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 .
Claim Objections
Claims 1 and 18 are objected to because of the following informalities:
In claim 1, line 5: “a infusion line set” should be “an infusion line set
In claim 1, line 9: “pressure chance” should be “pressure change”
In claim 18, line 1: “of claim 1” should be “of claim 11” (based on the header of the claim being for an “infusion pump”)
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 8 and 9 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 claims 8 and 9, the limitation “the amount of compression” in line 1 lack antecedent basis. However, claim 7 introduces the limitation “an amount of compression.” For compact prosecution purposes, claims 8 and 9 are interpreted as depending on claim 7.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 7, 9-13, 17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mazlish et al (US 2017/0203036).
Regarding claim 1, Mazlish discloses:
A method comprising: detecting, with one or more pressure sensors (¶0088) associated with an infusion pump (100; Fig. 2A), a pressure change outside of a pressure threshold in an intravenous infusion line associated with the infusion pump (100) (620; Fig. 10); determining whether the pressure change is due to backpressure (¶0010) associated with a infusion line set connected to the intravenous infusion line or due to static pressure associated with a fluid container providing a fluid to the intravenous infusion line (¶0010), said determining based at least in part on which of the one or more pressure sensors associated with the infusion pump detected the pressure chance (¶0048); determining that the pressure change occurred over a first threshold period of time (¶0048 – the signals are collected on a periodic basis, which indicates a period of time for the change); determining that the pressure change did not result from an occlusion event based on the pressure change occurring over the first threshold period of time (¶0050 – pressure change can be determined to be a hydrostatic pressure); and after determining that the pressure change did not result from an occlusion event: when the pressure change is due to backpressure, the method includes at least one of: (a) providing a first indication that the pressure change is associated with the patient infusion line set (¶0010 – “may indicate that an amount of insulin thought to have been delivered was not delivered”; ¶0052), and (b) generating, using a first decision model (Fig. 11), a backpressure adjustment for the infusion pump, the first decision model configured to generate the backpressure adjustment based at least in part on the pressure change and a characteristic of the infusion pump during the first threshold period of time, and causing the infusion pump to adjust operation in accordance with the backpressure adjustment (¶0054); and when the pressure change is due to static pressure, the method includes at least one of: (a) providing a second indication that the pressure change is associated with the fluid container (¶0052 – factors like altitude difference can be indicated), and (b) generating, using a second decision model (Fig. 10), a static pressure adjustment for the infusion pump, the second decision model configured to generate the static pressure adjustment based at least in part on the pressure change, a first characteristic of the infusion pump during the first threshold period of time (640), and a second characteristic of the fluid container (650), and causing the infusion pump to adjust operation in accordance with the static pressure adjustment (610; ¶0070).
Regarding claim 2, Mazlish discloses:
The method of claim 1, wherein providing the indication that the pressure change is associated with the fluid container comprises providing an audio or visual indication (¶0075 – tips can include an audiovisual presentation) that a height of the fluid container with respect to the infusion pump should be adjusted (¶0050).
Regarding claim 3, Mazlish discloses:
The method of claim 1, wherein providing the indication that the pressure change is associated with the patient infusion line set comprises providing an audio or visual indication (¶0075 – tips can include an audiovisual presentation) that a height of the patient infusion line set with respect to the infusion pump should be adjusted (¶0050).
Regarding claim 7, Mazlish discloses:
The method of claim 1, wherein causing the infusion pump to adjust operation in accordance with the backpressure adjustment (¶0054) comprises adjusting a motor speed of the infusion pump or an amount of compression provided to the intravenous infusion line by the infusion pump based on a first algorithm, and wherein causing the infusion pump to adjust operation in accordance with the static pressure adjustment comprises adjusting a motor speed of the infusion pump or an amount of compression provided to the intravenous infusion line by the infusion pump based on a second algorithm (¶0122 – the drive motor is adjusted and programmed based on the electronics module, which performs the different adjustments).
Regarding claim 10, Mazlish discloses:
The method of claim 1, further comprising: obtaining, by the infusion pump before the pressure change is detected, parameters pertaining to a desired flow rate and a type of the intravenous infusion line (¶0065 – parameters can be based on a preprogrammed schedule); wherein the motor speed of the infusion pump or an amount of compression provided to the intravenous infusion line is adjusted to adjust a current flow rate of the fluid within the intravenous infusion line towards the desired flow rate (¶0122 – the drive motor is adjusted and programmed based on the electronics module, which performs the different adjustments).
Regarding claim 11, Mazlish discloses:
An infusion pump (100; Fig. 2A), comprising: one or more pressure sensors (¶0088); a processor (242; Fig. 2B) configured to: detect, with the one or more pressure sensors (¶0088), a pressure change outside of a pressure threshold in an intravenous infusion line associated with the infusion pump (620; Fig. 10); determine whether the pressure change is due to backpressure (¶0010) associated with a patient infusion line set associated with the intravenous infusion line or due to static pressure associated with a fluid container providing a fluid to the intravenous infusion line (¶0048); determine that the pressure change occurred over a first threshold period of time (¶0048 – the signals are collected on a periodic basis, which indicates a period of time for the change); determine that the pressure change did not result from an occlusion event based on the pressure change occurring over the first threshold period of time (¶0050 – pressure change can be determined to be a hydrostatic pressure); and after determining that the pressure change did not result from an occlusion event: when the pressure change is due to backpressure, provide an indication that the pressure change is associated with the patient infusion line set (¶0054) and adjusting a motor speed of the infusion pump or an amount of compression provided to the intravenous infusion line by the infusion pump (¶0122 – the drive motor is adjusted and programmed based on the electronics module, which performs the different adjustments) based on a first algorithm (Fig. 11); and when the pressure change is due to static pressure, provide an indication that the pressure change is associated with the fluid container (¶0052 – factors like altitude difference can be indicated) and adjusting the motor speed of the infusion pump or the amount of compression provided to the intravenous infusion line by the infusion pump (¶0122) based on a second algorithm (Fig. 10).
Regarding claim 12, Mazlish discloses:
The infusion pump of claim 11, wherein providing the indication that the pressure change is associated with the fluid container comprises providing an audio or visual indication (¶0075 – tips can include an audiovisual presentation) that a height of the fluid container with respect to the infusion pump should be adjusted (¶0050) that a height of the fluid container with respect to the infusion pump should be adjusted.
Regarding claim 13, Mazlish discloses:
The infusion pump of claim 11, wherein providing the indication that the pressure change is associated with the patient infusion line set comprises providing an audio or visual indication (¶0075 – tips can include an audiovisual presentation) that a height of the patient infusion line set with respect to the infusion pump should be adjusted (¶0050).
Regarding claim 17, Mazlish discloses:
The infusion pump of claim 11, wherein the processor is further configured to: determine that the pressure change is due to backpressure and static pressure (¶0010); adjust the motor speed of the infusion pump or the amount of compression provided to the intravenous infusion line based on the first and second algorithms (¶0122 – the drive motor is adjusted and programmed based on the electronics module, which performs the different adjustments).
Regarding claim 20, Mazlish discloses:
The infusion pump of claim 11, wherein the processor is further configured to: obtain, by the infusion pump before the pressure change is detected, parameters pertaining to a desired flow rate and a type of the intravenous infusion line (¶0065 – parameters can be based on a preprogrammed schedule), wherein the motor speed of the infusion pump or an amount of compression provided to the intravenous infusion line is adjusted to adjust a current flow rate of the fluid within the intravenous infusion line towards the desired flow rate (¶0122 – the drive motor is adjusted and programmed based on the electronics module, which performs the different adjustments).
Allowable Subject Matter
Claims 4-6, 14-16, 18, and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 8-9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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