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 Objections
Claim 11 is objected to because of the following informalities: line 15 should be amended to - such that, the intravenous fluid is ejected from an outlet port into the intravenous fluid supply tube-. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: line 17 should be amended to - such that, the intravenous fluid is ejected from an outlet port into-. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1:
The limitation “wherein in an instance in which the pressure bag is adjacent to the intravenous fluid supply bag, and in an instance in which a fluid is pumped into the inlet port of the pressure bag by the pump” (emphasis added by the examiner) in lines 8-10 are unclear. The phrases “in an instance in which” raise a question of if the pressure bag should be adjacent to the intravenous fluid supply bag and if fluid should be pumped into the inlet port of the pressure bag. For the sake of examination, the office has assumed that these functions or structural limitations are required by the claim however the applicant should amend the claim to clarify.
Claims 2-10 are rejected due to their dependence on claim 1.
Regarding claim 6:
The claim recites the limitation "the pressure measurement" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 is rejected due to its dependence on claim 6.
Regarding claim 11:
The claim limitation “an intravenous fluid supply bag” in line 11 is unclear. The limitation is unclear because of the earlier recitation of the limitation “an intravenous fluid supply bag” in line 8 of the claim which raises a question of if two of intravenous fluid supply bag are required by the claim or only one. For the sake of examination, the office has assumed that only one intravenous fluid supply bag is required by the claim. However, the applicant should amend the claim to clarify.
Claims 12-16 are rejected due to their dependence on claim 11.
Regarding claims 12 and 14-16:
The limitation “The method of Claim 10, wherein” in line 1 is unclear. The limitation is unclear since it indicates the claims depends on the method of claim 10 however claim 10 is not a method claim. For the sake of examination, the office has interpreted the claims to depend on claim 11 and the indication that they depend on claim 10 is a typographical error.
Regarding claim 13
The claim recites the limitation "the controller" in line 1. There is insufficient antecedent basis for this limitation in the claim.
The claim recites the limitation "the patient" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 17:
The claim limitation “an intravenous fluid supply bag” in line 13 is unclear. The limitation is unclear because of the earlier recitation of the limitation “an intravenous fluid supply bag” in line 10 of the claim which raises a question of if two of intravenous fluid supply bag are required by the claim or only one. For the sake of examination, the office has assumed that only one intravenous fluid supply bag is required by the claim. However, the applicant should amend the claim to clarify.
Claims 18-20 are rejected due to their dependence on claim 17.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 8 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5399166 A to Laing.
Laing discloses:
Regarding claim 1:
An intravenous fluid supply system (figure 7) 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 the application of a 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 in an instance in which the pressure bag (230) is adjacent to the intravenous fluid supply bag (240) (as shown in figure 7), and in an instance in which a fluid is pumped into the inlet port of the pressure bag (230) by the pump (258), pressure is applied to the adjacent 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 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); and
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 (296) regulates an output of the pump (258) based at least in part on one or more measurements of 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).
PNG
media_image1.png
549
806
media_image1.png
Greyscale
Figure 1
Regarding claim 2:
The intravenous fluid supply system of Claim 1, wherein the intravenous fluid supply tube (245) is fluidly connected to a blood vessel of a patient (via needle 249; column 10, lines 35-60) and wherein the pressure sensor (280) measures the pressure of the intravenous fluid in the intravenous fluid supply tube (245) 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 3:
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 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:
The intravenous fluid supply system of Claim 2, wherein a cannula (249) is inserted into the blood vessel of the patient (infusion needle; column 10, lines 50-60), and the pressure sensor (280) measures the pressure in the intravenous fluid supply tube (245) between the patient and the cannula (249) (see arrangement of the sensor 280 and needle 249).
Regarding claim 5:
The intravenous fluid supply system of Claim 1, wherein the pressure sensor (280) measures a pressure measurement (measurement of the pressure sensor is the position of the sensor based on the pressure) of the intravenous fluid in the intravenous fluid supply tube (245) and transmits the pressure measurement (the position of the pressure sensor 280 actuates the location and activation of the controller 296) to the controller (296).
Regarding claim 6:
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:
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:
A method for regulating a pressure of an intravenous fluid supply (figure 7, 8 and column 11, lines 15-30), the method comprising:
receiving a pressure measurement of a plurality of pressure measurements (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 the pressure within an intravenous fluid supply tube (245)(as shown in figure 7), and
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);
determining 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; column 11, lines 15-30),
wherein the pressure bag (230) is adjacent to an intravenous fluid supply bag (240) containing an 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), pressure is applied to the intravenous fluid supply bag (240), such that, intravenous fluid is ejected from an 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).
Regarding claim 12:
The method of Claim 10, wherein the intravenous fluid supply tube (245) is fluidly connected to a blood vessel of a patient (via needle 249; column 10, lines 35-60) and wherein the pressure sensor (280) measures the pressure of the intravenous fluid in the intravenous fluid supply tube (245) 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:
The method of Claim 11, wherein the controller (296) regulates the output of the pump (258) such that the 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:
The method of Claim 10, wherein determining the output of the pump (258) further comprises comparing the pressure measurement received from the pressure sensor (280) to a minimum pressure threshold (column 11, lines 15-30), and reconfiguring the output of the pump (258) if the measurement received from the pressure sensor (280) 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:
The method of Claim 10, wherein altering the output of the pump (258) comprises activating and deactivating (column 11, lines 15-30) the pump (258).
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) 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).
Regarding claim 17:
Laing discloses:
A method configured to:
receive a pressure measurement of a plurality of pressure measurements (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 the pressure within an intravenous fluid supply tube (245)(as shown in figure 7), and
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);
determine 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; column 11, lines 15-30),
wherein the pressure bag (230) is adjacent to an intravenous fluid supply bag (240) containing an 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), pressure is applied to the intravenous fluid supply bag (240), such that, intravenous fluid is ejected from an 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 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:
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
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).
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 claim 18:
Laing discloses:
The computer program product of Claim 17, wherein the intravenous fluid supply tube (245) is fluidly connected to a blood vessel of a patient (via needle 249; column 10, lines 35-60) and wherein the pressure sensor (280) measures the pressure of the intravenous fluid in the intravenous fluid supply tube (245) 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 19:
Laing discloses:
The computer program product of Claim 17, wherein determining the output of the pump (258) further comprises comparing the pressure measurement received from the pressure sensor (280) to a minimum pressure threshold (column 11, lines 15-30), and reconfiguring the output of the pump (258) if the 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 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 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 fails 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 and Boyle.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5399166 A to Laing as applied to claim 1 above, and further in view of US 5207645 A to Ross et al. (Ross).
Regarding claim 10:
Laing fails 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20060009727-A1
O'Mahony
See IV bags 123
US-6604908-B1
Bryant
See the pressure bag 100
US-5207645-A
Ross
See the pressure bag 68
US-4332246-A
Thomson
See the pressure chamber 9
US-5549672-A
Maddock
See IV bags 20
WO-0235979-A2
O'MAHONY
See the controller 106
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WESLEY G HARRIS/Examiner, Art Unit 3783