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 .
Response to Amendment
The amendments filed July 17th, 2025 have been entered. Claims 26, 29-46 are pending in the application.
Response to Arguments
Applicant's arguments filed July 17th, 2025 have been fully considered but they are not persuasive. The Applicant’s arguments regarding 35 U.S.C. § 101:
Applicant states that the amended claims cannot be performed by a person collecting data and conducting mathematical calculations and are more than mere mathematical concepts. The Applicant is directed to the 101 rejection below, necessitated by amendment where the abstract ideas and additional elements are defined through underlining and bold text respectively. The claims recite ‘receiving data’ and describe ‘calculating’ using data which are grouped as a mental process, the additional elements of the ’sensor’, ‘signal processing apparatus’, and the ‘display’ are not part of the abstract idea, they are additional elements that are generically recited within the claims. The abstract ideas underlined in the 101 rejection fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind including observation, evaluation, judgement, opinion, and mathematical concepts. See MPEP 2106.04 (a)(2), subsection III.
Specifically, Claim 26, as shown in the 101 rejection below, recites receiving arterial blood waveform pressure data, detecting a plurality of continuous series of pulses from the data, calculating a baseline nominal cardiac output for a first pulse using data from both the first pulse and a second pulse within the detected series of pulses, wherein the first pulse is consecutive to the second pulse, calculating at least one value of nominal cardiac output for each of a plurality of pulses within a time period, determining a time-averaged mean of each of the plurality of values of nominal cardiac output, calculating relative change of the respective time-averaged mean value of nominal cardiac output based on the difference between the respective time-averaged mean value of nominal cardiac output and the baseline value of nominal cardiac output, and displaying calculated relative change of the respective time-averaged mean nominal cardiac output values. All of which encompass receiving data, making determinations from the data, making calculations using received data, evaluating the determinations and calculations made from the data, and outputting the results.
Applicant further argues that the claims ‘are directed to a practical implementation of the mathematical concepts beyond use the mathematical concepts on a computer or mental processes completed by a person.’, further reciting ‘…the collected blood pressure waveform data is transformed multiple times into both a recent baseline of nominal cardiac output and moving values of nominal cardiac output, that are then averaged and displayed as a relative change of the time averaged man nominal cardiac output values over period of time of the continuous monitoring into a format that is a better condition for human consumption.’.
It is important to note that according to 2106.05(a), 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.
Regarding the Applicant’s argument that Claim 26 and 44 contain a transformation of collected data to additional information “This is a textbook example of a transformation of collected data to additional different information, which is more than simply output for review. In other words, the collected blood pressure waveform data is transformed multiple times into both a recent baseline of nominal cardiac output and moving values of nominal cardiac output, that are then averaged and displayed as a relative change of the time averaged man nominal cardiac output values over period of time of the continuous monitoring into a format that is a better condition for human consumption. Without the transformation, only arterial blood pressure data could be output. ”.
The argued transformation is recited as ‘determining a time-averaged mean of each of the plurality of values of nominal cardiac output for the plurality of pulses within the sequence of n pulses; and for each of the time-averaged mean values of nominal cardiac output, calculating the relative change of the respective time-averaged mean value of nominal cardiac output based on the difference between the respective time-averaged mean value of nominal cardiac output and the baseline value of nominal cardiac output; before continuously displaying said calculated relative change of the respective time-averaged mean nominal cardiac output values.’. According to the MPEP, this is not a real transformation, it is data that is merely analyzed at a high level of generality. The calculating and determination steps are not specific, and calculating/analyzing data is not considered a transformation.
Consider the following from MPEP 2106.05(c ):
Where a transformation is recited in a claim, the following factors are relevant to the analysis:
1. The particularity or generality of the transformation. According to the Supreme Court, inventions comprising processes of “‘tanning, dyeing, making waterproof cloth, vulcanizing India rubber [or] smelting ores’ . . . are instances . . . where the use of chemical substances or physical acts, such as temperature control, changes articles or materials [in such a manner that is] sufficiently definite to confine the patent monopoly within rather definite bounds.” Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, 676 (1972) (discussing Corning v. Burden, 15 How. (56 U.S.) 252, 267-68 (1854)). Therefore, a more particular transformation would likely provide significantly more.
2. The degree to which the recited article is particular. A transformation applied to a generically recited article or to any and all articles would likely not provide significantly more than the judicial exception. A transformation that can be specifically identified, or that applies to only particular articles, is more likely to provide significantly more (or integrates a judicial exception into a practical application).
3. The nature of the transformation in terms of the type or extent of change in state or thing. A transformation resulting in the transformed article having a different function or use, would likely provide significantly more, but a transformation resulting in the transformed article merely having a different location, would likely not provide significantly more (or integrate a judicial exception into a practical application). For example, a process that transforms raw, uncured synthetic rubber into precision-molded synthetic rubber products, as discussed in Diamond v. Diehr, 450 U.S. 175, 184, 209 USPQ 1, 21 (1981)), provides significantly more (or integrate a judicial exception into a practical application).
4. The nature of the article transformed. Transformation of a physical or tangible object or substance is more likely to provide significantly more (or integrate a judicial exception into a practical application) than the transformation of an intangible concept such as a contractual obligation or mental judgment.
5. Whether the transformation is extra-solution activity or a field-of-use (i.e., the extent to which (or how) the transformation imposes meaningful limits on the execution of the claimed method steps). A transformation that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more (or integrate a judicial exception into a practical application). For example, in Mayo the Supreme Court found claims regarding calibrating the proper dosage of thiopurine drugs to be patent ineligible subject matter. The Federal Circuit had held that the step of administering the thiopurine drug demonstrated a transformation of the human body and blood. Mayo, 566 U.S. at 76, 101 USPQ2d at 1967. The Supreme Court disagreed, finding that this step was only a field-of-use limitation and did not provide significantly more than the judicial exception. Id. See MPEP § 2106.05(g) & (h) for more information on insignificant extra-solution activity and field of use, respectively.
Therefore, the claimed limitations that the applicant argues to be a transformation, are not a transformation, but are merely data gathering and analysis at a high level of generality. There is no transformation that is specified in the claim, and one of ordinary skill would not perceive a transformation of data in light of the MPEP’s guidance with regard to the Applicant’s arguments of a transformation of data within the limitations of Claims 26 & 44.
The evaluation of whether the claim as a whole integrates the recited judicial exception into a practical application of the exception or whether the claim is ‘directed to’ the judicial exception is performed by identifying additional elements recited in the claim beyond the judicial exception and evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See MPEP 2106.04(d). The claim recites the additional elements of a sensor, a processor, and a display. The claim recites that the processor (a computer) executes the limitations using the other additional elements listed.
Further, the limitations are executed on a processor (a computer) and utilize a sensor and a display. The processor, sensor, and display are recited at a high level of generality. The processor, sensor, and display are used to perform an abstract idea, such that it amounts to no more than mere instructions to apply the exception using a generic computer. See MPEP 2106.05(f). There is no indication that the claim as a whole includes an improvement to a computer or to a technological field, as a technical explanation of the asserted improvement presented in the specification is not reflected in the claims. See MPEP 2106.04(d)(1). According to the specification, existing systems for cardiac output monitoring include pulse contour and bio-impedance methods, and generally focusing on maintaining or optimizing flow (cardiac output), rather than blood pressure, suggesting the need for new technology and practice methods to further prevent hypotension. The disclosed system allegedly is to enable an anesthetist, or other medical professional to make faster and more accurate assessment and treatment decisions regarding cardiovascular management. The claimed invention fails to reflect this improvement in the technical field of posture detection. Thus, the claim as a whole does not integrate the judicial exception into a practical application such that the claim is not directed to the judicial exception. The additional elements, when considered in combination, do not integrate the abstract idea into a practical application because the claim does not improve the functioning of a computer or technical field.
Applicant further argues that the claims recite meaningful unconventional elements that amount to significantly more than the alleged abstract idea, stating that it includes additional elements that are sufficient to ensure the claims amount to significantly more than an abstract idea, the Applicant then recites the abstract ideas noted in the 101 rejection below as the basis for their argument. Examiner reiterates that the claims merely state that the data is received by the sensor continuously, and that the processor is configured to make determinations, and calculations as recited in the claims. There is no specific technique or detail within the claim.
Applicants arguments are not persuasive.
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 26 & 29-46 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.
Each of Claims 26 & 29-46 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 26 & 29-46 recites at least one step or instruction for receiving data, processing data, calculate parameters based on data received, and determining parameter values, which are grouped as a mental process under the 2019 PEG or a mathematical concept or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 26 & 29-46 recites an abstract idea.
Specifically,
Claim 26: A system for determining relative changes in at least one parameter (Judgement) of cardiovascular function, the system comprising:
a sensor configured to continuously monitor arterial blood pressure;
a signal processing apparatus, coupled to said sensor and configured to: continuously receive arterial blood waveform pressure data (Observation) from said sensor;
detect a plurality of continuous series of pulses from the arterial blood pressure waveform data (Observation), and for each series of pulses:
calculate at least one baseline value of nominal cardiac output for a first pulse using data from both the first pulse and a second pulse within the detected series of pulses (Mathematical Concept/Evaluation/Opinion), wherein the first pulse is consecutive to the second pulse;
calculate at least one value of nominal cardiac output for each of a plurality of pulses within a time period comprising a sequence of n pulses in the arterial blood pressure waveform data (Mathematical Concept/Evaluation/Opinion),
wherein there is an interval of fixed duration between the first pulse of the detected series of pulses and the start of the sequence of n pulses;
determine a time-averaged mean of each of the plurality of values of nominal cardiac output for the plurality of pulses within the sequence of n pulses (Judgement/Evaluation);
for each of the time-averaged mean values of nominal cardiac output, calculate the relative change of the respective time-averaged mean value of nominal cardiac output based on the difference between the respective time-averaged mean value of nominal cardiac output and the baseline value of nominal cardiac output (Mathematical Concept/Evaluation/Opinion); and
a display having a user interface configured to continuously display said calculated relative change of the respective time-averaged mean nominal cardiac output values (Evaluation/Opinion).
Claim 44: A computer-implemented method of determining relative changes in at least one parameter of cardiovascular function (Judgement), the method comprising:
continuously monitoring arterial blood pressure using a sensor;
continuously receiving arterial blood pressure waveform data (Observation) from the sensor;
detecting a plurality of continuous series of pulses from the arterial blood pressure waveform data (Observation) and
for each series of pulses: calculating at least one baseline value of nominal cardiac output for a first pulse using data from both a first pulse and a second pulse within the detected series of pulses (Mathematical Concept/Evaluation/Opinion),
wherein the first pulse is consecutive to the second pulse;
calculating at least one value of nominal cardiac output for each of a plurality of pulses within a time period comprising a sequence of n pulses in the arterial blood pressure waveform data (Mathematical Concept/Evaluation/Opinion),
wherein there is an interval of fixed duration between the first pulse of the detected series of pulses and the start of the sequence of n pulses;
determining a time-averaged mean of each of the plurality of values of nominal cardiac output for the plurality of pulses with the sequence of n pulses (Judgement/Evaluation); and
for each of the time time-averaged mean values of nominal cardiac output, calculating the relative change of the respective time-averaged mean value of nominal cardiac output based on the difference between the respective time-averaged mean value of nominal cardiac output and the baseline value of nominal cardiac output (Mathematical Concept/Evaluation/Opinion).
Claim 45: A method of preventing or treating hypotension, comprising: determining the relative changes in at least one parameter of cardiovascular function (Judgement) according to claim 44 (See Claim 44); and
administering a treatment in response to said relative changes in at least one parameter of cardiovascular function (Examiner’s Note: administering a treatment in response to relative changes in at least one parameter of cardiovascular function is recited generically, and is not a particular treatment. Thus, under the broadest reasonable interpretation, the limitation could constitute a prescription which individually or in combination with the other elements would not provide significantly more. See MPEP 2106.05.
Regarding the dependent claims, the following dependent claims are directed to steps that are also abstract or mathematical concepts.
Claims 29-43 include steps that are also abstract as a mental process through additional data gathering or analysis
Claims 29-33, 39 and 43 include steps that are also abstract as a mental process through mathematical concepts
Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 26, 44 and 45 (and their respective dependent Claims 29-43 and 46) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 26, 44 and 45), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: a system , a signal processing apparatus, a sensor, continuously monitoring arterial blood pressure using a sensor, a display, a user interface, and a memory as recited in independent Claims 26, 44 and 45 and their dependent claims are generically recited computer elements in independent Claims 26, 44 and 45 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 26, 44 and 45 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., signal processing apparatus as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 26 and 44 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 26, 44, and 45 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 26, & 29-46 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of a system, a signal processing apparatus, a sensor, continuously monitoring arterial blood pressure using a sensor, a display, a user interface, and a memory, etc. as recited in independent Claims 26, 44, and 45 and their dependent Claims.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, a system (Pg. 12, lines 28-32), a signal processing apparatus (Pg. 12, line 29-30; Pg. 13, lines 1-5), a sensor (Pg. 12, lines 34-35), a display (Pg. 12, lines 30-32), a user interface (Pg. 15, line 33-Pg. 16, line 16), and a memory (Pg. 9, lines 17-18). Accordingly, in light of Applicant’s specification, the claimed term “signal processing apparatus” are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the signal processing apparatus. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
Regarding the dependent claims, the dependent claims are directed to further recite additional elements at a high level of generality which are conventional in the art.
Claims 29, 31, 33-43 & 46 recite additional elements at a high level of generality which are conventional in the art
The recitation of the above-identified additional limitations in Claims 26 & 29-46 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. 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. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the system and method of Claims 26-46 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 26 & 29-46 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 26, 44, and 45 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 26 & 29-46 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 26 & 29-46 amounts to significantly more than the abstract idea itself. Accordingly, Claims 26 & 29-46 are not patent eligible and rejected under 35 U.S.C. 101.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 7651466 B2 to Hatib et al. (hereinafter, Hatib); US 20200008686 A1 to Khair;
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.
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791