DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 02 December 2025 has been entered.
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.
Claims 1-19 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. Regarding independent claims 1, 11, and 19, the originally filed Specification fails to provide support for using pharmacokinetic models and a current state of a patient to predict a future state of the patient. Regarding claims 4 and 14, the originally filed Specification fails to provide support for identifying a predicted future state using pharmacokinetic models, an identified current state, and spectrogram analysis. Regarding claims 6 and 16, the originally filed Specification fails to provide support for determining a predicted future state using pharmacokinetic models, an identified current state, and coherence information analysis.
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 1-7 and 9-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 11 follows.
Regarding claim 11, the claim recites a series of steps or acts, including identifying a current state of a patient based on a signature found within acquired physiological data, and predicting a future state of the patient using pharmacokinetic models and the identified current state. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. Naturally occurring patterns (signature profiles) are identified in the acquired physiological signals and are then used to identify a current state of a patient. This amounts to comparing acquired data with stored data in order to identify known patterns, and then providing an indication of a patient state based on the identified patterns. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea. The same analysis applies to the step of predicting a future state of the patient using pharmacokinetic models and the current state. Based on an identified current state and a stored model, a mental analysis may be performed to determine a predicted future state of the patient.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 11 recites generating a report as a real-time display indicative of the current and/or predicted future state of the patient, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The generated report does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the generated report, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of acquiring EEG data, assembling the EEG data into EEG time-series data, selecting alpha frequency signals from the EEG time-series, and analyzing the alpha frequency signals to determine signatures. These acquiring, assembling, selecting, and analyzing steps are each recited at a high level of generality such that they amount to insignificant presolution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and analyzing activity engaged in by medical professionals prior to Applicant's invention.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claims 1-7, 9 and 10, the abstract idea is performed using generic, well-known, and routinely used data acquisition and data analysis elements (non-specific sensors and a processor). Data is acquired and analyzed, and then a pattern (signature profile) is identified in the data in order to identify a state of a patient. With the exception of claims 8, 18, and 19, which recite elements and/or steps for administering a drug by a drug delivery system, the claims fail to recite "something more" than the abstract idea itself, and they fail to tie the abstract idea to a practical application. The additional element(s) or combination of elements in the claim(s) other than the abstract idea per se amount(s) to no more than: instructions to implement the idea on a computer, and/or the recitation of generic computer structure that serves to perform generic computer functions that are well-understood, routine, and conventional practices known in the medical industry. Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to analyzing the alpha frequency signals that do not tie the abstract idea to a practical application or provide something “significantly more” than the abstract idea itself.
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, 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.
Claims 1, 2, 4, 6-12, 14, and 16-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Scheib’620 (US Pub No. 2011/0118620 – previously cited) in view of Burton et al.’046 (US Pub No. 2011/0125046 – previously cited) further in view of Kern et al.’345 (US Pub No. 2008/0021345 – previously cited) further in view of Bouillon et al.’036 (USPN 7,556,036).
Regarding claim 1, Scheib’620 teaches a patient state monitoring system for monitoring a patient experiencing an administration of at least one drug having anesthetic properties (page 1, sections [0002] and [0006], page 4, section [0036]), the system comprising: a patient monitoring device (Figure 3) configured to acquire at least EEG signals from the patient (step 202 of Figure 2A, page 2, section [0023]); an interface configured to receive indications of at least one characteristic of the patient and at least one drug having anesthetic properties (page 3, section [0032], page 4, section [0039]), and at least one processor connected to the patient monitoring device (Figure 3) and configured to: receive electroencephalogram (EEG) data; assemble the EEG data into sets of time-series data in real time (page 2, section [0024]); select, from the time-series data, signals in an alpha frequency range; analyze the signals selected to identify signature profiles particular to the at least one drug administered; identify, using the signature profiles, a current state of the patient induced by the at least one drug; and generate a report as a real-time display indicating the current state of the patient induced by the drug (page 2, section [0018] – page 3, section [0030], page 4, section [0038], page 5, sections [0042], [0049] and [0051] – the method analyzes signals in the 7-14Hz alpha range to verify that spindle oscillation is occurring, which can indicate that the patient is in an unconscious state, page 6, section [0055], which states that the system provides an indication of a decrease in alpha activity, which is an indication to a clinician that a patient may be awakening or that there is little fear of the patient awakening). It is noted that an indication to a clinician that “a patient may be awakening” is equivalent to providing an indication of a predicted future state, the predicted future state being “awake”. It is further noted that section [0039] of Sheib'620 teaches that patient factors such as sex, age, and drug use may be input to the system and used to determine different templates for identifying/determining signature profiles that are then used to determine the patient’s current state. Therefore, the user interface taught by Scheib’620 is configured to receive an indication of both at least one characteristic of the patient (sex, age) and at least one drug having anesthetic properties (drug use), wherein the indications are used to select appropriate signature profiles (templates) that are then used to identify at least one of a current state and a predicted future state of the patient induced by the at least one drug.
Scheib’620 discloses all of the elements of the current invention, as discussed above, except for explicitly reciting that the system comprises an EEG electrode array configured to acquire the EEG signals from the patient. Scheib’620 requires EEG signals to be provided to the system processor, but fails to provide details of how the EEG signals are acquired. Burton et al.’046 provides details of an EEG electrode array configured to acquire EEG signals from a patient and transmit the acquired EEG signals to a processor of a system (page 24, section [0378]). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the system of Scheib’620 to include an EEG electrode array configured to acquire the EEG signals from the patient, as taught by Burton et al.'046, since it would merely be providing a conventional and well-known system element (an EEG electrode array) by which to acquire the necessary EEG signals of Scheib’620.
Scheib’620 discloses all of the elements of the current invention, as discussed above, except for the interface configured to receive an indication of at least one characteristic of the patient and the at least one drug having anesthetic properties being a user interface. Official notice is being taken that it is well known in the art to input patient specific information into a medical device for subsequent processing using a user interface. See, for example, section [0070] of Hickle'296 (US Pub No. 2002/0017296 – previously cited).
Scheib’620 in view of Burton et al.’046 discloses all of the elements of the current invention, as discussed above, except for associating the identified signatures with the at least one drug administered, wherein the identified signature is identified from a plurality of signatures associated with a different drug having anesthetic properties. Kern et al.’345 is drawn to a method of determining different drug effects from the EEG of a patient while the patient is being administered different drugs (see TITLE and ABSTRACT). Kern et al.’345 discloses that spatial differences in the EEG of a subject can be correlated with the types and/or levels of different drugs administered to produce anesthesia, and that spatio-temporal monitoring of the EEG can be used to assess the complete anesthetic state of the patient (page 1, section [0009], page 3, section [0030]). Page 2, sections [0024-0025] of Kern et al.'345 disclose that because different anesthetic drugs impact different subcortical structures in the brain, methods that characterize the differences may provide better information for sensing a patient's transition between changing CNS states. It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the method of Scheib’620 in view of Burton et al.'046 to include providing an indication of the at least one drug administered to the patient, as taught by Kern et al.'345, since different drugs have different effects on the patient's brain and knowing which drug is being administered to the patient could be used to select the correct template by which the patient's brain state is determined. Furthermore, based on the teachings of Kern et al.’345, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the method of Scheib’620 in view of Burton et al.’046 to include associating the identified signatures with the indicated at least one drug administered so that the correct template is chosen. This would necessarily require identifying a signature for the administered drug from a plurality of signatures associated with different drugs.
Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 discloses all of the elements of the current invention, as discussed above, except for the processor being configured to use pharmacokinetic models and the current state to predict a future state of the patient induced by the at least one drug. Bouillon et al.’036 teaches predicting when a patient under anesthesia will wake up by using pharmacokinetic models and a current state of the patient. Bouillon et al.’036 further teaches providing a display of the predicted/expected awakening time (col. 6, lines 39-67). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the processor of Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 to be configured to use pharmacokinetic models and the current state to predict a future state of the patient induced by the at least one drug, as this would allow an expected awakening time of the patient to be generated and displayed.
Regarding claim 2, one of ordinary skill in the art would have found it obvious to use a model of the pharmacokinetic models that is specific to the at least one drug administered to identify the predicted future state of the patient. Furthermore, Bouillon et al.’036 teaches using models specific to the drugs being administered to the patient (col. 6, lines 39-67).
Regarding claim 4, Scheib’620 discloses that the processor is configured to transform each set of time-series data into a spectrogram and analyze the spectrogram to determine at least one of the current state and a predicted future state of the patient (see ABSTRACT, page 1, sections [0010-0011], page 2, section [0017], Figure 1, and Figure 2A and description thereof).
Regarding claim 6, Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 discloses all of the elements of the current invention, as discussed above, except for the processor being configured to determine coherence information with respect to the sets of time-series data and analyze the coherence information using the determined signature profiles to determine at least one of the current state and the predicted future state of the patient. It is noted that section [0031] of Scheib’620 teaches that the visual technique of displaying the EEG signal as disclosed in Scheib'620 may be used along with another indicator, such as a bispectral index (BIS), as a way to verify the other indicator. Burton et al.’046 discloses a processor configured to determine coherence information (bi-coherence monitoring: page 2, section [0015] and page 3, section [0035]) with respect to sets of time-series data, and to analyze the coherence information using determined signature profiles to determine at least one of a current state and a predicted future state of the patient (the bispectral index is determined based on bi-coherence analysis -- see section [0045] of page 4 --, and is indicative of the current state of the patient). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the processor of Scheib'620 to be configured to determine a bispectral index indicator, as taught by Burton et al.’046 (which is determined by analyzing coherence information using determined signature profiles), as Scheib'620 teaches that its system may also be configured to display a bispectral index indicator with its already existing indicator.
Regarding claim 7, the indications of at least one of a characteristic of the patient and the at least one drug having anesthetic properties includes an age of the patient, and the drug use is capable of being drug use information of a drug selected from the list recited in the claim (page 4, section [0039] of Scheib’620).
Regarding claim 8, Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 discloses all of the elements of the current invention, as discussed above, except for the processor being configured to generate commands for a drug delivery system to direct the administration of the at least one drug to the patient to attain a predicted future state. Burton et al.’046 discloses using a processor to generate commands for a drug delivery system to direct the administration of at least one drug by the drug delivery system to a patient, wherein administration of the drug is capable of helping the patient attain a predicted future state (page 16, sections [0212-0213]). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the processor of Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 to be configured to provide closed-loop control of the administration of the at least one drug, as taught by Burton et al.'046, since it would provide automatic means for properly adjusting the drug administered to the patient to achieve a desired anesthetic effect.
Regarding claim 9, Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 discloses all of the elements of the current invention, as discussed above, except for the processor being configured to dynamically characterize the patient as exhibiting either a loss of consciousness or a recovery of consciousness. Burton et al.’046 teaches using a processor to dynamically determine a behavioral dynamic that includes at least one of a loss of consciousness (TCU) and a recovery of consciousness (TUC), and that a depth of anesthesia monitoring system that performs this function is preferable in that it provides an indication that a subject is "prematurely" emerging from unconsciousness (page 21, sections [0340-0346]). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the processor of Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 to be configured to dynamically characterize the patient as either losing consciousness or recovering consciousness, as taught by Burton et al.’046, since it would provide a real-time indication of whether a patient is prematurely emerging from consciousness, or whether a patient is properly losing consciousness.
Regarding claim 10, Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 discloses all of the elements of the current invention, as discussed above, except for explicitly reciting that the report indicates spatiotemoral activity at different states of the patient receiving the drug. Kern et al.’345 teaches providing indications of spatiotemporal activity at different states of a patient receiving an anesthetic drug in order to assess the complete anesthetic state of a patient undergoing surgery (page 1, section [0009]), and to provide guidance for anesthetic drug administration (page 2, section [0024] – page 3, section [0028]). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the processor of Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 to be configured to generate a report indicating spatiotemporal activity at different states of the patient receiving the drug, as taught by Kern et al.’345, since it would provide an additional indication of the complete anesthetic state of the patient, and since it would provide additional guidance to anesthetic drug administration.
Regarding claims 11, 12, 14, and 16-18, the above cited sections of Scheib’620, as modified by Burton et al.’046 and Kern et al.’345, disclose a method comprising a processor configured to perform the steps set forth in the claims. As each drug or combination of drugs administered to the patient will have a different signature, the method comprises determining signatures particular to the at least one drug administered from a plurality of signatures, wherein each of the plurality of signatures is associated with a different drug having anesthetic properties.
Claims 3 and 13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036, as applied to claims 2 and 12, further in view of Chemali et al. (Burst suppression probability algorithms: state-space methods for tracking EEG burst suppression – previously cited) further in view of Jensen’173 (WO 2012/010173 – previously cited).
Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for the processor being configured to use the determined signatures and the model to identify the predicted future state of the patient, wherein the processor is further configured to determine a burst suppression probability using the model and the set of time-series data. Chemali et al. teaches determining a burst suppression probability using a model and a set of time-series data in order to monitor, and eventually control, a brain state of a patient (see ABSTRACT and last paragraph of DISCUSSION). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the processor of Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 to be configured to determine a burst suppression probability using a model, as taught by Chemali et al., since it would provide a means by which to monitor, and eventually control, a brain state of a patient undergoing anaesthesia. The modification to Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 would provide a processor that is configured to use the determined signatures and the determined burst suppression probability (which is determined using a model) to identify and monitor a predicted future state of the patient.
Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 further in view of Chemali et al. discloses all of the elements of the current invention, as discussed above, except for the model being specific to the at least one drug administered. Jensen’173 teaches monitoring a patient’s state due to the administration of anaesthetics by using a model that is updated according to a specifically administered anaesthetic drug. Jensen’173 teaches that using such a drug specific model reduces errors due to both inter and intra individual variation (page 9, lines 12-21). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the processor of Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 further in view of Chemali et al. to be configured to use a model specific to the at least one drug administered, as taught by Jensen’173, since this would reduce errors due to both inter and intra individual variation. The modification to Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 further in view of Chemali et al. would ensure that the patient’s predicted future state is determined based on how the patient previously reacted to the at least one administered drug.
Claims 5 and 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036, as applied to claims 1 and 11, further in view of Leuthardt’391 (US Pub No. 2012/0022391 – previously cited) further in view of Bardakjian et al.’339 (US Pub No. 2013/0197339 – previously cited).
Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for the processor being configured to perform a phase-amplitude analysis on the sets of time-series data to measure a phase-amplitude coupling in a time-resolved fashion to identify modes of phase-amplitude coupling corresponding to at least one of the current state and the predicted future state of the patient. Leuthardt'391 teaches that an analysis of phase-amplitude coupling can be used to identify different cognitive processes in a patient (page 1, section [0022]). Bardakjian et al.’339 teaches that a strong phase-to-amplitude coupling between beta and gamma activities is typically observed in awake patients, and that the coupling tends to decrease as a person starts to lose consciousness after the introduction of induction agents (page 7 section [0078] – page 8, section [0082]). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the processor of Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 to be configured to perform a phase-amplitude analysis on the sets of time-series data to measure a phase-amplitude coupling, as taught by Leuthardt'391 and Bardakjian et al.'339, since it would provide an additional measure of the patient's current state.
Claim 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 further in view of Chemali et al. further in view of Jensen’173.
Scheib’620 teaches a system for monitoring a patient experiencing an administration of at least one drug having anesthetic properties (page 1, sections [0002] and [0006], page 4, section [0036]), the system comprising: an interface configured to receive indications of at least one characteristic of the patient and at least one drug having anesthetic properties (page 3, section [0032], page 4, section [0039]), and at least one processor (Figure 3) configured to: receive electroencephalogram (EEG) data; assemble the EEG data into sets of time-series data; select, from the time-series data, signals in an alpha frequency range; analyze the signals selected to identify signature profiles particular to the at least one drug administered; identify, using the signature profiles and the indications, a current state of the patient induced by the at least one drug; and generate a report indicating the current state of the patient induced by the drug (page 2, section [0018] – page 3, section [0030], page 4, section [0038], page 5, sections [0042], [0049] and [0051] – the method analyzes signals in the 7-14Hz alpha range to verify that spindle oscillation is occurring, which can indicate that the patient is in an unconscious state, page 6, section [0055], which states that the system provides an indication of a decrease in alpha activity, which is an indication to a clinician that a patient may be awakening or that there is little fear of the patient awakening). It is noted that an indication to a clinician that “a patient may be awakening” is equivalent to providing an indication of a predicted future state, the predicted future state being “awake”. It is further noted that section [0039] of Sheib'620 teaches that patient factors such as sex, age, and drug use may be input to the system and used to determine different templates for identifying/determining signature profiles that are then used to determine the patient’s current state. Therefore, the user interface taught by Scheib’620 is configured to receive an indication of both at least one characteristic of the patient (sex, age) and at least one drug having anesthetic properties (drug use), wherein the indications are used to select appropriate signature profiles (templates) that are then used to identify at least one of a current state and a predicted future state of the patient induced by the at least one drug.
Scheib’620 discloses all of the elements of the current invention, as discussed above, except for explicitly reciting that the system comprises a plurality of sensors configured to acquire the EEG signals from the patient. Scheib’620 requires EEG signals to be provided to the system processor, but fails to provide details of how the EEG signals are acquired. Burton et al.’046 provides details of a multi-electrode system configured to acquire EEG signals from a patient and transmit the acquired EEG signals to a processor of a system (page 24, section [0378]). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the system of Scheib’620 to include a plurality of sensors configured to acquire the EEG signals from the patient, as taught by Burton et al.'046, since it would merely be providing a conventional and well-known system element (EEG electrodes) by which to acquire the necessary EEG signals of Scheib’620.
Scheib’620 discloses all of the elements of the current invention, as discussed above, except for the interface configured to receive an indication of at least one characteristic of the patient and the at least one drug having anesthetic properties being a user interface. Official notice is being taken that it is well known in the art to input patient specific information into a medical device for subsequent processing using a user interface. See, for example, section [0070] of Hickle'296 (US Pub No. 2002/0017296 – previously cited).
Scheib’620 discloses all of the elements of the current invention, as discussed above, except for the processor being configured to generate commands for a drug delivery system to direct the administration of the at least one drug to the patient to attain a predicted future state. Burton et al.’046 discloses using a processor to generate commands for a drug delivery system to direct the administration of at least one drug by the drug delivery system to a patient, wherein administration of the drug is capable of helping the patient attain a predicted future state (page 16, sections [0212-0213]). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the processor of Scheib'620 to be configured to provide closed-loop control of the administration of the at least one drug, as taught by Burton et al.'046, since it would provide automatic means for properly adjusting the drug administered to the patient to achieve a desired anesthetic effect.
Scheib’620 in view of Burton et al.’046 discloses all of the elements of the current invention, as discussed above, except for associating the identified signature profiles with the at least one drug administered, wherein the identified signature profiles are identified from a plurality of signature profiles associated with a different drug having anesthetic properties. Kern et al.’345 is drawn to a method of determining different drug effects from the EEG of a patient while the patient is being administered different drugs (see TITLE and ABSTRACT). Kern et al.’345 discloses that spatial differences in the EEG of a subject can be correlated with the types and/or levels of different drugs administered to produce anesthesia, and that spatio-temporal monitoring of the EEG can be used to assess the complete anesthetic state of the patient (page 1, section [0009], page 3, section [0030]). Page 2, sections [0024-0025] of Kern et al.'345 disclose that because different anesthetic drugs impact different subcortical structures in the brain, methods that characterize the differences may provide better information for sensing a patient's transition between changing CNS states. It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the method of Scheib’620 in view of Burton et al.'046 to include providing an indication of the at least one drug administered to the patient, as taught by Kern et al.'345, since different drugs have different effects on the patient's brain and knowing which drug is being administered to the patient could be used to select the correct template by which the patient's brain state is determined. Furthermore, based on the teachings of Kern et al.’345, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the method of Scheib’620 in view of Burton et al.’046 to include associating the identified signature profiles with the indicated at least one drug administered so that the correct template is chosen. This would necessarily require identifying a signature profile for the administered drug from a plurality of signature profiles associated with different drugs.
Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 discloses all of the elements of the current invention, as discussed above, except for the at least one processor being configured to use pharmacokinetic models and the current state to predict a future state of the patient induced by the at least one drug. Bouillon et al.’036 teaches predicting when a patient under anesthesia will wake up by using pharmacokinetic models and a current state of the patient. Bouillon et al.’036 further teaches providing a display of the predicted/expected awakening time (col. 6, lines 39-67). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the method of Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 to include using pharmacokinetic models and the current state to predict a future state of the patient induced by the at least one drug, as this would allow an expected awakening time of the patient to be generated and displayed.
Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 discloses all of the elements of the current invention, as discussed above, except for selecting a drug-specific model based on the determined signatures, and using the drug-specific model along with the signatures and indication to identify the current state of the patient. Chemali et al. teaches determining a burst suppression probability using a model and a set of time-series data in order to monitor, and eventually control, a brain state of a patient (see ABSTRACT and last paragraph of DISCUSSION). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the processor of Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 to be configured to determine a burst suppression probability using a model, as taught by Chemali et al., since it would provide a means by which to monitor, and eventually control, a brain state of a patient undergoing anaesthesia. The modification to Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 would provide a processor that is configured to use the determined signature profiles and the determined burst suppression probability (which is determined using a model) to identify and monitor a current and/or predicted future state of the patient.
Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 further in view of Chemali et al. discloses all of the elements of the current invention, as discussed above, except for the model being specific to the at least one drug administered. Jensen’173 teaches monitoring a patient’s state due to the administration of anaesthetics by using a model that is updated according to a specifically administered anaesthetic drug. Jensen’173 teaches that using such a drug specific model reduces errors due to both inter and intra individual variation (page 9, lines 12-21). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the processor of Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 further in view of Chemali et al. to be configured to use a model specific to the at least one drug administered, as taught by Jensen’173, since this would reduce errors due to both inter and intra individual variation. The modification to Scheib’620 in view of Burton et al.’046 further in view of Kern et al.’345 further in view of Bouillon et al.’036 further in view of Chemali et al. would ensure that the patient’s current and/or predicted future state is determined based on how the patient previously reacted to the at least one administered drug. It is noted that in order to use a drug-specific model, the processor would need to associate the at least one drug administered with the corresponding model. One of ordinary skill in the art would understand that this association would either occur by providing an indication into the user interface of the at least one drug administered, or based on the determined signature specific to the at least one administered drug.
Response to Arguments
Applicant's arguments filed 02 December 2025 have been fully considered and they are not fully persuasive.
The rejection of the claims under 35 U.S.C. 101 stands as affirmed by the Patent Board Decision rendered on 30 September 2025. The addition of using a pharmacokinetic model and a current state to predict a future state of the patient is itself drawn to an Abstract Idea (a Mental Concept) and does not overcome the previously applied rejection under 35 U.S.C. 101. The addition of “real-time” EEG time-series assembly and a “real-time” display of the generated report also does not overcome the rejection as real-time assembly of EEG-data and real-time display of generated results is well-understood, routine, and conventional activity in the EEG signal analysis art. As evidenced by Scheib’620 (sections [0024] and [0038]) and Burton et al.’046 (sections [0071], [0081-0082], 0126], [0167], and [0219]), real-time EEG data assembly and real-time display of results with regard to EEG-based sedation monitoring is known in the art. A patient monitoring system comprising an EEG electrode array and connected to a processor remains a non-specific, generically claimed device. The use of an EEG electrode array connected to a processor to obtain and analyze EEG signals is well-understood, routine, and conventional. Finally, while Applicant asserts that the claims provide a specific improvement over prior systems, each claim has been rejected in view of prior art, which is an indication that no improvement is provided by the claimed invention.
The rejections of the claims under 35 U.S.C. 103 have been modified in response to the amendments made to the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Donofrio’970 (US Pub No. 2005/0066970) teaches predicting a future level of sedation based on changing levels of sedation over time (section [0130]). Gafni et al.’860 (US Pub No. 2007/0010860 – previously cited) discloses matching different measured EEG patterns with different drug effects (section [0125]). Viertio-Oja et al.’729 (US Pub No. 2002/0173729 – previously cited) teaches having a clinician enter patient characteristic information (weight, age, height, sex, body mass index, and the like) and drug name information into an EEG system during a closed loop drug administration method (section [0065]).
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