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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant’s submission filed on 6/12/2026 has been entered.
Information Disclosure Statement
On pages 7-8 of the Response to Office Action filed on 6/12/2026, there is a list of patents and patent applications of the Assignee that “Applicant wishes to draw the Examiner’s attention to”. However, this listing of patents and patent applications is not a proper information disclosure statement (IDS) since it fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. In particular, the listing of patents and patent applications does not provide a column that provides a blank space next to each document to be considered, for the examiner’s initials (requirement (4)) or a heading that clearly indicates that the list is an information disclosure statement (requirement (5)). The list of patents and patent applications of the Assignee on pages 7-8 of the Response to Office Action filed on 6/12/2026 has not been considered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitations are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 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 electrical signal” in line 12, but it is not clear if this recitation is referring to (1) “an electrical tetanic burst signal” in line 5; (2) “a sub-threshold electrical signal” in lines 10-11; (3) the frequency of the detection waveform of paragraph 0109 of the specification; or (4) “the stimulation frequency of the nerve locator device” of paragraph 0109 of the specification. Support for considering possibilities (3) and (4) as possible interpretations comes from paragraph 0109 of the specification, which provides:
PNG
media_image1.png
224
769
media_image1.png
Greyscale
Also, the claim language does not provide explicit antecedent basis for the frequency of the detection waveform or the stimulation of the nerve locator device. Thus, if possibility (3) or (4) is the intended interpretation, there is insufficient antecedent basis for these features in the claim. Clarification on these points is required.
Claims 2-10 are rejected by virtue of their dependence from claim 1.
Claim 11 recites “the electrical signal” in lines 9-10, but it is not clear if this recitation is referring to “an electrical tetanic burst signal” in line 6; “a sub-threshold electrical signal” in line 8; (3) the frequency of the detection waveform of paragraph 0109 of the specification; or (4) “the stimulation frequency of the nerve locator device” of paragraph 0109 of the specification. Support for considering possibilities (3) and (4) as possible interpretations comes from paragraph 0109 of the specification, as quoted above. Also, the claim language does not provide explicit antecedent basis for the frequency of the detection waveform or the stimulation of the nerve locator device. Thus, if possibility (3) or (4) is the intended interpretation, there is insufficient antecedent basis for these features in the claim. Clarification on these points is required.
Claims 12-20 are rejected by virtue of their dependence from claim 11.
Claim 14 recites “automatically applying the electrical tetanic burst signal” in lines 1-2, but it is not clear if this recitation is the same as, related to, or different from “applying an electrical tetanic burst signal to the electrode system in response to the detecting of the trigger condition, to provide a tetanic contraction” of claim 11, lines 6-7. Claim 11 does not refer to such an application of the electrical tetanic burst signal as being automatic. This deviation in phraseology creates confusion as to whether the recitation of claim 14 is referring to the recitation of claim 11. This confusion renders claim 14 indefinite.
Claim 15 recites “automatically applying the electrical tetanic burst signal “ in lines 1-2, but it is not clear if this recitation is the same as, related to, or different from “applying an electrical tetanic burst signal to the electrode system in response to the detecting of the trigger condition, to provide a tetanic contraction” of claim 11, lines 6-7. Claim 11 does not refer to such an application of the electrical tetanic burst signal as being automatic. This deviation in phraseology creates confusion as to whether the recitation of claim 15 is referring to the recitation of claim 11. This confusion renders claim 15 indefinite.
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, 6-13, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/084182 (Willand 2019)(previously cited), in view of U.S. Patent Application Publication No. 2003/0088185 (Prass)(previously cited), and further in view of U.S. Patent No. 8,731,657 (Shambayati)(previously cited), and further in view of U.S. Patent Application Publication No. 2016/0278841 (Panescu).
Willand 2019 teaches a method of operating a hand-held electrical stimulation device (FIG. 2A of Willand 2019), the method comprising: applying an electrical tetanic burst signal to an electrode system of the hand-held device to provide a tetanic contraction (applying pulse trains with the inter-pulse interval being 5 ms, 0-5 ms, 5-10 ms, greater than 10 ms, etc.; the pulses are output at a frequency of 10 Hz or lower to provide a tetanic like contraction. The frequency range may include 0.1-40 Hz, 0.1-0.2 Hz, 0.2-0.3 Hz, 0.3-0.4 Hz, 0.4-0.5 Hz, 0.5-1 Hz, 1-2 Hz, 2-3 Hz, 3-4 Hz, 4-5 Hz, 5-10 Hz, 10-15 Hz, 15-20 Hz, 20-30 Hz, 30-40 Hz; paragraphs 0249-0250 of Willand 2019).
Willand 2019 also teaches that, when an electrode is properly placed in contact with neural tissue, the electrode-tissue impedance will be smaller than the impedance when the electrode is not in contact with tissue (paragraph 0156 of Willand 2019). The impedance in such circumstance is typically less than 10 kOhm (e.g., 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-9, 9- 10, 3-8, 1-10, 4-8 kOhm, impedances between the foregoing ranges, etc.)(paragraph 0156 of Willand 2019). Resistances exceeding a threshold value (e.g., 10 kOhm) can be an indication of improper placement of the electrode and the system is configured of recognizing values exceeding such a threshold (paragraph 0156 of Willand 2019).
Prass teaches that the duration of time can be used to determine if the probe is going into position or determining a position (that is, “Whether the predetermined operations are initiated or completed depends upon the duration of continuous tissue contact…if the duration [of] continuous tissue contact is less than a preselected period of approximately one or two seconds, the controller will maintain the operational status of the nerve Integrity monitor in the ‘search’ mode”, paragraph 0150 of Prass). However, “if the duration of continuous tissue contact exceeds the preselected time period, the stimulator or controller may alert the surgeon with an indicator tone and controller will automatically change the operational status of the nerve integrity monitor to a quantitative assessment mode and provide a preprogrammed sequence of quantitative assessment stimulus pulses” (paragraph 0150 of Prass). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monitor the duration of continuous tissue contact and automatically operate the qualitative assessment mode of the device of Willand 2019 when the duration exceeds a preselected period of time, as suggested by Prass, since it ensures contact and automates the process.
Willand 2019 teaches that the system is configured to periodically detect the impedance during the continuous application of electrical stimulation (paragraph 00157 of Willand 2019). If relatively high impedance is detected (e.g., high compared to a threshold level or upper limit), the system can be designed and otherwise configured to pause the application of continuous electrical stimulation and enable an indicator 118 on the housing 114 to alert the operator. In other arrangements, the system is configured to terminate (e.g., automatically stop) the stimulus output and/or prompt the user. The indicator comprises a visual indicator, an auditory indicator and/or any other type of indicator, either in addition to or in lieu of visual indication (paragraph 0157 of Willand 2019).
Shambayati teaches that a very small stimulus current is sent through the electrode at regular intervals for contact detection (col. 7, lines 18-35 of Shambayati). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a very small stimulus current (smaller than the operational current) to periodically detect the impedance for contact detection during operation of the probe of Willand 2019 since it confirms electrode contact. With respect to the amount of the very small stimulus current, such an amount is suggested by Shambayati as being smaller than the operational current and Willand 2019 suggests that the contact detection is determined during operation. From these teachings, the amount of the very small stimulus current and its temporal application relative to the temporal application of the operational stimulus current would depend upon the level of non-interference between the very small stimulus current and the operational stimulus current and their respective desired effects and the level of certainty required for electrode contact. As such, the amount of the very small stimulus current and its temporal application relative to the temporal application of the operational stimulus current are results-effective variables that would have been optimized through routine experimentation based on the level of non-interference between the very small stimulus current and the operational stimulus current and their respective desired effects and the level of certainty required for electrode contact. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the amount of the very small stimulus current and its temporal application relative to the temporal application of the operational stimulus current so as to obtain the desired level of non-interference between the very small stimulus current and the operational stimulus current and their respective desired effects and the desired level of certainty required for electrode contact.
Willand 2019 teaches that the system is configured to periodically detect the impedance during the continuous application of electrical stimulation (paragraph 00157 of Willand 2019). Shambayati teaches that a very small stimulus current is sent through the electrode at regular intervals for contact detection (col. 7, lines 18-35 of Shambayati). Panescu teaches that the frequencies adapted for contact sensing may be outside the frequency range of operational interest (paragraph 0005 of Panescu).1 Such frequencies may be at least greater than five times or at least greater than ten times the frequencies of operational interest so as not to interfere with the readings of operational interest (paragraphs 0008 and 0122 of Panescu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a frequency for the very small stimulus current that is 5x or 10x greater than the application of the pulse trains of Willand 2019 since it prevents interference with the readings of operational interest.
Alternatively or additionally, Panescu teaches that the frequency for contact sensing are subject to changes due to the use of ranges (paragraphs 0008 and 0122 of Panescu). The frequencies adapted for contact sensing would depend upon the factors of designer preference and the prevention of interference. As such, the frequency for contact sensing is a results-effective variable that would have been optimized through routine experimentation based on the factors of designer preference and the prevention of interference. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the frequency for contact sensing, using the ranges of Panescu as a starting point. so as to obtain the desired designer preference and the prevention of interference.
With respect to claim 1, the combination teaches or suggests a method of operating a hand-held electrical stimulation device (FIG. 2A of Willand 2019), the method comprising:
detecting a trigger condition associated with a predefined tetanic burst stimulation (the detecting of when the duration of continuous tissue contact exceeds the preselected period of time of Prass; paragraph 0150 of Prass); and
automatically applying an electrical tetanic burst signal to an electrode system of the hand-held device, in response to the detecting of the trigger condition, to provide a tetanic contraction (applying pulse trains with the inter-pulse interval being 5 ms, 0-5 ms, 5-10 ms, greater than 10 ms, etc.; the pulses are output at a frequency of 10 Hz or lower to provide a tetanic like contraction. The frequency range may include 0.1-40 Hz, 0.1-0.2 Hz, 0.2-0.3 Hz, 0.3-0.4 Hz, 0.4-0.5 Hz, 0.5-1 Hz, 1-2 Hz, 2-3 Hz, 3-4 Hz, 4-5 Hz, 5-10 Hz, 10-15 Hz, 15-20 Hz, 20-30 Hz, 30-40 Hz; paragraphs 0249-0250 of Willand 2019 which is automatically activated when the duration of continuous tissue contact exceeds the preselected period of time of Prass; paragraph 0150 of Prass);
wherein detecting the trigger condition comprises detecting continuous contact between the electrode system and tissue for at least a predefined duration of time (the detecting of when the duration of continuous tissue contact exceeds the preselected period of time of Prass; paragraph 0150 of Prass); and
wherein during a detection waveform phase of the electrical tetanic burst signal, a sub-threshold electrical signal is provided to the electrode system to confirm the trigger condition (the very small stimulus current of Shambayati optimized in amount and its temporal application relative to the temporal application of the operational stimulus of Willand 2019),
wherein a frequency of the electrical signal during the detection waveform phase is greater than a firing frequency of a target nerve such that the sub-threshold electrical signal does not generate an action potential (the very small stimulus current of Shambayati using the frequency of Panescu or optimized in frequency based on the teachings of Panescu).
With respect to claims 2-3 and 12-13, Prass teaches that a suitable duration of time to determine electrode contact can be one or two seconds which can be used to determine if the probe is going into position or determining a position (paragraph 0150 of Prass). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use one or two seconds as a duration of time for determining electrode contact since a duration of time is required and Prass teaches such durations of time. Thus, the combination teaches or suggests “wherein the predefined duration of time is at least 0.1 seconds” (claim 2), “wherein the predefined duration of time is at least 0.5 seconds” (claim 3), “wherein the predefined duration of time is at least 0.1 seconds” (claim 12), and “wherein the predefined duration of time is at least 0.5 seconds” (claim 13).
With respect to claim 6, the combination teaches or suggests that the electrical tetanic burst signal has a frequency of 20 Hz (The frequency range may include 15-20 Hz or 20-30 Hz or any frequencies within the these ranges; paragraphs 0249-0250 of Willand 2019).
With respect to claim 7, the combination teaches or suggests generating an output configured to be detected by a user holding the hand-held device, the output being associated with the trigger condition in response to detecting the trigger condition (the visual indicator, the auditory indicator and/or any other type of indicator, either in addition to or in lieu of visual indication; paragraph 0157 of Willand 2019).
With respect to claims 8, 10, 18, and 20, Willand 2019 teaches that the system is configured to periodically detect the impedance during the continuous application of electrical stimulation. If relatively high impedance is detected (e.g., high compared to a threshold level or upper limit), the system can be designed and otherwise configured to pause the application of continuous electrical stimulation and enable an indicator 118 on the housing 114 to alert the operator. In other arrangements, the system is configured to terminate (e.g., automatically stop) the stimulus output and/or prompt the user. The indicator comprises a visual indicator, an auditory indicator and/or any other type of indicator, either in addition to or in lieu of visual indication (paragraph 0157 of Willand 2019). Willand 2019 also teaches that a haptic feedback indicator is also a suitable indicator for reporting proper conditions for application of operational stimulus current (paragraphs 0010, 0020, 0233-0234, and 0242 of Willand 2019). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a haptic feedback indicator in addition to the visual indicator for informing the user of electrode contact since Willand 2019 teaches that any other type of indicator can be used in addition to visual indication and Willand 2019 teaches one such type of indicator. Thus, the combination teaches or suggests “wherein the output comprises a haptic output” (claim 8), “wherein the output comprises a haptic output and a visual output” (claim 10), “wherein the output comprises a haptic output” (claim 18), and “wherein the output comprises a haptic output and a visual output” (claim 20).
With respect to claim 9, the combination teaches or suggests that the output comprises a visual output (the visual indicator; paragraph 0157 of Willand 2019).
With respect to claim 11, the combination teaches or suggests a method of operating a hand-held electrical stimulation device, the method comprising:
detecting a trigger condition associated with a predefined tetanic burst stimulation, wherein the trigger condition comprises continuous contact between an electrode system of the hand-held device and tissue for at least a predefined duration of time (the detecting of when the duration of continuous tissue contact exceeds the preselected period of time of Prass; paragraph 0150 of Prass); and
applying an electrical tetanic burst signal to the electrode system in response to the detecting of the trigger condition, to provide a tetanic contraction (applying pulse trains with the inter-pulse interval being 5 ms, 0-5 ms, 5-10 ms, greater than 10 ms, etc.; the pulses are output at a frequency of 10 Hz or lower to provide a tetanic like contraction. The frequency range may include 0.1-40 Hz, 0.1-0.2 Hz, 0.2-0.3 Hz, 0.3-0.4 Hz, 0.4-0.5 Hz, 0.5-1 Hz, 1-2 Hz, 2-3 Hz, 3-4 Hz, 4-5 Hz, 5-10 Hz, 10-15 Hz, 15-20 Hz, 20-30 Hz, 30-40 Hz; paragraphs 0249-0250 of Willand 2019 which is automatically activated when the duration of continuous tissue contact exceeds the preselected period of time of Prass; paragraph 0150 of Prass); and
providing a sub-threshold electrical signal to the electrode system during a detection waveform phase to confirm the trigger condition (providing the very small stimulus current of Shambayati optimized in amount and its temporal application relative to the temporal application of the operational stimulus of Willand 2019),
wherein a frequency of the electrical signal during the detection waveform phase is greater than a firing frequency of a target nerve such that the sub-threshold electrical signal does not generate an action potential (the very small stimulus current of Shambayati using the frequency of Panescu or optimized in frequency based on the teachings of Panescu).
With respect to claim 16, the combination teaches or suggests that the electrical tetanic burst signal has a frequency of 20 Hz (The frequency range may include 15-20 Hz or 20-30 Hz or any frequencies within the these ranges; paragraphs 0249-0250 of Willand 2019).
With respect to claim 17, the combination teaches or suggests generating an output configured to be detected by a user holding the hand-held device, the output being associated with the trigger condition in response to detecting the trigger condition (the visual indicator, the auditory indicator and/or any other type of indicator, either in addition to or in lieu of visual indication; paragraph 0157 of Willand 2019).
With respect to claim 19, the combination teaches or suggests that the output comprises a visual output (the visual indicator; paragraph 0157 of Willand 2019).
Claims 4-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/084182 (Willand 2019)(previously cited), in view of U.S. Patent Application Publication No. 2003/0088185 (Prass)(previously cited), and further in view of U.S. Patent No. 8,731,657 (Shambayati)(previously cited), and further in view of U.S. Patent Application Publication No. 2016/0278841 (Panescu), and further in view of WO 2023/137142 (Mooney)(previously cited).
Willand 2019 teaches the application of an electrical tetanic burst signal to an electrode system of the hand-held device to provide a tetanic contraction (applying pulse trains with the inter-pulse interval being 5 ms, 0-5 ms, 5-10 ms, greater than 10 ms, etc.; the pulses are output at a frequency of 10 Hz or lower to provide a tetanic like contraction. The frequency range may include 0.1-40 Hz, 0.1-0.2 Hz, 0.2-0.3 Hz, 0.3-0.4 Hz, 0.4-0.5 Hz, 0.5-1 Hz, 1-2 Hz, 2-3 Hz, 3-4 Hz, 4-5 Hz, 5-10 Hz, 10-15 Hz, 15-20 Hz, 20-30 Hz, 30-40 Hz; paragraphs 0249-0250 of Willand 2019).
Mooney teaches that a pulse width of 2 milliseconds and a train duration of 1 second can be used in such an application (paragraph 00232 of Mooney). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a pulse width of 2 milliseconds and a train duration of 1 second in the application of an electrical tetanic burst signal since pulse width and train duration are required and Mooney teaches such parameters and/or it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 4, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration between 10 milliseconds and 2 seconds (the train duration of 1 second of Mooney).
With respect to claim 5, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration of 500 milliseconds or less (the pulse width of 2 milliseconds of Mooney).
With respect to claim 14, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration between 10 milliseconds and 2 seconds (the train duration of 1 second of Mooney).
With respect to claim 15, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration of 500 milliseconds or less (the pulse width of 2 milliseconds of Mooney).
Claims 4-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/084182 (Willand 2019)(previously cited), in view of U.S. Patent Application Publication No. 2003/0088185 (Prass)(previously cited), and further in view of U.S. Patent No. 8,731,657 (Shambayati)(previously cited), and further in view of U.S. Patent Application Publication No. 2016/0278841 (Panescu), and further in view of U.S. Patent Application Publication No. 2018/0326220 (Kaula)(previously cited).
Willand 2019 teaches the application of an electrical tetanic burst signal to an electrode system of the hand-held device to provide a tetanic contraction (applying pulse trains with the inter-pulse interval being 5 ms, 0-5 ms, 5-10 ms, greater than 10 ms, etc.; the pulses are output at a frequency of 10 Hz or lower to provide a tetanic like contraction. The frequency range may include 0.1-40 Hz, 0.1-0.2 Hz, 0.2-0.3 Hz, 0.3-0.4 Hz, 0.4-0.5 Hz, 0.5-1 Hz, 1-2 Hz, 2-3 Hz, 3-4 Hz, 4-5 Hz, 5-10 Hz, 10-15 Hz, 15-20 Hz, 20-30 Hz, 30-40 Hz; paragraphs 0249-0250 of Willand 2019).
Kaula teaches that the pulse width of tonic pulses in a range between about 1 microsecond and about 10,000 microseconds can be used in such an application (paragraph 0129 of Kaula). Thus, Kaula teaches that the pulse width can be subject to optimization based on physiology, user preferences, and the condition of the patient. As such, the pulse width is a results-effective variable that would have been optimized through routine experimentation based on physiology, user preferences, and the condition of the patient. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the pulse width, using the range of Kaula as a starting point, so as to obtain the desired result based on physiology, user preferences, and the condition of the patient.
With respect to claim 4, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration between 10 milliseconds and 2 seconds (the optimization using the ranges of Kaula as a starting point; further, “about 10,000 microseconds” is close to the claimed range, which makes the value obvious (MPEP 2144.05: “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)”)).
With respect to claim 5, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration of 500 milliseconds or less (the optimization using the ranges of Kaula as a starting point; further, “about 1 microsecond and about 10,000 microsecond” is overlapping the claimed range, which makes the value obvious (MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)”)).
With respect to claim 14, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration between 10 milliseconds and 2 seconds (the optimization using the ranges of Kaula as a starting point; further “about 10,000 microseconds” is close to the claimed range, which makes the value obvious (MPEP 2144.05: “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)”)).
With respect to claim 15, the combination teaches or suggests that automatically applying the electrical tetanic burst signal comprises generating an electrical signal burst having a duration of 500 milliseconds or less (the optimization using the ranges of Kaula as a starting point; further, “about 1 microsecond and about 10,000 microsecond” is overlapping the claimed range, which makes the value obvious (MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)”)).
Response to Arguments
The Applicant’s arguments filed 6/12/2026 have been fully considered.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 6/12/2026, the previous clam rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph are withdrawn.
However, there are new grounds of rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Prior art rejection
The Applicant’s arguments with respect to the rejections of claims 1-20 have been considered but are moot because the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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, JACQUELINE CHENG can be reached at (571) 272-5596. 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.
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 Col. 50, lines 28-40 of U.S. Patent No. 11,109,789 (Bibian) similarly teaches that proper contacting of electrodes is performed using very small current at a predefined frequency that is outside the signals of interest so as to avoid corruption.
Prosecution Insights