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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 18 March 2026 has been entered.
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 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 18 March 2026 have been fully considered but they are not persuasive.
Regarding the rejections under 112, Applicant presents extensive discussion of what is disclosed in the specification or supposedly well known in the art, but makes no attempt to clarify the claims themselves.
Regarding measuring in a time series, the issue is not whether a time series exists, but how one could measure in a time series. It remains unclear if the intent is to measure some time series itself, measurement of a time series, or to perform some other measurement. Applicant’s definition of a time series fails to address the identified issue of measuring in a time series.
Similarly, regarding identification of cardiac cycles, the issue is not whether cardiac cycles exist but how they are identified in the method as claimed. The actual claimed method provides no instruction for identifying and using cardiac cycles; although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding the use of “a predetermined calibration parameter” as part of claim 1, Applicant agrees that “the claim does not dictate how the ‘predetermined parameter’ is determined”. However, in the absence of any indication of what this parameter might be or how it is determined, claim 1 as presented cannot be practiced. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding the use of a “compliance index”, Applicant states that determination of such “is outside the current scope of claim 1”. As claim 1 explicitly recites use of a compliance index, the complete absence of its determination or source thus renders the “current scope of claim 1” entirely indefinite. Examples of a compliance index found in other claims do not remedy the issue in claim 1 which must be definite on its own merits.
Regarding claim 2, again, the issue is not whether amplitudes of cycles can exist, but how this data or parameter is obtained and made available for use as part of the invention as claimed.
Regarding claim 3, Applicant asserts that it is “clear” that the dependence function is updated; it remains unclear what this dependence function is, and how the function is “updated”. The remainder of claim 3 is directed to finding a pulse pressure, where there is no defined relationship between the determined pulse pressure and any sort of dependence function. Applicant then returns to asserting that measuring “in a time series” is common, which it is not. Measurement of a time series is common, not measurement in a time series. Still further, no part of these remarks clarify what the dependence function is, how it relates to the determined pulse pressure, or how it is updated.
Regarding claim 5, Applicant states that the mean arterial blood pressure “can be determined over time before the methods described herein or during” and that it is “a well understood term”. Again, the issue is not in defining what a mean arterial blood pressure is but how it is involved in the method as claimed. In the absence of fully defining how to practice the method, its scope remains indefinite.
Applicant’s remarks regarding claim 6 do not address how that claim requires the applied pressures to be above the mean pressure while claim 5 calls for the applied pressure to be lower than the mean pressure.
Further, regarding the lack of antecedent basis for “the end of the increase of the back pressure”, Applicant points to “some implementations” of the method. This does not provide any antecedent basis for this reference to “the end of the increase of the back pressure”.
Regarding the reference to the compliance index, Applicant appears to assert that “the compliance index kmax” is the same as the compliance index k as defined in claim 1. If these are the same term they should be referred to as such. As claim 6 still refers to “the compliance index kmax”, not k, there is still no antecedent basis for this term as presented.
Regarding the order of operations in finding parameter B, Applicant asserts that there is no issue in presenting the determination of B as being steps further comprised within the method. As the method of claim 1 is an ordered set of operations and claim 6 calls for this set of operations to further comprise finding B, this requires these further steps to take place after the steps as defined in claim 1. If the intent is for this to take place at some other time within the method as already previously defined it should be clearly set forth as such. Merely asserting that a dependent claim inherently narrows an independent claim does not alter the actual language within the claims themselves. Applicant’s remarks appear to be based on intent, not what is actually recited.
Regarding claim 7, Applicant asserts that the claim is clearly directed to a second calibration procedure for determining B; this is not the issue. The actual language of the claim as presented calls for finding mean values of the time series using a formula for determining B. The claim does not call for finding these mean values using some other formula which uses an updated/different/determined B, but explicitly recites calculating mean values of the time series using the formula B=… Again, Applicant’s remarks reflect an apparent intent of the claims, not the actual language recited therein. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The claims remain rejected.
Conclusion
No art has been applied against the claims at this time; however, as all the claims are rejected under 112 they are not presently allowable and the question of prior art will be revisited if applicable once the scope has been resolved.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 KAREN E TOTH whose telephone number is (571)272-6824. The examiner can normally be reached Mon - Fri 9a-6p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at 571-272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAREN E TOTH/ Examiner, Art Unit 3791
Prosecution Insights