DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 24 February 2026 has been entered. Claim(s) 86-99 are now pending. Applicant’s amendments have overcome each and every objection to the claims previously applied in the rejection dated 25 November 2025.
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: respiratory gas analyzer in claims 86-97; preprocessing unit in claim 86, 88, 96; buffer memory unit in claim 86, 89, 96; detector unit in claim 86, 89, 96; integrator unit in claim 86, 96; the measuring system in claims 86, 96; measuring unit in claim 86, 93, 96 .
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. Corresponding structure may be found for the respiratory gas analyzer in Fig. 2 of the drawings and page 17, lines 18-26 of the specification; the preprocessing unit in page 18, lines 1-6 of the specification; the buffer memory unit in page 7, lines 5-15 of the specification; the detector unit in page 18, lines 13-20 of the specification; the integrator unit in page 18, lines 22-25 of the specification; the measuring unit in page 5, lines 26-30; the measuring system in Fig. 2 of the drawings and page 16, lines 1-4 of the specification;.
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 § 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.
Utilizing the two step process adopted by the Supreme Court (Alice Corp vs CLS Bank Int'l, US
Supreme Court, 110 USPQ2d 1976 (2014) and the recent 101 guideline Federal Register Vol. 84, No., Jan
2019)), determination of the subject matter eligibility under the 35 U.S.C. 101 is as follows: Specifically, the Step 1 requires claim belongs to one of the four statutory categories (process, machine, manufacture, or composition of matter). If Step 1 is satisfied, then in the first part of Step 2A (Prong One), identification of any judicial recognized exceptions in the claim is made. If any limitation in the claim is identified as judicial recognized exception, then in the second part of Step 2A (Prong Two), determination is made whether the identified judicial exception is being integrated into practical application. If the identified judicial exception is not integrated into a practical application, then in Step 2B, the claim is further evaluated to see if the additional elements, individually and in combination provide "inventive concept" that would amount to significantly more than the judicial exception. If the element and combination of elements do not amount to significantly more than the judicial recognized exception itself, then the claim is ineligible under the 35 U.S.C. 101.
Claims 86-99 are rejected under 35 U.S.C. 101.
Claim 86 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. The claim recite(s) "configured to normalize a current respiratory gas volume per breath as a percentage of a normal value of an inspiratory respiratory minute volume of a specific time in order to determine a normalized respiratory gas volume”, “configured to determine at least one sleep stage from the at least one temporarily stored normalized respiratory gas volume, the at least one detector unit being configured to determine a deviation of the normalized value from the normal value to filter the determined deviation with a low pass to reproduce the value smoothed in this manner as a respiratory disturbance index corresponding to the deviation, and to assign a current breath to a stage of sleep according to the determined value of the respiratory disturbance index or according to a stability level as a reciprocal value of the respiratory disturbance index”, and “configured to determine a sleep quality based on the at least one sleep stage determined by the at least one detector unit, the at least one integrator unit being configured to add up, at an end of a measuring period, times and proportions of the measuring period during which the respiratory disturbance index was in a range of deep sleep, light sleep, REM sleep or waking state, and to determine the sleep quality based on a duration of the detected sleep”. This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 86 satisfies Step 1, namely the claim is directed to one of the four statutory classes, machine. Following Step 2A Prong one, any judicial exceptions are identified in the claims. In claim 86, the limitations "configured to normalize a current respiratory gas volume per breath as a percentage of a normal value of an inspiratory respiratory minute volume of a specific time in order to determine a normalized respiratory gas volume”, “configured to determine at least one sleep stage from the at least one temporarily stored normalized respiratory gas volume, the at least one detector unit being configured to determine a deviation of the normalized value from the normal value to filter the determined deviation with a low pass to reproduce the value smoothed in this manner as a respiratory disturbance index corresponding to the deviation, and to assign a current breath to a stage of sleep according to the determined value of the respiratory disturbance index or according to a stability level as a reciprocal value of the respiratory disturbance index”, and “configured to determine a sleep quality based on the at least one sleep stage determined by the at least one detector unit, the at least one integrator unit being configured to add up, at an end of a measuring period, times and proportions of the measuring period during which the respiratory disturbance index was in a range of deep sleep, light sleep, REM sleep or waking state, and to determine the sleep quality based on a duration of the detected sleep” are abstract ideas as they are directed to mental processes and mathematical calculations. In particular, it is noted that each of these abstract ideas demonstrates mathematical operations which may be performed in the human mind alone or with the aid of pen and paper. It is additionally noted that the use of various computer elements to perform these limitations, may be seen as invoking computers to perform an existing process which may otherwise be performed in the human mind. With the identification of an abstract idea, the next phase is to proceed Step 2A, Prong Two, wherewith additional elements and taken as a whole, evaluation occurs of whether the identified abstract idea is integrated into a practical application.
In Step 2A, Prong Two, the claim does not recite any additional elements or evidence that amounts to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements “a respiratory gas analyzer” and “at least one measuring unit which is configured to determine at least one respiratory gas parameter from the respiratory gas”, “at least one preprocessing unit which is configured to analyze the at least one respiratory gas parameter and to determine at least one respiratory gas signal”, “at least one buffer memory unit which is configured to at least temporarily store the normalized respiratory gas volume”, “at least one detector unit which is configured to determine at least one sleep stage from the at least one temporarily stored normalized respiratory gas volume”, and “at least one integrator unit which is configured to determine a sleep quality based on the at least one sleep stage determined by the at least one detector unit”. However, these components may be seen as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for a mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. The steps lead to the final limitation of “determin[ing] the sleep quality” such that the end result of use of the system is only the generic determined sleep quality which may be any generic output, or no output at all. As this determination is not defined as requiring any further action, such as a form of prophylaxis or treatment or an improvement to a computer or other technology, the claim limitations constitute mere generation of data, in this case the gathering of data relating to a respiratory gas signal, such that the claim does not integrate the judicial exception into any practical application. Additionally, the limitations relating to these additional elements amount to nothing more than an instruction to apply the abstract idea using a generic computer, which does not render an abstract idea eligible. The steps performed by the additional elements are, as claimed, capable of being performed in the human mind similar to the examples given in MPEP 2106.04(a)(2)(III)(A)-(C), wherein it is described that “a claim to ‘collecting information, analyzing it, and displaying certain results of the collection and analysis’ where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind” recites a mental process and that claims which merely use a computer as a tool to perform a mental process are not eligible when “there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper” such as “mental processes of parsing and comparing data” when the steps are recited at a high level of generality and a computer is used merely as a tool to perform the processes. Furthermore, even if the abstract idea itself is an improvement over the existing technology, per Genetic Technologies Limited v. Merial LLC (Fed Cir., 2016) the inventive concept of step 2 of the Alice/Mayo analysis cannot be supplied by the abstract idea. The inventive concept necessary at step two of the Mayo/Alice analysis cannot be furnished by the unpatentable abstract idea itself. That is, under the Mayo/Alice framework, a claim directed to a newly discovered abstract idea cannot rely on the novelty of that discovery for the inventive concept necessary for patent eligibility; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity.” Mayo, 132 S. Ct. at 1294; see also Myriad, 133 S. Ct. at 2117; Ariosa, 788 F.3d at 1379. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea. Under the broadest reasonable interpretation, the claim elements are recited with a high level of generality (as written, the claimed functions of determining at least one sleep stage and determining a sleep quality may be performed by a human with access to the well-understood respiratory gas analyzer in an undefined manner such as making a personal judgment) that there are no meaningful limitations to the abstract idea. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea.
In Step 2B, claim 86 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements “a respiratory gas analyzer” and “at least one measuring unit which is configured to determine at least one respiratory gas parameter from the respiratory gas”, “at least one preprocessing unit which is configured to analyze the at least one respiratory gas parameter and to determine at least one respiratory gas signal”, “at least one buffer memory unit which is configured to at least temporarily store the normalized respiratory gas volume”, “at least one detector unit which is configured to determine at least one sleep stage from the at least one temporarily stored normalized respiratory gas volume”, and “at least one integrator unit which is configured to determine a sleep quality based on the at least one sleep stage determined by the at least one detector unit”. These limitations constitute extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic respiratory gas analyzer including generic computing elements for processing and evaluating, which Garg (Indian J Anaesth) describes as well-understood, routine, or conventional in its description of a “respiratory gas analysis” as “an integral part of the modern anaesthesia workstations” well as “various techniques for analysis of flow, volumes, and concentration” (Abstract). The limitation of “a measuring unit” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic measuring unit for a respiratory gas parameter, which Garg (Indian J Anaesth) describes as well-understood, routine, or conventional in its description of a “various devices available for measurement of flow and volume may also give flow characteristics” (Devices for flow and volume measurement) as well as “various techniques for analysis of flow, volumes, and concentration” (Abstract). This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea. In addition, the buffer memory unit may be seen as routine and conventional per Wiedenman (U.S. Patent No. 4334287A) which states that a “buffer memories may be employed in a variety of arrangements” (Column 1, lines 11-12) while the detector unit may be a generic detector unit, which Henry (U.S. 20190294649 A1) describes as conventional in its description of a “conventional low-pass filters” (Paragraph 0150). A generic integrator unit is also described as conventional by Inoue (U.S. Patent No. 4459668 A) in its description of a “conventional time calculator” (Column 7, lines 26-27). As discussed above with respect to integration of the abstract idea into a practical application, the present elements amount to no more than mere indications to apply the exception.
In Summary, claim 86 recites abstract idea without being integrated into a practical application, and does not provide additional elements that would amount to significantly more. As such, taken as a whole, the claim and is ineligible under the 35 U.S.C. 101.
Claims 87-99 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. As each of these claims depends from claim 86, which was rejected under 35 U.S.C. 101 in paragraph 8 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 86, or comprise significantly more than the limitations of claim 86.
Besides the abstract idea of claim 86, dependent claims 87-98 recite further limitations of the additional elements which have been found to be extra-solution activity and the abstract ideas of claim 86 as identified above, as well as further elements which are additionally well-understood, routine, or conventional and constitute extra-solution activity as explained below where applicable. The limitations of these claims provide no practical application, nor do they provide meaningful limitations to the abstract idea.
Besides the abstract idea of claim 86, claim 90 recites the limitation “wherein the respiratory gas analyzer is configured to control a polygraph device or diagnostic device and/or a PAP (positive airway pressure) device/respirator based on the determined sleep stage and/or the determined sleep quality”. The claim element of claim 86 of a respiratory gas analyzer is recited with a high level of generality (as written, determining at least one sleep stage and determining a sleep quality may be done by a human in an undefined manner). The limitation of “a polygraph device or diagnostic device and/or a PAP (positive airway pressure) device/respirator” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and is thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic PAP device, which Brydon (U.S. Patent No. 6840907 B1) describes as conventional in its description of a “conventional CPAP treatment” (Column 25, lines 6) and “standard review procedure of the polygraph” (Column 25, line 61). This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Besides the abstract idea of claim 86, claim 91 recites the limitation “wherein the respiratory gas analyzer is configured to transmit the sleep stage and or the sleep quality and/or the stability level and/or a sleep quality index to an operating and information system or to a display of a ventilator, the operating and information system or the display of the ventilator being configured to represent the sleep stage and/or the stability level and or the sleep quality index.” The claim element of claim 86 of a respiratory gas analyzer is recited with a high level of generality (as written, determining at least one sleep stage and determining a sleep quality may be done by a human in an undefined manner, including manually inputting the index into a respirator operating system). The limitation of “an operating and information system or to a display of a ventilator” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic operating system or display, which Friberg (U.S. 20100269824 A1) describes as well-understood, routine, or conventional in its description of “the display available for the user interface and the input unit on the devices known so far are in most cases reduced to a screen display” (Paragraph 0004) such that displays which work with a user interface are well established in the art. This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Besides the abstract idea of claim 86, claim 92 recites the limitation “wherein the respiratory gas analyzer further comprises an interface which is configured to interact with a terminal to represent the sleep quality on the terminal.” The claim element of claim 86 of a respiratory gas analyzer is recited with a high level of generality (as written, determining at least one sleep stage and determining a sleep quality may be done by a human in an undefined manner, including manually inputting the index into a respirator operating system). The limitation of “an interface which is configured to interact with a terminal” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic interface and terminal to display something, which Friberg (U.S. 20100269824 A1) describes as well-understood, routine, or conventional in its description of “the display available for the user interface and the input unit on the devices known so far are in most cases reduced to a screen display” (Paragraph 0004) such that displays which work with a user interface are well established in the art. This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Besides the abstract idea of claim 86, claim 93 recites the limitation “wherein the at least one measuring unit comprises at least one pressure sensor and/or at least one flow sensor”. The claim limitation constitutes adding a generic measuring system which comprises a generic sensor for pressure or flow, which Garg (Indian J Anaesth) describes as well-understood, routine, or conventional in its description of a “various devices available for measurement of flow and volume may also give flow characteristics” (Devices for flow and volume measurement…pressure transducer measures rapidly and accurately…) as well as “various techniques for analysis of flow, volumes, and concentration” (Abstract). This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Besides the abstract idea of claim 86, claim 95 recites the limitation “A device for carrying out a polygraph and/or a polysomnograph, wherein the device comprises the respiratory gas analyzer of claim 86”. The claim element of claim 86 of a respiratory gas analyzer is recited with a high level of generality (as written, determining at least one sleep stage and determining a sleep quality may be done by a human in an undefined manner). The limitation of “a polygraph and/or a polysomnograph” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and is thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic diagnostic device, which Brydon (U.S. Patent No. 6840907 B1) describes as conventional in its description of a “standard review procedure of the polygraph” (Column 25, line 61). This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Besides the abstract idea of claim 86, claim 96 recites the limitation “A method for controlling the respiratory gas analyzer of claim 86, wherein the method comprises:(a) acquiring of at least one respiratory gas parameter of the respiratory gas from a measuring system by the respiratory gas analyzer or determining at least one respiratory gas parameter from the respiratory gas by the at least one measuring unit, (b) analyzing the at least one determined or provided respiratory gas parameter and determining at least one respiratory gas signal by the at least one preprocessing unit, wherein the at least one respiratory gas signal is a respiratory gas volume of a current breath, and a current respiratory gas volume per breath is normalized as a percentage of a normal value of an inspiratory respiratory minute volume of a specific time in order to determine a normalized respiratory gas volume; (c) temporarily storing the normalized respiratory gas volume in the at least one buffer memory unit; (d) determining at least one sleep stage from the at least one temporarily stored normalized value of (c) by the at least one detector unit, wherein a deviation of the normalized value from the normal value is determined, a determined deviation is filtered by a low pass, a value smoothed in this manner is reproduced as a respiratory disturbance index corresponding to the deviation, and a current breath is assigned to a sleep stage according to the determined value of the respiratory disturbance index or according to a stability level as a reciprocal value of the respiratory disturbance index; (e) determining by the at least one integrator unit a sleep quality based on the at least one sleep stage determined by the at least one detector unit, wherein times and proportions of a measuring period during which the respiratory disturbance index was in a range of deep sleep, light sleep, REM sleep, or waking state are added up at an of the measuring period, and the sleep quality is determined based on a duration of the detected sleep stage; (f) representing the sleep quality as a sleep quality index.”. The claim element of claim 86 of a respiratory gas analyzer is recited with a high level of generality (as written, determining at least one sleep stage and determining a sleep quality may be done by a human in an undefined manner). The limitation of “a measuring system” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic measuring system for a respiratory gas parameter, which Garg (Indian J Anaesth) describes as well-understood, routine, or conventional in its description of a “various devices available for measurement of flow and volume may also give flow characteristics” (Devices for flow and volume measurement) as well as “various techniques for analysis of flow, volumes, and concentration” (Abstract). This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Besides the abstract idea of claim 86, claim 97 recites the limitation “wherein the method further comprises interacting with a terminal via an interface of the respiratory gas analyzer in order to represent the sleep quality on the terminal.” The claim element of claim 86 of a respiratory gas analyzer is recited with a high level of generality (as written, determining at least one sleep stage and determining a sleep quality may be done by a human in an undefined manner, including manually inputting the index into a respirator operating system). The limitation of “interacting with a terminal via an interface” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic interface and terminal to display something, which Friberg (U.S. 20100269824 A1) describes as well-understood, routine, or conventional in its description of “the display available for the user interface and the input unit on the devices known so far are in most cases reduced to a screen display” (Paragraph 0004) such that displays which work with a user interface are well established in the art. This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Besides the abstract idea of claim 86, claim 98 recites the limitation “wherein the method further comprises controlling a polygraph or diagnostic device based on the determined stability level and/or the determined sleep stage and/or the determined sleep quality”. The claim element of claim 86 of a respiratory gas analyzer is recited with a high level of generality (as written, determining at least one sleep stage and determining a sleep quality may be done by a human in an undefined manner). The limitation of “a polygraph or diagnostic device” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and is thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic diagnostic device, which Brydon (U.S. Patent No. 6840907 B1) describes as conventional in its description of a “standard review procedure of the polygraph” (Column 25, line 61). This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Besides the abstract idea of claim 86, claim 99 recites the limitation “wherein the respiratory gas analyzer is connected to or integrated in a polygraph device or diagnostic device and/or a positive airway pressure (PAP) respirator and controls the polygraph device or diagnostic device and/or the positive airway pressure (PAP) respirator based on the sleep stage and/or the sleep quality determined by the respiratory gas analyzer”. The claim element of claim 86 of a respiratory gas analyzer is recited with a high level of generality (as written, determining at least one sleep stage and determining a sleep quality may be done by a human in an undefined manner). The limitation of “a polygraph device or diagnostic device and/or a positive airway pressure (PAP) respirator” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and is thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic PAP device, which Brydon (U.S. Patent No. 6840907 B1) describes as conventional in its description of a “conventional CPAP treatment” (Column 25, lines 6) and “standard review procedure of the polygraph” (Column 25, line 61). This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Response to Arguments
Applicant's arguments filed 24 February 2026 have been fully considered but they are not persuasive.
The applicant argues in page 9 of the response dated 24 February 2026 that the alleged abstract idea cannot be performed in the human mind aided by pencil and paper, specifically pointing to “determining a deviation of a normalized value from the normal value and filtering the determined deviation with a low pass” as “not a mental process”.
However, determining a deviation can clearly be performed in the human mind via visual observation of a signal while filtering may be performed with the aid of pen and paper by performing a mathematical transformation of the signal. The performance of these steps using a “detector unit” does not preclude the steps from being capable of being performed in the human mind.
The applicant additionally argues that each of the operations of claim 86 has been analyzed individually but that, taken as a whole, the operations of claim 86 amount to significantly more than an abstract idea, specifically the integration of the abstract idea into a practical application.
However, the additional elements of the claims are substantially the same elements as the now-canceled claims 61-71, 73-75, 78, and 81-85, which were rejected in the office action dated 06 October 2023 and upheld in the patent board decision of 26 August 2025 and canceled claims 41-60, which were rejected under 35 U.S.C. 101 and affirmed in the Patent Trial and Appeal Board decision dated 01 March 2023.
As noted in the examiner’s answer to appeal brief dated 06 May 2024, the specification and claim language alike define the elements of the claims at a high level of generality and only be the functions they perform (such as broadly the use in respiration or carrying out a polygraph); the claims do not recite any improvement to technology or the computer itself, or the use of a particular machine, or effect any transformation or reduction of a particular article to a different state or thing, or any elements that apply the abstract idea in a meaningful way beyond generally linking them to a particular technological environment.
Therefore, it is herein asserted that the claims’ additional elements, as presently recited, neither integrate the judicial exception into a practical application nor provide an inventive concept that would render the claims patent eligible.
The applicant additionally argues that each of claims 90 and 98 recites a practical application as the claims each include a limitation which controls a device based on the outcome of the abstract idea (e.g., the determined sleep stage, sleep quality, etc.).
The limitations of “controlling…” a device based on the determinations in claims 90, 98, and new claim 99 are not seen as integrating the abstract idea into a practical application. These dependent claims provide no direction as to how any of the devices are controlled and cannot be seen to provide a practical application as a result. Specifically, as there is no specific step or function being performed as a result of “controlling”, the limitations can be reasonably construed as encompassing controlling any function of such a device, including a simple output on a screen to display the result of the determination which may thus be considered insignificant extra-solution activity which fails to integrate the abstract idea into a practical application.
Applicant additionally states that regarding claims 87-89, “the instant Office action does not appear to contain any explanation as to why these claims are directed to an abstract idea without significantly more”.
However, as noted above and in the previous office action, dependent claims 87-98 (which includes dependent claims 87-89) recite further limitations of the additional elements which have been found to be extra-solution activity and the abstract ideas of claim 86 as identified above, as well as further elements which are additionally well-understood, routine, or conventional and constitute extra-solution activity as explained below where applicable. Furthermore, also as noted above and in the previous office action, the additional elements of the claims are substantially the same elements as the now-canceled claims 61-71, 73-75, 78, and 81-85, which were rejected in the office action dated 06 October 2023 and upheld in the patent board decision of 26 August 2025 and canceled claims 41-60, which were rejected under 35 U.S.C. 101 and affirmed in the Patent Trial and Appeal Board decision dated 01 March 2023.
Claims 86-99 are rejected under 35 U.S.C. 101.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA ROBERTS/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791