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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/20/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4-15, and 17-26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 10-12 and 17-18 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.
In regards to claim 10, the term “optionally” in the claim raises questions as to what is actually required by the claim. In this case, it is unclear as to whether or not the stimulation signals need to be synchronized with the indication of sleep fragility. The examiner will interpret the claim with the broadest reasonable interpretation that the stimulation signals do not need to be synchronized with the indication of sleep fragility.
In regards to claim 17, the use of “and/or” clouds the metes and bounds of the range claimed. When “and” is used, the range is 10 Hz to 150 Hz. When “or” is used, the range is 0-150 Hz. It is unclear whether or not the applicant intends to claim stimulation between 0-10 Hz. Under the broadest reasonable interpretation, the Examiner will interpret the claim to limit stimulation to be between 10-150 Hz.
In regards to claim 18, the term “optionally” in the claim raises questions as to what is actually required by the claim. In this case, it is unclear as to whether or not the stimulation must be in a pair with opposite polarity. The examiner will interpret the claim with the broadest reasonable interpretation that the stimulation signals do not need to be paired and in opposite polarity.
In regards to claims 11-12, the claims stand rejected as being dependent on a claim rejected under 35 U.S.C. 112(b).
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.
(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) 22-26 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by U.S. Patent Application Publication 2011/0112590 to Wu (hereinafter “Wu”). In regards to claims 22-26, Wu discloses a stimulation device comprising:
a detection unit (Element 59) arranged to monitor deep brain activity of the nervous system of the patient by monitoring bioelectrical signals derived from monitoring transducers implanted in the neural network of a patient associated with arousal, and to detect characteristics of the monitored deep brain activity associated with a state of reduced arousal and/or wakefulness, wherein the neural network of the patient associated with arousal is the pedunculopontine nucleus or laterodorsal tegmentum ([0028] [0049]); and a stimulation generator arranged, responsive to detecting said characteristics of the monitored deep brain activity associated with a state of reduced wakefulness, to generate stimulation signals for supply to stimulation transducers arranged to apply electromagnetic stimulation to a neural network of a patient associated with arousal, the stimulation signals being selected to arouse the patient when the electrical stimulation is applied ([0144] [0149] [0156] [0157])
wherein the detection unit comprises a sleep stage detector arranged to detect characteristics indicative of a state of sleep of the patient in the monitored deep brain activity ([0093]-[0096])
wherein the detection unit comprises a sleep fragility detector arranged to detect an indication of sleep fragility in the patient in the monitored deep brain activity, and the stimulation generator is arranged to synchronize the stimulation signal with the detected indication of sleep fragility ([0104] [0105])
further comprising the monitoring transducers and/or an interface unit configured to receive signals indicative of peripheral activity of the patient (Element 22, [0032])
Wu also discloses a method of delivering stimulation to a patient comprising:
monitoring deep brain activity of the nervous system of the patient by monitoring bioelectrical signals derived from monitoring transducers implanted in the neural network of a patient associated with arousal ([0028] [0029]); detecting characteristics of the monitored deep brain activity associated with a state of reduced arousal and/or wakefulness, wherein the characteristics comprise an indication of sleep fragility in the patient ([0033] [0044] [0133] [0140] [0144] [0149]); in response to detecting said characteristics of the monitored deep brain activity associated with a state of reduced arousal and/or wakefulness, generating stimulation signals for supply to stimulation transducers arranged to apply electromagnetic stimulation to a neural network of a patient associated with arousal, the stimulation signals being selected to arouse the patient when the stimulation is applied ([0156] [0157])
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) 1, 4-10, 13-15, 17-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Arnulf, I., Ferraye, et al. (2009). “Sleep induced by stimulation in the human pedunculopontine nucleus area. Annals of Neurology.” (hereinafter “Arnulf”) In regards to claims 1, 4-10, 13-15, 17-19, and 21, Wu discloses a method comprising:
monitoring deep brain activity of the nervous system of the patient by monitoring bioelectrical signals derived from monitoring transducers implanted in a neural network of a patient associated with arousal, wherein the neural network of the patient associated with arousal is the pedunculopontine nucleus or laterodorsal tegmentum ([0028] [0049]); detecting characteristics of the monitored deep brain activity associated with a state of reduced arousal and/or wakefulness ([0144] [0149]); in response to detecting said characteristics of the monitored deep brain activity associated with a state of reduced arousal and/or wakefulness, generating stimulation signals for supply to stimulation transducers arranged to apply electromagnetic stimulation to an area of the patient associated with arousal, the stimulation signals being selected to arouse the patient when the stimulation is applied ([0156] [0157])
wherein the stimulation transducers comprise implanted deep brain electrodes and the electromagnetic stimulation is electrical stimulation ([0028] [0143])
wherein the monitoring transducers are integrated with or the same as the stimulation transducers ([0091] [0095], Lead 20 with electrodes 22 perform both sensing and stimulation)
wherein the characteristics of the monitored deep brain activity are indicative of a stage of sleep ([0093])
wherein the characteristics of the monitored deep brain activity correspond to cortical slow wave activity ([0029] [0030])
wherein the characteristic of the monitored deep brain activity correspond to cortical features indicative of non-rapid eye movement Sleep Stage 2, optionally comprising a least one of microarousals, k-complexes, and sleep spindles ([0030] [0031])
wherein the characteristics of the monitored deep brain activity are indicative of rapid eye movement sleep stage ([0030])
wherein the characteristics of the monitored deep brain activity comprise an indication of sleep fragility in the patient, and optionally the stimulation signals are synchronized with the indication of sleep fragility ([0038] [0044] [0133] [0140])
monitoring peripheral activity of the patient; and detecting characteristics of the monitored peripheral activity associated with a reduced state of wakefulness and/or arousal, wherein the stimulation signal is generated in response to detecting the characteristics of the monitored deep brain activity and the characteristics of the monitored peripheral activity ([0133] [0156])
wherein the monitored peripheral activity comprises at least one of: cardiovascular activity, musculoskeletal activity, or physical activity ([0133])
wherein the detected characteristics are patient-specific ([0005])
wherein the stimulation signals have a stimulation frequency of at least 10 Hz and/or at most 150 Hz ([0079])
wherein the stimulation signal comprises at least one stimulation pulse repeating in a cycle, optionally comprising a pair of stimulation pulses of opposite polarity ([0157], Fig. 6 shows a looped logic)
wherein the stimulation signals comprise one or more features representative of an endogenous activity pattern associated with arousal and/or wakefulness ([0022] [0023])
further comprising supplying the stimulation signals to the stimulation transducers ([0089])
However, specifically in reference to claim 1, while Wu distinctly discloses monitoring electrical signals within the pedunculopontine nucleus (PPN) ([0049]), Wu does not distinctly disclose stimulating in the PPN. Arnulf discloses a method of deep brain stimulation where stimulation to treat a patient’s arousal/wakefulness issues is completed by stimulating the PPN (pg. 546-547, see paragraphs beginning with “Two L-doparesponsive…” and “Patient 1…”). It would have been obvious before the effective filing date of the claimed invention to modify Wu to include stimulating at the same neural network that is monitored such as that taught by Arnulf as Arnulf discovered that “low-frequency stimulation of the pedunculopontine nucleus area increased alertness, whereas high-frequency stimulation induced non-rapid eye movement sleep. In addition, the sudden withdrawal of the low-frequency stimulation was consistently followed by rapid eye movement sleep episodes” (Abstract).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu and Arnulf as applied to claim 10 above, and further in view of Lavigne, G. J., et al (2016). “The Neurobiology of Orofacial Pain and Sleep and Their Interactions.” (hereinafter “Lavigne”). Wu and Arnulf do not disclose that the indication of sleep fragility comprises activity within the laterodorsal tegmentum corresponding to at least one of: a microarousal, a k-complex, or a sleep-spindle. However, Lavigne discloses a method of monitoring a patient’s sleep cycle wherein the indication of sleep fragility comprises activity within the laterodorsal tegmentum corresponding to at least one of: a microarousal, a k-complex, or a sleep-spindle (“Overview of Sleep and Underlying Mechanisms”). It would have been obvious before the effective filing date of the claimed invention to modify Wu and Arnulf to include that the indication of sleep fragility comprises activity within the laterodorsal tegmentum corresponding to at least one of: a microarousal, a k-complex, or a sleep-spindle such as that taught by Lavigne as monitoring sleep spindles can indicate the sleep stage of the patient (“Overview of Sleep and Underlying Mechanisms”).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wu and Arnulf as applied to claim 10 above, and further in view of Weber, F. (2017). “Modeling the mammalian sleep cycle. Current Opinion in Neurobiology” (hereinafter “Weber”). Wu and Arnulf do not teach that detecting the indication of sleep fragility comprises applying a machine learning algorithm trained to identify signals within the laterodorsal tegmentum indicative of sleep fragility. However, Weber discloses a method of monitoring the mammalian sleep cycle wherein detecting the indication of sleep fragility comprises applying a machine learning algorithm trained to identify signals within the laterodorsal tegmentum indicative of sleep fragility (Fig. 2 and description of figure). It would have been obvious before the effective filing date of the claimed invention to modify Wu and Arnulf to include that detecting the indication of sleep fragility comprises applying a machine learning algorithm trained to identify signals within the laterodorsal tegmentum indicative of sleep fragility such as that taught by Weber as these signals can provide an insight on when a patient switches from REM to non-REM sleep (Abstract).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu and Arnulf as applied to claim 19 above, and further in view of US Patent Application Publication 2018/0110960 to Youngblood (hereinafter “Youngblood”). Wu and Arnulf do not distinctly disclose that the stimulation signals comprise one or more features representative of one of: alpha, low gamma, or high gamma activity. However, Youngblood discloses a method of stimulating brain to help with sleep wherein the stimulation signals comprise one or more features representative of one of: alpha, low gamma, or high gamma activity ([0227]). It would have been obvious before the effective filing date of the claimed invention to modify Wu and Arnulf to include that the stimulation signals comprise one or more features representative of one of: alpha, low gamma, or high gamma activity such as that taught by Youngblood as these activity levels are associated with frequency bands that encourage sleep in a patient as discussed by Youngblood ([0049]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL JAMES CAREY whose telephone number is (571)270-7235. The examiner can normally be reached Monday-Friday (8am-5pm).
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/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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