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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2/23/2024 and 9/8/2025 are compliance being considered by the examiner.
Drawings
The drawings are objected to because the text in the axes in figure 5 is blurred/illegible. 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 use of the term “Bluetooth”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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: “control unit”, “indicating unit”, and “recording unit” in claim 1 and “light emitting unit” in claim 9.
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.
Based on Applicant’s specification the control unit includes a microprocessor (paragraph 87), indicating unit is comprised of light emitting units, which are light emitting parts such as different colored LEDs (paragraphs 103-105), and recording and communication unit is a unit comprising an EEG sensor and a wireless communication device such as Bluetooth (paragraphs 107-109).
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 1-20 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 1 recites the limitation "each measurement target" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the measurement target” in lines 6 and 8. It is not clear what target is being referred to as there can be more than one.
Claims 2—10 inherit the deficiencies of claim 1 and are likewise rejected.
Claim 2 recites several instances of the limitation “the measurement target” in lines 2-11. It is not clear what target is being referred to as there can be more than one.
Claim 2 recites the limitation “a wake state” in line 3. It is not clear is this is a new instance or is part of the wake states mentioned in line 6 of claim 1.
Claim 3 recites the limitation “the measurement target” in line 2. It is not clear what target is being referred to as there can be more than one.
Claim 7 recites the limitation “the critical value” in line 2. It is not clear which critical value is being referred to as there is more than one.
Claim 8 recites the limitation “the critical value” in line 1. It is not clear which critical value is being referred to as there is more than one.
Claim 9 recites several instances of the limitation “the measurement target” in lines 2 and 6-9. It is not clear what target is being referred to as there can be more than one.
Claim 9 recites the limitation "the wake state" in line 3. It is not clear which wake state is being referred to as there can be more than one.
Claim 9 recites the limitation "the REM sleep state" in line 4 and “the NREM sleep state” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Note that amending claim 9 to be dependent on claim 2 would resolve the 112 issues of the claim.
Claim 11 recites the limitation “each measurement target” in line 4. There is insufficient antecedent basis for this limitation in the claim. Note that as written this unclear as there is a measurement target in line 3 of the claim but the limitation can be more than one.
Claim 11 recites several instances of the limitation “the measurement target” in line 6-8. It is not clear which measurement target is being referred to as there can be more than one.
Claims 12-20 inherit the deficiencies of claim 11 and are likewise rejected.
Claim 12 recites several instances of the limitation “the measurement target” in lines 1-13. It is not clear which measurement target is being referred to.
Claim 13 recites the limitation “the measurement target” in lines 2-3. It is not clear which measurement target is being referred to as there can be more than one.
Claim 13 recites the limitation “the wake state” in line 4. It is not clear which wake state is being referred to as there can be more than one.
Claim 15 recites the limitation “the measurement target” in lines 1-2. It is not clear which measurement target is being referred to as there can be more than one.
Claim 15 recites the limitation “the critical value” in line 5. It is not clear which critical value is being referred to as there can be more than one.
Claim 16 recites the limitation “the measurement target” in lines 3-4. It is not clear which measurement target is being referred to as there can be more than one.
Claim 16 recites the limitation “the wake state” in line 5, “the REM sleep state” in line 6, and “the NREM sleep state” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation “the measurement target” in line 2. It is not clear which measurement target is being referred to as there can be more than one.
Claim 17 recites the limitation “the update” in line 3. There is insufficient antecedent basis for this limitation in the claim. Note that the update step is present in claim 15.
Claim 17 recites the limitation “the critical value” in line 3. It is not clear what is being referred to as there can be more than one critical value.
Claim 20 recites the limitation “the sleep state” in line 2. There is insufficient antecedent basis for this limitation in the 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 4, 5, 6, 9, 10, 11, 12, 14, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0007173 (Adamczyk et al., hereinafter Adamczyk) in view of JP2018122076A (Saito et al., hereinafter Saito).
In regards to claims 1 and 11, Adamczyk discloses a system used for sleep management (title and abstract; figures 1-7; paragraphs [0041]-[0105]). The device includes the following components that perform specific steps:
an electrode unit configured to measure biosignals including an electroencephalogram (EEG) and electromyography (EMG) of each measurement target forming the community (paragraph [0084]; electrodes to obtain EEG and EMG);
a control unit configured to compare the measured EEG and EMG with critical values and classify sleep and wake states of the measurement target (paragraphs [0042], [0056]-[0057], [0072], [0077]-[0081], [0090], [0095]-[0100]; computer with software, which would have a microprocessor/microcontroller, performs analysis for sleep classification such as an analysis of a feature vector and comparing to a standard/threshold feature vector ); and
a recording and communication unit configured to store or transmit the measured EEG and EMG to an external device (paragraph [0047], [0051], [0054], and [0079]; device records data into computer via electrodes and uses Bluetooth technology to interact with external devices).
While Adamczyk discloses the use of lights with different colors, the lights are being used to indicate functionality of the device note show sleep and wake states (paragraph [0088]). In a related area, Saito discloses a device that shows the physiological state of a person (title and abstract). Paragraph [0018] of the translation shows the use of different colored LED lights to indicate different sleep and wake states as well as other conditions. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the device and method of Adamczyk, to use different indicator lights to indicate different sleep and wake states as well as other body conditions as taught by Saito.
Regarding claims 2 and 12, Adamczyk and Saito disclose the limitations of claims 1 and 11. Adamczyk discloses the use of EEG, EMG, and accelerometer data (paragraph [0034] [0093]-[0099]) to determine if the subject is in REM, NREM 1, 2, or 3 sleep phases, or a wake phase. The classification mentioned by Adamczyk step of determining wake and sleep states using the different thresholds/critical values recited in the claim in order to make the sleep state determinations.
Regarding claim 4, Adamczyk and Saito disclose the limitations of claim 2. Furthermore, one of ordinary skill in the art would know that a wake state would have higher EMG activity than a REM state and would require a higher threshold/critical value for proper classification.
Regarding claims 5, 6, and 14, Adamczyk and Saito disclose the limitations of claims and 111. Adamczyk use of comparison of feature vectors with a standard (paragraphs [0056]–[0057] and [0090]) can be considered as programmed and pre-stored critical values. In addition, Adamczyk’s use of obtaining the feature vector uses biosignals (the EEG and EMG) taken over a predetermined time (paragraph [0088]; determined via sleep and wake times).
Regarding claims 9 and 16, Adamczyk and Saito disclose the limitations of claims 1 and 11. Adamczyk discloses the use of LED lights that indicate position of the measurement target related to the device (paragraph [0088]). Saito discloses the use of different LED colors for the wake state, REM sleep state, and the NREM sleep state (paragraphs [0018]-[0019]).
Regarding claims 10 and 19, Adamczyk and Saito disclose the limitations of claims 1 and 11. In addition, Saito discloses the measurement of heart rate and breathing/respiration for detecting sleep states in paragraph [0014]. Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device and method of Adamczyk and Saito to include measuring heart rate and breathing/respiration rates as taught by Saito to aid in detecting sleep states.
Regarding claim 17, Adamcyzk and Saito disclose the limitations of claim 16. Saito further shows several other LED colors for different conditions. Without further definition of what the critical value corresponds to, the light for the other conditions stated by Saito can be considered as an update for a different critical value.
Regarding claim 18, Adamczyk and Saito disclose the limitations of claim 11. In addition, Adamcyzk discloses connection to an external device to transmit measured EMG and EEG data (paragraphs [0077]-[0081], [0095]-[0099]).
Regarding claim 20, Adamczyk and Saito disclose the limitations of claim 11. Adamczyk discloses the use of a computer/tablet/mobile phone (paragraphs [0080]-0081) that performs the method. The computer/tablet/mobile phone would naturally contain the non-transitory storage medium containing the program as it is required to perform the method.
Claim(s) 3-4 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0007173 (Adamczyk et al., hereinafter Adamczyk) in view of JP2018122076A (Saito et al., hereinafter Saito) as applied to claims 2 and 12 above, and further in view of JP 20200005986A (Sankai).
Regarding claims 3, 4 and 13, Adamczyk and Saito disclose the limitations of claims 2 and 12. However, they do not explicitly state that the EMG value is larger than or equal to the first critical value and that the frontal EEG is smaller than or equal to the fourth critical value. In a related area Sankai discloses a physiological state evaluation device (title and abstract). Of particular interest are paragraphs [0051]-[0081] which show a process of sleep determination. Sankai notes that the EMG value of the wake state is higher than the REM and NREM states, which would make the first critical value higher (the wake state value) than the second critical value (the REM state value). Saito also states that the frontal EEG value are reduced in a wake state due to interference from the EMG. Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention, to modify the device and method of Adamcyzk and Saito to use the critical values disclosed by Sankai because these are the noted patient observations of EMG and EEG activity for these specific sleep and wake states.
Allowable Subject Matter
Claims 7, 8, and 15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 7 and 15, the prior art of record does not teach or suggest a device or a method, as claimed by Applicant, where the control unit updates each critical value at a predetermined period and uses a fixed critical value when the critical value is not out of a preset range.
Claims 8 is dependent on allowable matter from claim 7 and would be allowable once the 112 rejections are overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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