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 .
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea.
STEP 1
Each of the claims recites steps or instructions for ascertaining and processing data to measure a blood pressure of a mammal subject, which is grouped as a mental process. Accordingly, each of the claims recites an abstract idea.
Independent claim 1 recites limitations comprising:
receiving, by a hemodynamic monitor, sensed hemodynamic data representative of an arterial pressure waveform of the patient (additional element);
invoking, by the hemodynamic monitor, a sensory alarm to produce a sensory signal in response to the risk score satisfying a predetermined risk criterion (additional element); and
determining, by the hemodynamic monitor in real time based on the waveform analysis of the adjusted hemodynamic data, a risk score representing a probability of a future hypotension event for the patient ( mental process).
Independent claim 11 recites limitations comprising:
a hemodynamic sensor that produces hemodynamic data representative of an arterial pressure waveform of the patient (additional element, data-gathering);
a system memory that stores hypotension prediction software code including a predictive weighting module (additional element);
a user interface that includes a sensory alarm that provides a sensory signal to warn the medical personnel of the predicted future hypotension event prior to the patient entering a hypotensive state (additional element);
a hardware processor that is configured to execute the hypotension prediction software code (additional element);
determine, in real-time, using the predictive weighting module and based on the waveform analysis of the adjusted hemodynamic data, a risk score representing a probability of a future hypotension event for the patient ( mental process);
invoke the sensory alarm of the user interface in response to the risk score satisfying a predetermined risk criterion (additional element).
As indicated above, each independent claim recites at least one step or instruction grouped as a mental process. Therefore, each of the independent claims recites an abstract idea. Each limitation, aside from language reciting a generic computer components, can be grouped as a mental process (see italicized portions above), and is addressed as follows:
The limitations directed to determining a risk score representing a probability of a future hypotension event for the patient.
No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
The dependent claims merely include limitations that either further define the abstract idea (e.g. limitations relating to the data gathered or particular steps which are entirely embodied in the mental process) and amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data (Int. Ventures v. Cap One Financial), collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group), collection, storage, and recognition of data (Smart Systems Innovations).
Step 2A, Prong 2
The above-identified abstract idea is not integrated into a practical application because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use and/or serve to carry out insignificant extra-solution activity.
More specifically:
Independent claim 1 recites the additional element of hemodynamic monitor and a sensory alarm. Independent claim 11 recites the additional element of hemodynamic sensor, system memory, user interface, processor and a sensory alarm.
Such additional elements are generically recited elements which do not improve the functioning of a computer or any other technology or technical field. The claim recites merely acquiring data from generically recited sensors, having no operative connection to the processor besides data analysis and communication of obtained data/information, which amounts to insignificant, extra-solution activity in the form of mere data-gathering, which does not constitute an integration into a practical application. Although the sensors may imply particular structure, their use in the mental process is merely extra-solution. See MPEP 2106.05(b).III:
“Use of a machine 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 integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted)”
The processor is recited at a high-level of generality (i.e., as a generic processor performing a generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component.
Thus, such additional elements do not 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 generically recited elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer or perform solely data-gathering functions. For at least these reasons, the abstract idea is not integrated into a practical application.
Moreover, the above-identified abstract idea is not integrated into a practical application under because the system of claim 1 merely implements the above-identified abstract idea using rules (e.g., computer instructions) executed by a computer (e.g., processor 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 ideas identified above in the independent claims (and their respective dependent claims) are not integrated into a practical application.
Accordingly, the claims are each directed to an abstract idea.
Step 2B
None of the claims include additional elements that, when viewed as a whole, are sufficient to amount to significantly more than the abstract idea for at least the following reasons:
Independent claim 1 recites the additional element of hemodynamic monitor and a sensory alarm. Independent claim 11 recites the additional element of hemodynamic sensor, system memory, user interface, processor and a sensory alarm.
As per paragraph [0006] of Applicant’s specification: “Conventional patient monitoring for hypotension in the OR and ICU settings can include continuous or periodic blood pressure measurement.” Thus, Applicant’s disclosure makes apparent that the additional elements of hemodynamic sensor, system memory, user interface, processor and a sensory alarm are well-understood, routine, and conventional sensors. Simply appending well-understood, routine, and conventional sensors to act as data-gathering elements to the system recited in claim 1 or claim 11 do not allow the judicial exception recited therein to qualify as “significantly more.”
As per paragraph [0037] of Applicant’s specification, a processor is not described with particular structure other than generalized description of its functions, e.g., executing software embodied in a memory unit, receiving and communicating data, etc. Applicant’s specification does not describe any special programming or algorithms required for the processor for carrying out the processes recited, e.g., receiving data, performing a determination thereon. 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. 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 machine learning arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes such an additional element in a manner that indicates that the additional element is 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). Accordingly, in light of Applicant’s specification, a processor is 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 and merely utilize already available computers with their already available basic functions to use as tools in executing the claimed process.
Each dependent claim merely recites steps which further define the abstract idea and data/data-processing steps. Examiner notes that the dependent claims recite limitations which are extra-solution or part of the abstract idea itself do not constitute significantly more. See MPEP 2106.05(a):
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 recitation of the above-identified additional limitations in the claims amount 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 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.
For at least the above reasons, the claims are directed to applying an abstract idea 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. In other words, none of the claims provide 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 the independent claims do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment (processing of sensor data). 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. As such, the above-identified additional elements, when viewed as whole, 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, the claims merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself, or (ii) provide a technical solution to a problem in a technical field.
Therefore, none of the claims amounts to significantly more than the abstract idea itself.
Accordingly, the claims are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.
Examiner’s Note
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jang teaches the blood pressure estimating apparatus may obtain the second pulse wave signal by adjusting an offset of the pulse wave signal that is normalized so that a value of a predetermined reference point, e.g., a point of MAP, becomes 0. US 20200221960
Baronov teaches a risk-based patient monitoring system for critical care patients combines data from multiple sources to assess the current and the future risks to the patient, thereby enabling providers to review a current patient risk profile and to continuously track a clinical trajectory. US 20130231949
Addison teaches rSO.sub.2 as a function of MAP before and after applying a gradient adjustment. US 20180338731
Bjorling teaches data processing device 300 can further be used to transmit compensation factors that can be used by the IMD 100 to calculate absolute pressures, such as absolute mean arterial pressure (MAP) and/or pulse pressure (PP) from the value representative of systemic blood pressure. US 20110313302
The prior art of record fails to teach or suggest: in combination with the base claim, the details of offsetting the received signal based on the standard and adjusted MAP thresholds. The offset data then used to determine the risk score.
However, due to the rejections above, allowable subject matter cannot be identified.
Response to Arguments
Applicant's arguments filed 04/02/2026 have been fully considered but they are not fully persuasive.
Applicant contends that the “real-time” determination cannot be practically performed by a human using pen and paper or in their mind, on page 10 of the Remarks. Examiner disagrees. Examiner concedes that there are instances in which real-time computation is not feasible, e.g., large datasets, types of processing, etc. However, in this case, the computation is simple, requires only data of one physiological parameter, the offsetting is merely based on a difference of predetermined threshold values, and the calculated risk does not require a complex model.
Applicant contends that the additional elements integrate the abstract idea into a practical application, on page 11 of the Remarks. Examiner disagrees. It appears Applicant relies on the output to a medical personal as the practical application, however, this is merely carrying out insignificant extra solution activity. A practical application can be to provide or manage via therapy a condition or disease or the like based on the risk score.
Applicant’s arguments related to U.S.C. 103 are found persuasive. The rejection has been withdrawn.
Conclusion
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 MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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