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
Claims 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/03/2026.
In summary, claims 1-22 are pending, with claims 17-18 being withdrawn from consideration, and claims 1-16 and 19-22 are being examined on the merits.
Claim Objections
Claim 16 is objected to because of the following informalities:
Regarding claim 16, “bout” should read -about-
Appropriate correction is required.
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 15 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. In this instance, paragraph 009 of the instant specification recites priming the system with sterile fluid by placing the catheter into the sterile fluid reservoir, but does not recite a calibration method involving placing the catheter into the sterile fluid and making flow rate measurements.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites a catheter being inserted “into to fluid reservoir”. There does not appear to be antecedent basis for the fluid reservoir. For the purpose of examination, the limitation will be interpreted as -a fluid reservoir-
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In this instance, claim 19 recites that the aspiration off periods are no more than half as long as the aspiration on periods (i.e., ≤ 50%). Claim 20 recites the aspiration off periods being no more than 75% (≤ 75%), which is a broader range than in the independent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-3, 5-6, and 11-13 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Teigen (US 20200367917).
Regarding claim 1, Teigen discloses a method for aspirating a clot from a blood vessel using an aspiration catheter system (abstract), the method comprising:
initiating calibrated continuous aspiration (paragraph 0021 describes the system sampling flow in order to determine whether or not the system is clogged. The system calibrates/adjusts depending on the measurements, wherein calibration is broadly interpreted as adjusting);
evaluating aspiration measurements (paragraph 0067, “the controller characterizes the state of a catheter’s contents as unrestricted flow, restricted flow, or clogged”) and
adjusting application of based on aspiration measurements (paragraph 0071).
Regarding claim 2, Teigen discloses wherein the aspiration catheter system comprises an aspiration catheter assembly comprising an aspiration catheter (fig. 17, aspiration catheter 750)
fittings comprising a branched manifold (fig. 17, three-way joint 792) with a first branch comprising a hemostatic valve (fig. 17, first branch comprising connection tubing 706, paragraph 0088, “the second end [of connection tubing 706] is attached to the aspiration catheter with a rotating hemostasis valve) and a second branch comprising a connector (fig. 17, connector being connection tubing 706)
a pump (fig. 17, vacuum source 700)
a conduit connected to the pump (18) and to the connector of the second branch (fig. 17,
a flow meter connected to the fittings to measure flow to the pump (paragraph 0016, “The sensing unit may comprise any one or more of a variety of sensors, including… optical flow sensors”, paragraph 0018 describes the optical sensor within the connecting tube 706), and
a controller (paragraph 0088, “the controller may modulate a vacuum valve 799”)
Regarding claim 3, Teigen discloses wherein the aspiration measurements comprise flow rate and pressure measurements (paragraph 0016 describes any variety of one or more sensors, including pressure sensors and the flow sensors).
Regarding claim 5, Teigen discloses wherein if a flow rate reading is below a specified value, adjusting application of aspiration comprises initiating application of pulsed aspiration (paragraph 0017 describes calculating flow rate indicating unrestricted flow, restricted flow, or a clog using pressure measurements, paragraph 0073 describes pressure readings below minimums and maximums signify a change in catheter state to a clogged state or unrestricted flow state, paragraph 0080 describes extraction cycle used to clear occlusions. Measuring threshold of pressure values and threshold of flow rate values appears interchangeable since pressure is utilized to calculate flow).
Regarding claim 6, Teigen discloses wherein an aspiration pulse involves closing an automatic valve for a first period of time and opening the valve for a second period of time (paragraph 0088 describes the closing and opening of a vacuum valve 799 such that the changes in pressure are pressure pulses.
Regarding claim 11, Teigen discloses wherein during application of continuous aspiration, flow rate is periodically checked to determine if the clot has likely cleared the catheter (paragraph 0015, “automatically open the on-off valve at a predetermined interval to sample… and the valve will typically only remain open if the signal indicates a return to clot”).
Regarding claim 13, Teigen discloses wherein aspiration measurements comprise a flow rate reading indicating flow rate through an open catheter within about 5%, and/or a pressure reading in the catheter within about 5% of the pump pressure with unrestrained flow that indicate clot clearance (paragraph 0014 describes signal indicating unrestricted flow, that the clot is flowing through the connecting tube and/or the catheter is substantially free from contact with the clot. Indicating an unrestricted flow is within 5% of detecting an unrestricted flow), and further comprising stopping aspiration once these measurements are received indicating clot clearance (paragraph 0014, wherein the on-off valve stops flow through the connecting tube when signal indicates unrestricted flow).
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 4, 12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Teigen in view of Brady (WO 2018019829)
Regarding claim 4, Teigen discloses wherein the pressure and flow rate measurements are used to determine the presence and severity of the clot by wherein the pressure and flow rate measurements are used to estimate clot hardness by examining the flow rate relative to a maximum flow limit and the time dependence over a period of no more than about 2 seconds (paragraph 0021 describes a sampling mode to sample a test flow using 150 millisecond intervals), but does not teach wherein the pressure and flow rate measurements are used to estimate clot hardness by examining the flow rate relative to a maximum flow limit and the time dependence over a period of no more than about 2 seconds.
However, Teigen discloses wherein “restricted flow” has full vacuum aspiration be applied, and clogged flow has pulsed aspiration applied to enhance ingestion of large, tough or otherwise troublesome occlusions (paragraph 0011). Moreover, Brady teaches wherein, in the case of a very soft clot, the vacuum in the catheter decays quickly and quickly returns to its original level, wherein with a fibrin rich thrombus the vacuum will decay more slowly (pg. 22, lines 10-24). In this instance, the hardness of the thrombus is shown to be related to how long it takes for the thrombus to be removed, which in the case of Teigen determines the difference between classifying the problem between “restricted flow” and “clogged flow”.
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 method disclosed in Teigen wherein the pressure and flow rate measurements are used to estimate clot hardness by examining the flow rate relative to a maximum flow limit and the time dependence over a period of more than about 2 seconds, as suggested by Brady, for the purpose of providing an alternative means of determining the necessity of pulsatile vacuuming (see Brady, paragraph 0160, “the nature and condition of the material being aspirated may affect the waveform of the pulse generated in tube 708 and transmitted to the treatment catheter and thus to the patient).
Regarding claim 12, Teigen does not explicitly teach wherein if the clot is estimated to not be soft, adjusting application of aspiration comprises initiating pulsed aspiration at a frequency of at least about 20 hertz.
However, Teigen teaches wherein pulsed aspiration is applied when detecting a clogged condition (paragraph 0011), and Brady teaches wherein pulsed aspiration may be required for fibrin rich thrombi (pg. 22, lines 10-24). Moreover, Teigen teaches wherein the frequency may be optimized to extract the thrombus (paragraph 0081).
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 method disclosed in Teigen such that if the clot is estimated to not be soft, adjusting application of aspiration comprises initiating pulsed aspiration of at least about 20 hertz as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 16, Teigen does not teach wherein an evaluation of the clot is soft is based on the measurement of a pressure spike of at least about 10% relative to the pump pressure within about 0.5 s of initiating aspiration.
However, Brady teaches wherein, in the event of a soft clot, the vacuum decay is quick and at a steep angle (pg. 22, lines 10-24). The exact measurement of the pressure spike in terms of percentage and time appears to be a matter of routine optimization.
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 method disclosed in Teigen such that an evaluation of the clot is soft is based on the measurement of a pressure spike of at least about 10% relative to the pump pressure within about 0.5 s of initiating aspiration, as suggested by Brady, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 7-10 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Teigen.
Regarding claim 7, Teigen discloses wherein the pulsed aspiration involves a set of cycles of closing for a first period of time and opening for a second period of time an automatic valve (paragraph 0081) and wherein after the last cycle the flow rate is measured to determine if a further set of cycles should be performed based on flow rate measurements or alternatively whether continuous aspiration should be applied (paragraph 0103 describes if unrestricted flow is detected [i.e., the clot has been cleared or there was no clot], the on-off valve is turned off to stop flow), but does not explicitly teach wherein the pulsed aspiration involves a set of 1-30 cycles.
However, Teigen teaches wherein the frequency with which the on-off valve opens and closes may be varied depending on if the extraction cycle has trouble clearing a clog (paragraph 0083). This suggests that the number of cycles performed during the pulsed aspiration would be a result effective variable, wherein changing the frequency (and therefore the number of pulses) is utilized to better aspirate the clog
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 method disclosed in Teigen such that the pulsed aspiration involves a set of 1-30 cycles of closing for a first period of time and opening for a second period of time an automatic valve as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 8, Teigen does not explicitly teach wherein the first period of time is less than the second period of time.
However, Teigen teaches wherein the amount of time the valve is opened (i.e., the second period of time) may be altered to allow a larger volume of fluid from the pressure source to be introduced to help remove the clot (paragraph 0088, “Similarly, a controller may close vacuum valve 799 and open pressure valve 796 for a longer period of time, allowing a larger volume of fluid from the pressure source 790 to be introduced into the aspiration catheter 750 to facilitate movement of obstructive material”), establishing the second period of time as a result effective variable. In this case, one of ordinary skill in the art would modify the second period of time, including having it be larger than the first period of time, to optimize the amount of fluid from the pressure source introduced.
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 method disclosed in Teigen such that the first period of time is less than the second period of time as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 9, Teigen discloses wherein during application of continuous aspiration, flow rate is periodically checked to determine if the clot has likely cleared the catheter and aspiration is stopped if the clot has cleared the catheter (paragraph 0103)
Regarding claim 10, Teigen discloses wherein the flow rate measurement comprises evaluating whether or not the flow rate is below a set value and/or whether the flow rate is increasing over time greater than a specified slope (paragraph 0097, “The degree of success of a specific pressure pulse is typically commensurate with the amount of increased flow rate after the pressure pulse”) and wherein if the flow rate is below a specified value and/or the flow rate is not increasing at a sufficient rate then another set of pulsed aspiration cycles is performed (paragraph 0097, “If the efficacy of the loop begins to diminish, the system will return to the full library and start a fresh cycle”).
Regarding claim 19, Teigen discloses a method for aspirating a clot from a blood vessel using an aspiration catheter system (abstract), the method comprising:
applying pulsed aspiration with alternating aspiration on periods separated by aspiration off periods (paragraph 0088 describes switching a vacuum valve 799 off and on), but is silent to wherein the aspiration off periods are no more than half as long as the aspiration on periods and wherein the aspiration on periods are from about 0.25 second to about 25 seconds.
However, Teigen teaches wherein the pressure pulses may be in seconds, milliseconds, microseconds, etc. (paragraph 0095). Moreover, the amount of time the aspiration is off (i.e., when the vacuum valve is closed and the pressure valve 796 is opened) appears to be a result effective variable, describing the amount of time this happens to correlate to the amount of fluid from the pressure source to be introduced into the aspiration catheter to assist in removing the clot (paragraph 0088).
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 method disclosed in Teigen such that the aspiration off periods are no more than half as long as the aspiration on periods and wherein the aspiration on periods are from about 0.25 second to about 25 seconds, for the purpose of optimizing the treatment to remove the thrombus, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 20, Teigen is silent to wherein the aspiration off periods are no more than about 75% of the aspiration on periods
However, Teigen teaches wherein the amount of time the aspiration is off (i.e., when the vacuum valve is closed and the pressure valve 796 is opened) appears to be a result effective variable, describing the amount of time this happens to correlate to the amount of fluid from the pressure source to be introduced into the aspiration catheter to assist in removing the clot (paragraph 0088).
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 method disclosed in Teigen such that the aspiration off periods are no more than about 75% of the aspiration on periods as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 21, Teigen discloses the method further comprising initially applying continuous aspiration and evaluating flow during application of continuous aspiration (paragraph 0072 describes the sampling mode that briefly aspirates without pulsation and evaluates with pressure readings)
Regarding claim 22, Teigen discloses wherein the pulsed aspiration is applied after measurement of a flow rate value of no more than a specified value (paragraph 0017 describes calculating flow rate indicating unrestricted flow, restricted flow, or a clog using pressure measurements, paragraph 0073 describes pressure readings below minimums and maximums signify a change in catheter state to a clogged state or unrestricted flow state, paragraph 0080 describes extraction cycle used to clear occlusions. Measuring threshold of pressure values and threshold of flow rate values appears interchangeable since pressure is utilized to calculate flow), and wherein the pulsed aspiration involves a set of cycles of closing for aspiration off periods and opening for aspiration on periods an automatic valve (paragraph 0081) and wherein after the last pulsed aspiration cycle the flow rate is measured to determine if a further set of aspiration pulse cycles should be performed based on flow rate measurements or alternatively whether continuous aspiration should be applied (paragraph 0103 describes if unrestricted flow is detected [i.e., the clot has been cleared or there was no clot], the on-off valve is turned off to stop flow), but does not explicitly teach wherein the pulsed aspiration involves a set of 1-30 cycles.
However, Teigen teaches wherein the frequency with which the on-off valve opens and closes may be varied depending on if the extraction cycle has trouble clearing a clog (paragraph 0083). This suggests that the number of cycles performed during the pulsed aspiration would be a result effective variable, wherein changing the frequency (and therefore the number of pulses) is utilized to better aspirate the clog
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 method disclosed in Teigen such that the pulsed aspiration involves a set of 1-30 cycles of closing for a first period of time and opening for a second period of time an automatic valve as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Teigen in view of Deville (US 10531883).
Regarding claim 14, Teigen discloses a filter that captures a clot (fig. 4 shows a filter plate 86 to prevent clots from contaminating the container. The filter, under the broadest reasonable interpretation of the instant specification, may also be the section of the canister above the filter plate 86), wherein after a clot is taken out aspiration is stopped (paragraph 0011 discussed when unrestricted flow is detected, aspiration is restricted for blood saving purposes), the method further comprising receiving a measurement of a value from a sensor (paragraph 0016) in a filter indicating the presence of the clot in the filter (paragraph 0016 discusses the sensors detecting clogged flow and unrestricted flow, wherein going from clogged flow to unrestricted flow would indicate the thrombus has been removed.), but does not teach evaluating clot capture prior to stopping aspiration.
However, Deville teaches a thrombus trap with sensor-based thrombus-detection methods that can be used in conjunction with a filter, wherein afterwards a method of evaluating clot capture is done (col. 25, lines 51-55).
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 method disclosed in Teigen such that it further comprises receiving a measurement of a value from a sensor in a filter indicating the presence of the clot in the filter, and evaluating clot capture, as taught by Deville, for the purpose of providing a suitable means of allowing a user to confirm if a thrombus is fully removed (see Deville, col. 2, lines 29-41).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Teigen in view of Neta (US 20130237955).
Regarding claim 15, Teigen discloses wherein a catheter is inserted into a fluid reservoir before use (paragraph 0104 describe priming the aspiration catheter with uncompressible fluid), but does not teach the method further comprising calibrating flow rate and/or pressure prior to delivering aspiration for clot removal, wherein calibrating comprises measuring flow rate and/or pressure with an open valve to a pump with the catheter inserted into to fluid reservoir and measuring flow rate and/or pressure with the valve closed.
However, Neta teaches wherein calibration of a flow detector can be done during priming (paragraph 0183).
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 method discloses in Teigen such that it further comprises calibrating flow rate prior to delivering aspiration for clot removal, wherein calibrating flow rate comprises measuring flow rate with the catheter inserted into a fluid reservoir, as suggested by Neta, for the purpose of providing a suitable method to calibrate the system (see Neta, paragraph 0183).
Teigen, as modified by Neta, does not teach wherein calibrating flow rate comprises measuring flow rate with an open valve to a pump with the catheter inserted into a fluid reservoir and measuring flow rate with the valve closed.
However, Teigen teaches a similar method in a sampling mode, wherein a valve to a pump is reopened for a fixed time interval to establish a test flow, followed by closing the valve when characterizing the flow as unrestricted (paragraph 0021). As such, when a sample is being taken, the system continuously measures flow rate to determine unrestricted, restricted, or clogged flow.
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 method disclosed in Teigen in view of Neta such that calibrating flow rate comprises measuring flow rate with an open valve to a pump with the catheter inserted into a fluid reservoir and measuring flow rate with the valve closed, for the purpose of providing a suitable means of granting a sample flow during calibration (paragraph 0021).
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.
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/Brandon W. Levy/Examiner, Art Unit 3781
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