DETAILED ACTION
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
Claims 10-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/18/2026.
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.
Claim(s) 1-3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Panus (US 2018/0140411).
Regarding claim 1, Panus discloses a packaging assembly for storing a prosthetic heart valve (FIG 3, 4, and 9, [0034] discloses that use of 700 is optional. [0047] discloses “a prosthetic valve is loaded into jar 400 with or without any additional support devices such as a valve holder, valve collar 700”), the packaging assembly comprising: a valve tray (400) comprising an annular rim (Top of the jar around the region of threads 410, FIG 6) and a cavity extending away from the annular rim (Hollow interior space of the jar, FIG 6), wherein the cavity is configured to accept the prosthetic heart valve ([0030] “Jar 400 may be dimensioned for storing prosthetic valve 10, which is preferably but not necessarily assembled to valve holder 200”); a lid (600, FIG 3) configured to cover the annular rim (FIG 4); and a leaflet biasing element (800) disposed on a central portion of the lid (FIG 11), wherein: the leaflet biasing element comprises an extrusion (830 and 820, [0038]), the leaflet biasing element extends from a lower surface of the lid towards the valve tray (FIG 11), and the leaflet biasing element is configured to extend at least partially into an inflow end portion of the prosthetic heart valve (Due to the projecting shape of the leaf biasing element, as seen in FIG 11, the piece is at least configured to extend downward and at least partly into an inflow end portion of a prosthetic heart valve. Examiner notes the prosthetic heart valve is not a positively recited element of the claim and therefore the prior art does not need to explicitly show the leaf biasing element extending into the inflow end. However, since FIG 11 shows a valve is to be positioned into the cavity of the valve tray, and the uses of a valve holder and valve collar is optional, the device is at least configured such that 820 can extend directly into an interior lumen of a prosthetic valve) and secure a plurality of leaflets of the prosthetic heart valve in a desired configuration when the prosthetic heart valve is inserted in the cavity and the lid is closed over the annular rim (The prosthetic heart valve is interpreted as being secured in a desired position because the lid closes the opening of the cavity and therefore secures the valve within the packaging).
Panus shows a truncated cone shape of the extrusion of the leaflet biasing element, FIG 3 and 9, and therefore is silent regarding a paraboloid shape.
However, it would have been an obvious matter of design choice to modify the extension to have a paraboloid shape, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976). The modification would also be obvious since applicant has not disclosed that having the extension having a paraboloid shape provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with either designs. Paragraph [0102] of the specification of the present invention discloses” The leaflet biasing element can have a substantially paraboloid shape. However, the leaflet biasing element can have any other suitable shape, including a cylinder, a cone, a truncated cone, a dome, or a cuboid”, and does not provide criticality of one shape over the other.
Regarding claims 2-3, Panus discloses the invention substantially as claimed, as set forth above for claim 1. Panus further discloses the leaflet biasing element is configured to secure the plurality of leaflets of the prosthetic heart valve in an open configuration and wherein the leaflet biasing element is configured to extend at least partially through a central flow orifice of the prosthetic heart valve to contact the plurality of leaflets (The leaflet biasing element provides a projection into the cavity of the valve tray which is at least configured to be received in the valve in a manner which would secure them in an open configuration. Examiner notes the heart valve is not positively recited and therefore the prior art need not demonstrate explicitly the leaflet biasing element contacting the plurality of leaflets. However, the leaflet biasing element is at least sized and shaped such that it would be configured to be received in such a manner).
Regarding claim 7, Panus discloses the invention substantially as claimed, as set forth above for claim 1. Panus further discloses the packaging assembly further comprises a plurality of spacers circumferentially disposed on an inner lateral surface of the cavity (420, FIG 4-6).
Claim(s) 1-6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Liburd et al. (US 2020/0179093).
Regarding claim 1, Liburd et al. discloses a packaging assembly for storing a prosthetic heart valve (FIG 8), the packaging assembly comprising: a valve tray (92) comprising an annular rim (96) and a cavity extending away from the annular rim (90, [0056]), wherein the cavity is configured to accept the prosthetic heart valve (Such as valve 20, which FIGS 7-8 show is received within the cavity); a lid (62 and 50, FIG 4-5, [0053-0056]) configured to cover the annular rim (FIG 8); and a leaflet biasing element (22, FIG 1) disposed on a central portion of the lid (FIG 3-5), wherein: the leaflet biasing element comprises an extrusion (46, [0051]), the leaflet biasing element extends from a lower surface of the lid towards the valve tray (FIG 3-5 and 7-8), and the leaflet biasing element is configured to extend at least partially into an inflow end portion of the prosthetic heart valve (Due to the projecting shape of the leaf biasing element, as seen in FIG 1, the piece is at least configured to extend downward and at least partly into an inflow end portion of a prosthetic heart valve. Examiner notes the prosthetic heart valve is not a positively recited element of the claim and therefore the prior art does not need to explicitly show the leaf biasing element extending into the inflow end. Although shown extending along an exterior of the leaflets in FIG 2, the projections are at least configured to have been inserted into an inflow end portion of the prosthetic valve) and secure a plurality of leaflets of the prosthetic heart valve in a desired configuration when the prosthetic heart valve is inserted in the cavity and the lid is closed over the annular rim (The prosthetic heart valve is interpreted as being secured in a desired position in FIG 8 because the lid closes the opening of the cavity and therefore secures the valve within the packaging).
Liburd shows a truncated cone shape of the extrusion of the leaflet biasing element, FIG 1, and therefore is silent regarding a paraboloid shape.
However, it would have been an obvious matter of design choice to modify the extension to have a paraboloid shape, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976). The modification would also be obvious since applicant has not disclosed that having the extension having a paraboloid shape provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with either designs. Paragraph [0102] of the specification of the present invention discloses” The leaflet biasing element can have a substantially paraboloid shape. However, the leaflet biasing element can have any other suitable shape, including a cylinder, a cone, a truncated cone, a dome, or a cuboid”, and does not provide criticality of one shape over the other.
Regarding claims 2-3, Liburd discloses the invention substantially as claimed, as set forth above for claim 1. Liburd further discloses the leaflet biasing element is configured to secure the plurality of leaflets of the prosthetic heart valve in an open configuration and wherein the leaflet biasing element is configured to extend at least partially through a central flow orifice of the prosthetic heart valve to contact the plurality of leaflets (The leaflet biasing element provides a projection into the cavity of the valve tray which is at least configured to be received in the valve in a manner which would secure them in an open configuration. Examiner notes the heart valve is not positively recited and therefore the prior art need not demonstrate explicitly the leaflet biasing element contacting the plurality of leaflets. However, the leaflet biasing element is at least sized and shaped such that it would be configured to be received in such a manner).
Regarding claims 4-6, Liburd discloses the invention substantially as claimed, as set forth above for claim 1. Liburd further discloses the valve tray further comprises a plurality of lower gas channels (108, FIG 9A, [0059]) circumferentially disposed on the annular rim and projecting in a radial direction (FIG 9A), wherein the plurality of lower gas channels are configured to permit gas flow into the cavity ([0059]), wherein the lid further comprises a plurality of upper gas channels (58 and 54) circumferentially disposed on the lid and projecting in a radial direction (FIG 3), and wherein each of the upper gas channels is configured to align with a respective one of the lower gas channels when the lid is closed over the annular rim (FIGs 3-5 and 7-8, [0059]).
Regarding claims 8-9, Liburd discloses the invention substantially as claimed, as set forth above for claim 1. Liburd further discloses the packaging assembly further comprises a circular boss extruded from the lid (105, FIG 6C and 6D), wherein the circular boss is configured to frictionally engage an inner surface of the cavity between the annular rim and a lower ledge defined by and disposed beneath the annular rim (106, [0056], FIG 9).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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