DETAILED ACTION
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.
Claims 1-4 and 10-18 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.
Claims 1-4 and 10-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: a tracking device communicatively coupled to the wireless transmitter. Here, each of these claims are written as describing “a tracking system”, however these claims lack any elements which are described or known within the art as being capable of performing the claimed function of “tracking.” Thus, on their face, the claims lack an essential element, rendering the claims incomplete.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5-9, and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmidt (WO 2010/091811 A1), with evidence provided by Potyrailo (U.S. Pat. Pub. No. 2017/0124845 A1).
Regarding claim 1, Schmidt discloses a system (embodiment of Fig. 4) comprising: a first connector (filter adapter 60) having a needle (central needle portion of connection 66) extending from the first connector and a needle guard (cylindrical guard surrounding the central needle portion of connection 66) circumferentially surrounding the needle (see Fig. 4, [0038-0039], and [0042]); a second connector (portion of fluid connection device 50 which surrounds and defines fluid line 52, and which includes the central hollow cylinder within fluid connection socket 51) removably coupled to the first connector (by receiving the needle portion of the first connector within the hollow central cylinder of fluid connection socket 51, thereby forming a path of fluid communication - see Fig. 1 and 4, and [0038-0039]), the second connector having an opening (opening in central tube portion of fluid connection socket 51) configured to receive the needle when the first connector is coupled to the second connector (see Fig. 4, [0038]); a wireless transmitter (RFID transponder 68) disposed on the first connector (see Fig. 4 and [0046]), the wireless transmitter configured to wirelessly communicate with an external device (see Fig. 4, wherein it is clear that the wireless transmitter 68 is capable of communicating with an external device, such as a handheld RFID reader, when the first connector is disconnected from the second connector – see for example Potyrailo, Fig. 6, [0044-0053], and [0060-0074], wherein it is known that such a transmitter may be read by an RFID reader for a range of purposes, such as inventory tracking and connection verification); and a shield (portion of fluid connection device surrounding the fluid connection socket 51) coupled to the second connector (integrally, see Fig. 4), the shield configured to axially move relative to the wireless transmitter to block and unblock the wireless transmitter (see Fig. 4, wherein it is clear that the shield portion of fluid connection device 50 moves relative to the wireless transmitter when the first connector is moved closer to the second connector during connection, whereupon, upon connection, the shield portion covers the exposed face of the wireless transmitter 68, thereby blocking external access to the wireless transmitter 68 at least in regards to visual and physical access). Therefore, Schmidt discloses a “tracking system” as claimed.
Regarding claim 5, Schmidt further discloses: a tracking device (detection device/RFID reader 80) communicatively coupled to the wireless transmitter (see Fig. 4, [0023], [0026-0029], and [0046-0048]), wherein the tracking device is configured to transmit a signal to the wireless transmitter and receive a response signal from the wireless transmitter in response to the signal (see [0023-0029] and [0046-0048]). Here, the detection device, which may be embodied as RFID reader 80, is capable of transmitting a detection signal to the wireless transmitter, as described in [0029], whereupon the detection device may detect the presence of the first connector and its usage (tracking) status by receiving a response signal from the wireless transmitter ([0023], [0029], and [0046]). Finally, the detection device/RFID reader 80 is able to transmit a signal to the wireless transmitter, which is then passed to a writable digital storage device (EPROM) provided on the first connector or even within the wireless transmitter, in order to update data regarding the status of the first connector that is stored in the digital storage device, including data (Boolean value) tracking the number of times that the first connector and second connector have been used/connected together ([0026-0027] and [0046-0047]). Detection device/RFID reader 80 thus operates as a tracking device which communicates with the wireless transmitter and tracks/updates a count of the number of times connection between the first connector and second connector have been made in the manner claimed.
Regarding claim 6, Schmidt further discloses that the tracking device is disposed proximate the wireless transmitter (see Fig. 4 and [0047], wherein when the first connector and second connector are connected, the RFID reader 80 is positioned proximate to the wireless transmitter).
Regarding claim 7, Schmidt further discloses that the tracking device is configured to track a status change (presence of the first connector in connection to the second connector and/or usage status) of the wireless transmitter (see [0023], [0029], and [0046-0048]).
Regarding claim 8, Schmidt further discloses that the status change includes the wireless transmitter transitioning from the blocked state to the unblocked state and the wireless transmitter transitioning from the unblocked state to the blocked state (see [0023], [0029], and [0046-0048], wherein the detection device/RFID reader 80 is configured to detect the presence or lack of presence of the wireless transmitter as an indicator of the presence of the first connector in connection to the second connector, thus, because the wireless transmitter is blocked from external access when the first connector is connected to the second connector, the detection device/RFID reader 80 is effectively configured to detect that the wireless transmitter has transitioned from the blocked state to the unblocked state – connection has been made – and that the wireless transmitter has transitioned from the unblocked state to the blocked state – the connectors have been disconnected).
Regarding claim 9, Schmidt further discloses a flow control device (assembly of controller 40 and detection device/RFID reader 80) coupled to the second connector via a delivery line (fluid line 52) and configured to control a flow of fluid within the delivery line ([0037-0038]), the flow device including a tracking device (detection device/RFID reader 80) communicatively coupled to the wireless transmitter (here, while the tracking device – detection device/RFID reader 80 is provided externally to the controller 40, it is communicatively and functionally linked to the control device, executing the detection task that the controller oversees, therefore it may be considered to be part of the control device despite being externally provided, much like a wired sensor that is embedded within a component and connected back to a controller may be considered part of a control device/system that comprises both controller and sensor), wherein the tracking device is configured to transmit a signal to the wireless transmitter and receive a response signal from the wireless transmitter in response to the signal (see in re claim 5).
Regarding claim 15, Schmidt further discloses that the shield uncovers the wireless transmitter when the first connector is decoupled from the second connector (see Fig. 4, wherein when the first connector is decoupled from the second connector, the wireless transmitter 68 is no longer covered by the shield portion of the second connector, and therefore is unblocked).
Regarding claim 16, Schmidt further discloses that the shield blocks and covers the wireless transmitter when the first connector is coupled from the second connector (see in re claim 1).
Regarding claim 17, Schmidt further discloses that the shield is coupled to the first connector such that it circumferentially surrounds the needle guard and the needle (upon connection of the first connector and second connector, whereupon the first connector and all of its components are removably coupled to the second connector and all of its components, and whereupon the needle guard portion of the first connector is received within the fluid connection socket 51 formed by the shield portion of the second connector – see Fig. 4).
Regarding claim 18, Schmidt further discloses that the shield is coupled to the second connector such that it circumferentially surrounds the opening (see Fig. 4, wherein the shield is integrally coupled to the second connector as it is defined in re claim 1, and is formed as surrounding the entirety of the fluid connection socket 51, including the opening of the central hollow cylinder provided therein).
Regarding claim 19, Schmidt discloses a system comprising: a first connector having a needle extending from the first connector and a needle guard circumferentially surrounding the needle (see in re claim 1); a second connector removably coupled to the first connector, the second connector having an opening configured to receive the needle when the first connector is coupled to the second connector (see in re claim 1); a wireless transmitter disposed on the first connector, the wireless transmitter configured to wirelessly communicate with an external device (see in re claim 1); a shield coupled to the second connector, the shield configured to axially move relative to the wireless transmitter to block and unblock the wireless transmitter (see in re claim 1); and a tracking device communicatively coupled to the wireless transmitter, wherein the tracking device is configured to detect a status change of the wireless transmitter (see in re claims 5 and 7). Therefore, Schmidt discloses a “tracking system” as claimed.
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.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Beggs (U.S. Pat. Pub. No. 2020/0324047 A1) in view of Potyrailo.
Regarding claim 20, Beggs discloses a method of tracking a coupling device (see Fig. 8, [0005-0011], [0027], and [0049]), the method comprising: detecting a first status of a transmitter (contact sensor 200) coupled to a coupling device (connector, see [0035-0037]), the first status associated with the coupling device being in an uncoupled configuration and the transmitter being in a blocked state (see Fig. 8, step 703, [0030], [0034], [0038-0039], and [0049], ln 7-11, wherein when the connector is disconnected, the contact sensor is unable to make electrical connection between electrical contacts 202 and 203 and is thus blocked from transmitting to controller 300, whereupon controller 300 detects the lack of signal as an indicator of disconnection), wherein the coupling device (connector) includes a first connector (first connector portion at the end of a first section 801 of an IV line) coupled to a fluid source (medication reservoir 803 – see Fig. 1-2, [0032], and [0035]) and a second connector (second connector portion at the end of a second section 802) coupled to a patient (medication delivery device, which may administer fluid to a patient – see Fig. 1-2, [0027], and [0032]); detecting a second status of the transmitter, the second status associated with the coupling device being in a coupled configuration and the transmitter being in the unblocked state, wherein the second status is different than the first status (see Fig. 8, step 703, [0030], [0034], [0038-0039], and [0049], ln 7-11, wherein when the connector is connected, the contact sensor is able to make electrical connection between electrical contacts 202 and 203 and is thus unblocked from transmitting to controller 300, whereupon controller 300 detects the electrical signal as an indicator of connection); and determining a status change of the transmitter when the transmitter transitions the first status to the second status (see Fig. 8, step 705, [0038-0039], and [0049], ln 11-13).
Beggs fails to teach that the transmitter is wireless, and also fails to teach the method steps of, based on the status change, increasing a status change number associated with a total number of status changes detected for the wireless transmitter; comparing the status change number to a predetermined threshold; and generating an alert if the status change number exceeds the predetermined threshold.
Potyrailo exhibits a system and method for monitoring and tracking the status of a fluid connection between connectors of the type taught by Beggs (see Fig. 1-6, [0025-0037], and [0043-0046]). Like Beggs, Potyrailo teaches that a transmitter/sensor (RFID tag/sensor, 504, 610, 615) may be provided on one or both of the first connector and second connector of a connection (see Fig. 5-6, [0025-0030], [0044-0053], and [0070-0073]) and may be configured to transmit a signal to an external control device (control system, 536) indicating the connection status of the first connector and second connector ([0036], [0046], [0053-0054], [0056], and [0070-0071]), however, Potyrailo teaches that such a transmitter/sensor may be configured as a wireless transmitter capable of wireless communication with an external control device ([0025-0030], [0037], [0053-0054], [0060-0063], and [0070-0071]). Configuring such a transmitter/sensor to be wireless, rather than wired, has obvious and well-known advantages, including reducing the encumbrance of having to route and manage a cable/wire connection between the transmitter and control device, thereby imparting flexibility of in movement and assembly of the connection, as taught by Potyrailo ([0060], ln 1-7), improving the user experience. Thus, based upon the teachings and example of Potyrailo, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to embody the transmitter of Beggs as a wireless transmitter capable of wireless communication with the external controller 300, in order to thereby reduce the encumbrance of having to route and manage a cable/wire connection between the transmitter and controller, thus improving the user experience, as described by Potyrailo ([0060], ln 1-7).
Potyrailo further teaches that such a transmitter/sensor and control device may be configured to ensure that single-use components, such as connectors, are not re-used by configuring the wireless transmitter/sensor to output identification information concerning the connector(s) as well as status information ([0035-0036], [0046], [0052-0053], and [0067]) which may be evaluated by the control system to determine whether use of the connector is proper, or whether replacement is warranted ([0054-0055], [0083], [0085], and [0096]). As a part of such evaluation, the control device may perform the steps of based on a status change detected (such as a change in connection status), increasing a status change number (binary number representing the connection status) associated with the wireless transmitter/sensor (from 0 value to 1 upon first usage and associated connection/disconnection – see [0027], [0036], [0046], and [0056], ln 11-17); comparing the status change number to a predetermined threshold ([0036], ln 7-8, [0046], [0085], ln 1-4, and [0097], wherein the controller may compare the status number to a threshold, such as may be set as a value of 1 for a device that is single use, to thereby determine if an alert requiring the user to replace the device is warranted); and generating an alert if the status change number exceeds the predetermined threshold ([0046], [0085], ln 1-4, and [0097]). Finally, Potyrailo teaches that the use of single-use medical devices assists in reducing the time required for device preparation and cleaning, as well as helps prevent cross-contamination ([0035]). It follows that configuring a transmitter/sensor and control device to ensure that single-use connectors are not re-used provides/ensures at least the advantage of preventing cross-contamination. Thus, based on these teachings, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the transmitter/sensor (contact sensor 200) and control device (controller 300) of Beggs to be configured for use with single-use connectors according to the manner taught by Potyrailo, such that the wireless transmitter/sensor of Beggs is configured to output identification information concerning the connector(s) as well as status information and such that the control device may perform the steps of, based on the connection status change, increasing a connection status change number (binary/Boolean tracking number) associated with a total number of connection status changes detected for the wireless transmitter/sensor; comparing the status change number to a predetermined threshold; and generating an alert if the status change number exceeds the predetermined threshold, in the manner taught by Potyrailo, in order to thereby ensure that the single-use connectors are not re-used, thereby preventing cross-contamination and associated harm to the patient, as described by Potyrailo ([0035]).
Allowable Subject Matter
While no rejections over the prior art are presently presented for claims 2-4 and 10-14, any indication of allowability regarding these claims is reserved until the respective rejections under 35 U.S.C. 112(b) are overcome.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. This art includes
Roy (U.S. Pat. Pub. No. 2016/0230914 A1), which describes a luer slip connector assembly wherein a sensor/alarm assembly (300) is provided to indicate if disengagement has occurred between the male (10) and female (20) connectors, and wherein the sensor may be embodied as comprising a wireless transmitter (RF transmitter, see [0037]).
Py (U.S. Pat. Pub. No. 2013/0270820 A1) and Shultz (U.S. Pat. Pub. No. 2019/0022369 A1), each describing connector assemblies of the type claimed comprising shield members.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783