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
This office action is in response to amendment filed 04/13/2026. As directed by the amendment, claims 2-11 and 13-24 were canceled, claims 1, 12, and 25-26 were amended, and claims 27-42 were newly added. Thus, claims 1, 12, and 25-42 are presently pending in this application.
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 1, 12, and 25-42 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.
Regarding claim 1 lines 21-22 and claim 12 lines 22-23, the term “wherein the breath level trigger is configured to be more sensitive than the breath slope trigger” is unclear. Both the breath level trigger and breath slope trigger are used to detect breath (specification [0029]). In the specification, [0030] “The breath level trigger detects a breath when a threshold level of pressure (e.g., a threshold negative pressure) is reached upon inspiration.” Furthermore, in specification [0031] “a breath slope trigger detects breath when the slope of a pressure waveform indicates inspiration”. Thus, the breath level and breath slope triggers are doing essentially the same thing in differing ways, to provide more accurate breath detection (specification [0032]). The addition of the “sensitivity” language is unclear in both the claim and specification. The only mention of sensitivity regarding the breath level and breath slope triggers is in specification paragraphs [0033-0034], stating the breath sensitivity control is fixed, adjustable from a range of least to most sensitive, or programmable. The sensitivity of each trigger can be set to different relative levels. However, it is unclear how “sensitivity” is defined or measured within the context of breath level trigger with respect to breath slope trigger. As evidenced above, both the breath level and breath slope triggers are detecting breath, so how is one trigger more sensitive to detecting a breath than the other if the breath is occurring nonetheless? Is there a flow meter with different levels of sensitivity that the breath level and breath slope triggers are associated to trigger? Are their values of sensitivity associated with each trigger that show how one trigger could be more/less sensitive than the other? Thus, the specification fails to provide adequate written description as to how the invention functions.
Any remaining claims are rejected as being dependent upon a rejected base claim.
Response to Arguments
Applicant's arguments filed 04/13/2026 have been fully considered but they are not persuasive.
Applicant’s arguments, see pages 7-9 of the remarks, filed 04/13/2026, with respect to the rejection(s) of claim(s) 1, 3-6, 9-11, 23, and 25 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 USC 112(a) above.
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 GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
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/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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