Prosecution Insights
Last updated: April 19, 2026
Application No. 18/348,718

ARTERIAL-PRESSURE ESTIMATION APPARATUS, ARTERIAL-PRESSURE ESTIMATION SYSTEM, AND ARTERIAL-PRESSURE ESTIMATION METHOD

Non-Final OA §101§102§103§112
Filed
Jul 07, 2023
Examiner
KIM, SAMUEL CHONG
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Terumo Kabushiki Kaisha
OA Round
1 (Non-Final)
48%
Grant Probability
Moderate
1-2
OA Rounds
4y 0m
To Grant
99%
With Interview

Examiner Intelligence

Grants 48% of resolved cases
48%
Career Allow Rate
107 granted / 221 resolved
-21.6% vs TC avg
Strong +72% interview lift
Without
With
+71.5%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
43 currently pending
Career history
264
Total Applications
across all art units

Statute-Specific Performance

§101
11.1%
-28.9% vs TC avg
§103
39.7%
-0.3% vs TC avg
§102
7.7%
-32.3% vs TC avg
§112
36.5%
-3.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 221 resolved cases

Office Action

§101 §102 §103 §112
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. Information Disclosure Statement The information disclosure statements (IDS) submitted on 07/07/2023 , 10/06/2023, and 12/19/2023 were considered by the examiner. 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. No limitations were interpreted under 35 U.S.C. §112(f). Claim Rejections - 35 USC § 112 Claims 1-20 are 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 1 recites “ a pressure is gradually reduced ” in line 6. The term gradually” i s 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 the pressure is considered to be gradually/abruptly reduced. For the purposes of examination, the recitation will be interpreted to be “a pressure is continuously reduced”. Support is found in at least Fig. 4. Claims 16 and 20 recite similar limitations, so the claims are rejected on similar grounds. Claim 1 recites “the pressure” in line 11. Claim 1 recites “a pressure” in line 6 and “an arterial pressure” in line 10. It is unclear whether the recitations in line 11 refer to “a pressure” or “an arterial pressure”. The Examiner suggests amending the recitation of “a pressure” in line 6 of claim 1 to be “an applied pressure”. For the purposes of examination, “the pressure” in line 11 will be interpreted to be “the applied pressure”. Claims 2, 4-6 , 16, 17, 19, and 20 recite similar limitations, so the claims are rejected on similar grounds. Claims 2-15 are rejected by virtue of their dependence from claim 1. Claims 17-19 are rejected by virtue of their dependence from claim 16. Claim 4 recites “indicating, as the blood flow timing, a timing at which the one or more locations is compressed multiple times while the pressure is reduced at different rates each time, and the blood flow is detected for each heartbeat in each of the multiple times”. Claim 1 recites “indicating, as a blood flow timing, a timing at which a blood flow generated at one or more locations of a blood vessel downstream of an aorta is detected for each heartbeat when the one or more locations is compressed while a pressure is gradually reduced”. Claim 1 recites that the blood flow timing is indicated to be a first timing. Claim 4 recites that the blood flow timing is indicated as a different timing. It is unclear how a “timing” indicated as one thing can also be indicated as another different thing. The specification includes a description of a n embodiment in ¶ [0117] of the published application, but there is no description of how the blood flow timing can be indicated as two different things. For the purposes of examination, the limitation will be interpreted such that the blood flow timing is obtained while the one or more locations is compressed multiple times while the pressure is reduced at different rates each time. Claim 5 recites a similar limitation, so it is rejected on similar grounds. Claim 5 recites “the sensor data includes data indicating, as the blood flow timing, a timing at which the one or more locations is compressed multiple times while the pressure starts to be reduced at different rates each time and the pressure is reduced at a constant rate after a heartbeat at which the blood flow is detected, and the blood flow is detected for each heartbeat in each of the multiple times”, which is so grammatically awkward that the meaning is indefinite. How does a pressure start to be reduced at a constant rate while also being reducing at different rates each time? What is being indicated as the blood flow timing? Clarification is required. 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 a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1- 20 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 6 is as follows: Step 1: Claim 1 6 is directed to a process, which is a statutory category . Step 2A - Prong 1: Claim 1 6 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. Additionally or alternatively, claim 1 6 is directed to an abstract idea in the form of mathematical algorithms and/or formulas. In particular, claim 1 6 recites the following limitations: [A1]: acquir ing sensor data indicating, as a blood flow timing, a timing at which a blood flow is detected for each heartbeat when the one or more locations is compressed (a skilled artisan is capable of reading a printout of sensor data and mentally identifying blood flow timings); [B1]: record ing a value of the pressure corresponding to each blood flow timing (a skilled artisan is capable of memorizing a value of a pressure corresponding to the blood flow timings); [C1]: correct ing the value of the pressure corresponding to each blood flow timing included in an inspiration period of a respiration cycle (a skilled artisan is capable of mentally adjusting pressure values of each blood flow timing during an inspiration period; also see at least ¶¶ [0091]-[0092] of the published specification regarding the mathematical nature of the correction) ; [D1]: estimat ing a change in an arterial pressure over time by referring to the acquired sensor data and the recorded and corrected value of the pressure (a skilled artisan is capable of mentally estimating an arterial pressure by using the sensor data and corrected values). These el ements [A1]-[ D 1] of claim 1 6 are directed to an abstract idea because they are processes that, under their broadest reasonable interpretation, are mere steps that are capable of being mentally performed with the aid o f pen and paper for the reasons listed above . Additionally or alternatively, the element [ C1 ] are directed to an abstract idea because it is directed to mathematical algorithms and/or formulas for the reason listed above . Step 2A - Prong Two: Claim 1 6 does not recite additional elements that integrate the judicial exception into a practical application. Claim 1 recites the following additional elements : [A2]: compressing one or more locations of a blood vessel downstream of an aorta while a pressure is gradually reduced; [B2]: detecting with a sensor, for each heartbeat, a blood flow generated at the one or more locations. The elements [A2]-[ B 2] do not integrate the exception into a practical application . Specifically, the elements [A2]-[B2] 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). For example, the element [A2] is performed in order to gather data for the mental analysis steps. The element [B2] is mere data gathering using a generic sensor. 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]: compressing one or more locations of a blood vessel downstream of an aorta while a pressure is gradually reduced; [B2]: detecting with a sensor, for each heartbeat, a blood flow generated at the one or more locations. The elements [A2]-[ B 2] do not amount to significantly more than the judicial exception itself . Specifically, the elements [A2]-[B2] 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 2106.05(g). T he element [A2] is performed in order to gather data for the mental analysis step s . The element [B2] is mere data gathering using a generic sensor. Additionally, the elements [A2], [B2] are well-understood, routine, and conventional . For example, US 2013/0023777 A1 (Tokko) discloses a conventional electronic sphygmomanometer includes detecting a pulse produced by an artery with a pressure sensor via the cuff in a process of gradually reducing the cuff pressure (¶ [0002]). 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 individuall y. 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 co mputer implementation, i.e., the computer is simply a tool to perform the process. Independent claims 1 and 20 recite mirrored method and non-transitory storage medium limitations and are not patent eligible for substantially similar reasons. Claim 1 recites “a control unit”, and claim 20 recites “a non-transitory computer-readable medium storing a computer program that causes a computer to execute a process”. S imply reciting the elements do not integrate the exception into a practical application of the exception and do not qualify as significantly more because these 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). Additionally, 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 industr y (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). Claims 2 -15 depend from claim 1, and they recite the same abstract idea as clai m 1. Claims 17-19 depend from claim 16 , and they recite the same abstract idea as claim 16 . 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 10 recites “the control unit is configured to generate a trained model for acquiring an estimated value of the LVEDP by performing machine learning using at least a part of the estimation result of the change in the arterial pressure over time”. However, the element does not amount to a practical application or significantly more because the element is merely adding insignificant extra-solution activity to the judicial exception ( see MPEP 2106.05(g) ) and/or generally linking the use of the judicial exception to a particular technological environment or field of use (MPEP 2106.05(h)). Additionally the element is well-understood, routine and conventional as evidenced by US 2020/0121221 A1 (Hendricks) which discloses, in ¶ [0106], “ Methods of generating a machine learning model will be well known to the skilled person. Typically, this comprises obtaining training data comprising example input data (here: accumulated amount) and example output data (here: risk level), generating estimated output data by processing the example input data with a machine learning model (e.g. initialized with random parameter values) and modifying the machine learning model to minimize the difference between the estimated output data and the example output data. ” Claim 14 recites “a sensor configured to detect the blood flow ” . Claim 15 recites “an inflation portion configured to compress the at least one location”. However, the element s do not amount to a practical application or significantly more because the element is merely adding insignificant extra-solution activity to the judicial exception ( see MPEP 2106.05(g) ). Additionally, the element is well-understood, routine, and conventional . For example, US 2013/0023777 A1 (Tokko) discloses a conventional electronic sphygmomanometer includes detecting a pulse produced by an artery with a pressure sensor via the cuff in a process of gradually reducing the cuff pressure (¶ [0002]). 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. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claims 1 , 6-8, 11, 12, 14- 16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0265163 A1 (Marmor) (cited by Applicant). With regards to claims 1, 16, and 20, Marmor teaches a n arterial-pressure estimation apparatus (Fig. 2A and ¶ [0113] depict a device 150 for the noninvasive determination of ventricular pressure and related values ; ¶ [0085] discloses generation of an ascending arterial pressure waveform ) , method (¶ [0129] discloses algorithms to control and monitor device 100, sonic sensor 110, and blood-flow sensor 130 and displaying an arterial wave with relevant data points; Figs. 3-4 depict methods for non-invasively determining ventricular pressure and related values ) , and non-transitory computer-readable medium storing a computer program that causes a computer to execute a process (¶ [0129] discloses a processing unit 120 including processing components, memory components and other components related to processing) comprising: a control unit (¶ [0129] discloses a processing unit 120 including processing components, memory components and other components related to processing) configured to: acquire sensor data indicating, as a blood flow timing, a timing at which a blood flow generated at one or more locations of a blood vessel downstream of an aorta is detected for each heartbeat when the one or more locations is compressed while a pressure is gradually reduced (¶¶ [0 0 7 5 ] -[0076], [0085] depict a determining a time delay between opening of the aortic valve and the sensed blood-flow breakthrough from multiple cardiac cycles (e.g., a time delay between an R wave on an electrocardiogram and a brachial pulse) during gradual deflation of a pressure cuff , which indicates that the blood-flow breakthrough times are acquired ) ; record a value of the pressure corresponding to each blood flow timing (¶¶ [0078]-[0079] depict iteratively determining pressure values with respect to time to create a portion of a waveform graph, e.g., a portion of the graph in Fig. 1; ¶ [0085] discloses plotting a plurality of cuff pressure measurements against corresponding time delays between the opening of the aortic valve and the sensed blood-flow breakthrough from multiple cardiac cycles ; ¶ [0188] and Fig. 7 depict plotting points corresponding to the disclosure of Fig. 1 ) ; correct the value of the pressure corresponding to the blood flow timing included in an inspiration period of a respiration cycle ( ¶¶ [0059], [0091] disclos es g raph 10 is normalized such that systole, as defined in some instances, begins at origin 30 , and origin 30 coincides with LVEDP . ¶ ¶ [0188]- [ 0193 ] disclose the determination of a delay (i.e., the normalization) for arriving at a pressure curve. ¶¶ [0188], [0210] discloses measuring, for example, twenty heart strokes or measuring over the course of twenty seconds – wherein the twenty heart strokes or twenty seconds necessarily includes data points that include an inspiration period) ; and estimate a change in an arterial pressure over time by referring to the acquired sensor data and the recorded and corrected value of the pressure ( ¶ [0193] depicts a new function can be determined that may accurately reflect the pressure curve at the aorta wherein the new polynomial has points corrected from the empirical value to account for a known delay , wherein the new function amounts to the change in the arterial pressure over time ) . With regards to claim 6, Marmor further teaches the sensor data includes data indicating, as a cardiac output timing, a timing at which a cardiac output is detected for each heartbeat (¶¶ [0075]-[0076], [0085] depict a determining a time delay between opening of the aortic valve and the sensed blood-flow breakthrough from multiple cardiac cycles (e.g., a time delay between an R wave on an electrocardiogram and a brachial pulse) during gradual deflation of a pressure cuff, which indicates that a timing of the opening of the aortic valve is detected) ; and the control unit is configured to estimate the change in the arterial pressure over time according to a time difference between the cardiac output timing and the blood flow timing indicated by the sensor data and the recorded and corrected value of the pressure corresponding to each blood flow timing ( ¶ [0085] discloses plotting a plurality of cuff pressure measurements against corresponding time delays between the opening of the aortic valve and the sensed blood-flow breakthrough from multiple cardiac cycles ; ¶ [0188] and Fig. 7 depict plotting points corresponding to the disclosure of Fig. 1; ¶ [0193] depicts a new function can be determined that may accurately reflect the pressure curve at the aorta wherein the new polynomial has points corrected from the empirical value to account for a known delay , wherein the new function amounts to the change in the arterial pressure over time) . With regards to claim 7, Marmor further teaches the control unit is configured to estimate a left ventricular end-diastolic pressure (LVEDP) based on an estimation result of the estimated change in the arterial pressure over time (¶ [0194] discloses that LVEDP can be derived from this new function; see ¶¶ [0194]-[0209]) . With regards to claim 8, Marmor further teaches the control unit is configured to: estimate an arterial pressure waveform as the change in the arterial pressure over time ( ¶¶ [0193]-[0194] d iscloses the new function is an isovolumetric pressure curve of the aorta) ; estimate a left ventricular pressure waveform according to the estimated arterial pressure waveform (¶ [0199] d iscloses an end diastolic pressure being a function having a waveform) ; and acquire an estimated value of the LVEDP based on the estimated left ventricular pressure waveform (¶ [0209] discloses calculation of LVEDP based on the EDP waveform) . With regards to claim 11, Marmor further teaches control unit is configured to present an estimated value of the LVEDP to a user ( ¶ [0032] discloses an output for outputting data derived from the polynomial function describing blood pressure at the aorta; ¶ [0135] discloses displaying data and/or output from device 150; ¶¶ [0193]-[0194] discloses deriving LVEDP from the polynomial) . With regards to claim 12, Marmor further teaches control unit is configured to estimate a parameter related to intracardiac hemodynamics based on an estimation result of the change in the arterial pressure over time. (¶¶ [0055]-[0058] discloses the determination of isovolumetric contraction time (IVCT) which is the period of left ventricular mural tension in addition to the period of rising cavitary pressure within the left ventricle ; ¶ [0062] discloses calculation of IVCT based on the temporal points of Fig. 1; ¶¶ [0200]-[0205] depict calculation of IVCT) . With regards to claim 14, Marmor further teaches a n arterial-pressure estimation system comprising: the arterial-pressure estimation apparatus according to claim 1 (see the above analysis regarding claim 1) ; and a sensor configured to detect the blood flow (¶¶ [0079]-[0080] teaches a stethoscope, other listening device, doppler devices, may be used to determine the first brachial artery flow past the deflating cuff) . With regards to claim 15, Marmor further teaches an inflation portion configured to compress the at least one location (¶¶ [0079]-[0080] depict a deflating pressure cuff or sphygmomanometer arm cuff) . Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Clai m s 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0265163 A1 (Marmor) (cited by Applicant) , as applied to claim 1 above, in view of US 2016/0220195 A1 ( Abu-Tarif) and in view of US 11,504,013 B1 ( Young ) With regards to claim 4, Marmor teaches the arterial-pressure estimation apparatus according to claim 1. See the above rejection of claim 1 under 35 U.S.C. §102. Marmor further teaches that the sensor data includes data indicating, as the blood flow timing, a timing at which the blood flow is detected for each heartbeat (¶¶ [0075]-[0076], [0085] of Chen depict a determining a time delay between opening of the aortic valve and the sensed blood-flow breakthrough from multiple cardiac cycles (e.g., a time delay between an R wave on an electrocardiogram and a brachial pulse) during gradual deflation of a pressure cuff, which indicates that the blood-flow breakthrough times are acquired). Marmor is silent regarding whether the one or more locations is compressed multiple times while the pressure is reduced at different rates each time, and the blood flow is detected for each heartbeat in each of the multiple times; and the control unit is configured to match a timing at which the pressure starts to be reduced with the respiration cycle. In the same field of endeavor of monitoring blood pressure, Abu-Tarif teaches one or more locations is compressed multiple times while the pressure is reduced at different rates each time, and the blood flow is detected for each heartbeat in each of the multiple times ( Fig. 2 and ¶¶ [0021]- [0023] disclose varying a deflation rate (steps 226-228) based on HR as determined in block 208 or 224; ¶¶ [0018]-[0019] depict determination of HR based on pressure pulse signals for a number of cardiac pulses) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the compression of the one or more locations of Marmor to incorporate that it is performed multiple times while the pressure is reduced at different rates each time, and the blood flow is detected for each heartbeat in each of the multiple times as taught by Abu-Tarif. The motivation would have been to optimize the speed and accuracy of the determination of blood pressure (¶ [0010] of Abu-Tarif). In the same field of endeavor of monitoring blood pressure, Young teaches a control unit is configured to match a timing at which the pressure starts to be reduced with the respiration cycle (Col. 13, lines 19-31 disclose pressure ramp on the cuff can be controlled such that blood pressure measurements are taken only during a certain period (e.g., inhalation period), thereby enhancing the blood pressure measurement ) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure reduction of the above combination of Marmor in view of Abu-Tarif to occur during a certain period of the respiration cycle as taught by Young. The motivation would have been to enhance pressure measuremen t (Col. 13, lines 19-31 of Young). With regards to claim 5, Marmor teaches the arterial-pressure estimation apparatus according to claim 1. See the above rejection of claim 1 under 35 U.S.C. §102. Marmor further teaches that the sensor data includes data indicating, as the blood flow timing, a timing at which the blood flow is detected for each heartbeat (¶¶ [0075]-[0076], [0085] of Chen depict a determining a time delay between opening of the aortic valve and the sensed blood-flow breakthrough from multiple cardiac cycles (e.g., a time delay between an R wave on an electrocardiogram and a brachial pulse) during gradual deflation of a pressure cuff, which indicates that the blood-flow breakthrough times are acquired). Chen is silent regarding whether the one or more locations is compressed multiple times while the pressure is reduced at different rates each time, and the blood flow is detected for each heartbeat in each of the multiple times; and the control unit is configured to match a timing at which the pressure starts to be reduced with the respiration cycle. In the same field of endeavor of monitoring blood pressure, Abu-Tarif teaches one or more locations is compressed multiple times while the pressure is reduced at different rates each time and the pressure is reduced at a constant rate after a heartbeat at which the blood flow is detected, and the blood flow is detected for each heartbeat in each of the multiple times (Fig. 2 and ¶¶ [0021]-[0023] disclose varying a deflation rate (steps 226-228) based on HR as determined in block 208 or 224; ¶ [0022] indicates that making the deflation rate is constant if the determined HR is constant; ¶¶ [0018]-[0019] depict determination of HR based on pressure pulse signals for a number of cardiac pulses). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the compression of the one or more locations of Marmor to incorporate that it is performed multiple times while the pressure is reduced at different rates each time and the pressure is reduced at a constant rate after a heartbeat at which the blood flow is detected, and the blood flow is detected for each heartbeat in each of the multiple times as taught by Abu-Tarif. The motivation would have been to optimize the speed and accuracy of the determination of blood pressure (¶ [0010] of Abu-Tarif). In the same field of endeavor of monitoring blood pressure, Young teaches a control unit is configured to perform control to match a timing at which the pressure starts to be reduced with the respiration cycle (Col. 13, lines 19-31 disclose pressure ramp on the cuff can be controlled such that blood pressure measurements are taken only during a certain period (e.g., inhalation period), thereby enhancing the blood pressure measurement ) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure reduction of the above combination of Marmor in view of Abu-Tarif to occur during a certain period of the respiration cycle as taught by Young. The motivation would have been to enhance pressure measuremen t (Col. 13, lines 19-31 of Young). Clai ms 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0265163 A1 (Marmor) (cited by Applicant) , as applied to claim 7 above, in view of US 10,729,337 B2 (Liu) With regards to claim 9 , Marmor teaches the arterial-pressure estimation apparatus according to claim 7 . See the above rejection of claim 7 under 35 U.S.C. §102. Marmor is silent regarding whether the control unit is configured to input the estimation result of the change in the arterial pressure over time to a trained model and acquires an estimated value of the LVEDP from the trained model. In the same field of endeavor of determining blood pressure measurements, Liu teaches input ting an estimation result of a change in the arterial pressure over time to a trained model and acquires an estimated value of the LVEDP from the trained model ( Col. 2, lines 1-18 depict determination of LVEDP from a machine learning model based on a plurality of signals including at least one signal correlated with left ventricular blood pressure and at least one signal correlated with timing of heartbeat cycles of said subject’s heart; Col. 6, lines 22-31 depict the at least one signal correlated with left ventricular blood pressure corresponds to peripheral arter y blood pressure ). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the determination of LVEDP of Marmor to incorporate input ting an estimation result of a change in the arterial pressure over time to a trained model and acquires an estimated value of the LVEDP as taught by Liu. Because both the models of Marmor and Liu are capable of determining LVEDP, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. With regards to claim 10 , Marmor teaches the arterial-pressure estimation apparatus according to claim 7. See the above rejection of claim 7 under 35 U.S.C. §102. Marmor is silent regarding whether the control unit is configured to generate a trained model for acquiring an estimated value of the LVEDP by performing machine learning using at least a part of the estimation result of the change in the arterial pressure over time. In the same field of endeavor of determining blood pressure measurements, Liu teaches generat ing a trained model for acquiring an estimated value of the LVEDP by performing machine learning using at least a part of the estimation result of the change in the arterial pressure over time (Col. 2, lines 1-18 depict determination of LVEDP from a trained machine learning model based on a plurality of signals including at least one signal correlated with left ventricular blood pressure and at least one signal correlated with timing of heartbeat cycles of said subject’s heart; Col. 6, lines 22-31 depict the at least one signal correlated with left ventricular blood pressure corresponds to peripheral arter y blood pressure ). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the determination of LVEDP of Marmor to incorporate that it uses a trained model for acquiring an estimated value of the LVEDP , the train model generated by performing machine learning using at least a part of the estimation result of the change in the arterial pressure over time as taught by Liu. Because both the models of Marmor and Liu are capable of determining LVEDP, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Clai ms 13 is rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0265163 A1 (Marmor) (cited by Applicant) , as applied to claim 12 above, in view of US 10,729,337 B2 (Liu) With regards to claim 13, Marmor teaches the arterial-pressure estimation apparatus according to claim 12 . See the above rejection of claim 12 under 35 U.S.C. §102. Marmor is silent regarding whether the parameter includes a pulmonary artery pressure or a pulmonary wedge pressure. In the same field of endeavor of determining blood pressure measurements, Liu teaches estimating a parameter related to intracardiac hemodynamics based on an estimation result of the change in the arterial pressure over time, wherein the parameter includes a pulmonary artery pressure or a pulmonary wedge pressure ( Col. 2, lines 1-18 depict determination of pulmonary capillary wedge pressure (PCWP) from a trained machine learning model based on a plurality of signals including at least one signal correlated with left ventricular blood pressure and at least one signal correlated with timing of heartbeat cycles of said subject’s heart; Col. 6, lines 22-31 depict determination PCWP of based on an artery blood pressure) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Marmor to incorporate estimating a parameter related to intracardiac hemodynamics based on an estimation result of the change in the arterial pressure over time, wherein the parameter includes a pulmonary artery pressure or a pulmonary wedge pressure as taught by Marmor. The motivation would have been to provide a more complete diagnostic analysis of the patient. N o prior art rejections of claims 2-3 and 17-19 C laims 2-3 and 17-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. With regards to claims 2 and 17, the prior art does not teach or suggest “perform weighting according to an elapsed time in the inspiration period of the respiratory cycle to correct the value of the pressure corresponding to the blood flow timing included in the inspiration period ”. There are no prior art rejections of claims 3, 18, and 19 by virtue of their dependence from claims 2 and 17, respectively. US 2015/0245772 A1 (Kawamoto)( c ited by a pplicant) teaches obtain the parameters of the respiratory variation on the waveform of artery and the venous pressure at once based on the applied pressure and the pulse wave components overlapping with the applied pressure in one-time blood pressure measurement (¶ [0008]). However, Kawamoto does not teach or suggest a weighting according to an elapsed time in the inspiration period of the respiratory cycle to correct the value of the pressure corresponding to the blood flow timing included in the inspiration period. US 2016/02133332 A1 (Ukawa) (cited by applicant) teaches measuring a respiration-induced blood pressure fluctuation (¶ [0003]) and the respiration-induced blood pressure fluctuation is calculated by measuring the difference, between the expiratory and inspir atory phases, of the cuff pressure at which a Korotkoff sound begins to be heard (¶ [0006]). However, Ukawa does not teach or suggest a weighting according to an elapsed time in the inspiration period of the respiratory cycle to correct the value of the pressure corresponding to the blood flow timing included in the inspiration period. US 2016/0073905 A (Murai) teaches reduc ing the influence of respiratory variation of blood pressure by estimating a breathing period BP (combination of one inhal ation and one exhalation) corresponding to the breathing cycle from changes in blood pressure , and determining averages of blood pressure values of consecutive breathing periods (¶ [0045]) . However, Murai does not teach or suggest a weighting according to an elapsed time in the inspiration period of the respiratory cycle to correct the value of the pressure corresponding to the blood flow timing included in the inspiration period. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SAMUEL C KIM whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-8637 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8:00 AM - 5:00 PM EST . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Jacqueline Cheng can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-5596 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /S.C.K./ Examiner, Art Unit 3791 /JACQUELINE CHENG/ Supervisory Patent Examiner, Art Unit 3791
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Prosecution Timeline

Jul 07, 2023
Application Filed
Dec 16, 2025
Non-Final Rejection — §101, §102, §103 (current)

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