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 .
Terminal Disclaimer
The terminal disclaimer filed on 3/11/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patents 9925378; 10130816;10369364; and 11691012 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's amendment and arguments regarding Miyazawa et al. (2009/0112281) filed 3/11/2026 have been fully considered but they are not persuasive. Miyazawa discloses utilizing measures of association of two different biosignals (ratios, differences, summations, etc) to monitor pain and control stimulation, see par. [0097].
Applicant's amendment and arguments regarding Alves et al. (2014/0343623) filed 3/11/2026 have been fully considered but they are not persuasive. The Examiner notes the phrase “a different type of biosignal” is broad and Alves discloses calibrating the device by taking a first signal which is indicative of an unacceptable level of pain, storing it and then taking a second signal indicative of an acceptable level of pain. Either of this can be a first type of a biosignal (a type of when the pain level is known). Alves then discloses taking a second type of biosignal (a type of when the pain level is not known) and comparing it to the first type to determine a level of pain (par. [0088]). The rejection is maintained.
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 1-6, 8-11, 13, 15 and 16 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 “analyzing the biosignals”. It is unclear if Applicant is referring to “the plurality of biosignals” previously claimed or if Applicant is only referring to “the first biosignal” and “the second biosignal”. Due to Applicant’s amendment, the latter case seems the intent. If so, the Examiner suggests amending the analyzing step to read “analyzing the first and second biosignals to calculate at least one measure of association between the first and second biosignals; determining whether the at least one measure of association is indicative of pain; and altering, by the electrical stimulation device, at least one stimulation parameter of a stimulation system in response to the measure of association being indicative of pain” or some variant thereof.
Claim 4 recites “at least one of the biosignals”. It is unclear if this is one of the plurality of biosignals (which could be more than just the first and second biosignal) or if the claim is referring only to the first or second biosignal.
Claims 5 and 6 recite “analyzing the biosignals”; “determining that the biosignals”; and “at least one of the biosignals”. It is unclear if Applcaint is referring to the plurality of biosignals (which could be more than just the first and second biosignal) or if the claim is referring only to the first or second biosignal.
Claim 8 states the measure of association could be a coherence, bicoherence, phase-amplitude coupling, or correlation “of at least two of the biosignals”. However, Claim 1 was amended to require the measure of association to be between the first and second biosignals. It is unclear if Applicant is referring to other signals of the plurality or if the measures still need to be only the first and second biosignals.
Claim 9 states the signals are of the same type, which contradicts Claim 1 requiring the signals to be of different types.
Claims 9-11 refer to “the biosignals”. It is unclear if this is the previously claimed plurality of biosignals or if Applicant is referring only to the first and second biosignals.
Claims 10 and 11 also state “the same location”. There is insufficient antecedent basis for this limitation in the claims.
Claim 13 states “between at least two of the signals”. However Claim 11 only requires two signals. The Examiner suggests amending the claim to read “between the two biosignals” to maintain consistent language in the claims.
Claim 15 states “the two biosignals measured at a same location”. There is insufficient antecedent basis for this limitation in the claim. The same issue is found in Claim 16.
Claims 2 and 3 are rejected based on their dependence on indefinite claim 1.
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.
Claims 1-6, 8-13 and 17-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Alves et al. (2014/0343623).
Regarding Claims 1 and 4-6, Alves discloses a method for stimulating a patient using an electrical stimulation device 112 (Fig. 1A) comprising obtaining two different types of biosignals from a dorsal root ganglion (DRG), wherein a first type of signal is a signal in which the pain level is known (i.e. a calibration signal of an unacceptable level of pain and a calibration signal of an acceptable level of pain) and a second type of signal is one in which a level of pain is unknown (par. [0088]); analyzing the biosignals by comparing the frequency content (power spectrum) of the signal of the unknown level of pain to frequency content of the calibrated signals of known levels of pain (par. [0088]); and altering stimulation applied by the stimulation system (such as turning on the stimulator, see step 304, or adjusting stimulation parameters, see step 308; Fig. 3, par. [0066])) when the signals are indicative of pain, i.e. the signals match the frequency content, range of frequencies of known pain states.
In regard to Claims 2 and 17, Alves discloses the stimulation is applied to one or more selected electrodes 116 (Fig. 1A) that are selectable via switch device 135 (Fig. 1B; par. [0032-0033]).
With regard to Claims 3 and 18, Alves discloses the stimulation parameters are communicated to a control module (controller 134 can be programmed from programmer 122; or alternatively, control module 132 can be sent instructions from controller 134; pa. [0043]; Fig. 1B).
With regard to Claims 8, 10, 11 and 13, Alves discloses obtaining baseline signals from a DRG at a first time (one indicative of unacceptable pain levels and one indicative of reduced or acceptable pain levels). Subsequent signals from the DRG (same location, different time and type) are then compared to those signals to determine a measure of association (a correlation) and the signal is identified as a pain signal or acceptable signal based on the correlation of the frequency content (par. [0088]).
In regard to Claim 9, Alves discloses each of the electrodes 116 (which are spatially separated an thus obtain signals from different body locations) can be used to obtain bio signals (par. [0065]).
Regarding Claims 12, 19 and 20, Alves discloses a method for stimulating a patient using an electrical stimulation device 112 (Fig. 1A) comprising obtaining two different types of biosignals from a dorsal root ganglion (DRG), wherein a first type of signal is a signal in which the pain level is known (i.e. a calibration signal of an unacceptable level of pain and a calibration signal of an acceptable level of pain) and a second type of signal is one in which a level of pain is unknown (par. [0088]); analyzing the biosignals by comparing the frequency content (power spectrum) of the signal of the unknown level of pain to frequency content of the calibrated signals of known levels of pain (par. [0088]); and altering stimulation applied by the stimulation system (such as turning on the stimulator, see step 304, or adjusting stimulation parameters, see step 308; Fig. 3, par. [0066])) when the signals are indicative of pain, i.e. the signals match the frequency content, range of frequencies of known pain states.
Claims 1, 10, 12, 15 and 16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Miyazawa et al. (2009/0112281).
Regarding Claims 1,10 and 12, Miyazawa discloses obtaining biosignals (EEG signals using EEG scalp electrodes) from the brain of a patient (which is a group of nerves); obtaining power spectrum measurements from the EEG to brain data from the Delta, Theta, Alpha, etc. bands of the EEG signal (see Table I); determine whether the power levels in various bands are indicative of pain by determining a measure of association (ratios, summations, differences) between the different bands (par. [0097]); and altering stimulation based on a pain indication (par. [0093]). The various bands are commensurate in scope with how Applicant defines “two different types of biosignals”, see par. [0049] of Applicant’s specification as published.
Regarding Claims 15 and 16, the Examiner notes the EEG signals can be interpreted as being from the same location (the brain) and can also be considered measured from different locations (each individual electrode of the EEG electrode array). Applicant has not defined “location” with any level of specificity and the two interpretations fall within the BRI of the claim as currently written.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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