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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 17th, 2025 has been entered.
Response to Arguments
Regarding Applicant’s arguments on page 5 with respect to the Priority Claims, the newly disclosed claim limitations were not found within any of the parent applications such that the Priority section has been updated, below.
Applicant’s arguments, see page 5, filed December 17th 2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102 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 Therefore, the rejection has been withdrawn.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.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “consisting essentially of” recited on pages 6-7) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's arguments against the references individually on page 7, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Additionally, Applicant is arguing limitations present in claim 2 such that these arguments could have more weight if integrated into claim 1. However, Applicant’s arguments that there are many ways to stimulate smooth muscle, the Examiner reminds Applicant that the effect in tissue is only a functional limitation of the circuit and that there needs to be a clear demonstration of linking the circuitry/waveform to the desired tissue effect & how this is different from the current prior art of record.
Therefore, some of the arguments against Huang are found persuasive but not all, and this is reflected in the new grounds of rejection, below.
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, 62/489389, 62/511301, PCT/US17/63428 and 16/420809 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 1-19 are not entitled to the benefit of the prior applications as they do not disclose “wherein the circuitry comprises a switch network configured, for each said stimulatory electrical pulse, to (i) charge the capacitor from a power source and (ii) during the discharge interval disconnect the capacitor from the power source and connect the capacitor only to the at least one electrode such that no active driving circuitry regulates voltage or current during the discharge, whereby the discharge waveform is determined by the uncontrolled tissue resistance and the capacitance” such that the claims of this application will be given the earliest effective filing date of the earliest application: 08/12/2021.
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 1-8 & 10-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim recites “wherein the circuitry comprises a switch network configured, for each said stimulatory electrical pulse, to (i) charge the capacitor from a power source and (ii) during the discharge interval disconnect the capacitor from the power source and connect the capacitor only to the at least one electrode such that no active driving circuitry regulates voltage or current during the discharge, whereby the discharge waveform is determined by the uncontrolled tissue resistance and the capacitance” and the Specification fails to provide adequate support for this limitation. The Specification does not describe a switch or relay network. Paragraph [0052] recites “The capacitor discharge waveform has been found to require a lower voltage than other tested waveforms, resulting lower current and power requirements than other waveforms. This is particularly advantageous for battery-driven designs as described herein as well as for integrating the technology into another instrument where space for insulating the stimulation wiring may be limited. An “undriven” capacitor discharge waveform relies on the inherent discharge of voltage degradation/time constant from capacitors in a closed circuit and was found to be more efficacious in eliciting the response than a use of “driven capacitor discharge” waveform (e.g. matching a specific voltage degradation curve using a function generator)” but it does not describe the circuitry responsible for forming the waveform nor that it is the connection and subsequent disconnection of a capacitor via a switching network that produces this undriven capacitor discharge waveform.
Claims 2-8 & 10-19 are also rejected by virtue of their dependency on claim 1.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 & 10-19 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 1 recites the limitation “the discharge interval” in line 19. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the discharge” in line 21. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the discharge waveform” in line 23. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-8 & 10-19 are also rejected by virtue of their dependency on claim 1.
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 1-6 & 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (WO 2015123441 A1), herein referred to as “Huang” in view of Feldman et al. (U.S. Pub. No. 20180071527), herein referred to as “Feldman”.
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”).
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 and wherein the circuitry comprises a switch network configured, for each said stimulatory electrical pulse, to (i) charge the capacitor from a power source and (ii) during the discharge interval disconnect the capacitor from the power source and connect the capacitor only to the at least one electrode such that no active driving circuitry regulates voltage or current during the discharge, whereby the discharge waveform is determined by the uncontrolled tissue resistance and the capacitance.
However, Feldman discloses wherein the electrical stimulation energy comprises a plurality of stimulatory electrical pulses (see Fig. 7B), 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 (passive recovery period 98, see tissue resistance Rt in Fig. 7B),
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. 7B),
wherein the circuitry comprises a switch network configured, for each said stimulatory electrical pulse, to (i) charge the capacitor from a power source and (ii) during the discharge interval disconnect the capacitor from the power source and connect the capacitor only to the at least one electrode such that no active driving circuitry regulates voltage or current during the discharge, whereby the discharge waveform is determined by the uncontrolled tissue resistance and the capacitance ([0051]: FIG. 7B provides another example of the first mode of passive charge recovery in which the only passive recovery switches 178 closed are those associated with electrodes 16 that have been selected for stimulation, which is again assumed to be electrodes E1 and E2. However, in this example, a lower value for the resistance of variable resistor 188 is chosen (i.e., RZ1, selecting 50 ohms). This decreases the time constant T1 of the circuit, which decreases the passive recovery period 98 and decreases the time that passive recovery switches 178 must be closed (per RCV1 and RCV2) after each preceding pulse (second pulse phase 94b); wherein if the switches are closed after each preceding pulse, then this is seen as the switches being open during the pulse & see Fig. 7B where the switches RCV1 & RCV2 are before capacitors C1 & C2 such that the switches are closed to charge the capacitors and opened during discharge such that the discharge voltage/current is unregulated & the waveform is determined by the uncontrolled tissue resistance and the capacitance).
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 Feldman for the purpose of in active charge recovery, some residual charge may remain on the capacitors after the second phase of a biphasic pulse, such that passive chare recovery enables the normalization of any remaining charge and the continuous charge recovery enabling high frequency stimulation (Feldman: [0022], [0060]).
Regarding claim 2, Huang discloses 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).
Regarding claim 3, 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 4, 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).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Feldman 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 Feldman 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 Feldman 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 Feldman 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 Feldman 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 Feldman 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 Feldman 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 Feldman 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 Feldman 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 Feldman 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 Feldman 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 Feldman, 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.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794