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 amendment filed December 23, 2025 has been entered. Claims 1, 3-15, 20-21, 23-24, 26-28, and 31 are pending. Claims 2, 16-19, 22, 25, 29, and 30 are cancelled. Claims 20, 21, and 24 are withdrawn.
Applicant’s amendments are sufficient to obviate claim objections previously presented.
Applicant’s amendments are sufficient to overcome the rejections under 35 U.S.C. 112(b) previously presented.
Applicant’s amendments and argument are insufficient to overcome rejection of the claims under 35 U.S.C. 101.
Applicant’s amendments and argument are sufficient to overcome rejection of the claims under 35 U.S.C. 102 and 103.
Response to Arguments
Applicant's arguments filed April 24, 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument:
“The claims of the present Application necessarily incorporate a pressure cuff and a pressure sensor in the pressure cuff for measuring tissue pressure of the subject, which cannot be practically performed in the human mind. It follows that the steps reliant on the pressure signals derived from the pressure sensor cannot be practically performed in the human mind.”
The additional element of a pressure cuff and pressure sensor are identified as additional elements which solely perform data gathering for the abstract idea.
Regarding Applicant’s argument:
“Also, as in SiRF Technology, Inc. v. International Trade Commission, 601 F.3d 1319, 94 USPQ2d 1607 (Fed. Cir. 2010), the claims herein are therefore tied to a particular machine - a non-invasive blood pressure measuring device including a pressure cuff and a pressure sensor. In SiRF Technology, Inc., the Federal Circuit held inter alia that the claims did not recite mental processes because they were "tied to a particular machine." The Federal Circuit found that a GPS receiver is a machine and is "integral to" the claimed method, and that the method "could not be performed without the use of a GPS receiver." See SiRF Technology, 601 F.3d at 1332 (citations omitted) (emphasis added).”
The GPS receivers of SiRF Tech were identified as integral to the claims due to a calculation step involving pseudo-ranges between a particular GPS receiver and a plurality of GPS satellites, as well as the formation of a dynamic model to compute the position of the particular satellite signal receiver. The combination of these limitations make it clear that merely acquiring information from a generalized GPS receiver as a data-gathering tool would be insufficient to perform the claimed steps. That is, the position identification claimed in SiRF Tech are limited to particular GPS receivers, which makes the GPS receivers more than mere data-gathering elements – they are the subject upon which the calculations are performed relative to. Additionally, the formation of a dynamic model is used to compute the position of the satellite signal receiver, which is a step affirmed by the court as not being performable in the human mind.. At present, the steps identifiable as abstract idea steps are not incapable of being performed in the human mind, and the pressure cuff claimed performs solely data-gathering activity, whereby the end result of calculation (i.e., outputting a blood pressure measurement) does not consider the data-gathering element in its output, merely the gathered data therefrom. See per MPEP 2106.05(b):
“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)”
Regarding Applicant’s argument:
“In this context, the claimed process is an improvement to the technical field of medical testing and diagnosis, specifically blood pressure measuring systems. The technical problem addressed by the claimed process is inherent inaccuracies in determining blood pressure values using conventional non-invasive blood pressure measuring systems, and risks inherent in determining blood pressure values using conventional invasive blood pressure measuring systems, as indicated by the Specification…”
Applicant’s alleged improvement arises from evaluations of the abstract idea. As per 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.”
Regarding Applicant’s comments on Desjardins:
Desjardins is directed to addressing an issue associated with known AI algorithms at the time (i.e., “catastrophic forgetting” in continual learning systems). Applicant’s claimed invention is not directed to an improvement of a known algorithm, but is instead directed to a series of steps to determine blood pressure from a known data-gathering element, executed via generic computer elements.
Regarding Applicant’s argument:
“For example, claim 1 recites inter alia receiving the tissue pressure signal from a pressure sensor of the pressure cuff, determining at least one blood pressure value for the individual based on parameter functions, and displaying the at least one blood pressure value. Applicant submits that such improvements amount to "significantly more" than the assertedly abstract idea itself, transforming the abstract idea into a patent-eligible application. See, e.g., Alice Corp., 134 S. Ct. at 2357, 110 USPQ2d at 1981 (Syllabus at 3, Slip Op. at 15).”
The act of receiving data from a sensor and displaying a value determined as the result of a series of evaluations are both extra-solution activities of data-gathering and outputting, respectively. See MPEP 2106.05(g).
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, 3-15, 23, 26-28, and 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 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:
A method for non-invasively determining at least one blood pressure value from a tissue pressure signal using a pressure cuff applied to an individual, the tissue pressure signal having a sequence of tissue pressure pulse curves (evaluation, observation, or judgement; additional element; details of data-gathering),
the method comprising:
receiving the tissue pressure signal from a pressure sensor of the pressure cuff (additional element; data-gathering);
identifying at least two individual tissue pressure pulse curves in the tissue pressure signal (evaluation, observation, or judgement);
determining an amplitude parameter and an area parameter for each identified tissue pressure pulse curve, the amplitude parameter indicating an amplitude of the identified tissue pressure pulse curve and the area parameter indicating at least one partial area enclosed by the tissue pressure pulse curve (evaluation, observation, or judgement);
for each identified tissue pressure pulse curve, determining a pulsation power parameter indicating a shape of the tissue pressure pulse curve based on at least the amplitude parameter and the area parameter (evaluation, observation, or judgement);
generating a parameter function which indicates a functional relationship between the determined pulsation power parameters of the tissue pressure pulse curves and corresponding clamping pressures at the pressure cuff or measuring times (evaluation, observation, or judgement); and
determining at least one blood pressure value for the individual based on the parameter function (evaluation, observation, or judgement); and
displaying the at least one blood pressure value (extra-solution activity).
Independent claim 28 recites a measuring device configured to carry out process steps of claim 1, and differently recites:
A measuring device for the non-invasive determination of blood pressure values from a tissue pressure signal detected on an individual by means of a pressure cuff, the measuring device comprising at least one control unit which is configured to: [carry out the process of claim 1].
As indicated above, the independent claims recite 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:
Each limitation identified via italics is merely a mental process of evaluation carried out on data gathered (tissue pressure signals) from a generically recited sensor (a pressure cuff).
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.
Alternatively or additionally, these steps describe the concept of using implicit mathematical formula(s) (i.e., evaluation of geometric features of pulse curves and generation and evaluation of parameter functions to determine blood pressure) to derive a conclusion based on input of medical data, which corresponds to concepts identified as abstract ideas by the courts, such as in Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989). The concept of the recited steps above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
Dependent claims 3 and 4 recite details related to details of the data gathered (i.e., that the tissue pressure signal is gathered over varying clamping pressures).
Dependent claims 5-15, 23, 26, and 27 recite limitations which are further evaluation steps of the abstract idea.
Dependent claim 31 recites constructional details of the data-gathering element, i.e., the pressure cuff.
Thus, the dependent claims merely include limitations that either further define the abstract idea (e.g., limitations relating to the extra-solution 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.
More specifically:
Independent claim 1 recites the additional element of a pressure cuff.
Independent claim 28 differently recites the additional element of a control unit.
Such additional elements are generically recited and do not improve the functioning of a computer or any other technology or technical field.
The claim recites merely acquiring data from a generically recited pressure cuff, having no operative connection to the abstract idea besides (as best understood) communication of obtained data, 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 control unit is recited at a high-level of generality (i.e., as a generic processors and memory performing a generic computer function of performing calculations and storing data, respectively) 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. For at least these reasons, the abstract idea is not integrated into a practical application.
Moreover, the above-identified abstract idea of claim 28 is not integrated into a practical application under because the claimed method and device merely implements the above-identified abstract idea using rules (e.g., computer instructions), which are executed by a computer (e.g., control unit as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements in the case of claim 28 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. Applicant is reminded that abstract ideas cannot provide a practical application or significantly more (e.g., an improvement). Both Step 2A Prong 2 and Step 2B require an additional element, not an abstract idea, to provide a practical application or significantly more (e.g., an improvement). See Genetic Technologies Limited v. Merial LLC (Fed Cir 2016). Here, the additional elements of claims 1 and 28 are merely generically recited sensors or computer elements used as tools for executing the abstract ideas or insignificant extra-solution activity.
Dependent claims 3 and 4 recite an additional element pertaining to how the data is gathered, which is directed to mere extra-solution activity.
Dependent claims 5-15, 23, 26, and 27 do not recite any additional limitations aside from limitations of the abstract idea.
Dependent claim 31 “wherein the pressure cuff is formed as a shell wrap cuff comprising an inner kink-resistant shell,” which recites a constructional detail of the data-gathering element, which is a token addition to the claim. The use of the cuff still contributes nominally or insignificantly to the execution of the claimed process.
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 a pressure cuff.
Independent claim 28 differently recites the additional element of a control unit which merely performs determination from signals obtained “by means of a pressure cuff.”
The control unit is generically claimed, and, without further constructional details of the device comprising the control unit, encompasses a general purpose computer performing the processes claimed. Thus, the control unit is reasonably construed as a generic computing device.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the control unit carrying out the processes recited, and merely recites that the control unit is “adapted to carry out the methods” recited in the independent claims. 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 control unit because it describes such an additional element in a manner that indicates that a control unit 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).
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.
Dependent claims 3 and 4 recite an additional element pertaining to how the data is gathered, which is directed to mere extra-solution activity. The concept of operating a cuff from pressures ranging from a pressure below diastolic pressure to a pressure above systolic pressure is known from at least:
Pearce et al. (US 4625277 A) – Col. 1, lines 29-46, particularly: “In one well-known application of the oscillometric technique, the cuff is first inflated to a pressure above the patient's expected systolic pressure, and then slowly deflated over a pressure range inclusive of the patient's systolic and diastolic pressures.”
Ramsey III (US 4360029 A) – Col. 2, lines 7-30: gradual application of pressure over a range encompassing diastolic and systolic pressures.
Dependent claims 5-15, 23, 26, and 27 do not recite any additional limitations aside from limitations of the abstract idea. 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.
Dependent claim 31 “wherein the pressure cuff is formed as a shell wrap cuff comprising an inner kink-resistant shell,” which recites a constructional detail of the data-gathering element, which is a token addition to the claim. Such a structural is encompassed by blood pressure cuffs comprising what is known as a “curler,” which is considered a well-understood, routine, and conventional element as discussed by Jacober and Souma:
Jacober et al. (US 20190049977 A1) – Paragraphs 0001-0005: describing wrist-mounted blood pressure monitors, whereby a known attempt to solve the problem of transmitting adequate pressure is to include a curler. A curler is interpreted as encompassing “an inner kink-resistant shell.”
Souma et al. (US 20100106031 A1) – Paragraph 0080: “Conventionally, a damper formed by a stacked rigid plate member with large rigidity and foamed urethane is installed instead of the interrupting device 105.”
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 pressure cuff 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
Claims 5, 13, 15, and 23 do not have an art rejection applied; however, claims 5, 13, 15, and 23 are rejected under 35 U.S.C. 101.
The reasoning behind the lack of prior art rejections as applied is as follows:
Claim 5 requires an area parameter and amplitude parameter be “linked” (i.e., set in relation to each other, as interpreted in light of page 5 of Applicant’s Specification) by a multiplication of the amplitude parameter and the area parameter. The prior art of record does not teach such a calculation. What is typically performed is identification of an area under an oscillometric curve using a calculation involving amplitude.
Claim 13 requires determination of a mean blood pressure using the generated parameter function recited in claim 1 (derived from area parameters and amplitude parameters) by determining a second parameter function value preceding or following the maximum parameter function value, which has, with respect to the maximum parameter function value, a parameter function value reduced by a predetermined proportion and the corresponding second measuring time or the corresponding second clamping pressure. What is typically performed in the prior arts is identification of a maximum amplitude of an envelope formed from maximum amplitudes, areas under curves, differences of peaks and troughs, etc. of oscillometric pressure pulses, identification of a maximum value of the resulting amplitude and identifying MAP from the identified corresponding pressure.
Claim 15 requires a specific formula not discussed in the prior arts of record.
Claim 23 requires a specific calculation not discussed in the prior arts of record.
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.
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/JUSTIN XU/Primary Examiner, Art Unit 3791