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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/08/2026 has been entered.
Response to Amendment
The amendment filed 06/08/2026 has been entered. Claims 1-23 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 defines a distal extreme of the system, and is entirely unobstructed.
Look teaches an analogous system wherein an open distal end (16, Fig 4A) is located at a distal extreme of the aspiration catheter, and is entirely unobstructed (See Fig 4A).
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) and allow pieces of thrombi to easily pass through the lumen (Para 0072).
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, 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Look ‘877 (US 9,883,877) and further in view of Jarnagin (US 2013/0115120).
Claim 1, Look ‘877 discloses a system (10, Fig 1) for aspiration, comprising: an aspiration catheter (700, Fig 26) comprising an elongate shaft configured for placement within a blood vessel (165, Fig 26) of a subject, the shaft comprising an aspiration lumen (710, Fig 26) having a proximal end and an open distal end, wherein the open distal end (722, Fig 26) defines a distal extreme of the system, and is entirely unobstructed (See Figs 26 and 27 wherein the distal extreme is completely open and unobstructed); an extension tube (56, Fig 2) 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 (Col 4, lines 58-59; See Fig 1); a vacuum pump (22, Fig 1; Col 5, lines 5-7); a first sensor (58, Fig 2) configured to measure a characteristic of flow through at least one of the aspiration lumen or the lumen of the extension tube (Col 6, lines 36-41); and a controller (50, Fig 2) 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 (Col 6, lines 36-60).
Look ‘877 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 Look ‘877 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 Look ‘877 and Jarnagin discloses the first sensor (58, Fig 2 -Look ‘877) comprises a pressure transducer (Col 6, lines 36-60 -Look ‘877).
Regarding claim 7, Look ‘877 discloses a system (10, Fig 1) for catheter-based aspiration, comprising: an aspiration catheter (700, Fig 26) comprising an elongate shaft configured for placement within a blood vessel (165, Fig 26) of a subject, the shaft comprising an aspiration lumen (710, Fig 26) having a proximal end and an open distal end, wherein the open distal end (722, Fig 26) defines a distal extreme of the system, and is entirely unobstructed aspiration catheter (See Figs 26 and 27 wherein the distal extreme is completely open and unobstructed); an extension tube (56, Fig 2) 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 (Col 4, lines 58-59; See Fig 1); a vacuum pump (22, Fig 1; Col 5, lines 5-7); and a collection receptacle (“collection container”) having an interior, wherein the proximal end of the extension tube is configured to deliver the fluid into the interior of the collection receptacle (Col 7, line 67 – Col 8, line 1).
Look ‘877 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 Look ‘877 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 Look ‘877 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 Look ‘877 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 (Col 6, lines 36-60 -Look ‘877).
Regarding claim 16, the modified invention of Look ‘877 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 (Col 6, lines 36-60 -Look ‘877).
Regarding claim 18, the modified invention of Look ‘877 and Jarnagin discloses the two or more compression members (124, Fig 2 -Jarnagin) comprise two or more rollers (“rollers 124”, Para 0036 -Jarnagin).
Regarding Claim 21, the modified invention of Look ‘877 and Jarnagin discloses the aspiration catheter further comprises an a high-pressure tube (712, Fig 26 -Look ‘877) extending within the aspiration lumen to a distal portion of the aspiration lumen, the high-pressure tube comprising an injection lumen (708, Fig 26 –Look ‘877) extending within the high-pressure tube and having a distal end and a proximal end, and wherein the aspiration catheter further comprises an orifice (718, Fig 26 -Look ‘877) passing through a wall of the high-pressure tube and located at or near the distal end of the injection lumen, the orifice configured to create one or more jets into the aspiration lumen when pressurized fluid is injected through the injection lumen, the system further comprising an injection pump (26, Fig 2 -Look ‘877) configured to pressurize the fluid (Col 16, lines 32-40 -Look ‘877).
Regarding Claim 22, the modified invention of Look ‘877 and Jarnagin discloses the aspiration catheter further comprises an a high-pressure tube (712, Fig 26 -Look ‘877) extending within the aspiration lumen to a distal portion of the aspiration lumen, the high-pressure tube comprising an injection lumen (708, Fig 26 –Look ‘877) extending within the high-pressure tube and having a distal end and a proximal end, and wherein the aspiration catheter further comprises an orifice (718, Fig 26 -Look ‘877) passing through a wall of the high-pressure tube and located at or near the distal end of the injection lumen, the orifice configured to create one or more jets into the aspiration lumen when pressurized fluid is injected through the injection lumen, the system further comprising an injection pump (26, Fig 2 -Look ‘877) configured to pressurize the fluid (Col 16, lines 32-40 -Look ‘877).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Look ‘877 (US 9,883,877) in view of Jarnagin (US 2013/0115120) and further in view of Criado (US 2009/0024072).
Regarding claim 3, the modified invention of Look ‘877 and Jarnagin discloses a first sensor (58, Fig 2 -Look ‘877), 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 Look ‘877 (US 9,883,877) 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 Look ‘877, 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 Look ‘877, 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 Look ‘877, 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 Look ‘877 (US 9,883,877) in view of Jarnagin (US 2013/0115120) and further in view of Weston (US 2005/0261642).
Regarding claim 8, the modified invention of Look ‘877 and Jarnagin discloses a controller (50, Fig 2 -Look ‘877), 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 Look ‘877, 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 Look ‘877, 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, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Look ‘877 (US 9,883,877) and further in view of Jarnagin (US 2013/0115120) and further in view of Batiste (US 2018/0042623).
Regarding claim 10, Look ‘877 discloses a method for aspiration, providing a system (10, Fig 1) for aspiration comprising an aspiration catheter (700, Fig 26) and an extension tube (56, Fig 2) couplable to each other (See Fig 1), the aspiration catheter comprising an elongate shaft configured for placement within a blood vessel (165, Fig 26) of a subject, the shaft comprising an aspiration lumen (710, Fig 26) having a proximal end and an open distal end (722, Fig 26), wherein the open distal end defines a distal extreme of the system, and is entirely unobstructed (See Figs 26 and 27 wherein the distal extreme is completely open and unobstructed), 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 (Col 4, lines 58-59; See Fig 1); inserting a distal portion of the shaft end of the aspiration catheter into a blood vessel of the subject (See Fig 26); aspirating thrombus and blood of the subject through the aspiration lumen of the aspiration catheter and through the lumen of the extension tube (Col 16, lines 58-64; Col 7, line 67 – Col 8, line 1; the thrombus and blood are aspirated through the extension tube to the collection container at numeral 22, Fig 1).
Look ‘877 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 Look ‘877 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 Look ‘877 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 24E), 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 Look ‘877 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 Look ‘877, 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 Look ‘877, Jarnagin, and Batiste discloses providing the filter (2416, Fig 24E -Batiste)
Regarding claim 13, the modified invention of Look ‘877, Jarnagin, and Batiste discloses providing the extension tube (56, Fig 2 -Look ‘877).
Regarding claim 20, the modified invention of Look ‘877, Jarnagin, and Batiste discloses the two or more compression members (124, Fig 2 -Jarnagin) comprise two or more rollers (“rollers 124”, Para 0036)
Regarding Claim 23, the modified invention of Look ‘877, Jarnagin, and Batiste discloses the aspiration catheter further comprises an a high-pressure tube (712, Fig 26 -Look ‘877) extending within the aspiration lumen to a distal portion of the aspiration lumen, the high-pressure tube comprising an injection lumen (708, Fig 26 –Look ‘877) extending within the high-pressure tube and having a distal end and a proximal end, and wherein the aspiration catheter further comprises an orifice (718, Fig 26 -Look ‘877) passing through a wall of the high-pressure tube and located at or near the distal end of the injection lumen, the orifice configured to create one or more jets into the aspiration lumen when pressurized fluid is injected through the injection lumen, the system further comprising an injection pump (26, Fig 2 -Look ‘877) configured to pressurize the fluid (Col 16, lines 32-40 -Look ‘877).
Claims 17 are rejected under 35 U.S.C. 103 as being unpatentable over Look ‘877 (US 9,883,877) 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 Look ‘877 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 (Col 6, lines 36-60 -Look ‘877), 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 06/08/2026, on pages 8-11, 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 nonstatutory double patenting rejection regarding the instant application and Patent no 11,826,064. Therefore, it is unclear how this invalids the current double patenting rejection. Applicant has tried to make the argument that there is no need for a Terminal Disclaimer and thus no need for the double patenting rejection in this office action because issuance of this application would not extend the patent term. Regardless of whether that is true or not, it is not the only reason for a Terminal Disclaimer. As detailed in MPEP 804.02(VI), “There are at least two reasons for insisting upon a terminal disclaimer to overcome a nonstatutory double patenting rejection in an application subject to a 20-year term under 35 U.S.C. 154(a)(2)… Second, 37 CFR 1.321(c)(3) requires that a terminal disclaimer filed to obviate a nonstatutory double patenting rejection based on commonly owned conflicting claims include a provision that any patent granted on that application be enforceable only for and during the period that the patent is commonly owned with the application or patent which formed the basis for the rejection.”. The Terminal Disclaimer ensures that the patents stay linked and are enforced together. The section further states “Accordingly, a terminal disclaimer under 37 CFR 1.321 is required in an application to overcome a nonstatutory double patenting rejection, even if the application was filed on or after June 8, 1995 and even if the application claims the benefit under 35 U.S.C. 120, 121, 365(c), or 386(c) of the filing date of the patent or application which forms the basis for the rejection. Examiners should respond to arguments that a terminal disclaimer under 37 CFR 1.321 should not be required in a continuing application filed on or after June 8, 1995 to overcome a nonstatutory double patenting rejection due to the change to 35 U.S.C. 154 by citing to this section of the MPEP. See Terminal Disclaimers Required to Overcome Judicially-Created Double Patenting Rejections in Utility and Plant Applications Filed on or After June 8, 1995,1202 OG 112 (September 30, 1997). See also AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014)”. Therefore, the arguments pertaining to the issuance not extending the patent term is not a substantial argument to overcome the rejection.
Applicant’s arguments filed 06/08/2026, on page 11-12, regarding being unclear if the Japanese application 2018-064009 supports the relevant assertions in the Office Action have been fully considered, but are moot in view of the current rejection that no longer relies on Nakano.
Applicant’s arguments filed 06/08/2026, on pages 12-16, regarding Nakano and Nakano ‘661 failing to teach the amended limitations have been fully considered but are moot in view of the current rejection that no longer relies on those references.
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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