DETAILED ACTION
Response to Amendment
Drawings
The drawings were received on 2/2/2026. These drawings are accepted.
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) 1-9, 13, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Libermann (US 2003/0176833) in view of Wunsch (US 4,512,764).
In regard to claim 1, Libermann discloses a continuous fluid irrigation assembly (10) for use with at least a first irrigation bag (12) operably attached to a first irrigation tubing (16) and a second irrigation bag (14) operably attached to a second irrigation tubing (18), the continuous fluid irrigation assembly comprising: a first bag sensor (26) operably attached to the first irrigation bag (12) (see Fig. 1 and par. [0033]-[0034]), wherein the first bag sensor generates a first output signal based on a volume of fluid within the first irrigation bag (see par. [0034]; “Sensors 26 and 28 can be any suitable sensors for control of the quantity of liquid in the containers. Sensors 26 and 28 are arranged to determine by weight, volume, optical measurement, or in any other fashion, the quantity of fluid remaining in the associated container, or at least whether the respective container coupled to it is full or almost empty.”); a second bag sensor (28) operably attached to the second irrigation bag (14) (see Fig. 1 and par. [0033]-[0034]), wherein the second bag sensor generates a second output signal based on a volume of fluid within the second irrigation bag (see par. [0034]; “Sensors 26 and 28 can be any suitable sensors for control of the quantity of liquid in the containers. Sensors 26 and 28 are arranged to determine by weight, volume, optical measurement, or in any other fashion, the quantity of fluid remaining in the associated container, or at least whether the respective container coupled to it is full or almost empty.”); a first switching device (22), the first switching device including actuatable pinch elements having at least a first position and a second position for selectively restricting flow through the first and the second irrigation tubing (see par. [0033]; “An automatic closure device, here shown as an automatic clamping device 22, 24 is coupled to each fluid outlet conduit 16, 18 so as to permit or prevent fluid flow therethrough. Automatic clamping devices 22 and 24 can be any type of pinch valve which is capable of sufficient providing pressure on the tubing of the fluid outlet conduits to prevent fluid flow therethrough, including, but not limited to electromagnetic, pneumatic, and hydraulic pinch valves.”), wherein in the first position, free flow is allowed through the first irrigation tubing (see par. [0037]), in the second position, free flow is allowed through the second irrigation tubing (see par. [0038]), the first switching device (22) is communicatively coupled to the first and the second bag sensor (via controller 30; see par. [0037]-[0038]), and the first switching device moves from the first position to the second position based on at least one of the first and the second output signal (see par. [0037]-[0038]); and wherein the actuatable pinch elements are externally coupled to outer surfaces of the first and the second irrigation tubing (see par. [0033]).
In regard to claim 1, the examiner’s position is that Libermann has to include a guide tube because the system is shown diagrammatically only and an ordinary skilled artisan would understand that a guide tube for receiving the tubes would be included. However, Liberman doesn’t expressly show tube guides for receiving the first and the second irrigation tubing.
In a similar art, Wunsch discloses a system for dispensing solutions from IV bags (13), the system further comprising IV supply tubes (14) that extend from the bags through a manifold (10), wherein the manifold (10) comprises a plurality of pinch valves (40) for controlling fluid through the tubes. The manifold further includes guide tubes (26, 29) for receiving and guiding the tubes through the manifold.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liberman with the guide tubes of Wunsch because the guide tubes provide a suitable means for accommodating and guiding the tubes through manifold. The ordinary skilled artisan would appreciate that Libermann must have some type of tube accommodation and would recognize that the Wunsch teaching is a suitable choice.
In regard to claim 2, Libermann discloses wherein a microcontroller (30) is communicatively coupled to the first switching device (22), the first bag sensor (26) and the second bag sensor (28); the first and the second output signal are received by the microcontroller; the microcontroller processes at least one of the first and the second output signal; and the microcontroller controls the first switching device to move from the first position to the second position based on the processing (see Fig. 1 and par. [0033]-[0039]).
In regard to claim 3, Libermann discloses wherein the first output signal is sent from the first bag sensor when a weight of the first irrigation bag drops below a level (see par. [0038]).
In regard to claims 4-5, Libermann only discloses first and second bags (12, 14), first and second sensors (26, 28), and first and second switching devices (22, 24). Libermann fails to expressly disclose third and fourth sensors as is recited in claim 4. However, such a modification is only a duplication of parts which is well within the skill of the ordinary artisan. Furthermore, Wunsch shows four bags (13) and multiple switching devices (40) on the manifold (10). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liberman with the additional features if more than two IV bags were desired to be administered to the patient. In further regard to claim 5, Libermann discloses the use of a y-connector (20) after the first and second tubes pass through the switching devices (see Fig. 1).
In regard to claims 6-7, Libermann discloses that all of the switching devices (22, 24) are coupled to the microcontroller (30). The modification to add multiple switching devices would also have them controlled by microcontroller (30).
In regard to claims 8-9, the incorporation of more than two bags, sensors, and switching devices would incorporate a third Y-connector from the third and fourth switching devices.
In regard to claim 13, please see the rejection of claim 1 as the examiner believes all of the limitations are adequately addressed and the scope of claim 33 is substantially similar to that of claim 1.
In regard to claim 32, please see the rejection of claim 1 as the examiner believes all of the limitations are adequately addressed and the scope of claim 33 is substantially similar to that of claim 1.
In regard to claim 33, Libermann discloses wherein the switching device comprises a flow rate module to vary the flow rate through the one of the plurality of tubings where free flow is allowed (see par. [0033]-[0039]; the switching devices 22, 24 are pinch valves which allow for total free flow, modified free flow, and no free flow).
Claim(s) 10-12, 13-16, and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Libermann and Wunsch in further view of Oh et al. (US 2019/0262532; hereafter Oh).
In regard to claim 10, the combination fails to disclose the use of an effluent sensing device.
In a similar art, Oh discloses the assembly wherein the variable switching device is communicatively coupled to an effluent sensing device (fig. 4, 224); and the variable switching device moves to one of the plurality of positions based on a signal generated by the effluent sensing device, thereby varying the flow through the output irrigation tubing ([0087]-[0090]). Oh discloses the assembly wherein the effluent sensing device comprises a blood concentration measuring device (fig. 2, 224; [0087]-[0090]). Oh discloses the assembly wherein the assembly comprises a microcontroller (fig. 8, 332, 334, 336) communicatively coupled to the effluent sensing device and the variable switching device; the effluent sensing device generates the signal based on the blood concentration determined by the blood concentration measuring device ([0087]-[0090]); the signal is processed by a microcontroller ([0109]-[0111]); and the microcontroller controls the variable switching device to move to one of the plurality of positions based on the processing by the microcontroller ([0123]). The Oh system teaches that the system provides a system for determining an abnormality in the fluid flow to the patient (see par. [0090]).
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 combination with the features of Oh in order to a system for determining an abnormality in the fluid flow to the patient.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
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.
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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