DETAILED ACTION
Claims 1-20 were filed with the Preliminary Amendment dated 10/29/2024. Claims 21-66 were cancelled.
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 10/29/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1, 2, 4-12, and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Pat. Pub. No. 2012/0053514 (“Robinson”).
With regard to claim 1, Robinson discloses an actuator actuated valve for maintaining multi-lumen patency (Figs 7A-7B), comprising: a valve manifold (body at 150) including an input port (160; para [0101]), a first output port (170), and a second output port (174); and a valve spool (162) extending within the valve manifold (body at 150), wherein the valve spool (162) defines a first valve passageway (164) and a second valve passageway (168), wherein the valve spool (162) is rotatable relative to the valve manifold (body at 150) between a first position (position 164 lined up with 160) in which the input port (160) and the first output port (170) are in fluid communication via the first valve passageway (164) and a second position (position 168 lined up with 160) in which the input port (160) and the second output port (174) are in fluid communication via the second valve passageway (168) (see Figs 7A, 7B and para [0101]).
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With regard to claim 2, Robinson discloses that when the valve spool (162) is between the first position (position at 164 lined up at 160) and the second position (position at 168 lined up with 160), the input port (160) is not in fluid communication with the first output port (170) and the second output port (174) (between 164 and 168 is blocked port 180 preventing fluid communication, see para [0102] and Figs 7A-7B).
With regard to claim 4, Robinson discloses that the valve spool (162) is rotatable relative to the valve manifold (body at 150) between the first position (position with 164 lined up to 160), the second position (position with 168 lined up to 160), and a third position (position when 166 lined up with 160) in which the input port (160) is not in fluid communication with the first output port (170) and the second output port (174) (because at position when 166 lined up with 160, input port is in communication with output port 172, see Fig 7A).
With regard to claim 5, Robinson discloses that when the valve spool (162) is in the first position (position with 164 lined up with 160), the input port (160) is not in fluid communication with the second output port (174) (because it is lined up with 170), and wherein, when the valve spool (162) is in the second position (position with 168 lined up with 160), the input port (160) is not in fluid communication with the first output port (170) (because it is lined up with 174).
With regard to claim 6, Robinson discloses that the valve manifold (body at 150) further includes at least one further output port (172, see Fig 7A), wherein the valve spool (162) further defines at least one further valve passageway (166), wherein the valve spool (162) is further rotatable relative to the valve manifold (body at 150) between the first position (position where 164 lined up with 160), the second position (position where 168 lined up with 160), and at least one further position (position where 166 lined up with 160) in which in the input port (160) and the at least one further output port (166) are in fluid communication via the at least one further valve passageway (172, see Fig 7A).
With regard to claim 7, Robinson discloses that the valve spool (162) is rotatable between a plurality of positions including the first position (position where 164 lined up with 160), the second position (position where 168 lined up with 160), and the at least one further position (position where 166 lined up with 160) (para [0102]: “rotate valve 162 to place one of ports 164, 166, or 168 in fluid communication with inlet aperture 160”), and wherein, in the plurality of positions, (i) a single output port of the first output port (170), the second output port (174), and the at least one further output port (172) is in fluid communication with the input port (160) via a single valve passageway of the first valve passageway (164), the second valve passageway (168), and the at least one further valve passageway (166) and (ii) the other output ports of the first output port (170), the second output port (174), and the at least one further output port (172) are not in fluid communication with the input port (160) via the other valve passageways of the first valve passageway (164), the second valve passageway (168), and the at least one further valve passageway (166) (Robinson discloses rotating between one port at a time which prevents fluid communication with other ports, see paras [0101] [0102], and [0104]: “rotating valve 162 to expose one of fluid pathways 170, 172, or 174”).
With regard to claim 8, Robinson discloses a rotary actuator (connected to 176) configured to rotate the valve spool (162) relative to the valve manifold (body at 150) between the first position (position where 164 aligns with 160) and the second position (position where 168 aligns with 160) (para [0102]: “Processor 176 may execute instructions to generate signals that are communicated to an intermediate rotating device (not shown) such as an actuator, solenoid, motor, or the like to impart mechanical energy for rotating valve 176”).
With regard to claim 9, Robinson discloses a communication device (20, para [0102]) configured to receive control data from an external computing device (computing device [0037], telemetry 88); and a processor (176) configured to control, based on the control data (para [0102]: “processor 176, e.g., with the aid of instructions stored in memory or commands received from programmer 20”), the rotary actuator (connected to 176; (para [0102]: “Processor 176 may execute instructions to generate signals that are communicated to an intermediate rotating device (not shown) such as an actuator, solenoid, motor, or the like to impart mechanical energy for rotating valve 176”) to rotate the valve spool (162) relative to the valve manifold (body at 150) between the first position (position where 164 aligns with 160) and the second position (position where 168 aligns with 160).
With regard to claim 10, Robinson discloses that the communication device (20) includes a wireless communication device configured to wirelessly receive the control data from the external device (“wireless telemetry” para [0037]).
With regard to claim 11, Robinson discloses a housing (structure at box at 100 in Fig 4) connected to the valve spool (162; valve is shown inside 100; *para [0101] states “valve 162 for use in IMD 12, 100, 400”. Thus, valve 162 can be used in place of valve 122 in IMD 100 in Fig 4 ), wherein the housing (box at 100) includes the rotary actuator (connected to processor), the communication device (20), and the processor (176) (because valve of 7A can be used in 100 at Fig 4, para [0101]).
With regard to claim 12, Robinson discloses that the housing (box at 100) further includes a memory (104), a power source (118), and a user feedback device (“alarm” para [0132]).
With regard to claim 14, Robinson discloses that the input port (160) is removably connected to a fluid output of a fluid reservoir (when syringe tip is insert and then removed = “removably connected”) (fluid reservoir within syringe for percutaneous delivery; paras [0025] [0101]).
With regard to claim 15, Robinson discloses that the input port (160) is integrated with (“integrated with” is met by insertion of syringe for percutaneous delivery) a fluid output of a fluid reservoir (reservoir within syringe) (paras [0025] [0101]).
With regard to claim 16, Robinson discloses that the fluid reservoir (reservoir within a syringe) includes a syringe (para [0025]), and wherein the input port (160) is integrated with a tip of the syringe (paras [0025] [0101]).
With regard to claim 17, Robinson discloses that the valve spool (162) includes an actuator interface (identified by dashed line extend from an end of 162 leading to 176 in Fig 7A) extending from an end of the valve spool (162), and wherein the actuator interface is configured to interface with a rotary actuator (Para [0102]: “Processor 176 may execute instructions to generate signals that are communicated to an intermediate rotating device (not shown) such as an actuator, solenoid, motor, or the like to impart mechanical energy for rotating valve 176”).
With regard to claim 18, Robinson discloses a system for maintaining multi-lumen patency, comprising: an actuator actuated diverter valve (see figs 7A-7B) including: a valve manifold (body at 150) including an input port (160; para [0101]), a first output port (170), and a second output port (174); and a valve spool (162) extending within the valve manifold (body at 150), wherein the valve spool (162) defines a first valve passageway (164) and a second valve passageway (168), wherein the valve spool (162) is rotatable relative to the valve manifold (body at 150) between a first position (position 164 lined up with 160) in which the input port (160) and the first output port (170) are in fluid communication via the first valve passageway (164) and a second position (position 168 lined up with 160) in which the input port (160) and the second output port (174) are in fluid communication via the second valve passageway (168) (see Figs 7A, 7B and para [0101]); and a rotary actuator (connected to 176; para [0102]: “Processor 176 may execute instructions to generate signals that are communicated to an intermediate rotating device (not shown) such as an actuator, solenoid, motor, or the like to impart mechanical energy for rotating valve 176”) configured to rotate the valve spool (162) relative to the valve manifold (body at 150) between the first position (position with 164 lined up with 160) and the second position (position with 168 lined up with 160); a multi-lumen catheter (paras [0101] [0102] [0035]; valve in Figs 7A-7B used in IMDS 12, 100, 400, para [0101]) including: a first lumen connected to the first output port; and a second lumen connected to the second output port (catheter 18 may be multi-lumen; para [0035]; see Fig 4); and a fluid reservoir connected to the input port (reservoir can be reservoir within syringe or 112/114 in Fig 4).
With regard to claim 19, Robinson discloses that the fluid reservoir includes one of an IV bag, an infusion pump, and a syringe (syringe: paras [0025] [0101] for percutaneous delivery).
With regard to claim 20, Robinson discloses a communication device (20, para [0102]) configured to receive control data from an external computing device (computing device [0037], telemetry 88); and a processor (176) configured to control, based on the control data (para [0102]: “processor 176, e.g., with the aid of instructions stored in memory or commands received from programmer 20”), the rotary actuator (connected to 176; (para [0102]: “Processor 176 may execute instructions to generate signals that are communicated to an intermediate rotating device (not shown) such as an actuator, solenoid, motor, or the like to impart mechanical energy for rotating valve 176”) to rotate the valve spool (162) relative to the valve manifold (body at 150) between the first position (position where 164 aligns with 160) and the second position (position where 168 aligns with 160).
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.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Pat. Pub. No. 2012/0053514 (“Robinson”) in view of U.S. Pat. No. 11,285,258 (“Haase”).
With regard to claim 3, Robinson discloses all the claimed features with the exception of disclosing that when the valve spool (162) is between the first position and the second position, the input port is in fluid communication with each of the first output port and the second output port.
Haase teaches that it is known in the art to provide an actuator actuated valve (38) for an IMD with a catheter (see Figs 1, 2, and 4), similar to that of Robinson and to include that the valve spool (valve 38) when between positions, the input port is in fluid communication with first and second output ports (Haase teaches that output ports/pathways can be partially obstructed, thus having a spool between positions that allows communication between two ports; see col. 8, lines 25-29; see also col. 17, lines 46-48, and Fig 2).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the valve spool of Robinson to permit partial obstruction of ports to allow for communication with two ports, such as taught by Haase, for the purpose of providing fluid flow as desired to a variety of ports.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Pat. Pub. No. 2012/0053514 (“Robinson”) in view of U.S. Pat. Pub. No. 2010/0191106 (“Koyama”).
With regard to claim 13, Robinson discloses all the claimed features with the exception of disclosing a first check valve integrated with the first output port; a second check valve integrated with the second output port.
Koyama teaches that it is known in the art to provide a actuator actuated valve (valve spool 1, actuator 32 with first and second output ports 64, 68) similar to that of Robinson, to include a check valve 71 integrated with (i.e., connected with) a first output port 64 and a second check valve 73 integrated with (i.e., connected with) a second output port 68 (“check valves 71 to 73” para [0076]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to utilize a check valve integrated with each of the first and second output ports, such as taught by Koyama, in the valve of Robinson, for the purpose of preventing unwanted backflow through the output ports (see para [0144] of Koyama).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Pat. Pub. No. 2011/0071390 discloses a rotary valve spool with first and second valve passageways.
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/JESSICA CAHILL/Primary Examiner, Art Unit 3753