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 .
Election/Restrictions
Applicant’s election, with conditional traversal, of Group I, claims 1-11, in the reply filed on 9/29/25 is acknowledged. Upon further consideration, the requirement for restriction between Groups I-III is hereby withdrawn. No claims are currently withdrawn from consideration.
Response to Amendment
This office action is responsive to the amendment filed on 9/29/25. As directed by the amendment: claim 12 has been amended, claim 13 has been cancelled, and no new claims have been added. Thus, claims 1-12 and 14-20 are presently pending in this application.
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 5, 8, and 17 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 claim 5, the claim appears to positively recite a method step in a product claim, and it is further unclear whether what particular structure or function is intended to be recited.
Regarding claims 8 and 17, the limitation “a first occluder element and a second occluder element” (claim 8) and “first and second occluder elements” (claim 17) are recited, where parent claims previously recited “at least one occluder element”. It is not clear whether the first and second occluder elements are further modifying “at least one occluder element”, or are reciting elements in addition to the original “at least one” occluder element.
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.
Claim(s) 1-12 and 14-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamen et al. (US 20130177455).
Regarding claim 1, Kamen et al. discloses an occluder detection system (at least fig. 175-183 and par. 0626-0647), comprising: at least one occluder element (at least one occluder in the form of 706 and 709; additional occluder elements of inlet pinch valve and outlet pinch valve, see par. 0626 and 0644) configured to move according to a cam motion (cam 702 for 706,709; cams 701 and 703 for inlet and outlet pinch valves) to apply a periodic compression to a flexible infusion line when the flexible infusion line is placed between the occluder element and a plate assembly (par. 0626, 0634), wherein a section of the occluder element is configured to emit or modify an energy or magnetic field (par. 0644, types of sensors used, with plunger/pinch valves being sensed); a sensor configured to measure the energy or magnetic field being emitted or modified by the section of the occluder element (par. 0628, 0634; optical or Hall-effect); one or more processors (par. 0634) configured to: cause the at least one occluder element to move according to the cam motion to move a fluid within the flexible infusion line by periodically compressing the flexible infusion line; measure the energy or magnetic field via the sensor; obtain a current cam state associated with the cam motion at a time corresponding to the measured energy or magnetic field; determine, based on the measured energy or magnetic field, and the current cam state, a state of the occluder element; and cause, responsive to determining the state of the occluder element, an adjustment to a hardware element of a device associated with the flexible infusion line (par. 0626-0647, in particular at least par. 0634).
Regarding claim 2, Kamen et al. discloses an infusion pump 700 (par. 0626), wherein the hardware element is a cam of the infusion pump (par. 0634).
Regarding claim 3, Kamen et al. discloses the occluder element comprises a magnetic object configured to emit the magnetic field, and wherein the sensor is configured to measure a magnetic field emitted by the magnetic object, and wherein the state of the occluder element is determined based on a magnitude and direction of the measured magnetic field (Hall effect sensor; par. 0623, 0634).
Regarding claim 4, Kamen et al. discloses the occluder element comprises a magnetic object configured to emit the magnetic field, and wherein the sensor is a hall effect sensor or a linear inductive encoder configured to measure the magnetic field of the magnetic object and determine position of the magnetic object with respect to the sensor based on the measured magnetic field (Hall effect sensor; par 0623, 0634).
Regarding claim 5, as best understood, Kamen et al. discloses provide, for display on a display device, an indication of the state of the occluder element (such information is provided, such as in par. 0634, to controller/processor and fully capable of being provided for display; additionally, alarms such as described in par. 0629,0630 displayed visually via lights or display for communication with user, par. 0948).
Regarding claim 6, Kamen et al. discloses determining the state of the occluder element comprises: determining a linear displacement of the occluder element from a predetermined expected position of the occluder element corresponding to the current cam state (par. 0634; see further par. 0653).
Regarding claim 7, Kamen et al. discloses the occluder detection system further comprises: an infusion pump 700, wherein the one or more processors are further configured to: determine that the linear displacement of the occluder element did not correspond to a threshold compression of the flexible infusion line, wherein providing the indication of the state of the occluder element comprises activating an alarm indicating that an occluder valve corresponding to the at least one occluder element is defective (par. 0629).
Regarding claim 8, as best understood, Kamen et al. discloses the occluder detection system further comprises: a first occluder element (706,709) and a second occluder element (one of the inlet and outlet pinch valves), a first sensor and a second sensor each configured to measure the energy or magnetic field being emitted or modified by a respective first or second occluder element (optical or Hall effect; par. 0628 and 634; par. 0644 further indicating that such monitoring applies to the plunger as well as the inch valves); wherein the one or more processors are further configured to: cause the first and second occluder elements to move in a predetermined sequence to squeeze the flexible infusion line to infuse predetermined amounts of medication continuously and cyclically into a patient (see at least par. 0628, 0634, 0644); and obtain a current state of each of the first and second occluder elements based on the current cam state and based on determining a position of the respective occluder element based on the measured energy or magnetic field corresponding to the respective occluder element (par. 0626-0647, in particular at least par. 0634 and 0644) , wherein the alarm is activated responsive to determining that the linear displacement of at least one of the first and second occluder elements did not correspond to the threshold compression of the flexible infusion line (par. 0629).
Regarding claim 9, Kamen et al. discloses the state of the occluder element is determined based on the measured energy or magnetic field and the current cam state and a calibration parameter, wherein the one or more processors are further configured to: cause, prior to a normal operation of the occluder detection system, the at least one occluder element to move and apply an initial pressure to the flexible infusion line; and obtain a first measured energy or magnetic field corresponding to a first cam state when the initial pressure is applied; and determine the calibration parameter based on the first measured energy or magnetic field (par. 0955; calibration during assembly establishes normal volume/stroke).
Regarding claim 10, Kamen et al. discloses the state of the occluder element is determined based on the measured energy or magnetic field and the current cam state and a calibration parameter, wherein the one or more processors are further configured to: receive the calibration parameter as a result of a user input at an input device (par. 0628, 0955, 1031).
Regarding claim 11, Kamen et al. discloses the sensor is an photoelectric sensor configured to measure a position at least one occluder element based on detecting a diffusion characteristic of a light transmitted through a portion of the at least one occluder element, and wherein determining the state of the occluder element comprises: determining a linear displacement of the occluder element from a predetermined expected position of the occluder element corresponding to the current cam state (par. 0628, 0634, 0644. 0670, 0671).
Regarding claim 12, Kamen et al. discloses a machine-implemented method, performed by an occluder detection system (method and machine disclosed at least fig. 175-183 and par. 0626-0647), comprising: causing at least one occluder element (at least one occlude in the form of 706 and 709; additional occluder elements of inlet pinch valve and outlet pinch valve, see par. 0626 and 0644) associated with an infusion pump to move according to a cam motion to apply a periodic compression to a flexible infusion line when the flexible infusion line is placed between the occluder element and a plate assembly and to move a fluid within the flexible infusion line (cam 702 for 706,709; cams 701 and 703 for inlet and outlet pinch valves), wherein a section of the occluder element is configured to emit or modify an energy or magnetic field (par. 0644, types of sensors used, with plunger/pinch valves being sensed); measuring, using a sensor, the energy or magnetic field being emitted or modified by the section of the occluder element (par. 0628, 0634; optical or Hall-effect); obtaining a current cam state associated with the cam motion at a time corresponding to the measured energy or magnetic field; determining, based on the measured energy or magnetic field and the current cam state, a state of the occluder element; causing, responsive to determining the state of the occluder element, an adjustment to a hardware element of a device associated with the flexible infusion line (par. 0626-0647, in particular at least par. 0634); and providing, for display on a display device, an indication of the state of the occluder element (such information is provided, such as in par. 0634, to controller/processor; additionally, alarms such as described in par. 0629,0630 displayed visually via lights or display for communication with user, par. 0948).
Regarding claim 14, Kamen et al. further discloses the occluder element comprises a magnetic object configured to emit the magnetic field, and wherein the sensor is a hall effect sensor or a linear inductive encoder configured to measure the magnetic field of the magnetic object and determine position of the magnetic object with respect to the sensor based on the measured magnetic field (Hall effect sensor; par. 0623, 0634).
Regarding claim 15, Kamen et al. discloses determining the state of the occluder element comprises: determining a linear displacement of the occluder element from a predetermined expected position of the occluder element corresponding to the current cam state (par. 0634; see further par. 0653).
Regarding claim 16, Kamen et al. discloses determining that the linear displacement of the occluder element did not correspond to a threshold compression of the flexible infusion line, wherein providing the indication of the state of the occluder element comprises activating an alarm indicating that an occluder valve corresponding to the at least one occluder element is defective (par. 0629).
Regarding claim 17, as best understood, Kamen et al. discloses causing first and second occluder elements (first 706,709 and second at least one of the inlet or outlet pinch valves) to move in a predetermined sequence to squeeze the flexible infusion line to infuse predetermined amounts of medication continuously and cyclically into a patient (see at least par. 0628, 0634, 0644); obtaining, using first and second sensors, a current state of each of the first and second occluder elements based on the current cam state and based on determining a position of the respective occluder element based on the measured energy or magnetic field corresponding to the respective occluder element (par. 0626-0647, in particular at least par. 0634 and 0644), wherein the alarm is activated responsive to determining that the linear displacement of at least one of the first and second occluder elements did not correspond to the threshold compression of the flexible infusion line (par. 0629).
Regarding claim 18, Kamen et al. discloses the state of the occluder element is determined based on the measured energy or magnetic field and the current cam state and a calibration parameter, wherein the method further comprises: causing, prior to a normal operation of the infusion pump, the at least one occluder element to move and apply an initial pressure to the flexible infusion line; and obtaining a first measured energy or magnetic field corresponding to a first cam state when the initial pressure is applied; and determining the calibration parameter based on the first measured energy or magnetic field (par. 0955; calibration during assembly establishes normal volume/stroke).
Regarding claim 19, Kamen et al. discloses the state of the occluder element is determined based on the measured energy or magnetic field and the current cam state and a calibration parameter, the method further comprising: receiving the calibration parameter as a result of a user input at an input device (par. 0628, 0955, 1031).
Regarding claim 20, Kamen et al. discloses an infusion pump (at least fig. 175-183 and par. 0626-0647), comprising: a first occluder element (706,709) and a second occluder element (occlusion element of at least one of the inlet and outlet pinch valves, see par. 0626 and 0644) each configured to move within a respective occluder valve according to a cam motion (cam 702 for 706,709; cams 701 and 703 for inlet and outlet pinch valves) to apply a periodic compression to a flexible infusion line when the flexible infusion line is placed between the occluder element and a plate assembly (par. 0626, 0634), wherein a portion of the occluder element is configured to emit or modify an energy or magnetic field (par. 0644, types of sensors used, with plunger/pinch valves being sensed); a first sensor and a second sensor each configured to measure the energy or magnetic field being emitted or modified by a respective first or second occluder element (optical or Hall effect; par. 0628 and 634; par. 0644 further indicating that such monitoring applies to the plunger as well as the inch valves); one or more processors (par. 0634) configured to: cause the first and second occluder elements to move in a predetermined sequence according to the cam motion to squeeze the flexible infusion line to infuse predetermined amounts of medication continuously and cyclically into a patient (par. 0626-0647, in particular at least par. 0628, 0634, and 0644); measure, using the first and second sensors, the energy or magnetic field emitted or modified by each occluder element (par. 0628, 0634, 0644); obtain a current cam state associated with the cam motion at a time corresponding to the measured energy; determine, based on the current cam state and determining a position of the respective occluder element based on the measured energy or magnetic field corresponding to the respective occluder element, a current linear displacement of each of the first and second occluder elements with respect to a predetermined expected position of the occluder element corresponding to the current cam state; determining that the current linear displacement of at least one of the first and second occluder elements did not correspond to a threshold compression of the flexible infusion line (par. 0626-0647, in particular at least par. 0634 and 0644); and activate an alarm indicating that a respective occluder valve is defective responsive to determining that the current linear displacement did not correspond to the threshold compression of the flexible infusion line (par. 0629).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783