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 .
Specification
The disclosure is objected to because of the following informalities: On page 11, lines 7 and 11, “expended” should apparently be --expanded--, both occurrences. On page 14, line 14, reference character “811” is not believed to be present in the drawings; on line 38, “closes” should read --close--, and on line 40, reference should evidently be made to Figure 22 as well. Appropriate correction is required.
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.
Claims 1, 12-14, 16, and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Wei, US 2016/0174979 A1, which discloses a valve clamp 14 for preventing leaflet injury and comprising a pair of clamp arms 18 openably and closeably disposed on opposite sides of a fixed base 19, 74 via rotatably connected link members 68 (Figures 5, 6B, 8, 9A-9B; paragraphs 0001-0002, 0012, 0045, 0050, 0053, 0059-0060). Each clamp arm 18 is recessed inwardly to form a capture zone 50 that extends toward a free end of arm 18 and curves away from an opposite clamp arm 18 to form a first flanging section (Figures 5, 7B; paragraphs 0014, 0045-0047). An anti-slipping portion in various forms may be provided between the capture zone and the first flanging section so as to define a depth less than a capture zone depth for cooperating with a respective gripping arm 16 in engaging a natural valve leaflet (Figures 3A-3C, 4, 9A-9B, 10, 11A-11E, 12; abstract; paragraphs 0015, 0018, 0047-0048, 0069-0089).
Regarding claim 12, each gripping arm 16 is disposed between fixed base 19, 74 and a respective clamp arm 18 and is partially received in capture zone 50 in a natural or relaxed state (Figure 5; paragraphs 0047, 0058-0059). Regarding claims 13-14, drive or actuator mechanism 58 includes a drive shaft or actuator rod extending through shaft 12 and “axially extendable and retractable”, connecting seat 69 or 74, and connecting rods or link members 68 (paragraphs 0050, 0053); seat 69 has two pairs of connecting holes (Figures 6B, 7B, 8, 9A-9B). Regarding claim 16, in an inverted or everted state (Figure 8), an everted angle between clamp arms may range from “about 270 to 360 degrees”, with a span between free ends of the clamp arms being around 12 mm to 16 mm (paragraph 0057).
Regarding claims 18-21, the delivery system includes an outer sheath or catheter 86 and a mandrel 12 (Figures 5, 6A-7B; paragraphs 0036, 0051), with the method comprising the steps of pushing the drive shaft to a mitral valve and opening valve clamp 14 so that arms 16 and 18 are perpendicular to a coaptation line of the mitral valve (Figures 4, 9A-9B; paragraphs 0037, 0041, 0055), withdrawing valve clamp 14 proximally so that clamp arms 18 hold respective leaflets on the ventricular side (Figure 3A; paragraphs 0016, 0050, 0059), loosening control wires 90 to release gripping arms 16 on both sides so as to effect complete clamping of the valve leaflets (Figure 7A; paragraphs 0054, 0058), pushing mandrel 12 and the drive shaft to drive clamp arms 18 to close (Figures 3A-3C; paragraphs 0040, 0058-0060), and releasing connection between mandrel 12 and the drive shaft and withdrawing the delivery component from the body such that valve clamp 14 pulls the mitral leaflets toward each other to impart a double orifice structure and edge-to-edge repair (Figure 4; paragraphs 0041, 0055).
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.
Claims 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wei, US 2016/0174979 A1. Regarding claim 15, values within the specified range would have been obvious from Figure 6B and the span range (paragraph 0057) for the Figure 8 configuration (MPEP § 2125) under routine experimentation and/or analysis in order to minimize the overall diameter for endovascular or percutaneous delivery (paragraph 0001). Regarding claim 17, values within the specified range would likewise have been obvious from Figure 8 in order to help reduce trauma to the valve leaflets and to minimize entanglement with surrounding tissues (Figures 3B-3C; paragraph 0040).
Claims 2-5 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Wei, US 2016/0174979 A1, in view of Abunassar et al., US 2021/0186698. Regarding claims 7-11, second, third, and fourth flanging sections are taught by Abunassar et al. (e.g., Figures 4-6C), and to so modify Wei with these deformable flex portions would have been obvious in order to “increase contact patch area and corresponding capture” (Abunassar et al.: paragraphs 0044, 0050) and to “reduce or eliminate tissue erosion by more secure engagement at the desired locations” (ibid.: paragraph 0058), with further motivation (to combine) provided by Abunassar et al. being directed to similar structure (Figures 1-3A, 13) and purposes [paragraphs 0001, 0058 (“frictional elements”)] and Wei also being concerned about tissue trauma, as explained above. Regarding claims 2-5, flexible flanging sections are capable of forming different bending angles for adapting to various leaflet tissue portions, and as demonstrated above, the clamp arms of Wei may be adjusted and locked in a continuum of angular orientations relative to the fixed base and the central axis of the valve clamp, so values within the claimed ranges would have been obvious in order to accommodate a diversity of patents and uses (e.g., Wei: paragraph 0001).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David H. Willse, whose telephone number is 571-272-4762. The examiner can normally be reached on Monday through Thursday. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Melanie Tyson can be reached at telephone number 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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/DAVID H WILLSE/ Primary Examiner, Art Unit 3774