Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This office action is in response to the filing of the application on 3/25/2024. Since the initial filing claims 3-14, 16-22, 24-47 have been amended; no claims have been added or canceled. Thus claims 1-49 are pending in the application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
FIG 5A reference character “5150” and reference character “5135”
FIG 5B reference character reference character “5150”, reference character “5120”, and reference character “5135”
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 17, 20, 23, 39, 42, 43, and 49 are objected to because of the following informalities:
Claim 1
Ln 11 reads “analyse the pressure signal” and should be corrected to --analyze the pressure signal--
Ln 18 reads “first function characterising the system” and should be corrected to --first function characterizing the system--
Claim 17
Ln 2 reads “wherein the analyse of the pressure” and should be corrected to --wherein the analyze of the pressure--
Claim 20
Ln 2 reads “the patient interface based on the template curve” and should be corrected to --the patient interface based on a template curve--
Claim 23
Ln 3 reads “a delivery conduit for a respiratory therapy for a patient” and should be corrected to --a delivery the conduit of a respiratory therapy system for a patient--
Ln 9 reads “analysing the pressure signal” and should be corrected to --analyzing the pressure signal--
Claim 39
Ln 1 reads “analysing of the pressure signal” and should be corrected to --analyzing of the pressure signal--
Claim 42
Ln 2 reads “the patient interface based on the template curve” and should be corrected to --the patient interface based on a template curve--
Claim 43
Ln 1 reads “wherein the curve” and should be corrected to --wherein the system curve--
Claim 49
Ln 5 reads “analysing of the pressure signal” and should be corrected to --analyzing of the pressure signal--
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.
The following claim limitations are interpreted under 35 USC 112(f):
Means for supplying a flow of air to a patient interface (claim 49, ln. 2)
This phrase utilizes the generic placeholder “means”, and is not being modified by sufficient structure for performing the claimed function of “supplying a flow of air to a patient interface”. The specifications [0086] state, “a respiratory therapy system may comprise an RPT device 4000 for supplying a flow of air to the patient 1000 via an air circuit 4170 and a patient interface 3000”. Therefore, “a means for supplying a flow of air to a patient interface” is an RPT device that supplies a flow of air through an air circuit.
Means for generating a flow rate signal (claim 49, ln. 3)
This phrase utilizes the generic placeholder “means”, and is not being modified by sufficient structure for performing the claimed function of “generating a flow rate signal”. The specifications [0098] state, “one or more transducers 4270, such as pressure sensors 4272 and flow rate sensors 4274”. Therefore, “means for generating a flow rate signal” is a transducer that contains a flow rate sensor.
Means for generating a pressure signal (claim 49, ln. 4)
This phrase utilizes the generic placeholder “means”, and is not being modified by sufficient structure for performing the claimed function of “generating a pressure signal”. The specifications [0098] state, “one or more transducers 4270, such as pressure sensors 4272 and flow rate sensors 4274”. Therefore, “means for generating a flow rate signal” is a transducer that contains a pressure sensor.
Means for analysing the pressure signal and the flow rate signal (claim 49, ln. 5)
This phrase utilizes the generic placeholder “means”, and is not being modified by sufficient structure for performing the claimed function of “analysing the pressure signal and the flow rate signal”. The specifications [0031] state, “The controller may be configured to receive the pressure signal and the flow rate signal from the transducers. The controller may be configured to analyse the pressure signal and the flow rate signal to determine a system curve representing a pressure and flow characteristic of a respiratory therapy system that may include the apparatus, the delivery conduit and the patient interface” Therefore, “analysing the pressure signal and the flow rate signal” is a controller capable of receiving signals generated by the pressure and flow rate transducers and configuring the data into a system curve for analysis.
Means for deriving a pressure drop parameter (claim 49, ln. 8)
This phrase utilizes the generic placeholder “means”, and is not being modified by sufficient structure for performing the claimed function of “deriving a pressure drop parameter”. The specifications [0044] state, “The system may include means for deriving a pressure drop parameter that may be characteristic of pressure drop across a vent of the patient interface and/or a pressure drop up to the patient interface based on a first function that may characterize the system curve and a second function representing a component curve that represents a pressure and flow characteristic of at least one component of the system.” Therefore, “deriving the pressure drop parameter” is calculating a pressure drop across the vent of the patient interface based on the first function and second function.
Means for generating an output (claim 49, ln. 13)
This phrase utilizes the generic placeholder “means”, and is not being modified by sufficient structure for performing the claimed function of “deriving a pressure drop parameter”. The specifications [0032] state “the output may include at least one of (e.g., any one or more or all) of: saving data indicative of the derived pressure drop parameter to a storage device of a remote server; generating one or more signals to control operation of the pressure generator to adjust a property of the flow of air based on the pressure drop parameter; displaying information indicative of the derived pressure drop parameter on a display of the apparatus for respiratory therapy; and transmitting information indicative of the derived pressure drop parameter to a remote server.” Therefore, “generating an output”, is the RPT device saving data, generating control signals, displaying information about the system on a screen, or transmitting collected data to remote servers.
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 1-49 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claim 1, the applicant’s limitation of “a first function characterising the system curve” and “a second function representing the component curve” does not appear to be described in such a way as to allow one of ordinary skill in the art to make/or use the device without undue experimentation. While the Applicant depicts the system curve (i.e. the first function) as a characterization of a system curve, and a component curve (i.e. the second function) as a quadratic equation representing the pressure and flow characteristics of a component of the system, the Applicant neglects to include any corresponding details pertaining to how the system function is created and fit into an equation as well as how the characteristics of the components fit into another separate equation and how both equations are put together. The applicant’s disclosure does not give definite numbers or example equations for any of the many components claimed within the invention (i.e. component representing a patient interface, a component representing a humidifier, etc). The applicant does not give clear examples of both equations or significant details to allow one of ordinary skill to recreate the calculations and therefore the apparatus being claimed within the application.
An evaluation of the Wands factors support a determination that the disclosure does not satisfy the enablement requirement and that the necessary experimentation is "undue." See MPEP 2164.01 Examining the Wands factors:
(1) With respect to breadth, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims (MPEP 2164.08). Here, while the claim is not broad with respect to the disclosure, one skilled in the art could not make and use the entire scope of claimed invention without undue experimentation. If one skilled in the art created an apparatus that has utilized both a first function (a system curve) and a second function (component curve) the user would be unable to create a secondary function equation utilizing component information in order to program and use the device as indicated within the claim.
(2) With respect to the nature of the invention and state of the prior art, the prior art fails to show the claimed "first function" and "second function" as being well known in the art. Therefore, the applicant should be providing guidance as to what these functions are.
(3) With respect to the level of one of ordinary skill and level of predictability, it does not appear that the prior art teaches anything about including a secondary function for comparisons and utilization for a respiratory therapy device. As this programing does not seem "predictable" in the art, the applicant is required to provide detailed direction on how to achieve such a configuration and function. Such direction does not appear to be present within the specification. "The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee's instruction. Thus, the public's end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology" (See MPEP 2164.03).
(4) With respect to the amount of direction provided by the inventor, while the applicant may claim that there is a "high level of ordinary skill in the art," it is not clear how even one of "high" ordinary skill in the art would resolve producing a first function characterising the system curve and a second function representing the component curve. It does not appear that any level of skill in the art would understand how to recreate the functions without guidance.
(5) With respect to existence of working examples, the applicant may allege to have a working example, but such an example has not been demonstrated to the examiner at this time.
(6) With respect to quantity of experimentation, it would appear as though a large amount of experimentation would be necessary, as many different types of functions could be used as the "first function" and the "second function." There are nearly a limitless amount of mathematical functions that could be tested or experimented to determine if they are suitable for the applicant's apparatus or method.
Regarding claim 23, the applicant’s limitation of “a first function characterising the system curve” and “a second function representing the component curve” does not appear to be described in such a way as to allow one of ordinary skill in the art to make/or use the device without undue experimentation. While the Applicant depicts the system curve (i.e. the first function) as a characterization of a system curve, and a component curve (i.e. the second function) as a quadratic equation representing the pressure and flow characteristics of a component of the system, the Applicant neglects to include any corresponding details pertaining to how the system function is created and fit into an equation as well as how the characteristics of the components fit into another separate equation and how both equations are put together. The applicant’s disclosure does not give definite numbers or example equations for any of the many components claimed within the invention (i.e. component representing a patient interface, a component representing a humidifier, etc). The applicant does not give clear examples of both equations or significant details to allow one of ordinary skill to recreate the calculations and therefore the apparatus being claimed within the application.
An evaluation of the Wands factors support a determination that the disclosure does not satisfy the enablement requirement and that the necessary experimentation is "undue." See MPEP 2164.01 Examining the Wands factors:
(1) With respect to breadth, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims (MPEP 2164.08). Here, while the claim is not broad with respect to the disclosure, one skilled in the art could not make and use the entire scope of claimed invention without undue experimentation. If one skilled in the art created an apparatus that has utilized both a first function (a system curve) and a second function (component curve) the user would be unable to create a secondary function equation utilizing component information in order to program and use the device as indicated within the claim.
(2) With respect to the nature of the invention and state of the prior art, the prior art fails to show the claimed "first function" and "second function" as being well known in the art. Therefore, the applicant should be providing guidance as to what these functions are.
(3) With respect to the level of one of ordinary skill and level of predictability, it does not appear that the prior art teaches anything about including a secondary function for comparisons and utilization for a respiratory therapy device. As this programing does not seem "predictable" in the art, the applicant is required to provide detailed direction on how to achieve such a configuration and function. Such direction does not appear to be present within the specification. "The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee's instruction. Thus, the public's end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology" (See MPEP 2164.03).
(4) With respect to the amount of direction provided by the inventor, while the applicant may claim that there is a "high level of ordinary skill in the art," it is not clear how even one of "high" ordinary skill in the art would resolve producing a first function characterising the system curve and a second function representing the component curve. It does not appear that any level of skill in the art would understand how to recreate the functions without guidance.
(5) With respect to existence of working examples, the applicant may allege to have a working example, but such an example has not been demonstrated to the examiner at this time.
(6) With respect to quantity of experimentation, it would appear as though a large amount of experimentation would be necessary, as many different types of functions could be used as the "first function" and the "second function." There are nearly a limitless amount of mathematical functions that could be tested or experimented to determine if they are suitable for the applicant's apparatus or method.
Regarding claim 49, the applicant’s limitation of the applicant’s limitation of “a first function characterising the system curve” and “a second function representing the component curve” does not appear to be described in such a way as to allow one of ordinary skill in the art to make/or use the device without undue experimentation. While the Applicant depicts the system curve (i.e. the first function) as a characterization of a system curve, and a component curve (i.e. the second function) as a quadratic equation representing the pressure and flow characteristics of a component of the system, the Applicant neglects to include any corresponding details pertaining to how the system function is created and fit into an equation as well as how the characteristics of the components fit into another separate equation and how both equations are put together. The applicant’s disclosure does not give definite numbers or example equations for any of the many components claimed within the invention (i.e. component representing a patient interface, a component representing a humidifier, etc). The applicant does not give clear examples of both equations or significant details to allow one of ordinary skill to recreate the calculations and therefore the apparatus being claimed within the application.
An evaluation of the Wands factors support a determination that the disclosure does not satisfy the enablement requirement and that the necessary experimentation is "undue." See MPEP 2164.01 Examining the Wands factors:
(1) With respect to breadth, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims (MPEP 2164.08). Here, while the claim is not broad with respect to the disclosure, one skilled in the art could not make and use the entire scope of claimed invention without undue experimentation. If one skilled in the art created an apparatus that has utilized both a first function (a system curve) and a second function (component curve) the user would be unable to create a secondary function equation utilizing component information in order to program and use the device as indicated within the claim.
(2) With respect to the nature of the invention and state of the prior art, the prior art fails to show the claimed "first function" and "second function" as being well known in the art. Therefore, the applicant should be providing guidance as to what these functions are.
(3) With respect to the level of one of ordinary skill and level of predictability, it does not appear that the prior art teaches anything about including a secondary function for comparisons and utilization for a respiratory therapy device. As this programing does not seem "predictable" in the art, the applicant is required to provide detailed direction on how to achieve such a configuration and function. Such direction does not appear to be present within the specification. "The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee's instruction. Thus, the public's end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology" (See MPEP 2164.03).
(4) With respect to the amount of direction provided by the inventor, while the applicant may claim that there is a "high level of ordinary skill in the art," it is not clear how even one of "high" ordinary skill in the art would resolve producing a first function characterising the system curve and a second function representing the component curve. It does not appear that any level of skill in the art would understand how to recreate the functions without guidance.
(5) With respect to existence of working examples, the applicant may allege to have a working example, but such an example has not been demonstrated to the examiner at this time.
(6) With respect to quantity of experimentation, it would appear as though a large amount of experimentation would be necessary, as many different types of functions could be used as the "first function" and the "second function." There is nearly a limitless amount of mathematical functions that could be tested or experimented to determine if they are suitable for the applicant's apparatus or method.
Any remaining claims are rejected as being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 112(b)
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 3, 6-7, and 23-48 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 3 reads “flow characteristics of a vent” (ln 2-3) which renders the claim indefinite as there is insufficient antecedent basis for this limitation in the claim. It is unclear if the Applicant is meaning to claim there is a second vent upon the patient interface or if Applicant is meaning to say that the vent is the same vent previously claimed in claim 1.
Claim 25 reads “flow characteristics of a vent” (ln 2-3) which renders the claim indefinite as there is insufficient antecedent basis for this limitation in the claim. It is unclear if the Applicant is meaning to claim there is a second vent upon the patient interface or if Applicant is meaning to say that the vent is the same vent previously claimed in claim 23.
Any remaining claims are rejected as being dependent upon a rejected base 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 1-49 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.
Step 2A (Prong One) - Is the claim directed to a law of nature, natural phenomenon, or an abstract idea?
In accordance with MPEP 2106.04, each of Claims 1, 23, and 49 have been analyzed to determine whether it is directed to any judicial exceptions. Each of Claims 1, 23, and 49 recites at least one step or instruction for generating an output as well as the controller steps: receive the pressure signal and the flow rate signal from the transducers; analyse the pressure signal and the flow rate signal to determine a system curve representing a pressure and flow characteristic of a respiratory therapy system comprising the apparatus, the delivery conduit and the patient interface; access data associated with a component curve representing a pressure and flow characteristic of at least one component of the system; derive a pressure drop parameter that is characteristic of pressure drop across the vent of the patient interface and/or a pressure drop up to the patient interface, based on a first function characterising the system curve and a second function representing the component curve, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a certain method of organizing human activity in MPEP 2106.04(a)(2)(II) or mathematical concept in MPEP 2106.04(a)(2)(I). Accordingly, each of Claims 1, 23, and 49 recite an abstract idea.
Specifically, Claim 1 recites an apparatus for respiratory therapy, the apparatus comprising:
a pressure generator configured to generate a flow of air for delivery to a patient interface via a delivery conduit for a respiratory therapy for a patient, the patient interface comprising a vent;
a pressure transducer configured to generate a signal representing a pressure generated by the pressure generator;
a flow rate transducer configured to generate a signal representing a flow rate of the flow of air;
a controller configured to:
receive the pressure signal and the flow rate signal from the transducers;
analyse the pressure signal and the flow rate signal to determine a system curve representing a pressure and flow characteristic of a respiratory therapy system comprising the apparatus, the delivery conduit and the patient interface;
access data associated with a component curve representing a pressure and flow characteristic of at least one component of the system;
derive a pressure drop parameter that is characteristic of pressure drop across the vent of the patient interface and/or a pressure drop up to the patient interface, based on a first function characterising the system curve and a second function representing the component curve; and
based on the derived pressure drop parameter, effect an output.
Further, dependent Claims 2-22 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed.
Additionally, Claim 23 recites a method of operating in a respiratory treatment apparatus, comprising a pressure generator configured to generate a flow of air for delivery to a patient interface via a delivery conduit for a respiratory therapy for a patient, the patient interface comprising a vent , the method comprising:
receiving a pressure signal generated by a pressure transducer, the pressure signal representing a pressure of the flow of air at the pressure generator,
receiving a flow rate signal generated by a flow rate transducer, the flow rate signal representing a flow rate of the flow of air;
analysing the pressure signal and the flow rate signal to determine a system curve representing a pressure and flow characteristic of a respiratory therapy system comprising the apparatus, the delivery conduit and the patient interface; access data associated with a component curve representing a pressure and flow characteristic of at least one component of the system;
deriving a pressure drop parameter that is characteristic of pressure drop across the vent of the patient interface and/or a pressure drop up to the patient interface based on a first function characterizing the system curve and a second function representing the component curve; and
based on the derived pressure drop parameter, effecting an output.
Further, dependent Claims 24-48 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed.
Additionally, Claim 49 recites a system for controlling a respiratory therapy, comprising:
means for supplying a flow of air to a patient interface as a respiratory therapy;
means for generating a flow rate signal representing a flow rate of the flow of air;
means for generating a pressure signal representing a pressure of the flow of air;
means for analysing the pressure signal and the flow rate signal to determine a system curve representing a pressure and flow characteristic of a system comprising a delivery conduit and a patient interface;
means for deriving a pressure drop parameter that is characteristic of pressure drop across a vent of the patient interface and/or a pressure drop up to the patient interface based on a first function characterizing the system curve and a second function representing a component curve that represents a pressure and flow characteristic of at least one component of the system; and
means for generating an output based on the pressure drop parameter.
Further, there are no dependent claims that include limitations to either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed.
Step 2A (Prong Two) - Does the claim recite additional elements that integrate the judicial exception into a practical application?
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
The above-identified abstract idea in each of independent Claims 1, 23, and 49 (and their respective dependent Claims 2-22 and 24-48) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 1, 23, and 49), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). More specifically, the additional elements of:
Pressure transducer
Flow transducer
are generically recited computer elements in independent Claims 1, 23, and 49 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1, 23, and 49 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g. Sever, Controller, Display, storage device as claimed) In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1, 23, and 49 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Step 2B- Does the claim recite additional elements that amount to significantly more than the judicial exception?
None of Claims 1, 23, and 49 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
These claims require the additional elements of:
Pressure transducer
Flow transducer
Per Applicant’s specification [0031-0033], the flow and pressure transducers are being used by the apparatus in order to calculate a first and second function. Both transducers are being used for data collection and are merely input/output devices without any significant contribution to the over all device itself. The use of flow and pressure sensors are well understood and conventional in the art, as stated by Matich (US 10646676 B1) [col 3 ln 57-62]. The judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including “pressure transducer”, "flow transducer" are recited at a high level of generality (e.g., that the inputting/outputting of data is performed using generic computer components with instructions are executed to perform the claimed limitations). Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f). The claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at:
Paragraph [0031] “The apparatus may include a pressure transducer configured to generate a signal representing a pressure of the flow of air at the pressure generator. The apparatus may include a flow rate transducer configured to generate a signal representing a flow rate of the flow of air.”
Paragraph [0035] “The controller may be configured to detect one or more events of sleep disordered breathing by evaluating one or more of the signals received from the pressure transducer and/or the flow rate transducer, and to modify the target therapy pressure parameter based on the evaluating.”
Paragraph [0040] “The analysis may use the pressure signal and the flow rate signal that are generated by the pressure transducer and flow rate transducer during a therapy session that may include automatic positive airway pressure (APAP) therapy.”
Accordingly, in light of Applicant’s specification, the claimed terms pressure and flow transducers are 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 technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the flow and pressure transducer to generate an output. 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 MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
Summary
The recitation of the above-identified additional limitations in Claims 1, 23, and 49 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus and method of Claims 1, 23, and 49 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1, 23, and 49 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 1, 23, and 49 amounts to significantly more than the abstract idea itself. Accordingly, claims 1, 23, and 49 are not patent eligible and rejected under 35 U.S.C. 101.
Allowable Subject Matter
Claims 1-49 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, 35 U.S.C. 112(a), 35 U.S.C. 112(b), or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance:
derive a pressure drop parameter that is characteristic of pressure drop across the vent of the patient interface and/or a pressure drop up to the patient interface, based on a first function characterising the system curve and a second function representing the component curve
The prior art alone or in combination with fails to disclose or make obvious a respiratory therapy machine the utilizes a pressure drop parameter based upon a first function, system curve; and a second function, a component curve.
The closest prior art is HOLLEY et al. (WO 2021072486 A1), which discloses respiratory therapy machine that calculates its parameters with a pressure-flow curve. However, Holley does not disclose or make obvious the use of a secondary function created by the details of the RPT components in unsent with a first function (i.e. the system curve) in order to derive a pressure drop parameter across the vent of the patient interface. Furthermore, it would not have been obvious to modify the device of Holley to calculate the pressure drop across the vent of a patient interface using a second function (i.e. a component curve) and a first function (i.e. a system curve) as there is no motivation, absent hindsight, to do so. Additionally, no other references, or reasonable combination thereof, could be found which discloses or suggests these features in combination with other limitations in the claims.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ho et al. (US 20120247470 A1) discloses of a respiratory therapy device that contains a controller able to adjust the operations of said device in order to identify different patient interfaces being used by the user.
Rao et al (US 10328219 B2) discloses of a respiratory therapy device with an automated method to detect potential leaks within the device and the patient interface. This allows the device to better serve the user and allow for better respiratory treatment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B RESTAINO whose telephone number is (571)272-8697. The examiner can normally be reached Mon-Fri 8:00AM - 5:00PM.
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/DANIELLE B RESTAINO/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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