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 .
Status of Claims
Claims 1-8 are presently pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 21 April 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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:
“biopotential acquiring part” in claim 1-2 and 5
“bioinformation acquiring part” in claim 1, 3, and 6-8.
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.
For the limitation, “biopotential acquiring part”, found in specification [0006]-[0007], [0010], [0014]-[0015], [0018], [0028], and [0030] and denoted as element 12 in Figure 1. Thus, biopotential acquiring part is denoted to be any housing/structure that comprises a biopotential sensor.
For the limitation, “bioinformation acquiring part”, found in specification [0006],[0008], [0011], [0013]-[0014], [0016], [0019], [0021], [0028], and[0042] and denoted as element 16 in Figure 1. Thus, bioinformation acquiring part is denoted to be any housing/structure that comprises a sensor for acquiring biosignals other than biopotential.
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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stump (US Patent 12,089,914 B2), hereinafter Stump.
Regarding claim 1, Stump discloses a biosignal measurement device to be worn by a user (view Figure 1 and 4: enhanced monitoring device 140), the biosignal measurement device comprising
at least one biopotential acquiring part (first physiological sign monitoring portion 110) having a biopotential sensor (Column 19, lines 13-22: “in the example in FIG. 4, an electronic subsystem of first physiological sign portion 110 of enhanced monitoring device 140 may include one or more of a photoplethysmogram (PPG) sensor 115, an electrocardiogram (ECG) sensor 111, a pulse rate sensor 117, a ballistocardiogram (BCG) sensor 107, a head motion sensor 114, a neck motion sensor 113, a general motion sensor 112, a skin temperature sensor 106, a skin conductance (and/or skin resistivity) sensor 109, and an orientation sensor 108”) and
a bioinformation acquiring part (second physiological sign monitoring portion 120) having a bioinformation acquisition sensor for acquiring a biosignal other than the biopotential as bioinformation (Column 19, lines 22-34: “in the example in FIG. 4, an electronic subsystem of second physiological sign portion 120 of enhanced monitoring device 140 may include one or more of an electrocardiogram (ECG) sensor 121, a ballistocardiogram (BCG) sensor 127, an electrooculogram sensor 128, a head motion sensor 124, a neck motion sensor 123, a general motion sensor 122, a skin temperature sensor 126, a sweat chemistry (and/or sweat composition) sensor 116, and a skin conductance (and/or skin resistivity) sensor 129. In various embodiments, electrocardiogram (ECG) sensor 111 and/or electrocardiogram (ECG) sensor 121 includes an electrical potential sensor.”),
the biopotential acquiring part and the bioinformation acquiring part being attached at separate portions of the user (view 1A-1B, Column 17, line 66-Column 18, line 9: “a first physiological sign monitoring portion 110 of enhanced monitoring device 140 may be configured for deployment on a surface of the back of a respective ear (e.g., opposite a concha) of a subject 100, or over a mastoid region of the neck of the subject 100, and a second physiological sign monitoring portion 120 of enhanced monitoring device 140 may be configured for deployment on a surface of the neck over the pocket formed between the trapezius and the sternocleidomastoid muscles of the subject and under the levator scapulae of the subject 100”).
Regarding claim 2, Stump discloses the biosignal measurement device according to claim 1 (as shown above), wherein the biopotential acquiring part is attached to at least one of the back side of an auricle, head, shoulder, and back of the user (Column 17, line 66-Column 18, line 41: “a first physiological sign monitoring portion 110 of enhanced monitoring device 140 may be configured for deployment on a surface of the back of a respective ear (e.g., opposite a concha) of a subject 100, or over a mastoid region of the neck of the subject 100”, view Figure 1A-1B).
Regarding claim 3, Stump discloses the biosignal measurement device according to claim 2 (as shown above), wherein the bioinformation acquiring part is attached to the back neck part of the user (view Figure 1A-1B, Column 18, lines 3-41: “a second physiological sign monitoring portion 120 of enhanced monitoring device 140 may be configured for deployment on a surface of the neck over the pocket formed between the trapezius and the sternocleidomastoid muscles of the subject and under the levator scapulae of the subject 100”)
Regarding claim 4, Stump discloses the biosignal measurement device according to claim 3 (as shown above), wherein the biopotential sensor is configured to be able to measure at least one of an electroencephalogram, electrocardiogram, and electromyogram of the user (view Figure 4: pulse rate 117 and ECG 111).
Regarding claim 5, Stump discloses the biosignal measurement device according to claim 4 (as shown above), wherein the biopotential acquiring part is configured to be able to measure a bioimpedance (view Figure 4: skin conductance and resistance 109, Column 21, lines 21-26: “Values indicative of galvanic skin response (GSR), and values indicative of bioimpedance (BioZ), may be respectively determined from skin resistivity/skin conductivity data (e.g., in electronic signals generated by a skin conductance and resistance sensor 109 in first physiological sign portion 110”).
Regarding claim 6, Stump discloses the biosignal measurement device according to claim 5 (as shown above), wherein the bioinformation acquiring part is configured to be able to measure a blood pressure (Column 28, line 58-Column 29, line 2: “one or more physiological sign portions (110, 120) of enhanced monitoring device 140 may include a blood pressure sensor (not shown) that is configured to generate an electronic blood pressure signal….In various embodiments, a blood pressure sensor (not shown) is configured to receive an input from a PPG sensor 115 and a motion sensor (112, 122).”), plasma glucose (sweat chemistry/composition 116, Column 21, lines 28-32: “Values indicative of glucose levels may be determined from sweat chemistry/sweat composition data (e.g., in electronic signals generated by a sweat chemistry/sweat composition sensor 116 in second physiological sign portion 120)”), pulse (Figure 4: ECG sensor 121, Column 20, lines 16-22: “Values indicative of electrocardiogram (ECG) pulse rate, of premature ventricular complexes, of R-R interval, and/or of heart rate variability (HRV) may be respectively determined from ECG waveform data (e.g., in electronic signals generated by ECG sensor 111 in first physiological sign portion 110 and/or by ECG sensor 121 in second physiological sign portion 120)”), body surface temperature (Figure 4: skin temperature 126), and median acceleration (Figure 4: motion 122, neck motion 123, and head motion 124, Column 24, lines 56-64: “motion sensor (112, 122) provides an electronic signal input to a subject activity level sensor, and/or arterial characteristics sensor. In various embodiments, an electronic ballistocardiogram (BCG) signal provided by a BCG sensor (107, 127), or a head motion sensor (114, 124) may be used to generate respective machine readable values indicative of the number of steps that a subject 100 has taken over a period of time”) .
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.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stump as applied to claim 6 above, and further in view of Talati et al. (US 2019/0101984 A1), hereinafter Talati.
Regarding claim 7, Stump discloses the biosignal measurement device according to claim 6 (as shown above). Stump further discloses “second physiological sign portion 120 of enhanced monitoring device 140 (and/or another portion (not shown) of enhanced monitoring device 140) may include a liquid (e.g., blood) sensor 137 configured to detect liquid at and/or around a surface of the subject 100… In various embodiments, such integrated circuits may include a liquid sensor such as a liquid leakage sensor (e.g., light emitter, light receptor, photodiode)” (Column 41, lines 16-33), but fails to explicitly disclose wherein the bioinformation acquisition sensor includes a photoelectric sensor.
However, Talati teaches heartrate monitor and biometric monitor embedded in wearable systems ([0001]) wherein the bioinformation acquisition sensor includes a photoelectric sensor (view Figure 4, [0069] “The magnitude of light transmitted from light source 410 may be recorded and measured against the reflected light 420 and transmitted light 425. The optical measurement as shown in FIG. 4 may be a photoplethysmogram (PPG) measurement, whereby changes in the volume of the tissue in the user neck 405 are detected through changes in the absorption of the neck tissue that result from blood being pumped into the skin over the course of a user's cardiac cycle.”)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stump in view of Talati to have the bioinformation acquisition sensor includes a photoelectric sensor, as these prior art reference and the instant application are directed to biosignal detection devices. One would be motivated to do this to measure PPG signals, as recognized by Talati ([0069]).
Regarding claim 8, Stump in view of Talati teaches the biosignal measurement device according to claim 7 (as shown above). Stump further discloses wherein the bioinformation acquiring part is configured to be able to measure at least one of a bioimpedance, temperature, and acceleration (view Figure 4: skin temperature 126, motion 122, skin conductance and resistance 129).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ATTIYA SAYYADA HUSSAINI whose telephone number is (703)756-5921. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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