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 12/03/2024. Claims 1-20 have been amended. Currently, claims 1-20 are pending and are being examined on the merits.
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)(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, 5-7, and 11-12 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Grey (WO 2014151209).
Regarding claim 1, Grey discloses an aspiration system for an intravascular device (abstract), the aspiration system comprising:
an aspiration catheter configured for insertion into an associated blood vessel (fig. 2A, catheter 206 to be within a vessel 204); and
a normally closed flow control valve connected to control the aspiration of material from the associated blood vessel via the aspiration catheter (fig. 7, appliance 710 that controls aspiration of material, shown closed in step 1), the normally closed flow control valve including:
a flow inlet operatively connected with the aspiration catheter (see annotated fig. 7 below),
a flow outlet operatively connectable with an associated vacuum pump (see annotated fig. 7 below), and
a vacuum pull actuator operatively connected to the flow outlet whereby vacuum at the flow outlet operates the vacuum pull actuator to open the normally closed flow control valve.
Regarding claim 5, Grey discloses an aspiration system comprising:
an aspiration catheter configured for insertion into an associated blood vessel (fig. 7, “to catheter” for a catheter not shown); and
a normally closed flow control valve (fig. 7, section shown is considered the valve, including mechanism 710 and T section of tubing) having an inlet operatively connected with the aspiration catheter (see annotated fig. 7 below) and an outlet operatively connectable with an associated vacuum pump (see annotated fig. 7 below, connected to aspiration source 708) the control valve comprising:
a main valve body (fig. 7, main body in appliance 710); and
a biasing member (721) disposed within an interior of the main valve body (fig. 7, biasing mechanism 721);
wherein when a vacuum level at the outlet of the control valve is equal to or exceeds a predetermined vacuum threshold, biasing provided by the biasing member is overcome to initiate opening of the control valve (pg. 14, lines 19-31 describes a vacuum level pulling the biasing member down in order to open the valve to open the system to the ambient environment).
Regarding claim 6, Grey discloses wherein the control valve further comprises:
a vacuum-actuated piston assembly (718) that is normally closed by force applied by the biasing member (fig. 7, plunger 718 biased upwards by biasing mechanism 721), wherein when the vacuum level at the outlet of the control valve is equal to or exceeds the predetermined vacuum threshold the force applied by the biasing member is overcome by the vacuum-actuated piston assembly to initiate opening of the control valve (pg. 14, lines 19-31 describes a vacuum level pulling the biasing member down in order to open the valve to open the system to the ambient environment. The “predetermined vacuum threshold” to overcome the biasing member would come from the properties of the spring).
Regarding claim 7, Grey discloses wherein a piston cylinder (718) of the vacuum-actuated piston assembly is connected with the outlet of the control valve (fig. 7, plunger 718 connected to the outlet as defined wherein every component is connected to each other).
Regarding claim 11, Grey discloses wherein the biasing member comprises a spring (fig. 7, biasing mechanism 721 as a spring)
Regarding claim 12, Grey discloses the device further comprising a vacuum source configured to supply aspiration in the blood vessel (fig. 7, aspiration source 708).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Grey in view of Brady (US 20190239910).
Regarding claim 4, Grey is silent to the aspiration system further comprising:
a collection container interposed in a flow path from the outlet of the normally closed flow control valve to the associated vacuum pump, whereby material aspirated from the associated blood vessel via the aspiration catheter collects in the collection container.
However, Brady teaches a collection container (fig. 23A, reception canister 707) interposed in a flow path from the outlet of the normally closed flow control valve to the associated vacuum pump (fig. 23A-B, similar pulsation valve 711, or rotating valve 711, and pump 714, with canister 707 being between valve 711 and pump 714), whereby material aspirated from the associated blood vessel via the aspiration catheter collections in the collection container (paragraph 0152).
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 Grey such that the system further comprises a collection container interposed in a flow path from the outlet of the normally closed flow control valve to the associated vacuum pump, whereby material aspirated from the associated blood vessel via the aspiration catheter collects in the collection container, as taught by Brady, for the purpose of providing a suitable means of receiving aspirated blood or material (see Brady, paragraph 152).
Allowable Subject Matter
Claims 13-20 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 13, Grey discloses an intravascular treatment aspiration method (abstract), comprising:
inserting an aspiration catheter-into a blood vessel (abstract);
applying a vacuum to the aspiration catheter using a vacuum pump (fig. 7, aspiration source 708 to apply to a catheter not shown) and
with a vacuum-actuated valve-in-line between the aspiration catheter and the vacuum pump (fig. 7, valve as appliance 710 plus the T section of tubing between the appliance 710, catheter, and aspiration source 708);
but does not teach opening said valve to initiate aspiration of material in the blood vessel via the aspiration catheter; and during the aspiration, closing the vacuum-actuated valve in response to the vacuum level at the vacuum-actuated valve decreasing below the predetermined vacuum threshold to stop the aspiration of material in the blood vessel via the aspiration catheter
The appliance (710) is opened and closed when going above and below a pressure threshold determined by the properties of the biasing mechanism (721). However, the valve in question is meant to open and close off the system to the ambient environment when the valve is opened and closed, respectively. The valve does not open “to initiate” aspiration since the valve opens in response to aspiration pressure becoming too high. The valve can be closed by stopping aspiration, but the valve does not close “to stop the aspiration”.
Russo (US 7779842) teaches a valve that can be opened and closed to allow for and close off aspiration, such that one can open the valve to initiate aspiration of material in the blood vessel via the aspiration catheter, but does not teach the valve being vacuum-actuated (i.e., the vacuum level having an explicit effect on the valve opening and closing).
For these reasons, claim 13 is allowable.
Claims 14-20 are allowable by virtue of being dependent on claim 13.
Claims 2 and 8-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 2, Grey teaches wherein the vacuum pull actuator includes:
a piston cylinder (fig. 7, assembly 710 with a housing)
a piston assembly including a piston (fig. 7, plunger 718 as piston) disposed in the piston cylinder
a spring arranged to bias the piston assembly to a closed position (fig. 7, biasing mechanism 721 such as a spring)
but does not teach the piston assembly having a piston rod, the piston rod having a through-hole, wherein in a closed position the through-hole of the piston rod is misaligned with a fluid flow path from the flow inlet to the flow outlet.
The valve used in Grey is meant to create a pulsatile vacuum by opening up the ambient environment and breaking the vacuum. However, there does not appear to be a reason to add a piston rod and having a through-hole of the piston rod being misaligned with a fluid flow path from the flow inlet to the flow outlet.
Russo teaches a valve with a piston rod with a through-hole that opens and closes aspiration when the through-hole is aligned or misaligned (see fig. 3). However, there does not appear to be a motivation to make this valve vacuum-actuated/ having the valve function such that vacuum at the flow outlet operates the vacuum pull actuator to open the normally closed flow control valve as recited in claim 1.
For these reasons, claim 2 appears to contain allowable subject matter.
Claim 3 contains allowable subject matter by virtue of being dependent on claim 2.
Claim 8 contains allowable subject matter for similar reasons as recited in claim 2, notably wherein one of ordinary skill in the art would not have included a piston rod with an opening to align with the aspiration catheter, wherein the valve is vacuum actuated.
Claims 9-10 contain allowable subject matter by virtue of being dependent on claim 8.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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
