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 1, 6-7, 10, and 17 are objected to because of the following informalities:
Claim 1 “one or more processor” in lines 9 and 12 should recite “one or more processors”.
Claim 6 “one or more processor” in line 3 should recite “one or more processors”.
Claim 6 “processor is is configured” in line 3 should recite “processor is configured ...”.
Claim 7 “one or more processor” in line 3 should recite “one or more processors”.
Claim 10 line 3 and Claim 17 line 1 “one or more processor” should recite “one or more processors”.
Claim 10 line 5 and Claim 17 line 3 “[Equation 1]” should be removed from the claim.
Appropriate correction is required.
Examiner note: A 101 analysis was performed on claim 1 but concluded it was not necessary because the claimed electronic device is not well-understood, routine, and conventional due to requiring that the bio-impedance detection sensor is disposed adjacent to the optical sensor and that at least a portion of the optical path overlaps with at least a portion of the current path.
Claim Rejections - 35 USC § 101
Claims 16-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 16 follows.
STEP 1
Regarding claim 16, the claim recites a series of structural elements, including a device. Thus, the claims are directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claims are then analyzed to determine whether it is directed to any judicial exception. The steps of:
wherein the one or more processor is configured to determine an electrolyte concentration of the object based on an intensity of light detected using the optical sensor and a magnitude of impedance sensed using the bio-impedance detection sensor.
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 16 recites a housing; an optical sensor disposed on the housing and including a light emitting unit configured to radiate light to an object and a light receiving unit configured to detect an intensity of the light radiated from the light emitting unit; an bio-impedance detection sensor disposed adjacent to the optical sensor, and including a current transmitting unit configured to transmit a current and a current receiving unit configured to receive at least a portion of the current transmitted from the current transmitting unit, and one or more processor disposed in the housing, an intensity of light detected and a magnitude of impedance detected, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The optical sensor, bioimpedance sensor, processor, intensity of light, and magnitude of impedance does not provide an improvement to the technological field, the method/steps does not effect a particular treatment or effect a particular change based on the optical sensor, bioimpedance sensor, processor, intensity of light, and magnitude of impedance, nor does the method/steps use a particular machine to perform the Abstract Idea.
Regarding claim 16, the electronic device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited optical sensor and bio-impedance detection sensor are generic sensors configured to perform pre-solutional data gathering activity, and the processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
a housing;
an optical sensor disposed on the housing and including a light emitting unit configured to radiate light to an object and a light receiving unit configured to detect an intensity of the light radiated from the light emitting unit;
an bio-impedance detection sensor disposed adjacent to the optical sensor, and including a current transmitting unit configured to transmit a current and a current receiving unit configured to receive at least a portion of the current transmitted from the current transmitting unit, and
one or more processor disposed in the housing
The radiating, detecting, transmitting, and receiving steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the radiating, detecting, transmitting, and receiving steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 16, the electronic device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited optical sensor and bio-impedance detection sensor are generic sensors configured to perform pre-solutional data gathering activity, and the processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. The structure of the electronic device comprising a housing; an optical sensor disposed on the housing and including a light emitting unit configured to radiate light to an object and a light receiving unit configured to detect an intensity of the light radiated from the light emitting unit; an bio-impedance detection sensor disposed adjacent to the optical sensor, and including a current transmitting unit configured to transmit a current and a current receiving unit configured to receive at least a portion of the current transmitted from the current transmitting unit, and one or more processor disposed in the housing is generic and well-known – as evidenced by O. Farag, M. Mohamed, M. Abd El Ghany and K. Hofmann, "Integrated Sensors for Early Breast Cancer Diagnostics," 2018 IEEE 21st International Symposium on Design and Diagnostics of Electronic Circuits & Systems (DDECS), Budapest, Hungary, 2018, pp. 153-157, doi: 10.1109/DDECS.2018.00034; V. P. Rachim, T. H. Huynh and W. -Y. Chung, "Wrist Photo-Plethysmography and Bio-Impedance Sensor for Cuff-Less Blood Pressure Monitoring," 2018 IEEE SENSORS, New Delhi, India, 2018, pp. 1-4, doi: 10.1109/ICSENS.2018.8589559; Y. -S. Shu et al., "26.1 A 4.5mm2 Multimodal Biosensing SoC for PPG, ECG, BIOZ and GSR Acquisition in Consumer Wearable Devices," 2020 IEEE International Solid-State Circuits Conference - (ISSCC), San Francisco, CA, USA, 2020, pp. 400-402, doi: 10.1109/ISSCC19947.2020.9063112; K. Lee et al., "A Multi-Functional Physiological Hybrid-Sensing E-Skin Integrated Interface for Wearable IoT Applications," in IEEE Transactions on Biomedical Circuits and Systems, vol. 13, no. 6, pp. 1535-1544, Dec. 2019, doi: 10.1109/TBCAS.2019.2946875.
The dependent claims also fail to add something more to the abstract independent claims. Claims 17-18 are directed to abstract ideas (determining the electrolyte concentration) and claim 19 is directed to insignificant pre-solution activity, i.e. data gathering steps necessary to perform the abstract idea, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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.
Claim 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jung (US 20200029870 A1).
Regarding claim 1, Jung discloses an electronic device (“electronic device”, para. [0056]; apparatus 1000/1100, figs. 10-11), comprising: a housing (“electronic device”, para. [0056, 0110], “apparatus ... mounted in an electronic device”, figs. 10-11); an optical sensor (optical sensor 110/1010, figs. 3-4 & 10-11) disposed on the housing (“mounted”, para. [0110]) and comprising a light receiving unit and a light emitting unit (“light source and photodetector”, para. [0059-0063]) configured to radiate light to the light receiving unit through an optical path (as seen in fig. 4, para. [0059-0063]); a bio-impedance detection sensor (bioelectrical impedance sensor 120/1020, figs. 3-4 & 10-11) disposed adjacent to the optical sensor (as seen in figs. 3-4 & 11, “disposed symmetrically”, para. [0064, 0070]), and comprising a plurality of electrodes (electrodes 211-214, figs. 3-4, para. [0068-0069]) configured to transmit and receive a current through a current path (as seen in fig. 4, “apply a current ... measure a voltage ... calculate bioelectrical impedance”, para. [0069, 0077-0079]); and one or more processor (processor 1030, figs. 10-11) disposed in the housing (“mounted”, para. [0110-0111]), wherein at least a portion of the optical path overlaps at least a portion of the current path (unlabeled, but as seen by the shaded region in fig. 4, “same measurement region”, para. [0064, 0121, 0136]), and wherein the one or more processor (processor 1030, figs. 10-11) are configured to determine a biometric component based on an intensity of light detected by the optical sensor and a magnitude of impedance sensed by the bio-impedance detection sensor (“optical ... electric signal ... spectrum”; “calculate ... bioelectrical impedance”; “determine biometric information of an object of interest based on an optical signal measured by the optical sensor 1010 and depth-specific bioelectrical impedance measured by the bioelectrical impedance sensor 1020 ... estimation model may define a relationship”, para. [0061-0063, 0079, 0109]).
Regarding claim 2, Jung discloses the electronic device of claim 1, wherein the light receiving unit and the light emitting unit are between the plurality of electrodes (as seen in figs. 3-4, “centrally placed”, para. [0070]).
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 3, 5, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Olson (US 20220190188 A1).
Regarding claim 3 Jung discloses the electronic device of claim 1. Jung does not expressly disclose wherein the plurality of electrodes are between the light receiving unit and the light emitting unit.
However, Olson directed to an electro-optical physiologic sensor discloses a plurality of electrodes (electrode 206a, 206b, figs. 2B1-2B) are between a light receiving unit (216, figs. 2B1-2B) and a light emitting unit (214, figs. 2B1-2B) (as seen in figs. 2B1-2B, para. [0082]). Olson further discloses that the electro-optical sensors shown define a compact, integrated sensor that provides for co-location of an optical sensor and an electrode-based sensor at the same location of a subject's tissue (para. [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jung such that the plurality of electrodes are between the light receiving unit and the light emitting unit, in view of the teachings of Olson, as this would aid in defining a compact, integrated sensor that provides for co-location of an optical sensor and an electrode-based sensor at the same location of a subject's tissue.
Regarding claim 5, Jung discloses the electronic device of claim 4. Jung does not expressly disclose wherein the plurality of electrodes are transparent electrodes, and wherein the light receiving unit and the light emitting unit are disposed on the bio- impedance detection sensor.
However, Olson directed to an electro-optical physiologic sensor having a bio-impedance detection sensor having a plurality of electrodes (electrodes 106a-b/206a-b, figs. 1A & 2A), a light receiving unit (116/216, figs. 1A & 2A), and a light emitting unit (114/214, figs. 1A & 2A) discloses that the plurality of electrodes are transparent electrodes (“electrodes ... transparent conductive oxides (TCOs)”, para. [0091]), and that the light receiving unit and the light emitting unit are disposed on the bio- impedance detection sensor (“co-located”, para. [0065, 0091]). Olson further discloses that the electro-optical sensors shown define a compact, integrated sensor that provides for co-location of an optical sensor and an electrode-based sensor at the same location of a subject's tissue (para. [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jung such that the plurality of electrodes are transparent electrodes and the light receiving unit and the light emitting unit are disposed on the bio- impedance detection sensor, in view of the teachings of Olson, as this would aid co-locating light channels with electrodes for defining a compact, integrated sensor that provides for co-location of an optical sensor and an electrode-based sensor at the same location of a subject's tissue by incorporating the transparent conductive oxide to construct electrodes and optical windows.
Regarding claim 14, Jung discloses the electronic device of claim 1. Jung does not expressly disclose wherein at least a half of a volume of the optical path overlaps the current path.
However, Olson directed to an electro-optical physiologic sensor having a bio-impedance detection sensor having a plurality of electrodes (electrodes 106a-b/206a-b, figs. 1A & 2A), a light receiving unit (116/216, figs. 1A & 2A), and a light emitting unit (114/214, figs. 1A & 2A) discloses at least a half of a volume of the optical path overlaps the current path (as seen in figs. 2A-2B, “same region of body tissue”; “co-location”, para. [0023, 0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jung such that the plurality of electrodes are between the light receiving unit and the light emitting unit, in view of the teachings of Olson, as this would aid in providing a noise free signal for optical and electrical measurements of the tissue free of motion artifacts (Olson, para. [0023, 0065]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Moon (US 20190200883 A1).
Regarding claim 4, Jung discloses the electronic device of claim 1. Jung does not disclose wherein the bio-impedance detection sensor surrounds at least a portion of the optical sensor.
However, Moon directed to a bio-signal measuring apparatus including an optical sensor and an impedance measurer (fig. 2) discloses wherein the bio-impedance detection sensor surrounds at least a portion of the optical sensor (as seen in figs. 8-10, “surround”, para. [0122-0125]). Moon further discloses that the bio-signal measuring apparatus 700 of FIG. 7 may be embedded in an electronic device including a watch-type wearable device (para. [0115]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jung such that the bio-impedance detection sensor surrounds at least a portion of the optical sensor, in view of the teachings of Moon, as this would aid in embedding/mounting the bio-signal measuring apparatus into a watch-type wearable device (electronic device).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Korkala (US 20200060576 A1).
Regarding claim 6, Jung discloses the electronic device of claim1, further comprising a key input device disposed on the housing (input component 1110, fig. 11, “switch”, para. [0112]). Jung does not expressly disclose wherein the one or more processor is configured to determine at least one of an electrocardiogram or a body composition based on a user input provided to the key input device.
However, Korkala directed to garment 100 for measuring bioimpedance and electrocardiogram (ECG) (fig. 1, para. [0029]) discloses a key input device (“user interface 214 ... user input device”, para. [0033]) and one or more processor (processor 204 comprising a mode selector 504, para. [0051]) is configured to determine at least one of an electrocardiogram or a body composition based on a user input provided to the key input device (figs. 5-6, “electrocardiogram”; “full ECG mode ... full bioimpedance measurement mode ... mode selector ... selection ... user input”; “body composition”, para. [0029, 0051-0053, 0056], figs. 8 & 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jung such that the one or more processor is configured to determine at least one of an electrocardiogram or a body composition based on a user input provided to the key input device, in view of the teachings of Korkala, as this would aid configuring the electrodes for full ECG measurement or full bioimpedance measurement based on a user input to measure body composition and electrocardiogram.
Regarding claim 7, Jung, as modified by Korkala hereinabove, discloses the electronic device of claim 6. Jung, as modified by Korkala hereinabove, does not disclose a switching circuit configured to selectively and electrically connect the bio-impedance detection sensor or the key input device to the one or more processor.
However, Korkala discloses a switching circuit (switching mechanism 520, fig. 5, para. [0050]) configured to selectively and electrically connect the bio-impedance detection sensor or the key input device to the one or more processor (“switches the function ... electrodes ... bioimpedance measurement ... controlled by the processor ... selecting a measurement arrangement”; “couple ... electrodes”, para. [0050-0051, 0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jung such that the electronic device comprises a switching circuit configured to selectively and electrically connect the bio-impedance detection sensor or the key input device to the one or more processor, in view of the teachings of Korkala, as this would aid in switching the function of the measurement electrodes and configuring the electrodes for full bioimpedance measurement.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Soller (US 20040005717 A1).
Regarding claim 8, Jung discloses the electronic device of claim 1. Jung does not expressly disclose wherein a wavelength range of the light generated by the light emitting unit is 1400 nm to 1500 nm or 1900 nm to 2000 nm.
However, Soller directed to methods for non-invasive spectroscopic measurement of the concentration of an electrolyte discloses a wavelength range of the light generated by the light emitting unit is 1400 nm to 1500 nm or 1900 nm to 2000 nm (“concentrations of clinically important electrolytes present in whole blood ... light in a wavelength range of about 500 to about 2200 nm”, para. [0011, 0022, 0073], claim 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jung such that a wavelength range of the light generated by the light emitting unit is 1400 nm to 1500 nm or 1900 nm to 2000 nm, in view of the teachings of Soller, as this would aid in measuring the concentrations of clinically important electrolytes using wavelengths which advantageously pass through skin and bone without significant absorption.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Jersey-Willuhn (US 7184820 B2).
Regarding claim 9, Jung discloses the electronic device of claim 1 and the current generator current source 231. Jung does not expressly disclose wherein a frequency of the current generated by the bio-impedance detection sensor is 20 kHz or more.
However, Jersey-Willuhn directed to an infusion system having sensors 120 to acquire signals using two sensor technologies including a bio-impedance sensor and an optical sensor (col. 7 lines 14-26) discloses that a frequency of the current generated by the bio-impedance detection sensor is 20 kHz or more (“contact electrodes generally operate in a frequency range from about 10 kHz to 100 kHz”; “alternating current is applied ... frequency of about 20 kHz”, col. 11 line 54 – col. 12 line 7 & col. 24 lines 17-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jung such that a frequency of the current generated by the bio-impedance detection sensor is 20 kHz or more, in view of the teachings of Jersey-Willuhn, as this would aid in measuring impedance by operating contact electrodes to inject current across the monitored tissue.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Miller (US 20190246977 A1).
Regarding claim 13, Jung discloses the electronic device of claim 1. Jung does not expressly disclose wherein the housing comprises a rear cover comprising a first transmission area facing at least a portion of the light receiving unit and a second transmission area facing at least a portion of the light emitting unit, and wherein the plurality of electrodes are disposed on the rear cover.
However, Miller directed to methods, systems, apparatuses, and/or devices for taking optical measurements using an electronic device 400 including an optical sensor 420 and an impedance sensor 455 (fig. 4A) discloses wherein the housing (housing 410, fig. 4A) comprises a rear cover (“ underside of the housing ... outer surface ... that contacts the user”, para. [0060], as seen in fig. 4A) comprising a first transmission area facing at least a portion of the light receiving unit (cavity 462, fig. 4A, para. [0062]) and a second transmission area facing at least a portion of the light emitting unit (cavities 464 & 466, fig. 4A, para. [0062]), and wherein the plurality of electrodes are disposed on the rear cover (“impedance pads 450, 460 ... embedded into the one or more cavities of the underside of the housing 410”, para. [0060, 0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jung such that the housing comprises a rear cover comprising a first transmission area facing at least a portion of the light receiving unit and a second transmission area facing at least a portion of the light emitting unit, and wherein the plurality of electrodes are disposed on the rear cover, in view of the teachings of Miller, as this would aid in the sensor components contacting the skin of the user without extending beyond the plane defined by the underside of the housing by embedding the sensor components in the underside of the housing.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Miller 112 (US 11389112 B1).
Regarding claim 15, Jung discloses the electronic device of claim 1. Jung does not disclose at least one attachment member detachably connected to the housing.
However, Miller 112 directed to an electronic device 400/1000 (figs. 4A & 10A-D) including a housing 410, an optical sensor 420, light sources 430 and 440, an impedance sensor 455 (fig. 4A) disclose at least one attachment member (band 1092, figs. 10A-D) detachably connected to the housing (“removably attachable ... electronic device 1000”, col. 28 lines 51-col. 29 line 21, see also col. 21 line 49 – col. 22 line 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jung such that the electronic device comprises at least one attachment member detachably connected to the housing, in view of the teachings of Miller 112, as this would aid in maintain the electronic device affixed to a surface of the body and allow for coupling interchangeable bands for different sized wrists (col. 21 line 49 – col. 22 line 12).
Claim 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Bryenton (US 20050192488 A1).
Regarding claim 16, Jung discloses an electronic device (“electronic device”, para. [0056]; apparatus 1000/1100, figs. 10-11) comprising: a housing (“electronic device”, para. [0056, 0110], “apparatus ... mounted in an electronic device”, figs. 10-11); an optical sensor (optical sensor 110/1010, figs. 3-4 & 10-11) disposed on the housing (“mounted”, para. [0110]) and including a light emitting unit (“light source”, para. [0059-0060]) configured to radiate light to an object (as seen in fig. 4, para. [0059-0060]) and a light receiving unit (“photodetector”, para. [0059, 0061-0063]) configured to detect an intensity of the light radiated from the light emitting unit (as seen in fig. 4, “receive an optical signal”, para. [0061-0063]); an bio-impedance detection sensor (bioelectrical impedance sensor 120/1020, figs. 3-4 & 10-11, para. [0074-0076]) disposed adjacent to the optical sensor (as seen in figs. 3-4 & 11, “disposed symmetrically”, para. [0064, 0070]), and including a current transmitting unit (current source 231, fig. 4) configured to transmit a current (“231 ... apply a current”, para. [0076-0077]) and a current receiving unit (voltmeter 232 & impedance measurer 230, fig. 4) configured to receive at least a portion of the current transmitted from the current transmitting unit (“measure a voltage ... based on the current applied ... calculate a bioelectrical impedance”, para. [0076-0079]), and one or more processor (processor 1030, figs. 10-11) disposed in the housing (“mounted”, para. [0110-0111]). Jung further discloses the processor is configured to determine biometric information based on an intensity of light detected using the optical sensor and a magnitude of impedance sensed using the bio-impedance detection sensor (para. [0109]).
Jung does not expressly disclose wherein the one or more processor is configured to determine an electrolyte concentration of the object based on an intensity of light detected using the optical sensor and a magnitude of impedance sensed using the bio-impedance detection sensor.
However, Bryenton directed to the non-invasive analysis of physiological attributes using a sensor module (figs. 9-12) discloses one or more processor (processor subsystem 24, figs. 1 & 9-12, para. [0053]) configured to determine an electrolyte concentration of the object based on an intensity of light detected using the optical sensor and a magnitude of impedance sensed using the bio-impedance detection sensor (“combining ... optical spectrum analysis and one or more of bio-impedance analysis, RF impedance analysis, temperature and ECG ... measure ... body composition (e.g. local and total body water, fat and electrolytes)”; “body electrolytes ... local tissue electrolytes”; “optical, RF and local bio-impedance analysis subsystem function ... electrolytes ... determined”, para. [0025-0026, 0115-0116, 0118-0120], fig. 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jung such that the one or more processor is configured to determine an electrolyte concentration of the object based on an intensity of light detected using the optical sensor and a magnitude of impedance sensed using the bio-impedance detection sensor, in view of the teachings of Bryenton, as this would aid in non-invasively measuring electrolytes.
Regarding claim 20, Jung, as modified by Bryenton hereinabove, discloses the electronic device of claim 19, wherein at least a portion of the light emitted from the light emitting unit is configured to be transferred to the light receiving unit along an optical path (unlabeled, but as seen by the shaded region in fig. 4), at least a portion of the current transmitted from the current transmitting unit is configured to be transferred to the current receiving unit along a current path (unlabeled, but as seen in fig. 4), and at least a portion of the optical path overlaps at least a portion of the current path (as seen in fig. 4, “same region”, para. [0064, 0121, 0136]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Bryenton, as applied to claim 16 above, and further in view of Soller.
Regarding claim 19, Jung, as modified by Bryenton hereinabove, discloses the electronic device of claim 1. Jung, as modified by Bryenton hereinabove, does not expressly disclose wherein a wavelength range of the light generated by the light emitting unit is 1400 nm to 1500 nm or 1900 nm to 2000 nm.
However, Soller directed to methods for non-invasive spectroscopic measurement of the concentration of an electrolyte discloses a wavelength range of the light generated by the light emitting unit is 1400 nm to 1500 nm or 1900 nm to 2000 nm (“concentrations of clinically important electrolytes present in whole blood ... light in a wavelength range of about 500 to about 2200 nm”, para. [0011, 0022, 0073], claim 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jung, as modified by Bryenton hereinabove, such that a wavelength range of the light generated by the light emitting unit is 1400 nm to 1500 nm or 1900 nm to 2000 nm, in view of the teachings of Soller, as this would aid in measuring the concentrations of clinically important electrolytes using wavelengths which advantageously pass through skin and bone without significant absorption.
Allowable Subject Matter
Claims 10-12 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 17-18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, 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:
The prior art of record taken either singularly or in combination fails to anticipate, teach, or fairly suggest “wherein the one or more processor is configured to determine the electrolyte concentration using Equation 1 below: [Equation 1] electrolyte concentration , wherein e denotes the electrolyte concentration, c denotes a light absorption coefficient of an electrolyte in a user's blood, d denotes an electrode distance between the plurality of electrodes, n denotes a proportional constant between the current path and the electrode distance, k denotes a proportional constant between conductivity and the electrolyte concentration, Z denotes the magnitude of impedance detected by the bio-impedance detection sensor, Io denotes an intensity of light emitted from the light emitting unit, and I denotes an intensity of light received by the light receiving unit”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Marozas directed to system including a wearable device with integrated sensors for bio-signals (photoplethysmogram, electrocardiogram, bio-impedance, motions) and modules for recognizing and monitoring electrolyte (potassium, calcium, magnesium, etc.) imbalance (para. 0003]); Holweg (US 20170020424 A1) directed to test strip having a sensor unit discloses by the optical sensor 264, the sensor electrode unit 205 of the impedance spectroscopy unit 260, and by the sensor electrode unit 205 of the amperometric measurement unit 262 determining a salt concentration, a potassium concentration, a concentration of a chemical substance, a concentration of a biochemical substance (para. [0068,0078]); Jagtiani (US 20210229102 A1) directed to cartridges for analyzing a biological sample discloses an impedance sensor, which is configured to detect an analyte (e.g., a protein, enzyme, or electrolyte) and when the optical sensor is used in combination with the electrical impedance-based sensor, the optical sensors can be used to detect interfering substances or to detect a calibration factor for the impedance measurement (para. [0170]).
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/
Primary Examiner, Art Unit 3791
