DETAILED ACTION
Acknowledgements
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-19 are pending.
This action is Non-Final.
Election/Restrictions
Applicant’s election without traverse of Species B (claims 5-15) in the reply filed on 6/9/2026 is acknowledged. Claims 1-4, 16-19 are withdrawn from further consideration.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Fig. 1 ‘185’; Fig. 2 ‘291’; Fig. 9 ‘980’. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: paragraphs [52], [53] states “gathering elements 310-320”, however there are no elements between 310 and 320 such as 311, 312, …,319 in the drawings. The specification likely should be amended to recite “310 and 320”. 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. 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.
Specification
The disclosure is objected to because of the following informalities: paragraphs [52], [53] states “gathering elements 310-320”, however there are no elements between 310 and 320 such as 311, 312, …,319 in the drawings. The specification likely should be amended to recite “310 and 320”. Abbreviations should be defined prior to usage including EKG (defined first in [35], but used prior, PKG (never defined).
Appropriate correction is required.
Claim Objections
Claims 7-8, 11 are objected to because of the following informalities: claim terminology should be clear and consistent: Claims 7-8, 11 “said first signal” and “the first signal” should be limiting the “first biological signal”; claim 11 “the second signal” should read “the second biological signal”. Abbreviations should be described prior to usage, claim 11 refers to PKG which is not defined. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 11 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 19, 21-23 are rejected for inadequate written description because the specification as filed merely repeats the claim limitations without explaining how the claimed functional limitations generate the claimed results including for all parameters claimed.
Regarding claim 11, the term “PKG” is rejected for lack of adequate written description. While the claimed term is original to the disclosure as filed, the term is never set forth and it is not clear what is meant by “PKG”. It also does not appear to be a common term in the art, such that it is not clear what applicant means. Applicant is invited to explain what the term is and where basis for any additional description needed to properly define the term can be found. Otherwise the term should be removed from the claims. For these reasons, one of skill in the art would not have recognized applicant to be in possession of the claimed invention at the time the application was filed.
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 7, 11, 15 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 pre-AIA the applicant regards as the invention.
Regarding claim 7, the limitations “wherein said first indication is based at least in part on a first feature of said first signal or feature thereof, and said second indication is based at least in part on a first feature of a second biological signal or feature thereof” render the claim indefinite. Claim 7 is a method claim which depend on the claim 5 processes including “receiving a first indication to acquire a first biological signal or feature thereof from a patient; acquiring said first biological signal or feature thereof; receiving a second indication to stop acquiring said first biological signal or feature thereof, wherein the second indication relates to a detection of an end of a brain state change; and stopping acquisition of said first biological signal or feature thereof”. However, it is not clear how the first indication can be based on the first signal when the indication triggers acquiring the first signal. It appears that this process is not possible based on the required limitations set forth in claim 5. It is not clear what applicant intends by this limitation. This makes the metes and bounds of the claim unclear which renders the claim indefinite. No prior art can be speculatively applied to claim 7 as such would be improper, In re Steele. MPEP 2173.06:
“Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.”
Regarding claim 11, the term “PKG” renders the claim indefinite. As addressed above, while the claimed term is original to the disclosure as filed, the term is never set forth and it is not clear what is meant by “PKG”. It also does not appear to be a common term in the art, such that it is not clear what applicant means. Applicant is invited to explain what the term is and where basis for any additional description needed to properly define the term can be found. Otherwise the term should be removed from the claims. For these reasons, the metes and bounds of the claim are unclear which renders the claim indefinite.
Regarding claim 15, the limitations render the claim indefinite. The claim depends on claim 8 which sets forth alternatives, but claim 15 does not further limit any of the specific alternatives and does not contain proper antecedent basis. Therefore the metes and bounds are unclear and renders the claim indefinite. For examination purposes, the claim does not further limit the features of claim 8 and is thus met by the art teaching claim 8 features.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 5-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
Claim 5:
receiving a first indication to acquire a first biological signal or feature thereof from a patient (mental process including observation; mathematical concept related to signal comparisons)
receiving a second indication to stop acquiring said first biological signal or feature thereof, wherein the second indication relates to a detection of an end of a brain state change (mental process including observation; mathematical concept related to signal comparisons)
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
acquiring said first biological signal or feature thereof (features related to data gathering i.e. insignificant extra-solution activity)
stopping acquisition of said first biological signal or feature thereof (features related to data gathering (i.e. the lack of data gathering) i.e. insignificant extra-solution activity)
These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination, they do not add significantly more to the exception. Analyzing the additional claim limitations individually, the additional limitation that is not directed to the abstract idea are the same as those identified above in step 2A related to acquiring and stop acquiring data/signals. Such limitations are recognized by the courts as routine data gathering in order to input data to the mental process/algorithm, and thus, do not add a meaningful limitation to the method as it would be routinely used by those of ordinary skill in the art in order to apply the mathematical algorithm/mental process. The method does not contain any computing structure, such that the steps can all be analog/mental processing of the data gathered which further supports that the claims are directed to a judicial exception without significantly more. The additional limitations recited in the dependent claims are directed to further details of the data gathered using conventional, well-known, and routine signals (see art rejections), and to further details of judicial exceptions (A more specific abstraction is still an abstraction). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 5, 6, 8 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Denison et al. (US 2008/0269631).
Regarding claim 5, Dennison teaches a method, comprising:
receiving a first indication to acquire a first biological signal or feature thereof from a patient (see at least Figures 10, 14 yes of 312, [0149] brain potential model control signal to turn on, [0162] In each case, the module 202, 204 that is not being monitored at a given time may be turned off or its output may be ignored.);
acquiring said first biological signal or feature thereof (see at least Figure 14, [0150] acquire brain potential signals);
receiving a second indication to stop acquiring said first biological signal or feature thereof, wherein the second indication relates to a detection of an end of a brain state change (see at least Figure 14 “no” module turned off return to 310, yes, therapy delivered and module turned off to return to 310); and
stopping acquisition of said first biological signal or feature thereof (see at least [0149], [0162] turn off module when not actively monitoring signals).
Regarding claim 6, Dennison teaches wherein at least one of said first indication or said second indication is based at least in part on at least one second biological signal or feature thereof from said patient (see at least Figures 10, 14 yes of 312, impedance measurement).
Regarding claim 8, Dennison teaches wherein the first signal or feature thereof is selected from an autonomic signal or feature thereof, a neurologic signal or feature thereof, a metabolic signal or feature thereof, an endocrine signal or feature thereof, or a tissue stress marker signal or feature thereof (see at least Figure 14 brain potential).
Claims 5, 6, 8-15 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Osorio (US 2011/0251468).
Regarding claim 5, Osorio teaches a method, comprising:
receiving a first indication to acquire a first biological signal or feature thereof from a patient (1-desired time to monitor from milliseconds to years occurs: see at least [0120] “Monitoring 610 for an indication of a triggering event, such as a signal from autonomic or neurologic index detection unit 265a, is performed. Monitoring 610 may be performed at any desirable time scale (from milliseconds to years)”, [0121]; or 2- result of triggering event to perform test of responsiveness);
acquiring said first biological signal or feature thereof (1- see at least Figures 6a-e, 5, monitor collects index values after indication, [0074]; or 2- collects data from 640 including any of 681-688, including 690);
receiving a second indication to stop acquiring said first biological signal or feature thereof, wherein the second indication relates to a detection of an end of a brain state change (see at least (1- Figures 6A-C, no results at 620, 660, 675, 6e, and/or all paths leading back to 610, or 2- end of responsiveness testing); and
stopping acquisition of said first biological signal or feature thereof (1- see at least Figures 6a-e, [0120] time between 610 as desired from milliseconds to years for next 610; 2- until next triggering event has occurred).
Regarding claim 6, Osorio teaches wherein at least one of said first indication or said second indication is based at least in part on at least one second biological signal or feature thereof from said patient (alternatives claimed, see at least Figures 6a-e, no can be based on second signal to return to 610; [0121] index can also trigger 610).
Regarding claim 8, Osorio teaches wherein the first signal or feature thereof is selected from an autonomic signal or feature thereof, a neurologic signal or feature thereof, a metabolic signal or feature thereof, an endocrine signal or feature thereof, or a tissue stress marker signal or feature thereof (see at least Figure 5, [0121]).
Regarding claim 9, Osorio teaches wherein the second biological signal or feature thereof is selected from an electrocardiography (EKG) signal or feature thereof or a kinetic signal or feature thereof (2- see at least [0112]), and the first biological signal or feature thereof is selected from the other of said EKG signal or feature thereof and kinetic signal or feature thereof, an electroencephalography (EEG) signal or feature thereof, an electrocorticography (ECoG) signal or feature thereof, a reaction time signal or feature thereof, an awareness signal or feature thereof, or a responsiveness signal or feature thereof (2- see at least Figures 5, 6a-e, [0121], [0127], [0166]).
Regarding claim 10, Osorio teaches wherein said second biological signal or feature thereof is selected from at least one of a cardiac signal or feature thereof, a kinetic signal or feature thereof, or a respiratory signal or feature thereof (2- see at least Figure 5, [0074]-[0075], Figures 6A-E); said first biological signal or feature thereof is selected from at least one of said cardiac signal or feature thereof, said kinetic signal or feature thereof, and said respiratory signal or feature thereof, provided said first biological signal or feature thereof is different from said second biological signal or feature thereof (2- see at least [0088], [0112]); said first indication is based at least in part on said second biological signal or feature thereof (or 2- result of triggering event to perform test of responsiveness); and said first indication is indicative of an epileptic event (see at least [0062],[0127]).
Regarding claim 11, Osorio teaches wherein the first signal or feature thereof is a heart rate, a heart rate variability, an EKG morphology, or a PKG morphology (2- see at least [0088] In certain embodiments, one or more autonomic and/or neurologic indices may give information relating to the patient's attention and/or effort given to the test. [0112] physiological data such as autonomic and neurologic index values, such as heart rate or EKG morphology changes or breathing rate or pattern changes, among others, disease status (progression, regression, or stabilization), quality of life data, etc. [0096]), and the second signal or feature thereof is a different one of said heart rate, said heart rate variability, said EKG morphology, or said PKG morphology (2- see at least [0074] For still a further example, a plurality of autonomic and/or neurologic (e.g., brain, cranial nerve, or kinetic) index value(s) may be used to determine whether a medical event has occurred. For example, the triggering event may be a finding that the patient's heart rate is above a threshold value at a time when a body kinetic signal shows the patient's body orientation is reclined or when it indicates the patient stopped moving.).
Regarding claim 12, Osorio teaches wherein the second biological signal or feature thereof is a cortical brain signal or feature thereof (2- see at least [0116] EEG, [0074] For still a further example, a plurality of autonomic and/or neurologic (e.g., brain, cranial nerve, or kinetic) index value(s) may be used to determine whether a medical event has occurred. For example, the triggering event may be a finding that the patient's heart rate is above a threshold value at a time when a body kinetic signal shows the patient's body orientation is reclined or when it indicates the patient stopped moving.) and the first biological signal or feature thereof is an electrocardiography (EKG) signal or feature thereof, a respiratory signal or feature thereof, a kinetic signal or feature thereof, a reaction time signal or feature thereof, an awareness signal or feature thereof, or a responsiveness signal or feature thereof (2- see at least Figures 5, 6a-e, [0121], [0127], [0166]).
Regarding claim 13, Osorio teaches wherein said first indication is an indication of an occurrence of a seizure based on said EKG signal or feature thereof, and said second indication is of an end of said seizure based on said EKG signal or feature thereof (limitations further limit alternatives, thus the limitations are met by the alternatives being taught. In addition, see [0112], [0074]).
Regarding claim 14, Osorio teaches wherein at least one of said first indication or said second indication is based at least in part on at least one exosomatic signal or feature thereof (1-desired time to monitor from milliseconds to years occurs: see at least [0120] “Monitoring 610 for an indication of a triggering event, such as a signal from autonomic or neurologic index detection unit 265a, is performed. Monitoring 610 may be performed at any desirable time scale (from milliseconds to years)”, [0121]; or 2- result of triggering event to perform test of responsiveness).
Regarding claim 15, Osorio teaches the method of claim 8, wherein the at least one exosomatic signal or feature thereof is a time of day signal or feature thereof, a time of month signal or feature thereof, a luminance level signal or feature thereof, an acoustic noise level signal or feature thereof, a temperature signal or feature thereof, a barometric pressure signal or feature thereof, a signal or feature thereof indicative of a physical activity of said patient and when it was performed by said patient, a signal or feature thereof indicative of an attention level of said patient and when said patient was attentive, a signal or feature thereof indicative of a cognitive activity of said patient, the type of cognitive activity and when it was performed by said patient, a signal or feature thereof indicative of a time elapsed since the last seizure of said patient, the last seizure type or class, the last seizure severity of said patient, a signal or feature thereof indicative of a time elapsed since the delivery of a therapy to said patient, the type of therapy and its dose or parameters, the efficacy of said therapy, delivered to said patient, the adverse effects of said therapy and their type and severity, or a signal or feature thereof indicative of a time elapsed since the last caloric intake and its amount, a signal or feature thereof indicative of stress level and when it changes of said patient (the limitation further limits an alternative that is not claimed in claim 8, and is thus met by the rejection of claim 8).
Conclusion
No prior art rejections have been applied to claim 7 due to the speculation and uncertainty in the claimed features as explained in the 112 second paragraph rejections. No prior art can be speculatively applied to claim 7 as such would be improper, In re Steele. MPEP 2173.06:
“Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/ Primary Examiner, Art Unit 3791
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