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 Statement (IDS) filed 05/23/2023 has been considered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “AN” in fig. 7. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: "an sliding" in line 12 should read "a sliding". Appropriate correction is required.
Claim 2 is objected to because of the following informalities: "and proportional" in line 2 should read "and is proportional". Appropriate correction is required.
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.
Such claim limitations are: “program coding means” in claim 13 and “program coding means” in claim 14.
Three Prong Analysis for claim 13:
The claim recites “means”.
“suitable for carrying out the steps according to claim 1” is herein interpreted as functional language.
There is not sufficient structure recited in the claim to perform the aforementioned functions. Therefore, “program coding means” are herein interpreted 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Three Prong Analysis for claim 14:
The claim recites “means”.
“adapted to perform the steps according to claim 1” is herein interpreted as functional language.
There is not sufficient structure recited in the claim to perform the aforementioned functions. Therefore, “program coding means” are herein interpreted 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 1-15 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.
Regarding Claim 1, the claim recites “the unfiltered or high-pass filtered signal”. There is insufficient antecedent basis for this claim limitation. It is unclear to which signal “the unfiltered or high-pass filtered signal” refers. For the purposes of examination, “the unfiltered or high-pass filtered signal” is herein interpreted to be one of the two electrical signals. The claim also recites “the band-pass filtered signal”. There is insufficient antecedent basis for this claim limitation. It is unclear to which signal “the band-pass filtered signal” refers. For the purposes of examination, “the band-pass filtered signal” is herein interpreted to be one of the two electrical signals. The claim also recites “the electrical signal”. It is unclear to which of the two electrical signals “the electrical signal” refers. For the purposes of examination, “the electrical signal” is herein interpreted to be one of the two electrical signals. The claim also recites “the foot”. It is unclear to which of “a feet” “the foot” refers. The claim also recites “a neighborhood of a relative minimum of the same portion”. It is unclear what is meant by “a neighborhood”. It is relative term and the specification does not provide any clarification as to the metes and bounds of such a term. For the purposes of examination, “a neighborhood” is herein interpreted to be a portion of the same electrical signal. Due to the aforementioned reasons, claim 1 is rendered indefinite. Claims 2-15 are rejected due to their dependence on claim 1
Regarding Claim 3, the claim recites “the signal”. It is unclear to which signal “the signal” refers. The claim also recites “the relative minima”. There is insufficient antecedent basis for this claim limitation. The claim also recites “the current segment”. There is insufficient antecedent basis for this claim limitation. The claim recites “said neighborhood”. It is unclear if “said neighborhood refers to “a neighborhood” recited in claim 1 or “a neighborhood” recited in claim 3. The claim also recites “the foot”. It is unclear to which of “a feet”, recited in claim 1, “the foot” refers. The claim recites “the available portion”. There is insufficient antecedent basis for this claim limitation. The claim recites “the unfiltered or filtered high pass signal” and “the non-filtered or high-pass filtered signal”. There is insufficient antecedent basis for these claim limitations. It is unclear to which signals “the unfiltered or high pass filtered signal” and “the non-filtered or high-pass filtered signal” refers. Therefore, claim 3 is rendered indefinite.
Regarding Claim 4, the claim recites “the relative minima”, “the current segment”, “the next current segment”, and “the immediately preceding minimum of the tangent”. There is insufficient antecedent basis for these claim limitations. Therefore, claim 4 is rendered indefinite.
Regarding Claim 5, the claim recites “the current segment” and “the band pass filtering step”. There is insufficient antecedent basis for these claim limitations. The claim also recites “which precedes it”. It is unclear what is meant by “it”. Therefore, claim 5 is rendered indefinite.
Regarding Claim 6, the claim recites “said band-pass filtering” and “the fourth order”. There is insufficient antecedent basis for these claim limitations. Therefore, claim 6 is rendered indefinite.
Regarding Claim 7, the claim recites “the following operations”. There is insufficient antecedent basis for this claim limitation. The claim also recites “said filtering”. It is unclear to which filtering “said filtering” refers. The claim also recites “the signal”. It is unclear to which signal “the signal” refers. Therefore, claim 7 is rendered indefinite.
Regarding Claim 8, the claim recites “the step of calculating the PWV parameter”, “the basis of the distance”, “the basis of a time lag”, and “the same impulse”. There is insufficient antecedent basis for these claim limitations. Therefore, claim 8 is rendered indefinite.
Regarding Claim 9, the claim recites “the last values”, “the PWV parameter”, “the standard deviation”, and “the measurement”. There is insufficient antecedent basis for these claim limitations. Therefore, claim 9 is rendered indefinite.
Regarding Claim 10, the claim recites “the sensors”. It is unclear to which of “as many sensors suitable for detecting a pressure impulse at an artery of the human body”, recited in claim 1, “the sensors” refers. The claim also recites “this ratio”. There is insufficient antecedent basis for this claim limitation. It is unclear if “this ratio” refers to the “a signal-to-noise ratio”. Therefore, claim 10 is rendered indefinite.
Regarding Claim 11, the claim recites “the acquisition process” and “the pressure signal”. There is insufficient antecedent basis for these claim limitations. The claim also recites “the sensors”. It is unclear to which of “as many sensors suitable for detecting a pressure impulse at an artery of the human body”, recited in claim 1, “the sensors” refers. The claim also recites “the amplitude and phase of each segment is synchronized on with the pressure signal detected by the sensors”. It is unclear what is meant “synchronized on with the pressure signal detected by the sensors”. It is unclear what is meant”. Therefore, claim 11 is rendered indefinite.
Regarding Claim 12, the claim recites “said determined duration”. There is insufficient antecedent basis for this claim limitation. Therefore, claim 12 is rendered indefinite.
Regarding Claim 13, the claim recites “the body”. There is insufficient antecedent basis for this claim limitation. It is unclear if “the body” refers to “a human body” recited in claim 1. For the purposes of examination, “the body” is herein interpreted to refer to “a human body” recited in claim 1. Therefore, claim 13 is rendered indefinite.
Regarding Claim 14, the claim recites “the body”. There is insufficient antecedent basis for this claim limitation. It is unclear if “the body” refers to “a human body” recited in claim 1. For the purposes of examination, “the body” is herein interpreted to refer to “a human body” recited in claim 1. The claim also recites “said program”. It is unclear if “said program” refers to “a recorded program” recited earlier in the claim. For the purposes of examination, “said program” is herein interpreted to refer to “a recorded program”. Therefore, claim 14 is rendered indefinite.
Regarding Claim 15, the claim recites “sample them according to a succession of samples organized in segments”. It is unclear what is meant by “them”. For the purposes of examination, “them” is herein interpreted to be the “respective pressure signals” recited earlier in the claim. It is also unclear what is meant by “according to a succession of samples organized in segments”. Therefore, claim 15 is rendered indefinite.
Claim limitation “program coding means” in claims 13 and 14 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The claims and the specification fail to disclose what is meant by “program coding means” or any structure that performs the function of the ”program coding means”. Therefore, the claims are indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Examiner' s Comment
In light of the claim rejections for indefiniteness under 35 U.S.C. 112 2nd paragraph, as set forth above, the Examiner was only able to perform a rudimentary search of the prior art. Applicant is reminded that prior art rejections under 35 U.S.C. 102 and/or 35 U.S.C. 103 may be applied in the next Office action in light of any clarifying amendments, and that the next Office action can properly be made "Final" if the rejections are necessitated by the clarifying amendments. See MPEP 706.07.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including a process of acquisition of the two electrical signals. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of conducting a search, for each electrical signal, of the foot of the sphygmic wave in a portion of the unfiltered or high-pass filtered signal corresponding to a neighborhood of a relative minimum of the same portion of the band-pass filtered signal sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 fails to recite additional elements that integrate the judicial exception into a practical application. The search does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the search, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of acquisition of the two electrical signals. Acquiring data (two electrical signals) in order to perform some form of analysis is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the acquiring step is 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.
Regarding claim 8, the device recited in the claim sensors suitable for detecting a pressure impulse at an artery of the human body which are generic sensors configured to perform pre-solutional data gathering activity.
Regarding claim 13, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The sensors suitable for detecting a pressure impulse at an artery of the human body are generic sensors configured to perform pre-solutional data gathering activity and the computer program and program coding means are generic computer elements configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Regarding claim 14, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The sensors suitable for detecting a pressure impulse at an artery of the human body are generic sensors configured to perform pre-solutional data gathering activity and the computer readable means and program coding means are generic computer elements configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Regarding claim 15, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The pair of sensors are generic sensors configured to perform pre-solutional data gathering activity and the processing unit is a generic computer element configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Additionally or alternatively, Claim 14 is further rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to a computer-readable means. Under the broadest reasonable interpretation, a computer-readable means covers an ineligible signal per se. A claim that covers both statutory and non-statutory embodiments (under the broadest reasonable interpretation of the claim when read in light of the
specification and in view of one skilled in the art) embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. A computer-readable
means can encompass non-statutory forms of signal transmission, such as, a propagating electrical or electromagnetic signal per se. See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the broadest reasonable interpretation of machine readable media encompasses transitory forms of signal transmission, the claim is directed to non-statutory subject matter. It is suggested that Applicant amend the claim to recite a “non-transitory computer-readable means” in order to recite statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and the display of data. The comparing and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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.
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, 8 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kirenko (US Patent Pub. No. 20170164904) in view of Watson (US Patent Pub. No. 20140058231).
Regarding Claim 1, Kirenko discloses a real-time measurement method of a speed of a sphygmic wave (PWV) (a method for obtaining pulse transit time and/or pulse wave velocity information of a subject [0002]) acquired as a phase difference between a feet of the same sphygmic wave (The phase shift between PPG signals acquired from various body parts will be used for calculation of PTT, PWV [0104]) acquired at two different sites of a human body in the form of corresponding electrical signals (by analyzing the difference in phase and shape of two PPG signals acquired from both feet or both legs [0107]) generated by as many sensors suitable for detecting a pressure impulse at an artery of the human body (multiple “virtual sensors” (ROIs), from which various PPG-related information, in particular vital signs, such as SpO2, pulse shape, pulse amplitude etc. are derived [0101]), the method comprising a process of acquisition of the two electrical signals (In step S20 PPG signals are acquired from all detected ROIs (“virtual sensors”). [0104]) and a simultaneous analysis process of the two electrical signals in real time (In step S22 the PPG phase shift between two or more virtual sensors are analyzed. [0104]; The proposed device and method, in contrast, can unobtrusively, reliably and synchronously measure spatial PPG information from multiple body sites simultaneously [0071]), in which the analysis process includes a search, for each electrical signal, of the foot of the sphygmic wave in a portion of the unfiltered or high-pass filtered signal (a minimum value F of the photoplethysmogram as a foot pulse arrival time PAT.sub.foot [0074]; fig 3) corresponding to a neighborhood of a relative minimum of the same portion of the band-pass filtered signal (fig 3).
Kirenko fails to disclose in which said search is performed in two contiguous segments of the electrical signal by means of a sliding observation window, contained in said two contiguous segments, such as to always include an entire sphygmic wave.
However, Watson teaches using a sliding observation window to search for minimums and maximums in a PPG signal, contained in two contiguous segments, such as to always include an entire PPG wave (microprocessor 48 may use a sliding time window of a suitable size/length to detect the upstrokes (or downstrokes) in the PPG signal by finding the minimum and maximum points within the sliding time window [0038]; figs 5-6).
Kirenko and Watson are considered analogous art to the present invention because both inventions are directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Kirenko such that said search is performed in two contiguous segments of the electrical signal by means of a sliding observation window, contained in said two contiguous segments, such as to always include an entire sphygmic wave, as taught by Watson. Kirenko fails to disclose how the search is performed, as such it would have been obvious to use the method of Watson to perform the search. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 2, Kirenko in view of Watson teaches the invention as discussed above in claim 1. Kirenko in view of Watson fails to teach wherein said sliding observation window has a variable width and is proportional to a period calculated on a succession of identified event starters.
However, Watson teaches a sliding observation window has a variable width (a sliding time window that is slightly larger (e.g., between 1-2 times (e.g., 1.3-1.5) the duration of pulses) may be applied to the received PPG signal. [0008]) and is proportional to a period calculated on a succession of identified event starters (The overall maximum and minimum points within the sliding time window are determined… the initial size of the initial window can be a predetermined size and dynamically adjusted based on changes in pulse temporal lengths or heartbeats. [0008]).
It would have been obvious to one having ordinary skill in the art at the time of the effective date to have further modified the method of Kirenko in view of Watson such that the sliding observation window has a variable width and is proportional to a period calculated on a succession of identified event starters, as taught by Watson, because it would allow for the window to be adjusted based on the heartbeat of a user/subject.
Regarding Claim 8, Kirenko in view of Watson teaches the invention as discussed above in claim 1. Kirenko further discloses the step of calculating the PWV parameter on the basis of the distance between a first sensor associated with a first site and a second sensor associated with a second site (a calculation unit 34 for determining pulse transit time and/or pulse wave velocity information 35 from the PPG signals extracted from different regions of interest and the respective determined physical distance between the respective regions of interest [0067]; fig 2), and on the basis of a time lag between the feet of the same impulse detected in the first and the second site (The pulse wave velocity PWV is obtained by calculating PWV=D/PTT.sub.diff, where D is the distance between the hand and the foot, i.e. the positions where the PPG signals were measured. [0075]; fig 4).
Regarding Claim 13, Kirenko in view of Watson teaches a computer program (there are provided a computer program [0023 of Kirenko]) comprising
coding means suitable carrying out the steps according to claim 1 (which comprises program code means for causing a computer to perform the steps of the method disclosed herein [0023 of Kirenko]; see the rejection of claim 1 above),
when said program is run on a computer operatively connected with said sensors (a signal extraction unit 28 for extracting at least two photoplethysmographic (PPG) signals from at least two selected regions of interest from said set of image frames 19... a signal extraction unit 26 may particularly correspond to an analog or digital signal processor [0064 of Kirenko]) arranged to be associated in two different sites of the body to detect a pressure impulse (In step S22 the PPG phase shift between two or more virtual sensors are analyzed. The phase shift between PPG signals acquired from various body parts will be used for calculation of PTT, PWV and eventually for arterial stiffness estimation. [0104 of Kirenko]).
Regarding Claim 14, Kirenko in view of Watson teaches computer readable means (a non-transitory computer-readable recording medium [0023 of Kirenko]) comprising a recorded program (that stores therein a computer program product [0023 of Kirenko]),
said computer readable means comprising program coding means adapted to perform the steps according to claim 1 (a computer program product, which, when executed by a processor, causes the method disclosed herein to be performed [0023 of Kirenko]; see the rejection of claim 1 above),
when said program is run on a computer operatively connected with said sensors (a signal extraction unit 28 for extracting at least two photoplethysmographic (PPG) signals from at least two selected regions of interest from said set of image frames 19... a signal extraction unit 26 may particularly correspond to an analog or digital signal processor [0064 of Kirenko]) arranged to be associated in two different sites of the body to detect a pressure impulse (In step S22 the PPG phase shift between two or more virtual sensors are analyzed. The phase shift between PPG signals acquired from various body parts will be used for calculation of PTT, PWV and eventually for arterial stiffness estimation. [0104 of Kirenko]).
Regarding Claim 15, Kirenko discloses a real-time measurement system of a sphygmic wave velocity (PWV) (FIG. 1 shows an exemplary embodiment of a monitoring system 10 including a device 12 for obtaining pulse transit time and/or pulse wave velocity information of a subject 14 according to the present invention. [0059]) comprising a pair of sensors suitable for detecting a pressure impulse in correspondence with an artery of a human body (In step S22 the PPG phase shift between two or more virtual sensors are analyzed. The phase shift between PPG signals acquired from various body parts will be used for calculation of PTT, PWV and eventually for arterial stiffness estimation. [0104]), a processing unit operationally connected with said pair of sensors (a signal extraction unit 28 for extracting at least two photoplethysmographic (PPG) signals from at least two selected regions of interest from said set of image frames 19... a signal extraction unit 26 may particularly correspond to an analog or digital signal processor [0064]) and configured to acquire respective pressure signals (a signal extraction unit 26 may particularly correspond to an analog or digital signal processor [0064]).
Kirenko fails to disclose the processing unit is configured to sample them according to a succession of samples organized in segments.
However, Watson discloses sampling electrical signals according to a succession of samples organized in segments (microprocessor 48 may use a sliding time window of a suitable size/length to detect the upstrokes (or downstrokes) in the PPG signal by finding the minimum and maximum points within the sliding time window [0038]; figs 5-6).
It would have been obvious to one having ordinary skill in the art at the time of the effective date to have modified the system of Kirenko such that the processing unit is configured to sample them according to a succession of samples organized in segments, as taught by Watson, because sampling electrical signals is well-understood in the art and it would allow for analysis of the electrical signals, such as detecting minimum and maximum points. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kirenko (US Patent Pub. No. 20170164904) in view of Watson (US Patent Pub. No. 20140058231) as applied to claim 8 above, and further in view of Centen et al. (US Patent Pub. No. 20180199824) hereinafter Centen, and further in view of Goodman et al. (US Patent Pub. No. 20180256044) hereinafter Goodman.
Regarding Claim 9, Kirenko in view of Watson teaches the invention as discussed above in Claim 8. Kirenko in view of Watson fails to teach the method further comprising a step of calculating a standard deviation on a moving window of the last values of the PWV parameter and of indicating the measurement as reliable when the standard deviation is less than a predetermined threshold.
However, Centen teaches a standard deviation on a moving window of previous PWV parameters (The number of heartbeats over which a signal is to be averaged may be dynamically adjusted by the processor. The processor may evaluate the SNR and/or standard deviation of the cardiac signals, to determine the number of heartbeats over which the signal should be averaged. [0047]) because it impacts the quality of measurement (the duration of a measurement may be impacted by the quality of the signals [0047]).
Centen is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective date to have further modified the method of Kirenko in view of Watson such that it includes a step of calculating a standard deviation on a moving window of the last values of the PWV parameter, as taught by Centen, because doing so would allow for determining the quality of measurement. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Kirenko in view of Watson, and further in view of Centen fails to teach a step of indicating the measurement as reliable when the standard deviation is less than a predetermined threshold.
However, Goodman teaches indicating a measurement as reliable when pulse signal parameters satisfy a predetermined threshold (If the pulse signals satisfy the error condition thresholds (i.e. if the pulse signals are not considered erroneous or invalid based on the set thresholds) then the location may be identified as being a suitable location for identifying the individual's AoPWV. [0066]).
Goodman is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the method of Kirenko in view of Watson, and further in view of Centen such that it includes a step of indicating the measurement as reliable when the standard deviation is less than a predetermined threshold, because it would allow for a location, and therefore a measurement, to be identified as suitable for identifying a person’s PWV.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kirenko (US Patent Pub. No. 20170164904) in view of Watson (US Patent Pub. No. 20140058231) as applied to claim 1 above, and further in view of Goodman et al. (US Patent Pub. No. 20180256044).
Regarding Claim 10, Kirenko in view of Watson teaches the invention as discussed above in claim 1. Kirenko in view of Watson fails to teach a step of calculating a signal-to-noise ratio of the signals acquired by the sensors and of indicating as reliable when this ratio exceeds a second predetermined threshold.
However, Goodman teaches calculating a signal-to-noise ratio of signals acquired by sensors (the pulse signal may be analyzed to determine that it has a sufficient signal to noise ratio [0066]) and of indicating as reliable when this ratio exceeds a predetermined threshold (If the pulse signals satisfy the error condition thresholds (i.e. if the pulse signals are not considered erroneous or invalid based on the set thresholds) then the location may be identified as being a suitable location for identifying the individual's AoPWV. [0066]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the method of Kirenko in view of Watson such that it includes a step of calculating a signal-to-noise ratio of the signals acquired by the sensors and of indicating as reliable when this ratio exceeds a second predetermined threshold, as taught by Goodman, because it would allow for a location, and therefore a measurement, to be identified as suitable for identifying a person’s PWV.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kirenko (US Patent Pub. No. 20170164904) in view of Watson (US Patent Pub. No. 20140058231) as applied to claim 1 above, and further in view of Shirasaki et al. (US Patent Pub. No. 20040147848) hereinafter Shirasaki.
Regarding Claim 11, Kirenko in view of Watson teaches the invention as discussed above in claim 1. Kirenko in view of Watson teaches the acquisition process begins with segments having an amplitude corresponding to a predetermined length of time (Examiner notes all segments of a wave would have an amplitude that corresponds to some predetermined length of time). Kirenko in view of Watson fails to teach the method comprises a synchronization step wherein the amplitude and phase of each of segment is synchronized on with the pressure signal detected by the sensors, so that only one pressure pulse is contained in a segment.
However, Shirasaki teaches a method for measuring blood pressure (as the principle of oscillometric method, pulse waves (cuff pressure pulse waves) superposed on the cuff pressure signals are detected, but the pulse waves are not limited to the cuff pressure pulse waves [0049]) in which an amplitude and phase of each of segment is synchronized on with the pressure signal detected by sensors (the waveforms can be matched in time phase precisely on the basis of the characteristic waveforms synchronized with the heartbeats of the electrocardiographic signals [0029]; Preferably, the characteristic waveforms show the peak of R waves. Therefore, the time phase can be matched precisely on the basis of the peaks of R waves having small noise components. [0030]; Examiner notes that each heartbeat is a segment), so that only one pressure pulse is contained in a segment (The left sides in FIGS. 3A to 3C show an arterial pressure waveform 12 according to cuff pressure changes in one heartbeat period, respectively, and the right sides show an arterial volume waveform 13 showing volume changes due to arterial pressure waveform in one heartbeat period, that is, waveforms of pulse waves, respectively. [0055]) because pulse waves are correlated with heartbeats (Since the arterial pressure pulsates (changes) between the systolic pressure and diastolic pressure within one heartbeat period, the arterial volume changes accordingly. This volume change is detected as the cuff pressure change, which is known as pulse wave used in blood pressure calculation in the oscillometric method. [0055]).
Shirasaki is considered analogous art to the present invention because it is reasonably pertinent to a problem faced by the inventors.
Because each heartbeat includes a complete pressure pulse with a relative minimum and maximum, and pulse waves are correlated with heartbeats, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Kirenko in view Watson such that the method comprises a synchronization step wherein the amplitude and phase of each of segment is synchronized on with the pressure signal detected by the sensors, so that only one pressure pulse is contained in a segment, as taught by Shirasaki. A segment encompassing a full heartbeat would have all the information needed to calculate blood pressure and a pulse wave velocity parameter.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kirenko (US Patent Pub. No. 20170164904) in view of Watson (US Patent Pub. No. 20140058231) and further in view of Shirasaki (US Patent Pub. No. 20040147848) as applied to claim 11 above, and further in view of Shimuta et al. (US Patent Pub. No. 20150366473) hereinafter Shimuta.
Regarding Claim 12, Kirenko in view of Watson and further in view of Shirasaki teaches the invention as discussed above in claim 12. Kirenko in view of Watson and further in view of Shirasaki fails to teach wherein said predetermined duration is 1.5 seconds.
However, Shimuta teaches a pulse wave propagation time measurement device (abstract) in which segments of a pulse wave are classified by a period equivalent to a heartbeat (in the pulse wave propagation time measurement section 330, in the case where a peak is detected at only one side (upper or lower side) thereof and the peak interval takes a period equivalent to the heartbeat [0055]) and teaches that a heartbeat period can be 1.5 seconds long (the determination is made considering whether or not that period is within a typical range as a heartbeat interval (for example, 0.3 to 1.5 seconds) [0055]).
Shimuta is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective date to have modified the method of Kirenko in view of Watson and further in view of Shirasaki such that said predetermined duration is 1.5 seconds, as taught by Shimuta, because each segment is one heartbeat and Shimuta teaches a heartbeat period can be 1.5 seconds long.
Conclusion
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/JANKI M BAVA/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791