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 .
Status of Claims
Claims 13-26 are pending and examined on the merits.
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0016] of the disclosure (see US Publication 2026/0097196), the formula states “ΔT = E + K.(Factual – Fref)” where the dot that likely represents multiplication is positioned as a period. Examiner recommends simply replacing said dot with a space between K and the open parenthesis.
Appropriate correction is required.
Claim Objections
Claims 13 & 15 are objected to because of the following informalities:
Re Claim 13, the claim recites “configured to determine a time offset ΔT between the instant TR at which the QRS complex of the ECG signal is detected and the instant at which an ejection phase is initiated” (emphasis added), but it seems like TR is more specifically “the instant when the R-wave of the QRS complex is detected” (as stated in Claim 15). Examiner recommends better defining TR in Claim 13, i.e., that TR corresponds to the instant when the R-wave of the QRS complex of the ECG signal is detected.
Additionally in Claim 13, the formula states “ΔT = E + K.(Factual – Fref)” where the dot that likely represents multiplication is positioned as a period. Examiner recommends simply replacing said dot with a space between K and the open parenthesis.
Re Claim 15, since the variable TR was already mentioned in Claim 13, it would not be necessary to redefine what the variable represents, especially when that new definition appears to differ from that in the claim from which Claim 15 depends.
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.
Claims 13-26 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 13 recites a formula “ΔT = E + K.(Factual – Fref)” where E is a time value and K is a coefficient greater than zero, but it is not disclosed what these variables mean and how these variables come about. Even though the Specification provides some desirable values for each of E and K, e.g., E being between 0.22 and 0.27 seconds ([0064] of current disclosure), but it is also disclosed that the value can be variable without ever discussing how it is varied. In other words, Applicant is varying the value of E using some undisclosed method and subsequently one skilled in the art would not be able to know how to arrive at the necessary E value. For example, one skilled in the art would not know if an E value of 0.5 seconds would be contemplated by the current invention or ever be feasible.
Similarly, the value of the coefficient K is variable that appears to be randomly selected rather than being based on and/or adjustable but does not give guidance as to how the value can change. Looking at [0063] of the current disclosure, it is stated that “the value of K is variable and/or adjustable for example according to the variation of the rate Factual and/or according to the evolution of the venous pressure and/or the aortic pressure” but provides no disclosure as to how it is according to those other values.
Claims 14-26 depend from Claim 13 and each claim individually does not resolve the lack of enablement issue for both E and K values.
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 13-26 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.
Specifically, as explained above, Claim 13 recites a formula “ΔT = E + K.(Factual – Fref)” where E is a time value and K is a coefficient greater than zero, but it is not disclosed what these variables mean and how these variables come about. There are no upper bounds to the values of E and K, and without more information on how they are related to e.g., physiology of a patient, one skilled in the art cannot figure out what may be considered reasonable values for E and K. Therefore one skilled in the art would not be able to determine the metes and bounds of the claimed invention.
Claims 14-26 are rejected at least for being dependent from Claim 13 and thus incorporating said indefinite subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Inamori et al. (US 2008/0249456) discloses a extracorporeal blood circuit that calculates a time delay that is based on detecting the R wave.
Harjes et al. (US 2024/0207600) discloses an implantable blood pump that is varied based on an activity level of the patient based on the ECG of the patient. The rotational speed of the pump varies to generate a blood pressure pulse that is synchronized with the cardiac cycle of the patient.
Wieskotten et al. (WO 2024/126626, non-prior art) discloses a extracorporeal circuit that determines a delay time based on systole beginning.
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/SUSAN S SU/Primary Examiner, Art Unit 3781 29 September 2026
