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 .
Acknowledgment
The applicant file a remark on 2/25/2026 without any amendment to claims.
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(s) 19-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. ( US. 20100168535A1) (“Robinson”) in view of Williams et al. (US 20070083152 A1) (“Williams”) and further in view of Moubayed et al. (US. 20080071210A1) (“Moubayed”).
Re claim 19, Robinson discloses a method (Fig. 21, abstract, ¶0144) to concurrently deliver a solution from a total parental nutrition (“TPN”) solution from a TPN source container (fluid such as parental nutrition and saline see ¶0079 which similar to TPN as disclosed in ¶0025 of the current application ), and an insulin solution from an insulin source container that is separate from the TPN source container (calibration solution container can has an insulin ¶0079), the method comprising: providing a fluid administration set having a primary line (line from the saline to the variable valve, Fig. 21), a secondary line (line from calibration solution to the variable valve, Fig. 21), a common outlet line (line after the pump to the analyte sensor, Fig. 21), and a first chamber located between and in fluid communication with the primary line, the secondary line and the common outlet line (chamber from variable valve and include variable valve and to the pump and include the pump ¶0144 and ¶0018); connecting the primary line to the TPN source container (Fig. 21, ¶0144); connecting the secondary line to the insulin source container (Fig. 21, ¶0144); selectively allowing the primary line to feed TPN solution from the primary line to the first chamber (¶0144, when a percentage of TPN ); selectively allowing the secondary line to feed insulin solution to the first chamber (¶0144 when a percentage the insulin); mixing the TPN solution and the insulin solution in the first chamber to generate an infusion mixture before the common outlet line (mixing at the variable chamber ¶0144); driving with a positive displacement pumping mechanism the TPN solution from the first chamber through the common outlet line at a TPN dose rate (¶0016, ¶0144); concurrently with said driving the TPN solution, driving with the positive displacement pumping mechanism the insulin solution from the first chamber through the common outlet line at an insulin dose rate (¶0018, ¶0144); varying at least one of the TPN dose rate and the insulin dose rate to vary a ratio of TPN solution to insulin solution in the infusion mixture (the variable valve can control the mixing, ¶0144), and further it discloses a control system (¶0080, microprocessor and display), but it fails to discloses providing on a user interface, a plurality of user selectable modes for concurrent TPN and insulin infusion; wherein the user interface includes a first portion visualizing the plurality of user selectable modes for infusion of TPN and a second portion adjacent to the first portion visualizing concurrent infusion of insulin; and varying step according to one of the plurality of user selectable modes, wherein the plurality of user selectable modes comprised a predefined profiled a predefined profiled including a continues phase, taper phase, and keep vein open phase.
However, Williams discloses mixing concurrently fluids method (¶0004) and wherein the control panel (Fig. 1-15, ¶0059) is displaying planned values of the first fluid (Fig. 10. S, ¶0061) dose rate (¶0060) and the second fluid dose rate (fluid C, ¶0060) as a function of time on a Infusion Plot (Fig. 10), and providing on a user interface (Fig. 1, ¶0059), a plurality of user selectable modes for first fluid and second fluid infusion (15, first fluid only infused mode, second fluid only infused mode, concurrently with specific ratio mode ¶0077 ); wherein the user interface includes a first portion visualizing the plurality of user selectable modes for infusion of TPN (Fig. 1, Fig. 15, back portion in Fig. 15) and a second portion adjacent to the first portion visualizing concurrent infusion of insulin (1502 that can be similar to Fig. 10 has the concurrent infusion) ; and varying step according to one of the plurality of user selectable modes (¶0059, ¶0077, Fig. 10).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify method of Robinson to include a user interface as taught by Williams so that the method comprises a step of providing on a user interface, a plurality of user selectable modes for concurrent TPN and insulin infusion; wherein the user interface includes a first portion visualizing the plurality of user selectable modes for infusion of TPN and a second portion adjacent to the first portion visualizing concurrent infusion of insulin; and varying step according to one of the plurality of user selectable modes for the purpose permitting a graphical visualization to the user for the proper selection or changing the flows (Williams, ¶0060).
The modified Robinson fails to disclose wherein the plurality of user selectable modes comprised a predefined profiled including a continues phase, taper phase, and keep vein open phase.
However, Moubayed discloses a medical delivery device (Figs. 1-11, the device is delivering the total parental nutrition ¶0095 using a programable infusion pump, ¶0007 that store specific protocols ¶0010) and wherein a plurality of injection can be a user selectable modes comprised a predefined profiled (¶0011, Fig. 11, ¶0090) including a continues phase (Fig.3, ¶0047), taper phase (up ramp infusion, ¶0094, ¶0096), and keep vein open phase (KVO infusion, ¶0094, ¶0096).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify method of Robinson so that the plurality of user selectable modes comprised a predefined profiled including a continues phase, taper phase, and keep vein open phase as taught by Moubayed for the purpose of using quickly and conveniently stored injection setting in total parental nutrition (Moubayed., ¶0041, ¶0096).
Re claim 20, Robinson discloses wherein the varying of the ratio comprises ramping the TPN dose rate from zero to a continuous phase TPN dose rate during a user selectable duration (¶0144, wherein the variable valve can be selected to pump 100 % of TPN).
Re claim 21, Robinson discloses wherein the varying of the ratio comprises maintaining the TPN dose rate at a continuous phase TPN dose rate and maintaining the insulin dose rate at a selected fraction of the continuous phase TPN dose rate (¶0144, wherein the variable valve can be selected to pump 80 % of TPN continuously and insulin to be 20%).
Re claim 22, Robinson discloses wherein the varying of the ratio comprises tapering the TPN dose rate from a continuous phase TPN dose rate to a TPN dose rate of zero during a user selectable duration (¶0144, wherein the variable valve can be selected to pump 100 % of TPN and reduced to be 0% so the selection will be tapered from 100% to 0%).
Re claim 23, Robinson discloses wherein the varying of the ratio comprises decreasing the TPN dose rate from a continuous phase TPN dose rate to a Keep Vein Open (KVO) TPN dose rate during a user selectable duration (the user can select the variable valve can be selected at Keep Vein Open dose see ¶0064).
Re claim 24, Robinson discloses wherein the insulin dose rate is a first insulin dose rate and the method further comprises driving the insulin solution at a second insulin dose rate in response to input of the second insulin dose rate by a user (the user can select the variable valve to keep the glucose level low by selecting different dose than the first selection see ¶0144).
Re claim 25, Robinson discloses monitoring glucose level in a patient (from the analyte sensor which is glucose sensor and adjusting the insulin dose rate in response to the monitored glucose level (¶0127, ¶0144).
Re claim 26, Robinson fails to disclose displaying planned values of the TPN dose rate and the insulin dose rate as a function of time on a TPN/lnsulin Infusion Plot, and displaying an Infusion Progression indicator at a present infusion time on the TPN/lnsulin Infusion Plot.
However, Williams discloses mixing concurrently fluids method (¶0004) and wherein the control panel (Fig. 10, ¶0059) is displaying planned values of the first fluid (S, ¶0061) dose rate (¶0060) and the second fluid dose rate (fluid C, ¶0060) as a function of time on a Infusion Plot (Fig. 10), and displaying an Infusion Progression indicator at a present infusion time on the TPN/lnsulin Infusion Plot (¶0059, Fig. 10).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify method of Robinson to include the displaying method so that displaying planned values of the TPN dose rate and the insulin dose rate as a function of time on a TPN/lnsulin Infusion Plot, and displaying an Infusion Progression indicator at a present infusion time on the TPN/lnsulin Infusion Plot as taught by Williams for the purpose permitting a graphical visualization to the user for the proper selection or changing the flows (Williams, ¶0060).
Re claim 27, Robinson discloses a method (Fig. 21, abstract, ¶0144) to concurrently deliver a total parental nutrition ("TPN") solution (fluid such as parental nutrition and/or saline see ¶0079 which is similar to TPN as disclosed in ¶0025 of the current application, wherein the parental nutrition can include electrolytes) from a TPN source container (saline container, Fig.21) and an insulin solution from an insulin source container that is separate from the TPN source container (calibration solution container can has an insulin ¶0079), the method comprising: providing a fluid administration set having a primary line (line from the saline to the variable valve, Fig. 21), a secondary line (line from calibration solution to the variable valve, Fig. 21), a common outlet line (line after the pump to the analyte sensor, Fig. 21), and a first chamber located between and in fluid communication with the primary line, the secondary line and the common outlet line, wherein the TPN solution and the insulin solution are mixed in the first chamber to generate an infusion mixture before the common outlet line (chamber from variable valve and include variable valve and to the pump and include the pump ¶0144 and ¶0018); driving with a positive displacement pumping mechanism the TPN solution from the first chamber through the common outlet line at a TPN dose rate (Fig. 21, ¶0144, when a percentage of TPN ); concurrently with said driving the TPN solution, driving with the positive displacement pumping mechanism the insulin solution from the mixing chamber through the common outlet line at an insulin dose rate (¶0144, when a percentage of insulin); varying at least one of the TPN dose rate and the insulin dose rate to vary a ratio of TPN solution to insulin solution in the infusion mixture (the variable valve can control the mixing, ¶0144), and further it discloses a control system (¶0080, microprocessor and display), but it fails to discloses providing on a user interface, a plurality of user selectable modes for concurrent TPN and insulin infusion; wherein the user interface includes a first portion visualizing the plurality of user selectable modes for infusion of TPN and a second portion adjacent to the first portion visualizing concurrent infusion of insulin; and varying step according to one of the plurality of user selectable modes and wherein the plurality of user selectable modes comprised a predefined profiled.
However, Williams discloses mixing concurrently fluids method (¶0004) and wherein the control panel (Fig. 1-15, ¶0059) is displaying planned values of the first fluid (Fig. 10, S, ¶0061) dose rate (¶0060) and the second fluid dose rate (fluid C, ¶0060) as a function of time on a Infusion Plot (Fig. 10), and providing on a user interface (Fig. 1, ¶0059), a plurality of user selectable modes for first fluid and second fluid infusion (first fluid only infused mode, second fluid only infused mode, concurrently with specific ratio mode ¶0077); wherein the user interface includes a first portion visualizing the plurality of user selectable modes for infusion of TPN (Fig. 1, Fig. 15, back portion in Fig. 15) and a second portion adjacent to the first portion visualizing concurrent infusion of insulin (1502 that can be similar to Fig. 10 has the concurrent infusion) and varying step according to one of the plurality of user selectable modes (¶0059, ¶0077, Fig. 10).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify method of Robinson to include a user interface as taught by Williams so that the method comprises a step of providing on a user interface, a plurality of user selectable modes for concurrent TPN and insulin infusion; wherein the user interface includes a first portion visualizing the plurality of user selectable modes for infusion of TPN and a second portion adjacent to the first portion visualizing concurrent infusion of insulin; and varying step according to one of the plurality of user selectable modes for the purpose permitting a graphical visualization to the user for the proper selection or changing the flows (Williams, ¶0060).
The modified Robinson fails to disclose wherein the plurality of user selectable modes comprised a predefined profiled including a continues phase, taper phase, and keep vein open phase.
However, Moubayed discloses a medical delivery device (Figs. 1-11, the device is delivering the total parental nutrition ¶0095 using a programable infusion pump, ¶0007 that store specific protocols ¶0010) and wherein a plurality of injection can be a user selectable modes comprised a predefined profiled (¶0011, Fig. 11, ¶0090) including a continues phase (Fig.3, ¶0047), taper phase (up ramp infusion, ¶0094, ¶0096), and keep vein open phase (KVO infusion, ¶0094, ¶0096).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the method of Robinson so that the plurality of user selectable modes comprised a predefined profiled including a continues phase, taper phase, and keep vein open phase as taught by Moubayed for the purpose of using quickly and conveniently stored injection setting in total parental nutrition (Moubayed., ¶0041, ¶0096).
Response to Arguments
Applicant’s arguments, see remarks filed 2/25/2026 with respect the rejection(s) of claim(s) 19, 27 under 103 have been fully considered and are not persuasive.
Applicant argues that Williams fails to disclose that two interfaces with a first portion and a second portion are not adjacent portion as one is hidden behind the user interface 1502. This is found not pervasive as terms “adjacent” can be used to close or near. Also, at least 1502 can appear by pressing or clicking over a portion of main interface which mean for simplicity. In other word, it has an icon to be called in front when needed a window within the main interface (it is a portion of main interface).
Conclusion
THIS ACTION IS MADE FINAL. 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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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