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
Claims 11-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 7, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 20 is objected to because of the following informalities:
Regarding claim 20, it is recommended to amend the claim to recite “…arranged on an infusion pump” in line 3 to provide antecedent basis for the claim terminology.
Regarding claim 20, there is an extra semicolon in line 5.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, and 10 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hauke (US 20200405942).
Regarding claim 1, Hauke discloses a tube pull detection system for an infusion pump comprising:
a housing (second housing half 30B in fig. 8) with a door pivotally mounted to the housing (first housing half 30A in fig. 8; paragraph 59 discloses the halves are “hingedly” connected so as to be pivotal);
a tube channel positioned at least partially behind the door on the housing (contact face 44 in fig. 8), the tube channel configured to hold a tube in the infusion pump (fig. 8); and
a tube pull detection device (evaluation unit 23 in fig. 1) configured to detect tube pull based on one or more inputs from one or more sensors configured to detect the presence of the tube at a load point along the tube channel (paragraph 50 discloses the evaluation unit detects a change in situation of the line segment based on inputs from a monitoring device 20; fig. 8 and paragraph 64 discloses than an example monitoring device is a tactile sensor system 46 which is arranged to exert a load on tube 7A) or one or more additional sensors arranged on the infusion pump (the examiner notes that due to the presence of the term “or”, Hauke does not need to teach or disclose the “one or more additional sensors” since Hauke discloses the “one or more sensors”).
Regarding claim 2, the claim further limits the “one or more additional sensors” in claim 1. As claim 1 is directed towards “one or more sensors” or “one or more additional sensors” and Hauke discloses “one or more sensors”, Hauke does not need to teach or disclose the limitations of claim 2 under the BRI of claim 2.
Regarding claim 4, the claim further limits the “one or more additional sensors” in claim 1. As claim 1 is directed towards “one or more sensors” or “one or more additional sensors” and Hauke discloses “one or more sensors”, Hauke does not need to teach or disclose the limitations of claim 4 under the BRI of claim 4.
Regarding claim 10, the claim further limits the “one or more additional sensors” in claim 1. As claim 1 is directed towards “one or more sensors” or “one or more additional sensors” and Hauke discloses “one or more sensors”, Hauke does not need to teach or disclose the limitations of claim 10 under the BRI of claim 10.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hauke, as applied to claim 1 above, and further in view of Kopperschmidt (US 20090306574) and Orhan (US 20120273354).
Regarding claim 3, Hauke discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the tube pull detection device is configured to detect tube pull based on detecting a change of pressure in the tube.
Kopperschmidt teaches a device which is configured to detect tube pull (fig. 1) and that a tube pull leads to increased pressure loss (paragraph 10). Kopperschmidt further teaches a pressure sensor positioned upstream from a loop of the tube (pressure sensor 7 in fig. 1) and that the device detects tube pull based on a change in pressure of the tube (paragraph 38). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of Hauke to further comprise a pressure sensor positioned upstream from the loop (semi-circular portion 44a in fig. 9). Orhan teaches that providing an additional and redundant sensing means provides event confirmation which can improve reliability and accuracy (paragraph 374). The modification would also be enabled to provide pull detection in the event that the tactile sensor of Hauke is defective.
Once modified with the teachings of Kopperschmidt, the device of modified Hauke is configured to detect tube pull based on detecting a change of pressure in the tube.
Claim(s) 5, 6, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hauke, as applied to claim 1 above, and further in view of Ebler (US 20170102846).
Regarding claim 5, Hauke discloses all of the claimed limitations set forth in claim 1, as discussed above, and further discloses that an alarm is generated when sensor data is greater than a predetermined threshold (paragraph 23). However, Hauke does not teach or disclose the tube pull detection device further comprises a plurality of tube pull detection sensitivities, wherein each sensitivity comprises a range of limits of detected tube pull.
Ebler is directed towards a device comprising a detection device (processor device 30 in fig. 2A) which is configured to receive inputs from sensors (paragraph 80, sensors 50-90 in fig. 2A). Ebler further teaches that the detector device comprises a plurality of detection sensitivities (paragraph 22 discloses low, medium, and high priority alarm situations), wherein each sensitivities comprises a range of limits of detected sensor inputs (paragraph 22 discloses that the low, medium, and high priority alarms are based on sensor data being between predetermined ranges).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the pull tube detection device of Hauke to further comprise a plurality of tube pull detection sensitivities, wherein each sensitivity comprises a range of limits of detected tube pull, as taught by Ebler. Ebler teaches that this modification provides the user information regarding the nature of the alarm and how severe the situation may be (paragraph 123).
Regarding claim 6, in the modified system of Hauke, Hauke discloses a user feedback system (alarm unit 19 in fig. 1), wherein the user feedback system includes one or more visual or auditory cues configured to provide guidance to a user (paragraph 49 discloses an “optical alarm” which is interpreted to mean “visual cue”).
Regarding claim 20, Hauke discloses an infusion pump tube pull detection device comprising:
one or more sensors configured to detect the presence of a tube at a load point along a tube channel (tactile sensor system 46 in fig. 8 is configured to detect the presence of the tube at a point where tactile sensor 47 exerts a load against tube 7A positioned in channel 44) or one or more additional sensors arranged on the infusion pump, wherein the infusion pump tube pull detection device is configured to detect tube pull based on one or more inputs from the one or more sensors (paragraph 64 discloses detecting tension applied to the tube); and
a user feedback system (alarm unit 19 in fig. 1), wherein the user feedback system includes one or more visual or auditory cues configured to provide guidance (paragraph 49 discloses an “optical alarm” which is interpreted to mean a visual cue).
However, Hauke does not explicitly teach or disclose the user feedback system is configured to provide visual cues configured to provide guidance to a user specific to a plurality of tube pull detection sensitivities, wherein each sensitivity comprises a range of limits of detected tube pull based on the one or more inputs from the one or more sensors.
Ebler teaches a user feedback system (display apparatus 10 in fig. 1) which is configured to provide visual cues configured to provide guidance to a user specific to a plurality of sensor sensitivities (paragraph 79 discloses the display different alarm states indicating that the display is capable of displaying the claimed cues), wherein each sensitivity comprises a range of limits based on the one or more inputs from the one or more sensors (paragraph 22 discloses each sensitivity corresponds to a predetermined range).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the user feedback system of Hauke to be the display apparatus of Ebler so that it is configured to provide guidance to a user specific to a plurality of tube pull detection sensitivities, wherein each sensitivity comprises a range of limits of detected tube pull based on the one or more inputs from the one or more sensors. This modification would enable the user feedback system of Hauke to display more information to the user about the status of the device (paragraph 86).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hauke in view of Ebler, as applied to claims 1, 5, and 6 above, and further in view of Koenig (US 5041086).
Regarding claim 7, modified Hauke teaches all of the claimed limitations set forth in claims 1, 5, and 6, as discussed above, but does not teach or disclose the visual cues include a first light-emitting diode, a second light emitting diode, and a display.
Ebler teaches a user feedback system (user interface system 20 in fig. 2A) which includes a display (display apparatus 10 in fig. 2A). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the user feedback system of modified Hauke to include the display of Ebler, in order to optically relay data and alerts to a user, as known in the art.
Koenig teaches a user feedback system (fig. 2) comprising a display (display 32 in fig. 2) and a first and second light-emitting diode (LEDs 24a and 24a’ in fig. 2). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the user feedback system to comprise a plurality of light-emitting diodes, as taught by Koenig, since Koenig teaches these are beneficial in allowing the user to make a quick visual check of the status of the device (7:24-29).
Regarding the claimed “auditory cues”, the claim is dependent on claim 6 which claims that the feedback system comprises “visual or auditory cues”. As modified Hauke teaches visual cues, modified Hauke does not need to teach or disclose the claimed auditory cues under the BRI of the claim.
Regarding claim 8, in the modified system of Hauke, Ebler discloses in response to the tube pull detection device detecting tube pull within a specified sensitivity, at least one of the first light-emitting diode, the second light emitting diode, the display, the first alarm and the second alarm provides guidance to the user connected to the infusion pump (paragraph 123 discloses displaying an alarm state which would assist in guiding a user’s response).
Regarding claim 9, the claim further limits the “first and second alarms” which are part of the auditory cues. Claim 6 recites that the system includes “visual or auditory cues”. As modified Hauke teaches visual cues, modified Hauke does not need to teach or disclose the claimed auditory cues under the BRI of the claim.
Conclusion
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/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783