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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-20, Figs. 2-7 in the reply filed on 05/01/2026 is acknowledged. Thus, claims 1-20 are presently pending in this application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “54” has been used to designate both “first portion” and “middle catheter” in Fig. 2 instead of “middle catheter” 56. 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. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6-7 and 11-12 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Fischer et al. (2008/0188880) “Fischer”.
Regarding claim 1, Fischer discloses a valve preparation device (abstract and Fig. 3) configured to sever at least one leaflet of a prosthetic heart valve (abstract) comprising: a first capsule 32 comprising a first opening at a proximal end of the first capsule (opening that receives body member 11; Fig. 3); a second capsule 33 comprising a second opening at a distal end of the second capsule (the opening that receives body member 12; Fig. 3); a severing device (cutting rings 13/14; Fig. 3) configured to be compressed into a delivery configuration (Fig. 4-5), wherein a first portion 13 of the severing device is compressively retained in a contracted orientation within the first capsule 32 and a second portion of the severing device 14 is compressively retained in a contracted orientation within the second capsule 33 (Figs. 4-5 and par. 0039), wherein a proximal end of the first portion of the severing device is configured to extend outside of the first opening of the first capsule to self-expand to a first expanded orientation outside of the first capsule (par. 0024 and Figs. 4-5), and wherein a distal end of the second portion of the severing device is configured to extend outside of the second opening of the second capsule to self-expand to a second expanded orientation outside of the second capsule (par. 0024 and Fig. 4-5).
Regarding claim 2, Fischer discloses wherein the first portion 11 and the second portion 12 are configured to be moved together while the proximal end is in the first expanded orientation and the distal end is in the second expanded orientation to sever at least one leaflet of a prosthetic heart valve (pars. 0010 and 0036).
Regarding claim 3, Fischer discloses wherein the proximal end of the first capsule 32 comprises a first circumferential edge circumscribing the first opening of the first capsule in the first expanded orientation, the distal end of the second capsule 33 comprises a second circumferential edge circumscribing the second opening of the second capsule in the second expanded orientation (as shown in Fig. 2).
Regarding claim 4, Fischer discloses wherein the severing device comprises a punch-and-die configuration comprising the proximal end of the first portion and the distal end of the second portion (Fig. 1 and par. 0036 disclose the severing device 11/12 uses a punching process).
Regarding claims 6-7, Fischer discloses the first portion and the second portion comprise a shape-memory material and wherein the shape-memory material comprises nitinol (par. 0015).
Regarding claim 11, Fischer discloses a shaft 10 attached to the second capsule 33 and configured to move the second capsule (Fig. 13 and par. 0033).
Regarding claim 12, Fischer discloses at least one wire 15 connected to the first capsule 32 and configured to move the first capsule (wire 15 is attached to moving block 27 which if fully capable of moving the capsule 32 over the first portion 11; Fig. 2 and par. 0037).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Fischer et al. (2008/0188880) “Fischer” in view of Gabbay (2018/0098783).
Fischer discloses the claimed invention of claim 1; except for wherein one of the proximal end of the first portion and the distal end of the second portion comprises a circumferential knife edge and the other of the proximal end of the first portion and the distal end of the second portion comprises a circumferential groove configured to receive the circumferential knife edge to sever at least one leaflet of a prosthetic heart valve.
However, Gabbay teaches a similar valve preparation device (Fig. 9 and abstract) comprising one of the proximal end of the first portion 711 and the distal end of the second portion comprises a circumferential knife edge 711a (Fig. 10B) and the other of the proximal end of the first portion and the distal end of the second portion comprises a circumferential groove 713a configured to receive the circumferential knife edge to sever at least one leaflet of a prosthetic heart valve (female element 713 and a receiving edge 713a which receives spokes 711b; par. 0090 and Fig. 13). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the severing device in Fischer to include one of the proximal end of the first portion and the distal end of the second portion comprises a circumferential knife edge and the other of the proximal end of the first portion and the distal end of the second portion comprises a circumferential groove configured to receive the circumferential knife edge to sever at least one leaflet of a prosthetic heart valve, as taught and suggested by Gabbay, for providing a precision cutting method.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer et al. (2008/0188880) “Fischer” in view of Seguin (6830584).
Fischer discloses the claimed invention of claim 1; except for further comprising a first catheter attached to the first portion of the severing device and configured to move the first portion of the severing device; further comprising a second catheter attached to the second portion of the severing device and configured to move the second portion of the severing device; and wherein the second catheter is positioned over and coaxially aligned with the first catheter.
However, Seguin teaches a similar valve preparation device (Fig. 1 and abstract) comprising a first catheter 7 attached to the first portion 12 of a severing device 30 and configured to move the first portion of the severing device (col. 6, lin. 22-24 disclose moving portions 11 and 12); further comprising a second catheter 6 attached to the second portion of the severing device 12 and configured to move the second portion of the severing device (col. 6, lin. 22-24 disclose the catheter 6 slides with respect to catheter 7); and wherein the second catheter is positioned over and coaxially aligned with the first catheter (Fig. 1 and col. 6, lin. 22-24). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft 10 in Fischer to include a first catheter attached to the first portion of the severing device and configured to move the first portion of the severing device; further comprising a second catheter attached to the second portion of the severing device and configured to move the second portion of the severing device; and wherein the second catheter is positioned over and coaxially aligned with the first catheter, as taught and suggested by Seguin, for providing precise control over the valve cutting by sliding the device at the appropriate location (col. 2, lin. 36-61).
Allowable Subject Matter
Claims 13-20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter is allowable due to the limitations of “wherein the at least one wire is configured to be distally advanced to distally move the first capsule relative to the first portion to extend a proximal end of the first portion of the severing device outside of the first opening of the first capsule to self-expand to a first expanded orientation outside of the first capsule”, as set forth in claim 13. The combination of the wire, first catheter, second catheter and the shaft being connected to the severing device and the first/second capsule has not been found anticipated by or obvious over prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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