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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/28/2026 has been entered.
Response to Amendment
Applicant’s amendments filed on 01/28/2026 have been fully considered. Claims 1-17 are pending in this application. Claims 1-9 and 11-14 are amended. Claims 15-17 are newly added.
Response to Arguments
Applicant’s arguments with respect to amended independent claim(s) 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, 4-6, 8-13, and 17 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 system for facilitating aspiration of a thrombus in a vessel (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); and a suction device configured to generate, at a distal end of the flexible catheter, at least a first vacuum output (vacuum means 38 generates a suction force at a distal end of the catheter 104; Paragraph 0069; Figure 1).
Mallaby does not teach the first vacuum output having a repetitive cycle.
However, Ross teaches the first vacuum output having a repetitive cycle (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).
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 vacuum pulsing device of Ross, the vacuum pulsing device between the catheter and the 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 4, Mallaby in view of Ross teaches of the system of claim 1. The combination of Mallaby in view of Ross further teaches wherein the first vacuum output comprises a repetitive cycle of at least one of an intensity, a velocity, a flow, or a 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 5, Mallaby in view of Ross teaches of the system of claim 1. The combination of Mallaby in view of Ross further teaches wherein the suction device is in fluid communication with a lumen of the flexible catheter and is connected through a tubing directly to a proximal end of the flexible catheter or indirectly through a hemostatic valve to (i) the proximal end of the flexible catheter or (ii) the proximal end of the flexible catheter and a second catheter positioned within the flexible catheter.
Regarding claim 6, Mallaby teaches a system for facilitating aspiration of a thrombus in a vessel (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); and a suction device (vacuum means 38 generates a suction force at a distal end of the catheter 104; Paragraph 0069; Figure 1). Mallaby does not teach the suction device configured to generate at least a first cyclical suction output, wherein the suction device is configured to control at least one of an intensity, a velocity, a flow or a duration of at least the first cyclical suction output.
However, Ross teaches the suction device configured to generate at least a first cyclical suction output (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), wherein the suction device is configured to control at least one of an intensity, a velocity, a flow or a duration of at least the first cyclical suction output (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).
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 vacuum pulsing device of Ross, the vacuum pulsing device between the catheter and the 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 8, Mallaby in view of Ross teaches the system of claim 6. The combination of Mallaby in view of Ross further teaches wherein the first cyclical suction output comprises a repetitive cycle of at least one of the intensity, the velocity, the flow or the duration of the suction output (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 in view of Ross teaches the system of claim 6. The combination of Mallaby in view of Ross further teaches wherein the first cyclical suction output is configured to be generated or changed at a location between the suction device and a distal end of the flexible 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 10, Mallaby in view of Ross teaches the system of claim 6. The combination of Mallaby in view of Ross further teaches wherein the flexible catheter comprises an inner lumen (Mallaby; catheter has an inner lumen; Figure 1), wherein a change in suction intensity or pressure at a distal end of the flexible catheter is configured to result in a change in a square of a velocity of blood facilitating a desired thrombus aspiration (Ross; stepped vacuum intensities will increase and decrease the square velocity of fluid suction; Paragraph 0064; Figure 2-3), and wherein a change in the velocity of blood along with a square of a radius of the inner lumen of the flexible catheter is configured to directly impact flow of blood (Ross; change in velocity with square of a radius of the inner lumen of the catheter will impact flow of blood and break up tissue 120; Figures 2-3; Paragraph 0064).
Regarding claim 11, Mallaby in view of Ross teaches the system of claim 6. The combination of Mallaby in view of Ross further teaches wherein the flexible catheter comprises a connector, a hemostatic valve, a microcatheter, a distal access microcatheter, a guide catheter, a shuttle catheter, a venous catheter, a delivery catheter, a balloon guide catheter, a ventriculostomy catheter, an endoscope, a laparoscope, or combinations thereof (Mallaby; microcatheter for neurovascular access; Abstract).
Regarding claim 12, Mallaby in view of Ross teaches the system of claim 6. The combination of Mallaby in view of Ross further teaches wherein the suction device is in fluid communication with a lumen of the flexible catheter and is connected through a tubing directly to a proximal end of the flexible catheter (Mallaby; vacuum means 38 is connected to tubing that is directly connected to the proximal end of the catheter 104; Paragraph 0069; Figure 1) or indirectly through a hemostatic valve (Ross; vacuum pulsing device 156 is a valve that controls the vacuum that is delivered to the catheter produced by the vacuum pump 108 – pump 108 is indirectly connected through line 152 to catheter with valve 156 inbetween and valve that allows for the control of blood flow through the device; Paragraph 0066; Figure 1) to (i) the proximal end of the flexible catheter or (ii) the proximal end of the flexible catheter and a second catheter positioned within the flexible catheter (Ross; vacuum pulsing device 156 is used to change the suction pressure or flow of suction output; Paragraph 0066; Figure 1).
Regarding claim 13, Mallaby in view of Ross teaches the system of claim 6. The combination of Mallaby in view of Ross further teaches wherein the suction device is configured to be fluidically connected to a lumen of the flexible catheter and to flush fluid through the lumen of the flexible catheter before, during, or after advancing the flexible catheter into the vessel (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 17, Mallaby in view of Ross teaches the system of claim 1. 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 suction device and the distal end of the flexible 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; see rejection of claim 1 above).
Claim(s) 2-3, 7, and 15-16 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 1 and 6 above, and further in view of Zadno-Azizi (Publication No. US 2002/0052638 A1).
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 repetitive cycle comprises a change in intensity between 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), wherein the second intensity level is from 0 to -350 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 from -551 to -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 the first intensity level is from -551 to -760 mm Hg, wherein the second intensity level is from 0 to -350 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 3, Mallaby in view of Ross teaches the system of claim 1. The combination of Mallaby in view of Ross further teaches wherein the repetitive cycle comprises a change in intensity between 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 first intensity level is less negative than -760 mm Hg (Ross; second intensity level is zero vacuum; Paragraph 0064-0066; Figures 2-3). The combination of Mallaby in view of Ross does not teach the first intensity level is less negative than -760 mmHg.
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 the first intensity level and the second intensity level are each 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 7, Mallaby in view of Ross teaches the system of claim 6. The combination of Mallaby in view of Ross further teaches wherein the first cyclical suction output comprises at least two different intensity levels, wherein a first intensity level of the at least two different intensity levels has a first duration and a second intensity level of the at least two different intensity levels has a second 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 with a first and second duration; Paragraph 0064-0066; Figure 1-3).
The combination of Mallaby in view of Ross does not teach the first cyclical suction output with a first intensity level that is less negative than -760 mmHg.
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 the first cyclical suction output comprises at least two different intensity levels that are less negative than -760mm 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 15, Mallaby in view of Ross teaches the system of claim 6. The combination of Mallaby in view of Ross further teaches wherein the first cyclical suction output comprises a repetitive cycle of a first intensity level and a second intensity level having a suction pressure from 0 to -350 mm Hg (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). The combination of Mallaby in view of Ross does not teach the first intensity level having a suction pressure from -551 to -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 a first intensity level having a suction pressure from -551 to -760 mm Hg and a second intensity level having a suction pressure from 0 to -350 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 16, Mallaby in view of Ross teaches the system of claim 1. The combination of Mallaby in view of Ross does not teach wherein activation of the first vacuum output is automated or enabled using a manual syringe.
However, Zadno-Azizi teaches wherein activation of the first vacuum output is automated or enabled using a manual 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) 14 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 6 above, and further in view of Chou et al. (Publication No. US 2011/0034986 A1).
Regarding claim 14, Mallaby in view of Ross teaches the system of claim 6. The combination of Mallaby in view of Ross does not teach wherein the flexible catheter comprises at least one of(i) a variably-slotted hypotube comprising a plurality of interspersed cut patterns or (ii) filaments having variable braiding or coiling parameters.
However, Chou teaches wherein the flexible catheter comprises at least one of(i) a variably-slotted hypotube comprising a plurality of interspersed cut patterns or (ii) filaments having variable braiding or coiling parameters (expandable member 129 is a braid comprising filaments; Paragraph 0302; Figure 58).
Chou and Mallaby in view of Ross are both considered to be analogous to the claimed invention because they are in the same field of aspiration/vacuum catheters. 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 have the balloon of Mallaby in view of Ross to be an expandable braid member as taught by Chou. This would allow for the device to be held in place and prevent inadvertent removal when deployed in the blood vessel (Chou; Paragraph 0302).
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