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
The amendments filed 04/13/2026 have been entered.
Claims 1, 8 and 18 have thereby been amended.
Claim 17 has been cancelled.
Claim 21 has been added.
Claims 8-16 and 18-21 are being examined in this office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wehba (US 20070233520) in view of Stewart (US 20050277873) in further view of Tsoukalis (US 20160051750).
Regarding claim 8, Wehba discloses a method of associating an infusion container (Fig. 1, 3102), an administration set (page 6, para. [0066], second sentence: tube set and associated parts), and a pump (Fig. 1, 3130) of an infusion device (Fig. 1, 3130 and 3108), the method comprising: an administration set being coupled to a pump (para. [0082], sentence 3; the tubes are connected as needed to the infusion pump), the administration set comprising a tubing to which a force is applied by the pump to pump a fluid through the administration set (para. [0051], the pump acts with force upon the tubing); receiving, from the electronic medical records storage and retrieval system (POC server 3124 of the 3110 network), drug information about a content of an infusion container (para. [0067]: retrieval of information of infusion container identifier 3101 on infusion container 3102 from the POC server 3124); receiving drug information about a content of an infusion container associated with the administration set identifier (paras. [0089]-[0090]), receiving, separately from the received drug information and the administration set identifier, a drug identification for a medical fluid to be infused (para. [0084], sentence 3, the drug identification for a medical fluid being part of the medical order, which can be retrieved from both the drug information stored on the server and from the scannable identifier on the drug bag); comparing, by a processor, the drug identification with the drug information (para. [0162]; para. [0070], first sentence; program pump request includes drug identification and infusion contents: para. [0069]; para. [0077], sentences 5-7, comparison capabilities by processors); determining, by the processor based on the comparing, whether the drug information corresponds to the drug identification (para. [0070], first sentence; program pump request includes drug identification and infusion contents: para. [0069]; para. [0077], sentences 5-6); in accordance with determining that the drug information corresponds to the drug identification, permitting the pump to start an infusion of the medical fluid (page 7, para. [0070], third sentence, infuser required information including drug identifying information as stated in para. [0069]; para. [0074], first sentence; and para. [0076], first two sentences, the pump being permitted to start via manual start by the 3132); and responsive to determining that the drug information does not correspond to the drug identification of the medical fluid received at the pump, by the processor: preventing the pump from starting the infusion (para. [0070], sentence 4, the order is not sent to the pump thereby preventing the pump from being able to start); and generating an alert indicating that an infusion container for the medical fluid does not correspond to the drug identification received (page 7, para. [0070], sentence 4: reply message alert). However, Wehba fails to disclose an administration set identifier, and that the receiving, processing, and comparing of the drug information for validation occurs at a processor located at the infusion device itself.
Stewart teaches an analogous system and methods that includes an administration set identifier of the administration set (18, or 50 being part of the administration set according to para. [0030], third-to-last sentence), receiving, at an infusion device, an indication that an administration set is being coupled to a pump (para. [0054], sentences 1-3); detecting, by an administration set receiver of the infusion device an administration set identifier of the administration set (administration set receiver 20; para. [0031], sentences 4-5), the administration set identifier being transmitted by a communication module included in the administration set when the administration set is coupled to the pump (para. [0031], sentence 3); transmitting the administration set identifier (para. [0031], sentence 4); receiving, responsive to the transmitting, drug information about a content of an infusion container associated with the administration set identifier (para. [0031], sentence 6; para. [0026], the administration set communicating drug-specific information), receiving, at the infusion device, separately from the received drug information, a drug identification for a medical fluid to be infused (para. [0026], sentences 1-11, drug information is transmitted via the administration set identifier about the drug contents of the drug bag that should be connected and used); comparing, by a processor at the infusion device, the drug identification with the drug information (para. [0034], sentences 1-3); determining, by the processor at the infusion device based on the comparing, whether the drug information corresponds to the drug identification (para. [0034], sentences 1-3). Stewart also teaches that the determining, comparing, and verification of the correct drug information that permits the pump to start or directly prevents the pump from starting occurs by a processor at the infusion device itself (Fig. 1: processor “P” at infusion device 12; para. [0032], sentences 3-4 and last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the additional administration set identifier and its data transmission for verification of correct fluid container-administration set pairing taught by Stewart, as well as its data verification for pumping occurring at the infusion device, with the Wehba system and methods in order to verify all the correct components are being paired and used before the infusion commences, and to carry it all out automatically to reduce possible human error. It would have also been obvious for one of ordinary skill in the art to incorporate into Wehba the receival, comparison and determination based on the separate drug identification, taught by Stewart, such that the Wehba-Stewart method validates that both the fluid container and the administration set match the intended drug to be infused, further reducing the possibility of error. Upon this combination, it would be obvious for the comparing, determining, and receiving of drug identification by the processors taught by Wehba would occur at the infusion device itself, as taught by Stewart, as Stewart teaches the integration of the processor and validation all occurring at the infusion device itself without need to transmit additional information and validations. However, Wehba in view of Stewart fails to explicitly teach the mode by which the infusion pump is prevented from starting if validation fails.
Tsoukalis teaches an analogous infusion and administering system which, if validation/safety conditions are not met, works by preventing the pump from starting the infusion by deactivating a control element on the pump that allows the infusion to start (para. [0009]). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Wehba-Stewart system by incorporating the safety mode taught by Tsoukalis of disabling the ability for the infusion to initiate if certain conditions are not met, in order to increase the safety of the administration and ensure that there is no possibility that the infusion of a wrong medication can be started.
Regarding claim 9, Wehba in view of Stewart in further view of Tsoukalis teaches the method of claim 8, as described above, wherein the administration set identifier comprises a 2D barcode (Stewart: Fig. 3, 50; para. [0032], sentence 5).
Regarding claim 10, Wehba in view of Stewart in further view of Tsoukalis teaches the method of claim 9, as described above, wherein a scanner (Stewart: 20) used for scanning the 2D barcode includes a communication unit that transmits scanned information to the infusion device (Stewart: para. [0032], sentence 5; para. [0034], sentences 1-2).
Regarding claim 11, Wehba in view of Stewart in further view of Tsoukalis teaches the method of claim 10, as described above, wherein the electronic medical records storage and retrieval system (Wehba: POC server 3124 of the 3110 network) receives and stores the association of an infusion container identifier (Wehba: page 9, para. [0090], first sentence) with the administration set identifier (Stewart: para. [0032], sentences 3-5, being sent to the electronic medical records storage and retrieval system of Wehba instead of only the memory of the device of Stewart, upon the combination described above).
Regarding claim 12, Wehba in view of Stewart in further view of Tsoukalis teaches the method of claim 8, as described above, further comprising monitoring, by the infusion device, a usage metric of the administration set after the administration set is coupled with the pump (Wehba: page 8, para. [0077], sentences 1-5: monitoring of rate, total volume to be infused (VTBI), and duration of infusion; Stewart: para. [0026], 18 conveying wide range of usage metrics of the administration set itself).
Regarding claim 13, Wehba in view of Stewart in further view of Tsoukalis teaches the method of claim 8, as described above, wherein receiving, at the infusion device, the drug identification comprises receiving manually entered data (Wehba: page 8, para. [0075], last sentence).
Regarding claim 14, Wehba in view of Stewart in further view of Tsoukalis teaches the method of claim 8, as described above, wherein receiving, at the infusion device, the drug identification (Wehba: page 8, para. [0075], third sentence) comprises receiving the drug identification from an infusion order sent to the infusion device from the electronic medical records storage and retrieval system (Wehba: pages 6-7, para. [0068] sentences 3-4, and para. [0069] second sentence).
Regarding claim 15, Wehba in view of Stewart in further view of Tsoukalis teaches the method of claim 8, as described above, wherein the infusion device is configured to store a plurality of infusion orders (Wehba: page 20, para. [0165], sentence 5, plurality or stored orders in MMU), and automatically downloading infusion parameters associated with a respective one of the plurality of infusion orders involving the medical fluid to the pump the administration set is coupled to (Wehba: page 20, para. [0168], third sentence, MMU downloads stored orders to pump; page 1, para. [0012], first sentence, MMU automation).
Regarding claim 16, Wehba in view of Stewart in further view of Tsoukalis teaches the method of claim 8, as described above, wherein transmitting the administration set identifier (Stewart: 18) occurs after the administration set is coupled to the pump (Stewart: para. [0032], sentences 3-5; Wehba: page 6, para. [0066], placement and coupling of administration set and pump occurs first), and the electronic medical records storage and retrieval system sends infusion order information to the pump the administration set is coupled to, after determining that the drug information matches the drug identification (Wehba: page 7, para. [0070], validation prior to sending the order to the pump) of the medical fluid (Wehba: page 7, para. [0070], first sentence; program pump request includes drug identification and infusion contents: para. [0069]).
Regarding claim 18, Wehba discloses a non-transitory machine readable medium (the computer program product, which would be stored on the hard drive/hard disk: page 1, para. [0006], sentences 1-2) comprising instructions that, when executed by a machine (3108; page 5, para. [0057], sentences 2-3), cause the machine to perform a method of associating an infusion container (Fig. 1, 3102), an administration set (page 6, para. [0066], second sentence: tube set and associated parts), and a pump (Fig. 1, 3130) of an infusion device (Fig. 1, 3130 and 3108), the method comprising: an administration set being coupled to a pump (para. [0082], sentence 3; the tubes are connected as needed to the infusion pump), the administration set comprising a tubing to which a force is applied by the pump to pump a fluid through the administration set (para. [0051], the pump acts with force upon the tubing); receiving, from the electronic medical records storage and retrieval system (POC server 3124 of the 3110 network), drug information about a content of an infusion container (para. [0067]: retrieval of information of infusion container identifier 3101 on infusion container 3102 from the POC server 3124); receiving drug information about a content of an infusion container associated with the administration set identifier (paras. [0089]-[0090]), receiving, separately from the received drug information and the administration set identifier, a drug identification for a medical fluid to be infused (para. [0084], sentence 3, the drug identification for a medical fluid being part of the medical order, which can be retrieved from both the drug information stored on the server and from the scannable identifier on the drug bag); comparing, by a processor, the drug identification with the drug information (para. [0070], first sentence; program pump request includes drug identification and infusion contents: para. [0069]; para. [0077], sentences 5-7, comparison capabilities by processors); determining, by the processor based on the comparing, whether the drug information corresponds to the drug identification (para. [0070], first sentence; program pump request includes drug identification and infusion contents: para. [0069]; para. [0077], sentences 5-6); responsive to determining that the drug information corresponds to the drug identification, permitting the pump to start an infusion of the medical fluid (page 7, para. [0070], third sentence, infuser required information including drug identifying information as stated in para. [0069]; para. [0074], first sentence; and para. [0076], first two sentences, the pump being permitted to start via manual start by the 3132); and responsive to determining that the drug information does not correspond to the drug identification of the medical fluid received at the pump: preventing the pump from starting the infusion (para. [0070], sentence 4, the order is not sent to the pump thereby preventing the pump from being able to start); and generating an alert indicating that an infusion container for the medical fluid does not correspond to the drug identification received (page 7, para. [0070], sentence 4: reply message alert). However, Wehba fails to disclose an administration set identifier, and that the receiving, processing, and comparing of the drug information for validation occurs at a processor located at the infusion device itself.
Stewart teaches an analogous system and methods that includes an administration set identifier of the administration set (18, or 50 being part of the administration set according to para. [0030], third-to-last sentence), receiving, at an infusion device, an indication that an administration set is being coupled to a pump (para. [0054], sentences 1-3); detecting, by an administration set receiver of the infusion device an administration set identifier of the administration set (administration set receiver 20; para. [0031], sentences 4-5), the administration set identifier being transmitted by a communication module included in the administration set when the administration set is coupled to the pump (para. [0031], sentence 3); transmitting the administration set identifier (para. [0031], sentence 4); receiving, responsive to the transmitting, drug information about a content of an infusion container associated with the administration set identifier (para. [0031], sentence 6; para. [0026], the administration set communicating drug-specific information), receiving, at the infusion device, separately from the received drug information, a drug identification for a medical fluid to be infused (para. [0026], sentences 1-11, drug information is transmitted via the administration set identifier about the drug contents of the drug bag that should be connected and used); comparing, at the infusion device, the drug identification with the drug information (para. [0034], sentences 1-3); determining, at the infusion device based on the comparing, whether the drug information corresponds to the drug identification (para. [0034], sentences 1-3). Stewart also teaches that the determining, comparing, and verification of the correct drug information that permits the pump to start or directly prevents the pump from starting occurs by a processor at the infusion device itself (Fig. 1: processor “P” at infusion device 12; para. [0032], sentences 3-4 and last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the additional administration set identifier and its data transmission for verification of correct fluid container-administration set pairing taught by Stewart, as well as its data verification for pumping occurring at the infusion device, with the Wehba system and methods in order to verify all the correct components are being paired and used before the infusion commences, and to carry it all out automatically to reduce possible human error. It would have also been obvious for one of ordinary skill in the art to incorporate into Wehba the receival, comparison and determination based on the separate drug identification, taught by Stewart, such that the Wehba-Stewart method validates that both the fluid container and the administration set match the intended drug to be infused, further reducing the possibility of error. Upon this combination, it would be obvious for the comparing, determining, and receiving of drug identification by the processors taught by Wehba would occur at the infusion device itself, as taught by Stewart, as Stewart teaches the integration of the processor and validation all occurring at the infusion device itself without need to transmit additional information and validations. However, Wehba in view of Stewart fails to explicitly teach the mode by which the infusion pump is prevented from starting if validation fails.
Tsoukalis teaches an analogous infusion and administering system which, if validation/safety conditions are not met, works by preventing the pump from starting the infusion by deactivating a control element on the pump that allows the infusion to start (para. [0009]). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Wehba-Stewart system by incorporating the safety mode taught by Tsoukalis of disabling the ability for the infusion to initiate if certain conditions are not met, in order to increase the safety of the administration and ensure that there is no possibility that the infusion of a wrong medication can be started.
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Wehba (US 20070233520) in view of Stewart (US 20050277873), as applied to claim 18 above, in further view of Tsoukalis (US 20160051750) and in further view of Rader (US 5563584).
Regarding claim 19, Wehba in view of Stewart in further view of Tsoukalis teaches the non-transitory machine readable medium of claim 18 as described above, wherein the method further includes: a signaling device affixed to the infusion container (Wehba: 3101; page 4, para. [0054]), and receiving data associating the signaling device with an infusion container identifier (Wehba: page 6, para. [0067] retrieval of information of infusion container identifier 3101 on infusion container 3102 from the POC server 3124; page 8, para. [0075], association to container; page 6, para. [0067] retrieval of information of infusion container identifier 3101 on infusion container 3102 from the POC server 3124). However, in the Wehba-Stewart combination, Wehba only teaches the signaling device on the infusion container as an RFID chip. Wehba fails to teach a separate signaling device, with a signal sent upon being affixed to the infusion container, or a signal to the signaling device to activate a visual display indicating that the pump is associated with the infusion container. Rather, Wehba only teaches this indication of association being displayed on the infusion device display screen.
Radar teaches a separate signaling device (34), attachable to the infusion container (Fig. 1) with a variety of signaling methods. Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the additional visual indicator of a signaling device on the infusion container taught by Rader to indicate the signals taught by Wehba, in order to add an additional layer of visual cues of coupling to further reduce the chance of error onto the infusion container itself rather than only on the infusion device screen where many other cues are also displayed. It directly follows that the resulting incorporation of Rader into the Wehba-Stewart combination would meet the claimed structural limitations of receiving an indication that a signaling device has been affixed to the infusion container; transmitting, by the infusion device, a signal to the signaling device to activate a visual display indicating that the pump is associated with the infusion container.
Regarding claim 20, Wehba in view of Stewart in further view of Tsoukalis and in further view of Rader teaches the non-transitory machine readable medium of claim 19 as described above, wherein the signaling device comprises a RFID (Wehba: para. [0054]; additionally taught by Stewart: [0029], first sentence) and a plurality of LED emitting light of different colors (Rader: LEDs 40 and 42; col. 3, lines 18-20 indicating different colors). Although the separate signaling device incorporated from Rader does not explicitly teach the signaling device comprising an RFID, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have, upon incorporation of the separate signaling device taught by Rader into Wehba-Stewart, further incorporated the RFIDs taught by Wehba and Stewart as being on the container to be located on the now separate signaling device, in order to provide the same RFID validations of the correct parts for each separate component, as is taught by Wehba-Stewart.
Regarding claim 21, Wehba in view of Stewart in further view of Tsoukalis and in further view of Rader teaches the non-transitory machine readable medium of claim 19, as described above, wherein the signaling device comprises an element configured to receive the signal (Rader: col. 4, lines 5-14; claim 1), and wherein the visual display comprises an LED light and the signaling device is configured to activate the LED light responsive to receiving the signal (Rader: claim 1; col. 4, lines 5-14). Although Rader does not explicitly teach the signal being received by an RFID, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have, upon incorporation of the separate signaling device taught by Rader into Wehba-Stewart, further incorporated the RFIDs taught by Wehba and Stewart as being on the container to be located on the now separate signaling device, in order to provide the same RFID validations of the correct parts for each separate component, as is taught by Wehba-Stewart. As such, upon this combination it would have been obvious for the signal received by Rader to be received via an RFID rather than semiconductor device of the sensor (col. 4, lines 9-10).
Response to Arguments
Applicant’s arguments filed 04/13/2026 regarding the amended limitation for the mode by which the infusion is prevented from starting are moot, as the reference Tsoukalis is now relied upon in combination with Wehba and Stewart, to teach these newly added limitations to independent claims 8 and 18.
Regarding Applicant’s arguments on page 9 of the Remarks, Examiner has updated citations for Wehba and Stewart for the limitations regarding these arguments. However, Examiner maintains that it is Wehba in combination with Stewart, that are relied upon to teach all aspects of the limitations. Wehba teaches two modes by which identification of the drug to be infused is received, and Stewart teaches that all received information and identifications are received at the infusion device. Stewart also is relied upon to teach that the infusion device receives drug identification/information from both the barcode identifier on the drug bag and also on the administering line set itself that is inserted into the infusion pump. These teachings of Wehba and Stewart, in combination, teach all limitations of the transmitting and receiving of drug identification and information and administration set identification to the infusion pump, as claimed.
For these reasons, claims 8-16 and 18-21 stand rejected as recited above.
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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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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