DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/16/2026 has been entered.
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, 3-12, 14, 16-25, 27, 29-38 are pending.
This action is Non-Final.
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, 3-12, 14, 16-25, 27, 29-38 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, wherein the quality indicator classifies the individual heartbeat as either qualified for use in downstream processing or unqualified for use in the downstream processing; and
uses the quality indicator to produce a modified hemodynamic sensor signal by: producing the modified hemodynamic sensor signal to include the individual heartbeat in the modified hemodynamic sensor signal in response to determining that the quality indicator classifies the individual heartbeat as qualified for use in the downstream processing; and producing the modified hemodynamic sensor signal to not include the individual heartbeat in the modified hemodynamic sensor signal in response to determining that the quality indicator classifies the individual heartbeat as unqualified for use in the downstream processing;
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, wherein the quality indicator classifies the individual heartbeat as either qualified for use in downstream processing or unqualified for use in the downstream processing;
use the quality indicator to produce a modified hemodynamic sensor signal by: producing the modified hemodynamic sensor signal to include the individual heartbeat in the modified hemodynamic sensor signal in response to determining that the quality indicator classifies the individual heartbeat as qualified for use in the downstream processing; and producing the modified hemodynamic sensor signal to not include the individual heartbeat in the modified hemodynamic sensor signal in response to determining that the quality indicator classifies the individual heartbeat as unqualified for use in the downstream processing;
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, wherein the quality indicator classifies the individual heartbeat as either qualified for use in downstream processing or unqualified for use in the downstream processing;
using the quality indicator to produce a modified hemodynamic sensor signal by: producing the modified hemodynamic sensor signal to include the individual heartbeat in the modified hemodynamic sensor signal in response to determining that the quality indicator classifies the individual heartbeat as qualified for use in the downstream processing; and producing the modified hemodynamic sensor signal to not include the individual heartbeat in the modified hemodynamic sensor signal in response to determining that the quality indicator classifies the individual heartbeat as unqualified for use in the downstream processing;
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 from processor structures)
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 from processor structures)
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 one or more derived hemodynamic parameters (insignificant limitations related to post solution activities of outputting data from processor structures)
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 the amendments to the claims filed 1/16/2026; and IDS filed 2/17/2026.
Applicant’s arguments regarding the claim objections have been fully considered and are persuasive due to the amendments to the claims; the objections are withdrawn.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 101 have been fully considered but are not persuasive.
The crux to applicant’s updated position is that the claims are eligible under prong two for improvement to technology based on the amended features into the claims, however, the position with form of the claims is not sufficient to persuade that the rejection is in error for the form of claims presented. The updated amendments form part of the basis for a rationale of improvement, but these features are placed into or recite further exceptions or details of the exceptions. Prong two looks at the additional elements, outside the exception, to determine whether an improvement exists in the claims as a whole. In this case, the argued improvement lies within the exception itself as the additional features are insignificant pre and post solution activities; the additional limitations are to the data gathering, processor structures, and output of data (data input, data output from a computer black box). It is unclear which element or combination of elements allows for a practical realization of the argued improvement, which is argued and found to be within the exception itself. How is the argued improvement (exception itself) to monitoring hemodynamic technology practically realized by mere output of data (signal) under a BRI? While diagnostics can be a naturally gray area, the claims, as presented, do not move the claims to be more likely than not patent eligible. Perhaps there is additional structures that could be added to the claims that is not merely outputting a signal to be made along with how such allows for the improvement to be practicably realized to practice the improvement to technology (along with arguments of such features as a whole). The examiner is available for discussion if desired. For these reasons, the rejections are respectfully maintained as updated above to account for the amendments to the claims.
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);”
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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