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 .
Election/Restrictions
Applicant’s election without traverse of group II (claims 13-20) in the reply filed on 01/27/2026 is acknowledged.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 13-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maimon-247 (US 2016/0228247 A1).
Regarding claim 13, Maimon-247 teaches a delivery system for delivering and positioning a valve prosthesis within a diseased native valve (10, delivery apparatus, fig. 4A), the delivery system comprising:
a valve delivery catheter (18, shaft portion, fig. 4A);
a tether channel extending within or alongside the valve delivery catheter (22, lumen, fig. 4A), wherein the tether channel is configured to receive a tether that is attached to a spiral anchor (fig. 4F, The phrase “the tether channel is configured to receive a tether that is attached to a spiral anchor” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the guide catheter 16 is considered to be capable of receiving a tether that is attached to a spiral anchor. In addition, the examiner notes the claim is only limited to a tether channel and has not positively recited the tether or the spiral anchor as limitations of the claim (see MPEP 2115).); and
a positioning tool configured to extend through the tether channel and over the tether (16, guide catheter, fig. 4F), wherein the positioning tool comprises a first configuration (fig. 4A)and a second configuration (fig. 4B), wherein a stiffness of the positioning tool in the second configuration is greater than a stiffness of the positioning tool in the first configuration *¶ [0103-0104]).
Regarding claim 14, Maimon-247 further teaches the positioning tool in the second configuration comprises a fixed bend (the bend is fixed in the direction it bends due to the pattern of slots cut into the tube).
Regarding claim 15, Maimon-247 further teaches the positioning tool comprises a plurality of cutouts in a distal portion thereof (116, slots, fig. 9C), wherein the cutouts enable flexing of the positioning tool in the first configuration (¶ [0102]), and wherein the cutouts are fixed relative to one another in the second configuration (fig. 9C).
Regarding claim 16, a tether has only been recited as a part of functional language and is not a limitation of the delivery system. The prior art is not required to explicitly disclose the recited function but merely have the capability of performing [or being manipulate to] the recited function in order to meet the claim requirement. In this case, the tether channel 22 of Maimon-247 is capable of receiving a tether with a distal engagement element
Regarding claim 17, a tether has only been recited as a part of functional language and is not a limitation of the delivery system. The prior art is not required to explicitly disclose the recited function but merely have the capability of performing [or being manipulate to] the recited function in order to meet the claim requirement. In this case, the tether channel 22 of Maimon-247 is capable of receiving a tether with a beveled distal engagement element.
Regarding claim 18, Maimon-247 further teaches a proximal control comprising an actuator configured to control tension on the tether so as to compress the positioning tool (¶ [0055]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maimon-247 in view of Maimon-689 (US 2018/0153689 A1).
Regarding claim 19, Maimon-247 fails to teach the actuator comprises a knob. However, Maimon-689 discloses a valve delivery device that teaches a knob (148, threaded actuator nut, fig. 13) configured to enable sliding of a tether clamp relative to the positioning tool. The phrase “a knob configured to enable sliding of a tether clamp relative to the positioning tool ” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the threaded actuator nut is considered to be capable of enabling sliding of a tether relative to the positioning tool. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the actuator of Maimon-247 to include a knob as taught by Maimon-689 in order to translate the tether proximally or distally (Maimon-689, ¶ [0144]).
Regarding claim 20, Maimon-247 further teaches a proximal control configured to orient the positioning tool with respect to the tether (¶ [0055]).
Maimon-247 fails to teach the proximal control comprises a rotation mechanism. However, Maimon-689 further teaches a rotation mechanism (148, threaded actuator nut, fig. 13, ¶ [0143-0144]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the proximal control of Maimon-247 to include a rotation mechanism as taught by Maimon-689 in order to translate the tether proximally or distally (Maimon-689, ¶ [0144]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (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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/T.M.D./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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