DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 January 2026 has been entered.
Comments
The present application is being examined under the pre-AIA first to invent provisions. 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 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.
While the claims recite judicial exceptions, the claims recite the practical application of treatment with electrical therapy. Consequently, the claims are subject matter eligible.
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 February 2024.
Claims 1-9 and 14-17 are pending in the instant application.
Claims 14-17 are examined in the instant Office action.
Claim Comments - 35 USC § 112(f) - Means plus function
The following comments are reiterated:
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “body data processing module,” “seizure onset/termination unit,” “time window control module,” “spectral filter module,” “ratio determination unit,” “ and “ratio threshold comparison unit” in claims 14-17. Pages 26-32 of the specification give support for analysis units and modules being either medical devices or portions of a processor.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Response to arguments:
Applicant argues that the claims recite structure that exempt the claims for be analyzed under 35 U.S.C. 112(f). However, the claims recite “body data processing module,” “seizure onset/termination unit,” “time window control module,” “spectral filter module,” “ratio determination unit,” “ and “ratio threshold comparison unit” wherein the modules are indefinite in terms of structure. While pages 26-32 describe the structure of the modules, the structure of the modules needs to be recited the claims to exempt the claims form being analyzed under 35 U.S.C. 112(f).
Priority
The following comments are reiterated:
The instant application is a continuation-in-part of application 15729168, filed 10/10/2017. The instant application is a continuation of 15377922, filed 12/13/2016. Application ‘922 is a continuation of application 13554367, filed 7/20/2012. Application ‘367 claim benefit to provisional application 61547567, filed 10/14/2011.
Claim 14 recites “apply[ing] a spectral filter having a first predetermined power spectral density to the first time window and a second predetermined power spectral density to the second time window”.
The priority applications are silent with regard to describing power spectral densities, let alone different power spectral densities for different windows of data.
Claim 14 also recites “determin[ing] a ratio of a spectral power between the first time window and the second time window”.
However, the priority applications lack possession of a description of any ratio between spectral powers.
The priority applications do not have support for applying different predetermined power spectral density filters to different windows. This lack of support indicates a lack of possession of this limitation.
Consequently, the benefit date of claims 14-17 is the filing date of 11/15/2020.
Response to arguments:
Applicant's arguments filed 9 October 2025 have been fully considered but they are not persuasive.
While applicant provides general assertions that spectral power densities and ratios of spectral power densities are taught in the priority disclosures, applicant does not provide citations of the locations of the limitations in the priority disclosures. The Examiner did not locate spectral power densities and ratios of spectral power densities in the priority disclosures.
While applicant provides general assertions that Daubechies wavelet order 4, levels 3 and 4 are taught the priority disclosures, applicant does not provide citations of the locations of the limitations in the priority disclosures. The Examiner did not locate Daubechies wavelet order 4, levels 3 and 4 in the priority disclosures. Even assuming (en arguendo) that Daubechies wavelet order 4, levels 3 and 4 are taught in the priority disclosures, applicant provides no arguments or evidence connecting Daubechies wavelet order 4, levels 3 and 4 to the recited limitations of spectral power densities and ratios of spectral power densities.
While applicant argues that the priority disclosures teach autoregression and autoregressive nature of the STA/LTA and WTMM algorithms, applicant provides the general assertion that determination of AIF by analysis of ictal activity relates STA/LTA and WTMM to spectral power densities and ratios of spectral power densities. This argument is not persuasive because applicant does not provide evidence supporting this general assertion.
Claim Rejections - 35 USC § 112(a) - Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following rejection is reiterated:
Claims 14-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 14 has been amended to recite “apply[ing] a spectral filter having a first predetermined power spectral density to the first time window and a second predetermined power spectral density to the second time window”.
The specification is silent with regard to describing power spectral densities, let alone different power spectral densities for different windows of data.
Claim 14 also recites “determin[ing] a ratio of a spectral power between the first time window and the second time window”.
However, the original specification lacks possession of a description of any ratio between spectral powers.
Original claim 14 recites “apply[ing] a spectral filter having a predetermined power spectral density to each of the first time window and the second time window”.
The original specification and original claims do not have support for applying different predetermined power spectral density filters to different windows. This lack of support indicates a lack of possession of this limitation. This lack of possession yields a lack of WRITTEN DESCRIPTION.
Response to arguments:
Applicant's arguments filed 9 October 2025 have been fully considered but they are not persuasive.
While applicant provides general assertions that spectral power densities and ratios of spectral power densities are taught in the instant specification, applicant does not provide citations of the locations of the limitations in the instant specification. The Examiner did not locate spectral power densities and ratios of spectral power densities in the instant specification.
While applicant provides general assertions that Daubechies wavelet order 4, levels 3 and 4 are taught the instant specification, applicant does not provide citations of the locations of the limitations in the instant specification. The Examiner did not locate Daubechies wavelet order 4, levels 3 and 4 in the instant specification. Even assuming (en arguendo) that Daubechies wavelet order 4, levels 3 and 4 are taught in the instant specification, applicant provides no arguments or evidence connecting Daubechies wavelet order 4, levels 3 and 4 to the recited limitations of spectral power densities and ratios of spectral power densities.
While applicant argues that the instant specification teach autoregression and autoregressive nature of the STA/LTA and WTMM algorithms, applicant provides the general assertion that determination of AIF by analysis of ictal activity relates STA/LTA and WTMM to spectral power densities and ratios of spectral power densities. This argument is not persuasive because applicant does not provide evidence supporting this general assertion.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
The following rejection is reiterated:
35 U.S.C. 103 Rejection #1:
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Parhi et al. [IEEE Transactions on Biomedical Circuits and Systems, volume 13, August 2019, pages 645-657] in view of Abrams et al. [US Patent 6,117,066].
The document of Parhi et al. studies a discriminative ratio of spectral power and relative power features derived via frequency-domain model ratio with application to seizure prediction [title]. Figure 1 on page 646 of Parhi et al. illustrates an EEG from an electrode on a patient using a 10 second sliding window with no overlap. Figure 2 of Parhi et al. illustrates the spectral power 2 of the patient of Figure 1 of Parhi et al. with seizure onsets and terminations, the spectral power 3 of the patient of Figure 1 of Parhi et al. with seizure onsets and terminations, and the spectral power ratio 2 to 3 of the patient in Figure 1 of Parhi et al. with seizure onsets and terminations. Figure 2 of Parhi et al. is calculated based on the 10 second windows used in Figure 1 of Parhi et al. The paragraph bridging the columns on page 646 of Parhi et al. teaches onset and termination of seizures when the ratio exceeds and travels below a threshold, respectively. The mathematics in equations 2-15 on page 648 of Parhi et al. teach mathematical analysis of power spectral densities as a function of time.
Parhi et al. does not teach providing electrical therapy to the subject.
The document of Abrams et al. teaches prevention of a seizure arising from medical magnetoictal non-convulsive stimulation therapy [title]. Column 1 , lines 20-31 of Abrams et al. teaches providing electrical therapy to a subject.
It would have been obvious to one of ordinary skill in the art at the time of the instant invention to modify the threshold analysis of Parhi et al. by use of the electrical therapy of Abrams et al. wherein the motivation would have been that Abrams et al. provides a potential solution to the problem of seizures of Parhi et al. [Column 1 , lines 20-31 of Abrams et al.].
Response to arguments:
Applicant's arguments filed 9 October 2025 have been fully considered but they are not persuasive.
Applicant argues that in view of the allegedly incorrect benefit date associated with the claim, Parhi et al. does not qualify as prior art under 35 U.S.C. 103. This argument is not persuasive because the benefit date of 11/15/2020 assigned to the claim is accurate (for the reasoning discussed above). Consequent, the August 2019 publication date of Parhi et al. qualifies Parhi et al. as being prior art under 35 U.S.C. 103.
The following rejection is reiterated:
35 U.S.C. 103 Rejection #2:
Claims 15-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Parhi et al. in view of Abrams et al. as applied to claim 14 above, in further view of John et al. [US PGPUB 2002/0091335 A1].
Claim 15 recites that the body data processing module comprises an interface, a buffer, an amplifier, and A/D converter, a filter, and a memory.
Parhi et al. and Abrams et al. make obvious analysis of electrical data to control seizures, as discussed above.
Parhi et al. and Abrams et al. do not teach the structural limitations of the claim.
The document of John et al. teaches a brain function scan system [title]. The cover figure of John et al. illustrates the structural limitations of the claim.
With regard to claims 16-17, the Figure 1 of Parhi et al. illustrates electrical signals as a function of selectable time windows. Figure 2 of Parhi et al. illustrates applying spectral filters, determining spectral power ratios, and comparing these ratios to whether a threshold has been exceeded or undermined in order to determine onset and termination of a seizure.
It would have been obvious to one of ordinary skill in the art at the time of the instant invention to modify the threshold analysis of Parhi et al. and the electrical therapy of Abrams et al. by use of the structure of John et al. wherein the motivation would have been that John et al. automates analysis of brain signal data [cover figure of John et al.]. There would have been a reasonable expectation of success in combining Parhi et al., Abrams et al., and John et al. because all three studies analogously pertain to analysis of brain function data.
Response to arguments:
Applicant's arguments filed 9 October 2025 have been fully considered but they are not persuasive.
Applicant argues that Abrams et al. and John et al. do not cure the alleged deficiencies of Parhi et al. This argument is not persuasive because, as discussed above, Parhi et al. is not deficient.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
No claim is allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Russell Negin, whose telephone number is (571) 272-1083. This Examiner can normally be reached from Monday through Thursday from 8 am to 3 pm and variable hours on Fridays.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Larry Riggs, Supervisory Patent Examiner, can be reached at (571) 270-3062.
/RUSSELL S NEGIN/ Primary Examiner, Art Unit 1686 28 February 2026