Detailed Action
Status of Claims
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 .
Claims 1-20 are presented for examination.
Claims 1-20 are rejected.
This Action is Non-Final.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/22/2025;12/01/2025 and 02/19/206, the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a non-statutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
6. Claim 1 is non-provisionally rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1 of US Patent No: 12,288,618.
Application No:19/089,954
Patent No:12,288,618
Claim 1. An electronic tag, the electronic tag comprising:
a housing;
a processor within the housing;
a transceiver configured within the housing and coupled to the processor, wherein the processor is configured to send, via the transceiver, first signals to an infusion device and to receive, via the transceiver, second signals from the infusion device;
a display coupled to the housing and the processor, and configured to display information received via the transceiver; and
a clamping mechanism coupled to the housing and configured to secure the electronic tag to an intravenous (IV) tubing for a medication container, wherein at least a portion of the first signals associate the electronic tag with the medication container, and wherein at least a portion of the second signals include a name of a medication in the medication container, and wherein the information displayed via the display includes the name.
Claim 1. (Currently Amended) An electronic tag, the electronic tag comprising:
a housing;
a processor within the housing;
a transceiver configured within the housing and coupled to the processor, wherein the processor is configured to send, via the transceiver, first signals to an infusion device and to receive, via the transceiver, second signals from the infusion device;
a display coupled to the housing and the processor, and configured to display information received via the transceiver;
a clamping mechanism coupled to the housing and configured to secure the electronic tag to an intravenous (IV) tubing; and
a sensor configured within the housing, and configured to measure a property of a fluid in an IV tubing at a location of the clamping mechanism, wherein the sensor comprises an acoustic sensor configured to measure acoustics within at least a portion of the IV tubing or the sensor comprises a pressure sensor configured to detect a fluidic pressure of a fluid within the IV tubing at the location of the IV tubing, and wherein the property of the fluid measured by the sensor is transmitted via the transceiver to the infusion device, and wherein the information displayed by the display is displayed in response to a control signal received via the transceiver from the infusion device.
7. Claims 1-20 are non-provisionally rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claim 1 of Patent No: 12,288,618 (Please note that as both the Patent and co-pending application claimed similar subject matters, and in the interest of time, the examiner is selecting the independent claims 1 from the Patent and claim 1 from co-pending application for the instant double patenting rejection).
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.
8. Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over
Augustine et al. (US Patent No:11,160,170 B1) in view of De La Huerga (US Patent
Application Pub. No: 20020038392 A1), and further in view of Kohibrecher (US Patent Application Pub. No: 20160074573 A1).
As per claim 1,Augustine teaches an electronic tag [Fig.15, electronic and/or
electromechanical system 1500 of a medical system.], the electronic tag comprising:
a housing [Fig.2, a housing 299];
a processor within the housing [Fig.15, the processor 1502];
a display coupled to the housing and the processor, and configured to display information received via the transceiver [Fig.15,These various measurements may be electronically recorded (such as on mass storage1516 (FIG. 15) and displayed on the electronic anesthetic record display 226 (e.g., display device 1510, FIG. 15).]; and
a clamping mechanism coupled to the housing and configured to secure the electronic tag to an intravenous (IV) tubing for a medication container [Fig.10; col.40,ll.22-33,… an IV tubing clamp (e.g., 1060A, 1060B; FIG. 10) to inhibit injection. Operation 2122 can include saving an inhibit injection event information to one or more storage devices.].
Augustine does not explicitly disclose a transceiver configured within the housing and coupled to the processor, wherein the processor is configured to send, via the transceiver, first signals to an infusion device and to receive, via the transceiver, second signals from the infusion device;
wherein at least a portion of the first signals associate the electronic tag with the medication container, and wherein at least a portion of the second signals include a name of a medication in the medication container, and wherein the information displayed via the display includes the name.
De La Huerga discloses a transceiver configured within the housing and coupled to the processor [Paragraphs 0093;0095;100;0194, Device 10 also includes a communication device 16 and an interface device 18. Processor 14 is linked to each of the communication device 16, the memory and the interface device 18.], wherein the processor is configured to send, via the transceiver, first signals to an infusion device and to receive, via the transceiver, second signals from the infusion device [Paragraph 0152, Referring still to FIG. 18, exemplary memory content for one unit 108 includes physician information 61, IV medicant information 284, order verification information 290 and pump status information 291 (i.e., flow rate 292, duration 293, dose 294, volume to be infused 295 and volume infused 296).].
It would have been obvious one ordinary skill in the art before the effective filling date of the claimed invention, to include De La Huerga’s medical devices with controller unit into Augustine’s modular housing module for housing electronic and electromechanical medical device for the benefit of providing a system which enables simpler interfacing, which facilitates accurate prescription entry, verification that prescriptions are suitable at the time of delivery, avoidance of delivery of stale prescriptions, and accurate and automatic delivery record keeping (De La Huerga,[0029]) to obtain the invention as specified in claim 1.
Augustine and De La Huerga do not explicitly disclose wherein at least a portion of the first signals associate the electronic tag with the medication container, and wherein at least a portion of the second signals include a name of a medication in the medication container, and wherein the information displayed via the display includes the name.
Kohibrecher discloses wherein at least a portion of the first signals associate the electronic tag with the medication container, and wherein at least a portion of the second signals include a name of a medication in the medication container, and wherein the information displayed via the display includes the name [Paragraphs 0032;0040,…,Specifically, drug container specific identification information, such as barcoded information on the container 3102 may include patient identification information, including a patient name, patient number, medical record number for which the medication has been prescribed, medication identification information such as a medication name or solution within the IV container 3102, universal identification information which may be created or assigned at the hospital, medical device delivery information,….].
It would have been obvious one ordinary skill in the art before the effective filling date of the claimed invention, to include Kohibrecher’s system for identifying delayed infusion programs at infusion pump into De La Huerga’s medical devices with controller unit and Augustine’s modular housing module for housing electronic and electromechanical medical device for the benefit of providing a system which enables simpler interfacing, which facilitates accurate prescription entry, verification that prescriptions are suitable at the time of delivery, avoidance of delivery of stale prescriptions, and accurate and automatic delivery record keeping (De La Huerga, [0029]) and an auto-programming features reduce errors made manually by hospital caregivers; and data mining determines the manual programs that result in improved outcomes, less drug use and shorter patient stay; with the management system determines better outcomes of care result and cost saving; and also the caregiver determines the error at the pump quickly and performs subsequent actions in response to the error; also the condition causing the alarm is eliminated (Kohibrecher,[0107]) to obtain the invention as specified in claim 1.
As per claim 2, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 1 above, where Augustine teaches, an electronic tag, further comprising: a sensor configured within the housing [Augustine, Fig.15, e.g. sensors 1521.].
As per claim 3, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 2 above, where Augustine teaches, an electronic tag, wherein the sensor is configured to sense a fluid characteristic of a fluid in the fluid tubing at a location of the clamping mechanism [Augustine, col.7, II.3-13,…, the medication identification and measurement system 128, 228 can include one or more of: a sensor, such as barcode reader 436 of FIG. 4, configured to identify the one or more IV medications or fluids, or an input configured to receive the identity of the one or more IV medications or fluids, such as via the anesthetic record input component 224.].
As per claim 4, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 3 above, where Augustine teaches, an electronic tag, wherein the fluid characteristic of the fluid sensed by the sensor is transmitted via the transceiver to the infusion device [Augustine, col.7, II.3-13,…, the medication identification and measurement system 128, 228 can include one or more of: a sensor, such as barcode reader 436 of FIG. 4, configured to identify the one or more IV medications or fluids, or an input configured to receive the identity of the one or more IV medications or fluids, such as via the anesthetic record input component 224.], and wherein the information displayed by the display is displayed in response to a control signal received via the transceiver from the infusion device [Augustine , Fig.15,These various measurements may be electronically recorded (such as on mass storage1516 (FIG. 15) and displayed on the electronic anesthetic record display 226 (e.g., display device 1510, FIG. 15).].
As per claim 5, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 3 above, where De La Huerga and Kohibrecher teach, an electronic tag, wherein the processor is configured to: determine that a value of the fluid characteristic of the fluid deviates from an infusion delivery limit [Kohibrecher, Paragraphs 0108, ….if each line were to be programmed to deliver 500 mL/hr. or more, the pump system rate limit of 999 mL/hr. would be exceeded.]; and
send at least a portion of the first signals to the infusion device to trigger an alarm at a location remote to the electronic tag indicating a deviation [De La Huerga, Paragraph 0212, …After transmitting the control signal several times and not receiving a response, controller 260 generates an alarm (e.g., audible or visual) at block 480 indicating a failure to effect the command.].
As per claim 6, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 1 above, where De La Huerga teaches, an electronic tag, wherein the transceiver comprises a wireless communication device and is configured to communicate with the infusion device via a wireless connection [De La Huerga, Paragraph 0041,…All of this information is transferred to the controller (e.g. via wireless communication). The controller determines if the patient the IV bag is was dispensed for corresponds to the same patient that the controller was previously sent.].
As per claim 7, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 6 above, where De La Huerga teaches, an electronic tag, wherein the wireless communication device is a Bluetooth- compliant device [De La Huerga, Paragraph 0194, …Transponder 274 is a wireless transmitter/receiver for communicating via RF communication in the present example although other communication protocols are contemplated (e.g., an IRDA protocol, a Bluetooth protocol, etc.).].
As per claim 8, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 6 above, where De La Huerga teaches, an electronic tag, wherein the wireless communication device includes a near-field communication antenna [De La Huerga, Paragraph 0126,Antenna 216 is a conventional RF antenna or magnetic field sensor for receiving power from an external device and for transmitting information to an external device via RF signals.].
As per claim 9, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 1 above, where De La Huerga teaches, an electronic tag, wherein: the processor is configured to cause the electronic tag to receive from the infusion device, through the transceiver, an infusion parameter of an infusion process associated with the medication container [De La Huerga, Paragraphs 0149; 0194, Transponder 274 is a wireless transmitter/receiver for communicating via RF communication in the present example although other communication protocols are contemplated (e.g., an IRDA protocol, a Bluetooth protocol, etc.). Transponder 274 communicates via wireless communication with each of network 272, pumps 100a and 100b, physician device 40, patient device 10 and tags 200a, 200b, etc.]; and
the display is configured to display the infusion parameter [De La Huerga, Paragraphs 0173;0179, To this end, processor 104 may indicate the previous parameter settings via display 123 and provide icons via display 123 to accept, reject or adjust the settings.].
As per claim 10, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 2 above, where Augustine and De La Huerga teach, an electronic tag, wherein the housing comprises a first elongated receptacle configured to receive a portion of the IV tubing, and the clamping mechanism comprises a clamp arm a[Augustine,Fig.10; col.40,ll.22-33,… an IV tubing clamp (e.g., 1060A, 1060B; FIG. 10) to inhibit injection. Operation 2122 can include saving an inhibit injection event information to one or more storage devices.], and a spring configured to apply tension to the clamp arm to restrain the portion of the IV tubing within the first elongated receptacle [De La Huerga, Paragraphs 0017-0018, First, by requiring both a cord and an IV tube to be linked between each IV bag and a corresponding pump unit, the number of connections between IV bags and pump units is doubled.].
As per claim 11, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 10 above, where Augustine and De La Huerga teach, an electronic tag, wherein: the display is disposed on a first side of the housing, opposite the first elongated receptacle and the clamp arm [Augustine,Fig.10; col.40,ll.22-33,… an IV tubing clamp (e.g., 1060A, 1060B; FIG. 10) to inhibit injection. Operation 2122 can include saving an inhibit injection event information to one or more storage devices.]; and
wherein the clamp arm includes a second elongated receptacle, the first elongated receptacle and the second elongated receptacle being configured to jointly surround the portion of the IV tubing to restrain at least the portion of the IV tubing between the clamp arm and the first elongated receptacle [De La Huerga, Paragraphs 0017-0018, First, by requiring both a cord and an IV tube to be linked between each IV bag and a corresponding pump unit, the number of connections between IV bags and pump units is doubled.].
As per claim 12, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 11 above, where Augustine and De La Huerga teach, an electronic tag, wherein the first elongated receptacle and the second elongated receptacle form a substantially cylindrical shape when the claim arm is moved to restrain the IV tubing [Augustine, col.41,ll.42-54, Example 19 is a tamper-resistant, non-refillable syringe comprising: a cylindrical syringe barrel extending from a first end having an opening configured to receive a movable plunger to a second end adjacent a Luer taper connector;….], and wherein the sensor is disposed within the first elongated receptacle and is configured to contact the restrained IV tubing [De La Huerga, Paragraphs 0017-0018, First, by requiring both a cord and an IV tube to be linked between each IV bag and a corresponding pump unit, the number of connections between IV bags and pump units is doubled.].
As per claim 13, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 1 above, where Augustine teaches, an electronic tag, further comprising a lock to secure the electronic tag to the IV tubing [Augustine,col.9,ll. 10-24,The injection port 515 can be secured within the injection portal 411 and can be in fluid communication with IV tubing 520. In some examples, the injection portal 411 may include an injection portal tube 416, such as a transparent tube that is sized to receive and accommodate a syringe barrel 418 of a syringe 406. In some examples, the injection portal can be configured to receive a specific size syringe barrel 418. In some examples, multiple injection portals 411 can be provided to accommodate syringes 406 of different sizes.].
As per claim 14, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 13 above, where Augustine and Kohibrecher teach, an electronic tag, wherein the processor is configured to: receive a control signal from the infusion device to unlock the lock of the electronic tag [De La Huerga, Paragraph 0157, …processor 104 may proceed to facilitate medicant delivery to the patient (i.e., may enable a pump unit corresponding to the medicant, unlock a compartment (not illustrated) on an infusion pump unit 108 to allow the IV bag 140 to be mounted thereon, and/or provide an audible or visual indication to the attending physician).]; and
unlock the lock based on the control signal [Kohibrecher, Paragraph 0071, …The caregiver's action of unlocking the keypad may itself serve as the response to the error message at step 317.].
As per claim 15, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 1 above, where Augustine teaches, an electronic tag, further comprising at least one colored light emitting diode (LED), wherein the at least one colored LED is configured to emit a first color when a fault condition exists and to emit a second color, different from the first color, during normal operation [Augustine, col.24,ll.35-46, The digital flow-rate displays 1476A,B may be small LED or LCD displays that conveniently tell the operator the flow rate while they are manually adjusting the flow rate near the IV bags 1432A,B and drip chambers 1434A,B. The digital flow-rate displays 1476A,B are particularly convenient when the IV fluid identification and measurement system 130, 1430 is a free standing entity mounted on an IV pole 105 for example while being used on the ward or ICU.].
As per claim 16, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 1 above, where Augustine teaches, an electronic tag, further comprising a signal emitter configured to emit signals for associating the electronic tag with an infusion device or a second electronic tag [Augustine, col.24,ll.35-46, The digital flow-rate displays 1476A,B may be small LED or LCD displays that conveniently tell the operator the flow rate while they are manually adjusting the flow rate near the IV bags 1432A,B and drip chambers 1434A,B. The digital flow-rate displays 1476A,B are particularly convenient when the IV fluid identification and measurement system 130, 1430 is a free standing entity mounted on an IV pole 105 for example while being used on the ward or ICU.].
As per claim 17, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 16 above, where De La Huerga teaches, an electronic tag, wherein the signal emitter comprises an acoustic transducer or a pressure actuator [De La Huerga, Paragraph 0193, Display 264 is a textual and graphics display which can be used to examine information provided by processor 620. Indicator 268 is some type of light emitter (e.g., an LED) that is easily observable to a controller 260 user.].
As per claim 18, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 1 above, where De La Huerga teaches, an electronic tag, wherein the infusion device comprises a remote data server, and wherein the processor is configured to cause the transceiver to transmit, to the remote data server, location information to indicate where in a facility, the medication is being administered [De La Huerga, Paragraph 0161, …Physician credentials may be a function of any of several different factors including the patient identification (i.e., for a specific patient perhaps only one physician is authorized to administer medicant), medicant type (i.e., for a specific medicant, perhaps only two physicians at a facility are authorized to administer), etc.].
As per claim 19, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 1 above, where Augustine teaches, an electronic tag, wherein the portion of the first signals associating the electronic tag with the medication communicates an identity of the medication to the infusion device and receive a determination from the infusion device of a range of infusion rates for the medication [Augustine, col.24,ll.35-46, The digital flow-rate displays 1476A,B may be small LED or LCD displays that conveniently tell the operator the flow rate while they are manually adjusting the flow rate near the IV bags 1432A,B and drip chambers 1434A,B. The digital flow-rate displays 1476A,B are particularly convenient when the IV fluid identification and measurement system 130, 1430 is a free standing entity mounted on an IV pole 105 for example while being used on the ward or ICU.].
As per claim 20, Augustine, De La Huerga and Kohibrecher teach all the limitations of claim 1 above, where Kohibrecher teaches, an electronic tag, wherein the electronic tag is configured to be associated with the intravenous IV tubing of an IV set, and wherein the electronic tag is configured to display an expiration time of the IV set [Kohibrecher , Paragraph 0032 , The IV fluids and/or medications 3100 in barcode-identified containers 3102 may be supplied to hospitals by various vendors, with preexisting unique barcode identifiers which include medication information and other information, such as a National Disease Center (NDC) code, expiration information, drug interaction information, and the like.].
Conclusion
RELEVANT ART CITED BY THE EXAMINER
The following prior art made of record and not relied upon is cited to establish the level of skill in the applicant’s art and those arts considered reasonably pertinent to applicant’s disclosure. See MPEP 707.05(c).
References Considered Pertinent but not relied upon
Lanigan et al. (US Patent No: 11,524,151 B1) teaches the filling aid includes a needle housing portion including at least one tab having a starting position and a filling position, and a filling needle cradle including a filling needle, the filling needle cradle slidable connected to the needle housing portion and having a starting position and a filling position, wherein when the at least one tab on the needle housing moves from a starting position to a filling position, the filling needle cradle slides from a starting position to a filling position, and wherein when the at least one tab on the needle housing moves from a filling position to a starting position, the filling needle cradle slides from a filling position to a starting position.
Damiano et al. (US Patent No: 11,571,507 B2) teaches a multi-medicament or single medicament infusion systems for preventing the cross-channeling or improper delivery of medicaments. Damiano discloses the one or more of an infusion pump, medicament cartridges, cartridge connectors, a multi-channel fluid conduit, and an infusion set. Damiano suggests the medicament cartridges may be sized and shaped differently such that the medicament reservoirs can only be inserted into the pump under selected configurations.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GETENTE A YIMER whose telephone number is (571)270-7106. The examiner can normally be reached Monday-Friday 6:30-3:00.Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, IDRISS N ALROBAYE can be reached on 571-270-1023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GETENTE A YIMER/Primary Examiner, Art Unit 2181
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