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
A preliminary amendment was filed on 03/14/2024. Claim 5 was amended. Currently, claims 1-20 are pending and are being examined on the merits.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 8-10, 12-16, and 19 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Jalgaonkar (US 20210220528).
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 (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).
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 (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).
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).
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 2-3, 11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jalgaonkar 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 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); and,
Jalgaonkar does not teach wherein the sealing means is biased towards sealing the first conduit.
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.
Conclusion
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Brandon W. Levy/Examiner, Art Unit 3781