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 statements (IDS) been submitted on 08/01/24 has been considered by the examiner
Claim Objections
Claims 1, 2, 10-13 and 20 are objected to because of the following informalities:
Claims 1, 2, 10-13 and 20 recite “the sensor”. Examiner notes it should read “the photoplethysmographic sensor”.
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 1-20 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.
Claims 1, 12 and 20 recite the limitation “the light reflected”. There is no antecedent basis for this limitation.
Claims 1, 3, 6-9, 11, 12, 14 and 17-20 recite the limitation “the signal”. Does this refer to “photoplethysmographic signal” recited previously in claims 1, 12, and 20 or is it a new term? Additionally, there appear to be multiple instances of “a photoplethysmographic signal” in claim 1 in lines 1, 5, and 9. It is unclear whether there are separate instances of this signal or if it should refer to a single signal.
Claims 1, 12, and 20 recite the limitation “each combination”. Does this refer to “combination of parameters” recited previously in claims 1, 12, and 20 or is it a new term?
Claims 2 and 13 recite the limitation “the parameters”. Does this refer to “combination of parameters” recited previously or is it a new term?
Claim 10 recites the limitation “the light”. Does this refer to “the light reflected” or “the light emitted” recited previously or is it a new term?
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 1-20 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 a method for obtaining a photoplethysmographic signal suitable for medical measurement from a body of a patient. Thus, the claim is directed to a process, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
a photoplethysmographic sensor that is set to have different combinations of parameters, and converting, for each combination, the light reflected by or passing through the body and received by the sensor into a photoplethysmographic signal;
calculating a score for the signal corresponding to each combination based on a waveform of the signal
These limitations set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites determining one of the combinations of parameters, the score of which is the highest, to be used to generate a photoplethysmographic signal suitable for medical measurement, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The determining of a score of a parameter for generating a signal does not provide an improvement to the technological field, the system does not effect a particular treatment or effect a particular change based on the model, nor does the method use a particular machine to perform the Abstract Idea.
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:
emitting light multiple times toward the body using a photoplethysmographic sensor
Additionally, claim 12 recites the additional limitation
a wearable device, information processing apparatus
The providing and recording steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the providing and recording 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.
Independent claims 12 and 20 are rejected for similar reasons
Dependent claims 2-11 and 13-19 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 1-20 are not patent eligible under 35 USC 101.
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.
Claims 1, 12 and 20 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Sahu (US 2019/0361919)
Regarding claims 1 and 12, Sahu teaches a method and medical system for obtaining a photoplethysmographic signal suitable for medical measurement from a body of a patient [par. 20, 53, 60], the method and system comprising: a wearable device including a photoplethysmographic sensor [par. 20, 53, 60] for emitting light multiple times toward the body using a photoplethysmographic sensor that is set to have different combinations of parameters [par. 17, 20, 53, 60; Examiner notes that a PPG signal inherently indicates measurement of light], and converting, for each combination, the light reflected by or passing through the body and received by the sensor into a photoplethysmographic signal [par. 53, 60]; calculating a score for the signal corresponding to each combination based on a waveform of the signal [par. 17, 31, 32]; and determining one of the combinations of parameters, the score of which is the highest, to be used to generate a photoplethysmographic signal suitable for medical measurement [par. 53, 56]
Regarding claim 20, Engelbreech teaches a non-transitory computer readable medium storing a program causing a computer [par. 22] to execute a method for obtaining a photoplethysmographic signal suitable for medical measurement from a body of a patient [par. 20, 53, 60], the method comprising: emitting light multiple times toward the body using a photoplethysmographic sensor that is set to have different combinations of parameters [par. 17, 20, 53, 60; Examiner notes that a PPG signal inherently indicates measurement of light], and converting, for each combination, the light reflected by or passing through the body and received by the sensor into a photoplethysmographic signal [par. 53, 60]; calculating a score for the signal corresponding to each combination based on a waveform of the signa [par. 17, 31, 32]; and determining one of the combinations of parameters, the score of which is the highest, to be used to generate a photoplethysmographic signal suitable for medical measurement [par. 53, 56]
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 1-3, 5-6, 8-14, 16, 17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Engelbreech (US 2014/0073863) and in further view of Sahu
Regarding claims 1 and 12, Engelbreech teaches a method and medical system for obtaining a photoplethysmographic signal suitable for medical measurement from a body of a patient [par. 111, 116], the method and system comprising: a wearable device including a photoplethysmographic sensor [par. 116] for emitting light multiple times toward the body using a photoplethysmographic sensor that is set to have different combinations of parameters [par. 116, 152, 156], and converting, for each combination, the light reflected by or passing through the body and received by the sensor into a photoplethysmographic signal [par. 116, 155, 162];
However, Engelbreech does not teach calculating a score for the signal corresponding to each combination based on a waveform of the signal; and determining one of the combinations of parameters, the score of which is the highest, to be used to generate a photoplethysmographic signal suitable for medical measurement
Sahu teaches calculating a score for the signal corresponding to each combination based on a waveform of the signal [par. 17, 31, 32]; and determining one of the combinations of parameters, the score of which is the highest, to be used to generate a photoplethysmographic signal suitable for medical measurement [par. 53, 56]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Engelbreech, to incorporate calculating a score for the signal corresponding to each combination based on a waveform of the signal; and determining one of the combinations of parameters, the score of which is the highest, to be used to generate a photoplethysmographic signal suitable for medical measurement, to ensure the best or highest performance, as evidence by Sahu [par. 56]
Regarding claims 2 and 13, Engelbreech further teaches the parameters include output frequency and intensity of the light emitted from the sensor [par. 116, 156]
Regarding claims 3 and 14, Engelbreech further teaches calculating includes calculating autocorrelation coefficients of the waveform of the signal, and the score is calculated using the autocorrelation coefficients [par. 18, 176, 210]
Regarding claims 5 and 16, Engelbreech teaches wherein the autocorrelation coefficients are calculated for each of a plurality of portions of the waveform, and an average of maximum values of the autocorrelation coefficients for each portion is calculated as the score [par. 176-178; 441]
Regarding claims 6 and 17, Engelbreech further teaches each of the autocorrelation coefficients is calculated using a first plurality of amplitude values of the waveform of the signal and a second plurality of amplitude values of a delayed waveform of the signal such that a total number of the first plurality of amplitude values is identical with a total number of the second plurality of amplitude values [par. 176-178]
Regarding claims 8 and 19, Engelbreech teaches deriving an envelope curve of the waveform of the signal; and dividing amplitude values of the waveform by amplitude values of the envelop curve, wherein calculating includes using the divided values to calculate the score [par. 225, 226]
Regarding claim 9, Engelbreech teaches a higher score is output for a photoplethysmographic signal that has more periodicity [par. 176-179; Examiner notes autocorrelation of peaks implies more periodicity]
Sahu teaches determining feature amounts from the signal, wherein calculating includes inputting the feature amounts into a machine learning model and obtaining an output therefrom as the score, the machine learning model having been trained using photoplethysmographic signals [par. 53, 54]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Engelbreech, to incorporate determining feature amounts from the signal, wherein calculating includes inputting the feature amounts into a machine learning model and obtaining an output therefrom as the score, the machine learning model having been trained using photoplethysmographic signals, for allowing system to create a ranking of derived features, as evidence by Sahu [par. 55]
Regarding claim 10, Engelbreech teaches acquiring: a time of a day when the light was received, an acceleration rate of the sensor when the light was received, or information regarding the patient, wherein inputting includes inputting the time, the acceleration rate, or the information into the model to obtain the score [par. 116, 197]
Regarding claim 11, Engelbreech teaches emitting light toward the body using the sensor that is set to have said one of the combinations of parameters, and converting the light reflected by or passing through the body and received by the sensor into the photoplethysmographic signal for medical measurement [par. 116, 152, 156]
Regarding claim 20, Engelbreech teaches a non-transitory computer readable medium storing a program causing a computer [par. 135] to execute a method for obtaining a photoplethysmographic signal suitable for medical measurement from a body of a patient [par. 111, 116], the method comprising: emitting light multiple times toward the body using a photoplethysmographic sensor that is set to have different combinations of parameters [par. 116, 152, 156], and converting, for each combination, the light reflected by or passing through the body and received by the sensor into a photoplethysmographic signal [par. 116, 155, 162];
However, Engelbreech does not teach calculating a score for the signal corresponding to each combination based on a waveform of the signal; and determining one of the combinations of parameters, the score of which is the highest, to be used to generate a photoplethysmographic signal suitable for medical measurement
Sahu teaches calculating a score for the signal corresponding to each combination based on a waveform of the signa [par. 17, 31, 32]; and determining one of the combinations of parameters, the score of which is the highest, to be used to generate a photoplethysmographic signal suitable for medical measurement [par. 53, 56]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Engelbreech, to incorporate calculating a score for the signal corresponding to each combination based on a waveform of the signal; and determining one of the combinations of parameters, the score of which is the highest, to be used to generate a photoplethysmographic signal suitable for medical measurement, to ensure the best or highest performance, as evidence by Sahu [par. 56]
Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Engelbreech and Sahu and in further view of Sinha (US 2017/0065230)
Regarding claims 4 and 15, Engelbreech and Sahu teach a method and medical system for obtaining a photoplethysmographic signal suitable for medical measurement from a body of a patient, as disclosed above
However, Engelbreech and Sahu do not teach the score is a sum of the autocorrelation coefficients
Sinha teaches the score is a sum of the autocorrelation coefficients [par. 62]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Engelbreech and Sahu, to incorporate the score is a sum of the autocorrelation coefficients, for identifying the highest sum, as evidence by Sinha [par. 62]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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