DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed March 4, 2026 has been entered.
Applicant’s amendments have obviated interpretation of the claims under 35 U.S.C. 112(f) and rejections to the claims under 35 U.S.C. 112(b).
Applicant’s amendments are insufficient 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:
Regarding Applicant’s argument:
“For example, independent claim 1 describes analysis regarding a specific component (i.e., a venous component) that is specifically in a pulse wave from a sensor attached to a predetermined portion of a living body, a determination specifically regarding a circulating blood volume specifically based on a result of analyzing the state of the venous component, and specifically determining that the circulating blood volume is excessive, based specifically 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. Applicant submits that independent claims 11 and 12 also recite similar claim features.”
Further specifying specifics or particulars of an abstract idea or necessary data-gathering steps or components therefor does not make the abstract idea any less abstract. Additionally, in the previous Non-Final Office Action, Examiner does not assign the entirety of claim features as being directed to a judicial exception, with clear labeling of additional elements provided. The updated rejection under 35 U.S.C. 101 similarly delineates what is considered a judicial exception and what is considered an additional element.
Regarding Applicant’s argument:
“Applicant submits that the specific features of independent claim 1 (and similarly independent claims 11-12) achieve improvements to the technical field of circulating blood volume determination by providing a particular implementation that avoids highly invasive measures, and enables an accurate determination in a short time whether a procedure for making a circulating blood volume appropriate is necessary. See, e.g., Specification as filed at [0001]- [0013]. In contrast, the Specification as filed at [0005]-[0007] describes that other systems may be highly invasive and/or cannot accurately determine the stop or start of the fluid infusion in a short time.”
The technical field which Applicant performs comparison to is the field of invasive measurement for blood volume determination (see Specification, Paragraph 0005). Applicant does not improve on this field, but performs a differing method of assessing blood volume interpretation. Applicant neglects to make comparison to analogous technology, i.e., analysis of plethysmographic waveforms to assess blood volume status. Such technology is considered well-understood, routine, and conventional by at least:
Chon et al. (US 20120296219 A1) – Paragraph 0006: “Conventional devices use a PPG signal to non-invasively detect blood and fluid loss. Conventional systems also observe respiratory-induced variations in PPG signal amplitude for exaggerations that might relate to blood volume loss in mechanically ventilated patients;”
Shelley et al. (US 20100191128 A1) – Paragraph 0032: see cited papers, and particularly, “It has been shown that the responses of peripheral waveforms to respiration can be used as an indicator of hypovolemia. More specifically, arterial pressure waveforms in the periphery (e.g., radial artery) demonstrate increased systolic pressure variations in the context of hypovolemia (as a result of ventilation affecting venous return to the heart and hence affecting left ventricular stroke volume);”
Hu et al. (US 20190387972 A1) – Paragraph 0005: describing conventional PPG pulse oximeter operation and their use in determining blood volume variations and hypovolemia;
O’Brien et al. (US 20240156355 A1) – Paragraph 0041: “Optical spectroscopy-based tools have been developed for in vitro and in vivo measurement of hemoglobin, and continuous noninvasive optical spectroscopy tools have been used extensively in critical care patients to monitor changes in Hb concentration caused by hypovolemia;”
Thus, the technology which Applicant alleges as making an improvement upon is merely directed to a differing method of assessing blood volume, whereby Applicant does not provide evidence that their invention provides an alleged improvement to the more analogous and known technology of plethysmography-based blood volume monitoring.
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. A more explicit reference has been provided which clearly identifies a “venous component” of a plethysmographic waveform.
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 and 3-12 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 claims 1, 11, and 12 each similarly recite:
controller configured to detect a pulse wave from a sensor attached to a predetermined portion of a living body (additional element, data-gathering);
analyze a state of a venous component in the detected pulse wave (judgement or evaluation);
perform a determination as to a circulating blood volume based on the analysis result of the analysis unit (judgement or evaluation),
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 (additional element, judgement or evaluation).
Independent claims 11 and 12 recite limitations which are mutatis mutandis akin those recited in claim 1; thus, their analysis is analogous to that of claim 1.
As indicated above, independent claim 1 recites at least one step or instruction grouped as a mental process. Therefore, each of the independent claims recites an abstract idea. Each limitation, aside from language reciting a generic computer components, can be grouped as a mental process (see italicized portions above), and is addressed as follows:
The limitation of analyze a state of a venous component in the detected pulse wave amounts to no more than an individual performing appropriate evaluation or judgement on gathered data, which is a mental process.
The limitation of perform a determination as to a circulating blood volume based on the analysis result of the analysis unit is merely a further step the mental process of evaluation or judgement recited in the previous step.
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.
The dependent claims merely include limitations that either further define the abstract idea (e.g. limitations relating to the data gathered or particular steps which are entirely embodied in the mental process) and amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data (Int. Ventures v. Cap One Financial), collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group), collection, storage, and recognition of data (Smart Systems Innovations).
Step 2A, Prong 2
The above-identified abstract idea is not integrated into a practical application because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use.
More specifically:
Independent claim 1 recites the following additional elements:
a controller
a sensor
Such an additional element is generically recited and does not improve the functioning of a computer or any other technology or technical field. The claim recites merely acquiring data from a generically recited sensor, having no operative connection to the controller besides 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.
The terms controller is recited at a high-level of generality (i.e., as components of a generically-recited computer/memory performing generic computer functions of performing receiving data and performing calculations thereon) such that it amounts no more than mere instructions to apply the exception using a generic computer.
Thus, such additional elements do not serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified generically recited elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea is not integrated into a practical application.
Independent claims 11 and 12 recite a generically-recited sensor which performs an identical action to the sensor recited in claim 1, amounting to no more than an extra-solution data-gathering component. Independent claim 11 further recites “[a] non-transitory computer-readable storage medium that stores a circulating blood volume determination program,” which amounts to no more than implementing the abstract idea on a computer.
In each independent claim, 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 these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract ideas identified above in the independent claims (and their respective dependent claims) are not integrated into a practical application.
Dependent claims 2 and 3 recite further limitations directed to the abstract idea.
Dependent claim 4 further specifies that the sensor is a cuff, and particulars of the data gathered (“pulse wave… while the predetermined portion is pressurized by the cuff at a predetermined pressure). Such a cuff is generically recited element for gathering data.
Dependent claim 5 further specifies details of the data-gathering steps of the detection unit and further recites a venous pressure calculation unit (which performs abstract idea steps of further evaluation carried out through generic computer components) and output unit (which is a generic computer component amounting to display of results of data, which is extra-solution activity).
Dependent claim 6 specifies providing a warning based on the result of the abstract idea step of evaluation, which is extra-solution activity.
Dependent claim 7 recites a pulse wave variation unit (which is understood to be a generic processor component which performs abstract idea evaluation steps on received data) and output unit (which is a generic computer component amounting to display of results of data, which is extra-solution activity).
Dependent claims 8 and 9 recite further limitations directed to the abstract idea.
Dependent claim 10 specifies providing a warning based on the result of the abstract idea step of evaluation, which is extra-solution activity.
Accordingly, the claims are each directed to an abstract idea.
Step 2B
None of the claims include additional elements that, when viewed as a whole, are sufficient to amount to significantly more than the abstract idea for at least the following reasons:
Independent claim 1 recites the following additional elements:
a detection unit;
a sensor;
an analysis unit;
a determination unit.
Again, as best understood, a detection unit operates as merely a generically-recited component which receives sensor data.
As per Applicant’s Paragraph 0057, a sensor is described as any which is capable of detecting a pulse wave, such as via photelectric volume pulse or via a cuff. No special programming or algorithms is indicated for how such sensors operate. This lack of disclosure is acceptable under 35 U.S.C. 112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware (e.g., a cuff-based occlusive sensor or PPG sensor) is conventional and performs well understood, routine and conventional activities in the medical technology industry or medical technology arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The analysis unit and determination unit are also considered generic/conventional. As per Applicant’s disclosure, such units are components of a control unit 150 (Fig. 3), whereby such a control unit 150 “may be a dedicated medical device for testing circulating blood volume, or may be a personal computer, a smartphone, a tablet terminal, or the like in which a program for testing the circulating blood volume is installed” (Paragraph 0026). Accordingly, in light of Applicant’s specification, the analysis unit and determination unit are reasonably construed as implementation of abstract idea steps on a generic computing device.
Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear from the claims themselves and the specification that these limitations require no improved computer resources and merely utilize already available computers with their already available basic functions to use as tools in executing the claimed process.
Dependent claim 3 recite further limitations directed to the abstract idea and do not recite additional elements that, when viewed in combination with limitations of claim 1, are sufficient to amount to significantly more than the abstract idea.
Dependent claim 4 further specifies that the sensor is a cuff, and particulars of the data gathered (“pulse wave… while the predetermined portion is pressurized by the cuff at a predetermined pressure). The use of a cuff for acquiring pulse wave data is considered well-known, routine, and conventional, with Applicant’s disclosure stating that techniques for cuff-based pulse wave acquisition are known (Paragraph 0006). Examiner further notes that the well-known concepts of oscillometry and sphygmomanometry also involves acquisition of pulse waves via a cuff.
Dependent claims 5-7 and 10 recite limitations which amount to no more than instructions to implement abstract idea steps on a generic computer (see each term containing “unit”) or appending extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea. See MPEP 2106.05.II.
Dependent claims 8 and 9 recite further limitations directed to the abstract idea and do not recite additional elements that, when viewed in combination with limitations of claim 1, are sufficient to amount to significantly more than the abstract idea..
The recitation of the above-identified additional limitations in the claims amount to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
For at least the above reasons, the claims are directed to applying an abstract idea on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. In other words, none of the claims provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in the independent claims do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment (assessing blood volume). 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.
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. 102(a)(1) as being anticipated by:
Shelley et al. (US 20100191128 A1) (hereinafter – Shelley).
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”)
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).
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 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 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 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”).
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.
Claims 4-6 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).
Re. Claim 4: Shelley teaches the invention according to claim 1. Shelley does not teach the invention wherein the sensor is a cuff, and the controller is further configured to detect the pulse wave based on a pressure received by the cuff from a predetermined portion while a predetermined portion is pressurized by the cuff at a predetermined pressure.
Kawamoto teaches the invention wherein
the sensor is a cuff (Fig. 1: cuff 2), and
the controller is further configured to detect the pulse wave based on a pressure received by the cuff from a predetermined portion while a predetermined portion is pressurized by the cuff at a predetermined pressure (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
Re. Claim 5: Shelley as modified by Kawamoto teaches the invention according to claim 4. 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 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
Mestek et al. (US 20130226009 A1) (hereinafter – Mestek).
Re. Claim 8: Shelley 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 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
Huiku (US 20100081942 A1) (hereinafter – Huiku).
Re. Claim 10: Shelley 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 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
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/ Primary Examiner, Art Unit 3791
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