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
An amendment was filed on 05/04/2026. Claims 1 and 15 have been amended, and new claim 21 has been added. Currently, claims 1-21 are pending and are being examined on the merits.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 15 have been considered but are not persuasive and/or are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In this instance, newly cited Shaffer (US 20180353194) cures the deficiency of the first pressure source being in communication with the sealing mechanism to control operation of the sealing mechanism.
In response to the applicant’s arguments with respect to the prior art of record not teaching the limitations of claim 21, the examiner respectfully disagrees.
As described in the analysis of claim 21 further below, Jalgaonkar teaches wherein the first pressure source is air or gas due to having a relief valve in conjunction with the pump, and Hampsch teaching a biasing means. Moreover, as Jalgaonkar discusses a first mode before further intervention to be a continuous aspiration mode, it would have been obvious to bias the system towards utilizing the first pressure source
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites that the first pressure source may be air or gas, wherein the sealing mechanism is biased towards the first configuration such that the air or gas is applied to the catheter in a resting position. However, as best understood by the specification, the biasing means is meant to be biased towards the first position in which the deep vacuum pressure is applied. While the specification notes that the medium of both pressure sources may be air or inert gas (paragraph 0058), a biasing member may bias the sliding mechanism towards its first position (paragraph 0011), and the biasing system bay bias towards a higher pressure level (paragraph 0053), the specification does not appear to teach the system being biased to providing the air/gas, but rather biasing towards a deep vacuum. As such, it is not clear if the applicant had possession of the invention at the effective filing date, and therefore claim 21 appears to teach new matter.
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, 8-10, 12-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Jalgaonkar (US 20210220528) in view of Shaffer (US 20180353194).
Regarding claim 1, Jalgaonkar discloses an aspiration thrombectomy system (abstract), comprising:
a catheter (fig. 4, catheter 12);
a first pressure source (fig. 4, pump 18);
a second pressure source (fig. 4, fluid source reservoir 80 or alternatively an opening to the atmosphere, paragraph 0134);
a first conduit connected between the catheter and the first pressure source (fig. 4, tubing 20);
a second conduit connected between the catheter and the second pressure source (fig. 4, tubing 32); and
a sealing mechanism remote from the first pressure source (fig. 4, pulsator 76 implemented as a valve or otherwise, paragraph 0132. Paragraph 0139 describes the pulsator as comprising one or more pinch valves to open and close tubing);
wherein in a first configuration the sealing mechanism seals the second conduit such that the first pressure source applies a first pressure to the catheter (paragraph 0135 describes connection between the catheter 12 and the pump 18 and the disconnection between fluid source reservoir 80 and catheter 12);
wherein in a second configuration the sealing mechanism seals the first conduit such that the second pressure source applies a second pressure to the catheter (paragraph 0135 describes in another position establishing connection between the catheter 12 and the fluid source reservoir 80 and the disconnection between catheter 12 and pump 18); and,
wherein the second pressure is higher than the first pressure (In fig. 4, a pump 18 provides negative pressure. Fluid source reservoir 80, as described in paragraph 0139 may be replaced by the tubing 32 terminating in an opening to ambient air, which provides a neutral pressure with respect to ambient pressure, thus being a more positive value than the first pressure).
Jalgaonkar does not teach the first pressure source being in communication with the sealing mechanism to control operation of the sealing mechanism.
However, Shaffer teaches an aspiration device (abstract) that comprises a pressure sensor within the vacuum source/first pressure source (paragraph 0055), wherein the pressure sensor is in communication with the means of causing pulsation (paragraph 00276 describes using pressure sensor signals to see if the catheter is clogged, and if the algorithm detects a clog, the system generates a variety of pressure pulses).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Jalgaonkar such that the first pressure source is in communication with the sealing mechanism to control operation of the sealing mechanism, as taught by Shaffer, for the purpose of providing a suitable structure that can apply the pressure pulses in the event of detecting a clot (see Shaffer, paragraph 00276).
Regarding claim 8, Jalgaonkar discloses the system further comprising an actuator (82) for adjusting the sealing mechanism between the first configuration and the second configuration (fig. 4, actuator 82).
Regarding claim 9, Jalgaonkar discloses wherein the actuator is comprised of a solenoid (fig. 4, actuator 82 as a solenoid, paragraph 0137)
Regarding claim 10, Jalgaonkar discloses wherein the first pressure source and the second pressure source are comprised of a single pump (fig. 4 shows a pump 18 and a fluid source reservoir 80 or an ambient vent as described in paragraph 0134).
Regarding claim 12, Jalgaonkar discloses wherein in a first operational state, a static pressure is applied to the catheter (paragraph 0095 describes the pulsator being on, off, vary oscillate, etc. the application of suction force), and wherein in a second operational state, a dynamic pressure is applied to the catheter (paragraph 0095, the oscillation, varying, and pulsing serve as dynamic pressure application).
Regarding claim 13, Jalgaonkar discloses the system further comprising a switch for selecting between the first operational state and the second operational state (paragraph 0095 describes the pulsator being employed to switch on/off. The switch may be interpreted as actuator 82).
Regarding claim 14, Jalgaonkar discloses the system further comprising a heart rate monitor in communication with the sealing mechanism such that the sealing mechanism adjusts between the first configuration and the second configuration in sync with a cardiac rhythm of a patient (paragraph 0012 describes sensing circuitry to generate a signal indicative of the cardiac cycle of the patient, 0019 describes the control circuitry to synchronize the application of suction force with the cardiac cycle).
Regarding claim 15, Jalgaonkar discloses an aspiration thrombectomy system (abstract), comprising:
a catheter (fig. 4, catheter 12);
a pump (fig. 4, pump 18);
a first conduit connected between the catheter and the pump (fig. 4, tubing 20);
a second conduit connected between the catheter and the pump (fig. 4, tubing 32); and
a sealing mechanism remote from the pump (fig. 4, pulsator 76 implemented as a valve or otherwise, paragraph 0132. Paragraph 0139 describes the pulsator as comprising one or more pinch valves to open and close tubing);
wherein in a first configuration the first conduit applies a first pressure to the catheter and the second conduit is sealed by the sealing mechanism (paragraph 0135 describes connection between the catheter 12 and the pump 18 and the disconnection between fluid source reservoir 80 and catheter 12); and,
wherein in a second configuration the second conduit applies a second pressure to the catheter and the first conduit is sealed by the sealing mechanism (paragraph 0135 describes in another position establishing connection between the catheter 12 and the fluid source reservoir 80/ambient atmosphere and the disconnection between catheter 12 and pump 18. Ambient atmosphere as an alternative to fluid source reservoir 80 described in paragraph 0134).
Jalgaonkar does not teach the pump being in communication with the sealing mechanism to control operation of the sealing mechanism.
Regarding claim 16, Jalgaonkar discloses wherein the second pressure is greater than the first pressure (fig. 4, pump 18 offering a negative pressure, and the vent via tubing 32 described in paragraph 0134 is at ambient, thus being a more positive value than the first pressure).
Regarding claim 19, Jalgaonkar discloses the system further comprising a solenoid for adjusting the sealing mechanism between the first configuration in which the sealing mechanism seals the second conduit and the second configuration in which the sealing mechanism seals the first conduit (paragraph 0137 describes the actuator 82 as a solenoid, wherein the actuator moves the valve 76 between the first and second positions that seal the first conduit and open the second conduit and vice versa).
Claims 2-3, 11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jalgaonkar in view of Shaffer, and further in view of Brady (US 20190239910).
Regarding claim 2, Jalgaonkar is silent to wherein the first pressure is between 508-762 mmHg below ambient pressure.
However, Brady teaches a clot retrieval system (abstract) that the vacuum typically applied is between 500-760 mmHg (paragraph 0009).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Jalgaonkar such that the first pressure is between 508-762 mmHg, as taught by Brady, for the purpose of providing a suitable structure that can be utilized to properly urge a clot into a catheter mouth (see Brady, paragraph 0009); moreover, applicant appears to have not placed criticality on the claimed range (paragraph 0063 of the instant specification recites this level as merely an example), and it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 3, Jalgaonkar discloses wherein the second pressure is between 0-508 mmHg below ambient pressure (paragraph 0134 describes a relief vent where fluid source reservoir 80 can be omitted. A relief vent that opens to the atmosphere has the second pressure at 0mmHg below ambient since the pressure is ambient pressure).
Regarding claim 11, Jalgaonkar discloses wherein the first conduit and the second conduit are connected to the catheter by a T-joint (Fig. 4, three-way joint of the pulsator 76), but does not teach wherein the first conduit and the second conduit are connected to the catheter by a Y-joint.
However, Brady teaches that Y joints for connecting two sources to an outlet are known in the art (fig. 2, Y joint for connecting a vacuum pump 11 and a cyclical reciprocation machine 12 and a tubing for connector 15)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Jalgaonkar such that the first conduit and the second conduit are connected to the catheter by a Y joint, as taught by Brady, since it has been held that a change in shape absent persuasive evidence that the particular configuration was significant is of ordinary skill in the art. See MPEP 2144(IV)(B).
Regarding claim 17, Jalgaonkar discloses wherein the second pressure is between 0-508 mmHg below ambient pressure (paragraph 0134 describing the open to the ambient pressure allows a source to provide pressure 0 mmHg below ambient pressure), but does not teach wherein the first pressure is between 508-762 mmHg below ambient pressure.
However, Brady teaches a clot retrieval system (abstract) that the vacuum typically applied is between 500-760 mmHg (paragraph 0009).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Jalgaonkar such that the first pressure is between 508-762 mmHg, as taught by Brady, for the purpose of providing a suitable structure that can be utilized to properly urge a clot into a catheter mouth (see Brady, paragraph 0009); moreover, applicant appears to have not placed criticality on the claimed range (paragraph 0063 of the instant specification recites this level as merely an example), and it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 4-7, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jalgaonkar in view of Shaffer, and further in view of Hampsch (US 20030234053).
Regarding claim 4, Jalgaonkar discloses wherein the sealing mechanism is comprised of a pinch valve that is actuatable between the first configuration and the second configuration (paragraph 0134), but is silent to wherein the sealing mechanism is comprised of a sliding member which is slidable between the first configuration and the second configuration.
However, Hampsch teaches a pinch valve (abstract) that comprises a sliding member (40) slidable between the first and second configuration (figs 1 and 3 show valve member 40 sliding between a position where the right tube is compressed, and where the left tube is compressed).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed in Jalgaonkar such that pinch valve (and therefore the sealing mechanism) such that it comprises a sliding member which is slidable between the first configuration and the second configuration, as taught by Hampsch, for the purpose of providing a suitable structure that serves the function of a pinch valve for two conduits without the need for multiple pinch valves.
Regarding claim 5, Jalgaonkar, as modified by Hampsch discloses wherein in the first configuration the sliding member pinches the first conduit, and wherein in the second configuration the sliding member pinches the second conduit (paragraph 0139 describes a first pinch valve coupled to tubing 20 and a second pinch valve coupled to tubing 38, describing how one open and one closed lets each conduit separately operate. Paragraph further describes the valves implemented with a common actuator. Moving to Hampsch, fig. 1 shows a pinch in one conduit and releasing another, fig. 3 shows the opposite).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed in Jalgaonkar such that in the first configuration the sliding member pinches the first conduit, and wherein in the second configuration the sliding member pinches the second conduit, as taught by Hampsch, for the purpose of providing a suitable structure that serves the function of a pinch valve for two conduits without the need for multiple pinch valves.
Regarding claim 6, Jalgaonkar does not teach wherein the sealing mechanism is biased towards the first configuration.
However, Hampsch teaches a sealing mechanism (abstract) that is biased towards one configuration (fig. 1, biasing means 50 as a spring to force the valve member 40 into a first position, paragraph 0038).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed in Jalgaonkar such that the sealing mechanism biases towards a configuration, as taught by Hampsch, for the purpose of providing a suitable structure that allows for a mode to serve as a default at an initial state (see Hampsch, paragraph 0024)
Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention such that the sealing mechanism is biased towards the first configuration, as Jalgaonkar discloses this first configuration as an application of substantially continuous suction force (paragraph 0111 and 0133) which one of ordinary skill in the art would appreciate as a default mode before further intervention (such as requiring pulsation) is required, and as such one may intuit that the mode that deviates from the norm should be biased against.
Regarding claim 7, Jalgaonkar does not teach the system further comprising a spring for biasing the sealing mechanism towards the first configuration.
However, Hampsch teaches a spring for biasing a sealing mechanism towards a configuration (fig. 1, spring 50 biasing valve member 40).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed in Jalgaonkar such that it comprises a spring for biasing the sealing mechanism towards a configuration, as taught by Hampsch, for the purpose of providing a suitable structure that allows for a mode to serve as a default at an initial state (see Hampsch, paragraph 0024).
Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention such that the sealing mechanism is biased towards the first configuration, as Jalgaonkar discloses this first configuration as an application of substantially continuous suction force (paragraph 0111 and 0133) which one of ordinary skill in the art would appreciate as a default mode before further intervention (such as requiring pulsation) is required, and as such one may intuit that the mode that deviates from the norm should be biased against.
Regarding claim 18, Jalgaonkar does not teach wherein the sealing mechanism is comprised of a sliding member which is slidable between the first configuration and the second configuration.
However, Hampsch teaches a pinch valve (abstract) that comprises a sliding member (40) slidable between the first and second configuration (figs 1 and 3 show valve member 40 sliding between a position where the right tube is compressed, and where the left tube is compressed).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed in Jalgaonkar such that pinch valve (and therefore the sealing mechanism) such that it comprises a sliding member which is slidable between the first configuration and the second configuration, as taught by Hampsch, for the purpose of providing a suitable structure that serves the function of a pinch valve for two conduits without the need for multiple pinch valves.
Regarding claim 20, Jalgaonkar discloses an aspiration thrombectomy system (abstract) comprising:
a catheter (fig. 4, catheter 12);
a pumping means for applying a first pressure or a second pressure to the catheter (fig. 4, pump 18 applying a first pressure. Controlling an amount of suction force such that is applies a second pressure can be done by controlling a pulsator, paragraph 0133);
a first conduit connected between the catheter and the pumping means (fig. 4, tubing 20 between catheter 12 and pump 18);
a second conduit connected between the catheter and the pumping means (fig. 4, tubing 22 between pump 18 and catheter 12); and
a sealing means for selectively sealing the first conduit or the second conduit (fig. 4, pulsator 76 for selectively sealing the first conduit/ tubing 20, paragraph 0134 describes the valve 76 in a first position not fluidically coupling catheter 12 and pump 18. This position would seal the tubing 20) wherein the sealing means is remote from the pumping means (fig. 4, pulsator 76 remote from pump 18)
Jalgaonkar does not teach wherein the sealing means is biased towards sealing the first conduit, the pumping means being in communication with the sealing means to control operation of the sealing means.
However, Hampsch teaches a spring for biasing a sealing mechanism towards sealing one of two conduits (fig. 1, spring 50 biasing valve member 40 towards compressing the rightmost conduit).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed in Jalgaonkar such that the sealing means is biased towards sealing a conduit, as taught by Hampsch, for the purpose of providing a suitable structure that allows for a mode to serve as a default at an initial state (see Hampsch, paragraph 0024).
Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention such that the sealing mechanism is biased towards sealing the first conduit, as Jalgaonkar discloses this first configuration as an application of substantially continuous suction force (paragraph 0111 and 0133) which one of ordinary skill in the art would appreciate as a default mode before further intervention (such as requiring pulsation) is required, and as such one may intuit that the mode that deviates from the norm should be biased against.
Jalgaonkar does not teach the pumping means being in communication with the sealing means to control operation of the sealing means.
However, Shaffer teaches an aspiration device (abstract) that comprises a pressure sensor within the vacuum source/first pressure source (paragraph 0055), wherein the pressure sensor is in communication with the means of causing pulsation (paragraph 00276 describes using pressure sensor signals to see if the catheter is clogged, and if the algorithm detects a clog, the system generates a variety of pressure pulses).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Jalgaonkar such that the first pressure source is in communication with the sealing mechanism to control operation of the sealing mechanism, as taught by Shaffer, for the purpose of providing a suitable structure that can apply the pressure pulses in the event of detecting a clot (see Shaffer, paragraph 00276).
Regarding claim 21, Jalgaonkar discloses wherein the first pressure source is one of air or gas (the first pressure source may alternatively be interpreted as the collection of the pump 18, discharge reservoir 24, and relief valve 84 in fig. 4, the relief valve 84 controlling flow of gas into the external environment, paragraph 0132. This gas would also be applied to the catheter), but does not teach wherein the sealing mechanism is biased towards the first configuration such that the one of the air or gas is applied to the catheter in a resting position.
However, Hampsch teaches a spring for biasing a sealing mechanism towards sealing one of two conduits (fig. 1, spring 50 biasing valve member 40 towards compressing the rightmost conduit).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed in Jalgaonkar such that the sealing means is biased towards sealing a conduit, as taught by Hampsch, for the purpose of providing a suitable structure that allows for a mode to serve as a default at an initial state (see Hampsch, paragraph 0024).
Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention such that the sealing mechanism is biased towards the first configuration such that the one of the air or gas is applied to the catheter in a resting position, as Jalgaonkar discloses this first configuration as an application of substantially continuous suction force (paragraph 0111 and 0133) which one of ordinary skill in the art would appreciate as a default mode before further intervention (such as requiring pulsation) is required, and as such one may intuit that the mode that deviates from the norm should be biased against.
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 BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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 Eisenberg can be reached at 5712705879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brandon W. Levy/Examiner, Art Unit 3781
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