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 .
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12 is objected to for a typographical error wherein there is improper antecedent basis where the claim recites “and with a line control unit” and should instead recite “and with the line control unit”.
Appropriate correction is required.
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 12-20 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 12, the claim is indefinite where it is unclear what is required of the claim where the claim recites “and to send an indicator instruction to the one or more indicator devices in response to thereby cause the indicator signal to change”, as it is unclear what the response to is meant to be responding from. In claim 1, a similar claim limitation appears which reads “and to send an indicator instruction to the one or more indicator devices in response to one or more line conditions sensed by the line control unit to thereby cause the indicator signal to change”. For the purposes of compact prosecution, Examiner has understood claim 12 to require this limitation as well, however appropriate correction is required.
Claims 13-20 are indefinite based on their dependency on indefinite claim 12.
Claim Rejections - 35 USC § 103
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 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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burgess et al. (US 20220051792, henceforth Burgess) in view of Kamen et al. (US 20120185267, henceforth Kamen).
Regarding claim 1, 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 a communications device (infusion pump processor components for wireless communication as in [0047] and [0029]) 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 a line control unit (infusion pump as in [0047]), wherein the communications device is wirelessly connectable to the one or more indicator devices ([0047]), and wherein the communications device is configured to transmit 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]) 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.
Regarding claim 2, Burgess as modified discloses the system of claim 1, 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 multiple 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 in different ways ([0080]).
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,
Regarding claim 3, Burgess as modified discloses the system of claim 1, wherein 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 one or more 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 one or more 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 one or more 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).
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); and a communications device (infusion pump processor components for wireless communication as in [0047] and [0029]) 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 wirelessly connectable to the one or more indicator devices ([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]) 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]) 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.
Regarding claim 13, Burgess as modified discloses the system of claim 12, wherein the dongle is integrated with the line control unit (in the modified device, when the dongle of Kamen is connected to the processor of the infusion pump, the dongle is considered to be integrated with the processor of the infusion pump via that connection).
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), wherein the indicator signal is synchronized among the multiple indicator devices (the multiple devices communicate simultaneously with the infusion pump in the modified device through different modalities, [0080]).
Regarding claim 15, Burgess as modified discloses the system of claim 12, wherein 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 14, 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 not a pump (the cited line control unit is a processor and not a pump).
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).
Conclusion
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 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783