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 .
Priority
Acknowledgment is made of applicant' s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Applicant has claimed foreign priority to a US patent application and is therefore not entitled to the benefit of its filing date.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the second driving assembly being proximal to the first driving assembly (line 3, claim 11) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 2, 4 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Herbowy et al. (US 2010/0036360).
Regarding claim 1, Herbowy et al. disclose a delivery system (Figure 31) for implantable medical device (3104), comprising a balloon catheter (3116), and further comprising: a sheath (3102) in sliding fit over the balloon catheter and for covering the implantable medical device (¶[0116]); an adjustment string (3110) for releasably securing the implantable medical device over the balloon catheter, one end (3114) of the adjustment string is capable of being fixed to the balloon catheter, and the other end is capable of passing through the implantable medical device (through 3122) and has an eyelet (formed by knot 3124); and a locking wire (3108) having relative locked and unlocked states (¶[0116]), wherein in the locked state, the locking wire passes through the eyelet to restrain the implantable medical device, and in the unlocked state, the locking wire disengages from the eyelet to release the implantable medical device (evident from Figure 31 and ¶[0116]).
Regarding claim 2, there is only one joint (at 3124) between the adjustment string and the locking wire.
Regarding claim 4, the implantable medical device is provided with a ring (3122), and in the locked state, an end of the adjustment string having the eyelet engages with the locking wire after passing through the corresponding ring to restrain the implantable medical device (evident from Figure 31).
Regarding claim 17, an implantable medical device is not structurally required by the claim. The delivery system of Herbowy et al. is capable of delivering a device as claimed.
Regarding claim 18, Herbowy et al. disclose a delivery system (Figure 31) for implantable medical device, comprising a balloon catheter (3116), further comprising: a sheath (3102) in sliding fit over the balloon catheter and for covering the implantable medical device (¶[0116]); an adjustment string (3110) for releasably securing the implantable medical device over the balloon catheter, one end (3114) of the adjustment string is capable of being fixed to the balloon catheter, and the other end and has an eyelet is capable of passing through the implantable medical device (through 3122); and a locking wire (3108) having relative locked and unlocked states (¶[0116]), wherein in the locked state, the locking wire passes through the implantable medical device to limit detachment of the implantable medical device from the adjustment string, and in the unlocked state, the locking wire is detached from the implantable medical device, allowing the eyelet to disengage from and release the implantable medical device (evident from Figure 31 and ¶[0116]).
Regarding claim 19, Herbowy et al. disclose an implantable system, comprising an implantable medical device (3104) and a delivery system engaged with the implantable medical device; wherein the delivery system is the delivery system for implantable medical device according to claim 1 (as explained above in regard to claim 1).
Claims 1, 2, 4, 7-9 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rupp et al. (WO 2020/198101).
Regarding claim 1, Rupp et al. disclose a delivery system (104; Figure 1) for implantable medical device (102; Figure 2), comprising a balloon catheter (¶[054]), and further comprising: a sheath (110) in sliding fit over the balloon catheter and for covering the implantable medical device (Figure 5); an adjustment string (152) for releasably securing the implantable medical device over the balloon catheter, one end (154) of the adjustment string is capable of being fixed to the balloon catheter (Figure 3), and the other end is capable of passing through the implantable medical device (through 194) and has an eyelet (156); and a locking wire (150) having relative locked and unlocked states (¶[061]-[063]), wherein in the locked state, the locking wire passes through the eyelet to restrain the implantable medical device, and in the unlocked state, the locking wire disengages from the eyelet to release the implantable medical device (evident from Figure 3 and ¶[061]-[063]),
Regarding claim 2, there is only one joint (at 156) between the adjustment string and the locking wire.
Regarding claim 4, the implantable medical device is provided with a ring (194), and in the locked state, an end of the adjustment string having the eyelet engages with the locking wire after passing through the corresponding ring to restrain the implantable medical device (evident from Figure 3).
Regarding claim 7, the implantable medical device has a tubular device body (Figure 4), and the end of the adjustment string having the eyelet is threaded from an interior of the device body radially towards an exterior of the device body (capable of being threaded this way as evident from Figure 3).
Regarding claim 8, the delivery system further comprises a control handle (106), to which all of the balloon catheter, the sheath and the locking wire extend, and the balloon catheter, the sheath, and the locking wire are movable relative to each other (¶[0048]-[0063]).
Regarding claim 9, the control handle comprises a limiting port for threading the locking wire (wherever it emerges from the handle - ¶[0063]).
Regarding claim 17, an implantable medical device is not structurally required by the claim. The delivery system of Rupp et al. is capable of delivering a device as claimed.
Regarding claim 18, Rupp et al. disclose a delivery system (104; Figure 1) for implantable medical device (102; Figure 2), comprising a balloon catheter (¶[054]), and further comprising: a sheath (110) in sliding fit over the balloon catheter and for covering the implantable medical device (Figure 5); an adjustment string (152) for releasably securing the implantable medical device over the balloon catheter, one end (154) of the adjustment string is capable of being fixed to the balloon catheter (Figure 3), and the other end is capable of passing through the implantable medical device (through 194) and has an eyelet (156); and a locking wire (150) having relative locked and unlocked states (¶[061]-[063]), wherein in the locked state, the locking wire passes through the eyelet to restrain the implantable medical device, and in the unlocked state, the locking wire disengages from the eyelet to release the implantable medical device (evident from Figure 3 and ¶[061]-[063]),
Regarding claim 19, Rupp et al. disclose an implantable system, comprising an implantable medical device (102) and a delivery system engaged with the implantable medical device; wherein the delivery system is the delivery system for implantable medical device according to claim 1 (as explained above in regard to claim 1).
Regarding claim 20, the implantable medical device is a prosthetic heart valve (¶[040]).
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 non-obviousness.
Claims 3, 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Rupp et al. (WO 2020/198101) in view of Weng (US 2009/0099640).
Regarding claim 3, Rupp et al. fail to disclose more than one joint as claimed.
Weng et al. disclose a system for releasing a stent having at least two joints (at 421 and 431) between an adjustment string (42/43) and the locking wire (3), and wherein at least one of the joints restricts movement of the implantable medical device in a distal direction, and at least another one restricts movement of the implantable medical device in a proximal direction (evident from Figure 8a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to used the string and lockwire system of Weng to secure the device of Rupp et al. in order to better secure both the proximal and distal ends of the device to the catheter.
Regarding claim 5, as modified in view of Weng, the adjustment string would comprise: a first adjustment string (42) having a first eyelet (421) and connected to the balloon catheter and adjacent to a distal end of the balloon catheter; and a second adjustment string (43) having a second eyelet (431) and connected to the balloon catheter and adjacent to a proximal end of the balloon catheter (evident from Figure 8a of Weng); wherein at least two rings are provided, which are provided at two opposite ends of the implantable medical device; and wherein in the locked state, the locking wire passes through the first eyelet and the second eyelet as well as at least two rings (140 and 142 of Rupp et al.) simultaneously.
Regarding claim 6, the first adjustment string and the second adjustment string are both movably connected to the balloon catheter (¶[0051]-[0066] of Weng).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Rupp et al. (WO 2020/198101) in view of Alon et al. (US 2010/0049313).
Regarding claim 10, Rupp et al. fail to disclose that the control handle for operating the implantable medical device comprises a support and a first driving assembly provided on the support, and wherein the first driving assembly comprises: a first mounting base slidably arranged on the support; and a first driving member movably arranged on the support and in transmission fit with the first mounting base; and wherein the first mounting base comprises a main body with a lumen, and ports opened in the main body and communicated with the lumen: a distal port for docking with the balloon catheter; and a driving port for injecting fluid into the balloon catheter.
Alon et al. disclose a mechanism for retracting a sheath (Figures 57A-57B) having a support (1122) and a first driving assembly provided on the support, and wherein the first driving assembly comprises: a first mounting base (1118/1102/1106/1112) slidably arranged on the support; and a first driving member (1114) movably arranged on the support and in transmission fit with the first mounting base; and wherein the first mounting base comprises a main body with a lumen (see unlabeled distal lumen of sheath), and ports (e.g. formed by 1108 and distal unlabeled side port) in the main body and communicated with the lumen: a distal port (formed by 1108 - distal of something) for docking with the balloon catheter; and a driving port (unlabeled side port) capable of injecting fluid into the balloon catheter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the mechanism of Alon et al. on the handle of Rupp et al. as a suitable prior art means for retracting the sheath of Rupp et al. usable for a similar heart valve deployment device.
Allowable Subject Matter
Claims 11-16 are 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 above objection to the drawings would also need to be overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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