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 Objections
Claims 10, 19, 23, 30-32, and 34 are objected to because of the following informalities:
the phrase “being displaying” in the last limitation of each of claims 10, 23, and 32 should be amended to read “being displayed”;
the phrase “the state of subject” in each of claims 19, 30, and 34 should be amended to read “the state of the subject”;
the term “updating” in claim 31 should be amended to read “update”.
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.
Claims 18, 19, 29, 30, 33, and 34 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 claims 18, 29, and 33, the originally filed disclosure fails to provide support for the state of the subject being further based on a comparison of the frequency band at which the amplitude is the greatest to a baseline phase of the frequency band at which the amplitude of the baseline is the greatest.
Regarding claims 19, 30, and 34, the originally filed disclosure fails to provide support for the state of the subject being based on a correlation between a dose of anesthesia and the frequency band at which the amplitude is the greatest.
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 10-35 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 10, it is unclear what is meant by “a report of raw data”. As best understood by not only the specification and what is commonly understood in the art, “raw data” pertains to raw signals obtained from a physiological sensor. If the report is a report of raw signals (i.e., EEG waveforms), then how would the displayed report, which would be a display of raw EEG signals, be a display of real-time determinations of the current state of the subject? The real-time determinations are not raw data. For this examination, claim 10 is being interpreted such that a report including raw data is generated. The same indefiniteness issue and interpretation also apply to claims 23 and 32.
Regarding claim 12, the phrase “the state comprising information related to anesthetic properties indicating a type of state” renders the claim indefinite. It is unclear what limitation to the claimed invention this phrase is intending to impart. When read in combination with claim 10, claim 12 recites “determining a state comprising information related to anesthetic properties indicating a type of state”. It is unclear what is meant by this phrase. For this examination, the phrase in question in Claim 12 is not being given patentable weight. The same indefiniteness issue also applies to claim 24.
Regarding claim 13, the phrase “further comprising the analysis of the EEG data comprising a phase-amplitude coupling analysis comprising:” renders the claim indefinite in that it is unclear what it means. For this examination, the phrase is being interpreted as “wherein the analysis of the EEG data comprises a phase-amplitude coupling analysis comprising:”.
Regarding claim 14, the phrase “a respective frequency band” renders the claim indefinite. What is each frequency band respective to? For this examination, claim 14 is being interpreted such that the filter extracts a frequency band. The same indefiniteness issue and interpretation apply to claim 26.
Regarding claim 15, it is unclear what is meant by “a type of isolated band”. What is a “type” of isolated band? For this examination, claim 15 is being interpreted such that the filter is of a type that isolates a frequency band (e.g., a bandpass filter).
Regarding claim 18, it is unclear what aspect of the frequency band at which the amplitude is the greatest is being compared to a baseline phase of the frequency band at which the amplitude of the baseline phase is the greatest. What is the baseline phase being compared to? The same indefiniteness issue is also present in claims 29 and 33. As it is unclear what is being compared to the baseline phase, a proper prior art search of claims 18, 29, and 33 is unable to be performed.
Regarding claim 23, the phrase “a processor comprising:” followed by functional steps renders the claim indefinite. It is unclear how a processor would comprise steps. For this examination, claim 23 is being interpreted as if it reads “a processor configured to:”.
Regarding claim 27, the phrase “is further configured to determine a phase of the frequency band at which the amplitude of the frequency band at which the amplitude of another frequency band is greatest” renders the claim indefinite in that it is unclear what is meant by the phrase. For this examination, claim 27 is being interpreted as “is further configured to determine a phase of the frequency band at which the amplitude of another frequency band is greatest”.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
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 10-17, 19-28, 30-32, 34, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al.’701 (WO 2012/154701 – cited by Applicant) in view of Blike et al.’085 (US Pub No. 2010/0050085).
Regarding claims 10, 11, 13, 17, and 32, Brown et al.’701 discloses a method comprising: receiving, by a device, EEG data related to a subject, the EEG data corresponding to a time aligned with administration of an anesthetic drug to the subject (see TITLE, and sections [0023-0025], [0090]); analyzing, by the device, the EEG data, and determining a phase-amplitude frequency distribution (sections [0025], [0053], [0055], [0061-0066]), the determination comprising: constructing a set of phase-amplitude modulograms, each phase-amplitude modulogram comprising information indicating an amplitude of the EEG data in a frequency band as a function of a phase of another frequency band (sections [0056-0060]); and determining a phase of the frequency band at which the amplitude of the frequency band is greatest based on a phase of a sinusoid fit to a respective phase-amplitude modulogram (section [0061]); determining, by the device, based on the phase-amplitude frequency distribution, a current state of the subject (sections [0061-0063]); generating, by the device, a report corresponding to at least the current state of the subject (sections [0008], [0025], [0090-0091]); and providing, by the device, the report in a format capable of being displayed within a user interface, the provided report caused to be displayed in the format within the user interface, such that real-time determinations of the current state are provided within the user interface (sections [0025], [0090-0091]).
Brown et al.’701 discloses all of the elements of the current invention, as discussed above, except for the report including raw data. It is noted that section [0025] does disclose that the method comprises providing a display of raw signals as EEG waveforms. What Brown et al.’701 fails to explicitly disclose is the real-time display of the EEG waveforms (raw data) as part of the displayed report. Bilke et al.’085 teaches providing a real-time display of raw physiological signals as part of a report corresponding to a current state of a subject. The real-time display of the raw signal data permits artifact detection and provides signal quality information (section [0064]). 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 Brown et al.’701 to include displaying the raw data in real-time as part of the displayed report, as Bilke et al.’085 teaches that this would allow a clinician to analyze signal quality information/perform artifact detection in the acquired EEG data.
Regarding claim 12, the method comprises the state corresponding to a state of consciousness or a state of sedation during the administration (sections [0063], [0091], [00116-00117]).
Regarding claim 14, the method further comprises: extracting, via an applied filter to the EEG data, a frequency band; and determining, based on the extraction, an amplitude frequency band or phase frequency band according to a temporal resolution (section [0057]).
Regarding claim 15, the filter is a type corresponding to an isolated band (section [0057]).
Regarding claim 16, the method further comprises determining a phase of a frequency band at which the amplitude of another frequency band is greatest (sections [0061-0063]).
Regarding claim 19, the method further comprises the state of the subject being based on a correlation between a dose of anesthesia and the frequency band at which the amplitude is the greatest (section [0026], [00116-00117]).
Regarding claim 20, the phase-amplitude frequency distribution inherently comprises information related to a polarity and spatial distribution.
Regarding claim 21, while Brown et al.’701 in view of Bilke et al.’085 does not explicitly disclose intermittently determining the current state of the subject and updating the user interface with the intermittently determined current state of the subject, Official notice is being taken that it is well known in the art, particularly in methods drawn to determining a state of a patient receiving anesthesia, to intermittently determine the current state of the subject and update a user interface with the intermittently determined current state (see, for example, sections [0025] and [0108] of McKenna et al.’087 – US Pub No. 2012/0203087). 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 Brown et al.’701 in view of Bilke et al.’085 such that the current state of the subject is intermittently determined and displayed, as this would provide notifications to a medical professional of the subject’s current state over time, and would allow a medical professional to detect changes in the patient’s state over time.
Regarding claim 22, Brown et al.’701 discloses that the method further comprises the device being in communication with at least one sensor placed on the subject, wherein the EEG data is received via the at least one sensor (sections [0023], [0025]).
Regarding claims 23-28, 30, and 31, the sections of Brown et al.’701 cited above, as modified by Bilke et al.’085, disclose a system comprising a processor configured to perform the functions recited in the claims.
Regarding claims 34 and 35, see the rejections of claims 19 and 21 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Duke et al.’453 (US Pub No. 2013/0338453) discloses a method comprising generating, by a device, a report of raw data, and providing the report in real time within a user interface (section [0171]). Kiraly’219 (US Pub No. 2014/0058219) discloses a method comprising generating, by a device, a report of raw data, and providing the report in real time within a user interface (see claim 13). Davis et al.’796 (US Pub No. 2014/0066796) teaches determining a patient state, displaying the determined patient state in real time, and intermittently determining an updated real-time patient state and updating the display of the determined state (section [0044]). McGrath et al.’191 – US Pub No. 2012/0296191 teaches continuously determining a current state of a subject undergoing anesthesia and continuously updating a display of a subject state determination (section [0084]). Bardakjian et al.’339 (US Pub No. 2013/0197339 – cited by Applicant) discloses a method and system for monitoring consciousness of a subject experiencing anesthesia (see TITLE and ABSTRACT), the method and system comprising: a plurality of sensors 26 configured to be placed about the subject and configured to acquire electroencephalogram (EEG) data therefrom while the subject is receiving anesthesia (section [0027]); and at least one processor 30 configured to receive the EEG data from the plurality of sensors (section [0029]), perform a phase-amplitude coupling analysis using the received EEG data to determine a phase-amplitude frequency distribution (sections [0043], [0078-0080]), identify a current state of consciousness of the subject using the determined phase-amplitude frequency distribution (sections [0047], [0078-0080]), and generate a report indicative of the current state of consciousness of the subject (sections [0030], [0047]). Bardakjian et al.’339 further teaches the processor is further configured to determine a baseline phase-amplitude frequency distribution (see Figure 9A, and section [0047]), and identifying the current state of consciousness of the subject further comprises comparing the phase-amplitude frequency distribution to the baseline phase-amplitude frequency distribution (sections [0047], [0078-0080]).
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791