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 in the reply filed on 16 July 2026 is acknowledged.
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 16 July 2026.
Claim Rejections - 35 USC § 112
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.
Claims 10-23 are 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 10 recites the limitation "a valve" in line 6. However, a valve was previously disclosed in line 2. It is unclear if the second recitation of “a valve” is intended to refer back to the valve of line 2 or disclose an additional valve. For purposes of examination, the limitation of line 6 will be considered to refer back to the valve disclosed in line 2.
Claim 23 recites the limitation "the catheter lumen" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. Previously, a lumen was disclosed.
Claim Rejections - 35 USC § 102
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 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)(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.
Claim(s) 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Teigen et al. (2020/0367917).
With respect to claim 23, Teigen discloses a medical device for aspirating material from a patient comprising a suction source, an aspiration catheter defining a lumen, a valve configured to open or close to control a suction force applied to the lumen, and control circuitry configure to control the valve to open or close based on a flow rate and a flow rate reference value, as disclosed in paragraphs [0014] and [0074].
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.
Claim(s) 10-12, 14, and 16-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teigen et al. (2020/0367917).
With respect to claim 1, Teigen discloses a medical aspiration system comprising a valve configured to open or close to control a suction force applied to a catheter lumen, as disclosed in paragraph [0014]. A control circuitry is configured to determine a flow rate of a fluid within the catheter lumen, as disclosed in paragraph [0070], compare the flow rate to a flow rate reference value, as disclosed in paragraph [0074], and control the valve to control a suction force applied to the catheter lumen, as disclosed in paragraph [0078].
Teigen discloses all aspects of the claimed invention with the exception of the control circuitry being configured to determine a duty cycle of a first operational state of the valve and a second operational state of the valve based on a difference between the flow rate and the flow rate reference value. Teigen discloses that the control circuitry is configured to control the valve to be in first and second operational states (i.e. open and closed) based on the difference between the flow rate and the reference flow rate value, as disclosed in paragraph [0014], but remains silent as to determining the duty cycle of the first and second operational states. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention for the control circuitry of Teigen to be configured to determine a duty cycle of a first operational state and second operational state to achieve the predictable result of allowing the control circuitry to know if the valve is already open or closed before controlling the operation of the valve based on a difference between the flow rate and flow rate reference value.
With respect to claim 11, the first operational state comprises a closed valve state which enables application of a relatively low suction force to the catheter lumen and the second operational state comprises an open valve state with enables application of relatively high suction force to the catheter lumen, as disclosed in paragraph [0014].
With respect to claim 12, the control circuitry is configured to determine that a flow rate is greater than the flow rate reference value, as disclosed in paragraph [0025]. Teigen discloses that the valve is modified to be closed, as disclosed in paragraph [0025], and therefore the amount of time the valve is in the first operational state is increased and the amount of time the valve is in the second operation state is decreased.
With respect to claim 14, the control circuitry is configured to determine that the flow rate is less than the flow rate reference value, as disclosed in paragraph [0078]. Teigen discloses that the valve is modified to be opened, as disclosed in paragraph [0078], and therefore the amount of time the valve is in the first operational state is decreased and the amount of time the valve is in the second operation state is increased.
With respect to claim 16, determining the flow rate comprises determining the flow rate based on a flow rate measurement from a flow rate sensor, as disclosed in paragraph [0016]. Teigen discloses all aspects of the claimed invention with the exception of the flow rate reference value being greater than a flow rate noise amount of the flow rate sensor. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make the flow rate reference value of Teigen greater than a flow rate noise amount of the sensor to achieve the predictable result of a flow rate reference valve that is able to be distinguished from noise in the sensor and allow for an accurate comparison against the measured flow rate.
With respect to claim 17, determining the flow rate comprises determining a first flow rate based on a flow rate measurement from a flow rate sensor, as disclosed in paragraph [0016]. Teigen discloses all aspects of the claimed invention with the exception of the flow rate reference value being greater than a flow rate noise amount of the flow rate sensor. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make the flow rate reference value of Teigen greater than a flow rate noise amount of the sensor to achieve the predictable result of a flow rate reference valve that is able to be distinguished from noise in the sensor and allow for an accurate comparison against the measured flow rate. The control circuitry is further configured to control the valve to be in the second operational state for a predetermined amount of time, determine a second flow rate, and control the valve to be in the first or the second operational state based on the second flow rate value, as disclosed in paragraph [0021].
With respect to claim 18, the control circuitry is configured to determine a second duty cycle of the first and second operational states based on a difference between the second flow rate and the flow reference rate value and control the valve to be in either the first or second operational state according to the second duty cycle, as disclosed in paragraphs [0021-0022].
With respect to claim 19, Teigen discloses controlling the valve according to an adaptive algorithm, as disclosed in paragraph [0027].
With respect to claim 20, Teigen discloses in paragraph [0086] that the valve can be partially open or closed based on a difference between the flow rate and the flow rate reference value.
With respect to claim 21, the control circuitry is configured to determine the flow rate reference value based on a size (i.e. diameter) of the catheter lumen, as disclosed in paragraph [0015].
With respect to claim 22, Teigen discloses the system further comprise a suction source 40 and an elongated body defining the catheter lumen (i.e. aspiration catheter), as disclosed in paragraph [0060].
Allowable Subject Matter
Claims 13 and 15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Teigen, does not disclose determining the flow rate is greater or less than the flow rate reference value by a first difference amount. Teigen is only concerned with determining if the flow rate is greater than the flow rate reference value, and not with determining by how much. The prior art of record therefore does not disclose nor fairly suggest the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patents and Publications 10,702,415; 2020/0397465; 2022/01031931; and 2024/0115113 disclose medical aspiration systems comprising flow control valves.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNNE ANDERSON whose telephone number is (571)272-4932. The examiner can normally be reached Monday-Friday 10-6.
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/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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