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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the elements of claims 2 and 3 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 3 is objected to because of the following informalities: claim 3 recites “has or of” which appears to be a typographical error. Appropriate correction is required.
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.
Claim 2-3, 5-10, 14-15 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.
Claims 2-3 recite "an inductor for generating said stimulation pulses having at least five-poles" or “said inductor has or of five-poles, se. It is unclear what the scope of the term "inductor[ ... ] having at least five-poles" is, as it has no well recognized meaning in the context of the claims, leaving claim 2 unclear. This rejection may be overcome by amending in further limitations defining what the scope of this term means (see [0066] using the PG Pub for paragraph numbers) from the description into claim 2. For the above reasons the claim does not clearly define the metes and bounds of the claim and is indefinite.
Claim 5 recites “. . . response, and preferably, the measured . . .” the “preferably” causes a clarity issue. Is the portion after the preferably, namely “the measured nerve stimulus response, is measured both positively and negatively” required? Or not? For the above reasons the claim does not clearly define the metes and bounds of the claim and the claim is indefinite.
Claim 5 recites “the measured nerve stimulus response, is measured both positively and negatively.” which lacks clarity. Is this saying the measurement is either positive or negative? Or is it saying the result of the measurement is positive or negative? For the above reasons the claim does not clearly define the metes and bounds of the claim and the claim is indefinite.
Claim 7 recites “measuring a change of frequency between the generated stimulation pulse and the measured nerve stimulus response.” However, it’s unclear what is being measured by this. It recites measuring a “change of frequency”, but the frequency of what is being measured? When applying electrical stim pulse/burst etc. frequency is a stimulation parameter so you know what that is but what is the “change” being measured (reading the claim in view of the spec did I wasn’t exactly how this is being measured)? For the above reasons the claim does not clearly define the metes and bounds of what is claimed and the claim is indefinite. Examiner notes that currently it is believed to be a clarity issue but depending on what Applicants meant/amend it may be a 112a issue.
Claim 8 recites “said sequence of operational stimulation pulses ” however this lacks antecedent basis nowhere earlier in the claim or in the claim from which this depends is this referred to previously. As such it is unclear what the metes and bounds of the element are and the claim is indefinite. Examiner notes that the claim also recites “a sequence of scanning stimulation pulses . . . said control unit is arranged to generate a sequence of operational stimulation pulses, wherein said sequence of operational stimulation pulses comprise more extensive stimulation pulses than said calibration stimulation pulses”, while unclear Applicant may have meant to recite “scanning stimulation pulses”, which if so then the element should be referred to with consistency.
Claim 8 recites “a wider range of variety” which causes a lack of clarity. Examiner believes it’s the use of both “range” and “variety” which causes the confusion. For example, a wider “range” of timing or time-duration would be clear but “range of variety” causes confusion. It’s unclear what the scope of this is and/or what would read on being the same range of variety? For the above reasons the claim does not clearly define the metes and bounds of the claim and the claim is indefinite. Claims depending from this claim share this issue and are likewise rejected. If Applicants would like to discuss this Examiner would recommend an interview.
Claim 10 recites “said varying of said time duration of said stimulation pulses” however this lacks antecedent basis nowhere earlier in the claim or in the claim from which this depends is this referred to previously. As such it is unclear what the metes and bounds of the element are and the claim is indefinite.
Claim 14 recites “with a randomized variation pattern, which variation pattern is preferably a recurring variation pattern.” which causes confusion because it appears to be saying it is randomized pattern then recites the pattern is recurring. The elements seem to contradict each other because a recurring pattern isn’t random? For the above reasons the claim does not clearly define the metes and bounds of the claim and the claim is indefinite.
Claim 14 recites “. . . preferably . . .” the “preferably” causes a clarity issue. Is the portion after the preferably, namely “the measured nerve stimulus response, is measured both positively and negatively” required? Or not? For the above reasons the claim does not clearly define the metes and bounds of the claim and the claim is indefinite.
Claim 15 recites “wherein said randomized pattern” however there is no “randomized pattern” recited earlier in claim 15 or in claim 4 from which it depends. As such it is unclear what randomized pattern is referenced and by extension the claim does not clearly define the metes and bounds of the claim and the claim is indefinite. Examiner notes that as claim 14 recites a “randomized pattern” it is probably a typographical error; for purposes of compact prosecution, it is being interpreted that way for examination. That being said based on what is currently claimed this is a 112b issue.
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(s) 1, 4, 11, 16 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 2018154147 to Izvorski et al. (hereinafter Izvorski; cited in IDS dated 11/18/24).
Regarding Claim 1, an interpretation of Izvorski discloses an electrical nerve stimulation system for stimulating one or more nerves of a mammal with an electrical signal (abstract), said system comprising:
- a signal generation unit arranged for generating electrical stimulation pulses wherein an intensity of said pulses is configured for stimulating said one or more nerves of said mammal ([0048], [0052]-[0053], [0095], Fig. 1);
- a pair of electrodes connected to said signal generation unit and arranged for placement of said electrodes on the outer skin of said mammal ([0055]-[0056], [0152]-[0153] including “Generally, during use two or more electrodes of the device may be placed upon the surface of the body”, Figs. 1, 12A-D see also [0154]-[0158]);
- a control unit arranged for control of said signal generation unit ([0050]-[0052], [0058], [0060], Figs. 1);
- a power supply unit for powering said signal generation unit and said control unit ([0052], [0058], Fig. 1);
wherein said signal generation unit comprises an inductor for inducing said stimulation pulses applied in a symmetric inversed manner to said pair of electrodes ([0066], [0083], [0106]), and said control unit further being arranged to control a variation of the duration and/or timing of said stimulation pulses ([0009], [0050]-[0051] including “The control electronics module 12 may also include the various electronics which are used to effect the treatment, e.g., timers, clocks, DACs, etc. which control the output on/off state, pulse amplitude, timing, modulation, and other pulse parameters.”, [0053], [0063]).
Regarding Claim 4, an interpretation of Izvorski further discloses wherein said control unit is arranged to control generation of said stimulation pulses ([0050]-[0052], [0058], [0060], Figs. 1) as symmetric inversed stimulation pulses ([0066], [0083], [0106]).
Regarding Claim 11, an interpretation of Izvorski further discloses wherein an intensity of said stimulation pulses is configurable ([0009], [0050]).
Regarding Claim 16, an interpretation of Izvorski further discloses an interface unit arranged to provide an operator of said system to control said control unit ([0050]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Izvorski.
Regarding Claim 2, an interpretation of Izvorski discloses an inductor for generating said stimulation pulses (see the rejection of claim 1 above). an interpretation of Izvorski may not explicitly disclose wherein said inductor having at least five-poles.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include at least five poles instead of two, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding Claim 3, an interpretation of Izvorski discloses an inductor for generating said stimulation pulses (see the rejection of claim 1 above). an interpretation of Izvorski may not explicitly disclose wherein said inductor having at least five-poles.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include at least five poles instead of two, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim Rejections - 35 USC § 103
Claim(s) 5-6, 8, 10, 12-15, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Izvorski in view of WO 2021062345 to Lo et al. using US PG Pub US 20220386935 (hereinafter Lo) for paragraph numbers.
Regarding Claim 5, an interpretation of Izvorski may not explicitly disclose wherein said control unit is arranged to measure a nerve stimulus response, and wherein said signal generation unit is arranged to adapt said stimulation pulses based on said measured stimulus response, and preferably, the measured nerve stimulus response, is measured both positively and negatively.
However, in the same field of endeavor (medical stimulation devices), Lo teaches wherein said control unit is arranged to measure a nerve stimulus response ([0083], [0115], [0155]), and wherein said signal generation unit is arranged to adapt said stimulation pulses based on said measured stimulus response ([0115], [0155], [0160]-[0161] see also [0112], [0181], [0213]), and preferably, the measured nerve stimulus response, is measured both positively and negatively ([0083], [0115], [0155], [0160]-[0161] see also [0112], [0181], [0213]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the stimulation device with a power supply, electrodes, controller and stimulation generator of Izvorski to include measurement/sensing elements for feedback and adjusting the stimulation parameters based on the feedback as recited by Lo because it allows for the optimization of the stimulation ([0112], [0115]).
Regarding Claim 6, an interpretation of Izvorski further discloses wherein said adapting comprises varying said time duration of said stimulation pulses response ([0115], [0116] including “stimulation parameters (i.e., the firing timing, pulse width, frequency, intensity, and polarity, and the electrodes to be activated)”, [0155], [0160]-[0161] see also [0112], [0181], [0213]; discloses gathering data responsive to the stimulation determining stimulation parameter adjustments including pulse width).
Regarding Claim 8, an interpretation of Izvorski may not explicitly disclose wherein said control unit is arranged to operate in a scanning mode and an operational mode, wherein in said scanning mode, said control unit is arranged to generate a sequence of scanning stimulation pulses, and measuring a sequence of corresponding nerve stimulus responses, and wherein in said operational mode, said control unit is arranged to generate a sequence of operational stimulation pulses, wherein said sequence of operational stimulation pulses comprise more extensive stimulation pulses than said calibration stimulation pulses, and wherein said more extensive stimulation pulse of said operation mode in particular have a wider range of variety of timing and/or time-duration than said scanning stimulation pulses.
However, in the same field of endeavor (medical stimulation devices), Lo teaches wherein said control unit is arranged to operate in a scanning mode and an operational mode ([0078], [0083], [0090], [0187], [0194], [0196]; Discloses a plurality of modes including stimulation mode(s) (operational modes) and calibration/safety modes (scanning modes)), wherein in said scanning mode, said control unit is arranged to generate a sequence of scanning stimulation pulses, and measuring a sequence of corresponding nerve stimulus responses ([0078], [0083], [0194], [0196]), and wherein in said operational mode, said control unit is arranged to generate a sequence of operational stimulation pulses ([0090], [0187]), wherein said sequence of operational stimulation pulses comprise more extensive stimulation pulses than said calibration stimulation pulses, and wherein said more extensive stimulation pulse of said operation mode in particular have a wider range of variety of timing and/or time-duration than said scanning stimulation pulses ([0074], [0189], [0196]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the stimulation device with a power supply, electrodes, controller and stimulation generator of Izvorski to include calibration modes as recited by Lo where stimulation parameters are applied and the response gathered and based on the feedback the device can determine optimized parameters for stimulation in treatment ([0115], [0194]).
Regarding Claim 10, an interpretation of Izvorski may not explicitly disclose wherein said varying of said time duration of said stimulation pulses comprises randomly increasing or decreasing the time duration of each stimulation pulse within a predefined time duration bandwidth.
However, in the same field of endeavor (medical stimulation devices), Lo teaches wherein said varying of said time duration of said stimulation pulses comprises randomly increasing or decreasing the time duration of each stimulation pulse within a predefined time duration bandwidth ([0074], [0089], [0115], [0189] see also [0112]-[0113], [0213]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the stimulation device with a power supply, electrodes, controller and stimulation generator of Izvorski to include measurement/sensing elements for feedback and adjusting the stimulation parameters based on the feedback as recited by Lo because it allows for the optimization of the stimulation ([0112], [0115]).
Regarding Claim 12, an interpretation of Izvorski may not explicitly disclose wherein said configuration of said intensity of said stimulation pulses is adapted during treatment in accordance with a predefined stimulation pattern.
However, in the same field of endeavor (medical stimulation devices), Lo teaches wherein said configuration of said intensity of said stimulation pulses is adapted during treatment in accordance with a predefined stimulation pattern ([0187], [0189], [0191] see also [0193]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the stimulation device with a power supply, electrodes, controller and stimulation generator of Izvorski to include measurement/sensing elements for feedback and adjusting the stimulation parameters based on the feedback as recited by Lo because it allows for the optimization of the stimulation ([0112], [0115]).
Regarding Claim 13, an interpretation of Izvorski may not explicitly disclose wherein said signal generation unit is arranged for generating said stimulation pulses as symmetric stimulation pulses wherein the pulses supplied to each electrode of said pair of electrodes is inverted in respect of each other.
However, in the same field of endeavor (medical diagnostic devices), Lo teaches wherein said signal generation unit is arranged for generating said stimulation pulses as symmetric stimulation pulses wherein the pulses supplied to each electrode of said pair of electrodes is inverted in respect of each other ([0113], [0187], [0189]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the stimulation device with a power supply, electrodes, controller and stimulation generator of Izvorski to include measurement/sensing elements for feedback and adjusting the biphasic stimulation parameters based on the feedback as recited by Lo because it allows for the optimization of the stimulation ([0112]-[0113], [0115]).
Regarding Claim 14, an interpretation of Izvorski may not explicitly disclose wherein said variation of said stimulation pulses are varied in accordance with a randomized variation pattern, which variation pattern is preferably a recurring variation pattern.
However, in the same field of endeavor (medical stimulation devices), Lo teaches wherein said variation of said stimulation pulses are varied in accordance with a randomized variation pattern ([0088]-[0089], [0097], [0124]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the stimulation device with a power supply, electrodes, controller and stimulation generator of Izvorski to include measurement/sensing elements for feedback and adjusting the stimulation parameters based on the feedback as recited by Lo because it allows for the optimization of the stimulation ([0112], [0115]).
Regarding Claim 15, an interpretation of Izvorski may not explicitly disclose wherein said randomized pattern comprises a pattern of stimulation pulses in which at least one or more is varied of the group of pulse duration, pulse frequency, duty-cycle, time-interval.
However, in the same field of endeavor (medical stimulation devices), Lo teaches wherein said randomized pattern comprises a pattern of stimulation pulses in which at least one or more is varied of the group of pulse duration, pulse frequency, duty-cycle, time-interval ([0088]-[0089], [0097], [0112]-[0113], [0115] see also [0213]; varies one or more parameters).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the stimulation device with a power supply, electrodes, controller and stimulation generator of Izvorski to include measurement/sensing elements for feedback and adjusting the stimulation parameters based on the feedback as recited by Lo because it allows for the optimization of the stimulation ([0112], [0115]).
Regarding Claim 17, an interpretation of Izvorski further discloses wherein said control unit comprises a memory unit storing stimulation parameters ([0050], [0057], [0060]; recite “programmed” programs for microcontrollers are stored on memory).
An interpretation of Izvorski may not explicitly disclose a plurality of predefined stimulation signal varying time duration patterns, for said control unit to select one of said patterns and to control said signal generation unit to induce said stimulation pulses in accordance with said selected pattern.
However, in the same field of endeavor (medical stimulation devices), Lo teaches a memory unit storing a plurality of predefined stimulation signal varying time duration patterns ([0112], [0115], [0181] including “multiple configurations of stimulation settings can be stored in . . . the stimulation device in real-time for multitude of defined tasks.”, [0195] see also [0189], [0213]), for said control unit to select one of said patterns and to control said signal generation unit to induce said stimulation pulses in accordance with said selected pattern ([0088]-[0089], [0097], [0112]-[0113], [0115] see also [0213]; tests a plurality of alternatives to determine optimum parameters).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the stimulation device with a power supply, electrodes, controller and stimulation generator of Izvorski to include measurement/sensing elements for feedback and adjusting the stimulation parameters based on the feedback as recited by Lo because it allows for the optimization of the stimulation ([0112], [0115]).
Regarding Claim 18, an interpretation of Izvorski further discloses wherein said control unit comprises a memory unit storing stimulation parameters ([0050], [0057], [0060]; recite “programmed” programs for microcontrollers are stored on memory).
An interpretation of Izvorski may not explicitly disclose a plurality of predefined stimulation signal intensity patterns, for said control unit to select one of said patterns and to control said signal generation unit to induce said stimulation pulses in accordance with said selected pattern.
However, in the same field of endeavor (medical stimulation devices), Lo teaches a memory unit storing a plurality of predefined stimulation signal intensity patterns ([0112], [0115], [0181] including “multiple configurations of stimulation settings can be stored in . . . the stimulation device in real-time for multitude of defined tasks.”, [0195] see also [0189], [0213]), for said control unit to select one of said patterns and to control said signal generation unit to induce said stimulation pulses in accordance with said selected pattern ([0088]-[0089], [0097], [0112]-[0113], [0115] see also [0213]; tests a plurality of alternatives to determine optimum parameters).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the stimulation device with a power supply, electrodes, controller and stimulation generator of Izvorski to include measurement/sensing elements for feedback and adjusting the stimulation parameters based on the feedback as recited by Lo because it allows for the optimization of the stimulation ([0112], [0115]).
Claim Rejections - 35 USC § 103
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Izvorski in view of Lo in further view of US 20150328461 to Charlesworth et al. (hereinafter Charlesworth).
Regarding Claim 9, an interpretation of Izvorski may not explicitly disclose wherein said control unit is arranged to generate a first and second a sequence of calibration stimulation pulses, wherein said first sequence comprises a larger number of pulses then said second sequence, and wherein said first sequence comprises shorter pulse widths than said second sequence.
However, in the same field of endeavor (medical device stimulators), Lo discloses having a plurality of modes including a treatment (see the rejection of claim 8) and Charlesworth teaches controlling the stimulation to transition two or more properties including duty cycle and pulse widths rendering obvious controlling the generation of a first and second a sequence of calibration stimulation pulses, wherein said first sequence comprises a larger number of pulses then said second sequence, and wherein said first sequence comprises shorter pulse widths than said second sequence ([0015], [0204]-[0205] see also [0193], [0230]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the stimulation device with feedback parameters adjustments and multiple as recited by Izvorski in view of Lo to include controlling the generator to use test different possible pulse width and duty cycles as recited by Charlesworth because it allows for the optimization of comfort and efficacy for the particular user ([0180]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20170197081 to Charlesworth et al. (included in IDS dated 11/18/24)– [0009], [0029], [0203], [0317]
US 20200269046 (included in IDS dated 11/18/24) see [0252]
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/James Moss/Examiner, Art Unit 3792