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 .
Acknowledgments
In the reply, filed on March 17, 2026, Applicant amended claims 1-6 and 8-9.
Applicant cancelled claim 7.
Applicant added new claims 10-14.
In the non-final rejection of December 23, 2025, Examiner noted that the listing of references in the specification is not a proper information disclosure statement. Applicant cited the indicated reference in an information disclosure statement on March 31, 2026. Concern is withdrawn.
Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to the Disclosure. Applicant amended the Specification. Objection is withdrawn.
Examiner objected to claims 1-9. Applicant amended claims 1-9. Objection is withdrawn.
Examiner rejected claims 3 and 5 under 35 U.S.C. 112(b). Applicant amended claims 3 and 5. Rejection is withdrawn.
Currently, claims 1-6 and 8-14 are under examination.
Claim Objections
Claims 1 and 14 are objected to because of the following informalities:
In regards to claim 1, line 9, “the duration” should be changed to “a duration”.
In regards to claim 14, lines 3-4, “the second half of the aspirate operation” should be changed to “the second half of the duration of the aspirate operation”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10-11 and 13-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 10, lines 1-4 recite: wherein the processing device is configured to terminate operation of the pumping mechanism when the one or more pump measurements “obtained during the selected portion of the duration of the aspirate operation” satisfies the designated metric; however, such is new matter not described in the Specification.
In regards to claim 11, lines 1-5 recite: wherein the processing device is configured to disregard the one or more pump measurements “obtained during the selected portion of the duration of the aspirate operation” when the one or more pump measurements is characterized by transient increases therein from normal operation of the pumping mechanism; however, such is new matter not described in the Specification.
In regards to claim 13, lines 1-5 recite: “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 and the selected partial portion of the duration of the aspirate operation is during the subsequent remaining time period in the duration of the aspirate operation”; however, such is new matter not described in the Specification.
In regards to claim 14, lines 1-4 recite: “wherein the duration of the aspirate operation is characterized by a first half of the duration and a second half of the duration and the selected portion of the duration of the aspirate operation is the second half of the aspirate operation”; however, such is new matter not described in the Specification.
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 1-6 and 8-14 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 1, lines 8-9 recite “one or more pump measurements”. Claim 1, line 5 previously recites “one or more pump measurements”. It is unclear whether the two recitations are the same or different. Claims 2-6 and 8-14 are rejected by virtue of being dependent upon claim 1.
In regards to claim 2, lines 1-2 recite “the one or more pump measurements”. Claim 2 depends upon claim 1. Claim 1, line 5 recites “one or more pump measurements” and lines 8-9 recite “one or more pump measurements”. It is unclear which one or more pump measurements of claim 1 are being referred to in claim 2.
In regards to claim 3, lines 2-3 recite “the one or more pump measurements”. Claim 3 depends upon claim 1. Claim 1, line 5 recites “one or more pump measurements” and lines 8-9 recite “one or more pump measurements”. It is unclear which one or more pump measurements of claim 1 are being referred to in claim 3.
In regards to claim 4, line 3 recites “the one or more pump measurements”. Claim 4 depends upon claim 1. Claim 1, line 5 recites “one or more pump measurements” and lines 8-9 recite “one or more pump measurements”. It is unclear which one or more pump measurements of claim 1 are being referred to in claim 4. Claim 5 is rejected by virtue of being dependent upon claim 4.
In regards to claim 6, lines 5-6 recite “the one or more pump measurements”. Claim 6 depends upon claim 1. Claim 1, line 5 recites “one or more pump measurements” and lines 8-9 recite “one or more pump measurements”. It is unclear which one or more pump measurements of claim 1 are being referred to in claim 6.
In regards to claim 8, lines 2-3 recite “the one or more pump measurements”. Claim 8 depends upon claim 1. Claim 1, line 5 recites “one or more pump measurements” and lines 8-9 recite “one or more pump measurements”. It is unclear which one or more pump measurements of claim 1 are being referred to in claim 8.
In regards to claim 8, line 3 recites “one or more portions” of the duration of the aspirate operation. Claim 8 depends upon claim 1. Claim 1, line 9 recites “a selected portion” of the duration of the aspirate operation. It is unclear whether the two recitations are the same or different.
In regards to claim 9, lines 1-2 recite “the one or more pump measurements”. Claim 9 depends upon claim 1. Claim 1, line 5 recites “one or more pump measurements” and lines 8-9 recite “one or more pump measurements”. It is unclear which one or more pump measurements of claim 1 are being referred to in claim 9.
In regards to claim 11, line 3 recites “the one or more pump measurements”. Claim 11 depends upon claim 1. Claim 1, line 5 recites “one or more pump measurements” and lines 8-9 recite “one or more pump measurements”. It is unclear which one or more pump measurements of claim 1 are being referred to in claim 11.
In regards to claim 12, line 3 recites “aspirate operations”. Claim 12 depends upon claim 1. Claim 1, lines 3-4 recite “an aspirate operation”. It is unclear whether the two recitations are related or different.
In regards to claim 12, line 4 recites “some aspirate operations”. Claim 12 depends upon claim 1. Claim 1, lines 3-4 recite “an aspirate operation”. It is unclear whether the two recitations are related or different.
In regards to claim 12, line 4 recites “other aspirate operations”. Claim 12 depends upon claim 1. Claim 1, lines 3-4 recite “an aspirate operation”. It is unclear whether the two recitations are related or different.
In regards to claim 13, line 3 recites “the selected partial portion”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 13 depends upon claim 1. Claim 1, line 9 recites “a selected portion”. It is unclear whether the two recitations are the same or different.
In regards to claim 14, line 1 recites: The infusion device as claimed in “claim 7”. However, claim 7 is a cancelled claim. Thus, the dependency of claim 14 is unclear. For the purposes of examination, claim 14 is being examined as if dependent upon claim 1.
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 1-6, 9-10, and 12-14 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 one or more 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 2, Tieck teaches wherein the one or more 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 one or more 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 during the aspirate operation when the one or more pump measurements satisfies the designated metric, and determine when the additional pump measurements satisfies the designated metric before a 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 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 9, Tieck teaches wherein the one or more 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 10, Tieck teaches wherein the processing device is configured to terminate operation of the pumping mechanism when the one or more pump measurements obtained during the selected portion of the duration of the aspirate operation 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 12, Tieck teaches wherein the processing device is configured to analyze data chosen from number of aspirate operations performed by the pump, and to analyze some aspirate operations differently from other aspirate operations based on the data when determining if empty reservoir condition criteria are satisfied (column 47, lines 32-37: The fluid infusion device can include a suitably configured detection circuit that monitors and analyzes the current of the drive motor. The current can be analyzed as a function of time, angular position of the rotor, motor position, or the like. The detection circuit can compare the measured motor current against saved current profiles or response curves to determine whether the fluid pump mechanism is operating in a normal and expected manner, whether an upstream occlusion has occurred, whether a downstream occlusion has occurred, or the like. For example, 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. The detection circuit can be designed to take appropriate action if it observes this type of characteristic difference in the measured motor current. It should be appreciated that the methodology presented in this section can also be utilized to detect the presence of downstream occlusions if so desired)(column 51, lines 10-33: In practice, the detection circuit described in this section can be designed to observe signal characteristics that result from interaction between the sensing element and the sensor contact elements 1312, 1314. In this regard, a different signal pattern will be generated for each revolution of the rotor, which corresponds to one pumping cycle. The detection circuit can monitor the obtained sensor signal pattern to determine the current operating condition/state of the fluid pump mechanism. For the embodiment presented in this section, a detected pattern of S1=LOW+S2=HIGH indicates normal operation (where S1 is the state of the first sensor contact element 1314 and S2 is the state of the second sensor contact element). A detected pattern of S1=HIGH+S2=HIGH indicates an upstream occlusion condition, and a detected pattern of S1=LOW+S2=LOW indicates a downstream occlusion condition. Alternatively, the detection circuit can simply count the number of detected “hits” during each rotation of the rotor 1308, without necessarily keeping track of which sensor contact element 1312, 1314 was contacted: only one count indicates normal operation; two counts indicates an upstream occlusion; and zero counts indicates a downstream occlusion. This simple encoding scheme makes it easy for the detection circuit to distinguish the three operating conditions of interest).
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 and the selected partial portion of the duration of the aspirate operation is during the subsequent remaining time period in the duration of the aspirate operation (column 12, lines 15-21: 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)(Figure 15)(Figure 16)(Figure 43).
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 and the selected portion of the duration of the aspirate operation is the second half of the aspirate operation (column 12, lines 15-21: 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)(Figure 15)(Figure 16)(Figure 43).
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 8 and 11 are 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 the one or more 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 the one or more 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.
In regards to claim 11, Tieck is silent about wherein the processing device is configured to disregard the one or more pump measurements obtained during the selected portion of the duration of the aspirate operation when the one or more pump measurements is 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 the one or more pump measurements obtained during the selected portion of the duration of the aspirate operation when the one or more pump measurements is 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.
Response to Arguments
Applicant's arguments filed March 17, 2026, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: Claim 1, as amended herein to incorporate dependent claim 7, requires that the processing device analyze pump measurements "obtained during a selected portion of the duration of the aspirate operation." The Office Action references Tieck col. 15, 11. 1-7 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 (Remarks, pages 8-9). Examiner disagrees. Tieck teaches to analyze one or more pump measurements obtained during the aspirate operation and to analyze one or more pump measurements obtained during a selected portion of the duration of the aspirate operation (column 14, lines 63-67, to column 15, lines 1-7: status sensors 408 can be electrically coupled to the fluid pump mechanism 136 and to the printed circuit board 401 to monitor certain operating conditions, parameters, or characteristics of the fluid pump mechanism 136 and/or other components of the fluid infusion device 100. For example, the 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)(column 12, lines 15-21: 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).
In regards to claims 4-5, Applicant argued: Claim 4, however, requires conditional logic, that is, "when the one or more pump measurements satisfies the designated metric," the processing device analyzes "additional pump measurements" and determines that the additional pump measurements satisfy the designated metric "before terminating operation of the pumping mechanism." Claim 5 then ties termination to the additional pump measurements (i.e., "when the additional pump measurements satisfy the designated metric"). Tieck's laundry list of independent detection methodologies in col. 38, 11. 38-50 fail to teach the claimed sequence or confirmatory logic using "additional pump measurements" per claims 4 and 5. Tieck nowhere discloses conditioning termination on additional measurements, let alone additional pump measurements during that aspirate operations, nor any sequence of verification operations tied to pump measurements per claims 4 and 5 (Remarks, page 9). Examiner disagrees. Tieck teaches to analyze additional pump measurements during the aspirate operation (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), and to terminate 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, Applicant argued: In addition, 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 (Remarks, pages 9-10). 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)).
In regards to claim 8, Applicant argued: Claim 8 recites that the processing device "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." Tieck contains no disclosure of identifying transient portions within an aspirate operation, nor deliberately disregarding or excluding those data from the analysis. The Office Action expressly admits on page 10 that Tieck is silent on this limitation, and then attempts to overcome this deficiency of Tieck with a generic rationale that "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." In other words, the Examiner suggests modifying Tieck to disregard transients as recited in claim 8 since doing so would allegedly would improve reliability of Tieck. Applicant respectfully disagrees with this insufficient rationale for the proposed modification of Tieck. Tieck provides multiple disparate upstream occlusion (end of reservoir) detection methodologies (e.g., force sensors, optical sensors, motor-current profiling, and axial velocity per Methodologies 1 through 11 in Tieck c. 38, 1.18 through c. 52, 1. 45), but nowhere in Tieck teaches or suggests segmentation of a motor current trace during a pumping cycle as described with reference to Tieck, Fig. 15, c. 46, 1. 51 to c. 47, 1. 57 to discard any transient portions therein, nor is there any teaching or suggestion of doing so during the fluid intake period 816, to purportedly achieve the recitations of claim 8. Instead, Tieck teaches to observe the full-cycle current profile and identify peaks and returns to a baseline therein (e.g., Upstream Occlusion Detection: methodology 10). More specifically, Tieck describes using characteristic changes in motor current over the entire cycle to detect occlusion/end-of-reservoir conditions, not ignoring them. For example, with reference to Tieck col. 47, 11. 16-52, the current consumption of a DC motor is described as proportional to the output torque such that, when the rotor cam element 722 is traveling on a reference surface 736, the motor current is somewhat stable, flat, and relatively low. In contrast, when the rotor cam element 722 is engaged with the stator cam element 706, the net effect is an increase in drive current consumption whereby the drive current peaks when the rotor cam element 722 reaches the plateau of the stator cam element 706 and then gradually decreases as the rotor cam element 722 continues traveling across the plateau. After the rotor cam element 722 disengages from the stator cam element 706, the drive current returns to its relatively low and stable baseline level. If the fluid reservoir is empty, then the motor current will exhibit measurably different characteristics (e.g., the vacuum created by an empty reservoir will increase the output torque of the motor 138 to overcome the vacuum force during the fluid intake period and, 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). Thus, the detection circuit in Tieck compares the measured motor current against saved current profiles or response curves to determine whether the fluid pump mechanism is operating in a normal and expected manner, whether an upstream occlusion has occurred, whether a downstream occlusion has occurred, or the like. These example passages illustrate how Tieck uses motor current profiles or response curves for detection and there is no disclosure to disregard any motor current values. The Office Action provides no evidence of a finite set of predictable solutions leading to the claimed selective disregard solution (i.e., "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" per claim 8), nor of a reasoned motivation to implement the solution in claim 8 in Tieck's system. The rejection therefore rests on impermissible hindsight and fails under MPEP § 2143. Absent a teaching to identify and exclude transients in the fluid intake portion of a pumping cycle as shown in Tieck Fig. 15, and given the multitude of other processing choices in Tieck (e.g., Upstream Occlusion Detection (End of Reservoir Detection) Methodologies 1 through 11 in Tieck c. 38, 1.18 through c. 52, 1. 45), a person having ordinary skill in the art would not be led to modify Tieck with the specific approach of claim 8 (Remarks, pages 10-12). Examiner disagrees. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Thus, 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 the one or more 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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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