dDETAILED ACTION
Applicant's amendments and remarks, filed 1/20/26, are fully acknowledged by the Examiner. Currently, claims 1 and 93-115 are pending with claims 74-92 canceled, claims 93-115 added, and claim 1 amended. The following is a complete response to the 1/20/26 communication.
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 .
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.
Election/Restrictions
Newly submitted claims directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 93, 97 and Claim 110 recite.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
Claim(s) 1 and 95-96 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell (US 2015/0119875) in view of Toth (US 2016/0082180), in further view of Levin (US 2018/0110561).
Regarding claim 1, Fischell teaches a method of treating for preventing heart failure or a symptom of heart failure in a subject in need thereof comprising:
inserting a catheter into a vascular lumen defined by a vascular tissue of the subject (catheter 140);
guiding the catheter through the vascular lumen to a location proximate to a target nerve (par. [0048]),
stimulating the target nerve from within the vascular lumen and measuring a resultant signal in response to stimulating to determine a position of the target nerve (par. [0148]);
piercing, after determining the position of the target nerve (par. [0210]), the vascular tissue of the subject with a needle assembly extending outwards from the catheter towards the target nerve to produce an aperture in the vascular tissue (par. [0125] needle pokes hole to reach target tissue), wherein the telescopic needle assembly includes an electrode assembly (par. [0153]); and
delivering, from outside the vascular lumen, a stimulation energy to the target nerve with the electrode assembly (par. [0118] energy for ablating nerves from a generator outside the lumen), thereby fully or partially ablating the target nerve and treating or preventing heart failure or a symptom of heart failure in the subject (par. [0118]).
Fischell is silent regarding wherein the target nerve comprises the greater splanchnic nerve.
However, Toth teaches target nerves varying depending on the desired treatment, such as a splanchnic nerve (par. [0201]).
It would have been obvious to one of ordinary skill in the art to modify Fischell with treating splanchnic nerves as in Toth, depending on the target area desired to be treated.Fischell is silent regarding the vascular lumen being an intercostal vein or an azygous vein.However, Levin teaches reaching the splanchnic nerves through intercostal veins or azygos vein (par. [0034]).It would have been obvious to one of ordinary skill in the art that the lumen to be accessed is the intercostal or azygous vein, as in Levin, allowing for treatment of the greater splanchnic nerve.
Regarding claim 95, Fischell teaches extending an unsheathed needle of the needle assembly outwards from an exit port of the catheter, the unsheathed needle including the electrode assembly thereon (Fig. 2 with needle with electrodes extending out of an exit port of the catheter).
Regarding claim 96, Fischell teaches after ablating a nerve, stimulating the nerve and measuring a physiological response to determine if the ablating was successful (at least par. [0090]-[0091] measurement after nerve activity to see if ablation is successful).
Response to Arguments
Applicant’s arguments, see the remarks, filed 1/20/26, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive. The references do not teach the claims as amended. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Levin as a secondary reference.
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 BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO OUYANG/Examiner, Art Unit 3794 /JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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