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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5 May 2026 has been entered.
Response to Amendment
The rejection under 35 U.S.C. 103 has been withdrawn in light of the amendment to the claims filed on 5 May 2026.
The objection to the claims has been withdrawn in light of the amendment to the claims filed on 5 May 2026.
Claim Rejections - 35 USC § 112(a)
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 1-19 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.
In particular, Claim 1 now recites “based on one or more measurements of the processing step, determining the diaphragmatic pressure from a linear relation between either said propagation of said movement measured in step c), or said propagation speed of said movement measured in step c)”; however, the instant specification fails to show possession of the diaphragmatic pressure being determined based on a linear relationship because the instant specification does not describe “the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention” as laid out in MPEP § 2163.02. More specifically, the instant specification discloses linear relationship of transdiaphragmatic pressure (Pei) and not diaphragmatic pressure as claimed. The instant specification also makes a point to distinguish between transdiaphragmatic pressure and diaphragmatic pressure such that the diaphragmatic pressure is discloses as a functional parameter (see ¶ [0029, 0099, 0136, 0188]). No where in the instant specification is it disclosed that the functional parameter diaphragmatic pressure is determined based on a linear relationship of one or more of a linear relation between propagation of movement measured or propagation speed.
Furthermore, ¶ [0079] discloses that Pdi is determined based on:
“the determination of the transdiaphragmatic pressure is based on the variation of the propagation velocity of the shear wave. The linear relation between the transdiaphragmatic pressure and the propagation velocity of the shear wave, generated by the stimulation, may be used to determine the transdiaphragmatic pressure based on the sole value of the propagation velocity of the shear wave” (emphasis added).
Similarly, ¶ [0178-0180] discloses various linear relationships between Pdi and SMdi such as “mean Pdi swing and mean SMdi”, “Pdi swing and maximal SMdi”, and “max SMdi and Pdi swing.” However, the instant specification fails to disclose that the Pdi is determined based on a linear relationship of one or more of the measurements of step c). The instant specification only discloses a linear relationship between Pdi and propagation velocity of the shear wave or a species of SMdi.
Accordingly, the instant specification does not convey with reasonable clarity how one of ordinary skill in the art, as of the filing date sought, can show the inventor was in possession of “based on one or more measurements of the processing step, determining the diaphragmatic pressure from a linear relation between either said propagation of said movement measured in step c), or said propagation speed of said movement measured in step c).” Therefore, amended Claim 1 fails to meet the written description requirement of 35 U.S.C. 112(a).
Claims 16-17 recite similar limitations and are rejected under the same rationale as Claim 1. Dependent claims are rejected by virtue of their dependency to abovementioned claims.
Allowable Subject Matter
Claims 1-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a), set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The Office agrees that Chino alone or in combination with Goligher does not explicitly teach of a linear relationship between diaphragmatic pressure and one of propagation of movement or propagation speed of the diaphragm. More specifically, Chino teaches of measuring shear wave velocity of the diaphragm to determine inspiratory pressure, but does not teach or suggest of measuring diaphragmatic thickness of even relating said thickness to pressure. Goligher teaches of measuring thickness to determine transdiaphragmatic pressure but does not rely on any propagation/propagation speed.
Response to Arguments
Applicant’s arguments with respect to rejection under 35 U.S.C. 112(a) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Response to Arguments
Applicant's arguments regarding the rejection under 35 U.S.C. 112(a) have been fully considered but they are not persuasive. In particular, Applicant has failed to address the Office’s rationale behind said rejection. More specifically, the distinction between diaphragmatic pressure and transdiaphragmatic pressure. And the lack of explicit recitation linking diaphragmatic pressure to propagation and/or propagation speed of the diaphragm. Accordingly, the rejection is still maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571) 272-6402. The examiner can normally be reached M-F 9:00 am - 5:00 pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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