DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application repeats a substantial portion of prior Application No. 18/505324, filed 9 November 2023, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Information Disclosure Statement
The information disclosure statements filed 8 January 2026 fail to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
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 “inner perimeter” and “outer perimeter” of claim 42, the “vertical slots” of claim 48 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 § 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.
Claims 42-43, 46-47, 49, and 52-63 are rejected under 35 U.S.C. 103 as being unpatentable over Reed Miller, Start-Up Spotlight: 4C Addresses Mitral Regurgitation with Unique 'Dome' Device, https://medtech.citeline.com/MT105076/StartUp-Spodfght-4C- Addresses-Mitral-Regurgitation-With-Unique-Dome-Device Published by Citeline on June 29, 2017., “Miller” in view of Wen (CN 100584292 C), “Wen”.
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Modified Figure 1
Regarding claim 42, Miller teaches a collapsible and expandable prosthetic mitral valve implant (flexible self-expanding metal stent (pg. 2, par. 1)) comprising: an outer section (Modified Fig. 1, outer section) defines a convex top that is configured to promote apposition of the implant to a left atrium (outer section is ball-shaped and dimensioned to maximize atrial apposition and the stent sits entirely in the heart’s left atrium (pg. 2, par. 1)); an inner valve support section (Modified Fig. 1, inner support) that: extends in the outer section toward the convex top (Modified Fig. 1, inner support extends along outer section from bottom to top of stent); is part of a continuous structure that includes the outer section (Modified Fig. 1, inner support is within outer section); and supports prosthetic valve leaflets (stent frame sits around a bovine pericardial tissue valve (pg. 2, par. 1)); a transition section that: has an inner perimeter and an outer perimeter that are configured to converge with each other when the implant is compressed (Modified Fig. 1, radial region between inner and outer perimeters is subject to compression); and includes struts (Modified Fig. 1, struts), but fails to teach struts that are, during operation of the implant, disposed sub-annular with respect to an annulus of a native mitral valve; and a boss section that is configured to extend away from the outer section in a downstream direction.
Wen teaches an artificial heart bracket comprising struts that are, during operation of the implant, disposed sub-annular with respect to an annulus of a native mitral valve (Fig. 3, the upstream space 18 and aortic annulus are matched (i.e., mesh bracket 10 is external to annulus)); and a boss section that is configured to extend away from the outer section in a downstream direction (Fig. 3, deformable unit 101 comprising trumpet 182 extended below sealing ring 37). Wen discloses that the stent positioning increases the strength and service life of the synthetic valve. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Miller with the strut positioning and boss section taught by Wen in order to prolong the life of the implant and increase its functioning strength.
Regarding claim 43, Miller teaches wherein the boss section is integrated with the transition section (Fig. 3, deformable unit 101 comprising trumpet 182 extended below sealing ring 37).
Regarding claim 46, Miller teaches wherein the convex top is configured to prevent migration of the implant relative to a left atrium of a heart (Modified Fig. 1, outer section that is ball-shaped maximizes atrial apposition while the radial force from the implant maintains positioning (pg. 2, par. 1)).
Regarding claim 47, Miller teaches wherein the outer section has a round shape (Modified Fig. 1, outer section comprises ball shape).
Regarding claim 49, Miller teaches wherein the struts extend non-radially between the outer section and the inner valve support section (Modified Fig. 1, struts curve over and between outer section and inner perimeter of inner support rather than connecting radially in between).
Regarding claim 52, Miller teaches wherein the transition section is configured to mitigate against paravalvular leakage (Modified Fig. 1, radial region between inner and outer perimeters maximizes apposition to the tissue and minimizes the risk of stasis and supports the systolic “flush” cycle (pg. 2, par. 1)).
Regarding claim 53, Miller teaches wherein the transition section includes cells that are configured to be compressed when the implant is compressed (Modified Fig. 1, radial region between inner and outer perimeters of outer section comprises struts that expand and contract).
Regarding claim 54, Miller teaches wherein the transition section includes cells that define a bottom of the implant (Modified Fig. 1, struts which define cells extend around the top and bottom of the implant).
Regarding claim 55, Miller teaches wherein the bottom defines a flat surface (Modified Fig. 1, bottom of implant sits flat).
Regarding claim 56, Miller fails to teach the limitations of claim 56. Wen teaches an artificial heart bracket wherein the boss section is configured to be seated in native commissures of a native mitral valve (Fig. 3, deformable unit 101 comprising trumpet 182 extended below sealing ring 37 is positioned within mitral valve). Wen discloses that the upstream length of the device is changeable to avoid any obstruction of the mitral valve. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the implant taught by Miller with the boss section taught by Wen in order to provide an implant that does not obstruct the mitral valve.
Regarding claim 57, Miller teaches the outer section (Modified Fig. 1, outer section), but fails to teach the boss section. Wen teaches an artificial heart bracket wherein the boss section is configured to maintain alignment with native leaflets (Fig. 3, sealing ring 37 is compressed to adapt to fill the gap between the stent and the vessel wall (i.e., seal the valve in proper position)). Wen discloses that the sealing ring is sewn to the bracket of the device to form a seamless integration of the two. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the outer section taught by Miller with the boss section taught by Wen in order to strengthen the device against the valve forces.
Regarding claim 58, Miller teaches wherein the outer section is configured to be seated at the annulus (device sits in the atrium rather than within the valve annulus (pg. 1, par. 2)).
Regarding claim 59, Miller fails to teach the limitations of claim 59. Wen teaches an artificial heart bracket wherein the boss section is configured to extend into an annular throat (Fig. 3, upstream space comprising sealing ring 37 and trumpet 182 matches with annulus). Wen discloses that the sealing ring is sewn to the bracket of the device to form a seamless integration of the two. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the outer section taught by Miller with the boss section taught by Wen in order to strengthen the device against the valve forces.
Regarding claim 60, Miller fails to teach the limitations of claim 60. Wen teaches an artificial heart bracket wherein the boss section is configured to expand against an inner portion of the annular throat (Fig. 3, upstream space comprising sealing ring 37 and trumpet 182 matches with annulus in an expanded state). Wen discloses that the sealing ring is sewn to the bracket of the device to form a seamless integration of the two. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the outer section taught by Miller with the boss section taught by Wen in order to strengthen the device against the valve forces.
Regarding claim 61, Miller fails to teach the limitations of claim 61. Wen teaches an artificial heart bracket wherein the boss section is configured to mitigate against paravalvular leakage (Fig. 3, sealing ring 37 prevents leakage). Wen discloses that the sealing ring is sewn to the bracket of the device to form a seamless integration of the two. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the outer section taught by Miller with the boss section taught by Wen in order to strengthen the device against the valve forces.
Regarding claim 62, Miller teaches the transition section (Modified Fig. 1, radial region between inner and outer perimeters is subject to compression) but fails to teach wherein the transition section is at a bottom of the boss section. Wen teaches an artificial heart bracket wherein the transition section is at a bottom of the boss section (Fig. 3, sealing ring 37 and trumpet 182 connect with radial projecting structure 153 of middle section 15). Wen discloses that the sealing ring is sewn to the bracket of the device to form a seamless integration of the two. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the transition section taught by Miller with the boss section taught by Wen in order to strengthen the device against the valve forces.
Regarding claim 63, Miller teaches the transition section (Modified Fig. 1, radial region between inner and outer perimeters is subject to compression) but fails to teach wherein the transition section is at a bottom of the boss section. Wen teaches an artificial heart bracket wherein the transition section is at a bottom of the boss section (Fig. 3, sealing ring 37 and trumpet 182 connect with radial projecting structure 153 of middle section 15). Wen discloses that the sealing ring is sewn to the bracket of the device to form a seamless integration of the two. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the transition section taught by Miller with the boss section taught by Wen in order to strengthen the device against the valve forces.
Claims 44-45, 48, and 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over Reed Miller, Start-Up Spotlight: 4C Addresses Mitral Regurgitation with Unique 'Dome' Device, https://medtech.citeline.com/MT105076/StartUp-Spodfght-4C- Addresses-Mitral-Regurgitation-With-Unique-Dome-Device Published by Citeline on June 29, 2017., “Miller” in view of Wen (CN 100584292 C), “Wen”, and further in view of Levi et al. (US 2016/0374802 A1), “Levi”.
Regarding claim 44, Miller teaches wherein: the outer section includes first stent cells having a first size; (Modified Fig. 1, struts form cells) and the inner valve support section (Modified Fig. 1, inner support), but fails to teach second stent cells having a second size; and the second size is smaller than the first size.
Levi teaches an expandable and collapsible heart valve comprising struts and frame portions having second stent cells having a second size (Fig. 5, the second, third, and fourth row of struts 24, 26, 28 form intermediate rows of cells having openings 38); and the second size is smaller than the first size (Fig. 5, openings 38 are smaller than openings 40 of the upper row of cells). Levi discloses that the cells are formed in order to minimize the crimping profile of the leaflet structure [0057]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Miller with the varying cell sizes taught by Levi in order to minimize the leaflet structure profile of the device.
Regarding claim 45, Miller teaches the transition section (Modified Fig. 1, radial region between inner and outer perimeters is subject to compression) but fails to teach third cells having a third size; and the third size is: larger than the second size; and smaller than the first size.
Levi teaches an expandable and collapsible heart valve comprising struts and frame portions having third cells having a third size (Fig. 5, lower row of cells defines openings 36); and the third size is: larger than the second size; and smaller than the first size (Fig. 5, openings 36 are larger than openings 38 and smaller than openings 40). Levi discloses that the cells are formed in order to minimize the crimping profile of the leaflet structure [0057]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the transition section taught by Miller with the cell sizes taught by Levi in order to minimize the leaflet structure profile of the device.
Regarding claim 48, Miller teaches wherein the inner valve support section: supports prosthetic valve leaflets (Modified Fig. 1, stent frame sits around inner support which comprises a bovine pericardial tissue valve (pg. 2, par. 1)), but fails to teach vertical slots that are configured to receive extensions of the prosthetic valve leaflets.
Levi teaches an expandable and collapsible heart valve comprising vertical slots that are configured to receive extensions of the prosthetic valve leaflets (Fig. 5, commissure windows 20 adapted to mount commissures of the valvular structure 14 to the frame [0053]). Levi discloses that the commissure windows comprise a frame portion for mounting the leaflet structure which encompasses a configuration to enhance fatigue resistance under cyclic loading of the valve [0056]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the inner valve support section and leaflets taught by Miller with the vertical slots taught by Levi in order to prolong the life of the implant.
Regarding claim 50, Miller teaches the implant (flexible self-expanding metal stent (pg. 2, par. 1)) but fails to teach nesting of the struts. Levi teaches an expandable and collapsible heart valve wherein, when the implant is compressed, the struts are configured to nest with each other (Fig. 48, when the valve is radially compressed the spacing between struts is relatively small and prevents the leaflet structure from protruding from the frame [0090]). Levi discloses that the valve is radially collapsed for mounting and delivering into the body [0086]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the struts and implant taught by Miller with the nesting abilities taught by Levi in order to more easily deliver the device into the body.
Regarding claim 51, Miller teaches the struts (Modified Fig. 1, struts) and inner valve support section (Modified Fig. 1, inner support), but fails to teach wherein the struts are configured to rotate in response to compression of the implant.
Levi teaches an expandable and collapsible heart valve wherein the struts are configured to rotate in response to compression of the implant (Fig. 18, angled struts rotate toward the axial direction to align with the length of the frame when in delivery (i.e., compressed) configuration [0071]). Levi discloses that the valve is radially collapsed for mounting and delivering into the body [0086]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the struts and implant taught by Miller with the nesting abilities taught by Levi in order to more easily deliver the device into the body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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/G.G.R./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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