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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-4 in the reply filed on November 18, 2025 is acknowledged.
Claim 5 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 18, 2025.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
sound detection device in claim 1;
amplification factor setting unit in claim 1;
blood pressure calculation unit in claim 1.
The corresponding structure for a sound detection device is “a microphone” (Paragraph 0010).
The corresponding structure for both an amplification factor setting unit and blood pressure calculation unit appears to be directed to a generic computer processor (Paragraph 0031: “The control unit 110 includes a central processing unit (CPU) as a processor, and controls the entire operation of the sphygmomanometer 100;” Paragraph 0045: “… the control unit 110 acts as an amplification factor setting unit;” Paragraph 0048: “The control unit 110 works as a blood pressure calculation unit…”).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, and 4 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 blood pressure measuring cuff worn around the site to be measured (additional element);
a pressure device that supplies a fluid to the blood pressure measuring cuff to pressurize the blood pressure measuring cuff, or discharges a fluid from the blood pressure measuring cuff to depressurize the blood pressure measuring cuff (additional element);
a sound detection device that detects a sound generated by the site to be measured via the blood pressure measuring cuff (additional element, data-gathering);
an amplification factor setting unit that measures a first passage time required for pressure of the blood pressure measuring cuff to pass through a predetermined first pressure range in a pressurization process of the blood pressure measuring cuff by the pressure device, and variably sets an amplification factor for a Korotkoff sound component according to the first passage time (observation, evaluation, or judgement); and
a blood pressure calculation unit that receives an output of the sound detection device according to the sound from the blood pressure measuring cuff, amplifies a Korotkoff sound component included in the output with an amplification factor set by the amplification factor setting unit, and calculates a blood pressure of the site to be measured based on the amplified Korotkoff sound component in the pressurization process or a depressurization process subsequent to the pressurization process (additional element, data-processing, evaluation).
As indicated above, the independent claim recites at least one step or instruction grouped as a mental process. Therefore, each of the independent claims recites an abstract idea. As best understood in light of interpretation of terms under 35 U.S.C. 112(f), each function of the claimed amplification factor setting unit and blood pressure calculation unit are understood to be carried out by a generic computer processor. 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 limitation of measur[ing] a first passage time required for pressure of the blood pressure measuring cuff to pass through a predetermined first pressure range in a pressurization process of the blood pressure measuring cuff by the pressure device requires an individual to perform an observation of time required for observed data to pass a certain amount of time during operation of a blood pressure measuring device.
The limitation of variably set[ting] an amplification factor for a Korotkoff sound component according to the first passage time requires an individual to perform an evaluation to select a degree by which obtained data is modified.
The limitation of amplif[ying] a Korotkoff sound component included in the output with an amplification factor set by the amplification factor setting unit can be interpreted as performing evaluation on obtained data by which the selected degree of modification is applied. For instance, the claim language encompasses operations as simple as adding or multiplying a scalar value to each value of the data obtained.
The limitation of calculat[ing] a blood pressure of the site to be measured based on the amplified Korotkoff sound component in the pressurization process or a depressurization process subsequent to the pressurization process is a process of evaluation based on previous modifications of obtained data.
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.
Dependent claims 3 and 4 merely recite limitations directed to extra-solution data-gathering or further limitations directed to the abstract idea.
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 following additional elements:
a blood pressure measuring cuff;
a pressure device that supplies a fluid to the blood pressure measuring cuff;
a sound detection device;
an amplification factor setting unit;
a blood pressure calculation unit;
Such additional element are a 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 components having no operative connection to the abstract idea aside from 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 combination of a blood pressure measuring cuff, pressure device, and sound detection device may imply particular structure, their use in the claims is merely extra-solution data-gathering to the abstract idea. 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)”
Both the amplification factor setting unit and blood pressure calculation unit are recited at a high-level of generality and interpretable as generic processors and memory performing a generic computer functions 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. Examiner notes that while claim 1 recites that a “sphygmomanometer” comprises such elements, a sphygmomanometer in communication with a generic computer processor encompasses the claim.
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 (analyzing cuff signals), 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 is not integrated into a practical application under because the claimed method and system merely implements the above-identified abstract idea using rules (e.g., computer instructions) executed by a computer. 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 the claim 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’s disclosure identifies that a problem to be addressed is correctly setting an amplification factor for Korotkoff sounds such that differences in patient anatomy do not affect acquisition of Korotkoff sound levels (Paragraph 0004). As best understood, Applicant’s citation of previous arts which variably set a Korotkoff sound recognition level based on a depressurization speed is stated to be “designed to be able to stably recognize the Korotkoff sound” (Paragraph 0003). While Applicant states that previous arts do not consider the size of a site to be measured, it appears that variable compensation for Korotkoff sound detection already appropriately amplifies a Korotkoff sound and makes the size of a site to be measured a non-consideration. Furthermore, it is unclear why Applicant states in Paragraph 0005 “an object of the present invention is to provide a sphygmomanometer capable of reducing or eliminating the magnitude of a Korotkoff sound level,” since it appears that the claim is directed to adequately amplifying the Korotkoff sound. Furthermore, claim 1 does not provide sufficient detail to provide Applicant’s purported solution since the claimed amplification factor setting unit is claimed as “variably setting an amplification factor for a Korotkoff sound component” without consideration of a magnitude or direction of such amplification.
Dependent claims 3 and 4 merely recite limitations directed to extra-solution data-gathering or further limitations directed to the abstract idea. Dependent claim 3 recites consideration of an additional parameter of length when performing the steps of evaluating/judging to what degree the amplification factor is set. Dependent claim 4 recites performing an evaluation for a second passage time and second pressure range. Each of these claims are merely additional considerations for the abstract idea and do not provide integration of the abstract idea into a practical application.
Thus, for these additional reasons, the abstract ideas identified above in the claims are not integrated into a practical application.
Accordingly, claims 1, 3, and 4 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:
a blood pressure measuring cuff;
a pressure device that supplies a fluid to the blood pressure measuring cuff;
a sound detection device;
an amplification factor setting unit;
a blood pressure calculation unit;
The combination of additional elements of a blood pressure measuring cuff, a pressure device that supplies a fluid to the blood pressure measuring cuff, and sound detection device are known as well-understood, routine, and conventional components, as known from:
Dondelinger, R. M. (2005, May 1). The Fundamentals of Sphygmomanometers [Review of The Fundamentals of Sphygmomanometers]. AAMI Array; Biomedical Instrumentation and Technology. (hereinafter -- Dondelinger) – Page 210: describing blood pressure measurement involving a cuff, inflation thereof (implying the use of a pressure device) and detecting or recording Korotkoff signals (encompassing a sound detection device).
Additionally, each of the additional elements appear to be recited in Applicant’s description of conventional sphygmomanometers in background arts (Paragraph 0003). Thus, the combination of additional elements appear to be directed to no more than standard components of sphygmomanometers which measure Korotkoff sounds.
The recitation of an amplification factor setting unit and a blood pressure calculation unit 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. 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.
The dependent claims do not recite additional elements outside of the judicial exception.
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.
Allowable Subject Matter
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 2 recites limitations directed to a specific structure which is not found to be well-understood, routine, and conventional:
wherein the blood pressure measuring cuff includes:
an outer cloth extending in a longitudinal direction in a band shape and surrounding the site to be measured;
a pressing fluid bag that is provided to extend along the longitudinal direction on a side of the outer cloth facing the site to be measured, and compresses the site to be measured;
a sound acquisition fluid bag that is provided between the outer cloth and the pressing fluid bag in a thickness direction perpendicular to the outer cloth, and acquires a sound from the site to be measured via the pressing fluid bag,
the sphygmomanometer further comprising:
a first fluid pipe that connects the pressing fluid bag and the pressure device so as to be capable of flowing a fluid; and
a second fluid pipe that connects the sound acquisition fluid bag and the sound detection device so as to be capable of flowing a fluid, separately from the first fluid pipe.
Regarding lack of prior art rejections applied to the claims, Examiner presents the following closest arts of record:
Aelen (US 20180235488 A1) (hereinafter – Aelen)
Kaspari et al. (US 4058117 A) (hereinafter – Kaspari)
Tokko et al. (US 20110295130 A1) (hereinafter – Tokko)
Fujii et al. (US 20110015531 A1) (hereinafter – Fujii).
None of the prior arts of record teach or suggest:
an amplification factor setting unit that measures a first passage time required for pressure of the blood pressure measuring cuff to pass through a predetermined first pressure range in a pressurization process of the blood pressure measuring cuff by the pressure device, and variably sets an amplification factor for a Korotkoff sound component according to the first passage time.
Aelen, typical of many automated sphygmomanometers, chooses gains where low-frequency deviations are corrected and oscillatory pressure signals indictive of blood pressure are not levelled out (Paragraph 00300. Aelen does not consider the time required to pass through a particular pressure range in order to adjust gain.
Kaspari teaches a gain-adjusting circuit 73 (Fig. 3A); however, Kaspari adjusts gain based on sound intensity levels obtained from a microphone (Col. 5, line 52 – Col. 6, line 31), and does not consider the time required to pass through a particular pressure range in order to adjust gain.
Tokko teaches a pressure adjustment unit which variably controls gain (Paragraphs 0262-0263); however, the gain is adjusted based on wrapping strength, and not the time required to pass through a particular pressure range in order to adjust gain.
Fujii controls a decided gain state and considers a volume change elimination rate detected at a particular time; however, the gain control of Fujii is directed to increasing servo gain, i.e., control of inflation rate, and is not equivalent to applying a particular gain to an obtained Korotkoff sound component.
Thus, none of the prior arts of record, either alone or in combination, teach the amplification factor setting steps of claim 1.
Conclusion
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/JUSTIN XU/Primary Examiner, Art Unit 3791