Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This office action is responsive to the reply to the restriction requirement filed on September 24, 2025, claims 1-3, 5-7 and 9-20 have been elected without traverse, and claims 4 and 8 have been withdrawn from further consideration pursuant 37 CFR 1.142(B) as being nonelected species, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6 and 7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 6 recites “adaptively estimating.” The specification as filed provides written description of “adaptive measurement” (See Applicant specification [0064]), however does not provide adequate written description to what “adaptively estimating” entails.
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 6 and 7 are 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.
Regarding claim 6, the phrase "adaptively estimating" which renders the claim indefinite because it is unclear what adaptively is referring to.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 5-7, and 9-20 are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea. The claims as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than a mental process. A subject matter eligibility analysis of claims 1-9 is as follows. Step 1: Claims 1-3, 5-7, and 9-20 recite a method which falls within one of the four categories of invention.
Step 2A: When analyzed to determine whether the claim 1 recites or is directed to any judicial exception, the claim recites the limitations “estimating heartbeat, extracting a pulsatile component, estimating SpO2 and combine SpO2 estimates from each channel in the subset to generate a final SpO2” which sets forth a judicial exception. Under broadest reasonable interpretation, the limitation describes a mental process capable of being performed in the human mind (including observation, evaluation, judgment, opinion), but for the recitation of generic computer components. The claim does not forth any structure for performing the judicial exception, thus the claim is drawn to a mental process which is an abstract idea. When analyzed to determine whether the claim 11 recites or is directed to any judicial exception, the claim recites the limitations “estimate heartbeat, extract a pulsatile component, estimate SpO2, and combine SpO2 estimates from each channel in the subset to generate a final SpO2” which sets forth a judicial exception. Under broadest reasonable interpretation, the limitation describes a mental process capable of being performed in the human mind (including observation, evaluation, judgment, opinion), but for the recitation of generic computer components. The claim does not forth any structure for performing the judicial exception, thus the claim is drawn to a mental process which is an abstract idea. When analyzed to determine whether the claim 17 recites or is directed to any judicial exception, the claim recites the limitations “estimate heartbeat, extract a pulsatile component, estimate SpO2, and combine SpO2 estimates from each channel in the subset to generate a final SpO2” which sets forth a judicial exception. Under broadest reasonable interpretation, the limitation describes a mental process capable of being performed in the human mind (including observation, evaluation, judgment, opinion), but for the recitation of generic computer components. The claim does not forth any structure for performing the judicial exception, thus the claim is drawn to a mental process which is an abstract idea. Step 2A Prong Two: When analyzing claim 1 as a whole to determine whether the claim recites additional elements that integrate the judicial exception into a practical application besides the abstract idea. The claim recites “collecting data from plurality of light emitting diode-photodiode (LED-PD) channels; assigning a signal quality to each of the plurality of LED-PD channels; identifying a subset of the plurality of LED-PD channels with good signal quality, and channel in subset.” These claimed elements fail to recite any additional elements or combination of additional elements that apply or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The additional limitation “collecting data, assigning a signal and identifying, a subset” is merely used as pre-solution activity of data gathering to input data to the mental process. When analyzing claim 11, as a whole to determine whether the claim recites additional elements that integrate the judicial exception into a practical application besides the abstract idea. The claim recites “a plurality of light emitting photodiode (LED-PD) channels to collect data a processor for photoplethysmography, assign a respective signal quality to each of the plurality of LED-PD channels; identify a subset of the plurality of LED-PD channels, with each channel in the subset having a good respective signal quality.” These claimed elements fail to recite any additional elements or combination of additional elements that apply or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The additional limitation “collecting data, assigning a signal and identifying, a subset” is merely used as pre-solution activity of data gathering to input data to the mental process. As recited “a processor” is a generic part of a computer which allow the computer implementation of the mental process. Similarly when analyzing claim 17, as a whole to determine whether the claim recites additional elements that integrate the judicial exception into a practical application besides the abstract the claim recites “a plurality of light emitting diodes to emit light; a plurality of photodiodes to receive reflected LED light, with the plurality of LED and the plurality of photodiodes forming a plurality of light emitting diode-photodiode (LED-PD) channels to collect data; a plate to hold the LED and photodiodes; and a processor coupled to the plate to assigning a respective signal quality to each the plurality of LED-PD channels; identify a subset of the plurality of LED-PD channels, with each channel in the subset having a good respective signal quality.” The additional limitation “collecting data, assigning a signal and identifying, a subset” is merely use as pre-solution activity of data gathering to input data to the mental process. As recited “a processor” is a generic part of a computer which allow the computer implementation of the mental process.Step 2B: The claims do not include additional elements that are sufficient to amount for significantly more than the judicial exception, when considering separately and in combination. Analyzing the additional claim limitation individually, the additional limitation that are not directed mental process in claim 1, 11, and 17 are “collecting data from plurality of light emitting diode-photodiode (LED-PD) channels; assigning a signal quality to each of the plurality of LED-PD channels; identifying a subset of the plurality of LED-PD channels with good signal quality, and channel in subset” are limitations conventional and routine in the art as evidenced by (See Lange [0059]-[0072]) add insufficient pre/post- solution activity to the abstract idea that merely collects data to be used by the abstract idea.
In view of the above claims 1, 11, and 17 fail to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claims 2-3, 5-7, 9-10, 12-16,and 18-20 fail to cure the deficiencies of claim 1, 11, and 17 by merely reciting additional abstract idea already recited. Similarly, claims 5-7, 9-10, 12-16,and 18-20 merely reciting additional abstract ideas or further limitations on the abstract idea already recited in independent claims 1, 11, and 17.
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 1-3, 5-6, 9-11, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lange et al. (US20190015014A1; hereinafter known as “Lange”).
Regarding claim 1, Lange teaches a method for pulse oximetry (See Lange [0059], signals can be used for pulse oximetry), comprising: collecting data from a plurality of light emitting diode-photodiode (LED-PD) channels (See Lange [0059], multiple light sensors used); assigning a signal quality to each of the plurality of LED-PD channels (See Lange [0072], determine whether the signal is good quality by determining signal to noise ratio);
identifying a subset of the plurality of LED-PD channels with good signal quality, and for each channel in the subset (See Lange [0072], determine whether the signal is good quality by determining signal to noise ratio [0084][0086]):
estimating heartbeat (See Lange [0050][0053], determine heartbeat through ECG),
extracting a pulsatile component (See Lange [0050], pulse rate),
estimating SpO2 (See Lange [0060], pulse oximetry can yield SpO2); and
combining SpO2 estimates from each channel in the subset to generate a final SpO2 estimate (See Lange [0051][0060][0071]). Regarding claim 2, Lange teaches determining an accuracy of the final SpO2 estimate (See Lange [0077], determines whether accurate using perfusion index). Regarding claim 3, Lange teaches when the accuracy exceeds a selected threshold, reporting the final SpO2 estimate (See Lange [0077], when the perfusion index is calculated as a ratio difference, the larger the index the more accurate the final SpO2 estimate). Regarding claim 5, Lange teaches collecting data includes collecting data continuously (See Lange [0058], the sensors are in continuous contact and measurements can be taken during anytime [0039]).
Regarding claim 6, Lange teaches estimating heartbeat includes adaptively estimating heart rate from the collected data (See Lange [0052-0053]). Regarding claim 9, Lange teaches estimating SpO2 includes determining SpO2 in the time domain (See Lange [0065][0009], amplitude is measured over time). Regarding claim 10, Lange teaches comprising for each channel in the subset identifying noise and removing noise (See Lange [0054][0071][0084][0086], module removes noise). Regarding claim 11, Lange teaches a system for pulse oximetry (See Lange [0059], signals can be used for pulse oximetry) comprising: a plurality of light emitting diode-photodiode (LED-PD) channels to collect data (See Lange [0059], multiple light sensors used); a processor for photoplethysmography (See Lange [0009]) to: assign a respective signal quality to each of the plurality of LED-PD channels (See Lange [0072], determine whether the signal is good quality by determining signal to noise ratio); identify a subset of the plurality of LED-PD channels, with each channel in the subset having good respective signal quality (See Lange [0072], determine whether the signal is good quality by determining signal to noise ratio [0084][0086]), and for each channel in the subset: estimate heartbeat (See Lange [0050][0053], determine heartbeat through ECG),extract a pulsatile component (See Lange [0050], pulse rate), estimate SpO2 (See Lange [0060], pulse oximetry can yield SpO2); and combine SpO2 estimates from each channel in the subset to generate a final SpO2 estimate (See Lange [0051][0060][0071]). Regarding claim 17, Lange teaches a wearable device for pulse oximetry (See Lange [0059], signals can be used for pulse oximetry), comprising: a plurality of light emitting diodes (LED) to emit light (See Lange [0059], multiple light sensors); a plurality of photodiodes to receive reflected LED light,
with the plurality of LEDs and the plurality of photodiodes forming a plurality of light emitting diode-photodiode channels to collect data (See Lange [0059]);
a plate to hold the LEDs and photodiodes (See Lange Figure 4C 22a plate form with light sensors and transmitters); and
a processor coupled to the plate to: assign a respective signal quality to each of the plurality of LED-PD channels (See Lange [0072], determine whether the signal is good quality by determining signal to noise ratio); identify a subset of the plurality of LED-PD channels, with each channel in the subset having a good respective signal quality and for each channel in the subset (See Lange [0010-0011], processor configured to determine signal and obtain oxygen saturation):
estimate heartbeat (See Lange [0050][0053], determine heartbeat through ECG), extract a pulsatile component (See Lange [0050], pulse rate), estimate SpO2 (See Lange [0060], pulse oximetry can yield SpO2); and combine SpO2 estimates from each channel in the subset to generate a final SpO2 estimate (See Lange [0051][0060][0071]).
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.
Claims 7, 15, 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lange in view of Dubielczyk et al. (US20140221847A1; hereinafter known as “Dubielczyk”). Regarding claim 7, 15, and 20, Lange teaches the plurality of LED-PD channels includes a first channel, the first channel includes a light LED, and wherein estimating heartbeat includes estimating heartbeat using the light LED of the first channel (See Lange [0061], measures PPG can determine heartrate, uses red light). Lange is silent to green light LED.
Dubielczyk teaches green light LED (See Dubielczyk [0066]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify Lange with a green light LED as taught by Dubielczyk to provide the device with the ability to determine between signal strength of the channels, with green representing a strong signal strength and red representing a slow signal strength (See [0077]). Regarding claim 16, Lange teaches the plurality of LED-PD channels (See Lange [0061], measures PPG can determine heartrate, uses red light). Lange is silent to includes a first channel, and the first channel includes a green LED, a red LED, and an infrared LED. Dubielczyk teaches green light LED (See Dubielczyk [0066] 0077], measures PPG can determine heartrate, uses red light). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify Lange with a green light, a red LED, and an infrared LED as taught by Dubielczyk to provide the device with alternative wavelength combinations depending on the substance to be detected and alter the color of the LED depending on the signal strength (See [0066][0077]). Claims 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lange in view of Takahashi et al. (US20110098582A1; hereinafter known as “Takahashi”). Regarding claims 12 and 19, Lange teaches the system of claims 11 and 17, See Lange [0054][0071][0084][0086], module removes noise) but is silent to an adaptive filter to filter out the heartbeat. Takahashi teaches an adaptive filter to filter out the heartbeat (See [0015][0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Lange with an adaptive filter to filter out the heartbeat as taught by Takahashi to solely divide the heartbeat signal from the combined signal received (See Takahashi [0015][0019][0039]).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lange in view of Takahashi, as applied to claim 12 above, and further in view of Van Slyke (US20060094943A1; hereinafter known as “Van Slyke”). Regarding claims 13 and 14, Lange as modified with Takahashi teaches all of the limitations of the claims except that the adaptive filter is one of a cone filter and a bandpass filter. Van Slyke teaches an adaptive filter is a bandpass filter (See [0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify Lange in view of Takashi with an adaptive filter which has a bandpass filter in order to tune the adaptive filter to the patients pulse rate, and further remove motion rejection which can be used for improved pulse rate and SpO2 calculations (See Van Slyke [0083]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Lange in view of Ecker et al. (US20120232354A1; hereinafter known as “Ecker). Regarding claim 18, Lange teaches the plate (See Figure 4C) but is silent to a baffle coupled to the plate, wherein the baffle includes a raised structure between at least two plurality of LEDs.
Ecker teaches a baffle coupled to the plate, wherein the baffle includes a raised structure between at least two of the plurality of LEDs (See Ecker [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Lange with a baffle coupled to the plate, wherein the baffle includes a raised structure between at least two of the plurality of the LEDs as taught by Ecker to prevent direct, reflected or refracted transmission of light by tissue volume or united light (See [0027]).
Conclusion
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.R.K./Examiner, Art Unit 3791