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 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.
Claim 3 is 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 3 recites “The oxygen saturation measuring device of Claim 1, wherein, in a case in which the measured oxygen saturation does not reach a preset reference value, the notification portion provides, as the warning, a notice urging the measurement subject to measure oxygen saturation at a position of a fingertip.”. However, the only sensor mention previously is the first sensor portion attached to a band configured to be wound on the wrist of the subject in parent Claim 1. Therefore, it is unclear if this first sensor portion is also configured to measure oxygen saturation at a position of the fingertip of the subject, or an unmentioned sensor is configured to measure oxygen saturation at a position of a fingertip. For the purposes of substantive examination, it is presumed that either the first sensor portion or any other sensor can be utilized to measure saturation at a position of the fingertip of the subject.
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 1-7 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).
Claim 1 recites “a band wound on a wrist of a measurement subject”. By claiming a band wound on a wrist of the measurement subject, the Applicant is also claiming the wrist of the measurement subject, which is directed towards a human organism.
Claim 1 recites “the first sensor portion acquiring pulse wave signals of an artery of the wrist, and measuring oxygen saturation of the artery of the wrist on the basis of the acquired pulse wave signals”. By claiming a first sensor portion measuring oxygen saturation of the artery of the wrist, the Applicant is also claiming the artery of the wrist, which is directed towards a human organism.
Claims 2-5 are rejected by virtue of dependence on Claim 1.
Claim 6 recites “a band wound on a wrist of a measurement subject”. By claiming a band wound on a wrist of the measurement subject, the Applicant is also claiming the wrist of the measurement subject, which is directed towards a human organism.
Claim 6 recites “the first sensor portion acquiring pulse wave signals of an artery of the wrist, and measuring oxygen saturation of the artery of the wrist on the basis of the acquired pulse wave signals”. By claiming a first sensor portion measuring oxygen saturation of the artery of the wrist, the Applicant is also claiming the artery of the wrist, which is directed towards a human organism.
Claim 7 is rejected by virtue of dependence on Claim 6.
Claims 1-8 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 1 follows.
Regarding Claim 1, the claim recites an oxygen saturation measuring device. Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
in a case in which the oxygen saturation measured by the first sensor portion satisfies a preset condition, [providing] the measurement subject with a warning expressing a possibility of respiratory organ disorder
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
The plain meaning of the limitation “in a case in which the oxygen saturation measured by the first sensor portion satisfies a preset condition, provides the measurement subject with a warning expressing a possibility of respiratory organ disorder” includes mental processes that can be performed in the human mind by observations, evaluations, judgments, and opinions, or by a human with the aid of a pen and paper, or using a generic computer as a tool to perform these mental process steps in real time; and manually/mentally providing a warning, e.g. with voice, facial expression, or pen and paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
a band wound on a wrist of a measurement subject
a first sensor portion attached to the band, the first sensor portion acquiring pulse wave signals of an artery of the wrist, and measuring oxygen saturation of the artery of the wrist on the basis of the acquired pulse wave signals
The following limitations amount to a recitation of the words "apply it" (or an equivalent) and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
a notification portion
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
a band wound on a wrist of a measurement subject
a first sensor portion attached to the band, the first sensor portion acquiring pulse wave signals of an artery of the wrist, and measuring oxygen saturation of the artery of the wrist on the basis of the acquired pulse wave signals
a notification portion
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The band is considered to be well-understood, routine, and conventional based on a statement from the applicant's specification filed 01/03/2025 (“The material of the band 12 is an arbitrary material such as resin, fabric or metal”, [0027]).
The first sensor portion is considered to be well-understood, routine, and conventional based on a statement from the applicant's specification filed 01/03/2025 (“Specifically, the first sensor portion 11 of the present embodiment is structured by a base portion 14, contacting portions 16, light-emitting elements, light-receiving elements, and a computing section 18. The computing section 18 is housed within a case 25. Note that, in the present disclosure, the first sensor portion 11 can be structured arbitrarily provided that it can acquire the pulse wave signals of an artery of the wrist”, [0030]).
The notification portion is considered to be well-understood, routine, and conventional based on a statement from the applicant's specification filed 01/03/2025 (“The notification portion 26 is an image display device formed by liquid crystals for example”, [0054]).
Dependent Claim 2 also fails to add subject matter qualifying as significantly more to the abstract independent claims as it recites limitations that do not integrate the claims into a practical application (“wherein the first sensor portion is attached to an inner side of the band”), and does not recite significantly more than the identified abstract idea (“wherein the first sensor portion is attached to an inner side of the band”).
Dependent Claim 3 also fails to add subject matter qualifying as significantly more to the abstract independent claims as it merely further limits the abstract idea (“in a case in which the measured oxygen saturation does not reach a preset reference value, [providing], as the warning, a notice urging the measurement subject to measure oxygen saturation at a position of a fingertip”), recites limitations that do not integrate the claims into a practical application (“the notification portion”), and does not recite significantly more than the identified abstract idea (“the notification portion”).
Dependent Claim 4 also fails to add subject matter qualifying as significantly more to the abstract independent claims as it recites limitations that do not integrate the claims into a practical application (“a second sensor portion attached to the band and measuring oxygen saturation of an artery of a fingertip of the measurement subject”), and does not recite significantly more than the identified abstract idea (“a second sensor portion attached to the band and measuring oxygen saturation of an artery of a fingertip of the measurement subject”).
Dependent Claim 4 also fails to add subject matter qualifying as significantly more to the abstract independent claims as it recites limitations that do not integrate the claims into a practical application (“a second sensor portion attached to the band and measuring oxygen saturation of an artery of a fingertip of the measurement subject”), and does not recite significantly more than the identified abstract idea (“a second sensor portion attached to the band and measuring oxygen saturation of an artery of a fingertip of the measurement subject”)
Dependent Claim 5 also fails to add subject matter qualifying as significantly more to the abstract independent claims as it recites limitations that do not integrate the claims into a practical application (“wherein the second sensor portion is attached to an outer side of the band”), and does not recite significantly more than the identified abstract idea (“wherein the second sensor portion is attached to an outer side of the band”).
Regarding Claim 6, the claim recites an oxygen saturation measuring device. Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
in a case in which the oxygen saturation measured by the first sensor portion satisfies a preset condition, [providing] the measurement subject with a warning expressing a possibility of respiratory organ disorder
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
The plain meaning of the limitation “in a case in which the oxygen saturation measured by the first sensor portion satisfies a preset condition, provides the measurement subject with a warning expressing a possibility of respiratory organ disorder” includes mental processes that can be performed in the human mind by observations, evaluations, judgments, and opinions, or by a human with the aid of a pen and paper, or using a generic computer as a tool to perform these mental process steps in real time; and manually/mentally providing a warning, e.g. with voice, facial expression, or pen and paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
a band wound on a wrist of a measurement subject
a first sensor portion attached to the band, the first sensor portion acquiring pulse wave signals of an artery of the wrist, and measuring oxygen saturation of the artery of the wrist on the basis of the acquired pulse wave signals
a second sensor portion attached to the band and measuring oxygen saturation of an artery of a fingertip of the measurement subject
The following limitations amount to a recitation of the words "apply it" (or an equivalent) and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
a notification portion
a display portion displaying the oxygen saturation measured by the second sensor portion
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
a band wound on a wrist of a measurement subject
a first sensor portion attached to the band, the first sensor portion acquiring pulse wave signals of an artery of the wrist, and measuring oxygen saturation of the artery of the wrist on the basis of the acquired pulse wave signals
a second sensor portion attached to the band and measuring oxygen saturation of an artery of a fingertip of the measurement subject
a notification portion
a display portion displaying the oxygen saturation measured by the second sensor portion
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The band is considered to be well-understood, routine, and conventional based on a statement from the applicant's specification filed 01/03/2025 (“The material of the band 12 is an arbitrary material such as resin, fabric or metal”, [0027]).
The first sensor portion is considered to be well-understood, routine, and conventional based on a statement from the applicant's specification filed 01/03/2025 (“Specifically, the first sensor portion 11 of the present embodiment is structured by a base portion 14, contacting portions 16, light-emitting elements, light-receiving elements, and a computing section 18. The computing section 18 is housed within a case 25. Note that, in the present disclosure, the first sensor portion 11 can be structured arbitrarily provided that it can acquire the pulse wave signals of an artery of the wrist”, [0030]).
The notification portion is considered to be well-understood, routine, and conventional based on a statement from the applicant's specification filed 01/03/2025 (“The notification portion 26 is an image display device formed by liquid crystals for example”, [0054]).
The second sensor portion is considered to be well-understood, routine, and conventional based on a statement from the applicant's specification filed 01/03/2025 (“Note that, in the present disclosure, the second sensor portion can be structured arbitrarily provided that it can measure the oxygen saturation of an artery of a fingertip.”, [0072]).
The display portion is considered to be well-understood, routine, and conventional based on a statement from the applicant's specification filed 01/03/2025 (“The measured value of the measured oxygen saturation is displayed on the notification portion 26 that serves as a display portion”, [0079]).
Dependent Claim 7 also fails to add subject matter qualifying as significantly more to the abstract independent claims as it merely further limits the abstract idea (“”), recites limitations that do not integrate the claims into a practical application (“wherein the notification portion and the display portion form an integrated body”), and does not recite significantly more than the identified abstract idea (“wherein the notification portion and the display portion form an integrated body”).
Dependent Claim 7 also fails to add subject qualifying as significantly more to the abstract independent claims as it recites limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above and does not recite significantly more than the identified abstract idea.
Regarding Claim 8, the claim recites an oxygen saturation measuring method. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
acquiring pulse wave signals of an artery of a wrist of a measurement subject
in a case in which the measured oxygen saturation satisfies a preset condition, providing the measurement subject with a warning
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
The plain meaning of the limitation “acquiring pulse wave signals of an artery of a wrist of a measurement subject” includes mental processes that can be performed in the human mind by observations, evaluations, judgments, and opinions, or by a human with the aid of a pen and paper, or using a generic computer as a tool to perform these mental process steps in real time.
The plain meaning of the limitation “in a case in which the measured oxygen saturation satisfies a preset condition, providing the measurement subject with a warning” includes mental processes that can be performed in the human mind by observations, evaluations, judgments, and opinions, or by a human with the aid of a pen and paper, or using a generic computer as a tool to perform these mental process steps in real time.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
measuring oxygen saturation of the artery on the basis of the acquired pulse wave signals
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
measuring oxygen saturation of the artery on the basis of the acquired pulse wave signals
Therefore, Claims 1-8 are not patent eligible under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1-2 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hashimoto (US 20170251928 A1, cited in applicant’s IDS, hereinafter Hashimoto).
Regarding Claim 1, Hashimoto discloses an oxygen saturation measuring device (Element 100, Fig. 1) comprising:
a band (Element 14, Fig. 1) wound on a wrist of a measurement subject (“The measurement device 100 according to the first embodiment is a wristwatch-type portable device including a housing unit 12 and a belt 14, and can be installed on a wrist of the examinee by winding the belt 14 around the wrist serving as an example of the measurement site M”, [0032]);
a first sensor portion (Element 26, Fig. 1) attached to the band (See Fig. 1), the first sensor portion acquiring pulse wave signals of an artery of the wrist (“The detection device 26 (example of a detection unit) in FIG. 2 is an optical sensor which generates a pulse wave signal P indicating a pulse wave of the examinee”, [0034]), and measuring oxygen saturation of the artery of the wrist on the basis of the acquired pulse wave signals (“The measurement unit 30 sequentially identifies a numerical value (hereinafter, referred to as a “measurement value”) X of the oxygen saturation of the examinee from the pulse wave signal P generated by the detection device 26”, [0038]); and
a notification portion that, in a case in which the oxygen saturation measured by the first sensor portion satisfies a preset condition (“if a state where the measurement value X is the numerical value beyond the reference range R is continuous for a predetermined period of time, it can be estimated that the measurement value X varies due to the abnormal respiratory function of the examinee.”, [0049]), provides the measurement subject with a warning (ABNORMAL SpO2 IS DETECTED”, Fig. 7) expressing a possibility of respiratory organ disorder (“The measurement value X of the oxygen saturation means a proportion (%) of hemoglobin bound to oxygen in hemoglobin contained in the blood of the examinee, and is an index for evaluating a respiratory function of the examinee”, [0038]; “Therefore, in a case where the measurement value X is continuously below the lower limit value RL in the reference range R (X<RL) for the predetermined period of time, as illustrated in FIG. 7, the notification unit 36 causes the display device 24 to display the evaluation comment 54 notifying the abnormal oxygen saturation of the examinee as the measurement result.”, [0049]).
Regarding Claim 2, Hashimoto discloses the oxygen saturation measuring device of Claim 1, wherein the first sensor portion is attached to an inner side of the band (See Fig. 1).
Regarding Claim 8, Hashimoto discloses an oxygen saturation measuring method ([0014]) comprising:
acquiring pulse wave signals of an artery of a wrist of a measurement subject (“The detection device 26 (example of a detection unit) in FIG. 2 is an optical sensor which generates a pulse wave signal P indicating a pulse wave of the examinee”, [0034]);
measuring oxygen saturation of the artery on the basis of the acquired pulse wave signals (“The measurement unit 30 sequentially identifies a numerical value (hereinafter, referred to as a “measurement value”) X of the oxygen saturation of the examinee from the pulse wave signal P generated by the detection device 26”, [0038]); and
in a case in which the measured oxygen saturation satisfies a preset condition (“if a state where the measurement value X is the numerical value beyond the reference range R is continuous for a predetermined period of time, it can be estimated that the measurement value X varies due to the abnormal respiratory function of the examinee.”, [0049]), providing the measurement subject with a warning (ABNORMAL SpO2 IS DETECTED”, Fig. 7).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto in view of Kangas (US 20240000328 A1, hereinafter Kangas).
Regarding Claim 3, Hashimoto discloses the oxygen saturation measuring device of Claim 1, wherein, in a case in which the measured oxygen saturation does not reach a preset reference value, the notification portion provides, as the warning, a notice urging the measurement subject to correct the oxygen saturation device placement (“In a case where the measurement value X varies to be beyond the reference range R, as illustrated in FIG. 6, the notification unit 36 causes the display device 24 to display the evaluation comment 54 meaning the variations of the oxygen saturation (for example, a character string of “It is detected that SpO2 is slightly lowered”). If the measurement value X varies to be a numerical value beyond the reference range R, there is a possibility of an unexpected measurement error caused by the physical exercise (body movement) of the examinee or position misalignment of the detection device 26, for example. Therefore, at a stage immediately after the measurement value X varies to be the numerical value beyond the reference range R, as illustrated in FIG. 6, the notification unit 36 according to the first embodiment causes the display device 24 to display the evaluation comment 54 meaning a possibility that the oxygen saturation cannot be properly measured (for example, a character string of “Please confirm whether the device is correctly installed”).”, [0048]). Hashimoto discloses the claimed invention except for expressly a notice urging the measurement subject to measure oxygen saturation at a position of a fingertip. However, Kangas, which discloses the same base device as Hashimoto (an oxygen saturation measurement device, [0021]), teaches wherein, in a case in which the measured oxygen saturation does not reach a preset reference value (“In some cases, the processing module 230-a, may determine that a signal quality associated with light received by the first photodetector via the first optical path is below a threshold signal quality.”, [0100]), a processor then measures oxygen saturation at a different position of a fingertip (“In some examples, the processing module 230-a may configure the ring 104 to collect the physiological data associated with the blood oxygen saturation of the user 102 via the second optical path between the second light-emitting component and the first photodetector (e.g., switch optical paths) based on a higher signal quality associated with light received by the first photodetector via the second optical path (e.g., a signal quality above the threshold)”, [0100]). One of ordinary skill in the art would have realized that applying the known technique of utilizing an alternative sensor/sensing method to sense a parameter of interest when the primary sensor does not provide data above a desired quality threshold to the oxygen saturation device of Hashimoto would have predictably resulted in consistently accurate results above a desired quality threshold. Therefore, it would have been obvious to apply the known technique of Kangas to the oxygen saturation measurement device of Hashimoto such that wherein, in a case in which the measured oxygen saturation does not reach a preset reference value, the notification portion provides, as the warning, a notice urging the measurement subject to measure oxygen saturation at a position of a fingertip. See MPEP 2143(I)(D).
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto in view of Shin (US 20170027461 A1, hereinafter Shin).
Regarding Claim 4, Hashimoto discloses the oxygen saturation measuring device of Claim 1. Hashimoto discloses the claimed invention except for expressly disclosing the device further comprising a second sensor portion attached to the band and measuring oxygen saturation of an artery of a fingertip of the measurement subject. However, Shin, which also discloses an oxygen saturation measuring device ([0017]), teaches the device further comprising a second sensor portion (Element B, Fig. 2) attached to the band (See Fig. 2) and measuring oxygen saturation of an artery of a fingertip of the measurement subject (See Fig. 2; “For example, the PPG sensor module can be formed at a location where the electrodes of the ECG sensor module are formed. If the PPG sensor module is formed at the location where the electrodes of the ECG sensor module are formed, PPG and SpO.sub.2 signals as well as the ECG signal can be measured”, [0029]; “The measurement module may observe a blood flow rate in peripheral blood vessels of a fingertip or a be tip by irradiating light to the fingertip or the toe tip using a red light source and/or an infrared light source and measuring light transmitted or reflected by the human body using a photo sensor and may measure the PPG and SpO.sub.2 signals based on the observed blood flow rate”, [0017]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the second sensor of Shin to the device of Hashimoto, for a redundant measurement system which improves accuracy and more reliable measurements, as one sensor can be used if the other is faulty.
Regarding Claim 5, modified Hashimoto discloses the oxygen saturation measuring device of Claim 4. Modified Hashimoto discloses the claimed invention except for expressly disclosing wherein the second sensor portion is attached to an outer side of the band. However, Shin teaches wherein the second sensor portion (Element B, Fig. 2) is attached to an outer side of the band (See Fig. 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the second sensor of Shin to the device of Hashimoto (and in a different location than the first sensor, such as the outer side of the band), for a redundant measurement system which improves accuracy and more reliable measurements, as one sensor can be used if the other is faulty.
Regarding Claim 6, Hashimoto discloses an oxygen saturation measuring device comprising:
a band (Element 14, Fig. 1) wound on a wrist of a measurement subject (“The measurement device 100 according to the first embodiment is a wristwatch-type portable device including a housing unit 12 and a belt 14, and can be installed on a wrist of the examinee by winding the belt 14 around the wrist serving as an example of the measurement site M”, [0032]);
a first sensor portion (Element 26, Fig. 1) attached to the band (See Fig. 1), the first sensor portion acquiring pulse wave signals of an artery of the wrist (“The detection device 26 (example of a detection unit) in FIG. 2 is an optical sensor which generates a pulse wave signal P indicating a pulse wave of the examinee”, [0034]), and measuring oxygen saturation of the artery of the wrist on the basis of the acquired pulse wave signals (“The measurement unit 30 sequentially identifies a numerical value (hereinafter, referred to as a “measurement value”) X of the oxygen saturation of the examinee from the pulse wave signal P generated by the detection device 26”, [0038]);
a notification portion that, in a case in which the oxygen saturation measured by the first sensor portion satisfies a preset condition (“if a state where the measurement value X is the numerical value beyond the reference range R is continuous for a predetermined period of time, it can be estimated that the measurement value X varies due to the abnormal respiratory function of the examinee.”, [0049]), provides the measurement subject with a warning (ABNORMAL SpO2 IS DETECTED”, Fig. 7) expressing a possibility of respiratory organ disorder (“The measurement value X of the oxygen saturation means a proportion (%) of hemoglobin bound to oxygen in hemoglobin contained in the blood of the examinee, and is an index for evaluating a respiratory function of the examinee”, [0038]; “Therefore, in a case where the measurement value X is continuously below the lower limit value RL in the reference range R (X<RL) for the predetermined period of time, as illustrated in FIG. 7, the notification unit 36 causes the display device 24 to display the evaluation comment 54 notifying the abnormal oxygen saturation of the examinee as the measurement result.”, [0049]); and
a display portion (Element 24, Fig. 1) displaying the oxygen saturation measured (See Figs. 5-8).
Hashimoto discloses the claimed invention except for expressly disclosing a second sensor portion attached to the band and measuring oxygen saturation of an artery of a fingertip of the measurement subject; and
a display portion displaying the oxygen saturation measured by the second sensor portion.
However, Shin, which also discloses an oxygen saturation measuring device ([0017]), teaches a second sensor portion (Element B, Fig. 2) attached to the band (See Fig. 2) and measuring oxygen saturation of an artery of a fingertip of the measurement subject (See Fig. 2; “For example, the PPG sensor module can be formed at a location where the electrodes of the ECG sensor module are formed. If the PPG sensor module is formed at the location where the electrodes of the ECG sensor module are formed, PPG and SpO.sub.2 signals as well as the ECG signal can be measured”, [0029]; “The measurement module may observe a blood flow rate in peripheral blood vessels of a fingertip or a be tip by irradiating light to the fingertip or the toe tip using a red light source and/or an infrared light source and measuring light transmitted or reflected by the human body using a photo sensor and may measure the PPG and SpO.sub.2 signals based on the observed blood flow rate”, [0017]); and
a display portion displaying the oxygen saturation measured by the second sensor portion (“Biosignal information measured and/or estimated as described above may be provided to the user in real time through the display screen of the display module formed on the front of the biosignal measurement apparatus 100”, [0043]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the second sensor of Shin to the device of Hashimoto, for a redundant measurement system which improves accuracy and more reliable measurements, as one sensor can be used if the other is faulty.
Regarding Claim 7, modified Hashimoto discloses the oxygen saturation measuring device of Claim 6, wherein the notification portion (Element 24, Fig. 1) and the display portion (Element 24, Fig. 1) form an integrated body (See Fig. 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Ko et al (US 20210244301 A1): Element 10, Fig. 1, Fig. 8.
See Bushnell et al (US 10866619 B1)
See Galdi (US 20220104719 A1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN EPHRAIM COOPER whose telephone number is (571)272-2860. The examiner can normally be reached Monday-Friday 7:30AM-5:30PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN E. COOPER/ Examiner, Art Unit 3791
/JACQUELINE CHENG/ Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights