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 .
Detailed Action
This is in response to the non-provisional application filed 05/06/2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/10/2026 has been entered.
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.
Claim(s) 1, 3, 4, 11, 13-16, 18, 19, 24, 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0316127 (Beck et al.) in view, U.S. Patent Publication Number 2024/0245414 (Calderon et al.)
Regarding claims 1, 11, 13-15 Beck discloses as shown in Figures 6, 7A, 7B, a method of clot removal, the method comprising: positioning an aspiration catheter (aspiration catheter 12, see paragraph [0100]) adjacent to a first clot material within a patient; actuating a pressure source one or more times by trigger a control (flow control 76, see paragraph [0100]), wherein each actuation of the pressure source: aspirates the first clot material and blood, filters the first clot material from the blood, and drives the filtered blood into a collection chamber (chamber within pump, syringe or reservoir, see paragraphs [0097], [0098]) wherein actuating the pressure source comprises (a) aspirating blooding and clot from the aspiration catheter and (b) collecting filtered blood in a reservoir in one step and driving filtered blood from the reservoir to the collection chamber in another step, wherein each actuation comprises a first stroke and a second stroke, wherein the first stroke comprises a first movement of a piston of the pressure source and wherein the second stroke comprises a return movement of the piston of the pressure source, wherein the first stroke comprises a negative pressure stroke and the second stroke comprises a positive pressure stroke, wherein the first stroke results in a first flow rate by which clot material is aspirated with blood and wherein the second stroke results in a second flow rate by which filtered blood is driven into the collection chamber.
Beck et al. fails to disclose wherein the first flow rate is greater than the second flow rate, wherein aspirating and filtering the blood are performed at a first flow rate and driving the filtered blood to the collection chamber is performed at a second flow rate slower than the first flow rate.
Calderon et al., from a related filed of endeavor teaches a similar method as shown in Figure 1, a first stroke that aspirates a predetermined volume of the first clot material and blood at a first flow rate, and a second stroke that drives the clot material and blood towards a filter that filters the first clot material from the blood, and drives the filtered blood into towards a collection chamber a second flow rate is slower than the first flow rate, where actuation the pressure source is automatically actuated by a controller (controller 108, see paragraph [0152]) for the purpose of creating momentum during aspiration and ensuring the blood is properly during the second stroke, wherein the controller is further programmed to aspirate and filter the blood at a first flow rate and drive the filtered blood to the collection chamber at a second flow rate slower than the first flow rate. See paragraph [0272].
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 method disclosed by Beck et al. by modifying the first flow rate is greater than the second flow rate, wherein aspirating and filtering the blood are performed at a first flow rate and driving the filtered blood to the collection chamber is performed at a second flow rate slower than the first flow rate in order to create momentum during aspiration and ensuring the blood is properly during the second stroke.
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 method disclosed by Beck et al. to include the controller taught by Calderon et al. such that wherein the controller is further programmed to aspirate and filter the blood at a first flow rate and drive the filtered blood to the collection chamber at a second flow rate slower than the first flow rate in order to control the first and second stroke automatically and remotely.
So modified, the Office interprets Beck et al. in view of Skujins and Calderon as disclosing wherein the first stroke results in a first flow rate by which clot material is aspirated with blood and wherein the second stroke results in a second flow rate by which filtered blood is driven into the collection chamber.
So modified, the Office interprets Beck et al. in view of Skujins and Calderon as disclosing wherein the first flow rate is greater than the second flow rate, wherein aspirating and filtering the blood are performed at a first flow rate and driving the filtered blood to the collection chamber is performed at a second flow rate slower than the first flow rate.
Regarding claims 16, 18, 19 Beck discloses as shown in Figures 6, 7A, 7B, a method of clot removal, the method comprising: positioning an aspiration catheter (aspiration catheter 12, see paragraph [0100]) adjacent to a first clot material within a patient; actuating a control to trigger a pressure source, wherein each actuation causes the pressure source to: aspirate the first clot material, filter the first clot material from blood, and drive filtered blood to the a collection chamber (chamber within pump, syringe or reservoir), wherein the first stroke comprises a negative pressure stroke and the second stroke comprises a positive pressure stroke, wherein the first stroke results in a first flow rate by which clot material is aspirated with blood and wherein the second stroke results in a second flow rate by which filtered blood is driven to the collection chamber. see paragraphs [0097], [0098]).
Calderon et al., from a related filed of endeavor teaches a similar method as shown in Figure 1, a first stroke that aspirates a predetermined volume of the first clot material and blood at a first flow rate, and a second stroke that drives the clot material and blood towards a filter that filters the first clot material from the blood, and drives the filtered blood into towards a collection chamber a second flow rate is slower than the first flow rate, where actuation the pressure source is automatically actuated by a controller (controller 108, see paragraph [0152]) for the purpose of creating momentum during aspiration and ensuring the blood is properly during the second stroke, wherein the controller is further programmed to aspirate and filter the blood at a first flow rate and drive the filtered blood to the collection chamber at a second flow rate slower than the first flow rate. See paragraph [0272].
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 method disclosed by Beck et al. by modifying the first flow rate is greater than the second flow rate, wherein aspirating and filtering the blood are performed at a first flow rate and driving the filtered blood to the collection chamber is performed at a second flow rate slower than the first flow rate in order to create momentum during aspiration and ensuring the blood is properly during the second stroke.
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 method disclosed by Beck et al. to include the controller taught by Calderon et al. such that wherein the controller is further programmed to aspirate and filter the blood at a first flow rate and drive the filtered blood to the collection chamber at a second flow rate slower than the first flow rate in order to control the first and second stroke automatically and remotely.
So modified, the Office interprets Beck et al. in view of Skujins and Calderon as disclosing wherein the first stroke results in a first flow rate by which clot material is aspirated with blood and wherein the second stroke results in a second flow rate by which filtered blood is driven into the collection chamber.
So modified, the Office interprets Beck et al. in view of Skujins and Calderon as disclosing wherein the first flow rate is greater than the second flow rate, wherein aspirating and filtering the blood are performed at a first flow rate and driving the filtered blood to the collection chamber is performed at a second flow rate slower than the first flow rate.
Regarding claim 24, Beck et al. discloses as shown in Figures 6, 7A, 7B a method of clot removal, the method comprising: positioning an aspiration catheter adjacent to a first clot material within a patient; actuating a control to trigger a pressure source, wherein each actuation causes the pressure source to generate a negative pressure stroke that aspirates the first clot material and a positive pressure stroke that drives filtered blood to a collection chamber (chamber within pump, syringe or reservoir, see paragraphs [0097], [0098]), wherein the blood is filtered during the negative pressure stroke and/or the positive pressure stroke.
Beck et al. fails to disclose repositioning the aspiration catheter to be adjacent to a second clot material within the patient; and actuating the control to trigger the pressure source, wherein each actuation causes the pressure source to generate the negative pressure stroke that aspirates the second clot material and the positive pressure stroke that drives filtered blood to the collection chamber, wherein the blood is filtered during the negative pressure stroke and/or the positive pressure stroke.
Calderon et al., from a related filed of endeavor teaches a similar method as shown in Figure 1, a first stroke that aspirates a predetermined volume of the first clot material and blood at a first flow rate, and a second stroke that drives the clot material and blood towards a filter that filters the first clot material from the blood, and drives the filtered blood into towards a collection chamber a second flow rate is slower than the first flow rate, where actuation the pressure source is automatically actuated by a controller (controller 108, see paragraph [0152]) for the purpose of creating momentum during aspiration and ensuring the blood is properly during the second stroke, wherein the controller is further programmed to aspirate and filter the blood at a first flow rate and drive the filtered blood to the collection chamber at a second flow rate slower than the first flow rate. See paragraph [0272].
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 method disclosed by Beck et al. by modifying the first flow rate is greater than the second flow rate, wherein aspirating and filtering the blood are performed at a first flow rate and driving the filtered blood to the collection chamber is performed at a second flow rate slower than the first flow rate in order to create momentum during aspiration and ensuring the blood is properly during the second stroke.
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 method disclosed by Beck et al. to include the controller taught by Calderon et al. such that wherein the controller is further programmed to aspirate and filter the blood at a first flow rate and drive the filtered blood to the collection chamber at a second flow rate slower than the first flow rate in order to control the first and second stroke automatically and remotely.
So modified, the Office interprets Beck et al. in view of Skujins and Calderon as disclosing wherein the first stroke results in a first flow rate by which clot material is aspirated with blood and wherein the second stroke results in a second flow rate by which filtered blood is driven into the collection chamber.
So modified, the Office interprets Beck et al. in view of Skujins and Calderon as disclosing wherein the first flow rate is greater than the second flow rate, wherein aspirating and filtering the blood are performed at a first flow rate and driving the filtered blood to the collection chamber is performed at a second flow rate slower than the first flow rate.
Claim(s) 7, 8, 21, 22, 27, 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0316127 (Beck et al.) in view of U.S. Patent Publication Number 2024/0245414 (Calderon et al.), as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2022/0409857 (Saadat et al.)
Regarding claims 7, 8, 21, 22, 27, 28 Nyguyen et al. fails to disclose sensing that the aspiration catheter is adjacent to the first clot material using one or more clot sensors, wherein sensing comprises sensing an electrical signal, wherein sensing comprises sensing an electrical impedance.
Saadat et al., from the same field of endeavor teaches a similar method that includes sensing that the aspiration catheter is adjacent to the first clot material using one or more clot sensors, wherein sensing comprises sensing an electrical signal, wherein sensing comprises sensing an electrical impedance, for the purpose of tracking a clot. See paragraph [0044].
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 method disclosed by Nyguyen to include sensing that the aspiration catheter is adjacent to the first clot material using one or more clot sensors, wherein sensing comprises sensing an electrical signal, for the purpose of tracking a clot.
Claim(s) 9, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0316127 (Beck et al.) in view of U.S. Patent Publication Number 2024/0245414 (Calderon et al.), as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2010/0185048 (Lonky et al.)
Regrading claims 9, 10 Beck et al. is silent about wherein each actuation of the pressure source comprises operating a control in communication with the pressure source, wherein operating the control comprises pushing a button.
Lonky et al., from the same field of endeavor teaches a similar method wherein actuation of the pressure source comprises operating a control in communication with the pressure source, wherein operating the control comprises pushing a button. See paragraph [0070].
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 method disclosed by Beck et al. to include the push-button switch taught by Lonky, in order to remotely actuate the pressure source.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0316127 (Beck et al.) in view of U.S. Patent Publication Number 2024/0245414 (Calderon et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2010/0185048 (Lonky et al.)
Regrading claim 23 Beck et al. is silent about wherein operating the control comprises pushing a button.
Lonky et al., from the same field of endeavor teaches a similar method wherein actuation of the pressure source comprises operating a control in communication with the pressure source, wherein operating the control comprises pushing a button. See paragraph [0070].
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 method disclosed by Beck et al. by substituting the control contemplated by Beck et al. for the push-button disclosed by Lonky because it would only require the simple substitution of one known alternative for another it produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 29, 30, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0316127 (Beck et al.) in view U.S. Patent Publication Number 2024/0245414 (Calderon et al.) as applied to claims 1, 16, and 24 respectively above, and further in view of of U.S. Patent Publication Number 2020/0323546 (Skujins et al.),
Regarding claims 29-31, Beck et al. fails to disclose repositioning the aspiration catheter adjacent to a second clot material within the patient; and actuating the pressure source one or more times, wherein each actuation of the pressure source: aspirates the second clot material and blood, filters the clot material from blood, and drives filtered blood to the collection chamber.
Skujins et al., from the same field of endeavor teaches a similar method as shown in Figure 1, where the method includes the step of repositioning the aspiration catheter adjacent to a second clot material within the patient; and actuating the pressure source one or more times, for the purpose of ensuring the catheter is in contact and will remove the clot material. See paragraph [0041].
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 method disclosed Beck et al. to include the steps of repositioning the aspiration catheter adjacent to a second clot material within the patient; and actuating the pressure source one or more times, wherein each actuation of the pressure source: aspirates the second clot material and blood in order to ensure the catheter is in contact and will remove the clot material.
So modified, the Office interprets Beck et al. in view of Skujins et al as disclosing repositioning the aspiration catheter adjacent to a second clot material within the patient; and actuating the pressure source one or more times, wherein each actuation of the pressure source: aspirates the second clot material and blood, filters the clot material from blood, and drives filtered blood to the collection chamber (chamber within pump, syringe or reservoir, see paragraphs [0097], [0098]).
Response to Arguments
Applicant's arguments filed 02/10/2026, see pages 7-13 have been fully considered but are moot in view of the new grounds of rejection
Conclusion
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771