DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on August 6, 2025 were received and fully considered. No claims were amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4-10, 13, and 15-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 13 follows.
Regarding claim 13, the claim recites a method of measuring a blood pressure of a subject. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“…calculating a diastolic blood pressure value and a mean arterial blood pressure value of the subject from the pulse wave; estimating a systolic blood pressure value based on a ratio relating the diastolic blood pressure value, mean arterial blood pressure value, and the systolic blood pressure value, wherein the ratio is calculated based on a shape of the measured pulse wave, wherein the ratio is between a first difference and a second difference, the first difference being between the diastolic blood pressure value and the mean arterial blood pressure value, and the second difference being a difference between the systolic blood pressure value and the mean arterial blood pressure value…”
These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“measuring a pulse wave of the subject; causing a predetermined pressure to be applied to a predetermined portion of the subject during measurement of the pulse wave… wherein the applied predetermined pressure is equal to or greater than a venous pressure and less than the diastolic blood pressure value, and is applied by a blood pressure cuff, and controlling pressurization and depressurization operation of the blood pressure cuff, the pressurization including gradually increasing the predetermined pressure to the predetermined portion of the subject from a first state for cuff pressure, and the depressurization beginning after measurement of the diastolic and mean arterial blood pressure values.”
These additional limitations do not integrate the judicial exception into a practical application as they amount to extra-solution activity, e.g., steps necessary to obtain pulse wave data. See MPEP 2106.05g1.
The additional limitations also do not add significantly more to the identified judicial exception because they amount to conventional oscillometric blood pressure measurement techniques, i.e., utilizing a generically recited blood pressure cuff to pressurize and/or depressurize the cuff to obtain pulse wave data is widely known. Please also consider the following references, which further establish that the additional limitations are widely-understood, routine, and conventional:
2011/0054331 (applied in the current prior art section): see Fig. 2; par.18
2010/0274142: see par.58
2008/0235058: par.50, 53, 60
2007/0232938: par.33, 40
Independent claim 1 recites mirrored apparatus limitations and is also not patent eligible for substantially similar reasons.
Dependent claims 4-10 and 15-22 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1, 4-10, 13, and 15-22 are not patent eligible under 35 USC 101.
Response to Arguments
Applicant's arguments filed with respect to the 35 USC 101 rejections raised in the previous office action have been fully considered, but they are not persuasive. Examiner maintains the claimed invention recites a judicial exception (mathematical calculations and/or mental process) that is (1) not integrated into a practical application; and (2) the additional limitations do not recite significantly more. In the latest remarks, applicant appears to argue that the additional limitations2 integrate that claims into a practical application and/or recite significantly more. Examiner respectfully disagrees. As set forth in the previous and current office actions, applying a predetermined pressure to a subject (via conventional cuff, for example) and controlling pressurization and depressurization as set forth in the claims merely amounts to extra-solution activity (data gathering steps, see MPEP 2106.05g) and would not integrate the claims into a practical application (Step 2A of the 101 analysis). Moreover, Examiner maintains that applying pressure and controlling pressurization and depressurization as set forth in the claims is widely known, as evidence by prior art cited in current and previous office actions. As such, these additional limitations further fail to recite significantly more than the identified judicial exception (Step 2B of the 101 analysis). For at least these reasons, the 35 USC 101 rejections are hereby maintained. Please see corresponding rejection heading above for more detailed 101 analysis.
Applicant’s arguments filed with respect to the 35 USC 103 rejections raised in the previous office action were persuasive. Therefore, these rejections are withdrawn.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 MPEP 2106.05g: mere data gathering does not integrate the judicial exception into a practical application.
2 “measuring a pulse wave of the subject… causing a predetermined pressure to be applied to a predetermined portion of the subject during measurement of the pulse wave… controlling pressurization and depressurization operation of the blood pressure cuff, the pressurization including gradually increasing the predetermined pressure to the predetermined portion of the subject from a first state for cuff pressure, and the depressurization beginning after measurement of the diastolic and mean arterial blood pressure values… the applied predetermined pressure is equal to or greater than a venous pressure and less than the diastolic blood pressure value, and is applied by a blood pressure cuff…”