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 .
Election/Restrictions
Applicant’s election without traverse of Group II, Species E (Figures 7A-7B), and Species F (Figure 2) in the reply filed on 01/27/26 is acknowledged.
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 38-52 are rejected under 35 U.S.C. 103 as being unpatentable over Hogendijk (US 2007/0021774 A1) in view of Chen et al. (US 2016/0091399 A1) and in further view of Merritt et al. (US 2020/0046368 A1).
Regarding claim 38, Hogendijk discloses a system for treating clot material in a vasculature of a patient (Figs. 1A-B, feat. 10; ¶0030-0031), comprising: an aspiration assembly (11; ¶0031), comprising: an aspiration catheter configured to be intravascularly advanced through the vasculature of the patient to at and/or proximate to the clot material (Figs. 1A-B, 6A-B, feat. 20; ¶0032 and 0035), a chamber (32; ¶0032), a first pressure source configured to generate vacuum pressure in the chamber (Figs. 1A-B and 6A, feat. 26; ¶0032, 0041, and 0053-0054); a filter (31; ¶0032-0033); a first tubing assembly (Figs. 1A-B, 6A-B, feat. 28; ¶0032) between the aspiration catheter (20) and the chamber (32) , wherein the first tubing assembly includes an aspiration valve (30; ¶0032: inflow/aspiration path 28 and outflow/reintroduction path 29 each include a valve) configured to be moved between (a) a first position that inhibits fluid flow from the aspiration catheter to the chamber (Figs. 3B, 6B; ¶0040 and 0042) and (b) a second position that permits fluid flow from the aspiration catheter to the chamber (Figs. 3A and 6A; ¶0040-0041), and the filter is configured to filter the blood from the portion of the clot material (¶0033); a filtered clot material assembly (Figs. 1A-B, 6A-B, feats. 29, 31; ¶0032), comprising: a second tubing assembly configured to fluidly couple the chamber to the vasculature of the patient (29; ¶0042), wherein the second tubing assembly comprises a reintroduction valve (30; ¶0032: inflow/aspiration path 28 and outflow/reintroduction path 29 each include a valve), and a second pressure source configured to generate positive pressure to drive the filtered blood at least partially through the second tubing assembly into the vasculature of the patient (Figs. 1A-B and 6B, feat. 26; ¶0032, 0042, and 0053-0054: syringe 26 also acts as a positive pressure source).
Hogendijk does not disclose that the filter is positioned in the chamber. The valves of Hogendijk are pressure operated (¶0040), and therefore Hogendijk does not disclose that the first pressure source is configured to generate the vacuum pressure in the chamber while the aspiration valve is in the first position, that the chamber is configured to store the vacuum pressure while the aspiration valve in the first position, or that the aspiration valve is movable from the first position while the vacuum pressure is stored in the chamber to the second position, thereby applying the vacuum pressure to the aspiration catheter such that at least a portion of the clot material and blood are aspirated through the aspiration catheter into the chamber.
Chen teaches a syringe (Figs. 1-5; ¶0026-0033) comprising a filter (4; ¶0030) held in a receptacle (20; ¶0028) positioned in the barrel or chamber of the syringe (10; ¶0027). The syringe further comprises a plunger (7; ¶0031) which is pulled back to apply negative pressure to the barrel to aspirate fluid into the barrel (Fig. 3; ¶0035) and pushed forward to apply positive pressure to the barrel to push the fluid through the filter and expel it from the syringe, thereby depositing solid material onto the filter (Fig. 4; ¶0037). Chen teaches that positioning the filter in the syringe barrel or chamber advantageously provides quick and convenient operation, achieves excellent filtration and specimen collection, and provides stable reciprocal operation (¶0046), which is advantageous for the clot treatment system of Hogendijk, which may employ multiple syringe actuations in order to treat multiple volumes of blood (Hogendijk: ¶0042). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Hogendijk so that the filter is positioned in the chamber in order to provide quick and convenient operation, excellent clot filtration and collection, and stable reciprocal operation as taught by Chen.
Hogendijk in view of Chen does not suggest that that the first pressure source is configured to generate the vacuum pressure in the chamber while the aspiration valve is in the first position, that the chamber is configured to store the vacuum pressure while the aspiration valve in the first position, or that the aspiration valve is movable from the first position while the vacuum pressure is stored in the chamber to the second position, thereby applying the vacuum pressure to the aspiration catheter such that at least a portion of the clot material and blood are aspirated through the aspiration catheter into the chamber.
Merritt teaches a system for treating clots (Figs. 1-3D, feat. 10; ¶0047) comprising an aspiration catheter (102), a tubing assembly (120) connected to an aspiration valve or stopcock (126; ¶0049-0050), and a pressure source (Fig. 1, feat. 140; ¶0052) such as a syringe (Fig. 2, feat. 240; Figs. 3A-D, feat. 340; ¶0054) comprising a chamber or barrel (244). In use, the aspiration valve or stopcock is closed before activating the pressure source so that the barrel or chamber becomes pre-charged with vacuum pressure, and after the vacuum pressure reaches the desired level, the aspiration valve or stopcock can then be opened (¶0052 and 0056). Merritt teaches that pre-charging the vacuum pressure before opening the valve to the catheter advantageously generates greater suction forces and blood flow velocities for removing clot material from the patient, compared to simply activating the pressure source when it is connected to the catheter (¶0052). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Hogendijk in view of Chen so that the aspiration valve is a stopcock as taught by Merritt, resulting in a system in which the first pressure source is configured to generate the vacuum pressure in the chamber while the aspiration valve is in the first position, the chamber is configured to store the vacuum pressure while the aspiration valve in the first position, and the aspiration valve is movable from the first position while the vacuum pressure is stored in the chamber to the second position, thereby applying the vacuum pressure to the aspiration catheter such that at least a portion of the clot material and blood are aspirated through the aspiration catheter into the chamber in order to generate greater suction forces for removing clot material from the patient than the pressure operated valves of Hogendijk as taught by Merritt.
Regarding claim 39, Hogendijk in view of Chen and in further view of Merritt suggests the system of claim 38, and Hogendijk further discloses that the second pressure source is configured to generate the positive pressure within the chamber to drive the filtered blood at least partially through the second tubing assembly into the vasculature of the patient (Fig. 6B; ¶0042 and 0054). Regarding claim 40, Hogendijk further discloses that the first pressure source and the second pressure source are a same pressure source (Figs. 1A-B, 6A-B, feat. 26; ¶0041-0042). Regarding claim 41, Hogendijk further discloses that the same pressure source comprises a syringe (Figs. 1A-B, 6A-B, feat. 26; ¶0032 and 0041-0042). Regarding claim 42, Hogendijk further discloses that the second pressure source comprises a syringe (Fig. 6B, feat. 26; ¶0032 and 0042). Regarding claim 43, Hogendijk further discloses that the chamber comprises a barrel of a syringe (Figs. 1A-B, feats. 26, 32; ¶0032 and 0041), and wherein the first pressure source comprises a plunger of the syringe (33). Regarding claim 44, Hogendijk further discloses that the reintroduction valve is movable between (a) a first position that inhibits fluid flow from the second pressure source to the vasculature of the patient (Figs. 3B and 6A, feats. 29 and 30; ¶0040-0041: during aspiration, the valve 30 in the outflow/reintroduction path 29 is closed, thereby preventing fluid flow from the syringe to the catheter and vasculature) and (b) a second position that permits fluid flow from the second pressure source to the vasculature of the patient (Figs. 3A and 6B, feats. 29 and 30; ¶0040 and 0042).
Regarding claim 45, Hogendijk in view of Chen and in further view of Merritt suggests the system of claim 44. Hogendijk further discloses that the reintroduction valve is closed during aspiration (Figs. 3B and 6A, feats. 29 and 30; ¶0040-0041), and therefore when the system of Hogendijk in view of Chen and in further view of Merritt is storing vacuum pressure in the chamber, the reintroduction valve would be closed. Therefore, Hogendijk further discloses that the reintroduction valve is configured to be in the first position while the vacuum pressure is stored in the chamber.
Regarding claim 46, Hogendijk in view of Chen and in further view of Merritt suggests the system of claim 44, and Hogendijk further discloses that the reintroduction valve (Figs. 1B and 6A, feats. 29 and 30) is configured to be in the first position while the aspiration valve is in the second position (Figs. 1B and 6A, feats. 28 and 30; ¶0040-0042).
Regarding claim 47, Hogendijk in view of Chen and in further view of Merritt suggests the system of claim 38, and Hogendijk further discloses that the chamber comprises a barrel of a syringe (Figs. 1A-B, feats. 26, 32; ¶0032 and 0041), wherein the first pressure source and the second pressure source comprise a plunger of the syringe (33), wherein the plunger is configured to move in a first direction through the barrel to generate the vacuum pressure in the barrel (Fig. 6A; ¶0041) and to move in a second direction through the barrel to generate the positive pressure (Fig. 6B; ¶0042). Regarding claim 48, Hogendijk further discloses that the first direction is opposite to the second direction (Figs. 6A-B, feat. 33; ¶0041-0042). Regarding claim 49, Hogendijk further discloses that the reintroduction valve comprises a one-way valve (Figs. 1B, feats. 29 and 30; ¶0040-0042). Regarding claim 50, Hogendijk further discloses that the one-way valve permits fluid flow from the second pressure source to the vasculature of the patient and inhibits fluid flow from the vasculature of the patient to the second pressure source (¶0040-0042).
Regarding claim 51, Hogendijk in view of Chen and in further view of Merritt suggests the system of claim 38. As discussed above, Merritt teaches an aspiration valve which is a user-actuatable stopcock which is moved between a first position and a second position (Figs. 1-3D, feat. 126; ¶0049-0050). Therefore, Hogendijk in view of Chen and in further view of Merritt further suggests that the aspiration valve is user-actuatable to move between the first position and the second position.
Regarding claim 52, Hogendijk in view of Chen and in further view of Merritt suggests the system of claim 38. As discussed above, Merritt teaches an aspiration valve which is a user-actuatable stopcock which is moved between a first position and a second position (Figs. 1-3D, feat. 126; ¶0049-0050). Merritt further teaches an embodiment in which the user actuatable stopcock may be used as a reintroduction valve (Figs. 20D-E, feat. 126; ¶0137). Therefore, Hogendijk in view of Chen and in further view of Merritt further suggests that the reintroduction valve is user-actuatable to fluidly couple the second pressure source to the vasculature of a patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Batiste (US 2018/0042623 A1) discloses blood clot treatment systems.
Evans et al. (US 2001/0049486 A1) discloses a system for aspirating, filtering, and re-infusing blood.
Peter et al. (US 2021/0260262 A1) discloses a manual clot aspiration and filtration system.
Hogendijk (US 2004/0019310 A1) discloses a blood aspiration system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 5712727159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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