DETAILED ACTION
Applicant’s arguments, filed 06/02/2026, have been fully considered. Applicant has canceled claim 10 and added claim 21. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 1-9 and 11-21 are the current claims hereby under examination.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/02/2026 has been entered.
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 1-9 and 11-21 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 claims 1 and 12, the claims recite a transducer array coupled with the digital processor and configured to generate analog signals. However, it is unclear what analog signals the transducer is generating. Does the transducer measure signals from the artery? Should the transducer array obtain the waveforms through non-invasive contact with the artery as analog signals? For examination purposes, that is how the claim will be interpreted. However, Applicant should clarify the relationship between the transducer array and how it generates analog signals. Claims 2-9 and 11-21 are also rejected due to their dependence on claims 1 and 12.
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.
1-9 and 11-21 are rejected under 35 U.S.C. 101 because the claimed invention is
directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without
significantly more.
Analysis of independent claims 1 and 12:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 12 is directed to a system, which describes one of the four statutory categories of
patentable subject matter, i.e., a machine. Claim 1 is directed to a computer implemented method,
which describes one of the four statutory categories of patentable subject matter, i.e., a method.
Therefore, further consideration is necessary regarding the claims.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1 and 12 recite an abstract idea. In particular, the claims generally recite
the following:
Identifying, by the digital processor, a first set of segments of the pABP waveform in time that are in steady state;
Identifying, by the digital processor, a second set of segments of the ABF waveform in time that are in steady state;
estimating, by the digital processor, the MAP based on the identified first set of segments of the pABP waveform in time that are in steady state and the identified second set of segments of the ABF waveform in time that are in steady state; and
generating, by the digital processor, without calibration, an absolute arterial blood pressure (ABP) waveform by level shifting the pABP waveform by the MAP.
These elements recited in claims 1 and 12 are drawn to an abstract idea since they involve mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
“identifying a first set of segments of the pABP waveform in time that are in steady state” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably view a blood pressure waveform and identify a segment in steady state. There is nothing to suggest an undue level of complexity in “identifying a first set of segments of the pABP waveform in time that are in steady state”.
“identifying a second set of segments of the ABF waveform in time that are in steady state” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably view a blood flow waveform and identify a segment in steady state. There is nothing to suggest an undue level of complexity in “identifying a second set of segments of the ABF waveform in time that are in steady state”.
“estimating the MAP based on the identified first set of segments of the pABP waveform in time that are in steady state and the identified second set of segments of the ABF waveform in time that are in steady state” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably compute MAP from the waveforms in steady state, which is a known mathematical formula to one of ordinary skill in the art. There is nothing to suggest an undue level of complexity in “estimating the MAP based on the identified first set of segments of the pABP waveform in time that are in steady state and the identified second set of segments of the ABF waveform in time that are in steady state”.
“generating, without calibration, an absolute arterial blood pressure (ABP) waveform by level shifting the pABP waveform by the MAP” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably level-shift a waveform by a constant value. There is nothing to suggest an undue level of complexity in “generating, without calibration, an absolute arterial blood pressure (ABP) waveform by level shifting the pABP waveform by the MAP”.
Prong Two: Claims 1 and 12 do not recite additional elements that integrate the exception
into a practical application. Therefore, the claims are "directed to" the abstract idea. The additional
elements merely:
Recite the words "apply it" or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “a storage” (claim 12), "a digital processor" (claims 1 and 12), “a biomedical device” (claims 1 and 12), “a transducer array” (claims 1 and 12), and “circuitry” (claims 1 and 12)) and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data gathering components (e.g., "obtaining a pulsatile blood pressure waveform" (claim 1), "obtaining an arterial blood flow waveform" (claim 1), “obtain a pulsatile arterial blood pressure (pABP) waveform as first digital signals of the digital signals” (claim 12), and “obtain an arterial blood flow (ABF) waveform as second digital signals of the digital signals” (claim 12));
As a whole, the additional elements merely serve to gather information to be used by the
abstract idea, while generically implementing it on a computer. There is no practical application because
the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed
remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the
technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the
abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 12 do not include additional elements, alone or in combination, that are
sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the
same reasons as described above. E.g., all elements are directed to implementing the abstract ideas on
generic processing components, the pre-solution activity of using generic data-gathering components,
and generic post-solution activities, which merely facilitate the abstract idea.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and
conventional. For example, "a digital processor” and a “storage” as disclosed in Applicant’s specification paragraph 0036, “the method of FIGURE 1 can be performed by a processor, such as digital processor 518, which may include processing corresponding instructions stored in memory, such as storage 516 described herein”. A “biomedical device” is disclosed as “a biomedical device is provided that includes a storage, and a digital processor coupled to the storage” (Paragraph 0009), with an example given as an ultrasound or an MRI (Paragraph 0053).
These elements do not qualify as significantly more because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric PowerGroup, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014); SAP Am. v. lnvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a
practical application and do not amount to significantly more than the above-judicial exception (the
abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing
that is not already present when looking at the elements taking individually. There is no indication that
the combination of elements improves the functioning of a computer, for example, or improves any
other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of
elements include a particular solution to a computer-based problem or a particular way to achieve a
desired computer-based outcome. Rather, the collective functions of the claimed invention merely
provide conventional computer implementation, i.e., the computer is simply a tool to perform the
process.
Analysis of dependent claims 2-9, 11, and 13-21:
Claims 3, 5-6, 8, and 15-17 recite mental steps that may be performed in the human mind with the aid of pen and paper or a generic computer, which add to the abstract idea. The mental steps are identified as:
“identifying a set of contiguous segments where, for each pair of segments in the set of contiguous segments, all pairwise differences between two pressure data points at the end-diastoles of the pair of segments are less than a threshold” (claim 3);
“identifying the second set of segments of the ABF waveform that corresponds to the first set of segments of the pABP waveform” (claim 5);
“determining a mean pulsatile arterial pressure for the first set of segments of the pABP waveform; determining a mean arterial flow for the set of segments of the ABF waveform; and estimating a peripheral resistance (PR) based on the mean pulsatile arterial pressure and the mean arterial flow” (claim 6);
“estimating the MAP based on the PR and a time-averaged volumetric flow determined from the ABF waveform during steady state” (claim 8);
“wherein the digital processor is configured to identify the first set of segments of the pABP waveform in steady state at least in part by identifying a set of contiguous segments where, for each pair of segments in the set of contiguous segments, all pairwise differences between two pressure data points at the end-diastoles of the pair of segments are less than a threshold” (claim 15);
“wherein the digital processor is configured to identify the first set of segments of the pABP waveform at least in part by identifying the set of segments of the ABF waveform that corresponds to the first set of segments of the pABP waveform” (claim 16);
“determine a mean pulsatile arterial pressure for the first set of segments of the pABP waveform; determine a mean arterial flow for the set of segments of the ABF waveform; and estimate a peripheral resistance (PR) based on the mean pulsatile arterial pressure and the mean arterial flow” (claim 17);
Claims 7, 9, and 18-19 recite steps that are mathematical concepts, which add to the abstract idea. The mathematical concepts are identified as:
“wherein estimating the PR based on the mean pulsatile arterial pressure and the mean arterial flow includes determining the PR as a slope of a best fit line relating the mean arterial flow versus the mean arterial pressure” (claim 7);
“estimating the MAP by multiplying the PR and a time-averaged volumetric flow determined from the ABF waveform” (claim 9);
“wherein the digital processor is configured to estimate the PR based on the mean pulsatile arterial pressure and the mean arterial flow at least in part by determining the PR as a slope of a best fit line relating the mean arterial flow versus the mean arterial pressure” (claim 18);
“estimate the MAP by multiplying the PR and a time-averaged volumetric flow determined from the ABF waveform” (claim 19);
Claims 2, 4, 11, 13-14, and 20-21 recite limitations in addition to the abstract idea: they merely
Further describe the abstract idea (“wherein the first set of segments of the pABP waveform includes cardiac cycles defined as period between end diastoles” (claim 2), “wherein the threshold is 0.5 millimeters of mercury (mmHg)” (claim 4), “wherein the first set of segments of the pABP waveform includes cardiac cycles defined as period between end diastoles” (claim 14),
Further describe the pre-solution activity (“an analog front end configured to process the analog signals; and an analog-to-digital converter (ADC) configured to generate the digital signals from the analog signals” (claim 20)), and
Further describe the post-solution activity (“wherein displaying an indication of the estimated MAP includes displaying the indication on a display of the biomedical device” (claim 11), “a display device configured to display an indication of the pABP waveform” (claim 13), and “a display device, with the digital processor further configured to cause the display device to output the absolute ABP waveform to an end-user” (claim 21)).
Taken alone or in combination, the additional elements do not integrate the judicial exception
into a practical application at least because the abstract idea is not applied, relied on, or used in a
meaningful way. The additional elements do not add anything significantly more than the abstract idea.
The collective functions of the additional elements merely provide computer/electronic implementation
and processing, and no additional elements beyond those of the abstract idea. There is no indication
that the combination of elements permits automation of specific tasks that previously could not be
automated. There is no indication that the combination of elements improves the functioning of a
computer, output device, improves technology other than the technical field of the claimed invention, etc. The result of the abstract idea does not cause the computing device and/or application to perform
different.
Therefore, claims 1-9 and 11-21 are rejected as being directed to non-statutory subjection matter.
Prior Art
The prior art of record, Baura, Parlikar, and Zalevsky, teach analogous devices to the instant application as discussed above.
Baura teaches a method to estimate a mean arterial pressure by obtaining pulsatile arterial blood pressure and arterial blood flow waveforms (Fig. 3a, steps 306, 307, 310, and 312; Fig. 3b, step 314; Col. 5, lines 62-66) to estimate the MAP based on the waveforms (Fig. 3a, steps 338 and 340). Baura fails to teach identifying segments of the waveforms that are in steady state or level-shifting the pABP waveform by the MAP to obtain an absolute arterial blood pressure waveform.
Parlikar teaches a system for measuring blood parameters from blood pressure waveforms during steady state (Paragraph 0053); however, Parlikar fails to teach identifying steady state in a blood flow waveform. Parlikar also fails to teach level-shifting the pABP waveform by the MAP to obtain an absolute arterial blood pressure waveform.
Zalevsky teaches a system for monitoring blood circulation (abstract) but fails to teach level-shifting a pABP waveform by the MAP to obtain an absolute arterial blood pressure waveform.
Thus, the prior art of record, alone or in combination, fails to teach or provide an obviousness rationale to combine the prior art to read on independent claims 1 and 12.
Response to Arguments
Applicant's arguments, see pages 7-12, filed 06/02/2026, with respect to the 35 U.S.C. §101 rejection have been fully considered but they are not persuasive.
Applicant points to the additional elements amended into claim 1 that permit, at least partially, achieving the improvement of generating an absolute ABP waveform without calibration, see page 8. Examiner disagrees that the digital processor, transducer array, biomedical device, storage, and/or circuitry are additional elements that lead to the improvement of generating an absolute ABP waveform. These additional elements are well-understood, routine, and conventional, specified at a high level of generality. That is, the additional elements are not identified as a specific or special element or configuration for obtaining waveforms, manipulating the waveform data, and/or generating the absolute waveform result. The digital processor, biomedical device, transducer array, storage, and circuitry are generic processing components that append well-understood, routine, and conventional activities to the judicial exception.
Further, the claim must include more than mere instructions to perform the method on generic components/processing components to qualify as an improvement to the technology. As discussed above, the digital processor amounts to mere instructions to apply the abstract ideas on a generic computer.
Applicant further argues that the claims provide an improvement to biomedical devices and the technical field of non-invasive estimation of mean arterial pressure and absolute arterial blood pressure as no calibration is required and is more efficient than and improved over traditional biomedical devices, see page 9. Examiner respectfully disagrees.
While it may be true that the claimed method may provide an improvement to the generation of an absolute arterial blood pressure waveform, the improvement cannot rely solely within the judicial exception. That is, the judicial exception alone cannot provide the improvement.
The judicial exception, as described above, is identified as the abstract ideas of identifying segments of the ABF and pABP waveforms, estimating the MAP, and generating, without calibration, an absolute arterial blood pressure waveform. Applicant asserts that the improvement of the method is generating the absolute ABP waveform without calibration; however, this improvement is the abstract idea, and the abstract idea itself is not an improvement in the technology (see MPEP 2106.05(a)).
Applicant further argues, see page 10, that dependent claim 20 currently covers structure and does not further describe the alleged abstract idea of a mental process. As noted above, the analog front end and analog-to-digital converter merely contribute to the pre-solution activity of processing the analog signals into a digital signal prior to the limitations identified as the mental processes (i.e., the steps of identifying segments of waveforms, estimating the MAP, and generating the absolute ABP).
Applicant further argues, see page 10, that the dependent claims, citing specifically claims 11 and 21, are an integral part of the practical application of a biomedical device. Examiner interprets these claims as displaying calculated data onto a display of a biomedical device. The mere output of data is considered insignificant post-solution activity and does not integrate the judicial exception into a practical application. Applicant argues that this display “provides a characterization of the status of a cardiovascular system … and can be a predictor for cardiovascular diseases”; however, Examiner points out that these argued limitations are not recited. The claims require displaying an indication of the MAP and/or the absolute ABP waveform, which is interpreted as merely displaying calculated data values.
Therefore, Applicant’s argument is found not persuasive. The rejection above has been updated to reflect the amendments made to the claims.
Applicant states that the Office Action fails to apply the Alice/Mayo test separately to each one of dependent claims 2-9, 11, and 13-21, see page 10. The rejection above reflects the application of the Alice/Mayo test to the dependent claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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