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 June 30, 2026, has been entered and made of record.
Previously Set Forth Rejections
The 35 USC 102(a)(2) rejection of claims 1-4, 6-17, 19-21 and 38-43 as being anticipated by Pansecu et al. (U.S. Patent Application Publication No. 2021/0128229) is hereby maintained and is applied to newly filed claims 45-59 below.
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, 2, 4, 6-17, 19-21, 38-43 and 45-59 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, 2, 4, 6-9, 19, 20, 38, 45-53 and 55-59, 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 while the catheter 102 is positioned within the vascular lumen of the intercostal vein (see Fig. 10 and para. 0288), a nerve stimulation test can be carried out (applied by the catheter 102) 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, to better position the side port 109 (see para. 0362). Nerve stimulation parameters may include 50 Hz and 1V used to generate an action potential of a GSN (see para. 0362). Distal electrodes 123, 124 on the surface of the catheter may be used to deliver the nerve stimulation signal (see para. 0362 and Figs. 31 and 33). In regard to claim 54, see para. 0280.
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.
Response to Arguments
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive.
Regarding amended independent claim 1, applicant argues that Panescu et al. does not disclose or suggest any notion of measuring action potential through a target nerve (see page 11 of the response filed 6/30/2026). Regarding newly filed independent claim 47, applicant argues that Panescu et al. does not disclose “measuring from with the vascular lumen a physiological response to determine the target nerve is in sufficient proximity to an exit port of the catheter” (see page 11 of the response filed 6/30/2026). Regarding newly filed independent claim 52, applicant argues that Pansecu et al. does not disclose “delivering from within the vascular lumen and via a first electrode disposed on the catheter, a preliminary stimulation energy to the target nerve; measuring from within the vascular lumen and via the first electrode, a physiological response to the preliminary stimulation energy; after delivering the preliminary stimulation energy and measuring the physiological response, piercing the vascular tissues of the subject with a puncture mechanism extending outwards from the catheter towards the target nerve, wherein the puncture mechanism includes an electrode including a second electrode, and delivering a stimulation energy to the target nerve with the electrode, thereby fully or partially ablating the target nerve and treating or preventing heart failure or a symptom of heart failure in the subject” (see pages 11-12 of the response filed 6/20/2026).
As set forth above, after a further consideration of the applied Panescu et al. reference, Pansecu et al. does teach issuing the preliminary stimulation from the catheter 102 as it is positioned within the vascular lumen (see, e.g., para. 0288). Panescu et al. also teaches measuring the action potential through the target GSN (see, e.g., para. 0362). Panescu et al. also teach issuing the preliminary stimulation before the needle is deployed from the side port 109 and thus the proximity to the side port 109 would be determined. Similarly, Panescu et al. teach that the catheter 102 delivers the preliminary stimulation energy while the delivery device 115 on the needle delivers the ablation energy (see the above rejection).
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.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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