DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. According to the Amendment, filed 27 July 2026, the status of the claims is as follows:
Claims 1, 2, and 4-6 are as originally filed;
Claims 3 and 7-13 are previously presented;
Claims 15-18 are withdrawn; and
Claims 14 and 19 are cancelled.
Response to Arguments
3. Applicant’s arguments, see Remarks, pp. 7-9, filed 27 July 2026, with respect to the rejection of claims 1-7 and 11-13 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more, have been fully considered, but they are not persuasive.
Applicant contends, see Remarks, pp. 7-8, the following:
First, claim 1 is not directed to a mental process as alleged. Claim 1 instead recites language that requires dynamic, real-time physical interactions with a pneumatic system. Specifically, claim 1 recites "applying, with a fluid evacuation system, compression to a cuff on a limb of the patient" and "measuring a pressure of the cuff during the compression to obtain a pressure response curve". These steps require physical actuation of a fluid evacuation system to apply pressure to a cuff, and concurrent measurement of pressure changes of the cuff. This is a specialized technical process inextricably tied to the physical fluid evacuation system, which cannot practically be performed in the human mind.
However, respectfully, this argument is not persuasive. The steps of "applying, with a fluid evacuation system, compression to a cuff on a limb of the patient" and "measuring a pressure of the cuff during the compression to obtain a pressure response curve" are conventional and routine in the art (for example, see Ward et al., U.S. Patent Application publication No. 2004/0044290 A1, issued on 04 March 2004, para. [0045], [0047], and [0053], and figs. 1, 2, and 8A). Thus, these features add insignificant pre-solution activity to the abstract idea, i.e. the mental process of “analyzing the pressure response curve …” and “using information …” steps of base claim 1, that merely collects data to be used by the abstract idea.
Applicant contends, see Remarks, p. 8, the following:
Second, even if the claims were considered to recite an abstract idea, they are fully integrated into a practical application under Step 2A, Prong 2. MPEP § 2106.04(d) states that a claim integrates an abstract idea into a practical application if it "improves the functioning of a computer or improves another technology or technical field". Here, the Specification explicitly identifies the technical shortcomings of prior art vascular testing systems. For example, the Specification explains that "[t]he limb volume increase in diseased patients may be quite small.
The small signal renders the DC method prone to noise and affected by volume and pressure levels in the sensing cuff. As the increase is gradual it can be difficult to define a point at which the increase starts". Specification at Page 1, lines 18-21.
Claim 1 addresses this specific technological problem by actively inducing fluid flow and analyzing the resulting pressure response curve to identify an "incompressible region". The claim explicitly defines this region as "indicative of a bodily fluid having been substantially evacuated from at least a portion of the limb as a result of the compression". Utilizing this specifically identified region can promote "characteriz[ation] of the system at an empirical level and thereby overcomes measurement issues related to patient limb size, bladder volume, and elasticity of limb and bladder". Specification at Page 16, lines 14-17.
The physical compression is accordingly not mere "pre-solution activity"; it is a meaningful physical mechanism that actively induces the incompressible state required to execute the technological improvement. By using the incompressible region of the pressure response curve generated during this active compression, the system extracts a precise evaluation from a noisy environment, providing a clear, demonstrable improvement to the technology of non-invasive venous testing.
However, respectfully, this argument is not persuasive. As stated above, the steps of "applying, with a fluid evacuation system, compression to a cuff on a limb of the patient" and "measuring a pressure of the cuff during the compression to obtain a pressure response curve" add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the abstract idea. Based on broadest reasonable interpretation, the limitations “analyzing the pressure response curve RVR to identify an incompressible region, wherein the incompressible region is a portion of the pressure response curve RVR indicative of a bodily fluid having been substantially evacuated from at least a portion of the limb as a result of the compression” and “using information about the incompressible region of the pressure response curve RVR (i) to screen for one or more problems with the fluid system or (ii) to evaluate an efficacy of the fluid evacuation system in evacuating the bodily fluid from the limb of the patient” are directed to receiving data and performing a mathematical operation, which can be done mentally or using pen and paper. There are no steps using the result of the abstract idea for a practical purpose to solve a technical problem.
Applicant contends, see Remarks, pp. 8-9, the following:
Third, and finally, under Step 2B, the claims recite an ordered combination that is not well-understood, routine, or conventional. As the next section describes in further detail, the prior art does not teach the specific combination of steps recited in claim 1, including applying compression to a cuff on a limb of a patient with a fluid evacuation system, measuring a pressure of the cuff during the compression to obtain a pressure response curve, analyzing the pressure response curve to identify an incompressible region, and using information about the incompressible region of the pressure response curve (i) to screen for one or more problems with the fluid system or (ii) to evaluate an efficacy of the fluid evacuation system in evacuating the bodily fluid from the limb of the patient.
However, respectfully, this argument is not persuasive. Analyzing the limitations as an ordered combination, any improvement to technology or technical field is not yet realized as the analysis and use of information to screen for one or more problems or to evaluate an efficacy of the fluid evacuation system is not yet realized in the real world. There are no meaningful limitations that improves the functioning of a computer, is an improvement to any other technology or technical field, applies the abstract idea with or by use of, a particular machine, effect a transformation or reduction of a particular article to a different state or thing, add a specific limitation other than what is well-understood, routine, conventional activity in the field, add unconventional steps that confine the claim to a particular useful application, or other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment. See MPEP § 2106.05(I)(A). Thus, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
4. Applicant’s arguments, see Remarks, pp. 9-11, filed 27 July 2026, with respect to the rejection of claims 1-7 and 11-13 under 35 U.S.C. 102(a)(1) as being anticipated by Plichi, W.O. Patent No. 2020/260981 A1 (“Plichi”), have been fully considered, and are persuasive. Therefore, the rejection has been withdrawn.
Claim Rejections - 35 USC § 101
5. 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.
6. Claims 1-7 and 11-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more.
Step 1 of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.03):
Claims 1-6, 11, and 12 are directed to a “method”, which describes one of the four statutory categories of patentable subject matter, i.e. a process. Claim 13 is directed to a “[o]ne or more computer-readable storage media encoded with instructions”, which describes one of the four statutory categories of patentable subject matter, i.e. a machine.
Step 2A of the Revised Patent Subject Matter Eligibility Guidance (see MPEP 2106.04):
Claim(s) 1-7 and 11-13, recite the following mental process:
…
analyzing the pressure response curve to identify an incompressible region, wherein the incompressible region is a portion of the pressure response curve indicative of a bodily fluid having been substantially evacuated from at least a portion of the limb as a result of the compression; and
using information about the incompressible region of the pressure response curve (i) to screen for one or more problems with the fluid system or (ii) to evaluate an efficacy of the fluid evacuation system in evacuating the bodily fluid from the limb of the patient.
Based on broadest reasonable interpretation, these limitations are directed to receiving data and performing a mathematical operation, which can be done mentally or using pen and paper.
This abstract idea is not integrated into a practical application because the additional limitations of “applying, with a fluid evacuation system, compression to a cuff on a limb of the patient; measuring a pressure of the cuff during the compression to obtain a pressure response curve;” in claims 1 and 13, add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process.
The additional limitation “[o]ne or more computer-readable storage media encoded with instructions” in claim 13 is merely a part of a computer to be used as a tool to perform the mental process, and amounts to computer implementation of the abstract idea.
Step 2B of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.05):
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, when considered separately and in combination.
Analyzing the additional claim limitations individually, the additional limitations that are not directed to the mental process are “applying, with a fluid evacuation system, compression to a cuff on a limb of the patient; measuring a pressure of the cuff during the compression to obtain a pressure response curve;” in claims 1 and 13, and “wherein applying compression to the cuff comprises pumping a working fluid into the cuff at a constant rate, wherein the working fluid is compressed air, oxygen, or water” in claim 11. Such features are conventional and routine in the art (for example, see Ward et al., U.S. Patent Application Publication No. 2004/0044290 A1, issued on 04 March 2004, para. [0045], [0047], and [0053], and figs. 1, 2, and 8A), and add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the abstract idea.
The additional limitation “[o]ne or more computer-readable storage media encoded with instructions” in claim 13 is merely a part of a computer to be used as a tool to perform the mental process, and amounts to computer implementation of the abstract idea.
The additional limitations of dependent claims 2-7 and 12 are merely directed to and further narrow the scope of the mental process or further narrow the scope of the additional limitations that do not integrate the mental process into a practical application or are not significantly more than the mental process.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide computer implementation of the abstract idea using collected data without: improvement to the functioning of a computer or to any other technology or technical field; applying the mental process with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; applying or using the mental process in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment; or adding a specific limitation other than what is well-understood, routine, conventional activity in the field.
Allowable Subject Matter
7. Claims 1-13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office Action.
8. The following is a statement of reasons for the indication of allowable subject matter:
As to Claim 1, Plichi teaches the following:
A method for assessing a fluid system of a patient (see “A device for non-invasive venous-pressure sensing comprises an occlusive element (OC) configured to be applied to a proximal portion of a human limb in order to apply an occlusion pressure thereto, and a dilation-sensing element (VS) configured to be applied to a distal portion of a human limb in order to detect an extent of dilation thereof.” on Abstract, and see figs. 1-4), comprising:
applying, with a fluid evacuation system (“occlusion element”) OC, compression to a cuff (“pneumatic cuff”, not labeled) on a limb of the patient (see “In one or more embodiments, the occlusion element OC may comprise a (first) pneumatic cuff that can be positioned on the proximal stretch of the limb and can be controlled by the circuit 10 (for example, via a pressure control 104 co-operating with an occlusion- pressure sensor 106) for application of occlusion pressures P.sub.0c with increasing programmable values (for example, in the range of about 4 to 24 mmHg or 5 to 35 mmHg).” on p. 12, ll. 13-21);
measuring (“detection (measurement)” by a “occlusion-pressure sensor 106”) a pressure (“occlusion pressures P.sub.0c”) POC of the cuff during the compression to obtain a pressure response curve (“rapid volume response (RVR)”) RVR (see “To the signal-processing unit (CPU) 100 there may be associated (according to current criteria) a display unit 102 for presenting to a user - who may be the patient P himself - various signals inherent in operation of the system and in the results of the action of detection (measurement).” in p. 11, ll. 25-30; and see “It may in fact be noted that the effect of the venous pressures VP induced by the occlusion pressure Pocv in the case where the latter is higher than the venous pressure VP of the patient, expresses itself with a variation in volume (dilation) of the distal portion of limb, known also as rapid volume response (RVR) , determined uniquely by the venous dilation conterbalanced by the resistance of the surrounding tissues.” on p. 13, ll. 8-16);
…
As to Claims 1, neither Plichi nor the prior art of record teaches the method of base claim 1, including the following, in combination with all other limitations of the base claim:
analyzing the pressure response curve RVR to identify an incompressible region, wherein the incompressible region is a portion of the pressure response curve RVR indicative of a bodily fluid having been substantially evacuated from at least a portion of the limb as a result of the compression; and
using information about the incompressible region of the pressure response curve RVR (i) to screen for one or more problems with the fluid system or (ii) to evaluate an efficacy of the fluid evacuation system in evacuating the bodily fluid from the limb of the patient.
Conclusion
9. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 10/05/2026
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