DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on December 17, 2025 were received and fully considered. Claims 1 and 9 were amended1. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
Claim Rejections - 35 USC § 112B
Claim 4 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 4 recites “the reflected light is distributed substantially uniformly across the sensor” in lines 4-5, which is indefinite for multiple reasons. First “substantially uniformly across the sensor” pertains to relative terminology. What is “substantially uniformly”?
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 1-8 and 21-27 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 computer-based wearable pressure pulse waveform measurement device for predicting one or more cardiovascular diseases. 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:
“...compare the entire shape of one periodic cycle as a whole of the measured digital PWM data to an entire shape of one periodic cycle as a whole of the digital reference pulse waveform data and to predict the occurrence of the one or more cardiovascular diseases continuously, in real-time using machine learning logic without determining specific pulse waveform parameters from the pressure pulse waveform...”
These limitations describe a mathematical calculation. When given their broadest reasonable interpretation in light of the specification, the limitations identified above including the recited machine learning logic are mathematical calculations. See also 2024 AI SME Update, which held a similar claim construction was not patent eligible (see claim 2 of example 47, using a trained artificial neural network to analyze anomalies on input data equated to a patent ineligible mathematical calculation). Furthermore, the limitations also describe 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, or using simple pen/paper. The 2024 AI SME Update also sets forth that machine learning logic amounts to a mental process (see claim 2 of example 47), more so since the machine learning logic is recited at a high level of generality.
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.
For this part of the 101 analysis, the following additional limitations are considered:
“...a first light source adapted to transmit light to a blood carrying artery at a single measurement location; an optical sensor adapted to receive a reflected light in response to the transmitted light from the blood carrying artery; a processor configured to measure the reflected light and to convert the reflected light into measured digital pulse waveform measurement (PWM) data indicative of an entire shape of one cycle of the pressure pulse waveform in the blood carrying artery at the measurement location; and the processor further configured to receive digital reference pulse waveform data... and to provide an indication of the one or more diseases to the user”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity. Examiner notes that mere data gathering steps and outputting a result do not integrate the judicial exception into a practical application. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they amount to well-understood, routine, and conventional components in the art. Per Berkheimer, Examiner takes official notice that “a first light source” and “an optical sensor” are widely known in PPG measurement techniques. Moreover, it is conventional to utilize “a processor”, which also is recited at a high level of generality, and thereby does not recite significantly more.
Dependent claims 2-8 and 21-27 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1-8 and 21-27 are not patent eligible under 35 USC 101.
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.
Claims 1, 2, 6-8, and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Li (2018/0303354 A1).
Li was applied in the previous office action.
With respect to claim 1, Li teaches a computer-based wearable pressure pulse waveform measurement device for predicting one or more cardiovascular diseases of a user (abstract), comprising: a first light source adapted to transmit light to a blood carrying artery artery (par.0092 “pulse wave sensor is a photoplethysmography sensor”, which is widely known to first need infrared light transmitted to patient’s tissue/skin in order to detect reflected light via PPG sensor); a processor configured to measure the reflected light and to convert the reflected light into measured digital pulse waveform measurement (PWM) data indicative of an entire shape of one cycle of the pressure pulse waveform in the blood carrying artery at the measurement location (pulse wave sensor 1 measures pulse wave signal and is converted to digital domain via A/D 106, and subsequently analyzed via processor 100; see Fig. 12; see also par.0083-84 “continuously or periodically measuring a pulse wave signal of the subject”, which continuously measuring would encompass large amounts of data, in its entirety, from many cycles of the pressure pulse waveform including various shapes, features, peaks, etc.); and the processor further configured to receive digital reference pulse waveform data (par.0083-84 “plurality of reference metrics... matched reference pulse wave signal”; par.0100 “memory 103 for storing the digital data... and the plurality of reference pulse wave signals”), and configured to compare the entire shape of one periodic cycle as a whole of the measured digital PWM data to an entire shape of one periodic cycle as a whole of the digital reference pulse waveform data and to predict the occurrence of the one or more cardiovascular diseases continuously, in real-time without determining specific pulse waveform parameters from the pressure pulse waveform, and to provide an indication of the one or more diseases to the user (par.0083-84 “continuously monitoring...comparing a metric of the pulse wave signal with a plurality of reference metrics corresponding to a plurality of disease or health conditions; selecting a matched reference pulse wave signal having a closet resemblance to the pulse wave signal of the subject based on a result of the comparing; and transmitting a signal to a receiver when the matched reference pulse wave signal corresponding to an abnormal disease condition”; Note: comparing pulse wave metrics to a plurality of reference metrics is understood to compare metric/features of the continuously sensed pulse wave data to metric/features of reference pulse wave data, which would include an entire shape of one periodic cycle as a whole when taking into consideration broadest reasonable interpretation; par.0084-85 “matched reference pulse wave signal corresponding to an abnormal disease condition… the disease or condition is … atherosclerosis”).
Although Li does not expressly teach transmitting light to a blood carrying artery solely at a single measurement location; and using machine learning logic, further modification to incorporate these features would have been obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons. First, Li discloses a pulse wave sensor that measures pulse waves at two arterial sites (par.0094); and that “Optionally, the main body of the apparatus may be worn on one location of a subject [e.g., the wrist of the subject], and another sensor may be placed on an arterial site away from the main body [e.g., on the subject’s leg])”. As such, Li discloses transmitting light solely at single measurement locations (wrist and/or leg). Moreover, Examiner argues that solely transmitting light to one location (e.g. wrist only) for the purposes of deriving a pulse wave signal in the manner recited would involve only mere routine skill in the art and cites additional references that demonstrate the well-known nature of doing so. Please see prior art of record section at the end of the current office action for example teachings. Regarding the recited machine learning logic, Li teaches that an algorithm is utilized when comparing continuously obtained pulse wave signals to reference data in order to predict cardiovascular disease, abnormal blood pressure, atherosclerosis, etc. (par.0044-45, 0047, 0063, 0066, 0084-85, 0087, 0089, 0103). Also, using machine learning logic to analyze large amounts of medical data (e.g. continuously measured pulse wave signals) is widely known in the art for the purpose of improving diagnostic accuracy. Li also provides examples of predictive modeling methods (see par.0073, last sentence), which provides motivation for PHOSITA to consider using complex machine learning logic in order to yield more robust predicative modeling. As such, modifying Li’s algorithm to instead use machine learning logic (generally understood to involve more complex and sophisticated algorithms) would be obvious to PHOSITA when the invention was filed as a simple substitution. Moreover, Examiner notes that the claims do not recite any specificity with regards to “using machine learning logic”. Rather, “using machine learning logic”, as currently claimed, can involve simple and/or complex algorithms when considering broadest reasonable interpretation. Thus, PHOSITA would have had predictable success when the invention was filed modifying Li’s algorithm with using another simple algorithm (machine learning logic) as this would be a simple substitution that would yield predictable results, i.e., allowing for in real-time health assessment based on analysis of large amounts of continuously obtained pulse wave data.
With respect to claim 2, Li teaches the light source is transmitted to a radial artery (par.0094).
With respect to claim 6, Li does not explicitly teach teaches the machine learning logic comprises at least one of: support vector machines (SVMs), neural networks, and random forest, and the machine learning logic is trained using at least one of: PWM data from other users, normal and abnormal PWM data, and theoretical PWM data, to identify the cardiovascular disease abnormalities. However, Li teaches other types of predictive modeling methods (last sentence of par.0073). Therefore, modifying Li when the invention was filed to utilize one of support vector machines (SVMs), neural networks, and random forest would be obvious to PHOSITA when the invention was filed as a simple substitution, i.e., replacing Li’s prediction modelling with one of SVM, neural network, and random forest would only require routine skill in the art.
With respect to claim 7, Li teaches the one or more cardiovascular diseases comprises at least one of: heart failure, hypovolemia, aortic stenosis, aortic regurgitation, bradycardia, heart block, atherosclerosis, hypertrophic cardiomyopathy, and ventricular failure (par.0085, last sentence).
With respect to claim 8, Lie teaches the processor identifies a period from the measured pulse waveform by finding the time between pulses obtained by at least one of time domain convolution and frequency domain analysis (par.0004, 0018).
With respect to claim 21, Li teaches the processor is further configured to extract pulse waveform segments from the PWM data and to average the extracted pulse waveform segments, as averaged pulse waveform segments (par.0071-72).
With respect to claim 22, Li teaches the pulse waveform segments are extracted by finding a time between pulses obtained by at least one of time domain convolution and frequency domain analysis (par.0068).
With respect to claim 23, Li teaches the processor is further configured to perform a mathematical curve fit to the averaged pulse waveform segments to obtain a fitted pulse waveform curve (par.0081 “regression model that best fits”).
With respect to claim 24, Li does not explicitly teach the fitted pulse waveform curve comprises at least one of: exponential and Gaussian. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed as a simple substitution since exponential and Gaussian fitting techniques are widely known in the art.
With respect to claim 25, Li does not explicitly teach the processor is further configured to convolve the PWM data with a standard pulse waveform curve. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed as a simple substitution since applying convolution with standard waveforms are widely known in the art.
With respect to claim 26, Li does not explicitly teach the convolving of the PWM data with a standard pulse waveform curve is repeated multiple times in an iterative fashion. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed as a simple substitution since applying convolution with standard waveforms in an iterative fashion is widely known in the art.
With respect to claim 27, Li teaches the processor is further configured to provide an alert when the at least cardiovascular disease is predicted (par.0099 “an alarm 107 for transmitting a signal to a receiver when an abnormal disease condition is detected in the subject”).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Mathews (US Patent No. 5431170).
Mathews was applied in the previous office action.
With respect to claims 3 and 4, Li teaches computer-based wearable pressure pulse waveform measurement device for determining one or more health parameters or health conditions, as established above.
However, Li does not teach the limitations further recited in claims 3 and 4.
Regarding claim 3, Mathews teaches the first light source comprises an LED (Light Emitting Diode) having a wavelength in the range of 500-640 nm (col. 3, lines 35-37 “yellow light”; Note: yellow light is widely known to have a wavelength range of 575 -585 nm).
Regarding claim 4, Mathews teaches a second light source adapted to transmit light to the blood carrying artery at the measurement location, and wherein the optical sensor is disposed between the first and second light sources, and wherein the reflected light being in response to light from the first and second light sources such that the reflected light is distributed substantially uniformly across the sensor (emitters 20 and 22, in which reflected light us distributed substantially uniformly across sensors 21 and 23; see Fig. 2).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Li to utilize multiple light sources including having a wavelength in the range of 500-640 nm, as claimed, in order to account for vibrations due to movements, and in particular due to the feet striking the ground as the user jogs, as evidence by Mathews (see col. 3, lines 39-42).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Demirtas et al. (US PG Pub. No. 2018/0000424 A1) (hereinafter “Demirtas”).
Demirtas was applied in the previous office action.
With respect to claim 5, Li teaches computer-based wearable pressure pulse waveform measurement device for determining one or more health parameters or health conditions, as established above.
However, Li does not teach the limitations further recited in claim 5.
Demirtas teaches the processor measures the reflected light at a sampling rate in the range of 100-500 Hz (par.0091 “processor 206 may be configured to decimate the T2-period worth of PPG data to a lower sampling rate (e.g. from 100 Hz to 10 Hz) and then compute the DFT on the decimated data”).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to measure reflected light from a PPG at lower sampling rate in order to first, advantageously allow to “zoom” into a smaller frequency axis, e.g. a frequency axis between −5 Hz to +5 Hz, and therefore obtain a better frequency resolution if the same number of DFT samples are used. Second, such decimation may reduce the computational burden of DFT computing if a DFT is chosen to be computed for fewer samples instead, for the same frequency resolution. See Demirtas, par.0091.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 and 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10980428. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of one another.
Response to Arguments
Applicant's arguments filed with respect to the 35 USC 112A rejections were persuasive in view of the current amendment and accompanying remarks. Therefore, these rejections are withdrawn.
Applicant’s arguments filed with respect to the 35 USC 112B rejections raised in the previous office action were fully considered, but they are not persuasive. Regarding claim 4, Examiner maintains that “substantially uniformly” is a relative term that renders the claim indefinite. Moreover, “substantially uniformly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For at least these reasons, the indefiniteness rejection is maintained.
Applicant’s arguments filed with respect to the 35 USC 101 (Alice) rejections raised in the previous office action have been fully considered, but they are not persuasive. Applicant appears to hold these rejections in abeyance until prior art issues are resolved. As there are no substantive patent eligibility arguments set forth in applicant’s current reply, Examiner maintains the 35 USC 101 rejections.
Applicant’s arguments with respect to the 35 USC 103 rejections raised in the previous office action were fully considered, but they were not persuasive. The amendment does not overcome the current obviousness rejections for the following reasons. First, transmitting light to a blood carrying artery “solely at a single measurement location” versus Li’s device that allows for transmitting light to multiple locations would merely involve routine skill in the art. Moreover, Examiner cites additional references at the end of the current office action that demonstrate it is well-established to gather pulse wave signals solely at a single measurement location, e.g., the wrist. Please see prior art of record section below for example teachings. Applicant goes on argue that Li’s disclosure of “a metric” (see par.83-84) does not teach and/or suggest comparing the entire shape of one periodic cycle as a whole… to an entire shape of one periodic cycle as a whole of the digital reference pulse waveform data, as amended. Examiner respectfully disagrees. Other embodiments from Li suggest that the metric can merely be a highest level, peak, etc. in the pulse wave signal, which is utilized in order to compare with a similar metric/peak in the reference waveform (see for example, par.0063). Accordingly, there is not further processing/determining of specific pulse wave parameters as the metric (peak, highest level, etc.) is merely part of the existing pulse wave signal. Moreover, Li expressly discloses comparing metric of the pulse wave signal with reference signal metrics “having a closest resemblance” (par.82-84), thereby suggesting a shape comparison. Examiner also argues that comparing an entire shape of one periodic cycle as a whole to an entire shape of one periodic cycle as a whole of the digital reference pulse waveform data (i.e. comparison involving more data versus a smaller data set) would involve mere routine skill in the art. Furthermore, and solely for purposes of compact prosecution, Examiner cites an additional reference (originally cited in the previous office action) that further demonstrates comparing an entire shape of one periodic cycle as a whole to an entire shape of one periodic cycle as a whole of the digital reference pulse waveform data. See prior art of record section below for more detail. For at least these reasons, the obviousness rejections are maintained.
Lastly, the double patenting rejections are hereby maintained as applicant continues to hold these rejections in abeyance.
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Newly cited:
US Patent No. 6334065, see abstract
Previously cited:
John Allen et al 2005 Physiol. Meas. 26 811
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 Claims 9-20 remain withdrawn from consideration on the merits pursuant to restriction requirement with mailing date October 27, 2023.