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
Information Disclosure Statement (IDS) submitted on 02/20/2024 and 04/14/2025 have been entered and fully considered by the examiner.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-13 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Regarding independent claims 1 and 11, claims recite the limitation: “a setting configured to arrange the coil on an ear of the subject.” Therefore, it appears as though the ear of the subject is part of the setting wherein the coil is arranged on the ear. The applicant is advised to use language such as “a setting comprising a coil configured to be placed on the ear of the subject”.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. (“Wearable fabric loop sensor based on magnetic field induced conductivity for simultaneous detection of cardiac activity and respiration signals, sensor, 2022) hereinafter “Cho” in view of Rezaei et al. (“Trace: An Earlobe Mounted Sensor for Continuous Measurement of Heart Rate Dynamics”, sensors, 2019) hereinafter “Rezaei”.
Regarding claim 1, Cho discloses an eddy current measurement device [see abstract of Cho], comprising:
a sensor including:
a coil; and [fabric loop sensors comprising a coil (i.e. a spiral loop made of metal; see Table 1 and page 6, section. 4. Materials and methods; last paragraph of the page]
a setting structure combined with the coil [see FIG. 5a (the structure holding the coil to the fabric is the setting structure)], the setting structure configured to arrange the coil on a subject and place an emission surface of the coil towards a measurement area of the subject; [see FIG. 5; the setting structure is placed on the chest area] and
a control module coupled to the coil, the control module configured to drive the coil to perform eddy current induction measurement on the measurement area and obtain at least one physiological information of the subject. [see page 8, section under 4.4. data collection and analysis]
Cho does not disclose that the device is ear-worn, that the setting structured is configured to arrange the coil on the ear of the subject.
Rezaei, directed towards a heart body worn rate sensor [see abstract of Rezaei] further discloses that the device is ear-worn, that the setting is configured on the ear of the subject. [see FIG. 1 of Rezaei; the entire sensor is placed on the ear lobe of the subject]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the device of Cho such that the device is ear-worn, that the setting structured is configured to arrange the coil on the ear of the subject according to the teachings of Rezaei since the earlobe is well suited for heart rate detection for not containing any tendons or muscles and is less susceptible to motion artifacts. [see page 2 of Rezaei, first full paragraph]
Regarding claim 2, Cho as modified by Rezaei discloses all the limitations of claim 1 [see rejection of claim 1 above]
Rezaei further discloses that the ear measurement area is located on an ear lobe of the subject. [see Fig. 1A or Rezaei]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the device of Cho as modified by Rezaei such that the ear measurement area is located on an ear lobe of the subject according to the teachings of Rezaei since the earlobe is well suited for heart rate detection for not containing any tendons or muscles and is less susceptible to motion artifacts. [see page 2 of Rezaei, first full paragraph]
Regarding claim 3, Cho as modified by Rezaei discloses all the limitations of claim 1 [see rejection of claim 1 above]
Cho further discloses that the eddy current induction measurement includes: transmitting, with the coil, a first electromagnetic signal to the measurement area; and receiving, by the coil, a feedback electromagnetic signal from the measurement area to obtain a sensing signal. [see page 4, section. 3. Principals of heart-rate and respiration rhythm measurement, continued in page 5 of Cho and FIG. 1]
Cho does not disclose that the device the setting structured is configured to arrange the coil on the ear of the subject.
Rezaei, directed towards a heart body worn rate sensor [see abstract of Rezaei] further discloses that the device is ear-worn, that the setting is configured on the ear of the subject. [see FIG. 1 of Rezaei; the entire sensor is placed on the ear lobe of the subject]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the device of Cho such that the device is ear-worn, that the setting structured is configured to arrange the coil on the ear of the subject according to the teachings of Rezaei since the earlobe is well suited for heart rate detection for not containing any tendons or muscles and is less susceptible to motion artifacts. [see page 2 of Rezaei, first full paragraph]
Regarding claim 4, Cho as modified by Rezaei discloses all the limitations of claim 1 [see rejection of claim 1 above]
Cho further discloses that the control module includes: a filter unit coupled to the coil, the filter unit configured to partition a sensing signal provided by the coil into an alternating current part. [see page 8, section under 5. Results and discussion, continued in page 10 of Cho discloses a bandpass filter for detecting the heart rate signal from the returned waves]
Cho does not disclose separating a direct current part of the signal.
Rezaei further discloses separating a direct current part of the signal [see page 2, left column, second paragraph and FIG. 4 of Rezaei]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the device of Cho as modified by Rezaei such that separating a direct current part of the signal according to the teachings of Rezaei in order to separate the signal that is caused by movement of the head itself [see page 2, left column, second paragraph of Rezaei]
Regarding claim 5, Cho as modified by Rezaei discloses all the limitations of claim 1 [see rejection of claim 1 above]
Cho further discloses that the at least one physiological information includes a heart rate signal of the subject, and the heart rate signal corresponds to the alternating current part. [see FIG. 7 and page 10 disclosing extracting the cardiac activity from the alternating part of the signal]
Regarding claim 8, Cho as modified by Rezaei discloses all the limitations of claim 1 [see rejection of claim 1 above]
Cho further discloses that the control module includes: a signal generation unit coupled to the coil, [see page 7, section 4.2. hardware disclosing an oscillator; see FIG. 4] the signal generation unit configured to generate an alternating current signal, and provide the alternating current signal to the coil for generating a first electromagnetic signal; [see page 7, section 4.2. hardware disclosing an oscillator for generation of the signal] and a processing unit coupled to the coil, the processing unit configured to receive a sensing signal from the coil, and calculate the at least one physiological information according to the sensing signal. [see page 7, last paragraph and FIG. 4 disclosing a processor for generating a digital filter to process the signal and calculate the heart rate]
Regarding claim 9, Cho as modified by Rezaei discloses all the limitations of claim 1 [see rejection of claim 1 above]
Cho further discloses that the at least one physiological information includes heart rate or blood glucose of the subject. [see FIG. 7; the heart rate is calculated]
Regarding claim 10, Cho as modified by Rezaei discloses all the limitations of claim 1 [see rejection of claim 1 above]
Cho further discloses that the control module includes: a communication unit configured to output the at least one physiological information to an electronic device. [see FIG. 5; the wire that connects the sensor to the processor is the communication unit]
Regarding claim 11, Cho discloses a sensor [see abstract of Cho], comprising:
a coil; and [fabric loop sensors comprising a coil (i.e. a spiral loop made of metal; see Table 1 and page 6, section. 4. Materials and methods; last paragraph of the page]
a setting structure combined with the coil [see FIG. 5a (the structure holding the coil to the fabric is the setting structure)], the setting structure configured to arrange the coil on a subject and place an emission surface of the coil towards a measurement area of the subject; [see FIG. 5; the setting structure is placed on the chest area]
Cho does not disclose that the device is ear-worn, that the setting structured is configured to arrange the coil on the ear of the subject.
Rezaei, directed towards a heart body worn rate sensor [see abstract of Rezaei] further discloses that the device is ear-worn, that the setting is configured on the ear of the subject. [see FIG. 1 of Rezaei; the entire sensor is placed on the ear lobe of the subject]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the device of Cho such that the device is ear-worn, that the setting structured is configured to arrange the coil on the ear of the subject according to the teachings of Rezaei since the earlobe is well suited for heart rate detection for not containing any tendons or muscles and is less susceptible to motion artifacts. [see page 2 of Rezaei, first full paragraph]
Regarding claim 12, Cho as modified by Rezaei discloses all the limitations of claim 11 [see rejection of claim 11 above]
Rezaei further discloses that the ear measurement area is located on an ear lobe of the subject. [see Fig. 1A or Rezaei]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the device of Cho as modified by Rezaei such that the ear measurement area is located on an ear lobe of the subject according to the teachings of Rezaei since the earlobe is well suited for heart rate detection for not containing any tendons or muscles and is less susceptible to motion artifacts. [see page 2 of Rezaei, first full paragraph]
Regarding claim 13, Cho as modified by Rezaei discloses all the limitations of claim 11 [see rejection of claim 11 above]
Cho further discloses that the coil is configured to perform eddy current induction measurement on the measurement area and obtain at least one physiological information of the subject. [see page 4, section. 3. Principals of heart-rate and respiration rhythm measurement, continued in page 5 of Cho and FIG. 1]
Cho does not disclose that the device the setting structured is configured to arrange the coil on the ear of the subject.
Rezaei, directed towards a heart body worn rate sensor [see abstract of Rezaei] further discloses that the device is ear-worn, that the setting is configured on the ear of the subject. [see FIG. 1 of Rezaei; the entire sensor is placed on the ear lobe of the subject]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the device of Cho such that the device is ear-worn, that the setting structured is configured to arrange the coil on the ear of the subject according to the teachings of Rezaei since the earlobe is well suited for heart rate detection for not containing any tendons or muscles and is less susceptible to motion artifacts. [see page 2 of Rezaei, first full paragraph]
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. (“Wearable fabric loop sensor based on magnetic field induced conductivity for simultaneous detection of cardiac activity and respiration signals, sensor, 2022) hereinafter “Cho” in view of Rezaei et al. (“Trace: An Earlobe Mounted Sensor for Continuous Measurement of Heart Rate Dynamics”, sensors, 2019) hereinafter “Rezaei” as applied to claim 4 above and further in view of Wolf (U.S. Publication No. 2007/0167867) hereinafter “Wolf”.
Regarding claim 6, Cho as modified by Rezaei discloses all the limitations of claim 4 [see rejection of claim 4 above]
Cho as modified by Rezaei doesn’t disclose that the at least one physiological information includes subcutaneous tissue fluid information of the subject, and the subcutaneous tissue fluid information at least corresponds to the direct current part.
Wolf, directed towards an electromagnetic sensor for detecting subcutaneous fluid [see abstract of Wolf] further discloses that the at least one physiological information includes subcutaneous tissue fluid information of the subject, and the subcutaneous tissue fluid information at least corresponds to the direct current part. [see [0016] of Wolf]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the device of Cho as modified by Rezaei further such that the at least one physiological information includes subcutaneous tissue fluid information of the subject, and the subcutaneous tissue fluid information at least corresponds to the direct current part according to the teachings of Wolf in order to provide a non-invasive method of driving properties of tissue [see [0005] of Wolf]
Regarding claim 7, Cho as modified by Rezaei and Wolf discloses all the limitations of claim 6 [see rejection of claim 6 above]
Wolf further discloses that the at least one physiological information includes subcutaneous tissue fluid information of the subject, [see [0016] of Wolf] and the subcutaneous tissue fluid information corresponds to an intermediate value calculated from peak values and trough values of the alternating current part. [see [0057] of Wolf]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the device of Cho as modified by Rezaei and wolf further such that the at least one physiological information includes subcutaneous tissue fluid information of the subject, and the subcutaneous tissue fluid information corresponds to an intermediate value calculated from peak values and trough values of the alternating current part according to the teachings of Wolf in order to provide a non-invasive method of driving properties of tissue [see [0005] of Wolf]
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN - SABOKTAKIN whose telephone number is (303)297-4278. The examiner can normally be reached M-F 9 am-5pm CT.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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