DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I, Claims 1 – 12 drawn to a method configured to provide adaptive and closed loop hemorrhagic shock resuscitation using an automated tourniquet and controller, in the reply filed on 12 August 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13 – 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12 August 2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
200 as shown in Figure 2.
501 as shown in Figure 5.
507b as shown in Figure 5.
507c as shown in Figure 5.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 11 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 8 recites “detecting, based on the component pressure measurement, hemorrhage associated with a first appendage of the patient.” The limitation “hemorrhage” lacks antecedent basis. The Examiner suggests amending this limitation to recite “a hemorrhage” to provide antecedent basis for the claim limitation.
Claim 11 recites “wherein the causing activation of the automated tourniquet comprises…”. However, this causing activation step lacks antecedent basis based on the dependency of Claim 11. Claim 11 depends upon Claim 1 while the causing activation step of the automated tourniquet is recited in Claim 6.
Claim Interpretation
Claim 1 recites “[a] method configured to provide adaptive and closed loop hemorrhagic shock resuscitation using an automated tourniquet and an adaptive resuscitation controller, the method comprising…”. Any terminology in the preamble that limits the structure of the claimed invention must be treated as a claim limitation. See, e.g., Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257, 9 USPQ2d 1962, 1966 (Fed. Cir. 1989); MPEP 2111.02(I). The Examiner interprets the preamble of Claim 1 to recite the functional claim language of “configured to provide adaptive and closed loop hemorrhagic shock resuscitation” while positively reciting “an automated tourniquet and an adaptive resuscitation controller.” The Examiner bases this interpretation on dependent Claims 6 and 11 each reciting “the automated tourniquet” The limitation of “the automated tourniquet” of Claims 6 and 11 receives antecedent basis from the recitation of “an automated tourniquet” within the preamble of Claim 1. If the Applicant did not intend to positively recite the “automated tourniquet” within Claim 1 then the Examiner suggests clarifying the claim language of Claims 6 and 11 and providing an explanation of the claim scope within rebuttal arguments.
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.
Claim(s) 1 – 4, 6, 7, and 9 – 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hahn et al. (US 2020/0038587 A1) (hereinafter referred to as “Hahn”) and Snider et al. (NPL – Supervisory Algorithm for Autonomous Hemodynamic Management Systems) (hereinafter referred to as “Snider NPL”).
Hahn is cited within the IDS dated 1 July 2024.
With regard to claim 1, Hahn discloses method (200) (see [0030] and Figure 2) configured to provide adaptive and closed loop hemorrhagic shock resuscitation using an adaptive resuscitation controller (101) (see [0021] and [0030]), the method comprising:
causing activation of the adaptive resuscitation controller by:
determining a desired mean arterial pressure setpoint (see [0023] “In some implementations, information associated with a population may also be provided via input 102. In addition, a user may provide selections for time range of data analysis, or one or more desirable thresholds for particular CV parameters (such as, for example, high and low BP thresholds),” [0034] “For example, measured BP can be used to calculate mean arterial pressure (MAP) (as such, herein, any reference to BP may refer to BP or MAP, and vice versa)” and [0045] “in aspects where there is a low threshold and a high threshold, a goal range may be set (that is, a range between the low threshold and the high threshold), and process block 212 may include determining a probability that BP will remain within the goal range.” Here the desired mean arterial pressure setpoint is the disclosed goal range); and
causing, based on the desired mean arterial pressure setpoint, the adaptive resuscitation controller to infuse a first quantity of fluids into a patient (see step 216 in Figure 2 and [0052] “Alternatively, or additionally, process block 214 may include generating a report as an output for controlling a treatment unit to automatically administer a fluid volume at process block 216.”);
monitoring blood pressure parameters of the patient (see step 202 in Figure 2 and [0053] “ process blocks 202-214 (or process blocks 202-216) may be repeated in a loop so that new reports are periodically generated based on updated information (that is, new CV data and new volume administration information)”); and
based on comparing the blood pressure parameters to the desired mean arterial pressure setpoint, causing the adaptive resuscitation controller to infuse a second quantity of fluids into the patient (see [0053] “ process blocks 202-214 (or process blocks 202-216) may be repeated in a loop so that new reports are periodically generated based on updated information (that is, new CV data and new volume administration information)”).
However, Hahn is silent with regards to the method using an automated tourniquet.
Nonetheless Snider NPL, which is within the analogous art of supervisory algorithm for autonomous hemodynamic management systems (see abstract and title), teaches a method configured to provide adaptive and closed loop hemorrhagic shock resuscitation using an automated tourniquet and an adaptive resuscitation controller (see page 2 “As an initial proof of concept for a simple supervisory algorithm, we integrated the performance of our closed-loop tourniquet controller [16] and our closed-loop hemorrhage resuscitation controller [17] as deployed in a physiologically relevant benchtop model of hemorrhage and resuscitation.” Also see Figure 1 on page 3 and the disclosure on page 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Hahn in view of a teaching of Snider NPL such that the method is configured to provide adaptive and closed loop hemorrhagic shock resuscitation using an automated tourniquet and an adaptive resuscitation controller. One of ordinary skill in the art would have been motivated to make this modification because using a tourniquet stops the extremity bleeding by activating. See page 4 of Snider NPL. Additionally, the method configured to provide adaptive and closed loop hemorrhagic shock resuscitation using an automated tourniquet and an adaptive resuscitation controller allows for the management of complex patients like combat causalities without the need for repeated intervention by a healthcare professional. Rather the system performs the casualty management treatment. See Abstract of Snider NPL.
The method of Hahn modified in view of a teaching of Snider NPL will hereinafter be referred to as the method of Hahn and Snider NPL.
With regard to claim 2, the method of Hahn and Snider NPL teaches the claimed invention of claim 1, and Hahn further teaches wherein the determining the desired mean arterial pressure setpoint comprises:
determining, based on the desired mean arterial pressure setpoint, a plurality of different intermediate mean arterial pressure setpoints (see [0023] “In some implementations, information associated with a population may also be provided via input 102. In addition, a user may provide selections for time range of data analysis, or one or more desirable thresholds for particular CV parameters (such as, for example, high and low BP thresholds),” [0034] “For example, measured BP can be used to calculate mean arterial pressure (MAP) (as such, herein, any reference to BP may refer to BP or MAP, and vice versa)” and [0045] “in aspects where there is a low threshold and a high threshold, a goal range may be set (that is, a range between the low threshold and the high threshold), and process block 212 may include determining a probability that BP will remain within the goal range.” Here the plurality of different intermediate mean arterial pressure setpoints is any of the mean arterial pressures along the goal range)
wherein the causing the adaptive resuscitation controller (100) to infuse the first quantity of fluids into the patient is based on a first intermediate mean arterial pressure setpoint of the plurality of different intermediate mean arterial pressure setpoints (see step 216 in Figure 2 and [0052] “Alternatively, or additionally, process block 214 may include generating a report as an output for controlling a treatment unit to automatically administer a fluid volume at process block 216.”), and
wherein the causing the adaptive resuscitation controller to infuse the second quantity of fluids into the patient is based on a second intermediate mean arterial pressure setpoint of the plurality of different intermediate mean arterial pressure setpoints (see [0053] “ process blocks 202-214 (or process blocks 202-216) may be repeated in a loop so that new reports are periodically generated based on updated information (that is, new CV data and new volume administration information)”).
With regard to claim 3, the method of Hahn and Snider NPL teaches the claimed invention of claim 1, however, Hahn is silent with regards to the method further comprising:
determining a correction factor based on a difference between:
a predicted time of an increase in mean arterial pressure, and
an actual time of an increase in mean arterial pressure indicated by the blood pressure parameters of the patient,
wherein the causing the adaptive resuscitation controller to infuse the second quantity of fluids into the patient is based on the correction factor.
Nonetheless Snider NPL, which is within the analogous art of supervisory algorithm for autonomous hemodynamic management systems (see abstract and title), the method further comprising:
determining a correction factor (see page 3 and the formula for the correction factor) based on a difference between:
a predicted time of an increase in mean arterial pressure (see tpredicted within the page 3 formula), and
an actual time of an increase in mean arterial pressure indicated by the blood pressure parameters of the patient (see tactual within the page 3 formula),
wherein the causing the adaptive resuscitation controller to infuse the second quantity of fluids into the patient is based on the correction factor (see last paragraph on page 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Hahn and Snider NPL in view of a further teaching of Snider such that the method further comprises determining a correction factor based on a difference between: a predicted time of an increase in mean arterial pressure, and an actual time of an increase in mean arterial pressure indicated by the blood pressure parameters of the patient, wherein the causing the adaptive resuscitation controller to infuse the second quantity of fluids into the patient is based on the correction factor. One of ordinary skill in the art would have been motivated to make this modification because Snider teaches that this correction factor helps address complex patient injuries by making up for the time required to achieve a MAP increase. See abstract, page 3, and page 18 of Snider NPL.
With regard to claim 4, the method of Hahn and Snider NPL teaches the claimed invention of claim 1, and Hahn further teaches wherein the causing the adaptive resuscitation controller (100) to infuse the second quantity of fluids into the patient (see [0053] “ process blocks 202-214 (or process blocks 202-216) may be repeated in a loop so that new reports are periodically generated based on updated information (that is, new CV data and new volume administration information)”) comprises:
determining a volume-pressure relationship between:
one or more of:
a total fluid volume associated with the patient (see step 204 in Figure 2 and [0031] “previous volume administration information is obtained” when the process has been repeated multiple times see [0039], [0053], and Figure 3); or
a volume of the first quantity of fluids (see step 204 in Figure 2 and [0031] “previous volume administration information is obtained” when the process has been repeated only once see [0053]); and
at least one of the blood pressure parameters (see step 202 in Figure 2 and [0053] “ process blocks 202-214 (or process blocks 202-216) may be repeated in a loop so that new reports are periodically generated based on updated information (that is, new CV data and new volume administration information)”) , and
determining, based on the volume-pressure relationship, a volume of the second quantity of fluids (see [0053] “ process blocks 202-214 (or process blocks 202-216) may be repeated in a loop so that new reports are periodically generated based on updated information (that is, new CV data and new volume administration information)”).
With regard to claim 6, the method of Hahn and Snider NPL teaches the claimed invention of claim 1, however Hahn is silent with regards to the method further comprising:
causing activation of the automated tourniquet by causing the automated tourniquet to increase pressure of a component of the automated tourniquet to impede extremity bleeding of a patient;
monitoring component pressure measurements corresponding to the component of the automated tourniquet; and
based on the component pressure measurements, causing modification of one or more operating parameters of the automated tourniquet by:
detecting air pressure oscillations in the component; and
increasing a volume of air in the component.
Nonetheless Snider NPL, which is within the analogous art of supervisory algorithm for autonomous hemodynamic management systems (see abstract and title), teaches the method further comprising:
causing activation of the automated tourniquet by causing the automated tourniquet to increase pressure of a component of the automated tourniquet to impede extremity bleeding of a patient (see page 4 “the aTKT sub-component could perform its function of arresting uncontrolled hemorrhage in an extremity [16], while ARC could perform fluid resuscitation should the subject drop their MAP value from hemorrhagic shock…The aTKT independently was able to tighten the tourniquet and verified that the hemorrhage had stopped.” See also page 11 which recites “re-inflated by aTKT”);
monitoring component pressure measurements corresponding to the component of the automated tourniquet (see page 4 “For detecting loosening of the tourniquet, SACM relied on input from aTKT, which was modified for this study to check for detection of air pressure oscillations in the cuff after tourniquet engagement (indicating a likely rebleed) as well as large drops in air pressure from the previous engagement (>33%, suggesting mechanical failure)”); and
based on the component pressure measurements, causing modification of one or more operating parameters of the automated tourniquet by:
detecting air pressure oscillations in the component; and
increasing a volume of air in the component (see page 4 “For detecting loosening of the tourniquet, SACM relied on input from aTKT, which was modified for this study to check for detection of air pressure oscillations in the cuff after tourniquet engagement (indicating a likely rebleed) as well as large drops in air pressure from the previous engagement (>33%, suggesting mechanical failure). If SACM detected that the tourniquet was loose, it intervened by initiating aTKT as a separate and independent process, so it ran concurrently with the supervisory algorithm. The aTKT was able to operate normally to retighten the tourniquet and stop the extremity bleed.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Hahn and Snider NPL in view of a further teaching of Snider NPL such that the method further comprising: causing activation of the automated tourniquet by causing the automated tourniquet to increase pressure of a component of the automated tourniquet to impede extremity bleeding of a patient; monitoring component pressure measurements corresponding to the component of the automated tourniquet; and based on the component pressure measurements, causing modification of one or more operating parameters of the automated tourniquet by: detecting air pressure oscillations in the component; and increasing a volume of air in the component.
One of ordinary skill in the art would have been motivated to make this modification because Snider NPL teaches that this process allows for the tourniquet to be retightened and stop the extremity bleed upon detection of air pressure oscillations or large drops in air pressure from the previous engagement. See abstract and page 4 of Snider NPL.
With regard to claim 7, the method of Hahn and Snider NPL teaches the claimed invention of claim 6, however Hahn is silent with regards to wherein the causing the adaptive resuscitation controller to infuse the second quantity of fluids into the patient comprises causing the adaptive resuscitation controller to infuse the second quantity of fluids into the patient at the same time as causing modification of the one or more operating parameters of the automated tourniquet.
Nonetheless Snider NPL, which is within the analogous art of supervisory algorithm for autonomous hemodynamic management systems (see abstract and title), teaches the causing the adaptive resuscitation controller to infuse the second quantity of fluids into the patient comprises causing the adaptive resuscitation controller to infuse the second quantity of fluids into the patient at the same time as causing modification of the one or more operating parameters of the automated tourniquet (see Fig. 1, the volumetric infusion flow rate on page 2, page 4 “As all three algorithms (SACM, ARC, and aTKT) were designed to run concurrently during this monitoring phase, at any given time the system was capable of re-tightening a loose tourniquet while simultaneously performing a hemorrhagic shock fluid resuscitation,” and Figure 7 which shows the resuscitation with ARC from time points 3 - 4 which is after the resuscitation with ARC from time points 2 – 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Hahn and Snider NPL in view of a further teaching of Snider such that the causing the adaptive resuscitation controller to infuse the second quantity of fluids into the patient comprises causing the adaptive resuscitation controller to infuse the second quantity of fluids into the patient at the same time as causing modification of the one or more operating parameters of the automated tourniquet. One of ordinary skill in the art would have been motivated to make this modification because Snider NPL teaches that the tightening of the automated tourniquet and infusion of the second quantity of fluids can occur simultaneously to treat complex patients. See Abstract and page 4 of Snider NPL.
With regard to claim 9, the method of Hahn and Snider NPL teaches the claimed invention of claim 6, however Hahn is silent with regard to wherein the causing the adaptive resuscitation controller to infuse the second quantity of fluids into the patient is further based on the component pressure measurements.
Nonetheless Snider NPL, which is within the analogous art of supervisory algorithm for autonomous hemodynamic management systems (see abstract and title), the causing the adaptive resuscitation controller (ARC) to infuse the second quantity of fluids into the patient is further based on the component pressure measurements (see Figure 1, see pages 12 – 14, and Figures 7 - 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Hahn and Snider NPL in view of a further teaching of Snider NPL such that the causing the adaptive resuscitation controller to infuse the second quantity of fluids into the patient is further based on the component pressure measurements. One of ordinary skill in the art would have been motivated to make this modification because Snider teaches that this configuration of the method step allows for the managing of complex combat causalities using an automated tourniquet and adaptive resuscitation controller. See abstract and pages 12 – 14.
With regard to claim 10, the method of Hahn and Snider NPL teaches the claimed invention of claim 6, however Hahn is silent with regards to wherein the causing modification of the one or more operating parameters of the automated tourniquet is further based on the blood pressure parameters of the patient.
Nonetheless Snider NPL, which is within the analogous art of supervisory algorithm for autonomous hemodynamic management systems (see abstract and title), teaches the causing modification of the one or more operating parameters of the automated tourniquet is further based on the blood pressure parameters of the patient (see page 4 “As all three algorithms (SACM, ARC, and aTKT) were designed to run concurrently during this monitoring phase, at any given time the system was capable of re-tightening a loose tourniquet while simultaneously performing a hemorrhagic shock fluid resuscitation,” page 9 “Then, an extremity bleed was induced (bleed site from the silicone arm analogue). At this point, SACM was initiated, which initially activated aTKT (Figure 5A, Interval 1–2). The activation of aTKT applied incremental increasing tourniquet pressures (Figure 5B, Interval 1–2), which caused the MAP distal to the arm to fall to near zero; however, the central MAP in the system remained near 75 mmHg (Figure 5C, Interval 1–2),” Page 11 “As with Scenario #1, the initial hemorrhage reduced the MAP distal to the arm and the central MAP to around 75 mmHg (Figure 6A, Interval 0–1). The extremity bleed was initiated and SACM activated aTKT to engage the tourniquet (Figure 6B, Interval 1–2), which reduced the MAP distal to the arm to near zero, while the central MAP was stabilized (Figure 6A,C, Interval 1–2).” Figures 5 – 6, and page 16 “Next, we highlighted the effect a secondary internal hemorrhage had on SACM. This resulted in a reduction in blood pressure that the aTKT was not capable of stopping, leading to resuscitation and indication of a secondary hemorrhage to the end user by ARC”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Hahn and Snider NPL in view of a further teaching of Snider NPL such that the causing modification of the one or more operating parameters of the automated tourniquet is further based on the blood pressure parameters of the patient. One of ordinary skill in the art would have been motivated to make this modification because Snider NPL teaches that the tourniquet can be used to tighten around a bleed in the extremity until the bleed is controlled. See the Abstract and page 6 of Snider NPL. Additionally, the retightening of the tourniquet prevents any inadvertent loosening from occurring.
With regard to claim 11, the method of Hahn and Snider NPL teaches the claimed invention of claim 1, however Hahn is silent with regards to wherein the causing activation of the automated tourniquet comprises deactivating an automatic functioning of the automated tourniquet, and wherein causing activation of the adaptive resuscitation controller comprises deactivating an automatic functioning of the adaptive resuscitation controller.
Nonetheless Snider NPL, which is within the analogous art of supervisory algorithm for autonomous hemodynamic management systems (see abstract and title), teaches the causing activation of the automated tourniquet comprises deactivating an automatic functioning of the automated tourniquet, and wherein causing activation of the adaptive resuscitation controller comprises deactivating an automatic functioning of the adaptive resuscitation controller (see page 4 “The system, as designed, assumed that the subject had a bleeding extremity and was entering hemorrhagic shock (Figure 1B). Upon manually being started, SACM initiated the active intervention phase in which it sequentially acted to stop the bleed in the affected extremity and then moved to manage the hypovolemic shock. SACM first engaged the tourniquet to stop the extremity bleed by activating and yielding system control to the a TKT sub-component. The aTKT independently was able to tighten the tourniquet and verified that the hemorrhage had stopped. Once aTKT completed its operation, it returned control to SACM, which proceeded to activate the ARC sub-component. ARC automatically performed hemorrhagic shock resuscitation by infusing fluids until it detected that a target MAP had been reached. The ARC was allowed to complete its operation and then returned control to the supervisory algorithm. It was at this point that the system entered a “monitoring and intervention” phase.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Hahn and Snider NPL in view of a further teaching of Snider such that the method further comprises the causing activation of the automated tourniquet comprises deactivating an automatic functioning of the automated tourniquet, and wherein causing activation of the adaptive resuscitation controller comprises deactivating an automatic functioning of the adaptive resuscitation controller. One of ordinary skill in the art would have been motivated to make this modification because Snider NPL teaches that this configuration allows the system to enter a monitoring and intervention phase thereby allowing the system to address the complicated injuries to the patient’s as the system senses them without requiring direct intervention by a healthcare professional. See abstract and page 4 of Snider NPL.
With regard to claim 12, the method of Hahn and Snider NPL teaches the claimed invention of claim 1, however Hahn is silent with regards to further comprising:
based on determining that the blood pressure parameters are within a user-defined error level of the desired mean arterial pressure setpoint, causing the adaptive resuscitation controller to cease infusion of fluids.
Nonetheless Snider NPL, which is within the analogous art of supervisory algorithm for autonomous hemodynamic management systems (see abstract and title), teaches based on determining that the blood pressure parameters are within a user-defined error level of the desired mean arterial pressure setpoint, causing the adaptive resuscitation controller (ARC) to cease infusion of fluids (see Figure 1 at step < 85 mmHg and the “no” arrow; wherein when the ARC is not run there is a cease in the infusion of fluids) (Additionally, see page 2 “This process of infusing to an intermediate setpoint and calculating a new one continued to loop until the measured MAP was within 99.5% of the overall target setpoint”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Hahn and Snider NPL in view of a further teaching of Snider NPL such that the method further comprises based on determining that the blood pressure parameters are within a user-defined error level of the desired mean arterial pressure setpoint, causing the adaptive resuscitation controller to cease infusion of fluids. One of ordinary skill in the art would have been motivated to make this modification because Snider NPL teaches that the system would continue infuse additional volumes of fluid until the MAP is above < 85 mmHg. Upon the MAP being above this threshold then the ARC would not operate thereby ceasing infusion of further fluids. See abstract and figure 1 of Snider NPL. By ceasing fluid infusion, a patient is prevented from receiving more fluid than their body can handle during resuscitation procedures.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being obvious over Hahn and Snider NPL as applied to claim 1 above, and further in view of Vega et al. NPL – Adaptive closed-loop resuscitation controllers for hemorrhagic shock resuscitation (hereinafter referred to as “Vega NPL”).
Vega NPL is cited in the IDS dated 1 July 2024.
With regard to claim 5, the method of Hahn and Snider NPL teaches the claimed method of claim 1, however, Hahn is silent with regards to wherein the comparing the blood pressure parameters to the desired mean arterial pressure setpoint comprises:
determining, based on a Dubick constant of approximately 0.337 ml/mmHg/kg, a volume of the second quantity of fluids.
Nonetheless Vega NPL, which is within the analogous art of adaptive closed-loop resuscitation controllers for hemorrhagic shock resuscitation (see title of the article), teaches
the comparing the blood pressure parameters to the desired mean arterial pressure setpoint comprises:
determining, based on a Dubick constant of approximately 0.337 ml/mmHg/kg, a volume of the second quantity of fluids (see section 2.3 | Iterative ARC design – Dubick-o-Matic on page S233 of the article).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Hahn and Snider NPL in view of Vega NPL, such that the comparing the blood pressure parameters to the desired mean arterial pressure setpoint comprises: determining, based on a Dubick constant of approximately 0.337 ml/mmHg/kg, a volume of the second quantity of fluids. One of ordinary skill in the art would have been motivated to make this modification because Vega teaches that the Dubick constant reduces sudden changes in fluid infusion rates calculated by the controller thereby improving the accuracy of the tuning process. See section 2.3 | Iterative ARC design – Dubick-o-Matic on page S233 of the article.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being obvious over Hahn and Snider NPL as applied to claim 1 above, and further in view of Sondeen et al. NPL – Uncontrolled Hemorrhage Differs From Volume – or Pressure – Matched Controlled Hemorrage in Swine (hereinafter referred to as “Sondeen NPL”).
With regard to claim 5, the method of Hahn and Snider NPL teaches the claimed method of claim 1, however, Hahn is silent with regards to wherein the comparing the blood pressure parameters to the desired mean arterial pressure setpoint comprises:
determining, based on a Dubick constant of approximately 0.337 ml/mmHg/kg, a volume of the second quantity of fluids.
Nonetheless Sondeen NPL, which is within the analogous art of uncontrolled hemorrhage differs from volume or pressure matched controlled hemorrhage in swine (see abstract and title), teaches the comparing the blood pressure parameters to the desired mean arterial pressure setpoint comprises:
determining, based on a Dubick constant of approximately 0.337 ml/mmHg/kg, a volume of the second quantity of fluids (see Abstract “Group U resulted in a blood loss of 17.6 ± 0.7 mL Kg-1 …group V pigs resulted in a higher mean arterial pressure (42 ± 5 mmHg) to match group U blood volume loss profiles” wherein 16.9 mL Kg-1 divided by 47 mmHg is equal to a constant of 0.36 mL/mmHg/kg which is approximately 0.337 ml/mmHg/kg).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Hahn and Snider NPL in view of a teaching of Sondeen NPL such that the comparing the blood pressure parameters to the desired mean arterial pressure setpoint comprises: determining, based on a Dubick constant of approximately 0.337 ml/mmHg/kg, a volume of the second quantity of fluids. One of ordinary skill in the art would have been motivated to make this modification because Sondeen teaches that this constant of approximately 0.337 ml/mmHg/kg can be used to approximate the amount of blood loss during hemorrhaging. See abstract of Sondeen NPL. One of ordinary skill in the art would have been motivated to make this modification would incorporate this Dubick constant of approximately 0.337 ml/mmHg/kg within the determining volume of the second quantity of fluids step of the method of Hahn and Snider NPL because the constant simulates the amount of fluid lost during hemorrhaging.
Allowable Subject Matter
Claim 8 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
10/15/2026
