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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/25/2026 has been entered.
Response to Amendment
Claims 15 and 24 have been amended. Claim 35 has been added. Claims 15-18, 20-33, and 35 remain pending.
Claim Objections
Claims 20-22 are objected to because of the following informalities:
Claims 20-22 are objected to for a typographical error wherein they recite “A vacuum aspiration system” and should instead recite “The vacuum aspiration system” in the respective claims.
Appropriate correction is required.
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.
Claim(s) 15-18, 20-33, and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaffer et al. (US 20180353194, henceforth Shaffer) in view of Benjamin et al. (US 20100004730, henceforth Benjamin).
Regarding claim 15, Shaffer discloses a vacuum aspiration system (system 40, fig. 2) comprising: an aspiration catheter (see Abstract, the system is for use with a catheter which is not shown in the provided figures but is shown as catheter 22 in fig. 1; see also [0040]); a housing (enclosure 46, fig. 3A) configured to be positioned downstream of the aspiration catheter (since flow goes from the catheter towards canister 44 through connector 110 as in [0040], the enclosure 46 is downstream of the catheter as claimed) and comprising a reservoir (the interior space of canister 44 in fig. 4 is a reservoir as claimed) for receiving thrombus and blood retrieved through the aspiration catheter ([0040]); a fluid flow path (the path of air flowing through connector 52 into an interior of console 42 and through enclosure 46 and vent 70 is a flow path as claimed, [0034]) extending through the housing ([0034]), wherein the fluid flow path is configured to fluidically connect the aspiration catheter with a source of aspiration (see [0034], the flow path connects the catheter at 110 of canister 44 to pump 68 which is a source of aspiration as claimed) downstream of the housing (see [0034], pump 68 is downstream of post 50 of housing 46 and is thus considered to be downstream of the housing as claimed); an operator-actuated control (switch 60, fig. 2) configured to be positioned between the housing and the aspiration catheter (the aspiration catheter is connected to the system at connector 110 in fig. 2; see annotated fig. 2 showing how switch 60 is between the enclosure 46 and connector 110) and configured to regulate a fluid flow ([0034]); a vent (lid 80, fig. 4) positioned on the housing (see fig. 2, lid 80 can sit on canister 44 which can be placed on enclosure 46 and thus lid 80 can be positioned on enclosure 46 as claimed) and being configured to place the fluid flow path in fluid communication with atmosphere (lid 80 keeps canister 44 which includes a part of the fluid flow path closed from the environment when it is assembled onto the canister; it is thus configured to place the canister 44 in fluid communication with the ambient environment when it is removed as this allows the fluid flow path to be exposed).
Shaffer does not disclose a hemostasis valve configured to be positioned along an access path into the aspiration catheter upstream of the operator-actuated control and co-axial with an aspiration lumen of the aspiration catheter. Benjamin teaches an introducer (introducer 12, fig. 1A) which is configured to direct a catheter (catheter 20, fig. 1A, see also [0005] and [0008]) where the introducer comprises a hemostasis valve (seal 16, fig. 1A, which can be a hemostasis valve as in [0045]) configured to be positioned along an access path into the catheter (see fig. 1B) co-axial with a lumen of the aspiration catheter (see fig. 1B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an introducer with a seal to the system of Shaffer to allow for the introducer to be used to place the catheter into the target area for treatment (see Benjamin [0005]), and further to have had the seal be a hemostasis valve to allow the introducer to seal against different sizes of aspiration catheters (Benjamin [0015]). Such a modified system would then include the catheter of Shaffer being inserted into the added introducer of Benjamin such that the hemostasis valve would be upstream of the operator-actuated control since the seal would be closer to the site of the clot than the pump (68) and switch (60) of Shaffer.
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Annotated fig. 2 from Shaffer showing a line from enclosure 46 to connector 110 with switch 60 in the middle
Regarding claim 16, Shaffer as modified discloses the system of claim 15 wherein the vent comprises an operator-actuatable vent control (the edges of the lid 80 are considered to be an operator-actuatable vent control as claimed where an operator can assemble, or close, the lid during use, or the operator can disassemble, or open, the lid between uses; this is considered to be a controlling, see at least [0036]).
Regarding claim 17, Shaffer as modified discloses the system of claim 16 wherein the operator-actuatable vent control is biased in a closed direction (when canister 44 is placed under vacuum as a result of pump 68 being operated, lid 80 and its edges are considered to be biased in a closed direction as the vacuum pressure in canister 44 biases the lid to stay sealed in place, see at least [0036]).
Regarding claim 18, Shaffer as modified discloses the system of claim 15 wherein the operator-actuated control is configured to turn off the fluid flow (see [0034], switch 60 can act as an on/off switch).
Regarding claim 20, Shaffer as modified discloses the system of claim 15 wherein the hemostasis valve is carried by the housing (in the modified device, when the introducer and catheter are sealingly engaged as in Benjamin [0015], the hemostasis valve is carried by the housing since it is locked to the catheter which is assembled onto connector 110 which is assembled on the enclosure 46 as in fig. 2).
Regarding claim 21, Shaffer as modified discloses the system of claim 15 wherein the vent is configured to evacuate the blood from the reservoir (lid 80 is configured to evacuate blood from the reservoir where it can be removed by a user after use to allow the user to dump aspirated blood and clot from canister 44).
Regarding claim 22, Shaffer as modified discloses the system of claim 15 wherein the housing comprises a transparent window (main body 78 of canister 44, fig. 4, which is usually clear as in [0037]).
Regarding claim 23, Shaffer as modified discloses the system of claim 15 wherein the housing comprises a removable filter (filter plate 86, fig. 4).
Regarding claim 24, Shaffer discloses a vacuum aspiration system (system 40, fig. 2) comprising: an aspiration catheter (see Abstract, the system is for use with a catheter which is not shown in the provided figures but is shown as catheter 22 in fig. 1; see also [0040]) comprising a proximal end (proximal end of the catheter, [0040]), a distal end (if the catheter has a proximal end as in [0040], it must have a distal end) and an aspiration lumen (since the catheter is for aspirating clot, see Abstract, it is considered to have an aspiration lumen) extending between the proximal end and the distal end (see at least [0011] and [0012], the catheter provides for clot aspiration from a spot in the blood at its distal end and transports the clot to its proximal end at the canister, and thus the aspiration lumen must extend as claimed); and a handle (since the elements claimed as part of the handle can be carried by a human’s hands, they are considered to be a handle as claimed; see below for the particular elements of the handle) comprising: a housing (enclosure 46, fig. 3A); a fluid flow path (the path of air flowing through connector 52 into an interior of console 42 and through enclosure 46 and vent 70 is a flow path as claimed, [0034]) extending through the housing ([0034]), wherein the fluid flow path is configured to fluidically connect the aspiration lumen with a source of aspiration (see [0034], the flow path connects the catheter at 110 of canister 44 to pump 68 which is a source of aspiration as claimed) positioned downstream of the handle (see [0034], pump 68 is downstream of post 50 of housing 46 and is thus considered to be downstream of the housing as claimed); a flow regulator (switch 60, fig. 2) configured to regulate aspiration through the fluid flow path ([0034]); a clot container (collection canister 44 including lid 80, figs. 2 and 4) positioned along the fluid flow path (see at least [0034], [0039], and [0040], aspirated clot flows from the catheter into the canister, and then air from the canister is further vented out of the console 42 entirely via the same flow path); a vent (lid 80, fig. 4) in fluid communication with the clot container (since lid 80 seals or exposes canister 44 from the ambient environment, it is considered to be in fluid communication with canister 44 as claimed).
Shaffer does not disclose a hemostasis valve configured to be positioned along an access path into the aspiration catheter upstream of the operator-actuated control and co-axial with an aspiration lumen of the aspiration catheter. Benjamin teaches an introducer (introducer 12, fig. 1A) which is configured to direct a catheter (catheter 20, fig. 1A, see also [0005] and [0008]) where the introducer comprises a hemostasis valve (seal 16, fig. 1A, which can be a hemostasis valve as in [0045]) configured to be positioned along an access path into the catheter (see fig. 1B) co-axial with a lumen of the aspiration catheter (see fig. 1B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an introducer with a seal to the system of Shaffer to allow for the introducer to be used to place the catheter into the target area for treatment (see Benjamin [0005]), and further to have had the seal be a hemostasis valve to allow the introducer to seal against different sizes of aspiration catheters (Benjamin [0015]). Such a modified system would then include the catheter of Shaffer being inserted into the added introducer of Benjamin such that the hemostasis valve would be upstream of the operator-actuated control since the seal would be closer to the site of the clot than the pump (68) and switch (60) of Shaffer.
Regarding claim 25, Shaffer as modified discloses the system of claim 24 wherein the flow regulator is an operator-actuatable control (switch 60 is an operator-actuatable control as claimed where it is an element which an operator can actuate to control the aspiration system as in [0034]) provided on the housing (see fig. 2).
Regarding claim 26, Shaffer as modified discloses the system of claim 24 wherein the clot container comprises a removable filter (filter plate 86, fig. 4).
Regarding claim 27, Shaffer as modified discloses the system of claim 24 wherein the clot container comprises a transparent side wall (see [0037], main body 78 is clear).
Regarding claim 28, Shaffer as modified discloses the system of claim 24 wherein the flow regulator is configured to restrict or shut off flow between the aspiration catheter and the clot container when aspiration is supplied to the handle from the source of aspiration (see [0033], switch 60 is an on-off switch which means it can turn the pump 68 off when it is on).
Regarding claim 29, Shaffer as modified discloses the system of claim 24 further comprising aspiration tubing in fluid communication with the clot container (the tubing or hollow space extending between pump 68 and connector 52 is aspiration tubing as claimed, see at least [0034] and [0038], and it is in communication with canister 44 when the system 40 is assembled as in fig. 2), wherein the aspiration tubing is configured to fluidically connect with the source of aspiration ([0034]).
Regarding claim 30, Shaffer as modified discloses the system of claim 24 wherein the vent is configured to vent the clot container to atmosphere (lid 80 is configured to evacuate blood from the reservoir where it can be removed by a user after use to allow the user to dump aspirated blood and clot from canister 44).
Regarding claim 31, Shaffer as modified discloses the system of claim 24 wherein the vent comprises an operator-actuatable vent control (the edges of the lid 80 are considered to be an operator-actuatable vent control as claimed where an operator can assemble, or close, the lid during use, or the operator can disassemble, or open, the lid between uses; this is considered to be a controlling, see at least [0036]) provided on the housing (see fig. 2, lid 80 can sit on canister 44 which can be placed on enclosure 46 and thus lid 80 can be positioned on enclosure 46 as claimed).
Regarding claim 32, Shaffer as modified discloses the system of claim 31 wherein the operator-actuatable vent control is biased in a closed direction (when canister 44 is placed under vacuum as a result of pump 68 being operated, lid 80 and its edges are considered to be biased in a closed direction as the vacuum pressure in canister 44 biases the lid to stay sealed in place, see at least [0036]).
Regarding claim 33, Shaffer as modified discloses the system of claim 24 further comprising a source of aspiration (pump 68, fig. 3C), wherein the source of aspiration comprises an aspiration pump (see [0006], [0007], [0012], and [0013], the vacuum pump 68 is an aspiration pump because it creates a vacuum used for aspiration) in communication with a collection canister (collection canister 44 excluding lid 80 makes up the collection canister as claimed, fig. 4).
Regarding claim 35, Shaffer as modified discloses the system of claim 24 wherein: the clot container comprises an inlet (connector 110, fig. 4) and an outlet (vacuum port 102, fig. 5); the clot container is configured to receive thrombus and blood retrieved through the aspiration catheter via the inlet ([0040]), the outlet is configured to place the clot container in fluid communication with a source of aspiration (see [0033], [0038], and [0040]); and the inlet and the outlet are positioned on a same end of the clot container (see figs. 4 and 5, the inlet and outlet are both on the half, or end, of canister 44 opposite base 98, and thus they are on the same end of the canister 44).
Response to Arguments
Applicant’s arguments with respect to claim(s) 15 and 24 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.
The previous Double Patenting rejection is withdrawn as the amendments made to claim 15 require additional features regarding the arrangement of elements present in claim 17 of US. Pat. No. 11457936 which do not appear to have been obvious in combination with the prior art, especially with respect to the newly added limitations regarding the arrangement of the hemostasis valve and operator-actuated control.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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