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)(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 1-5 and 7-23 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Rolando et al., US 2014/0046434 A1. Regarding claim 16-18, 20-22, and others, Rolando et al. disclose a valve prosthesis system comprising a prosthetic valve 1 having an expandable frame 2 configured to collapse radially for delivery and expand radially upon deployment to an expanded configuration (Figures 1, 24-27; paragraphs 0046, 0049-0050, 0054-0055, 0061-0062) and including a plurality of anchors 10 expandable from a collapsed anchor configuration to an expanded configuration so as to extend from a distal end of expandable frame 2 towards a proximal end along a longitudinal axis of frame 2 (Figures 5a-6b, 22a, 24-25, 27; abstract; paragraphs 0011, 0059-0060, 0071+, 0094, 0101-0103, 0121, 0126); a delivery instrument includes an outer catheter member S resiliently and frictionally attached to expandable frame 2 adjacent its proximal end via inflow end anchor portions 10b and an inner balloon catheter member B forcibly engaging expandable frame 2 adjacent its distal and proximal ends (Figures 24-26; paragraphs 0139-0140, 0143, 0146), inner balloon catheter member B being retractable into outer catheter member S to pivot each of the anchors 10 to an inverted position in the collapsed anchor configuration (Figures 22a, 24-25; paragraphs 0010, 0097, 0122-0123, 0126, 0146-0148, 0150, 0153-0154).
Regarding claims 3-5, 7-8, 11, 14-15, 19, and 23, an expanded anchor configuration may involve a foot angle β of approximately 30° (Figures 6b, 26; paragraphs 0102, 0121), and a collapsed anchor configuration defines a continuum of foot angles under 180° and well above 45° (Figures 22a, 24; paragraphs 0122, 0126, 0146-0148; MPEP § 2125). Regarding claim 1-2, 11-12, and 15, the delivery methods are explained in paragraphs 0139-0162 and illustrated in Figures 22a through 27, with expanded anchors 10 being oriented or angled to contact sub-annular locations (abstract; paragraphs 0008, 0058, 0084, 0109, 0135, 0137, 0162). Regarding claim 9-10, anchors 10 are locked into the collapsed anchor configuration (Figure 24) prior to advancing the delivery instrument in the sense that anchors 10 are frictionally engaged with outer catheter member S before positioning and/or repositioning the delivery instrument to the native heart valve (paragraphs 0122-0123, 0126, 0146-0148, 0150, 0153). Regarding claim 11, a centrally located hub from which anchors 10 collectively extend is defined by a partial sheet-like covering 210 (paragraphs 0014, 0017, 0063-0070, 0131-0137) or by “one or more annular members” of a “wire-like” or “stent-like structure” (paragraphs 0061-0062).
Claims 16-20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Cooper et al., US 2018/0296336 A1, which discloses a system delivering a valve prosthesis configured to be deployed within a native heart valve at a native heart valve annulus (Figures 16A-16D, 17; paragraphs 0010, 0029, 0068, 0086), the system including collapsing a prosthetic valve having an expandable frame inside of a delivery instrument (Figures 15A-15C, 16A-16D, 17; paragraphs 0015, 0029, 0036, 0089, 0116, 0119+) such that a plurality of spaced ventricular anchors extending from a distal end of the expandable frame towards a proximal end (Figure 15B; abstract; paragraphs 0010, 0017, 0028, 0034, 0073, 0079, 0083-0084, 0108-0109) are collapsed to an inverted position (Figure 15A; paragraphs 0016, 0036, 0127); advancing the delivery instrument a first distance such that the ventricular anchors extend below the native heart valve annulus (Figures 16B-16D, 17, 20; paragraphs 0073, 0078-0079, 0120-0121); and releasing each of the spaced ventricular anchors so as to reposition from the inverted position to an expanded configuration for contacting a sub-annular ventricular location (Figures 3B-3C, 16D, 20; paragraphs 0031-0032, 0073, 0078, 0107, 0110, 0123-0124).
The delivery instrument may involve inner and outer sheaths (paragraph 0128), a pusher member, and a guide [Figures 16A-16D and 17-19 (inner pointed member of what is apparently a guidewire); paragraph 0121 (“advancing a pusher device distally against the prosthetic valve and/or retracting the sheath 502 relative to the prosthetic valve”)], all of which are viewed as catheter members: the inner and outer sheaths are both matingly engaged with and frictionally attached to the expandable frame or main body adjacent proximal and distal ends of the body or frame. Regarding claims 16-20, retracting the inner sheath further into outer sheath 502 pulls the ventricular anchors back into the catheter so as to force the anchors to an outward and progressively downward (i.e., inverted) position, and extending the inner sheath relative to outer sheath 502 has the opposite effect (paragraphs 0036, 0122, 0127-0128; Figures 15A-15C, 16A-16D). Regarding claim 19, a foot angle may be adjusted so as to be within the range of 0° to 45° relative to a frame longitudinal axis upon release from the delivery instrument [Figures 9, 9A, 15A-15C, 16A-16D; paragraphs 0034 (“deployment of the main body causes the distal end portions of the ventricular anchors to rotate toward the main body”; emphasis added), 0109 (in Figure 9A, angle 260 may be “about 25 degrees” as an example), 0122 (“progressively pivot”)]; during a collapsing step, the spaced ventricular anchors pivot to outward and progressively downward positions towards a foot angle of 180° [Figures 3B, 15A-15C; paragraphs 0016, 0036, 0083, 0119 (“ventricular anchors 116 can be contained within the sheath 502 in a substantially linear arrangement, distal to the main body 108, such that the distal end portions 126 are axially aligned with the intermediate portions 124 and the proximal end portions 122”), 0120 (“rotate”, “pivot”), 0127].
Response to Arguments
Applicant’s remarks have been considered but are deemed partially moot in view of the new grounds of rejection, necessitated by the altered scope of the method claims, with Rolando et al. being “fully applied” (MPEP § 706.07) to all claims as appropriate. Regarding Cooper et al., Applicant’s claim 16 does not require that the inner catheter member be directly attached to the plurality of anchors; inner and outer sheaths of Cooper et al. are selectively moved relative to each other so as to effect a collapsed anchor configuration or an expanded anchor configuration [Figures 15A-15C, 16A-16D; paragraphs 0036 (“recapture the plurality of ventricular anchors within the interior of the outer sheath”), 0122, 0127-0128].
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL (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 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 Thomas Barrett can be reached at telephone number 571-272-4746. 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
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