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 .
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 1-7 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 1 now calls for “measuring, in time series, two volume curves by two volume sensors”. It is entirely unclear how one can measure in time series. Is the intent to measure over time? Or to generate a time series of measurements? Clarification is required.
Claim 1 still calls for determining an amplitude of the difference signal “between the two volume curves for each cardiac cycle”. How and when are cardiac cycles identified as being represented in the volume curves? Are these found based on features in the volume curves themselves? Or is additional physiological data showing cardiac cycles also obtained and synchronized with the volume curves? It remains entirely unclear how cardiac cycles are found and used in the invention as claimed. Further, it is unclear how a single amplitude value is found for an amplitude of a signal over a duration of a cardiac cycle or any other duration longer than a single measurement point. Is each ΔV a value over time? Or a single value? If a single value is this an amplitude of a max of the difference signal? Or an average of the difference signal? Clarification is still required.
Claim 1 still calls for calculating the atrial blood pressure using “a predetermined calibration parameter” from each amplitude of the difference signal and the back pressures. Is the predetermined parameter somehow derived from these values? or is the parameter an additional input to the calculation?
Further, these formulas still include a parameter defined as “a compliance index determined for each cardiac cycle” – where or how is this determined? What parameters are involved in determining this compliance index? Is this determination part of the method? Or is it determined independently and simply received as an input? Similarly, “B” is defined only as “a parameter determined by previous individual calibration” – calibration of what? Is this method considered a calibration? Or is there some other method of calibration involved that needs to be performed? These still require clarification.
Claim 2 still calls for use of ΔV1 and ΔV2 where each of these are amplitudes of each cycle – does the method include determining these amplitudes? if not, how is this data obtained?
Claim 3 still refers to “the dependence function” which is defined only in the preamble of claim 1, such that it is not clear if this is the same as the various formulas used to find arterial blood pressure or if this is some other function used to find some other pressure. Further, if “the dependence function” is not one of the formulas used to find arterial pressure in claim 1, what aspect of the invention as claimed is the dependence function? Regardless of which function is “the dependence function”, how is this function “updated”? Is there a change to the function itself, or merely an “update” of input parameters? Clarification is still required.
Claim 5 still requires the applied pressures to be “lower than a mean arterial blood pressure” – is this a measured parameter? Or an input value? Is this determined from the subject themselves or is this some population average? The source of this data is entirely undefined. Clarification is still required.
Claim 6 still calls for the applied pressure to be increased “above a mean arterial pressure while the difference of pressure applied by the two volume sensors is maintained”. It is unclear how this mean pressure is measured or determined. However, it does not appear possible for this to depend from claim 5 as this requires the applied pressures to be above the mean pressure while claim 5 calls for the pressure to be lower than the mean pressure. Clarification is required.
Claim 6 further refers to “the end of the increase of the back pressures”; there is no antecedent basis for this limitation in the claim. The claim does not define any conclusion to “increasing the back pressures applied by the two volume sensors”. Is this “end” an arbitrary point in time or some fixed value?
Claim 6 also still refers to “the compliance index kmax”; there is no antecedent basis for this limitation in the claim. It remains entirely unclear what this index might be or how it is obtained.
Further, claim 6 is defined as the method of claim 1 further comprising the various steps to determine the value of B; claim 1 already calls for use of parameter B, such that it does not appear to be possible to travel back in time after executing claim 1 to then execute the steps of claim 6 and then time travel back to claim 1 to use the determined value of B in claim 1. Clarification is required.
Claim 7 is ostensibly directed to determination of B, but still concludes by defining “calculating… the mean values of the time series of the parameters… by using the formula B=”. This is entirely unclear – is the calculating step directed to calculating the mean values or to determining the value of B? Further, are these calculated “time series” of each parameter the values for each cardiac cycle as defined in claim 1 or some other “time series” of each parameter? The claim further includes parameters which have not been clearly defined with subscripts that appear to represent that they are mean values? If so they should be defined as such. Still further, does the calculated “mean values of the time series of the parameters” refer to mean values of a single time series representing all of the parameters? Or mean values of each parameter over time? Clarification is still required.
Response to Arguments
Applicant's arguments filed 29 October 2025 have been fully considered but they are not persuasive.
Applicant’s remarks merely assert that all of the previous rejections have been overcome by the amendments to the claims; as noted above, this is entirely untrue as many of the previous rejections still have not been addressed, and the amendments have further added additional issues also noted above. The claims remain rejected.
Conclusion
No art has been applied against the claims at this time; however, 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 are not presently allowable and the question of prior art will be revisited upon resolution of the above issues.
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.
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/KAREN E TOTH/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791