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 .
Response to Amendment
This office action is responsive to the amendment filed on 10/29/2025. As directed by the amendment: claims 1 and 13 have been amended, claim 12 has been cancelled, and claims 15-20 have been added. Thus, claims 1, 4-6, 8-10, 13, and 15-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments filed 10/29/2025 with respect to the independent and dependent claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-6, 9, 13, 15-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200281503 A1, henceforth written as Salamini, in view of US 20210153771 A1, henceforth written as Ting.
Regarding Claim 1,
Salamini discloses:
A method of monitoring a fluid injection procedure, the method comprising: disposing an electrical impedance sensor on a catheter,
(paragraph 9+16+300-304+309; distal electrode pair 5302 and proximal electrode pair 5304, together considered the claimed sensor which measures electrical impedance, can be considered disposed on catheter 2508 by the manner by which they are disposed on stylet 2504 which is carried by, and thus on, catheter 2508; fig 53)
wherein the electrical impedance sensor is in proximity to a tip of the catheter;
(fig 53 illustrates electrode pairs 5302 5304 proximate a distal tip of catheter 2508)
inserting at least the tip of the catheter into a patient;
(paragraph 114+273+300; the system of fig 53 may be disposed in the vasculature of a patient)
delivering a fluid to a location within the patient via the tip of the catheter;
(paragraph 254-268; a controller 114 may control the medium introduction mechanism 5004 to inject a controlled volume/rate of fluid out of fluid exit point 2503, therein extending of a tip of catheter 2508 and thus via its tip, based on information received from sensors or at a constant predetermined rate; fig 50)
and automatically monitoring a sensor signal from the electrical impedance sensor while the fluid is being delivered; wherein the sensor signal pertains to the fluid;
(paragraph 116+119-121+197+254-268+289+300-304+309+323+380-384; electrode pairs 5302 5304 measure an impedance parameter of the injected fluid to make some determinations such as position of the catheter within the vasculature, presence of injected fluid in blood, direction of blood flow, flow magnitude & profile, pulsatility, and laminar v turbulent flow; fig 4+8+63)
wherein the fluid injection procedure is embolotherapy
(paragraph 285; the invention may be used to perform an embolization procedure)
wherein the monitoring includes detection of a condition selected from the group consisting of: stasis of flow of the fluid, near-stasis of flow of the fluid, free flow of blood and reflux of the fluid.
(paragraph 131-132+380-391; during the detection of anatomical position of the catheter within the vasculature, the different anatomical locations will yield different detectable flow conditions, and thus different dissipation patterns of the injected fluid; fig 4+8+63+94-97; examiner's annotation of Salamini's figure 8 demonstrates the detection of the claimed conditions as determines of catheter position)
Examiner notes that the above claim language does not necessitate nor recite such methodogical steps included in applicant's disclosure, such as making the condition determination based on impedance thresholds distinguishing forward flow from near-stasis, near-stasis from stasis, and stasis from reflux, see page 9 line 7-12 of applicant's disclosure. Further the claimed reflux of fluid here is not limited to refluxing of fluid caused by an embolus forming downstream of a catheter which fills a target vessel until reflux occurs. Instead the claims rely on the broadest reasonable interpretation of claim terms such as stasis, near-stasis, free-flow, and reflux to a person of ordinary skill in the art, which can be interpreted in a manner not inconsistent with applicant's disclosure as pertaining to a magnitude, or lack thereof, of flow in a particular direction.
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Salamini discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
where the fluid delivered via the catheter is intended to form an embolus within the patient and downstream of the catheter,
However Ting teaches:
where the fluid delivered via the catheter[, and having its electrical impedance measured,] is intended to form an embolus within the patient and downstream of the catheter
(paragraph 135, electrodes 110 120, for detecting a tissue and fluid electrical impedance, are disposed on catheter 105; paragraph 209+215, material injected by the invention can be polymerized via waveguide coating 120 to form an embolus to produce hemostasis in a blood vessel)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention that embolotherapy use case disclosed by Salamini may incorporate Ting’s teachings of tracking the injection of embolic material during embolotherapy, in order to advantageously arrive at an embolotherapy catheter system which integrates its device insertion and embolic delivery mechanisms which consequently reduces procedure time and accuracy of device/fluid placement as there is no need to exchange or re-position multiple devices, see paragraph 215 of Ting.
Regarding claim 4, the modified invention of Salamini in view of Ting discloses:
The method of claim 1, wherein delivery of the fluid to the patient is performed under closed loop control using the sensor signal as an input to a control system.
Salamini: (paragraph 119+125+256+262+265; the controlled volume/rate of fluid may change depending on the location of the system within the vasculature -for example the volume/rate may increase as the catheter tip gets closer to the heart- which is determined from the impedance sensor signal)
Regarding claim 5, the modified invention of Salamini in view of Ting discloses:
The method of claim 1, wherein the tip of the catheter is located within a blood vessel of the patient while the fluid is being delivered.
Salamini: (paragraph 114+273+300; the system of fig 53 may be disposed in the vasculature of a patient)
Regarding Claim 6,
The modified invention of Salamini in view of Ting discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Salamini in view of Ting is silent regarding:
The method of claim 5, wherein the sensor signal can be further used to sense perforation or dissection of the blood vessel by the catheter.
Examiner notes that notably in paragraph 419 Salamini discloses that its controller may detect when its sensor is in contact with a vessel wall and make some adjustment in relation to this condition.
However, Ting further teaches:
wherein the [impedance] sensor signal can be further used to sense perforation or dissection of the blood vessel by the catheter.
(paragraph 115-117+190-191+214; electrical impedance is utilized to determine when the invention has penetrate, therein perforating/dissecting, a specific type of tissue, such as a blood vessel and sends a warning to user)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Ting’s impedance sensor detecting and communicating vessel penetration to the modified catheter system/method disclosed by Salamini in view of Ting in order to advantageously arrive at an invention which can warn a user when injection of a fluid media could be hazardous, such as when a blood vessel has been penetrated, see paragraph 190 of Ting.
Regarding claim 9, the modified invention of Salamini in view of Ting discloses:
The method of claim 1, wherein a composition of the fluid is selected to provide an impedance contrast between the fluid and blood.
Salamini: (paragraph 300-302+309; injected fluid medium has an impedance distinct from that of blood)
Regarding Claim 13,
Salamini discloses:
A method of monitoring a fluid injection procedure, the method comprising: disposing an electrical impedance sensor on a catheter,
(paragraph 9+16+300-304+309; distal electrode pair 5302 and proximal electrode pair 5304, together considered the claimed sensor which measures electrical impedance, can be considered disposed on catheter 2508 by the manner by which they are disposed on stylet 2504 which is carried by, and thus on, catheter 2508; fig 53)
wherein the electrical impedance sensor is in proximity to a tip of the catheter;
(fig 53 illustrates electrode pairs 5302 5304 proximate a distal tip of catheter 2508)
inserting at least the tip of the catheter into a patient;
(paragraph 114+273+300; the system of fig 53 may be disposed in the vasculature of a patient)
delivering a fluid to a location within the patient via the tip of the catheter; and
(paragraph 254-268; a controller 114 may control the medium introduction mechanism 5004 to inject a controlled volume/rate of fluid out of fluid exit point 2503, therein extending of a tip of catheter 2508 and thus via its tip, based on information received from sensors or at a constant predetermined rate; fig 50)
automatically monitoring a sensor signal from the electrical impedance sensor while the fluid is being delivered; wherein the sensor signal pertains to the fluid;
(paragraph 116+119-121+197+254-268+289+300-304+309+323+380-384; electrode pairs 5302 5304 measure an impedance parameter of the injected fluid to make some determinations such as position of the catheter within the vasculature, presence of injected fluid in blood, direction of blood flow, flow magnitude & profile, pulsatility, and laminar v turbulent flow; fig 4+8+63)
wherein the fluid injection procedure is embolotherapy --
(paragraph 285; the invention may be used to perform an embolization procedure)
further comprising performing automatic end-point detection for the fluid injection procedure using the sensor signal.
Examiner notes that the broadest reasonable interpretation of the claim language of "end-point detection for the fluid injection procedure" is not so specific as to require an interpretation that injected material has reached the level of the sensor or detecting a condition of near-stasis, as disclosed in page 8 line 14-17 and page 3 line 25-27 of applicant's disclosure. Instead the broadest reasonable interpretation of the claimed step includes detecting the completion, or end, of some step in a fluid injection procedure, as the end-point of the fluid injection procedure has not been further defined to pertain to automatically detecting when the catheter has reached a certain anatomy, dispensed a certain amount of therapeutic material, reached a certain filling stage of target vessel, or a number of other possible steps that could be completed in a fluid injection procedure like embolotherapy.
(paragraph 128-129+179-181+256+266+269+300+390-391; the controller analyzes impedance sensor data to determine when the catheter system has reached the target anatomy location, thus detecting an end-point of a step of the fluid injection procedure, and doing so automatically as this information is automatically communicated to an operator via a graphical user interface or an audible alert; fig 23)
Salamini discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
where the fluid delivered via the catheter is intended to form an embolus within the patient and downstream of the catheter,
However Ting teaches:
where the fluid delivered via the catheter[, and having its electrical impedance measured,] is intended to form an embolus within the patient and downstream of the catheter
(paragraph 135, electrodes 110 120, for detecting a tissue and fluid electrical impedance, are disposed on catheter 105; paragraph 209+215, material injected by the invention can be polymerized via waveguide coating 120 to form an embolus to produce hemostasis in a blood vessel)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention that embolotherapy use case disclosed by Salamini may incorporate Ting’s teachings of tracking the injection of embolic material during embolotherapy, in order to advantageously arrive at an embolotherapy catheter system which integrates its device insertion and embolic delivery mechanisms which consequently reduces procedure time and accuracy of device/fluid placement as there is no need to exchange or re-position multiple devices, see paragraph 215 of Ting.
Regarding claim 15, the modified invention of Salamini in view of Ting discloses:
The method of claim 13, wherein delivery of the fluid to the patient is performed under closed loop control using the sensor signal as an input to a control system.
Salamini: (paragraph 119+125+256+262+265; the controlled volume/rate of fluid may change depending on the location of the system within the vasculature -for example the volume/rate may increase as the catheter tip gets closer to the heart- which is determined from the impedance sensor signal)
Regarding claim 16, the modified invention of Salamini in view of Ting discloses:
The method of claim 13, wherein the tip of the catheter is located within a blood vessel of the patient while the fluid is being delivered.
Salamini: (paragraph 114+273+300; the system of fig 53 may be disposed in the vasculature of a patient)
Regarding Claim 17,
The modified invention of Salamini in view of Ting discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Salamini in view of Ting is silent regarding:
The method of claim 16, wherein the sensor signal can be further used to sense perforation or dissection of the blood vessel by the catheter.
Examiner notes that notably in paragraph 419 Salamini discloses that its controller may detect when its sensor is in contact with a vessel wall and make some adjustment in relation to this condition.
However, Ting further teaches:
wherein the [impedance] sensor signal can be further used to sense perforation or dissection of the blood vessel by the catheter.
(paragraph 115-117+190-191+214; electrical impedance is utilized to determine when the invention has penetrate, therein perforating/dissecting, a specific type of tissue, such as a blood vessel and sends a warning to user)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Ting’s impedance sensor detecting and communicating vessel penetration to the modified catheter system/method disclosed by Salamini in view of Ting in order to advantageously arrive at an invention which can warn a user when injection of a fluid media could be hazardous, such as when a blood vessel has been penetrated, see paragraph 190 of Ting.
Regarding claim 19, the modified invention of Salamini in view of Ting discloses:
The method of claim 13, wherein a composition of the fluid is selected to provide an impedance contrast between the fluid and blood.
Salamini: (paragraph 300-302+309; injected fluid medium has an impedance distinct from that of blood)
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Salamini in view of Ting as applied to claim 1 and 13 above, and further in view of US 7842031 B2, henceforth written as Abboud.
Regarding Claim 8,
Salamini in view of Ting discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The method of claim 1, wherein the sensor signal is at a predetermined frequency,
Salamini: (paragraph 125+129+304; sampling frequency can be 50hz and depends on the frequencies within the detect impedance signal from the blood fluid mixture)
However Salamini in view of Ting is silent regarding:
wherein the predetermined frequency is selected to provide an impedance contrast between the fluid and blood.
However, Abboud teaches a fluid monitoring impedance sensor on a catheter
wherein the predetermined frequency is selected to provide an impedance contrast between the fluid and blood.
(col 10 line 64 - col 11 line 22, "The impedance measurement signal is then processed using a signal processor 108 that can extract relevant data from a specific frequency range to correlate the impedance change, if any, due to a gas egress into the blood stream… The electrical field 110 may be called a "virtual balloon" capable of detecting a fluid egress or expulsion 104 from the catheter 34"; fig 5+10)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Abboud’s teaching of distinguishing blood and injected media by examining impedance at a distinct frequency, to the modified invention of Salamini in view of Ting in order to improve the sensitivity of the system to changes in impedance of the surrounding fluid, and therein improve its sensitivity to detecting changed in flow characteristics.
Regarding Claim 18,
Salamini in view of Ting discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The method of claim 13, wherein the sensor signal is at a predetermined frequency,
Salamini: (paragraph 125+129+304; sampling frequency can be 50hz and depends on the frequencies within the detect impedance signal from the blood fluid mixture)
However Salamini in view of Ting is silent regarding:
wherein the predetermined frequency is selected to provide an impedance contrast between the fluid and blood.
However, Abboud teaches a fluid monitoring impedance sensor on a catheter
wherein the predetermined frequency is selected to provide an impedance contrast between the fluid and blood.
(col 10 line 64 - col 11 line 22, "The impedance measurement signal is then processed using a signal processor 108 that can extract relevant data from a specific frequency range to correlate the impedance change, if any, due to a gas egress into the blood stream… The electrical field 110 may be called a "virtual balloon" capable of detecting a fluid egress or expulsion 104 from the catheter 34"; fig 5+10)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Abboud’s teaching of distinguishing blood and injected media by examining impedance at a distinct frequency, to the modified invention of Salamini in view of Ting in order to improve the sensitivity of the system to changes in impedance of the surrounding fluid, and therein improve its sensitivity to detecting changed in flow characteristics.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Salamini in view of Ting as applied to claims 1 and 13 above, and further in view of WO 03026525 A1,henceforth written as Pearson
Regarding Claim 10,
Salamini in view of Ting discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Salamini in view of Ting is silent regarding:
The method of claim 1, wherein the sensor signal is an impedance spectrum at a predetermined frequency range.
However, Pearson teaches a fluidically monitoring impedance sensor on a catheter
wherein the sensor signal is an impedance spectrum at a predetermined frequency range.
(fig 7a-7b; page 23 line 14-22, “As shown in Figure 7a and 7b, because tissue [blood] conducts differently at frequencies, measurements made across a range of excitation frequencies results in an impedance frequency response curve 500 (Figure 7a) or a series of complex impedance frequency response curves (Figure 7b) …”)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Pearson’s teaching of analyzing the impedance frequency response curve over a set frequency range to the modified invention of Salamini in view of Ting since particular frequencies may result in different impedances for different tissues/tissue conditions [i.e. blood and blood’s relative concentration of contrast/impedance agent mixture] and thus advantageously arrive at an invention with improved sensitivity to the impedance measurand and consequently increased sensitivity to detecting changes in this measurand which may be indicative of changes in the measured tissue, such as blood flow changing or blood composition changing to comprise more/less injected media.
Regarding Claim 20,
Salamini in view of Ting discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Salamini in view of Ting is silent regarding:
The method of claim 13, wherein the sensor signal is an impedance spectrum at a predetermined frequency range.
However, Pearson teaches a fluidically monitoring impedance sensor on a catheter
wherein the sensor signal is an impedance spectrum at a predetermined frequency range.
(fig 7a-7b; page 23 line 14-22, “As shown in Figure 7a and 7b, because tissue [blood] conducts differently at frequencies, measurements made across a range of excitation frequencies results in an impedance frequency response curve 500 (Figure 7a) or a series of complex impedance frequency response curves (Figure 7b) …”)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Pearson’s teaching of analyzing the impedance frequency response curve over a set frequency range to the modified invention of Salamini in view of Ting since particular frequencies may result in different impedances for different tissues/tissue conditions [i.e. blood and blood’s relative concentration of contrast/impedance agent mixture] and thus advantageously arrive at an invention with improved sensitivity to the impedance measurand and consequently increased sensitivity to detecting changes in this measurand which may be indicative of changes in the measured tissue, such as blood flow changing or blood composition changing to comprise more/less injected media.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure, particularly the matters pertaining to detecting a liquid flow velocity/rate and/or liquid reflux from an analysis of impedance data:
US 20220240791 A1
US 20120078074 A1
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 FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783