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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/5/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19) in the reply filed on 6/4/2026 is acknowledged.
Claims 20-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6/4/2026.
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 1-19 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.
In regard to claim 1, there is no antecedent basis for “the thrombus” on the second and third to last line of the claim.
In regard to claim 2, it is unclear if the recited “a vent fluid source” is a reference to the already functionally recited “a vent fluid source” of claim 1. For the purposes of this action, the assumption is that they are the same.
In regard to claim 3, there is no antecedent basis for “the catheter lumen”.
The dependent claims are rejected by virtue of their dependency on the rejected independent claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Deville et al. (US 10,531,883; hereafter Deville) .
In regard to claim 1, Deville discloses an aspiration system for removing thromboembolic material from a blood vessel using a catheter system (see Abstract) including an aspiration catheter (660) having a proximal portion, a distal end and a lumen (see Fig. 47; the examiner notes that the catheter system is interpreted as being functionally recited), the aspiration system comprising: a vacuum source (610) configured to supply vacuum to the catheter system (see col. 35, lines 19-41), wherein the vacuum source has a maximum steady state vacuum level (vacuum level when vacuum valve is left open sufficient amount of time); a vacuum valve (620) fluidically coupled to the vacuum source and configured to be fluidically coupled to the proximal portion of the aspiration catheter (see Fig. 47); a vent valve (650) configured to be fluidically coupled to (a) a vent fluid source (640) containing a vent fluid (642) and (b) the proximal portion of the aspiration catheter (see Fig. 47); and a controller (700) configured to cyclically open and close the vacuum valve and the vent valve in a predetermined cycle based on the catheter system (see at least par. 22-23 of “Summary of the Invention”) including - (a) a vacuum phase in which the vacuum valve is open and the vent valve is closed (see par. 162 of “The Detailed Description Section”), (b) a vent phase in which the vent valve is open and the vacuum valve is closed to impart a distal shift of a fluid column in the lumen of the aspiration catheter (see par. 162 of “The Detailed Description Section”), and (c) the vent phase is terminated and the vacuum phase is reapplied thereby quelling the distal shift of the fluid column such that an exit flow out from the distal end of the aspiration catheter during each cycle is in a range from at least approximately zero to a limited predetermined volume of liquid whereby the reapplied vacuum recaptures the thrombus before the thrombus is uncontrollably ejected from the distal end of the aspiration catheter (see par. 162 of “The Detailed Description of the Embodiments” section).
Deville does not expressly disclose the limitations “such that when thromboembolic material blocks the distal end of the aspiration catheter a super-vacuum level at the distal end of the aspiration catheter occurs for a temporary super-vacuum period before reducing to the maximum steady state vacuum level of the vacuum source, wherein the super-vacuum level is greater than the maximum steady state vacuum level of the vacuum source, and wherein the vent phase is timed to start before the temporary super-vacuum reduces to the maximum steady state vacuum of the vacuum source.
Turning to the applicant’s disclosure (see par. [0342] of the pg-publication of the instant application), the creation of the super vacuum is discussed; “By having vacuum applied very quickly (open suddenly, e.g., less than approximately 10 ms, in particular, less than approximately 5 ms), the column of fluid in the extension line 674 gets drawn towards the vacuum source 610 and, because the liquid column has mass and is incompressible, the column develops momentum towards the vacuum source 610. That momentum makes the liquid column behave like a plunger of a syringe, therefore creating a deeper, momentary vacuum at the distal end 664 of the catheter 660.” The recited super vacuum is created by applying the vacuum rapidly for less than 10 ms. Deville fails to expressly disclose creating the super vacuum by applying the vacuum less than approximately 10 ms but Deville does disclose a Vacon duration (624) that is between approximately 10 ms and approximately 50 ms) (see par. [0178] of “The Detailed Description of the Embodiments” section). The prior art range of Deville immediately abuts the claimed range of less than 10 ms. Accordingly, one of ordinary skill in the art would have had reason to investigate values immediately beyond the disclosed range as part of routine optimization, particularly because Deville recognizes the parameter as adjustable (see par.156 of “The Detailed Description of the Embodiments” section; “Thus, by adjusting a timing of the vacuum and vent valves to match a compliance and length of a particular catheter system (which can include the catheter and also the manifold and valves and other lumens in line with the catheter), a ROAR effect can be achieved for that catheter). By opening the vacuum valve of Deville with the recited time of less 10 ms, a super vacuum would be formed. The Deville device functions otherwise the same as the applicant’s invention.
In regard to claim 2, Deville teaches, further comprising a vent fluid source (640), and wherein: the vent fluid source is configured to provide vent fluid at a pressure greater than body pressure; and the controller is configured to cyclically open and close the vacuum valve and the vent valve to alternate between a negative pressure and a positive pressure at the distal end of the aspiration catheter during each cycle (see par. 162 of “The Detailed Description of the Embodiments” section
In regard to claim 3, Deville discloses wherein the controller (700) is configured to cyclically open and close the vacuum valve and the vent valve such that movement of the fluid column at the distal end of the aspiration catheter is a positive amount of exit flow limited to less than 20 microliters before fluid is drawn back into the catheter lumen (see par. 154 of “The Detailed Description of the Embodiments” section
In regard to claim 4, Deville discloses wherein the controller (700) is configured to cyclically open and close the vacuum valve and the vent valve in a cycle comprising a vacuum-only state in which the vacuum valve is open and the vent valve is closed, an off-off state in which the vacuum valve is closed while the vent valve is closed for a controlled period of time, and a vent-only state in which the vacuum valve is closed and the vent valve is open (see par. 177 of “The Detailed Description of the Embodiments” section
In regard to claim 5, Deville discloses wherein the vacuum-only state is 40-60% of the cycle, the vent-only state is approximately 20-25% of the cycle, and the off-off state is the remainder of the cycle (see par. 178 of “The Detailed Description of the Embodiments” section
In regard to claim 6, Deville discloses wherein: the controller (700) is configured to cyclically open and close the vacuum valve and the vent valve in a cycle comprising (a) a first off-off state in which the vacuum valve is closed while the vent valve is closed, (b) a vacuum-only state following the first off-off state in which the vacuum valve is open while the vent valve is closed, (c) a second off-off state following the vacuum-only state in which the vacuum valve is closed while the vent valve is closed, and (d) a vent-only state following the second off-off state in which the vacuum valve is closed while the vent valve is open; and the cycle is repeated (see par. 177 of “The Detailed Description of the Embodiments” section.
In regard to claim 7, Deville discloses wherein the cycle is repeated at a frequency of 6 Hz to 16 Hz (see par. 32 of “The Summary of the Invention”).
In regard to claim 8, Deville discloses wherein during each cycle a pressure differential at the distal end of the aspiration catheter is at least approximately 15 inHg to 25 inHg in a time of not greater than 20 ms to 50 ms (see par. 161 of the “The Detailed Description of the Embodiments” section)
In regard to claim 9, Deville discloses wherein the cycle is repeated at a frequency of 8 Hz to 12 Hz and during each cycle the pressure differential at the distal end of the aspiration catheter is at least approximately 20 inHg in a time of not greater than approximately 20 ms “The Detailed Description of the Embodiments” section)
In regard to claim 10, Deville discloses wherein the controller is configured to cyclically open and close the vacuum valve and the vent valve in a predetermined cycle comprising: a first double-off state in which the vacuum valve is off while the vent valve is off; initiating the vacuum phase by opening the vacuum valve while the vent valve is closed such that vacuum rapidly increases to the super-vacuum level in no greater than approximately 20 ms and terminating the vacuum phase by closing the vacuum valve while the super-vacuum level exists; and initiating the vent phase by opening the vent valve such that vent fluid is introduced to the aspiration catheter while the super-vacuum level exists at the distal end of the aspiration catheter (see par. 177 of “The Detailed Description Section”).
In regard to claim 11, please see the rejection of claim 1.
In regard to claim 12, Deville discloses wherein the cycle is repeated at a frequency of 6 Hz to 16 Hz (see par. 32 of “The Summary of the Invention”).
In regard to claim 13, Deville discloses wherein during each cycle a pressure differential at the distal end of the aspiration catheter is at least approximately 15 inHg to 25 inHg in a time of not greater than 20 ms to 50 ms (see par. 161 of the “The Detailed Description Section”).
In regard to claim 14, Deville discloses wherein the cycle is repeated at a frequency of 8 Hz to 12 Hz and during each cycle the pressure differential at the distal end of the aspiration catheter is at least approximately 20 inHg in a time of not greater than approximately 20 ms (see par. 161 of the “The Detailed Description Section”).
In regard to claim 15, Deville discloses wherein the controller is configured to cyclically open and close the vacuum valve and the vent valve in a predetermined cycle comprising: a first double-off state in which the vacuum valve is off while the vent valve is off; initiating the vacuum phase by opening the vacuum valve while the vent valve is closed such that vacuum rapidly increases to the super-vacuum level in no greater than approximately 20 ms and terminating the vacuum phase by closing the vacuum valve while the super-vacuum level exists; a second double-off state in which the vacuum valve is off while the vent valve is off; and initiating the vent phase by opening the vent valve such that vent fluid is introduced to the aspiration catheter while the super-vacuum level exists at the distal end of the aspiration catheter (see par. 177 of “The Detailed Description Section”).
In regard to claim 16, please see the rejection of claim 1.
In regard to claim 17, Deville discloses wherein the cycle is repeated at a frequency of 6 Hz to 16 Hz (see par. 32 of “The Summary of the Invention”).
In regard to claim 18, Deville discloses wherein during each cycle a pressure differential at the distal end of the aspiration catheter is at least approximately 15 inHg to 25 inHg in a time of not greater than 20 ms to 50 ms (see par. 161 of the “The Detailed Description Section”).
19. (Original) The aspiration system of claim 15 wherein the cycle is repeated at a frequency of 8 Hz to 12 Hz and during each cycle the pressure differential at the distal end of the aspiration catheter is at least approximately 20 inHg in a time of not greater than approximately 20 ms (see par. 161 of the “The Detailed Description Section”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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