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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 2-7 and 10-19 in the reply filed on 14 July 2026 is acknowledged.
Upon reconsideration of the restriction requirement mailed 30 June 2026 and pursuant to the procedures set forth in MPEP § 821.04, claims 8 and 9 directed to the system of Invention II are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 30 June 2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
data acquisition unit first appearing in claim 2, corresponding to element 110 described in at least paragraph [50] of the original specification
storage device first appearing in claim 2, corresponding to element 324 described as a memory for data storage in at least paragraph [60] of original specification
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-19 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.
Claim 2 recites “collecting physiological signal data” and subsequently recites “detect periodic bursts of electromyographic (EMG) activity”. It is unclear whether the EMG activity is intended to be included in, or related to, the physiological signal data collected.
The same issue appears in claims 6 and 8.
Claim 4 recites the limitation “the extracted features” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitations “the plurality of waveforms” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “indicating a transitioning of the sleep stage of the patient from sleep to awake as the patient falls asleep” (emphasis added). As written, it is unclear how the patient’s sleep stage may be transitioning from sleep to awake at the same time as the patient is falling asleep.
The same issue appears in claims 14 and 15.
Claim 8 recites the limitation “collects physiological signal data” and subsequently recites “receive physiological signal data”. It is unclear whether the physiological signal data of the “receive” step is the same as that of the “collects” step.
Claim 9 recites an apparatus comprising “a sensor” and “are operable to perform the method of claim 5”, while its parent claim 2 (which is encompassed by claim 5) recites “at least one sensor”. It is unclear how many sensor(s) applicant intends to require in claim 9 as claim 9 recites a single sensor while parent claim 5 (which encompasses claim 2) encompasses “at least one sensor”.
Claim 11 recites “a storage device” while parent claim 2 recites “a storage device”. It is unclear whether the storage device of claim 11 is intended to be the same as that of parent claim 2.
Claim 13 recites the limitation “the plurality of electromyographic (EMG) activity spectra waveforms” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “detect periodic bursts of electromyographic (EMG) activity…falls asleep” while parent claim 2 recites the limitation “detect periodic bursts of electromyographic (EMG) activity…falls asleep”. It is unclear whether the “detect” step is intended to be the same or different in each claim.
Claim 17 recites the limitation “the plurality of power spectra waveforms” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 6-8, 12, 14, 15, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2003/0167019 (Viertio-Oja et al.).
Regarding claim 6, Viertio-Oja teaches a method for detecting mechanical ventilation-induced wakefulness in a patient (abstract; see note below), the method comprising: receiving physiological signal data of the patient, over a time period, from a data acquisition unit (304-314) electrically coupled to at least one sensor (300) affixed to the patient that generates the physiological signal data ([0075]; [0096]; [0116]-[0119]; Figure 11); and
detecting temporal changes in electromyographic (EMG) activity indicating transitioning of a sleep stage of the patient from sleep to wake (EMG activity indicating patient waking, [0091] and [0105]).
Note: When reading the preamble in the context of the entire claim, the recitation “for detecting mechanical ventilation-induced wakefulness in a patient” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Regarding claim 7, Viertio-Oja teaches an automated feature extraction, wherein the detecting temporal changes in electromagnetic (EMG) activity indicating a transitioning of the sleep stage of the patient from sleep to awake as the patient falls asleep is presented by a graphical user interface (318) ([0096]; [0119]; Figure 11).
Regarding claim 8, Viertio-Oja teaches a system for detecting mechanical ventilation-induced wakefulness in a patient (abstract; see note below), the system comprising:
a data acquisition unit (304-314) electrically capable of being coupled to at least one sensor (300) configured to affix to the patient, wherein the data acquisition unit collects physiological signal data of the patient generated by the at least one sensor ([0075]; [0096]; [0116]-[0119]; Figure 11);
at least one hardware processor (316) ([0119]; Figure 11); and
a storage device coupled to the at least one hardware processor, the storage device storing instructions that (“storage device” construed as memory of computational unit 316 storing instructions for executing disclosed method, [0119]), when executed by the at least one hardware processor, are operable to:
receive physiological signal data of the patient, over a time period, from the data acquisition unit ([0078]; [0096]; [0116]-[0119]); and
detect temporal changes in electromyographic (EMG) activity corresponding to delivery of increased assist-controlled ventilator support as the patient falls asleep (The limitation “detect temporal changes in electromyographic (EMG) activity corresponding to delivery of increased assist-controlled ventilator support as the patient falls asleep” is functional language. Since the “hardware processor” 316 of Viertio-Ojo is configured for detecting temporal changes in EMG activity corresponding to the patient falling asleep, the ”hardware processor” 316 is capable of detecting temporal EMG activity changes corresponding to delivery of increased assist-controlled ventilator support as the patient falls asleep, [0091], [0104]).
Note: When reading the preamble in the context of the entire claim, the recitation “for detecting mechanical ventilation-induced wakefulness in a patient” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Regarding claim 12, Viertio-Oja teaches the temporal changes in electromyographic (EMG) activity are periodic bursts of EMG activity ([0105]; repeated EMG activity, Figure 9b).
Regarding claims 14 and 15, Viertio-Oja teaches the detecting periodic bursts of electromyographic (EMG) activity indicating a transitioning of the sleep stage of the patient from sleep to awake as the patient falls asleep is presented by a graphical user interface (318) (see rejection under 35 U.S.C. 112(b) above; “periodic bursts” construed as repeated EMG activity as patient is waking up, Figure 9b).
Regarding claim 18, Viertio-Oja teaches the method further comprising “filtering the physiological signal data into a plurality of frequency bands corresponding to a plurality of power spectra waveforms ([0095]-[0096]).
Regarding claim 19, Viertio-Oja teaches the storage device coupled to the at least one hardware processor (316) stores further instructions that, when executed by the at least one hardware processor, are operable to: filter the physiological signal data into a plurality of frequency bands corresponding to a plurality of power spectra waveforms ([0095]-[0096]; [0119]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-5, 9-11, 13, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2003/0167019 (Viertio-Oja et al.) in view of U.S. Patent Application Publication No. 2005/0004489 (Sarkela et al.).
Regarding claim 2, Viertio-Oja teaches a method for detecting wakefulness under sedation in a patient (abstract), comprising:
collecting physiological signal data of the patient, over a time period, using a data acquisition unit (304-314) electrically coupled to at least one sensor (300) affixed to the patient that generates the physiological signal data ([0075]; [0096]; [0116]-[0119]; Figure 11);
using one or more hardware processors (316) executing instructions stored in a storage device causing the one or more hardware processors to detect periodic bursts of electromyographic (EMG) activity as the patient falls asleep (“hardware processor” construed as processor of computational unit 316, and “storage device” construed as memory of computational unit 316 storing instructions for executing disclosed method, [0119]; “periodic bursts” construed as repeated EMG activity as patient is falling asleep, [0091]; [0104], Figure 9b).
Viertio-Oja teaches detecting wakefulness under sedation, but does not specify the sedation additionally includes mechanical ventilation, such that the EMG activity corresponds to delivery of increased assist-controlled ventilator support.
However, Sarkela teaches a method of detecting mechanical ventilation-induced wakefulness in a patient (abstract), comprising: collecting physiological signal data of the patient, over a time period, using a data acquisition unit electrically coupled to at least one sensor affixed to the patient that generates the physiological signal data; using one or more hardware processors to detect bursts of electromyographic (EMG) activity corresponding to delivery of increased assist-controlled ventilator support as the patient falls asleep (“patient might be…fighting against ventilator”, [0008]; frontal electromyographic (FEMG) signals…can sense pain reactions when the anesthesia is not adequate…give an early warning of arousal and may also indicate inadequate analgesia”, [0012]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Viertio-Oja such that the patient is provided mechanical ventilation and the EMG activity corresponds to delivery of increased assist-controlled ventilator support as the patient falls asleep in light of the teaching of Sarkela, because Sarkela recognizes sedation may include mechanical ventilation, wherein monitoring EMG activity is an indicator of insufficient analgesia and anesthesia, when a patient is moving into or out of a sleep state, and/or “fighting against [the] ventilator” ([0006]; [0008]; [0012]).
Regarding claim 3, Viertio-Oja in view of Sarkela teaches all the limitations of claim 2. Viertio-Oja as modified teaches the delivery of increased assist-controlled ventilator support results in the patient’s sleep stage transitioning between sleep and wake (increasing sedation, which would include increased ventilator support, would result in the patient falling asleep; Viertio-Oja: [0091]; “patient loses consciousness”, [0104]; “subsequently anesthetized again”, [0106]).
Regarding claim 4, Viertio-Oja in view of Sarkela teaches all the limitations of claim 2. Viertio-Oja as modified teaches the extracted features from the physiological signal data are characterized as sleep or awake ([0091]; [0104]-[0105]).
Regarding claim 5, Viertio-Oja in view of Sarkela teaches all the limitations of claim 2. Viertio-Oja as modified teaches the physiological signal used to characterize sleep or awake is monitored for one or more epochs over the time period, each of the one or more epochs corresponding to a first time scale, and at least one waveform of the plurality of waveforms is monitored for at least a portion of the time period, the portion of the time period is on a second time scale that is longer than the first time scale (EMG signal is monitored for the duration of treatment, wherein the “time period” may be construed as 25 minutes, each “epoch” is construed as a 5 minute segment such that the “first time scale” is construed as a 5 minute period, and the longer, “second time scale” is construed as a 10 minute period, which is a “portion” of the “time period”, see Figure 9b and [0104]-[0105]).
Regarding claim 9, Viertio-Oja in view of Sarkela teaches all the limitations of claim 5. Viertio-Oja as modified teaches an apparatus for detecting mechanical ventilation-induced wakefulness in a patient (Viertio-Oja: [0116]-[0119]; see discussion for claim 2), the system comprising: a data acquisition unit (304-314) configured to receive physiological signal data of the patient collected by a sensor (300) ([0075]; [0096]; [0116]-[0119]; Figure 11); at least one hardware processor (316) ([0119]; Figure 11); and a storage device coupled to the at least one hardware processor and the data acquisition unit, the storage device storing instructions that, when executed by the at least one hardware processor, are operable to perform the method of claim 5 (“storage device” construed as memory of computational unit 316 storing instructions for executing disclosed method, [0119]; “periodic bursts” construed as repeated EMG activity as patient is falling asleep, [0091]; [0104], Figure 9b; see discussion for claims 2 and 5).
Regarding claim 10, Viertio-Ojo in view of Sarkela teaches all the limitations of claim 2. Viertio-Ojo as modified teaches a system for detecting mechanical ventilation-induced wakefulness in a patient (Viertio-Oja: [0116]-[0119]; see discussion for claim 2), the system comprising: a data acquisition unit (304-314) electrically coupled to at least one sensor (300) configured to affix to the patient, wherein the data acquisition unit collects physiological signal data of the patient generated by the at least one sensor ([0075]; [0096]; [0116]-[0119]; Figure 11); at least one hardware processor (316) ([0119]; Figure 11); and a storage device coupled to the at least one hardware processor and the data acquisition unit, the storage device storing instructions that, when executed by the at least one hardware processor, are operable to perform the method of claim 2 (“storage device” construed as memory of computational unit 316 storing instructions for executing disclosed method, [0119]; “periodic bursts” construed as repeated EMG activity as patient is falling asleep, [0091]; [0104], Figure 9b; see discussion for claim 2).
Regarding claim 11, Viertio-Ojo in view of Sarkela teaches all the limitations of claim 2. Viertio-Ojo as modified teaches the one or more hardware processors (316) executing instructions stored in a storage device causing the one or more hardware processors to further perform the following: filter the physiological signal data into a plurality of frequency bands corresponding to a plurality of electromyographic (EMG) activity spectra waveforms ([0095]-[0096]).
Regarding claim 13, Viertio-Oja in view of Sarkela teaches all the limitations of claim 4. Viertio-Oja as modified teaches the physiological signal used to characterize sleep or awake is monitored for one or more epochs over the time period, each of the one or more epochs corresponding to a first time scale, and at least one waveform of the plurality of waveforms is monitored for at least a portion of the time period, the portion of the time period is on a second time scale that is longer than the first time scale (EMG signal is monitored for the duration of treatment, wherein the “time period” may be construed as 25 minutes, each “epoch” is construed as a 5 minute segment such that the “first time scale” is construed as a 5 minute period, and the longer, “second time scale” is construed as a 10 minute period, which is a “portion” of the “time period”, see Figure 9b and [0104]-[0105]).
Regarding claim 16, Viertio-Ojo in view of Sarkela teaches all the limitations of claim 2. Viertio-Ojo as modified teaches the one or more hardware processors (316) further perform the following: filter the physiological signal data into one or more frequency bands to obtain one or more corresponding power spectra waveform ([0095]-[0096]); and detect periodic bursts of electromyographic (EMG) activity corresponding to delivery of increased assist-controlled ventilator support as the patient falls asleep (see discussion for claim 2).
Regarding claim 17, Viertio-Ojo in view of Sarkela teaches all the limitations of claim 2. Viertio-Ojo as modified teaches the physiological signal used to characterize sleep or wake is monitored for one or more epochs over the time period, each of the one or more epochs corresponding to a first time scale, and at least one waveform of the plurality of waveforms is monitored for at least a portion of the time period, the portion of the time period is on a second time scale that is longer than the first time scale (EMG signal is monitored for the duration of treatment, wherein the “time period” may be construed as 25 minutes, each “epoch” is construed as a 5 minute segment such that the “first time scale” is construed as a 5 minute period, and the longer, “second time scale” is construed as a 10 minute period, which is a “portion” of the “time period”, see Figure 9b and [0104]-[0105]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Carrie R Dorna whose telephone number is (571)270-7483. The examiner can normally be reached 8am-5pm.
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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