflet brace slidable over the anterior guide wire loop in order to tighten the annulus at two separate locations (posterior and anterior) to reduce regurgitation.
Regarding claim 21, Righini discloses a prosthetic heart valve (valve body 72, see paragraph [0079]); and a valve delivery catheter having the prosthetic heart valve coupled to a distal end portion thereof in a radially compressed state, wherein the valve delivery catheter (release device 74 or support device 66, see paragraph [0079]) is configured to position the radially compressed prosthetic heart within a support ring formed by the first and second tubular braces and the first and second fasteners and to transition the radially compressed prosthetic heart valve to a radially expanded state for capture of the first leaflet between the first tubular brace and the prosthetic heart valve and capture of the second leaflet between the second tubular brace and the prosthetic heart valve.
Response to Arguments
Applicant's arguments filed 01/22/2026, see pages 7-14 have been fully considered but they are not persuasive.
The applicant argues the addition of a second snare catheter and second snare wire is not a mere duplication of parts because it produces a new and unexpected result. More specifically, the applicant argues the formation an anterior guide wire loop around a second leaflet produces the new and unexpected result of formation of loops around each of the posterior and anterior leaflets that cannot be achieved by the prior art.
In response, the Office respectfully disagrees. As the applicant admits, the claimed second snare catheter and second snare wire are used for the same purpose of forming a loop around a leaflet in the heart. It being used in a different area of the heart does not make it new. Furthermore, using the second snare catheter and second snare wire in the manner to produce the exact same result (loop around a leaflet) is not unexpected. It produces the same result of forming a loop around the leaflet in order guide a brace in place.
"Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of obviousness thereof." See In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967).
In this case, the second snare catheter and second snare wire are used to achieve the same beneficial result (guiding a loop around the leaflet to deliver a brace, see paragraph [0087] of the specification) as the first snare catheter and first wire. Accordingly, this beneficial result is considered expected and the use of second snare catheter and second snare wire to achieve it not unexpected but expected.
The applicant further argues the use of a second snare catheter and snare wire would change how the device functions and render it unsatisfactory for its intended purpose. In response, the Office respectfully disagrees.
The applicant is speculating that the single loop configuration is critical to how Righini functions. This is something that is simply not described in the reference. Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
In fact, Righini discloses that one embodiment there is a first snare catheter and first snare wire in paragraph [0052] and that the disclosed embodiments are examples which should be understood as limiting paragraph [0014].
The introducer sheath 10 has large interior lumen that could clearly accommodate a second snare catheter and snare wire without affecting the functions of anything else in the device. See Figure 2.
Thus, not only is the applicant’s position unsupported by evidence, it is directly contradicted by Righini’s disclosure.
The applicant further argues the modified device would require forming two separate loops-each captured and secured independently which means it method operation is altered. In response the office respectfully disagrees. In the applicant’s hypothetical, the snare catheters and snare wires would be doing the same operation of snaring wires, albeit in a different location.
The applicant’s reading of case law would exclude any modification of a reference. Other court cases and (MPEP 2143.01 VI.) make clear:
If the proposed modification or combination of the prior art would change the principle of operation of the prior art invention being modified, then the teachings of the references are not sufficient to render the claims prima facie obvious. See In re Ratti, 270 F.2d 810, 813, 123 USPQ 349, 352 (CCPA 1959).
It is the position of the Office that adding a second snare catheters and snare wire and snaring loops in slightly different manner to achieve the exact same result does not alter the principle of operation of Righini’s which is snaring wires in the heart.
The applicant further speculates the formation of two separate loops would result in the two components of the annular structure each being on a different guide wire and would prevent the pins and holes of the components from being in the proper orientation for mating. In response, the Office respectfully disagrees rebuts the finding of obvious because it is simply not supported by the reference.
Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
Applicant’s arguments cannot be considered persuasive for that reason alone.
Furthermore, the applicant’s proposed hypothetical is not the only way a second snare catheters and second snare wire could be used. A second snare catheters and second snare wire could be used to adjust the position of the wire loops which are out of position but remote from the first snare catheter and first snare wire. Thus, including a second snare catheters and second snare wire could provide the benefit of assisting the first snare catheter and first snare wire without changing how Righini operates at all.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is (571)270-1965. The examiner can normally be reached on Monday – Friday, 9:30 am – 6 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771