DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
The “output unit” in claims 1-6 and 21. Corresponding structure is disclosed at least in the form of screen 904 on Page 19 of the instant Specification or a network interface 818 such as a Wi-Fi or Bluetooth transmitter on Page 19 of the instant Specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 – Please change the language “the estimated systolic blood pressure estimated” to “the estimated systolic blood pressure are estimated.”
Appropriate correction is required.
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 7-19 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite an abstract idea as discussed below. This abstract idea is not integrated into a practical application for the reasons discussed below. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons discussed below.
Step 1 of the 2019 Guidance requires the examiner to determine if the claims are to one of the statutory categories of invention. Applied to the present application, the claims belong to one of the statutory classes of a process or product as a computer implemented method or a computer system/product.
Step 2A of the 2019 Guidance is divided into two Prongs. Prong 1 requires the examiner to determine if the claims recite an abstract idea, and further requires that the abstract idea belong to one of three enumerated groupings: mathematical concepts, mental processes, and certain methods of organizing human activity.
Claim 7 is copied below, with the limitations belonging to an abstract idea being underlined.
An electronically-implemented method for translation of signals having shared origin, the method comprising:
obtaining, from a sensor device of a device, a source biological signal corresponding to a user of the device;
decomposing the source biological signal into a first source component and a second source component, wherein the first source component encodes oscillatory behavior of the source biological signal and the second source component encodes steady-state behavior of the source biological signal;
mapping, using one or more trained models, the first source component and the second source component to a first target component and a second target component respectively, wherein the first target component encodes estimated oscillatory behavior of a target biological signal and the second target component encodes estimated steady-state behavior of the target biological signal; and
reconstructing the target biological signal from the first target component and the second target component; and
outputting the target biological signal.
Claim 14 is copied below, with the limitations belonging to an abstract idea being underlined.
A non-transitory computer readable storage medium storing instructions which, when executed by a device comprising one or more processors, cause the device at least to:
obtain, from a sensor device of the device, a source biological stochastic signal corresponding to a user of the device;
transform, using a first transformation process, the source biological stochastic signal to a first complex map, wherein the first complex map encodes an oscillatory behavior of the source biological stochastic signal;
transform, using a second transformation process, the source biological stochastic signal to a second complex map, wherein the second complex map encodes a steady-state behavior of the source biological stochastic signal;
map, using one or more neural networks, the first complex map and the second complex map to a third complex map and a fourth complex map respectively, wherein the third complex map and the fourth complex map are associated with a target biological stochastic signal;
transform, using a first inverse transformation process associated with the first transformation process, the third complex map to a first component of the target stochastic signal, wherein the first component of the target stochastic signal represents the oscillatory behavior of the target biological stochastic signal;
transform, using a second inverse transformation process associated with the second transformation process, the fourth complex map to a second component of the target stochastic signal, wherein the second component of the target biological stochastic signal represents the steady-state behavior of the target biological stochastic signal;
reconstruct the target biological stochastic signal from the first component of the target biological stochastic signal and the second component of the target biological stochastic signal; and
outputting the target biological stochastic signal.
The limitations underlined can be considered to describe a mathematical concept, namely a series of calculations leading to one or more numerical results or answers, obtained by a sequence of mathematical operations on numbers and/or mental steps. The lack of a specific equation in the claim merely points out that the claim would monopolize all possible appropriate equations for accomplishing this purpose in all possible systems. These steps recited by the claim therefore amount to a series of mental and/or mathematical steps, making these limitations amount to an abstract idea.
In summary, the highlighted steps in the claim above therefore recite an abstract idea at Prong 1 of the 101 analysis.
The additional elements in the claim have been left in normal font.
The claims do not integrate the abstract idea into a practical application. Various considerations are used to determine whether the additional elements are sufficient to integrate the abstract idea into a practical application. The claim does not recite a particular machine applying or being used by the abstract idea. The claim does not effect a real-world transformation or reduction of any particular article to a different state or thing. (Manipulating data from one form to another or obtaining a mathematical answer using input data does not qualify as a transformation in the sense of Prong 2.). The claims do not recite a particular machine applying or being used by the abstract idea and thus fail to recite a particular practical application for the use of the abstract idea.
Claim 21 specifies that the device is a wearable blood pressure estimation device. However, this does not serve to amount to the recitation of a particular practical application for the abstract idea because no particular device is recited and a large number of types of devices would be within the scope of being a “wearable device” (i.e., watches, head bands, rings, athletic apparel such as shirts and shoes, etc.).
Step 2b of the 2019 Guidance requires the examiner to determine whether the additional elements cause the claim to amount to significantly more than the abstract idea itself.
The additional limitations in relation to electronic implementation, a storage medium including processor instructions, and the use of neural networks amounts to the recitation of general-purpose computer elements for implementing the abstract idea through use of a general-purpose computer and do not serve to amount to the recitation of significantly more than the abstract idea itself (see ALICE CORP. v. CLS BANK INT’L 573 U. S. 208 (2014)).
The additional limitations of obtaining necessary data for the implementation of the abstract idea amounts to the recitation of mere extrasolution data activity, i.e. data gathering (see MPEP 2106.05(g)).
The additional limitation of outputting the algorithm results amounts to extrasolution data activity, i.e. data reporting (see MPEP 2106.05(g)).
The claim does not contain additional elements which describe the functioning of a computer, or which describe a particular technology or technical field, being improved by the use of the abstract idea. (This is understood in the sense of the claimed invention from Diamond v Diehr, in which the claim as a whole recited a complete rubber-curing process including a rubber-molding press, a timer, a temperature sensor adjacent the mold cavity, and the steps of closing and opening the press, in which the recited use of a mathematical calculation served to improve that particular technology by providing a better estimate of the time when curing was complete. Here, the claim does not recite carrying out any comparable particular technological process.) In all of these respects, the claim fails to recite additional elements which might possibly integrate the claim into a particular practical application. Instead, based on the above considerations, the claim would tend to monopolize the abstract idea itself, rather than integrate the abstract idea into a practical application.
Therefore, claims 7 and 14 are rejected under 35 U.S.C. 101 as directed to an abstract idea without significantly more.
Dependent claims 8-13 and 15-19 are similarly ineligible. The dependent claims merely add limitations which further detail the abstract idea, namely further mathematical/mental steps detailing how the data processing algorithm is implemented, i.e. additional software limitations, and/or further define or add insignificant extrasolution data activity. These do not help to integrate the claim into a practical application or make it significantly more than the abstract idea (which is recited in slightly more detail, but not in enough detail to be considered to narrow the claim to a particular practical application itself).
Claim 21 specifies that the device is a wearable blood pressure estimation device. However, the use of such wearable devices in performing blood pressure estimation is well-understood, routine, and conventional [See US 20140296669 A1 and US 20210369129 A1] and the use of such a device in performing blood pressure estimation thus does not serve to amount to significantly more than the recitation of the use of a general-purpose computer in the implementation of the abstract idea.
Examiner Note Regarding Prior Art
As per claim 7, the prior art of record discloses the limitation discussed above.
Ferber further discloses an electronically-implemented method for translation of signals having shared origin (see Abstract and paragraph 0045: non-invasive/cuffless blood pressure estimation using PPG signals, i.e. translating PPG signals to blood pressure signal, i.e. signals have a shared origin), the method comprising:
decomposing a source signal into a first source component and a second source component, wherein the first source component encodes oscillatory behavior of the source signal and the second source component encodes steady-state behavior of the source signal (see paragraphs 0015 and 0106: determines AC component and DC component of the signal, i.e. PPG signal).
The prior Athaya further discloses mapping, using one or more trained models, an oscillatory PPG signal with a the DC component removed, i.e. the first source component to a first target component, wherein the first target component encodes estimated oscillatory behavior of a target signal (see page 5 first paragraph and Fig. 4 and Fig. 9: generates a blood pressure waveform from a PPG signal using machine learning network; and see page 5 section 3.2 pre-processing of data: PPG signal data is filed to remove baseline wandering, values below 0.5Hz); and
reconstructing the target signal from the first target component (see Fig. 9: shows estimated blood pressure signal).
However the prior art of record fails to disclose mapping, using one or more trained models, the first source component and the second source component to a first target component and a second target component respectively, wherein the first target component encodes estimated oscillatory behavior of a target signal and the second target component encodes estimated steady-state behavior of the target signal; and
reconstructing the target signal from the first target component and the second target component.
As per claim 14, the prior art of record discloses the limitations discussed above.
The prior art Ferber discloses a non-transitory computer readable medium storing instructions which, when executed by a device comprising one or more processors, cause the device to carry out the steps of obtaining a source stochastic signal (see Fig. 3A and paragraph 0122-0123: processor/computer with memory obtain PPG signal, i.e. the recited source stochastic device; see paragraphs 0258-0259: non-transitory memory with instructions).
Lychagov (US 20240268720) further discloses transforming, using a first transformation process, the source stochastic signal to a first complex map, wherein the first complex map encodes an oscillatory behavior of the source stochastic signal (see paragraph 0138: separates PPG signal into an AC component and transforms the AC signal to frequency domain, i.e. complex map as described in the specification);
transforming, using a second transformation process, the source stochastic signal to a second complex map, wherein the second complex map encodes a steady-state behavior of the source stochastic signal (see paragraph 0138: separates PPG signal into a DC component and transforms the DC signal to frequency domain, i.e. complex map as described in the specification).
The prior art Li (US 20230363651) transforming, using a first transformation process, the source stochastic signal to a first complex map, wherein the first complex map encodes an oscillatory behavior of the source stochastic signal (see Abstract and Fig. 6);
transforming, using a first inverse transformation process associated with the first transformation process, the third complex map to a first component of the target stochastic signal, wherein the first component of the target stochastic signal represents the oscillatory behavior of the target stochastic signal to generate an arterial blood pressure data (see Abstract and Fig. 6).
However the prior art of record fails to disclose the combination of mapping, using one or more neural networks, the first complex map and the second complex map to a third complex map and a fourth complex map respectively, wherein the third complex map and the fourth complex map are associated with a target stochastic signal;
transforming, using a first inverse transformation process associated with the first transformation process, the third complex map to a first component of the target stochastic signal, wherein the first component of the target stochastic signal represents the oscillatory behavior of the target stochastic signal;
transforming, using a second inverse transformation process associated with the second transformation process, the fourth complex map to a second component of the target stochastic signal, wherein the second component of the target stochastic signal represents the steady-state behavior of the target stochastic signal; and
reconstructing the target stochastic signal from the first component of the target stochastic signal and the second component of the target stochastic signal.
Allowable Subject Matter
Claims 1-6 are allowed.
As per claim 1, the prior art Ferber (US 20170245767) discloses a device for cuff-less blood pressure estimation (see Abstract and paragraph 0045: non-invasive/cuffless blood pressure estimation);
a photoplethysmogram (PPG) sensor configured to obtain PPG measurements from a user of the device (see paragraphs 0011 and 0012: measurement apparatus, measurement signal may be a PPG signal);
a processing unit comprising one or more processors configured to obtain, from the PPG sensor, a PPG signal (see Fig. 3A and paragraph 0122-0123);
decompose the PPG signal into one or more source components, the one or more source components comprising at least an AC component of the PPG signal (see paragraphs 0015 and 0106: determines AC component and DC component of the signal, i.e. PPG signal);
and calculate a blood pressure value from the signal metrics and an output unit configured to provide a blood pressure value and/or alerts (see paragraph 0119-0120 and 0194: discusses calculation of blood pressure; and paragraphs 0120 and 0261: display to display data/blood pressure to a user).
The prior Athaya (An Estimation Method of Continuous Non-Invasive Arterial Blood Pressure Waveform Using Photoplethysmography: A U-Net Architecture-Based Approach) discloses mapping, using one or more trained machine learning models, the PPG signal to a target blood pressure signal (see page 5 first paragraph and Fig. 4 and Fig. 9: generates a blood pressure waveform from a PPG signal using machine learning network).
However, the prior art of record fails to disclose a processor configured to map, using one or more trained machine learning models, the one or more source components to a target AC component and a target DC component; and
generate a transformed target AC component from the target AC component such that a first average value determined from the transformed target AC component matches a second average value determined from the target DC component, wherein the transformed target AC component corresponds to an approximate arterial blood pressure (ABP) signal for the user.
Claims 2-6 are allowed based on their dependence from Claim 1.
Response to Arguments
Applicant argues:
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Examiner’s Response:
The corresponding rejections are hereby withdrawn.
Applicant argues:
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Examiner’s Response:
The Examiner respectfully disagrees.
The additional limitations of obtaining necessary data for the implementation of the abstract idea amounts to the recitation of mere extrasolution data activity, i.e. data gathering (see MPEP 2106.05(g)).
The additional limitation of outputting the algorithm results amounts to extrasolution data activity, i.e. data reporting (see MPEP 2106.05(g)).
Applicant argues:
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677
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202
979
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157
975
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Examiner’s Response:
The Examiner respectfully disagrees. Receiving a non-specific signal, performing mathematical operations on the signal to transform it, and then outputting the signal is the recitation of the abstract idea of a mathematical algorithm being performed in conjunction with a general-purpose computer. That the transformed signal could be used to improve non-specific and unrecited “downstream tasks” does not impact the conclusion that the claims recite an abstract idea – no improvement to any particular field of endeavor is accomplished through the recited method (and corresponding computer-readable medium) and Claims 7 and 14 would serve to monopolize the abstract idea across a broad range of technological contexts.
Applicant argues:
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Examiner’s Response:
The Examiner respectfully disagrees. The limitations of the independent and dependent claims have (each) been considered individually and as a whole and a prima facie case of subject matter ineligibility has been properly established. Claim 6 was determined to recite eligible subject matter, for example.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 12527481 B1 – Determining Blood Pressure Using Photoplethysmography (PPG), see Fig. 1 and corresponding text.
US 20240032825 A1 – Photoplethysmography Based Non-Invasive Blood Glucose Prediction By Neural Network, see Paragraph [0067] – “If the PPG signals are collected in analogue format, the signals are digitized in step 1010 by A/D converter 220. The digitized signal 252 may be stored in database 250 as part of step 1010. Next, the digitized signal 252 is subjected to signal processing in step 1020 by the signal processor 222. In one embodiment, as mentioned above, the signal processing step 1020 may comprise decomposing the signal into high frequency part and low frequency part, such as separating its AC component from the DC component. In another embodiment, the signal processing step 1020 may comprise transforming the signal using transformation methods such as Fourier transformation, wavelet transformation, Hilbert-Huang transformation or any other transformation related to any time-frequency analysis. In an embodiment, the digitized signals are processed into signal windows which are digitized segments of the PPG signal as disclosed above. Results of the signal processing 1020 may be stored in memory 250 as part of step 1020.”
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE ROBERT QUIGLEY whose telephone number is (313)446-4879. The examiner can normally be reached 9AM-5PM EST.
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, Arleen Vazquez can be reached at (571) 272-2619. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE R QUIGLEY/ Primary Examiner, Art Unit 2857
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