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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/11/2026 has been entered.
Response to Arguments
Applicant’s amendment and arguments filed 02/11/2026, with respect to the rejections set forth in the Final Rejection dated 11/20/2025 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Carroll (PGPUB 2021/0138245) and Palermo et al. (2008/0208287) .
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 1-20 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.
Applicant has amended Claim 1 to require the “intermittent current waveforms” to “have a pulse width in a range of 100-5000 microseconds, and/or pulses are repeated with a frequency of 1-100 Hz”. However, Applicant’s originally field disclosure states in par. [0050]: “Thus, the first stimulation generating unit and the second stimulation generating unit may generate signals having a relatively high frequency. The frequency of the signal in the first pulse and the frequency of the signal in the second pulse may be so high as not to affect, or minimally affect, the nerve. By selecting these frequencies to be high, such as in the range of 5 kHz - 1 MHz or in the range of 50 kHz - 1 MHz, the nerve is not stimulated by the first pulses and the second pulses individually. Rather, stimulation of the nerve may be provided solely by the interferential signal between the first intermittent current waveform and the second intermittent current waveform.” Par. [0052] then states: “According to an embodiment, the first stimulation generating unit and the second stimulation generating unit are configured to generate the first intermittent current waveform and the second intermittent current waveform with a difference in frequency in a range of 1 Hz - 10 kHz, such as 1 - 5 kHz.” And par. [0053] states: “Thus, the beat frequency may be in the range of 1 Hz - 10 kHz or in the range of 1 - 5 kHz.”. Paragraph [1042] states: “The stimulation paradigm may further involve repeating the pulses with a frequency of 1 - 100 Hz, such as 20 - 30 Hz. This is a repetition frequency of repeating the pulses and should not be confused with the beat frequency of the interferential signal 152.”
In summary, it is not the intermittent current waveforms as claimed that have these parameters but instead these are the parameters of what Applicant calls a “stimulation paradigm”. Applicant defines “stimulation paradigm” in par. [0024] as “A stimulation paradigm may define a desired beat frequency, a number of pulses in the sequence of pulses, duration of pulses, duration between pulses within a sequence of pulses, duration of “off time” between sequences of pulses, number of sequences of pulses, etc. The stimulation paradigm may be defined for providing a desired effect of the stimulation of the nerve, such as for providing control of a part of the body or an organ, or for providing treatment of a condition of the living being, such as treatment of epilepsy or depression of a human being.” In other words, the “stimulation paradigm” relates to the parameters of the pulses within the envelope of the beat signal and not the parameters of the individual intermittent waveforms that are used to create the beat signal. Applicant has clearly indicated that the intermittent signals are chosen to have a frequency that will not stimulate the nerve and that the beat signal is the only signal that provides stimulation to the nerve. Therefore, any discussion of a “stimulation paradigm” for actually stimulating the nerve would be with respect to the beat signal and not the intermittent signals. This is further highlighted by par. [0142] which states: “Depending on the purpose of stimulating the nerve 10, different settings of the stimulation paradigm may be used. Typically, the stimulation paradigm may involve providing pulses for stimulating the nerve 10 having a pulse width in a range of 100 -5000 microseconds, such as 100 - 500 microseconds. The pulse width relates to a pulse of the interferential signal 152, which is achieved by providing corresponding pulse widths of the first pulses 116a, 116b and the second pulses 136a, 136b. The stimulation paradigm may further involve repeating the pulses with a frequency of 1 - 100 Hz, such as 20 - 30 Hz. This is a repetition frequency of repeating the pulses and should not be confused with the beat frequency of the interferential signal 152.”(emphasis added). Reference to “the pulses with a frequency of 1-100Hz” references back to “the pulse width relates to a pulse of the interferential signal”. As best understood, the frequency defined is of the pulses within the beat envelope and not the envelope signal itself. The lowest frequency contemplated by Applicant for the intermittent pulses is 500 Hz with a maximum of 1 MHz.
Claims 13, 14 and 20 contain the same issue. Claims 2-12 and 15-19 are also rejected for being dependent on rejected claims 1, 13, 14 and 20. Appropriate clarification and/or correction is respectfully requested.
Claim Rejections - 35 USC § 112
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 6, 7, 16 and 17 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 6 states the pulses have a frequency of 500Hz -1 MHz. However, Claim 1 from which Claim 6 depends, states the pulses of the intermittent waveforms have a frequency of 1-100 Hz. It is unclear what frequency range is required. Appropriate correction and/or clarification is respectfully requested.
Claim 7 states a difference in frequency of the intermittent waveforms between 1 Hz-10kHz. However, Claim 1 form which Claim 7 depends limits the frequency of the intermittent waveforms to 1-100Hz. There can never be a difference that is greater than 100 Hz between waveforms in that range. The metes and bounds of the claim are unclear.
Claim 16 states the pulses have a frequency of 50 kHz -1 MHz. However, Claim 1 from which Claim 6 depends, states the pulses of the intermittent waveforms have a frequency of 1-100 Hz. It is unclear what frequency range is required. Appropriate correction and/or clarification is respectfully requested.
Claim 17 states a difference in frequency of the intermittent waveforms between 1 Hz-5kHz. However, Claim 1 form which Claim 7 depends limits the frequency of the intermittent waveforms to 1-100Hz. There can never be a difference that is greater than 100 Hz between waveforms in that range. The metes and bounds of the claim are unclear.
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)(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, 2, 5-7, 10-14 and 17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Carroll (PGPUB 2021/0138245).
Regarding Claims 1, 2, 12 and 14, Carroll discloses an interferential stimulation system that has an interferential current generator 102 that can simultaneously apply current on multiple pairs of electrodes 108a-g (up to 8 electrodes and four unique pairs)spaced apart around target tissue, such as the spinal cord (see Fig. 1-5C; par. [0010, 0033]) to create a beat signal to stimulate a nerve (thus synchronizing the signals to one another). Therefore, the generator is functionally described as having multiple stimulating circuits, e.g. stimulating units) that provide unique and distinct intermittent current waveforms for each pair of electrodes, see par. [0033]. Carroll discloses a control unit 118 that controls the frequency, amplitudes, pulse widths of each signal to cerate an interferential stimulation signal (Fig. 2, 5A), wherein each individual signal can have a pulse width of 210 microseconds (par. [0037]).
With regard to Claim 5, Carroll discloses modulating the amplitudes of the individual signals (par. [0031, 0044]; Fig. 2).
In regard to Claims 6, 7 and 17, Carroll discloses an example in which a first signal has a frequency of 5 kHz; a second signal has a frequency of 5.1kHz; and a beta frequency of 100 Hz (the difference in the two), see par. [0058]).
Regarding Claim 10, Carroll discloses each electrode or electrode set that is set up in a stimulation pair sources current from a first electrode or set of electrode and sinks the current in a corresponding electrode or set of electrodes. See Fig. 3-5 for the various examples.
In regard to Claim 11, Carroll discloses the signals can be sinusoidal (see Fig. 2; par. [0036]).
With regard to Claim 13, Carroll discloses all of Claim 1 (see rejection above) and further discloses implanting the electrodes and wirelessly communicating with an external unit (par. [0102]).
Claims 1, 4, 14-16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Palermo et al. (2008/0208287).
Regarding Claims 1 and 14, Palermo discloses setting up electrodes 118a, b and 102a, b in interferential pairs (Fig. 4E; par. 0067] and discloses that interferential stimulation can be applied with various pulse train patterns such as those disclosed on Fig. 2A-H (par. [0102]). Palermo discloses a first channel A (electrodes 118a, b) providing a first set of intermittent pulses having a frequency in the range of 1-5Hz for a first time period; a second channel B (electrodes 120a,b) providing a second set of intermittent pulses having a frequency in the range of 1-5 Hz in the same time period to produce an interferential signal (par.[0102]; Fig. 2F, G).
In regard to Claims 4, 15, 18 and 19, Palermo discloses turning off the stimulation between burst application of pulses on the first and second channels (see Fig. 2F, 2G).
Regarding Claim 16, Palermo discloses a signal can have a frequency up to 1 MHz and can be bursted at a frequency of 0.01-250 Hz (par. [0149-0150]; Fig. 5B, C).
With regard to Claim 20, Palermo discloses the pulses can have frequencies of 5-20 Hz and 20-250 Hz in other time windows (Fig. 2F, G).
Claim Rejections - 35 USC § 103
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 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.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Carroll (PGPUB 2021/0138245) in view of Hamner et al. (2021/0283400). Carroll discloses utilizing an implantable neurostimulation device to provide interferential therapy to nerves in the body but fails to disclose the use of nerve cuff electrodes. However, Hamner, in the same field of endeavor of implantable neurostimulation systems that provide interferential therapy (see par. [00137]) discloses utilizing nerve cuff electrodes as the particular electrodes for the purpose of providing stimulation that more accurately targets a specific nerve and allows current to flow toward that specific nerve (par. [0087]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Carroll reference to include a nerve cuff electrode, as taught and suggested by Hamner, for the purpose of more accurately targeting a specific nerve and allowing current to flow toward that specific nerve.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Carroll (PGPUB 2021/0138245) in view of Hall (US Patent 4,848,347). Carroll discloses operating electrodes in a source/sink pairing with respect to a respective current source/circuit and discloses controlling the circuits with a processor but fails to disclose the exact internal configuration of these circuits. However, Hall, in the same field of endeavor of electrical stimulation, particularly interreferential current electrical stimulation, discloses constructing the current generators with a combination of oscillators 12 and amplifiers 16 for the purpose of allowing selective control of the signal amplitude and frequency (Abstract; Fig. 1). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Carroll reference to include an oscillator and amplifier in the current generation unit, as taught and suggested by Hall, for the purpose of allowing selective control of the signal amplitude and frequency.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Carroll (PGPUB 2021/0138245) in view of Peterson (PGPUB 2018/0241564). Carroll discloses utilizing an external device using wireless communication such as RF communication(par. [0102]) to provide stimulation but fails to disclose that the wireless communication is an inductive coupling link. However, Peterson, concerned with the same problem of secure wireless communications between a programmer and a stimulator discloses near-field communication (NFC), such as an inductive link; Bluetooth communications; and far-field communications such as RF communication are all-art recognized possibilities for the coupling link which can be selected based on the design needs of the system (par. [0042]). Therefore, it would have been obvious to try a NFC inductive link since there are a finite number of identified, predictable solutions (as set forth by Peterson) , each having a reasonable expectation of success. Additionally, Peterson shows that inductive links, RF links, Bluetooth, etc. are equivalent structures known in the art. Therefore, because these various communication types were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute an inductive link for an RF or Bluetooth link.
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796