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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
This Office Action is responsive to the amendment filed 01/12/2026 (“Amendment”). Claims 10, 12, 13, 15, 16, and 18-20 are currently under consideration. The Office acknowledges the amendments to claims 10, 12, 15, and 18-20, as well as the cancellation of claims 9, 11, and 17. Claim 14 remains withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 10, 15, and 18 are objected to because of the following informalities:
Regarding claims 10, 15, and 18, there is no “and” before the last elements of a list. For example, in claim 10, there is no “and” before “a second flow-attribute sensor.” In claim 15, there is no “and” before “provide, based on the sensing.” In claim 18, there is no “and” before “a therapeutic gas delivery device,” “a second valve,” or “wherein when the controller.”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “source of therapeutic gas” in claim 18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof (e.g. for “source of therapeutic gas,” a gas cylinders as described in ¶ 0049 of the specification as filed).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10, 12, 13, 15, 16, and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 10 and 18, there is no support for utilizing the second set of values if the attribute of airflow is above a second predetermined threshold, since this means that the thresholds for the first and second sets of values are different. The specification does not contemplate or suggest this. Instead, based on e.g. claim 12 and ¶ 0053 of the specification as filed, the suggestion is that the threshold is the same – one corresponding to sufficient flow.
Claims 12, 13, 15, 16, 19, and 20 are rejected because they depend on rejected claims.
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 18-20 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.
Regarding claim 18, there is insufficient antecedent basis for the recitations of “the first flow sensor” and “the second flow sensor.” For purposes of examination, they will be interpreted as the first and second flow-attribute sensors.
Claims 19 and 20 are rejected because they depend on rejected claims.
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 10, 12, 13, 15, 16, and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 10, 12, 13, 15, 16, and 18-20 are directed to a “system,” which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 10 and 18 recite (“set forth” or “describe”) the abstract idea of a mental process, substantially as follows:
read a first set of values indicative of carbon dioxide from the first CO2 sensor; read a second set of values indicative of carbon dioxide from the second CO2 sensor; create a capnographic waveform using at least one of the first and second sets of values indicative of carbon dioxide; read the attribute of airflow from the first flow-attribute sensor; read the attribute of airflow from the second flow-attribute sensor; utilize the first set of values indicative of carbon dioxide if the attribute of airflow from the first flow-attribute sensor is above a first predetermined threshold; and utilize the second set of values indicative of carbon dioxide if the attribute of airflow from the second flow-attribute sensor is above a second predetermined threshold.
The reading, creating, and utilizing steps can be practically performed in the human mind, with the aid of a pen and paper, but for performance on a generic computer, in a computer environment, or merely using the computer as a tool to perform the steps. If a person were to see a printout of e.g. the carbon dioxide and flow-attribute data, they would be able to read the values, select a set to utilize, and create a waveform based thereon. There is nothing to suggest an undue level of complexity in the steps. Therefore, a person would be able to perform the calculations mentally or with pen and paper.
Prong Two: Claims 10 and 18 do not include additional elements that integrate the mental process into a practical application. Therefore, the claims are “directed to” the mental process. The additional elements merely:
recite the words “apply it” (or an equivalent) with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. a controller), and
add insignificant extra-solution activity (the extra-solution activity of: obtaining carbon dioxide and airflow data, using generic data-gathering components associated with a nasal cannula; sensing an inhalation; and providing a therapeutic gas from a source via a valve arrangement (notably, this provision is not based on the created capnographic waveform), etc.).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the capnographic waveform is not outputted in any way such that a diagnostic benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 10 and 18 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
Dependent Claims
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
further describe the abstract idea (e.g. averaging data (claims 12, 13, and 19), etc.), and
further describe the pre-solution activity (or the structure used for such activity) (e.g. valves (claim 15), used for providing a therapeutic gas (claim 15 - notably, this provision is not based on the created capnographic waveform), modifying provision (claims 16 and 20 – again, not based on the created capnographic waveform), etc.).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way (e.g. nothing is done with the created capnographic waveform). They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves another technology or technical field, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
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 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2014/0194766 (“Al-Ali”) in view of US Patent Application Publication 2019/0150831 (“Payton”) and US Patent Application Publication 2006/0169281 (“Aylsworth’281”).
Regarding claim 10, Al-Ali teaches [a] system (Fig. 3, respiratory monitoring system 300) comprising: a controller (Fig. 3, preprocessor 365; paras. 0029 and 0042); a first carbon dioxide sensor (CO2 sensor) (Fig. 3, sensor 355 determines the concentration of carbon dioxide; para. 0042) fluidly coupled to a first hose connection (Fig. 3, sensor 355 is positioned at a second end of cannula tube 310; para. 0008; para. 0042), and communicatively coupled to the controller (Fig. 3, the sensor 355 transfers data to preprocessor 365 of the sensing module 345; para. 0042); a second CO2 sensor (Fig. 3, sensor 354; paras. 0009, 0042) fluidly coupled to a second hose connection (Fig. 3, sensor 354 is positioned at a second end of cannula tube 320; para. 0008; para. 0042), and communicatively coupled to the controller (Fig. 3, the sensor 354 transfers data to preprocessor 365 of the sensing module 345; para. 0042); …; wherein the controller (Fig. 3, preprocessor 365) is configured to: read a first set of values indicative of carbon dioxide from the first CO2 sensor (Fig. 3, the preprocessor 365 processes signals from the sensor 355); read a second set of values indicative of carbon dioxide from the second CO2 sensor (Fig. 3, the preprocessor 365 processes signals from the sensor 354); and create [an output] using at least one of the first and second sets of values indicative of carbon dioxide (Fig. 1, Fig. 3, the data from sensors 345, 355 is processed and transmitted; para. 0042); … .
Al-Ali does not appear to explicitly teach creating a capnographic waveform.
Payton teaches a system (system; para. 0006) that creates a capnographic waveform (gas sensor or capnography device measurements are processed for determination of an expired gas waveform; para. 0105; para. 0541).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to create a capnographic waveform using the data of Al-Ali, as in Payton, for the purpose of providing a detailed and accurate representation of respiratory function, including for being able to determine airway patency (Payton: ¶ 0556, Fig. 6).
Al-Ali-Payton does not appear to explicitly teach a first flow-attribute sensor electrically coupled to the controller and configured to fluidly couple to the first hose connection, wherein the first flow-attribute sensor senses an attribute of airflow through the first hose connection; a second flow-attribute sensor electrically coupled to the controller and configured to fluidly couple to the second hose connection, wherein the second flow-attribute sensor senses an attribute of airflow of the second hose connection; wherein when the controller creates the capnographic waveform, the controller is further configured to: read the attribute of airflow from the first flow-attribute sensor; read the attribute of airflow from the second flow-attribute sensor; utilize the first set of values indicative of carbon dioxide if the attribute of airflow from the first flow-attribute sensor is above a first predetermined threshold; and utilize the second set of values indicative of carbon dioxide if the attribute of airflow from the second flow-attribute sensor is above a second predetermined threshold.
Aylsworth'281 teaches a first sensor (Fig. 1, flow sensor 46) electrically coupled to the controller (Fig. 1, processor 28) and configured to fluidly couple (Fig. 1, flow sensor 46 is fluidly coupled to the right naris via cannula 26; para. 0036; para. 0053) to the first hose connection (Fig. 1, the flow sensor 46 couples to the cannula 26), the first sensor (Fig. 1, flow sensor 46) sensing an attribute of airflow through the first hose connection (Fig. 1, the monitoring and control system 10 measures airflow of the patient's right naris; para. 0039; para. 0040; para. 0042); a first valve (Fig. 1, valve 40) electrically coupled to the controller (Fig. 1, processor 28) and configured to fluidly couple a source hose connection to the first hose connection (Fig. 1, the valve 40 fluidly couples a gas source 12 to the cannula 26); a second sensor (Fig. 1, flow sensor 48) electrically coupled to the controller (Fig. 1, processor 28) and configured to fluidly couple (Fig. 1, flow sensor 48 is fluidly coupled to the left naris via cannula 26; para. 0036; para. 0053) to the second hose connection (Fig. 1, the flow sensor 48 couples to the cannula 26), the second sensor (Fig. 1, flow sensor 48) sensing an attribute of airflow of the second hose connection (Fig. 1, the monitoring and control system 10 senses airflow of the patient's left naris; para. 0039; para. 0040; para. 0042); a second valve (Fig. 1, valve 42) electrically coupled to the controller (Fig. 1, processor 28) and configured to fluidly couple the source hose connection to the second hose connection (Fig. 1, the valve 42 fluidly couples a gas source 12 to the cannula 26); wherein when the controller (Fig. 1, processor 28) creates the capnographic waveform, the controller is further configured to: read the attribute of airflow from the first sensor (Fig. 1, the monitoring and control system 10 senses airflow of the patient's right naris; para. 0039; para. 0040; para. 0042); read the attribute of airflow from the second sensor (Fig. 1, the monitoring and control system 10 senses airflow of the patient's left naris; para. 0039; para. 0040; para. 0042). Aylsworth’281 also teaches the desirability of using data from a patent airway (¶ 0041, etc.), where patency is determined by a threshold amount of an airflow attribute (Fig. 3, blocks 320 and 324, ¶¶s 0044-0049, etc.; it would have been obvious to set these thresholds as desired since they are known results-effective variables (Aylsworth’281: ¶ 0044, claim 11, etc.), and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the sensors and control of Aylsworth'281 into the combination, for the purpose of not wasting therapeutic gas (Aylsworth'281: ¶ 0003). It would have been obvious to utilize carbon dioxide data only from a patent or otherwise suitable airway, as in Aylsworth’281, for the purpose of obtaining accurate data, it being known that data from e.g. blocked airways is suspect (Aylsworth’281: ¶¶s 0003, 0041, 0046-0049, etc., accounting for congestion, physical abnormality, narial valve collapse, the mouth being closed, the cannula having slipped off, etc.).
Regarding claim 15, Al-Ali-Payton-Aylsworth’281 teaches all the features with respect to claim 10, as outlined above. Al-Ali-Payton-Aylsworth’281 further teaches a first valve electrically coupled to the controller and configured to fluidly couple a source hose connection to the first hose connection; and a second valve electrically coupled to the controller and configured to fluidly couple the source hose connection to the second hose connection; wherein the controller is further configured to: sense an inhalation by way of the first flow-attribute sensor or the second flow-attribute sensor; provide, based on the sensing, a flow of therapeutic gas to the first hose connection by way of the first valve (Aylsworth'281 teaches a first valve (Fig. 1, valve 40) electrically coupled to the controller (Fig. 1, processor 28) and configured to fluidly couple a source hose connection to the first hose connection (Fig. 1, the valve 40 fluidly couples a gas source 12 to the cannula 26); a second valve (Fig. 1, valve 42) electrically coupled to the controller (Fig. 1, processor 28) and configured to fluidly couple the source hose connection to the second hose connection (Fig. 1, the valve 42 fluidly couples a gas source 12 to the cannula 26); wherein the controller (Fig. 1, processor 28) is further configured to: sense an inhalation (Fig. 1, sensing airflow of each naris; para. 0042) by way of the first sensor (Fig. 1, flow sensor 46) or the second sensor (Fig. 1, flow sensor 48); provide, based on the sensing, a flow of therapeutic gas to the first hose connection by way of the first valve (Fig. 1, a patient's flow prescription is delivered to the patient's right naris, and in the event that either the left or right naris becomes clogged or blocked, the system provides therapeutic gas to the naris where airflow is sensed; para. 0037; para. 0040; para. 0042). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further incorporate the valves and control of Aylsworth'281 into the combination, for the purpose of not wasting therapeutic gas (Aylsworth'281: ¶ 0003)).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali-Payton-Aylsworth’281 in view of US Patent Application Publication 2011/0245579 (“Bruggerman”).
Regarding claim 12, Al-Ali-Payton-Aylsworth’281 teaches all the features with respect to claim 10, as outlined above. Al-Ali-Payton-Aylsworth’281 does not appear to explicitly teach wherein when the controller creates the capnographic waveform utilizing both the first and second set of values indicative of carbon dioxide, the controller creates the capnographic waveform using both the first and second sets of values indicative of carbon dioxide, wherein when the controller creates the capnographic waveform, the controller is further configured to average corresponding values in the first and second sets of values indicative of carbon dioxide.
Bruggerman teaches that prior art capnometry cannulas combine oral and nasal measurements to come up with an average measurement (¶ 0125)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take an average of the capnometry measurements of the combination, as in Bruggerman, for the purpose of simplifying to have only one set of data for further processing, so that it does not appear like the patient is not breathing when one nare or the mouth is closed/blocked, and as the simple substation of one known capnometry method for another with predictable results (obtaining a capnographic waveform to further evaluate breathing).
Regarding claim 13, Al-Ali-Payton-Aylsworth’281-Bruggerman teaches all the features with respect to claim 12, as outlined above. Al-Ali-Payton-Aylsworth’281-Bruggerman further teaches wherein when the controller averages, the controller is further configured to average the values of the first and second sets of values indicative of carbon dioxide at corresponding points in time (Aylsworth’281 teaches making a determination of total sensed volume and relative percentage of volume per orifice on a per-breath basis or an average of all breaths sensed, to know which orifice to deliver to (¶ 0041), which suggests that the data from corresponding points in time of each signal/orifice is evaluated. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the average determination of the combination based on corresponding points in time in the signals, as in Aylsworth’281, for the purpose of capturing an accurate waveform (with e.g. no distortion due to time delay), and for enabling real-time control (Aylsworth’281: ¶ 0041, control on a per-breath basis, etc.)).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali-Payton- Aylsworth’281 in view of US Patent Application Publication 2004/0230108 (“Melker”).
Regarding claim 16, Al-Ali-Payton-Aylsworth’281 teaches all the features with respect to claim 15, as outlined above. Al-Ali-Payton-Aylsworth’281 does not appear to explicitly teach wherein the controller is further configured to modify a volume of therapeutic gas provided in a subsequent inhalation based on the capnographic waveform.
Melker teaches a system (monitor system; para. 0026). wherein the controller (controller; para. 0189) is further configured to modify a volume of therapeutic gas provided in a subsequent inhalation based on the capnographic waveform (the release of the supply of oxygen or oxygen-rich air is adjusted to match the actual bodily requirement based on detection of ventilation failure; para. 0045; para. 0164-0165; para. 0214; para. 0219).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to control delivery of therapeutic gas in the combination based on a carbon dioxide measurement (or a capnographic waveform), as in Melker, for the purpose of optimizing oxygen delivery in a rapid manner (Melker: paras. 0149-0150, 0164-0165, etc.).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali in view of Aylsworth’281 and Payton.
Regarding claim 18, Al-Ali teaches [a] system (Fig. 3, respiratory monitoring system 300) comprising: a source of therapeutic gas (Fig. 3, oxygen supply 340); a … nasal cannula (Fig. 3, cannula tube 310, 320 define a nasal cannula; paras. 0020, 0042); a [device] comprising: a controller (Fig. 3, preprocessor 365; paras. 0029 and 0042); a first carbon dioxide sensor (CO2 sensor) (Fig. 3, sensor 355 determines the concentration of carbon dioxide; para. 0042) fluidly coupled to a first lumen of the … nasal cannula (Fig. 3, sensor 355 is positioned at a second end of cannula tube 310; para. 0008; para. 0042), and communicatively coupled to the controller (Fig. 3, the sensor 355 transfers data to preprocessor 365 of the sensing module 345; para. 0042); a second CO2 sensor (Fig. 3, sensor 354; paras. 0009, 0042) fluidly coupled to a second lumen of the … nasal cannula (Fig. 3, sensor 354 is positioned at a second end of cannula tube 320; para. 0008; para. 0042), and communicatively coupled to the controller (Fig. 3, the sensor 354 transfers data to preprocessor 365 of the sensing module 345; para. 0042); … wherein the controller (Fig. 3, preprocessor 365) is configured to: …; read a first set of values indicative of carbon dioxide from the first CO2 sensor during an exhalation (Fig. 3, the preprocessor 365 processes signals from the sensor 355); read a second set of values indicative of carbon dioxide from the second CO2 sensor during the exhalation (Fig. 3, the preprocessor 365 processes signals from the sensor 354); and create [an output] using at least one of the first and second sets of values indicative of carbon dioxide (Fig. 1, Fig. 3, the data from sensors 345, 355 is processed and transmitted; para. 0042); … .
Al-Ali does not appear to explicitly teach a bifurcated nasal cannula, a therapeutic gas delivery device coupled to the source of therapeutic gas, and coupled to the bifurcated nasal cannula, the therapeutic gas delivery device comprising: a first flow-attribute sensor electrically coupled to the controller and configured to fluidly couple to the first lumen of the bifurcated nasal cannula, wherein the first flow-attribute sensor senses an attribute of airflow through the first lumen; a first valve electrically coupled to the controller and configured to fluidly couple to the source of therapeutic gas to the first lumen; a second flow-attribute sensor electrically coupled to the controller and configured to fluidly couple to the second lumen of the bifurcated nasal cannula, wherein the second flow-attribute sensor senses an attribute of airflow of the second lumen; a second valve electrically coupled to the controller and configured to fluidly couple the source of therapeutic gas to the second lumen; wherein the controller is configured to: sense an inhalation by way of the first flow sensor or the second flow sensor; provide a flow of therapeutic gas to the first lumen of the bifurcated nasal cannula; …; wherein when the controller creates the output, the controller is further configured to: read the attribute of airflow from the first flow-attribute sensor; read the attribute of airflow from the second flow-attribute sensor; utilize the first set of values indicative of carbon dioxide if the attribute of airflow from the first flow-attribute sensor is above a first predetermined threshold; and utilize the second set of values indicative of carbon dioxide if the attribute of airflow from the second flow-attribute sensor is above a second predetermined threshold.
Aylsworth'281 teaches a system (Fig. 1, delivery system 100), comprising: a bifurcated nasal cannula (Fig. 1, cannula 26 is a bifurcated nasal cannula; para. 0039); a therapeutic gas delivery device (Fig.1, monitoring and control system 10) coupled to a source of therapeutic gas (Fig. 1, as shown), and coupled to the bifurcated nasal cannula (Fig. 1, as shown), the therapeutic gas delivery device comprising: a first sensor (Fig. 1, flow sensor 46) electrically coupled to the controller (Fig. 1, processor 28) and configured to fluidly couple (Fig. 1, flow sensor 46 is fluidly coupled to the right naris via cannula 26; para. 0036; para. 0053) to a first lumen (Fig. 1, the flow sensor 46 couples to the cannula 26), the first sensor (Fig. 1, flow sensor 46) sensing an attribute of airflow through the first lumen (Fig. 1, the monitoring and control system 10 measures airflow of the patient's right naris; para. 0039; para. 0040; para. 0042); a first valve (Fig. 1, valve 40) electrically coupled to the controller (Fig. 1, processor 28) and configured to fluidly couple a source of therapeutic gas to the first lumen (Fig. 1, the valve 40 fluidly couples a gas source 12 to the cannula 26); a second sensor (Fig. 1, flow sensor 48) electrically coupled to the controller (Fig. 1, processor 28) and configured to fluidly couple (Fig. 1, flow sensor 48 is fluidly coupled to the left naris via cannula 26; para. 0036; para. 0053) to a second lumen (Fig. 1, the flow sensor 48 couples to the cannula 26), the second sensor (Fig. 1, flow sensor 48) sensing an attribute of airflow of the second lumen (Fig. 1, the monitoring and control system 10 senses airflow of the patient's left naris; para. 0040; para. 0042); a second valve (Fig. 1, valve 42) electrically coupled to the controller (Fig. 1, processor 28) and configured to fluidly couple the source of therapeutic gas to the second lumen (Fig. 1, the valve 42 fluidly couples a gas source 12 to the cannula 26); wherein the controller (Fig. 1, processor 28) is configured to: sense an inhalation (Fig. 1, sensing airflow of each naris; para. 0042) by way of the first flow sensor (Fig. 1, flow sensor 46) or the second flow sensor (Fig. 1, flow sensor 48); provide a flow of therapeutic gas to the first lumen of the bifurcated nasal cannula (Fig. 1, a patient's flow prescription is delivered to the patient's right naris, and in the event that either the left or right naris becomes clogged or blocked, the system provides therapeutic gas to the naris where airflow is sensed; para. 0037; para. 0040; para. 0042); wherein when the controller creates the waveform, the controller is further configured to: read the attribute of airflow from the first flow-attribute sensor (Aylsworth’281: Fig. 1, the monitoring and control system 10 senses airflow of the patient's right naris; para. 0039; para. 0040; para. 0042); read the attribute of airflow from the second flow-attribute sensor (Aylsworth’281: Fig. 1, the monitoring and control system 10 senses airflow of the patient's left naris; para. 0039; para. 0040; para. 0042); utilize the first set of values indicative of carbon dioxide if the attribute of airflow from the first flow-attribute sensor is above a first predetermined threshold; and utilize the second set of values indicative of carbon dioxide if the attribute of airflow from the second flow-attribute sensor is above a second predetermined threshold (Aylsworth’281 teaches the desirability of using data from a patent airway (¶ 0041, etc.), where patency is determined by a threshold amount of an airflow attribute (Fig. 3, blocks 320 and 324, ¶¶s 0044-0049, etc.; it would have been obvious to set these thresholds as desired since they are known results-effective variables (Aylsworth’281: ¶ 0044, claim 11, etc.), and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the cannula, valves, sensors, and control of Aylsworth'281 into Al-Ali, for the purpose of not wasting therapeutic gas (Aylsworth'281: ¶ 0003) and for enabling control on a nare-by-nare basis (Aylsworth’281: ¶ 0037, 0042, etc.). It would have been obvious to utilize carbon dioxide data only from a patent or otherwise suitable airway, as in Aylsworth’281, for the purpose of obtaining accurate data, it being known that data from e.g. blocked airways is suspect (Aylsworth’281: ¶¶s 0003, 0041, 0046-0049, etc., accounting for congestion, physical abnormality, narial valve collapse, the mouth being closed, the cannula having slipped off, etc.).
Al-Ali-Aylsworth’281 does not appear to explicitly teach creating a capnographic waveform.
Payton teaches a system (system; para. 0006) that creates a capnographic waveform (gas sensor or capnography device measurements are processed for determination of an expired gas waveform; para. 0105; para. 0541).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to create a capnographic waveform using the data of the combination, and to use it for analysis, as in Payton, for the purpose of providing a detailed and accurate representation of respiratory function, including for being able to determine airway patency (Payton: ¶ 0556, Fig. 6).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali-Aylsworth’281-Payton in view of US Patent Application Publication 2011/0245579 (“Bruggerman”).
Regarding claim 19, Al-Ali-Aylsworth’281-Payton teaches all the features with respect to claim 18, as outlined above. Al-Ali-Aylsworth’281-Payton does not appear to explicitly teach wherein when the controller creates the capnographic waveform using both the first and second sets of values indicative of carbon dioxide, the controller is further configured to average corresponding values in the first and second sets of values indicative of carbon dioxide.
Bruggerman teaches that prior art capnometry cannulas combine oral and nasal measurements to come up with an average measurement (¶ 0125)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take an average of the capnometry measurements of the combination, as in Bruggerman, for the purpose of simplifying to have only one set of data for further processing, so that it does not appear like the patient is not breathing when one nare or the mouth is closed/blocked, and as the simple substation of one known capnometry method for another with predictable results (obtaining a capnographic waveform to further evaluate breathing).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali-Aylsworth’281-Payton in view of US Patent Application Publication 2004/0230108 (“Melker”).
Regarding claim 20, Al-Ali-Aylsworth’281-Payton teaches all the features with respect to claim 18, as outlined above. Al-Ali-Aylsworth’281-Payton does not appear to explicitly teach wherein the controller is further configured to control a volume of therapeutic gas delivered based on a capnographic waveform associated with a prior exhalation.
Melker teaches a system (monitor system; para. 0026). wherein the controller (controller; para. 0189) is further configured to modify a volume of therapeutic gas provided in a subsequent inhalation based on the capnographic waveform (i.e., based on a prior exhalation - the release of the supply of oxygen or oxygen-rich air is adjusted to match the actual bodily requirement based on detection of ventilation failure; para. 0045; para. 0164-0165; para. 0214; para. 0219).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to control delivery of therapeutic gas in the combination based on a carbon dioxide measurement (or a capnographic waveform), as in Melker, for the purpose of optimizing oxygen delivery in a rapid manner (Melker: paras. 0149-0150, 0164-0165, etc.).
Response to Arguments
Applicant’s arguments filed 01/12/2026 have been fully considered.
In response to the arguments regarding the rejections under 35 USC 101, they are not persuasive. There is nothing in the claims to suggest an undue quality or quantity of data to be analyzed. The sensor data/output can readily be visually observed and decisions made based on the morphology of the data. The claims also do not impose any particular time constrains that would make mental analysis impossible.
Regarding an improvement to the field of capnography, it is maintained that nothing is done with the capnographic waveform. Thus, the improvement, if any, remains in a processing black box and is limited to an improvement in the abstract idea itself. An improvement to an abstract idea is still an abstract idea, and is therefore not eligible.
Regarding Example 3 of the 2014 Interim Eligibility Guidance, which is outdated guidance, it is different because it involves the transformation of an image (tied to the processors ability to process digital images)), as well as an improvement to the functioning of the computer itself (using less memory). Further, Applicant has not explained how the current claims are similar to those in Example 3.
In response to the arguments regarding the rejections under 35 USC 103, they are persuasive to the extent that the previous combination did not teach some of the newly added features. However, these features are found in the teachings of Aylsworth’281, which Applicant has not addressed, and all claims remain rejected in light of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791