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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/27/2026 has been entered.
This Office Action is in response to the amendment filed on 01/30/2026. Claims 1-2, 4-18, and 20 have been amended. Claims 3 and 19 are canceled. As such, claims 1-2, 4-18, and 20 are pending in the instant application.
All rejection pursuant of 35 U.S.C. 112(b) are withdrawn in light of the amendments.
Claim Objections
Claims 1 and 18 are objected to because of the following informalities:
Claim 1, line 16: “measure end-tidal carbon dioxide value” should read “measure an end-tidal carbon dioxide value” for clarity.
Claim 1, lines 18-19: “a processor in electrical communication the gas flow sensor, and the carbon dioxide sensor” should read “a processor in electrical communication with the gas flow sensor and the carbon dioxide sensor” for clarity.
Claim 1, lines 34-37: “sensor information representative of a measured end-tidal carbon dioxide value of the subject subsequent to provision of the positive pressure inhalation breath by use of the resuscitator bag” should read “sensor information representative of the measured end-tidal carbon dioxide value of the subject subsequent to the provision of the positive pressure inhalation breath by use of the resuscitator bag” for consistency and clarity.
Claim 1, lines 43-44: “the obtained end-tidal carbon dioxide value” should read “the received end-tidal carbon dioxide value” for consistency and clarity.
Claim 1, lines 48-49: “when it is determined that the end-tidal carbon dioxide of the subject” should read “when it is determined that the end-tidal carbon dioxide value” for clarity and consistency.
Claim 18, line 19: “a resuscitator bag” should read “the resuscitator bag” for consistency and clarity.
Appropriate correction is required.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18 and 20 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.
Claim 18 recites the limitation "the received measured end-tidal carbon dioxide value" in lines 29-30. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the received measured end-tidal carbon dioxide value is a recitation of the measured end-tidal carbon dioxide from the carbon dioxide sensor in lines 21-24 of claim 18, or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitation will be interpreted as – the measured end-tidal carbon dioxide from the carbon dioxide sensor – as recited in lines 21-24 of claim 18.
Claim 20 is rejected as it depends from a rejected claim.
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 1-2, 4-18, and 20 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 1-2, 4-18, and 20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of claims 1-2, 4-18, and 20 recites at least one step or instruction for observation, judgement, or evaluation, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. The claimed limitations involve acquiring data and making judgements based on said acquired data, where a computer may be required for the acquisition of data, but the judgements and observations made may be performed in the human mind or by a human using pen and paper, which is a mental process under the 2019 PEG. Accordingly, each of claims 1-2, 4-18, and 20 recites an abstract idea.
Specifically, claim 1 recites: A manual ventilation and resuscitation apparatus comprising:
a resuscitator bag configured to provide a positive pressure inhalation breath to a subject (additional element);
an expiratory coupler defining an exhaled gas channel (additional element); and
a monitoring apparatus (additional element), the monitoring apparatus comprising:
a gas flow sensor (additional element) disposed in the exhaled gas channel and configured to measure flow rates of exhaled gases of the subject subsequent to provision of the positive pressure inhalation breath by use of the resuscitator bag (additional element - insignificant extra-solution activity); and
a processor in electrical communication the gas flow sensor (additional element); and
a memory storing instructions (additional element) that, when executed, cause the processor to perform operations (additional element – insignificant extra-solution activity) comprising:
receiving an ideal body weight or a predicated body weight of the subject (additional element – insignificant extra-solution activity);
determining a first tidal volume range based on the ideal body weight or the predicated body weight of the subject (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
determining an end-tidal carbon dioxide range (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
receiving, from the gas flow sensor, sensor information representative of a measured flow rate of exhaled gasses of the subject subsequent to provision of the positive pressure inhalation breath by use of the resuscitator bag (additional element - insignificant extra-solution activity);
determining an exhaled tidal volume of the subject based on the received measured flow rate (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
receiving, from the carbon dioxide sensor, sensor information representative of a measured end-tidal carbon dioxide value of the subject subsequent to provision of the positive pressure inhalation breath by use of the resuscitator bag (insignificant extra-solution activity);
determining an end-tidal carbon dioxide range of the subject based on the received measured end-tidal carbon dioxide value (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
determining whether the exhaled tidal volume is within the first tidal volume range (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
determining whether the obtained end-tidal carbon dioxide value is within the end-tidal carbon dioxide range (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
performing a first tidal volume warning (insignificant extra-solution activity) when it is determined that the exhaled tidal volume is not within the first tidal volume range (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
performing the end-tidal carbon dioxide warning (insignificant extra-solution activity) when it is determined that the end-tidal carbon dioxide of the subject is not within the end-tidal carbon dioxide range (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG).
Specifically, claim 18 recites: A method for providing manual ventilation and resuscitation in a subject the method comprising:
receiving, by a monitoring apparatus of a manual ventilation and resuscitation apparatus (additional element), an ideal body weight or a predicated body weight of a subject (additional element - insignificant extra-solution activity);
determining, by the monitoring apparatus (additional element), a first tidal volume range based on the ideal body weight or the predicated body weight of the subject (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
compressing a resuscitator bag (additional element) of the manual ventilation and resuscitation apparatus (additional element) to provide positive pressure ventilation to the subject (additional element - insignificant extra-solution activity);
receiving, from a gas flow sensor disposed in an exhaled gas channel of the manual ventilation and resuscitation apparatus (additional element), sensor information representative of a measured flow rate of exhaled gas of the subject subsequent to provision of a positive pressure inhalation breath by use of a resuscitator bag of the manual ventilation and resuscitation apparatus (additional element - insignificant extra-solution activity);
receiving, from a carbon dioxide sensor disposed in the exhaled gas channel of the manual ventilation and resuscitation apparatus (additional element), sensor information representative of a measured end-tidal carbon dioxide of the subject subsequent to provision of the positive pressure inhalation breath by use of the resuscitator bag (additional element - insignificant extra-solution activity);
determining an end-tidal carbon dioxide range of the subject (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
determining, by the monitoring apparatus (additional element), an exhaled tidal volume of the subject based on the received measured flow rate (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
determining, by the monitoring apparatus (additional element), an end-tidal carbon dioxide value of the subject based on the received measured end-tidal carbon dioxide value (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
determining, by the monitoring apparatus (additional element), whether the determined exhaled tidal volume is within the first tidal volume range (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
performing, by the monitoring apparatus (additional element), a first tidal volume warning (additional element - insignificant extra-solution activity) when the determined exhaled tidal volume is not within the first tidal volume range (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
performing, by the monitoring apparatus (additional element), an end-tidal carbon dioxide warning (additional element - insignificant extra-solution activity) when the determined end-tidal carbon dioxide value of the subject is not within the end-tidal carbon dioxide range (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, 4-17, and 20 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 and 18 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent claims 1 and 18), 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: a manual ventilation and resuscitation apparatus, a resuscitator bag, an exhaled gas channel, a gas flow sensor, a carbon dioxide sensor, and a monitoring apparatus as recited in independent claims 1 and 18; and an expiratory coupler, a processor, and a memory storing instructions as recited in independent claim 1) are generically recited computer/structural elements in independent claims 1 and 18 (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 and 18 (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) using rules (e.g., computer instructions) executed by a computer (e.g., a processor 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 and 18 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent claims 1 and 18 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of claims 1-2, 4-18, or 20 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: a manual ventilation and resuscitation apparatus, a resuscitator bag, an exhaled gas channel, a gas flow sensor, a carbon dioxide sensor, and a monitoring apparatus as recited in independent claims 1 and 18; and an expiratory coupler, a processor, and a memory storing instructions as recited in independent claim 1.
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 “processor 220 may be a general purpose processor, for example, a general purpose central processing unit (CPU), a network processor (NP), or a microprocessor, or may be an application-specific integrated circuit (ASIC), or one or more integrated circuits configured to control execution of a program in the solutions of the present disclosure, or may be a digital signal processor (DSP), an ASIC, a field programmable gate array (FPGA), or another programmable logic device, a discrete gate, a transistor logic device, or a discrete hardware component” ([0040]).
Accordingly, in light of Applicant’s specification, the claimed term processor 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 processor. 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 claims 1-2, 4-18, and 20 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 apparatuses and methods of claims 1-2, 4-18, and 20 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 1-2, 4-18, and 20 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 and 18 (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 1-2, 4-18, and 20 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 claims 1-2, 4-18, or 20 amounts to significantly more than the abstract idea itself.
Accordingly, claims 1-2, 4-18, and 20 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.
It is recommended to amend independent claims 1 and 18 to include a limitation drawn toward adjusting or modifying the operation of the manual ventilation and resuscitation apparatus based on determinations of an end-tidal carbon dioxide value being within or not within an end-tidal carbon dioxide range, or an exhaled tidal volume being within or not within a first tidal volume range. Alternatively, it is recommended to amend independent claims 1 and 18 to include a limitation drawn toward adjusting or modifying the operation of the manual ventilation and resuscitation apparatus based on an end-tidal carbon dioxide warning or a first tidal volume warning being performed.
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 1-2, 5-8, 10-15, 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Silver et al. (US 20200000680 A1; hereinafter “Silver”) in view of Johnson & Koos (US 20180147375 A1; hereinafter “Johnson”).
Regarding claim 1, Silver discloses a manual ventilation and resuscitation apparatus (Figs. 1A, 1B) comprising:
a resuscitator bag (112; Fig. 1A) configured to provide a positive pressure inhalation breath to a subject ([0260], lines 7-9; [0372], lines 8-9);
an expiratory coupler defining an exhaled gas channel (connector to connect ventilation bag 112 to patient defines airflow pathway 114, where exhaled gas flows through airflow pathway 114, see [0264]); and
a monitoring apparatus (elements of system 10; Figs. 1A, 1B), the monitoring apparatus (elements of system 10; Figs. 1A, 1B) comprising:
a gas flow sensor (ventilation sensor 22, where ventilation sensor 22 is a flow sensor; [0264], line 5) disposed in the exhaled gas channel (Fig. 1A; first two sentences of [0264]) and configured to measure flow rates of exhaled gases of the subject subsequent to provision of the positive pressure inhalation breath by use of the resuscitator bag ([0353], lines 1-8); and
a processor (30; Fig. 1B) in electrical communication the gas flow sensor (first sentence of [0266]); and
a memory (computer readable memory associated with input device 12 and processor 30; [0328], last line of paragraph; [0398], lines 6-9) storing instructions ([0328], last line of paragraph) that, when executed, cause the processor to perform operations (0328], last line of paragraph; [0398], lines 6-9) comprising:
receiving an ideal body weight or a predicated body weight of the subject ([0382], lines 2-5; [0382], lines 14-16; [0382], lines 20-23);
determining a first tidal volume range based on the ideal body weight or the predicated body weight of the subject ([0382], lines 14-23);
receiving, from the gas flow sensor (22), sensor information representative of a measured flow rate of exhaled gasses of the subject subsequent to provision of the positive pressure inhalation breath by use of the resuscitator bag (22 measures exhalation airflow to monitor ventilations provided by 112; [0264], lines 4-6; [0353], lines 1-8);
determining an exhaled tidal volume of the subject based on the received measured flow rate ([0264], lines 4-11);
determining whether the exhaled tidal volume is within the first tidal volume range ([0267], lines 3-16, where the resuscitation parameter is the obtained exhaled tidal volume of the user, and the target resuscitation criteria is the target tidal volume range); and
performing a first tidal volume warning when it is determined that the exhaled tidal volume is not within the first tidal volume range ([0267], lines 16-19).
Silver is silent to the monitoring apparatus (elements of system 10; Figs. 1A, 1B) configured to provide an end-tidal carbon dioxide warning, the monitoring apparatus further comprising:
a carbon dioxide sensor disposed in the exhaled gas channel and configured to measure end-tidal carbon dioxide value of the subject subsequent to provision of the positive pressure inhalation breath by use of the resuscitator bag; and
the processor (30; Fig. 1B) in electrical communication with the carbon dioxide sensor; and
the memory (computer readable memory associated with input device 12 and processor 30; [0328], last line of paragraph; [0398], lines 6-9) storing instructions ([0328], last line of paragraph) that, when executed, cause the processor to perform operations (0328], last line of paragraph; [0398], lines 6-9) further comprising:
determining an end-tidal carbon dioxide range;
receiving, from the carbon dioxide sensor, sensor information representative of a measured end-tidal carbon dioxide value of the subject subsequent to provision of the positive pressure inhalation breath by use of the resuscitator bag;
determining an end-tidal carbon dioxide range of the subject based on the received measured end-tidal carbon dioxide value of the subject;
determining whether the obtained end-tidal carbon dioxide value is within the end-tidal carbon dioxide range; and
performing the end-tidal carbon dioxide warning when it is determined that the end-tidal carbon dioxide of the subject is not within the end-tidal carbon dioxide range.
However, Johnson teaches an analogous resuscitation and ventilation monitoring system (Fig. 1; [0008]) with a resuscitation bag ([0040], lines 5-8) and a CO2 sensor (106; Fig. 1; [0041], lines 13-15) in communication with a processor of a controller (processor of controller 108; [0045], lines 17-19; [0019], lines 1-4), wherein said CO2 sensor (106) measures an end tidal CO2 of a subject ([0039], line 26) and is positioned in an inlet (102; Fig. 1) that defines a pathway for expiratory gases to flow ([0040], lines 8-12; [0041], line 13-15). Johnson further teaches the controller (108) determines a range of acceptable CO2 levels of the subject ([0010], lines 7-8, where a range of acceptable CO2 levels is a range of acceptable end tidal CO2 levels), determines whether a measured end tidal CO2 value of the subject is within the range of acceptable CO2 levels ([0010], lines 7-11), and outputs an alarm to communicate to the user when the end tidal CO2 level is not within the obtained range of acceptable CO2 levels ([0010], lines 8-11; [0043], lines 1-7).
Therefore, 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 manual ventilation and resuscitation apparatus taught by Silver with the CO2 sensor and functions of the processor and the controller, as taught by Johnson above, such that the monitoring apparatus (elements of system 10; Figs. 1A, 1B) includes a CO2 sensor (Johnson 106; Johnson [0041], lines 13-15) to measure end tidal CO2 of a subject after a positive pressure inhalation breath is delivered to the subject (Johnson [0039], line 26, where it is obvious and well-known to one of ordinary skill in the art that exhalation subsequently follows inhalation, hence the measure of an end-tidal carbon dioxide of the subject is subsequent to the provision of the positive pressure inhalation breath by use of the resuscitator bag) and is in communication with the processor (Johnson 106 in communication with Silver 30, as taught by Johnson [0045], lines 17-19 and [0019], lines 1-4); and the operations performed by the processor (30) further include:
determining an end-tidal carbon dioxide range (Johnson [0010], lines 7-8, where a range of acceptable CO2 levels is a range of acceptable end tidal CO2 levels);
receiving, from the carbon dioxide sensor, sensor information representative of a measured end-tidal carbon dioxide value of the subject subsequent to provision of the positive pressure inhalation breath by use of the resuscitator bag (Johnson [0039], line 26; Johnson [0045], lines 17-19; Johnson [0019], lines 1-4);
determining an end-tidal carbon dioxide range of the subject based on the received measured end-tidal carbon dioxide value of the subject (Johnson [0010]; Johnson [0045]);
determining whether the obtained end-tidal carbon dioxide value is within the end-tidal carbon dioxide range (Johnson [0010], lines 7-11); and
performing the end-tidal carbon dioxide warning when it is determined that the end-tidal carbon dioxide of the subject is not within the end-tidal carbon dioxide range (Johnson [0010], lines 8-11; Johnson [0043], lines 1-7; Johnson [0045]) to determine whether the patient has a pulse (e.g., after cardiac arrest) and improve the monitoring of a patient’s cardiac output and ventilations (Johnson [0039], lines 27-29).
Regarding claim 2, Silver as modified teaches the invention as set forth in claim 1, wherein, when the instructions are configured to cause the monitoring apparatus (elements of system 10; Figs. 1A, 1B) to receive the ideal body weight or the predicated body weight of the subject ([0382], lines 2-5; [0382], lines 14-16; [0382], lines 20-23), the instructions are configured to cause the monitoring apparatus to:
receive patient information of the subject ([0382], lines 2-5), wherein the patient information comprises a height and a gender of the subject ([0382], lines 2-20); and
obtain the ideal body weight or the predicated body weight of the subject based on the patient information ([0382], lines 20-23).
Regarding claim 5, Silver as modified teaches the invention as set forth in claim 1, wherein the operations (instructions executed by processor 30 as modified, see claim 1 above) further comprise:
obtaining a respiratory rate range (target ventilation rate; [0280], lines 1-7);
obtaining a respiratory rate of the subject ([0264], lines 5-11);
determining whether the respiratory rate of the subject is within the respiratory rate range ([0267], lines 3-16, where the resuscitation parameter is the obtained respiratory rate of the user, and the target resuscitation criteria is the respiratory rate range); and
when it is determined that the respiratory rate of the subject is not within the respiratory rate range, performing a respiratory rate warning ([0267], lines 16-19).
Regarding claim 6, Silver as modified teaches the invention as set forth in claim 5, wherein the respiratory rate range is between 5 breaths per minute and 20 breaths per minute (target ventilation rate of 10 ventilation breaths per minute to 20 ventilation breaths per minute, see [0280], lines 1-7).
Regarding claim 7, Silver as modified teaches the invention as set forth in claim 1, wherein the operations (instructions executed by processor 30 as modified, see claim 1 above) further comprise:
obtaining a desired respiratory rate (target ventilation rate; [0280], lines 1-7);
obtaining a predetermined time interval based on the desired respiratory rate ([0280], lines 1-8); and
at each predetermined time interval, performing a count-down message ([0372], lines 1-7; Fig. 8B).
Regarding claim 8, Silver as modified teaches the invention as set forth in claim 7, wherein the desired respiratory rate is 10 per minute (target ventilation rate is 10 ventilation breaths per minute for adults; [0280], lines 2-4).
Regarding claim 10, Silver as modified teaches the invention as set forth in claim 1, wherein the first tidal volume warning comprises at least one of an audio message and a visual message ([0372], last line of paragraph).
Regarding claim 11, Silver as modified teaches the invention as set forth in claim 10, wherein:
the audio message (audible alarm, [0372], last line of paragraph) comprises at least one of:
a beep sound ([0355], lines 4-6) by a speaker of the manual ventilation and resuscitation apparatus (audio feedback via speakers 28),
a pre-recorded voice by the speaker of the manual ventilation and resuscitation apparatus, and
a text-to-voice generated by the manual ventilation and resuscitation apparatus; and
the visual message (visual alarm, [0372], last line of paragraph) comprises at least one of:
light from a warning light of the manual ventilation and resuscitation apparatus (light on feedback device 24, [0355], lines 4-7; [0356], lines 10-11),
flashing light of the warning light ([0372], lines 9-15),
a flashing symbol displayed on a display of the manual ventilation and resuscitation apparatus, and
a warning message displayed on the display, the warning message comprising at least one of a text, a symbol, or a graphic message.
Regarding claim 12, Silver as modified teaches the invention as set forth in claim 1, wherein:
the first tidal volume range ([0382], lines 14-23) is between a first low tidal volume threshold and a first high tidal volume threshold (it is well-understood by one of ordinary skill in the art that the first tidal volume range includes a first minimum tidal volume value and a first maximum tidal volume value to form the boundary of the first tidal volume range, where the first tidal volume range inherently is between said first minimum tidal volume value and said first maximum tidal volume value); and
the operations (instructions executed by processor 30 as modified, see claim 1 above) further comprise:
calculating the first tidal volume range based on the ideal body weight or the predicated body weight of the subject ([0382], lines 14-23);
multiplying the ideal body weight or the predicated body weight and 8 ml/Kg to obtain the first high tidal volume threshold (Equation 3, see below [0295]; Table 1; [0294]-[0295]; [0402], line 20 to end of paragraph); and
multiplying the ideal body weight or the predicated body weight and 6 ml/Kg to obtain the first low tidal volume threshold (Equation 3, see below [0295]; Table 1; [0294]-[0295]; [0402], line 20 to end of paragraph).
Regarding claim 13, Silver as modified teaches the invention as set forth in claim 12, wherein the operations (instructions executed by processor 30 as modified, see claim 1 above) further comprise:
determining whether the exhaled tidal volume is larger than the first high tidal volume threshold ([0267], lines 3-16, where the resuscitation parameter is the obtained exhaled tidal volume of the user, and the target resuscitation criteria is the target tidal volume range, where the target tidal volume range includes a maximum tidal volume value, hence it is inherent determining whether the exhaled tidal volume is within the first tidal volume range would include determining whether the exhaled tidal volume is larger than the maximum tidal volume value);
when it is determined that the exhaled tidal volume is larger than the first high tidal volume threshold, performing a first high tidal volume warning ([0358], lines 15-20, where the relevant resuscitation parameters include ventilation tidal volume, the target criteria is the target tidal volume range, and the numerical value is the exhaled tidal volume, hence an exhaled tidal volume outside of the target tidal volume range, or larger than the maximum tidal volume value, causes feedback device 24 to provide an indication);
determining whether the exhaled tidal volume is smaller than the first low tidal volume threshold ([0267], lines 3-16, where the resuscitation parameter is the obtained exhaled tidal volume of the user, and the target resuscitation criteria is the target tidal volume range, where the target tidal volume range includes a minimum tidal volume value, hence it is inherent determining whether the exhaled tidal volume is within the first tidal volume range would include determining whether the exhaled tidal volume is smaller than the minimum tidal volume value); and
when it is determined that the exhaled tidal volume is smaller than the first low tidal volume threshold, performing a first low tidal volume warning ([0358], lines 15-20, where the relevant resuscitation parameters include ventilation tidal volume, the target criteria is the target tidal volume range, and the numerical value is the exhaled tidal volume, hence an exhaled tidal volume outside of the target tidal volume range, or smaller than the minimum tidal volume value, causes feedback device 24 to provide an indication).
Regarding claim 14, Silver as modified teaches the invention as set forth in claim 1. While Silver does teach an equation to calculate a usable tidal volume target range based on the ideal body weight, or the predicted body weight of the subject, and a target ventilation tidal volume range of 6 mL/kg to 8 mL/kg (Equation 3, see below [0295]; [0402], lines 31-32), Silver fails to explicitly teach the operations (instructions executed by processor 30 as modified, see claim 1 above) further comprise:
calculating a second tidal volume range based on the ideal body weight or the predicated body weight of the subject;
determining whether the exhaled tidal volume is within the second tidal volume; and
when it is determined that the exhaled tidal volume is not within the second tidal volume range, performing a second tidal volume warning.
However, an alternate embodiment of Silver states a target ventilation tidal volume range of 6 mL/kg to 10 mL/kg may be used for resuscitation given in a cardiac arrest context. states a target ventilation tidal volume range of 6 mL/kg to 10 mL/kg may be used for resuscitation given in a cardiac arrest context.
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Equation 3 of Silver with the above alternate example of Silver, such that Equation 3 calculates a usable tidal volume target range based on the ideal body weight, or the predicted body weight of the subject, and a target ventilation tidal volume range of 6 mL/kg to 10 mL/kg. Hence, the calculations with the new Equation 3 would result in a second tidal volume range based on the ideal body weight or the predicated body weight of the subject. Moreover, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify a first embodiment of Silver with a second embodiment of Silver, wherein the operations (instructions executed by processor 30 as modified, see claim 1 above) further comprise:
calculating a second tidal volume range based on the ideal body weight or the predicated body weight of the subject (new Equation 3, where a usable tidal volume target range is calculated based on the ideal body weight, or the predicted body weight of the subject, and a target ventilation tidal volume range of 6 mL/kg to 10 mL/kg);
determining whether the exhaled tidal volume is within the second tidal volume ([0267], lines 3-16, where the resuscitation parameter is the obtained exhaled tidal volume of the user, and the target resuscitation criteria is the target tidal volume range as calculated by the new Equation 3); and
when it is determined that the exhaled tidal volume is not within the second tidal volume range, performing a second tidal volume warning ([0267], lines 16-19, where the feedback device 24 provides an indication when the exhaled tidal volume is not within the usable tidal volume target range calculated with new Equation 3) to determine if a patient is experiencing cardiac arrest, and provide proper resuscitation and ventilation services to a patient experiencing cardiac arrest ([0402], lines 28-29; [0402], lines 32-36).
Regarding claim 15, Silver as modified teaches the invention as set forth in claim 14, wherein the second tidal volume warning (the second tidal volume warning is performed when the exhaled tidal volume is not within the second tidal volume range, where the second tidal volume range is calculated with a new Equation 3, where new Equation 3 calculates a usable tidal volume target range based on a target ventilation tidal volume range of 6 mL/kg to 10 mL/kg, see claim 14) is different from the first tidal volume warning (the first tidal volume warning is performed when the exhaled tidal volume is not within the first tidal volume range, where the first tidal volume range is calculated with an Equation 3, where new Equation 3 calculates a usable tidal volume target range based on a target ventilation tidal volume range of 6 mL/kg to 8 mL/kg, see Equation 3 below [0295], hence the requirements to provide the second tidal volume warning are different from the requirements to provide the first tidal volume warning, and the second tidal volume warning is different from the first tidal volume warning).
Regarding claim 16, Silver as modified teaches the invention as set forth in claim 1. While Silver does teach the processor (30) has a computer memory associated with an input device (12; Fig. 2) to store images captured by a camera (16; Figs. 1-2; [0328]), a record of past modified target chest compression criteria and recorded chest compression parameters ([0398]), Silver, alone or as modified in claim 1 above, is silent to the operations (instructions executed by processor 30 as modified, see claim 1 above) further comprise:
storing the exhaled tidal volume of the subject; and
sending the stored exhaled tidal volume of the subject to a second device.
However, Johnson teaches a controller (108) including data processing and non-transient storage hardware ([0045], lines 1-2), where the data processing hardware is a processor ([0045], lines 3-4) that includes, or is coupled to, the non-transient storage hardware with instructions ([0045], lines 3-5). Further, Johnson teaches a measured exhaled tidal volume of the patient being stored in said non-transient storage medium ([0045], lines 16-24), where the stored measured exhaled tidal volume of the patient can be sent to a second device ([0045], last sentence of paragraph).
Therefore, 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 processor and instructions executed by said processor, as taught by Silver as modified in claim 1 above, with the above teachings of Johnson, such that the operations (instructions executed by processor 30 as modified, see claim 1 above) further comprise: storing the exhaled tidal volume of the subject (Johnson [0045], lines 16-24); and sending the stored exhaled tidal volume of the subject to a second device (Johnson [0045], last sentence of paragraph) to download and view the collected and stored data at a later time for analysis (Johnson [0045], last sentence of paragraph).
Regarding claim 17, Silver as modified teaches the invention as set forth in claim 1, wherein the monitoring apparatus (elements of system 10; Figs. 1A, 1B) is disposed at an exhalation side of the resuscitator bag (Fig. 1, where all elements of system 10 reside on a side of a manual resuscitator where exhaled air from the user is located or can be located).
Regarding claim 18, as best understood by the Examiner, Silver discloses a method for providing manual ventilation and resuscitation in a subject ([0254]; [0011]; [0008]-[0009]; [0014]) the method comprising:
receiving, by a monitoring apparatus (elements of system 10; Figs. 1A, 1B) of a manual ventilation and resuscitation apparatus (Figs. 1A-1B), an ideal body weight or a predicated body weight of a subject ([0382], lines 2-5; [0382], lines 14-16; [0382], lines 20-23);
determining, by the monitoring apparatus, a first tidal volume range based on the ideal body weight or the predicated body weight of the subject ([0382], lines 14-23);
compressing a resuscitator bag of the manual ventilation and resuscitation apparatus to provide positive pressure ventilation to the subject ([0353], lines 26-27, hence the ventilation bag 112 must be compressed to provide ventilation to the patient),
receiving, from a gas flow sensor (22; Figs. 1A-1B) disposed in an exhaled gas channel of the manual ventilation and resuscitation apparatus (Fig. 1A; first two sentences of [0264]), sensor information representative of a measured flow rate of exhaled gas of the subject subsequent to provision of a positive pressure inhalation breath by use of a resuscitator bag of the manual ventilation and resuscitation apparatus (22 measures exhalation airflow to monitor ventilations provided by 112; [0264], lines 4-6; [0353], lines 1-8);
determining, by the monitoring apparatus, an exhaled tidal volume of the subject based on the received measured flow rate ([0264], lines 4-11);
determining, by the monitoring apparatus, whether the determined exhaled tidal volume is within the first tidal volume range ([0267], lines 3-16, where the resuscitation parameter is the obtained exhaled tidal volume of the user, and the target resuscitation criteria is the target tidal volume range);
performing, by the monitoring apparatus, a first tidal volume warning when the determined exhaled tidal volume is not within the first tidal volume range ([0267], lines 16-19).
Silver fails to disclose the method further comprising: receiving, from a carbon dioxide sensor disposed in the exhaled gas channel of the manual ventilation and resuscitation apparatus, sensor information representative of a measured end-tidal carbon dioxide of the subject subsequent to provision of the positive pressure inhalation breath by use of the resuscitator bag;
determining an end-tidal carbon dioxide range of the subject;
determining, by the monitoring apparatus, an end-tidal carbon dioxide range value of the subject based on the received measured end-tidal carbon dioxide value; and
performing, by the monitoring apparatus, an end-tidal carbon dioxide warning when the determined end-tidal carbon dioxide value of the subject is not within the end-tidal carbon dioxide range.
However, Johnson teaches an analogous resuscitation and ventilation monitoring system (Fig. 1; [0008]) with a resuscitation bag ([0040], lines 5-8) and a CO2 sensor (106; Fig. 1; [0041], lines 13-15) in communication with a processor of a controller (processor of controller 108; [0045], lines 17-19; [0019], lines 1-4), wherein said CO2 sensor (106) measures an end tidal CO2 of a subject ([0039], line 26). Johnson further teaches the controller (108) determines a range of acceptable CO2 levels of the subject ([0010], lines 7-8, where a range of acceptable CO2 levels is a range of acceptable end tidal CO2 levels), determines whether a measured end tidal CO2 value of the subject is within the range of acceptable CO2 levels ([0010], lines 7-11), and outputs an alarm to communicate to the user when the end tidal CO2 level is not within the obtained range of acceptable CO2 levels ([0010], lines 8-11; [0043], lines 1-7).
Therefore, 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 method for providing manual ventilation and resuscitation in a subject and monitoring apparatus taught by Silver with the CO2 sensor and functions of the processor and the controller, as taught by Johnson above, such that the method for providing manual ventilation and resuscitation in a subject further includes:
receiving measured end tidal CO2 values of a subject from a CO2 sensor (Johnson 106; Johnson [0041], lines 13-15) after a positive pressure inhalation breath is delivered to the subject (Johnson [0039], line 26, where it is obvious and well-known to one of ordinary skill in the art that exhalation subsequently follows inhalation, hence the measure of an end-tidal carbon dioxide of the subject is subsequent to the provision of the positive pressure inhalation breath by use of the resuscitator bag; Johnson [0045], lines 17-19; Johnson [0019], lines 1-4);
determining an end-tidal carbon dioxide range of the subject (Johnson [0010], lines 7-8, where a range of acceptable CO2 levels is a range of acceptable end tidal CO2 levels);
determining, by the monitoring apparatus, an end-tidal carbon dioxide range value of the subject based on the received measured end-tidal carbon dioxide value (Johnson [0010]; Johnson [0045]); and
performing, by the monitoring apparatus, an end-tidal carbon dioxide warning when the determined end-tidal carbon dioxide value of the subject is not within the end-tidal carbon dioxide range (Johnson [0010], lines 8-11; Johnson [0043], lines 1-7; Johnson [0045]) to determine whether the patient has a pulse (e.g., after cardiac arrest) and improve the monitoring of a patient’s cardiac output and ventilations (Johnson [0039], lines 27-29).
Regarding claim 20, Silver as modified teaches the invention as set forth in claim 18, further comprising:
determining, by the monitoring apparatus, a respiratory rate range (target ventilation rate; [0280], lines 1-7);
determining, by the monitoring apparatus, a respiratory rate of the subject ([0264], lines 5-11);
determining, by the monitoring apparatus, whether the respiratory rate of the subject is within the respiratory rate range ([0267], lines 3-16, where the resuscitation parameter is the obtained respiratory rate of the user, and the target resuscitation criteria is the respiratory rate range); and
when it is determined that the respiratory rate of the subject is not within the respiratory rate range, performing, by the apparatus, a respiratory rate warning ([0267], lines 16-19).
Silver as modified fails to explicitly teach a respiratory sensor to collect measurement information such that the monitoring apparatus determines the respiratory rate of the subject based on the measurement information from the respiratory sensor.
However, Johnson teaches an airflow meter (104; Fig. 1) to measure respiratory rates of a subject ([0041], lines 1-8).
Therefore, 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 monitoring apparatus taught by Silver, with the airflow meter, as taught by Johnson, such that the monitoring apparatus (elements of system 10; Figs. 1A, 1B) can determine a respiratory rate of the subject ([0264], lines 5-11) based on respiratory rates of the subject measured by an airflow meter (Johnson 104; Silver [0267], lines 3-16, where the resuscitation parameter is the obtained respiratory rate of the user, and the target resuscitation criteria is the respiratory rate range; Johnson [0041], lines 1-8) to ensure patient safety during manual ventilation and resuscitation (Johnson [0045], lines 17-27).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20200000680 A1) in view of Johnson (US 20180147375 A1) as applied to claim 1 above, and further in view of Freeman et al. (US 20120302910 A1; hereinafter “Freeman”).
Regarding claim 4, Silver as modified teaches the invention as set forth in claim 1, but fails to teach the end-tidal carbon dioxide range is between 20 mmHg and 45 mmHg.
However, Freeman teaches an end tidal carbon dioxide range to compare end tidal CO2 data from a patient to monitor ventilation of said patient and determine if the ventilation is being properly or improperly applied to said patient ([0173], lines 1-5), where said end tidal carbon dioxide range is larger than 30 mmHg and smaller than 40 mmHg ([0173], lines 11-14). The end tidal carbon dioxide range taught by Freeman (30 mmHg to 40 mmHg; [0173], lines 11-14) is within the range of 20 mmHg to 45 mmHg.
Therefore, 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 end-tidal carbon dioxide range, as taught by Silver as modified in claim 1, to be between 20 mmHg and 45 mmHg, as taught by Freeman above, to ensure the patient receives proper ventilation (Freeman [0173], lines 5-7).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 20200000680 A1) in view of Johnson (US 20180147375 A1) as applied to claim 1 above, and further in view of Lurie et al. (US 20100319691 A1; hereinafter “Lurie”).
Regarding claim 9, Silver as modified teaches the invention as set forth in claim 1, but fails to teach a positive end-expiratory pressure (PEEP) valve configured to partly define the exhaled gas channel.
However, Lurie teaches a ventilation system with a pressure regulation system (Figs. 22A-22B), where the pressure regulation system includes an expiratory control valve assembly (2250; Figs. 22A-22B) that operates as a PEEP valve ([0192], line 28 to end of paragraph) positioned at an end of an expiratory gas outlet port (2224; Fig. 22A; [0206], lines 15-18).
Therefore, 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 exhaled gas channel taught by Silver with a PEEP valve positioned at an end thereof, as taught by Lurie (Lurie 2250; Lurie Figs. 22A-22B; Lurie [0192], line 28 to end of paragraph; Lurie [0206], lines 15-18) to minimize patient rebreathing of exhaled gases by facilitating the control of the flow of exhale gases (Lurie [0197], line 18 to end of paragraph).
Response to Arguments
On pages 12-14 of the Remarks (filed on 01/30/2026), Applicant argues the claims are not directed to a mental process as the mathematical steps disclosed in the claims are “inherently tied to the physical measurements performed by medical sensors and do not exist as standalone abstract concepts” (see Remarks pg. 12). However, the sensors recited in the claims are not considered an abstract idea, but rather additional elements that are performing insignificant extra-solution activities (i.e. receiving/measuring data), which does not further limit the abstract idea of determining end-tidal carbon dioxide ranges and first tidal volume ranges, nor does it further limit the abstract idea of determining if an end-tidal carbon dioxide value is within said determined carbon dioxide ranges or if a first tidal volume is within said determined first tidal volume ranges. As such, the sensors are being interpreted as common additional structural elements that are well-known in the art.
Applicant further argues the human mind is not capable of “receiving, from the gas flow sensor, sensor information representative of a measured flow rate of exhaled gasses” or “receiving, from the carbon dioxide sensor, sensor information representative of a measured end-tidal carbon dioxide value”, as recited in claim 1, and similarly recited in claim 18 (see Remarks pg 13). However, if the gas flow sensor or carbon dioxide sensor has a visual or audible indicator of the flow rates measured or the end-tidal carbon dioxide values measured, the human mind would be capable of receiving said measurements from the corresponding gas flow sensor or carbon dioxide sensor. Moreover, as described in the 101 rejection above, the gas flow sensor and the carbon dioxide sensor not considered an abstract idea, but rather additional elements that are performing insignificant extra-solution activities (i.e. receiving/measuring data). Hence, the limitations of “receiving, from the gas flow sensor, sensor information representative of a measured flow rate of exhaled gasses” and “receiving, from the carbon dioxide sensor, sensor information representative of a measured end-tidal carbon dioxide value” do not integrate the abstract idea of determining end-tidal carbon dioxide ranges and first tidal volume ranges, nor the abstract idea of determining if an end-tidal carbon dioxide value is within said determined carbon dioxide ranges or if a first tidal volume is within said determined first tidal volume ranges into a practical application (see MPEP 2106.04).
On pages 14-15 of the Remarks, Applicant argues the pending claims are eligible because the claimed features provide a technical solution to improve the technical field of emergency medicine and manual resuscitation by utilizing physical sensors and calculating individualized safety ranges based on ideal body weight or predicated body weight. However, the claimed sensors are generic sensors that are common and well-known in the art, and are considered additional elements. Furthermore, the measurements made by said sensors are insignificant extra-solution activity. Additionally, calculating safety ranges based on provided values of ideal body weight or predicated body weight is a process that can be performed in the human mind, or by a human with a pen and pencil. As such, the pending claims do not qualify as eligible subject matter under 35 U.S.C. 101 (see 101 rejection above).
On page 16 of the Remarks, Applicant argues the specific arrangement of the claimed sensors is not well-understood, routine, or conventional in the field of manual resuscitators. However, Silver discloses a gas flow sensor located within an expiratory flow channel, and Johnson teaches a carbon dioxide sensor disposed at an end of an expiratory flow channel (see 103 rejection of claim 1 above). As such, the claimed arrangement of the gas flow sensor and the CO2 sensor does not render the pending claims eligible (see 101 rejection above).
For at least the above reasons, Applicant’s arguments regarding the 101 rejection are unpersuasive.
On pages 17-18 of the Remarks, Applicant argues Silver and Johnson fail to teach or suggest “determining a first tidal volume range based on the ideal body weight or the predicated body weight of the subject”, as recited in amended claims 1 and 18. However, Silver discloses determining a ventilation tidal volume based on an ideal body weight of a patient ([0223], [0276], [0295]). Additionally, Applicant argues Silver does not teach or suggest calculating individualized safety ranges for both tidal volume and end tidal CO2 based on a calculated ideal body weight (see Remarks pg 18). However, Silver does teach calculating a tidal volume range based on a calculated ideal body weight (see Silver [0223], [0276], [0295]; see 103 rejection of claims 1 and 18 above). In response to applicant's argument that Silver fails to show calculating an individualized safety range for end tidal CO2 based on a calculated ideal body weight, it is noted that the features upon which applicant relies (i.e., calculating an individualized safety range for end tidal CO2 based on a calculated ideal body weight) are not recited in the rejected claim(s) (see amended claim 1, lines 28 and 38-39; see amended claim 18, lines 28-30). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As such, Applicant's arguments (filed on 01/30/2026), in regard to claims 1 and 18, have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim 1 regarding the specific physical architecture of a gas flow sensor and a CO2 sensor being disposed in an exhaled gas channel of an expiratory coupler, as recited in amended claim 1, have been considered but not persuasive as Silver discloses a connector between the patient and ventilation bag (112) that defines an exhaled gas flow pathway ([0264]) and a ventilation sensor (22) positioned therein (Fig. 1A; first two sentences of [0264]). Further, Silver in combination with Johnson teaches a CO2 sensor (Johnson 106) positioned within the exhaled gas flow pathway taught by Silver (see 103 rejection of claim 1 above).
On page 19 of the Remarks, Applicant argues the combination of Silver and Johnson does not result in the invention as claimed because it lacks the synergistic safety benefit of the claimed apparatus by failing to teach or suggest the determination of individualized safety ranges for both volume and CO2 based on ideal body weight or predicated body weight. However, Silver discloses determining a ventilation tidal volume based on an ideal body weight of a patient ([0223], [0276], [0295]). Additionally, the feature of an individualized safety range of CO2 based on ideal body weight or predicated body weight is not recited in the rejected claim(s) (see amended claim 1, lines 28 and 38-39; see amended claim 18, lines 28-30). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As such, Silver in combination with Johnson does teach a multi-parametric safety system that monitors gas flow and end-tidal CO2, and determines safety ranges for both tidal volume and end-tidal CO2 based on data received from a gas flow sensor and a CO2 sensor, respectively, as well as an ideal body weight of a user (see 103 rejection of claim 1 above). Hence, Applicant’s arguments are not persuasive.
On page 19 of the Remarks, Applicant argues the combination of Silver and Johnson further lacks the synergistic safety benefit of the claimed apparatus as the cited portions of the prior art fail to teach the specific physical integration of sensors within an expiratory coupler, as recited in amended claim 1. Applicant’s argument has been considered but is not persuasive as Silver in combination with Johnson teaches a connector between the patient and ventilation bag (Silver 112) that defines an exhaled gas flow pathway (Silver [0264]) with a ventilation sensor (Silver 22) and a CO2 sensor (Johnson 106) positioned within the exhaled gas flow pathway taught by Silver (first two sentences of Silver [0264]; see 103 rejection of claim 1 above).
On pages 19-20 of the Remarks, Applicant argues neither Silver nor Johnson, alone or in combination, suggest a system that functionally links the calculation of an end tidal CO2 safety range to the specific physiological requirements of a subject determined via idea body weight or predicated body weight. In response to applicant's argument that Silver fails to show calculating an end tidal CO2 safety range functionally corresponding to the specific physiological requirements of a subject determined via ideal body weight or predicated body weight, it is noted that the features upon which applicant relies (i.e., calculating an end tidal CO2 safety range for based on ideal body weight or predicated body weight) are not recited in the rejected claim(s) (see amended claim 1, lines 28 and 38-39; see amended claim 18, lines 28-30). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As such, Applicant's arguments (filed on 01/30/2026), in regard to claim 12, have been fully considered but they are not persuasive.
Applicant further argues the Examiner’s assertion that Silver’s Equation 3 is “inherently” the same as Applicant’s thresholds is a classic example of hindsight reconstruction, as Silver’s Equation 3 calculates a “usable tidal volume”, which is a single value, and not the specific safety thresholds of 6 ml/kg and 8 ml/kg applied to a calculated ideal body weight, as recited in claim 12. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Furthermore, Silver’s Equation 3 discloses calculating a ventilation tidal volume by multiplying a patient’s ideal body weight and target ventilation tidal volume range of 6 mL/kg to 8 mL/kg, where the ventilation tidal volume is a range (see Silver Table 1, Silver [0294]-[0295], and Silver [0402]). Hence, Applicant’s arguments are not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Palatnik (US 20070261698 A1): Regarding a respiration gas monitoring device with sensors located at a connector between a resuscitator bag and a patient interface.
Löser & Kullik (US 20150328417 A1): Regarding a ventilation system with a carbon dioxide sensor and a gas flow sensor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAYLE DALE whose telephone number is (571)272-1080. The examiner can normally be reached Monday-Friday from 8:45am to 5:45pm ET.
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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.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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