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
The amendment filed 12/15/2025 has been entered:
Claims 1, 3-5, 8-10, and 17-20 are pending in the present application. Claim 1 is amended and claims 19-20 are new.
Applicant’s amendments have been acknowledged, and overcome each and every objection and 112(b) rejection to the claims and specification previously set forth in the non-final office action mailed 8/15/2025. All previous objections and 112(b) rejection have been withdrawn.
Response to Arguments
Applicant’s amendments necessitated a new grounds of rejection. Applicant’s arguments with respect to claim(s) 1, 3-5, 8-9, and 17 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.
Merritt remains as the primary reference in rejecting the present claims, for disclosing a majority of the claimed invention.
Bouchard is being introduced as a secondary reference in the present rejection for disclosing and/or rendering obvious the newly amended limitations of claim 1.
Bendele, Bass, and Ogle remain in the present rejection for disclosing and/or rendering obvious the remaining claim limitations.
Applicant’s arguments regarding the dependent claims are moot as claim 1 remains rejected.
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.
Claims 1, 3-5, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Merritt et al. (US 2020/0046368 A1), in view of Cupit (US 2013/0186815 A1), and Bouchard et al. (US 6,905,479 B1).
Regarding claim 1, Merritt teaches a clot removal system (Figs. 1 and 19-21B; Abstract) comprising a clot capture module (canister 1940 in Fig. 19, filter device 2050 in Figs. 20A-20E, and filter device 2150 in Figs. 21A-B) for use in a thrombectomy system (¶s 1-2 and 7-8 describe thrombectomy use), the clot capture module comprising:
a housing (barrel portion 2070) comprising a proximal housing and a distal housing separated by a tubular side wall (proximal housing being at end 2074 and distal end being at 2076 separated by the tubular wall formed by barrel 2072; ¶ 134);
a clot capture chamber in the housing (formed by filter portion 2060);
a filter in the clot capture chamber (filter 2064), the filter having an upstream surface in a downstream surface (the downstream surface faces pressure source 340 and the upstream surface faces to 2076 and catheter 102, as shown in Fig. 20C);
an incoming flow path configured to direct incoming blood from an aspiration catheter against the upstream surface of the filter (connector 128 and tip 2076);
an aspiration control valve in the incoming flow path (flow control device 126; ¶ 49 describes the flow control device as a stopcock), the aspiration control valve configured to block the flow of incoming aspirated blood until actuated to permit inflow of aspirated blood (¶s 50-51); and
an outgoing flow path configured to direct blood from a downstream side of the filter to a remote vacuum canister (¶ 71 describes how a vacuum canister can be used instead of a syringe).
Merritt does teach the use of transparent barrels (¶ 54), but does not clearly describe the proximal housing and the distal housing being separated by transparent tubular sidewall, a window in the housing to permit visual inspection of the clot chamber, and the filter being visible through the window, or a user actuatable vent positioned on the distal housing, wherein, when the vent is actuated, the vent is configured to permit intake of ambient air.
However, in addressing the same problem as applicant, the problem being windows for viewing filters, Cupit teaches a filter housing (Fig. 3, housing 36; Abstract), comprising a transparent tubular sidewall separating proximal and distal ends of the housing, and forming a window to permit visual inspection of the filter chamber (viewing window 33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular side wall of Merritt to comprise a transparent window as taught by Cupit. Doing so would thus comprise a window in the housing which would permit visual inspection of the clot capture chamber, and the filter being visible through the window. Doing so would be advantageous to allow the filter to be inspected without having to disassemble the system (¶ 51 of Cupit).
The combination of Merritt and Cupit still does not explicitly teach a user actuatable vent positioned on the distal housing, wherein, when the vent is actuated, the vent is configured to permit intake of ambient air.
However, Bouchard teaches a filter cartridge for blood clot removal (Fig. 1; Abstract), thus being in the same field of endeavor, comprising a user actuatable vent (vent valve 126; Col. 20, lines 58-65 describe how the vent is controllable; Col. 21, lines 12-17 describe how the control may be via process or more annual means), wherein, when said vent is actuated, the vent is configured to permit intake of ambient air (Col. 20, lines 58-65 and Col. 22, lines 51-68 further describe atmospheric equilibration which would thus be capable of intaking ambient air).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Merritt and Cupit to comprise the controllable valve of Bouchard. Doing so would be advantageous in equilibrating pressure within the chamber (Col. 20, lines 58-65 and Col. 22, lines 51-68 of Bouchard), such as before disassembly or in the event of clogs.
Regarding claim 3, the combination of Merritt, Cupit, and Bouchard substantially discloses the invention of claim 1. Merritt further teaches the upstream surface of the filter facing the inner wall of the barrel (Fig. 19, Figs. 20A-20E, and Figs. 21A-B).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular side wall of Merritt to comprise a transparent window as taught by Cupit. Doing so would thus comprise the upstream surface of the filter being visible through the window. Doing so would be advantageous to allow the filter to be inspected without having to disassemble the system (¶ 51 of Cupit).
Regarding claim 4, Cupit further teaches the upstream surface of the filter being substantially planar (Fig. 2 shows filter 20 having flat, planar ends).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the filter of Merritt, Cupit, and Bouchard such that the upstream surface of the filter is substantially planar. Doing so would be obvious as one of ordinary skill in the art before the effective filing date of the claimed invention would have found that the shape did not sufficiently alter the device as a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996). Also see MPEP 2144/04 (IV)(B). In the instant case, applicant has not demonstrated that the particular configuration of the filter is critical or significant (¶ 12 of Applicant’s specification really states that the filter “may” be planar; ¶ 52 recites that the planar filter depends only on a “desired configuration”).
Regarding claim 5, Merritt further teaches the upstream surface of the filter is convex (Fig. 19, Figs. 20A-20E, and Figs. 21A-B all show the filter shape being convex).
Regarding claim 8, Cupit further teaches window comprises a transparent tubular portion of the housing (window 33 of housing 36).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular side wall of Merritt to comprise a transparent window as taught by Cupit. Doing so would be advantageous to allow the filter to be inspected without having to disassemble the system (¶ 51 of Cupit).
Regarding claim 9, Merritt further teaches an aspiration actuator configured to control the aspiration control valve (fluid control 126 is show to comprise a handle; ¶ 49 describes it as a stopcock; also see ¶s 89 and 136-137).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Merritt, Cupit, and Bouchard, as applied to claim 1 above, and further in view of Bendele (US 2012/0095391 A1).
Regarding claim 10, the combination of Merritt and Cupit does not explicitly teach (claim 10) the aspiration actuator comprises a rocker switch.
However, in addressing the same problem as Applicant, the problem being actuation means for valves in tube sets, Bendele teaches the use of a rocker valve and stopcock valve (¶ 100).
Thus, Bendele shows that a rocker valve (i.e. rocker switch) is an equivalent structure known in the art. Therefore, because these two valve means were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the rocker switch valve of Bendele for the original valve means of Merritt. Doing so would allow for analogous valve control.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Merritt, Cupit, and Bouchard, as applied to claim 1 above, and further in view of Bass (US 3,858,577 A).
Regarding claim 17, the combination does not explicitly teach the proximal housing in the distal housing being releasably connected to the transparent tubular sidewall.
However, in addressing the same problem as Applicant, the problem being widows which contact body fluids, Bass teaches a medical device comprising a window (window 41 in Fig. 3; Abstract), which is removable from a housing (Col. 3, lines 49-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Merritt and Cupit to comprise a removable window as taught by Bass. Doing so with thus comprise the transparent tubular sidewall (i.e. window) being releasably connected to the proximal and distal housing. Doing so would be advantageous in readily replacing a damaged or coated window (recognized in Col. 3, lines 49-57 of Bass).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Merritt, Cupit, and Bouchard, as applied to claim 1 above, and further in view of Ogle (US 2006/0047301 A1).
Regarding claim 18, the combination of Merritt, Cupit, and Bouchard does not explicitly teach further comprising a coating to inhibit blood accumulation on an interior surface of the window.
However, Ogle teaches an emboli removal system (Fig. 1; Abstract), thus being in the same field of endeavor, thus being in the same field of endeavor, which uses a blood compatible coating on inner surfaces of flow components (¶ 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blood contacting surfaces of Merritt and Cupit, which would include the interior surface of the window, to comprise the blood compatible coating of Ogle. Doing so would be advantageous in preventing or reducing damage to blood components flowing there through (¶ 21 of Ogle).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Merritt, Cupit, and Bouchard, as applied to claim 1 above, and further in view of Harhen (US 5,692,729 A).
Regarding claim 20, the combination of Merritt and Cupit does not explicitly teach the incoming flow path comprises a collapsible portion extending through the housing, and wherein the aspiration control valve is further configured to compress the collapsible portion.
However, in addressing the same problem as Applicant, the problem being flow control for medical tubing and surgical tools, Harhen teaches a flow control apparatus (Fig. 1; Abstract), which utilizes an incoming flow path comprising a collapsible tube portion extending through a housing (resilient tube 26), and wherein the control valve is further configured to compress the collapsible portion (Figs. 1-2 show how to 26 is compressed and uncompressed by the valve actuation; Col. 5, lines 61 – Col. 6, line 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Merritt, Cupit, and Bouchard, to comprise the control valve of Harhen. Doing so would thus comprise the incoming flow path comprising a collapsible portion extending through the housing, and wherein the aspiration control valve is further configured to compress the collapsible portion. Doing so would be advantageous as such a valve configuration enables easy actuation without the need for electrical components for this element (Col. 5, lines 1-18 of Harhen).
Allowable Subject Matter
Claim 19 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons for Indicating Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance:
The closest prior art drawn to Merritt, fails to show or make obvious the claimed combination of elements, particularly the limitations as set for in claim 19, which recites features not taught or suggested by the prior art.
While separable housings would generally be obvious to one of ordinary skill in the art, Merritt does not exquisitely teach the proximal and distal housing’s being separable explicitly such that the distal housing and the transparent tubular sidewall are removably coupled to each other, and wherein the transparent tubular sidewall and the filter are carried by the proximal housing.
While devices such as Miller (US 5,957,761 A) may suggest the claimed configuration, they do not appear within the same field of endeavor or to be reasonably pertinent to the problem faced by Applicant, particularly as the configuration of Merritt would already likely render such a modification non-obvious.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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, Rebecca E 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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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781