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
This action is entered in response to Applicant’s amendment and reply of September 21, 2026. Claims 1 and 16 are amended. Claims 1-10, 12-19 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed September 21, 2026, with respect to the rejection of Claims 1-7, 9, 10, 16-19 under 35 U.S.C. 102(a)(2) as being anticipated by Baker et al, US 2022/0047283 A1 have been fully considered and are persuasive in combination with the amendments to the claims, which have changed the scope of the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Baker et al, US 2022/0047283 A1 in view of Ragab, US 3,929,133.
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.
Claims 1-7, 9, 10, 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al, US 2022/0047283 A1 in view of Ragab, US 3,929,133.
Regarding claims 1 and 16 and 19, Baker discloses an aspiration system (Figs. 1, 5, 6A-B, 7A-C, 9, paras [0047]; [0054]-[0078]) comprising:
an aspiration pump (suction device 154) configured for location outside of a sterile field (suction device 154 is capable of being located away outside of sterile field);
a housing (system 300, 310 of Fig. 5 can be used with system of lithotripsy system of Fig. 1) comprising a chamber (interior of housing 310, Fig. 5) configured for location within the sterile field (300 is capable of being located at any position within a sterile field);
a first tube (270 or length of tubing coupled to housing 310 and extending external to housing, para [0064]) having a first inner diameter (Fig. 5) at a portion of the first tube external to the chamber (Fig. 5), the first tube configured to provide a fluid flow path for aspirated material into the chamber (para [0066]); and
a second tube (316, Fig. 5) having a second inner diameter (Fig. 5) at a portion of the second tube external to the chamber (Fig. 5), the second tube configured to extend between the chamber and the aspiration pump and configured to place the chamber and the aspiration pump in communication with each other (para [0065]);
a filter (306) (Fig. 5, para [0067]) located within the chamber, the filter comprising a plurality of openings (mesh has openings, para [0067]);
wherein the first tube and the second tube are connected to opposite ends of the housing (paras [0065]-[0066], Fig. 5); and
a vent valve (338, Fig. 5) configured to selectively permit fluid communication between atmosphere and the chamber (para [0066]; atmosphere can be by way of the tubing connected to chamber when valve is open).
Baker teaches that the chamber 310 with filter 306 can be used in different systems such as in Fig. 9, and the ports on either end of chamber 310 can be adjusted to accommodate different size external catheter/tubes (para [0078]) but is silent as to wherein the first inner diameter is larger than the second inner diameter.
However, Ragab, in the same field of art, teaches an aspiration system (Figure 1 and col. 2, line 50 to col. 4, line 28) comprising: an aspiration pump (14) configured for location (i.e., capable of being located) outside of a sterile field; a filter (50) located within a chamber (16) configured for location (i.e., capable of being located) within the sterile field; a first tube (21, 20) having a first inner diameter at a portion of the first tube external to the chamber (col. 4, lines 5-9), the first tube configured to provide a fluid flow path for aspirated material into the chamber; and a second tube (31, 30) having a second inner diameter at a portion of the second tube external to the chamber (col. 4, lines 19-25), the second tube configured to extend between the chamber and the aspiration pump and configured to place the chamber and the aspiration pump in communication with each other (col. 3, lines 5-30); wherein the first inner diameter is larger than the second inner diameter (tube 21 is of maximum inner diameter of 10 mm while tube 31 is of maximum inner diameter of 5 mm, col. 4, lines 5-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the tubes of Baker having a first tube with a first diameter larger than the second tube inner diameter as taught by Ragab in order to provide the stated benefits of allowing different sized particles to pass from the patient into the filter and then prevent any large particles from exiting the filter chamber (Ragab, col. 4, lines 5-30). In addition, since Baker acknowledges that different size tubes could be used, a person of ordinary skill in the art would find a reasonable expectation of success and predictable results of controlling the amount of fluid and/or particles through the system when substituting a larger diameter tube on one side than the other side of the housing/chamber.
Regarding claims 2 and 17, Baker as modified discloses the aspiration system of Claim 1, and Baker further teaches wherein the first tube is configured to fluidly couple the chamber with a distal end of an aspiration catheter (paras [0064]-[0065]).
Regarding claims 3 and 18, Baker as modified discloses the aspiration system of Claims 2 and 17, and Baker further teaches wherein the chamber is configured to capture a clot aspirated by the aspiration catheter (stone fragments, para [0067]).
Regarding claim 4, Baker as modified discloses the aspiration system of Claim 1, further comprising an aspiration catheter (270, Fig. 3) configured to be in communication with the first tube, wherein the first tube and the aspiration catheter are separate components (para [0064]).
Regarding claim 5, Baker as modified discloses the aspiration system of Claim 4, wherein the first tube is fluidly coupled to a proximal end of the aspiration catheter (para [0064]).
Regarding claim 6, Baker as modified discloses the aspiration system of Claim 1, wherein housing comprises a first port (314) and a second port (port at 316), the first port fluidly connected to the first tube, and the second port fluidly connected to the second tube (para [0064]).
Regarding claim 7, Baker as modified discloses the aspiration system of Claim 6 wherein a size of the first port is larger than a size of the second port (opening at 314 is larger than 316, Fig. 5).
Regarding claim 9, Baker as modified discloses the aspiration system of Claim 5 wherein the chamber is in fluid communication with the first port and the second port (Fig. 5, para [0064]).
Regarding claim 10, Baker as modified discloses the aspiration system of Claim 6 wherein the first port and the second port are positioned on opposite ends of the housing body (Fig. 5, para [0064]).
Claims 8, 12, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Baker and Ragab as applied to claim 1 above, and further in view of Deville et al, US 10,531,883 B1.
Regarding claim 8, Baker as modified discloses the aspiration system of Claim 6, but is silent as to wherein the housing body further comprises a third port configured to permit injection of fluid into the chamber.
However, Deville, in the same field of art, namely aspiration catheters and systems, teaches an aspiration system (Figs. 18-20) having an aspiration pump (vacuum pump 80), a housing (200) with a chamber (interior of 200, Fig. 18, col. 24, lines 8-50) intended to capture clot material aspirated into the chamber, where the housing body has a first port (input 212, col. 25, lines 1-50), a second port (output 232, col. 5, lines 1-50) and further comprises a third port (exit of bleed valve 214, col. 25, lines 1-25) configured to permit injection of fluid into the chamber (bleed valve can intake clear liquid, col. 25, lines 5-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to make the housing of Baker with a third port as taught by Deville in order to provide the stated advantages of visualizing the trapped clot/material inside the chamber by providing a temporary transparency due to injecting air instead of blood and allow for easier inspection of the materials caught in filter (Deville, col. 25, lines 25-50).
Regarding claim 12, Baker as modified discloses the aspiration system of Claim 1, further comprising a valve (338, Fig. 5) configured to selectively permit fluid communication with at least one of atmosphere or the aspiration pump (para [0066]), but is silent as to a button configurated to permit a user to manually actuate the valve.
However, Deville, in the same field of art, namely aspiration catheters and systems, teaches an aspiration system (Figs. 18-20) having an aspiration pump (vacuum pump 80), a housing (200) with a chamber (interior of 200, Fig. 18, col. 24, lines 8-50) intended to capture clot material aspirated into the chamber, where the housing body has a valve (214, col. 25, lines 1-50) configured to selectively permit fluid communication with at least one of atmosphere or the aspiration pump (col. 5, lines 5-25), and button (bleed switch, col. 25, lines 25-30) configurated to permit a user to manually actuate the valve (col. 25, lines 25-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to make the system of Baker with a button as taught by Deville in order to provide the stated advantages of visualizing the trapped clot/material inside the chamber by providing a temporary transparency due to injecting air instead of blood and allow for easier inspection of the materials caught in filter (Deville, col. 25, lines 25-50).
Regarding claim 13, Baker as modified discloses the aspiration system of Claim 1, but is silent as to further comprising a sensor configured to determine when a fluid flow through the chamber has stopped.
However, Deville, in the same field of art, namely aspiration catheters and systems, teaches an aspiration system (Figs. 18-20) having an aspiration pump (vacuum pump 80), a housing (200) with a chamber (interior of 200, Fig. 18, col. 24, lines 8-50) intended to capture clot material aspirated into the chamber, where the housing body has a first port (input 212, col. 25, lines 1-50), a second port (output 232, col. 5, lines 1-50) and further comprises a sensor (pressure sensor, col. 26, lines 48-65) configured to determine when a fluid flow through the chamber has stopped (col. 26, lines 48-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to make the system of Baker with a sensor as taught by Deville in order to provide the stated advantages of determining whether the vacuum chamber is clogged or there is a lack of flow to confirm whether a clot is trapped and ensuring presence of a thrombus in the chamber (Deville, col. 26, lines 48-65).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Baker and Ragab as applied to claim 1 above, and further in view of Nair et al, US 2022/0339339 A1.
Regarding claim 14, Baker as modified discloses the aspiration system of Claim 1, but is silent as to further comprising a clamp positioned along the first tube, the clamp configured to restrict fluid flow along the first tube.
However, Nair, in the same field of art, teaches an aspiration system having an aspiration pump (209, Fig. 8), a housing (205) with a chamber (interior of 205, Fig. 8) intended to capture clot material aspirated into the chamber (para [0113]), a first tube (203) positioned on one side of the chamber and a second tube (207) positioned on an opposite side of the chamber, and a clamp (231, para [0113]) positioned along the first tube, the clamp configured to restrict fluid flow along the first tube (paras [0113]; [0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to make the first tube of Baker with a clamp as taught by Nair in order to provide the stated advantages of shutting down or slowing the flow into the chamber as a manual override backup option (Nair, para [0113]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Baker and Ragab as applied to claim 1 above, and further in view of Howard et al, US 2008/0243028 A1.
Regarding claim 15, Baker as modified discloses the aspiration system of Claim 1, wherein the filter comprises a plurality of openings, but is silent as to wherein the each of the plurality of openings of the filter is less than or equal to about 1 mm.
However, Howard, in the same field of art, namely aspiration systems, teaches an aspiration system (90, Fig. 1, 4A-D) with a tissue collection apparatus having a housing with a chamber (42) having a first tube (50) and a second tube (52) on opposite sides, and a filter (47) inside the chamber intended for capturing tissue or other clots, where the filter has a plurality of openings and wherein the each of the plurality of openings of the filter is less than or equal to about 1 mm (para [0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to make filter openings of Baker in the range of less than or equal to about 1 mm as taught by Howard in order to allow fluid to pass while isolating and retaining the clot particles that are a certain size in dimension to prevent further thrombosis in the blood stream (Howard, para [0042]).
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 KATRINA M STRANSKY whose telephone number is (571)270-3843. The examiner can normally be reached Monday-Friday 8:30 am-5:00 pm EST.
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/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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