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 .
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.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-8, 10-12, 14-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dixon (20210145571).
With regards to claim 1, Dixon discloses a valve repair device for repairing a native valve of a patient (100, 200), the valve repair device comprising: a central component (212); a paddle (120, 122, 220, 222) coupled to the central component (FIG 13); a gripping member (3500, formed of 3510 and 3530; 4400 formed of 4410 and 4430; 5200 formed of 5210 and 5230; see [0248]); wherein the gripping member (3500, formed of 3510 and 3530; 4400 formed of 4410 and 4430; 5200 formed of 5210 and 5230) and the paddle (120, 122, 220, 222) are movable to form a capture region for capturing a leaflet of the native valve ([248], FIG 10); an indicator (3550, 4450, 5250) that is configured to move into the capture region when the gripping member is in a closed position, the paddle is in a closed position and the leaflet of the native valve is not disposed in the capture region (FIG 40); and wherein the indicator (3550, 4450, 5250) is configured to push against the central component and be pressed to a flattened condition when the gripping member is in the closed position, the paddle is in the closed position and the leaflet of the native valve is disposed in the capture region at least a minimum insertion depth (FIG 43).
With regards to claim 2, Dixon discloses the valve repair device of claim 1, wherein the indicator (3550) is configured to pass through one or more of the paddle and the gripping member (FIG 40, passing through paddle 122 and fixed arms 3510 of gripping member).
With regards to claim 3, Dixon discloses the valve repair device of claim 1 wherein the paddle (220, 222) includes an inner paddle portion (222) and an outer paddle portion (220), wherein at least a portion of the indicator is disposed between the inner paddle portion and the outer paddle portion when the gripping member is in the closed position, the paddle is in the closed position and the leaflet of the native valve is disposed in the capture region at the minimum insertion depth ([0240]).
With regards to claim 5, Dixon discloses the valve repair device of claim 1, wherein the central component (212) comprises a spacer (210).
With regards to claim 6, Dixon discloses the valve repair device of claim 1, wherein a fixed arm of the gripping member (5210, FIG 110) comprises a first beam (5210 on the right), a second beam (5210 on the left), and an engaging member between the first beam and the second beam (1031).
With regards to claim 7, Dixon discloses the valve repair device of claim 6, further comprising an indicator marker ([0523]) attached to the indicator (5250).
With regards to claim 8, Dixon discloses the valve repair device of claim 1, wherein the indicator (3550) is configured as an indicator arm comprises a fixed end and a moving end (see annotated FIG 42).
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With regards to claim 10, Dixon discloses a valve repair system for repairing a native valve of a patient (102, 100, 200, [0050]), the valve repair system comprising: a delivery system (102); a valve repair device coupled to the delivery system (100, 200), the valve repair device comprising: a central component (212); a paddle (120, 122, 220, 222) coupled to the central component (FIG 13); a gripping member (3500, formed of 3510 and 3530; 4400 formed of 4410 and 4430; 5200 formed of 5210 and 5230; see [0248]); wherein the gripping member (3500, formed of 3510 and 3530; 4400 formed of 4410 and 4430; 5200 formed of 5210 and 5230) and the paddle (120, 122, 220, 222) are movable to form a capture region for capturing a leaflet of the native valve ([248], FIG 10); an indicator (3550, 4450, 5250) that is configured to move into the capture region when the gripping member is in a closed position, the paddle is in a closed position and the leaflet of the native valve is not disposed in the capture region (FIG 40); and wherein the indicator is configured to push against the central component and be pressed to a flattened condition when the gripping member is in the closed position, the paddle is in the closed position and the leaflet of the native valve is disposed in the capture region at least a minimum insertion depth (FIG 43).
With regards to claim 11, Dixon discloses the valve repair system of claim 10 wherein the indicator (3550) is configured to pass through one or more of the paddle and the gripping member (FIG 40, passing through paddle 122 and fixed arms 3510 of gripping member).
With regards to claim 12, Dixon discloses the valve repair system of claim 10 wherein the paddle (220, 222) includes an inner paddle portion (222) and an outer paddle portion (220), wherein at least a portion of the indicator is disposed between the inner paddle portion and the outer paddle portion when the gripping member is in the closed position, the paddle is in the closed position and the leaflet of the native valve is disposed in the capture region at the minimum insertion depth ([0240]).
With regards to claim 14, Dixon discloses the valve repair system of claim 10, wherein the gripping member (4400) and the indicator (4450) are made from a single piece of flat material ([0277], “the clasp 4400 can be laser cut from a flat sheet or a tube of shape-memory alloy, such as Nitinol, and then shape-set into a desired shape”).
With regards to claim 15, Dixon discloses the valve repair system of claim 10, wherein a fixed arm of the gripping member (5210, FIG 110) comprises a first beam (5210 on the right), a second beam (5210 on the left), and an engaging member between the first beam and the second beam (1031).
With regards to claim 16, Dixon discloses the valve repair system of claim 15, further comprising an indicator marker ([0523]) attached to the indicator (5250).
With regards to claim 17, Dixon discloses the valve repair system of claim 10, wherein the indicator (3550) is configured as an indicator arm comprises a fixed end and a moving end (see annotated FIG 42).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dixon (20210145571).
With regards to claim 4, Dixon discloses the valve repair device of claim 1, wherein the indicator (3550) comprises a marker comprising a radiopaque material (radiopaque marker 2410 on indicator arm 3550 [0253]). Dixon fails to disclose that the gripping member comprises a marker comprising a radiopaque material.
In an alternate embodiment, Dixon discloses that the gripping member (5200) comprises a marker comprising a radiopaque material (radiopaque marker 1030 on gripping member [0313]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Dixon’s valve repair device to include that the gripping member comprises a marker comprising a radiopaque material, as taught by the alternative embodiment, in order to assist the user in determining whether the leaflet is properly positioned in the clasp/gripping member ([0313]).
With regards to claim 13, Dixon discloses the valve repair system of claim 10, wherein the indicator (3550) comprises a marker comprising a radiopaque material (radiopaque marker 2410 on indicator arm 3550 [0253]). Dixon fails to disclose that the gripping member comprises a marker comprising a radiopaque material.
In an alternate embodiment, Dixon discloses that the gripping member (5200) comprises a marker comprising a radiopaque material (radiopaque marker 1030 on gripping member [0313]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Dixon’s valve repair device to include that the gripping member comprises a marker comprising a radiopaque material, as taught by the alternative embodiment, in order to assist the user in determining whether the leaflet is properly positioned in the clasp/gripping member ([0313]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (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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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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