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 11/10/2025 has been entered. Claims 1-20 are pending in the application.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13-15 of U.S. Patent No. 11,826,064 (Culbert’064) in view of Look (US 2017/0056032).
Claim 1 of Culbert’064 is drawn to the same structural limitations of a system for catheter-based aspiration, comprising an aspiration catheter comprising an elongate shaft configured for placement within a blood vessel of a subject, the shaft comprising an aspiration lumen having a proximal end and an open distal end; an extension tube having a distal end and a proximal end and a lumen extending therebetween, a distal end of the lumen of the extension tube configured to be hydraulically coupled to the aspiration lumen of the aspiration catheter at or adjacent to the proximal end of the aspiration lumen of the aspiration catheter; a peristaltic pump configured for driving fluid through the extension tube and comprising a pump base having a pressure shoe, and a rotatable head, the rotatable head including two or more compression elements arrayed therearound; a compressible tubular portion disposed between the distal end and the proximal end of the extension tube, the compressible tubular portion configured to be coupled to the pressure shoe and the rotatable head of the peristaltic pump, such that operation of the peristaltic pump causes the rotatable head to rotate such that the two or more compression elements drive fluid from the aspiration lumen of the aspiration catheter through the extension tube from the distal end of the extension tube to the proximal end of the extension tube, a first sensor configured to measure a characteristic of flow through at least one of the aspiration lumen or the lumen of the extension tube, and a controller configured to receive a first signal from the first sensor and configured to vary the operation of the peristaltic pump based at least in part on the first signal received from the first sensor related to a change in the characteristic of flow.
Culbert’064 does not explicitly recite wherein the open distal end is located at a distal extreme of the aspiration catheter.
Look teaches an analogous system wherein an open distal end (24, Fig 1) is located at a distal extreme of the aspiration catheter (4, Fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aspiration catheter to have an open distal end located at a distal extreme of the aspiration catheter as taught by Look in order to aid in the tracking through tortuous or occluded vasculature (Para 0058).
Claim 2 of the current application is rejected on the grounds of nonstatutory double patenting as being unpatentable over Claim 13 of Culbert’064 as the specific limitations of claim 2 are recited in claim 13 of the patent.
Claim 3 of the current application is rejected on the grounds of nonstatutory double patenting as being unpatentable over Claim 14 of Culbert’064 as the specific limitations of claim 3 are recited in claim 14 of the patent.
Claim 4 of the current application is rejected on the grounds of nonstatutory double patenting as being unpatentable over Claim 15 of Culbert’064 as the specific limitations of claim 4 are recited in claim 15 of the patent.
Claim 7 is rejected on the grounds of nonstatutory double patenting as being unpatentable over Claim 1 of Culbert’064 in view of Mollstam (US 2008/0243054).
Claim 1 of Culbert’064 teaches a system for catheter-based aspiration, comprising an aspiration catheter comprising an elongate shaft configured for placement within a blood vessel of a subject, the shaft comprising an aspiration lumen having a proximal end and an open distal end, an extension tube having a distal end and a proximal end and a lumen extending therebetween, the lumen of the extension tube configured to be hydraulically coupled to the aspiration lumen of the aspiration catheter, a peristaltic pump configured for driving fluid through the extension tube and comprising a pump base having a pressure shoe, and a rotatable head, the rotatable head including two or more compression elements arrayed therearound, a compressible tubular portion disposed between the distal end and the proximal end of the extension tube, the compressible tubular portion configured to be coupled to the pressure shoe and the rotatable head of the peristaltic pump, such that operation of the peristaltic pump causes the rotatable head to rotate such that the two or more compression elements drive fluid from the aspiration lumen of the aspiration catheter through the extension tube from the distal end of the extension tube to the proximal end of the extension tube, however is silent regarding teaches a collection receptacle having an interior, wherein the proximal end of the extension tube is configured to deliver the fluid into the interior of the collection receptacle.
Mollstam teaches analogous system for catheter-based aspiration (See Fig 11) comprising a collection receptacle (35, Fig 11) having an interior, wherein the proximal end of the extension tube (34, Fig 11) is configured to deliver the fluid into the interior of the collection receptacle (Para 0108).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system to comprise a collection receptacle so that the aspirated liquid can be disposed of (Para 0108).
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.
Claims 1-2, 7, 14-16, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Nakano (US 2020/0397465) in view of Nakano ‘661 (US 12,133,661) and further in view of Jarnagin (US 2013/0115120).
Claim 1, Nakano discloses a system for catheter-based aspiration (system of Fig 1), comprising: an aspiration catheter (20, Fig 1) comprising an elongate shaft configured for placement within a blood vessel of a subject (Para 0023), the shaft comprising an aspiration lumen (35, Fig 3) having a proximal end (end of lumen 35 near seal 42a, Fig 3) and a distal end (end of lumen 35 near treatment unit 21, Fig 3); an extension tube (45, Fig 3) having a distal end and a proximal end and a lumen extending therebetween (Para 0025), a distal end of the lumen of the extension tube configured to be hydraulically coupled to the aspiration lumen of the aspiration catheter at or adjacent to the proximal end of the aspiration lumen of the aspiration catheter (Para 0034; See Fig 3); a pump (54, Fig 1) configured for forcing fluid through the extension tube; a first sensor (70, Fig 9) configured to measure a characteristic of flow through at least one of the aspiration lumen or the lumen of the extension tube (Para 0054); and a controller configured to receive a first signal from the first sensor and configured to vary the operation of the peristaltic pump based at least in part on the first signal received from the first sensor related to a change in the characteristic of flow (Para 0054).
While Nakano teaches that the aspiration lumen is in fluid communication with the blood vessel as described in Para 0054, it is not clear where the opening is located. Further, Nakano is silent regarding the pump being a peristaltic pump configured for forcing fluid through the extension tube and comprising a pump base having a pressure shoe, and a rotatable head, the rotatable head including two or more compression members arrayed therearound; a compressible tubular portion disposed between the distal end and the proximal end of the extension tube, the compressible tubular portion configured to be coupled to the pressure shoe and the rotatable head of the peristaltic pump, such that operation of the peristaltic pump causes the rotatable head to rotate such that the two or more compression members force fluid from the aspiration lumen of the aspiration catheter through the extension tube from the distal end of the extension tube to the proximal end of the extension tube.
Nakano ‘661 teaches an analogous system for catheter-based aspiration (system of Fig 1), comprising: an aspiration catheter (30, Fig 1) comprising an elongate shaft configured for placement within a blood vessel of a subject (Col 3, lines 60-64), the shaft comprising an aspiration lumen (31, Fig 3) having a proximal end and an open distal end (33, Fig 3), wherein the open distal end is located at a distal extreme of the aspiration catheter (Col 6, lines 45-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aspiration catheter to include an opening at the distal extreme of the aspiration catheter as taught by Nakano ‘661 in order to promote aspiration of the cut object into the aspiration lumen (Col 6, lines 45-55).
The modified invention of Nakano and Nakano ‘661 disclose all of the elements of the invention as discussed above, however, is silent regarding the pump being a peristaltic pump configured for forcing fluid through the extension tube and comprising a pump base having a pressure shoe, and a rotatable head, the rotatable head including two or more compression members arrayed therearound; a compressible tubular portion disposed between the distal end and the proximal end of the extension tube, the compressible tubular portion configured to be coupled to the pressure shoe and the rotatable head of the peristaltic pump, such that operation of the peristaltic pump causes the rotatable head to rotate such that the two or more compression members force fluid from the aspiration lumen of the aspiration catheter through the extension tube from the distal end of the extension tube to the proximal end of the extension tube.
Jarnagin teaches an analogous system for catheter-based aspiration (Para 0004, Par 0012) comprising a peristaltic pump (pump of Fig 2) configured for forcing fluid through the extension tube (at least partially defined by tubing 155, Fig 6) and comprising a pump base (122, Fig 2) having a pressure shoe (136, Fig 2), and a rotatable head (120, Fig 2), the rotatable head including two or more compression members (124, Fig 2) arrayed therearound; a compressible tubular portion (155, Fig 6) disposed between the distal end and the proximal end of the extension tube (See Fig 1), the compressible tubular portion configured to be coupled to the pressure shoe and the rotatable head of the peristaltic pump, such that operation of the peristaltic pump causes the rotatable head to rotate such that the two or more compression members force fluid from the aspiration lumen of the aspiration catheter through the extension tube from the distal end of the extension tube to the proximal end of the extension tube (Para 0034, 0036, 0051).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pump disclosed by Nakano to instead be a peristaltic pump as taught by Jarnagin in order to have a pump arranged and configured to reduce load and enhance safety and pump operation (Para 0008).
Regarding claim 2, the modified invention of Nakano, Nakano ‘661 and Jarnagin discloses the first sensor (70, FIG 9 -Nakano) comprises a pressure transducer (Par 0054 -Nakano).
Regarding claim 7, Nakano discloses a system for catheter-based aspiration (system of Fig 1), comprising: an aspiration catheter (10, Fig 1) comprising an elongate shaft (20, Fig 1) configured for placement within a blood vessel of a subject (Para 0023), the shaft comprising an aspiration lumen (35, Fig 3) having a proximal end (end of lumen 35 near seal 42a, Fig 3) and a distal end (end of lumen 35 near treatment unit 21, Fig 3); an extension tube (45, Fig 3) having a distal end and a proximal end and a lumen extending therebetween (Para 0025), a distal end of the lumen of the extension tube configured to be hydraulically coupled to the aspiration lumen of the aspiration catheter at or adjacent to the proximal end of the aspiration lumen of the aspiration catheter (Para 0034; See Fig 3); a pump (54, Fig 1) configured for forcing fluid through the extension tube; and wherein the proximal end of the extension tube is configured to deliver the fluid to a discharge portion (Para 0025).
While Nakano teaches that the aspiration lumen is in fluid communication with the blood vessel as described in Para 0054, it is not clear where the opening is located. Further, Nakano is silent regarding the pump being a peristaltic pump configured for forcing fluid through the extension tube and comprising a pump base having a pressure shoe, and a rotatable head, the rotatable head including two or more compression members arrayed therearound; a compressible tubular portion disposed between the distal end and the proximal end of the extension tube, the compressible tubular portion configured to be coupled to the pressure shoe and the rotatable head of the peristaltic pump, such that operation of the peristaltic pump causes the rotatable head to rotate such that the two or more compression members force fluid from the aspiration lumen of the aspiration catheter through the extension tube from the distal end of the extension tube to the proximal end of the extension tube and a collection receptacle having an interior, wherein the proximal end of the extension tube is configured to deliver the fluid into the interior of the collection receptacle.
Nakano ‘661 teaches an analogous system for catheter-based aspiration (system of Fig 1), comprising: an aspiration catheter (30, Fig 1) comprising an elongate shaft configured for placement within a blood vessel of a subject (Col 3, lines 60-64), the shaft comprising an aspiration lumen (31, Fig 3) having a proximal end and an open distal end (33, Fig 3), wherein the open distal end is located at a distal extreme of the aspiration catheter (Col 6, lines 45-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aspiration catheter to include an opening at the distal extreme of the aspiration catheter as taught by Nakano ‘661 in order to promote aspiration of the cut object into the aspiration lumen (Col 6, lines 45-55).
The modified invention of Nakano and Nakano ‘661 disclose all of the elements of the invention as discussed above, however, is silent regarding the pump being a peristaltic pump configured for forcing fluid through the extension tube and comprising a pump base having a pressure shoe, and a rotatable head, the rotatable head including two or more compression members arrayed therearound; a compressible tubular portion disposed between the distal end and the proximal end of the extension tube, the compressible tubular portion configured to be coupled to the pressure shoe and the rotatable head of the peristaltic pump, such that operation of the peristaltic pump causes the rotatable head to rotate such that the two or more compression members force fluid from the aspiration lumen of the aspiration catheter through the extension tube from the distal end of the extension tube to the proximal end of the extension tube and a collection receptacle having an interior, wherein the proximal end of the extension tube is configured to deliver the fluid into the interior of the collection receptacle.
Jarnagin teaches an analogous system for catheter-based aspiration (Para 0004, Par 0012) comprising a peristaltic pump (pump of Fig 2) configured for forcing fluid through the extension tube (at least partially defined by tubing 155, Fig 6) and comprising a pump base (122, Fig 2) having a pressure shoe (136, Fig 2), and a rotatable head (120, Fig 2), the rotatable head including two or more compression members (124, Fig 2) arrayed therearound; a compressible tubular portion (155, Fig 6) disposed between the distal end and the proximal end of the extension tube (See Fig 1), the compressible tubular portion configured to be coupled to the pressure shoe and the rotatable head of the peristaltic pump, such that operation of the peristaltic pump causes the rotatable head to rotate such that the two or more compression members force fluid from the aspiration lumen of the aspiration catheter through the extension tube from the distal end of the extension tube to the proximal end of the extension tube (Para 0034, 0036, 0051) and a collection receptacle having an interior, wherein the proximal end of an extension tube is configured to deliver the fluid into the interior of the collection receptacle (Para 0034, 0059).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pump disclosed by Nakano to instead be a peristaltic pump as taught by Jarnagin in order to have a pump arranged and configured to reduce load and enhance safety and pump operation (Para 0008). Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the discharge portion to be a collection receptacle as taught by Jarnagin in order to collect/dispose of the aspirate (Para 0034)
Regarding claim 14 the modified invention of Nakano, Nakano ‘661 and Jarnagin discloses the two or more compression members (124, Fig 2 -Jarnagin) comprise two or more rollers (“rollers 124”, Para 0036)
Regarding claim 15, the modified invention of Nakano, Nakano ‘661 and Jarnagin discloses the controller is configured to vary rotation speed (i.e., stopping) of the rotatable head of the peristaltic pump based at least in part on the first signal received from the first sensor related to a change in the characteristic of flow (Para 0054 -Nakano).
Regarding claim 16, the modified invention of Nakano, Nakano ‘661 and Jarnagin discloses the controller is configured to stop rotation of the rotatable head of the peristaltic pump based at least in part on the first signal received from the first sensor related to a change in the characteristic of flow (Para 0054 -Nakano).
Regarding claim 18, the modified invention of Nakano, Nakano ‘661 and Jarnagin discloses the two or more compression members (124, Fig 2 -Jarnagin) comprise two or more rollers (“rollers 124”, Para 0036).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Nakano (US 2020/0397465) in view of Nakano ‘661 (US 12,133,661) and further in view of Jarnagin (US 2013/0115120) and further in view of Criado (US 2009/0024072).
Regarding claim 3, the modified invention of Nakano, Nakano ‘661, and Jarnagin discloses a first sensor (flow sensor 70, Fig 9 -Nakano), however, is silent regarding it being an ultrasound sensor.
Criado teaches a flow sensor (1135, Fig 11) comprising an ultrasound sensor (Para 0122).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flow sensor to be an ultrasound sensor as taught by Criado in order to have a flow sensor that does not have to contact the internal lumen or blood flowing through it (Para 0122).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Nakano (US 2020/0397465) in view of Nakano ‘661 (US 12,133,661) and further in view of Jarnagin (US 2013/0115120) and further in view of Criado (US 2009/0024072) and further in view of Krimsky (US 2018/0078119).
Regarding claim 4, the modified invention of Nakano, Nakano ‘661, Jarnagin, and Criado discloses all of the elements of the invention as discussed above, however, is silent regarding the controller is configured to count the number of times during a predetermined time period that a signal output by the ultrasound sensor surpasses a predetermined threshold amplitude.
Krimsky teaches a system wherein a controller configured to count the number of times during a predetermined time period that a signal output by the flow sensor surpasses a predetermined threshold amplitude (Para 0087-0088).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to count the number of times during a predetermined time period that a signal output by the ultrasound sensor surpasses a predetermined threshold amplitude as taught by Krimsky in order to prevent against or indicate failure of the system (Para 0087)
Regarding claim 5, the modified invention of Nakano, Nakano ‘661, Jarnagin, Criado, and Krimsky discloses the controller is further configured to determine whether the number of times during the predetermined time period is less than or less than or equal to a predetermined value or greater than or greater than or equal to the predetermined value (Para 0087-0088 -Krimsky).
Regarding claim 6, the modified invention of Nakano, Nakano ‘661, Jarnagin, Criado, and Krimsky discloses a communicator coupled to the controller and configured to be in a first communication mode (continue pumping) if the number of times during the predetermined time period is less than or less than or equal to the predetermined value and to be in a second communication mode (stop pumping) if the number of times during the predetermined time period is greater than or greater than or equal to the predetermined value (Para 0087-0088 -Krimsky).
Claims 8-9, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nakano (US 2020/0397465) in view of Nakano ‘661 (US 12,133,661) and further in view of Jarnagin (US 2013/0115120) and further in view of Weston (US 2005/0261642).
Regarding claim 8, the modified invention of Nakano, Nakano ‘661, and Jarnagin a controller (51, Fig 2 -Nakano), however, is silent regarding a level sensor coupled to the collection receptacle and configured to send a signal to the controller when a predetermined fluid height or fluid volume is reached.
Weston teaches an analogous collection receptacle comprising a level sensor coupled to the collection receptacle and configured to send a signal to the controller when a predetermined fluid height or fluid volume is reached (Para 0040; the pump is stopped when the container exceeds a predetermined quantity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the collection receptacle to include a level sensor as taught by Weston in order to prevent the collection receptacle from exceeding a predetermined quantity (Para 0040).
Regarding claim 9, the modified invention of Nakano, Nakano ‘661, Jarnagin, and Weston discloses the controller is configured to stop rotation of the rotatable head of the peristaltic pump based at least in part on the signal from the level sensor (Para 0040 -Weston; the pump is stopped when the container exceeds a predetermined quantity).
Regarding claim 19, the modified invention of Nakano, Nakano ‘661, and Jarnagin discloses all of the elements of the invention as discussed above, however, is silent regarding a scale configured to weigh fluid in the interior of the collection receptacle and to output a signal related to the measured weight.
Weston teaches an analogous collection receptacle comprising a level sensor coupled to the collection receptacle and configured to send a signal to the controller when a predetermined fluid height or fluid volume is reached (Para 0040; the pump is stopped when the container exceeds a predetermined quantity); the level sensor comprising a scale (weight sensor, Para 0040).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the collection receptacle to include a scale as taught by Weston in order to prevent the collection receptacle from exceeding a predetermined quantity (Para 0040).
Claims 10-13, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nakano (US 2020/0397465) in view of Nakano ‘661 (US 12,133,661) and further in view of Jarnagin (US 2013/0115120) and further in view of Batiste (US 2018/0042623).
Regarding claim 10, Nakano discloses a method of operating a system for catheter-based aspiration (Para 0007), comprising: providing an aspiration catheter (10, Fig 1) and an extension tube (45, Fig 3) couplable to each other (Para 0034; See Fig 3), the aspiration catheter comprising an elongate shaft (20, Fig 1) configured for placement within a blood vessel of a subject (Para 0023), the shaft comprising an aspiration lumen (35, Fig 3) having a proximal end (end of lumen 35 near seal 42a, Fig 3) and a distal end (end of lumen 35 near treatment unit 21, Fig 3), the extension tube having a distal end and a proximal end and a lumen extending therebetween, a distal end of the lumen of the extension tube configured to be hydraulically coupled to the aspiration lumen of the aspiration catheter at or adjacent to the proximal end of the aspiration lumen of the aspiration catheter (Par 0034; See Fig 3); inserting a distal end of the aspiration catheter into a blood vessel of a subject (Para 0023); aspirating thrombus and blood of the subject through the aspiration lumen of the aspiration catheter and through the lumen of the extension tube (Para 0006).
While Nakano teaches that the aspiration lumen is in fluid communication with the blood vessel as described in Para 0054, it is not clear where the opening is located. Further, Nakano is silent regarding the pump being a peristaltic pump configured for forcing fluid through the extension tube and comprising a pump base having a pressure shoe, and a rotatable head, the rotatable head including two or more compression members arrayed therearound; a compressible tubular portion disposed between the distal end and the proximal end of the extension tube, the compressible tubular portion configured to be coupled to the pressure shoe and the rotatable head of the peristaltic pump, such that operation of the peristaltic pump causes the rotatable head to rotate such that the two or more compression members force fluid from the aspiration lumen of the aspiration catheter through the extension tube from the distal end of the extension tube to the proximal end of the extension tube.
Nakano ‘661 teaches an analogous system for catheter-based aspiration (system of Fig 1), comprising: an aspiration catheter (30, Fig 1) comprising an elongate shaft configured for placement within a blood vessel of a subject (Col 3, lines 60-64), the shaft comprising an aspiration lumen (31, Fig 3) having a proximal end and an open distal end (33, Fig 3), wherein the open distal end is located at a distal extreme of the aspiration catheter (Col 6, lines 45-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aspiration catheter to include an opening at the distal extreme of the aspiration catheter as taught by Nakano ‘661 in order to promote aspiration of the cut object into the aspiration lumen (Col 6, lines 45-55).
The modified invention of Nakano and Nakano ‘661 disclose all of the elements of the invention as discussed above, however, is silent regarding Nakano is silent regarding the extension tube further comprising a compressible tubular portion disposed between the distal end and the proximal end of the extension tube, the compressible tubular portion configured to be coupled to a pressure shoe and a rotatable head of a peristaltic pump, such that operation of the peristaltic pump causes the rotatable head to rotate such that the two or more compression members force fluid from the aspiration lumen of the aspiration catheter through the extension tube from the distal end of the extension tube to the proximal end of the extension tube; aspirating thrombus and blood by causing the rotatable head of the peristaltic pump to rotate such that the two or more compression members compress the compressible tubular portion of the extension tube; and returning at least some of the blood to vasculature of the subject via a return conduit hydraulically coupled to the extension tube.
Jarnagin teaches an analogous system for catheter-based aspiration (Para 0004, Par 0012) comprising a peristaltic pump (pump of Fig 2) configured for forcing fluid through the extension tube (at least partially defined by tubing 155, Fig 6) and comprising a pump base (122, Fig 2) having a pressure shoe (136, Fig 2), and a rotatable head (120, Fig 2), the rotatable head including two or more compression members (124, Fig 2) arrayed therearound; a compressible tubular portion (155, Fig 6) disposed between the distal end and the proximal end of the extension tube (See Fig 1), the compressible tubular portion configured to be coupled to the pressure shoe and the rotatable head of the peristaltic pump, such that operation of the peristaltic pump causes the rotatable head to rotate such that the two or more compression members force fluid from the aspiration lumen of the aspiration catheter through the extension tube from the distal end of the extension tube to the proximal end of the extension tube, aspirating by causing the rotatable head of the peristaltic pump to rotate such that the two or more compression members compress the compressible tubular portion of the extension tube (Para 0034, 0036, 0051).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pump disclosed by Nakano to instead be a peristaltic pump as taught by Jarnagin in order to have a pump arranged and configured to reduce load and enhance safety and pump operation (Para 0008).
the modified invention of Nakano, Nakano ‘661 and Jarnagin discloses all of the elements of the invention as discussed above, however, is silent regarding returning at least some of the blood to vasculature of the subject via a return conduit hydraulically coupled to the extension tube.
Batiste teaches an analogous method of operating a system for catheter-based aspiration system comprising providing an aspiration catheter (2410, Fig 24R), and returning at least some of the blood to vasculature of the subject via a return conduit (2456, Fig 24E) hydraulically coupled to the extension tube (2420, Fig 24E) (Para 0081-0082).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method disclosed by Nakano and Jarnagin to include a return conduit having a filter 2416 to return at least some of the blood to vasculature of the subject as taught by Batiste in order to limit blood loss during aspiration of blood clots and allow for longer working times and complete clot removal (Para 0012)
Regarding claim 11, the modified invention of Nakano, Nakano ‘661, Jarnagin, and Batiste discloses filtering a portion of the blood with a filter disposed between the extension tube and the return conduit (Para 0081-0082 -Batiste).
Regarding claim 12, the modified invention of Nakano, Nakano ‘661, Jarnagin, and Batiste discloses providing the filter (2416, Fig 24E -Batiste)
Regarding claim 13, the modified invention of Nakano, Nakano ‘661, Jarnagin, and Batiste discloses providing the extension tube (45, Fig 3 -Nakano)
Regarding claim 20, the modified invention of Nakano, Nakano ‘661, Jarnagin, and Batiste discloses the two or more compression members (124, Fig 2 -Jarnagin) comprise two or more rollers (“rollers 124”, Para 0036)
Claims 17 are rejected under 35 U.S.C. 103 as being unpatentable over Nakano (US 2020/0397465) in view of Nakano ‘661 (US 12,133,661) and further in view of Jarnagin (US 2013/0115120) and further in view of Westenbrink (US 2019/0376504).
Regarding claim 17, the modified invention of Nakano, Nakano ‘661, and Jarnagin discloses the controller is configured to stop rotation of the rotatable head of the peristaltic pump based at least in part on the first signal received from the first sensor related to a change in the characteristic of flow (Para 0054 -Nakano), however is silent regarding a first compression member of the two or more compression members causes occlusion of the extension tube at the compressible tubular portion.
Westenbrink teaches stopping a first compression member (42, Fig 1) of the two or more compression members (42 and 44, Fig 1) to causes occlusion of the extension tube (12, Fig 1) at the compressible tubular portion (Para 0007,0013, 0077)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the peristatic pump to stop a compression member to causes occlusion of the extension tube as taught by Westenbrink in order to prevent the escape or backflow of fluid contained in the flexible tube (Para 0007).
Response to Arguments
Applicant’s arguments filed 11/10/2025, on pages 6-8, regarding the double patenting rejection have been fully considered but are not persuasive. The Terminal Disclaimer in application 16/88,500 regarding Patent no. 10,716,880 has no bearing on the instant application and Patent no 11,826,064. Therefore, it is unclear how this invalids the current double patenting rejection. If the instant application were to go to issue, the 20-year date would be based on the filing date of 10/17/2023 and would thus extend past expiration date of June 13, 2039. Therefore, the double patenting rejection is still valid and remains in this current office action.
Applicant’s arguments filed 11/10/2025, on page 9, regarding being unclear if the Japanese application 2018-064009 supports the relevant assertions in the Office Action have been fully considered, but are not persuasive. Examiner has provided a machine translation of the Japanese Application mailed with the Non-Final office action mailed 08/08/2025. Applicant has not provided any specific shortcomings of the art and therefore it is unclear what the Applicant is asking for. Regardless, Nakano falls under prior art under 35 U.S.C. 102(a)(2) as it is a US application, names another inventor, and was effectively filed before the effective filing date of the claimed invention.
Applicant’s arguments filed 11/10/2025, on pages 10-12, regarding the Office Action failing has not established that the aspiration opening 33 is an open distal end located at a distal extreme of the medical device of Nakano ‘661 have been fully considered but are not persuasive. Examiner points to the claim language regarding the open distal end as reciting “an aspiration catheter comprising an elongate shaft configured for placement within a blood vessel of a subject, the shaft comprising an aspiration lumen having a proximal end and an open distal end, wherein the open distal end is located at a distal extreme of the aspiration catheter”. The language is regarding an aspiration catheter (20, Fig 3 -Nakano) having an open distal end at a distal extreme of the aspiration catheter (not a distal extreme of the entire medical device or system as Applicant state in the arguments). The distal extreme of the aspiration catheter 20 is open as it receives the treatment unit 21. Similarly, the aspiration tube 30 of Nakano ‘661 has an open distal end as it receives the cutting tool 40. Therefore, Applicant is arguing a feature that is, in fact, not claimed.
Applicant’s arguments filed 11/10/2025, on pages 12-14, regarding the prior art failing to teach that the treatment unit 21 and drive shaft 30 can be pulled into the outer sheath have been fully considered but are not persuasive. It is unclear to the Examiner what claim limitation Applicant is addressing in these arguments. The current rejections do not cite elements 21 and 30 of Nakano to teach any of the claimed elements and thus there is no reason to show that they can be pulled into the outer sheath.
Applicant’s arguments filed 11/10/2025, on pages 16, regarding the Office Action has not established that Nakano teaches aspirating thrombus and blood of the subject through the aspiration lumen of the aspiration catheter and through the lumen of the extension tube have been fully considered but are not persuasive. As detailed in Para 0037 of Nakano and Col 6, lines 45-55 of Nakano ‘661, the system aspirates thrombus and blood from the blood vessel. Therefore, the combine invention of Nakano, Nakano ‘661, and Batiste discloses all of the claimed limitations.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783