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 2-11 and 13-22 are pending in this application. Claims 2, 8-10, 14-16, and 21 are amended. Claims 1 and 12 are cancelled.
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. 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 2, 8-10, 14-16, and 21 required a change in the grounds of rejection as detailed below in the prior art rejection.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 16-17, 19, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5 of U.S. Patent No. 12,478,390. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the patented case recite the claim limitations required in the current application. The table below shows the mapping of the overlapping claims between the current application and the patented case.
Instant Claims
Patented Claims of Patent No. 12,478,390 B2
16
1
17
2
19
3
21
5
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2, 4-5, 7-11, and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bagaoisan et al. (US 6,152,909 A).
Regarding claim 2, Bagaoisan discloses a controlled aspiration system for aspirating thrombi from 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 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) and a working lumen (catheter 150 has a lumen; Figure 17; Column 14, lines 3-22), wherein the working lumen is configured to be flushed with fluid (catheter 150 has a lumen is fully capable of being flushed with fluid before use) and to be maintained in a fluid- filled condition (catheter is an aspiration catheter for being placed within the blood vessel thus lumen of catheter fully capable of being placed in a fluid-filled condition; Column 15, line 46 to Column 16, line 3) and 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); a vacuum source that, when in use, is in fluid communication with (i) the catheter or (ii) the catheter and a second catheter positioned within the catheter through suction tubing (suction device comprising a vacuum source 160 and tubing 154 produces vacuum for distal tip of catheter 150; Figure 17; Column 14, lines 3-38); and 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 at least one of (i) the distal tip of the catheter or (ii) a distal tip of the second catheter (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), wherein the first suction output comprises one or a plurality of intensity levels (“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; Figure 17; Column 14, lines 3-38). The term “atraumatic” is interpreted to be designed to minimize tissue damage or not causing injury or trauma, as defined by Merriam-Webster Dictionary.
Regarding claim 4, Bagaoisan discloses the system of claim 2. Bagaoisan further discloses wherein the vacuum source comprises a manual suction device (activation of vacuum is enable by syringe; Column 14, lines 23-27). Regarding claim 5, Bagaoisan discloses the system of claim 2. Bagaoisan further discloses wherein activation of the valve or switch is configured to be automated in a repetitive cycle or enabled manually by an operator (valve is activated manually by the user in a repetitive cycle; Column 14, lines 3-38), 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 (“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 suction pressure is repeating cyclical suction output by opening the valve which is the first suction output and when the valve is closed, the first suction output is paused; Figure 17; Column 14, lines 3-38).
Regarding claim 7, Bagaoisan discloses the system of claim 2. Bagaoisan further discloses 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 (“The stopcock 158 may be opened and closed repeatedly to deliver the aspiration pressure in a pulsed manner if desired.”, meaning that the change in the first suction output by closing and opening the valve repetitively changes the pressure, velocity, fluid flow, and time duration by the user; Figure 17; Column 14, lines 3-38).
Regarding claim 8, Bagaoisan discloses the system of claim 6. Bagaoisan further discloses wherein the 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 (aspiration catheter 150; Figure 17; Column 14, lines 3-22).
Regarding claim 9, Bagaoisan discloses a controlled aspiration system for use within 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 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); and a suction device (suction device comprising source 160 and tubing 154; Column 14, lines 3-22; Figure 17) comprising a vacuum source (vacuum source 160; Figure 17; Column 14, lines 3-22) that, when in use, is fluidically connected to (i) the catheter or (ii) the catheter and a second catheter positioned within the catheter, through suction tubing (source 160 is connected to catheter 150 through suction tubing 154; Figure 17; Column 14, lines 3-22), wherein the catheter or the catheter and the second catheter are configured to be flushed with fluid (catheter 150 is fully capable of being flushed with fluid before use) and to be maintained in a fluid-filled condition (catheter is an aspiration catheter for being placed within the blood vessel thus fully capable of being placed in a fluid-filled condition; Column 15, line 46 to Column 16, line 3), and wherein the suction device is configured to change a first vacuum output or a plurality of vacuum outputs to (i) the distal tip of the catheter or (ii) a distal tip of the second catheter (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), wherein the first vacuum output is configured to be controlled or changed at a location between the vacuum source and the distal tip of least one of (i) the catheter or (ii) the second catheter (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), 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 (“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 paused, or when the valve is closes, at a second duration and the first intensity is when valve is opened for a first duration; Figure 17; Column 14, lines 3-38).
Regarding claim 10, Bagaoisan discloses the system of claim 9. Bagaoisan further discloses 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, 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 regulator, thermal sensors, pressure sensors, electric sensors, a valve, a luer lock, a switch, an external control panel, or combinations thereof (valve 158; Column 14, line 3-22).
Regarding claim 11, Bagaoisan discloses the system of claim 9. Bagaoisan further discloses 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 (aspiration catheter able to aspirate “emboli, plaque, thrombi or other occlusions from a blood vessel” from the blood vessel, indicating that the first vacuum output could be used to aspirate soft, acute clots or hard, aged, and adherent clots; Column 5, lines 22-33).
Regarding claim 14, Bagaoisan discloses the system of claim 9. Bagaoisan further discloses wherein activation of the suction device is configured to be automated in a repetitive cycle or enabled manually by an operator (activation of vacuum is enable by syringe and controlled by valve; Column 14, lines 23-38), and wherein the system comprises a single vacuum source (vacuum source 160 is a single vacuum source; Figure 17).
Regarding claim 15, Bagaoisan discloses the system of claim 9. Bagaoisan further discloses wherein the 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 (aspiration catheter 150; Figure 17; Column 14, lines 3-22).
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) 3, 16-18, 20-22 rejected under 35 U.S.C. 103 as being unpatentable over Bagaoisan et al. (US 6,152,909 A) in view of Iwakoshi et al. (Patent No. US 4,973,311 A).
Regarding claim 3, Bagaoisan discloses the system of claim 2. Bagaoisan does not teach wherein the vacuum source comprises an automated suction device, and wherein the system comprises one vacuum source. Bagaoisan does teach that a pump can be used in replacement of the syringe (Column 16, lines 7-9).
However, Iwakoshi teaches the vacuum source comprises an automated suction device (suction pump 62 is actuated automatically with the turning of a main switch; Figure 3; Column 3, line 47-51), and wherein the system comprises one vacuum source (pump 62 is the singular source; Figure 3).
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 vacuum source of Iwakoshi be the vacuum source of Bagaoisan. This allows for the aspiration to be performed automatically after the activation of the switch by the user (Iwakoshi; Column 3, lines 52-59).
Regarding claim 16, Bagaoisan teaches a controlled aspiration system for aspirating thrombi from vasculature (aspiration system is controllable using the valve 158 to aspirate thrombi; Figure 17; Abstract; Column 14, lines 3-38) using suction, 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 a proximal end (adaptor 153 of catheter 150; Figure 17; Column 14, lines 3-22), an 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), and a working lumen (catheter 150 has a lumen; Figure 17; Column 14, lines 3-22), 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); a vacuum source that, when in use, is in fluid communication with (i) the first catheter or (ii) the catheter and a second catheter positioned within the catheter, through suction tubing (suction device comprising a vacuum source 160 and tubing 154 produces vacuum for distal tip of catheter 150; Figure 17; Column 14, lines 3-38). Bagaoisan does not teach a suction control unit.
However, Iwakoshi teaches a suction control unit (electromagnetic valve 65 with controller 64, controlled by button 63; Figure 3; Column 3, lines 23 to Column 4, line 12).
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 valve of Bagaoisan to be an electromagnetic valve with controller of Iwakoshi. This allows for the aspiration to be performed automatically after the activation of the button by the user (Iwakoshi; Column 3, lines 52-59). The combination of Bagaoisan in view of Iwakoshi further teaches the suction control unit is 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 at least one of (i) the distal tip of the catheter or (ii) a distal tip of the second catheter (Iwakoshi; pressing the button 63 for the controller 64 controls the activation of the pump, which impacts the change in intensity, velocity, fluid flow, and time duration; Column 3, line 23 to Column 4, line 12; see combination above).
Regarding claim 17, Bagaoisan in view of Iwakoshi teaches the system of claim 16. The combination of Bagaoisan in view of Iwakoshi does not teach wherein the vacuum source comprises an automated suction device.
However, Iwakoshi teaches the vacuum source comprises an automated suction device (suction pump 62 is actuated automatically with the turning of a main switch; Figure 3; Column 3, line 47-51), and wherein the system comprises one vacuum source (pump 62 is the singular source; Figure 3).
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 vacuum source of Iwakoshi be the vacuum source of Bagaoisan. This allows for the aspiration to be performed automatically after the activation of the switch by the user (Iwakoshi; Column 3, lines 52-59).
Regarding claim 18, Bagaoisan in view of Iwakoshi teaches the system of claim 16. The combination of Bagaoisan in view of Iwakoshi further teaches wherein the vacuum source comprises a manual suction device (Bagaoisan; activation of vacuum is enabled by syringe; Column 14, lines 23-27).
Regarding claim 20, Bagaoisan in view of Iwakoshi teaches the system of claim 16. The combination of Bagaoisan in view of Iwakoshi further teaches wherein the working lumen is configured to be flushed with fluid (catheter 150 is fully capable of being flushed with fluid before use; Abstract) and to maintain a fluid-filled condition (catheter is an aspiration catheter for being placed within the blood vessel thus fully capable of being placed in a fluid-filled condition; Column 15, line 46 to Column 16, line 3).
Regarding claim 21, Bagaoisan in view of Iwakoshi teaches the system of claim 16. The combination of Bagaoisan in view of Iwakoshi further teaches wherein the first vacuum output is configured to be generated or changed at a location between the vacuum source and at least one of (i) the distal tip of the catheter or (ii) a distal tip of 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 22, Bagaoisan in view of Iwakoshi teaches the system of claim 16. The combination of Bagaoisan in view of Iwakoshi further teaches wherein the suction control unit comprises at least one of a valve, a switch, or an external control panel (Iwakoshi; electromagnetic valve 65 with controller 64, controlled by button 63; Figure 3; Column 3, lines 23 to Column 4, line 12), wherein activation of the suction control unit is configured to be automated in a repetitive cycle or enabled manually by an operator (Iwakoshi; user manually activates button; Figure 3; Column 3, lines 23 to Column 4, line 12), wherein, when the suction control unit is activated or enabled, 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 (Iwakoshi; when valve 65 is activated has button 63 is pressed, first vacuum output occurs and when valve 65 is closed, first vacuum output is paused; Figure 3; Column 3, line 23 to Column 4, line 12).
Claim(s) 6 and 13 rejected under 35 U.S.C. 103 as being unpatentable over Bagaoisan et al. (US 6,152,909 A) in view of Zadno-Azizi (Publication No. US 2002/0052638 A1).
Regarding claim 6, Bagaoisan discloses the system of claim 2. Bagaoisan further teach wherein the first suction output comprises a plurality of intensity levels (a first intensity level is when stopcock is opened and vacuum is delivered to the catheter and second intensity level is when stopcock is closed and no vacuum is delivered; Column 14, lines 28-38) and: wherein suction pressure of a second intensity level is 0 mm Hg to -350 mm Hg (a second intensity level having a second suction pressure at 0 mm Hg when the stopcock is in the closed position; Column 14, lines 28-38). Bagaoisan does not teach wherein suction pressure of a first intensity level is -551 mm Hg 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).
Bagaoisan 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 Bagaoisan to incorporate the teachings of Zadno-Azizi and have the negative pressure range of Zadno-Azizi, in between -551 and -760 mm Hg, and as the first intensity of the first pressure produced by the vacuum source of Bagaoisan. This allows for the aspiration of larger emboli into the system (Zadno-Azizi; Paragraph 0200).
Regarding claim 13, Bagaoisan discloses the system of claim 9. Bagaoisan further teaches wherein a suction intensity level and pressure during the second duration is 0 mm Hg (a second intensity level having a second suction pressure at 0 mm Hg when the stopcock is in the closed position; Column 14, lines 28-38). Bagaoisan 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).
Bagaoisan 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 Bagaoisan to incorporate the teachings of Zadno-Azizi and have the negative pressure range of Zadno-Azizi, less negative than -760 mmHg, and as the first intensity of the first pressure produced by the vacuum source of Bagaoisan. This allows for the aspiration of larger emboli into the system (Zadno-Azizi; Paragraph 0200). The combination of Bagaoisan in view of 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 (both the first intensity level and second intensity level has suction pressure less negative than -760 mm Hg; see combination above).
Allowable Subject Matter
Claim 19 is objected to as being dependent upon a rejected base claim under non-statutory double patenting rejection of claim 16, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, as well as overcoming the non-statutory double patenting rejection of claim 16.
Reasons for Indicating Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: the prior art of the record, alone or in combination, fails to disclose all of the structural and functional limitations as described in the claims.
The invention is drawn to a thrombus aspirating device that comprises a catheter with an atraumatic tip and an open working lumen and a negative suction device with a control unit that has a repetitive cycle of suction outputs comprising a plurality of intensity levels. The closest prior art found is Bagaoisan et al. (Patent No. US 6,152,909 A), Iwakoshi et al. (Patent No. US 4,973,311 A), and Ross et al. (Publication No. US 2010/0191178 A1) with none of these references disclosing the required “a catheter comprising an atraumatic distal tip, wherein at least the distal tip of the catheter is flexible” that would be operational with a suction device comprising a suction control unit configured to generate one or a plurality of suction outputs as required by the claim limitations of claim 19.
Instead, Bagaoisan discusses a system (Abstract) having a catheter comprising an 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) with a suction device (“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 suction pressure is repeating cyclical suction output by closing and opening the valve 158 repetitively and the suction device comprising a vacuum source 160 and tubing 154 produces vacuum for distal tip of catheter 150; Figure 17; Column 14, lines 3-38), but does not teach a suction control unit having the ability to make a first vacuum output comprising a repetitive cycle.
Iwakoshi instead discusses a system for aspirating (Abstract; Figure 3) comprising an endoscope with a suction control unit that is able to produce a first vacuum output comprising a repetitive cycle (Column 3, line 23 to Column 4, line 12; Figure 3). Iwakoshi does not teach a system that comprises a catheter with an atraumatic tip.
Ross instead discusses an aspirating device (Abstract; Figure 1) with a negative suction device with a control unit that has a repetitive cycle of suction outputs comprising a plurality of intensity levels (device 104 with a pump 108 and a control console 112 to control vacuum levels; Paragraph 0059; Figure 1). Ross does not teach a system that comprises a catheter with an atraumatic tip.
The closest is the disclosure of Bagaoisan, however, it would not have been obvious to modify the device of Bagaoisan with a suction control unit that would be compatible with the aspiration catheter of Bagaoisan that could perform the repetitive cycle, as required by the claim limitation of claim 19. For these reasons, claim 19 is indicated as allowable subject matter.
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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