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 .
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
Claim 1, in line 22, recites “the initial phase;” when all other recitations of this recite “initial phase (AP)”. If the same initial phase it should be referred to consistently throughout the claims.
Claim 3 recites “an RMS determination area (RBF1, RBF2)”; it is unclear if this is actually determining two parameters, or if both are used as a single reference, or if this refers to two versions or options of performing the method. Clarification is required.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9, 11, and 12 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 1 defines “a controllable gas supply device” which comprises “a mobile application configured to run on a mobile device”. It is unclear how the gas supply device can comprise an application which is configured to run on some other unrelated device which has not been provided as part of the method. Further, this application is “for representing the hypoxic session index” – it is entirely unclear how the index is to be “represented”, whether this is actually a presentation rather than a representation, or if the index is represented by some other value or parameter? Clarification is required.
Claim 1 also refers to “the hypoxic session index of the response of the patient to a hypoxic training”; all other references to a hypoxic session index include its abbreviation, such that this should also recite “the hypoxic session index (HSI)”. Further, there is no antecedent basis for this particular phrase, as the preamble defines “a hypoxic session index (HSI) as a measure of the response of a patient to hypoxic training”, and it should be referred to as such.
Further, claim 1 concludes by calling for “using the hypoxic session index (HSI) to control hypoxic training for the patient”; it is unclear how this relates to any other part of the method as no part of the method has been defined as being considered “hypoxic training”, or if this is merely an intended use of the index that could then be used as part of some other method? At best, the method includes providing a device that measured a response to hypoxic training, and providing an application for representing the index which measures the response to hypoxic training, but it is not clear which of the recited method steps, if any are considered “hypoxic training” that could then theoretically be adjusted in some further iteration even though the claim also does not call for more than one iteration such that it is not possible to perform an adjustment in the invention as presented even if the various method steps I-VI were considered training as the method only calls for them to take place one time. Further, several of the recited adjustments do not reflect the method as recited in steps I-VI, which do not include use of a target value or any repetitions of any phase, such that, again, even if these steps were considered “hypoxic training” they could not be adjusted via the recited parameter adjustments. Clarification is required.
Claim 2 recites “an HCS reference value”; the terms which HCS stands for have been removed from earlier in the claim such that as presented it is unclear what an HCS reference value might be. Correction is required.
Claim 3 recites “an RMS safety time”; the terms which RMS stands for have been removed from earlier in the claim such that as presented it is unclear what an RMS safety time might be. Correction is required.
Claim 5 recites “a DS reference time”; the terms which DS stands for have been removed from earlier in the claim such that as presented it is unclear what DS reference time might be. Correction is required.
Claim 6 recites “an RI reference time”; the terms which RI stands for have been removed from earlier in the claim such that as presented it is unclear what an RI reference time might be. Correction is required.
Claim 7 still calls for determining a score “by averaging” without defining what is being averaged. As multiple parameters are recited in the claim it is entirely unclear which is to be averaged.
Claim 9 still calls for setting a boundary line “wherein the lower boundary line in the hypoxic phase (HP) shows smaller values of the index KG than the reference curve (48), and the upper boundary line shows greater values of the index (KG) than the reference curve” – as the index is a measured/determined parameter, its values cannot be predetermined such that it is unclear how the boundary line could be defined to guarantee these relative relationships. It appears the intent is for the boundary lines to show when the index is above or below the reference curve by virtue of the boundary lines themselves having higher or lower values/amplitude relative to the reference curve, not the boundary lines being the index itself, but it has not been defined as such. Clarification is still required.
Claim 9 further still recites that “the boundary lines are determined from measurements in one or more subjects” – claim 1 is directed to measuring/determining values a patient, and also calls for use of a reference person/persons. Are these additional “subjects” the same as the reference person(s) or are these additional people who have been monitored? Clarification is still required.
Claim 9 further still recites “wherein only values of the index (KG) are considered for determining the hypoxic session index (HSI), which values are smaller than the value of the index (KG) in the upper boundary line and greater than the value of the index (KG) in the lower boundary line at the time of measurement of the respective value of the index (KG).” As presented, “wherein only values of the index (KG) are considered for determining the hypoxic session index (HSI)” is a complete and independent clause; the recitation of “which values are smaller… and greater…” calls for performing a determination of such. It appears that the intent may be to define that only the values which are greater or smaller are “considered”, and for the purposes of examination will be treated as such. However, it is unclear what “considered” is – included in the actual determination, or evaluated for possible inclusion? Clarification is required.
Claim 11 recites “the pulse curve”; there is insufficient antecedent basis for this limitation in the claim. It is unclear what “the pulse curve” might be; as the claim calls for plotting various values, it appears this may be considered a pulse curve? If so it should be clearly identified as such. Clarification is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-9, 11, and 12 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “determining the index (KG) from the measured oxygen saturation, and determining a mean value of the index (KG) in the initial phase”, “determining the index (KG) over time during the hypoxic phase”, “determining the index (KG) over time during the reoxygenation phase”, “plotting by the controller the index (KG) against time”, “determining the hypoxic session index”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. The final clause of the claim recites “using the hypoxic session index (HSI) to control hypoxic training for the patient”, but does not recite any particulars of how this is achieved, or how any adjustments are directly tied to any HSI result, or even what this training is or how it relates to the remainder of the claimed invention. See Example 43 of the Office’s 101 guidance for discussion of providing a particular treatment or prophylaxis. Further, the use of a controller for performing some, but not all, of the steps of the abstract idea is no more than the recitation of a generic computing device which provides a general link to a technological environment for execution of the abstract idea itself.
As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are a gas supply device comprising a mask for supplying gas, a finger clip with sensor for measuring oxygen saturation, some application, and a controller. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. Further, the use of conventional components to deliver a gas and make measurements tied to the delivery of that gas is no more than insignificant extrasolution data gathering, See MPEP 2106.05(d), where determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional. Similarly, generation of a result which can “optionally” be displayed is no more than the insignificant postsolution activity of outputting a result (see MPEP 2106.05 - Presenting data, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93 - another type of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity). The step of “control hypoxic training” appears to be wholly disembodied, such that it does not include the use of any additional elements that might provide something significantly more. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 2-9, 11, and 12 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited. Each of the dependent claims also recites analyzing obtained data as part of the abstract idea itself. Thus, claim(s) 1-9, 11, and 12 is/are rejected under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed 13 January 2026 have been fully considered but they are not persuasive.
Regarding the rejections under 112, the Examiner notes that several of the rejections presented in the previous Office Action were not resolved by Applicant’s amendments, contrary to the assertion in the remarks. As Applicant merely asserted that all issues were resolved, these rejections, and the numerous other rejections caused by these amendments, have been presented above.
Regarding the rejections under 101, Applicant first asserts that the invention as claimed is implemented using “a specific hypoxic training system” which “importantly” uses the determined HSI to control hypoxic training; as discussed above, these conventional components used for data gathering do not provide a practical application of the identified abstract idea. Further, the method does not provide any particular recitation of use of the determined index to provide a specific or particular treatment or prophylaxis, as the recited “control” is not identified with any particular specificity nor is it clear what is even being controlled as no part of the method is recited as comprising hypoxic training.
As noted above, the Office’s 101 guidance example 43 addressed providing a particular treatment or prophylaxis in response to a determined parameter; no part of the invention as claimed identifies what takes place in response to any particular determined index, nor is it clear what is being controlled or what is considered training that could be controlled, such that the assertion that this provides a practical application is entirely unpersuasive.
Applicant asserts that the determined index is required to “be used to actively control the operation of a hypoxic gas delivery system”; this has not been recited, only that the determine index is used “to control hypoxic training” with no including of a particular system, nor is it clear if “a hypoxic gas delivery system” is the recited “controllable gas supply device” or if this refers to some other system, such that this argument is moot.
Applicant’s arguments conclude with the assertion that “the claimed controller and sensor operate in a specific technological context and in cooperation with a hypoxic gas delivery system to achieve a concrete therapeutic result”; it is entirely unclear what part of the invention as claimed might be considered a “therapeutic result”, nor is there any particular interaction between controller and sensors beyond sending data from the sensor to the controller, where transfer of data cannot be considered a therapeutic result, and the delivery of gas is performed entirely for obtaining data, also not a therapeutic result, nor is there any particular control of the delivery of gas that might be intended to achieve any sort of therapeutic result, such that this assertion is also unpersuasive.
The claims remain rejected.
Conclusion
No art has been applied against the claims at this time; however, as all claims are rejected under 112 and 101 they are not presently allowable and the question of prior art will be revisited if applicable upon resolution of the other issues.
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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/KAREN E TOTH/ Examiner, Art Unit 3791