DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 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
Applicant’s election without traverse of Group II (claims 21-37) in the reply filed on 8/3/2026 is acknowledged.
Claims 1-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group I, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/3/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed 5/30/2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information in the foreign language referred to therein has not been considered.
Drawings Objections
The drawings are objected to because Figs. 6-8 contain more than one figure.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 21 is objected to because of the following informalities: amend “the basis” to -a basis- in ll. 8. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: amend “the laparoscopic applicator” to -the applicator- in ll. 1. Appropriate correction is required.
Claim 32 is objected to because of the following informalities: amend “the delivery of energy” to -delivery of the energy- in ll. 2. Appropriate correction is required.
Claim 33 is objected to because of the following informalities: amend “a delivery of energy” to -delivery of the energy- in ll. 1. Appropriate correction is required.
Claim 33 is objected to because of the following informalities: amend “the same or different locations” to -a same location or different locations- in ll. 2. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitations “in contact perivascularly and/or perineurally with a perimeter of the vessel or tissue or nerve or lie against a perimeter of the vessel or tissue or nerve”. First, the limitations of “in contact…with” and “lie against” are the same and thus duplicative. Second, it is unclear if the second recitation of “a perimeter of the vessel or tissue or nerve” is the same as the first. It is suggested to delete one of these limitations within the claim.
Claim 28 recites the limitation “the electrodes of the applicator”; however, claim 21, upon which claim 28 depends, recites “at least two electrodes of the applicator”. It is unclear if the “electrodes” are the same as or different from one another. For purposes of examination, they will be interpreted as being the same.
Claim 28 recites the limitation “a target vessel or target tissue or target nerve”; however, claim 21, upon which claim 28 depends, recites “a vessel or tissue nerve”. It is unclear if the “target vessel or target tissue or target nerve” are the same as or different from the “vessel or tissue nerve”. For purposes of examination, they will be interpreted as being the same.
Claim 32 recites the limitation “the basis of a protocol by means of PFA pulses or on the basis of a protocol by means of a combination of PFA pulses and RF pulses”. First, it is unclear if the “basis of a protocol by means of PFA pulses” is the same as or different from the “basis of a protocol which has at least one pulse of a pulsed field ablation (PFA)” recited in claim 21, upon which claim 32 depends. Second, it is unclear how many protocols are being claimed. Third, it is unclear if the “PFA pulses” are the same as or different from the “at least one pulse of a pulsed field ablation (PFA)” in claim 21. For purposes of examination, the claim will be interpreted as “the protocol” of claim 21 further comprises delivery of the energy by combination of PFA pulses and RF pulses, the PFA pulses including the at least one PFA pulse of claim 21.
Claim 34, recites the limitation “perivascular and/or perineural neuromodulation occurs by carrying out the denervation”; however, claim 21, upon which claim 34 recites, “carrying out a denervation by delivering energy” when the applicator is positioned “in contact perivascularly and/or perineurally with a perimeter of the vessel or tissue or nerve or lie against a perimeter of the vessel or tissue or nerve”. It is unclear how claim 34 actually further limits claim 21 form which it deepens.
Claim 37 recites the limitation “at a chosen ablation site”; however, claim 21, upon which claim 37 depends, recites the limitation “positioning a distal end of the applicator at a vessel or tissue or nerve of the patient such that at least two electrodes of the applicator are in contact perivascularly and/or perineurally with a perimeter of the vessel or tissue or nerve or lie against a perimeter of the vessel or tissue or nerve”. It is unclear if the “chosen ablation site” is different from the site the applicator is positioned, and also since it recites “ablation” and not “denervation” since no other “ablation” is recited. For purposes of examination, the “chosen ablation site” will be interpreted as being the site of denervation where the applicator is positioned.
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.
(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) 21-22, 26-28, 33-34 & 37 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Weadock (2015/0141810).
Concerning claim 21¸as illustrated in at least Figs. 4A-B, Weadock et al. disclose a method for perivascular and/or perineural neuromodulation (methods of providing energy to one or more nerves; [0001]), comprising:
inserting an applicator into a patient (device 100 may be inserted into the body of a patient; [0047], [0063]);
positioning a distal end of the applicator at a vessel or tissue or nerve of the patient such that at least two electrodes of the applicator are in contact perivascularly and/or perineurally with a perimeter of the vessel or tissue or nerve or lie against a perimeter of the vessel or tissue or nerve (clamp-type end effector having contact surfaces 170A and 170B or 175A and 175B are maneuvered in contact with a target nerve; [0041], [0065]);
carrying out a denervation by delivering energy via the at least two electrodes, wherein the delivery of energy is effected on the basis of a protocol which has at least one pulse of a pulsed field ablation (PFA) (Once the nerve component (ganglion or plexus) to be treated is in contact with at least one energy applying surface of the end effector, the user can introduce energy to the end effector and treat the nerve component to be treated, energy applied may be sufficient to cause irreversible electroporation (IRE) with pulsed signals; [0036-0039], [0056-0057], [0066]);
withdrawing the applicator (Once the desired energy is applied to the nerve component or components to be treated, the energy applying device may be removed; [0067]).
Concerning claim 22¸Weadock et al. disclose an irreversible electroporation is carried out ([0056-0057]).
Concerning claim 26¸ Weadock et al. disclose the applicator is inserted and/or withdrawn by means of an open surgical procedure ([0033]).
Concerning claim 27¸ Weadock et al. disclose after the applicator has been inserted, geometric unfolding of a distal end of the applicator is initiated and a form of the distal end that conforms to a vessel or tissue or nerve is thus achieved ([0046-0047]; Fig. 4A-B).
Concerning claim 28¸ Weadock et al. disclose the electrodes of the applicator are brought into contact with a target vessel or target tissue or target nerve ([0041], [0046-0047], [0065]).
Concerning claim 33¸ Weadock et al. disclose a delivery of energy is effected once or multiple times at the same or different locations of the vessel or tissue or nerve ([0058]).
Concerning claim 34¸ Weadock et al. disclose perivascular and/or perineural neuromodulation occurs by carrying out the denervation ([0066-0067]).
Concerning claim 37¸ Weadock et al. disclose measuring a temperature at a chosen ablation site ([0061]).
Claim(s) 21-25, 27-32, 34 & 36-37 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Deem et al. (2018/0311503).
Concerning claim 21¸as illustrated in at least Fig. 7, 14C, 16, disclose a method for perivascular and/or perineural neuromodulation (methods of renal neuromodulation; Abstract), comprising:
inserting an applicator into a patient; positioning a distal end of the applicator at a vessel or tissue or nerve of the patient such that at least two electrodes of the applicator are in contact perivascularly and/or perineurally with a perimeter of the vessel or tissue or nerve or lie against a perimeter of the vessel or tissue or nerve (Apparatus 200 comprising trocar 220 and electrode element 230 comprises a laparoscopic or percutaneous PEF system configured for insertion in proximity to the track of the renal neural supply along the renal artery or vein or hilum and/or within Gerota's fascia, where distal section has at least one electrode or groups of electrodes; [0088-0092], [0097], [0104]);
carrying out a denervation by delivering energy via the at least two electrodes, wherein the delivery of energy is effected on the basis of a protocol which has at least one pulse of a pulsed field ablation (PFA) (pulsed electric field then may be generated by the PEF generator 100 to achieve renal neuromodulation; [0103-0104]);
withdrawing the applicator (percutaneously retracting probe from treatment site; [0092], [0105]).
Concerning claim 22¸ Deem et al. disclose an irreversible electroporation is carried out ([0103]).
Concerning claim 23, Deem et al. disclose reversible electroporation energy is carried out ([0142]).
Concerning claim 24¸ Deem et al. disclose the applicator (230) is inserted and/or withdrawn by a laparoscopic procedure ([0088]).
Concerning claim 25¸ Deem et al. disclose the laparoscopic applicator (230) is inserted into a patient's torso by means of a trocar (220) ([0097]; Fig. 7).
Concerning claim 27¸ Deem et al. disclose after the applicator has been inserted, geometric unfolding of a distal end of the applicator is initiated and a form of the distal end that conforms to a vessel or tissue or nerve is thus achieved ([0097-0104]; Fig. 5-7).
Concerning claim 28¸ Deem et al. disclose the electrodes of the applicator are brought into contact with a target vessel or target tissue or target nerve ([0088]).
Concerning claim 29¸ Deem disclose checking a positioning of the applicator by means of a local impedance measurement ([0139]; Claim 68).
Concerning claim 30¸ Deem disclose the protocol comprises only PFA pulses ([0039]).
Concerning claim 31¸ Deem disclose the protocol comprises a combination of PFA pulses and radiofrequency (RF) pulses ([0039], [0046]).
Concerning claim 32¸ Deem disclose choosing whether the delivery of energy for the denervation is to be carried out on the basis of a protocol by means of PFA pulses or on the basis of a protocol by means of a combination of PFA pulses and RF pulses ([0039]).
Concerning claim 34¸ Deem et al. disclose perivascular and/or perineural neuromodulation occurs by carrying out the denervation ([0086], [0088]).
Concerning claim 36¸ Deem disclose after the denervation has been carried out, characterizing the denervation by means of at least two stimulation and measuring electrodes (233) ([0042-0043], [0097]).
Concerning claim 37¸ Deem et al. disclose measuring a temperature at a chosen ablation site ([0139]; Claim 68).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deem (2018/0311503), as applied to claim 21, in further view of Pellegrino et al. (2017/0202613) or Vrba et al. (2017/0348049).
Concerning claims 35-36¸while Deem discloses delivering stimulation signals to interrogate target tissue to determine a need, or parameters, for therapy, as well as to determine impedance of the nerve and nerve electrodes ([0139]), Deem fail to specifically disclose before the denervation is carried out, quantifying a conductivity of the vessel or tissue or nerve by means of at least two stimulation and measuring electrodes and after the denervation has been carried out, characterizing the denervation by means of at least two stimulation and measuring electrodes. However, Pellegrino et al. disclose a method for perivascular and/or perineural neuromodulation comprising preoperatively or postoperatively measure nerve conduction at the treatment region using two stimulating electrodes (106, 108) ([0035], [0137]). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Deem such that before the denervation is carried out, quantifying a conductivity of the vessel or tissue or nerve by means of at least two stimulation and measuring electrodes and after the denervation has been carried out, characterizing the denervation by means of at least two stimulation and measuring electrodes as taught by Pellegrino et al. in order to provide the benefit of determining location for denervation and confirmation of denervation as taught by Deem et al. In the alternative, Vrba et al. disclose a method for perivascular and/or perineural neuromodulation comprising measuring, detect, or monitoring sympathetic tone before, during, and or after treatment to provide information about the procedure. Vrba et al. further disclose measuring conduction along the length of the nerve fibers such that a degree of nerve disruption can be quantitatively determined thereby leading to the possibility of a real-time intra-procedural diagnostic during the procedure. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Deem such that before the denervation is carried out, quantifying a conductivity of the vessel or tissue or nerve by means of at least two stimulation and measuring electrodes and after the denervation has been carried out, characterizing the denervation by means of at least two stimulation and measuring electrodes in order to provide the benefit of the most direct measurement conceivable to determine whether nerves have been ablated or denervated and the neural connections disrupted and in order to provide the benefit of a quantitative signal correlating a degree of nerve disruption as real-time procedure feedback as taught by Vrba et al. ([0433-0434], [0443]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Coates et al. (2019/0223955) teach based on the thermal and electrical conductivity associated with different tissue types identified from computer model 32 of the region of the patient, processor 25 may determine the volumetric reach to which energy or denervation stimulation may be electrically or thermally conducted from electrodes 16a ([0157]). Sverdlik et al. (2014/0012133) teach measuring neural activity, conductivity and/or continuity before and/or during and/or after a denervation treatment, for example to determine the effectiveness of the treatment ([0087]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
