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 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:
“attachment mechanism” in claim 1;
“standoff mechanism” in claim 1.
The claim limitation “attachment mechanism” is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function (“for fixing the one or more RF electromagnetic transmitters and receivers to the subject”). The term “attachment mechanism” is modified by functional language (i.e., “for”). The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. The corresponding structure for “attachment mechanism” is:
“… a belt, a strap, a watch band, an adhesive tape, an article of clothing (a sock, a glove, a pants, a shirt, an arm band, an arm warmer, a leg warmer, etc.). In some cases, the attachment mechanism 150 comprises a band. In some cases, the attachment mechanism 150 comprises: Velcro®, straps, adhesive, silicone, and/or any other suitable attachment mechanism or combination thereof” (Paragraph 0029).
The claim limitation “standoff mechanism” is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function (“for fixing the one or more RF electromagnetic transmitters and receivers at a known stand-off distance from the target body region”). The term “standoff mechanism” is modified by functional language (i.e., “for”). The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. The corresponding structure for “standoff mechanism” appears to be any structure which spaces an RF transmitter and RF receiver at a set distance from a target body region, as shown in Figs. 1A-1D.
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 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, 10, 11, 5, 12, 6, 7, 13, 14, 8, 9, 18, 19, and dependent claims thereof 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.
Re. Claim 1: Claim 1 possesses multiple issues of indefiniteness.
Claim 1 recites the limitation "the frequency range." There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “(a) … transmit… towards a target body region on a subject… (b) transmitting… towards a target body region of a subject.”
It is unclear whether point (a) establishes antecedent basis for “a target body region” as recited in point (b) or whether “a target body region of a subject” recited in point (b) differs from “a target body region” as recited in point (a).
Further, point (b) specifies “a subject” while point (a) already appears to establish antecedent basis for “a subject.” Thus, similar to the previous discussion, it is unclear what subject point (b) refers to.
Examiner recommends amending (b) to instead recite “(b) transmitting one or more RF signals having a frequency in the range of 30-300 GHz towards the target body region
Claim 1 recites the limitation “the reflection of the transmitted one or more RF signals.” There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “at least one waveform data set based on the raw or modified IF signal,” which implies recitation of “the modified IF signal,” which does not possess sufficient antecedent basis. Further, no prior limitations discuss or define modification of the IF signal.
Re. Claim 10: Claim 10 recites the limitation "the current PCA eigenvector values.” There is insufficient antecedent basis for this limitation in the claim. No principal component analysis (PCA) is recited as being performed in the dependency chain of claim 10; thus, details of PCA (e.g., “the current PCA eigenvector values”) do not possess context in the claim and are rendered unclear.
Re. Claim 11: Claim 11 possesses multiple issues of indefiniteness:
Claim 11 recites two limitations which lack sufficient antecedent basis: 1) “the current PCA eigenvector values” and 2) “the historical PCA eigenvector values.” See rejection of claim 10 regarding discussion of lack of PCA details in the dependency chain of claim 11.
Additionally, it is unclear what Applicant means by “noise” or “jumps” as it pertains to a PCA eigenvector or the removal of such features therefrom. A first principal component eigenvector represents the continuous direction of maximum variance in the form of a vector of coefficients, which is inherent to the data set analyzed; the PCA eigenvector itself does not appear to possess what can be considered a jump or discontinuity since all values are needed to specify a particular direction in vector space. Examiner requests clarification of what Applicant defines as a “jump” or “discontinuity” as it relates to a PCA eigenvector. Further, a PCA eigenvector captures the maximum variance in a set of data, but does not itself possesses what can be considered “noise.” Examiner requests clarification of what Applicant defines as a “noise” as it relates to a PCA eigenvector. Should Applicant clarify that the terms “noise” is merely the noise of the underlying data, it is unclear how such noise is removed from the PCA eigenvector values since the claim requires detection of detection or noise or jumps after a PCA eigenvector has already been calculated based on an initial set of data (“detection of noise or jumps in the current PCA eigenvector values”). Removing values of the PCA eigenvector would no longer provide the same eigenvector by virtue of how PCA is calculated.
Re. Claim 5: Claim 5 recites two limitations which lack sufficient antecedent basis: 1) “the frequency domain” and 2) “the Principal Component Analysis.” See rejection of claim 10 regarding discussion of lack of PCA details in the dependency chain of claim 5.
Re. Claim 12: Claim 12 possesses multiple issues of indefiniteness:
Principal component analysis (PCA) is not recited as being performed in the dependency chain of claim12; thus, details of PCA (e.g., “first set of principal components”) do not possess context in the claim and are rendered unclear.
Additionally, claim 12 recites the limitation "the highest amount of variability.” There is insufficient antecedent basis for this limitation in the claim.
Additionally, claim 12 recites the limitation “the data;” however, it is unclear what is the antecedent basis for “data” since, in the dependency chain, since the following instances recite the term “data:”
“signal data from one or more channels of the RF electromagnetic transmitter and the RF electromagnetic receiver;”
“waveform data;”
“cardiovascular data.”
Re. Claim 6: Claim 6 possesses multiple issues of indefiniteness:
Claim 6 recites the limitation "the frequency domain signal.” There is insufficient antecedent basis for this limitation in the claim.
Additionally, no signal transformation to the frequency domain is recited as being performed in the dependency chain of claim 6; thus, details of a frequency domain signal (e.g., “spectral regions”) do not possess context in the claim and are rendered unclear.
Re. Claim 7: Claim 7 recites the limitation "the PCA.” There is insufficient antecedent basis for this limitation in the claim.
Re. Claim 13: Claim 13 recites “based on the largest output waveform amplitude swing.” It is unclear what is meant by “frequency swing” as utilized in claim 13 since Applicant’s disclosure fails to define the term, and the term is not commonly utilized or implicit in the process of PCA.
Re. Claim 14: Claim 14 recites the limitation "the higher order principal components.” There is insufficient antecedent basis for this limitation in the claim. Examiner additionally notes that while higher order principal components may be used to represent, e.g., respiratory signals or motion artifacts, such an association may be inaccurate since principal components are based on variance of the underlying data. There are cases in which the first three principal components (i.e., PC1, PC2, PC3), are unrelated to respiratory signals or motion artifacts.
Re. Claim 8: Claim 8 recites the limitation "the window.” There is insufficient antecedent basis for this limitation in the claim. The first instance of a window is recited in claim 6, which is not part of the dependency chain of claim 8.
Re. Claim 9: No principal component analysis (PCA) is recited as being performed in the dependency chain of claim 9; thus, details of PCA (e.g., “first set of principal components”) do not possess context in the claim and are rendered unclear.
Re. Claim 18: The terms “weak,” “noisy,” and “small” in claim 18 are relative terms which renders the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining requisite degrees of such terms, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the limitation of a “first abnormality” is rendered indefinite.
Re. Claim 19: Claim 19 possesses multiple issues of indefiniteness:
Claim 19 “adjusting the IF gain/filter settings,” which implies “the IF gain” and “the filter settings.” Neither of these terms are provided with sufficient antecedent basis.
Additionally, since claim 19 recites “adjusting the IF gain/filter settings,” it is unclear if the claim requires adjusting IF gain and IF filter settings or IF gain and non-IF filter settings.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over:
Shay et al. (US 20190282106 A1) (hereinafter – Shay) in view of
Hazra et al. (US 20230393259 A1) (hereinafter – Hazra) in further view of
Presura (US 20170172435 A1) (hereinafter – Presura).
Re. Claim 1: Shay (commonly-assigned) teaches a method for monitoring cardiovascular health using a wearable device (Abstract; Fig. 1), the method comprising:
(a) providing a wearable device comprising one or more RF electromagnetic transmitters (Figs. 1, 2, 12: electromagnetic transmitter 110),
each configured to transmit an RF signal in the frequency range of 30-300 GHz towards a target body region on a subject (Paragraph 0019: “In one embodiment, the transmit signal is in the millimeter wave frequency band (e.g. between 30 and 300 GHz)”),
one or more RF electromagnetic receivers configured to receive reflected RF signals from the target body region (Figs. 1, 2, 12: electromagnetic receiver 120),
an attachment mechanism for fixing the one or more RF electromagnetic transmitters and receivers to the subject (Fig. 1: attachment mechanism 150), and
a standoff mechanism for fixing the one or more RF electromagnetic transmitters and receivers at a known stand-off distance from the target body region (Figs. 1, 2, 12: stand-off mechanism 160; Abstract: “… a stand-off mechanism 160 for fixing the electromagnetic transmitter and electromagnetic receiver at a known standoff distance from a target body region on the user”);
(b) transmitting one or more RF signals having a frequency in the range of 30-300 GHz towards a target body region of a subject, said target body region comprising skin over an artery in the subject (Paragraph 0033: “The preferred embodiment of S210 includes transmitting millimeter-wave signals. More preferably, the electromagnetic transmitter transmits signals with a frequency of 30 to 300 GHz”);
(c) receiving one or more reflected RF signals corresponding to the reflection of the transmitted one or more RF signals from the target body region (Paragraph 0034: “The step collecting a reflected signal dataset S220 functions to receive signals generated by the electromagnetic transmitter and reflected off of the user”).
Shay measures cardiovascular-related parameters of a user (Paragraph 0018), but does not provide further detail regarding how such a process is performed aside from, e.g., “the processor may perform mixing, filtering and signal processing of the received signal to extract information related to the position and motion of the target body region of a user” (Paragraph 0020). Thus, Shay does not teach:
(d) generating a raw Intermediate Frequency (IF) signal by mixing or comparing the transmitted one or more RF signals and the reflected one or more RF signals,
wherein the raw IF signal comprises signal data from one or more channels of the RF electromagnetic transmitter and the RF electromagnetic receiver.
Hazra teaches analogous art in the technology of analyzing human vital signs using millimeter wave radar sensing (Abstract). Hazra further teaches the invention comprising:
(d) generating a raw Intermediate Frequency (IF) signal by mixing or comparing the transmitted one or more RF signals and the reflected one or more RF signals (Paragraph 0041: “For example, in some embodiments, during step 204, the transmitted and received radar signals are mixed to generate an intermediate frequency (IF) signal”),
wherein the raw IF signal comprises signal data from one or more channels of the RF electromagnetic transmitter and the RF electromagnetic receiver (see previous citation – implicit in mixing signals from transmitter and receiver);
Examiner notes that such a process is part of a technique known as range FFT (see Hazra, Fig. 2).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the technique of detecting motion for vital sign determination utilizing an intermediate frequency as taught by Hazra for the undisclosed technique to detect motion of Shay. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Shay as modified by Hazra does not discuss
(e) generating, via a processor, at least one waveform data set based on the raw or modified IF signal, wherein Dimensionality Reduction is used to combine signals from two or more channels to form a composite waveform;
(f) extracting one or more features from the composite waveform; and
(g) generating cardiovascular data from the features by using a cardiovascular model.
Presura teaches analogous art in the technology of wearable devices which determine a cardiovascular property of a person (Abstract). Presura further teaches intaking detection signals, applicable to the mixed signals described in Shay, which are processed via principal component analysis (PCA), a common dimensionality reduction technique. Detection signals are linearly combined as principal components, which may be considered a composite waveform as claimed (Paragraphs 0016, 0045). From this, a repetitive rate of the processed detection signals is extracted as a feature (Paragraphs 0017, 0045), whereby the cardiovascular data of pulse rate is obtained (see previous citations).
It would have been obvious to one having skill in the art before the effective filing date to have modified Shay as modified by Hazra to have included the detection signal processing as taught by Presura, the motivation being that doing so cleans the signals from movement artifacts (Paragraphs 0016, 0045).
Presura, in the modification of Shay as modified by Hazra, further teaches the invention comprising:
(f) extracting one or more features from the composite waveform (Paragraph 0045: identification of repetitive rate); and
(g) generating cardiovascular data from the features by using a cardiovascular model (Paragraph 0045: “…wherein the physiological property determination unit 9 may be adapted to determine a repetitive rate of the cleaned detection signals as the pulse rate”).
Re. Claim 2: Shay as modified by Hazra and Presura teaches the invention according to claim 1. Hazra, in teaching further detail regarding the incorporated IF signal technique, further teaches the invention wherein the raw IF signal comprises any one, any two, any three, any four, any five, or any six of: timing, shape, phase, envelope, offset, and amplitude of the reflected RF signal (see citations of claim 1; Examiner notes that intermediate frequency signal production shifts a carrier frequency to a fixed lower frequency, which preserves the signal’s modulation).
Re. Claim 3: Shay as modified by Hazra and Presura teaches the invention according to claim 1. Shay further teaches the invention where each channel comprises a signal measured by its own antenna and measurement circuit (Examiner notes these components are implicit in both an RF transmitter and receiver).
Re. Claim 4: Shay as modified by Hazra and Presura teaches the invention according to claim 1. Hazra, in teaching further detail regarding the incorporated dimensionality reduction technique, further teaches the invention where the Dimensionality Reduction technique consists of Principal Component Analysis (PCA) (Paragraphs 0016, 0045).
Claims 15, 16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over:
Shay et al. (US 20190282106 A1) (hereinafter – Shay) in view of
Hazra et al. (US 20230393259 A1) (hereinafter – Hazra) in further view of
Presura (US 20170172435 A1) (hereinafter – Presura) in further view of
Chao et al. (US 20180317854 A1) (hereinafter – Chao).
Re. Claim 15: Shay as modified by Hazra and Presura teaches the invention according to claim 1, but does not teach the invention further comprising performing a first quality assessment on the raw IF signal, via the processor.
Chao teaches analogous art in the technology of analyzing physiological signals (Abstract). Chao further teaches the invention further comprising performing a first quality assessment on the raw IF signal, via the processor (Fig. 2: determining whether the requirement is satisfied; Paragraph 0040: “… whether the processed PPG signal satisfies with the requirement means whether the amplitude or signal stability of the processed PPG signal satisfies with the requirement;” Examiner notes that this is an assessment of quality).
It would have been obvious to one having skill in the art before the effective filing date to have modified Shay as modified by Hazra and Presura to include the quality assessment of Chao, the motivation being that doing so accounts for variation in signal quality to maintain signal quality (Paragraph 0031).
Re. Claim 16: Shay as modified by Hazra, Presura, and Chao teaches the invention according to claim 15. Chao, in teaching further detail regarding the incorporated quality assessment, further teaches the invention wherein the first quality assessment comprises:
a. detecting a first abnormality with the raw IF signal (Fig. 2: assessing if received signal meets requirement for, e.g., signal stability), and
b. applying a first corrective measure based on the first abnormality to form a corrected raw IF signal (Fig. 2: adjusting the control signal; Fig. 4: steps S45-S47 involving adjustment of control signals based on determination of beam intensity or gain).
Re. Claim 18: Shay as modified by Hazra, Presura, and Chao teaches the invention according to claim 16. Chao, in teaching further detail regarding the incorporated quality assessment, further teaches the invention wherein the first abnormality comprises signal saturation, a weak signal, a noisy signal, a small amplitude, or a combination thereof (Paragraph 0007: discussion of whether the amplitude of a received signal is too small (i.e., reading on “weak signal” and “small amplitude”).
Re. Claim 19: Shay as modified by Hazra, Presura, and Chao teaches the invention according to claim 18. Chao, in teaching further detail regarding the incorporated quality assessment, further teaches the invention wherein the first corrective measure comprises
i) reducing or increasing a strength of the transmitted electromagnetic signal (Fig. 4: adjusting intensity of intensity of beam, akin to the transmitted RF signal of Shay),
ii) adjusting the IF gain / filter settings, or
iii) a combination thereof.
Re. Claim 20: Shay as modified by Hazra, Presura, and Chao teaches the invention according to claim 18. Chao, in teaching further detail regarding the incorporated quality assessment, further teaches the invention wherein the applying the first corrective measure is performed in real-time (the processes of Figs. 2-4 occur as the signal is received; Examiner further notes that the term “real-time” is not provided with definition in Applicant’s disclosure or the claims and possesses a definition as broad as including any action performed in time).
Examiner’s Note
Claims 10, 11, 5, 12, 6, 7, 13, 14, 8, 9, and 17 do not possess prior art rejections. However, due to the complexity and degree to which the claims possess issues of indefiniteness under 35 U.S.C. 112(b), rewriting the claims and incorporating such subject matter into a base claim would not render such claims allowable. The question of prior art will be revisited upon resolution of the numerous 35U.S.C. 112(b) and clarity issues noted above.
Conclusion
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/JUSTIN XU/ Examiner, Art Unit 3791