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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/30/2026 has been entered.
Response to Amendment
Applicant’s amendments filed on 01/30/2026 have been fully considered. Claims 1-15 are pending in this application. Claims 1-4 and 6-9 are amended. Claims 11-15 are newly added.
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.
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) 1-2, 4-5, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Mallaby (Publication No. US 2010/0204712 A1) in view of Ross et al. (Publication No. US 2010/0191178 A1).
Regarding claim 1, Mallaby teaches a controlled aspiration system for vasculature (system that aspirates clots in the neurovasculature; Paragraph 0040; Abstract; Figure 1), the system comprising: a flexible catheter comprising an open, atraumatic distal tip (catheter 104 is flexible and has a soft, atraumatic tip to navigate neurovasculature; Paragraph 0066; Figure 4); suction tubing configured to extend from a canister to (i) the flexible catheter or (ii) the flexible catheter and a second catheter positioned within the flexible catheter (suction tubing is connected from canister/receptacle 36 to catheter 104; Figure 1; Paragraph 0081); a vacuum source configured to facilitate aspiration of a thrombus through (i) the flexible catheter or (ii) the flexible catheter and the second catheter positioned within the flexible catheter, and the suction tubing to the canister (aspiration means 38 configured to facilitate aspiration to catheter 104 through suction tubing to the canister/receptacle 36; Figure 1; Paragraph 0081). Mallaby does not teach 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.
However, Ross teaches 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 (control console 112 with circuitry controls the vacuum pump by controlling the pressure and fluid flow of the aspiration and can turn on/off the pump; Paragraph 0090-0092; Figure 1). Furthermore, Mallaby teaches wherein the aspiration means 38 can be disabled (Paragraph 0085).
Mallaby and Ross are both considered to be analogous to the claimed invention because they are in the same field of aspiration/vacuum devices for medical treatment. 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 Mallaby to incorporate the teachings of Ross such that the aspiration pump of Mallaby is connected to the control console and circuitry with the on/off switch of Ross. This allows for the user to control the operation of the aspirating pump based on operation status (Ross; Paragraph 0092).
Regarding claim 2, Mallaby in view of Ross teaches the system of claim 1. The combination of Mallaby in view of Ross further teaches wherein the vacuum source comprises an automated suction device or a vacuum pump (Mallaby; aspiration means 38 is a vacuum pump 38; Figure 1; Paragraph 0081).
Regarding claim 4, Mallaby in view of Ross teaches the system of claim 1. The combination of Mallaby in view of Ross 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 (Ross; when switch for pump is ON, suction is permitted, when switch for pump is OFF, suction is paused; Figure 1; Paragraph 0090-0092; see rejection of claim 1 above).
Regarding claim 5, Mallaby in view of Ross teaches the system of claim 1. The combination of Mallaby in view of Ross further teaches further comprising at least one of a customized integrated circuit board, an integrated chip or an external control panel (Ross; control console 112 is an external control panel; Paragraph 0090-0092; Figure 1).
Regarding claim 13, Mallaby in view of Ross teaches the system of claim 1. The combination of Mallaby in view of Ross further teaches wherein: the vacuum source, when in use, is in fluid communication with a lumen of the flexible catheter or the flexible catheter and the second catheter, and is connected through the suction tubing to the canister (Mallaby; aspiration source 38 is in fluid communication with lumen of catheter 104 through suction tubing to receptacle 38; Figure 1; Paragraph 0081), and the system, when in use, is configured to flush fluid through the lumen of the flexible catheter or the flexible catheter and the second catheter before, during, or after advancing the flexible catheter or the flexible catheter and the second catheter within the vasculature (Mallaby; system introduces catheter 104 and advances through vasculature and delivers fluid after advancing the catheter and before aspiration; Paragraph 0081 and 0083-0084).
Regarding claim 14, Mallaby in view of Ross teaches the system of claim 1. The combination of Mallaby in view of Ross 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 (Ross; surgeon can manually turn on and off the pump or automatically turn on or off; Paragraph 0066 and 0092; Figure 1).
Regarding claim 15, Mallaby in view of Ross teaches the system of claim 1. The combination of Mallaby in view of Ross further teaches wherein the suction is configured to be generated or changed at a location between the vacuum source and a distal end of the flexible catheter or the second catheter (Mallaby; suction is changed between the source 38 and the catheter 104; Paragraph 0081; Figure 1).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Mallaby (Publication No. US 2010/0204712 A1) in view of Ross et al. (Publication No. US 2010/0191178 A1), as applied to claim 1 above, and further in view of Zadno-Azizi (Publication No. US 2002/0052638 A1).
Regarding claim 3, Mallaby in view of Ross teaches the system of claim 1. The combination of Mallaby in view of Ross does not teach wherein the vacuum source comprises a manual suction device or a syringe.
However, Zadno-Azizi teaches wherein the vacuum source comprises a manual suction device or a syringe (bulb 821 is connected to system to aspirate liquid carrying emboli 818; Figure 41; Paragraph 0200).
Mallaby in view of Ross and Zadno-Azizi are both considered to be analogous to the claimed invention because they are in the same field of emboli aspiration. 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 Mallaby in view of Ross to incorporate the teachings of Zadno-Azizi and have the bulb of Zadno-Azizi be the aspirating means of Mallaby in view of Ross. This allows for the aspiration of larger emboli into the bulb (Zadno-Azizi; Paragraph 0200).
Claim(s) 6-12 are rejected under 35 U.S.C. 103 as being unpatentable over Mallaby (Publication No. US 2010/0204712 A1) in view of Ross et al. (Publication No. US 2010/0191178 A1) and Zadno-Azizi (Publication No. US 2002/0052638 A1).
Regarding claim 6, Mallaby teaches a controlled aspiration system for vasculature (system that aspirates clots in the neurovasculature; Paragraph 0040; Abstract; Figure 1), the system comprising: a flexible catheter comprising an open, atraumatic distal tip (catheter 104 is flexible and has a soft, atraumatic tip to navigate neurovasculature; Paragraph 0066; Figure 4); suction tubing configured to extend from a canister to (i) the flexible catheter or (ii) the flexible catheter and a second catheter positioned within the flexible catheter (suction tubing is connected from canister/receptacle 36 to catheter 104; Figure 1; Paragraph 0081); a vacuum source configured to facilitate aspiration of a thrombus through (i) the flexible catheter or (ii) the flexible catheter and the second catheter positioned within the flexible catheter, and the suction tubing to the canister (aspiration means 38 configured to facilitate aspiration to catheter 104 through suction tubing to the canister/receptacle 36; Figure 1; Paragraph 0081). Mallaby does not teach 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, 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.
However, Ross teaches 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 (control console 112 with circuitry controls the vacuum pump by controlling the pressure and fluid flow of the aspiration and can turn on/off the pump; Paragraph 0090-0092; Figure 1), 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 (turning on and off the pump is done by a first duration and a pause duration, respectively; Paragraph 0090-0092; Figure 1).
Mallaby and Ross are both considered to be analogous to the claimed invention because they are in the same field of aspiration/vacuum devices for medical treatment. 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 Mallaby to incorporate the teachings of Ross such that the aspiration pump of Mallaby is connected to the control console and circuitry with the on/off switch of Ross. This allows for the user to control the operation of the aspirating pump based on operation status (Ross; Paragraph 0092).
The combination of Mallaby in view of Ross does not teach comprising a pressure that is less negative than -760 mm Hg.
However, Zadno-Azizi teaches comprising a pressure that is less negative than -760 mm Hg (vacuum produced is approximately 3-30 inches of mercury, or 76.2 mmHg to 762 mmHg; Paragraph 0200; Figure 41).
Mallaby in view of Ross and Zadno-Azizi are both considered to be analogous to the claimed invention because they are in the same field of emboli aspiration. 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 Mallaby in view of Ross to incorporate the teachings of Zadno-Azizi and have the negative pressure range of Zadno-Azizi produced by the aspirating means of Mallaby in view of Ross. This allows for the aspiration of larger emboli into the system (Zadno-Azizi; Paragraph 0200).
The combination of Mallaby in view of Ross and Zadno-Azizi further teaches comprising a pressure that is less negative than -760 mm Hg (Zadno-Azizi; vacuum produced by bulb 821 is approximately 3-30 inches of mercury, or 76.2 mmHg to 762 mmHg; Paragraph 0200; Figure 41 – obvious that pressure of less than -760 mmHg could be produced).
Regarding claim 7, Mallaby in view of Ross and Zadno-Azizi teaches the system of claim 6. Mallaby further teaches wherein the vacuum source comprises an automated suction device or a vacuum pump (Mallaby; aspiration means 38 is a vacuum pump 38; Figure 1; Paragraph 0081).
Regarding claim 8, Mallaby in view of Ross and Zadno-Azizi teaches the system of claim 6. The combination of Mallaby in view of Ross and Zadno-Azizi does not teach wherein the vacuum source comprises a manual suction device or a syringe.
However, Zadno-Azizi teaches wherein the vacuum source comprises a manual suction device or a syringe (bulb 821 is connected to system to aspirate liquid carrying emboli 818; Figure 41; Paragraph 0200).
Mallaby in view of Ross and Zadno-Azizi are both considered to be analogous to the claimed invention because they are in the same field of emboli aspiration. 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 Mallaby in view of Ross to incorporate the teachings of Zadno-Azizi and have the bulb of Zadno-Azizi be the aspirating means of Mallaby in view of Ross. This allows for the aspiration of larger emboli into the bulb (Zadno-Azizi; Paragraph 0200).
Regarding claim 9, Mallaby in view of Ross and Zadno-Azizi teaches the system of claim 6. The combination of Mallaby in view of Ross and Zadno-Azizi 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 (Ross; when switch for pump is ON, suction is permitted manually or in an automated repetitive cycle, when switch for pump is OFF, suction is paused; Figure 1; Paragraph 0090-0092; see rejection of claim 6 above). Regarding claim 10, Mallaby in view of Ross and Zadno-Azizi teaches the system of claim 6. The combination of Mallaby in view of Ross and Zadno-Azizi further teaches further comprising at least one of a customized integrated circuit board, an integrated chip or an external control panel (Ross; control console 112 is an external control panel; Paragraph 0090-0092; Figure 1).
Regarding claim 11, Mallaby in view of Ross and Zadno-Azizi teaches the system of claim 6. The combination of Mallaby in view of Ross and Zadno-Azizi further teaches wherein the suction is configured to be generated or changed at a location between the vacuum source and a distal end of the flexible catheter or the second catheter (Mallaby; suction is changed between the source 38 and the catheter 104; Paragraph 0081; Figure 1).
Regarding claim 12, Mallaby in view of Ross and Zadno-Azizi teaches the system of claim 6. The combination of Mallaby in view of Ross and Zadno-Azizi further teaches wherein: the vacuum source, when in use, is in fluid communication with a lumen of the flexible catheter or the flexible catheter and the second catheter, and is connected through the suction tubing to the canister (Mallaby; aspiration source 38 is in fluid communication with lumen of catheter 104 through suction tubing to receptacle 38; Figure 1; Paragraph 0081), and the system, when in use, is configured to flush fluid through the lumen of the flexible catheter or the flexible catheter and the second catheter before, during, or after advancing the flexible catheter or the flexible catheter and the second catheter within the vasculature (Mallaby; system introduces catheter 104 and advances through vasculature and delivers fluid after advancing the catheter and before aspiration; Paragraph 0081 and 0083-0084).
Conclusion
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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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781