DETAILED ACTION
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 to Amendment
The amendment filed May 13th, 2026 has been entered. Applicant’s amendments to the claims have overcome the 112(a) and 112(b) rejections previously set forth in the Non-Final Rejection mailed March 13th, 2026.
Response to Arguments
Regarding Applicant’s arguments on page 6 with respect to the Priority Claims, Applicant has been told several times that they need to provide the paragraph numbers and/or Figures of the provisional applications that provide support for the identified limitations for priority to be established (see also, Interview Summary mailed August 27th, 2025). Until that is done, the Examiner will maintain the priority date given and the Priority section has been updated, below.
Applicant’s arguments, see pages 6-8, filed May 13th, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art that teaches the newly disclosed claim limitations.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/426974 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Accordingly, claims 1-3, 5-8, 10-19 & 21-23 are not entitled to the benefit of the prior applications as they do not disclose an undriven discharge comprising an initial charge which discharges with an exponential waveform having a time constant equal to the product of an uncontrolled tissue resistance and a capacitance of a capacitor in a closed circuit with the tissue proximate the target anatomy. However, provisional applications 62/489389 and 62/511301 provide support in view of Applicant's arguments dated September 4th, 2025 such that the claims of this application will be given the earliest effective filing date of the earliest application: 04/24/2017.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cauller et al. (U.S. Pub. No. 20110106219), herein referred to as “Cauller”
Regarding claim 1, Cauller teaches an electrical power supply ([0029]: a neural stimulation system) for inducing an observable response in a target anatomy ([0029]: These capacitive currents may directly or indirectly cause an action potential 106 in the nerve 102) for use with a stimulator having at least one electrode (electrodes 108a, 108b) configured to treat the target anatomy ([0029]: A stimulus is applied to the electrodes 108a, 108b by the stimulus source 110, generating a current 112 between the electrodes 108. The current 112 generates an electric field 114. The electric field 114 attracts and repels electrons 116 and ionized atoms 118 within the tissue 104, generating capacitive currents. These capacitive currents may directly or indirectly cause an action potential 106 in the nerve 102), said electrical power supply comprising:
circuitry ([0034]: With reference to FIG. 3, a circuit diagram) comprising a capacitor (stimulus capacitance 122) configured to be placed in a closed circuit with tissue proximate the target anatomy (see the closed circuit of capacitor 122 with the electrodes 108a, 108b if the switch is closed ([0034]: Stimulation control 124 operates the switch 120 and provides power to the stimulus capacitance 122)), the circuitry connectable to said at least one electrode and configured to deliver electrical stimulation energy through said stimulator to the tissue proximate the target anatomy ([0034]: A switch 120 closes and connects a stimulus capacitance 122 between electrodes 108a, 108b to generate a stimulus; [0029]: A stimulus is applied to the electrodes 108a, 108b by the stimulus source 110, generating a current 112 between the electrodes 108. The current 112 generates an electric field 114. The electric field 114 attracts and repels electrons 116 and ionized atoms 118 within the tissue 104, generating capacitive currents. These capacitive currents may directly or indirectly cause an action potential 106 in the nerve 102),
wherein the electrical stimulation energy comprises a plurality of stimulatory electrical pulses ([0028]: Stimulation pulses), each stimulatory electrical pulse consisting of an undriven capacitive discharge from the capacitor comprising an initial charge which inherently discharges from the capacitor through the tissue with an exponential waveform having a time constant equal to a product of an uncontrolled tissue resistance and a capacitance of the capacitor in the closed circuit with the tissue proximate the target anatomy ([0030]: a graph depicts a stimulation waveform, in accordance with an embodiment. The stimulation waveform shown is an exponential pulse; [0034]: With reference to FIG. 3, a circuit diagram depicts a neural stimulation circuit in accordance with an embodiment. A switch 120 closes and connects a stimulus capacitance 122 between electrodes 108a, 108b to generate a stimulus. The stimulus waveform, in this embodiment, takes the form of exponential decay as the charge stored on the stimulus capacitance 110 is discharged between the electrodes 108a, 108b, generating electric fields in the nearby tissue 104. Stimulation control 124 operates the switch 120 and provides power to the stimulus capacitance 122), wherein the exponential waveform of the undriven capacitive discharge through the tissue is formed without a function generator or a controller to shape the exponential waveform (see circuit diagram in Fig. 3), and
wherein the target anatomy comprises a ureter, and wherein the circuitry is configured to elicit a peristaltic response from the ureter when said at least one electrode is positioned so as to deliver said electrical stimulation energy to the tissue proximate the ureter ([0029]: A stimulus is applied to the electrodes 108a, 108b by the stimulus source 110, generating a current 112 between the electrodes 108. The current 112 generates an electric field 114. The electric field 114 attracts and repels electrons 116 and ionized atoms 118 within the tissue 104, generating capacitive currents. These capacitive currents may directly or indirectly cause an action potential 106 in the nerve 102; [0028]: Stimulation of the pudental nerve may be used in treatment for bladder control; wherein this is seen as being capable of eliciting a peristaltic response from a ureter).
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.
Claims 1-3, 5-6, 15-19 & 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (WO 2015123441 A1), herein referred to as “Huang” in view of Cauller.
Regarding claim 1, Huang discloses an electrical power supply (power supply 15) for inducing an observable response in a target anatomy (Abstract: operating the power supply so that the electrical signal is applied to the tissue; and visually observing the tissue to determine the presence of a ureter in the tissue) for use with a stimulator (probe 10) having at least one electrode (electrode tips 45A, 45B) configured to treat the target anatomy (page 22, lines 4-5: contacting the target tissue with electrode tips 45A, 45B), said electrical power supply comprising:
circuitry (circuitry shown in Fig. 10) comprising a capacitor (capacitor C1 or C2, Fig. 10) configured to be placed in a closed circuit with tissue proximate the target anatomy (see circuit in Fig. 10), the circuitry circuity connectable to said at least one electrode and configured to deliver electrical stimulation energy through said stimulator to the tissue proximate the target anatomy (Page 17, lines 16-20: Cable 20 connects the output of power supply 15 to electrical connector 50A and electrical connector 50B of probe 10, so that the output of power supply 15 can be applied to electrode tip 45A and electrode tip 45B of probe 10),
wherein the electrical stimulation energy comprises a plurality of stimulatory electrical pulses (page 17, lines 2-3: the electrical signal provided by power supply 15 is a pulsatile signal), each stimulatory electrical pulse consisting of an undriven capacitive discharge from the capacitor comprising an initial charge which inherently discharges from the capacitor through the tissue with an exponential waveform having a time constant equal to a product of an uncontrolled tissue resistance and a capacitance of the capacitor in the closed circuit with the tissue proximate the target anatomy (page 13, lines 10-14: "smooth muscles" (which include structures such as the ureter) are able to respond (e.g., contract and peristalse) when electrically stimulated. The present invention utilizes this fact to identify the ureter during a surgical procedure; page 13, lines 16-21 & page 14, lines 1-8: electrical stimulator which generates a low-level electrical current (preferably but not necessarily in a pulsatile form), such that when the tip of the electrical stimulator is positioned on or near the ureter, the low-level electrical current provided by the electrical stimulator will cause the ureteral muscles to contract up and down the length of the ureter. This results in movement of the anatomy that can then be visualized by the surgeon, even if the ureter is obscured by other tissues (e.g., scar tissue). In this way, the location of the ureter can be identified (or confirmed) so that it may be avoided during the surgical procedure; Fig. 10; In reference to the Instant Application’s Specification, paragraph [0022] recites “In specific instances, the power supply is configure to elicit a peristaltic or contractile response in a ureter when the at least one electrode is positioned to deliver the stimulatory energy to tissue proximate the ureter” such that Huang’s “low-level electrical current provided by the electrical stimulator will cause the ureteral muscles to contract up and down the length of the ureter” is seen as producing “each stimulatory electrical pulse consisting of an undriven capacitive discharge from the capacitor comprising an initial charge which inherently discharges from the capacitor through the tissue with an exponential waveform having a time constant equal to a product of an uncontrolled tissue resistance and a capacitance of the capacitor in the closed circuit with the tissue proximate the target anatomy”),
wherein the target anatomy comprises a ureter, and wherein the circuitry is configured to elicit a peristaltic response from the ureter when said at least one electrode is positioned so as to deliver said electrical stimulation energy to the tissue proximate the ureter (page 8, lines 16-21: a power supply connected to said at least one electrode for providing an electrical signal to said at least one electrode, wherein said electrical signal is configured to elicit a peristaltic response from a ureter when said at least one electrode is positioned so as to deliver said electrical signal to the ureter).
But Huang fails to disclose wherein the exponential waveform of the undriven capacitive discharge through the tissue is formed without a function generator or a controller to shape the exponential waveform.
However, Cauller discloses wherein the electrical stimulation energy comprises a plurality of stimulatory electrical pulses ([0028]: Stimulation pulses), each stimulatory electrical pulse consisting of an undriven capacitive discharge from the capacitor comprising an initial charge which inherently discharges from the capacitor through the tissue with an exponential waveform having a time constant equal to a product of an uncontrolled tissue resistance and a capacitance of the capacitor in the closed circuit with the tissue proximate the target anatomy ([0030]: a graph depicts a stimulation waveform, in accordance with an embodiment. The stimulation waveform shown is an exponential pulse; [0034]: With reference to FIG. 3, a circuit diagram depicts a neural stimulation circuit in accordance with an embodiment. A switch 120 closes and connects a stimulus capacitance 122 between electrodes 108a, 108b to generate a stimulus. The stimulus waveform, in this embodiment, takes the form of exponential decay as the charge stored on the stimulus capacitance 110 is discharged between the electrodes 108a, 108b, generating electric fields in the nearby tissue 104. Stimulation control 124 operates the switch 120 and provides power to the stimulus capacitance 122; see circuit in Fig. 3 where there is nothing within the circuit that controls tissue resistance or capacitance of the capacitor),
wherein the exponential waveform of the undriven capacitive discharge through the tissue is formed without a function generator or a controller to shape the exponential waveform (see circuit diagram in Fig. 3),
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the circuit of Huang to the circuit of Cauller for the purpose of the circuit enabling the generation of capacitive currents that may directly or indirectly cause an action potential in nerves (Cauller: [0029]).
Regarding claim 2, Huang discloses wherein each undriven capacitive discharge has a peak voltage in a range from 5 V to 500 V (page 17, lines 4-5: variable pulse intensity (e.g., 60 mV - 500 V)).
Regarding claim 3, Huang discloses wherein the peak voltage is in a range from 6 V to 60 V (page 17, lines 4-5: variable pulse intensity (e.g., 60 mV - 500 V)).
Regarding claim 5, Huang discloses wherein each undriven capacitive discharge has a resultant variable current less than 1 A (page 17, lines 5-6: variable pulse amperage (e.g., 5 - 200 mA).
Regarding claim 6, Huang discloses wherein a resultant variable current is in a range from 5 mA to 125 mA (page 17, lines 5-6: variable pulse amperage (e.g., 5 - 200 mA).
Regarding claim 15, Huang discloses wherein the circuitry is configured to allow a user to adjust parameters of said undriven capacitive discharge (page 17, lines 10-14: To this end, power supply 15 preferably comprises a power on/off switch 60, an associated power on/off indicator 65, a pulse width control 70, a pulse frequency control 75, a pulse intensity control 80 and an activate button 85).
Regarding claim 16, Huang discloses wherein parameters of said undriven capacitive discharge are preset (page 20, lines 6-10: the electrical signal provided by power supply 15 has a preset pulse width (e.g., 100 milliseconds), a preset pulse frequency (e.g., 1 Hz) and a preset pulse intensity (e.g., 200 V)).
Regarding claim 17, Huang discloses wherein the circuitry is configured to deliver a bipolar undriven capacitive discharge (page 23, lines 1-8: electrical stimulator 5 is described as comprising two electrodes, i.e., electrode tips 45A, 45B. In general, such a "bipolar" construction is preferred since it provides a more specific localization and a more localized current when attempting to target a smaller field and tissue).
Regarding claim 18, Huang discloses wherein the at least one electrode comprises only a single electrode, and wherein the circuitry is configured to deliver a monopolar undriven capacitive discharge to the single electrode and to connect to a dispersive pad (page 23, lines 8-12: However, it is also anticipated that electrical stimulator 5 may comprise a "monopolar" construction having only one electrode tip, with the "return" being provided by a grounding pad).
Regarding claim 19, Huang discloses wherein the electrical power supply is a tabletop power supply connected to the stimulator by a tether cord (page 18, lines 1-2: cable 20 is connected to probe 10 and power supply 15; page 21, lines 15-16: By way of example but not limitation, power supply 15 may comprise a 9 V battery 110).
Regarding claim 21, Huang discloses a handle (handle 105), wherein the circuitry is disposed on a printed circuit board within the handle (see circuitry in Figs. 8 & 9 comprising a printed circuit board) and wherein the electrical power supply is powered by at least one battery disposed within the handle (page 22, lines 13-16: probe 10 may include an enlarged handle 105 carrying power supply 15 therein. By way of example but not limitation, power supply 15 may comprise a 9 V battery).
Regarding claim 22, Huang discloses wherein the stimulator comprises a shaft (shaft 25) configured to be advanced through a trocar, and wherein the shaft has a width of less than 6 millimeters (page 15, lines 13-15: shaft 25 has a length of approximately 330 mm and a diameter of approximately 5 mm; page 23, lines 17-18: probe 10 may be inserted into the abdominal cavity through a 5 mm trocar port).
Regarding claim 23, Huang discloses wherein the at least one electrode comprises two electrodes spaced apart by at least 1 millimeter and separated by a nonconductive material (page 16, lines 7-12: electrode tip 45A and electrode tip 45B may be separated by an insulating mass which physically separates the anode and cathode from one another so as to ensure that the electrical signal must pass through tissue in contact with the device; page 18, lines 5-19: Next, and looking now at Fig. 3, probe 10 is advanced to the surgical site (e.g., through a cannula 95 extending through the skin 100 of a patient) . Then probe 10 is advanced to the region where the ureter is believed to lie, electrode tips 45A and 45B are placed against the tissue, and then activate button 85 is depressed so as to apply a low-level pulsatile electrical current to the tissue. When electrode tips 45A and 45B are located in the vicinity of the ureter, the electrical signal will cause the ureter to generate a rhythmic twitch as the ureteral muscles contract up and down the length of the ureter. The surgeon can observe this muscular response of the ureter, whereby to confirm ureter presence as well as the ureter path; wherein in reference to the Instant Application’s Specification, paragraph [0062] states that “The human ureter is on average 3 millimeters wide” such that Huang’s Figs. 3-6 show a device with electrodes spaced apart by at least 1 mm).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Cauller as applied to claim 1 above, and further in view of Johanek (U.S. Pub. No. 20180369593, previously cited), herein referred to as “Johanek”.
Regarding claim 7, Huang in view of Cauller fails to disclose wherein each undriven capacitive discharge is greater than 30 µC to 450 µC.
However, Johanek discloses wherein each undriven capacitive discharge is greater than 30 µC to 450 µC ([0033]: the high dose of electrical stimulation therapy may have a charge delivery of about 100 microCoulombs to about 2,000 microCoulombs per second; [0073]: Power source 38 may include one or more capacitors, batteries, or other energy storage devices). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the undriven capacitive discharge of Huang in view of Cauller to the range of Johanek for the purpose of sufficiency of electrical stimulation in producing a desired therapeutic effect may be based on the amount of charge delivered to the tissue of the patient per unit of time and relatively low amplitude of the pulses may also help keep the stimulation intensity level less than a perception or paresthesia threshold intensity level for the patient (Johanek: [0033], [0038]).
Regarding claim 8, Huang in view of Cauller fails to disclose wherein each undriven capacitive discharge is in a range from 40 µC to 450 µC.
However, Johanek discloses wherein the undriven capacitive discharge is in a range from 40 µC to 450 µC ([0033]: the high dose of electrical stimulation therapy may have a charge delivery of about 100 microCoulombs to about 2,000 microCoulombs per second; [0073]: Power source 38 may include one or more capacitors, batteries, or other energy storage devices). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the undriven capacitive discharge of Huang in view of Cauller to the range of Johanek for the purpose of sufficiency of electrical stimulation in producing a desired therapeutic effect may be based on the amount of charge delivered to the tissue of the patient per unit of time and relatively low amplitude of the pulses may also help keep the stimulation intensity level less than a perception or paresthesia threshold intensity level for the patient (Johanek: [0033], [0038]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Cauller and Johanek as applied to claims 7 and 8, above, and further in view of Bar-Yoseph et al. (U.S. Pub. No. 20110301662, cited in IDS), herein referred to as “Bar-Yoseph”.
Regarding claim 10, Huang in view of Cauller and Johanek fail to disclose wherein each undriven capacitive discharge has a resultant total energy in a range from 0.05 mJ to 9 mJ.
However, Bar-Yoseph discloses wherein each undriven capacitive discharge has a resultant total energy in a range from 0.05 mJ to 9 mJ ([0201]: the controller is configured to drive the pulse, the pulse having an energy of between 0.00001 Joule and 0.1 Joule; where 0.05 mJ = 0.00005 J, 9 mJ = 0.009 J & this overlaps with 0.00001 joule to 0.1 joule; [0498]: In an exemplary embodiment of the invention, controller 84 generates or triggers a stimulation signal via stimulation circuitry 89, for example, a capacitor with a switch). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the range of Huang in view of Cauller and Johanek to the range of Bar-Yosef for the purpose of the range being configured to stimulate an afferent nerve, to modify the sensitivity of a sensory receptor, and to avoid causing pain to the subject (Bar-Yoseph: [0207]-[0209]).
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Cauller and Johanek as applied to claims 7 and 8, above, and further in view Mishra et al. (U.S. Pub. No. 20190001139, previously cited), herein referred to as “Mishra”.
Regarding claim 11, Huang in view of Cauller and Johanek fail to disclose wherein each undriven capacitive discharge has a decay constant duration in a range from 10 ps to 20 ms.
However, Mishra discloses wherein each undriven capacitive discharge has a decay constant duration in a range from 10 μs to 20 ms ([0360]: then decay to lower current levels (e.g. a level of approximately 100 nA), with a time constant on the order of 1 μsec to 100 μsec). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the undriven capacitive discharge of Huang in view of Cauller and Johanek to have the decay constant as taught by Mishra, for the purpose of allowing complete decay of the charge (Mishra: [0433]).
Regarding claim 12, Huang in view of Cauller, Johanek and Mishra discloses wherein the decay constant duration is in a range from 100 μs to 4 ms (Mishra: [0360]: then decay to lower current levels (e.g. a level of approximately 100 nA), with a time constant on the order of 1 μsec to 100 μsec).
Regarding claim 13, Huang discloses wherein the electrical power supply is configured to deliver consecutive undriven capacitive discharges at a rate from 0.1 Hz to 2 Hz (page 17, line 4: variable pulse frequency (e.g., 1 - 5 Hz)).
Regarding claim 14, Huang discloses wherein the electrical power supply is configured to deliver consecutive undriven capacitive discharges at a rate from 0.5 Hz to 1 Hz (page 17, line 4: variable pulse frequency (e.g., 1 - 5 Hz)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
Prosecution Insights