DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see page 11, filed 12/01/2025, with respect to the objection to Claims 31, 41-42, and 45 have been fully considered and are persuasive. The objection to Claims 31, 41-42, and 45 has been withdrawn.
Applicant’s arguments, see page 11, filed 12/01/2025, with respect to the rejection of Claims 31-54 under 35 U.S.C. § 103 have been fully considered and are persuasive. Specifically, the Examiner agrees that the closest prior art, Ikegami does not suggest or teach determining that a loss of consciousness has occurred or is predicted to occur based on an absence of the breathing waveform. The rejection of Claims 31-54 under 35 U.S.C. § 103 has been withdrawn.
Applicant's arguments filed 12/01/2025 have been fully considered but they are not persuasive.
Regarding the rejection of Claim 31 under 35 U.S.C. § 101, the Applicant has argued the claims recited several devices that are integrated to achieve real-time, or near real-time, technology solution which cannot be achieved in the human mind. The applicant has argued the limitation “derive an amplitude of the breathing waveform” is too complex to be performed in the human mind because, in a typical embodiment: 1) the accelerometer output signal has three independent orthogonal components; 2) the accelerometer output signal includes a static gravity component spread across the three orthogonal components depending on the orientation of the device in space; and 3) at low movement amplitudes of interest, the signal/noise ratio becomes significant and signal processing methods are needed to distinguish signal from noise (page 12). However, the broadest reasonable interpretation of the clause “derive an amplitude of the breathing waveform” covers all embodiments, not just typical embodiments. The phase "an amplitude", could refer to the amplitude of a single axis, no signal processing methods to distinguish signal from noise are claimed (much less claimed in real-time), and continual derivation of amplitudes beyond the limits of human concentration are not claimed--the broadest reasonable interpretation still encompasses a single amplitude derivation.
In addition, the Applicant has argued “Claim 31 details a complex "real-time, or near real-time" data analysis and execution of a processing system utilizing inputs from a detector and stored signals and reference criteria, which, in a typical embodiment, provides computer processed outputs, such as: 1) a derived amplitude of the breathing waveform; 2) a determined change in amplitude of the breathing waveform, 3) a determination in real-time or near real-time that an opioid overdose has occurred or is predicted to occur; and 4) a determination in real-time or near real-time that a loss of consciousness has occurred or is predicted to occur.”
Amended Claim 31 now recites:
“automatically, via execution of instructions by a digital processor, provide an alert in response to the real-time or near real-time, output signal, that an opioid overdose has occurred or is predicted to occur”
and
“automatically, via execution of instructions by the digital processor, provide an alert in response to the real-time or near real-time output signal, that a loss of consciousness has occurred or is predicted to occur based on an absence of the breathing waveform”.
The Examiner notes that the alerts are provided in response to the real-time or near real-time signals—not that the derivations themselves must be real-time or near real-time derivations. This is a critical distinction that allows for a single derivation to happen at a later period.
In addition, the Applicant has argued that the claim limitation “automatically, via execution of instructions provided by a digital processor…” means that these claim features cannot be performed in the human mind. However, this limitation recites performing abstract idea using generic computing components, which cannot integrate an abstract idea into a practical application.
Finally, the Examiner notes the word “automatically” provides little patentable weight, as all digital processors function in at least some way without direct human input, including providing alerts.
The Applicant is strongly urged to consider adding quantitative temporal constraints to the recited mental processes of the independent claims as recited in page 21, lines 4-8 of the originally filed specification, or adding the previously claimed drug deliver systems to the independent claims to overcome the rejection under 35 U.S.C. § 101.
Claim Objections
Claim 31 is objected to because of the following informalities:
In Claim 31, “An opiod overdose detection system” should read “An [[opiod]] opioid overdose detection system”.
In Claim 31, for greater clarity, the Examiner recommends “access a first stored reference criterion for the amplitude” instead recites “access a first stored reference criterion for the amplitude representing an opioid overdose amplitude threshold limit”.
In Claim 31, for greater clarity in allowability determination, the Examiner recommends “access a second stored reference criterion for the change in amplitude of the breathing waveform” instead recites “access a second stored reference criterion for the change in amplitude of the breathing waveform representing an opioid overdose threshold change in amplitude limit”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 31-54 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding Claim 31, the claim recites an opioid overdose detection system. Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
store the output signal derived directly from movement of a chest wall of the patient as a breathing waveform
derive an amplitude of the breathing waveform;
determine a change in amplitude of the breathing waveform;
access a first stored reference criterion for the amplitude; access a second stored reference criterion for the change in amplitude of the breathing waveform
provide an alert in response to the real-time or near real-time, output signal, that an opioid overdose has occurred or is predicted to occur based on: the amplitude crossing an opioid overdose amplitude threshold limit represented by the first stored reference criterion; or the rate of change of reduction in amplitude crossing an opioid overdose threshold change in amplitude limit represented by the second stored reference; and
provide an alert in response to the real-time or near real-time output signal, that a loss of consciousness has occurred or is predicted to occur based on an absence of the breathing waveform
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
A human is capable of manually/mentally storing the output signal derived directly from movement of a chest wall of the patient as a breathing waveform.
Deriving an amplitude of the breathing waveform is a mathematical calculation that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
Determining a change in amplitude of the breathing waveform is a mathematical calculation that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
A human is capable of manually/mentally accessing a first stored reference criterion for the amplitude or accessing a second stored reference criterion for the change in amplitude of the breathing waveform, e.g. by rote memory or consulting a database or a written document.
A human is capable of manually/mentally providing an alert in response to the real-time or near real-time, output signal, that an opioid overdose has occurred or is predicted to occur based on thresholds, e.g. with voice, pen and paper, or using generic computing components.
A human is capable of manually/mentally providing an alert in response to the real-time or near real-time output signal, that a loss of consciousness has occurred or is predicted to occur based on an absence of the breathing waveform, e.g. with voice, pen and paper, or using generic computing components.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
a detector comprising an accelerometer configured to be worn directly on a chest of a patient so as to produce an output signal derived directly from movement of a chest wall of the patient, and configured to communicate the output signal in real-time, or near real-time, to a processing system
The following limitations amount to a recitation of the words "apply it" (or an equivalent)and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
wherein the processing system is configured to…
automatically, via execution of instructions by a digital processor…
automatically, via execution of instructions by the digital processor…
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
a detector comprising an accelerometer configured to be worn directly on a chest of a patient so as to produce an output signal derived directly from movement of a chest wall of the patient, and configured to communicate the output signal in real-time, or near real-time, to a processing system
wherein the processing system is configured to…
automatically, via execution of instructions by a digital processor…
automatically, via execution of instructions by the digital processor…
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The detector comprising an accelerometer is considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 04/26/2019 ("The detector may comprise a motion sensor, such as an accelerometer", page 1; accelerometers are well-known in the motion detecting arts).
The processing system and digital processor are considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 04/26/2019 ("The processing module 22 may comprise a logic circuit, processor, integrated circuit (IC), field programmable gate array (FPGA), application specific integrated circuit (ASIC) or any other suitable digital processing means", page 18).
Independent claims 41-42 are also not patent eligible for substantially similar reasons.
Dependent Claims 32-34 and 37-40 also fail to add subject matter qualifying as significantly more to the abstract independent claims as they merely further limit the abstract idea.
Dependent Claims 32-34 and 37-40 also fail to add subject qualifying as significantly more to the abstract independent claims as they recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above.
Dependent Claims 32-34 and 37-40 also fail to add subject matter integrating the judicial exception or qualifying as significantly more to the abstract independent claims as they do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Regarding Claim 43, the claim recites an opioid overdose detection system. Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
store the output signal derived directly from movement of a chest wall of the patient as a breathing waveform;
derive a breathing rate of the breathing waveform;
access a stored overdose reference criterion for the breathing rate; and to
provide an alert in response to the real-time or near real-time output signal, that an opioid overdose has occurred or is predicted to occur based on the breathing rate crossing an opioid overdose threshold limit represented by the stored overdose reference criterion for the breathing rate.
provide an alert in response to the real-time or near real-time output signal, that a loss of consciousness has occurred or is predicted to occur based on an absence of the breathing waveform in real-time, or near real-time.
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
A human is capable of manually/mentally storing the output signal derived directly from movement of a chest wall of the patient as a breathing waveform.
Deriving a breathing rate of the breathing waveform is a mathematical calculation that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
A human is capable of manually/mentally accessing a stored overdose reference criterion for the breathing rate, e.g. by rote memory or consulting a database or a written document.
A human is capable of manually/mentally providing an alert in response to the real-time or near real-time output signal, that an opioid overdose has occurred or is predicted to occur based on the breathing rate crossing an opioid overdose threshold limit represented by the stored overdose reference criterion for the breathing rate, e.g. with voice, pen and paper, or using generic computing components.
A human is capable of manually/mentally providing an alert in response to the real-time or near real-time output signal, that a loss of consciousness has occurred or is predicted to occur based on an absence of the breathing waveform in real-time, or near real-time, e.g. with voice, pen and paper, or using generic computing components.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
a detector comprising an accelerometer configured to be worn directly on a chest of a patient so as to produce an output signal derived directly from movement of a chest wall of the patient, and configured to communicate the output signal in real-time, or near real-time, to a processing system
The following limitations amount to a recitation of the words "apply it" (or an equivalent)and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
wherein the processing system is configured to
automatically, via execution of instructions by a digital processor…
automatically, via execution of instructions by the digital processor…
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
a detector comprising an accelerometer configured to be worn directly on a chest of a patient so as to produce an output signal derived directly from movement of a chest wall of the patient, and configured to communicate the output signal in real-time, or near real-time, to a processing system
wherein the processing system is configured to
automatically, via execution of instructions by a digital processor…
automatically, via execution of instructions by the digital processor…
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The detector comprising an accelerometer is considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 04/26/2019 ("The detector may comprise a motion sensor, such as an accelerometer", page 1; accelerometers are well-known in the motion detecting arts).
The processing system and digital processor are considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 04/26/2019 ("The processing module 22 may comprise a logic circuit, processor, integrated circuit (IC), field programmable gate array (FPGA), application specific integrated circuit (ASIC) or any other suitable digital processing means", page 18).
Independent claims 53-54 are also not patent eligible for substantially similar reasons.
Dependent Claims 44-46 and 49-52 also fail to add subject matter qualifying as significantly more to the abstract independent claims as they merely further limit the abstract idea.
Dependent Claims 44-46 and 49-52 also fail to add subject qualifying as significantly more to the abstract independent claims as they recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above.
Dependent Claims 44-46 and 49-52 also fail to add subject matter integrating the judicial exception or qualifying as significantly more to the abstract independent claims as they do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, Claims 31-34, 37-46, and 49-54 are not patent eligible under 35 U.S.C. § 101.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Li et al (US 20110201945 A1), which discloses a stored reference criterion for the change in amplitude of the breathing waveform (“In an example, characterization of the respiration and activity signals can occur only if specified respiration sensor activation conditions are met, such as those described above. The respiration signal can be characterized, for example, by determining a time rate of change of a respiration rate, a time rate of change of a respiration depth, or a time rate of change of a respiration morphological pattern”, [0050]; thresholds for these characteristics are further described). However, Li fails to teach this threshold to represent an opioid overdose threshold change in amplitude limit.
See Inoue et al (JP 2005237479 A), which discloses a stored reference criterion for the change in amplitude of the breathing waveform, and determining that a posture change event has occurred based on the rate of change of reduction in amplitude crossing a threshold change in amplitude limit represented by the second stored reference criterion (page 4 of the attached machine translation). However, Inoue fails to teach wherein this threshold is related to opioid overdoses, overdoses of any kind, and is not pertinent to any problem the instant application is trying to solve.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791