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 1-17 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Solem, US 2013/0090728 A1, which discloses a method of repairing a native heart valve, the method comprising intravascularly delivering a prosthetic device to the native heart valve (paragraphs 0019, 0052, 0057, 0085, 0131+), the prosthetic device comprising a frame [Figures 6c, 13a, 13b; paragraphs 0028, 0031, 0109 (attachment position 290, strengthened base 296)] and prosthetic valve leaflets configured to open and close during a cardiac cycle (Figure 6c; paragraphs 0015, 0022, 0030, 0082, 0109); transitioning the prosthetic device from a delivery state to a deployed state (paragraphs 0131+); positioning the prosthetic device at a target position within the native heart valve (Figures 13a, 13b; paragraphs 0019, 0055, 0136) via a support catheter coupled to the prosthetic device [Figures 5a, 5i; paragraphs 0021, 0049 (connecting means may be tubular to accommodate a guide wire), 0087 (connecting means 246 may be flexible and “forced to a desired shape within the patient” by using a pre-shaped catheter), 0097 (“connecting means may be tubular” or hollow and of a flexible material), 0101 (pre-shaped catheter 135), 0127, 0136]; locking the support catheter to suspend and maintain the prosthetic device within the native heart valve (Figures 5a-5i, 13a-13b; paragraphs 0033, 0036-0037, 0044, 0046-0049, 0086-0087, 0096-0102) such that the native heart valve leaflets open during the cardiac cycle and close to co-apt against the prosthetic valve (abstract; paragraphs 0013-0014, 0017, 0022, 0120), wherein the support catheter remains in situ after delivery of the prosthetic device (paragraphs 0035-0036, 0083-0084, 0131+).
Regarding claim 2, the percutaneous insertion utilizes a delivery catheter 502 (Figure 14a; paragraphs 0055, 0057, 0085, 0131+). Regarding claim 3, the native heart valve may be a tricuspid valve (paragraphs 0010, 0035, 0089, 0119-0120, 0126+, 0136). Regarding claims 4, 10, and 15, the support catheter is deflected and locked (paragraphs 0046-0048, 0087, 0097, 0101, 0127). Regarding claim 6, strengthened base 296 (Figure 6c; paragraph 0109) defines a ring, and the support catheter, frame, and prosthetic valve, at least in some embodiments, expand upon deployment [paragraphs 0084 (“apparatus 42 may be compressed to a very small diameter”), 0096, 0104 (“valve means is therefore oversized so that it will certainly contact and seal against the leaflets of the native valve”), 0131+]. Regarding claim 9, retracting a cover 504 releases an expanding frame of the prosthetic device (paragraphs 0084-0085, 0104, 0131-0132, 0136). Regarding claims 11-12, in some embodiments, the support catheter extends the prosthetic device from a blood vessel to the target position within the native heart valve without anchoring to either an atrial or ventricular wall of the heart (Figures 13a-13b; paragraphs 0035-0036, 0089, 0127). Regarding claim 13, a hula tube 506 (paragraphs 0131, 0136) and/or other mechanisms for advancing the prosthetic device (paragraphs 0136+) are viewed as actuators. Regarding claim 14, the support catheter may include shaped or stiff collars (Figures 5a-5e, 5i; paragraphs 0098+). Regarding claims 16-17, rotations among the components are innate because of the twisting and turning during deployment (paragraphs 0131+); an outer support sheath and inner support tube may be locked (Figure 5i; paragraphs 0047-0049, 0098-0101). The further limitations of other claims are readily apparent (MPEP § 707) from the figures and passages cited above.
Response to Arguments
Applicant’s remarks have been considered but are deemed moot in view of the new grounds of rejection.
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 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/DAVID H WILLSE/ Primary Examiner, Art Unit 3774