DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/23/2026 was considered by the examiner.
Claim Interpretation
Claim 32 recites “typical… male”, which will be interpreted in light of ¶ [0071] of the Applicant’s specification which discloses “The rib model 800C represents some rib and ICS measurements of a typical male. The rib model 800C may be derived empirically, e.g., by measuring the width (e.g., in the vertical direction or generally parallel to the spine) of, among potentially others, the first, second, and third ICSs and the second and third ribs across a population of male subjects and then taking an average, mean, median, or the like for each ICS measurement and each rib measurement across the population.”
Claim 32 recites “typical… female”, which will be interpreted in light of ¶ [0069] of the Applicant’s specification which discloses “The rib model 800B represents some rib and ICS measurements of a typical female. The rib model 800B may be derived empirically, e.g., by measuring the width (e.g., in the vertical direction or generally parallel to the spine) of, among potentially others, the first, second, and third ICSs and the second and third ribs across a population of female subjects and then taking an average, mean, median, or the like for each ICS measurement and each rib measurement across the population.”
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 32 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.
The terms “large male” and “small female” in claim 32 are relative terms which render the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degrees, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this case, it is unclear when something starts/stops being considered large/small. Although paragraphs [0070] and [0072] of the Applicant’s specification recite “an average, mean, median of the smallest 10% (or other percentage) of the measurements from the population of females” and “an average, mean, median of the largest 10% (or other percentage) of the measurements from the population of males”, there is no indication of what the other percentage includes, which makes it unclear when something starts/stops being considered small/large.
Claim Rejections - 35 USC § 103
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 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 27 is rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0029833 A1 (Tang)(cited by Applicant) in view of US 2020/0229743 A1 (Choi) (previously cited).
With regards to claim 27, Tang teaches a method to measure oxygen saturation (¶ [0058] discloses measuring SpO2), comprising: generating a first signal of a subject using a first optical sensor of a torso sensor device (¶¶ [0058], [0061] and Figs. 3A-3B depict an optical system 60 of an optical sensor 36 comprising an array of six photodetectors 62 which each detect reflected radiation); generating a second signal of the subject using a second optical sensor of the torso sensor device (¶¶ [0058], [0061] and Figs. 3A-3B depict an optical system 60 of an optical sensor 36 comprising an array of six photodetectors 62 which each detect reflected radiation), the second optical sensor spaced apart from the first optical sensor such that the first and second signals are generated from different locations of the subject (Figs. 3A-3B depict the photodetectors being spaced apart such that they would produce different signals); generating an oxygen saturation measurement of the subject based on the first and/or second signal (¶ [0058] discloses the determination of an SpO2 based on the reflected radiation), and outputting the oxygen saturation measurement (¶ [0052] discloses calculating vital signs including SpO2 and transmitting the data)
Tang is silent regarding generating a first oxygen saturation measurement of the subject based on the first signal; generating a second oxygen saturation measurement of the subject based on the second signal; determining which of the first or second oxygen saturation measurements is better, wherein determining which of the first or second oxygen saturation measurements is better comprises: determining which of the first oxygen saturation measurement or the second oxygen saturation measurement is greater and selecting as the better oxygen saturation measurement the first oxygen saturation measurement or the second oxygen saturation measurement that is greater of the two; and outputting the better oxygen saturation measurement.
In a system relevant to the problem of selecting an optimal signal for determining oxygen saturation, Choi teaches generating a first oxygen saturation measurement of the subject based on a first signal (¶¶ [0023], [0068] discloses a processor 130 which determines oxygen saturation of each channel; Fig. 1 and ¶ [0042] depict a pulse wave sensor 110 and a processor 130; Fig. 2 and ¶ [0046] depict a first channel and a second channel); generating a second oxygen saturation measurement of the subject based on a second signal (¶¶ [0023], [0068] discloses a processor 130 which determines oxygen saturation of each channel; Fig. 1 and ¶ [0042] depict a pulse wave sensor 110 and a processor 130; Fig. 2 and ¶ [0046] depict a first channel and a second channel); determining which of the first or second oxygen saturation measurements is better (¶¶ [0023], [0074] discloses the processor 130 selecting, as the channel to be used for estimating bio-information, the channel having the greatest oxygen saturation within a predetermined time interval), determining which of the first or second oxygen saturation measurements is better comprises: determining which of the first oxygen saturation measurement or the second oxygen saturation measurement is greater (¶¶ [0023], [0074] of Choi discloses the processor 130 selecting, as the channel to be used for estimating bio-information, the channel having the greatest oxygen saturation within a predetermined time interval); and selecting as the better oxygen saturation measurement the first oxygen saturation measurement or the second oxygen saturation measurement that is greater of the two (¶ [0074] of Choi discloses using the greatest oxygen saturation); and using the better oxygen saturation measurement (¶ [0074] discloses using the greatest oxygen saturation to select the channel to be used in estimating bio-information). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of oxygen saturation of Tang to incorporate, based on the teachings of Choi generating a first oxygen saturation measurement of the subject based on the first signal; generating a second oxygen saturation measurement of the subject based on the second signal; determining which of the first or second oxygen saturation measurements is better; and outputting the better oxygen saturation measurement. The motivation would have been to select a channel which best corresponds with an object of interest (see ¶ [0073] of Choi), thereby improving the signal accuracy.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0029833 A1 (Tang)(cited by Applicant) in view of US 2020/0229743 A1 (Choi), as applied to claim 27 above, and further in view of US 2002/0042558 A1 (Mendelson) (previously cited)
With regards to claim 29, the above combination teaches attaching the torso sensor device to the subject’s torso (¶ [0058] of Tang teaches the optical sensor measures signals from the patient’s chest, which indicates that the optical sensor 36 is attached to the chest).
The above combination is silent regarding whether the attachment includes: locating an intercostal space (ICS) of the subject; positioning at least one of the first optical sensor or the second optical sensor over the ICS of the subject; and coupling the torso sensor device to the subject’s torso with at least one of the first optical sensor or the second optical sensor positioned over the ICS of the subject.
In the same field of endeavor of pulse oximeters applied to the chest, Mendelson teaches attaching a sensor to a subject’s torso (¶ [0092] discloses a photodetector ring mounted to a chest) including: positioning at least one of the first optical sensor or the second optical sensor over the ICS of the subject; and coupling the torso sensor device to the subject’s torso with at least one of the first optical sensor or the second optical sensor positioned over the ICS of the subject (¶ [0092] discloses a sensor comprising a continuous photodetector ring mounted on a chest, a portion of the photodetector ring lies over a rib, and the remaining part of the photodetector is positioned over the intercostal space). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for attaching the torso sensor device to the subject’s chest of the above combination to incorporate that it includes: locating an intercostal space (ICS) of the subject; positioning at least one of the first optical sensor or the second optical sensor over the ICS of the subject; and coupling the torso sensor device to the subject’s torso with at least one of the first optical sensor or the second optical sensor positioned over the ICS of the subject as taught by Mendelson. It would have been the simple substitution of one known equivalent method for attaching a pulse oximetry device to a chest for another to obtain predictable results. See [0058] of Tang; ¶ [0092] of Mendelson.
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0029833 A1 (Tang)(cited by Applicant) in view of US 2020/0229743 A1 (Choi) (previously cited) and US 2002/0042558 A1 (Mendelson) (previously cited), as applied to claim 29 above, and further in view of US 2015/0157225 A1 (Gillberg) (previously cited).
With regards to claim 30, the above combination teaches or suggests the torso sensor device includes: a first surface configured to be positioned against the subject’s torso and an opposing second surface (Figs. 2A-2B and 4 of Tang depict the optical sensor 36 comprising a bottom surface and a top surface), each of the first and second optical sensors positioned at the first surface of the housing (Figs. 2B and 4 of Tang depict the circular array of photodetectors 62 being positioned at the bottom surface); a first set of one or more alignment guides on the second surface and aligned to a first sensor axis of the first optical sensor (Figs. 2A-2B and 4 of Tang depict the top of the optical sensor 36 comprising a first set of one or more markings which are aligned with an axis of at least one of the photodetectors); and a second set of one or more alignment guides on the second surface and aligned to a second sensor axis of the second optical sensor (Figs. 2A-2B and 4 of Tang depict the top of the optical sensor 36 comprising a second set of one or more markings which are aligned with an axis of at least another one of the photodetectors); the sensor axes of the first and second optical sensors are parallel (Figs. 2A and 4 of Tang depict the sensor axes being parallel); the first set of one or more alignment guides is configured to visually identify a location, alignment, or both the location and alignment, of the first sensor axis of the first optical sensor (Figs. 2B and 4 of Tang depict the markings being capable of indicating a location and/or alignment of the photodetectors because they are parallel to the sensor axes); the second set of one or more alignment guides is configured to visually identify the location, alignment, or both a location and alignment, of the second sensor axis of the second optical sensor (Figs. 2B and 4 of Tang depict the markings being capable of indicating a location and/or alignment of the photodetectors because they are parallel to the sensor axes), the method further comprises positioning the at least one of the first optical sensor or the second optical sensor over the ICS of the subject (¶ [0092] of Mendelson).
The above combination is silent regarding whether the method further comprises positioning at least one of the first set of one or more alignment guides or the second set of one or more alignment guides over the ICS to position the at least one of the first optical sensor or the second optical sensor over the ICS of the subject
In a system relevant to the problem of accurately positioning a sensor over a desired anatomical location, Gillberg teaches positioning at least one alignment guide over a desired location to position a sensor over the desired location (¶ [0096] discloses at least one alignment marker used to align the device to one or more anatomical features of the patient such that the sensor array is positioned in a desired location). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate positioning at least one alignment guide over a desired location to position a sensor over the desired location as taught by Gillberg to arrive at positioning at least one of the first set of alignment guides or the second set of alignment guides over the ICS to position the at least one of the first optical sensor or the second optical sensor over the ICS of the subject. The motivation would have been to ensure that the sensors are located at the desired anatomical feature.
With regards to claim 31, the above combination is silent regarding aligning at least one of the first set of one or more alignment guides or the second set of one or more alignment guides parallel to the ICS, or an adjacent rib of the subject to align at least one of the first sensor axis or the second sensor axis parallel to the ICS or the adjacent rib.
In a system relevant to the problem of accurately positioning a sensor over a desired anatomical location, Gillberg teaches aligning at least one alignment marker parallel to an anatomical feature such that the sensors are aligned with the desired location (¶ [0096] discloses the alignment marker is aligned with the sternum (i.e., parallel with and over the sternum). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate aligning at least one alignment marker parallel to an anatomical feature such that the sensors are aligned with the desired location as taught by Gillberg to arrive at aligning at least one of the first set of alignment guides or the second set of alignment guides parallel to the ICS, or an adjacent rib of the subject to align at least one of the first sensor axis or the second sensor axis parallel to the ICS or the adjacent rib. The Examiner notes that aligning the markings of Tang to be parallel with the intercostal space necessarily results in the sensor axes being parallel with the intercostal space. The motivation would have been to ensure that the sensors are located at the desired anatomical feature in an optimal orientation.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0029833 A1 (Tang)(cited by Applicant) in view of US 2020/0229743 A1 (Choi), as applied to claim 27 above, and further in view of US 2017/0231600 A1 (Piraino)
With regards to claim 32, the above combination is silent regarding whether a center-to-center spacing of the first and second optical sensors is more than a width of a typical or large male subject's second rib or third rib in the parasternal area of the subject, and less than a width of a typical or small female subject's second intercostal space (ICS) in the parasternal area of the subject.
In a system relevant to the problem of spacing sensors relative to intercostal spaces, Piraino teaches a center-to-center spacing of the first and second sensors varies based on a typical intercostal distance (¶¶ [0045]-[0046] discloses distances between two transducers may be the average distance between two ribs on an average-sized human being, 1/2, 1/3, or 1/4 of a typical intercostal distance X), with the desired distance being chosen to reduce a likelihood that the transducers are obstructed by a rib (¶ [0046]).
The center-to-center spacing of the first and second sensors would depend upon the desired likelihood that the transducers are not obstructed by a rib. As such, the center-to-center spacing of the first and second sensors is a results-effective variable that would have been optimized through routine experimentation based on the desired likelihood that the transducers are not obstructed by a rib. It would have been obvious to one of ordinary skill in the art at the time of invention to select the center-to-center spacing of the first and second optical sensors to be more than a width of a typical or large male subject's second rib or third rib in the parasternal area of the subject, and less than a width of a typical or small female subject's second intercostal space (ICS) in the parasternal area of the subject to obtain the desired likelihood that the transducers are not obstructed by a rib. Alternatively or additionally, claim 31 would have been obvious in view of the combination since the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (MPEP 21044.04).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0029833 A1 (Tang)(cited by Applicant) in view of US 2020/0229743 A1 (Choi), as applied to claim 27 above, and further in view of US 2018/0353075 A1 (Duval)
With regards to claim 33, the above combination is silent regarding whether each of the first and second optical sensors comprises one or more optical emitters and one or more optical detectors.
In a system relevant to the problem of detecting a PPG signal, Duval teaches first and second optical sensors comprises one or more optical emitters and one or more optical detectors (Fig. 1 and ¶ [0044] depict an array 100 of multiwavelength optical sensors disposed around a central element 104, wherein the optical sensors 101 comprise at least one light emitter unit 102 and a peripheral optical detector 106; Fig. 12 depicts selecting a channel pair). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the each of the first and second optical sensors with the optical sensors comprising one or more optical emitters and one or more optical detectors as taught by Duval. Because both elements are capable of being used for measuring a PPG signal (see ¶ [0067] of Duval and ¶ [0058] of Tang), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Response to Arguments
Claim Objections
In view of the claim amendments filed 07/22/2026, the claim objections were withdrawn.
Claim Rejections under 35 U.S.C. §112(b)
There are new grounds of claim objections necessitated by the claim amendments filed 07/22/2026.
Claim Rejections under 35 U.S.C. §103
Applicant's arguments filed 07/22/2026 have been fully considered but they are not persuasive.
On page 7 of the remarks filed 07/22/2026, the Applicant asserts that Choi does not output the oxygen saturation measurement itself.
This argument is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The combination of Tang in view of Choi teaches or suggests outputting the better oxygen saturation measurement. Specifically, Tang teaches outputting an oxygen saturation measurement (¶ [0052] discloses calculating vital signs including SpO2 and transmitting the data). Choi teaches using the better oxygen saturation measurement (¶ [0074] discloses using the greatest oxygen saturation). The above combination of Tang in view of Choi teaches or suggests modifying the output oxygen saturation measurement of Tang such that the better oxygen saturation measurement of Choi is used and subsequently output.
On page 8 of the remarks filed 07/22/2026, the Applicant asserts that Choi teaches a single optical sensor which produces PPG waveforms that are used to determine a single SpO2 value, so Tang does not teach generating a first oxygen saturation measurement based on a first signal from a first optical sensor and generating a second oxygen saturation measurement based on a second signal from a spaced-apart optical sensor.
This argument is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Tang teaches the determination of different PPG waveforms using the array of photodetectors 62 (¶ [0058]). Choi teaches the calculation of first and second oxygen saturation measurements based on respective first and second signals from respective first and second optical sensors (¶¶ [0023], [0068] discloses a processor 130 which determines oxygen saturation of each channel; Fig. 1 and ¶ [0042] depict a pulse wave sensor 110 and a processor 130; Fig. 2 and ¶ [0046] depict a first channel and a second channel). Therefore, the combination of Tang in view of Choi teaches or suggests the above limitation.
On page 8 of the remarks filed 07/22/2026, the Applicant asserts that Choi’s approach is directed to identifying a channel whose optical path passes through a large artery, while Tang measures SpO2 from capillary beds, so one of ordinary skill in the art would not have been motivated to apply Choi's large-artery channel-selection technique to Tang's chest-capillary SpO2 measurement because the underlying physiological assumptions differ.
This argument is not persuasive. The selection of a channel based on a greatest oxygen saturation of ¶ [0074] of Choi is based on whether the optical path of the channel passes through the artery as taught by ¶ [0072] of Choi, which necessarily leads to a greater oxygen saturation measurement. The underlying principle of selecting a channel with an optical path which passes through a blood vessel based on a greatest oxygen saturation measurement is also relevant to the device of Tang because both a capillary bed and artery are blood vessels, wherein channels above the capillary bed would necessarily have a higher oxygen saturation measurement. Therefore, the teachings of Choi are applicable to the device of Tang.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
