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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 17, 2026 has been entered. Claims 1, 4, 6, 9-11 and 17-20 have been amended. Claim 12 has been cancelled. Claims 1-11 and 13-20 are currently pending.
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.
Claim(s) 1-4, 11, 13-15, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kramer et al. (Kramer; US Pub No. 2014/0243738 A1) in view of Carlisle et al. (Carlisle; US Pub No. 2009/0026146 A1).
As per claim 1, Kramer teaches a method for monitoring an intravenous (IV) fluid bag, comprising:
retrieving data representative of hydrostatic pressure at an injection port of [[in]] the IV fluid bag (paragraph [0089], lines 9-12)… and
calculating, based on the retrieved data, at least one of remaining fluid volume in the IV fluid bag (paragraph [0144], line 18), discharge rate from the IV fluid bag (paragraph [0144], line 17), and flow occlusion in the IV fluid bag (paragraph [0141]; paragraph [0089]; paragraph [0091]).
Kramer does not expressly teach retrieving data representative of hydrostatic pressure at an injection port of [[in]] the IV fluid bag from a sensor coupled to a fluid port of the [[an]] IV fluid bag,
wherein the hydrostatic pressure corresponds to a height difference between an IV fluid level of the IV fluid bag and the fluid port.
Carlisle teaches retrieving data representative of hydrostatic pressure at an injection port of [[in]] the IV fluid bag from a sensor coupled to a fluid port of the [[an]] IV fluid bag,
wherein the hydrostatic pressure corresponds to a height difference between an IV fluid level of the IV fluid bag and the fluid port (Fig. 7, Inline Sensor 900; paragraphs [0006] & [0013]: It would have been obvious to one having ordinary skill in the art at the time the invention was made to take the manual pressure determination as taught by Carlisle and replace the pressure determination with a sensor device, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art.).
As the prior art of Kramer teaches determining a pressure based on the height of the fluid bag, therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to implement the sensing method, sensor device and hydrostatic pressure determination as taught by Carlisle, since Carlisle states in paragraph [0006] that such a method for determining hydrostatic pressure is well known in the art.
As per claim 2, Kramer in view of Carlisle further teaches the method of claim 1, further comprising:
storing at least values for an initial pressure and a current pressure (Kramer, paragraph [0154]); and
calculating the remaining fluid volume based on the current pressure and the initial pressure (Kramer, paragraphs [0158]-[0178]).
As per claim 3, Kramer in view of Carlisle further teaches the method of claim 2, further comprising calibrating the calculation of the remaining fluid volume based on an initial fluid volume (Kramer, paragraph [0077], lines 15-18).
As per claim 4, Kramer in view of Carlisle further method the method of claim 1, further comprising:
determining the remaining fluid volume is below a given threshold; and
generating an alert or alarm based on the remaining fluid volume [[being]] below the given threshold (Kramer, paragraph [0068]; paragraph [0072], lines 16-20).
As per claim 11, (see rejection of claim 1 above) an intravenous (IV) fluid bag monitoring system comprising:
a sensor comprising a pressure sensor coupled to a fluid port of an [[the]] IV fluid bag, wherein the sensor is configured to measure hydrostatic pressure at an injection port of [[in]] the IV fluid bag,
wherein the hydrostatic pressure corresponds to a height difference between an IV fluid level of the IV fluid bag and the fluid port; and
a controller component configured to:
retrieve data representative of the hydrostatic pressure at an injection port of [[in]] the IV fluid bag from the sensor
calculate, based on the retrieved data, at least one of remaining fluid volume in the IV fluid bag, discharge rate from the IV fluid bag, and flow occlusion in the IV fluid bag.
As per claim 13, (see rejection of claim 2 above) the intravenous (IV) fluid bag monitoring system of claim 11, wherein the controller component is configured to calculate the remaining fluid volume based on an initial pressure and a current pressure.
As per claim 14, (see rejection 3 above) the intravenous (IV) fluid bag monitoring system of claim 11, wherein the controller component is further configured to calibrate the calculation of the remaining fluid volume based on an initial fluid volume.
As per claim 15, Kramer in view of Carlisle further teaches the intravenous (IV) fluid bag monitoring system of claim 11, wherein the controller component comprising a user interface to receive initial data representative of an initial volume of the IV fluid bag from a user (Kramer, paragraph [0084]).
As per claim 19, (see rejection of claim 1 above) a 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 configured to:
retrieve data representative of hydrostatic pressure at an injection port of [[in]] an IV fluid bag from a sensor coupled to the IV fluid bag,
wherein the hydrostatic pressure corresponds to a height difference between an IV fluid bag and the fluid port; and
calculate, based on the retrieved data, at least one of remaining fluid volume from the IV fluid bag, discharge rate in the IV fluid bag, and flow occlusion in the IV fluid bag.
As per claim 20, (see rejection of claim 1 above) a computing device, comprising:
a memory configured to store computer-readable instructions;
a processor communicatively coupled to the memory, wherein the processor is configured to execute computer-readable instructions to:
retrieve data representative of hydrostatic pressure at an injection port of [[in]] an IV fluid bag from a sensor coupled to the IV fluid bag,
wherein the hydrostatic pressure corresponds to a height difference between an IV fluid level of the IV fluid bag and the fluid port; and
calculate, based on the retrieved data, at least one of remaining fluid volume from the IV fluid bag, discharge rate in the IV fluid bag, and flow occlusion in the IV fluid bag.
Claim(s) 5, 6, 10, 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kramer in view of Carlisle as applied above, and further in view of Wilcox et al. (Wilcox; US Pub No. 2019/0314575 A1).
As per claim 5, Kramer in view of Carlisle teaches the method of claim 1.
Kramer in view of Carlisle does not expressly teach further comprising:
calculating an average pressure change rate based on pressure data reading values over a plurality of time blocks;
storing, for each of the plurality of time blocks, the average pressure change rate as an instance; and
calculating average discharge rate deviation based on the average pressure change rate over a plurality of stored instances.
Wilcox teaches further comprising:
calculating an average pressure change rate based on pressure data reading values over a plurality of time blocks (paragraph [0070], lines 13-15; paragraph [0073], lines 1-8);
storing, for each of the plurality of time blocks, the average pressure change rate as an instance (paragraph [0070], lines 13-15; paragraph [0073], lines 1-8); and
calculating average discharge rate deviation based on the average pressure change rate over a plurality of stored instances (paragraph [0070], lines 15-16; paragraph [0073]).
It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to implement the pressure calculations as taught by Wilcox, since Wilcox states in paragraph [0070] that such a modification would result in detecting malfunctions within the fluid delivery system.
As per claim 6, Kramer in view of Carlisle teaches the method of claim 1.
Kramer in view of Carlisle does not expressly teach further comprising:
generating a flow discharge alert or alarm based on a difference between an average discharge rate deviation of a prior instance and a current average discharge rate deviation of a current instance [[being]] greater than or less than a threshold value of the average discharge rate deviation of the prior instance.
Wilcox teaches further comprising:
generating a flow discharge alert or alarm based on a difference between an average discharge rate deviation of a prior instance and a current average discharge rate deviation of a current instance [[being]] greater than or less than a threshold value of the average discharge rate deviation of the prior instance (paragraph [0074]).
It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to implement the output of an alarm as taught by Wilcox, since Wilcox states in paragraph [0074] that such a modification would result in providing a notification of an abnormality within the fluid delivery system.
As per claim 10, Kramer in view of Carlisle teaches the method of claim 1.
Kramer in view of Carlisle does not expressly teach further comprising:
determining a number of successive flow occlusion events [[is being]] greater than an occlusion counter flag; and
determining an occurrence of the flow occlusion.
Wilcox teaches further comprising:
determining a number of successive flow occlusion events [[is being]] greater than an occlusion counter flag; and
determining an occurrence of the flow occlusion (paragraph [0108]).
It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to implement the difference determination as taught by Paiam, since Paiam states in paragraph [0176] that such a modification would result in accurately identifying an occlusion event.
As per claim 16, (see rejection of claim 5 above) the intravenous (IV) fluid bag monitoring system of claim 11, wherein the controller component is further configured to:
calculate an average pressure change rate based on pressure data reading values over a plurality of time blocks;
store, for each of the plurality of time blocks, the average pressure change rate as an instance; and
calculate average discharge rate deviation based on the average pressure change rate over a plurality of stored instances.
As per claim 18, (see rejection of claim 10 above) the intravenous (IV) fluid bag monitoring system of claim 11, wherein the controller component is further configured to:
determining a number of successive flow occlusion events [[is being]] greater than an occlusion counter flag; and
determine an occurrence of the flow occlusion.
Claim(s) 7-9 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kramer in view of Carlisle as applied above, and further in view of Paiam et al. (Paiam; US Pub No. 2021/0330881 A1).
As per claim 7, Kramer in view of Carlisle teaches the method of claim 1.
Kramer in view of Carlisle does not expressly teach further comprising:
counting a number of successive flow occlusion events.
Paiam teaches further comprising:
counting a number of successive flow occlusion events (paragraph [0108]).
It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to implement the occlusion counter as taught by Paiam, since Paiam states that such a modification would result in quickly identifying an occlusion event and minimizing possible harm to a patient.
As per claim 8, Kramer in view of Carlisle, and further in view of Paiam, further teaches the method of claim 7, wherein the successive flow occlusion events comprise a decrease in average discharge rate deviation below a given threshold (Paiam, paragraph [0108]).
As per claim 9, Kramer in view of Carlisle teaches the method of claim 1.
Kramer in view of Carlisle does not expressly teach further comprising:
determining a difference between an average discharge rate deviation of a prior instance and a current average discharge rate deviation of a current instance is [[being]] less than 1% of the average discharge rate deviation of the current instance; and
incrementing an occlusion counter.
Paiam teaches further comprising:
determining a difference between an average discharge rate deviation of a prior instance and a current average discharge rate deviation of a current instance is [[being]] less than 1% of the average discharge rate deviation of the current instance; and
incrementing an occlusion counter (paragraph [0086], [0176]).
It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to implement the difference determination as taught by Paiam, since Paiam states in paragraph [0176] that such a modification would result in accurately identifying an occlusion event.
As per claim 17, (see rejection of claim 9 above) the intravenous (IV) fluid bag monitoring system of claim 11, wherein the controller component is further configured to:
determine a difference between an average discharge rate deviation of a prior instance and a current average discharge rate deviation of a current instance [[is being]] less than 1% of the average discharge rate deviation of the current instance; and
increment an occlusion counter.
Response to Arguments
Applicant’s arguments with respect to the above 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
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/NAOMI J SMALL/ Primary Examiner, Art Unit 2685