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 Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 12: “calculates” should be replaced with –is configured to calculate–.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 30 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 30 recites “gradually increases or decreases” in line 2. The term “gradually” is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this case, it is unclear when something starts/stops being considered gradual or abrupt, and the specification does not provide a standard for ascertaining the scope. For the purposes of examination, the recitation will be interpreted to be “the pressurization device is configured to increase or decrease the variable pressure.
Claim 30 recites “the pressurization device gradually increases or decreases the variable pressure” in lines 1-2 which is a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)). For the purposes of examination, the recitation will be interpreted to be “the pressurization device is configured to increase or decrease the variable pressure.
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 1-4, 6, 13, 20, 23, 29, and 30 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. Claims 1-4, 6, 13, 20, 23, 29, and 30 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019), and the 2024 Guidance Update on Patent Subject Matter Eligibility (Federal Register, Vol. 89, No. 137 p. 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is directed to a machine.
Step 2A - Prong 1: Claim 1 is directed to an abstract idea in the form of a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components.
In particular, claim 1 recites the following limitations:
[A1]: calculate a mapped constant pressure arterial wave by mapping the constant pressure arterial wave to the variable pressure arterial wave;
[B1]: calculate a blood pressure value by using the mapped constant pressure arterial wave;
[C1]: calculates the mapped constant pressure arterial wave by adjusting an amplitude of the constant pressure arterial wave so that the amplitude-adjusted constant pressure arterial wave overlaps with the variable pressure arterial wave at deformation start and end times of the variable pressure arterial wave.
The elements [A1]-[C1] of claim 1 are directed to an abstract idea because they are processes that, under their broadest reasonable interpretation, are a mere steps that are capable of being mentally performed with the aid of pen and paper. For example, a skilled artisan is capable of reading a constant pressure arterial wave and a variable pressure arterial wave, calculating a mapped constant pressure arterial wave by aligning the constant pressure arterial wave with the variable pressure arterial wave and adjusting an amplitude of the constant pressure arterial wave, then determining a blood pressure which corresponds to the mapped constant pressure arterial wave.
Step 2A - Prong Two: Claim 1 does not recite additional elements that integrate the judicial exception into a practical application. Claim 1 recites the following additional elements:
[A2]: a sensor unit configured to detect a constant pressure arterial wave at a first site of a body under constant pressure and detect a variable pressure arterial wave at a second site of the body under variable pressure;
[B2]: a pulse wave processing unit;
[C2]: a blood pressure calculation unit; and
[D2]: a display device configured to display the blood pressure value.
The elements [A2]-[D2] do not integrate the exception int a practical application.
The elements [A2] and [D2] do not integrate the exception into a practical application of the exception because the elements amount to adding insignificant extra-solution activity to the judicial exception – See MPEP 2106.04(d) and MPEP § 2106.05(g).
The elements [B2]-[C2] do not integrate the exception into a practical application of the exception because the elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - See MPEP 2106.04(d) and MPEP 2106.05(f).
Accordingly, each of the additional elements do not integrate the abstract into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. Claim 1 recites the following additional elements:
[A2]: a sensor unit configured to detect a constant pressure arterial wave at a first site of a body under constant pressure and detect a variable pressure arterial wave at a second site of the body under variable pressure;
[B2]: a pulse wave processing unit;
[C2]: a blood pressure calculation unit; and
[D2]: a display device configured to display the blood pressure value.
The elements [A2]-[D2] do not amount to significantly more than the judicial exception itself.
The elements [A2] and [D2] do not qualify as significantly more because the elements amount to adding insignificant extra-solution activity to the judicial exception – See MPEP § 2106.05(g). In this case, the element [A2] amounts to mere data gathering. The element [D2] amounts to displaying data, which is selecting a particular type of data to be manipulated and/or an insignificant application. Additionally, the elements are well-understood, routine, and conventional.
With regards to element [A2], US 2017/0258340 A1 (Przybyszewski) (previously cited) teaches that during calibration of cuff-less methods, recording of ECG and PPG or multiple PPG signals is usually paired with a cuff-based measurement of blood pressure (¶ [0017]). Przybyszewski therefore teaches that sensing elements for determining cuff-less ECG and PPG or multiple PPG signals (i.e., body arterial waves determined at sites under constant pressure) are usually paired with sensing elements for determining cuff-based pressure signals (i.e., a variable pressure arterial wave determined at a site where a cuff applies a variable pressure). Przybyszewski teaches the usual pairing, which indicates the well-understood, routine, and conventional nature of the limitations. US 2006/0074322 A1 (Nitzan ‘322) also teaches the element [A2] in ¶ [0016].
With regards to element [D2], US 6,228,035 B1 (Packman) teaches a conventional blood pressure monitor includes a display for displaying status information and the blood pressure measured by blood pressure monitor (Col. 1, lines 26-34).
Simply reciting the elements [B2] and [C2] do not qualify as significantly more because the elements are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (See MPEP 2106.05(d)(II); Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (See MPEP 2106.05(d)(II); Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Independent claim 20 recites method limitations and is not patent eligible for substantially similar reasons.
Claims 2-4, 6, 13, and 30 depend from claim 1, and they recite the same abstract idea as claim 1. Claims 23 and 29 depend from claim 20, and they recite the same abstract idea as claim 20. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process or mathematical algorithm) and/or append abstract ideas (that is, the claims only recite limitations that add further mental processes or mathematical algorithms) except for the following limitations.
Claim 2 recites “the sensor unit is configured to simultaneously measure the constant pressure arterial wave and the variable pressure arterial wave”. However the above element does not integrate the exception into a practical application of the exception or qualify as significantly more because the element amount to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.04(d); MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional, as is evidenced by US 2017/0258340 A1 (Przybyszewski) (previously cited) in ¶ [0017] which discloses that multiple PPG signals or ECG and PPG signals can be obtained at two different points of a body, wherein a cuff-based measurement of blood pressure is capable of being measured simultaneously with the PPG/ECG signals.
Claim 3 recites “the sensor unit includes a first sensor configured to detect the constant pressure arterial wave, and a second sensor configured to detect the variable pressure arterial wave”. However the above element does not integrate the exception into a practical application of the exception or qualify as significantly more because the element amount to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.04(d); MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional, as is evidenced by US 2017/0258340 A1 (Przybyszewski) (previously cited) in ¶ [0017], which discloses that multiple sensors for detecting multiple PPG signals or ECG and PPG signals and a sensor for determining a cuff-based measurement of blood pressure.
Claim 4 recites “the second sensor is a pressure sensor”. However the above element does not integrate the exception into a practical application of the exception or qualify as significantly more because the element amount to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.04(d); MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional, as is evidenced by US 2017/0258340 A1 (Przybyszewski)(previously cited) in ¶ [0017], which discloses a cuff-based measurement of blood pressure, wherein the cuff-based measuring system amounts to a pressure sensor.
Claim 6 recites “the constant pressure is less than or equal to a diastolic blood pressure, and the variable pressure is greater than or equal to the diastolic blood pressure”. However the above element does not integrate the exception into a practical application of the exception or qualify as significantly more because the element amount to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.04(d); MPEP 2106.05(g). Additionally or alternatively, the element amounts to generally linking the use of a judicial exception to a particular technological environment or field of use - see MPEP 2106.04(d); MPEP § 2106.05(h). Additionally, the element is well-understood, routine, and conventional, as is evidenced by US 2017/0258340 A1 (Przybyszewski) (Previously cited) in ¶ [0017], which discloses measuring a pulse-wave-transit-time model and a cuff-based measurement of blood pressure. The Examiner notes that a pulse-wave-transit-time model necessarily involves measuring arterial waves without applied pressure (i.e., wherein a constant pressure is less than or equal to a diastolic blood pressure) and a cuff-based measurement of blood pressure necessarily includes applied pressures at or above diastolic blood pressure.
Claim 13 recites “a pressurization device configured to apply the variable pressure to the second site of the body”. However the above element does not integrate the exception into a practical application of the exception or qualify as significantly more because the element amount to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.04(d); MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional, as is evidenced by US 4,924,873 A (Sorensen) (previously cited) in Col. 1, lines 14-20.
In view of the above, the additional elements do not integrate the abstract idea into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
No Prior Art Rejections
With regards to claim 1, the prior art does not teach or suggest “the pulse wave processing unit calculates the mapped constant pressure arterial wave by adjusting an amplitude of the constant pressure arterial wave so that the amplitude-adjusted constant pressure arterial wave overlaps with the variable pressure arterial wave at deformation start and end times of the variable pressure arterial wave” along with the other features of claim 1. Claim 20 recites similar features which are not taught or suggested by the prior art. Claims 2-4, 13, 23, 29 and 30 do not have prior art rejections by virtue of their dependence from claims 1 and 20, respectively.
US 2018/0116534 A1 (Tal) teaches generating a composite blood pressure waveform based on multiple sensor waveforms in paragraphs [0073]-[0075] and Fig. 7, but Tal does not teach or suggest calculating the mapped constant pressure arterial wave by adjusting an amplitude of the constant pressure arterial wave so that the amplitude-adjusted constant pressure arterial wave overlaps with the variable pressure arterial wave at deformation start and end times of the variable pressure arterial wave, along with the other features of claims 1 and 20.
Response to Arguments
Specification
In view of the amendment to the abstract filed 01/29/2026, the objection to the specification was withdrawn.
Claim Objections
There are new grounds of claim objections necessitated by the claim amendment filed 01/29/2026.
Claim Rejections – 35 USC §112(a)
Applicant’s amendments and arguments, see page 7 of the response filed 01/29/2026, with respect to the rejections under 35 U.S.C. §112(a) have been fully considered and are persuasive. The rejections under 35 U.S.C. §112(a) have been withdrawn.
Claim Rejections – 35 USC §112(b)
There are new grounds of rejections under 35 U.S.C. §112(b) necessitated by the claim amendment filed 01/29/2026.
Claim Rejections – 35 USC §101
Applicant's arguments filed 01/29/2026 have been fully considered but they are not persuasive.
On pages 9-10 of the response filed 01/29/2026, the Applicant asserts that “a display device configured to display the blood pressure value” is an additional element that integrates the claims into a practical application and amounts to significantly more than the abstract idea.
This argument is not persuasive. The element does not integrate the claims into a practical application or qualify as significantly more because the element amounts to adding insignificant extra-solution activity to the judicial exception – See MPEP § 2106.05(g). In this case, the element [D2] includes displaying data, which is selecting a particular type of data to be manipulated and/or an insignificant application. Additionally, the elements are well-understood, routine, and conventional. With regards to element [D2], US 6,228,035 B1 (Packman) teaches a conventional blood pressure monitor includes a display for displaying status information and the blood pressure measured by blood pressure monitor (Col. 1, lines 26-34).
On pages 9-10 of the response filed 01/29/2026, the Applicant asserts:
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This argument is not persuasive. First, Applicant merely sets forth the improvement in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art). See MPEP 2106.05(a). The specification is completely silent as to how the claimed mapping results in a faster blood calculation time, and it is not apparent to one of ordinary skill in the art how the claimed mapping provides the alleged improvement. Additionally, the alleged improvement to the technical problem is in blood pressure calculation and the mapping a constant pressure arterial wave to a variable pressure arterial wave, which are mental processes. MPEP 2106.05(a) recites, “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” MPEP 2106.05(a)(II) further recites “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology.” An improvement to the mental processes of blood pressure calculation and the mapping are improvements to the abstract idea, which do not qualify as improvements to technology or a technical field.
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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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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