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 .
Claim Objections
2. Claim 11, 13, and 17-18 are objected to because of the following informalities:
a) In claim 11 lines 2-3, please change "an infusion consumable associated with each the preset consumable information" to --an infusion consumable associated with each of the preset consumable information--. b) In claim 13 lines 3-4, please change "preset consumable information associated with each the identification information" to -- --preset consumable information associated with each of the identification information;--.
c) In claim 17 line 1, please change "wherein controller is further configured to adjust" to: --wherein the controller is configured to adjust--.
d) In claim 18 line 3, please change "controller is further configured to determine" to: --the controller is further configured to determine--. Appropriate correction is required.
Claim Rejections - 35 USC § 102
3. 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 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.
4. Claim(s) 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lau et al. (US Pat. Pub. 2016/0263315, hereinafter "Lau").
In regards to claim 1, Lau teaches a control method of an infusion pump (Lau abstract and paragraph [0020] teach a method for controlling an infusion pump device), comprising:
determining at least one of identification information or consumable information of a target infusion consumable set to the infusion pump (Lau paragraphs [0005]-[0007] teach identifying a fluid type (identification or consumable information) of a target infusion fluid (consumable) currently onboard (set to) the infusion pump that has different pharmacokinetics characteristics than an earlier fluid);
determining, according to the at least one of identification information or consumable information, a control rule corresponding to the target infusion consumable of the infusion pump (Lau paragraphs [0005]-[0007] teach determining a respective set of one or more control parameters (control rule) corresponding to each fluid type that reflect the pharmacokinetics characteristics associated with the onboard target infusion fluid);
adjusting the control rule corresponding to the target infusion consumable according to a preset correction rule (Lau paragraphs [0005]-[0007] teach updating (adjusting) the one or more control rule parameters referenced by a control module from first values associated with a first fluid type to second values associated with a second fluid type when the second different fluid is identified, and paragraph [0065] teaches utilizing the relationship between the pharmacokinetics information associated with the identified fluid type and reference pharmacokinetics information associated with a reference set of control parameters (preset control rule) to convert the control parameters into updated values suitable for use with the identified fluid type); and
operating the infusion pump according to the control rule (Lau paragraphs [0005]- [0007] teach operating the infusion device to deliver the identified fluid according to the operating mode and updated control parameters (control rule) for the identified fluid type).
In regards to claim 2, Lau teaches the method wherein the control rule comprises at least one of: an infusion accuracy control rule, a blocking pressure control rule, a bubble judgment rule, and a drive mechanism current adjustment rule (Lau paragraph [0037] teaches where the control parameter (control rule) of the control electronics comprises at least command signals that operate a motor driver to regulate the amount of power (drive mechanism current) supplied to the pump motor from a power supply, for actuating the drive train components of the drive system to force fluid from the reservoir along a fluid path).
In regards to claim 3, Lau teaches the method wherein the step of determining at least one of identification information or consumable information of the target infusion consumable set to the infusion pump (Lau paragraphs [0005]-[0007] teach identifying a fluid type (identification or consumable information) of a target infusion fluid (consumable) currently onboard (set to) the infusion pump that has different pharmacokinetics characteristics than an earlier fluid) comprises:
determining the at least one of identification information or consumable information of the target infusion consumable by at least one of a consumable identification device or an interaction device in communication with the infusion pump (Lau paragraph [0072] teaches determining the identification information of the target infusion consumable by using corresponding sensors (such as a optical sensing device) in communication with the infusion pump to scan a barcode identifying the target fluid).
In regards to claim 4, Lau teaches the method wherein the step of adjusting the control rule corresponding to the target infusion consumable according to the preset correction rule (Lau paragraphs [0005]-[0007] teach updating (adjusting) the one or more control rule parameters referenced by a control module from first values associated with a first fluid type to second values associated with a second fluid type when the second different fluid is identified, and paragraph [0065] teaches utilizing the relationship between the pharmacokinetics information associated with the identified fluid type and reference pharmacokinetics information associated with a reference set of control parameters (preset control rule) to convert the control parameters into updated values suitable for use with the identified fluid type), comprises:
obtaining feedback information of the infusion pump for a preset time period (Lau paragraph [0066] teaches obtaining feedback information of the infusion pump for a preset time period when a new reservoir containing a different type of insulin drug replaces the depleted previous reservoir);
wherein the feedback information comprising fluid information of the infusion pump (Lau paragraphs [0005]-[0007] teach receiving feedback information that the second fluid onboard the infusion device has different pharmacokinetics characteristics);
determining, according to the feedback information, the preset correction rule, and adjusting the control rule of the target infusion consumable according to the preset correction rule (Lau paragraphs [0005]-[0007] teach updating (adjusting) the one or more control rule parameters using the feedback information that a different second fluid is onboard, and paragraph [0065] teaches utilizing the relationship between the pharmacokinetics information associated with the identified fluid type and reference pharmacokinetics information associated with a reference set of control parameters (preset control rule) to convert the control parameters into updated values suitable for use with the identified fluid type).
In regards to claim 5, Lau teaches the method (Lau abstract) further comprising:
determining a plurality of control rules for the target infusion consumable (Lau paragraph [0058] and [0065] teach determining a plurality of control parameters that are influenced or otherwise dictated by the pharmacokinetics of the fluid being delivered);
determining, according to the feedback information, the preset correction rule and adjusting the control rule of the target infusion consumable according to the preset correction rule (Lau paragraph [0065] teaches determining, according to the feedback information with an identified different fluid type, a reference set of control parameters (preset control rule) for carrying out adjustments to convert (adjust) the control parameters into updated values suitable for use with the identified fluid type), by:
determining, according to the feedback information, a preset correction rule corresponding to a first control rule of the target infusion consumable (Lau paragraph [0065] teaches determining a reference set of control parameters including for a first control parameter, according to the feedback information of the identified different fluid type); and
adjusting at least one control rule of the target infusion consumable according to the preset correction rule of the first control rule (Lau paragraph [0065] teaches adjusting the control rule according to the preset correction rule (including the first control rule parameter) being scaled up or down).
In regards to claim 6, Lau teaches the method further comprising:
determining for the infusion pump a plurality of control rules for a plurality of infusion consumables stored therein (Lau paragraph [0065] teaches determining a plurality of control parameters (control rules) for a plurality of infusion consumables (different types of fluids), each having their own unique set of control parameters),
adjusting a control rule of at least one other type of infusion consumable stored within the infusion pump according to the preset correction rule (Lau paragraph [0065] teaches determining appropriate adjustments to the control rule of at least one of the other types of infusion consumables (depending on which fluid is onboard) relative to the reference set of control parameters (preset control rule)).
In regards to claim 7, Lau teaches the method wherein the step of obtaining feedback information from the infusion pump for the preset time period (Lau paragraph [0066] teaches obtaining feedback information of the infusion pump for a preset time period when a new reservoir containing a different type of insulin drug replaces the depleted previous reservoir) is followed by:
determining, according to the feedback information, actual consumable information of the target infusion consumable (Lau paragraphs [0005]-[0007] teach determining according to the identification feedback that a different fluid is onboard, actual pharmacokinetics characteristics (consumable information) of the identified fluid).
In regards to claim 8, Lau teaches the method wherein the method further comprises: updating the control rule of the target infusion consumable (Lau paragraphs [0005]-[0007] teach updating (adjusting) the one or more control rule parameters referenced by a control module to the proper control parameters of identified different fluid).
In regards to claim 9, Lau teaches a control method of an infusion pump (Lau abstract and paragraph [0020] teach a method for controlling an infusion pump device), comprising:
determining a control rule of a target infusion consumable set to the infusion pump (Lau paragraphs [0005]-[0007] teach determining a respective set of one or more control parameters (control rule) corresponding to each fluid type that reflect the pharmacokinetics characteristics associated with the onboard target infusion fluid);
operating the infusion pump according to the control rule, and obtaining feedback information of the infusion pump for a preset time period, wherein the feedback information comprises fluid information of the infusion pump (Lau paragraphs [0005]-[0007] teach operating the infusion pump according to the control parameters (control rule) and obtaining feedback that a different fluid type is currently onboard the infusion device pump; Lau paragraph [0066] teaches obtaining feedback information of the infusion pump for a preset time period when a new reservoir containing a different type of insulin drug replaces the depleted previous reservoir);
determining, according to the feedback information, actual consumable information of the target infusion consumable (Lau paragraphs [0005]-[0007] teach determining according to the identification feedback that a different fluid is onboard, actual pharmacokinetics characteristics (consumable information) of the identified fluid).
In regards to claim 10, Lau teaches the method wherein the control rule comprises at least one of: an infusion accuracy control rule, a blocking pressure control rule, a bubble judgment rule, and a drive mechanism current adjustment rule (Lau paragraph [0037] teaches where the control parameter (control rule) of the control electronics comprises at least command signals that operate a motor driver to regulate the amount of power (drive mechanism current) supplied to the pump motor from a power supply, for actuating the drive train components of the drive system to force fluid from the reservoir along a fluid path).
In regards to claim 11, Lau teaches the method wherein a plurality of preset consumable information and identification information of an infusion consumable associated with each the preset consumable information are stored in the infusion pump (Lau paragraphs [0007], [0058], and [0065] teach where a plurality of preset pharmacokinetics characteristics (consumable information) and identification information of an infusion consumable fluid associated with each type of different consumable fluid are stored in a data storage element of the infusion pump);
the method further comprising:
comparing the actual consumable information with the plurality of preset consumable information stored in the infusion pump to determine identification information for the target infusion consumable (Lau paragraphs [0005]-[0007] and [0065] teach comparing the actual consumable pharmacokinetics characteristics with the plurality of preset consumable information stored in the data storage element to identify whether a different fluid from a previous fluid is onboard the infusion pump).
In regards to claim 12, Lau teaches the method wherein the method further comprises: outputting the identification information of the target infusion consumable (Lau paragraph [0038] teaches outputting the identification information of the program parameters and delivery profiles of the target infusion consumable fluid onto a display 226).
In regards to claim 13, Lau teaches the method further comprising:
storing in the infusion pump identification information of a plurality of infusion consumables and preset consumable information associated with each the identification information (Lau paragraphs [0007], [0058], and [0065] teach storing a plurality of preset pharmacokinetics characteristics (consumable information) and identification information of an infusion consumable fluid associated with each type of different consumable fluid in a data storage element of the infusion pump)
obtaining the identification information of the target infusion consumable (Lau paragraphs
[0005]-[0007] teach obtaining an identification of a fluid type (identification or consumable information) and its pharmacokinetics characteristics
determining, according to the identification information, preset consumable information associated with the identification information (Lau paragraphs [0005]-[0007] teach determining respective fluid pharmacokinetics associated with the identification information of each fluid); and
calculating a deviation value between the actual consumable information and the preset consumable information (Lau paragraph [0005]-[0007] teach calculating a difference (deviation value) between an actual consumable information of pharmacokinetic characteristics of a second fluid onboard the infusion pump that is different from the pharmacokinetic characteristics of the preset first/previous fluid), and issuing an alarm prompt when the deviation value reaches a preset deviation threshold (Lau paragraph [0067] teaches issuing an alert (alarm prompt) when different pharmacokinetics for a new insulin drug trigger the diagnostic checks (reach a preset deviation threshold) to reflect the different pharmacokinetics).
In regards to claim 14, Lau teaches the method further comprising:
determining the actual consumable information of the target infusion consumable (Lau paragraphs [0005]-[0007] teach determining the actual pharmacokinetics characteristics of the second fluid type onboard the infusion pump); and
adjusting a control rule stored within the infusion pump associated with the actual consumable information (Lau paragraphs [0005]-[0007] and [0065] teach adjusting the control parameters (control rule) associated with the pharmacokinetics characteristics of the second fluid).
In regards to claim 15, Lau teaches an infusion pump (Lau abstract and paragraph [0020] teach an infusion pump), comprising:
a controller, a drive mechanism, an extrusion member and an infusion consumable (Lau paragraphs [0030]-[0032] and [0036] teach where the infusion pump comprises an electronics assembly (204) comprising control electronics (224), a drive mechanism (208), an extrusion member slide 206, and an infusion consumable fluid);
wherein the controller is connected to the drive mechanism, the drive mechanism is connected to the extrusion member in a drive connection, and the extrusion member is disposed on a tube wall of the infusion consumable (Lau Fig. 4 teaches where the control electronics (224) is connected to the drive mechanism (208), the drive mechanism connected to the extrusion member slide (206), and the extrusion member slide is disposed to push a plunger 217 on a reservoir barrel (tube) wall 219 of the infusion consumable fluid for displacing the infusion consumable fluid);
the controller is configured to cause the infusion pump to perform a control method of an infusion pump (Lau paragraph [0037] teaches the control electronics being configured to operate a control method of an infusion pump by regulating the amount of power supplied to the motor to displace the slide to administer doses of consumable fluid), the controller being further configured:
to determine at least one of identification information or consumable information of a target infusion consumable set to the infusion pump (Lau paragraphs [0005]-[0007] teach identifying a fluid type (identification or consumable information) of a target infusion fluid (consumable) currently onboard (set to) the infusion pump that has different pharmacokinetics characteristics than an earlier fluid);
to determine, according to the at least one of identification information or consumable information, a control rule corresponding to the target infusion consumable of the infusion pump (Lau paragraphs [0005]-[0007] teach determining a respective set of one or more control parameters (control rule) corresponding to each fluid type that reflect the pharmacokinetics characteristics associated with the onboard target infusion fluid); and
to adjust the control rule corresponding to the target infusion consumable according to a preset correction rule (Lau paragraphs [0005]-[0007] teach updating (adjusting) the one or more control rule parameters referenced by a control module from first values associated with a first fluid type to second values associated with a second fluid type when the second different fluid is identified, and paragraph [0065] teaches utilizing the relationship between the pharmacokinetics information associated with the identified fluid type and reference pharmacokinetics information associated with a reference set of control parameters (preset control rule) to convert the control parameters into updated values suitable for use with the identified fluid type).
In regards to claim 16, Lau teaches the infusion pump (Lau abstract and paragraph [0020]), wherein the controller is further configured to determine the at least one of identification information and consumable information of the target infusion consumable set to the infusion pump (Lau paragraphs [0005]-[0007] teach identifying a fluid type (identification or consumable information) of a target infusion fluid (consumable) currently onboard (set to) the infusion pump that has different pharmacokinetics characteristics than an earlier fluid) by determining the at least one of identification information or consumable information of the target infusion consumable by at least one of a consumable identification device or an interaction device in communication with the infusion pump (Lau paragraph [0072] teaches determining the identification information of the target infusion consumable by using corresponding sensors (such as a optical sensing device) in communication with the infusion pump to scan a barcode identifying the target fluid).
In regards to claim 17, Lau teaches the infusion pump (Lau abstract and paragraph [0020]), wherein controller is further configured to adjust the control rule corresponding to the target infusion consumable according to the preset correction rule (Lau paragraphs [0005]-[0007] teach updating (adjusting) the one or more control rule parameters referenced by a control module from first values associated with a first fluid type to second values associated with a second fluid type when the second different fluid is identified, and paragraph [0065] teaches utilizing the relationship between the pharmacokinetics information associated with the identified fluid type and reference pharmacokinetics information associated with a reference set of control parameters (preset control rule) to convert the control parameters into updated values suitable for use with the identified fluid type), by:
operating the infusion pump according to the control rule corresponding to the target infusion consumable (Lau paragraphs [0005]-[0007] teach operating the infusion pump according to the control parameters (control rule));
obtaining feedback information of the infusion pump for a preset time period (Lau paragraph [0066] teaches obtaining feedback information of the infusion pump for a preset time period when a new reservoir containing a different type of insulin drug replaces the depleted previous reservoir);
wherein the feedback information comprising fluid information of the infusion pump (Lau paragraphs [0005]-[0007] teach receiving feedback information that the second fluid onboard the infusion device has different pharmacokinetics characteristics);
determining, according to the feedback information, the preset correction rule, and adjusting the control rule of the target infusion consumable according to the preset correction rule (Lau paragraphs [0005]-[0007] teach updating (adjusting) the one or more control rule parameters using the feedback information that a different second fluid is onboard, and paragraph [0065] teaches utilizing the relationship between the pharmacokinetics information associated with the identified fluid type and reference pharmacokinetics information associated with a reference set of control parameters (preset control rule) to convert the control parameters into updated values suitable for use with the identified fluid type).
In regards to claim 18, Lau teaches the infusion pump (Lau abstract and paragraph [0020]), wherein the target infusion consumable is associated with a plurality of control rules (Lau paragraph [0058] and [0065] teach wherein the target infusion fluid consumable is associated with a plurality of control parameters that are influenced or otherwise dictated by the pharmacokinetics of the fluid);
controller is further configured to determine, according to the feedback information, the preset correction rule and adjusting the control rule of the target infusion consumable according to the preset correction rule (Lau paragraph [0065] teaches determining, according to the feedback information with an identified different fluid type, a reference set of control parameters (preset control rule) for carrying out adjustments to convert (adjust) the control parameters into updated values suitable for use with the identified fluid type), by:
determining, according to the feedback information, a preset correction rule corresponding to a first control rule of the target infusion consumable (Lau paragraph [0065] teaches determining a reference set of control parameters including for a first control parameter, according to the feedback information of the identified different fluid type);
adjusting at least one control rule of the target infusion consumable according to the preset correction rule of the first control rule (Lau paragraph [0065] teaches adjusting the control rule according to the preset correction rule (including the first control rule parameter) being scaled up or down).
In regards to claim 19, Lau teaches the infusion pump (Lau abstract and paragraph [0020]), wherein
the infusion pump is in communication with a storage device that stores a plurality of control rules for a plurality of infusion consumables (Lau paragraphs [0007], [0058], and [0065] teach where the infusion pump is in communication with a data storage element or parameter registers that store a plurality of control parameters (rules) for the plurality of infusion consumables), the controller being further configured to adjust a control rule of at least one other type of infusion consumable stored within the infusion pump according to the preset correction rule (Lau paragraph [0065] teaches the controller adjusting the control rule parameters of at least one of the other types of infusion consumables (depending on which fluid is onboard) relative to the reference set of control parameters (preset control rule)).
In regards to claim 20, Lau teaches the infusion pump (Lau abstract and paragraph [0020]), wherein the controller is further configured to update the control rule of the target infusion consumable (Lau paragraphs [0005]-[0007] teach the control system updating (adjusting) the one or more control rule parameters to the proper control parameters of identified different fluid).
Pertinent Art
5. Applicants are directed to consider additional pertinent prior art included on the Notice of References Cited (PTOL 892) attached herewith. The Examiner has pointed out particular references contained in the prior art of record within the body of this action for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply. Applicant, in preparing the response, should consider fully the entire reference as potentially teaching all or part of the claimed invention, as well as the context of the of the passage as taught by the prior art or disclosed by the Examiner. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
B. Campbell et al. (US Pat. Pub. 2007/0118405) discloses User Interface for Infusion Pump Remote Controller and Method of Using the Same.
C. Carlisle et al. (US Pat. Pub. 2010/0063765) discloses Flow Sensor Calibrated by Volume Changes.
D. Kawamura (US Pat. Pub. 2011/0152697) discloses Circulatory Pressure Monitoring Using Infusion Pump Systems.
E. Imhof et al. (US Pat. Pub. 2014/0180238) discloses Pump Controlling Device that Obtains Parameter Values from Insulin Pump for Executing Functions.
F. Zhu (US Pat. Pub. 2014/0207057) discloses Infusion Pump and Method to Enhance Long Term Medication Delivery Accuracy.
G. Blomquist (US Pat. Pub. 2015/0217044) discloses Expert System for Insulin Pump Therapy.
H. Tsoukalis (US Pat. Pub. 2017/0290974) discloses Infusion Pump System.
I. Lee (US Pat. Pub. 2020/0147303) discloses Infusion Pump Control Method, Infusion Pump and Tube Cassette for Fluid Delivery.
J. Estes (US Pat. Pub. 2020/0188588) discloses Operating an Infusion Pump System.
K. Abal et al. (US Pat. Pub. 2021/0369963) discloses Integrated Liquid Flow Closed Loop Sensing and Control.
Conclusion
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL D LEE whose telephone number is (571)270-1598. The examiner can normally be reached on M to F, 9:30 am to 6 pm.
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, Arleen Vazquez can be reached at 571-272-2619. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL D LEE/Primary Examiner, Art Unit 2857 6/8/2026
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