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 .
In light of the amendments to the claims filed 09/16/2025 in which claims 1-6 and 14-22 were cancelled and claims 23-40 were added, claims 23-40 are pending in the instant application and are examined on the merits herein.
Priority
The instant application claims priority to U.S. Provisional App. 63/143,230 filed on 01/29/2021 and 63/069,224 filed on 08/24/2020.
Claims 23-40 receive priority to the prior-filed application, filed on 08/24/2020.
Response to Arguments
Objections to the Drawings
The objections to the drawings are withdrawn in view of the replacement drawings filed 09/16/2025.
Objections to the Specification
The objections to the specification are withdrawn in view of the amendments to the specification filed 09/16/2025.
Objections to the Claims
The objections to the claims are withdrawn in view of the amendments to the claims filed 09/16/2025.
Rejections of the Claims under 35 U.S.C. 101
The rejections of the claims under 35 U.S.C. 101 are withdrawn in view of the amendments to the claims filed 09/16/2025.
Rejections of the Claims under 35 U.S.C. 102
Applicant's arguments filed 09/16/2025 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding the newly added claims, the applicant argues that the prior art fails to disclose the newly added limitations.
In response to the applicant’s argument, the examiner respectfully notes that the references used in the rejection below were not used in the previous Office Action filed 04/17/2025 to read on the limitations at issue and that the claim amendments have necessitated new grounds of rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 26-29 and 30-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 26 (which claims 27-29 are dependent upon) and 33 (which claims 31-39 are dependent upon) require the apparatus of the instant claims to comprise computer-accessible storage that comprises a data array that may be created through the population of values determined in use of the apparatus. The applicant’s specification (pg. 6 ln. 24-28 and 7 ln. 1-2) discloses a data set that is a matrix of measured values against aspiration setpoints for any fluid in the catheter. Further, the applicant’s specification (Fig. 4B-4C; pg. 25, and pg. 26 ln. 1-5) discloses sub-ranging of data by fluid characteristics. This disclosure very generally refers to storage whereas “the variable data are retained for any purpose” (pg. 25 ln. 16-18) and “standard deviation and range are also calculated and stored” (pg. 26 ln. 4-5). This disclosure while related to a data set comprising fluid characteristics (water, half and half, 5W20 motor oil, and SAE 30 motor oil), pump speeds, and pressure values does not disclose that this data set is in controller-accessible storage or how this data set is created which the claims are directed to.
Claims 27-28 and 34-35 are also directed to the creation of a data array. As explained above, this is not disclosed in the applicant’s specification.
Claims 29 and 36 are directed to a keypad display which may prompt a user to input a fluid characteristic to the data array. The applicant’s specification (pg. 27 ln. 7-9) discloses a keypad display that allows for user input and read-out of data, but does not disclose the prompting of a fluid characteristic to a user.
Claims 37-39 are directed to sorting of a created data array. As explained above, this is not disclosed in the applicant’s specification.
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 27-28, 33, and 35-36 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 27 recites the limitation “is configured to operate the CSDP at a first setpoint” in ln. 3. This limitation is indefinite in that it is unclear whether the first setpoint is the same as that claimed in claim 25, which claim 27 is dependent upon. For the sake of compact prosecution, the examiner is treating the claim as though it reads “at the first setpoint”.
Claim 28 recites the limitations “a first pressure measurement” and “a second pressure measurement” in ln. 3 and 6 respectively. This limitation is indefinite in that it is unclear whether the first and second pressure measurements are the same as those claimed in claim 23, which claim 28 is dependent upon. For the sake of compact prosecution, the examiner is treating them as though they are different from claim 23.
Claim 33 recites the limitations “a first pressure measurement” and “a second pressure measurement” in ln. 8 and 12 respectively. This limitation is indefinite in that it is unclear whether the first and second pressure measurements are the same as those claimed in claim 31, which claim 33 is dependent upon. For the sake of compact prosecution, the examiner is treating them as though they are different from claim 31.
Claim 35 recites the limitations “a first pressure measurement” and “a second pressure measurement” in ln. 3 and 8 respectively. This limitation is indefinite in that it is unclear whether the first and second pressure measurements are the same as those claimed in claims 31 and 33, which claim 35 is dependent upon. For the sake of compact prosecution, the examiner is treating them as though they are different from claims 31 and 33.
Claim 36 recites the limitations “a first fluid characteristic” and “a second fluid characteristic” in ln. 4 and 8 respectively. This limitation is indefinite in that it is unclear whether the first and second fluid characteristics are the same as those claimed in claim 34, which claim 36 is dependent upon. For the sake of compact prosecution, the examiner is treating them as though they are different from claim 34.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over US/2017/0030818 A1 to Baek in view of US/2004/0099060 A1 to Kijlstra.
Regarding claim 23, Baek discloses an apparatus (Fig. 2B; Fig. 6A-6B) comprising: a conduit configured to receive a fluid (para. 0072, liquid flow channel; para. 0099; Fig. 2B, flow channel 34,35,36 through viscosity sensor 612); a controlled source of differential pressure that is fluidically coupled to the conduit (Fig. 6B, pump 630; para. 0073); pressure sensors that measure a pressure of the fluid (Fig. 1, sensor cell; para. 0022), wherein the pressure sensors are fluidically coupled to the conduit at a distance from a first end of the conduit (Fig. 2B, pressure sensors 33 created in pressure sensor membrane 37; para. 0055-0056); and a controller (Fig. 6A, controller 660) wherein the controller: (a) places the CSDP in the off state and receives a first pressure measurement from the pressure sensor, (b) places the CSDP in the setpoint state and receives a second pressure measurement from the pressure sensor (para. 0062, control can be instructed to dispense fluids at different flow rates in sequence with or without flow stoppage; para. 0063; para. 0089; para. 0131).
Baek differs from the instantly claimed invention in that Baek fails to disclose one, and only one, pressure sensor that measures a pressure of the fluid, wherein the pressure sensor is fluidically coupled to the conduit at a distance from a first end of the conduit; and wherein the apparatus computes the pressure drop of the fluid across the distance based on the first and second pressure measurements, thereby determining pressure drop using a single pressure sensor.
Kijlstra teaches a viscometer (Fig. 1) comprising a conduit configured to receive a fluid (Fig. 1, connecting tubing); a controlled source of differential pressure that is fluidically coupled to the conduit (Fig. 1, connecting tubing connected to liquid pump [shown to be hydrostatic pump in Fig. 1]; para. 0021); one, and only one, pressure sensor that measures a pressure of the fluid (Fig. 1, sensor cell; para. 0022), wherein the pressure sensor is fluidically coupled to the conduit at a distance from a first end of the conduit (Fig. 1, sensor cell fluidically coupled to connecting tubing around a midpoint); and the apparatus configured to measure pressure under no fluid flow and measure pressure under dynamic conditions as a function of a flow rate D, wherein the apparatus computes the pressure drop of the fluid across the distance based on the first and second pressure measurements, thereby determining pressure drop using a single pressure sensor, thereby decreasing the complexity of the system (para. 0097-0102).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Baek to comprise a single pressure sensor as taught by Kijlstra, because Kijlstra teaches that pressure drop/viscous pressure can be determined from modifying flow rate over a single pressure sensor (para. 0006; para. 0078), which decreases the complexity of the system.
Regarding claim 25, the cited prior art suggests the invention of claim 23. Baek further discloses wherein, in the setpoint state, the CSDP is operable at a first setpoint and at a second setpoint (para. 0062, control can be instructed to dispense the liquid at different flow rates in sequence; para. 0063).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Baek and Kijlstra as applied above, and further in view of US/2008/0127717 A1 to Lesieur.
Regarding claim 24, the cited prior art suggests the invention of claim 23; however, the prior art differs from the instantly claimed invention in that the prior art fails to suggest wherein the controller is configured to: (a) receive time-varying pressure data from the pressure sensor while the CSDP is in the setpoint state; (b) compute an arithmetic mean of the time-varying pressure data; and (c) designate the arithmetic mean as the second pressure measurement.
Lesieur teaches a viscometer configured to receive time-varying pressure data from pressure gauges while a pump is running and computing an arithmetic mean of said data, thereby providing a more precise calculated test value (para. 0048) (para. 0046; para. 0048).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the controller of Baek and Kijlstra to utilize an arithmetic mean as the second pressure measurement as taught by Lesieur, because Lesieur teaches that this provides a more precise calculated test value (para. 0048).
Claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Baek and Kijlstra as applied above, and further in view of US/2003/0140682 A1 to Eggen.
Regarding claims 26-28, the cited prior art suggests the invention of claim 25. Baek discloses
(Claim 26) wherein the fluid: (i) has a fluid characteristic (para. 0002; all liquids would be considered to have a fluid characteristic); and (ii) is a reference liquid having "REFERENCE LIQUID" as the fluid characteristic (para. 0002; para. 0069, may store a history of measured viscosity values with appropriate identification; fluid characteristic is arbitrary); the apparatus comprising: controller-accessible storage (para. 0062, measured viscosity may be stored in a controller memory; para. 0069; para. 0077; para. 0131);
(Claim 27) wherein the controller is configured to operate the CSDP at a first setpoint (para. 0062, control can be instructed to dispense the liquid at different flow rates in sequence; para. 0063); and
(Claim 28) wherein the controller places the CSDP at the first setpoint and receives a first pressure measurement; and places the CSDP at the second setpoint and receives a second pressure measurement (para. 0062, control can be instructed to dispense fluids at different flow rates in sequence with or without flow stoppage; para. 0063; para. 0089; para. 0131).
The cited prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose
(Claim 26) wherein the controller-accessible storage is configured with a data array, the data array comprising a data block, the data block comprising: (i) a first field, the first field configured to receive a pressure; and (ii) a second field, the second field configured to receive a fluid characteristic; wherein the controller: (a) designates the first pressure measurement as an inlet reservoir pressure and stores the inlet reservoir pressure to the data array; (b) designates the second pressure measurement as a fluid pressure; (c) designates "REFERENCE LIQUID" as the fluid characteristic; and (d) stores the fluid pressure to the first field of the data block and stores "REFERENCE LIQUID" to the second field of the data block;
(Claim 27) wherein the controller is configured to store the first setpoint to the third field of the data block; and
(Claim 28) wherein the controller-accessible storage contains a first data block and a second data block; and wherein the controller stores the first pressure measurement to the first field and stores the first setpoint to the third field of the first data block; and stores the second pressure measurement to the first field and stores the second setpoint to the third field of the second data block.
Eggen teaches a rheometry system for non-Newtonian fluids comprising a controller that creates a data set based on pump speed and pressure values that may be compared with previously acquired data sets to relate the viscosity curve of an unknown fluid to a known fluid, thereby allowing for classification of unknown non-Newtonian fluids (para. 0024; para. 0070-0076).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the controller-accessible storage of Baek and Kijlstra to comprise a populatable data array as taught by Eggen, because Eggen teaches that the viscosity of non-Newtonian fluids is not independent of the rate of shear and that this provides a viscosity curve of an unknown fluid that can be compared to a viscosity curve of a known fluid for classification (para. 0024; para. 0070-0076).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Baek and Kijlstra as applied above, and further in view of WO/2020/023541 A1 to Teigen.
Regarding claim 30, the cited prior art suggests the invention of claim 23; however, the prior art differs from the instantly claimed invention in that the prior art fails to suggest wherein the conduit is a catheter.
Teigen teaches a thrombectomy system comprising a catheter configured to be in fluid communication with a patient vascular system that comprises pressure sensors to determine a pressure differential indicative of unrestricted flow, restricted flow, or a clog to allow for fluid flow characterization to ensure that excessive blood loss does not occur during aspiration of healthy blood (Fig. 7A, connecting tube 206 connected to aspiration catheter via external unit 204; Fig. 12, pressure transducers 282/284; Fig. 17; para. 0014; para. 0061; para. 0066-0068; para. 0072-0073; para. 0088, distal end of aspiration catheter 750 in communication with obstructive material).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Baek and Kijlstra such that the conduit is a catheter as taught by Teigen, because Teigen teaches that characterization of fluid flow is important in thrombectomy to ensure that excessive blood loss does not occur during aspiration of healthy blood (para. 0066-0068).
Claims 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over US/2017/0010191 A1 to Jiang and further in view of US/2004/0099060 A1 to Kijlstra.
Regarding claim 31, Jiang discloses an apparatus (Fig. 4) comprising: a conduit (Fig. 4, conduit 1), the conduit physically configured to receive a first fluid at a first time and a second fluid at a second time (para. 0030-0033, reference fluid and test sample); a controlled source of differential pressure that is fluidically coupled to the conduit (Fig. 4, injector 2; para. 0038, processor controls injector 2; para. 0071, other devices are acceptable such as a rotary piston pump or a peristaltic pump), wherein the CSDP has a setpoint state and an off state (para. 0071, fixed flow rate or 0 flow rate); one, and only one, pressure sensor coupled to the conduit at a distance from a first end of the conduit (Fig. 4, pressure sensor 5 coupled to conduit 1 at a distance from both ends of conduit 1; para. 0038); and a controller, wherein the controller: (a) places the CSDP in the setpoint state, (b) receives a first pressure measurement from the pressure sensor at the first time, the first pressure measurement corresponding to the first fluid, and (c) receives a second pressure measurement from the pressure sensor at the second time, the second pressure measurement corresponding to the second fluid (para. 0035-0048); wherein the apparatus computes a scalar difference between a first pressure drop of the first fluid across the distance and a second pressure drop of the second fluid across the distance based on the first and second pressure measurements, thereby determining the difference between the first pressure drop and the second pressure drop using a single pressure sensor and without computing either the first pressure drop or the second pressure drop (para. 0038-0048).
Jiang differs from the instantly claimed invention in that Jiang fails to disclose wherein the pressure sensor is fluidically coupled to the conduit.
Kijlstra teaches a viscometer comprising a pressure sensor fluidically coupled to a conduit, thereby accurately determining pressure directly within the conduit (Fig. 1, pressure cell fluidically coupled to connecting tubing; para. 0035-0037).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pressure sensor of Jiang that senses the pressure in the conduit, for the pressure cell fluidically connected to the conduit of Kijlstra since these mechanisms perform the same function of determining pressure in the conduit. Simply substituting one pressure sensing means for another would yield the predicable result of providing an accurate value of pressure within a conduit. See MPEP 2143.
Regarding claim 32, the cited prior art suggests the invention of claim 31. Jiang further discloses wherein, in the setpoint state, the CSDP is operable at a first setpoint and at a second setpoint (para. 0071, fixed flow rate or 0 flow rate, first and second may be the same).
Claims 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang and Kijlstra as applied above, and further in view of US/2003/0140682 A1 to Eggen.
Regarding claims 33-35, the cited prior art suggests the invention of claim 32. Jiang further discloses
(Claim 33) wherein the controller places the CSDP at the first setpoint and receives a first pressure measurement at the first time, the first pressure measurement corresponding to the first fluid, and receives a second pressure measurement at the second time, the second pressure measurement corresponding to the second fluid (para. 0038-0048);
(Claim 34) wherein the first fluid has a first fluid characteristic and the second fluid has a second fluid characteristic (para. 0030-0033, reference fluid and test sample; all liquids would be considered to have a fluid characteristic); and
(Claim 35) wherein, at the first time while the first fluid is received by the conduit, the controller: places the CSDP at the first setpoint and receives a first pressure measurement and places the CSDP at the second setpoint and receives a second pressure measurement (para. 0071, fixed flow rate or 0 flow rate, first and second may be the same).
The cited prior art differs from the instantly claimed invention in that the cited prior art fails to suggest
(Claim 33) controller-accessible storage, wherein the controller-accessible storage comprises a data array, the data array comprising: a first data block comprising: a first field, the first field configured to receive a pressure, and a second field, the second field configured to receive a setpoint; and a second data block configured identically to the first data block; and stores the first pressure measurement to the first field of the first data block, and stores the first setpoint to the second field of the first data block; and stores the second pressure measurement to the first field of the second data block, and stores the first setpoint to the second field of the second data block;
(Claim 34) wherein the first data block of the data array further comprises a third field, the third field configured to receive a fluid characteristic; and wherein the controller: (a) designates "FIRST FLUID" as the first fluid characteristic and designates "SECOND FLUID" as the second fluid characteristic; (b) stores "FIRST FLUID" to the third field of the first data block; and (c) stores "SECOND FLUID" to the third field of the second data block; and
(Claim 35) wherein, at the first time while the first fluid is received by the conduit, the controller stores, to the first data block: the first pressure measurement to the first field, the first setpoint to the second field, and the first fluid characteristic to the third field; and stores, to the second data block: the second pressure measurement to the first field, the second setpoint to the second field, and the first fluid characteristic to the third field.
Eggen teaches a rheometry system for non-Newtonian fluids comprising a controller that creates a data set based on pump speed and pressure values that may be compared with previously acquired data sets to relate the viscosity curve of an unknown fluid to a known fluid, thereby allowing for classification of unknown non-Newtonian fluids(para. 0024; para. 0070-0076).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the controller-accessible storage of Jiang and Kijlstra to comprise a populatable data array as taught by Eggen, because Eggen teaches that the viscosity of non-Newtonian fluids is not independent of the rate of shear and that this provides a viscosity curve of an unknown fluid that can be compared to a viscosity curve of a known fluid for classification (para. 0024; para. 0070-0076).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Jiang and Kijlstra as applied above, and further in view of WO/2020/023541 A1 to Teigen.
Regarding claim 40, the cited prior art suggests the invention of claim 31; however, the prior art differs from the instantly claimed invention in that the prior art fails to suggest wherein the conduit is a catheter.
Teigen teaches a thrombectomy system comprising a catheter configured to be in fluid communication with a patient vascular system that comprises pressure sensors to determine pressure differential indicative of unrestricted flow, restricted flow, or a clog to allow for fluid flow characterization to ensure that excessive blood loss does not occur during aspiration of healthy blood (Fig. 7A, connecting tube 206 connected to aspiration catheter via external unit 204; Fig. 12, pressure transducers 282/284; Fig. 17; para. 0014; para. 0061; para. 0066-0068; para. 0072-0073; para. 0088, distal end of aspiration catheter 750 in communication with obstructive material).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of such that the conduit of Jiang and Kijlstra is a catheter as taught by Teigen, because Jiang teaches a system directed to blood smear for characterization of blood products (para. 0002) and Teigen teaches that characterization of fluid flow/viscosity is important in thrombectomy to ensure that excessive blood loss does not occur during aspiration of healthy blood (para. 0066-0068).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
30 January 2026