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
Applicant’s amendments filed on 03/27/2026 have been fully considered. Claims 1-15 are pending in this application. Claims 1-2, 6-7, 11-13, and 15 are amended.
Response to Arguments
Applicant’s arguments with respect to amended independent claims 1 and 6 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. More specifically, the claim amendment requires “wherein at least the distal tip of the catheter is flexible” which further narrows the scope of the claimed invention.
Though the same prior art reference is re-used herein, amended claims 1-2, 6-7, 11-13, and 15 required a change in the grounds of rejection as detailed below in the prior art rejection.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bagaoisan et al. (Patent No. US 6,152,909 A) in view of Iwakoshi et al. (Patent No. US 4,973,311 A).
Regarding claim 1, Bagaoisan teaches a controlled aspiration system for vasculature (aspiration system is controllable using the valve 158 to aspirate thrombi; Figure 17; Abstract; Column 14, lines 3-38), the system comprising: a catheter (aspiration catheter 150; Figure 17; Column 2, lines 50-67, Column 3, lines 8-21, and Column 14, lines 3-22) comprising an open, atraumatic distal tip (“The distal tip 22… is preferably soft to prevent damage to the patient's vasculature.”; Column 8, lines 26-29; Figure 17), wherein a least the distal tip of the catheter is flexible (“The distal tip on the catheter is formed of a more flexible material than that used to form the rest of the catheter shaft.”; Column 3, lines 8-20; Figure 17); suction tubing (tubing 154; Figure 17; Column 14, lines 3-22); a vacuum source (vacuum source 160; Figure 17; Column 14, lines 3-22); and an ON/OFF valve or switch configured to control the vacuum source to generate suction by controlling at least one of a pressure, a velocity, a fluid flow, or a duration (“The stopcock 158 may be opened and closed repeatedly to deliver the aspiration pressure in a pulsed manner if desired.”, meaning that the pulsing of first suction output is repeating cyclical suction output by closing and opening the valve 158 repetitively between a second intensity and a first intensity, where the second intensity is when suction is OFF, or when the valve is closed, at a second duration and the first intensity is when valve is opened/ON for a first duration, impacting the pressure, velocity, fluid flow, and duration; Figure 17; Column 14, lines 3-38). Bagaoisan does not teach a canister.
However, Iwakoshi teaches a canister (suction flask 61; Figure 3; Column 2, line 66 to Column 3, line 2 and Column 3, lines 23-59).
Bagaoisan and Iwakoshi are both considered to be analogous to the claimed invention because they are in the same field of aspiration systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bagaoisan to incorporate the teachings of Iwakoshi and have the suction flask/container of Iwakoshi between the valve and the vacuum source of Bagaoisan. This allows for the exudate to be collected into the suction container to be discarded and is separable from the vacuum source and catheter (Iwakoshi; Column 3, lines 47-59).
The combination of Bagaoisan in view of Iwakoshi further teaches the suction tubing configured to extend from the canister to (i) the catheter or (ii) the catheter and a second catheter positioned within the catheter (suction tubing 154 and catheter 160 of Bagaoisan is attached to canister of Iwakoshi; see combination above), the vacuum source configured to facilitate aspiration of a thrombus through (i) the catheter or (ii) the flexible catheter and the second catheter positioned within the catheter, and the suction tubing to the canister (source 160 is used to aspirate thrombi through the catheter 160, suction tubing 154, and into the canister of Iwakoshi; see combination above; Bagaoisan; Column 14, lines 3-38).
Regarding claim 2, Bagaoisan in view of Iwakoshi the system of claim 1. The combination of Bagaoisan in view of Iwakoshi further teaches wherein the vacuum source comprises an automated suction device or a vacuum pump (Bagaoisan; source 160 can be a pump instead of a syringe; Figure 17; Column 16, lines 4-16), and wherein the vacuum source is a single vacuum source (Bagaoisan; source 160 is a singular vacuum source; Figure 17). Regarding claim 3, Bagaoisan in view of Iwakoshi the system of claim 1. The combination of Bagaoisan in view of Iwakoshi further teaches wherein the vacuum source comprises a manual suction device or a syringe (Bagaoisan; vacuum source 160 is a syringe; Figure 17; Column 14, 3-38).
Regarding claim 4, Bagaoisan in view of Iwakoshi the system of claim 1. The combination of Bagaoisan in view of Iwakoshi further teaches wherein, when the ON/OFF valve or switch is in an ON position, the ON/OFF valve or switch permits the suction, and wherein, when the ON/OFF valve or switch is in an OFF position, the ON/OFF valve or switch pauses the suction (Bagaoisan; “The stopcock 158 may be opened and closed repeatedly to deliver the aspiration pressure in a pulsed manner if desired.”, meaning that the pulsing of first suction output is repeating cyclical suction output by closing and opening the valve 158 repetitively between a second intensity and a first intensity, where the second intensity is when suction is OFF, or when the valve is closed, at a second duration and the first intensity is when valve is opened/ON for a first duration, impacting the pressure, velocity, fluid flow, and duration; Figure 17; Column 14, lines 3-38).
Regarding claim 5, Bagaoisan in view of Iwakoshi the system of claim 1. The combination of Bagaoisan in view of Iwakoshi does not teach further comprising at least one of a customized integrated circuit board, an integrated chip or an external control panel.
However, Iwakoshi teaches further comprising at least one of a customized integrated circuit board, an integrated chip or an external control panel (control portion 5 containing button 63 and knob and buttons; Column 2, lines 60-65).
Bagaoisan and Iwakoshi are both considered to be analogous to the claimed invention because they are in the same field of aspiration systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bagaoisan in view of Iwakoshi to incorporate the teachings of Iwakoshi and have the control panel with the additional buttons and knobs of Iwakoshi on the device of Bagaoisan. This allows for the user to have all of the controls to be accessed in a singular control portion (Iwakoshi; Column 2, lines 50-65).
Regarding claim 6, Bagaoisan teaches a controlled aspiration system for vasculature (aspiration system is controllable using the valve 158 to aspirate thrombi; Figure 17; Abstract; Column 14, lines 3-38), the system comprising: a catheter (aspiration catheter 150; Figure 17; Column 2, lines 50-67, Column 3, lines 8-21, and Column 14, lines 3-22) comprising an open, atraumatic distal tip (“The distal tip 22… is preferably soft to prevent damage to the patient's vasculature.”; Column 8, lines 26-29; Figure 17), wherein at least the distal tip of the catheter is flexible (“The distal tip on the catheter is formed of a more flexible material than that used to form the rest of the catheter shaft.”; Column 3, lines 8-20; Figure 17); suction tubing (tubing 154; Figure 17; Column 14, lines 3-22); a vacuum source (vacuum source 160; Figure 17; Column 14, lines 3-22) and a valve or switch configured to control the vacuum source to generate suction by controlling at least one of a fluid flow or an intensity level comprising a pressure that is less negative than -760 mm Hg, and wherein the valve or switch is configured to facilitate application of suction having (i) the at least one of the fluid flow or the intensity level for a first duration or (ii) a pause for a pause duration (“The stopcock 158 may be opened and closed repeatedly to deliver the aspiration pressure in a pulsed manner if desired.”, meaning that the pulsing is repeating cyclical suction output by closing and opening the valve 158 repetitively between a fluid flow and a pause, where the pause is when suction is OFF, or when the valve is closed at a pause duration and the fluid flow is when valve is opened/ON for a first duration, impacting the pressure, velocity, fluid flow, and duration; Figure 17; Column 14, lines 3-38). Bagaoisan does not teach a canister.
However, Iwakoshi teaches a canister (suction flask 61; Figure 3; Column 2, line 66 to Column 3, line 2 and Column 3, lines 23-59).
Bagaoisan and Iwakoshi are both considered to be analogous to the claimed invention because they are in the same field of aspiration systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bagaoisan to incorporate the teachings of Iwakoshi and have the suction flask/container of Iwakoshi between the valve and the vacuum source of Bagaoisan. This allows for the exudate to be collected into the suction container to be discarded and is separable from the vacuum source and catheter (Iwakoshi; Column 3, lines 47-59).
The combination of Bagaoisan in view of Iwakoshi further teaches the suction tubing configured to extend from the canister to (i) the catheter or (ii) the catheter and a second catheter positioned within the catheter (suction tubing 154 and catheter 160 of Bagaoisan is attached to canister of Iwakoshi; see combination above), the vacuum source configured to facilitate aspiration of a thrombus through (i) the catheter or (ii) the flexible catheter and the second catheter positioned within the catheter, and the suction tubing to the canister (source 160 is used to aspirate thrombi through the catheter 160, suction tubing 154, and into the canister of Iwakoshi; see combination above; Bagaoisan; Column 14, lines 3-38).
Regarding claim 7, Bagaoisan in view of Iwakoshi teaches the system of claim 6. The combination of Bagaoisan in view of Iwakoshi further teaches wherein the vacuum source comprises an automated suction device or a vacuum pump (Bagaoisan; source 160 can be a pump instead of a syringe; Figure 17; Column 16, lines 4-16), and wherein the vacuum source is a single vacuum source (Bagaoisan; source 160 is a singular vacuum source; Figure 17).
Regarding claim 8, Bagaoisan in view of Iwakoshi teaches the system of claim 6. The combination of Bagaoisan in view of Iwakoshi further teaches wherein the vacuum source comprises a manual suction device or a syringe (Bagaoisan; vacuum source 160 is a syringe; Figure 17; Column 14, 3-38).
Regarding claim 9, Bagaoisan in view of Iwakoshi teaches the system of claim 6. The combination of Bagaoisan in view of Iwakoshi further teaches wherein activation of the valve or switch is automated in a repetitive cycle or enabled manually by an operator, and wherein, when the valve or switch is activated or enabled, the valve or switch permits the suction, and wherein, when the valve or switch is not activated or enabled, the valve or switch pauses the suction (Bagaoisan; “The stopcock 158 may be opened and closed repeatedly to deliver the aspiration pressure in a pulsed manner if desired.”, meaning that the pulsing of first suction output is repeating cyclical suction output by closing and opening the valve 158 manually and repetitively between activation and non-activation/paused, where the non-activation/pause occurs when the valve is closed, and activation when the valve is opened; Figure 17; Column 14, lines 3-38).
Regarding claim 10, Bagaoisan in view of Iwakoshi teaches the system of claim 6. The combination of Bagaoisan in view of Iwakoshi does not teach further comprising at least one of a customized integrated circuit board, an integrated chip, or an external control panel.
However, Iwakoshi teaches further comprising at least one of a customized integrated circuit board, an integrated chip or an external control panel (control portion 5 containing button 63 and knob and buttons; Column 2, lines 60-65).
Bagaoisan and Iwakoshi are both considered to be analogous to the claimed invention because they are in the same field of aspiration systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bagaoisan in view of Iwakoshi to incorporate the teachings of Iwakoshi and have the control panel with the additional buttons and knobs of Iwakoshi on the device of Bagaoisan. This allows for the user to have all of the controls to be accessed in a singular control portion (Iwakoshi; Column 2, lines 50-65).
Regarding claim 11, Bagaoisan in view of Iwakoshi teaches the system of claim 6. The combination of Bagaoisan in view of Iwakoshi further teaches wherein the suction is configured to be generated or changed at a location between the vacuum source and the distal tip of the catheter or the second catheter (Bagaoisan; valve 158 is used to control the first suction output created by vacuum source 160 at a location between vacuum source 160 and the distal tip of the catheter; Figure 17; Column 14, lines 3-38).
Regarding claim 12, Bagaoisan in view of Iwakoshi teaches the system of claim 6. The combination of Bagaoisan in view of Iwakoshi further teaches wherein: the vacuum source, when in use, is in fluid communication with a lumen of the catheter or the catheter and the second catheter, and is connected through the suction tubing to the canister (source 160 is in fluid communication with lumen of catheter 150 through the tubing 154 and to the canister of Iwakoshi; see rejection of claim 1 above), and the system, when in use, is configured to flush fluid through the lumen of the catheter or the catheter and the second catheter before, during, or after advancing the catheter or the catheter and the second catheter within the vasculature (catheter 150 is fully capable of being flushed with fluid before use; Abstract).
Regarding claim 13, Bagaoisan in view of Iwakoshi the system of claim 1. The combination of Bagaoisan in view of Iwakoshi further teaches wherein: the vacuum source, when in use, is in fluid communication with a lumen of the catheter or the catheter and the second catheter, and is connected through the suction tubing to the canister (source 160 is in fluid communication with lumen of catheter 150 through the tubing 154 and to the canister of Iwakoshi; see rejection of claim 1 above),
and the system, when in use, is configured to flush fluid through the lumen of the catheter or the catheter and the second catheter before, during, or after advancing the catheter or the catheter and the second catheter within the vasculature (catheter 150 is fully capable of being flushed with fluid before use; Abstract).
Regarding claim 14, Bagaoisan in view of Iwakoshi the system of claim 1. The combination of Bagaoisan in view of Iwakoshi further teaches wherein activation of the ON/OFF valve or switch is automated by turning on and off cyclically or enabled manually by an operator (Bagaoisan; ON/OFF valve is enabled manually by the user; Figure 17; Column 14, lines 3-38).
Regarding claim 15, Bagaoisan in view of Iwakoshi the system of claim 1. The combination of Bagaoisan in view of Iwakoshi further teaches wherein the suction is configured to be generated or changed at a location between the vacuum source and the distal tip of the catheter or the second catheter (Bagaoisan; valve 158 is used to control the first suction output created by vacuum source 160 at a location between vacuum source 160 and the distal tip of the catheter; Figure 17; Column 14, lines 3-38).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781
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