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
Applicant’s election without traverse of Group I, claims 1-14 in the reply filed on 11/19/25 is acknowledged.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 11/19/25. The claims 2-20 are pending. The claims 2-10 are amended. Claims 15-20 are withdrawn. Claim 1 has been cancelled.
Response to Arguments
Applicant’s arguments, filed 11/19/25 with respect to the rejections of claims 1-4, 10, 11, 13, and 14 under 35 U.S.C. 102(a)(1) as being anticipated by Rajpara (US2019/358018) have been fully considered but they are not persuasive. Applicant argues, nowhere does Rajpara teach the cited walls 1110 extend upward from the bottom wall of the cavity 1130. Examiner disagrees, as stated in the rejection the walls as shown in the annotated Fig. 14B are shown to extend upward from a bottom wall of the cavity 1130. Where the walls incorporate the sections around the cavity 1130 as well. There is no distinction of the side walls being the inner walls within the cavity as Applicant argues. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the side walls being the inner walls of the cavity) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to the rejection of claim 10 as amended, Applicant argues, Rajpara fails to teach a rinsing bowl or is used for any rinsing element. The rejection of claim 10 now cites the claimed rinsing bowl as the cavity defined by 1330. Furthermore, the cavity 1330 is interpreted as a rinsing bowl by being a cavity capable of holding fluid that could be used to rinse a component within it.
With respect to the rejection of claim 4, Applicant argues Rajpara does not teach a particular size of the cavity and therefore fails to teach any particular amount of fluid that may be held by the cavity. Examiner disagrees, the sizing of the cavity is stated in paragraph [0116] “The cavity 1130 can be dimensioned so as to at least accommodate a volume of hydrating fluid that is sufficient to submerge the prosthetic valve contained within valve cover”. Therefore, the cavity can be dimensioned to hold the 3 liters of fluid as claimed. See MPEP 2114 section I “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Applicant further argues, Rajpara fails to teach a loading tools kit as required by amended claim 10. 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.
Applicant further argues, the at least one rinsing bowl is not removably disposable within a fluid cavity. Examiner now relies on the cavity of 1330 as the claimed rinsing bowl, when would be removably disposable within the fluid cavity of 1130 when the top and bottom portions are engaged and disengaged as stated in paragraph [0120] and shown in Fig. 12.
Applicant’s arguments, filed 11/19/25 with respect to the rejections of claims 1-9 under 35 U.S.C. 102(a)(1) as being anticipated by Wilkinson (US2006/0282045) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
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.
Claims 2-11, 13, 14, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rajpara (US 2019/0358018 – cited in Applicant’s IDS).
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 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]);
at least one rinsing bowl (cavity defined by 1330, see Fig. 12); and
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).
Regarding claim 2, Rajpara discloses the kit of claim 10, 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 discloses the kit of claim 10, 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 discloses the kit of claim 10, wherein 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 [0116]).
Regarding claim 5, Rajpara discloses the kit of claim 10, 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 discloses the kit of claim 5, 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 discloses the kit of claim 5, 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 discloses the kit of claim 5, 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 discloses the kit of claim 10, 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 discloses the kit of claim 10, wherein the at least one rinsing bowl 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).
Regarding claim 13, Rajpara discloses the kit of claim 10, wherein each of the at least one rinsing bowl is configured to hold about 500 milliliters of fluid (cavity 1330 is capable of holding fluid in the same manner as the cavity 1130, [0116]).
Regarding claim 14, Rajpara discloses the kit of claim 10, 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 discloses the kit of claim 10, 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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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 of this title, 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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Rajpara (US2019/358018 – cited in Applicant’s IDS).
Regarding claim 12, Rajpara discloses the kit of claim 10; yet, is silent regarding wherein the at least one rinsing bowl includes three rinsing bowls. Rajpara teaches a single cavity 1130 (see Fig. 12). However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the application to duplicate the rinsing bowl, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774