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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 31, 2026, has been entered.
Acknowledgments
In the reply, filed on July 31, 2026, Applicant requested the consideration of the amendment of July 24, 2026. The amendment is now considered.
In the reply, filed on July 24, 2026, Applicant amended claims 1-4, 6, 8-9, and 12-14.
Applicant cancelled claims 10-11.
In the final rejection of May 26, 2026, Examiner objected to claims 1 and 14. Applicant amended claims 1 and 14. Objection is withdrawn.
Examiner rejected claims 10-11 and 13-14 under 35 U.S.C. 112(a). Applicant cancelled claims 10-11, and persuasively argued support for claims 13-14 (Remarks, pages 5-6). Rejection is withdrawn.
Examiner rejected claims 1-6 and 8-14 are rejected under 35 U.S.C. 112(b). Applicant amended claim 1-4, 6, 8-9, 12-14, and cancelled claim 11. Rejection is withdrawn.
Claim Objections
Claims 6 and 12 are objected to because of the following informalities:
In regards to claim 6, lines 5-6, “the selected measurements” should be changed to “the selected pump measurements”.
In regards to claim 12, line 4, “that aspirate operations” should be changed to “the aspirate operations”.
Appropriate correction is required.
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 1-3, 6, 9, and 13-14 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) comprising:
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 the 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 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)
wherein the processing device is configured to analyze selected pump measurements corresponding to the one or more pump measurements obtained during a selected portion of a duration of the aspirate operation (column 47, lines 41-52: if the fluid reservoir is empty (or if the upstream fluid flow path is blocked), then the motor current will exhibit measurably different characteristics than that described above. In this regard, the vacuum created by an empty reservoir or an upstream occlusion will increase the output torque during the fluid intake period (because the drive motor 138 must overcome the force created by the vacuum). Thus, the measured motor current will exhibit a steeper rise and a higher maximum value during the fluid intake period, relative to the normal motor current characteristics associated with non-occluded operation of the fluid pump mechanism)
In regards to claim 2, Tieck teaches wherein the selected 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 the pumping mechanism when the selected pump measurements satisfiy 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 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 9, Tieck teaches wherein the selected pump measurements are pump motor current (column 47, lines 41-44: if the fluid reservoir is empty…, then the motor current will exhibit measurably different characteristics).
In regards to claim 13, Tieck teaches wherein the duration of the aspirate operation is characterized by a first time period in the duration and a subsequent remaining time period in the duration (column 47, line 50: fluid intake period) and the selected portion of the duration of the aspirate operation is during the subsequent remaining time period in the duration of the aspirate operation (column 47, lines 48-50: the measured motor current will exhibit a steeper rise and a higher maximum value during the fluid intake period).
In regards to claim 14, Tieck teaches wherein the duration of the aspirate operation is characterized by a first half of the duration and a second half of the duration (column 47, line 50: fluid intake period) and the selected portion of the duration of the aspirate operation is the second half of the duration of the aspirate operation (column 47, lines 48-50: the measured motor current will exhibit a steeper rise and a higher maximum value during the fluid intake period).
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.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Tieck, as applied to claim 1 above.
In regards to claim 4, Tieck is silent about wherein the processing device is configured to analyze additional pump measurements during the aspirate operation when the selected pump measurements satisfy the designated metric, and determine when the additional pump measurements satisfies the designated metric before a terminate 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 analyze additional pump measurements during the aspirate operation when the selected pump measurements satisfy the designated metric, and determine when the additional pump measurements satisfies the designated metric before a terminate operation of the pumping mechanism, as such will provide for verification and confirmation that the designated metric is satisfied in order to prevent a premature terminate operation of the pumping mechanism based on the selected pump measurements alone.
In regards to claim 5, in the modified infusion device of Tieck, Tieck is silent about wherein the processing device is configured to terminate the pumping mechanism when the additional pump measurements satisfy the designated metric. 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 modified infusion device of Tieck, to be configured to terminate the pumping mechanism when the additional pump measurements satisfy the designated metric, as such will provide for verification and confirmation that the designated metric is satisfied in order to prevent a premature terminate operation of the pumping mechanism based on the selected pump measurements alone.
Response to Arguments
Applicant's arguments filed July 24, 2026, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: Claim 1 requires that the processing device analyze pump measurements "obtained during a selected portion of the duration of the aspirate operation." The final Office Action references Tieck col. 15, 11. 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" which merely describes generic processing of information provided by status sensors 408. Tieck's status sensors 408 do not teach or suggest pump measurements obtained during the aspirate operation as recited in claim 1, nor analyzing pump measurements obtained during a selected portion of the aspirate operation as recited in claim 1. More specifically, Tieck col. 15, 11. 1-7 merely states "information provided by the status sensors 408 can be processed or otherwise utilized to determine the revolution count of the fluid pump mechanism 136, to determine the resting position of the fluid pump mechanism 136, to detect a downstream occlusion in the fluid delivery path, to detect when the reservoir of the fluid cartridge module 104 is empty, or the like" and the Office Action focuses on "to detect when the reservoir of the fluid cartridge module 104 is empty." This excerpt and the rest of Tieck are completely void of any teaching or suggestion of using pump measurements obtained during an aspirate operation, nor during a selected portion thereof per claim 1… Applicant respectfully submits that a claim is anticipated only when each and every element of the claim is disclosed in a single prior art reference, arranged as in the claim. Here, Tieck does not disclose the claimed processing device configured to "analyze the one or more pump measurements obtained during a selected portion of a duration of the aspirate operation," as recited in independent claim 1. The final Office Action relies on Tieck, column 15, lines 1-7, to allegedly teach this limitation. That passage states only that "information provided by the status sensors 408 can be processed or otherwise utilized" to determine pump revolution count, determine resting position, detect downstream occlusion, detect an empty reservoir, "or the like." This passage in Tieck is merely a generic statement that status-sensor information may be used for various device-status determinations. This passage in Tieck does not disclose analyzing pump measurements obtained during a selected portion of the duration of an aspirate operation, nor does it identify any selected portion of an aspirate-operation duration from which the analyzed pump measurements are obtained… Tieck's more specific motor-current disclosure confirms the distinction rather than eliminating it. In Tieck's "Upstream Occlusion Detection: Methodology 10," Tieck states that a detection circuit may monitor motor current and compare measured motor current against saved current profiles or response curves to determine whether the pump is operating normally or whether an occlusion has occurred. Tieck further states that, when the reservoir is empty or the upstream flow path is blocked, motor current may exhibit a steeper rise and a higher maximum value during the fluid intake period. See Tieck, col. 48, 11. 9-55. This disclosure concerns comparison of motor-current profiles or response curves and observation of characteristic differences during a fluid intake period. It still does not disclose the claim 1 requirement that the processing device analyze pump measurements obtained during a selected portion of the duration of the aspirate operation (Remarks, pages 6-9). Examiner disagrees. Tieck teaches a processing device (420) configured to analyze one or more pump measurements obtained during the aspirate operation and determine when the one or more 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), wherein the processing device is configured to analyze selected pump measurements corresponding to the one or more pump measurements obtained during a selected portion of a duration of the aspirate operation (column 47, lines 41-52: if the fluid reservoir is empty (or if the upstream fluid flow path is blocked), then the motor current will exhibit measurably different characteristics than that described above. In this regard, the vacuum created by an empty reservoir or an upstream occlusion will increase the output torque during the fluid intake period (because the drive motor 138 must overcome the force created by the vacuum). Thus, the measured motor current will exhibit a steeper rise and a higher maximum value during the fluid intake period, relative to the normal motor current characteristics associated with non-occluded operation of the fluid pump mechanism).
In regards to claim 6, Applicant argued: Regarding claim 6, the Office Action references Tieck, col. 27, 11. 42-49 that state: "[W]hen 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)." This excerpt from Tieck is merely a qualitative description of conduit collapse under vacuum, and fails to disclose or suggest any threshold or range or waveform shape of pump measurements to define a designated metric as required by claim 6… Applicant respectfully traverses the Examiner's allegation, in the Response to Arguments, that Tieck discloses "wherein the designated metric is a pressure threshold corresponding to a pump measurement value exceeded when the reservoir is empty" as recited in claim 6 based on Tieck's statement at col. 27, 11. 42-49 that, "when the fluid cartridge module 900 is empty, the stopper ... no longer moves" and therefore "the fluid pump mechanism 902 generates negative pressure on the inlet side" that "collapses the fluid conduit 904 to a greater extent than during normal delivery." Applicant respectfully disagrees. This cited passage describes a qualitative physical condition, that is, greater conduit collapse when the cartridge is empty. This cited passage does not disclose a designated metric, does not disclose a pressure threshold, and does not disclose any pump measurement value that is exceeded when the reservoir is empty. Claim 6 is not satisfied merely because Tieck describes negative pressure or greater conduit collapse. Claim 6 requires the designated metric itself to be one or more of the recited metric types, including "a pressure threshold corresponding to a pump measurement value exceeded when the reservoir is empty," "a range of pump measurement values indicating a pressure above normal operating pressure of the pump," or "a designated shape of a signal waveform corresponding to the one or more pump measurements indicating a pressure above the normal operating pressure of the pump." Tieck, col. 27, 11. 42-49 identifies none of those metrics. The passage does not quantify pressure, set a threshold, define a range of pump measurement values, or identify a waveform shape used as the designated metric. At most, Tieck describes that conduit 904 collapses more than during normal delivery and does not recover to its nominal shape. Accordingly, the Examiner's cited passage does not disclose all limitations of claim 6 arranged as claimed. In addition, claim 6 depends from claim 1 and therefore also includes the claim 1 requirement that the processing device analyze pump measurements obtained during a selected portion of the duration of the aspirate operation, which Tieck does not disclose for the reasons discussed above. Applicant respectfully submits that Tieck does not anticipate claim 6 and requests withdrawal of the rejection of at least claim 6 under 35 U.S.C. § 102(a)(1) (Remarks, pages 11-13). Examiner disagrees. 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)). As the negative pressure collapses fluid conduit 904 to a greater extent and does not recover back to its nominal shape, said negative pressure must be a higher value over a value of negative pressure during normal aspirate operation (i.e. exceeding a normal pressure threshold).
In regards to claims 13-14, Applicant argued: The same deficiencies of Tieck described with respect to claim 1 are found with respect to claims 13 and 14. The final Office Action relies on Tieck's general description of rotor movement and internal valve operation, together with Figures 15, 16, and 43, for the alleged first/subsequent remaining time period and first half/second half limitations recited, respectively, in claims 13 and 14. Although the Tieck description of Figures 15, 16, and 43 may describe pump cycle mechanics, such description does not disclose the processing device analyzing pump measurements obtained during a selected portion of the duration of the aspirate operations that is during the subsequent remaining time period per claim 13, or during the second half of the aspirate operation duration per claim 14. Thus, the Tieck description does not teach the claim limitations as arranged. Because Tieck fails to disclose at least the selected portion analysis required by independent claim 1, Tieck cannot anticipate claim 1 or claims 2-6, 9 and 12-14 depending therefrom. Applicant respectfully requests withdrawal of the rejection under 35 U.S.C. § 102(a)(1) (Remarks, pages 14-15). Examiner disagrees. In regards to claim 13, Tieck teaches the selected portion of the duration of the aspirate operation is during the subsequent remaining time period in the duration of the aspirate operation (column 47, lines 48-50: the measured motor current will exhibit a steeper rise and a higher maximum value during the fluid intake period). And in regards to claim 14, Tieck teaches the selected portion of the duration of the aspirate operation is the second half of the duration of the aspirate operation (column 47, lines 48-50: the measured motor current will exhibit a steeper rise and a higher maximum value during the fluid intake period).
Allowable Subject Matter
Claims 8 and 12 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.
In regards to claim 8, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of an infusion device, as claimed, specifically including wherein the processing device is configured to disregard the selected pump measurements that are characterized by transient increases therein from normal operation of the pumping mechanism.
Tieck teaches a processing device (420) and a pumping mechanism (column 12, lines 13-14: rotor is actuated in a controlled manner by a drive motor 138)
However, Tieck is silent about wherein the processing device is configured to disregard the selected pump measurements that are characterized by transient increases therein from normal operation of the pumping mechanism.
Thus, claim 8 is 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 1.
In regards to claim 12, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of an infusion device, as claimed, specifically including wherein the processing device is configured to perform aspirate operations corresponding to a plurality of the aspirate operation and to analyze data chosen from runtime of a motor in the pumping mechanism, number of that aspirate operations performed by the pump, and estimated fluid amount delivered by the pump, and to analyze some of the aspirate operations differently from other ones of the aspirate operations based on the data when determining if empty reservoir condition criteria are satisfied.
Tieck teaches wherein the processing device (420) is configured to perform aspirate operations corresponding to a plurality of the aspirate operation (column 24, lines 35-36: various intake… cycles).
However, Tieck is silent about wherein the processing device is configured to analyze data chosen from runtime of a motor in the pumping mechanism, number of that aspirate operations performed by the pump, and estimated fluid amount delivered by the pump, and to analyze some of the aspirate operations differently from other ones of the aspirate operations based on the data when determining if empty reservoir condition criteria are satisfied.
Thus, claim 12 is 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 1.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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