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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 27, 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on April 27, 2026. As directed by the amendment: claims 16, 24 and 29-30 have been amended, claims 1-15 and 17 have been cancelled, and no claims have been added. Thus, claims 16 and 18-30 are presently pending in this application. Applicant’s amendments are sufficient to overcome the §112(a) rejections of the previous action.
Response to Arguments
Applicant’s arguments, see Remarks, filed April 27, 2026, with respect to the rejections of claims 16 and 18-30 under 35 U.S.C. §112(a) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Buck et al. (Buck) US 2021/0316127 A1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16, 18-20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Buck et al. (Buck) US 2021/0316127 A1 in view of Bonnette et al. (Bonnette) US 2007/0129679 A1 in view of Sunenshine et al. (Sunenshine) US 2022/0226555 A1 in view of Saadat et al. (Saadat) US 11,376,028 B1.
Regarding claim 16, Buck discloses a method of clot removal and blood return (P0097-0099 and Fig. 6) comprising: positioning an aspiration catheter (catheter 12, P0097) adjacent to a first clot material (thrombus, P0097) within a patient; cause a pressure source (syringe 50, P0097) to deliver a first stroke (retracting the plunger, P0097) and a second stroke (pushing the plunger, P0098), wherein each actuation causes the pressure source to: aspirate the first clot material on the first stroke, filter the first clot material from blood (actuation of the pump 50 by proximally retracting the plunger draws thrombus through the access catheter 12 and into the thrombus filter 66 where thrombus and thrombus particles having a size greater than a predetermined threshold will be entrapped, P0097), and drive filtered blood to a blood return line (bypass tube 70, P0098) for return to the patient on the second stroke (by reversing the pump by pushing the plunger and pushing filtered blood back into the patient, P0098).
Buck does not teach a fluidic driver for reciprocal movement of the plunger.
However, Bonnette teaches a pneumatically-operated thrombectomy catheter having a fluidic driver (compressed air, see annotated Fig. 6a below).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the embodiment of Buck in Fig. 6 with a fluidic driver as taught by Bonnette, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Buck in view of Bonnette does not teach actuating a control one or more times to trigger the fluidic driver of Bonnette to retract and push the plunger of Buck.
However, Sunenshine teaches a filtration system and method of removing a clot including actuating a control (on/off switch 93, P0049 and show in Figs. 15-16) one or more times to trigger a fluidic driver.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Buck in view of Bonnette with a control as taught by Sunenshine for the purpose of controlling the fluidic driver of Bonnette on and off to control the flow of bodily fluid, Sunenshine P0049.
Buck in view of Bonnette in view of Sunenshine does not teach repositioning the aspiration catheter to be adjacent to a second clot material within the patient; and actuating the control one or more additional times to trigger the fluidic driver to cause the pressure source to deliver a first stroke and a second stroke, wherein each actuation causes the pressure source to: aspirate the second clot material on the first stroke, filter the second clot material from blood, and drive the filtered blood to the patient on the second stroke.
However, Saadat teaches a method (shown in Figs. 33A-C) for removing obstructive material (thrombus O) from body lumens wherein the aspiration catheter is repositioned to a second clot material (second clot material, see annotated Fig. 33A below) to remove a second clot (c 41 ln 15-25).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to reposition the catheter of Buck in view of Bonnette in view of Sunenshine prior to repeating the method of Buck in view of Bonnette in view of Sunenshine for the purpose of removing additional clots as taught by Saadat, to further improve patient blood circulation.
Regarding claim 18, Buck in view of Bonnette in view of Sunenshine in view of Saadat teaches the method of claim 16, wherein the first stroke comprises a negative pressure stroke and the second stroke comprises a positive pressure stroke (Buck, P0097-0098).
Regarding claim 19, Buck in view of Bonnette in view of Sunenshine in view of Saadat teaches the method of claim 16, wherein the first stroke results in a first flow rate by which clot material is aspirated with blood (retraction of the plunger results in a first flow rate that includes unfiltered blood) and wherein the second stroke results in a second flow rate by which filtered blood is returned to the patient (the second stroke sends the blood through filter 66 of Buck to remove clots and therefore results in a second flow rate of filtered blood returned to the patient, and wherein the flow path of blood forms a loop back to the patient that aspirates unfiltered blood from the patient and returns filtered blood to the patient).
Regarding claim 20, Buck in view of Bonnette in view of Sunenshine in view of Saadat teaches the method of claim 19, wherein the first flow rate is greater than the second flow rate (flow rate is a measure of the volume or mass of fluid passing through a specific area per unit of time, and the method removes mass (clotting) so that the first flow rate is greater than the second rate because the fluid flows in a loop and returns less mass to the patient).
Regarding claim 23, Buck in view of Bonnette in view of Sunenshine in view of Saadat teaches the method of claim 16, wherein actuating the control comprises pushing a button (Sunenshine, on/off switch 93, P0049).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Buck in view of Bonnette in view of Sunenshine in view of Saadat, and further in view of Saadat et al. (Saadat ‘857) US 2022/0409857 A1.
Regarding claim 21, Buck in view of Bonnette in view of Sunenshine in view of Saadat teaches the method of claim 16.
Buck in view of Bonnette in view of Sunenshine in view of Saadat does not teach the method further comprising sensing, using one or more sensors on the aspiration catheter, that the aspiration catheter is adjacent to the first clot material.
However, Saadat ‘857 teaches an apparatus and method for tracking obstructive material within a suction catheter further comprising sensing (sensing modalities, P0289), using one or more sensors on the aspiration catheter (one or more sensors may be positioned at the distal end of the catheter P0289), that the aspiration catheter is adjacent to the first clot material (for detecting the presence and/or detecting the proximity of clot material relative to the distal end opening of a suction catheter, P0289).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Buck in view of Bonnette in view of Sunenshine in view of Saadat with sensors as taught by Saadat ‘857 for the purpose of identifying clot material for removal.
Regarding claim 22, Buck in view of Bonnette in view of Sunenshine in view of Saadat in view of Saadat ‘857 teaches the method of claim 21, wherein sensing comprises sensing an electrical impedance (Saadat ‘857, impedance, P0289).
Claims 24-26 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Buck in view of Bonnette in view of Sunenshine in view of Saadat.
Regarding claim 24, Buck discloses a method of clot removal and blood return (P0097-0099 and Fig. 6) comprising: positioning an aspiration catheter (catheter 12, P0097) adjacent to a first clot material (thrombus, P0097) within a patient; drive a pressure source (syringe 50, P0097), wherein the pressure source generates a negative pressure stroke (retracting the plunger, P0097) that aspirates the first clot material (actuation of the pump 50 by proximally retracting the plunger draws thrombus through the access catheter 12 and into the thrombus filter 66 where thrombus and thrombus particles having a size greater than a predetermined threshold will be entrapped, P0097) and a positive pressure stroke (pushing the plunger, P0098) that drives filtered blood to a blood return line for return to the patient (by reversing the pump by pushing the plunger and pushing filtered blood back into the patient, P0098), wherein the blood is filtered during the negative pressure stroke and/or the positive pressure stroke (negative pressure stroke).
Buck does not teach a fluidic driver for reciprocal movement of the plunger.
However, Bonnette teaches a pneumatically-operated thrombectomy catheter having a fluidic driver (compressed air, see annotated Fig. 6a below).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the embodiment of Buck in Fig. 6 with a fluidic driver as taught by Bonnette, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Buck in view of Bonnette does not teach actuating a control one or more times to trigger the fluidic driver of Bonnette to retract and push the plunger of Buck.
However, Sunenshine teaches a filtration system and method of removing a clot including actuating a control (on/off switch 93, P0049 and show in Figs. 15-16) one or more times to trigger a fluidic driver.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Buck in view of Bonnette with a control as taught by Sunenshine for the purpose of controlling the fluidic driver of Bonnette on and off to control the flow of bodily fluid, Sunenshine P0049.
Buck in view of Bonnette does not teach repositioning the aspiration catheter to be adjacent to a second clot material within the patient; and actuating the control one or more additional times to trigger the fluidic driver to drive the pressure source after the aspiration catheter has been repositioned, wherein each actuation causes the pressure source to generate a negative pressure stroke that aspirates the second clot material and a positive pressure stroke that drives filtered blood to a blood return line for return to the patient, wherein the blood is filtered during the negative pressure stroke and/or the positive pressure stroke.
However, Saadat teaches a method (shown in Figs. 33A-C) for removing obstructive material (thrombus O) from body lumens wherein the aspiration catheter is repositioned to a second clot material (second clot material, see annotated Fig. 33A below) to remove a second clot (c 41 ln 15-25).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to reposition the catheter of Buck in view of Bonnette prior to repeating the method of Buck in view of Bonnette for the purpose of removing additional clots as taught by Saadat, to further improve patient blood circulation.
Regarding claim 25, Buck in view of Bonnette in view of Sunenshine in view of Saadat teaches the method of claim 24, wherein the negative pressure stroke results in a first flow rate (retraction of the plunger results in a first flow rate that includes unfiltered blood) by which clot material is aspirated with blood and wherein the positive pressure stroke results in a second flow rate by which filtered blood is returned to the patient (the second stroke sends the blood through filter 66 of Buck to remove clots and therefore results in a second flow rate of filtered blood returned to the patient, and wherein the flow path of blood forms a loop back to the patient that aspirates unfiltered blood from the patient and returns filtered blood to the patient).
Regarding claim 26, Buck in view of Bonnette in view of Sunenshine in view of Saadat teaches the method of claim 25, wherein the first flow rate is greater than the second flow rate (flow rate is a measure of the volume or mass of fluid passing through a specific area per unit of time, and the method removes mass (clotting) so that the first flow rate is greater than the second rate because the fluid flows in a loop and returns less mass to the patient).
Regarding claim 29, Buck in view of Bonnette in view of Sunenshine in view of Saadat teaches the method of claim 24, wherein the fluidic driver (Bonnette, see annotated Fig. 6a below) is coupled to a fluidic actuator (Bonnette, see annotated Fig. 6a below) and the pressure source comprises an aspirator (Buck, syringe 50) and wherein the fluidic actuator delivers a pressurized drive fluid to the fluidic driver which generates the negative pressure stroke that aspirates the first clot material and a positive pressure stroke that drives filtered blood to the patient.
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Regarding claim 30, Buck in view of Bonnette in view of Sunenshine in view of Saadat teaches the method of claim 29, wherein the fluidic driver comprises a pneumatic air cylinder (Bonnette, compressed air tank 40, P0064) and the aspirator comprises a syringe (Buck, syringe 50).
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Buck in view of Bonnette in view of Sunenshine in view of Saadat, and further in view of Saadat ‘857.
Regarding claim 27, Buck in view of Bonnette in view of Sunenshine in view of Saadat teaches the method of claim 24.
Buck in view of Bonnette in view of Sunenshine in view of Saadat does not teach the method further comprising sensing, using one or more sensors on the aspiration catheter, that the aspiration catheter is adjacent to the first clot material.
However, Saadat ‘857 teaches an apparatus and method for tracking obstructive material within a suction catheter further comprising sensing (sensing modalities, P0289), using one or more sensors on the aspiration catheter (one or more sensors may be positioned at the distal end of the catheter P0289), that the aspiration catheter is adjacent to the first clot material (the one or more sensors may be positioned at the distal end of the catheter for detecting the presence and/or detecting the proximity of clot material relative to the distal end opening of a suction catheter, P0289).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Buck in view of Bonnette in view of Sunenshine in view of Saadat with sensors as taught by Saadat ‘857 for the purpose of identifying clot material for removal.
Regarding claim 28, Buck in view of Bonnette in view of Sunenshine in view of Saadat in view of Saadat ‘857 teaches the method of claim 27, wherein sensing comprises sensing an electrical impedance (Saadat ‘857, impedance, P0289).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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