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 .
Status of Claims
2. Claims 1-15 are pending and currently under consideration for patentability under 37 CFR 1.104.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
In the instant case, the abstract states “Various exemplary embodiments of the present disclosure encompass” which is language that can be implied, and should be deleted.
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.
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11, line 4 recites “a patient” and the Examiner suggests –the patient—to clarify the antecedent basis from line 2.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 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, lines 7-8 recite “sustaining a physiological parameter monitoring of the patient by the physiological monitor at a baseline” which is confusing because “a physiological parameter” has already been recited (line 2), and it is unclear what is meant by sustaining a physiological parameter monitoring. Is this referring to: 1) sustaining the physiological parameter at a baseline, or 2) sustaining a physiological parameter monitoring (i.e., the act of monitoring the physiological parameter)? If this is referring to the latter case, it is unclear what is meant by sustaining a physiological parameter monitoring (the act of monitoring) … at a baseline.
Claim 6, lines 3-4 recite “the mechanical CPR device” which lacks antecedent basis.
Claim 11, lines 7-8 recite “sustaining a physiological parameter monitoring of the patient by the physiological monitor at a baseline” which is confusing because “a physiological parameter” has already been recited (line 4), and it is unclear what is meant by sustaining a physiological parameter monitoring. Is this referring to: 1) sustaining the physiological parameter at a baseline, or 2) sustaining a physiological parameter monitoring (i.e., the act of monitoring the physiological parameter)? If this is referring to the latter case, it is unclear what is meant by sustaining a physiological parameter monitoring (the act of monitoring) … at a baseline.
The remaining claims are rejected based on the rejected base claim.
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.
Claim(s) 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Woerlee et al. (WO 2010/004499 A1).
Regarding claim 1, Woerlee discloses a cardiopulmonary resuscitation ("CPR") system (Fig. 1), comprising:
a physiological monitor (physiological parameter sensor 107, Fig. 1) configured to monitor a physiological parameter (blood perfusion, see page 2, lines 13-14. Blood perfusion can specifically be monitored through pulse photoplethysmography, sPO2, CW and PW ultrasound Doppler, blood pressure, ETCO2 and/or oxygen saturation measurements, see page 10, lines 25-29) of a patient (human chest 104, Fig. 1) during CPR on the patient (blood perfusion is optimized during administration of the automated cardiopulmonary resuscitation, see page 1, lines 2-4);
a mechanical CPR device (chest compression actuator 102, chest compression actuator driver 110, Fig. 1) having an adjustable configuration (operating parameter adjuster 108 allows various operating parameters of the CPR device to be adjusted, including compression depth, compression rate, waveform, duty cycle, compression velocity, see page 7, lines 30-33; see page 10, lines 16-22; see page 13, line 33 through page 14, line 5) for regulating chest compressions on the patient during CPR on the patient (the operating parameter adjuster 108 regulates chest compressions by varying the operating parameters of the CPR, see page 2, lines 15-20; see also Figure 4 and page 13, line 20, through page 14, line 13); and
a CPR controller (operating parameter adjuster 108, Fig. 1, which includes tendency analyzer 240, operating parameter limiter 250, and evaluator 260 as seen in Fig. 2; see page 11, line 33 through page 12, line 7) configured to control the adjustable configuration (configured to control the adjustment of the operational parameter(s)) of the mechanical CPR device (see page 2, lines 15-20) based on sustaining a physiological parameter monitoring of the patient (a monitored physiological parameter of the patient, such as ETCO2, see page 10, lines 16-29, is sustained towards a target value, see page 12, lines 4-32) by the physiological monitor (“blood perfusion sensor 107 provides the measured values of a physiological parameter related to blood perfusion to an operating parameter adjuster 108” see page 11, lines 1-2) at a baseline physiological parameter level for the patient (“Tendency analyzer 240 determines how the blood perfusion measurements react to changes of the operating parameters, in particular whether blood perfusion has improved or degraded due to a modification of one or several of the operating parameters … Ao and Bo are target values for the [physiology] parameters A and B” see page 12, lines 4-15; “end-tidal CO2 pressure ETCO2 is used as the physiology parameter of interest. The target value Ao is 35 mmHg.” Thus, the operating parameters are adjusted to sustain the blood perfusion, represented as an ETCO2, to be at a baseline value of 35 mmHg).
Regarding claim 2, Woerlee discloses wherein the CPR controller (operating parameter adjuster 108, Figs. 1-2) being configured to control the adjustable configuration (configured to control the adjustment of the operational parameter(s)) of the mechanical CPR device (see page 2, lines 15-20) includes: the CPR controller (108) configured to communicate a mechanical instruction to the mechanical CPR device (operating parameter adjuster 108 has output signals 109 and 115 that provide mechanical instructions to the CPR device 110 to adjust the operating parameters, see Fig. 1 and page 11, lines 4-13), the mechanical instruction being informative of an adjustment of at least one of a compression depth, a compression rate and a compression position to be executed by the mechanical CPR device (the operating parameters that are adjusted include at least compression depth and compression rate, see page 7, lines 30-33; see page 10, lines 16-22; see page 13, line 33 through page 14, line 5).
Regarding claim 3, Woerlee discloses wherein the CPR controller (operating parameter adjuster 108, Figs. 1-2) being configured to control the adjustable configuration (configured to control the adjustment of the operational parameter(s)) of the mechanical CPR device (see page 2, lines 15-20) includes: the CPR controller (108) configured to intermittently communicate a mechanical instruction to the mechanical CPR device (operating parameter adjuster 108 has output signals 109 and 115 that provide mechanical instructions to the CPR device 110 to adjust the operating parameters, see Fig. 1 and page 11, lines 4-13. The instructions are configured to be intermittent because the operating parameter adjuster 108 is comparing the performance of a current set of operational parameters to a previous set of operational parameters, and instructions are set at branching point(s) at 407-413, Fig. 4, see page 13, line 20 through page 14, line 13. See also page 3, lines 19-20), each mechanical instruction being informative of a next-interval adjustable configuration of the mechanical CPR device (each mechanical instruction is adjusting the operating parameter for a next interval of compressions such as increasing the compression depth, or resetting the compression depth to a previous setting, see page 13, line 20 through page 14, line 13) derived from a current-interval physiological parameter monitoring of the patient by the physiological monitor (“Measured values relative to blood perfusion, such as ETCO2 and CBF, are collected and compared with previous values in block 404. A cost function S(p) for the current iteration p is calculated in block 405 using the measured values as arguments. A previous result of calculating the cost function S(p-1) is retrieved and the difference ΔS = S(o) – S(p-1) is determined in block 406… If the result of the determination within branching point 407 is yes (Y), then the method continues at a second branching point 408 where operating parameter N (e.g., the compression depth) is changed, and more particularly increased. If the determination at branching point 407 is negative (N), then optionally the operating parameter is reset to its previous setting.” See page 13, line 20, through page 14, line 13).
Regarding claim 4, Woerlee discloses wherein the CPR controller (operating parameter adjuster 108, Figs. 1-2) being configured to control the adjustable configuration (configured to control the adjustment of the operational parameter(s)) of the mechanical CPR device (see page 2, lines 15-20) includes: the CPR controller (108) is configured to implement a functional linking of the physiological parameter monitoring of the patient by the physiological monitor (107) to the adjustable configuration of the mechanical CPR device (see the method steps in Figure 4 and page 14, line 20, through page 14, line 13. The method functionally links physiological monitoring 107 from blood perfusion such as ETCO2 to the adjustable operational parameters such as compression depth, to optimize blood perfusion. The goal is to optimize blood perfusion based upon its functional link to the CPR operational parameters, see lines 10-19 of the Abstract. See also page 12, lines 4-31).
Regarding claim 5, Woerlee discloses wherein the CPR controller (operating parameter adjuster 108, Figs. 1-2) being configured to control the adjustable configuration (configured to control the adjustment of the operational parameter(s)) of the mechanical CPR device (see page 2, lines 15-20) is a function of at least one of: historical adjustable configurations of the mechanical CPR device during the CPR of the patient (see steps 406-411 in Figure 4, “a previous result of calculating the cost function S(p-1) is retrieved and the difference ΔS = S(o) – S(p-1) is determined in block 406… If the result of the determination within branching point 407 is yes (Y), then the method continues at a second branching point 408 where operating parameter N (e.g., the compression depth) is changed, and more particularly increased. If the determination at branching point 407 is negative (N), then optionally the operating parameter is reset to its previous setting.” See page 13, line 20, through page 14, line 13. See also Figure 2, the memory of the operating parameter adjuster 108 includes section 271 which stores “previous operating parameter values” and section 274 “in which previous measurements of blood perfusion are stored” so the tendency analyzer 240 can determine “whether blood perfusion has improved or degraded due to a modification of one or several of the operating parameters” see page 11, line 18 through page 19, line 7); historical patient physiological parameter monitoring of the patient by the physiological monitor during the CPR of the patient (See Figure 2, the memory of the operating parameter adjuster 108 includes section 274 “in which previous measurements of blood perfusion are stored” so the tendency analyzer 240 can determine “whether blood perfusion has improved or degraded due to a modification of one or several of the operating parameters” see page 11, line 18 through page 19, line 7); a personalization of the baseline physiological parameter level for the patient (the patient can enter weight factors Wn and Wnm which affect the cost function S that is used to achieve the baseline level, see page 12, lines 13-19); or static information of the patient (the anterior-posterior chest diameter of the patient can be entered as “slim”, “normal”, or “large.” This is static information of the patient. This input is used so the maximum value of the compression depth operational parameter is “limited to 20% of the A-P diameter” based upon the size of the patient, see page 4, lines 4-12; see also page 19, lines 11-15. This would be part of the operating parameter limiter 250 that defines admissible ranges for the operating parameters, see page 12, lines 20-31).
Regarding claim 6, Woerlee discloses a cardiopulmonary resuscitation ("CPR") controller (operating parameter adjuster 108, Fig. 1, which includes tendency analyzer 240, operating parameter limiter 250, and evaluator 260 as seen in Fig. 2; see page 11, line 33 through page 12, line 7), comprising:
a non-transitory machine-readable storage medium encoded with instructions for execution by at least one processor (“a computer program is presented that enables a processor to carry out the method” see page 6, lines 12-16; see also page 17, lines 3-9) to control an adjustable configuration (operating parameter adjuster 108 allows various operating parameters of the CPR device to be adjusted, including compression depth, compression rate, waveform, duty cycle, compression velocity, see page 7, lines 30-33; see page 10, lines 16-22; see page 13, line 33 through page 14, line 5) of the mechanical CPR device (chest compression actuator 102, chest compression actuator driver 110, Fig. 1) for regulating chest compressions on a patient during CPR on the patient (the operating parameter adjuster 108 regulates chest compressions by varying the operating parameters of the CPR, see page 2, lines 15-20; see also Figure 4 and page 13, line 20, through page 14, line 13), the non- transitory machine-readable storage medium including the instructions to:
input a physiological parameter monitoring of the patient (a measured blood perfusion value, such as ETCO2 is input to the operating parameter adjuster 108 from physiological parameter sensor 107, see Figs. 1-2; see page 10, lines 25-29; “Blood perfusion sensor 107 provides the measured values of a physiological parameter relating to blood perfusion to an operating parameter adjuster 108” see page 11, lines 1-2) by a physiological monitor (physiological parameter sensor 107, Fig. 1) during CPR of the patient (blood perfusion is optimized during administration of the automated cardiopulmonary resuscitation, see page 1, lines 2-4); and
control the adjustable configuration (control the adjustment of the operational parameter(s)) of the mechanical CPR device (see page 2, lines 15-20) based on sustaining the physiological parameter monitoring of the patient (a monitored physiological parameter of the patient, such as ETCO2, see page 10, lines 16-29, is sustained towards a target value, see page 12, lines 4-32) at a baseline physiological parameter level for the patient (“Tendency analyzer 240 determines how the blood perfusion measurements react to changes of the operating parameters, in particular whether blood perfusion has improved or degraded due to a modification of one or several of the operating parameters … Ao and Bo are target values for the [physiology] parameters A and B” see page 12, lines 4-15; “end-tidal CO2 pressure ETCO2 is used as the physiology parameter of interest. The target value Ao is 35 mmHg.” Thus, the operating parameters are adjusted to sustain the blood perfusion, represented as an ETCO2, to be at a baseline value of 35 mmHg).
Regarding claim 7, Woerlee discloses wherein the instructions to control the adjustable configuration (instructions associated with operating parameter adjuster 108, Figs. 1-2) of the mechanical CPR device includes instructions to communicate a mechanical instruction to the mechanical CPR device (operating parameter adjuster 108 has output signals 109 and 115 that provide mechanical instructions to the CPR device 110 to adjust the operating parameters, see Fig. 1 and page 11, lines 4-13), the mechanical instruction being informative of an adjustment of at least one of a compression depth, a compression rate and a compression position to be executed by the mechanical CPR device (the operating parameters that are adjusted include at least compression depth and compression rate, see page 7, lines 30-33; see page 10, lines 16-22; see page 13, line 33 through page 14, line 5).
Regarding claim 8, Woerlee discloses wherein the instructions to control the adjustable configuration (instructions associated with operating parameter adjuster 108, Figs. 1-2) of the mechanical CPR device includes instructions to: intermittently communicate a mechanical instruction to the mechanical CPR device (operating parameter adjuster 108 has output signals 109 and 115 that provide mechanical instructions to the CPR device 110 to adjust the operating parameters, see Fig. 1 and page 11, lines 4-13. The instructions are configured to be intermittent because the operating parameter adjuster 108 is comparing the performance of a current set of operational parameters to a previous set of operational parameters, and instructions are set at branching point(s) at 407-413, Fig. 4, see page 13, line 20 through page 14, line 13. See also page 3, lines 19-20), each mechanical instruction being informative of a next-interval adjustable configuration of the mechanical CPR device (each mechanical instruction is adjusting the operating parameter for a next interval of compressions such as increasing the compression depth, or resetting the compression depth to a previous setting, see page 13, line 20 through page 14, line 13) derived from a current-interval physiological parameter monitoring of the patient by the physiological monitor (“Measured values relative to blood perfusion, such as ETCO2 and CBF, are collected and compared with previous values in block 404. A cost function S(p) for the current iteration p is calculated in block 405 using the measured values as arguments. A previous result of calculating the cost function S(p-1) is retrieved and the difference ΔS = S(o) – S(p-1) is determined in block 406… If the result of the determination within branching point 407 is yes (Y), then the method continues at a second branching point 408 where operating parameter N (e.g., the compression depth) is changed, and more particularly increased. If the determination at branching point 407 is negative (N), then optionally the operating parameter is reset to its previous setting.” See page 13, line 20, through page 14, line 13).
Regarding claim 9, Woerlee discloses wherein the instructions to control the adjustable configuration (instructions associated with operating parameter adjuster 108, Figs. 1-2) of the mechanical CPR device includes instructions to: implement a functional linking of the physiological parameter monitoring of the patient by the physiological monitor (107) to the adjustable configuration of the mechanical CPR device (see the method steps in Figure 4 and page 14, line 20, through page 14, line 13. The method functionally links physiological monitoring 107 from blood perfusion such as ETCO2 to the adjustable operational parameters such as compression depth, to optimize blood perfusion. The goal is to optimize blood perfusion based upon its functional link to the CPR operational parameters, see lines 10-19 of the Abstract. See also page 12, lines 4-31).
Regarding claim 10, Woerlee discloses wherein the instructions to control the adjustable configuration (instructions associated with operating parameter adjuster 108, Figs. 1-2) of the mechanical CPR device are a function of at least one of: historical adjustable configurations of the mechanical CPR device during the CPR of the patient (see steps 406-411 in Figure 4, “a previous result of calculating the cost function S(p-1) is retrieved and the difference ΔS = S(o) – S(p-1) is determined in block 406… If the result of the determination within branching point 407 is yes (Y), then the method continues at a second branching point 408 where operating parameter N (e.g., the compression depth) is changed, and more particularly increased. If the determination at branching point 407 is negative (N), then optionally the operating parameter is reset to its previous setting.” See page 13, line 20, through page 14, line 13. See also Figure 2, the memory of the operating parameter adjuster 108 includes section 271 which stores “previous operating parameter values” and section 274 “in which previous measurements of blood perfusion are stored” so the tendency analyzer 240 can determine “whether blood perfusion has improved or degraded due to a modification of one or several of the operating parameters” see page 11, line 18 through page 19, line 7); historical patient physiological parameter monitoring of the patient by the physiological monitor during the CPR of the patient (See Figure 2, the memory of the operating parameter adjuster 108 includes section 274 “in which previous measurements of blood perfusion are stored” so the tendency analyzer 240 can determine “whether blood perfusion has improved or degraded due to a modification of one or several of the operating parameters” see page 11, line 18 through page 19, line 7); a personalization of the baseline physiological parameter level for the patient (the patient can enter weight factors Wn and Wnm which affect the cost function S that is used to achieve the baseline level, see page 12, lines 13-19); or static information of the patient (the anterior-posterior chest diameter of the patient can be entered as “slim”, “normal”, or “large.” This is static information of the patient. This input is used so the maximum value of the compression depth operational parameter is “limited to 20% of the A-P diameter” based upon the size of the patient, see page 4, lines 4-12; see also page 19, lines 11-15. This would be part of the operating parameter limiter 250 that defines admissible ranges for the operating parameters, see page 12, lines 20-31).
Regarding claim 11, Woerlee discloses a cardiopulmonary resuscitation ("CPR") method (using the CPR system of Figs. 1-2, including the method steps of Figure 4) for regulating chest compressions (via operating parameter adjuster 108, Figs. 1-2) on a patient (human chest 104, Fig. 1) during CPR on the patient (blood perfusion is optimized during administration of the automated cardiopulmonary resuscitation, see page 1, lines 2-4) by a mechanical CPR device (chest compression actuator 102, chest compression actuator driver 110, Fig. 1) having an adjustable configuration (operating parameter adjuster 108 allows various operating parameters of the CPR device to be adjusted, including compression depth, compression rate, waveform, duty cycle, compression velocity, see page 7, lines 30-33; see page 10, lines 16-22; see page 13, line 33 through page 14, line 5), the CPR method comprising:
monitoring, by a physiological monitor (physiological sensor 107, Fig. 1), a physiological parameter of a patient (blood perfusion, see page 2, lines 13-14. Blood perfusion can specifically be monitored through pulse photoplethysmography, sPO2, CW and PW ultrasound Doppler, blood pressure, ETCO2 and/or oxygen saturation measurements, see page 10, lines 25-29) during CPR on the patient (blood perfusion is optimized during administration of the automated cardiopulmonary resuscitation, see page 1, lines 2-4); and
controlling, by a CPR controller (operating parameter adjuster 108, Fig. 1, which includes tendency analyzer 240, operating parameter limiter 250, and evaluator 260 as seen in Fig. 2; see page 11, line 33 through page 12, line 7), the adjustable configuration (operating parameter adjuster 108 controls the adjustment of the operational parameter(s)) of the mechanical CPR device (see page 2, lines 15-20) based on sustaining a physiological parameter monitoring of the patient (a monitored physiological parameter of the patient, such as ETCO2, see page 10, lines 16-29, is sustained towards a target value, see page 12, lines 4-32) by the physiological monitor (“blood perfusion sensor 107 provides the measured values of a physiological parameter related to blood perfusion to an operating parameter adjuster 108” see page 11, lines 1-2) at a baseline physiological parameter level for the patient (“Tendency analyzer 240 determines how the blood perfusion measurements react to changes of the operating parameters, in particular whether blood perfusion has improved or degraded due to a modification of one or several of the operating parameters … Ao and Bo are target values for the [physiology] parameters A and B” see page 12, lines 4-15; “end-tidal CO2 pressure ETCO2 is used as the physiology parameter of interest. The target value Ao is 35 mmHg.” Thus, the operating parameters are adjusted to sustain the blood perfusion, represented as an ETCO2, to be at a baseline value of 35 mmHg).
Regarding claim 12, Woerlee discloses wherein the controlling, by the CPR controller (108), of the adjustable configuration of the mechanical CPR device includes communicating, by the CPR controller (108), a mechanical instruction to the mechanical CPR device (operating parameter adjuster 108 has output signals 109 and 115 that provide mechanical instructions to the CPR device 110 to adjust the operating parameters, see Fig. 1 and page 11, lines 4-13), the mechanical instruction being informative of an adjustment of at least one of a compression depth, a compression rate and a compression position to be executed by the mechanical CPR device (the operating parameters that are adjusted include at least compression depth and compression rate, see page 7, lines 30-33; see page 10, lines 16-22; see page 13, line 33 through page 14, line 5).
Regarding claim 13, Woerlee discloses wherein the controlling, by the CPR controller (108), the adjustable configuration of the mechanical CPR device includes: intermittently communicating, by the CPR controller (108), a mechanical instruction to the mechanical CPR device (operating parameter adjuster 108 has output signals 109 and 115 that provide mechanical instructions to the CPR device 110 to adjust the operating parameters, see Fig. 1 and page 11, lines 4-13. The instructions are configured to be intermittent because the operating parameter adjuster 108 is comparing the performance of a current set of operational parameters to a previous set of operational parameters, and instructions are set at branching point(s) at 407-413, Fig. 4, see page 13, line 20 through page 14, line 13. See also page 3, lines 19-20), each mechanical instruction being informative of a next-interval adjustable configuration of the mechanical CPR device (each mechanical instruction is adjusting the operating parameter for a next interval of compressions such as increasing the compression depth, or resetting the compression depth to a previous setting, see page 13, line 20 through page 14, line 13) derived from a current-interval physiological parameter monitoring of the patient by the physiological monitor (“Measured values relative to blood perfusion, such as ETCO2 and CBF, are collected and compared with previous values in block 404. A cost function S(p) for the current iteration p is calculated in block 405 using the measured values as arguments. A previous result of calculating the cost function S(p-1) is retrieved and the difference ΔS = S(o) – S(p-1) is determined in block 406… If the result of the determination within branching point 407 is yes (Y), then the method continues at a second branching point 408 where operating parameter N (e.g., the compression depth) is changed, and more particularly increased. If the determination at branching point 407 is negative (N), then optionally the operating parameter is reset to its previous setting.” See page 13, line 20, through page 14, line 13).
Regarding claim 14, Woerlee discloses wherein the controlling, by the CPR controller (108), the adjustable configuration of the mechanical CPR device includes: implementing, by the CPR controller, a functional linking of the physiological parameter monitoring of the patient by the physiological monitor (107) to the adjustable configuration of the mechanical CPR device (see the method steps in Figure 4 and page 14, line 20, through page 14, line 13. The method functionally links physiological monitoring 107 from blood perfusion such as ETCO2 to the adjustable operational parameters such as compression depth, to optimize blood perfusion. The goal is to optimize blood perfusion based upon its functional link to the CPR operational parameters, see lines 10-19 of the Abstract. See also page 12, lines 4-31).
Regarding claim 15, Woerlee discloses wherein the controlling, by the CPR controller (108), the adjustable configuration of the mechanical CPR device is a function of at least one of: historical adjustable configurations of the mechanical CPR device during the CPR of the patient (see steps 406-411 in Figure 4, “a previous result of calculating the cost function S(p-1) is retrieved and the difference ΔS = S(o) – S(p-1) is determined in block 406… If the result of the determination within branching point 407 is yes (Y), then the method continues at a second branching point 408 where operating parameter N (e.g., the compression depth) is changed, and more particularly increased. If the determination at branching point 407 is negative (N), then optionally the operating parameter is reset to its previous setting.” See page 13, line 20, through page 14, line 13. See also Figure 2, the memory of the operating parameter adjuster 108 includes section 271 which stores “previous operating parameter values” and section 274 “in which previous measurements of blood perfusion are stored” so the tendency analyzer 240 can determine “whether blood perfusion has improved or degraded due to a modification of one or several of the operating parameters” see page 11, line 18 through page 19, line 7); historical patient physiological parameter monitoring of the patient by the physiological monitor during the CPR of the patient (See Figure 2, the memory of the operating parameter adjuster 108 includes section 274 “in which previous measurements of blood perfusion are stored” so the tendency analyzer 240 can determine “whether blood perfusion has improved or degraded due to a modification of one or several of the operating parameters” see page 11, line 18 through page 19, line 7); a personalization of the baseline physiological parameter level for the patient (the patient can enter weight factors Wn and Wnm which affect the cost function S that is used to achieve the baseline level, see page 12, lines 13-19); or static information of the patient (the anterior-posterior chest diameter of the patient can be entered as “slim”, “normal”, or “large.” This is static information of the patient. This input is used so the maximum value of the compression depth operational parameter is “limited to 20% of the A-P diameter” based upon the size of the patient, see page 4, lines 4-12; see also page 19, lines 11-15. This would be part of the operating parameter limiter 250 that defines admissible ranges for the operating parameters, see page 12, lines 20-31).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kaufman et al. (2015/0265497) discloses a related CPR chest compression system with physiological parameter input, and feedback. Paradis et al. (2012/0016179) discloses a related CPR chest compression system with physiological sensor(s) providing feedback so the chest compression routine is adjusted to optimize sensed blood flow. Lampe (2021/0045967) discloses a related system for optimizing CPR chest compressions using sensor feedback. Freeman (2011/0301513) discloses a CPR system that dynamically adjusts compression parameters based upon sensor feedback. Lund et al. (2008/0146973) discloses a related CPR system for providing feedback on chest compression(s). Salcido et al. (2016/0317385) discloses a related CPR system that incorporates biological feedback. Ehrstedt et al. (2022/0125676) discloses a CPR system that adjusts the position of the compression point relative to the chest based upon feedback from sensors. Helkowski et al. (2021/0322265) discloses a related data management system for chest compression devices that has sensor feedback. Taylor et al. (10,729,615) discloses a CPR system with dynamic parameters based on physiological feedback. Woerlee (WO 2009156924 A1) discloses sensor-based feedback loop for optimizing parameters of chest compressions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER E MILLER whose telephone number is (571)270-1473. The examiner can normally be reached Mon-Fri 9:00-5:30 (Eastern).
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/CHRISTOPHER E MILLER/Examiner, Art Unit 3785
