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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/23/26 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 4/23/36. As directed by the amendment: claims 1 and 10 have been amended, no claims have been cancelled, and no new claims have been added. Thus, claims 1-21 are presently pending in this application, claims 6-8, 15-17, and 19-21 being withdrawn from consideration.
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.
Claims 1-5, 9-14, and 18 are 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. Independent claim 1 recites the newly amended limitation regarding the actuator held opposite the anvil at a specific longitudinal position along the flow switch; independent claim 10 recites the newly amended limitation regarding the pinch valve anvil and actuator held relative to one another along a longitudinal body axis of the elongated body. These amended limitations are not described in the specification as originally filed and constitute new matter. The specification only describes these elements being held opposite each other (see par. 0042), without any relative reference to “a specific longitudinal position” or “along a longitudinal axis of the elongated body”. The scope of this claim language is also not clearly evident from the figures. The dependent claims incorporate these same limitations and are thus rejected on the same grounds as the independent claims.
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.
Claim(s) 1-5 and 9-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eichler (DE 102015202967).
Regarding claim 1, as best understood, Eichler discloses a medical system for aspirating material from a patient (fig. 1-13), the system comprising: a flow switch 1 comprising: an anvil 23; an actuator 22 held opposite the anvil at a specific longitudinal point along the flow switch (held by one of the vertical guide grooves 28 at one of the points delineated by a vertical guide groove 28); and a surface feature 24 on at least one of the anvil and actuator (both options are disclosed, see fig. 3 and fig. 4), wherein the flow switch is configured to: move the actuator away from the anvil to create a flow path in a flexible tube for the aspiration of the material (position illustrated in fig. 3 and 4 when moved up/down in a groove 28 as seen in fig. 12); and move the actuator toward the anvil to reduce the flow path by creating at least one channel defined by the surface feature (as illustrated in fig. 5-7 when moved up/down in a groove 28 as seen in fig. 12).
Regarding claim 2, Eichler discloses the flexible tube (portion of 9 housed within 1) coupled to an elongated body of a catheter (see fig. 1) that is configured to aspirate the material from the patient and wherein the material is thrombus (9 is characterized as an aspiration line, par. 0034-0035, and fully capable of aspirating thrombus material).
Regarding claim 3, Eichler discloses the actuator and the anvil are configured to compress the flexible tube from an open configuration to a compressed configuration (as illustrated in fig. 5-7), wherein when the flexible tube is in the open configuration and is fluidically coupled to the elongated body of the catheter, a suction source 10 that is fluidically coupled to the flexible tube is configured to cause a first flow rate through the lumen of the flexible tube, and wherein the surface feature is configured to cause the channel within the lumen of the flexible tube to remain open when the flexible tube is compressed such that the channel allows a second flow rate through the lumen that is greater than zero and less than or equal to 5% of the first flow rate (par. 0006, 0034, 0040; the mechanism allows adjusting the flow rate between high and low values, and allows setting a very low flow rate while preventing complete closing of the line, and is thus fully capable of adjusting between a high flow rate and a low flow rate that is less than or equal to 5% of a selected high flow rate).
Regarding claim 4, Eichler discloses a surface of the at least one of the actuator or the anvil defines the surface feature (both options are disclosed, see fig. 3 and 4), wherein the surface feature comprises at least one of a protrusion extending outwardly from the surface or a recess extending inwardly from the surface (recess, see fig. 3 and 4).
Regarding claim 5, Eichler discloses the protrusion or the recess extends in a direction along the longitudinal tube axis of the flexible tube to cause the channel to extend along the longitudinal tube axis (see fig. 9, 10, and 12).
Regarding claim 9, Eichler discloses a suction source 10; and a catheter in fluidic connection to the suction source and designed for use within a peripheral vascular system of the patient (lumen of 6 connected to suction source, fully capable of use as claimed).
Regarding claim 10, Eichler discloses a medical aspiration system (fig. 1-13) comprising: a suction source 10; an elongated body 9 defining a lumen (interior lumen of 9) fluidically coupled to the suction source; and a pinch valve 1 configured to actuate between a high flow configuration and a low flow configuration (as illustrated in fig. 5-7), wherein in the low flow configuration the pinch valve is configured to compress the elongated body while still enabling fluid flow through the lumen (par. 006, 0034, 0040), wherein the pinch valve comprises an anvil 23 and an actuator 22 held relative to each other along a longitudinal axis of the elongated body (22 is trapped within groove system 27/28 and thus fixed to the anvil 23, positioned together along the elongated body longitudinal axis as shown in fig. 12; furthermore, as illustrated in fig. 12 and associated description, the anvil/actuator, being relatively positioned via one of the vertical guide grooves 28, are relatively held as claimed).
Regarding claim 11, Eichler discloses the pinch valve is configured to allow a first flow rate through the lumen in the high flow configuration and to allow a second flow rate through the lumen in the low flow configuration that is less than or equal to 5% of the first flow rate (par. 0006, 0034, 0040; the mechanism allows adjusting the flow rate between high and low values, and allows setting a very low flow rate while preventing complete closing of the line, and is thus fully capable of adjusting between a high flow rate and a low flow rate that is less than or equal to 5% of a selected high flow rate).
Regarding claim 12, Eichler discloses the elongated body is positioned between the actuator and the anvil (see fig. 3-7), wherein at least one of the actuator or the anvil are configured to move towards the other of the anvil or the actuator to compress the elongated body (as illustrated in fig. 5-7), wherein at least one of the anvil or the actuator comprises a surface feature 24 (both options disclosed, see fig. 3 and 4) configured to cause a channel within the lumen to remain open when the elongated body is compressed between the anvil and the actuator (see fig. 7; par. 0006, 0034, 0040).
Regarding claim 13, Eichler discloses a surface of the at least one of the actuator or the anvil defines the surface feature comprising at least one of a protrusion extending outwardly from the surface or a recess extending inwardly from the surface (see fig. 3-7).
Regarding claim 14, Eichler discloses the protrusion or the recess extends in the direction along a longitudinal body axis of the elongated body to cause the channel to extend along the longitudinal body axis (see fig. 9, 10, and 12).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 and 11, in the alternative, is/are rejected under 35 U.S.C. 103 as being unpatentable over Eichler.
Regarding claims 3 and 11, Eichler discloses [claim 3] the actuator and the anvil are configured to compress the flexible tube from an open configuration to a compressed configuration (as illustrated in fig. 5-7), wherein when the flexible tube is in the open configuration and is fluidically coupled to the elongated body of the catheter, a suction source 10 that is fluidically coupled to the flexible tube is configured to cause a first flow rate through the lumen of the flexible tube, and wherein the surface feature is configured to cause the channel within the lumen of the flexible tube to remain open when the flexible tube is compressed such that the channel allows a second flow rate through the lumen that is greater than zero and less than or equal to 5% of the first flow rate (par. 0006, 0034, 0040; the mechanism allows adjusting the flow rate between high and low values, and allows setting a very low flow rate while preventing complete closing of the line, and is thus fully capable of adjusting between a high flow rate and a low flow rate that is less than or equal to 5% of a selected high flow rate); and [claim 11] the pinch valve is configured to allow a first flow rate through the lumen in the high flow configuration and to allow a second flow rate through the lumen in the low flow configuration that is less than or equal to 5% of the first flow rate (par. 0006, 0034, 0040; the mechanism allows adjusting the flow rate between high and low values, and allows setting a very low flow rate while preventing complete closing of the line, and is thus fully capable of adjusting between a high flow rate and a low flow rate that is less than or equal to 5% of a selected high flow rate).
In addition to the analyses of claims 3 and 11 above, there is no evidence of record that establishes that changing the percentage of low flow rate vs high flow rate would result in a difference in function of Eichler. A person having ordinary skill in the art, being faced with modifying the system of Eichler, would have a reasonable expectation of success in making such a modification and it appears the system would function as intended being given the claimed relative percentage of low flow vs. high flow. Lastly, applicant has not disclosed that the claimed range solves any stated problem, and offers other acceptable ranges (par. 0025), and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the percentage of low flow rate vs. high flow rate in Eichler to be limited as less than or equal to 5% as an obvious matter of design choice within the skill of the art.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eichler in view of Brundage et al. (US 20190143008).
Regarding claim 18, Eichler discloses the system as claimed, including the pinch valve configured to actuate the actuator to only the high flow configuration or the low flow configuration (valve 1 is only actuatable to positions with either full flow or flow less than full flow), except for the pinch valve comprises a solenoid. However, Brundage et al. teaches utilizing a solenoid as an actuator in a vacuum line pinch valve (par. 0027, fig. 2A-F). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a solenoid actuator in Eichler, as taught by Brundage et al., for the purpose of providing sufficient structure to allow the system to be capable of both user actuation and automation as needed (par. 0027).
Response to Arguments
Applicant's arguments filed 4/23/26 have been fully considered but they are not persuasive.
Applicant argues, on pg. 7-8 of the Remarks, that the newly amended limitations of claims 1 and 10 are supported by the written description in fig. 2A, 2B, and 3A and associated description in the specification. Examiner respectfully disagrees. The rejection under 35 U.S.C. 112(a) has been updated to reflect the amended language.
Applicant argues on pg. 9-10 of the Remarks that Eichler does not disclose the amended limitations of independent claims 1 and 10 because vertical grooves 28 are accompanied by horizontal groove 27 which allows horizontal movement. Examiner respectfully disagrees, and does not interpret the claims to completely preclude any possibility of horizontal movement. As discussed in the rejections above, each vertical groove 28 is clearly disclosed by Eichler as holding element 22 in a specific position relative to element 23.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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