DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-39 are pending.
This action is Final.
Claim Objections
Claim 27 is objected to because of the following informalities: claim 27 “outputting the derived hemodynamic parameters” should read “ outputting the one or more derived hemodynamic parameters”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-39 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
Claim 1:
segregates the received hemodynamic sensor signal into a plurality of heartbeat portions, each heartbeat portion representative of the ABP of the patient for one of a plurality of individual heartbeats of the patient;
determines, for each of the plurality of heartbeat portions, a set of coefficients representative of frequency components of the respective heartbeat portion to produce a plurality of sets of coefficients, each set of coefficients comprising a same number of coefficients; and
normalizes each set of coefficients to produce a plurality of sets of normalized coefficients;
determines a set of reference coefficients based on the plurality of sets of normalized coefficients; and
provides a quality indicator in real-time associated with an individual heartbeat based on a comparison of a set of normalized coefficients for the individual heartbeat to the set of reference coefficients; and
uses the quality indicator to produce a modified hemodynamic sensor signal;
derives one or more hemodynamic parameters from the modified hemodynamic sensor signal
which are collective features of an algorithm containing features individually that can be performed by mental processes, including pen and paper, and/or the algorithm forms a mathematical concept in data processing to generate parameters.
Claim 14:
segregate the received hemodynamic sensor signal into a plurality of heartbeat portions, each heartbeat portion representative of the ABP of the patient for one of a plurality of individual heartbeats of the patient;
determine, for each of the plurality of heartbeat portions, a set of coefficients representative of frequency components of the respective heartbeat portion to produce a plurality of sets of coefficients, each set of coefficients comprising a same number of coefficients;
normalize each set of coefficients to produce a plurality of sets of normalized coefficients;
determine a set of reference coefficients based on the plurality of sets of normalized coefficients;
compare a set of normalized coefficients for an individual heartbeat to the set of reference coefficients;
determine, in real-time and based on the comparing, a quality indicator associated with the individual heartbeat;
use the quality indicator to produce a modified hemodynamic sensor signal;
derive one or more hemodynamic parameters from the modified hemodynamic sensor signal;
which are collective features of an algorithm containing features individually that can be performed by mental processes, including pen and paper, and/or the algorithm forms a mathematical concept in data processing to generate parameters.
Claim 27:
segregating the sampled hemodynamic sensor signal into a plurality of heartbeat portions, each heartbeat portion representative of the ABP of the patient for one of a plurality of individual heartbeats of the patient;
determining, for each of the plurality of heartbeat portions, a set of coefficients representative of frequency components of the respective heartbeat portion to produce a plurality of sets of coefficients, each set of coefficients comprising a same number of coefficients;
normalizing each set of coefficients to produce a plurality of sets of normalized coefficients;
determining a set of reference coefficients based on the plurality of sets of normalized coefficients;
comparing a set of normalized coefficients for an individual heartbeat to the set of reference coefficients;
determining, in real-time and based on the comparing, a quality indicator associated with the individual heartbeat;
using the quality indicator to produce a modified hemodynamic sensor signal;
deriving one or more hemodynamic parameters from the modified hemodynamic sensor signal;
which are collective features of an algorithm containing features individually that can be performed by mental processes, including pen and paper, and/or the algorithm forms a mathematical concept in data processing to generate parameters.
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
Claim 1:
a sensor interface that receives a hemodynamic sensor signal from a hemodynamic sensor, the hemodynamic sensor signal representative of arterial blood pressure (ABP) of a patient (insignificant limitations related to data gathering; extra solution)
a beat detection module, a model parameter module, a heartbeat classification module, and a hemodynamic processing module (modules interpreted as processor hardware with firmware such as using it as a tool to implement judicial exceptions)
outputs the one or more derived hemodynamic parameters (insignificant limitations related to post solution activities of outputting data)
Claim 14:
a hemodynamic sensor configured to sense arterial blood pressure (ABP) of a patient (insignificant limitations related to data gathering; extra solution)
a hemodynamic monitor connected to the hemodynamic sensor (computer structures used as a tool to implement the exception(s)), the hemodynamic monitor comprising:
a sensor interface configured to receive, from the hemodynamic sensor, a hemodynamic sensor signal representative of the ABP of the patient sensed by the hemodynamic sensor (insignificant limitations related to data gathering; extra solution);
one or more processors sensor (computer structures used as a tool to implement the exception(s)); and
non-transitory computer-readable memory encoded with instructions that, when executed by the one or more processors, cause the hemodynamic monitor to sensor (computer structures used as a tool to implement the exception(s)):
output the one or more derived hemodynamic parameters (insignificant limitations related to post solution activities of outputting data)
Claim 27:
producing, using a hemodynamic sensor, an analog hemodynamic sensor signal representative of arterial blood pressure (ABP) of a patient (insignificant limitations related to data gathering; extra solution)
sampling the analog hemodynamic sensor signal at a defined sampling rate to produce a sampled hemodynamic sensor signal representative of the ABP of the patient (insignificant limitations related to data gathering; extra solution)
outputting the derived hemodynamic parameters (insignificant limitations related to post solution activities of outputting data)
These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination, they do not add significantly more to the exception. Analyzing the additional claim limitations individually, the additional limitation that is not directed to the abstract idea are the same as those identified above in step 2A. Such limitations related to the sensors are recognized by the courts as routine data gathering in order to input data to the mathematical algorithm, and thus, do not add a meaningful limitation to the method as it would be routinely used by those of ordinary skill in the art in order to apply the mathematical algorithm. In addition, these sensor structures are generic off the shelf sensors and examples include from US 20180214033. The method does not contain any computing structure, such that the steps can all be analog/mental processing of the equation from the data gathered which further supports that the claims are directed to a judicial exception without significantly more. The computer structures cited above are claimed as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The additional limitations recited in the dependent claims are directed to further limitations of the judicial exception (A more specific abstraction is still an abstraction). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations.
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims filed 10/27/2025; and Rule 130 affidavit filed 10/27/2025 and signed by applicant on 10/24/2025.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 101 have been fully considered and are partially persuasive. The prior rejections of claim 14 are withdrawn, but the amendments move claim 14 rejections to mirror those made prior for claims 1 and 27. As such, the amendments have necessitated the new grounds of rejection and the rejections are updated to account for the amendments to the claims.
Applicant’s arguments are that the amendment adding in “real-time” for when processing occurs in the determining a quality indicator remove the exception(s) from being mental process(es). The examiner respectfully disagrees. The addition of real-time merely puts a directive to complete a process at the time the particular data is present of an individual heartbeat and does not preclude a person from making such determination, which still falls under a mental process for the steps being completed, even if such steps are claimed as being completed by a computer. The examiner is not persuaded that the limitations listed as exceptions are not individually and/or collectively mental processes based on the amended features. In addition, Electric Power Group is an example of a mental process involving real-time computer processes as stated in MPEP 2106:
“Examples of product claims reciting mental processes include:
• A wide-area real-time performance monitoring system for monitoring and assessing dynamic stability of an electric power grid – Electric Power Group, 830 F.3d at 1351 and n.1, 119 USPQ2d at 1740 and n.1;
Applicant further argues that the claims do not recite mathematical concepts such as mathematical relationships, formulas, equations, or calculations. The examiner respectfully disagrees. While the choice of claim terms indeed do not use “calculate” expressly, the series of steps claimed and identified in the rejection are algorithmic steps of mathematical concepts to form different data/variables (i.e. taking data in one form, processing data according to algorithmic mathematical rules to form data in other forms) through a series of processes, which certainly are mathematical concepts recited in the claims in view of the disclosure as filed. The MPEP 2106 provides guidance:
“A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the “mathematical concepts” grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word “calculating” in order to be considered a mathematical calculation. For example, a step of “determining” a variable or number using mathematical methods or “performing” a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.”
Applicant further argues that the claims as a whole include additional elements that integrate the exceptions into a practical application containing improvements in the field of hemodynamic monitoring, and the improvement is to the quality indicator, and cites to paragraph 30. The examiner is not persuaded based on the form of the claims and the arguments presently made for the form of the independent claims. First, the passage highlighted in paragraph 30 appears to be conclusory that analysis in the frequency domain, as opposed to the time domain, is less computational complex and more consistent, as this appears to be mere opinion considering the time domain data must be converted to frequency domain prior to further analysis, which in itself is computationally more complex yields little to persuade. As the disclosure does not discuss false determinations in time and frequency, a determination of consistency improvement cannot be ascertained; the remarks are given less weight in forming such improvement in consistency. The second issue is that what additional elements outside the exception, considered as a whole, form the improvement? As claimed, the additional limitations are to the data gathering, processor structures, and output of data (data leaves the black box). It is unclear which element or combination of elements allows for practical realization of an alleged improvement, which is argued and found to be within the exception itself.
MPEP 2106 “If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art. For example, in McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea. McRO, 837 F.3d at 1313-14, 120 USPQ2d at 1100-01. In contrast, the court in Affinity Labs of Tex. v. DirecTV, LLC relied on the specification’s failure to provide details regarding the manner in which the invention accomplished the alleged improvement when holding the claimed methods of delivering broadcast content to cellphones ineligible. 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016).
After the examiner has consulted the specification and determined that the disclosed invention improves technology, the claim must be evaluated to ensure the claim itself reflects the disclosed improvement in technology. Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (Fed. Cir. 2016) (patent owner argued that the claimed email filtering system improved technology by shrinking the protection gap and mooting the volume problem, but the court disagreed because the claims themselves did not have any limitations that addressed these issues). That is, the claim must include the components or steps of the invention that provide the improvement described in the specification. However, the claim itself does not need to explicitly recite the improvement described in the specification (e.g., “thereby increasing the bandwidth of the channel”). The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification). In making this determination, it is critical that examiners look at the claim “as a whole,” in other words, the claim should be evaluated “as an ordered combination, without ignoring the requirements of the individual steps.” When performing this evaluation, examiners should be “careful to avoid oversimplifying the claims” by looking at them generally and failing to account for the specific requirements of the claims. McRO, 837 F.3d at 1313, 120 USPQ2d at 1100.
An important consideration in determining whether a claim improves technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102-03; DDR Holdings, 773 F.3d at 1259, 113 USPQ2d at 1107. In this respect, the improvement consideration overlaps with other considerations, specifically the particular machine consideration (see MPEP § 2106.05(b)), and the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)). Thus, evaluation of those other considerations may assist examiners in making a determination of whether a claim satisfies the improvement consideration.
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.”
“The courts have also identified limitations that did not integrate a judicial exception into a practical application:
Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);”
Applicant concludes that the features of the claim (presumed those from paragraph 30) increase the accuracy and reliability of hemodynamic parameters derived from sensed ABP waveforms of a patient. However, this is not found to be persuasive for the same reasons previously discussed in relations to paragraph 30 and the form of the limitations in the independent claims (Is this statement actually in reference to the features of claim 1? or features of 13, not in the independent claims?).
For these reasons, the rejections are respectfully maintained as updated above to account for the amendments to the claims.
Applicant’s arguments regarding the rejections of the claims in view of prior art have been fully considered and are persuasive due to the sworn statements made and invoking exception b(1)(a); the rejections are withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20180214033 teaches related subject matter.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791