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 .
Status of Claims
This Office Action is in response to the remarks and amendments filed on February 13th, 2026. Claims 6-8 have been withdrawn and claims 16 and 18 have been canceled as such claims 1-5, 9-15, and 17-22 are pending consideration in this Office Action.
Response to Amendment
The rejections pursuant to 101 with respect to claims 1-5, 9-15, and 17-22 are not withdrawn in light of the amendments (see 101 section below and response to arguments section).
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 1-5, 9-15, 17, and 19-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 1-5, 9-15, 17, and 19-22 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-5, 9-15, 17, and 19-22 recites at least one step or instruction for monitoring patient data and measured data of concentration ratios of potassium and sodium ions to determine a condition of a patient, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 1-5, 9-15, 17, and 19-22 recites an abstract idea.
Specifically, Claim 1 recites
a monitoring system, comprising:
a sensor positioned along a breathing circuit (additional element);
one or more processors configured to cause the monitoring system (additional element) to perform operations comprising:
receive patient data for a patient being treated with a mechanical ventilation procedure (prior extra-solutional activity), wherein the patient data includes at least an indication of an illness of the patient that led to the treatment with the mechanical ventilation procedure (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
set an expected ratio of ions for the patient based on the patient data (extra-solutional activity);
measure data by the sensor (additional element) positioned along a breathing circuit during a mechanical ventilation procedure for a patient (extra-solutional activity);
analyze the data to determine respective concentrations of potassium ions and sodium ions at the sensor (additional element) and to calculate a detected ratio of the respective concentrations of the ions (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG) at the sensor;
compare the detected ratio to the expected ratio to determine a lung condition of the patient (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG); and
output a notification (post extra-solutional activity) to indicate the lung condition of the patient (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG).
Specifically, Claim 13 recites
a method of operating a monitoring system, the method comprising:
measuring ion concentrations, by a sensor positioned along a breathing circuit (additional element), at a plurality of times during a mechanical ventilation procedure for a patient (prior extra-solutional activity);
analyzing, with one or more processors (additional element), the measured ion concentrations to determine a detected ratio of respective concentrations of potassium ions and sodium ions (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG) at the sensor;
comparing, with the one or more processors (additional element), the detected ratio to an expected ratio (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
determining a difference between the detected ratio and the expected ratio (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
based on the difference between the detected ratio and the expected ratio, determining a severity of a condition of the patient (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
based on the plurality of measurements, determining a trend in the detected ratio (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
generating a prediction of a future state of the condition of the patient based on the determined trend (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG); and
generating a notification (post extra-solutional activity) indicating the determined severity of the condition and the predicted future condition (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG).
Specifically, Claim 17 recites
a monitoring system, comprising:
a tracheal tube (additional element) comprising;
a first cuff; a second cuff positioned proximally from the first cuff (additional elements), wherein the first cuff and the second cuff allow the tracheal tube to isolate one lung of a patient to deliver respiratory gases to the one lung of the patient (prior extra-solutional activity);
a sensor, molded (product by process) into the first cuff and exposed at an exterior surface of the first cuff (additional element) configured to generate data indicative of respective concentrations of ions (extra-solutional activity);
a ventilator configured to couple to the tracheal tube and comprising one or more processors (additional elements) configured to:
instruct delivery of respiratory gases through the tracheal tube during a mechanical ventilation procedure for a patient (prior extra-solutional activity);
receive the data from the sensor during the mechanical ventilation procedure (prior extra-solutional activity);
analyze the data to calculate a detected ratio of the respective concentrations of the ions (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
compare the detected ratio to an expected ratio to determine a condition of the lung isolated by the tracheal tube (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG); and
output a notification ((post extra-solutional activity) via a display screen of the ventilator (additional element) to indicate the condition of the patient (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG).
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent Claims 2-5, 9-12, 14, 15, and 19-22 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 1, 13, and 17 (and their respective dependent Claims 2-5, 9-12, 14, 15, and 19-22) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1, 13, and 17), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of:
One or more processors, a sensor, and a breathing circuit as recited in independent claim 1 and its dependents;
One or more processors, a sensor, and a breathing circuit as recited in independent claim 13 and its dependents; and
A tracheal tube with a first cuff, second cuff, sensor, ventilator, one or more processors, and a displace screen as recited in independent claim 17 and its dependent claims
are generically recited computer/structural elements in independent Claims 1, 13, and 17 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 1, 13, and 17 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a one or more processors as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1, 13, and 17 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1, 13, and 17 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-5, 9-15, and 19-22 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of:
One or more processors, a sensor, and a breathing circuit as recited in independent claim 1 and its dependents;
One or more processors, a sensor, and a breathing circuit as recited in independent claim 13 and its dependents; and
A tracheal tube with a first cuff, second cuff, sensor, ventilator, one or more processors, and a displace screen as recited in independent claim 17 and its dependent claims
The above-identified additional elements are generically claimed computer/structural components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the “one or more processors may include multiple microprocessors, one or more “general-purpose” microprocessors, one or more special-purpose microprocessors and/or one or more application specific integrated circuits (ASICS) or some combination thereof” [0021] which is configured to process data and execute instructions [0020].
Accordingly, in light of Applicant’s specification, the claimed term one or more processors is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the one or more processors. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in 1-5, 9-15, and 19-22 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method and systems of 1-5, 9-15, and 19-22 are directed to applying an abstract idea (e.g., mental process or certain method of organizing human activity) on a general purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of Claims 1-5, 9-15, and 19-22 provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 ,13, and 17 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-5, 9-15, and 19-22 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-5, 9-15, and 19-22 amounts to significantly more than the abstract idea itself.
Accordingly, Claims 1-5, 9-15, and 19-22 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5 and 9-11, 13-15, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Finneran (US 20110230742) in view of Kane (US 20070270675) and further in view of Siegel (US 20150324527).
Regarding claim 1, Finneran discloses
a monitoring system (figs. 2 and 8; system for monitoring blood analytes in the respiratory tract; [0004], [0038]), comprising:
a sensor positioned along a breathing circuit (figs. 1-8; sensor 36 may be embedded into cuff 84 or coupled to the tracheal tube body; [0040]-[0041]);
one or more processors configured to cause the monitoring system to perform operations (figs. 2 and 8; interface circuit 62 is configured to receive and process measurement data and monitor includes software adapted to process measurements acquired by the sensor; [0027], [0035]; therefore, it would be readily understood that processors are used in the circuit and monitor) comprising:
measure data by the sensor positioned along a breathing circuit (figs. 2 and 8; interface circuit 62 is configured to receive and process measurement data; [0035]) during a mechanical ventilation procedure for a patient (figs. 2 and 8; “the monitor 66 that is adapted to interpret and display the measurements received from the sensor 36 via the interface circuit 62. The monitor 66 may be connected to the ventilator 68 that supplies air to the patient 52 through connector 18; [0035]);
analyze the data to determine respective concentrations of ions at the sensor and to calculate a detected ratio of the respective concentrations of the ions at the sensor (figs. 2 and 8; the sensor 36 acquires measurements indicative of the presence or concentration of one or more blood gases or blood analytes in the tracheal mucosa; [0029] and [0036])
determine a lung condition of the patient (monitor 66 and interface circuit 62 monitors state of patient through interprets sensor data of blood gas and analyte levels in the respiratory tract of a patient experiencing respiratory arrest; [0017], [0029] and [0036])
output a notification to indicate the lung condition of the patient (displays data indicative of the measured levels to an end user (medical technician, doctor, nurse); [0017], therefore, notifying the blood levels of the respiratory tract of the patient to the end user).
Finneran does not explicitly disclose one or more processors configured to cause the monitoring system to perform operations comprising: receive patient data for a patient being treated with a mechanical ventilation procedure, wherein the patient data includes at least an indication of an illness of the patient that led to the treatment with the mechanical ventilation procedure; set an expected ratio of ions for the patient based on the patient data; analyze the data to determine respective concentrations of potassium ions and sodium ions at the sensor and to calculate a detected ratio of the respective concentrations of the ions at the sensor; compare the detected ratio to the expected ratio to determine a lung condition of the patient.
Kane discloses an implantable heart device with chemical sensors that detect concentration/activity of ion channels ([0025]) and may be used to observe respiratory signals ([0122] and [0126]) where
one or more processors configured to cause the monitoring system to perform operations (a processor to calculate analyte concentrations; [0115]) comprising:
set an expected ratio of ions for the patient (see Tables 1-2 in [0139], Table 1 shows detected concentration values compared to Table 2 showing normal concentrations, for blood/extracellular fluid)
analyze the data to determine respective concentrations of potassium ions and sodium ions at the sensor (analyzes data using physiological ions such as sodium and potassium, [0025], [0126], and [0129]);
compare the detected ratio to the expected ratio (see Tables 1-2 in [0139], Table 1 shows detected concentration values compared to Table 2 showing normal concentrations, for blood/extracellular fluid) to determine a lung condition of the patient (“methods can include the detection of an excessive or inadequate potassium level” and delivering message to the patient regarding the condition [0129] and using sodium concentration with respiration rates to determine fluid overload conditions [0126] and then employ logic into an algorithm to create a warning indicator/local alert [0126] or deliver a message to the patient regarding the condition without caregiver intervention [0129])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor and monitoring system of Finneran with the method/algorithm of calculating and comparing a detected concentrations of potassium and sodium from a known concentration range/ratio as taught in Kane in order to use concentrations such as potassium and sodium to determine and diagnose the condition of a patient such as fluid volume overload conditions in the lungs of the patient (Kane: [0126] and [0129]).
The modified device of Finneran does not explicitly disclose one or more processors configured to cause the monitoring system to perform operations comprising: receive patient data for a patient being treated with a mechanical ventilation procedure, wherein the patient data includes at least an indication of an illness of the patient that led to the treatment with the mechanical ventilation procedure; set an expected ratio of ions for the patient based on the patient data.
Siegel discloses a healthcare system for monitoring and providing personalized healthcare [0020] where
one or more processors configured to cause the monitoring system to perform operations (learning health system 10 executed by an associated processor) comprising:
receive patient data for a patient being treated (knowledge base 12 stores data such as biochemical parameters taken from a patient’s biochemical assays, a plurality of clinical parameters associated with the patient (health record databases, biometric parameters previous diagnoses and procedures; [0022]), wherein the patient data includes at least an indication of an illness of the patient that led to the treatment (individualized medical data can be used to provide a personalized medical protocol using deep medical knowledge of an individual and his/her own trend and history over time, and provide early indications of onset of specific conditions that may require treatment or life-style modification which allows for earlier treatment);
set an expected value for the patient based on the patient data (baseline calculation component 22 calculates an expected component for the patient’s biochemical parameters from at least the clinical parameters and biochemical parameters; [0023]);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the monitoring system and process of the modified system of Finneran with the learning health system of Siegel to have a knowledge base, baseline calculation component, and analytical modeling that uses a patient’s personalized information, therefor, shifting the current medical model from a reactive, symptom-based approach to a predictive/preventative approach based on personalized information (Siegel: [0017]).
Regarding claim 2, Finneran further discloses
the monitoring system (Finneran: system that monitors blood analytes in the respiratory tract; Kane: calculations/comparison of potassium and sodium ions; Siegel; learning health care system) of claim 1, comprising
the sensor, wherein the sensor is positioned along a tracheal tube (figs. 1-8; sensor 36 may be embedded into cuff 84 or coupled to the tracheal tube body; [0040]-[0041]).
Regarding claim 3, Finneran further discloses
the monitoring system (Finneran: system that monitors blood analytes in the respiratory tract; Kane: calculations/comparison of potassium and sodium ions; Siegel; learning health care system) of claim 2,
wherein the sensor is positioned along the tracheal tube at a location that is configured to be inserted into a body passage of the patient (see figs. 2 and 8; tracheal tube body is inserted into the user’s airway passage; sensor 36 may be embedded into cuff 84 or coupled to the tracheal tube body; [0040]-[0041]) during the mechanical ventilation procedure (see figs. 2 and 8; the tracheal tubes may be placed in the trachea and coupled to a ventilator and may be used in conjunction with the ventilator; [0017]).
Regarding claim 4, Finneran further discloses
the monitoring system (Finneran: system that monitors blood analytes in the respiratory tract; Kane: calculations/comparison of potassium and sodium ions; Siegel; learning health care system) of claim 2,
wherein at least a portion of the sensor is exposed on an exterior surface of the tracheal tube (figs. 1-8; sensor 36 may be coupled to the tracheal tube body; [0040]-[0041]; see figs. 1-2 where the sensor 36 is placed around the exterior surface of the tracheal tube).
Regarding claim 5, Finneran discloses
the monitoring system (Finneran: system that monitors blood analytes in the respiratory tract; Kane: calculations/comparison of potassium and sodium ions; Siegel; learning health care system) of claim 2, sensor 36 being coupled to the tracheal tube body; see figs. 1-2 and [0040]-[0041], but is silent as to how the sensor and tracheal tube is made.
However, the recitation wherein a body of the sensor is molded into the tracheal tube, is considered to be a product by process limitation. In product-by-process claims, "once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection is made, the burden shifts to the applicant to show an unobvious difference." MPEP 2113. MPEP 2113 clearly states "Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different processes." In this instance, the product taught by Finneran of the sensor being coupled to the tracheal tube is the same as or makes the product claimed obvious, meeting the limitation of the claims. This rejection under 35 U.S.C. 102/103 is proper because the "patentability of a product does not depend on its method of production." In re Thorpe, 227 USPQ 964,966 (Fed. Cir.1985).
Regarding claim 9, the modified device of Finneran further discloses
the monitoring system (Finneran: system that monitors blood analytes in the respiratory tract; Kane: calculations/comparison of potassium and sodium ions; Siegel; learning health care system) of claim 1,
wherein the one or more processors are configured to determine a baseline ratio (Siegel: baseline calculation component 22 calculates an expected component for the patient’s biochemical parameters from at least the clinical parameters and biochemical parameters; [0023]; in other words from the patient’s baseline biochemical parameters; Kane: see Tables 1-2 in [0139], Table 1 shows detected concentration values of sodium and potassium compared to Table 2 showing normal concentrations, for blood/extracellular fluid) for the patient during an initial portion (Siegel: uses patient’s data before treatment to predict/monitor a patient’s condition earlier in their disease course so that they can come into treatment; [0017]-[0020]) of the mechanical ventilation procedure (Finneran: monitoring blood analyte levels in a tracheal tube while providing ventilation; [0017]) and to calculate the expected ratio further based on the baseline ratio (Siegel: baseline calculation component 22 calculates an expected component for the patient’s biochemical parameters; Kane: see Tables 1-2 in [0139], Table 1 shows detected concentration values of sodium and potassium compared to Table 2 showing normal concentrations, for blood/extracellular fluid).
Regarding claim 10, the modified device of Finneran further discloses
the monitoring system (Finneran: system that monitors blood analytes in the respiratory tract; Kane: calculations/comparison of potassium and sodium ions; Siegel; learning health care system) of claim 1,
wherein the one or more processors are configured to monitor a trend in the detected ratio over time (Finneran: figs. 2 and 8; the sensor 36 acquires measurements indicative of the presence or concentration of one or more blood gases or blood analytes in the tracheal mucosa which can be done over a predetermined period of time; [0027], [0029], [0036]; Siegel: processor uses patient’s data trends; [0017] and [0024]) and to predict a future condition of the patient based on the trend (Siegel: uses patients trend and history to predict an onset of a condition (future condition); [0017] and uses an analytics modeling component 24 with a predictive model to compare calculated expected time series and measured time series of the biometric parameters thereby predicting the likelihood of one of plurality of disorders based on the deviations;[0023]-[0024]).
Regarding claim 11, the modified device of Finneran further discloses
the monitoring system (Finneran: system that monitors blood analytes in the respiratory tract; Kane: calculations/comparison of potassium and sodium ions; Siegel; learning health care system) of claim 1,
wherein the one or more processors are configured to cause the system to:
process, by a machine learning model, an input to generate a predicted future condition of the patient (Siegel: uses an analytics modeling component 24 with a predictive model to compare calculated expected time series and measured time series of the biometric parameters thereby predicting the likelihood of one of plurality of disorders based on the deviations; [0017]-[0020], [0023]-[0024]),
wherein the input includes a trend in the detected ratio and at least one of patient data, a baseline ion ratio, or ventilation data (Siegel: a deviation of the time series of values of the measured biometric series from the calculated expected time series and apply the deviation as an input to one or more predictive models associated with respective conditions of the plurality of conditions; [0017]-[0020], [0023]-[0024]).
Regarding claim 13, Finneran discloses
a method of operating a monitoring system (using figs. 2 and 8; system for monitoring blood analytes in the respiratory tract; [0004], [0038]), the method comprising:
measuring ion concentrations (figs. 2 and 8; the sensor 36 acquires measurements indicative of the presence or concentration of one or more blood gases or blood analytes in the tracheal mucosa; [0029] and [0036]), by a sensor positioned along a breathing circuit (figs. 2 and 8; interface circuit 62 is configured to receive and process measurement data; [0035]), at a plurality of times during a mechanical ventilation procedure for a patient (figs. 2 and 8; the monitor 66 may include software adapted to integrate measurements taken at preset intervals over a predetermined period of time; [0026]-[0027]);
analyzing, with one or more processors, the measured ion concentrations to determine a detected ratio of respective concentrations figs. 2 and 8; the sensor 36 acquires measurements indicative of the presence or concentration of one or more blood gases or blood analytes in the tracheal mucosa; [0029] and [0036]).;
generating a notification indicating the condition of the patient (displays data indicative of the measured levels to an end user (medical technician, doctor, nurse); [0017], therefore, notifying the blood levels of the respiratory tract of the patient to the end user)
Finneran does not disclose determine a detected ratio of respective concentrations of potassium ions and sodium ions at the sensor; comparing, with the one or more processors, the detected ratio to an expected ratio; determining a difference between the detected ratio and the expected ratio; based on the difference between the detected ratio and the expected ratio, determining a severity of a condition of the patient; based on the plurality of measurements, determining a trend in the detected ratio; generating a prediction of a future state of the condition of the patient based on the determined trend; and generating a notification indicating the predicted future condition and the determined severity of the condition
Kane discloses an implantable heart device with chemical sensors that detect concentration/activity of ion channels ([0025]) and may be used to observe respiratory signals ([0122] and [0126]) where
determine a ratio of respective concentrations of potassium ions and sodium ions at the sensor (analyzes data using physiological ions such as sodium and potassium, [0025], [0126], and [0129]);
comparing, with the one or more processors (a processor to calculate analyte concentrations; [0115]), the detected ratio to an expected ratio (see Tables 1-2 in [0139], Table 1 shows detected concentration values compared to Table 2 showing normal concentrations, for blood/extracellular fluid);
based on the plurality of measurements, determining a trend in the detected ratio (method of using a sensing element to determine analyte concentrations, storing the information, and evaluating as a function of time, identifying trends and events; [0113]-[0114]);
generating a notification indicating the condition of the patient (“methods can include the detection of an excessive or inadequate potassium level” and delivering message to the patient regarding the condition [0129] and using sodium concentration with respiration rates to determine fluid overload conditions [0126] and then employ logic into an algorithm to create a warning indicator/local alert [0126] or deliver a message to the patient regarding the condition without caregiver intervention [0129])
determining a difference between the detected ratio and the expected ratio (see Tables 1-2 in [0139], Table 1 shows detected concentration values compared to Table 2 showing normal concentrations, for blood/extracellular fluid; methods can include detecting excessive or inadequate potassium level [0129] and using sodium concentration with respiration rates to determine fluid overload conditions [0126], in other words the difference of the measured sodium and potassium values are compared to their expected/normal values);
based on the difference between the detected ratio and the expected ratio, determining a severity of a condition of the patient (method of using monitored/measured data level/concentrations to categorized a patient’s current condition as within the bounds of self-management or requiring the intervention of a medical professional; [0129]-[0131]; in other words, monitoring the severity of the condition of the patient).
generating a notification indicating the determined severity of the condition (“methods can include the detection of an excessive or inadequate potassium level” and delivering message to the patient regarding the condition [0129] and using sodium concentration with respiration rates to determine fluid overload conditions [0126] and then employ logic into an algorithm to create a warning indicator/local alert [0126] or deliver a message to the patient regarding the condition without caregiver intervention [0129).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor and monitoring system of Finneran with the method/algorithm of calculating and comparing a detected concentrations of potassium and sodium from a known concentration range/ratio as taught in Kane in order to use concentrations such as potassium and sodium to determine and diagnose the condition of a patient such as fluid volume overload conditions in the lungs of the patient or excessive or inadequate potassium level (Kane: [0126] and [0129]-[0131]).
The modified device of Finneran does not explicitly disclose generating a prediction of a future state of the condition of the patient based on the determined trend; and generating a notification indicating the predicted future condition.
Siegel discloses a healthcare system for monitoring and providing personalized healthcare with an associated processor [0020] where
generating a prediction of a future state of the condition of the patient based on the determined trend (uses patients trend and history to predict an onset of a condition (future condition); [0017]; uses baseline calculation component 22 and an analytics modeling component 24 with a predictive model to compare calculated expected time series and measured time series of the biometric parameters thereby predicting the likelihood of one of plurality of disorders based on the deviations;[0023]-[0024]); and
generating a notification indicating the predicted future condition (health learning system further comprises a clinician decision support component 83 to notify the clinician of the analytic process such as the comparison of the current assay with the baseline assay).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the monitoring system and process of the modified system of Finneran with the learning health system of Siegel to have a knowledge base, baseline calculation component, and analytical modeling that uses a patient’s personalized information, therefor, shifting the current medical model from a reactive, symptom-based approach to a predictive/preventative approach based on personalized information (Siegel: [0017]).
Regarding claim 14, the modified method of Finneran further discloses
the method (Finneran: using system that monitors blood analytes in the respiratory tract; Kane: calculations/comparison of potassium and sodium ions; Siegel; learning health care system) of claim 13, comprising:
determining, with the one or more processors, a baseline ratio for the patient ((Siegel: baseline calculation component 22 calculates an expected component for the patient’s biochemical parameters from at least the clinical parameters and biochemical parameters; [0023]; in other words from the patient’s baseline biochemical parameters; Kane: see Tables 1-2 in [0139], Table 1 shows detected concentration values of sodium and potassium compared to Table 2 showing normal concentrations, for blood/extracellular fluid) during an initial portion ((Siegel: uses patient’s data before treatment to predict/monitor a patient’s condition earlier in their disease course so that they can come into treatment; [0017]-[0020]) of the mechanical ventilation procedure (Finneran: monitoring blood analyte levels in a tracheal tube while providing ventilation; [0017]); and
calculating, with the one or more processors, the expected ratio based on the baseline ratio (Siegel: baseline calculation component 22 calculates an expected component for the patient’s biochemical parameters; Kane: see Tables 1-2 in [0139], Table 1 shows detected concentration values of sodium and potassium compared to Table 2 showing normal concentrations, for blood/extracellular fluid).
Regarding claim 15, the modified method of Finneran further discloses
the method (Finneran: using system that monitors blood analytes in the respiratory tract; Kane: calculations/comparison of potassium and sodium ions; Siegel; learning health care system) of claim 13, comprising:
receiving, at the one or more processors, patient data comprising physiological parameters, gender, age, smoking history, or any combination thereof (Siegel: knowledge base 12 of health learning system processor stores data such as biochemical parameters taken from a patient’s biochemical assays, a plurality of clinical parameters associated with the patient (health record databases, biometric parameters (including e.g., age, weight, blood pressure, temperature, glucose levels, etc.), previous diagnoses, and procedures, etc.; [0022]); and
calculating, with the one or more processors, the expected ratio based on the patient data (Siegel: baseline calculation component 22 calculates an expected component based on the patient’s biochemical parameters and clinical parameters; Kane: see Tables 1-2 in [0139], Table 1 shows detected concentration values of sodium and potassium compared to Table 2 showing normal concentrations, for blood/extracellular fluid).
Regarding claim 22, the modified device of Finneran further discloses
the monitoring system (Finneran: using system that monitors blood analytes in the respiratory tract; Kane: calculations/comparison of potassium and sodium ions; Siegel; learning health care system) of claim 1,
wherein the patient data further comprises at least one of gender, age, smoking history, heart rate, or oxygen saturation (Siegel: knowledge base 12 of health learning system processor stores data such as biochemical parameters taken from a patient’s biochemical assays, a plurality of clinical parameters associated with the patient (health record databases, biometric parameters (including e.g., age, weight, blood pressure, temperature, glucose levels, etc.), previous diagnoses, and procedures, etc.; [0022]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Finneran (US 20110230742) in view of Kane (US 20070270675) and further in view of Siegel (US 20150324527) and Bell (US 10980954).
Regarding claim 12, the modified device of Finneran discloses
the monitoring system (Finneran: system that monitors blood analytes in the respiratory tract; Kane: calculations/comparison of potassium and sodium ions; Siegel; learning health care system) of claim 1, further comprising
a ventilator with a display screen (fig. 2; ventilator 66 may be used in conjunction with the monitor 66 may include a memory, a display, code configured to provide a specific output, and so forth; [0017], [0027], [0035]),
and the one or more processors are configured to output the notification on the display screen (displays data indicative of the measured levels to an end user (medical technician, doctor, nurse); [0017], therefore, notifying the blood levels of the respiratory tract of the patient to the end user).
Bell discloses intubating and mechanically ventilating the patient with an endotracheal tube and monitoring system
wherein the notification includes one or more recommended ventilation parameters based on monitored data (“the operator receives feedback of ventilating progress by monitoring the patient's oxygen level from a suitable patient blood oxygen readout on an operator display. Additionally, the amount of CO.sub.2 in the expiratory flow is important to understand how well the lung functions by the exchange rate of oxygen into the blood”; col. 17, lines 53-58), and the one or more processors (microprocessor capable of monitoring all the sensor data interfacing with the display; Col. 12, Lines 57-67 and Col. 13, Lines 1-23) are configured to output the notification on the display screen (Fig. 5; ventilator operator interface display; Col. 12, Lines 57-58 and Col. 13, Lines 21-23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system that monitors blood gas and analyte level of Finneran with the ventilator and display of Bell to be able to ventilate the patient, monitor all sensor data, have a touch-screen to switch and see new displays for alarms, various control pages, information pages, setup pages, etc., and provide feedback to the operator based on monitored data that is representative of how well the lung functions based on the exchange rate of oxygen in the blood (Bell: col. 17, lines 53-5; Col. 12, Lines 57-67 and Col. 13, Lines 1-23).
It directly follows that the resultant system that monitors blood gas and analyte level of Finneran combined with the ventilator and display of Bell would meet the claimed structural limitations since:
The modified device of Finneran and Bell combined discloses
wherein the notification includes one or more recommended ventilation parameters (the operator receives feedback of ventilating progress by monitoring the patient's oxygen level from a suitable patient blood oxygen readout on an operator display. Additionally, the amount of CO.sub.2 in the expiratory flow is important to understand how well the lung functions by the exchange rate of oxygen into the blood”; col. 17, lines 53-58) based on the comparison of the detected ratio to the expected ratio (Finneran: figs. 2 and 8; the sensor 36 acquires measurements indicative of the presence or concentration of one or more blood gases or blood analytes in the tracheal mucosa; [0029] and [0036]; Kane: see Tables 1-2 in [0139], Table 1 shows detected concentration values compared to Table 2 showing normal concentrations, for blood/extracellular fluid).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Finneran (US 20110213264; note this is different from Finneran used in independent claims 1 and 13) in view of Sutherland (US 20200069898) and further in view of Kane (US 20070270675) and Siegel (US 20150324527).
Regarding claim 17, Finneran discloses
a monitoring system (figs. 1-6; system for monitoring blood analytes in the respiratory tract; [0005], [0033]), comprising:
a tracheal tube (figs. 1-6; tracheal tube 12; [0029]) comprising;
a first cuff (figs. 1-3; cuff 24; [0026]).
a sensor, exposed at an exterior surface of the first cuff (sensor 40 is coupled to the exterior of the cuff; see figs. 1-2 and [0021]) and configured to generate data indicative of respective concentrations of ions (“the sensor 40 may contact the tracheal mucosa directly to obtain a blood gas or blood analyte measurement or may obtain the measurement via equilibration with gases or analytes”; [0003]-[0004], [0014], [0025]);
a ventilator configured to couple to the tracheal tube (fig. 3; a ventilator 60 that supplies air to the patient 46 through connector 18 of tracheal tube 12; [0027]) and comprising one or more processors (fig. 3; interface circuit 54 is configured to receive and process measurement data and monitor 58 includes software adapted to process measurements acquired by the sensor; [0016], [0027]; therefore, it would be readily understood that processors are used in the circuit and monitor) configured to:
instruct delivery of respiratory gases through the tracheal tube during a mechanical ventilation procedure for a patient (the ventilator delivers respiratory air to the patient 46 during the ventilation procedure and may cooperate with the tracheal tube and other accessories to maintain airflow to the lungs of the patient; [0016]);
receive the data from the sensor during the mechanical ventilation procedure (fig. 3; an interface circuit and/or a monitor that is configured to receive data from the sensor, process such data, and display the processed data to an end user; [0016] which can be done in conjunction with the tracheal tube to maintain airflow; [0016]);
analyze the data to calculate a detected ratio of the respective concentrations of the ions (the sensor is used to sense one or more indicators of blood flow characteristics, such as a level of blood gases and/or blood analytes, in the respiratory tract while the interface circuit and/or a monitor that is configured to receive data from the sensor, process such data; [abstract and [0027]);
output a notification via a display screen of the ventilator to indicate the condition of the patient (displays data indicative of the measured levels to an end user (medical technician, doctor, nurse); [0016], therefore, notifying the blood levels of the respiratory tract of the patient to the end user)
While Finneran discloses sensor 40 being coupled to the exterior of the cuff; see figs. 1-2 and [0021], but is silent as to how the sensor and tracheal tube is made.
However, the recitation a sensor, molded into the first cuff, is considered to be a product by process limitation. In product-by-process claims, "once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection is made, the burden shifts to the applicant to show an unobvious difference." MPEP 2113. MPEP 2113 clearly states "Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different processes." In this instance, the product taught by Finneran of the sensor being coupled to the exterior of the first cuff is the same as or makes the product claimed obvious, meeting the limitation of the claims. This rejection under 35 U.S.C. 102/103 is proper because the "patentability of a product does not depend on its method of production." In re Thorpe, 227 USPQ 964,966 (Fed. Cir.1985).
Finneran does not disclose a second cuff positioned proximally from the first cuff , wherein the first cuff and the second cuff allow the tracheal tube to isolate one lung of a patient to deliver respiratory gases to the one lung of the patient; compare the detected ratio to an expected ratio to determine a condition of the lung isolated by the tracheal tube.
Sutherland discloses a similar tracheal tube assembly with
a second cuff positioned proximally from the first cuff (see fig. 1; cuff 90 is positioned proximal to cuff 92; [0041]), wherein the first cuff and the second cuff allow the tracheal tube to isolate one lung of a patient to deliver respiratory gases to the one lung of the patient (figs. 1-2; the isolation tube assembly is able to use a control valve the cuffs to isolate the left and right lung; [0038], [0041]-[0042]);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tracheal tube of Finneran with the second cuff and control valve of Sutherland to be able to close airflow or oxygen through the lumens; therefore, isolating a lung om a way that is easy to use in emergency situations in the field (Sutherland: [0003]-[0004]).
The modified device of Finneran does not disclose compare the detected ratio to an expected ratio to determine a condition of the lung isolated by the tracheal tube.
Kane discloses an implantable heart device with chemical sensors that detect concentration/activity of ion channels ([0025]) and may be used to observe respiratory signals ([0122] and [0126]) where
analyze the data to calculate a detected ratio of the respective concentrations of the ions (analyzes data using physiological ions such as sodium and potassium, [0025], [0126], and [0129]);
compare the detected ratio to an expected ratio (see Tables 1-2 in [0139], Table 1 shows detected concentration values compared to Table 2 showing normal concentrations, for blood/extracellular fluid) to determine a condition of the lung (patient (“methods can include the detection of an excessive or inadequate potassium level” and delivering message to the patient regarding the condition [0129] and using sodium concentration with respiration rates to determine fluid overload conditions [0126] and then employ logic into an algorithm to create a warning indicator/local alert [0126] or deliver a message to the patient regarding the condition without caregiver intervention [0129]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor and monitoring system of Finneran with the method/algorithm of calculating and comparing a detected concentrations of potassium and sodium from a known concentration range/ratio as taught in Kane in order to use concentrations such as potassium and sodium to determine and diagnose the condition of a patient such as fluid volume overload conditions in the lungs of the patient (Kane: [0126] and [0129]).
It directly follows that the resultant sensor and monitoring system of Finneran combined with the method/algorithm of calculating and comparing of Kane would meet the claimed structural limitations since:
The modified device of Finneran and Kane combined discloses
determine a condition of the lung (Kane: (“methods can include the detection of an excessive or inadequate potassium level” and delivering message to the patient regarding the condition [0129] and using sodium concentration with respiration rates to determine fluid overload conditions [0126] and then employ logic into an algorithm to create a warning indicator/local alert [0126] or deliver a message to the patient regarding the condition without caregiver intervention [0129]) isolated by the tracheal tube (Finneran: tracheal tube 12 with cuff 24 with sensor 40 that measures blood analytes levels/concentrations; Sutherland: see fig. 1; cuff 90 is positioned proximal to cuff 92 (cuff 24); [0041] to isolate lung; [0038], [0041]-[0042]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Finneran (US 20110213264) in view of Sutherland (US 20200069898) and further in view of Kane (US 20070270675) and Siegel (US 20150324527).
Regarding claim 19, the modified device of Finneran discloses
the monitoring system (Finneran: system that monitors blood gas and analytes levels in respiratory tract; Sutherland: lung isolation tube assembly; Kane: method/algorithm of calculating and comparing a detected concentrations of potassium and sodium) of claim 17,
wherein the one or more processors are configured to monitor the detected ratio over time (Finneran: fig. 3; the sensor 40 acquires measurements indicative of the presence or concentration of one or more blood gases or blood analytes [abstract] in the tracheal mucosa can be done over a predetermined period of time which the monitor 58 processes and displays; [0025], [0027]];
The modified device of Finneran does not disclose wherein the one or more processors are configured to monitor a trend and to predict a future condition of the patient based on the trend.
Siegel discloses a healthcare system for monitoring and providing personalized healthcare [0020] where
wherein the one or more processors (associated processor of learning healthcare system 10; [0021]) are configured to monitor a trend (processor uses patient’s data trends; [0017] and [0024]) and to predict a future condition of the patient based on the trend (uses patients trend and history to predict an onset of a condition (future condition); [0017] and uses an analytics modeling component 24 with a predictive model to compare calculated expected time series and measured time series of the biometric parameters thereby predicting the likelihood of one of plurality of disorders based on the deviations;[0023]-[0024]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the monitoring system and process of the modified system of Finneran with the learning health system of Siegel to have a knowledge base, baseline calculation component, and analytical modeling that uses a patient’s personalized information, therefor, shifting the current medical model from a reactive, symptom-based approach to a predictive/preventative approach based on personalized information (Siegel: [0017]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Finneran (US 20110213264) in view of Sutherland (US 20200069898) and further in view of Kane (US 20070270675) and Torben (Article: Na+-K+ Pump Stimulation Improves Contractility in Damaged Muscle Fibers).
Regarding claim 20, the modified device of Finneran discloses
the monitoring system (Finneran: system that monitors blood gas and analytes levels in respiratory tract; Sutherland: lung isolation tube assembly; Kane: method/algorithm of calculating and comparing a detected concentrations of potassium and sodium) of claim 17,
wherein the ions comprise sodium ions and potassium ions (Kane: analyzes data using physiological ions such as sodium and potassium, [0025], [0126], and [0129]), and
the detected ratio and the expected ratio relate the respective concentrations of the sodium ions and the potassium ions to one another.
While the modified device of Finneran does not explicitly disclose the detected ratio and the expected ratio relate the respective concentrations of the sodium ions and the potassium ions to one another, it would have been obvious to one of ordinary skill in the art before the effective filing date that one could create a comparison with the sodium and potassium concentrations (blood analytes) as measured in Finneran and Kane to create a ratio. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to compare such ratios as “it is essential for our ability to move and survive, that the sodium potassium pumps can pump out the sodium gained and reaccumulate the potassium lost, allowing restoration and maintenance of excitability and the ability to carry out contractions” (Torben: Article: Na+-K+ Pump Stimulation Improves Contractility in Damaged Muscle Fibers, page 286-287, Paragraph 1 under Introduction).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Finneran (US 20110213264) in view of Sutherland (US 20200069898) and further in view of Kane (US 20070270675) and Bell (US 10980954).
Regarding claim 17, the modified device of Finneran discloses
the monitoring system (Finneran: system that monitors blood gas and analytes levels in respiratory tract; Sutherland: lung isolation tube assembly; Kane: method/algorithm of calculating and comparing a detected concentrations of potassium and sodium) of claim 17,
The modified device of Finneran does not explicitly disclose wherein the notification includes a recommended adjustment to ventilation parameters.
Bell discloses intubating and mechanically ventilating the patient with an endotracheal tube and monitoring system
wherein the notification includes a recommended adjustment to ventilation parameters (“the operator receives feedback of ventilating progress by monitoring the patient's oxygen level from a suitable patient blood oxygen readout on an operator display. Additionally, the amount of CO.sub.2 in the expiratory flow is important to understand how well the lung functions by the exchange rate of oxygen into the blood”; col. 17, lines 53-58).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system that monitors blood gas and analyte level of Finneran with the ventilator and display of Bell to be able to ventilate the patient, monitor all sensor data, have a touch-screen to switch and see new displays for alarms, various control pages, information pages, setup pages, etc., and provide feedback to the operator based on monitored data that is representative of how well the lung functions based on the exchange rate of oxygen in the blood (Bell: col. 17, lines 53-5; Col. 12, Lines 57-67 and Col. 13, Lines 1-23).
Response to Arguments
Applicant's arguments filed 02/13/2026 have been fully considered but they are not persuasive.
On page 8 of the remarks, Applicant argues that Office action has not established a prima facie case of obviousness as the references fail to teach or suggest all of the recited limitations of claims.
More specifically, on pages 8-9, with respect to claim 1 that none of the prior art (Chou or LibreTexts) discloses the newly amended limitation of “receive patient data for a patient being treated with a mechanical ventilation procedure, wherein the patient date includes at least an indication of an illness of the patient that t led to the treatment with the mechanical ventilation procedure” and setting an expected ratio of ions for the patient based on the data. Applicant’s arguments with respect to claims 1 have been considered but are moot because the new ground of rejection regarding this particular limitation does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On page 9 of the remarks, with respect to claim 13, Applicant argues that cited references fail to disclose the newly amended limitation “determining a difference (…) a trend in the detected ratio” and “generating ap reaction of a future state of condition of the patient based on the determine trend”. More specifically, that Kane does not disclose the concepts of comparing a detect ratio to an expected ion ratio to determine a severity of a condition; however, Kane further discloses a method of determining whether the analyte level is excessive or inadequate [0129] and using monitored/measured data level/concentrations to categorized a patient’s current condition as within the bounds of self-management or requiring the intervention of a medical professional ([0129]-[0131]). In other words, the method monitors measured data in relation to an expected value and then determines whether the condition is severe enough that it would require intervention of a medical professional. In regards to the limitation of prediction a future state of the condition of the patient based on the trend, they are moot because the new ground of rejection regarding this particular limitation does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On page 9 of the remarks, Applicant argues that the cited references fail to disclose the newly amended limitations of claim 17 where “a tracheal tube comprising: (…) generate data indicative of respective concentration of ions”. Applicant’s arguments with respect to claims 17 have been considered but are moot because the new ground of rejection regarding this particular limitation does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On page 10 of the remarks, Applicant argues that a sensor-based monitoring system is not a “mental process” or a “certain method of organizing human activity”, more specifically that a sensor that measures ion concentrations is not a mental process or a method of organizing human activity. However, as further describes in the 101 above, the sensor is not considered an abstract idea, but rather an additional structural element that is performing extra-solutional activity (i.e. receiving/measuring data) that does not further limit the abstract idea which is determining/calculating ion concentrations to determine a condition of a patient. It is agreed that the sensor is not a generic computing component, but rather that the sensor is being interpreted as a common well known additional structural element that is known in the art.
Applicant further argues that independent claim 13 is also not directed towards an abstract idea due to the recited operation of “measuring ion concentrations, by a sensor positioned along a breathing circuit, at a plurality of time during mechanical ventilation”. However, as recited above this measuring of ions at a plurality of times is extra-solutional activity that is being performed by the sensor which is an additional element.
For these reasons, the arguments regarding the 101 are unpersuasive.
To overcome a 101 rejection it is recommended to integrate the abstract idea into practical application by using the abstract idea in a closed loop. An example would be, “wherein the ventilator is configured to be adjusted based on the determined condition of the patient”. It is noted that outputting a notification on a display, is not enough to overcome a 101 as it is considered a generic computer component.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Amar (US 20040144387) – endotracheal assembly for isolating one lung during anesthesia and surgery
Chou (US 20180156775) – a biochemical sensing device that can measure EBC and can estimate the severity of a patient’s disease or condition
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SYDNEY REYES RUSSELL whose telephone number is (703)756-4567. The examiner can normally be reached M-F 930am -6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.R.R./Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
Prosecution Insights