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
Claim 1 is objected to because of the following informalities: Claim 1 recites “photoplethysmography” in the preamble, but instead should be -- photoplethysmography (PPG)--. Claim 1 recites “first and second sensors” in line 6, but instead should be --first and second PPG sensors--. Appropriate correction is required.
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.
Claims 6-7 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.
Claim 6 recites “adjust using equation 1” but is indefinite. What is being adjusted? What is equation 1? Applicant must provide what is being adjusted and what the equation is to properly examine the limitation.
Following the rejection of Claim 6 above, Claim 7 is also indefinite because it is unclear what equation and coefficients are being referenced. As written, it is unclear how the limitation is further limiting the claim set. In summary, the recitation of “the coefficients” lacks antecedent basis, it is unclear what coefficients are optimized in the undisclosed equation, and unclear as to whether equation in claim 6 and 7 are the same.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 3 and 4 are not dependent on solely one claim, but are required to depend on only one claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-7 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.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including estimating RR and SpO2. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of estimating RR and SpO2 sets forth a judicial exception. This step describes 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. The RR and SpO2 values do not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the computed values, nor does the method use a particular machine to perform the Abstract Idea. Moreover, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited PPG and colorimetry sensors are generic sensors configured to perform pre-solutional data gathering activity, and the computer system 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 acquiring PPG data with two sensors, a colorimetry sensor for detecting skin tone, and adjusting measured signal based on skin thickness and pigmentation. Obtaining data (PPG and colorimetry sensor data) to adjust physiological parameters is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the acquiring, retrieving, and comparison steps are each recited at a high level of generality such that it amounts to insignificant presolution 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.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and processing. The acquiring and adjusting steps recited in the independent claim maintains a high level of generality even when considered in combination with the dependent claims.
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Jumbe et al. (US 20250271896), hereinafter Jumbe, further in view of Campbell et al. (US 20080221410), hereinafter Campbell.
Regarding claim 1, Jumbe teaches a photoplethysmography system (abstract, ¶[0027], and table 2, “sensor comprises one or more of a vibroacoustic sensor, a PPG/SpO2 sensor, and an electric potential sensor”) comprising:
a first PPG sensor disposed to be worn on a patient’s finger (¶[0169] and table 2, sensors that can be incorporated “Finger Heart Rate and Pulse Oximeter Smart Sensor”); a second PPG sensor disposed to be worn on the patient’s wrist (¶[0217], the enclosure (wearable device) can be placed on various parts of the body including the wrist. ¶[0049], An example is provided here that teaches multiple enclosure (device wearable around the wrist and patch over the carotid artery) can be used in combination. Thus, in ¶[0027,0049,0217] and tables 1-2, teaches the use of a finger pulse ox and heart rate device with a wrist PPG sensor embedded within an enclosure, that can have a plurality of other sensors therewithin), and a processor configured to continuously estimate RR and SpO2 using data from the first and second sensors (table 2, the finger device measures SpO2, and respiratory rate is measured by a separate sensor included therewithin) but fails to teach a colorimetry sensor for detecting skin tone; and, adjusting for the patient’s skin thickness and pigmentation based on data from the colorimetry sensor.
Campbell teaches it is desirable to determine the location of a sensor, e.g. pulse oximetry, so that the sensor may be calibrated to improve the accuracy of the calculations performed by the processor (¶[0023]). As such, skin thickness and skin pigmentation are analyzed to correctly calibrate the sensor (¶[0013,0024-25,0035,0042-43], colorimetry sensor is based on the “fiber optic sensor 12 of FIG. 1, in some embodiments the calibration information used by the monitor may be chosen based on a determination of skin color of the patient at the sensor site, e.g. skin pigmentation”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Jumbe, such that a colorimetry sensor for detecting skin tone and adjusting SpO2 data for skin thickness and pigmentation, as taught by Campbell, to aid in improving the accuracy and calculation performed by the monitoring device.
Regarding claim 2, Jumbe teaches comprising a glove into which the first and second sensors and processors are disposed (¶[0029,0049,0058], glove enclosure).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Jumbe in view of Campbell, as applied to claim 1, and further in view of Jarchi et al. (Detection of Sleep Apnea/hypopnea Events Using Synchrosqueezed Wavelet Transform-2019), hereinafter Jarchi.
Regarding claim 3, Jumbe-Campbell fail to teach wherein the processor is configured to apply inverse synchro squeezed wavelet transform (ISSWT) to the sensor data to derive RR.
Jarchi teaches a noninvasive method to determine respiration rate by applying ISSWT to the signal (see abstract and algorithm 1). Respiration rate (same as respiration frequency as seen in Jarchi) is determined by applying ISSWT and SSWT (algorithm 1). While the measurement is based on an ECG signal, Jarchi teaches that “[t]he method is expected to provide a new tool for determination of sleep apnea events from photoplethysmography (PPG) signals” and “[t]his signal contains significant information that is expected to be retrieved from the PPG signals as an unobtrusive way in future studies to be evaluated against airflow signals” (see Introduction, ¶[3], and Method, ¶[3]). Therefore, using ISSWT on PPG signals provides a way, that does not use machine learning, to determine sleep apnea.
Therefore, it would have been obvious to one ordinary skill in the art at the time the invention was effectively filed to have modified the system of Jumbe-Campbell, such that the processor is configured to apply ISSWT to the sensor data to derive RR, as taught by Jarchi, to aid in determining sleep apnea events, and recover and analyze respiratory components (see Introduction, ¶[3], “we look in detail into the time-frequency domain of the ECG-derived respiratory modulation to recover and analyse the main respiratory component”).
Claim 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Jumbe in view of Campbell, as applied to claim 1, and further in view of Sokol et al. (US 20180325422), hereinafter Sokol.
Regarding claim 4, Jumbe teaches further comprising an integrated environmental sensor for detection of environmental information (¶[0098], “ present technology, the devices, methods and systems may capture and process data relating to the environment”), but fails to teach that the information is particulate matter.
Sokol teaches a wearable environment sensing device (¶[0082]) configured to determine particulate matter in the environment to monitor user’s health and health conditions (¶[0004,0007,0009,0159]).
Therefore, it would have been obvious to one ordinary skill in the art at the time the invention was effectively filed to have modified the system of Jumbe-Campbell, such that detection of environmental atmospheric particulates is performed, as taught by Sokol, to aid in monitoring the user’s health and health conditions, and provide recommendations to mitigate the effects of pollution.
Regarding claim 5, Jumbe teaches gathering environmental information (¶[0098] of Jumbe), but fail to teach estimating a probability of pulmonary exposure to the environmental atmospheric particulates.
Sokol teaches a wearable device (¶[0082]) for accurately sensing the environment and monitor user’s health and health conditions (¶[0004]). The device is configured to further provide recommendations to assist a user in mitigating the effects of air pollution on the user’s health by determining whether the user is exposed to pollutants or is likely to be exposed to pollutants (¶[0082,0118], “ to determine the probability of future exposure to the pollutants” indicating a probability of pulmonary exposure).
Therefore, it would have been obvious to one ordinary skill in the art at the time the invention was effectively filed to have modified the system of Jumbe-Campbell-Kurani, such that a probability of pulmonary exposure to the environmental atmospheric particulates is estimated, as taught by Sokol, to aid in monitoring the user’s health and health conditions, and provide recommendations to mitigate the effects of pollution (¶[0004,0571]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Jumbe in view of Campbell, as applied to claim 1, and further in view of Edelberg et al. (US 20252143622), hereinafter Edelberg.
Regarding claim 6, Jumbe teaches using an algorithm (¶[0057,0128], machine learning model to monitor, enhance, prevent, or predict a condition of the user), but fails to explicitly teach that the model is adjusted.
Edelberg teaches a system for monitoring a cardiac health status for a subject (abstract). The system uses a neural network, such as recurrent neural network (RNN), to adjust coefficients of the model to improve the predictive capacity of the model (¶[0075-77]).
Therefore, it would have been obvious to one ordinary skill in the art at the time the invention was effectively filed to have modified the system of Jumbe-Campbell, such that the model is adjusted, as taught by Edelberg, to aid in improving the predictive capacity of Jumbe’s model. Moreover, Jumbe requires using a machine learning model, but fails to provide details, and Edelberg teaches that an RNN with adjustable model parameters can be used to predict health conditions.
Regarding claim 7, Edelberg teaches wherein the coefficients for equation are optimized using a recurrent neural network (¶[0075-77], “model parameters include weights associated with nodes in layers of neural network, support vectors in a support vector machine, node values in a decision tree, and coefficients in a regression model. The model parameters of the risk prediction model are trained (e.g., adjusted) using the training data to improve the predictive capacity of the risk prediction model”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shelton teaches physiological monitoring system comprising color, SpO2, respiratory rate, environment sensors. US 20220240869
Toth teaches a system of a plurality of wearable devices to monitor the user’s health. US 20170231490
Matsui teaches correction of the emitted light amount of the LED, the sensitivity of the light receiving sensor, and the like is necessary depending on the thickness of the skin at the measurement site, the color of the skin, and the like. US 20190298175
Tiron teaches instead of storing underlying data that was used to generate the different regression coefficients for the different individuals in order to generate the general machine learning model, the parameters of each individual's trained machine learning model can be used to adjust and/or train the general machine learning model. US 20230420124
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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, Robert (Tse) Chen can be reached at (571) 272-3672. 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.
/MARTIN NATHAN ORTEGA/ Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights