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 .
Response and Amendment Filed
Applicant’s response and amendment, filed May 18, 2026, has been entered and made of record.
Previously Set Forth Objections and Rejections
The status of the objections and rejections set forth in the previous Office action (mailed February 17, 2026) is as follows:
The objection to the drawings under 37 CFR 1.83(a) has been overcome by amendments to claim 11.
The 35 USC 112(b) rejection of claims 11-18 has been overcome by amendments to claim 11.
The 35 USC 112(d) of claim 16 has been overcome by amendments to claim 16.
The 35 USC 102(a)(2) rejection of claims 1, 2, 4-11 and 13-20 as being anticipated by Lenker et al. (U.S. Patent Application Publication No. 2023/0107208) is hereby withdrawn.
The following new grounds of rejection are set forth:
Claim Rejections - 35 USC § 102
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 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)(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.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lenker et al. (U.S. Patent Application Publication No. 2025/0057560).
In regard to claims 1, 2, 10 and 11, Lenker et al. teach a sheath 1126 that couples to a sheath hub 710 (see Fig. 7) and a dilator body 1102 having a proximal end portion and a tapered tip portion 1106, where the body 1102 has a cylindrical wall defining an inner surface and an outer surface where the outer surface has an outer diameter and the inner surface defines a dilator lumen 1130 extending through an entire length of the body (see Fig. 11B). A dilation balloon 1116 (membrane) is disposed about the outer surface of the dilator body 1102 and is configured to transition from a collapsed state adapted for delivery through sheath 1126 to an expanded state when positioned distal to a distal leading edge of the sheath 1126 (see Fig. 11B and paras. 0067-0068). Figure 11B shows the balloon 1116 being “refolded” down into a low-profile configuration to be pulled back into the sheath 1126 (see also para. 0068). Figure 11B also shows that the diameter of the balloon 1116 in the “refolded” configuration nearest the distal edge of the sheath 1126 is smaller than an inner diameter of the sheath 1126 and the diameter of the balloon 1116 in the expanded configuration is greater than an inner diameter of the sheath 1126. In regard to claims 3 and 12, see para. 0068 of Lenker et al. In regard to claims 4-6 and 13-15, Lenker et al. teach that balloon 1116 is inflated to a volume 1118 with water, saline or the like through an inflation channel 1112 (see Figs. 11A and 11B and para. 0068). In regard to claims 7-9 and 16-18, Lenker et al. teach a guidewire 804 inserted through the central lumen 1130 where the guidewire 804 has an electrode 1132 at the tip (see Figs. 11A and 11B and para. 0069). In regard to claim 19, it should be noted that it has been held that 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 satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Also, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). Thus, if the prior art structure is capable of performing the intended use, then it meets the claim. In the instant application, the structure of Lenker et al. is capable of performing the method steps of “making a dilator” which essentially means assembling the structural elements. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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