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 1-9 and 11-20, Figs. 1-6 and 8A-8B in the reply filed on 05/22/2026 is acknowledged. Claims 10 and 21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and invention, there being no allowable generic or linking claim. Thus, claims 1-9 and 11-20 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Amended claim 13 is now directed to a prosthetic valve and not a delivery apparatus. Dependent claim 15 fails to further limit the prosthetic valve of claim 13 since the delivery device is not part of the prosthetic valve structure. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 15 recites the limitation "the delivery device”. There is insufficient antecedent basis for this limitation in the claim.
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, 9, 11-13, 16-18 and 20 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Levi et al. (2015/0320556) “Levi”.
Regarding claims 1 and 13, Levi discloses a prosthetic valve 10 (Fig. 2) comprising: an annular frame 12; and a valvular structure 14 mounted within the annular frame (Fig. 2), the valvular structure comprising a plurality of leaflets 40 defining a plurality of commissures 116 (Fig. 21) coupled to the annular frame (tabs 116 connect to the frame at windows 30; Fig. 29), each leaflet 40 comprising a leaflet free edge 114 that is offset in a downstream direction from the commissures 116 by side edges 114 that are not attached to the annular frame (Fig. 21 discloses the free edge 114 is offset from the tabs 116 by the notch 114 separating them; when the tab 112 is folded downwardly, the notch folds and curves adjacent the annular frame but is not attached), wherein the side edges contribute a material slack respectively at the opposite ends of the leaflet free edge that extends a radial reach of the leaflet free edge for coaptation (Fig. 30 and par. 0072 discloses the side edges 114 creates a material slack when the tab 112 is folded downwardly where the slack extends a radial reach of the edge 110 when the leaflets coapt).
Regarding claim 2, Levi discloses wherein each leaflet 40 comprises: a first primary tab and a second primary tab on sides of the leaflet (tabs 116; Fig. 21), wherein the first and second primary tabs are offset from the leaflet free edge 110 by the side edges 114 that are not attached to the annular frame (Fig. 21 discloses the free edge 114 is offset from the tabs 116 by the notch 114 separating them; when the tab 112 is folded downwardly, the notch folds and curves adjacent the annular frame but is not attached), wherein each primary tab is paired with an adjacent primary tab of an adjacent leaflet to form one of the commissures (as shown in Figs. 24 and 25).
Regarding claim 3, Levi discloses wherein each leaflet 40 further comprises a first secondary tab and a second secondary tab 112 connected respectively to the opposite ends of the leaflet free edge 110, the first and second secondary tabs folded about a fold line to position the first and secondary tabs in a cooperating relation with the first and second primary tabs 116 (par. 0072 and Fig. 30 disclose the tabs 112 fold downwardly to cooperate with tabs 116).
Regarding claim 4, Levi discloses wherein each leaflet 40 comprises a leaflet attachment edge 108 in opposing relation to the leaflet free edge110 (Fig. 21), and wherein each leaflet comprises first and second opposing side edges 120 extending axially between the leaflet attachment edge 108 and the first and second primary tabs 116 (Fig. 21).
Regarding claim 6, Levi discloses at least one skirt 18 disposed around the annular frame 12 as a sealing member (par. 041).
Regarding claim 7, Levi discloses wherein the annular frame comprises a plurality of curved struts 24/26 arranged to define a plurality of columns of cells 38 (Figs. 5 and 8 disclose the circular cells formed by curved struts).
Regarding claim 9, Levi discloses wherein the leaflets 40 are configured to move between an open state and a close state to regulate the flow of blood through the prosthetic valve 14 (Fig. 2 and par. 0042), and wherein the side edges 114 of the leaflets that are not attached to the annular frame 12 are spaced radially inwardly from the annular frame when the leaflets are in the closed state (the notch 114 is spaced radially inwardly when the tab 112 folds downwardly since the side edges of the tabs 112 and 116 attach to the frame; Figs. 29-30).
Regarding claim 11, Levi discloses wherein each leaflet 40 comprises a leaflet attachment edge 108 in opposing relation to the leaflet free edge 110, and wherein the leaflet attachment edge is connected to the frame (Fig. 2).
Regarding claim 12, Levi discloses wherein the leaflet attachment edge 108 forms a truncated V-shape 120 (par. 0065).
Regarding claim 16, Levi discloses wherein each leaflet 40comprises an upper material portion extending between the side edges that are not attached to the annular frame and protruding relative to the plurality of commissures in the downstream direction by a select height (the folded portion of the tab 112 extends between notch 114 and tabs 116; Fig. 29), the upper material portion to contribute a material slack that extends a radial reach of the free edge for coaptation (Fig. 30 and par. 0072 discloses the side edges 114 creates a material slack when the tab 112 is folded downwardly where the slack extends a radial reach of the edge 110 when the leaflets coapt).
Regarding claim 17, Levi discloses wherein each leaflet 40 comprises a first primary tab and a second primary tab 116 projecting respectively from opposite sides of the leaflet (Fig. 21) and a first secondary tab and a second secondary tab 112 connected respectively to opposite ends of the free edge 110 of the leaflet 40 (Fig. 21), and wherein the first and second primary tabs and the first and second secondary tabs of the plurality of leaflets form the plurality of commissures (as shown in Figs. 29-30).
Regarding claim 18, Levi discloses wherein the first and second secondary tabs 112 of each leaflet are folded about a fold line that is aligned with the free edge 110 of the leaflet (par. 0072 and Fig. 30).
Regarding claim 20, Levi discloses wherein the annular frame 12 has an inflow end 15, an outflow end 19, and a longitudinal axis extending from the inflow end to the outflow end and defining an axial direction (Fig. 1), wherein the plurality of commissures 116 are offset from the outflow end 19 in the axial direction (the commissures are below the outflow end edge; Fig. 30), and wherein the upper material portion of each leaflet is positioned in a portion of the annular frame between the plurality of commissures and the outflow end (the folded portion of tabs 112 is located between the commissures 116 and outflow end 19 (Figs. 30 and 32).
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.
Claims 5 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Levi et al. (2015/0320556) “Levi”.
Levi discloses the claimed invention of claims 1, 13 and 16; except for a height of the side edges that are not attached to the annular frame is in a range from 0.5 mm to 5 mm. However, Levi does disclose a certain select height of the side edges 114 (Fig. 21). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify a height of the side edges that are not attached to the annular frame is in a range from 0.5 mm to 5 mm, since these are result effective variables that contribute to the flexibility and slack of the folded tabs 112, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. MPEP 2144.05.
Claims 8 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Levi et al. (2015/0320556) “Levi” in view of Cohen et al. (2019/0060057) “Cohen”.
Levi discloses the claimed invention of claims 1 and 13; except for wherein the annular frame further comprises at least one actuator portion coupled to at least a portion of the curved struts and operable to deflect the at least a portion of the curved struts to radially expand or radially compress the annular frame; and, as best understood, wherein the delivery device further comprises an elongated shaft extending distally from the handle and at least one actuator assembly extending distally through the elongated shaft, and wherein the at least one actuator assembly is releasably engaged with the at least one actuator portion.
However, Cohen teaches a similar prosthetic valve 100 (Fig. 1) comprising an annular frame 102 further comprises at least one actuator portion 130 coupled to at least a portion of struts 108 (Fig. 2) and operable to deflect the at least a portion of the struts to radially expand or radially compress the annular frame (par. 0043); and, as best understood, wherein a delivery device 200 (Fig. 4) further comprises an elongated shaft 224 extending distally from the handle 210 and at least one actuator assembly 240 extending distally through the elongated shaft (Fig. 5), and wherein the at least one actuator assembly 240 is releasably engaged with the at least one actuator portion 130 (Fig. 11 and par. 0072). 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 prosthetic valve in Levi to include the annular frame further comprises at least one actuator portion coupled to at least a portion of the curved struts and operable to deflect the at least a portion of the curved struts to radially expand or radially compress the annular frame; and, as best understood, wherein the delivery device further comprises an elongated shaft extending distally from the handle and at least one actuator assembly extending distally through the elongated shaft, and wherein the at least one actuator assembly is releasably engaged with the at least one actuator portion, as taught and suggested by Cohen, for allowing percutaneous introduction of the prosthetic valve and providing enhanced mechanical expansion of the valve at the appropriate implantation site (par. 0003).
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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