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 .
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 2-5, 14-17, and 20-22 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.
Regarding claim 14, the phrase “the neural signals” in line 4 lacks proper antecedent basis. For this examination, the phrase is being interpreted as “neural signals”.
Regarding claim 16, it is unclear what further limitation the claim provides to the invention as claim 14 already recites providing treatment in step (d).
Regarding claim 17, the recitation of “the treatment includes one or more of the following: vagus nerve stimulation (VNS), responsive neurostimulation (RNS), deep brain stimulation (DBS) trigeminal nerve stimulation (TNS)” renders the claim indefinite in that these treatments are already recited in claim 14 (emphasis added). Claim 14 requires targeting an onset zone with one of VNS, RNS, DBS, or TNS, but then claim 17 provides an option for not providing one of those treatments (according to claim 17, the subject could be treated with anti-seizure medication, sleep medication, medical cannabis, or “ketogenic diet therapy”). Further regarding claim 17, it is unclear how a “ketogenic diet therapy” would be “administered” to the subject. A recommendation for ketogenic diet therapy could be provided, but it remains unclear how the ketogenic diet therapy itself would be administered to a subject.
Regarding claim 20, the phrase “and/or specific region” lacks proper antecedent basis.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
Claim Rejections - 35 USC § 102
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.
Claims 2, 3, 14-17, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Modur’370 (US Pub No. 2018/0000370 – previously cited).
Regarding claim 14, Modur’370 discloses a method for predicting a location in the brain of a subject that is associated with epilepsy (see TITLE, ABSTRACT, and section [0014]), the method comprising: identifying HFOs by detrending neural signals (sections [0005], [0048], [0069]); identifying the HFOs through one or more objective and training-free strike tests selected from the group consisting of (i) amplitude, (ii) rhythmicity, and (iii) ringing (sections [0048], [0069] – amplitude, as discussed in the last line of section [0069]), wherein the neural signals are obtained from the brain of the subject (see above); analyzing presentation of the HFOs (sections [0014], [0055-0057], [0066-0067], [0093]); determining a seizure onset zone based upon the analyzed presentation of HFOs ([0014], [0055-0057], [0066-0067], [0093]); and targeting the onset zone with responsive neurostimulation (sections [0021], [0040], [0043], [0056]).
Regarding claim 2, the neural signals are obtained using EEG (see ABSTRACT and sections [0005], [0044]).
Regarding claim 3, the neural signals are obtained using ECoG or iEEG (section [0044]).
Regarding claim 15, the presentation of the HFOs includes a presence of HFOs in numbers above a predetermined threshold and/or a presence of HFOs in a determined location (sections [0014], [0055-0057], [0066-0067], [0093]).
Regarding claim 16, Modur’370 discloses that the method further comprises providing treatment to the subject (see ABSTRACT, and sections [0021], [0040], [0043], [0056]).
Regarding claim 17, the treatment includes responsive neurostimulation and/or anti-seizure medication (sections [0021], [0040], [0043], [0056]).
Regarding claim 21, the subject has been diagnosed as having epilepsy (treatment of epilepsy is provided for subjects having epilepsy; furthermore, sections [0075] and [0098] disclose performing the method on subjects having epilepsy).
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 2, 14-17, 20, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over He et al.’247 (US Pub No. 2021/0106247 – previously cited) in view of Modur’370.
Regarding claim 14, He et al.’247 discloses a method for predicting a location in the brain of a subject that is associated with epilepsy (see TITLE, ABSTRACT, and sections [0010], [0018-0019], [0054]), the method comprising: identifying HFOs by detrending neural signals obtained from the brain of the subject (sections [0021-0023]); identifying HFOs through one or more objective and training-free tests selected from the group consisting of (i) amplitude and (ii) rhythmicity (sections [0022-0023], and see claim 7); analyzing presentation of the HFOs (sections [0010], [0018-0019], [0032-0033], [0043-0045]); and determining a seizure onset zone based upon the analyzed presentation of HFOs (see TITLE, ABSTRACT, and sections [0010], [0018-0019], [0032-0033], [0043-0045], [0054]).
He et al.’247 discloses all of the elements of the current invention, as discussed above, except for the method comprising targeting the onset zone with vagus nerve stimulation, responsive neurostimulation, deep brain stimulation, or trigeminal nerve stimulation. It is noted that He et al.’247 does disclose using neurostimulation that targets an epileptogenic zone to treat a subject (sections [0003], [0009]). Modur’370 teaches a method of providing neurostimulation to an epileptogenic zone responsive to identifying HFOs (see ABSTRACT). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of He et al.’247 such that its neurostimulation is provided to identified epileptogenic zones in response to the identification of HFOs, as it would merely be combining prior art methods according to known methods to yield predictable results. The modification to He et al.’247 would ensure that neurostimulation is provided to a target location upon the identification of the target location.
Regarding claim 2, the neural signals are obtained using MEG or EEG (sections [0010-0011], [0018-0019] of He et al.’247).
Regarding claim 15, presentation of the HFOs includes a presence of HFOs in a determined location (see Figure 1, boxes 103 and 104, Figure 3, Figures 6A, 6B, 6F, 6G, and sections [0010], [0019] of He et al.’247).
Regarding claims 16 and 17, the responsive neurostimulation taught by He et al.’247 in view of Modur’370 is a treatment that includes responsive neurostimulation. Furthermore, He et al.’247 discloses that subjects having epilepsy are usually treated with anti-seizure medication to suppress or prevent seizures (section [0003]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of He et al.’247 to include treating the subject with anti-seizure medication, as He et al.’247 teaches that subjects having epilepsy are usually treated with anti-seizure medication to suppress or prevent seizures. Additionally, He et al.’247 discloses in its ABSTRACT that the method can be used as an aid in surgical resection for the treatment of epilepsy, and further discloses in sections [0003-0005] that HFO identification can be used to guide effective resective surgery. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of He et al.’247 to further include providing treatment to the subject (resective surgery), as He et al.’247 teaches that its method can be used to aid in surgical resection for the treatment of epilepsy. The modification to He et al.’247 would provide a method that not only identifies epileptogenic zones based on identified HFOs, but also provides treatment to the subject.
Regarding claim 20, the method further comprises determining whether the onset zone is a candidate for surgical intervention (see ABSTRACT, and section [0019] of He et al.’247).
Regarding claim 21, the subject has been diagnosed as having epilepsy (see ABSTRACT of He et al.’247 – treatment of epilepsy is provided for subjects having epilepsy; section [0010] of He et al.’247: “… with a process for identifying HFOs in scalp EEG recordings for patients with medical refractory epilepsy…”).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over He et al.’247 in view of Modur’370, as applied to claim 1, further in view of Weiss et al.’347 (US Pub No. 2021/0145347 – previously cited).
Regarding claims 4 and 5, He et al.’247 in view of Modur’370 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the identifying step including ringing strike tests. Weiss et al.’347 teaches performing a ringing strike test on candidate ripple events (the same type of candidate ripple events taught by He et al.’247) in order to determine whether the candidate ripple event is a true ripple event or not (section [0097]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of He et al.’247 in view of Modur’370 to be configured to implement a ringing strike test to identify HFOs, as this would help identify true HFOs as opposed to ones that result from filter ringing.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over He et al.’247 in view of Modur’370, as applied to claim 14, in view of Weiss et al.’345 (US Pub No. 2019/0307345 – previously cited).
He et al.’247 in view of Modur’370 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the method comprising conducting multiple identifications of HFOs and comparing presentation of the HFOs from the multiple identifications. Weiss et al.’345 teaches generating a brain stimulation regimen based on a history of HFO detections (section [0041]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of He et al.’247 in view of Modur’370 to include conducting multiple identifications of HFOs and comparing presentation of the HFOs from the multiple identifications, as this would allow a brain stimulation regimen to be generated based on historical HFO data. The modification to He et al.’247 in view of Modur’370 would allow treatment to the subject to be adjusted based on trend data, which is a well known method step in the medical diagnostic and treatment art.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Modur’370 in view of He et al.’247, as applied to claim 14, in view of Weiss et al.’345.
Modur’370 discloses all of the elements of the current invention, as discussed in paragraph 5 above, except for the method comprising conducting multiple identifications of HFOs and comparing presentation of the HFOs from the multiple identifications. Weiss et al.’345 teaches generating a brain stimulation regimen based on a history of HFO detections (section [0041]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Modur’370 to include conducting multiple identifications of HFOs and comparing presentation of the HFOs from the multiple identifications, as this would allow a brain stimulation regimen to be generated based on historical HFO data. The modification to Modur’370 would allow treatment to the subject to be adjusted based on trend data, which is a well known method step in the medical diagnostic and treatment art.
Response to Arguments
Applicant's arguments filed 03 April 2026 have been fully considered.
Regarding the previous rejections of claims under 35 U.S.C. 112(b), while the amendments to the claims have overcome some of the rejections, as noted in paragraph 3 above, indefiniteness issues remain in some claims. With specific regard to claim 17, it remains unclear how a diet therapy would be administered to a subject. It is understood how it could be recommended to a subject to adhere to a specific diet, but it is not clear how a diet itself would be “administered” to the subject.
Regarding the rejection of the claims under 35 U.S.C. 101, the amendments to the claims have overcome the rejection by reciting targeting the determined seizure onset zone with treatment.
Regarding the rejections of the claims in view of the previously cited prior art, Applicant’s arguments are not persuasive.
With regard to the He reference, Applicant argues that “objective and training-free” in the present applications refers to HFO identification that does not rely on tuned/heuristic parameter thresholds or training/parameter fitting based on prior labeled or unlabeled datasets, and that He’s pipeline includes steps using tuned parameters (it is noted that Applicant does not point to where “He’s pipeline includes steps using tuned parameters”). The Examiner respectfully disagrees. Sections [0022-0023] and claim 8 of He make clear that the thresholds used to identify HFOs are determined from the acquired EEG signals themselves, not from “tuned/heuristic parameters” or “training/parameter fitting based on prior labeled or unlabeled datasets”. Like Applicant’s invention, the tests taught by He compare event properties to surrogate values derived from the event itself.
Applicant’s argument that He does not disclose “targeting the onset zone with VNS, RNS, DBS, or TNS” as required by amended claim 14 has been addressed by modifying He in view of Modur.
Applicant’s argument that He does not disclose determining a seizure onset zone based upon the analyzed presentation of HFOs is not persuasive. He explicitly discloses determining a seizure onset zone based on the analyzed presentation of HFOs (TITLE, ABSTRACT, and sections [0010], [0018-0019], [0032-0033], [0043-0045], [0054]). As modified by Modur, the determined seizure onset zone is targeted with RNS.
With regard to the Modur reference, Applicant argues that Modur fails to disclose “objective and training-free strike tests” because Modur “relies on predetermined thresholds and/or other tuned criteria” – it is noted that Applicant does not cite to where Modur teaches “predetermined thresholds and/or other tuned criteria”). The Examiner respectfully disagrees. Section [0048] and the last sentence of section [0069] of Modur clearly disclose determining a threshold based on an acquired EEG signal. Like Applicant’s invention, the tests taught by Modur compare event properties to surrogate values derived from the event itself.
Applicant’s argument that Modur does not disclose “targeting the onset zone with VNS, RNS, DBS, or TNS” is not persuasive as Modur clearly discloses targeting the onset zone with RNS (sections [0021], [0040], [0043], [0056]). Contrary to Applicant’s assertion, claim 14 does not require targeting the determined onset zone with VNS/DBS/TNS in addition to RNS. The claim requires targeting the determined onset zone with one of VNS, RNS, DBS, or TNS. Modur clearly discloses targeting the determined onset zone with RNS.
Applicant’s argument that Modur does not “disclose the ordered combination culminating in neuromodulation targeting based on HFO-derived seizure onset zone determination” is not persuasive as Applicant does not explain why Modur does not “disclose this complete integrated workflow as claimed”. Furthermore, it is noted that the steps recited in a method claim need not be performed in the order in which they appear in the claim unless the claim specifically recites the order in which the steps are performed.
Applicant’s arguments against modifying He in view of Weiss are not persuasive as Applicant provides arguments against the Weiss reference alone and not the combination of He in view of Weiss. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding the rejection of claims 16 and 17 in view of He, the Examiner respectfully disagrees with Applicant’s argument that statements that epilepsy patients are commonly treated with anti-seizure medication and that HFO identification may aid surgical resection do not teach or suggest modifying He to perform the claimed additional method steps. Such statements provide motivation to perform the treatments that are commonly used to treat epilepsy patients.
Regarding the rejection of claim 22, Applicant argues that Weiss’345 does not provide a reasoned basis to modify He or Modur to include conducting multiple identifications of HFOs and comparing presentation of the HFOs from the multiple identifications. The Examiner respectfully disagrees. Weiss’345 provides motivation to modify both He and Modur so that a brain stimulation treatment plan can be generated based on historical HFO data. The Examiner maintains that it is well known in the art to adjust treatment to a subject based on physiological signal analysis over time. Treatment is adjusted based on how it affects the subject. The effect of the treatment can be seen in any changes in the presentation of HFOs over time.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Blanco et al.’481 (US Pub No. 2012/0245481 – previously cited) teaches a method for identifying high frequency oscillations in neural signals of the brain, wherein the method is used to identify a location in the brain associated with epilepsy. It specifically teaches detrending a neural signal. Al-Bakri (High Frequency Oscillations… – previously cited) discloses the claimed subject matter, but does not qualify as prior art due to an embargo placed on the reference.
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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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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