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 .
Response to Amendment
Claim 12 was previously objected to for a typographical error and has been amended. The objection to claim 12 is thus withdrawn.
Claims 12-20 were previously rejected for indefiniteness under 35 U.S.C. 112(b); claim 12 has been amended which has overcome the prior rejection, and thus the previous rejection under 35 U.S.C. 112(b) is withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 14 regarding the devices providing the same indicator signal at the same time as newly claimed have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 08/10/2026 regarding claim 12 (see Applicant’s Remarks at pgs. 7-9) have been fully considered but they are not persuasive.
Applicant has argued that Burgess in view of Kamen does not disclose the newly claimed system of claim 12, particularly where Applicant argues Burgess does not disclose “a line control unit comprising an external computer device configured to process sensor data associated with the line condition” and a dongle wherein the dongle is “physically separable from the line control unit”. Examiner respectfully disagrees. Burgess discloses a line control unit comprising an external computer device configured to process sensor data associated with the line condition where it discloses a processor configured to process sensor data at [0047], where the processor of the infusion pump is external to the wireless transceiver as these are disclosed to be different components. Further, in the modified device of Burgess in view of Kamen, the transceiver of Burgess is arranged on a dongle as taught by Kamen since Kamen teaches dongles to be usable to provide communications bridges using modalities not made possible by processors alone ([0289], [0290]), because Kamen teaches dongles to be more adaptable over the passage of time ([0289]), and because Kamen teaches attachable dongles to be known equivalents to hardwire communications equipment in medical devices (see at least [0268] and [0289]). Thus, in the modified system, the processor and dongle are separate devices when arranged in a working system and are external relative to each other.
Thus, Examiner respectfully finds Applicant’s arguments unpersuasive and rejects the claims ad indicated below.
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) 1 and 3-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burgess et al. (US 20220051792, henceforth Burgess, previously made of record) in view of Kamen et al. (US 20120185267, henceforth Kamen, previously made of record) and Day et al. (US 20150317891, henceforth Day).
Regarding claim 1, Burgess discloses a medical line indication system (combination of figs. 1 and 4 as in [0044]), comprising: a plurality of indicator devices (electronic tag 400, shown in fig. 4A and described in the chosen embodiment in [0084]-[0085]) configured for attachment to a medical line (see [0050], tag 400 attaches to IV tubing 408 as in fig. 4A), the plurality of indicator devices each being configured to provide an indicator signal (see [0044], display 406 is configured to provide an indicator signal where it is displaying pertinent relevant information); and a communications device (infusion pump processor components for wireless communication as in [0047] and [0029]) which is configured for communicative connection with the plurality of indicator devices (see [0047], the infusion pump communicates wirelessly with electronic tags 400) and with a line control unit (infusion pump as in [0047]), wherein the communications device is wirelessly connectable to the plurality of indicator devices ([0047]), and wherein the communications device is configured to transmit an indicator instruction to the plurality of indicator devices (this is the information transmitted from the infusion pump to the electronic tags as in [0047]) in response to one or more line conditions sensed by the line control unit (infusion container is empty is a possible sensed condition to be sensed by the infusion pump which can be transmitted for display as in [0047]) to thereby cause the indicator signal to change (this is displayed by the screen or multicolored LEDs as in [0046]).
Burgess does not disclose that the communications device is a dongle. Kamen teaches the use of a dongle as a communications device (dongle 133, [0289]) to provide wireless communications ([0289], [0290]) which can more easily be adjusted over time or connect to devices in multiple ways where a processor might not be able to on its own ([0290]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have changed the infusion pump processor components for wireless communication of Burgess to be arranged on a dongle as in Kamen as Kamen teaches dongles to be usable to provide communications bridges using modalities not made possible by processors alone ([0289], [0290]), because Kamen teaches dongles to be more adaptable over the passage of time ([0289]), and because Kamen teaches attachable dongles to be known equivalents to hardwire communications equipment in medical devices (see at least [0268] and [0289]), and thus making such a modification would have yielded the same, predictable result of an infusion pump which is capable of wireless communications with external devices such as electronic tags.
Burgess as modified does not explicitly disclose the system wherein the indicator signal is synchronized among the plurality of indicator devices. However, Burgess teaches that the system can be used to provide urgent alarms (see at least [0027], [0029], and [0047]) and that the multiple indicator devices are simply exchanging information with the infusion pump at different locations (see especially [0084]-[0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have sent indicator signals from the infusion pump to the plural electronic tags of Burgess as modified at the same time to provide alerts without causing any delay as the alerts could be important regarding empty containers or improper infusion rates ([0008], [0087]). Thus, in the modified device, the indicator would be synchronized between the multiple electronic tags of Burgess as modified since the alarm signals would be sent at the same time, or simultaneously.
Burgess as modified does not explicitly disclose the system wherein the plurality of indication devices each provide the same indicator signal at the same time. Day teaches that a plurality of indicator devices (different devices such as tablets and nurses stations, [0033]) can be configured to provide an indicator signal (alarms such as in [0033]) where the plurality of indicator devices can be synchronized such that each of the indicator devices provides the same indicator signal at the same time (see [0033], alarm messages can be synchronized to provide the same alert across devices at the same time).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the synchronized plurality of indicator devices of Burgess as modified to have each provided the same indicator signal at the same time as claimed as Day teaches this arrangement to be beneficial for preventing a mistaken impression that there are more indicators than there actually are, particularly in the case of alerts regarding infusion information ([0033]).
Regarding claim 3, Burgess as modified discloses the system of claim 1, wherein the indicator signal includes a light (an electronic ink display 306 includes lights to show different colors, see [0045] and [0046]).
Regarding claim 4, Burgess as modified discloses the system of claim 1, wherein the one or more line conditions include line pressure, fluid flow rate, fluid temperature, bubble or precipitate detection, or concentration of a fluid component (see [0047], an empty container means a fluid flow rate of zero and is disclosed as a potential line condition to be sent from the infusion pump to the electronic tags).
Regarding claim 5, Burgess as modified discloses the system of claim 1, wherein the plurality of indicator devices and the dongle are wirelessly connectable via a radio wave connection (see [0029], the system may use RF telecommunications).
Burgess as modified does not explicitly disclose that the radio wave connection relies on an ultra high frequency (UHF). Kamen teaches RF communications and UHF radio communications to be known equivalent methods of wireless communication in pump systems ([0486]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a UHF for the wireless communications of Burgess as Burgess teaches that it can rely on different modalities of communication (see at least [0029] and [0080]) and because Kamen teaches RF and UHF to be known equivalents in the art ([0486]) such that relying on UHF instead of RF would have yielded the same, predictable result of wireless communications being achieved through waves.
Regarding claim 6, Burgess as modified discloses the system of claim 1, wherein the system is configured to generate different indicator signals (see [0045] and [0046], different colors or displayed elements are configured to be shown by electronic tags 400) in response to different respective infusion conditions sensed by the line control unit (see at least [0045]-[0047]).
Regarding claim 7, Burgess as modified discloses the system of claim 6, wherein the different indicator signals include different patterns and/or different colors of light (different colors of light as in [0045] and [0046]).
Regarding claim 8, Burgess as modified discloses the system of claim 1, wherein the plurality of indicator devices include one or more sensors (sensor 420, fig. 4C and [0053]) for sensing a line condition (see [0053], the line condition is pressure of the fluid in the tubing of the IV set), and wherein the dongle is further configured to receive data from the one or more indicator devices (see [0077], the portion of the infusion pump which is the dongle is configured to receive information from the sensor 420) and to communicate the received data with the line control unit (see at least [0077]).
Regarding claim 9, Burgess as modified discloses the system of claim 8, wherein the data from the plurality of indicator devices includes an indication that a medicine has been injected into the medical line (the infusion line is meant to receive medicated fluid as in [0022], and thus a pressure measurement of the infusion line which indicates that there is fluid in the line as in [0053] and [0054] is an indication that a medicine has been injected into the medical line as claimed).
Regarding claim 10, Burgess as modified discloses the system of claim 1, wherein the line control unit is associated with a pump (the control unit is a pump, see [0047]).
Regarding claim 11, Burgess as modified discloses the system of claim 1, wherein the dongle is integrated with the line control unit ([0047], the dongle is integrated with the line control unit where it is a part of it).
Claim(s) 12 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burgess et al. (US 20220051792, henceforth Burgess, previously made of record) in view of Kamen et al. (US 20120185267, henceforth Kamen, previously made of record).
Regarding claim 12, Burgess discloses a medical line indication system (combination of figs. 1 and 4 as in [0044]), comprising: one or more indicator devices (electronic tag 400, fig. 4A) configured for attachment to a medical line (see [0050], tag 400 attaches to IV tubing 408 as in fig. 4A), the one or more indicator devices each being configured to provide an indicator signal (see [0044], display 406 is configured to provide an indicator signal where it is displaying pertinent relevant information) and each including one or more sensors (sensor 420, fig. 4C and [0053]) for sensing a line condition (see [0053], the line condition is pressure of the fluid in the tubing of the IV set); a line control unit (infusion pump processor as in [0047] excluding the communications components) comprising an external computer device (infusion pump processor as in [0047] excluding the communications components, the claim does not require that the line control unit has anything other than a computer device, and the processor of [0047] excluding the communications components is considered to be external to the communications components) configured to process sensor data associated with the line condition (see at least [0092], the processor of the infusion device and the processor of the electronic tag are each configured to process sensor data); and a communications device (infusion pump processor components for wireless communication as in [0047] and [0029], particularly a transceiver) which is configured for communicative connection with the one or more indicator devices (see [0047], the infusion pump communicates wirelessly with electronic tags 400) and with the line control unit (infusion pump as in [0047]), wherein the communications device is physically separable from the line control unit (see [0029], the processor of the infusion pump includes a communication system; the electronic components of the processor and infusion are capable of being physically separated if the device is disassembled) and is wirelessly connectable to the one or more indicator devices ([0029] and [0047]), and wherein the communications device is configured to receive sensor data (see at least [0074]) transmitted from the one or more indicator devices (see at least [0074]), communicate the sensor data to the line control unit (see [0074], “The electronic tag 400 may also transmit, via Bluetooth, a warning message to the pump”, where the warning is information coming from the sensor and is thus considered to be interpreted sensor data), receive an indicator instruction generated by the line control unit based on the sensor data from the line control unit (see at least [0045] “a display 406 is coupled to the processor and is configured to display information received via the transceiver” and [0047]); and to send an indicator instruction to the one or more indicator devices (this is the information transmitted from the infusion pump to the electronic tags as in [0047]) to thereby cause the indicator signal to change (this is displayed by the screen or multicolored LEDs as in [0046]).
Burgess does not disclose that the communications device is a dongle. Kamen teaches the use of a dongle as a communications device (dongle 133, [0289]) to provide wireless communications ([0289], [0290]) which can more easily be adjusted over time or connect to devices in multiple ways where a processor might not be able to on its own ([0290]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have changed the infusion pump processor components for wireless communication of Burgess to be arranged on a dongle as in Kamen as Kamen teaches dongles to be usable to provide communications bridges using modalities not made possible by processors alone ([0289], [0290]), because Kamen teaches dongles to be more adaptable over the passage of time ([0289]), and because Kamen teaches attachable dongles to be known equivalents to hardwire communications equipment in medical devices (see at least [0268] and [0289]), and thus making such a modification would have yielded the same, predictable result of an infusion pump which is capable of wireless communications with external devices such as electronic tags.
Regarding claim 15, Burgess as modified discloses the system of claim 12, wherein the indicator signal includes a light (an electronic ink display 306 includes lights to show different colors, see [0045] and [0046]).
Regarding claim 16, Burgess as modified discloses the system of claim 12, wherein the one or more line conditions include line pressure, fluid flow rate, fluid temperature, bubble or precipitate detection, or concentration of a fluid component (see [0047], an empty container means a fluid flow rate of zero and is disclosed as a potential line condition to be sent from the infusion pump to the electronic tags).
Regarding claim 17, Burgess as modified discloses the system of claim 12, wherein the one or more indicator devices and the dongle are wirelessly connectable via an ultra high frequency (UHF) radio wave connection (see [0029], the system may use RF telecommunications which rely on UHF wave connections).
Regarding claim 18, Burgess as modified discloses the system of claim 12, wherein the system is configured to generate different indicator signals (see [0045] and [0046], different colors or displayed elements are configured to be shown by electronic tags 400) in response to different respective infusion conditions sensed by the line control unit (see at least [0045]-[0047]).
Regarding claim 19, Burgess as modified discloses the system of claim 12, wherein the line control unit is configured to control the one or more indicator devices independent of an infusion pump (see [0022], in an embodiment where multiple, separate infusion pumps are used, the line control unit can control the electronic tags of the system to send an indicator warning related to one of the pumps independent of one of the other infusion pumps).
Regarding claim 20, Burgess as modified discloses the system of claim 19, wherein the medical line is an infusion line (see [0050], the medical line is IV tubing which is capable of being used for an infusion) and wherein the system is configured to use gravity feed for infusion (the system is structurally capable of using gravity to feed the infusion if the pump is left to not clamp the tube closed and the IV bag is held above a user; gravity would then pull the fluid down for infusion into the user).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burgess et al. (US 20220051792, henceforth Burgess, previously made of record) in view of Kamen et al. (US 20120185267, henceforth Kamen, previously made of record) as applied to claim 12 above, and further in view of Day et al. (US 20150317891, henceforth Day).
Regarding claim 14, Burgess as modified discloses the system of claim 12, wherein the system comprises multiple indicator devices (see [0080], multiple electronic tags can be used in the system).
Burgess as modified does not explicitly disclose the system wherein the indicator signal is synchronized among the plurality of indicator devices. However, Burgess teaches that the system can be used to provide urgent alarms (see at least [0027], [0029], and [0047]) and that the multiple indicator devices are simply exchanging information with the infusion pump at different locations (see especially [0084]-[0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have sent indicator signals from the infusion pump to the plural electronic tags of Burgess as modified at the same time to provide alerts without causing any delay as the alerts could be important regarding empty containers or improper infusion rates ([0008], [0087]). Thus, in the modified device, the indicator would be synchronized between the multiple electronic tags of Burgess as modified since the alarm signals would be sent at the same time, or simultaneously.
Burgess as modified does not explicitly disclose the system wherein the plurality of indication devices each provide the same indicator signal at the same time. Day teaches that a plurality of indicator devices (different devices such as tablets and nurses stations, [0033]) can be configured to provide an indicator signal (alarms such as in [0033]) where the plurality of indicator devices can be synchronized such that each of the indicator devices provides the same indicator signal at the same time (see [0033], alarm messages can be synchronized to provide the same alert across devices at the same time).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the synchronized plurality of indicator devices of Burgess as modified to have each provided the same indicator signal at the same time as claimed as Day teaches this arrangement to be beneficial for preventing a mistaken impression that there are more indicators than there actually are, particularly in the case of alerts regarding infusion information ([0033]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
