DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed December 31, 2025.
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 31, 2025 has been entered.
Status of Claims
2. Claims 1-20 are pending and currently under consideration for patentability.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on December 31, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Response to Arguments
4. Applicant’s arguments with respect to claim(s) 1-20 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.
Willard et al. (US 5,419,774) is newly presented as the primary reference for rejection, and Ross et al. (US PGPUB 2010/0191178 A1) is newly presented as the secondary reference for rejection, herein.
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.
5. Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Willard et al. (US 5,419,774) in view of Ross et al. (US PGPUB 2010/0191178 A1).
6. With regard to claim 1, Willard discloses an aspiration thrombectomy system (thrombus extraction device, 10; abstract; Figs. 1, 4, 10a), the system (10) comprising: an aspiration catheter (multi-lumen catheter body, 20) comprising a proximal end (connected to manifold system, 12), a distal end (including atraumatic distal tip, 16), and a lumen (30; Fig. 4); a vacuum source (vacuum pump, 54) and a driving apparatus (23) configured to facilitate vacuum thrombectomy (col. 5, line 38 – col. 6, line 56).
While Willard suggests that the vacuum source (54) can be regulated and adjusted to control the negative pressure (col. 5, lines 47-51), Willard fails to explicitly disclose a controller configured to facilitate computer-assisted vacuum thrombectomy, wherein the controller is further configured to change a level of vacuum at the distal end of the aspiration catheter.
However, within the same field of endeavor, Ross discloses a tissue removal system (100; abstract; Figs. 1-4; [0059]), comprising an aspiration catheter (tissue removal device, 104) with a proximal end (136), distal end (132) and lumen (aspiration line, 144; [0060-0061]); a vacuum source (vacuum pump, 108); and a controller (control console, 112) configured to facilitate computer-assisted vacuum tissue removal ([0062-0063]; [0065-0067]), wherein the controller (112) is further configured to change a level of vacuum at the distal end of the aspiration catheter (104; [0013]; [0021]; [0062-0065]; [0082]; [0089]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system disclosed by Willard to include a controller configured to change the level of vacuum at the distal end of the aspiration catheter, similar to that disclosed by Ross, in order to regulate, adjust and control the negative pressure, as suggested by Willard in column 5, lines 47-51, while also allowing for a surgeon to select among various preset (predetermined, preprogrammed, etc.) vacuum pulsing programs, and/or adjust vacuum pulsing parameters in real time (on the fly), as suggested by Ross in paragraph [0063].
7. With regard to claim 11, Willard discloses an aspiration thrombectomy system (thrombus extraction device, 10; abstract; Figs. 1, 4, 10a), the system (10) comprising: a vacuum source (vacuum pump, 54); a catheter (multi-lumen catheter body, 20) comprising a proximal end (connected to manifold system, 12), a distal end (including atraumatic distal tip, 16), and a lumen (30; Fig. 4; col. 5, line 38 – col. 6, line 56).
While Willard suggests that the vacuum source (54) can be regulated and adjusted to control the negative pressure (col. 5, lines 47-51), Willard fails to explicitly disclose a controller configured to turn off and on cyclically to change a level of vacuum at the distal end of the catheter and control a flow rate at the distal end of the catheter.
However, within the same field of endeavor, Ross discloses a tissue removal system (100; abstract; Figs. 1-4; [0059]), comprising a catheter (tissue removal device, 104) with a proximal end (136), distal end (132) and lumen (aspiration line, 144; [0060-0061]); a vacuum source (vacuum pump, 108); and a controller (control console, 112) configured to turn off and on cyclically to change a level of vacuum at the distal end of the catheter (104; [0013]; [0021]; [0062-0066]; [0082]; [0089]; [0092]) and control a flow rate at the distal end of the catheter (104; [0008]; [0013]; [0065-0066]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system disclosed by Willard to include a controller configured to turn off and on cyclically to change the level of vacuum and control the flow rate at the distal end of the aspiration catheter, similar to that disclosed by Ross, in order to regulate, adjust and control the negative pressure, as suggested by Willard in column 5, lines 47-51, while also allowing for a surgeon to select among various preset (predetermined, preprogrammed, etc.) vacuum pulsing programs, and/or adjust vacuum pulsing parameters in real time (on the fly), wherein the cyclical breaking and restoring of the vacuum applied at the distal tip significantly affects the fluid flow rate, as suggested by Ross in paragraphs [0063] and [0065].
8. With regard to claims 2 and 12, Willard as modified by Ross discloses the controllers of claims 1 and 11, respectfully; further, Ross discloses that the controller (112) comprises at least one of an integrated circuit board with random access memory ([0090]), a printed circuit board ([0021]; [0066]; [0090-0091]), a human machine interface (control and input mechanisms, 118), electronics ([0021]; [0066]; [0090-0091]), or software to facilitate computer-assisted vacuum thrombectomy ([0090-0091]).
9. With regard to claims 3 and 13, Willard as modified by Ross discloses the controllers of claims 1 and 11, respectfully; further, Ross discloses that the controller (112) comprises a motor controller ([0089]), an electric energy regulator (1762, 1766; [0095]), pressure sensors (pressure transducer, 184; [0021]; [0073]; [0088-0089]), a valve ([0035]; [0066]), a switch ([0021-0022]; [0064]), foot pedals (116; [0028]; [0066-0067]), or combinations thereof.
10. With regard to claims 4, 5 and 14, Willard as modified by Ross discloses the controllers of claims 1 and 11, respectfully; further, Ross discloses that the level of the vacuum at the distal end of the aspiration catheter (104) comprises a repetitive cycle of a first pressure for a first duration and a second pressure for a second duration (Figs. 2, 3; [0013]; [0015]; [0029]; [0062-0066]; [0082]; [0089]; [0092]); and while Ross specifies a low/zero mm Hg second pressure (Figs. 2, 3; [0013]; [0015]; [0029]; [0062-0066]; [0082]; [0089]; [0092]), Willard specifies a first vacuum pressure operating condition between 20 and 25 inches of mercury (or between -508 mm Hg and -635 mm Hg; col. 5, lines 47-51).
11. With regard to claims 6 and 15, Willard discloses that the vacuum source (54) is in fluid communication with the lumen (24) of the aspiration catheter (20) and is connected through a tubing (conduits, 13 and 15) directly to the proximal end of the aspiration catheter (20; Fig. 1).
12. With regard to claims 7 and 16, Willard further discloses that the system (10; Fig. 1) further comprises an infusion bag (fluid supply means, 48) configured to contain a volume of fluid (irrigation saline), and wherein fluids are configured to be infused through a tubing (unnumbered conduit connected to port, 46) into the lumen (24) of the aspiration catheter (20; Fig. 1; col. 5, lines 60-65; col. 6, lines 44-56; col. 11, lines 45-61).
13. With regard to claims 8 and 18, Willard as modified by Ross discloses the controllers and plurality of vacuum levels of claims 1 and 11, respectfully; further, Willard discloses that the level of the vacuum at the distal end of the aspiration catheter comprises one of a plurality of pressures each less negative than -760 mm Hg (between 20 and 25 inches of mercury; or between -508 mm Hg and -635 mm Hg; col. 5, lines 47-51).
14. With regard to claim 9, Willard as modified by Ross discloses the controller of claims 1; further, Willard discloses that the vacuum source (54) can be regulated and adjusted to control the negative pressure at a location between the vacuum source (54) and the distal end of the catheter (20; Fig. 1; col. 5, lines 47-51); and Ross discloses that the controller (control console, 112) is configured to turn off and on cyclically to change a level of vacuum at the distal end of the catheter (104; [0013]; [0021]; [0062-0066]; [0082]; [0089]; [0092]).
15. With regard to claims 10 and 17, Willard as modified by Ross discloses the controller of claim 11; further, Willard discloses that the vacuum source (54) can be regulated and adjusted to control the negative pressure at a location between the vacuum source (54) and the distal end of the catheter (20; Fig. 1; col. 5, lines 47-51); and Ross discloses that the level of vacuum at the distal end of the catheter (104) is configured to be generated or changed at a location between the vacuum source (108) and the distal end of the catheter (104; Fig. 1; [0013]; [0021]; [0062-0065]; [0082]; [0089]).
16. With regard to claim 19, Willard as modified by Ross discloses the controller of claim 11; further, Ross discloses that the controller comprises a valve (“valve mechanism” or vacuum pulsing device, 156) configured to open and close to cyclically change the level of the vacuum at the distal end of the catheter (104; [0021-0023]; [0028-0029]; [0035]; [0066]; [0088-0089]).
17. With regard to claim 20, Willard discloses that the catheter (20) is selected from the group consisting of: an aspiration tubing, a venous catheter, a delivery catheter, an aspiration catheter, and combinations thereof (Fig. 1; col. 6, lines 11-43; col. 11, line 8 – col. 12, line 47).
Conclusion
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781