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 Preliminary Amendment, filed 05 October 2023, the status of the claims is as follows:
Claims 3 and 7-13 are currently amended;
Claims 1, 2, 4-6, and 15-18 are as originally filed; and
Claims 14 and 19 are cancelled.
Election/Restrictions
3. Applicant’s election without traverse of Group I, claims 1-13, in the reply filed on 23 January 2026 is acknowledged.
Claims 15-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 101
4. 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.
5. 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.
Claim Rejections - 35 USC § 102
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
7. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
8. Claims 1-7 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Plichi, W.O. Patent No. 2020/260981 A1 (“Plichi”).
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);
analyzing the pressure response curve RVR to identify an incompressible region (“the condition of the pressure P.sub.0c being higher than the venous pressure VP of the patient”), 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 (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; and see “It has likewise been noted that for an RVR to appear that can be used for reliable sensing of the venous pressure VP, in addition to the condition of the pressure P.sub.0c being higher than the venous pressure VP of the patient, it is advantageous to maintain the pressure P.sub.0c for a certain time interval TP.sub.0c in order to enable stabilization of the RVR.” in p. 13, ll. 17-23); 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 (see “It has likewise been noted that for an RVR to appear that can be used for reliable sensing of the venous pressure VP, in addition to the condition of the pressure P.sub.0c being higher than the venous pressure VP of the patient, it is advantageous to maintain the pressure P.sub.0c for a certain time interval TP.sub.0c in order to enable stabilization of the RVR.” on p. 13, ll. 17-23).
As to Claim 2, Plichi teaches the following:
wherein the limb is a leg of the patient, the cuff is disposed on a calf of the leg when the compression is applied, and the at least the portion of the limb comprises the calf (see “As has already been said, reference, for simplicity of illustration, to an upper limb (arm) is not to be understood as in any way limiting the embodiment: one or more embodiments may in fact be applied to different areas of the body, for example to a lower limb (leg).” on p. 10, ll. 24-29).
As to Claim 3, Plichi teaches the following:
wherein analyzing the pressure response curve RVR to identify the incompressible region comprises identifying an inflection point in the pressure response curve RVR that marks a transition from a compressible region of the pressure response curve RVR to the incompressible region (see “… if, instead, no drop is detected in the pressure signal P.sub.Scv i.e., P.sub.Sc < ThresholdMin, then the outcome is negative ("OFF response", i.e., no reduction is detected in the degree of dilation of the distal stretch of the limb) , the device will indicate - once again, for example, via the unit 102 - that the venous pressure VP is higher than the occlusion pressure P.sub.0c applied and, automatically or after prior consent, the test will be repeated with a subsequent value of XX mmHg of the pressure P.sub.0cv higher or lower than the value of X mmHg programmed by the system.” on p. 17, ll. 25-35).
As to Claim 4, Plichi teaches the following:
wherein the compression is applied to the cuff in a compression cycle, wherein the inflection point corresponds to a point in the compression cycle in which a predetermined amount of bodily fluid has been evacuated from the at least the portion of the limb (see “- if the occlusion pressure P.sub.0c is higher than the venous pressure VP, a signal generated by the sensor VS will be noted, which indicates the fact that the veins downstream of the occlusion element OC have increased in volume owing to occlusion of the return flow and that, by removing the pressure P.sub.0cv the return venous flow has been restored, with a consequent reduction in volume of the aforesaid veins, with a (rapid) reduction in volume that brings the signal of the sensor VS back to zero (or to a reference level);” on p. 19, ll. 26-35).
As to Claim 5, Plichi teaches the following:
screening for an obstruction in the fluid system based on a pressure value at the inflection point (see “In a device as exemplified herein, the control circuit may be configured for detecting (for example, 208) in said sensing signal (for example, pressure sensing signal or plethysmographic sensing signal) a variation of an amount greater than a variation threshold (for example, a drop in pressure of an amount greater than a certain pressure-drop threshold), and issuing said signal (for example, 102, 210) indicating a venous pressure in said human limb that is lower than said at least one sub-diastolic occlusion pressure (VP < P.sub.oc) as a result of detection, in said sensing signal, of a variation of an amount greater than said variation threshold.” on p. 28, ll. 3-15).
As to Claim 6, Plichi teaches the following:
fitting a line to the incompressible region of the pressure response curve; and determining, using the line, an amount of bodily fluid evacuated from the at least the portion of the limb during the compression (see “- if the occlusion pressure P.sub.0c is higher than the venous pressure VP, a signal generated by the sensor VS will be noted, which indicates the fact that the veins downstream of the occlusion element OC have increased in volume owing to occlusion of the return flow and that, by removing the pressure P.sub.0cv the return venous flow has been restored, with a consequent reduction in volume of the aforesaid veins, with a (rapid) reduction in volume that brings the signal of the sensor VS back to zero (or to a reference level);” on p. 19, ll. 26-35).
As to Claim 7, Plichi teaches the following:
screening for an obstruction in the fluid system based on an absence in the pressure response curve of an inflection point between a compressible region of the pressure response curve and an incompressible region of the pressure response curve (see “A device according to one or more embodiments may consequently, envisage verifying whether there occurs a drop in the pressure signal P.sub.Sc (i.e., a reduction having a value greater than a programmable threshold, e.g., 0 . 1 mmHg) , which expresses a reduction in the RVR following upon release of the occlusion and consequently the fact that the venous pressure VP of the patient is lower than the occlusion pressure value Poc applied.” on p. 15, ll. 24-30).
As to Claim 11, Plichi teaches the following:
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 (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).
As to Claim 12, Plichi teaches the following:
wherein the fluid system is a venous system and the fluid is blood, the fluid system is an arterial system and the fluid is blood (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), or the fluid system is a lymphatic system and the fluid is lymph.
As to Claim 13, Plichi teaches the following:
One or more computer-readable storage media encoded with instructions that, when executed by one or more computers (“signal-processing unit (CPU)”) 100, cause the one or more computers to 10 perform operations (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; see “As exemplified in Figures 2 and 3, in one or more embodiments, the signal-processing circuit 10 may comprise a signal-processing unit (CPU) 100 capable of co-ordinating the operation of the other components of the system, for example according to the flowchart of Figure 5.” in p. 11, ll. 19-24; 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);
analyzing the pressure response curve RVR to identify an incompressible region (“the condition of the pressure P.sub.0c being higher than the venous pressure VP of the patient”), 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 (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; and see “It has likewise been noted that for an RVR to appear that can be used for reliable sensing of the venous pressure VP, in addition to the condition of the pressure P.sub.0c being higher than the venous pressure VP of the patient, it is advantageous to maintain the pressure P.sub.0c for a certain time interval TP.sub.0c in order to enable stabilization of the RVR.” in p. 13, ll. 17-23); 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 (see “It has likewise been noted that for an RVR to appear that can be used for reliable sensing of the venous pressure VP, in addition to the condition of the pressure P.sub.0c being higher than the venous pressure VP of the patient, it is advantageous to maintain the pressure P.sub.0c for a certain time interval TP.sub.0c in order to enable stabilization of the RVR.” on p. 13, ll. 17-23).
Allowable Subject Matter
9. Claims 8-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
10. The following is a statement of reasons for the indication of allowable subject matter:
As to Claim 8, 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:
… wherein the compression is applied to the cuff in a first compression-decompression cycle, and the method comprises:
applying compression to the cuff in a second compression-decompression cycle following the first compression-decompression cycle;
determining a slope of a second incompressible region in the pressure response curve, wherein the second incompressible region occurs during compression in the second compression-decompression cycle;
determining a slope of a pre-evacuation region in the pressure response curve, wherein the pre-evacuation region precedes the second incompressible region during compression in the second compression-decompression cycle;
comparing the slope of the pre-evacuation region to the slope of the second incompressible region; and
assessing vessel insufficiency based on a result of comparing the slope of the pre-evacuation region to the slope of the second incompressible region.
As to Claim 9, 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:
applying decompression to the cuff following the compression, including:
decompressing the cuff in a first phase from a peak pressure to a first reduced pressure that is less than a defined amount of column height pressure;
pausing, for a first paused interval, the decompression after the first phase upon reaching the first reduced pressure;
decompressing the cuff in a second phase from the first reduced pressure to a second reduced pressure that is below the column height pressure;
pausing, for second paused interval, the decompression after the second phase upon reaching the second reduced pressure;
decompressing the cuff in a third phase from the second reduced pressure to a third reduced pressure;
measuring the pressure of the cuff during the decompression, including during the first phase, the second phase, and the third phase, and augmenting the pressure response curve with a pressure response measured during the decompression; and
assessing vessel insufficiency based on characteristics of the pressure response curve during at least one of the first paused interval or the second paused interval.
As to Claim 10, 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:
… wherein the compression is applied to the cuff in a first compression-decompression cycle, and the method comprises:
applying compression to the cuff in a second compression-decompression cycle following the first compression-decompression cycle, wherein the compression in the second compression-decompression cycle is initiated before the bodily fluid substantially refills in the limb;
measuring the pressure of the cuff during the compression in the second compression- decompression cycle, and augmenting the pressure response curve with a pressure response measured during the compression in the second compression-decompression cycle; and
assessing ejection function of a heart of the patient based on at least one characteristic of the pressure response measured during the compression in the second compression- decompression cycle.
Conclusion
11. 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 03/16/2026