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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 31, 2026 has been entered.
Response to Amendment
The amendment filed July 31, 2026 has been entered.
Applicant’s amendments are sufficient to overcome the rejection under 35 U.S.C. 101.
Applicant’s amendments necessitate new grounds of rejection under 35 U.S.C. 103.
Response to Arguments
Applicant's arguments filed March 4, 2026 have been fully considered but they are not persuasive.
35 U.S.C. 101:
As discussed during the interview held July 16, 2026, the limitation “based on the controller determining that the state of the venous component satisfies the predetermined condition, change a cuff pressure of the cuff” is open-ended such that it encompasses activities which are not necessarily directed to data-gathering steps. Thus, such control of a device based on evaluation of data is not a step which is mentally performable or particular enough to be directed to insignificant extra-solution activity.
The rejection to the claims under 35 U.S.C. 101 is withdrawn.
35 U.S.C. 103
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102
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, 3-7, 9, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over:
Shelley et al. (US 20100191128 A1) (hereinafter – Shelley) in view of
Kawamoto et al. (US 11903684 B2) (hereinafter – Kawamoto) in further view of
Miyawaki et al. (US 4703760 A) (hereinafter – Miyawaki).
Re. Claims 1, 11, and 12: Shelley teaches a circulating blood volume determination apparatus (Abstract)
a controller (Paragraphs 0101-0102: particularly, “In general, it will be apparent to one of ordinary skill in the art that various embodiments described herein may be implemented in, or in association with, many different embodiments of software, firmware and/or hardware”).
While Shelley teaches a controller configured to detect a pulse wave from a sensor (Paragraph 0008: obtaining plethysmographic (PG) waveform), Shelley does not teach the invention wherein the sensor detect a pulse wave from a sensor of a cuff while the cuff is attached to a predetermined portion of a living body, wherein the controller is configured to detect the pulse wave based on a pressure received by the cuff from the predetermined portion while the predetermined portion is pressurized by the cuff at a predetermined pressure.
Kawamoto teaches the invention configured to:
detect a pulse wave from a sensor of a cuff while the cuff is attached to a predetermined portion of a living body, wherein the controller is configured to detect the pulse wave based on a pressure received by the cuff from the predetermined portion while the predetermined portion is pressurized by the cuff at a predetermined pressure (Fig. 1: cuff 2; Fig. 2: obtaining pulse wave signals and control of cuff pressure while obtaining such signals).
It would have been obvious to one having skill in the art before the effective filing date to have modified Shelley to include the use of a cuff as taught by Kawamoto, the motivation being that the invention of Shelley analyzes both peripheral venous pressure and plethysmographic signals, but measures both from separate instruments (Paragraph 0081: PPG sensor and arterial line and peripheral IV), whereby the cuff and operation thereof of Kawamoto allows for gathering both venous pressure and plethysmographic signals in a single device, forming a more compact system.
Shelley as modified by Kawamoto further teaches the invention comprising a controller configured to:
analyze a state of a venous component in the detected pulse wave (Figs. 6, 7; Paragraph 0093-0096 identification of changes in PG signal during hypovolemia and hypervolemia);
and perform a determination as to a circulating blood volume based on a result of analyzing the state of the venous component (Figs. 6, 7; Paragraph 0093-0096 assessing changes in PG signal leads to determination/identification of hypovolemia and hypervolemia).
wherein the controller is configured to determine that the circulating blood volume is excessive, based on the controller determining that the state of the venous component satisfies a predetermined condition based on the result of analyzing the state of the venous component (Fig. 6 as described in Paragraph 0095: venous component of PG signal used identify hypervolemia, i.e., excessive blood volume, based on peak height; Figs. 7-9, as described in Paragraph 0096: power spectra used to differentiate hypovolemia and hypervolemia).
Shelley as modified by Kawamoto does not teach the invention wherein the controller is configured to, based on the controller determining that the state of the venous component satisfies the predetermined condition, change a cuff pressure of the cuff.
Miyawaki teaches analogous art in the technology of analysis of pulse waves utilizing a cuff-based pulse wave sensor (Abstract). Miyawaki further teaches the controller being configured to, based on determining that the state of the venous component satisfies the predetermined condition, change a cuff pressure of the cuff (Fig. 17: step ST12, exhausting air after computation of pulse wave information in step ST4, ST9).
It would have been obvious to one having skill in the art before the effective filing date to have modified Shelley as modified by Kawamoto to include exhausting air from the cuff after determination of pulse wave parameters as taught by Miyawaki, the motivation being that doing so enables a patient to end measurement and release the cuff from their arm after processing of sufficient data has occurred.
Independent claims 11 and 12 recite limitations which are mutatis mutandis akin those recited in claim 1; thus, their rejection is analogous to that of claim 1.
Re. Claim 3: Shelley as modified by Kawamoto and Miyawaki teaches the invention according to claim 1. Shelley further teaches the invention wherein the controller is further configured to determine that the circulating blood volume is appropriate or insufficient based on the controller determining that the state of the venous component does not satisfy the predetermined condition based on the result of analyzing the state of the venous component (see portions of citations of claim 1 referring to “hypovolemia,” i.e., insufficient blood volume).
Re. Claim 7: Shelley as modified by Kawamoto and Miyawaki teaches the invention according to claim 3. Shelley further teaches the invention wherein the controller is further configured to:
calculate a pulse wave variation based on the detected pulse wave, based on the controller determining that the state of the venous component does not satisfy the predetermined condition (Figs. 6-9: variations or changes in the pulse waves are identified in cases where predetermined condition for excessive blood volume is not satisfied, i.e., hypovolemic conditions; alternatively or additionally, see calculation of the index of ventilation-induced variation (VIV) of a PG signal described at Paragraph 0081);
output the calculated pulse wave variation together with a result of the determination as to the circulating blood volume (Paragraph 0100: detected/processed data and index values may be displayed, including graphs shown in Figs. 6-9 showing; particularly, Fig. 9 shows labeled hypovolemia determination (i.e., not satisfying the predetermined condition in claim 1) and its variation); and
determine that the circulating blood volume is insufficient according to a comparison between the calculated pulse wave variation and a predetermined threshold value (Paragraph 0095: peaks quantify pulse wave variation and are compared to AC component peaks; Paragraph 0096: spectra analysis also quantifies pulse wave variation due to identifying changes in frequency content, and further distinguishes hypovolemia from hypervolemia based on the presence of spectral lines at side band frequencies).
Re. Claim 9: Shelley as modified by Kawamoto and Miyawaki teaches the invention according to claim 1. Shelley further teaches the invention wherein the predetermined condition is a condition for a predetermined statistical index value of the pulse wave (Paragraphs 0095 and 0096 considers maximum (peak, highest frequency) values relative to certain thresholds, such as AC component states and high frequency band presence, which encompass the definition of statistical parameter as recited by Applicant’s Specification at Paragraph 0034: “The statistical index value includes, for example, at least one of an average pressure value, a maximum pressure value, a minimum pressure value, a sum of squares, RMS, a variance, a gradient, a kurtosis, and a skewness”).
Re. Claim 5: Shelley as modified by Kawamoto and Miyawaki teaches the invention according to claim 1. Kawamoto, in teaching particulars of the incorporated subject matter, further teaches the invention wherein the controller is further configured to detect the pulse wave in a process of increasing, to the predetermined pressure, a pressure at which the predetermined portion is pressurized by the cuff, the process of increasing the pressure including a process of maintaining the pressure at the predetermined pressure (Col. 12, lines 56-58: “Further, the cuff pressure may be stepwise or continuously increased to obtain the mean venous pressure during the pressurization process (the second process)”),
the controller is further configured to:
calculate a venous pressure based on the detected pulse wave, based on the controller determining that the state of the venous component satisfies the predetermined condition based on the result of analyzing the state of the venous component (see previous citation – determination of venous pressure implies the existence of a venous pressure determination unit; Fig. 2: average venous pressure is calculated as final step, thus encompassing scenarios in which, as best understood, a predetermined condition is met);
and output the calculated venous pressure together with a result of the determination as to the circulating blood volume (Fig. 7: such display implies the existence of an output unit; see also – citations of Paragraph 0100 Shelley regarding display of obtained data in rejection of claim 7).
Re. Claim 6: Shelley as modified by Kawamoto and Miyawaki teaches the invention according to claim 5. Kawamoto, in teaching particulars of the incorporated subject matter, further teaches the invention wherein the controller is further configured to output an alarm warning that the circulating blood volume is excessive based on the controller determining that the state of the venous component satisfies the predetermined condition (Fig. 7: display possesses warning of insufficient or excessive circulation amounts; see also citations of Huiku of claim 10).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over:
Shelley et al. (US 20100191128 A1) (hereinafter – Shelley) in view of
Kawamoto et al. (US 11903684 B2) (hereinafter – Kawamoto) in further view of
Miyawaki et al. (US 4703760 A) (hereinafter – Miyawaki) in further view of
Mestek et al. (US 20130226009 A1) (hereinafter – Mestek).
Re. Claim 8: Shelley as modified by Kawamoto and Miyawaki teaches the invention according to claim 1, but does not teach the invention wherein the predetermined condition is that a value of a predetermined percentile of the pulse wave is less than a predetermined threshold value, the predetermined percentile being a percentile of a time length of the pulse wave, and
the controller is further configured to analyze the state of the venous component in the pulse wave by calculating the predetermined percentile of the pulse wave.
Mestek teaches analogous art in the technology of monitoring hypovolemia (Abstract). Mestek teaches identifying features of a plethysmographic waveform including what can be identified as a “percentile of a time length of the pulse wave,” i.e., peak-to-peak variation 112 and/or trough-to-trough variation 114 (Fig. 4). Mestek utilizes both of these features and trends thereof to determine hypovolemia risk (Paragraph 0055; claims 9-13).
It would have been obvious to one having skill in the art before the effective filing date to have modified Shelley as modified by Kawamoto and Miyawaki to further include analysis of features encompassing percentile time length of a PG waveform as taught by Mestek, the motivation being that doing so provides the invention with an alternative method of identifying hypovolemia which can be used to validate the method of Shelley.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over:
Shelley et al. (US 20100191128 A1) (hereinafter – Shelley) in view of
Kawamoto et al. (US 11903684 B2) (hereinafter – Kawamoto) in further view of
Miyawaki et al. (US 4703760 A) (hereinafter – Miyawaki) in further view of
Huiku (US 20100081942 A1) (hereinafter – Huiku).
Re. Claim 10: Shelley as modified by Kawamoto and Miyawaki teaches the invention according to claim 7, but does not teach the invention wherein the controller is further configured to output an alarm warning that the circulating blood volume is insufficient based on the controller determining that the circulating blood volume is insufficient.
Huiku teaches the invention wherein the controller is further configured to output an alarm warning that the circulating blood volume is insufficient based on the controller determining that the circulating blood volume is insufficient (Paragraph 0061: “In one embodiment, the indicator unit may thus display the SPV, dPP and/or dDown and the hemoglobin concentration trends and indicate in an alarm or message field additional information about the possible reasons of the volemia status”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Shelley as modified by Kawamoto and Miyawaki to output an alarm based on a state of volemia status as taught by Huiku, the motivation being that doing so would be beneficial to the goal Shelley, i.e., monitoring fluid status during fluid replacement (Abstract, Paragraph 0046), whereby alarm warnings would allow caregivers to distinguish between different states of volemia and further allow caregivers to intervene at moments when sufficient levels of volemia arise.
Conclusion
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/JUSTIN XU/ Primary Examiner, Art Unit 3791
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