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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/9/26 has been entered.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 7/9/26. The claims 2-21 are pending. The claims 10-13, 15, 16 are amended. Claims 15-20 are withdrawn.
Response to Arguments
Applicant’s arguments, filed 7/9/26 with respect to the rejections of claims 2-11, 13, 14, and 21 under 35 U.S.C. 102(a)(1) as being anticipated by Rajpara (US2019/358018) have been fully considered and the amendment overcomes the previous rejection. However, a new grounds of rejection has been made in view of Rajpara (US2019/358018) in view of Maples (WO2021/011821).
With respect to the rejection of claim 10, Applicant argues Rajpara fails to disclose a loading tools kit. Examiner respectfully disagrees, as stated in paragraph [0125] “once the flushing of the catheter lumen is complete, the loading of the heart valve can be performed by pressing the button 1236 to actuate the loading of the heart valve within the delivery sheath”. Therefore, Rajpara explicitly discloses a loading step of the heart valve within the delivery sheath, where all the components of the handle and delivery sheath are interpreted as the claimed loading tools kit.
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 2-14, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Rajpara (US 2019/0358018 – cited in Applicant’s IDS) in view of Maples (WO 2021/011821).
Regarding claim 10, Rajpara discloses a kit for preparing a replacement heart valve implant for delivery, comprising:
a tray assembly (1100/1300), comprising:
a bottom portion (1100) having a bottom wall (bottom wall defined by floor 1112 of cavity 1130, see Fig. 12) and a first side wall, a second side wall, a third side wall, and a fourth side wall (walls 1110 surrounding the cavity 1130, see annotated Fig. 14B) each extending upward from a perimeter of the bottom wall (see Fig. 12) to collectively define a fluid cavity in the bottom portion (cavity 1130 accommodates fluid, [0116]); and
a top portion (1300) having a top wall (1320) and a first side, a second side, a third side, and a fourth side (where the sides of the top portion 1300 would be identified the same as the corresponding sides to the bottom portion 1100, see annotated Fig. 14B);
wherein the top portion is configured to releasably engage the bottom portion ([0120]);
wherein the bottom portion includes at least one notch (the engaging surface 1134 that is a contoured surface of the tray 1100 to permit access to the end port 1234 of the handle 1230 without removing the handle 1230 from the tray 1100, [0119], see Fig. 14B) formed in an upper edge of the first side wall (see Fig. 14B), the at least one notch being configured to receive an elongate shaft of an implant delivery device (the engaging surface 1134 is configured to receive a tubular structure and would therefore be capable of receiving an elongate shaft, [0119]);
a loading tools kit ([0125]) for attaching the replacement heart valve implant to an implant delivery device ([0125]), wherein the loading tools kit includes a tool tray assembly (the portion the tray where the tools are assembled, see Fig. 12, [0125]) and a plurality of loading tools (all of the tools in the assembly that load the heart valve within the delivery sheath, [0125]) disposed within the tool tray assembly;
wherein the at least one rinsing bowl and the loading tools kit are removably disposable within the fluid cavity (the tools and the cavity defined by 1330 are both removably engageable with the bottom portion 1100) such that the top portion of the tray assembly is engageable with the bottom portion of the tray assembly with the at least one rinsing bowl and the loading tool kit disposed within the fluid cavity (where the kit would be arranged in the manner as claimed when top portion 1300 and bottom portion 1100 are engaged with tools inside as shown in Fig. 12).
Rajpara does not disclose at least two rinsing bowls that are separate elements each removable from the bottom and top portions of the tray assembly. Rajpara teaches the cavity 1130 of the bottom portion 1100 having space for fluid and therefore would have space for holding nested bowls ([0116], see Fig. 12). Maples, teaches a transport system that includes at least one tertiary package 300 for containing a medical tools and/or tissue ([0029]). Where a plurality of tertiary packages 300 can be stacked ([0029]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have nested bowls within the cavity of Rajpara as taught by Maples for having additional packaging for transporting materials after the procedure is performed ([0037]). Where one having ordinary skill in the art would know the dimensions required for nesting the bowls of Maples within the cavity of Rajpara.
Regarding claim 2, Rajpara/Maples makes obvious the kit of claim 10, Rajpara further discloses wherein the bottom portion includes at least one tab (groove structure defined by recess 1122) extending outward from the third side wall (1122 extends outward from one of the sides, see Fig. 14B).
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Regarding claim 3, Rajpara/Maples makes obvious the kit of claim 10, Rajpara further discloses wherein the first side wall is disposed opposite the third side wall and the second side wall is disposed opposite the fourth side wall (Fig. 3).
Regarding claim 4, Rajpara/Maples makes obvious the kit of claim 10, Rajpara further discloses the bottom portion is sized and configured to hold about 3 liters of fluid (cavity 1130 is dimensioned to retain fluid and is capable of holding 3 liters of fluid, since it is sized to house a prosthetic valve and a distal portion of the elongate delivery system, [0026]). If Applicant should disagree Rajpara/Maples discloses the bottom portion is sized and configured to hold about 3 liters of fluid. Rajpara discloses the cavity 1130 is dimensioned to retain fluid and can hold some amount of fluid and is sized to house a prosthetic valve and a distal portion of the elongate delivery system ([0026], [0116]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have changed the size of the kit and therefore the cavity size, since the modification merely involves a change in size of the packaging, which is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 5, Rajpara/Maples makes obvious the kit of claim 10, Rajpara further discloses wherein the top portion includes a first nesting portion (half portion of 1330 that extends downward from lid 1300, Fig. 12) extending from the top wall and a second nesting portion (other portion of 1330 that extends downward from lid 1300, Fig. 12) extending from the top wall.
Regarding claim 6, Rajpara/Maples makes obvious the kit of claim 5, Rajpara further discloses wherein the first nesting portion and the second nesting portion extend downward from the top wall when the top portion is engaged with the bottom portion (see Fig. 12).
Regarding claim 7, Rajpara/Maples makes obvious the kit of claim 5, Rajpara further discloses wherein the first nesting portion includes a first recess (one of the tabs 1332 in the half portion of 1330, see Fig. 12) configured to receive a first end of a handle of the implant delivery device (first end of the handle would be capable of being received by recess 1332, see Fig. 12) and the second nesting portion includes a second recess (the other tab 1332 in the other half portion of 1330, see Fig. 12) configured to receive a second end of the handle of the implant delivery device (second end of the handle would be capable of being received by recess 1332, see Fig. 12).
Regarding claim 8, Rajpara/Maples makes obvious the kit of claim 5, Rajpara further discloses wherein the first nesting portion is disposed adjacent the first side and the second side of the top portion, and the second nesting portion is disposed adjacent the second side and the third side of the top portion (see Fig. 12).
Regarding claim 9, Rajpara/Maples makes obvious the kit of claim 10, Rajpara further discloses wherein the top portion (1300) includes at least one tab (lip extending outward from the side of the wall as shown in Fig. 12) extending outward from the third side (see Fig. 12).
Regarding claim 11, Rajpara/Maples makes obvious the kit of claim 10, the modified invention further discloses wherein the at least two rinsing bowls and the loading tools kit nest inside of the tray assembly with the top portion engaged with the bottom portion (the parts sit on top of each other and are therefore interpreted as nested, see Fig. 13; where the bowls as taught by Maples would be nested inside the tray assembly by being nested within the cavity 1130 of Rajpara).
Regarding claim 12, Rajpara/Maples makes obvious the kit of claim 10, Maples further teaches the at least one rinsing bowl includes three rinsing bowls (Maples teaches nesting a plurality of bowls, see Fig. 4B, [0029]).
Regarding claim 13, Rajpara/Maples makes obvious the kit of claim 10, the modified invention further discloses wherein each of the at least two rinsing bowl are configured to hold about 500 milliliters of fluid (the bowls as taught by Maples are capable of holding fluid in the same manner as the cavity 1130, [0116] of Rajpara; where package can hold 600 ml of fluid since it holds a pack that is 600 ml as described in [0022] of Maples). If Applicant should disagree, Rajpara/Maples discloses each of the at least two rinsing bowls are configured to hold about 500 millimeters. Maples teaches where package can hold 600 ml of fluid since it holds a transfer pack that is 600 ml ([0022]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the bowls configured to hold about 500 milliliters in order to provide an appropriate size bowl for transport of medical materials ([0022] of Maples).
Regarding claim 14, Rajpara/Maples makes obvious the kit of claim 10, Rajpara further discloses wherein when the top portion is engaged with the bottom portion ([0121]): the first side of the top portion is engaged with the first side wall of the bottom portion; the second side of the top portion is engaged with the second side wall of the bottom portion; the third side of the top portion is engaged with the third side wall of the bottom portion; and the fourth side of the top portion is engaged with the fourth side wall of the bottom portion (see Fig. 13).
Regarding claim 21, Rajpara/Maples makes obvious the kit of claim 10, Rajpara further discloses wherein the top portion includes a channel (the groove formed by the inside of the walls of the upper portion 1300, see annotated Fig. 12-2) extending around the perimeter of the top wall, the channel being configured to receive upper edges of the first side wall, the second side wall, the third side wall, and the fourth side wall of the bottom portion therein (see Fig. 12).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
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