DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11 December 2025 has been entered.
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.
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, 3, 4, 6-19 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 now calls for “determining an average of each of the oxygen measurements and the FiO2 measurements over the plurality of intervals of time”, but later calls for “determining, utilizing the signal processor, an oxygenation index and an oxygen saturation index for each of the plurality of intervals of time based upon the mean airway pressure measurements, the average oxygen measurements, and the average FiO2 measurements”. As the determined averages are found “over the plurality of intervals of time”, the claim calls for only finding a single average of each type of measurement, an average “over the plurality of intervals of time”. Further, the MAP is recited as being “measured for a plurality of intervals” but there is no indication of whether this mean value is a mean of measured values for each interval or the mean of the total plurality of intervals, particularly as there is no recited specificity of how long an “interval” might be when MAP is generally measured per respiratory cycle. As such, the determination of the oxygenation index and the oxygen saturation index “for each of the plurality of intervals” is unclear when the input parameters used for the determination of each of these indices is not found over a duration of an interval but over durations of pluralities of intervals. Clarification is required.
Claim 1 further calls for adjusting the flow of nitric oxide and/or the breathing gas to result in a particular oxygenation index “during subsequent intervals of time of the plurality of intervals of time”; as presented, there is no indication of when any calculations are performed, particularly not after one interval such that a subsequent interval could have different characteristics. Rather, the invention as claimed calls for performing all the determinations and calculations over the entire plurality of intervals, that is, after the plurality of intervals have concluded, such that this does not allow for traveling back in time to cause an intermediate interval within that plurality to experience any changes. The same is true of causing adjustments “if the oxygen saturation index is dropping between one interval of time and a subsequent interval of time”, which even if the indices could be determined on an interval basis, still would result in analysis of the plurality of indices over the plurality of intervals and then later adjusting parameters if there was a “drop” between any of the previous intervals, unless again time travel is involved. Clarification is required.
Further, it is unclear how an index could be “dropping” between two intervals – dropping involves an active change over time, whereas a comparison of two static values might show a difference or drop but not be “dropping”. Clarification is required.
The above issues are also found in claims 13 and 16.
Response to Arguments
Applicant's arguments filed 11 December 2025 have been fully considered but they are not persuasive.
Regarding the rejections under 112b, Applicant asserts that the claims are now directed to determination of an oxygenation index and an oxygen saturation index for each interval and thus all previous issues have been resolved; as noted above, the claims as presented do not permit this. The claims remain rejected.
Conclusion
No art has been applied against the claims at this time; however, as all the pending claims are rejected under 112 they are not presently allowable and the question of prior art will be revisited if applicable upon resolution of the other issues.
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/KAREN E TOTH/ Examiner, Art Unit 3791
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