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
The amendment filed on 12/16/2025 has been entered. Claims 1-24 are pending in the application. The amendments to the claims overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed on 9/18/2025.
Claim Objections
Claims 2, 8, and 12 are objected to because of the following informalities:
-Claim 2, line 1: please correct “the system” to “the medical system”
-Claim 8, line 2: please correct “the amount” to “an amount”
-Claim 12, line 6: please correct “the distal end” to “a distal end”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3, 5-14, and 16-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Culbert et al. (US 2019/0381223 A1).
Regarding claim 1, Culbert discloses a medical system (system 1240, see Figs. 20-24) comprising:
a catheter (catheter 1242) having a proximal end (end of catheter 1242 at ports 1244 and 1246) and a distal end (end of catheter 1242 in Fig. 21) and configured to traverse vasculature of a patient (see par. [0190]-[0191]);
a suction source (vacuum source 1262) configured to apply a suction force to the catheter (catheter 1242) to aspirate a material proximate the distal end (end of catheter 1242 in Fig. 21) of the catheter (catheter 1242) and from within the vasculature of the patient (see par. [0190]-[0191]), the suction force originating at a location proximal to the proximal end (end of catheter 1242 at ports 1244 and 1246) of the catheter (catheter 1242) (see Fig. 20, par. [0190]); and
a fluid controller (pump 1254) configured to control an introduction of a fluid into the catheter (catheter 1242) between the proximal end (end of catheter 1242 at ports 1244 and 1246) and the distal end (end of catheter 1242 in Fig. 21) to reduce an amount of blood aspirated from a blood vessel of the vasculature of the patient through the catheter (catheter 1242) (see par. [0190]-[0193]).
Regarding claim 2, Culbert discloses the medical system of claim 1, wherein the system (system 1240, see Figs. 20-24) is configured to displace the blood aspirated into the catheter (catheter 1242) through an opening at or near the distal end (end of catheter 1242 in Fig. 21) by the introduction of the fluid into the catheter (catheter 1242) (see Fig. 21, par. [0190]-[0193]).
Regarding claim 3, Culbert discloses the medical system of claim 1, further comprising control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254) configured to control the suction force at a distal opening of the catheter (catheter 1242) and control the fluid controller (pump 1254) to reduce the amount of the blood aspirated from the blood vessel relative to an amount of the blood aspirated from the blood vessel without the introduction of the fluid (see par. [0190]-[0193]).
Regarding claim 5, Culbert discloses the medical system of claim 1, further comprising control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254) configured to control the fluid controller (pump 1254) to introduce the fluid to the catheter (catheter 1242) when the suction source (vacuum source 1262) is actively applying the suction force to the catheter (catheter 1242) (see par. [0191], the maceration dilutes the aspirate meaning that the fluid can be delivered while suction is applied).
Regarding claim 6, Culbert discloses the medical system of claim 1, further comprising control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254) configured to control the fluid controller (pump 1254) to introduce the fluid to the catheter (catheter 1242) when the suction source (vacuum source 1262) is not actively applying the suction force to the catheter (catheter 1242) (see par. [0191], aspiration can be applied, then stopped, then fluid can be infused).
Regarding claim 7, Culbert discloses the medical system of claim 1, wherein the suction source (vacuum source 1262) is configured to apply the suction force to a lumen of the catheter (catheter 1242) (see par. [0190]), the medical system (system 1240, see Figs. 20-24) further comprising:
a fluid source (saline bag 1248, spike 1252, tubing set 1250, and cassette 1258) configured to introduce the fluid into the lumen via the fluid controller (pump 1254) (see Figs. 20 and 23-24, par. [0190]); and
control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254) configured to control the suction source (vacuum source 1262), the fluid source (saline bag 1248, spike 1252, tubing set 1250, and cassette 1258), and the fluid controller (pump 1254) to alternate the application of the suction force to the catheter (catheter 1242) and the introduction of the fluid into the lumen (see par. [0190]-[0193]).
Regarding claim 8, Culbert discloses the medical system of claim 1, further comprising:
an aspiration valve (valve 1260) configured to control the amount of the suction force applied by the suction source (vacuum source 1262) to the catheter (catheter 1242) (see Fig. 20, par. [0190]-[0192]); and
control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254) configured to control at least one of the suction source (vacuum source 1262) or the aspiration valve (valve 1260) to apply the suction force to the catheter (catheter 1242) in one or more pulses (see par. [0190]-[0193], suction and infusion can be alternated), wherein the suction force is configured to remove a first volume of blood from the patient via the catheter (catheter 1242) during the one or more pulses (see par. [0190]-[0193], suction and infusion can be alternated), and wherein the control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254) is configured to control at least one of a fluid source (saline bag 1248, spike 1252, tubing set 1250, and cassette 1258) or the fluid controller (pump 1254) to introduce a second volume of the fluid to the catheter (catheter 1242) between one or more of the one or more pulses (see par. [0190]-[0193], suction and infusion can be alternated).
Regarding claim 9, Culbert discloses the medical system of claim 8, wherein the suction source (vacuum source 1262) is configured to aspirate a thrombus through a lumen of the catheter (catheter 1242) in a first flow direction, wherein the fluid source (saline bag 1248, spike 1252, tubing set 1250, and cassette 1258) is configured to introduce the fluid to the lumen in a second flow direction opposite the first flow direction, and wherein the second volume is equal to or greater than the first volume, and wherein the second volume of the fluid displaces the first volume of the blood in the second flow direction (see par. [0190]-[0193], the volume of fluid infused and aspirated is controllable such that the volume aspirated can be equal to or greater than the volume infused).
Regarding claim 10, Culbert discloses the medical system of claim 1, further comprising control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254) configured to control the fluid controller (pump 1254) to introduce the fluid to the catheter (catheter 1242) based on at least one of determining that the catheter (catheter 1242) has not captured a thrombus (see par. [0191] and [0193]).
Regarding claim 11, Culbert discloses the medical system of claim 1, further comprising control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254) configured to control the fluid controller (pump 1254) to stop introducing the fluid to the catheter (catheter 1242) based on at least one of determining that the catheter has captured a thrombus (see par. [0191] and [0193]).
Regarding claim 12, Culbert discloses a method (see Figs. 20-24) comprising:
controlling, by control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254), an active suction source (vacuum source 1262) to apply a suction force to a proximal end (end of catheter 1242 at ports 1244 and 1246) of a catheter (catheter 1242) to aspirate a material at a distal opening of the catheter (catheter 1242) and from within vasculature of a patient (see Fig. 20, par. [0190]-[0191]); and
controlling, by the control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254), a fluid controller (pump 1254) to introduce a fluid into the catheter (catheter 1242) between the proximal end (end of catheter 1242 at ports 1244 and 1246) and the distal end (end of catheter 1242 in Fig. 21) of the catheter (catheter 1242) to reduce an amount of blood aspirated from a blood vessel of the patient through the catheter (catheter 1242) (see par. [0190]-[0193]).
Regarding claim 13, Culbert discloses the method of claim 12, wherein controlling the fluid controller (pump 1254) to introduce the fluid comprises controlling the fluid controller (pump 1254) to introduce the fluid into the catheter (catheter 1242) to displace the blood aspirated into the catheter (catheter 1242) through the distal opening of the catheter (catheter 1242) (see par. see Fig. 21, par. [0190]-[0193]).
Regarding claim 14, Culbert discloses the method of claim 12, wherein controlling the suction source (vacuum source 1262) comprises controlling, by the control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254), an aspiration valve (valve 1260) to control an amount of the suction force applied by the suction source (vacuum source 1262) at the distal opening of the catheter (catheter 1242) (see par. [0190]-[0193]),
wherein controlling the aspiration valve (valve 1260) and the fluid controller (pump 1254) reduces the amount of the blood aspirated from the blood vessel relative to an amount of the blood aspirated from the blood vessel without the introduction of the fluid (see par. [0190]-[0193]).
Regarding claim 16, Culbert discloses the method of claim 12, wherein controlling the fluid controller (pump 1254) to introduce the fluid into the catheter (catheter 1242) comprises controlling the fluid controller (pump 1254) to introduce the fluid into the catheter (catheter 1242) when the suction source (vacuum source 1262) is not actively applying the suction force to the catheter (catheter 1242) (see par. [0191], aspiration can be applied, then stopped, then fluid can be infused).
Regarding claim 17, Culbert discloses the method of claim 12, wherein controlling the fluid controller (pump 1254) to introduce the fluid into the catheter (catheter 1242) comprises controlling the fluid controller (pump 1254) to introduce the fluid into the catheter (catheter 1242) when the suction source (vacuum source 1262) is actively applying the suction force to the catheter (catheter 1242) (see par. [0191], the maceration dilutes the aspirate meaning that the fluid can be delivered while suction is applied).
Regarding claim 18, Culbert discloses the method of claim 12, wherein a fluid source (saline bag 1248, spike 1252, tubing set 1250, and cassette 1258) is configured to introduce the fluid into the catheter (catheter 1242) via the fluid controller (pump 1254) (see Figs. 20 and 23-24, par. [0190]), and wherein controlling the suction source (vacuum source 1262) to apply the suction force to the catheter (catheter 1242) and controlling the fluid controller (pump 1254) to introduce the fluid into the catheter (catheter 1242) comprises controlling, by the control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254), the suction source (vacuum source 1262) and the fluid source (saline bag 1248, spike 1252, tubing set 1250, and cassette 1258) to alternate the application of the suction force to the catheter (catheter 1242) and the introducing the fluid to the catheter (catheter 1242) (see par. [0190]-[0193]).
Regarding claim 19, Culbert discloses the method of claim 12, wherein controlling the suction source (vacuum source 1262) to apply the suction force to the catheter (catheter 1242) comprises controlling, by the control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254), at least one of the suction source (vacuum source 1262) or an aspiration valve (valve 1260) to apply the suction force to the catheter (catheter 1242) in one or more pulses, wherein the suction force is configured to remove a first volume of the blood from the patient via the catheter (catheter 1242) during the one or more pulses (see Fig. 20, par. [0190]-[0193], suction and infusion can be alternated), and
wherein controlling the fluid controller (pump 1254) to introduce the fluid into the catheter (catheter 1242) comprises controlling at least one of a fluid source (saline bag 1248, spike 1252, tubing set 1250, and cassette 1258) or the fluid controller (pump 1254) to introduce a second volume of the fluid to the catheter between one or more of the one or more pulses (see par. [0190]-[0193], suction and infusion can be alternated).
Regarding claim 20, Culbert discloses the method of claim 19, wherein the suction source (vacuum source 1262) is configured to aspirate a thrombus through a lumen of the catheter (catheter 1242) in a first flow direction, wherein the fluid source (saline bag 1248, spike 1252, tubing set 1250, and cassette 1258) is configured to introduce the fluid to the lumen in a second flow direction opposite the first flow direction, and wherein the second volume is equal to or greater than the first volume, and wherein the second volume of the fluid displaces the first volume of the blood in the second flow direction (see par. [0190]-[0193], the volume of fluid infused and aspirated is controllable such that the volume aspirated can be equal to or greater than the volume infused).
Regarding claim 21, Culbert discloses the method of claim 12, further comprising:
determining, by the control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254), that at least one of the catheter (catheter 1242) has not captured a thrombus (see par. [0191] and [0193]); and
controlling, by the control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254), the fluid controller (pump 1254) to introduce the fluid based on determining that at least one of the catheter has not captured the thrombus (see par. [0191] and [0193]).
Regarding claim 22, Culbert discloses the method of claim 12, further comprising:
determining, by the control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254), that at least one of the catheter has captured a thrombus (see par. [0191] and [0193]); and
controlling, by the control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254), the fluid controller to introduce the fluid based on determining that at least one of the catheter has captured the thrombus (see par. [0191] and [0193]).
Claims 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malhi et al. (US 2016/0128715 A1).
Regarding claim 23, Malhi discloses a medical aspiration system (see Figs. 1 and 17-18) comprising:
a catheter (catheter 12/512) defining a catheter lumen (see Figs. 17-18);
a suction source (exhaust fluid reservoir 18) configured to apply a suction force to the catheter lumen to remove a thrombus from a blood vessel of a patient via the catheter lumen (see par. [0061] and [0089]);
a fluid source (infusion fluid source 14) configured to supply a fluid to the catheter lumen in a distal direction to displace blood in the catheter lumen (see par. [0061], [0089]-[0090]);
a fluid control valve (control device 22 includes an adjustable valve, see par. [0068]) configured to control an introduction of the fluid into the catheter lumen (see par. [0068]); and
control circuitry (see par. [0068]-[0073], the system is electrically controlled) configured to control at least one of the suction source (exhaust fluid reservoir 18), the fluid source (infusion fluid source 14), or the fluid control valve (adjustable valve, see par. [0068]) to cycle between applying the suction force to the catheter lumen and introducing the fluid into the catheter lumen, wherein introducing the fluid into the catheter lumen displaces an amount of the blood into the blood vessel of the patient and reduces a volume of the blood aspirated from the blood vessel through the catheter lumen (see par. [0068]-[0073], and [0089]-[0090]).
Regarding claim 24, Malhi discloses the medical aspiration system of claim 23, wherein the control circuitry (see par. [0068]-[0073], the system is electrically controlled) is configured to control the at least one of the suction source (exhaust fluid reservoir 18), the fluid source (infusion fluid source 14), or the fluid control valve (adjustable valve, see par. [0068]) to cycle between applying the suction force to the catheter lumen and introducing the fluid into the catheter lumen by at least controlling the suction source (exhaust fluid reservoir 18) or an aspiration valve (restrictor 23) to apply the suction force to the catheter (catheter 12/514) in one or more pulses (see par. [0070], [0072]-[0073], and [0090]) and controlling at least one of the fluid source (infusion fluid source 14) or the fluid control valve (adjustable valve, see par. [0068]) to introduce the fluid to the catheter (catheter 12/512) between one or more of the one or more pulses (see par. [0068]-[0070], [0072]-[0073], and [0089]-[0090]).
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.
Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Culbert et al. (US 2019/0381223 A1), as applied to claims 1 and 12 above, in view of Malhi et al. (US 2016/0128715 A1).
Regarding claim 4, Culbert discloses the medical system of claim 1, further comprising:
an aspiration valve (valve 1260) configured to control an amount of the suction force applied by the suction source (vacuum source 1262) to the catheter (catheter 1242) (see Fig. 20, par. [0190]-[0192]); and
control circuitry (circuitry for aspiration monitoring system 1270 and pump 1254) configured to control the fluid controller (pump 1254).
However, Culbert fails to state the control circuitry is configured to control the fluid controller to increase a rate at which the fluid is introduced into the catheter prior to controlling the aspiration valve to increase the suction force at a distal opening of the catheter.
Malhi teaches a medical system (see Figs. 1 and 17-18) wherein the control circuitry (see par. [0068]-[0073], the system is electrically controlled) is configured to control the fluid controller (control device 22) to increase a rate at which the fluid is introduced into the catheter (catheter 12/512) prior to controlling the aspiration valve to increase the suction force at a distal opening of the catheter (catheter 12/512) (see par. [0061], [0068]-[0070], and [0072]-[0073]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Culbert to include that the control circuitry is configured to control the fluid controller to increase a rate at which the fluid is introduced into the catheter prior to controlling the aspiration valve to increase the suction force at a distal opening of the catheter, as taught by Malhi, in order to assist in breaking up the occlusive material (see Malhi par. [0068]).
Regarding claim 15, Culbert discloses the method of claim 12. However, Culbert fails to state controlling, by the control circuitry, the fluid controller to increase a rate at which the fluid is introduced into the catheter prior to controlling an aspiration valve to increase the suction force at the distal opening of the catheter.
Malhi teaches a method (see Figs. 1 and 17-18) comprising controlling, by the control circuitry (see par. [0068]-[0073], the system is electrically controlled), the fluid controller (control device 22) to increase a rate at which the fluid is introduced into the catheter (catheter 12/512) prior to controlling an aspiration valve to increase the suction force at the distal opening of the catheter (catheter 12/512) (see par. [0061], [0068]-[0070], and [0072]-[0073]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Culbert to include controlling, by the control circuitry, the fluid controller to increase a rate at which the fluid is introduced into the catheter prior to controlling an aspiration valve to increase the suction force at the distal opening of the catheter, as taught by Malhi, in order to assist in breaking up the occlusive material (see Malhi par. [0068]).
Response to Arguments
Applicant’s arguments with respect to claims 1, 7, 9, 12, and 20 have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument. The amendments to claims 1 and 12 change the scope of the claims, necessitating the new grounds of rejection.
Applicant’s arguments with respect to claim 23 have been fully considered but they are not persuasive. Applicant argues that Malhi teaches two separate suction and irrigation lumens and therefore Malhi does not teach the claimed limitations of a catheter lumen, a suction force being applied to the [same] catheter lumen, and the fluid being supplied to the [same] catheter lumen. This argument is not found to be persuasive. The Examiner interprets that the entirety of the space within the catheter 512 can be considered “the catheter lumen” (see Fig. 17) as recited in the claim. Nevertheless, the fluid from the fluid source is delivered into 528 and 532 and are positioned such that at least portions of the delivered fluids are aspirated back into the exhaust lumen 530 (see Fig. 17, par. [0089]-[0090]), such that the exhaust lumen 530 would also meet the claimed recitations regarding “the catheter lumen”. Therefore, Applicant’s arguments regarding claim 23 are not found persuasive and the rejection is maintained.
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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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