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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 31 Aug 2026, to include the amendment filed 15 Jun 2026, has been entered.
Claims 1-4, 6-7 and 9-15 are pending in the application with claim 8 canceled. Claims 1, 11 and 15 are currently amended. Applicant’s amendment to the Claims have overcome each and every objection previously set forth in the Final Office Action mailed 29 Dec 2025.
Claim Objections
Claim(s) 7 is/are objected to because of the following informalities:
Claim 7, Ln. 2 recites “a partial pressure of oxygen” which should read “the partial pressure of oxygen” following after claim 1
Appropriate correction is required.
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.
Claim(s) 1-4, 6-7 and 9-15 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Amended claim 1 recites “a carbon dioxide sensor configured to determine a partial pressure of carbon dioxide within the ventilation mask or the re-breathing bag” in Ln. 13-14. The originally filed application fails to discuss any consideration of carbon dioxide sensor 30 as being located where it would be able to “determine a partial pressure of carbon dioxide within the ventilation mask.” The disclosed carbon dioxide sensor 30 is only ever discussed as located to determine a partial pressure of carbon dioxide within the re-breathing bag 10 (e.g. Figs. 1-2 & 4-5a). Thus, the application as originally filed lacks sufficient written description support for the first part of the “or” clause of the present limitation.
Amended claim 1 further recites “the control system is configured to control the flow of oxygen through the first gas feed based on the altitude, the partial pressure of carbon dioxide, or the partial pressure of oxygen, in the ventilation mask or the re-breathing bag, or a combination thereof” in Ln. 15-18. The originally filed application fails to discuss any consideration of either oxygen sensor 28 or carbon dioxide sensor 30 as being located where it would be able to determine values “in the ventilation mask.” The disclosed oxygen sensor 28 and carbon dioxide sensor 30 are only ever discussed as located to determine a partial pressure of carbon dioxide within the re-breathing bag 10 (e.g. Figs. 1-2 & 4-5a). Similarly, altitude sensor 14 is only ever discussed as located to ventilation mask 41 (e.g. Figs. 1, 4a & 5a) and would not have been expected by one of ordinary skill in the art to be able to determine an altitude in the re-breathing bag. Based upon its various “or” clauses the present limitation defines claim scope beyond what applicant has reasonably disclosed in the originally filed application. Thus, the application as originally filed lacks sufficient written description support for the overall scope of combinations defined by the “or” clauses of the present limitation.
The same issues as discussed above in regard to claim 1 are also present in amended claim 15.
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.
Claim(s) 1-4, 6-7 and 9-14 is/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 recites the limitation "the partial pressure of oxygen" in Ln. 17. There is insufficient antecedent basis for this limitation in the claim. For the purposes of limitation will be interpreted as reading “a partial pressure of oxygen." Further, the limitation is indefinite because the claim has recited the functionality of the control system performing a control of the flow of oxygen potentially based on a partial pressure of oxygen without reciting any structure to determine a partial pressure of oxygen. The limitation is thus overly broad in attempting to recite a function of the apparatus without defining sufficient structure to perform the claimed function (see MPEP 2173.05(g)). For the purposes of examination the claim will be interpreted as including the oxygen sensor of claim 7, which is the disclosed structure suitable to determine a partial pressure of oxygen.
Allowable Subject Matter
Claim(s) 1-4, 6-7 and 9-14 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim 15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, it is initially noted that amended claim 1 draws upon limitations of former claim 8, which was indicated as allowable subject matter in the preceding Office action. However, amended claim 1 is broader in scope based upon its multiple use of “or” clauses in its amended portion.
The claim is understood to define the particular structures of a ventilation mask, a re-breathing bag in direct two-way fluid communication with the ventilation mask, an altitude sensor, a carbon dioxide sensor, and an oxygen sensor (based upon the 35 U.S.C. 112(b) rejection and interpretation of the claim). A control system of the apparatus then controls a flow of oxygen to the ventilation mask based upon a measured altitude, partial pressure or carbon dioxide or partial pressure of oxygen which must each be measured in either the ventilation mask or the re-breathing bag. The prior art is not found to teach or suggest the required combination of sensors in an apparatus where a re-breathing bag is in direct two-way fluid communication with the ventilation mask and then when control of oxygen delivery is specifically regulated based upon the claimed sensors.
Beyond the discussion of allowable subject matter in the preceding Office actions further note is made of the previously cited Studer et al. (WO Pub. 2020/016422 A1). Studer includes limited discussion on sensing a pressure of both carbon dioxide and oxygen (Pg. 72, Ln. 32 – Pg. 73, Ln. 4). Studer is not expressly clear on a locational placement of the sensors for carbon dioxide and oxygen. However, more importantly, Studer only had limited discussion of a bag for receiving exhaled gas (Pg. 47, Ln. 7-13; Pg. 54, Ln. 1-8; Pg. 71, Ln. 13-21 & Pg. 75, Ln. 12-15). Those passages are generally drawn to the embodiments shown in Figs. 15, 17 & 19-21. Notably, while exhaled gas has a path for exiting the mask in Figs. 19-21 exhaled gas is only returned to the mask after having traveled a path through the gas mixing device 3. Studer thus has no consideration of the presently claimed second gas feed which provides exhaled air directly back into the ventilation mask as a re-supply. One of ordinary skill in the art would not have considered it prima facie obvious to have modified Studer in order to provide exhaled gas directly back into the ventilation mask instead of first following its intended path through the gas mixing device without improper hindsight reasoning.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 15, the claim is found allowable over the prior art for the same general reasons discussed above in regard to claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
