DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendments filed on 03/27/2026 have been fully considered. Claims 1-17 are pending in this application. Claims 1, 5-6, 9-14, and 17 are amended.
Response to Arguments
Applicant’s arguments with respect to 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. More specifically, the claim amendment requires “wherein at least the distal tip of the catheter is flexible” which further narrows the scope of the claimed invention.
Though the same prior art reference is re-used herein, amended claims 1, 5-6, 9-14, and 17 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.
Claims 1-4, 6, 8-9, 14-15, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, and 15 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. More specifically, claim 1 and 8 of the instant application requires a repetitive cyclical suction output in addition to the components of the aspiration system, which is recited in the published patent. 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
1
1
2
3
3
7
4
1
6
6
8
6
9
11
14
14
15
8
17
5
Claim Objections
Claim 15 is objected to because of the following informalities:
Line 2: “the first intensity level” should read “a first intensity level”;
Line 3: “a suction pressure” should read “a first suction pressure”;
Line 4: “a suction pressure” should read “a second suction pressure”. Appropriate correction is required.
Claim 4 is objected to because of the following informalities:
Line 2: “a repetitive cycle” should read “the repetitive cycle”.
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) 1, 4-6, 8-13, and 16-17 are rejected under 35 U.S.C. 102(a) as being anticipated by Bagaoisan et al. (US 6,152,909 A).
Regarding claim 1, Bagaoisan discloses a system for facilitating aspiration of a thrombus in a vessel (aspiration system for aspirating thrombi; Figure 17; Abstract; Column 14, lines 3-22), the system comprising: a catheter (aspiration catheter 150; Figure 17; Column 2, lines 50-67, Column 3, lines 8-21, and Column 14, lines 3-22) comprising an open, atraumatic distal tip (“The distal tip 22… is preferably soft to prevent damage to the patient's vasculature.”; Column 8, lines 26-29; Figure 17), wherein at least the distal tip of the catheter is flexible (“The distal tip on the catheter is formed of a more flexible material than that used to form the rest of the catheter shaft.”; Column 3, lines 8-20; Figure 17); and a suction device configured to generate, at the distal tip of the catheter, at least a first vacuum output having a repetitive cycle (“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). 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 1. Bagaoisan further discloses wherein the first vacuum output comprises a repetitive cycle of at least one of an intensity, a velocity, a flow, or a duration (“The stopcock 158 may be opened and closed repeatedly to deliver the aspiration pressure in a pulsed manner if desired.”, meaning that the pulsing of suction pressure is repeating cyclical suction output by closing and opening the valve repetitively and comprising a repetitive cycle of intensity and duration; Figure 17; Column 14, lines 3-38).
Regarding claim 5, Bagaoisan discloses the system of claim 1. Bagaoisan further discloses wherein the suction device comprises a single vacuum source (vacuum source 160 is a single vacuum source; Figure 17) and is in fluid communication with a lumen of the catheter and is connected through a tubing directly to the proximal end of the catheter or indirectly through a valve to (i) the proximal end of the catheter (vacuum source 160 is connected to valve 158, to tubing 154, and to proximal end of catheter 150 for fluid communication with lumen of the catheter; Figure 17; Column 14, lines 3-38) or (ii) the proximal end of the catheter and a second catheter positioned within the catheter.
Regarding claim 6, Bagaoisan discloses a system for facilitating aspiration of a thrombus in a vessel (aspiration system for suctioning thrombi; Figure 17; Abstract; Column 14, lines 3-22), the system comprising: a catheter (aspiration catheter 150; Figure 17; Column 2, lines 50-67, Column 3, lines 8-21, and Column 14, lines 3-22) comprising an open atraumatic distal tip (“The distal tip 22… is preferably soft to prevent damage to the patient's vasculature.”; Column 8, lines 26-29; Figure 17), wherein at least the distal tip of the catheter is flexible (“The distal tip on the catheter is formed of a more flexible material than that used to form the rest of the catheter shaft.”; Column 3, lines 8-20; Figure 17); and a suction device configured to generate at least a first cyclical suction output (source of aspiration/syringe 160 and tube 154 produces vacuum; Figure 17; Column 14, lines 23-38), 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 (“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 repetitively and comprising a repetitive cycle of intensity and duration; Figure 17; Column 14, lines 3-38).
Regarding claim 8, Bagaoisan discloses the system of claim 6. Bagaoisan further discloses wherein the first cyclical suction output comprises a repetitive cycle of at least one of an intensity, a velocity, a flow, or a duration of the 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 closing and opening the valve repetitively and comprising a repetitive cycle of intensity and duration; Figure 17; Column 14, lines 3-38).
Regarding claim 9, Bagaoisan discloses the system of claim 6. Bagaoisan further discloses wherein the first cyclical suction output is configured to be generated or changed at a location between the suction device and the distal tip of the catheter (negative pressure is generated/changed at the valve 158 between the source 158 and distal tip of catheter 150; Figure 17; Column 14, lines 3-22).
Regarding claim 10, Bagaoisan discloses the system of claim 6. Bagaoisan further discloses wherein the catheter comprises an inner lumen (catheter 150 has an inner lumen; Column 17, Column 3-22), wherein a change in suction intensity or pressure at the distal tip of the catheter is configured to result in a change in a square of a velocity of blood facilitating a desired thrombus aspiration (pulsing of open and closing the valve 158 changes the square of the velocity of blood flow from zero to a given threshold; Column 14, lines 3-38), and wherein a change in the velocity of blood along with a square of a radius of the inner lumen of the catheter is configured to directly impact flow of blood (obvious that change in velocity of blood flow within the inner lumen will directly impact flow of blood).
Regarding claim 11, Bagaoisan discloses the system of claim 6. Bagaoisan further discloses wherein the catheter comprises a connector, a valve, a microcatheter, a distal access microcatheter, a guide catheter, a shuttle catheter, a venous catheter, an aspiration catheter, a delivery catheter, a balloon guide catheter, a ventriculostomy catheter, an endoscope, a laparoscope, or combinations thereof (aspiration catheter 150 has a valve 158 and adaptor 153/connecter; Figure 17; Column 14, lines 3-22).
Regarding claim 12, Bagaoisan discloses the system of claim 6. Bagaoisan further discloses wherein the suction device comprises a single vacuum source (vacuum source 160 is a single vacuum source; Figure 17) and is in fluid communication with the lumen of the catheter and is connected through a tubing directly to the proximal end of the catheter or indirectly through a valve to (i) the proximal end of the catheter or (ii) the proximal end of the catheter and a second catheter positioned within the catheter (vacuum source 160 is connected to valve 158, to tubing 154, and to proximal end of catheter 150 for fluid communication with lumen of the catheter; Figure 17; Column 14, lines 3-38).
Regarding claim 13, Bagaoisan discloses the system of claim 6. Bagaoisan further discloses wherein the suction device is configured to be fluidically connected to the lumen of the catheter (vacuum source 160 is connected to valve 158, to tubing 154, and to proximal end of catheter 150 for fluid communication with lumen of the catheter; Figure 17; Column 14, lines 3-38) and to flush fluid through the lumen of the catheter before, during, or after advancing the catheter into the vessel (Column 14, lines 3-38).
Regarding claim 16, Bagaoisan discloses the system of claim 1. Bagaoisan further discloses wherein activation of the first vacuum output is automated or enabled using a manual syringe (activation of vacuum is enable by syringe; Column 14, lines 23-27).
Regarding claim 17, Bagaoisan discloses the system of claim 1. Bagaoisan further discloses wherein the first vacuum output is configured to be generated or changed at a location between the suction device and the distal tip of the catheter (negative pressure is generated/changed at the valve 158 between the source 158 and distal tip of catheter 150; Figure 17; Column 14, lines 3-22).
Claim Rejections - 35 USC § 103
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, 7, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bagaoisan et al. (Patent No. US 6,152,909 A) in view of Zadno-Azizi (Publication No. US 2002/0052638 A1).
Regarding claim 2, Bagaoisan discloses the system of claim 1. Bagaoisan further teaches wherein the repetitive cycle comprises a change in intensity between a first intensity and a second intensity level (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 the second intensity level is between 0 and -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 the first intensity level is between -551 and -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 3, Bagaoisan discloses the system of claim 1. Bagaoisan further teaches wherein the repetitive cycle comprises a change in intensity between a first intensity level and a second intensity level (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 the second intensity level is less negative than -760 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 intensity level 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 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). The combination of Bagaoisan in view of Zadno-Azizi further teaches wherein the first intensity level and the second intensity level are each less negative than -760 mm Hg (see combination above).
Regarding claim 7, Bagaoisan discloses the system of claim 6. Bagaoisan further teaches wherein the first cyclical suction output comprises a second intensity level that is less negative than -760 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 a first 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 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).
The combination of Bagaoisan in view of Zadno-Azizi further teaches wherein the first cyclical suction output comprises at least two different intensity levels that are less negative than -760 mm Hg (first intensity level is less than -760 mm Hg and second intensity level is 0 mm Hg; see combination above), and 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 (obvious that switching between the first intensity level and the second intensity levels would have a first and second duration).
Regarding claim 15, Bagaoisan discloses the system of claim 6. Bagaoisan further teaches wherein the first cyclical suction output comprises a repetitive cycle (“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 between 0 mm Hg/second intensity level to a first intensity level by closing and opening the valve repetitively; Figure 17; Column 14, lines 28-38) of the first intensity level (a first intensity level when stopcock is opened and vacuum is delivered to the catheter; Column 14, lines 28-38) and a second intensity level having a suction pressure between 0 and -350 mm Hg (a second intensity level at 0 mm Hg when the stopcock is in the closed position; Column 14, lines 28-38). Bagaoisan does not teach the first intensity level having a suction pressure between -551 and -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, 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).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bagaoisan et al. (Patent No. US 6,152,909 A) in view of Chou et al. (Publication No. US 2011/0034986 A1).
Regarding claim 14, Bagaoisan discloses the system of claim 6. Bagaoisan 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 Bagaoisan 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 Bagaoisan to have the expandable braid member as taught by Chou on the catheter of Bagaoisan. 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
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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