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 .
Election/Restrictions
Newly submitted claims 23-30 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claims 23+ and 11+ are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because it does not require the closing of the valve to be the cause of a reduced flow rate. The subcombination has separate utility such as allowing evaluation of capnography data.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 23-30 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 11-22 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 11 calls for reopening of the valve “to resume the HFOT”; no part of the claim calls for the HFOT to stop or pause, such that it is unclear how the HFOT can then later “resume”. The claimed reduced flow rate of breathing cases is explicitly recited as being delivered “during the HFOT”, such that this cannot be considered a ceasing of HFOT that could then allow the HFOT to later resume, and no other action that might affect the delivery of HFOT is recited in the claim. As such, it is entirely unclear how opening a valve could “resume the HFOT” when the HFOT has not been stopped in any manner. It is unclear if the period of reduced flow rate is considered to be separate from HFOT despite being defined taking place during HFOT, or if some other step has been omitted which would include a stop to delivery of HFOT that would then allow it to be later resumed, such that the scope of the claim is unclear when it is not readily apparent when HFOT is taking place and what steps are involved that adjust flow rates and what is considered to be part of HFOT, and whether additional steps have been omitted that might be necessary for properly performing the set of operations as presented.
Where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. See MPEP 2173.06. The claims cannot be further treated on the merits.
Claim 16 now calls for “causing an oxygen concentration level to be increased”; it remains unclear how this relates to any other part of the invention as no element is defined as having an oxygen concentration level. Is this part of the breathing gases that are delivered? Or is additional oxygen delivered as part of HFOT? Clarification is still required.
Claim 17 calls for delivering the breathing gases during the set duration at an oxygen concentration level “that is greater than an operational concentration level delivered during the HFOT”. As noted above, claim 11 explicitly defines that the “set duration” takes place “during the HFOT”, such that it is entirely unclear how the concentration can be both increased during the set duration taking place during HFOT but also remain at the operational level associated with HFOT. Clarification is required.
Claim 18 calls for adjustment of “the set duration or a flow rate during the set duration” during a subsequent valve closure; as defined in claim 11 “the set duration” comprises a valve closure. It is unclear how some subsequent valve closure that takes place after the valve closure of the set duration can affect aspects of the set duration that has already occurred. Clarification is required.
Claim 19 defines both “an operational flow rate during the HFOT” and “the flow rate during the set duration”; as noted above, the set duration takes place “during the HFOT” such that it is not possible for this to have two different defined flow rates both taking place during the HFOT. Clarification is required.
Claim 21 recites that “the valve is positioned at a coupling between a patient interface tubing and an inspiratory limb from the ventilator”. Per claim 11 the valve is “coupled to ventilation tubing”. It is unclear if one of the interface tubing and inspiratory limb is considered the “ventilation tubing” or if the “ventilation tubing” is also connected to the valve, such that it would be coupled to all three of the interface tubing, inspiratory limb, and ventilation tubing. Clarification is required.
Response to Arguments
Applicant's arguments filed 12 November 2025 have been fully considered but they are not persuasive.
Regarding the rejections under 112, Applicant asserts that the claims have been amended “as suggested in the Office Action”; as the Office Action did not suggest amending the claims to be even more indefinite than they were previously, this is untrue. The claims remain rejected above.
Regarding the art rejections, as a result of the amendments to the claims they are too indefinite in scope to allow examination on the merits; Applicant’s remarks regarding the art rejections have been noted but will not be further addressed until the scope of the claims has been resolved, if still applicable at that time.
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 KAREN E TOTH whose telephone number is (571)272-6824. The examiner can normally be reached Mon - Fri 9a-6p.
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/KAREN E TOTH/ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791