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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1 and 6-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8 and 15 of copending Application No. 18/055,897 in view of Zelickson et al. (WO 2008073985 A2).
Regarding Claims 1 and 9, Claims 1, 8, and 15 of Copending Application No. 18/055,897 teaches all of the limitations in the instant claims, but does not explicitly disclose wherein an energy source coupled to the catheter, the energy source configured to generate energy radiation distally of the catheter to the UIM.
Zelickson teaches a device and method for improving the surgical procedure of soft tissue removal by aspiration and more particularly to a device and method utilizing laser energy directed at the edge of the inlet port to more readily and safely facilitate the separating of soft tissue from a patient in vivo (see Abstract) comprising: an energy source (a laser energy source (not shown) coupled to a laser guide tube 36 and a laser energy transmission guide 115 to transmit laser energy across inlet port 20, see pg. 7 paragraph 1) coupled to the catheter (aspiration cannula 112), the energy source configured to generate energy radiation distally of the catheter to the UIM (distal end 56 of the laser energy transmission guide 115 can be configured to direct laser energy across the face of the aspiration inlet port(s) 20, see pg. 7 paragraph 1).
Claims 1, 8 and 15 of Copending Application No. 18/055,897 and Zelickson are analogous art because both teach an aspiration catheter.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the system and methods of Claims 1, 8 and 15 of Copending Application No. 18/055,897 and further include wherein an energy source coupled to the catheter, the energy source configured to generate energy radiation distally of the catheter to the UIM, as taught by Zelickson. Zelickson teaches improving the surgical procedure of soft tissue removal by aspiration and more particularly to a device and method utilizing laser energy directed at the edge of the inlet port to more readily and safely facilitate the separating of soft tissue from a patient in vivo (see pg. 1 paragraph 1).
Regarding Claim 6, Claim 5 of Copending Application No. 18/055,897 further teaches wherein the determination that the measurement violates the threshold corresponds to a clog present in the system.
Regarding Claim 7, Claim 6 of Copending Application No. 18/055,897 further teaches wherein: the threshold comprises a target aspiration flow rate; and modulation of the aspiration flow rate causes an aspiration flow rate of the fluid and the UIM to align with the target aspiration flow rate.
Regarding Claim 8, Claim 2 of Copending Application No. 18/055,897 further teaches wherein the sensor is selected from the group consisting of a pressure sensor configured to sense the vacuum pressure, a weight sensor configured to sense a weight of the canister, a flow sensor configured to sense an amount of the aspiration, and a current sensor configured to sense a current drawn by the pressure source.
This is a provisional nonstatutory double patenting rejection.
Claim Objections
Claim 13 is objected to because of the following informalities: “the energy source” in line 14 should be “an energy source”. Appropriate correction is required.
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.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Teigen et al. (US 20200397957 A1) and Zelickson et al. (WO 2008073985 A2).
Regarding Claim 1, Teigen teaches a system for removing an undesirable intravascular material (UIM) from a vasculature of a subject (a vacuum system 40 of the type useful with the apparatus and methods for controlled clot aspiration from a patient's vasculature, see Figure 7A; Paragraphs [0002] and [0051]), the system comprising:
a catheter configured to be inserted within the vasculature of the subject (external unit 204 connected to a proximal end of an aspiration catheter, see Paragraph [0061]);
a canister coupled to the catheter, the canister configured to receive fluid and UIM from the catheter (blood/clot canister 44 of the vacuum system 40, see Paragraph [0051]);
a pressure source coupled to the catheter, the pressure source configured to generate a vacuum pressure through the catheter for aspirating the fluid and the UIM (pump 68 comprised in the vacuum console of the vacuum system 40, see Paragraphs [0051] and [0052]);
a sensor configured to sense a parameter associated with at least one of the catheter, the canister, or the pressure source (the vacuum console 42 having a pressure sensor 64, see Paragraph [0053]; Figure 3C); and
a computer system coupled to the sensor (the pressure output form the sensor 64 goes through the microprocessor controller 74, see Paragraph [0054]), the computer system comprising a processor and a memory, the memory storing instructions that, when executed by the processor, cause the computer system to (controller 220 implements an algorithm that uses pressure sensor data to analyze the contents flowing through an aspiration catheter and characterizes it as unrestricted flow, restricted flow, or clogged, see Paragraph [0071]; if the algorithm determines that a catheter has little to no flow, it may initiate an extraction cycle to help remove any clogs or occlusions, see Paragraph [0080])
cause the pressure source to initiate the vacuum pressure throughout the catheter (an extraction cycle is typically initiated when an aspiration catheter is already under full vacuum, i.e. the controller has initiated the vacuum pressure, see Paragraph [0081]),
receive a measurement of the parameter from the sensor (by providing a first pressure sensor 224 in the base unit 210 and a second, axially separated pressure sensor 246 in the external unit 240; the material flow rate through the connecting tube can be calculated based upon measured differential pressure by the controller; the controller may analyze the pressure differentials and flow rate to determine the contents flowing through the aspiration catheter, connective tubing, or both, see Paragraph [0066]),
determine whether the measurement violates a threshold associated with the parameter (a signal representative of such flow, typically as either unrestricted flow, restricted flow, or clogged, such flow may benefit from an extraction cycle, see Paragraph [0027]; When the system detects restricted flow state, it enters the maintenance mode, see Paragraph [0098]), and
modulate an aspiration flow rate and/or the energy radiation at a tip of the catheter in response to a determination that the measurement violates the threshold (an extraction cycle alternates between providing vacuum aspiration and relative positive pressure, see Paragraph [0081]).
However, Teigen does not explicitly disclose an energy source coupled to the catheter, the energy source configured to generate energy radiation distally of the catheter to the UIM.
Zelickson teaches a device and method for improving the surgical procedure of soft tissue removal by aspiration and more particularly to a device and method utilizing laser energy directed at the edge of the inlet port to more readily and safely facilitate the separating of soft tissue from a patient in vivo (see Abstract) comprising: an energy source (a laser energy source (not shown) coupled to a laser guide tube 36 and a laser energy transmission guide 115 to transmit laser energy across inlet port 20, see pg. 7 paragraph 1) coupled to the catheter (aspiration cannula 112), the energy source configured to generate energy radiation distally of the catheter to the UIM (distal end 56 of the laser energy transmission guide 115 can be configured to direct laser energy across the face of the aspiration inlet port(s) 20, see pg. 7 paragraph 1).
Teigen and Zelickson are analogous art because both discloses an aspiration catheter for removing an undesirable intravascular material (UIM) from a vasculature of a subject.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter system of Teigen and further including an energy source coupled to the catheter, the energy source configured to generate energy radiation distally of the catheter to the UIM, as taught by Zelickson. Zelickson teaches improving the surgical procedure of soft tissue removal by aspiration and more particularly to a device and method utilizing laser energy directed at the edge of the inlet port to more readily and safely facilitate the separating of soft tissue from a patient in vivo (see pg. 1 paragraph 1).
Regarding Claim 2, Teigen and Zelickson teaches all of the limitations as discussed above in claim 1 and Teigen further teaches wherein the vacuum pressure is initiated to generate a first aspiration flow rate (when the system detects restricted flow state, it enters the maintenance mode where pressure pulses have a consistent frequency and amplitude, see Paragraph [0098]) and the modulated aspiration flow rate is at a second aspiration flow rate, greater than the first aspiration flow rate (when the system detects a clogged state, it enters the cycling up mode where successive pressure pulses are stronger in terms of amplitude and/or frequency, see Paragraph [0098]).
Regarding Claim 3, Teigen and Zelickson teaches all of the limitations as discussed above in claim 1 and Teigen further teaches wherein the modulating of the aspiration flow rate and/or energy radiation includes:
modulating the aspiration flow rate at the tip of the catheter (an extraction cycle alternates between providing vacuum aspiration and relative positive pressure, see Paragraph [0081]);
receiving another measurement of the parameter from the sensor (by providing a first pressure sensor 224 in the base unit 210 and a second, axially separated pressure sensor 246 in the external unit 240; the material flow rate through the connecting tube can be calculated based upon measured differential pressure by the controller; the controller may analyze the pressure differentials and flow rate to determine the contents flowing through the aspiration catheter, connective tubing, or both, see Paragraph [0066]);
determining whether the another measurement violates the threshold associated with the parameter (when the system detects a clogged state, see Paragraph [0098]).
Zelickson further teaches modulating the energy radiation at the tip of the catheter (distal end 56 of the laser energy transmission guide 115 can be configured to direct laser energy across the face of the aspiration inlet port(s) 20, see pg. 7 paragraph 1) in response to a determination that the another measurement violates a threshold (it is noted that the devices of the present invention can include sensors that indicate proper suction activity and thereby inhibit the activation of the laser fiber by a safety switch if proper suction are not present, see pg. 16 lines 19-22).
Regarding Claim 4, Teigen and Zelickson teaches all of the limitations as discussed above in claim 3 and Zelickson further teaches wherein the causing of the pressure source to initiate the vacuum pressure throughout the catheter includes initiating the vacuum pressure while the energy source is not activated (the pump is activated initially and the resultant negative pressure at the inlet port draws a small portion of the soft tissue into the lumen 113 of the cannula 112 before the laser is activated, see pg. 16 lines 23-26).
Regarding Claim 5, Teigen and Zelickson teaches all of the limitations as discussed above in claim 4 and Zelickson further teaches wherein the modulating of the energy radiation includes activating the energy source to generate energy radiation distally of the catheter to the UIM (the devices of the present invention can further provide pulsed delivery of laser energy. For example, a pulse of laser energy timed with the aspirator suction can provide bursts of higher energy radiation at programmed, intermittent or event activated intervals, see pg. 15 lines 18-24).
Regarding Claim 6, Teigen and Zelickson teaches all of the limitations as discussed above in claim 1 and Teigen further teaches wherein the determination that the measurement violates the threshold corresponds to the tip of the catheter being proximate the UIM in the vasculature or a clog present in the system (a signal representative of such flow, typically as clogged, such flow may benefit from an extraction cycle, see Paragraph [0027]).
Regarding Claim 7, Teigen and Zelickson teaches all of the limitations as discussed above in claim 1 and Teigen further teaches wherein:
the threshold comprises a target aspiration flow rate (the algorithm determining the contents flowing through the catheter to be restricted flow, and when the algorithm detects restricted flow, it may cause the system to enable full vacuum aspiration, see Paragraph [0027]); and
modulation of the aspiration flow rate and/or energy radiation causes an aspiration flow rate of the fluid and the UIM to align with the target aspiration flow rate (cause the system to enable full vacuum aspiration, see Paragraph [0027]).
Regarding Claim 8, Teigen and Zelickson teaches all of the limitations as discussed above in claim 1 and Teigen further teaches wherein the sensor is selected from the group consisting of a pressure sensor configured to sense the vacuum pressure, a weight sensor configured to sense a weight of the canister, a flow sensor configured to sense an amount of the aspiration, and a current sensor configured to sense a current drawn by the pressure source (The sensing unit may comprise any one or more of a variety of sensors, including flow sensors, see Paragraph [0016]).
Regarding Claim 9, Teigen teaches a computer-implemented method for removing undesirable intravascular material (UIM) from a subject using a system (microprocessor controller 74 controlling a vacuum system 40 of the type useful with the apparatus and methods for controlled clot aspiration from a patient's vasculature, see Figure 7A; Paragraphs [0002], [0051], and [0054]), the system comprising a catheter configured to be inserted within a vasculature of the subject (external unit 204 connected to a proximal end of an aspiration catheter, see Paragraph [0061]), a canister coupled to the catheter, the canister configured to receive fluid and the UIM from the catheter (blood/clot canister 44 of the vacuum system 40, see Paragraph [0051]), a pressure source coupled to the catheter, the pressure source configured to generate a vacuum pressure through the catheter for aspirating the fluid and the UIM (pump 68 comprised in the vacuum console of the vacuum system 40, see Paragraphs [0051] and [0052]) and a sensor configured to sense a parameter associated with at least one of the catheter, the canister, or the pressure source (the vacuum console 42 having a pressure sensor 64, see Paragraph [0053]; Figure 3C), the method comprising:
causing, by a computer system coupled to the pressure source, the energy source and the sensor (the pressure output form the sensor 64 goes through the microprocessor controller 74, see Paragraph [0054]), the pressure source to initiate the vacuum pressure throughout the catheter (when the system detects restricted flow state, it enters the maintenance mode where pressure pulses have a consistent frequency and amplitude, see Paragraph [0098]);
receiving, by the computer system, a measurement of the parameter from the sensor (by providing a first pressure sensor 224 in the base unit 210 and a second, axially separated pressure sensor 246 in the external unit 240; the material flow rate through the connecting tube can be calculated based upon measured differential pressure by the controller; the controller may analyze the pressure differentials and flow rate to determine the contents flowing through the aspiration catheter, connective tubing, or both, see Paragraph [0066]),
determining, by the computer system, whether the measurement violates a threshold associated with the parameter (a small differential or a pressure differential approaching zero indicates a clog, such flow may benefit from an extraction cycle, see Paragraph 0067]); and
modulating, by the computer system, an aspiration flow rate and/or the energy source at a tip of the catheter in response to a determination that the measurement violates the threshold (an extraction cycle alternates between providing vacuum aspiration and relative positive pressure, see Paragraph [0081]; may be determined or responsive to pressure sensor data).
However, Teigen does not explicitly disclose an energy source coupled to the catheter, the energy source configured to generate energy radiation distally of the catheter to the UIM.
Zelickson teaches a device and method for improving the surgical procedure of soft tissue removal by aspiration and more particularly to a device and method utilizing laser energy directed at the edge of the inlet port to more readily and safely facilitate the separating of soft tissue from a patient in vivo (see Abstract) comprising: an energy source (a laser energy source (not shown) coupled to a laser guide tube 36 and a laser energy transmission guide 115 to transmit laser energy across inlet port 20, see pg. 7 paragraph 1) coupled to the catheter (aspiration cannula 112), the energy source configured to generate energy radiation distally of the catheter to the UIM (distal end 56 of the laser energy transmission guide 115 can be configured to direct laser energy across the face of the aspiration inlet port(s) 20, see pg. 7 paragraph 1).
Teigen and Zelickson are analogous art because both discloses an aspiration catheter for removing an undesirable intravascular material (UIM) from a vasculature of a subject.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter system of Teigen and further including an energy source coupled to the catheter, the energy source configured to generate energy radiation distally of the catheter to the UIM, as taught by Zelickson. Zelickson teaches improving the surgical procedure of soft tissue removal by aspiration and more particularly to a device and method utilizing laser energy directed at the edge of the inlet port to more readily and safely facilitate the separating of soft tissue from a patient in vivo (see pg. 1 paragraph 1).
Regarding Claim 10, Teigen and Zelickson teaches all of the limitations as discussed above in claim 9 and Teigen further teaches wherein the vacuum pressure is initiated to generate a first aspiration flow rate (when the system detects restricted flow state, it enters the maintenance mode where pressure pulses have a consistent frequency and amplitude, see Paragraph [0098]) and the modulated aspiration flow rate is at a second aspiration flow rate, greater than the first aspiration flow rate (when the system detects a clogged state, it enters the cycling up mode where successive pressure pulses are stronger in terms of amplitude and/or frequency, see Paragraph [0098]).
Regarding Claim 11, Teigen and Zelickson teaches all of the limitations as discussed above in claim 9 and Teigen further teaches wherein the modulating of the aspiration flow rate and/or energy radiation includes:
modulating the aspiration flow rate at the tip of the catheter (an extraction cycle alternates between providing vacuum aspiration and relative positive pressure, see Paragraph [0081]);
receiving another measurement of the parameter from the sensor (by providing a first pressure sensor 224 in the base unit 210 and a second, axially separated pressure sensor 246 in the external unit 240; the material flow rate through the connecting tube can be calculated based upon measured differential pressure by the controller; the controller may analyze the pressure differentials and flow rate to determine the contents flowing through the aspiration catheter, connective tubing, or both, see Paragraph [0066]);
determining whether the another measurement violate the threshold associated with the parameter (when the system detects a clogged state, see Paragraph [0098]).
Zelickson further teaches modulating the energy radiation at the tip of the catheter in response to a determination that the another measurement violates the threshold (distal end 56 of the laser energy transmission guide 115 can be configured to direct laser energy across the face of the aspiration inlet port(s) 20, see pg. 7 paragraph 1) in response to a determination that the another measurement violates a threshold (it is noted that the devices of the present invention can include sensors that indicate proper suction activity and thereby inhibit the activation of the laser fiber by a safety switch if proper suction are not present, see pg. 16 lines 19-22).
Regarding Claim 12, Teigen and Zelickson teaches all of the limitations as discussed above in claim 9 and Zelickson further teaches wherein the causing of the pressure source to initiate the vacuum pressure throughout the catheter includes initiating the vacuum pressure while the energy source is not activated (the pump is activated initially and the resultant negative pressure at the inlet port draws a small portion of the soft tissue into the lumen 113 of the cannula 112 before the laser is activated, see pg. 16 lines 23-26).
Regarding Claim 13, Teigen teaches a method comprising:
activating a pump (pump 68 comprised in the vacuum console of the vacuum system 40, see Paragraphs [0051] and [0052]) to initiate a first aspiration flow rate to be generated through the catheter to aspirate a fluid and UIM (a responsive extraction cycle that can provide maintenance pressure pulses when restrictive flow is detected, see Paragraph [0098]);
receiving a first measurement of a parameter from the sensor (by providing a first pressure sensor 224 in the base unit 210 and a second, axially separated pressure sensor 246 in the external unit 240; the material flow rate through the connecting tube can be calculated based upon measured differential pressure by the controller; the controller may analyze the pressure differentials and flow rate to determine the contents flowing through the aspiration catheter, connective tubing, or both, see Paragraph [0066]); and
determining whether the first measurement violates a threshold associated with the parameter thereby determining a state of the system (an algorithm that is used to interpret pressure sensor signals to determine whether the contents flowing through a catheter should be characterized as unrestricted, restricted, or clogged., see Paragraph 0027]);
wherein, when the first measurement does not violate the threshold, the first aspiration flow rate is maintained through the catheter (when the system detects unrestricted flow state, it enters the maintenance mode providing maintenance pressure pulses, where pressure pulses have a consistent frequency and amplitude, see Paragraph [0098]),
wherein, when the first measurement is determined to violate the threshold according to a first condition (when the system detects a clogged state, it enters the cycling up mode, see Paragraph [0098]), a second aspiration flow rate is generated through the catheter, wherein the second aspiration flow rate is a faster aspiration flow rate than the first aspiration flow rate (cycling up, where successive pressure pulses are stronger in terms of amplitude and/or frequency, see Paragraph [0098]).
However, Teigen does not explicitly disclose an energy source is activated to generate an energy radiation at the distal end of the catheter.
Zelickson teaches a device and method for improving the surgical procedure of soft tissue removal by aspiration and more particularly to a device and method utilizing laser energy directed at the edge of the inlet port to more readily and safely facilitate the separating of soft tissue from a patient in vivo (see Abstract) comprising: an energy source (a laser energy source (not shown) coupled to a laser guide tube 36 and a laser energy transmission guide 115 to transmit laser energy across inlet port 20, see pg. 7 paragraph 1) coupled to the catheter (aspiration cannula 112), the energy source configured to generate energy radiation distally of the catheter to the UIM (distal end 56 of the laser energy transmission guide 115 can be configured to direct laser energy across the face of the aspiration inlet port(s) 20, see pg. 7 paragraph 1).
Teigen and Zelickson are analogous art because both discloses an aspiration catheter for removing an undesirable intravascular material (UIM) from a vasculature of a subject.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter system of Teigen and further including an energy source coupled to the catheter, the energy source configured to generate energy radiation distally of the catheter to the UIM, as taught by Zelickson. Zelickson teaches improving the surgical procedure of soft tissue removal by aspiration and more particularly to a device and method utilizing laser energy directed at the edge of the inlet port to more readily and safely facilitate the separating of soft tissue from a patient in vivo (see pg. 1 paragraph 1).
Regarding Claim 14, Teigen and Zelickson teaches all of the limitations as discussed above in claim 13 and Teigen further teaches wherein, when the first measurement does not violate the threshold, the state of the system is determined to be in a free flow state (Generally, unrestricted flow is a high flow that may be characterized as excessive and may be primarily or completely comprised of healthy blood, clot-free blood, or blood free of vessel-obstructing clot that is not helpful to aspirate, see Paragraph [0027]).
Regarding Claim 15, Teigen and Zelickson teaches all of the limitations as discussed above in claim 13 and Teigen further teaches wherein, when the measurement is determined to violate the threshold according to the first condition, the state of the system is determined to be in a UIM detected state (When the algorithm detects restricted flow, it may cause the system to enable full vacuum aspiration or maintenance mode, see Paragraph [0027] and [0098]).
Regarding Claim 16, Teigen and Zelickson teaches all of the limitations as discussed above in claim 13 and Teigen further teaches wherein, when the measurement is determined to violate the threshold according to the second condition, the state of the system is determined to be in obstructed state (when the system detects a clogged state, it enters the cycling up mode, see Paragraph [0098]).
Regarding Claim 17, Teigen and Zelickson teaches all of the limitations as discussed above in claim 13 and Teigen further teaches herein, when the measurement is determined to violate the threshold according to the second condition, the second aspiration flow rate is generated through the catheter (cycling up, where successive pressure pulses are stronger in terms of amplitude and/or frequency, see Paragraph [0098]).
Zelickson further teaches while the energy source is activated (the devices of the present invention can further provide pulsed delivery of laser energy. For example, a pulse of laser energy timed with the aspirator suction can provide bursts of higher energy radiation at programmed, intermittent or event activated intervals, see pg. 15 lines 18-24).
Regarding Claim 18, Teigen and Zelickson teaches all of the limitations as discussed above in claim 17 and Teigen further teaches
receiving a second measurement of the parameter from the sensor (an algorithm that is used to interpret pressure sensor signals to determine whether the contents flowing through a catheter should be characterized as unrestricted, restricted, or clogged, see Paragraph [0027]); and
determining whether the second measurement violates the threshold associated with the parameter (algorithm detects unrestricted, restricted, and clogged flow and if extraction cycle should be activated, see Paragraph [0027]);
wherein, when the second measurement does not violate the threshold (when the system detects unrestricted flow state, it enters the maintenance mode providing maintenance pressure pulses, where pressure pulses have a consistent frequency and amplitude, see Paragraph [0098]); and
wherein, when the second measurement is determined to violate the threshold according to a third condition (when the system detects unrestricted flow state, it enters the maintenance mode providing maintenance pressure pulses, where pressure pulses have a consistent frequency and amplitude, see Paragraph [0098]), and the aspiration flow rate is returned to the first aspiration flow rate through the catheter (when the system detects unrestricted flow state, it enters the maintenance mode providing maintenance pressure pulses, where pressure pulses have a consistent frequency and amplitude, see Paragraph [0098]).
Zelickson further teaches the energy source remains activated and the second aspiration flow rate is maintained through the catheter (the devices of the present invention can further provide pulsed delivery of laser energy. For example, a pulse of laser energy timed with the aspirator suction can provide bursts of higher energy radiation at programmed, intermittent or event activated intervals, see pg. 15 lines 18-24) and the energy source is deactivated (it is noted that the devices of the present invention can include sensors that indicate proper suction activity and thereby inhibit the activation of the laser fiber by a safety switch if proper suction are not present, see pg. 16 lines 19-22).
Regarding Claim 19, Teigen and Zelickson teaches all of the limitations as discussed above in claim 18 and Teigen further teaches modulating a control element to cause the aspiration flow rate within the catheter to be returned to the first aspiration flow rate (the algorithm may be responsive and adaptable to changing circumstances and may adjust sampling modes, see Paragraph [0027]).
Regarding Claim 20, Teigen and Zelickson teaches all of the limitations as discussed above in claim 13 and Teigen further teaches modulating a control element to generate the second aspiration flow rate (when the system detects a clogged state, it enters the cycling up mode where successive pressure pulses are stronger in terms of amplitude and/or frequency, see Paragraph [0098])), wherein the control element is selected from the group consisting of: a valve configured to control the aspiration through tubing connecting the canister to the catheter, an air leak control element configured to modulate the vacuum pressure, a secondary pump configured to control the aspiration through the tubing, and a booster reservoir configured to modulate the vacuum pressure (the controller is connected to receive the signal representative of flow through the connecting tube and to open and close one or more on-off valve(s) in response to the signal; and the controller is configured to initiate pulsed aspiration when the signal indicates a clog, see Paragraph [0014]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/ERIC RASSAVONG/ (6/18/2026)Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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