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 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.
Claim(s) 1, and dependents, is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 1, Applicant recites the limitation “a second flow sensor for detecting a liquid flow rate at the liquid outlet…” While this is an originally presented claim limitation and there is verbatim support for this limitation found in the Brief Summary of the Invention (Par. 9) based upon the Detailed Description of the Embodiments and the accompanying figures it is believed that this limitation may be in error and the scope of the disclosed invention should provide for the second flow sensor to be associated with the second inlet (not the outlet). Specifically, as described in the Detailed Description (Par. 33) the second flow sensor (17) is used for “detecting a liquid flow rate at the second liquid inlet 12”. Looking to Figure 1 this arrangement is confirmed where the second flow sensor (17) is indeed located at/within the second inlet and not provided in association with the outlet. Looking to dependent Claim 5 the system is described as being configured to acquire detected information “of the second liquid inlet”. While such a function would not necessarily be attributable to the second flow sensor (as opposed to implying further inclusion of additional hardware, e.g. a third flow sensor) consideration of the claims in view of the entirety of the disclosure would appear to suggest that this function should be attributable to the second flow sensor which would require the second flow sensor to be associated with the second inlet, not the outlet. As such, confusion over the scope of the claim exists where it is unclear if Claim 1 presents an error as to the location/function of the second flow sensor OR if the second flow sensor (as described in the specification – see element 17) is being interpreted as indirectly allowing for detection of a liquid flow rate at the outlet despite not being associated with and located in the outlet (see Fig. 1).
Appropriate correction is required.
Claim(s) 5, 8, and dependents, is/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 5, Applicant recites “flow information of the second liquid inlet”. However, the system, as claimed, does not include any of the necessary hardware to provide “flow information of the second liquid inlet”. Rather the “second flow sensor” of Claim 1 is associated with the liquid outlet, not the inlet. Examiner submits that the specification is internally conflicting as to whether the second flow sensor should be associated with the second inlet or the outlet. As such, it is unclear if the function to monitor the flow at the second liquid inlet should be attributable to hardware already presented in the claim or if the claim is implicitly requiring additional unclaimed hardware which would be understood to be necessary to perform this function.
Regarding Claim 8, similar to Claim 5 Applicant recites a function of the controller to provide “flow information of the second liquid inlet”. However, strictly speaking, no hardware claimed is configured to perform that function presuming that Claim 1 is accurate in associating the second flow sensor with the outlet (not the second inlet).
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) 1-4, 8-13, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2019/0326012 (“Witt”) in view of U.S. Publication No. 2023/0264010 (“Picot”).
Regarding Claim 1, Witt discloses an infusion system (1200 – see generally Fig. 12), comprising:
An IV set (1124) comprising a first liquid inlet (143) for an intravenous infusion liquid or a syringe and a liquid outlet (144) communicating with an IV catheter including a venipuncture needle (see 122 – 189 – see generally Fig. 12).
Witt discloses that the system may comprise an information matching structure (see 100) comprising a first identification code (106 – see Par. 115)) for identifying the information about the IV set (1124) and an identifier (1104) for identifying the first identification code (Par. 11);
A detection structure (re: the “sensor” for sensing “at least one physical state of the at least one first device to determine at least one first physical parameter of the at least one first device” – Par. 11), wherein the sensor(s) may comprise pressure sensors (Par. 42, 75), flow rate sensors (Par. 170), and other sensors which “detect problems with a system component” (Par. 167), wherein information from these sensors can be acquired by a controller (1104, 1110) for recording the information sensed and provide warning indicates to give alarms when the information is abnormal and use the sensed data to monitor and control fluid flow (Par. 169), the controller acquiring and associating the identity information identified by the identifier to assign the sensor data with the appropriate component (Par. 11, 136, 153, 169, 170, 177, 179, 181, 182, 186, 187).
Witt discloses the invention substantially as claimed except that that the IV set comprises a three-way valve, rather Witt only explicitly discloses a single inlet, needless valve connector (143). However, it must be understood that the specific arrangement of selected medical devices (1120) disclosed by Witt is not intended to be exhaustive, but only exemplary of the diverse type of fluid connectors which would be useable in the disclosed system including syringes, IV bags, valves, catheters…etc. (see Par. 152, 174, 179, 182, 183) for tracking their usage and functioning. However, Picot discloses a medical fluid handling system that utilizes a fluid handling manifold in the form of a three-way valve (101) to permit fluid communication between medical devices including a first inlet (108) for communication with a source of IV fluids, a second inlet (112) for communication with a syringe, and an outlet (110) for communication with an IV. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure one of the nodes of the system of Witt (see generally at Fig. 12) as a three-way valve, as disclosed by Picot, in order to allow for communication with an IV bag and a syringe simultaneously for administration of various fluids to the patient via an intravenous catheter/venipuncture needle.
It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure each way of the node of the three-way valve of modified Witt with suitable sensors including a first flow sensor at the first inlet, a second flow sensor at the liquid outlet and/or second inlet, and a pressure sensor at the outlet, as disclosed by Witt, in order to permit the system to monitor connection status and flow rates through the three-way valve for managing its usage (see Witt, Par. 134, 150, 170). Here the implementation of the tracking system of Witt in association with a three-way valve as a specific implementation of a known connector found in the prior art to be useful for allowing for diverse fluid connection for intravenous delivery of medicaments and providing a various combination of specific sensors in association with this component at the various connection/fluid flow path points is found to be an obvious implementation of the invention to achieve a known and expected outcome of usefully monitoring fluid flow rates and port connection status at the various flow paths of the node.
Regarding Claim 2, here the phrase “attachment area” is held to limit only the intended use of an ‘area’ of the valve to provide for receipt of a second ID code associated within the patient via identifying information. Witt discloses that the identifier is configured to identify an identification code associated with the patient so that the data of the fluid delivery system can be assigned to the patient history/profile (see Par. 160, 170). Within the broad functional language of the instant claim, the device of Witt, modified to include a three-way valve in light of Picot, is configured to receive a patient identifier at any of a variety of locations on the valve including at on the surface of any of the inlet/outlets or on the handle of the stopcock without further modification.
Regarding Claim 3, Witt discloses the controller is configured to send successful matching information after receiving the identity information and the patient information. (see 800, 900, 1000), i.e. the controller receives information from the patient identifier and the various node component identifiers, determines their connection status, monitors their operation, and writes this information to an event registry for record management.
Regarding Claim 4, Witt discloses the controller is configured to acquire and record the information detected by the first flow sensor and the second flow sensor (see Par. 170) with data comprising injection/delivery time and injection dosage (Par. 170). Witt discloses the invention substantially as claimed except that that the data further expressly includes a “stop time”, rather only explicit consideration is made with respect to the start time of the fluid delivery, although Witt does suggest that time stamps may be provided for any changes in the physical states of the devices (see Par. 151). Examiner submits that it would have been obvious to include a stop time based upon assigning a time stamp to the change of the physical state of the device to measuring no fluid flow thereby indicating a stop time for an injection procedure, as a product of obvious data processing and assigning a time stamp to a particular physical state change of the valve system.
Regarding Claim 8, Witt discloses the controller is configured to send system start information when flow information of the first liquid inlet or flow information of the second liquid inlet is matched with pressure information of the liquid outlet in order to indicate start time of fluid dispensing treatments (Par. 151).\
Regarding Claims 9, 11, 12, 13, and 17, Witt, as modified, discloses that the three-way valve is provided with a reader for identifying drug information of a syringe at the second liquid inlet, i.e. the tracking device – see (300), (500)…etc. is set up as not only an identifier, but also a reader (see at 306) such that the tag can communicate directly with tags on other devices, such as syringes (510, 500a) in order to convey information about the syringe including drug information for associating that drug delivery with the particular administration node (Par. 132, 134, 135, 143, 170).
Regarding Claims 10, 18-20, Witt discloses that the drug information comprises a drug name and a drug concentration (Par. 5, 170 – re: the medication identifier identifies the dose and formulation within the syringe such that confirmation can be made as to whether the medication contained therein is the correct dose and formulation to be administered in accordance with the prescribed therapy).
Claim(s) 5 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2019/0326012 (“Witt”) in view of U.S. Publication No. 2023/0264010 (“Picot”) as applied above, and further in view of CN 109268535 (“Ma”).
Regarding Claim 5, Witt discloses the controller is configured to control the warning indicator to give the alarm when the controller receives sensor information which is suggestive of an “error condition” based on the detected physical parameters (Par. 167). However, Witt does not suggest that such error conditions may be determined via the disagreement between a pressure measurement at the liquid outlet and flow information at the first or second inlets (i.e. measuring flow at the inlets, but no pressure at the outlet or measuring pressure at the outlet, but no flow at the inlets). Rather, Witt only uses the pressure sensor to determine a connection state of the outlet and does not explicitly correlate it with flow rate conditions.
However, Ma discloses a related three-way valve (Fig. 1) which has flow sensors (1) associated with the inlet (3) of the valve and a pressure sensor (6) associated with the outlet (7) of the valve. Ma discloses the system includes a controller which is configured to monitor this sensor data and utilize an alarm (15) to alert the operator to abnormal sensor signals associated with valve leakage and/or pressure and flow signal abnormalities. It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize the pressure sensor data from the invention of Witt to monitor flow pressure at the outlet in combination with its connection status, as disclosed by Ma, in order to allow the controller to monitor this sensor data to use it to determine not only whether the valve is connected or if fluid is flowing through the outlet in a normal and expected condition. As such, the ordinary artisan would have found it obvious to provide warning alarms for abnormal conditions of the sensor data including, but not limited to, the indication of flow at the inlets, but no pressure indication at the outlet (signifying an error wherein flow is occurring at the inlets but that flow is not being provided to a downstream connected line via the outlet) and pressure readings at the outlet, but no flow information from the respective inlets despite flow being expected (signifying an error wherein there is an obstruction at the inlet – such as a closed valve – that is preventing expected fluid flow to the outlet).
Regarding Claims 14, Witt, as modified, discloses that the three-way valve is provided with a reader for identifying drug information of a syringe at the second liquid inlet, i.e. the tracking device – see (300), (500)…etc. is set up as not only an identifier, but also a reader (see at 306) such that the tag can communicate directly with tags on other devices, such as syringes (510, 500a) in order to convey information about the syringe including drug information for associating that drug delivery with the particular administration node (Par. 132, 134, 135, 143, 170).
Claim(s) 6 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2019/0326012 (“Witt”) in view of U.S. Publication No. 2023/0264010 (“Picot”) as applied above, and further in view of WO 2023/141729 (“Weiss”)
Regarding Claim 6, Witt, as modified, discloses the invention substantially as claimed except that that the controller is configured to control the warning indicator to give an alarm when a pressure at the liquid outlet is “greater than a preset threshold”. Rather, the pressure sensor is used by Witt to verify connection between nodes, whereby Witt is largely concerned with anomalously low pressure measurements at the outlet node (Par. 150). Although Witt does suggest that sensors may be provided with monitor other physical conditions of the fluid handling components (Par. 169-170). However, Weiss discloses a related multiway valve with a pressure sensor wherein the system will issue a warning alert when the monitored pressure exceeds a threshold which might indicate a downstream occlusion (Pg. 4-6). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the pressure sensor of the invention of Witt to trigger an alert condition in the event that abnormally high pressure values are encountered, as disclosed by Weiss, thereby signifying an error in the system (such as a downstream occlusion) that requires intervention by the user.
Regarding Claims 15, Witt, as modified, discloses that the three-way valve is provided with a reader for identifying drug information of a syringe at the second liquid inlet, i.e. the tracking device – see (300), (500)…etc. is set up as not only an identifier, but also a reader (see at 306) such that the tag can communicate directly with tags on other devices, such as syringes (510, 500a) in order to convey information about the syringe including drug information for associating that drug delivery with the particular administration node (Par. 132, 134, 135, 143, 170).
Claim(s) 7 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2019/0326012 (“Witt”) in view of U.S. Publication No. 2023/0264010 (“Picot”) as applied above, and further in view of CN 109268535 (“Ma”) and U.S. Patent No. 4,585,441 (“Archibald”).
Regarding Claim 7, Witt discloses the invention substantially as claimed except that that the warning indicator is a voice warning indicator arranged at the three-way valve. Rather, Witt is silent as to the exact nature of the warning indicator (e.g. visual, audible, tactile…etc.) and indicates the warning indicated to be arranged as part of a common receiver (104, 1104) and not part of the node (i.e. the valve) itself. However, Ma discloses a related three-way valve (Fig. 1) which comprises an alarm (15) integrated with the valve itself (see Fig. 1). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the valve of modified Witt to provide for local processing an issuing of alarm conditions associated with the valve, as disclosed by Ma, in order to allow a user to quickly confirm that the warning is a product of that particular node assisting in faster location and addressing of error conditions.
Witt, in view of Ma, discloses the invention substantially as claimed except that that the warning indicator is a “voice warning”. Here, “voice warning” is understood to be an audible alert which includes recognizable speech output. However, Archibald discloses that audible alerts can be usefully given as synthesized speech (Col. 4, Ln. 30-38). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the warning of the invention of modified Witt as synthesized speech, as disclosed by Archibald, in order to provide clear direction as to the cause of the warning helping to distinguish the warning over other medical devices which might issue more generic sirens, beeps, or chirps allowing for quicker identification of the error conditions.
Regarding Claims 16, Witt, as modified, discloses that the three-way valve is provided with a reader for identifying drug information of a syringe at the second liquid inlet, i.e. the tracking device – see (300), (500)…etc. is set up as not only an identifier, but also a reader (see at 306) such that the tag can communicate directly with tags on other devices, such as syringes (510, 500a) in order to convey information about the syringe including drug information for associating that drug delivery with the particular administration node (Par. 132, 134, 135, 143, 170).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/ Primary Examiner, Art Unit 3783
07/08/2026
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