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
Status of Claims
This office action is responsive to the amendment filed on 08/18/2026. As directed by the amendment: claims 43-49, 59 and 75-77 are presently pending in this application.
Response to Arguments
Applicant's arguments with respect to the rejection of claims 49 and 59 have been fully considered but are not persuasive. Wheatley (2021/0126688) disclose the newly amended limitations a first end of each of said first and second articulating members is connected to said first axial longitudinal member of each of said frame cells in said distal row; a first end of each of said first and second articulating members is connected to said first axial longitudinal member of each of said frame cells in said proximal row, said first axial longitudinal member in each frame cell of said distal and proximal rows is positioned parallel to a central axis of said expandable metal frame (Fig. 3 discloses the first ends of the zig-zag struts in distal and proximal rows are connected to the longitudinal/vertical bars which are parallel to the longitudinal/central axis of the frame).
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 49 is rejected under 35 U.S.C. 103 as being unpatentable over Wheatley (2021/0126688) in view of Bressloff et al. (2019/0224008) “Bressloff” further in view of Kim et al. (20100016951) “Kim”.
Wheatley discloses a method for repairing a valve 10 (abstract and Fig. 3) comprising: a. providing an expandable prosthetic valve 10; said expandable prosthetic valve includes an expandable frame 22 that is configured to expand from an unexpanded orientation to an expanded orientation (par. 0088) and has distal and proximal ends (top and bottom ends of frame 22; Fig. 3); and a leaflet structure 34 that is supported by said expandable metal frame; said expandable frame has an open cell configuration comprises: a distal row of frame cells and a proximal row of frame cells; each of said distal and proximal rows includes a plurality of frame cells; each of said distal and proximal rows includes a same number of frame cells; a lower end of said distal row terminates at said distal end of said expandable metal frame; an upper end of said proximal row terminates at said proximal end of said expandable metal frame; said proximal row of frame cells is positioned above said distal row of frame cells along a longitudinal axis of said expandable metal frame (as shown in Fig. 3, the cells formed by zig-zag struts in stacked rows from distal/top to proximal/bottom end);
each of said frame cells in said distal and proximal rows includes a first axial longitudinal member (vertical bar separating adjacent cells formed by the struts; Fig. 3) and first and second articulating members (struts forming the cells; Fig. 3); an end of each of said first and second articulating members is connected to said first axial longitudinal member (the ends of the struts are connected to the vertical bar; Fig. 3); said first axial longitudinal member is positioned parallel to a central axis of said expandable metal frame when said expandable metal frame is in said unexpanded orientation (the vertical bar is parallel to the central longitudinal axis of the stent 22; Fig. 3); positioning said expandable prosthetic valve in a treatment area; a first end of each of said first and second articulating members is connected to said first axial longitudinal member of each of said frame cells in said distal row; a first end of each of said first and second articulating members is connected to said first axial longitudinal member of each of said frame cells in said proximal row, said first axial longitudinal member in each frame cell of said distal and proximal rows is positioned parallel to a central axis of said expandable metal frame (Fig. 3 discloses the first ends of the zig-zag struts in distal and proximal rows are connected to the longitudinal/vertical bars which are parallel to the longitudinal/central axis of the frame); and expanding said expandable metal frame expandable prosthetic valve in said treatment area (abstract and Figs. 9A-9C).
Wheatley is silent regarding said expandable metal frame has longitudinal foreshortening along a longitudinal axis of said expandable metal frame of no more than 5% when said expandable metal frame is expand from said unexpanded orientation to said expanded orientation; wherein expansion of said expandable metal frame results in no more than 5% longitudinal foreshortening when said expandable metal frame is expanded from said unexpanded orientation to said expanded orientation; a middle region of each of said first and second articulating members in each frame cell in said proximal row is positioned below an upper end of said first axial longitudinal member when said expandable metal frame is in said unexpanded orientation; a middle region of each of said first and second articulating members in each frame cell of said distal row is positioned above an lower end of said first axial longitudinal member when said expandable metal frame is in said unexpanded orientation.
However, Bressloff teaches a similar metal frame (Fig. 2A) comprising longitudinal foreshortening along a longitudinal axis of said expandable metal frame of no more than 5% when said expandable metal frame is expand from said unexpanded orientation to said expanded orientation; wherein expansion of said expandable metal frame results in no more than 5% longitudinal foreshortening when said expandable metal frame is expanded from said unexpanded orientation to said expanded orientation (par. 0057).
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 metal frame in Wheatley to include longitudinal foreshortening along a longitudinal axis of said expandable metal frame of no more than 5% when said expandable metal frame is expand from said unexpanded orientation to said expanded orientation; wherein expansion of said expandable metal frame results in no more than 5% longitudinal foreshortening when said expandable metal frame is expanded from said unexpanded orientation to said expanded orientation, as taught and suggested by Bressloff, for better alignment of the frame with the native tissue (par. 0119).
Furthermore, Kim teaches a similar metal frame comprising a middle region of each of said first and second articulating members in each frame cell in said proximal row is positioned below an upper end of said first axial longitudinal member when said expandable metal frame is in said unexpanded orientation; a middle region of each of said first and second articulating members in each frame cell of said distal row is positioned above an lower end of said first axial longitudinal member when said expandable metal frame is in said unexpanded orientation (Fig. 4 discloses the middle region of articulating members 4 is within the ends of the longitudinal member 14 at distal and proximal row ends). 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 frame in Wheatley in view of Bressloff to include a middle region of each of said first and second articulating members in each frame cell in said proximal row is positioned below an upper end of said first axial longitudinal member when said expandable metal frame is in said unexpanded orientation; a middle region of each of said first and second articulating members in each frame cell of said distal row is positioned above an lower end of said first axial longitudinal member when said expandable metal frame is in said unexpanded orientation, as taught and suggested by Kim for ease of insertion in the bodily lumen minimizing stent deformation (par. 0023).
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Wheatley (2021/0126688) in view of Bressloff et al. (2019/0224008) “Bressloff” further in view of Kim et al. (20100016951) “Kim” further in view of Patel et al. (2016/0237541) “Patel” .
Wheatley in view of Bressloff and Kim disclose the claimed inventions of claim 49; except for wherein said expandable frame is at least partially formed of a metal alloy that includes at least 0.1 wt.% rhenium. However, Patel teaches a similar expandable frame comprising at least partially formed of a metal alloy that includes at least 0.1 wt.% rhenium (par. 0013). 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 frame in Wheatley in view of Bressloff and Kim to include frame is at least partially formed of a metal alloy that includes at least 0.1 wt.% rhenium, as taught and suggested by Patel, for providing a frame having materials with sufficient yield and tensile strength (par. 0004).
Allowable Subject Matter
Claims 43-48 and 75-77 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 “a combined weight percentage of rhenium and said one or more alloy agents is at least 98 wt.%; said expandable metal frame has one or more of the following properties selected from the group consisting of [[i]] I) said expandable metal frame is formed of a material that has a recoil of less than 10% thus resulting in reduced recoil of said expandable metal frame when expanded from said crimped orientation to said expanded orientation, [[ii]] II) at least 70-100% of said expandable metal frame is formed of a metal alloy that has a yield strength of at least 110 ksi, [[iii]] III) at least 70-100% of said expandable metal frame is formed of a metal alloy that has a modulus of elasticity of at least 35000 ksi, [[iv]] IV) an outer surface of said expandable metal frame includes an enhancement layer that includes [[a]] A) at least 60 wt.% carbon, [[b]] B) at least 40 wt.% chromium and one or more of nitrogen, carbon and oxygen, [[c]] C) at least 20 wt.% titanium and one or more of nitrogen, oxygen, and carbon, or [[d]] D) at least 35 wt.% zirconium and one or more of nitrogen, oxygen and carbon; b. positioning said expandable prosthetic valve in a treatment area; and c. expanding said expandable metal frame expandable prosthetic valve in said treatment area; and wherein expansion of said expandable metal frame results in no more than 5% longitudinal foreshortening when said expandable metal frame is expand from said unexpanded orientation to an expanded orientation” as set forth in claim 43 and “wherein a combined weight percentage of rhenium and said one or more alloy agents is at least 98 wt.%; an outer surface of said expandable metal frame includes an enhancement layer that includes a) at least 60 wt.% carbon, b) at least 40 wt.% chromium and one or more of nitrogen, carbon and oxygen, c) at least 20 wt.% titanium and one or more of nitrogen, oxygen, and carbon, or d) at least 35 wt.% zirconium and one or more of nitrogen, oxygen and carbon; b. positioning said expandable prosthetic valve in said treatment area; and c. expanding said expandable metal frame expandable prosthetic valve in said treatment area; and wherein expansion of said expandable metal frame results in no more than 5% longitudinal foreshortening when said expandable metal frame is expanded from said unexpanded orientation to said expanded orientation” as set forth in claim 75, which has not been found anticipated by or obvious over prior art. The closest prior art of record of Wheatley (2021/0126688), Bressloff et al. (2019/0224008) “Bressloff”, Kim et al. (20100016951) “Kim” and Patel et al. (2016/0237541) “Patel” fail to disclose these limitations.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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. 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
