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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered:
WO 2015/157174 (paragraphs [0036][0038])
Specification
The abstract of the disclosure is objected to because:
In line 2, “An infusion pump” should be changed to “The infusion pump”
In line 3, “pump measurements” should be changed to “the pump measurements”
In line 3, “aspiration” should be changed to “the aspiration”
In line 4, “pump measurements” should be changed to “the pump measurements”
In lines 4-5, “an empty reservoir condition” should be changed to “the empty reservoir condition”
In line 6, “a reservoir” should be changed to “the reservoir”
In lines 8-9, “normal operating pressure” should be changed to “the normal operating pressure”
In line 9, “Devices” should be changed to “The devices”
In line 9, “methods” should be changed to “the methods”
In line 10, “the duration” should be changed to “a duration”
In lines 10-11, “the aspirate operation” should be changed to “an aspirate operation”
In lines 11-12, “the pumping mechanism” should be changed to “a pumping mechanism”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
A Cross-Reference to Related Application section is missing in which it is stated that the application is a 371 of PCT/US2021/062577, filed 12/09/2021, and has priority to US 63/125,486, filed 12/15/2020.
Appropriate correction is required.
Claim Objections
Claims 1-9 are objected to because of the following informalities:
In regards to claim 1, line 1, “comprises” should be changed to “comprising”.
In regards to claim 1, line 3, “fluid” should be changed to “the fluid”.
In regards to claim 1, line 6, “the one or more of the pump measurements” should be changed to “the one or more pump measurements”.
In regards to claim 2, line 1, “An infusion device” should be changed to “The infusion device”.
In regards to claim 2, line 2, “the pump measurements” should be changed to “the one or more pump measurements”.
In regards to claim 3, line 1, “An infusion device” should be changed to “The infusion device”.
In regards to claim 3, lines 2-3, “the one or more of the pump measurements” should be changed to “the one or more pump measurements”.
In regards to claim 4, line 1, “An infusion device” should be changed to “The infusion device”.
In regards to claim 4, line 2, “the one or more of the pump measurements” should be changed to “the one or more pump measurements”.
In regards to claim 4, line 4, “terminate operation” should be changed to “a terminate operation”.
In regards to claim 5, line 1, “An infusion device” should be changed to “The infusion device”.
In regards to claim 6, line 1, “An infusion device” should be changed to “The infusion device”.
In regards to claim 6, line 5, “the pump measurements” should be changed to “the one or more pump measurements”.
In regards to claim 6, lines 5-6, “normal operating pressure” should be changed to “the normal operating pressure”.
In regards to claim 7, line 1, “An infusion device” should be changed to “The infusion device”.
In regards to claim 7, line 2, “the pump measurements” should be changed to “the one or more pump measurements”.
In regards to claim 7, lines 2-3, “the duration” should be changed to “a duration”.
In regards to claim 8, line 1, “An infusion device” should be changed to “The infusion device”.
In regards to claim 8, line 2, “the pump measurements” should be changed to “the one or more pump measurements”.
In regards to claim 8, line 3, “the duration” should be changed to “a duration”.
In regards to claim 9, line 1, “An infusion device” should be changed to “The infusion device”.
In regards to claim 9, line 1, “the pump measurements” should be changed to “the one or more pump measurements”.
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 3 and 5 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.
In regards to claim 3, line 2 recites “operation”. Claim 3 depends upon claim 1. Claim 1, lines 3-4 recite “an aspiration operation” and line 4 recites “a dispense operation”. It is unclear whether “operation” is the same as or different from “an aspiration operation” or “a dispense operation”.
In regards to claim 5, line 2 recites “operation”. Claim 5 depends upon claim 4. Claim 4, line 4 recites “terminate operation”. Claim 4 depends upon claim 1. Claim 1, lines 3-4 recite “an aspiration operation” and line 4 recites “a dispense operation”. It is unclear whether “operation” is the same as or different from “terminate operation”, “an aspiration operation”, or “a dispense operation”.
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 1-7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tieck (US 10,010,668).
In regards to claim 1, Tieck teaches an infusion device (Figures 1-4) comprises:
a pump (136) comprising a chamber of fluid (column 12, lines 10-20: rotationally actuated micro pump that delivers a calibrated amount of medication fluid… drawing in the medication fluid), and a pumping mechanism (column 12, lines 13-14: rotor is actuated in a controlled manner by a drive motor 138) configured to control aspiration of a volume of fluid from a reservoir into the chamber during an aspirate operation and dispensing the fluid from the chamber during a dispense operation (column 12, lines 15-23: translating rotational movement of the rotor into axial displacement of the rotor relative to the stator. In turn, the translational movement results in the opening and closing of a series of valves that are internal to the fluid pump mechanism 136 for purposes of drawing in the medication fluid from the fluid cartridge module 104. A biasing force (e.g., a spring force) forces the rotor toward the stator, which expels the fluid through the outlet of the fluid pump mechanism 136)
a processing device (420) configured to analyze one or more pump measurements obtained during the aspirate operation and determine when the one or more of the pump measurements satisfies a designated metric related to an empty reservoir condition of the reservoir (column 15, lines 1-7: the information provided by the status sensors 408 can be processed or otherwise utilized… to detect when the reservoir of the fluid cartridge module 104 is empty)
In regards to claim 2, Tieck teaches wherein the pump measurements are measurements of motor current of the pump (column 47, lines 41-44: if the fluid reservoir is empty…, then the motor current will exhibit measurably different characteristics).
In regards to claim 3, Tieck teaches wherein the processing device is configured to terminate operation of the pumping mechanism when the one or more of the pump measurements satisfies the designated metric (column 27, lines 40-49: It should be appreciated that the output of the EAP sensor 906 can also be monitored to detect an “end of reservoir” condition. In this regard, when the fluid cartridge module 900 is empty, the stopper of the fluid reservoir no longer moves because it has reached the limit of its travel. Thus, the fluid pump mechanism 902 generates a negative pressure on the inlet side, which collapses the fluid conduit 904 to a greater extent than experienced during normal delivery (and the fluid conduit 904 does not recover back to its nominal shape).
In regards to claim 4, Tieck teaches wherein the processing device is configured to analyze additional pump measurements when the one or more of the pump measurements satisfies the designated metric, and determine when the additional pump measurements satisfies the designated metric before terminate operation of the pumping mechanism (column 38, lines 38-50: various techniques and technologies for detecting an empty fluid reservoir (also referred to as an upstream occlusion). These techniques are desirable to increase the safety of a medication infusion device. With particular reference to the fluid pump mechanism described here, end of reservoir detection can employ one or more of the following general methodologies, without limitation: (1) detecting that the stopper has reached an end position; (2) detecting that the fluid pump mechanism is pulling on a vacuum rather than drawing in fluid; (3) measurement of the stopper position over the length of the reservoir; and (4) observing axial displacement characteristics of the rotor relative to the stator).
In regards to claim 5, Tieck teaches wherein the processing device is configured to terminate operation of the pumping mechanism when the additional pump measurements satisfy the designated metric (column 39, lines 41-43: the stopper 1068 is frozen in the barrel 1066,… the movement of the stopper 1068 is impeded).
In regards to claim 6, Tieck teaches wherein the designated metric is a pressure threshold corresponding to a pump measurement value exceeded when the reservoir is empty (column 27, lines 42-49: when the fluid cartridge module 900 is empty, the stopper of the fluid reservoir no longer moves because it has reached the limit of its travel. Thus, the fluid pump mechanism 902 generates a negative pressure on the inlet side, which collapses the fluid conduit 904 to a greater extent than experienced during normal delivery (and the fluid conduit 904 does not recover back to its nominal shape)).
In regards to claim 7, Tieck teaches wherein the processing device is configured to analyze one or more of the pump measurements obtained during a selected portion of the duration of the aspirate operation (column 15, lines 1-7: the information provided by the status sensors 408 can be processed or otherwise utilized… to detect when the reservoir of the fluid cartridge module 104 is empty).
In regards to claim 9, Tieck teaches wherein the pump measurements are chosen from pump motor current (column 47, lines 41-44: if the fluid reservoir is empty…, then the motor current will exhibit measurably different characteristics).
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tieck, as applied to claim 1 above.
In regards to claim 8, Tieck is silent about wherein the processing device is configured to disregard one or more of the pump measurements obtained during one or more portions of the duration of the aspirate operation characterized by transient increases therein from normal operation of the pumping mechanism. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processing device, of the infusion device of Tieck, to be configured to disregard one or more of the pump measurements obtained during one or more portions of the duration of the aspirate operation characterized by transient increases therein from normal operation of the pumping mechanism, as such will allow for long-term, reliable pump measurements to be relied upon rather than short-term, potentially inaccurate pump measurements, such as transient increases, when accurately determining the empty reservoir condition of the reservoir.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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