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
Per the amendments to the abstract, the abstract objection has been withdrawn.
Per the amendments to the specification, the objections that haven’t been addressed are maintained and the ones that have been addressed are withdrawn, new objections have been presented.
Per the amendments to the claims, the claim objections have been withdrawn.
Per the amendments to the claims, the 112(b) rejections that haven’t been addressed are maintained and that ones that have been addressed are withdrawn.
Per the amendments to the claims, the 112(d) rejection has been withdrawn.
Per the amendments to the claims, the 101 rejections have been maintained, see the examiner’s note below pertaining.
Specification
The disclosure is objected to because of the following informalities:
(new): Per Applicant’s reply of pg. 5 “6” of the substitute specification, it is unclear as to how the page would is reamended over from the amended “5”, correctly addressing the reference characters not in Figure 1, being strike through, to then reinclude the reference characters and strike through different ones incorrectly as previously objected to in the filed non-final rejection 10/24/2025 on pages 3-4, e-f.
(new): Additionally, pg. 6 “6” lines 3-4 recite “the predicted predicted gas flow setpoint value 133”, but should read ---the scaled predicted gas flow setpoint value 133---.
(maintained): Reference character “146” for figure 5 is not mentioned in the specification section of figure 5 descriptions.
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.
See examiner’s note below at the end of the section.
Claim 1 is 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.
In accordance with MPEP 2106.04, Claim 1 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Claim 1 recites at least one step or instruction for determining or calculating a gas flow value, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a certain method of organizing human activity in MPEP 2106.04(a)(2)(II) or mathematical concept in MPEP 2106.04(a)(2)(I).
List of abstract ideas in MPEP 2106.04(a)(2):
1) Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations (see MPEP 2106.04(a)(2)(I));
2) Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (see MPEP 2106.04(a)(2)(II)); and
3) Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP 2106.04(a)(2)(III))]]
Accordingly, Claim 1 recites an abstract idea.
Specifically, Claim 1 recites a ventilator, wherein the ventilator comprises a control unit that is configured and designed to execute a method for regulating a gas flow of at least one first gas to be admixed to at least one second gas (additional element)
which method comprises at least one step of a control of a gas valve, wherein at least one manipulated variable for the control of the gas valve is determined from at least one correction regulator component and at least one feedforward component, an input variable of the at least one feedforward component being a predicted gas flow setpoint value of the at least one first gas, and which method further comprises:
- a first step of a total flow prediction, wherein a predicted total gas flow setpoint value of a gas mixture of the at least two gases is determined starting from a set pressure value and a ventilation situation
Determining values and predicting values (judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
- a second step for flow scaling, wherein a scaled predicted total gas flow setpoint value and/or the scaled predicted gas flow setpoint value is calculated from a predicted total flow setpoint value alone or from the predicted total gas flow setpoint value together with the predicted gas flow setpoint value: and
Calculating values and predicting values (judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
- a third step for determining a predicted gas flow setpoint value and/or a scaled predicted gas flow setpoint value, wherein a scaled predicted total gas flow setpoint value and/or a scaled predicted gas flow setpoint value is calculated from the predicted gas flow setpoint value.
Determining values and calculating values (judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
Further, dependent Claims 4-5, 8-15 and 17 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 claimed functions/steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in Claim 1 and the respective dependent claims are not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claim 1) either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). More specifically, the additional elements of: a ventilator, wherein the ventilator comprises a control unit that is configured and designed to execute a method for regulating a gas flow of at least one first gas to be admixed to at least one second gas are generically recited data regulating steps in independent Claim 1 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a).
Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) 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 according to MPEP 2106.04(d)(2) and 2106.05(e).
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 in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claim 1 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) 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 computer (e.g., a control unit as claimed 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 according to MPEP 2106.05(f).
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 according to MPEP 2106.05(a). 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 Claim 1 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claim 1 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of Claim 1 includes any additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
The claim requires the additional elements of: a ventilator, wherein the ventilator comprises a control unit that is configured and designed to execute a method for regulating a gas flow of at least one first gas to be admixed to at least one second gas.
The above-identified additional elements use generically claimed computer 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, MPEP 2106.05(d)(II) along with 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.
In light of Applicant’s specification, the claimed terms “control unit”, “correction regulator component”, “feedforward component” are reasonably construed as generic computing devices. 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 technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
The recitation of the above-identified additional limitations in Claim 1 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 MPEP 2106.05(f) along with 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. See MPEP 2106.05(a) along with 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, per MPEP 2106.05(a), 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, Claim 1 is directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing 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 according to MPEP 2106.04(d)(2) and 2106.05(e).
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 1 (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 according to MPEP 2106.05(h).
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 according to MPEP 2106.05(h).
When viewed as whole, the above-identified additional elements 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 according to MPEP 2106.04(d)(2) and 2106.05(e).
Moreover, 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 according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claim 1 amounts to significantly more than the abstract idea itself.
Accordingly, Claim 1 and its dependent claims are not patent eligible and rejected under 35 U.S.C. 101.
Examiner’s Note
To overcome the 101 rejection, Applicant should claim how the determination steps result in operation/ control of the gas valve for the ventilator.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 4 and 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 4 and 5 recite “a ventilation situation” in lines 11, 2-4 and 3 respectively. The use of the term “situation” in this limitation and lack of description of one specific situation renders the phrase indefinite. Using broadest reasonable interpretation, a ventilation situation is any embodiment with the use of a ventilator or respiratory apparatus with a control unit.
Response to Arguments
Applicant's arguments filed 01/23/2026 have been fully considered but they are not persuasive.
Applicant argues, per page 5 of the remarks, with respect to claim 7 that claim 7 has not been rejected as unpatentable over any combination of Chang, Keitel, Williams, Miller, and Jonsson. Claim 7 is substantially represented in claim 6 of the previous non-final rejection filed on 10/24/2025, and claim 6 has been prior art rejected previously (see pg. 21-22).
Furthermore, it is noted that the invention has been shifted from a control unit for a ventilator to a ventilator that comprises a control unit.
Claim Rejections - 35 USC § 103
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 1, 4, 5, 8-10, 13 and 14 are rejected under 35 U.S.C. 103 as being obvious over Chang (US 20190275273 A1) in view of Keitel (US 6216690 B1) and further in view of Williams (US 20210361899 A1).
Regarding claim 1, Chang discloses (currently amended) a ventilator comprises a control unit (Chang; [014] lines 8-11, [011]; controller that acts as a control unit for a ventilator);
that is configured and designed to execute a method for regulating a gas flow of at least one first gas to be admixed to at least one second gas (Chang [014] lines 1-5, abstract);
which method comprises at least one step of a control of a gas valve (Chang [014] lines 9-13, [0016] “control the air flow modulator and optionally the oxygen control valve”);
wherein at least one manipulated variable for the control of the gas valve is determined from at least one correction regulator component and at least one feedforward component (Chang [014] lines 9-13; controlling the flow modulators, wherein the flow modulator can be a valve or a variable speed pump, [00229] D. lines 1-3; “pressure error becomes the input”, “corrects the pressure command”, and modifies based on pressure error);
an input variable of the at least one feedforward component being a predicted gas flow setpoint value of the at least one first gas (Chang [0046] lines 1-6; a command comprising a parameter target to a flow, can be measured as feedback, [0234] I.; algorithm is used to get oxygen flow as input to the controller and can be the error rate that gets feedback, and [0231]; algorithm is predicting a target flow);
and which method further comprises:
- a first step of a total flow prediction, wherein a predicted total gas flow setpoint value of a gas mixture of the at least two gases is determined starting from a set pressure value and a ventilation situation (Chang [0231]; algorithm predicts target air flow, [0067] lines 1-3; controller configured to provide a mixed gas and [0067] lines 6-9; having a target pressure where the mixed gas is delivered);
and - a third step for determining a predicted gas flow setpoint value and/or a scaled predicted gas flow setpoint value (Chang [0046] lines 1-6; a command comprising a parameter target to a flow, can be measured as feedback, [0234] I.; algorithm is used to get oxygen flow as input to the controller and can be the error rate that gets feedback, and [0231]; algorithm is predicting a target flow);
Chang fails to disclose a second step for flow scaling.
Keitel discloses a system for control of a gas concentration comprising:
- a second step for flow scaling (Keitel col. 7 lines 34-35: flow priority control mode).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Chang by providing a second step for flow scaling as taught by Keitel since a second step would help to solve the problem of slow response time and inefficient management of gas flow (Keitel col. 2 lines 46-48).
Modified Chang fails to disclose a scaled predicted total gas setpoint value being calculated.
Williams discloses a control unit wherein:
a scaled predicted total gas flow setpoint value and/or the scaled predicted gas flow setpoint value is calculated from a predicted total flow setpoint value alone or from the predicted total gas flow setpoint value together with the predicted gas flow setpoint value (Williams [0355]; model error corrects prediction – thereby varying the prediction flow value, [0026]; gas flow rate can be the total gas rate, [0523]; gas flow setpoint value = output total value, [0258] lines 3-5; “one or more model parameters” are calculating the parameter data – including the setpoint values);
wherein a scaled predicted total gas flow setpoint value and/or a scaled predicted gas flow setpoint value is calculated from the predicted gas flow setpoint value (Williams [0355]; model error corrects prediction – thereby varying the prediction flow value, [0026]; gas flow rate can be the total gas rate, [0523]; gas flow setpoint value = output total value and [0258] lines 3-5; “one or more model parameters” are calculating the parameter data – including the setpoint values).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Chang in view of Keitel with the scaled predicted total gas flow setpoint value and/or the scaled predicted gas flow setpoint value that is calculated as taught by Williams, since the patient specific model includes the predicted values of Williams and helps to provide better control over the oxygen saturation output from the patient (Williams [0497] lines 9-10).
Regarding claim 4, modified Chang in view of Williams further discloses (currently amended) the ventilator of claim [[2]] 1.
Modified Chang fails to disclose the first step comprises a patient flow model, wherein a set pressure value and a ventilation situation are at least partially incorporated in the patient flow model and wherein a result of the patient flow model and at least partially the ventilation situation are incorporated in a calculation of a predicted total gas flow setpoint value.
Williams discloses the control unit wherein:
the first step comprises a patient flow model (Williams [0497]; patient specific flow model);
wherein a set pressure value and a ventilation situation are at least partially incorporated in the patient flow model (Williams [0493]; SpO2 values of model can be pre-set, figure 5,6; patient model of flow and patient model in ventilation situation, [0493] lines 4-5; pressure is in the loop of flow in patient model, also in figure 6 of the ventilation situation);
and wherein a result of the patient flow model and at least partially the ventilation situation are incorporated in a calculation of a predicted total gas flow setpoint value (Williams, figure 4; patient flow model result over time of oxygen saturation from a patient, figure 2; a specific patient model is generated, [0043, 0047]; prediction of output, and Williams [0523]; explanation of predicted control value of input).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Chang in view of Keitel with the patient flow model of Williams which includes a ventilation situation with a set pressure value, since the patient specific model of Williams helps to provide better control over the oxygen saturation output from the patient (Williams [0497] lines 9-10).
Regarding claim 5, modified Chang in view of Williams further discloses (currently amended) the ventilator of claim [[2]] 1.
Modified Chang fails to disclose a first step with starting values for a patient model that are determined from a patient model from a ventilation situation.
Williams discloses the control unit wherein:
in the first step, starting values for a patient flow model are determined via a patient model from a ventilation situation (Williams figure 2; starting values, [00001] & [0507]; equation for parameter in patient flow model with initial values, figure 5; patient model in respiratory situation).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Chang in view of Keitel with the patient flow model of Williams wherein in the first step starting values for a patient flow model that are determined from a patient model from a ventilation situation, since the patient specific model of Williams helps to provide better control over the oxygen saturation output from the patient (Williams [0497] lines 9-10).
12. Regarding claim 8, modified Chang in view of Williams further discloses (currently amended) the ventilator of claim [[2]] 1, wherein the second step comprises a scaling, wherein separate scaling factors and/or scaling functions (Keitel col. 4 lines 30-36, col. 7 lines 44-45; where you can change the variation of rates making it separate);
are determined for inspiration and expiration (Keitel col.7 lines 34-38, 44-45 where you can change the variation of rates);
and a switch is made via a switch between the scaling factors and/or scaling functions depending on inspiration or expiration (Keitel col. 4 lines 30-34; processor is programmed to selectively switch modes based on the measured characteristic of breathing gas, provides control priority to achieve a desired inspiratory setting).
13. Regarding claim 9, modified Chang in view of Williams further discloses (currently amended) the ventilator of claim 8.
Modified Chang fails to disclose a comparison between a provided inspiration or expiration volume and having a real applied inspiration or expiration volume taken into consideration to determine the scaling factors/functions.
Williams discloses the control unit wherein:
at least one comparison between a provided inspiration or expiration volume (Williams [0353]; comparison of expiration volume, past predicted value here of patient parameter – SpO2 (output));
and a real applied inspiration or expiration volume is taken into consideration to determine the scaling factors and/or the scaling functions (Williams [0044]; real applied = “measured SpO2”, [0355]; scaling factors/functions – error is used to correct the predicted rate – varying the rate).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Chang in view of Keitel with the comparison between a provided inspiration or expiration volume and a real applied inspiration or expiration volume as taught by Williams wherein the comparison between a provided inspiration or expiration volume and a real applied inspiration or expiration volume is taken into consideration to determine the scaling factors/functions, since the scaling factors are used in the patient specific model and the model helps to provide better control over the oxygen saturation output from the patient (Williams [0497] lines 9-10).
14. Regarding claim 10, modified Chang in view of Williams further discloses (currently amended) the ventilator of claim [[2]] 1.
Modified Chang fails to disclose a calculation of the predicted gas flow setpoint value from a predicted total flow setpoint value.
Williams discloses the control unit wherein:
the third step comprises a calculation of the predicted gas flow setpoint value from a predicted total flow setpoint value (Williams [0523]; predicted gas flow, [0026]; output is the total and gas flow rate can be total gas flow rate, [0258]; lines 3-5; calculation of model parameters which include setpoint values).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Chang in view of Keitel, with the calculation of the predicted gas flow setpoint value from a predicted total flow setpoint value of Williams, such that the patient specific model in Williams includes the prediction of flow and helps to provide better control over the oxygen saturation output from the patient (Williams [0497] lines 9-10).
15. Regarding claim 13, modified Chang in view of Williams further discloses (currently amended) the ventilator of claim 1.
Chang discloses a ventilator wherein:
an input variable for the feedforward component (Chang [0046]; input variable, [0234] algorithm; feedforward component, [0231]; predicts gas flow);
for determining the manipulated variable for the control of the gas valve (Chang [00229]; feedforward + correction regulator component);
is the predicted gas flow setpoint value (Chang [0231]; predicts gas flow value);
(Chang [0046]; target volume is the output of a digital command of the controller, [0065]; target parameter is exhalation period).
Chang fails to disclose that the predicted gas flow setpoint value is scaled.
Keitel discloses a system for control of a gas concentration wherein:
the gas flow rate is scaled (Keitel col. 7 lines 34-35; varying the flow rates).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to use the scaling technique taught by Keitel to scale the predicted gas flow setpoint value of Keitel to solve the problem of slow response time and inefficient management of gas flow (Keitel col. 2 lines 46-48).
16. Regarding claim 14, modified Chang in view of Williams further discloses (currently amended) the ventilator of claim 1.
Chang discloses the ventilator wherein:
the manipulated variable for the correction regulator component comprises at least one parameter (Chang [0029] D. lines 1-3; pressure error becomes the input, [00228] C. “pressure target and pressure feedback” is input);
which describes a deviation of a gas flow actual value (Chang [0046] lines 6-8; producing a target flow by commanding a flow modulator);
determined by at least one flow sensor from (Chang [0014] lines 5-7, [0067] lines 7-9; “pressure sensor and flow sensor and controlling the flow modulators to provide gas mixture having a target pressure”).
17. Regarding claim 17, modified Chang in view of Williams further discloses (currently amended) the ventilator of claim 1.
Chang discloses the ventilator wherein:
wherein the control unit is configured to calculate an exhalation volume V_Ruck (Chang, figure 5; calculation goes to air flow output, [0046]; output volume);
on the basis of measurement data of at least one flow sensor (Chang, figure 5; flow sensor).
18. Claims 11 and 12 are rejected under 35 U.S.C. 103 as being obvious over Chang (US 20190275273 A1) in view of Keitel (US 6216690 B1) further in view of Williams (US 20210361899 A1) and even further in view of Miller (US 20170095634 A1).
19. Regarding claim 11, modified Chang in view of Williams further discloses (currently amended) the ventilator of claim [[2]] 1, wherein there is an exhalation volume V_Ruck (Chang [0046]; target volume is the output of a digital command of the controller, [0065]; target parameter is exhalation period).
Modified Chang in view of Williams fails to disclose a determination of a mean concentration mcO2% of the first gas in the second gas.
Miller discloses a system for analyzing gas wherein:
the third step comprises a determination of a mean concentration mcO2% of the first gas in the second gas (Miller [0133] lines 24-26; display of multiple gas concentration after a calculating a rolling average, [0134] lines 1-4; calculates a rolling average of one or more gases, and lines 29-30; oxygen concentration into a blended gas mix of rolling average);
is also incorporated in the determination of the mean concentration mcO2% of the first gas (Miller [0133] lines 24-26; display of multiple gas concentration after a calculating a rolling average, [0134] lines 1-4; calculates a rolling average of one or more gases, and lines 29-30; oxygen concentration into a blended gas mix of rolling average).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify modified Chang in view of Williams with the determination of the mean concentration mcO2% of Miller to determine the concentration of the first gas in the second gas and to incorporate the exhalation volume, since there is an advantage over having new methods and systems to more conveniently administer a gas (Miller [0002] lines 12-16, [0003] lines 1-4).
20. Regarding claim 12, modified Chang in view of Williams, further in view of Miller further discloses (currently amended) the ventilator of claim [[2]] 1.
Chang discloses the ventilator comprising:
determining the predicted gas flow setpoint value (Chang [0234], [0231]; algorithm predicts flow setpoint value and gets an error rate through feedback).
Miller discloses a system for analyzing gas wherein:
in the third step, a determined mean concentration mcO2% of the first gas is incorporated in a determination of the predicted gas flow setpoint value (Miller [0133] lines 24-26; display of multiple gas concentration after a calculating a rolling average, [0134] lines 1-4; calculates a rolling average of one or more gases, and 29-30; oxygen concentration into a blended gas mix of rolling average).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the taught predicted gas flow setpoint value from modified Chang in view of Williams with the determination of the mean concentration mcO2% of Miller to determine the concentration of the first gas, since there is an advantage over having new methods and systems to more conveniently administer a gas (Miller [0002] lines 12-16, [0003] lines 1-4).
21. Claim 15 is rejected under 35 U.S.C. 103 as being obvious over Chang (US 20190275273 A1) in view of Keitel (US 6216690 B1) further in view of Williams (US 20210361899 A1) and even further in view of Jonsson (US 3741208 A).
22. Regarding claim 15, modified Chang in view of Williams further discloses (currently amended) the ventilator of claim 1.
Chang discloses the ventilator wherein:
wherein the correction regulator component of the manipulated variable for the control of the gas valve
Jonsson discloses a lung ventilator wherein:
becomes zero when a gas flow value corresponds to a predetermined gas flow setpoint value (Jonsson (5) lines 1-2, 9-17; achieving the average flow despite errors, remaining error becomes 0 when desired flow can’t be maintained).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the control unit of modified Chang in view of Williams to become zero when the gas flow value corresponds to a gas flow setpoint value, as taught by Jonsson, since, having a system that helps to detect leakage and in the patient circuit (Jonsson col. 2 lines 17-18) and provide a lung ventilator in which the disadvantages of leaks are eliminated (Jonsson col. 2 lines 24-25), helps to solve the issue of insufficient ventilation for patients (Jonsson col.2 lines 15-16).
Conclusion
23. The following prior art were considered but not used on a 35 U.S.C. § 102 or 103 rejection:
US 20210322711 A1: a respiration gas source assembly with inspiratory gas and targets of gas based on a flow sensor.
US 20160067434 A1: a breathing device and method for controlling a respiratory gas source, characteristic of inhalation or exhalation.
GB 2417206 A: a method of plotting pressure-volume curves during artificial respiration, controlling exhalation, with a preselected setpoint value.
24. 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.
/AISLINN M JONES/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785