DETAILED ACTION
Applicant’s arguments, filed 01/09/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicant has canceled claim 10 and added claim 21.
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 .
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.
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 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;
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; and
generating, 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) and "a digital processor" (claim 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" (claims 1 and 12) and "obtaining an arterial blood flow waveform" (claims 1 and 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 digital processor and storage are cited as being merely a part of another structure of the system and does not qualify as significantly more because this limitation is 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 the dependent claims:
Claims 2-9, 11, and 13-21 depend from the independent claims. Dependent claims 2-9, 11, and 13-21 merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: 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), “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), “wherein the threshold is 0.5 millimeters of mercury (mmHg)” (claim 4), “identifying the first 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), “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 based on the PR and a time-averaged volumetric flow determined from the ABF waveform during steady state” (claim 8), “estimating the MAP by multiplying the PR and a time-averaged volumetric flow determined from the ABF waveform” (claim 9), “a display for displaying an indication of the pABP waveform” (claim 13), “wherein the segment of the pABP waveform includes cardiac cycles defined as period between end diastoles” (claim 14), “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), “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), and “a transducer array; an analog front end for processing analog signals received from the transducer array; and an analog-to-digital converter (ADC) for generating digital signals from the analog signals, wherein the digital processor obtains the pABP waveform and the ABF waveform as the digital signals from the ADC converter” (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 a biomedical device” (claim 11) 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, the claims are rejected as being directed to non-statutory subjection matter. Claims 1-9 and 11-21 are rejected.
Allowable Subject Matter
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 page 6, filed 01/09/2026, with respect to the 35 U.S.C. §112(b) rejection have been fully considered and are persuasive. Applicant has amended claims 7 and 18 to recite mean pulsatile arterial pressure. The rejection of the claims has been withdrawn.
Applicant's arguments filed 01/09/2026, with respect to the 35 U.S.C. §101 rejection have been fully considered but they are not persuasive.
Applicant asserts that the claims amount to significantly more than the abstract idea because the abstract idea improves the technical field of biomedical devices and non-invasive and non-obtrusive estimate of mean arterial pressure and absolute arterial blood pressure. Examiner respectfully disagrees.
Applicant’s argument fails to point to additional elements that would implement that abstract idea into a practical application. Rather, Applicant’s argument merely states that the abstract idea itself is integrated into a practical application.
Claims 1 and 12 are directed towards a judicial exception (i.e., the abstract ideas identified above). The collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process of mean arterial pressure and absolute arterial blood pressure estimation. The claims do not recite additional elements that are sufficient enough to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. The absolute ABP or MAP estimations are not implemented in a type of diagnosis, applied to a particular machine that is arranged in a particular way to improve said machine, or adds specific limitations other than what is well-understood, routine, and conventional. The rejection above has been updated to reflect the amendments made to the claims.
Applicant’s arguments, see page 8, filed 01/09/2026, with respect to the 35 U.S.C. §103 rejections have been fully considered and are persuasive. The rejection has been withdrawn. Examiner notes that claim 10 was inadvertently left out of the indication of allowable subject matter in the Office Action filed 09/17/2025 and the explanation can be seen above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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