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
This office action is responsive to the amendment filed on 01/12/2026. As directed by the amendment: claims 1-3, 11-12, 17, and 19-20 have been amended, claim 10 has been cancelled, and claim 21 has been added. Thus, claims 1-9 and 11-21 are presently pending in this application, with no claims being withdrawn from consideration. Applicant’s amendments to the claims, specification, and drawings have overcome each and every objection and 112 rejection, barring the two drawing objections discussed below, as set forth in the Non-Final Office Action mailed on 10/17/2025.
Response to Arguments
Applicant’s arguments see p.13-14 of “Remarks”, filed 01/12/2026, with respect to the rejection(s) of claim 2 of record under 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments see p.15 of “Remarks”, filed 01/12/2026, with respect to the rejection(s) of claim 10 of record under 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show at least para. 0114-0115 as described in the specification.
For example. Para. 0114 states “when the plunger 120 of the first pumping syringe 114 moves to expel the medical fluid form the barrel 118 towards the patient, as shown in Fig. 4C” which should recite “as shown in Fig. 4D”.
For example. Para. 0115 states “when the plunger 120 of the second pumping syringe 116 moves to expel the medical fluid from the barrel 118 towards the patient, as shown in Fig. 4D” which should recite “as shown in Fig. 4C”.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 20 is 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.
Regarding claim 20, the limitation “sealing the reservoir within the enclosure of the pump” is new matter. The disclosure does not have support for a method including a step of sealing the reservoir within the enclosure of the pump. The specification discloses in para. 0102 that the system may comprise an enclosure 78 containing the entire reservoir 12 or at least a portion thereof. Para. 0121 and Fig. 5 disclose the method having a step 210 for attaching the pump 10 to a reservoir, but there is no step reciting sealing the reservoir within the enclosure. The specification nor the drawings provide support for this limitation. Given that there is no support in the disclosure for the newly added claim limitation, it is new matter.
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.
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) 1-5, 7, 9, 11-12, 14-19, and 21 rejected under 35 U.S.C. 103 unpatentable over Teague (U.S Patent Pub. No. 20170021951 A1) in view of Tuin (U.S Patent Pub. No. 20240325634 A1) in view of Chong (U.S Patent Pub. No. 20130345633 A1).
Regarding claim 1, Teague discloses (Claim 1) a pump (400 in Fig. 9-10) for delivering fluid from a reservoir (470) to the patient (see Fig. 10a-10b and para. 0027), comprising: at least one pumping syringe (420a, 420b) comprising a barrel and a plunger (422a, 422b) movable through the barrel (see Fig. 9 and para. 0066 – syringes 420a and 420b have a barrel structure seen in Fig. 9 similar to barrel 124 seen in Fig. 1); at least one actuator (410 and 412b) for moving the plunger (422a, 422b) through the barrel to draw the fluid from the reservoir (470) into the barrel and to expel the fluid from the barrel towards the patient (see Fig. 9-10 and para. 0064 – motor 410 couples with coupler 412b which couples with grooved portion 412at of plunger 422a to form a first actuator in the form of an electromechanical linear actuator that converts rotational movement from motor 410 to linear movement of the plunger 422, motor 410 and coupler 412b also couples with grooved portion 412bt of plunger 422b to form a second actuator in the same manner described above); at least one inflow valve (426ai, 426bi) between the reservoir (470) and the barrel of the at least one pumping syringe (420a, 420b) that opens when the plunger (422a, 422b) of the at least one pumping syringe (420a, 420b) moves to aspirate the fluid from the reservoir (470) into the barrel of the at least one pumping syringe (420a, 420b, see Fig. 10a-10b and para. 0067); at least one outflow valve (426ao, 426bo) between the barrel of the at least one pumping syringe (420a, 420b) and the patient that opens when the plunger (422a, 422b) moves to expel the fluid from the barrel of the at least one pumping syringe (420a, 420b) towards the patient (see Fig. 10a-10b and para. 0067).
While Teague discloses a dual syringe pump (400) that may be compact (see para. 0072), Teague does not explicitly disclose the pump (400) is (Claim 1) a wearable pump configured to be worn by an ambulatory patient, and comprises an enclosure that contains at least a portion of the at least one pumping syringe and the reservoir.
Tuin discloses a wearable infusion device (1 in Fig. 1) comprising two syringe type pumps (11, 12 in Fig. 2) coupled with a reservoir (2, 3) and configured for drawing fluid into one syringe pump while expelling fluid from the other syringe pump (see Fig. 1, Abstract, para. 0104-0105, and 0110), wherein Tuin teaches (Claim 1) a wearable pump (1 in Fig. 1) configured to be worn by an ambulatory patient (see para. 0001).
Since Teague discloses a fluid supply pump (400) comprising two syringe type pumps (420a, 420b) coupled with a reservoir (470), and Tuin discloses a wearable infusion device (1 in Fig. 1) comprising two syringe type pumps (11, 12 in Fig. 2) coupled with a reservoir (2, 3 in Fig. 1, see Abstract and para. 0104-0105), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid supply pump taught by Teague to be a wearable pump worn by an ambulatory patient as taught by Tuin. Tuin teaches that wearable infusion pumps allow a patient to have free mobility and decreases the need of nursery care over traditional intravenous administration from an infusion pump (see para. 0002).
While Tuin in modified Teague does illustrate the wearable infusion pump (1 in Fig. 1) having some form of housing surrounding the components of the infusion pump as seen in Fig. 1, modified Teague fails to explicitly disclose (Claim 1) an enclosure that contains at least a portion of the at least one pumping syringe and the reservoir.
Chong discloses a wearable infusion device (600 in Fig. 10) comprising at least one pumping syringe (604 in Fig. 10) and a reservoir (602 in Fig. 10, see para. 0055), wherein Chong teaches (Claim 1) an enclosure (606 in Fig. 10) that contains at least a portion of the at least one pumping syringe (604) and the reservoir (602, see para. 0056).
Since modified Teague discloses the dual syringe pump may be a wearable pump configured to be worn by an ambulatory patient, and Chong discloses a wearable infusion pump comprising an enclosure that contains at least one pumping syringe and reservoir, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pump taught by modified Teague to have an enclosure that contains at least a portion of the at least one pumping syringe and the reservoir as taught by Chong as Chong teaches that a housing such as that seen in Fig. 10 encloses and protects the internal components (see para. 0056).
Regarding claim 2, modified Teague discloses the pump of claim 1, as discussed above. In modified Teague, Teague discloses (Claim 2) wherein the fluid comprises at least one of saline, a liquid medication, or a total parenteral nutrition liquid (examiner notes the fluid is a functional limitation and thus the fluid supply pump 400 is capable of being configured of supplying a fluid such as saline, a liquid medication, or a total parenteral nutrition liquid).
Regarding claim 3, modified Teague discloses the pump of claim 1, as discussed above.
While Teague discloses schematic diagrams in Fig. 10a-10b schematically showing couplings of the inflow valves (426ai, 426bi) with the reservoir and the outflow valves (426ao, 426bo) with the patient line (490), Teague is silent to (Claim 3) further comprising a valve set contained in the enclosure and connected to the at least one pumping syringe and to the reservoir, the valve set comprising: a housing enclosing at least one fluid chamber; at least one inflow port, wherein the fluid passes from the reservoir to the at least one fluid chamber through the at least one inflow port; at least one syringe port fluidly connected to an interior of the barrel of the at least one pumping syringe, wherein the fluid passes between the interior of the barrel and the at least one fluid chamber through the at least one syringe port; and at least one outflow port, wherein the fluid passes from the at least one fluid chamber to the patient through the at least one outflow port.
Tuin discloses a wearable infusion device (1 in Fig. 1) comprising two syringe type pumps (11, 12 in Fig. 2) coupled with a reservoir (2, 3) and configured for drawing fluid into one syringe pump while expelling fluid from the other syringe pump (see Fig. 1, Abstract, para. 0104-0105, and 0110), wherein Tuin teaches (Claim 3) further comprising a valve set (10, 20 in Fig. 2) connected to the at least one pumping syringe (11, 12 in Fig. 2) and to the reservoir (2, 3 in Fig. 1, see para. 0110), the valve set (10, 20) comprising: a housing enclosing at least one fluid chamber (see Fig. 2 and para. 0104 – the valve set is comprised of the fluid path structures 10 and 20 which as illustrated comprise conduits interpreted as the housing which enclose fluid chambers); at least one inflow port (73 in Fig. 2, see para. 0105), wherein the fluid passes from the reservoir (2,3) to the at least one fluid chamber through the at least one inflow port (73, see para. 0105 – port 73 connects the fluid chambers defined by the conduits of fluid path structures 10 and 20 to the reservoirs 2, 3); at least one syringe port (71, 72 in Fig. 2) fluidly connected to an interior (41, 42 in Fig. 2-3) of the barrel (21, 22 in Fig. 2-3) of the at least one pumping syringe (11, 12 in Fig. 2-3, see para. 0094-0095, 0110, and 0112); and at least one outflow port (81, 82 in Fig. 2-3, see para. 0097-0098), wherein the fluid passes from the at least one fluid chamber to the patient through the at least one outflow port (81, 82, see Fig. 2-3, para. 0110, and 0112– fluid flows through chamber defined by conduits of structures 10 and 20 to the patient through outflow ports 81 and 82).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid supply pump taught by modified Teague to incorporate the valve set of Tuin. In combination, the schematic diagram of Teague in Fig. 10a-10b showing only generic connections between the reservoir (470), patient line (490), valves, (426ai, 426bi, 426ao, 426bo), and syringes (420a, 420b) would be replaced with a valve set (10, 20) of Tuin having a housing providing at least one inflow port between the reservoir (470) and the inlet valves (426ai, 426ab), at least one outflow port between the outflow valves (426ao, 426bo) and the patient line (490), and at least one fluid chamber extending along the fluid pathways therebetween. As taught by Tuin, incorporating enclosed fluid conduits forming the valve set allows for valves and bubble detectors to be placed along the fluid pathways to selectively control and monitor the infusion process (see para. 0034-0035).
Chong discloses a wearable infusion pump (600) comprising a valve assembly (614 in Fig. 10) between the reservoir (602) and the at least one pumping syringe (604 in Fig. 10 and para. 0057), wherein Chong teaches (Claim 3) a valve set (614 in Fig. 10) contained in the enclosure (606 in Fig. 10, see para. 0056-0057).
Since modified Teague discloses the dual syringe pump with the valve set of Tuin which may be a wearable pump configured to be worn by an ambulatory patient, and Chong discloses a wearable infusion pump comprising an enclosure that contains at least one pumping syringe, reservoir, and a valve set therebetween, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pump taught by modified Teague to have the valve set contained in the enclosure as taught by Chong as Chong teaches that a housing such as that seen in Fig. 10 encloses and protects the internal components (see para. 0056).
Regarding claim 4, modified Teague discloses the pump of claim 1, as discussed above. In modified Teague, Teague discloses (Claim 4) wherein the at least one inflow valve (426ai, 426bi) comprises an inflow check valve that automatically opens as the fluid is aspirated into the barrel of the at least one pumping syringe (420a, 420b, see Fig. 10a-10b and para. 0060 and 0067 – examiner notes the inflow valves 426ai and 426bi function as check valves as they only open when the pressure in their respective syringe is low thus indicating aspiration), and wherein the at least one outflow valve (426ao, 426bo) comprises an outflow check valve that automatically opens when the fluid is expelled from the barrel of the at least one pumping syringe (420a, 420b, see Fig. 10a-10b, para. 0060, and 0067 – examiner notes the outflow valves 426ao and 426bo function as check valves as they only open when the pressure in their respective syringe is high thus indicating injection).
Regarding claim 5, modified Teague discloses the pump of claim 4, as discussed above. In modified Teague, Teague discloses (Claim 5) wherein a cracking pressure of the inflow check valve and/or the outflow check valve is greater than atmospheric pressure to prevent siphoning of the fluid from the reservoir (470) through the inflow check valve and the outflow check valve (see Fig. 10a-10b, para. 0060, and 0067 – inflow valves 426ai, 426bi and outflow valves 426ao, 426bo operate as check valves that are closed until a cracking pressure from the syringes 420a, 420b opens them, thus indicating that their cracking pressure is greater than the atmospheric pressure).
Regarding claim 7, modified Teague discloses the pump of claim 1, as discussed above. In modified Teague, Teague discloses (Claim 7) further comprising a pump controller (460) electrically coupled to the at least one actuator (410 and 412b) configured to cause the at least one actuator (410 and 412b) to repeatedly move the plunger (422a, 422b) through the barrel of the at least one pumping syringe (420a, 420b) at a predetermined rate (see Fig. 10a-10b and para. 0065).
Regarding claim 9, modified Teague discloses the pump of claim 7, as discussed above. In modified Teague, Teague discloses (Claim 9) comprising at least one position sensor (412a) for detecting a position of the plunger (422a, 422b) within the barrel (see Fig. 10a-10b and para. 0065), wherein the pump controller (460) is configured to cause the at least one actuator (410 and 412b) to change direction of the plunger (422a, 422b) based on information detected by the at least one position sensor (412a, see para. 0053, 0065, and 0069).
Regarding claim 11, modified Teague discloses the pump of claim 1, as discussed above.
In modified Teague, Teague discloses (Claim 11) the reservoir (470), the at least one inflow valve (426ai, 426bi), the at least one outflow valve (426ao, 426bo), the at least one pumping syringe (420a, 420b), and the at least one actuator (410 and 412b).
However, modified Teague fails to disclose (Claim 11) wherein the reservoir is removable from the at least one inflow valve and the at least one outflow valve allowing the reservoir to be replaced while the at least one inflow valve is closed and fluid remains in the at least one pumping syringe and without ceasing operation of the at least one actuator and the at least one pumping syringe.
Tuin discloses a wearable infusion device (1 in Fig. 1) comprising two syringe type pumps (11, 12 in Fig. 2) coupled with a reservoir (2, 3) and configured for drawing fluid into one syringe pump while expelling fluid from the other syringe pump (see Fig. 1, Abstract, para. 0104-0105, and 0110), wherein the valve set of Tuin comprises a reservoir selector valve (53) for selectively removing the connection between either the first reservoir (2) or the second reservoir (3, see para. 0105). Thus, Tuin teaches (Claim 11) wherein the reservoir (2,3) is removable from the at least one inflow valve (inflow of 51, 52) and the at least one outflow valve (outflow of 51, 52) allowing the reservoir (2, 3) to be replaced while the at least one inflow valve (inflow of 51, 52) is closed and fluid remains in the at least one pumping syringe (11, 12) and without ceasing operation of the at least one actuator (31, 32) and the at least one pumping syringe (11, 12, see Fig. 1-3 and para. 0105-0108, 0111, and 0113 – the selector valve 53 can be operated by the controller 8 to selectively remove the reservoirs 2 or 3 from the fluid path including both valves 51 and 52 if the reservoir in use is empty while the inflow valve of the syringe aspirating fluid form the reservoir is closed and the outflow valve of the other syringe remains open for continuing expelling the fluid within said syringe).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pump taught by modified Teague to have a removable reservoir allowing the reservoir to be replaced without ceasing operation of the at least one actuator and the at least one pumping syringe as taught by Tuin. Tuin discloses that if the reservoir in use is detected to be empty, then the controller (8) will control the selector valve (53) to remove said reservoir from use and replace it with another reservoir which provides the important advantage that the intake of air or gas bubble from the empty reservoir is prevented while at the same time not interrupting infusion therapy (see para. 0111 and 0113). In combination, modified Teague would be modified to have a selector valve which allows for the fluid path to the reservoir to be selectively closed to allow for replacement of the reservoir while the pump is still operational.
Regarding claim 12, modified Teague discloses the pump of claim 1, as discussed above. In modified Teague, Teague discloses (Claim 12) wherein the at least one pumping syringe (420a, 420b) comprises a first pumping syringe (420a) and a second pumping syringe (420b), and wherein the at least one actuator (410 and 412b) comprises a first actuator that moves the plunger (422a) of the first pumping syringe (420a) and a second actuator that moves the plunger (422b) of the second pumping syringe (420b, see Fig. 9-10 and para. 0064 – motor 410 couples with coupler 412b which couples with grooved portion 412at of plunger 422a to form a first actuator in the form of an electromechanical linear actuator that converts rotational movement from motor 410 to linear movement of the plunger 422, motor 410 and coupler 412b also couples with grooved portion 412bt of plunger 422b to form a second actuator in the same manner described above).
In modified Teague, Tuin discloses that a dual syringe pump (1) is a wearable pump, and further in modified Teague, Chong discloses that wearable pump (600) should have an enclosure (606 in Fig. 10) to enclose and protect all internal components. Thus, in combination, modified Teague discloses (Claim 12) that the first pumping syringe (420a) and second pumping syringe (420b) each are contained in the enclosure.
Regarding claim 14, modified Teague discloses the pump of claim 12, as discussed above. In modified Teague, Teague discloses (Claim 14) wherein the fluid expelled from the first pumping syringe (420a) and the fluid expelled from the second pumping syringe (420b) pass to the patient through a common patient line (490, see Fig. 10a-10b and para. 0069).
Regarding claim 15, modified Teague discloses the pump of claim 12, as discussed above. In modified Teague, Teague discloses (Claim 15) wherein the at least one inflow valve (426ai, 426bi) comprises: a first inflow valve (426ai) between the reservoir (470) and the barrel of the first pumping syringe (420a) that opens when the plunger (422a) of the first pumping syringe (420a) moves to aspirate the fluid from the reservoir (470) into the barrel of the first pumping syringe (420a, see Fig. 10, para. 0060, and para. 0067); and a second inflow valve (426bi) between the reservoir (470) and the barrel of the second pumping syringe (420b) that opens when the plunger (422b) of the second pumping syringe (420b) moves to aspirate the fluid from the reservoir (470) into the barrel of the second pumping syringe (420b, see Fig. 10a, para. 0060, and para. 0067), wherein the first inflow valve (426ai) closes when the plunger (422a) of the first pumping syringe (420a) moves to expel the fluid from the barrel of the first pumping syringe (420a, see Fig. 10a, para. 0060, and 0067), and the second inflow valve (426bi) closes when the plunger (422b) of the second pumping syringe (420b) moves to expel the fluid from the barrel of the second pumping syringe (420b, see Fig. 10b, para. 0060, and para. 0067).
Regarding claim 16, modified Teague discloses the pump of claim 12, as discussed above. In modified Teague, Teague discloses (Claim 16) wherein the at least one outflow valve (426ao, 426bo) comprises a first outflow valve (426ao) between the barrel of the first pumping syringe (420a) and the patient that opens when the plunger (422a) of the first pumping syringe (420a) moves to expel the fluid from the barrel towards the patient (see Fig. 10a, para. 0060, and para. 0067), and a second outflow valve (426bo) between the barrel of the second pumping syringe (420b) and the patient that opens when the plunger (422b) of the second pumping syringe (420b) moves to expel the fluid from the barrel towards the patient (see Fig. 10b, para. 0060, and para. 0067).
Regarding claim 17, modified Teague discloses the pump of claim 12, as discussed above.
While Teague discloses schematic diagrams in Fig. 10a-10b schematically showing couplings of the inflow valves (426ai, 426bi) with the reservoir and the outflow valves (426ao, 426bo) with the patient line (490), Teague is silent to (Claim 17) further comprising a valve set contained in the enclosure and connected to the first pumping syringe, the second pumping syringe, and the reservoir, the valve set comprising: a housing enclosing at least one fluid chamber; an inflow port, wherein the fluid passes from the reservoir to the at least one fluid chamber through the inflow port; a first syringe port fluidly connected to an interior of the barrel of the first pumping syringe, wherein the fluid passes between the interior of the barrel of the first pumping syringe and the at least one fluid chamber through the first syringe port; a second syringe port fluidly connected to an interior of the barrel of the second pumping syringe, wherein the fluid passes between the interior of the barrel of the second pumping syringe and the at least one fluid chamber through the second syringe port; a first outflow port, wherein the fluid passes from the barrel of the first pumping syringe toward the patient through the first outflow port; and a second outflow port, wherein the fluid passes from the barrel of the second pumping syringe toward the patient through the second outflow port.
Tuin discloses a wearable infusion device (1 in Fig. 1) comprising two syringe type pumps (11, 12 in Fig. 2) coupled with a reservoir (2, 3) and configured for drawing fluid into one syringe pump while expelling fluid from the other syringe pump (see Fig. 1, Abstract, para. 0104-0105, and 0110), wherein Tuin teaches (Claim 17) further comprising a valve set (10, 20 in Fig. 2) connected to the first pumping syringe (11 in Fig. 2), the second pumping syringe (12, in Fig. 2), and the reservoir (2, 3 in Fig. 1, see para. 0110), the valve set (10, 20) comprising: a housing enclosing at least one fluid chamber (see Fig. 2 and para. 0104 – the valve set is comprised of the fluid path structures 10 and 20 which as illustrated comprise conduits interpreted as the housing which enclose fluid pathways together interpreted at the at least one fluid chamber); at least one inflow port (73 in Fig. 2, see para. 0105), wherein the fluid passes from the reservoir (2,3) to the at least one fluid chamber through the at least one inflow port (73, see para. 0105 – port 73 connects the fluid chambers defined by the conduits of fluid path structures 10 and 20 to the reservoirs 2, 3); a first syringe port (71 in Fig. 2) fluidly connected to an interior (41 in Fig. 2) of the barrel (21 in Fig. 2) of the first pumping syringe (11) and the at least one fluid chamber through the first syringe port (71, see Fig. 2 and para. 0094-0095, 0110, and 0112); a second syringe port (72 in Fig. 3) fluidly connected to an interior (42 in Fig. 3) of the barrel (22 in Fig. 3) of the second pumping syringe (12 in Fig. 3) toward the patient through the first outflow port (81 in Fig. 2, see para. 0094-0095, 0110, and 0112); a first outflow port (81 in Fig. 3, see para. 0097-0098), wherein the fluid passes from the barrel (21 in Fig. 3) of the first pumping syringe (11 in Fig. 3) at least one fluid chamber to the patient through the first outflow port (81, 82, see Fig. 3, para. 0110, and 0112 – fluid flows through chamber defined by conduits of structures 10 and 20 to the patient through the outflow port 81); and a second outflow port (82 in Fig. 2, see para. 0097-0098), wherein the fluid passes from the barrel (22 in Fig. 2) of the second pumping syringe (12 in Fig. 2) at least one fluid chamber to the patient through the second outflow port (82, see Fig. 2, para. 0110, and 0112 – fluid flows through chamber defined by conduits of structures 10 and 20 to the patient through the outflow port 82)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid supply pump taught by modified Teague to incorporate the valve set of Tuin. In combination, the schematic diagram of Teague in Fig. 10a-10b showing only generic connections between the reservoir (470), patient line (490), valves, (426ai, 426bi, 426ao, 426bo), and syringes (420a, 420b) would be replaced with a valve set (80) having a housing providing an inflow port between the reservoir (470) and the inlet valves (426ai, 426ab), first and second syringe ports fluidly communication with each barrel of the syringes (420a, 420b), and first and second outflow ports fluidly communicating the barrel of each of the syringes (420a, 420b) and the patient line (490). As taught by Tuin, incorporating enclosed fluid conduits forming the valve set allows for valves and bubble detectors to be placed along the fluid pathways to selectively control and monitor the infusion process (see para. 0034-0035).
Chong discloses a wearable infusion pump (600) comprising a valve assembly (614 in Fig. 10) between the reservoir (602) and the at least one pumping syringe (604 in Fig. 10 and para. 0057), wherein Chong teaches (Claim 17) a valve set (614 in Fig. 10) contained in the enclosure (606 in Fig. 10, see para. 0056-0057).
Since modified Teague discloses the dual syringe pump with the valve set of Tuin which may be a wearable pump configured to be worn by an ambulatory patient, and Chong discloses a wearable infusion pump comprising an enclosure that contains at least one pumping syringe, reservoir, and a valve set therebetween, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pump taught by modified Teague to have the valve set contained in the enclosure as taught by Chong as Chong teaches that a housing such as that seen in Fig. 10 encloses and protects the internal components (see para. 0056).
Regarding claim 18, modified Teague discloses the pump of claim 12, as discussed above. In modified Teague, Teague discloses (Claim 18) further comprising a pump controller (460) electronically coupled to the first actuator (410 and 412b) and the second actuator (410 and 412b, see Fig. 10a-10b and para. 0053 and 0064-0065), configured to cause the plunger (422a, 422b) of the first pumping syringe (420a) and the second pumping syringe (420b) to move substantially simultaneously in opposite directions (see para. 0064), which causes fluid to be expelled from the pump (400) toward the patient as a continuous or substantially continuous flow (see para. 0069).
Regarding claim 19 modified Teague discloses the pump of claim 1, as discussed above. In modified Teague, Teague discloses (Claim 19) a fluid infusion system (see Fig. 10a-10b), comprising: the pump (400), the reservoir (470) fluidly connected to the pump (400, see para. 0068), wherein the reservoir (470) contains the fluid to be delivered to the patient (see para. 0068); and at least one patient line (490) fluidly connected to the barrel of the at least one pumping syringe (420a, 420b) at a position distal to the at least one outflow valve (426ao, 426bo, see Fig. 10a-10b for distal position and para. 0069), wherein the patient line (490) is configured to deliver the fluid from the pump (400) to vasculature of the patient (see para. 0069 – fluid supply port 490 is capable of being configured to deliver fluid form pump 400 to a patient’s vasculature).
In modified Teague, Chong discloses the enclosure (606 in Fig. 10), wherein the reservoir (602 in Fig. 10) is contained in the enclosure (606 in Fig. 10) of the pump (600, see Fig. 10 and para. 0055-0056).
However, modified Teague fails to disclose (Claim 19) wherein the patient line extends from the enclosure of the pump.
Chong discloses the wearable pump (600) which comprises enclosure (606), wherein the pump (600) may comprise a fluid delivery conduit interpreted as the patient line (see para. 0057), wherein the patient line may be implemented as seen in the embodiments of Fig. 1 and Fig. 3 where the patient line (122 in Fig. 2) extends from the enclosure (102 in Fig. 1-2) of the pump (100 in Fig. 1-2, see para. 0034), or in Fig. 3 where the patient line (201 in Fig. 3) extends from the enclosure (202 in Fig. 3) of the pump (300, see Fig. 3 and para. 0035).
Since modified Teague discloses the dual syringe pump may be a wearable pump configured to be worn by an ambulatory patient, and Chong discloses a wearable infusion pump comprising an enclosure that contains at least one pumping syringe and reservoir, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pump taught by modified Teague to have the patient line extend from the enclosure of the pump as taught by Chong. Chong discloses that at least a portion of the patient line must be external to the enclosure to allow for fluid communication with the patient (see para. 0034).
Regarding claim 21, modified Teague discloses the pump of claim 1, as discussed above. In modified Teague, Chong discloses (Claim 21) wherein the reservoir (602 in Fig. 10) is entirely contained within the enclosure (606 in Fig. 10, see para. 0055-0056).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Teague in view Tuin in view of Chong as applied to claim 1 above, and further in view of Nakanishi et al. (W.O Patent Pub. No. 2012114417 A1, “Nakanishi”).
Regarding claim 6, modified Teague discloses the pump of claim 1, as discussed above.
However, modified Teague is silent to (Claim 6) wherein a volume of the barrel of the at least one pumping syringe is from about 3 mL to about 5 mL.
Nakanishi discloses a syringe pump (1) comprising a syringe (200) for infusing fluid to a patient (see Fig. 1, Fig. 3, and para. 014), wherein Nakanishi teaches (Claim 6) wherein a volume of the barrel of the at least one pumping syringe (200) is from about 3 mL to about 5 mL (see para. 018 – the syringe barrel may have a volume of 2.5 mL or 5 mL).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the undisclosed size syringe taught by modified Teague to specifically have a volume from about 3 mL to about 5 mL as taught by Nakanishi as claimed by known methods to yield predictable results. One of ordinary skill in the art could have used a syringe with a volume of about 3 mL to about 5 mL in the device of Teague by known methods to achieve predictable results.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Teague in view Tuin in view of Chong as applied to claim 7 above, and further in view of Hanson et al. (U.S Patent Pub. No. 20110160666 A1, “Hanson”).
Regarding claim 8, modified Teague discloses the pump of claim 7, as discussed above.
However, modified Teague fails to disclose (Claim 8) wherein the pump controller is configured to monitor a torque exerted by the at least one actuator on the plunger to detect when the plunger approaches an end of stroke position, and to change direction of the plunger when the torque increases above a threshold.
Hanson discloses a wearable infusion pump (12 in Fig. 3) comprising a syringe type pump having a barrel and plunger (see Fig. 3 and para. 0096), wherein the pump (12) further comprises a pump controller (422) communicating with a force sensor (140) which measures the torque exerted by a linkage mechanism (170) driven by the drive mechanism (180) on the plunger (160). Hanson teaches (Claim 8) the pump controller (422) configured to monitor a torque exerted by the at least one actuator (170 and 180) on the plunger (160) to detect when the plunger (160) approaches an end of stroke position, and to change direction of the plunger (160) when the torque increases above a threshold (see Fig. 15-16 and para. -0137-139 and 0141 – controller 422 can detect when the torque on the plunger 160 is above a threshold caused by a condition preventing the plunger 160 from moving within the reservoir 168 such as an end of stroke position, the controller 422 then may alter the direction of the motor 184 to move the plunger 160 in an opposite direction).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pump taught by modified Teague to incorporate a force sensor communicating with the controller as taught by Hanson. In combination, the actuator (410 and 412b) comprising the coupler (412b) which exerts a rotational force on the plungers (422a, 422b) would thus have a force sensor measuring the torque exerted on the plungers (422a, 422b) and the controller (460) would receive signals that would indicate an end of stroke position and control the movement of the plungers (422a, 422b), accordingly. Hanson teaches that such a force sensor allows for indicating the presence of an occlusion or another condition preventing the plunger arm from moving within the reservoir (see para. 0137).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Teague in view of Tuin in view of Chong as applied to claim 12 above, and further in view of Wang et al (CN Patent No. 110585517 A1, “Wang”).
Regarding claim 13, modified Teague discloses the pump of claim 12, as discussed above.
While modified Teague discloses the syringes (420a, 420b) schematically coupled with separate lines to the fluid supply conduit (490, see Fig.9 ), modified Teague does not explicitly disclose (Claim 13) wherein the fluid expelled from the first pumping syringe passes to a first patient line and fluid expelled from the second pumping syringe passes to a second patient line that is separate from the first patient line.
Wang discloses an infusion set (see Fig. 1) comprising two pumping syringes connected to a reservoir (2) for delivering fluid through puncture (1) to the patient (see Fig. 1 and para. 017). Wang teaches (Claim 13) wherein the fluid expelled from the first pumping syringe passes to a first patient line and fluid expelled from the second pumping syringe passes to a second patient line that is separate from the first patient line (see annotated Wang drawing 1 below and para. 017).
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Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patient line taught by modified Teague to incorporate a first and second patient line as taught Wang as claimed by known methods to yield predictable results. In combination, Teague would incorporate a first and second patient line extending from each outflow valve (426ao, 426bo) and connected to the supply conduit (490) in a similar manner as those line annotated above and connected to the puncture (1) as taught by Wang. One of ordinary skill in the art could have modified the schematically shown pathways in Fig. 9 of Teague to be first and second patient lines as taught by Wang according to known methods in infusion sets to yield predictable results.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Teague in view of Tuin in view of Chong as applied to claim 1 above, and further in view of Morton et al. (U.S Patent Pub. No. 20240207509 A1, “Morton”).
Regarding claim 20, modified Teague discloses the pump of claim 1, as discussed above. In modified Teague, Teague discloses the limitations of (Claim 20) a method for fluid infusion, the method comprising: attaching the pump (400) to the reservoir (470, see para. 0058 and 0068), such that the reservoir (470) is in fluid communication with the barrel of the at least one pumping syringe (420a, 420b, see Fig. 10a-10b and para. 0068); placing the pump (400) in fluid communication with a subject (see para. 0069); and causing the at least one actuator (410 and 412b) of the pump (400) to repeatedly move the plunger (422a, 422b) through the barrel of the at least one pumping syringe (420a, 420b) thereby causing the fluid to pass from the reservoir (470) into the barrel of the at least one pumping syringe (420a, 420b) and from the barrel of the at least one pumping syringe (420a, 420b) to the patient (see para. 0069).
In modified Teague, Chong discloses (Claim 20) sealing the reservoir (602 in Fig. 10) within the enclosure (606) of the pump (600 in Fig. 10, see para. 0056).
However, Teague fails to disclose that the fluid supply device is for fluid infusion to a patient, wherein the method comprises placing the pump in fluid communication with the vasculature of the patient.
Morton discloses a fluid injector apparatus (2000) comprising syringe-type pumps (10A,10B) coupled to reservoirs (19A,19B) to execute filling and injection operations (see Fig. 1 and para. 0142), wherein Morton teaches (Claim 20) a method for fluid infusion to a patient, the method comprising: placing the pump (2000) in fluid communication with the vasculature of the patient (see para. 0139).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid supply device taught by Teague to be placed in fluid communication with a patient’s vasculature for a method of fluid infusion as taught by Morton as claimed by known methods to yield predictable results. This modification is motivated as it is advantageous to have a fluid supply device that can perform filling and injection operations such as saline, contrast solution, or other medical fluids in a continuous manner to a patient’s vasculature as taught by Morton (see para. 0003 and 0139). Further, one of ordinary skill in the art could have modified the fluid supply device of Teague to be in fluid communication with a patient’s vasculature as taught by Morton as claimed by known methods to yield predictable results.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783