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 .
DETAILED ACTION
Response to Amendment
In the Amendment dated 21 May 2026, the following occurred:
Claim 14 was canceled.
Claims 1-3, 5-13, and 15 are pending.
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.
Claims 1-3, 5-13, and 15 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.
Claims 1 and 15 (Claim 1 being representative) contain 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. This is a new matter rejection.
Claim 1 recites:
controlling the ventilation system to operate according to the one or more recommended values
The specification (including cited Para. 102, 119, 125, 129, and 132) is devoid of any description of the computer controlling the ventilator, evidencing that the Applicant did not have possession of the invention at the time of filing. In fact, at multiple locations the specification describes a person (clinician/end user) implementing the recommendations (Page 6, Line 35-37; Page 18, Line 5-6, 9-10).
By virtue of their dependence from Claim 1, this basis of rejection also applies to dependent Claims 2, 3, and 5-13.
Response to Arguments
Rejection under 35 U.S.C. § 112
Regarding the written description rejection of Claims 1-3, 5-13, and 15, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Applicant argues:
…even if the clinician does input or change a ventilator setting, the clinician is not actually controlling the ventilator to implement those settings—the computer is.
Regarding (a), the Examiner respectfully disagrees. If the clinician is inputting or changing a ventilator setting, they are using the computer as a tool to achieve the described result.
The specification does not have to say, in the exact terms, that “the ventilator applies computer control to set or update ventilation settings”—automatically or otherwise—to meet the § l12(a) disclosure obligations.
Regarding (b), the Examiner respectfully agrees. However, the rejection is not based on the absence of the exact recited terminology. The Specification must provide adequate written description support for the claimed limitation. The Specification does not demonstrate possession of a computer-controlled ventilation system. Accordingly, Applicant’s argument does not overcome the rejection.
The Office Action seems to read the claims as being limited only to automatic (closed-loop) control of the ventilator with no human interaction whatsoever… this is not warranted by the text of the claims, which recite a step of “control[ling] the ventilation system to operate according to the one or more recommended values”—automatically or after a clinician enters it.
Regarding (c), the Examiner respectfully disagrees. Interpreting that the ventilator is controlled automatically by the computer without human interaction is the distinction that allowed the claims to be considered subject matter eligible. The computer-controlled ventilation functionality is the technological application relied upon in the eligibility analysis, but the Specification must actually disclose that functionality to support the claim under § l12(a). Applicant’s argument further supports Examiner’s original assertion that the Specification does not describe a computer-controlled ventilation system, and instead relies on clinician intervention.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Palit et al. (U.S. 2017/0091789) which discloses systems and methods for calibrating user and consumer data.
Vasudevan et al. (U.S. 2021/0375437) which discloses systems and methods for discharge evaluation triage.
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 CAMRYN B LEWIS whose telephone number is (703)756-1807. The examiner can normally be reached Monday - Friday, 11:00 am - 8:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert W Morgan can be reached on 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAMRYN B LEWIS/
Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683
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