DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Remarks
This action is in response to the remarks filed 06/24/2025.
Claims 2-18 are pending.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 06/24/2025, with respect to the rejection of claims 2-18 under 35 U.S.C. 103(a) have been fully considered and are persuasive. Applicant argues that Hickle or Hickle in view of Uutela does not disclose controlling the drug administration device based on the combined index, and further that Hickle does not disclose the first physiological parameter and the one or more additional physiological parameters. Further, Applicant argues that Uutela does not disclose the claimed combined index. The argument that Hickle does not disclose the first physiological parameter and the one or more additional physiological parameters is not found to be persuasive. Hickle discloses the first physiological parameter (e.g. par. [0126]: first physiological parameter is considered to be perfusion index or oxygen saturation) and the one or more additional physiological parameters (e.g. par. [0126]: blood pressure and heart rate can be measured based on perfusion index). As explained in par. [0127], these measurements are used to determine management of drug delivery to the patient. Therefore, Hickle is still eligible as prior art. The claims are now rejected as explained in the office action below.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2-9, 13, 15, and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hickle (US Patent Application Publication 2005/0010166 – of record), further in view of Viertio-Oja et al. (US Patent Application Publication 2002/0173729 – of record), hereinafter Viertio-Oja.
Regarding claim 2, Hickle discloses a physiological monitoring system (e.g. Abstract) comprising:
a drug administration device (e.g. par. [0030]: drug delivery controller); and
one or more processors (e.g. par. [0027]: microprocessor; Claim 97) configured to:
receive, from a non-invasive optical sensor, a first sensor signal responsive to physiological characteristics of a patient (e.g. par. [0064]: pulse oximeter);
receive, from a bio-potential sensor, a second sensor signal responsive to physiological characteristics of the patient (e.g. par. [0064]: EEG measured);
receive, from an additional sensor, at least a third sensor signal (e.g. par. [0064]: additional sensors such as a capnometer or blood pressure monitors or acoustic monitors);
determine, based on the first sensor signal, a first physiological parameter (e.g. par. [0126]: first physiological parameter is considered to be perfusion index or oxygen saturation);
determine, based on the second sensor signal, a second physiological parameter (e.g. par. [0064]: EEG measured);
determine, based on at least one of the first sensor signal, the second sensor signal, or the third sensor signal, one or more additional physiological parameters (e.g. par. [0126]: blood pressure and heart rate can be measured based on perfusion index); and
control the drug administration device based at least in part on feedback (e.g. par. [0030]: drug delivery controller; par. [0071]: drug dosage changes can be made based on feedback; par. [0127]: provide drug delivery based on signals from patient monitoring devices).
While Hickle discloses controlling the drug administration device based on the received feedback including patient monitoring signals (e.g. par. [0030]: drug delivery controller; par. [0071]: drug dosage changes can be made based on feedback; par. [0127]: provide drug delivery based on signals from patient monitoring devices), Hickle fails to specifically disclose determining, based on a combination of a value of the first physiological parameter, a value of the second physiological parameter, and values of the one or more additional physiological parameters, a combined index indicative of at least a level of pain of the patient, and using the combined index to control drug administration.
Viertio-Oja is directed towards a method and apparatus for controlling the administration of a hypnotic drug to a patient. Viertio-Oja discloses combining multiple physiological parameters into a combined diagnostic index indicative of a level of pain and depth of consciousness of the patient (e.g. par. [0047]: determining a combined diagnostic index) to determine if the patient needs more hypnotic drugs (e.g. par. [0044]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hickle with the combined index and control of the drug administration based on the combined index as taught by Viertio-Oja, because doing so would allow a doctor to determine if the patient is in pain and needs additional drug administration (e.g. Viertio-Oja, par. [0044]).
Regarding claim 3, Hickle further discloses wherein the first physiological parameter comprises at least one of: perfusion index, plethysmograph variability index, heart rate, blood pressure, or oxygen saturation (e.g. par. [0126]: blood pressure and heart rate can be measured based on perfusion index).
Regarding claim 4, Hickle further discloses wherein the first physiological parameter is indicative of the level of pain of the patient (e.g. par. [0119]: if the patient is suffering from pain as evidenced by high respiratory rate or high blood pressure then drug dosage can be changed).
Regarding claim 5, Hickle further discloses wherein the second physiological parameter comprises at least one of: EEG, ECG, or heart rate (e.g. par. [0064]: EEG measured; par. [0112]: heart rate measured; par. [0126]: heart rate can be measured).
Regarding claim 6, Hickle fails to specifically disclose wherein the second physiological parameter is indicative of at least one of: the level of pain of the patient, or a depth of consciousness of the patient. Viertio-Oja is directed towards a method and apparatus for controlling the administration of a hypnotic drug to a patient. Viertio-Oja discloses wherein the EEG is indicative of the level of pain of the patient, or a depth of consciousness of the patient (e.g. par. [0047]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hickle in view of Viertio-Oja to include wherein the ECG is indicative of the level of pain and depth of consciousness of the patient as taught by Viertio-Oja, because doing so would allow a doctor to determine if the patient is in pain and needs additional drug administration (e.g. Viertio-Oja, par. [0044]).
Regarding claim 7, Hickle further discloses wherein the one or more additional physiological parameters comprise at least one of: ECG, respiration rate, respiratory air flow, heart rate, or blood pressure (e.g. par. [0126]: blood pressure can be measured).
Regarding claim 8, Hickle further discloses wherein the one or more additional physiological parameters are indicative of at least one of: the level of pain of the patient, or a depth of consciousness of the patient (e.g. par. [0119]: if the patient is suffering from pain as evidenced by high respiratory rate or high blood pressure then drug dosage can be changed).
Regarding claim 9, Hickle fails to disclose wherein the combined index is further indicative of at least a depth of consciousness of the patient. Viertio-Oja is directed towards a method and apparatus for controlling the administration of a hypnotic drug to a patient. Viertio-Oja discloses wherein the combined index is further indicative of at least a depth of consciousness of the patient (e.g. par. [0047]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hickle in view of Viertio-Oja to include wherein the combined index is further indicative of at least a depth of consciousness of the patient as taught by Viertio-Oja, because doing so would allow a doctor to determine if the patient is in pain and needs additional drug administration (e.g. Viertio-Oja, par. [0044]).
Regarding claim 13, Hickle further discloses wherein the physiological monitoring system comprises a monitor (e.g. Fig. 1: display device 35; Figs. 22A, B: display shown). However, Hickle fails to disclose wherein the non-invasive optical sensor, the bio-potential sensor, and the additional sensor are in communication with a monitor via a single cable. Viertio-Oja is directed towards a method and apparatus for controlling the administration of a hypnotic drug to a patient. Viertio-Oja discloses multiple sensors being in communication with a monitor via a single cable (e.g. par. [0054]: electrodes are formed into a single cable).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hickle in view of Viertio-Oja to include the sensors in communication with the monitor via a single cable as taught by Viertio-Oja, because doing so would reduce the number and complexity of cables in use in the system.
Regarding claim 15, Hickle further discloses wherein controlling the drug administration device comprises: outputting feedback to the drug administration device configured to provide a pharmacological agent to the patient, wherein the feedback is outputted to the drug administration device so as to regulate administration of the pharmacological agent for a desired effect (e.g. par. [0030]: drug delivery controller; par. [0071]: drug dosage changes can be made based on feedback). However, Hickle fails to specifically disclose wherein the feedback includes the combined index. Viertio-Oja is directed towards a method and apparatus for controlling the administration of a hypnotic drug to a patient. Viertio-Oja discloses combining multiple physiological parameters into a combined diagnostic index indicative of a level of pain and depth of consciousness of the patient (e.g. par. [0047]: determining a combined diagnostic index) to determine if the patient needs more hypnotic drugs (e.g. par. [0044]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hickle in view of Viertio-Oja with the combined index and control of the drug administration based on the combined index as taught by Viertio-Oja, because doing so would allow a doctor to determine if the patient is in pain and needs additional drug administration (e.g. Viertio-Oja, par. [0044]).
Regarding claim 16, Hickle further discloses wherein the drug administration device comprises at least one of drug-infusion equipment or medical gas ventilation equipment (e.g. par. [0079]).
Claims 10-12, 17, and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hickle (US Patent Application Publication 2005/0010166 – of record), further in view of Viertio-Oja et al. (US Patent Application Publication 2002/0173729 – of record), hereinafter Viertio-Oja, as applied to claim 2 above, and further in view of Uutela et al. (US Patent Application Publication 2008/0242955 – of record), hereinafter Uutela.
Regarding claim 10, Hickle further discloses wherein at least one of the second physiological parameter or the one or more additional physiological parameters comprises heart rate (e.g. par. [0112]: heart rate can be measured; par. [0126]: heart rate can be measured). However, Hickle fails to specifically disclose the parameter comprising ECG. Uutela, in a similar field of endeavor, is directed towards determining a diagnostic index indicative of a clinical state. Uutela discloses measuring ECG signals to determine level of nociception (e.g. par. [0037]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hickle in view of Viertio-Oja to include the ECG signals as taught by Uutela, because doing so would result in determining a level of nociception of the user.
Regarding claim 11, Hickle fails to specifically disclose wherein the ECG is indicative of the level of pain of the patient. Uutela, in a similar field of endeavor, is directed towards determining a diagnostic index indicative of a clinical state. Uutela discloses wherein the ECG is indicative of the level of pain of the patient (e.g. par. [0037]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hickle in view of Viertio-Oja and Uutela to include wherein the ECG is indicative of the level of pain of the patient as taught by Uutela, because doing so would result in determining a level of nociception of the user.
Regarding claim 12, Hickle fails to disclose wherein the one or more processors are further configured to: determine, based on the first physiological parameter and the ECG of the patient, a combined indication of the level of pain of the patient. Viertio-Oja is directed towards a method and apparatus for controlling the administration of a hypnotic drug to a patient. Viertio-Oja discloses combining multiple physiological parameters into a combined diagnostic index indicative of a level of pain and depth of consciousness of the patient (e.g. par. [0047]: determining a combined diagnostic index) to determine if the patient needs more hypnotic drugs (e.g. par. [0044]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hickle in view of Viertio-Oja and Uutela with the combined index and control of the drug administration based on the combined index as taught by Viertio-Oja, because doing so would allow a doctor to determine if the patient is in pain and needs additional drug administration (e.g. Viertio-Oja, par. [0044]).
However, Hickle in view of Viertio-Oja and Uutela fails to specifically disclose the parameter comprising ECG. Uutela, in a similar field of endeavor, is directed towards determining a diagnostic index indicative of a clinical state. Uutela discloses measuring ECG signals to determine level of nociception (e.g. par. [0037]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hickle in view of Viertio-Oja and Uutela to include the ECG signals as taught by Uutela, because doing so would result in determining a level of nociception of the user.
Regarding claim 17, Hickle further discloses wherein the one or more processors are further configured to: generate a displayable output including a visual indication (e.g. Figs. 22A, B: display showing monitored conditions such as heart rate, oxygen saturation, etc.). However, Hickle fails to specifically disclose displaying a visual indication of the combined index. Uutela, in a similar field of endeavor, is directed towards determining a diagnostic index indicative of a clinical state. Uutela discloses displaying a visual indication of the combined index (e.g. par. [0037]: a nociception index is determined based on “a photoplethysmographic (PPG) signal, a blood pressure (BP) signal, an ECG signal, or a Laser Doppler flow signal in peripheral tissues”; Fig. 6b: graph displaying the index; Fig. 10: graph displaying the diagnostic index; par. [0054]: describing Fig. 6b; par. [0069]: describing fig. 10).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hickle in view of Viertio-Oja to include displaying the combined index as taught by Uutela, because doing so would result in an easy-to-understand display that depicts an index of level of nociception in the patient to determine a need of treatment (Uutela, par. [0001]).
Regarding claim 18, Hickle fails to specifically disclose wherein the visual indication comprises at least one of: a number, a color, or a graph. Uutela, in a similar field of endeavor, is directed towards determining a diagnostic index indicative of a clinical state. Uutela discloses wherein the visual indication comprises a graph (e.g. Fig. 6b: graph displaying the index; Fig. 10: graph displaying the diagnostic index; par. [0054]: describing Fig. 6b; par. [0069]: describing fig. 10).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hickle in view of Viertio-Oja and Uutela to include displaying the combined index as a graph as taught by Uutela, because doing so would result in an easy-to-understand display that depicts an index of level of nociception in the patient to determine a need of treatment (Uutela, par. [0001]).
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hickle (US Patent Application Publication 2005/0010166 – of record), further in view of Viertio-Oja et al. (US Patent Application Publication 2002/0173729 – of record), hereinafter Viertio-Oja, as applied to claim 13 above, and further in view of Al-Ali et al. (US Patent Application Publication 2008/0188760 – APPLICANT CITED, of record), hereinafter Al-Ali.
Regarding claim 14, Hickle further discloses a non-invasive optical sensor (e.g. par. [0064]: pulse oximeter), the bio-potential sensor configured to be attached to the patient and configured to output at least the second sensor signal (e.g. par. [0064]: EEG measured), and the additional sensor configured to be attached to the patient and configured to output at least the third sensor signal (e.g. par. [0064]: additional sensors such as a capnometer or blood pressure monitors or acoustic monitors). However, Hickle fails to specifically disclose the non-invasive optical sensor comprising: an emitter configured to emit light into tissue of the patient, and a detector configured to detect the emitted light after attenuation by the tissue and output the first sensor signal responsive to the detected light. Al-Ali is directed towards a plethysmogram waveform processor. Al-Ali discloses non-invasive optical sensor comprising: an emitter configured to emit light into tissue of the patient (e.g. Fig. 1, emitter 122), and a detector configured to detect the emitted light after attenuation by the tissue and output the first sensor signal responsive to the detected light (e.g. Fig. 1, signal outputted from detector 124 to front-end electronics 112 and digital signal processor 140).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Hickle in view of Viertio-Oja to include the emitter and detector as taught by Al-Ali, because doing so would result in the determining measures of plethysmograph variability.
Conclusion
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796