DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
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) 1-6, 8 and 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5399166 A to Laing in view of EP 0319273 A1 to Garrison.
Regarding claim 1:
Laing discloses:
An intravenous fluid supply system comprising:
an intravenous fluid supply tube (245; column 10, lines 50-60) in fluid connection with an outlet port (see outlet port A in figure 1 below) of an intravenous fluid supply bag (240; column 10, lines 50-60) containing an intravenous fluid (fluid within bag 240; medical or drug bag as indicated in column 10, lines 50-60),
wherein the intravenous fluid is ejected into the intravenous fluid supply tube (245) upon an application of an applied pressure on the intravenous fluid supply bag (240) (expansion of pressure bag 230 applied to intravenous fluid supply bag 240 results in the ejection of fluid from port A in figure 1 below; column 10, lines 50-60);
a pump (258) fluidly connected to an inlet port (see the inlet port B in figure 1 below) of a pressure bag (230)(column 11, lines 20-30),
wherein the pressure bag (230) is adjacent to the intravenous fluid supply bag (240) (as shown in figure 7), and wherein a fluid is pumped into the inlet port of the pressure bag (230) by the pump (258), such that the applied pressure is applied to the intravenous fluid supply bag (240) (as described above expansion of pressure bag 230 compresses bag 240 and expels fluid out of port A in figure 1 below)(column 11, lines 20-30);
a pressure sensor (280) positioned to measure a supply tube pressure within the intravenous fluid supply tube (245) (as shown in figure 7 the pressure sensor is connected to intravenous fluid supply tube 245; column 10, line 60- column 11, line 2),
a controller (see the controller 296 as shown in figure 8) communicatively connected to the pressure sensor (280) and the pump (258), wherein the controller regulates an output of the pump based at least in part on the pressure measurement received from the pressure sensor (280) (controller 296 turns the pump on and off based on the position of the pressure sensor 265; column 11, lines 15-30).
Laing fails to disclose:
A pressure sensor comprising:
a pressure sensing diaphragm isolated from the intravenous fluid by a pressure transmitting medium, and
a sensor circuitry configured to generate an electrical signal as a function of the supply tube pressure, wherein the electrical signal corresponds to a pressure measurement of the supply tube pressure in the intravenous fluid supply tube.
Garrison teaches:
A pressure sensor (figure 115) that includes a diaphragm (710), an pressure transmitting medium (silicone oil within 714; column 53, lines 10-25). Further, the reference indicates the sensor includes an electrical circuit (716) that sends an electrical signal (column 53, lines 20-25) that indicates the pressure downstream of a pump.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Laing and replace the pressure sensor with the pressure sensor (including the diaphragm, pressure transmitting medium and sensor circuitry) as taught by Garrison. This is a simple substitution of one known element (pressure sensor of Laing) for another (pressure sensor of Garrison) to obtain predictable results (to measure the pressure within the intravenous fluid supply tube).
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Figure 1 - figure 1 of Laing, annotated by the examiner
Regarding claim 2:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Laing and Garrison:
The intravenous fluid supply system of Claim 1, wherein the intravenous fluid supply tube (245 of Laing) is fluidly connected to a blood vessel of a patient (via needle 249 of Laing; column 10, lines 35-60) and wherein the pressure sensor (see the pressure sensor of Garrison incorporated into Laing) measures the supply tube pressure of the intravenous fluid in the intravenous fluid supply tube (245 of Laing) between the intravenous fluid supply bag (240 of Laing) and the blood vessel of the patient (column 3, lines 48-53; column 3, lines 65-68; teaches maintaining the pressure in the supply tube 245 so that the fluid flows through the needle and since the system is an infusion system the system maintains the pressure greater than the pressure in the blood vessel).
Regarding claim 3:
Laing discloses:
The intravenous fluid supply system of Claim 2, wherein the controller (see the controller 296 as shown in figure 8) regulates the output of the pump (258) such that the supply tube pressure of the intravenous fluid in the intravenous fluid supply tube (245) is greater than a blood pressure of the patient (inherent function as shown by check or one way valve 246a/246 which only allows fluid to flow out of the supply tube 245 which indicates fluid only flows when the pressure in line 245 is greater than the pressure in the blood vessel).
Regarding claim 4:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Laing and Garrison:
The intravenous fluid supply system of Claim 2, wherein a cannula (249 of Laing) is inserted into the blood vessel of the patient (infusion needle of Laing; column 10, lines 50-60), and the pressure sensor (see the pressure sensor of Garrison incorporated into Laing) measures the supply tube pressure in the intravenous fluid supply tube (245 of Laing) between the patient and the cannula (249 of Laing) (see arrangement of the sensor 280 and needle 249).
Regarding claim 5:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Laing and Garrison:
The intravenous fluid supply system of Claim 1, wherein the pressure sensor (see the pressure sensor of Garrison incorporated into Laing) measures the supply tube pressure (measures and sends signal regarding pressure as taught by Garrison) of the intravenous fluid in the intravenous fluid supply tube (245) and transmits the supply tube pressure (Garrison, column 53, lines 20-25) to the controller (296).
Regarding claim 6:
Laing discloses:
The intravenous fluid supply system of Claim 1, wherein in an instance in which the pressure measurement drops below a minimum pressure threshold (column 11, lines 15-30), the controller (296) adjusts the output of the pump (258).
Regarding claim 8:
Laing discloses:
The intravenous fluid supply system of Claim 1, wherein regulating the output of the pump (258) comprises activating and deactivating (column 11, lines 15-30) the pump (258).
Regarding claim 11:
Laing discloses:
A method for regulating a pressure of an intravenous fluid supply (figure 7, 8 and column 11, lines 15-30), the method comprising:
receiving, by a controller (296), a pressure measurement (column 10, line 60- column 11, line 5; signal sent via 257) from a pressure sensor (280),
wherein the pressure sensor (280) is positioned to measure a supply tube pressure within an intravenous fluid supply tube (245)(as shown in figure 7),
wherein the intravenous fluid supply tube (245) is fluidly connected to an outlet port (A in figure 1 above) of an intravenous fluid supply bag (240) (as shown in figure 7) containing an intravenous fluid (fluid within tube 245),
wherein the intravenous fluid (fluid within tube 245) is ejected into the intravenous fluid supply tube (245) upon an application of an applied pressure (pressure applied via bag 230 as it inflates; column 10, lines 50-60) on the intravenous fluid supply bag (240), and
determining, by the controller (296), an output of a pump (258), fluidly connected to an inlet port (see the inlet port B in figure 1 above) of a pressure bag (230), based at least in part on the pressure measurement received from the pressure sensor (280) (controller 296 turns the pump on and off based on the position of the pressure sensor 265 and therefore the pressure of the pump indirectly through the application of pressure on bag 240; column 11, lines 15-30),
wherein the pressure bag (230) is adjacent to the intravenous fluid supply bag (240) containing the intravenous fluid (fluid within bag 240; medical or drug bag as indicated in column 10, lines 50-60) (as shown in figure 7), and
wherein in an instance in which a fluid is pumped into the inlet port of the pressure bag (230), the applied pressure is applied to the intravenous fluid supply bag (240), such that, the intravenous fluid is ejected from the outlet port (A in figure 1 above) into the intravenous fluid supply tube (245) (as described above expansion of pressure bag 230 compresses bag 240 and expels fluid out of port A in figure 1 below) (column 11, lines 20-30); and
altering the output of the pump (258) based at least in part on the pressure measurement received from the pressure sensor (280) (controller 296 turns the pump on and off based on the position of the pressure sensor 265; column 11, lines 15-30).
Laing fails to disclose:
wherein the pressure sensor comprises a pressure sensing diaphragm isolated from the intravenous fluid by a pressure transmitting medium, and a sensor circuitry configured to generate an electrical signal as a function of the supply tube pressure, wherein the pressure measurement corresponds to the electrical signal representing the supply tube pressure in the intravenous fluid supply tube; and
Garrison teaches:
A pressure sensor (figure 115) that includes a diaphragm (710), an pressure transmitting medium (silicone oil within 714; column 53, lines 10-25). Further, the reference indicates the sensor includes an electrical circuit (716) that sends an electrical signal (column 53, lines 20-25) that indicates the pressure downstream of a pump.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Laing and replace the pressure sensor with the pressure sensor (including the diaphragm, pressure transmitting medium and sensor circuitry) as taught by Garrison. This is a simple substitution of one known element (pressure sensor of Laing) for another (pressure sensor of Garrison) to obtain predictable results (to measure the pressure within the intravenous fluid supply tube).
Regarding claim 12:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Laing and Garrison:
The method of Claim 11, wherein the intravenous fluid supply tube is fluidly connected to a blood vessel of a patient (via needle 249; column 10, lines 35-60) and wherein the pressure sensor (see the pressure sensor of Garrison incorporated into Laing) measures the supply tube (245) pressure of the intravenous fluid in the intravenous fluid supply tube between the intravenous fluid supply bag (240) and the blood vessel of the patient (column 3, lines 48-53; column 3, lines 65-68; teaches maintaining the pressure in the supply tube 245 so that the fluid flows through the needle and since the system is an infusion system the system maintains the pressure greater than the pressure in the blood vessel).
Regarding claim 13:
Laing discloses:
The method of Claim 12, wherein the controller (296) regulates the output of the pump (258) such that the supply tube pressure of the intravenous fluid in the intravenous fluid supply tube (245) is greater than a blood pressure of the patient (column 3, lines 48-53; column 3, lines 65-68; teaches maintaining the pressure in the supply tube 245 so that the fluid flows through the needle and since the system is an infusion system the system maintains the pressure greater than the pressure in the blood vessel).
Regarding claim 14:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Laing and Garrison:
The method of Claim 13, wherein determining the output of the pump (258 of Laing) further comprises comparing the pressure measurement received from the pressure sensor (see the pressure sensor of Garrison incorporated into Laing) to a minimum pressure threshold (column 11, lines 15-30 of Laing), and reconfiguring the output of the pump (258 of Laing) if the pressure measurement received from the pressure sensor (280 of Laing) is below the minimum pressure threshold (the position of the pressure sensor 280 actuates the location and activation of the controller 296).
Regarding claim 15:
Laing discloses:
The method of Claim 11, wherein altering the output of the pump (258) comprises activating and deactivating (column 11, lines 15-30) the pump (258).
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5399166 A to Laing in view of US 5433704 A to Ross et al. (Ross) and EP 0319273 A1 to Garrison.
Regarding claim 17:
Laing discloses:
A method configured to:
receive, by a controller (296), a pressure measurement (column 10, line 60- column 11, line 5; signal sent via 257) from a pressure sensor (280),
wherein the pressure sensor (280) is positioned to measure a supply tube pressure within an intravenous fluid supply tube (245)(as shown in figure 7),
wherein the intravenous fluid supply tube (245) is fluidly connected to an outlet port (A in figure 1 above) of an intravenous fluid supply bag (240) (as shown in figure 7) containing an intravenous fluid (fluid within tube 245),
wherein the intravenous fluid (fluid within tube 245) is ejected into the intravenous fluid supply tube (245) upon an application of an applied pressure (pressure applied via bag 230 as it inflates; column 10, lines 50-60) on the intravenous fluid supply bag (240), and
determine, by the controller (296), an output of a pump (258), fluidly connected to an inlet port (see the inlet port B in figure 1 above) of a pressure bag (230), based at least in part on the pressure measurement received from the pressure sensor (280) (controller 296 turns the pump on and off based on the position of the pressure sensor 265 and therefore the pressure of the pump indirectly through the application of pressure on bag 240; column 11, lines 15-30),
wherein the pressure bag (230) is adjacent to the intravenous fluid supply bag (240) containing the intravenous fluid (fluid within bag 240; medical or drug bag as indicated in column 10, lines 50-60) (as shown in figure 7), and
wherein in an instance in which a fluid is pumped into the inlet port of the pressure bag (230), the applied pressure is applied to the intravenous fluid supply bag (240), such that, the intravenous fluid is ejected from the outlet port (A in figure 1 above) into the intravenous fluid supply tube (245) (as described above expansion of pressure bag 230 compresses bag 240 and expels fluid out of port A in figure 1 below) (column 11, lines 20-30); and
alter, by the controller (296), the output of the pump based at least in part on the pressure measurement received from the pressure sensor (280) (controller 296 turns the pump on and off based on the position of the pressure sensor 265; column 11, lines 15-30).
Laing fails to disclose:
A computer program product for regulating a pressure of an intravenous fluid supply, the computer program product comprising at least one non-transitory computer-readable storage medium having computer-readable program code portions stored therein, the computer-readable program code portions comprising an executable portion
wherein the pressure sensor comprises a pressure sensing diaphragm isolated from the intravenous fluid by a pressure transmitting medium, and a sensor circuitry generate an electrical signal as a function of the supply tube pressure, wherein the pressure measurement corresponds to the electrical signal representing the supply tube pressure in the intravenous fluid supply tube.
Ross teaches:
A computer program product for regulating a pressure of an intravenous fluid supply, the computer program product comprising at least one non-transitory computer-readable storage medium having computer-readable program code portions (see the computer readable code in the controller; page 2, line 35-page 3, line 5) stored therein, the computer-readable program code portions comprising an executable portion that senses the pressure from a pressure sensor (page 2, lines 30-35) and operates a pump accordingly (page 2, lines 25-35). Further, the system shows (in figure 2a) the pump as supplying pressure to a pressure bag (206) surrounding an intravenous fluid supply bag (208)(¶00081).
Garrison teaches:
A pressure sensor (figure 115) that includes a diaphragm (710), an pressure transmitting medium (silicone oil within 714; column 53, lines 10-25). Further, the reference indicates the sensor includes an electrical circuit (716) that sends an electrical signal (column 53, lines 20-25) that indicates the pressure downstream of a pump.
Regarding the limitation “A computer program product for regulating a pressure of an intravenous fluid supply, the computer program product comprising at least one non-transitory computer-readable storage medium having computer-readable program code portions stored therein, the computer-readable program code portions comprising an executable portion”:
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Laing to perform the method/function outlined in the claim via a controller/computer program product/code and pressure sensor as taught by Ross. This is a simple substitution of one known element (sensor and circuitry of Laing) for another (computer code/computer/controller and sensor as taught by Ross) to obtain predictable results (to control the pump attached to the pressure bag based on the pressure sensed by a sensor).
Regarding the limitation “wherein the pressure sensor comprises a pressure sensing diaphragm isolated from the intravenous fluid by a pressure transmitting medium, and a sensor circuitry generate an electrical signal as a function of the supply tube pressure, wherein the pressure measurement corresponds to the electrical signal representing the supply tube pressure in the intravenous fluid supply tube”:
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Laing and replace the pressure sensor with the pressure sensor (including the diaphragm, pressure transmitting medium and sensor circuitry) as taught by Garrison. This is a simple substitution of one known element (pressure sensor of Laing) for another (pressure sensor of Garrison) to obtain predictable results (to measure the pressure within the intravenous fluid supply tube).
Regarding claim 18:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 17 by Laing, Ross and Garrison:
The computer program product of Claim 17, wherein the intravenous fluid supply tube (245 of Laing) is fluidly connected to a blood vessel of a patient (via needle 249; column 10, lines 35-60) and wherein the pressure sensor (see the pressure sensor of Garrison incorporated into Laing) measures the supply pressure of the intravenous fluid in the intravenous fluid supply tube (245 of Laing) between the intravenous fluid supply bag (240 of Laing) and the blood vessel of the patient (column 3, lines 48-53; column 3, lines 65-68; teaches maintaining the pressure in the supply tube 245 so that the fluid flows through the needle and since the system is an infusion system the system maintains the pressure greater than the pressure in the blood vessel).
Regarding claim 19:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 17 by Laing, Ross and Garrison:
The computer program product of Claim 17, wherein determining the output of the pump (258 of Laing) further comprises comparing the pressure measurement received from the pressure sensor (see the pressure sensor of Garrison incorporated into Laing) to a minimum pressure threshold (column 11, lines 15-30 of Laing), and reconfiguring the output of the pump (258 of Laing) if the pressure measurement received from the pressure sensor is below the minimum pressure threshold (the position of the pressure sensor 280 actuates the location and activation of the controller 296).
Regarding claim 20:
Laing discloses:
The computer program product of Claim 17, wherein altering the output of the pump (258) comprises activating and deactivating (column 11, lines 15-30) the pump (258).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5399166 A to Laing and EP 0319273 A1 to Garrison as applied to claim 6 above, and further in view of WO 2017184777 A1 to Miller et al. (Miller).
Regarding claim 7:
Laing fails to disclose:
The intravenous fluid supply system of Claim 6, wherein the minimum pressure threshold is between 275 and 285 millimeters of mercury and the pressure of the intravenous fluid in the intravenous fluid supply tube is maintained between 275 millimeters of mercury and 310 millimeters of mercury.
Miller teaches:
An intravenous fluid supply system (see figure 1a) wherein the system starts at a pressure of 275 mm Hg (or millimeters of mercury) and ramps up to a pressure of 300 mm Hg (or millimeters of mercury) (see ¶0010). This indicates that the system maintains a minimum pressure of 275 mm Hg (or millimeters of mercury) and indicates the ideal operating pressure for the system is 300 mm Hg (or millimeters of mercury). It maintains this pressure to perform rapid infusions of fluid (¶0009).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Laing for the system to have a minimum pressure of 275 mm Hg (or millimeters of mercury) (in the 275-285 range of millimeters of mercury) and maintain a pressure of 275 mm Hg (in the ranges of 275-310 millimeters of mercury) as taught by Miller to allow rapid infusion of fluid from the intravenous fluid supply bag (Miller, ¶0009).
Claim(s) 9 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5399166 A to Laing and EP 0319273 A1 to Garrison as applied to claims 1 and 11 above, and further in view of US 20170000946 A1 to Boyle et al. (Boyle).
Regarding claim 9:
Laing and Garrison fail to disclose:
The intravenous fluid supply system of Claim 1, wherein the controller transmits the one or more measurements of the pressure sensor to a display device.
Boyle teaches:
An intravenous fluid supply system (figure 3) that includes a pump (230), pressure bag (310) and fluid bag (130). The system further includes a display which is capable of displaying the pressure measured by the pressure sensor (¶0008).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Laing to further a display for displaying the pressure measured by the pressure sensor as taught by Boyle to allow for control of the system (Boyle, ¶0038).
Regarding claim 16:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 9 by Laing, Garrison and Boyle.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5399166 A to Laing and EP 0319273 A1 to Garrison as applied to claim 1 above, and further in view of US 5207645 A to Ross et al. (Ross).
Regarding claim 10:
Laing and Garrison fail to disclose:
The intravenous fluid supply system of Claim 1, further comprising an additional pressure sensor, wherein the additional pressure sensor is fluidly connected to the pressure bag through a second outlet port, wherein the additional pressure sensor is communicatively connected to the controller, and wherein the controller regulates the output of the pump based at least in part on one or more measurements of the additional pressure sensor.
Ross teaches:
An intravenous fluid supply system (figure 5) that includes a pressure bag (68) and an intravenous fluid supply bag (18). The system also includes a pump (72) connected to the pressure bag. Further, the system includes a pressure sensor (78) connected to a second outlet port (78) which measure the pressure of the fluid/air into the pressure bag. The pressure sensor supplies the pressure to the controller (82) for controlling the flow of fluid/air into the pressure bag (column 7, line 55- column 8, line 16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Laing to further include a second outlet port and pressure sensor connected to the controller as taught by Ross in order to control the pump based on the pressure within the pressure bag (Ross, column 7, line 55- column 8, line 16).
Response to Arguments
Applicant’s arguments, see remarks, filed 7/14/26, with respect to the rejection(s) of claim(s) 1-20 under 35 USC 102/103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Laing and Garrison or Laing, Ross and Garrison.
Regarding the claim objections:
The applicant’s amendments to the claims have addressed the previous claim objections and for this reason they have been withdrawn.
Regarding the 35 USC 112(b) claim rejections:
The applicant’s amendments to the claims have addressed the previous claim rejections and for this reason they have been withdrawn.
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 WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (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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/WESLEY G HARRIS/Examiner, Art Unit 3783
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