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 March 26, 2026.
Status of Claims
1. Claims 1-20 are pending and currently under consideration for patentability.
Information Disclosure Statement
2. The information disclosure statements (IDS) submitted on March 26, 2026 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
3. Applicant's arguments filed March 26, 2026 have been fully considered but they are not persuasive.
With regard to applicant’s argument that Ross and Willard do not teach or suggest the claimed combination, including a system configured to facilitate increased aspiration of a thrombus as recited, examiner respectfully disagrees. While examiner agrees that the present application is directed to a catheter in which the lumen in configured to aspiration or suction-based removal of a thrombus, rather than for mechanical disruption using internal elements, as discussed during the March 18, 2026 interview, the instant invention, as presently claimed, does not necessarily remove Willard and Ross from the scope of rejection. However, Willard remains as the primary reference for rejection of the claims, as presently amended, since Willard clearly discloses an open lumen (30), wherein at least the distal end of the aspiration catheter (20) is flexible (col. 5, line 66 – col. 6, line 10). Examiner maintains the suggestions from the March 18, 2026 interview regarding the inclusion of “an aspiration-only catheter” or the catheter including “a single open lumen.” Similar to examiner’s suggestion from the March 18, 2026 interview, another suggestion would be the inclusion of functional language specific to facilitation of complete thrombus removal via aspiration only (in order to avoid prior art catheters with internal elements for mechanical disruption of thrombus). Additionally, while examiner agrees that Willard fails to explicitly disclose the newly amended limitation of the controller configured to facilitate increased suction, it is maintained that Ross discloses and renders obvious these limitations, as Ross discloses 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 to facilitate increased aspiration of a thrombus (104; [0013]; [0021]; [0062-0065]; [0082]; [0089]).
In response to applicant's argument that Ross teaches rigid aspiration conduits to preserve pulsed vacuum energy, whereas applicant’s claims recite at least a flexible distal end of the catheter, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). As stated above, Willard is the primary reference for rejection and already discloses a flexible distal end of the catheter – Ross is merely utilized for rejection as a secondary reference, providing a clear teaching/suggestion to one having ordinary skill in the art to incorporate the teachings of 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 to facilitate increased aspiration of a thrombus, and render obvious the limitations untaught by Willard. Examiner is not bodily incorporating the rigid catheter distal end disclosed by Ross into the teachings of Willard, but rather combining the teachings of the references to conclude obviousness based on what the references would have suggested to those of ordinary skill in the art.
Accordingly, the claims, as presently amended, remain 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), as outlined below.
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.
4. 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).
5. 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 an open lumen (30; Fig. 4), wherein at least the distal end of the aspiration catheter (20) is flexible (col. 5, line 66 – col. 6, line 10); 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 to facilitate increased aspiration of a thrombus.
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) to facilitate increased aspiration of a target tissue ([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 to facilitate increased aspiration of a thrombus, 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) to increased levels capable of breaking up a target tissue, as suggested by Ross in paragraphs [0063-0064].
6. 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 an open lumen (30; Fig. 4; col. 5, line 38 – col. 6, line 56), wherein at least the distal end of the aspiration catheter (20) is flexible (col. 5, line 66 – col. 6, line 10).
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 to facilitate increased aspiration of a thrombus.
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), to facilitate increased aspiration of a target tissue ([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) to increased levels capable of breaking up a target tissue, 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 [0063-0065].
7. 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]).
8. 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.
9. 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).
10. With regard to claims 6 and 15, Willard discloses that the vacuum source (54) is a single vacuum source (54; Fig. 1) and 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).
11. 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).
12. 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).
13. 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]).
14. 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]).
15. 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]).
16. 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
17. 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.
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..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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