The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Response to Arguments
On pages 11-12 of the remarks dated February 23, 2026, the applicant provides a summary of the Carroll reference. Notably, the applicant states, “Carroll, however, intentionally uses two beat signals with different frequencies. In particular, the first beat signal 130 has a beat frequency of about 5 kHz and the second beat signal 132 has a beat frequency of about 5.1 kHz. Interaction of the first beat signal 130 (having a beat frequency of about 5 kHz) and the second beat signal 132 (having a beat frequency of about 5.1 kHz) results in a combined beat signal 134 being about 100 Hz (5.1 kHz – 5 kHz = 100 Hz). The combined beat signal 134, which is created by two different beat signals, is used to create one strong hotspot for tonic spinal cord stimulation at the frequency 100 Hz (Paragraphs 56-58).” The examiner agrees with this characterization of Carroll.
On page 13 of the remarks, the applicant states that “It is therefore clear that Carroll not only uses different beat signal frequencies to generate the combined beat signal 134 but purposefully chooses different beat signal frequencies because the resultant additive effect of the two is deemed particularly advantageous. That said, Carroll does not teach or suggest… the first envelope frequency and the second envelope frequency being equal to one another… as recited in amended claim 7.” The examiner agrees with this characterization as well.
However, the examiner notes that if “the first envelope frequency and the second envelope frequency being equal to one another” as now recited in claim 7, then “Interaction of the first beat signal (having a beat frequency of about X kHz) and the second beat signal (having a beat frequency of about X kHz) results in a combined beat signal being about zero Hz (X kHz – X kHz = zero Hz)”, which would simply be a constant, flat, horizontal straight line on a graph of amplitude versus time. Therefore, its not clear why such a combined/superimposed signal would result in the signal shown in Figure 5 of the instant application, when the applicant summarizes and/or paraphrases the Carroll reference as quoted above. For this reason, the following rejection under 35 USC 112(a) applies to the claims as now amended, which positively requires the first envelope frequency (i.e., a first beat frequency) to be equal to the second envelope frequency (i.e., a second beat frequency).
It is noted that claim 17 previously recited, “wherein said second envelope frequency is equal to the frequency difference between the third carrier frequency and the fourth carrier frequency, and equal to the first envelope frequency” within section (iii). Therefore, this is not changed in claim 17, and subsequently this action is non-final for this reason.
Claim Rejections - 35 USC § 112
First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(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 7-8 and 10-18 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
According to MPEP 23164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
(A) The breadth of the claims
Independent claims 7 and 17 recite interferential electrical stimulation with four pairs of electrodes. The frequencies of two overlapping/superimposed stimulation areas, which are generated by two separate pairs of electrodes, is determined by the difference of the two electrical fields, and these overlapping areas are recited in the claims as generating first and second envelope frequencies. These claims recite that these first and second envelope frequencies are equal, and also overlap/superimpose at least partially with one another and that this superimposed portion defines the target signal used for treatment.
(B) The nature of the invention
The invention, and subsequently independent claims 7 and 17, relates to methods for stimulating peripheral nerves for the treatment of, preferably, an inflammatory disease (see claim 16 for dependency from claim 1, see preamble of claim 17). The stimulation modality is electrical energy, and particularly to interferential electrical stimulation. Paragraph 8 of the specification details that this technique is previously used within the brain, and not the peripheral nerves, and also that the techniques of the application provide for improved spatial accuracy.
(C) The state of the prior art
In paragraph 7 of the specification, it states “For example, US10981003B1 discloses a system and a method employing interferential electrical stimulation following shoulder surgery.” In this patent, the target nerves are the suprascapular nerve, and at least one of the axillary and supraclavicular nerves (see Abstract). These nerves are each peripheral nerves, and interferential electrical stimulation is used as the stimulation method. In column 1, lines 31-34 the patent states that “In the 1950s, the use of interferential current therapy (IFC) was developed to provide dual current therapy to provide deeper tissue penetration to allow for improved pain relief.” This illustrates that interferential electrical stimulation is a known technique.
Carroll (US Patent Pub. No. 2021/0138245) teaches interferential electrical stimulation techniques utilizing at least four pairs of electrodes. The technique is nearly the same as that of the application’s claimed invention, with the exception of the nerve being stimulated and the fact that the first and second beat frequencies (i.e., envelope frequencies as claimed in the instant application) are different. This is commonly seen throughout the prior art because of the fact that when a first signal at a first frequency overlaps with a second signal having a second frequency, the resultant signal in the overlapping region has a frequency equal to the difference of the two combined signal, while the amplitude is additive. This is known throughout the prior art, as exemplified by the teachings within Carroll, as well as within the abstract of US Patent 6,560,487; within paragraph 7 of US Patent Pub. No. 2006/0030906; WO 2004/012807 teaches this on page 3, lines 1-14; WO 2004/047911 teaches this on page 3, the second paragraph and specifically for use with peripheral sites.
In the response dated February 23, 2026 to the initial Office action (i.e., on pages 11-12), the applicant states the following, “Carroll, however, intentionally uses two beat signals with different frequencies. In particular, the first beat signal 130 has a beat frequency of about 5 kHz and the second beat signal 132 has a beat frequency of about 5.1 kHz. Interaction of the first beat signal 130 (having a beat frequency of about 5 kHz) and the second beat signal 132 (having a beat frequency of about 5.1 kHz) results in a combined beat signal 134 being about 100 Hz (5.1 kHz – 5 kHz = 100 Hz). The combined beat signal 134, which is created by two different beat signals, is used to create one strong hotspot for tonic spinal cord stimulation at the frequency 100 Hz (Paragraphs 56-58).”
Therefore, the current state of the art teaches that the combining of two electrical signals, as well as the combining of two beat signals, results in another signal that has a frequency that is the difference of the frequencies of the two combined signals.
(D) The level of one of ordinary skill
The level of ordinary skill in the art is exemplified by the discussion above in section (C). Once of ordinary skill in the art would be a person within the medical field who utilizes electrical stimulation and understands how electrical fields work within the body, and/or would be a person who understands signal processing and how frequencies combine within areas of multiple electric fields.
(E) The level of predictability in the art
The field of interferential electrical stimulation is not new, as exemplified by US Patent No. 10,981,003 which states in column 1, lines 31-34, “In the 1950s, the use of interferential current therapy (IFC) was developed to provide dual current therapy to provide deeper tissue penetration to allow for improved pain relief.” Additionally, prior art teaches that overlapping electrical signals result in a new signal having additive amplitude with a frequency equal to the difference of the frequencies of each original signal. Carroll teaches, and the applicant appears to agree in the remarks dated February 23, 2026, that this is true for the overlapping of two beat signals. As such, two beat frequencies that are equal would presumably result in a new signal having a frequency of zero Hz.
(F) The amount of direction provided by the inventor
In the application itself, and particularly in paragraph 19 of the specification, the application states that “the generated envelope signals have a common envelope frequency equal to the first envelope frequency and the second envelope frequency, the generated envelope signals are at least partially superimposed to the superimposed part of the first and second envelope signal, the common superimposed part of all the envelope signals defines the targeting signal used to stimulate the target area.” In paragraph 39 it states “The frequency of the envelope signal 322 is equal to the frequency of the envelope signal 320.” Paragraph 56 also states “In another preferred embodiment, if there are more than four pairs of electrodes, e.g., 6, 8, 10... pairs of electrodes, envelope signals are generated for each of every two pairs of electrodes. The generated envelope signals have a common envelop frequency equal to envelope signals 320 and 322.” Figure 5 illustrates a supposed combined first and second envelope/beat signal. No greater detail is provided as to how or why the combining of two beat signals/envelopes as described and claimed results in the signal shown in Figure 5.
On pages 11-12 of the remarks dated February 23, 2026, the applicant provides a summary of the Carroll reference. Notably, the applicant states, “Carroll, however, intentionally uses two beat signals with different frequencies. In particular, the first beat signal 130 has a beat frequency of about 5 kHz and the second beat signal 132 has a beat frequency of about 5.1 kHz. Interaction of the first beat signal 130 (having a beat frequency of about 5 kHz) and the second beat signal 132 (having a beat frequency of about 5.1 kHz) results in a combined beat signal 134 being about 100 Hz (5.1 kHz – 5 kHz = 100 Hz). The combined beat signal 134, which is created by two different beat signals, is used to create one strong hotspot for tonic spinal cord stimulation at the frequency 100 Hz (Paragraphs 56-58).” Then, on page 13 of the remarks, the applicant states that “It is therefore clear that Carroll not only uses different beat signal frequencies to generate the combined beat signal 134 but purposefully chooses different beat signal frequencies because the resultant additive effect of the two is deemed particularly advantageous. That said, Carroll does not teach or suggest… the first envelope frequency and the second envelope frequency being equal to one another… as recited in amended claim 7.”
The examiner notes that if “the first envelope frequency and the second envelope frequency being equal to one another” as now recited in claim 7, then “Interaction of the first beat signal (having a beat frequency of about X kHz) and the second beat signal (having a beat frequency of about X kHz) results in a combined beat signal being about zero Hz (X kHz – X kHz = zero Hz)” (where this quote is the same wording as the applicant described and quoted Carroll, but specific frequencies have been replaced with X to represent them being equal), which would simply be a constant, flat, horizontal straight line on a graph of amplitude versus time. Therefore, it is not clear why such a combined/superimposed signal would result in the signal shown in Figure 5 of the instant application, when the applicant summarizes and/or paraphrases the Carroll reference as quoted above. No additional discussion is provided in either the application or in the remarks that makes it clear why the frequency would be anything other than zero
(G) The existence of working examples
The application does not clearly present results of a working example of the claimed method. Related prior art, such as Carroll, clearly teaches that the combining of a first and second beat signal results in another signal having additive amplitude, but a frequency equal to the difference of the two original signals’ frequencies.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure
There would be a low burden of experimentation to make or use the invention based on the content of the disclosure. For instance, the system and methods of Carroll are identical, except for the output of the signal generator. As such, one of ordinary skill in the art could easily set up the system and perform the methods disclosed based on the content of the disclosure.
Based on the above description of Factors (A) – (H), and particularly Factors (C), (E), (F) and (G), claims 7-8 and 10-18 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 enablement requirement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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/JAMES KISH/ Primary Examiner, Art Unit 3792