DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 08/26/2025 has been entered. Amendments to claims 12, 14, 16, and 18, and new claim 21 are acknowledged. Claims 12-18 and 21 remain pending in the application.
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.
Claim(s) 12-14 and 16-18 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 12 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 12 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “acquire… first impedance data representative of at least one dependent region of lungs of a patient;”, “receive at least one of a flow rate from within a breathing circuit of the patient and a pressure from within the breathing circuit;”, “compare an increase or decrease in the first impedance data with an increase or decrease in one or more of the flow rate within the breathing circuit of the patient, the pressure within the breathing circuit, and a second impedance data representative of a second region of the lungs of the patient comprising at least a non-dependent region to identify a respiratory effort of the patient,”, “based on the comparison and determine if the respiratory effort is ineffective”, and “identify the ineffective effort in a user-interface device”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “an electrical impedance tomography system”, “at least one processor”, “at least one non-transitory computer readable storage medium”, “user interface device” and “a breathing circuit”. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0003]: “Breathing circuits are commonly utilized in the operating room” of Daugherty (US 20050178381 A1), para [0174]: “known user interface systems” of Martin et al. (US 20180236191 A1) and paras [0003-0004]: “Devices for electrical impedance tomography (EIT) are well known from the state of the art… an electrical impedance tomograph having an array of a plurality of electrodes, power input to at least two electrodes, signal acquisition at the remaining electrodes”) of Gärber (US 20190038173 A1). Regarding the processor and non-transitory computer readable storage medium, generic computer structures are not significantly more according to Alice v. CLS. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 12 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 13-14 and 16-18 fail to cure the deficiencies of independent claim 12 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or additional elements that are not significantly more. Claim 13 recites the limitation “at least one gas monitoring sensor”. However, this elements is not “significantly more” because they are well-known, routine, and/or conventional as evidenced by Fisher et al. (US 20070062531 A1) abstract: “breathing circuit e) means to identify phase of breathing… by gas sensors or other means known to those skilled in the art;”. Thus, claim(s) 12-14 and 16-18 is/are rejected under 35 U.S.C. 101.
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 12-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kremeier (US 2020/0260985 A1) in view of Martin (US 2018/0236191 A1).
Regarding claim 12, Kremeier discloses a system for determining a respiratory effort of a patient (title), the system comprising: an electrical impedance tomography system ([0037]: “elements for capturing the impedance of the living body”, [0041]: “with ascertainment of an image information item of the electrical impedance”); at least one processor coupled to the electrical impedance tomography system ([0009]: “The control unit, at least intermittently, evaluates information items about the impedance and information items about the respiration and/or ventilation”); acquire, with the electrical impedance tomography system, first impedance data (Fig 3, [0066]) representative of at least one dependent region of lungs of a patient ([0087]: "According to the invention, there can be a consideration of the entire lung or else separate evaluation of ventral and dorsal, or arbitrary, lung portions"); receive at least one of a flow rate from within a breathing circuit of the patient and a pressure from within the breathing circuit ([0060]: “The ventilator comprises a device for establishing pressure and/or flow and/or volume (23, 24) of the respiratory gas.”, Fig 2 element 5 and 6 comprising the breathing circuit, [0063]: “ventilator (20) comprises a (pneumatic or electronic or optical) pressure measuring input and a pressure sensor (23).”).
Kremeier fails to disclose at least one non-transitory computer readable storage medium storing instructions thereon. While Kremier discloses and comparing an increase or decrease in the first impedance data with an increase or decrease in one or stored patterns of impedance data representative of the first region of the lungs ([0037]: “A first ventilation setting is stipulated for at least one instance of respiration and/or ventilation and, in the process, a first impedance variation is ascertained and, subsequently, a second ventilation setting is stipulated for at least one instance of respiration and/or ventilation and, in the process, the one second impedance variation is ascertained and at least the first and the second (or any further) impedance variations are compared to one another”, Fig 5 elements 37 and 38 and 39, [0078]: “The impedance variation (39) is the difference between end-expiratory (lowest) impedance and end-inspiratory (highest) impedance; it represents the change in the thoracic impedance when taking a breath.”, wherein the impedance variation represents a change in impedance which is compared to another change in impedance), to identify a respiratory effort of the patient based on the comparison and determine if the respiratory effort is ineffective ([0070]: "Inspiratory impedances (38) that lie below the threshold (48) are assessed as failed triggers (38′). Here, inspiratory effort by the patient does not lead to inspiration (by the ventilator).", wherein the respiratory effort is ineffective as it does not lead to inspiration from the ventilator, [0078]: “An increase in the impedance variation (39) indicates an increase of the respiratory gas volume. In very much simplified terms, the ventilation of the lung is then improved.”, wherein the increase/decrease in variation as per comparison represents if the effort is successful), and identifying the ineffective effort on a user interface device ([0072]: “The failed triggers (38′) can be directly visualized in the region of a display (3).”), they fail to specifically disclose comparing an increase or decrease in the first impedance data with an increase or decrease in one or more of the flow rate within the breathing circuit of the patient, the pressure within the breathing circuit, and a second impedance data representative of a second region of the lungs of the patient comprising at least a non-dependent region to identify a respiratory effort of the patient based on the comparison and determine if the respiratory effort is ineffective.
Martin discloses a device to determine a disconnection in a breathing circuit (abstract) including and at least one non-transitory computer readable storage medium storing instructions thereon ([0229]: “such as the one or more set of algorithms 4300 expressed as computer programs stored in a non-transitory computer readable storage medium, such as memory 4260.), comparing an increase or decrease in the first impedance data with increases or decreases of one or more of a flow rate within a breathing circuit of the patient, a pressure within the breathing circuit ([0106]: “a processor configured to repeatedly calculate instantaneous impedance values based on the values of instantaneous pressure and values of instantaneous flow rate… detect an occurrence of a respiratory event within the system.” Wherein the impedance value is in relation to the pressure and flow value, [0140]: “show traces for respiratory flow and airway pressure over time and instantaneous conductance and instantaneous impedance over time”, Fig 7H (i) and (ii), and wherein the event is a breathing effort per [0431]: “will be said to have occurred when an apnea is detected that is due to a reduction in breathing effort, or the absence of breathing effort, despite the airway being patent”).
It would have been obvious to a person of ordinary skill in the art to substitute the known method of determining respiratory effort via historical impedance data comparison as disclosed by Kremier as modified by Martin to the known method of flow rate/pressure and impedance comparison as disclosed by Martin for the predictable result of determining respiratory effort. It would have been additionally obvious to a person of ordinary skill in the art prior to the effective filing date to further modify the system disclosed by Kremier to include the non-transitory computer readable storage medium storing instructions disclosed by Martin in order to allow for automation of the respiratory effort determination system to improve ease of operation.
Regarding claim 13, Kremeier further discloses at least one gas monitoring sensor operably coupled to the system, the at least one gas monitoring sensor configured to measure one or both of the pressure and the flow rate within the breathing circuit ([0063]: “the ventilator (20) comprises a (pneumatic or electronic or optical) pressure measuring input and a pressure sensor (23)” consistent with applicant’s specification page 11 lines 16-17 “the gas monitoring sensor may include one or more of a pressure, a flow, and a gas concentration sensor.”).
Regarding claim 14, Kremeier as modified by Martin fails to disclose determining an asynchrony between the patient and a ventilator responsive to measuring an increase in the first impedance without a corresponding increase in one or more of the second impedance, the flow rate, and the pressure within the breathing circuit.
Martin further discloses determining an asynchrony between the patient and a ventilator responsive to measuring an increase in the first impedance without a corresponding increase in one or more of the second impedance, the flow rate, and the pressure within the breathing circuit ([0275]: “For instance, inspiratory activity may be associated with an increase in delivered flow rate, or a reduction in airway pressure, or both, depending on the circuit type. The inverse may occur with patient expiratory effort. A conductance or impedance profile used to estimate breath phase may therefore be more sensitive and more universal across circuit configurations. Therefore, a conductance or impedance profile or absolute magnitude may be used to trigger and cycle the RPT device in synchrony with the patient's efforts, or be used to provide feedback to the clinician regarding potential asynchrony between the machine's breath phase and that of the patient”).
As Kremeier discloses a method to identify inefficient breathing in relation to a ventilator (Kremeier [0070]), it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the system disclosed by Kremeier to include the asynchrony detection as disclosed by Martin in order to provide additional data in relation to insufficient effort (Martin [0275]).
Regarding claim 15, Kremeier as modified by Martin discloses the system of claim 12 but fails to disclose the instructions are further configured to cause the at least one processor to send a command to start a respiratory cycle responsive to identifying an asynchrony between the patient and a ventilator.
Martin further discloses the instructions are further configured to cause the at least one processor to send a command to initiate one or more corrective actions responsive to identifying an asynchrony between the patient and a ventilator ([0275]: “Therefore, a conductance or impedance profile or absolute magnitude may be used to trigger and cycle the RPT device in synchrony with the patient's efforts”, [0279], wherein the RPT device is the respiratory pressure therapy device).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the system disclosed by Kremeier to include triggering of a respiratory cycle in order to allow for treatment of asynchrony (Martin [0275]).
Regarding claim 16, Kremeier further discloses comparing the first impedance data with the second impedance data responsive to determining an increase in the first impedance without a corresponding increase in one or both of the pressure and the flow rate in the breathing circuit ([0033]: "and at least the first and the second (or any further) end-expiratory impedances are compared to one another and a recommendation for the PEEP pressure that causes the lowest end-expiratory impedance is stored or output for the operator of the ventilator or there is an automatic selection and application of this PEEP pressure.", wherein the comparison is made in relation to the set pressure).
Regarding claim 17, Kremeier further discloses with the electrical impedance tomography system, first impedance data representative of at least one dependent region of lungs of a patient comprises acquiring the first impedance data of only a dependent region of the lungs ([0087]: "According to the invention, there can be a consideration of the entire lung or else separate evaluation of ventral and dorsal, or arbitrary, lung portions").
Regarding claim 18, Kremeier as modified by Martin discloses comparing the first impedance data with the second impedance data ([0070], Fig 5), and the historical impedance data of the first region (Fig 3, threshold values), but fails to disclose comparing the first impedance data with each of the flow rate within the breathing circuit, the pressure within the breathing circuit.
Martin further discloses comparing the first impedance data with the flow rate within the breathing circuit and the pressure within the breathing circuit ([0275]: “a continuous determination of instantaneous impedance or conductance values based on measured or estimated pressure (P) and flow rate (Q) parameters may be used to estimate the phase of the patient's breathing.”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the system disclosed by Kremeier to include additional comparisons of impedance to flow and pressure as disclosed by Martin in order to obtain a more robust data set.
Regarding claim 21, Martin further discloses wherein identifying the ineffective effort on a user interface device comprises displaying a graph including flow and airway pressure as a function of time and displaying a shaded region on the graph corresponding to a time period during which the ineffective effort occurs (Fig 6a).
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/13/2026, with respect to the rejection(s) of claim(s) 12-18 under 35 U.S.C. § 101 have been fully considered and are persuasive. Dependent claim 15 successfully effects a particular treatment by “initiating one or more corrective actions”. Therefore, the rejection has been withdrawn with respect to claim 15. However, the rejection is maintained with respect to claims 12-14 and 16-18 (see above).
Applicant's arguments with respect to the rejection(s) of claim(s) 12-18 under 35 U.S.C. § 103 have been fully considered but they are not persuasive.
Applicant argues on page 13 of Remarks that claim 12 is allowable over 35 U.S.C. 103 as Kremier does not correlate impedance values of the lung to one another or other physiological signals. However, Martin discloses a comparison of impedance with flow rate/pressure (see rejection above). As such, the rejection is maintained.
Conclusion
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/KAVYA SHOBANA BALAJI/ Examiner, Art Unit 3791
/DANIEL L CERIONI/ Primary Examiner, Art Unit 3791
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