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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/18/2026 has been entered.
Response to Amendment
Applicant’s amendments filed on 02/18/2026 have been fully considered. Claims 2-11 and 13-22 are pending in this application. Claims 2-11 and 13-21 are amended. Claim 22 is newly added.
Response to Arguments
Applicant’s arguments with respect to amended independent claims 2, 9, and 16 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.
Though some of the same prior art references are used herein, at least applicant’s amended independent claims 2, 9, and 16 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) 2-3, 5, 7, 9-11, 14-17, and 20-22 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 2, Mallaby teaches a controlled aspiration system for aspirating thrombi from vasculature (system that aspirates clots in the neurovasculature; Paragraph 0040; Abstract; Figure 1), the system comprising:
a flexible catheter comprising an atraumatic distal tip (catheter 104 is flexible and has a soft, atraumatic tip to navigate neurovasculature; Paragraph 0066; Figure 4) and a working lumen (lumen of microcatheter 102; Figure 1; Paragraph 0041), wherein the working lumen is configured to be flushed with fluid and to be maintained in a fluid-filled condition (lumen of microcatheter 102 that is fully capable of being flushed with fluid and fluid filled for aspirating blood clots and suctioning fluid into the catheter system; Figure 1; Paragraph 0041);
a vacuum source that, when in use, is in fluid communication with (i) the flexible catheter or (ii) the flexible catheter and a second catheter positioned within the flexible catheter, through suction tubing (vacuum means 38 generates a suction force at a distal end of the catheter 104; Paragraph 0069, 0081, and 0084-0085; Figure 1).
Mallaby does not teach a valve or switch configured to control or intermittently allow suction generated by the vacuum source or fluid flow resulting therefrom to change at least a first suction output at a location between the vacuum source and the distal tip of at least one of (i) the flexible catheter or (ii) a distal tip of the second catheter, wherein the first suction output comprises one or a plurality of intensity levels.
However, Ross teaches a valve or switch (vacuum pulsing device 156; Paragraph 0064-0066; Figure 1-3) configured to control or intermittently allow suction generated by the vacuum source or fluid flow resulting therefrom to change at least a first suction output at a location between the vacuum source and the distal tip of at least one of (i) the flexible catheter or (ii) a distal tip of the second catheter, wherein the first suction output comprises one or a plurality of intensity levels (oscillating pressure with square waves/step functions or vacuum off function of vacuum pulsing device 156 with control console 112 switches vacuum pressure from a first pressure having a higher first suction intensity to a second pressure having a lower suction intensity at zero vacuum at a location between the vacuum pump 108 and the distal end of the catheter; Paragraph 0064-0066; Figure 1-3).
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 vacuum pump of Mallaby is connected to the control console and circuitry with the vacuum pulsing device of Ross, the vacuum pulsing device between the catheter and the vacuum pump of Mallaby. This allows for the user to control the change in vacuum intensities based on the desired treatment (Ross; Paragraph 0064-0066 and 0092).
Regarding claim 3, Mallaby in view of Ross teaches the system of claim 2. The combination of Mallaby in view of Ross further teaches wherein the vacuum source comprises an automated suction device (Ross; vacuum pump 108 has a control console 112 to allow for automatic control of suctioning; Paragraph 0065; Figure 1), and wherein the system comprises one vacuum source (Mallaby; vacuum means 38; Paragraph 0069, 0081, and 0084-0085; Figure 1).
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 vacuum pump of Mallaby is connected to the control console and circuitry with the vacuum pulsing device of Ross, the vacuum pulsing device between the catheter and the vacuum pump of Mallaby. This allows for the user to control the change in vacuum intensities based on the desired treatment (Ross; Paragraph 0064-0066 and 0092).
Regarding claim 5, Mallaby in view of Ross teaches the system of claim 2. The combination of Mallaby in view of Ross further teaches wherein activation of the valve or switch is configured to be automated in a repetitive cycle or enabled manually by an operator (Ross; oscillating pressure with square waves/step functions or vacuum off function of vacuum pulsing device 156 with control console 112 switches vacuum pressure from a first pressure having a higher first suction intensity to a second pressure having a lower suction intensity at zero vacuum; Paragraph 0064-0066; Figure 1-3), and wherein, when the valve or switch is activated or enabled, the valve or switch permits the first suction output, and wherein, when the valve or switch is not activated or enabled, the valve or switch pauses the first suction output (Ross; vacuum pulsing device 156 with control console 112 can activate pump 108 when in ON mode and pause activation of vacuum pump 108 in OFF mode; Paragraph 0089 and 0092; Figure 1-3).
Regarding claim 7, Mallaby in view of Ross teaches the system of claim 2. The combination of Mallaby in view of Ross further teaches wherein the first suction output is configured to be generated by controlling at least one parameter selected from the group consisting of: pressure, velocity, fluid flow, and time duration (Ross; oscillating pressure with square waves/step functions or vacuum off function of vacuum pulsing device 156 switches vacuum pressure from a first pressure having a higher first suction intensity to a second pressure having a lower suction intensity at zero vacuum; Paragraph 0064-0066; Figure 1-3).
Regarding claim 9, Mallaby teaches a controlled aspiration system for use within vasculature (system that aspirates clots in the neurovasculature; Paragraph 0040; Abstract; Figure 1), the system comprising: a flexible catheter comprising an atraumatic distal tip (catheter 104 is flexible and has a soft, atraumatic tip to navigate neurovasculature; Paragraph 0066; Figure 4); and a suction device comprising a vacuum source that, when in use, is fluidically connected to (i) the flexible catheter or (ii) the flexible catheter and a second catheter positioned within the flexible catheter, through suction tubing (vacuum means 38 generates a suction force at a distal end of the catheter 104; Paragraph 0069, 0081, and 0084-0085; Figure 1), wherein the flexible catheter or the flexible catheter and the second catheter are configured to be flushed with fluid and to be maintained in a fluid-filled condition (lumen of microcatheter 102 that is fully capable of being flushed with fluid and fluid filled for aspirating blood clots and suctioning fluid into the catheter system; Figure 1; Paragraph 0041). Mallaby does not teach wherein the suction device is configured to change a first vacuum output or a plurality of vacuum outputs to a distal end of (i) the flexible catheter or (ii) the flexible catheter and the second catheter, wherein the first vacuum output is configured to be controlled or changed at a location between the vacuum source and the distal end of least one of (i) the flexible catheter or (ii) the second catheter, and comprises at least (a) a first duration during which suction is applied, and (b) a second duration during which suction is reduced or paused.
However, Ross teaches wherein the suction device is configured to change a first vacuum output or a plurality of vacuum outputs to a distal end of (i) the flexible catheter or (ii) the flexible catheter and the second catheter (vacuum pump 108 with control console 112 to allow for change of the first vacuum output to the distal end of the catheter; Paragraph 0064-0066; Figure 1-3), wherein the first vacuum output is configured to be controlled or changed at a location between the vacuum source and the distal end of least one of (i) the flexible catheter or (ii) the second catheter, and comprises at least (a) a first duration during which suction is applied, and (b) a second duration during which suction is reduced or paused (oscillating pressure with square waves/step functions or vacuum off function of vacuum pulsing device 156 with the control console 112 switches vacuum pressure from a first pressure having a higher first suction intensity to a second pressure having a lower suction intensity at zero vacuum at a location between the vacuum pump 108 and the distal end of the catheter; Paragraph 0064-0066; Figure 1-3).
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 vacuum pump of Mallaby is connected to the control console and circuitry with the vacuum pulsing device of Ross, the vacuum pulsing device between the catheter and the vacuum pump of Mallaby. This allows for the user to control the change in vacuum intensities based on the desired treatment (Ross; Paragraph 0064-0066 and 0092).
Regarding claim 10, Mallaby in view of Ross teaches the system of claim 9. The combination of Mallaby in view of Ross further teaches wherein the first vacuum output is configured to be generated by controlling at least one parameter selected from the group consisting of: pressure, velocity, fluid flow, and time duration (Ross; oscillating pressure with square waves/step functions or vacuum off function of vacuum pulsing device 156 switches vacuum pressure from a first pressure having a higher first suction intensity to a second pressure having a lower suction intensity at zero vacuum; Paragraph 0064-0066; Figure 1-3), and wherein the first vacuum output is configured to be enabled by at least one of: a customized integrated circuit board, an integrated chip, a motor controller, a regulator, thermal sensors, pressure sensors, electric sensors, flow sensors, a valve, a luer lock, a switch, an external control panel, or combinations thereof (Ross; valve in vacuum pulsing device 156 is controlled by a control console 112 which comprises circuitry, a display interface, switches, etc.; Paragraph 0090-0092; Figure 1).
Regarding claim 11, Mallaby in view of Ross teaches the system of claim 9. The combination of Mallaby in view of Ross further teaches wherein the first vacuum output is configured for aspiration of soft, acute clots or minimization of blood loss during aspiration of clots, or wherein the first vacuum output is configured for thrombus aspiration of hard aged or adherent clots, or the plurality of vacuum outputs are configured to be combinations thereof (Mallaby; vacuum of device is designed to remove clots, thrombus, and soft tissue; Paragraph 0012, 0038, and 0040 – device of Mallaby in view of Ross with oscillating suction is fully capable of removing soft or hard clots).
Regarding claim 14, Mallaby in view of Ross teaches the system of claim 9. The combination of Mallaby in view of Ross further teaches wherein activation of the suction device is configured to be automated in a repetitive cycle or enabled manually by an operator (Ross; vacuum pump 108 has a control console 112 to allow for automatic control of suctioning; Paragraph 0065; Figure 1).
Regarding claim 15, Mallaby in view of Ross teaches the system of claim 9. The combination of Mallaby in view of Ross further teaches wherein the flexible catheter or the second catheter are selected from the group consisting of: a microcatheter, a distal access microcatheter, a guide catheter, a shuttle catheter, a venous catheter, a delivery catheter, an aspiration catheter, a balloon guide catheter, a ventriculostomy catheter, an endoscopy tube, a laparoscope, or combinations thereof (Mallaby; microcatheter for neurovascular access; Abstract).
Regarding claim 16, Mallaby teaches a controlled aspiration system for aspirating thrombi from vasculature using suction (system that aspirates clots in the neurovasculature using suction; Paragraph 0040; Abstract; Figure 1), the system comprising: a flexible catheter comprising a proximal end, a distal end having an atraumatic tip (catheter 104 is flexible with a proximal and distal end and has a soft, atraumatic tip to navigate neurovasculature; Paragraph 0066; Figure 4), and a working lumen (lumen of microcatheter 102; Figure 1; Paragraph 0041); a vacuum source that, when in use, is in fluid communication with (i) the flexible catheter or (ii) the flexible catheter and a second catheter positioned within the flexible catheter, through suction tubing (vacuum means 38 generates a suction force at a distal end of the catheter 104; Paragraph 0069, 0081, and 0084-0085; Figure 1). Mallaby does not teach a suction control unit configured to control at least one of an intensity, a velocity, a fluid flow or a time duration of suction generated by the vacuum source to change at least a first vacuum output at the distal end of at least one of (i) the flexible catheter or (ii) a distal end of the second catheter.
However, Ross teaches a suction control unit (vacuum pulsing device 156 with control console 112; Paragraph 0064-0066; Figure 1-3) configured to control at least one of an intensity, a velocity, a fluid flow or a time duration of suction generated by the vacuum source to change at least a first vacuum output at the distal end of at least one of (i) the flexible catheter or (ii) a distal end of the second catheter (oscillating pressure with square waves/step functions or vacuum off function of vacuum pulsing device 156 with control console 112 switches vacuum pressure from a first pressure having a higher first suction intensity to a second pressure having a lower suction intensity at zero vacuum at a location between the vacuum pump 108 and the distal end of the catheter; Paragraph 0064-0066; Figure 1-3).
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 vacuum pump of Mallaby is connected to the control console and circuitry with the vacuum pulsing device of Ross, the vacuum pulsing device between the catheter and the vacuum pump of Mallaby. This allows for the user to control the change in vacuum intensities based on the desired treatment (Ross; Paragraph 0064-0066 and 0092). Regarding claim 17, Mallaby in view of Ross teaches the system of claim 16. The combination of Mallaby in view of Ross further teaches wherein the vacuum source comprises an automated suction device (Ross; vacuum pump 108 has a control console 112 to allow for automatic control of suctioning; Paragraph 0065; Figure 1), and wherein the system comprises one vacuum source (Mallaby; vacuum means 38; Paragraph 0069, 0081, and 0084-0085; Figure 1).
Regarding claim 20, Mallaby in view of Ross teaches the system of claim 16. The combination of Mallaby in view of Ross further teaches wherein the working lumen is configured to be flushed with fluid and to maintain a fluid-filled condition (Mallaby; lumen of microcatheter 102 that is fully capable of being flushed with fluid and fluid filled for aspirating blood clots and suctioning fluid into the catheter system; Figure 1; Paragraph 0041).
Regarding claim 21, Mallaby in view of Ross teaches the system of claim 16. The combination of Mallaby in view of Ross further teaches wherein the first vacuum output is configured to be generated or changed at a location between the vacuum source and the distal end of at least one of (i) the flexible catheter or (ii) the second catheter (Ross; vacuum pulse device 156 generates oscillating pressures at a location between the vacuum pump 108 and the distal end of the catheter; Figure 1 and 2-3).
Regarding claim 22, Mallaby in view of Ross teaches the system of claim 16. The combination of Mallaby in view of Ross further teaches wherein the suction control unit comprises at least one of a valve, a switch, or an external control panel (Ross; valve in vacuum pulsing device 156 is controlled by a control console 112 which comprises circuitry, a display interface, switches, etc.; Paragraph 0090-0092; Figure 1), wherein activation of the suction control unit is configured to be automated in a repetitive cycle or enabled manually by an operator, wherein, when the suction control unit is activated or enabled (Ross; oscillating pressure with square waves/step functions or vacuum off function of vacuum pulsing device 156 with the control console 112 switches vacuum pressure from a first pressure having a higher first suction intensity to a second pressure having a lower suction intensity at zero vacuum at a location between the vacuum pump 108 and the distal end of the catheter; Paragraph 0064-0066; Figure 1-3), the at least one of the valve or the switch or the external control panel permits the first vacuum output, and wherein, when the suction control unit is not activated or enabled, the at least one of the valve or the switch or the external control panel pauses the first vacuum output (Ross; vacuum pulsing device 156 with control console 112 can activate pump 108 when in ON mode and pause activation of vacuum pump 108 in OFF mode; Paragraph 0089 and 0092; Figure 1-3).
Claim(s) 4, 6, 8, 13, and 18-19 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), as applied to claims 2, 9, and 16 above, and further in view of Zadno-Azizi (Publication No. US 2002/0052638 A1).
Regarding claim 4, Mallaby in view of Ross teaches the system of claim 2. The combination of Mallaby in view of Ross does not teach wherein the vacuum source comprises a manual suction device.
However, Zadno-Azizi teaches wherein the vacuum source comprises a manual suction device (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 6, Mallaby in view of Ross teaches the system of claim 2. The combination of Mallaby in view of Ross further teaches wherein the first suction output comprises a plurality of intensity levels (Ross; oscillating pressure with square waves/step functions of vacuum pulsing device 156 switches vacuum pressure from a first pressure having a higher first suction intensity to a second pressure having a lower suction intensity at zero vacuum; Paragraph 0064-0066; Figure 1-3), and wherein the second intensity level is less negative than -760 mm Hg (Ross; second intensity is zero vacuum; Paragraph 0064-0066; Figure 1-3). The combination of Mallaby in view of Ross does not teach wherein the first intensity level is less than -760 mm Hg.
However, Zadno-Azizi teaches comprising a suction pressure that is approximately 3-30 inches of mercury, or about 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 as the first intensity of the first pressure 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 wherein suction pressure of a first intensity level is -551 mm Hg to -760 mm Hg, and wherein suction pressure of a second intensity level is 0 mm Hg to -350 mm Hg; or wherein suction pressure of the first intensity level is -551 mm Hg to -760 mm Hg and wherein suction pressure of the second intensity level is -351 mm Hg to -550 mm Hg; or wherein suction pressure of the first intensity level is -351 mm Hg to -550 mm Hg and wherein suction pressure of the second intensity level is 0 mm Hg to -350 mm Hg; or wherein suction pressure of the first intensity level is 0 mm Hg to -350 mm Hg and wherein suction pressure of the second intensity level is also 0 mm Hg to -350 mm Hg; or wherein suction pressure of each of the plurality of intensity levels is less negative than -760 mm Hg (square wave pattern of vacuum pulses from the device of Mallaby in view of Ross can have a first suction pressure with a first intensity level of less than -760 mmHg, as taught by Zadno-Azizi, and a second suction pressure with a second intensity level of between 0 and -350 mmHg, as taught by Ross; Zadno-Azizi; Figure 41; Paragraph 0200; Ross; second pressure with a second intensity of zero vacuum; Paragraph 0064; Figures 2-3; see combination above).
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 further teaches wherein the flexible catheter or the second catheter are selected from the group consisting of: a microcatheter, a distal access microcatheter, a guide catheter, a shuttle catheter, a venous catheter, a delivery catheter, an aspiration catheter, a balloon guide catheter, a ventriculostomy catheter, an endoscopy tube, a laparoscope, or combinations thereof (Mallaby; microcatheter for neurovascular access; Abstract).
Regarding claim 13, Mallaby in view of Ross teaches the system of claim 9. The combination of Mallaby in view of Ross further teaches wherein a suction intensity level and pressure during the second duration is 0 mm Hg (Ross; second intensity at OFF mode is zero vacuum; Paragraph 0064-0066, 0089, and 0092; Figure 1-3). The combination of Mallaby in view of Ross does not teach wherein the first vacuum output or the plurality of vacuum outputs comprise any intensity level that is less negative than -760 mm Hg.
However, Zadno-Azizi teaches comprising a suction pressure that is approximately 3-30 inches of mercury, or about 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 as the first intensity of the first duration 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 wherein the first vacuum output or the plurality of vacuum outputs comprise any intensity level that is less negative than -760 mm Hg (square wave pattern of vacuum pulses from the device of Mallaby in view of Ross can have a first suction pressure with a first intensity level of less than -760 mmHg, as taught by Zadno-Azizi; Figure 41; Paragraph 0200).
Regarding claim 18, Mallaby in view of Ross teaches the system of claim 16. The combination of Mallaby in view of Ross does not teach wherein the vacuum source comprises a manual suction device.
However, Zadno-Azizi teaches wherein the vacuum source comprises a manual suction device (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 19, Mallaby in view of Ross teaches the system of claim 16. The combination of Mallaby in view of Ross teaches wherein the first vacuum output comprises a repetitive cycle of a first intensity level and a second intensity level (Ross; oscillating pressure with square waves/step functions of vacuum pulsing device 156 switches vacuum pressure from a first pressure having a higher first suction intensity to a second pressure having a lower suction intensity at zero vacuum; Paragraph 0064-0066; Figure 1-3), and wherein the second intensity level is less negative than -760 mm Hg (Ross; second intensity is zero vacuum; Paragraph 0064-0066; Figure 1-3).
The combination of Mallaby in view of Ross does not teach wherein the first intensity level is less than -760 mm Hg.
However, Zadno-Azizi teaches comprising a suction pressure that is approximately 3-30 inches of mercury, or about 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 as the first intensity of the first pressure 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 wherein suction pressure of a first intensity level is -551 mm Hg to -760 mm Hg, and wherein suction pressure of a second intensity level is 0 mm Hg to -350 mm Hg; or wherein suction pressure of the first intensity level is -551 mm Hg to -760 mm Hg and wherein suction pressure of the second intensity level is -351 mm Hg to -550 mm Hg; or wherein suction pressure of the first intensity level is -351 mm Hg to -550 mm Hg and wherein suction pressure of the second intensity level is 0 mm Hg to -350 mm Hg; or wherein suction pressure of the first intensity level is 0 mm Hg to -350 mm Hg and wherein suction pressure of the second intensity level is also 0 mm Hg to -350 mm Hg; or wherein suction pressure of each of the plurality of intensity levels is less negative than -760 mm Hg (square wave pattern of vacuum pulses from the device of Mallaby in view of Ross can have a first suction pressure with a first intensity level of less than -760 mmHg, as taught by Zadno-Azizi, and a second suction pressure with a second intensity level of between 0 and -350 mmHg, as taught by Ross; Zadno-Azizi; Figure 41; Paragraph 0200; Ross; second pressure with a second intensity of zero vacuum; Paragraph 0064; Figures 2-3; see combination above).
Conclusion
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781