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 Invention I (claims 1-4, 6-17, 19-21 and 38-43) in the reply filed on February 17, 2026 is acknowledged. Accordingly, claims 25-30 and 44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statement filed December 15, 2023 has been entered and the references cited therein have been considered by the examiner.
Preliminary Amendment
The preliminary amendment filed November 14, 2024 has been entered and made of record.
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) 1-4, 6-17, 19-21 and 38-43 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Panescu et al. (U.S. Patent Application Publication No. 2021/0128229).
In regard to claims 1-4, 6-9, 19, 20, Panescu et al. teach methods of treating at least one of heart failure and hypertension where the devices and methods may be used for ablating one or more splanchnic nerves where the device is advanced endovascularly to the target vessel in the region of a target nerve including a preganglionic greater splanchnic nerve (GSN) (see para. 0227). A device 100 includes a catheter 102 that is advances into the venous system along a guidewire (see Fig. 1 and paras. 0242-0243) and the device 100 includes a needle guide 101 that is deployable from the catheter 102 (see Figs. 2 and 3). When in the deployed position, the needle guide 101 is deployable from the catheter 102 via a side port 109 (see Figs. 2 and 3 and para. 0248) and a needle 105 with a sharp protruding end 107 is deployable from the needle guide 101 (see Figs. 3 and 4 and para. 0250). A delivery device 115 is deployable from within the needle 105 and the delivery device 115 can be an RF energy delivery device (electrode assembly) (see Fig. 5, para. 0035 and para. 0254). Panescu et al. outline a method of use (see Fig. 9) that includes advancing a catheter distal portion 108 over a guidewire 900 through the venous system and into the T10 intercostal vein 902 to a target location within the intercostal vein 902 when the treatment is for ablation of the GSN 904 (see Fig. 9 and para. 0288). The needle guide 101 may then be deployed from the catheter 102 until the needle guide distal end 103 is forced against the vein wall 908 and then the needle 105 may be deployed from the needle guide distal end 103 to puncture the vein wall 908 with the sharp puncturing end 107 of the needle 105 (see paras. 0291-0292 and Figs. 10-12). A treatment may then be delivered to the region exterior of the vein 902 when the delivery device 115 is deployed from the puncturing end 107 (see para. 0294). Pansecu et al. also teach that the catheter 102 may be advanced about 3 cm or greater into the T10 intercostal vein and then a stimulation pulse may be applied from the catheter 102 and if the pulse stimulates the sympathetic chain, the catheter can be withdrawn slightly and stimulation and withdrawal can be repeated until the stimulation pulse stimulates the GSN without stimulating the sympathetic chain (see para. 0288). Panescu et al. teach that a nerve stimulation test can be carried out to confirm the position of the delivery device 115 with respect to the GSN 904 and other nerves or anatomical structures (see paras. 0293-0295) stimulation of the GSN may result in a measurable physiological response such as an epigastric response, increased heart rate or increased blood pressure (see para. 0362). A positive stimulation of a GSN can confirm that the ablation element is in an appropriate location to ablate the targeted GSN while lack of response can suggest the ablation element needs to be moved (see para. 0362). Nerve stimulation parameters may include 2 Hz and 2V (see para. 0362). In regard to claim 10, see para. 0033 of Panescu et al. In regard to claim 11, see para. 0288 of Panescu et al. In regard to claim 12, see Fig. 9 and paras. 0288-0289 of Panescu et al. In regard to claim 13, see Figs. 9-13 and paras. 0288-0289 of Panescu et al. In regard to claim 14, see Figs. 9-13 and para. 0289 of Panescu et al. In regard to claims 15-17, see paras. 0359 and 0363 of Panescu et al. In regard to claim 21, see para. 0343 of Panescu et al. In regard to claims 39-43, see paras. 0293 and 0359 of Panescu et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Levin et al., PCT Publication No. WO 2018/023132; Gelfand et al. U.S. Application Publication No. 2019/0175912; Levin et al., U.S. Patent No. 11,376,066; and Levin et al., U.S. Patent No. 10,376,308.
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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