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 .
DETAILED ACTION
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) 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.
Claims 1-7, 9-17 and 21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Brand et al (U.S. Pub. No: 2022/0118240 A1) in view of Dembski et al (U.S. Pub. No: 2021/0262916 A1).
Regarding claim 1, Brand discloses a system comprising: an image capture device configured to capture a set of images of a movable component of a needleless connector and at least one processor configured to: receive the set of images of the movable component of the needleless connector (see page 2, paragraphs, [0018-0020] in aspects, the system further includes a “positional sensor” configured to detect movement of the needleless connector, wherein the one or more processors are further programmed and/or configured to: determine, based on the detected movement of the needleless connector, In aspects, the system further includes: a color sensor configured to detect a color of a fluid in the “fluid flow” path (movable component), of the “needleless connector”, wherein the one or more processors are further programmed and/or configured to: determine, based on the color of the fluid detected in the fluid flow path of the needleless connector, at least one of a blood-draw in the needleless connector and a retention of blood in the needleless connector. In aspects, the system further includes: a “visual indicator” configured to provide a visual indication associated with the at least one of: the scrubbing event in which the needleless connector is scrubbed with the disinfectant, the flushing event in which the needleless connector is flushed with the solution, the connection event in which the needleless connector is connected to the medical device, the disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof.
Also, pages 13-15, paragraphs, [0166] and [0188], Input component may include a component that permits device to receive information, such as via user input (e.g., a touch “screen display”, a keyboard, a keypad, a mouse, a button, a switch, a microphone, a “camera”, an electroencephalogram (EEG) monitor, patient monitoring system etc.). Additionally, or alternatively, input component may include a sensor for sensing information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, etc.). Output component may include a component that provides output information from device 300 (e.g., a display, a speaker, one or more light-emitting diodes (LEDs), and/or the like). Referring also to FIG. 2A, a plurality of medication source devices 206a, 206b, of a medication source system 102 are connected to a plurality of lumens 212a, 212b, 212n, and each medication source 206 device may include a “visual indicator”, user input. For example, visual indicator 210 may emit a predetermined light pattern (e.g., blink rapidly and/or emit a predetermined color to indicate that medication source device 206 is in a pairing mode, etc.) in response to a predetermined user input to pairing input 208 (e.g., in response to a user pressing and holding a button of pairing input 208, etc.) of medication source device 206.
Finally, page 21, paragraph, [0225] as described in more detail herein with respect to sensor 254, a time-varying signal may be measured with a force sensor, a seismograph, a pressure sensor, an optical sensor, a microphone, an acoustic sensor for air waves in the audible range, a hydrophone, an acoustic sensor for liquid waves, a pickup or a transducer that captures or senses mechanical vibrations, or any combination thereof);
and process the set of images of the movable component of the needleless connector to determine whether a medical device is connected to the needleless connector (see abstract, a “signal measured” by a sensor connected to a needleless connector including a fluid flow path may be obtained to determine, based on the signal, an event associated with the needleless connector, such as at least one of: a scrubbing event in which the needleless connector is scrubbed with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device.
Also page 1, paragraphs, [0015-0016] the one or more processors are further programmed or configured to: determine, based on the force signal, a pattern of events including a plurality of the least one of: the scrubbing event in which the needleless connector is scrubbed with the disinfectant, the flushing event in which the needleless connector is flushed with the solution, the connection event in which the needleless connector is connected to the medical device, the disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof; and determine, based on the pattern of events, a medication administration event in which a “medication is administered” to a patient via the needleless connector. In some non-limiting embodiments or aspects, the system further includes: an identification sensor configured to detect an “identification tag” on a medical device connected to or being connected to the needleless connector.
Also page 2, paragraphs, [0020-0021] In some non-limiting embodiments or aspects, the system further includes: a visual indicator configured to provide a visual indication associated with the at least one of: the scrubbing event in which the needleless connector is scrubbed with the disinfectant, the flushing event in which the needleless connector is flushed with the solution, the connection event in which the needleless connector is connected to the medical device, the disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof. According to some non-limiting embodiments or aspects, provided is a method including: measuring, with a force sensor connected to a needleless connector including a fluid flow path, a force signal; receiving, with at least one processor from the force sensor, the force signal; and determining, with at least one processor, based on the force signal, at least one of: a scrubbing event in which the needleless connector is scrubbed with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof.
Finally, page 4, paragraphs, [0053-0055] According to some non-limiting embodiments or aspects, provided is a system, including: a needleless connector including a fluid flow path and a septum; an optical sensor connected to the needleless connector, wherein the optical sensor is configured to “detect a movement” of the septum; and one or more processors programmed and/or configured to: receive, from the optical sensor, a signal associated with the movement of the septum; and determine, based on the signal, an event associated with the needleless connector. The event associated with the needleless connector includes at least one of: a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device. In some non-limiting embodiments or aspects, the septum includes one or more markings, and wherein the optical sensor is configured to detect a movement of the one or more markings to detect the movement of the septum.
However, regarding claim 1, Brand discloses a “visual indicator”; and one or more processors programmed and/or configured to: and control the visual indicator to provide a visual indication associated with the at least one of: the scrubbing event in which the needleless connector is scrub. Also includes a display, a processor, a memory, an input device, and a network interface. A “computing system” may include one or more computing devices or computers. An shown in FIG. 2C, smart device 104 may include visual indicator 252 (e.g., one or more visual indicators, a plurality of visual indicators, a multi-color LED(s), a plurality of LEDs, output component 312, etc.), sensor 254 (e.g., one or more sensors, a plurality of sensors, a sensor suite, etc.), pairing input 256 (e.g., one or more buttons, one or more force sensors, one or more accelerometers, input component 310, etc.), battery 258, and/or energy harvester 260 (e.g., a thermoelectric energy harvester, a photovoltaic energy harvester, a piezoelectric energy harvester, etc.). Visual indicator 252, sensor 254, pairing input 256, battery 258, energy harvester 260 and all or a portion of needleless connector 214 may be included within “housing 250 of smart device” 104. Visual indicator 252 may be visible through and/or extend from a “sidewall of housing” and finally, component 310 may include a component that permits device 300 to receive information, such as via user input (e.g., a touch screen display, a keyboard, a keypad, a mouse, a button, a switch, a microphone, a camera.
But, does not explicitly state that “capturing set of images”.
On the other hand, Dembski, in the same field of “a particle sorting module having an opening that is configured for visualizing droplets of a deflected flow stream”, teaches (see page 10, paragraphs, [0064-0067] Systems according to certain embodiments include a particle sorting module having an opening configured for visualizing droplets of a deflected flow stream as described above and an imaging sensor configured to “capture one or more images” through the opening (e.g., the boundaries of sample collection ports at the distal end of the particle sorting module). The imaging sensor may be any suitable device capable of capturing and converting an optical image into an electronic data signal, including but not limited to charge-coupled devices, semiconductor charge-coupled devices (CCD), active pixel sensors (APS), complementary metal-oxide “semiconductor (CMOS)” image sensors or N-type metal-oxide semiconductor (NMOS) image sensors. In some embodiments, the imaging sensor is a CCD camera. For example, the camera may be an electron multiplying CCD (EMCCD) camera or an intensified CCD (ICCD) camera. In other embodiments, the imaging sensor is a CMOS-type camera. The number of imaging sensors in the subject systems may vary, as desired. For example, the subject systems may include one imaging sensor or more, such as two imaging sensors or more, such as three imaging sensors or more, such as four imaging sensors or more, such as five imaging sensors or more and including ten imaging sensors or more. In certain embodiments, systems include one imaging sensor. Where the subject systems include more than one imaging sensor, each imaging sensor may be the same or a combination of sensors. For example, where the subject systems include two imaging sensors, in some embodiments the first imaging sensor is a CCD-type device and the second imaging sensor is a CMOS-type device. In other embodiments, both the first and second imaging sensor are CCD-type devices. In yet other embodiments, both the first and second imaging sensors are CMOS-type devices.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the Brand invention according to the teaching of Dembski because to combine, Brand reference that teaches using a sensors and cameras to monitor and collect information about needleless connectors with Dembski invention that teaches to monitor the flow, and improved method for type of fluid and other information by way of captured images.
Regarding claim 2, Brand discloses the system of claim 1, wherein the movable component of the needleless connector includes a bellow, and wherein the bellow is configured to compress from an expanded state to a compressed state in response to a connection of the medical device to the needleless connector (see abstract, also page 2, paragraph, [0031], a signal measured by a sensor “connected to a needleless connector including a fluid flow path” may be obtained to determine, based on the signal, an event associated with the needleless connector, such as at least one of: a scrubbing event in which the needleless connector is scrubbed with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof. An indication of the determined event may be provided. See Fig. 4A-4C. Alternatively to, or in addition to, direct measurements of forces with a transducer and/or the like, measurements of changes in connector components can be used to indicate how a device (e.g., a needleless connector, a smart device, a lumen, etc.) is used or being used. For example, in a needleless connector the central valve, or membrane may be “compressed” along a central axis when a connection to another medical device is formed, and the compression of the membrane may be measured using optical and/or other encoding techniques (e.g., to determine an amount of compression, a distance of compression, a frequency of compression, a time of compression, a frequency, etc.).
Regarding claim 3, Brand discloses the system of claim 2, wherein the needleless connector includes a fluid flow path in a housing between an inlet and an outlet opposite the inlet, and wherein the bellow is included within the housing (see claim1, also page 11, paragraph, [0156] referring also to FIG. 4A, FIG. 4A is a side view of non-limiting embodiments or aspects of an implementation 400A of a needleless connector 214. As shown in FIG. 4A, a needleless connector 214 may include a fluid flow path in a housing 402 between an inlet 404 and an outlet 406 opposite the inlet 404. Inlet 404 may be fluidically sealed by a displaceable septum 408 configured to be displaced to open or connect inlet 404 to the fluid flow path in response to connection of needleless connector 214 to a medical device (e.g., an infusion pump, an IV bag, a syringe, an IV line, etc.). For example, the needleless connector 214 may include the BD MaxPIus™ connector, the BD MaxZero™ needle-free connector, and/or the like. However, non-limiting embodiments or aspects are not limited thereto, and the needleless connector 214 may include any needleless connector 214 for use in fluid administration. For example, needleless connector 214 may include a port, a manifold, a stopcock, an open connector, a leer connector, and/or any other connector that does not rely on (but may or may not include) a needle to form a connection with a device and/or a patient. In some non-limiting embodiments or aspects, one or more components of smart device 104 may be included within housing 402 of needleless connector 214. For example, housing 402 of needleless connector 214 may include housing 250 of smart device 104 (e.g., housing 250 may be integrated with housing 402, encompassed within housing 402, etc.)).
Regarding claim 4, Brand discloses the system of claim 3, wherein the image capture device is integrated with the housing of the needleless connector (see claim1, also page 11, paragraph, [0156] referring also to FIG. 4A, FIG. 4A is a side view of non-limiting embodiments or aspects of an implementation 400A of a needleless connector 214. As shown in FIG. 4A, a needleless connector 214 may include a fluid flow path in a housing 402 between an inlet 404 and an outlet 406 opposite the inlet 404. Inlet 404 may be fluidically sealed by a displaceable septum 408 configured to be displaced to open or connect inlet 404 to the fluid flow path in response to connection of needleless connector 214 to a medical device (e.g., an infusion pump, an IV bag, a syringe, an IV line, etc.). For example, the needleless connector 214 may include the BD MaxPIus™ connector, the BD MaxZero™ needle-free connector, and/or the like. However, non-limiting embodiments or aspects are not limited thereto, and the needleless connector 214 may include any needleless connector 214 for use in fluid administration. For example, needleless connector 214 may include a port, a manifold, a stopcock, an open connector, a leer connector, and/or any other connector that does not rely on (but may or may not include) a needle to form a connection with a device and/or a patient. In some non-limiting embodiments or aspects, one or more components of smart device 104 may be included within housing 402 of needleless connector 214. For example, housing 402 of needleless connector 214 may include housing 250 of smart device 104 (e.g., housing 250 may be integrated with housing 402, encompassed within housing 402, etc.)).
Regarding claim 5, Brand discloses the system of claim 3, wherein the image capture device is external to the housing of the needleless connector (see claim 1, also page 19, paragraphs, [0213] in aspects, sensor 254 measures at least one signal including at least one of a pressure signal and an acoustic signal. For example, sensor 254 may measure the at least one signal including at least one of a pressure signal and an acoustic signal, and smart device 104 (and/or medication source system 102, central computing system 108, and/or terminal/mobile computing system 110) may obtain the at least one signal including at least one of a pressure signal and an acoustic signal from sensor 254. For example, smart device 104 may include communication circuitry (e.g., communication interface 314, etc.) that wirelessly transmits the at least one signal to a remote computing system. As an example, smart device 104 may process the pressure signal and/or the acoustic signal on a microprocessor within a housing of smart device 104 including sensor 254 and the microprocessor, and/or smart device 104 may wirelessly transmit (and/or transmit via wired connection) the pressure signal and/or the acoustic signal to a remote computer that perform digital signal processing on the pressure signal and/or the acoustic signal, to identify and classify events of interest (e.g., infiltration, extravasation, catheter occlusion, etc.).
Also page 21, paragraphs, [0221-0225] in aspects, smart device 104 and/or needleless catheter may include communication circuitry (e.g., communication interface 314, etc.) that wirelessly transmits the at least one signal to a remote computing system. As an example, smart device 104 and/or needleless connector 214 may process the pressure signal and/or the acoustic signal on a microprocessor within housing 250 of smart device 104 and/or within housing 402 of needleless connector 214 including sensor 254 and the microprocessor, and/or smart device 104 and/or needleless connector 214 may wirelessly transmit (and/or transmit via a wired connection) the pressure signal and/or the acoustic signal to a remote computer. In some non-limiting embodiments or aspects, smart device 104 may provide real-time feedback during catheter insertion (e.g., via visual indicator 252, output component 312. As described in more detail herein with respect to sensor 254, a time-varying signal may be measured with a force sensor, a seismograph, a pressure sensor, an optical sensor, a microphone, an acoustic sensor for air waves in the audible range, a hydrophone, an acoustic sensor for liquid waves, a pickup or a transducer that captures or senses mechanical vibrations, or any combination thereof).
Regarding claim 7, Brand discloses the system of claim 1, further comprising: communication circuitry configured to communicate with an external computing device (see claim 1, also pages 5, 9, paragraphs, [0078] and [0143], clause 16. The method of clause 15, further comprising: transmitting, with “communication circuitry”, the force signal to a remote computing system. Referring now to FIG. 1, FIG. 1 is a diagram of an example environment 100 in which devices, systems, methods, and/or products described herein, may be implemented. As shown in FIG. 1, environment 100 includes medication source system 102, smart device 104, communication network 106, central computing system 108, and terminal/mobile computing system 110. Systems and/or devices of environment 100 can interconnect via wired connections, wireless connections, or a combination of wired and wireless connections).
Regarding claim 9, Brand discloses the system of claim 1, wherein the medical device includes a syringe (see page 3, paragraph, [0043] in some non-limiting embodiments or aspects, the plurality of types of medical devices includes two or more of the following: a cap, a syringe, a tubing, a medical device connector, or any combination thereof).
Regarding claim 12, Brand discloses the method of claim 11, wherein the movable component of the needleless connector includes a bellow, wherein the bellow is configured to compress from an expanded state to a compressed state in response to a connection of the medical device to the needleless connector, and wherein processing the set of images to determine whether medical device is connected to the needleless connector includes identifying a state of the bellow as shown in the set of images (see abstract, also page 2, paragraph, [0031], a signal measured by a sensor “connected to a needleless connector including a fluid flow path” may be obtained to determine, based on the signal, an event associated with the needleless connector, such as at least one of: a scrubbing event in which the needleless connector is scrubbed with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof. An indication of the determined event may be provided. Alternatively to, or in addition to, direct measurements of forces with a transducer and/or the like, measurements of changes in connector components can be used to indicate how a device (e.g., a needleless connector, a smart device, a lumen, etc.) is used or being used. For example, in a needleless connector the central valve, or membrane may be compressed along a central axis when a connection to another medical device is formed, and the compression of the membrane may be measured using optical and/or other encoding techniques (e.g., to determine an amount of compression, a distance of compression, a frequency of compression, a time of compression, a frequency, etc.).
Regarding claim 13, Brand discloses the method of claim 12, wherein the needleless connector includes a fluid flow path in a housing between an inlet and an outlet opposite the inlet, and wherein the bellow is included within the housing, and wherein capturing, with the image capture device, the set of images of the movable component of the needleless connector includes capturing, with the image capture device, the set of images of the movable component of the needleless connector through a light transmissive portion of the housing (see claim1, also page 11, paragraph, [0156] and [0159], referring also to FIG. 4A, FIG. 4A is a side view of non-limiting embodiments or aspects of an implementation 400A of a needleless connector 214. As shown in FIG. 4A, a needleless connector 214 may include a fluid flow path in a housing 402 between an inlet 404 and an outlet 406 opposite the inlet 404. Inlet 404 may be fluidically sealed by a displaceable septum 408 configured to be displaced to open or connect inlet 404 to the fluid flow path in response to connection of needleless connector 214 to a medical device (e.g., an infusion pump, an IV bag, a syringe, an IV line, etc.). For example, the needleless connector 214 may include the BD MaxPIus™ connector, the BD MaxZero™ needle-free connector, and/or the like. However, non-limiting embodiments or aspects are not limited thereto, and the needleless connector 214 may include any needleless connector 214 for use in fluid administration. For example, needleless connector 214 may include a port, a manifold, a stopcock, an open connector, a leer connector, and/or any other connector that does not rely on (but may or may not include) a needle to form a connection with a device and/or a patient. In some non-limiting embodiments or aspects, one or more components of smart device 104 may be included within housing 402 of needleless connector 214. For example, housing 402 of needleless connector 214 may include housing 250 of smart device 104 (e.g., housing 250 may be integrated with housing 402, encompassed within housing 402, etc.)). For example, medication source device 206 may establish a short range wireless communication connection (e.g., an NFC communication connection, an RFID communication connection, a Bluetooth® communication connection, etc.) with smart device 104. As an example, visual indicator 210 may be configured to emit a predetermined light pattern (e.g., to blink rapidly to indicate that medication source device 206 is in a pairing mode, etc.) in response to a predetermined user input to pairing input 208 (e.g., in response to a user pressing and holding a button of pairing input 208, etc.) of medication source device 206. In such an example, smart device 104 may be configured to establish communication with medication source device 206 (e.g., pair and/or activate a pairing sequence for pairing smart device 104 with medication source device 206, etc.).
Regarding claim 14, Brand discloses the method of claim 11, wherein capturing, with the image capture device, the set of images of the movable component of the needleless connector includes capturing the set of images based on at least one of the following: visible light, non-visible light, thermal radiation, depth, motion, or any combination thereof (see claim 1, also page 12, paragraphs, [0160-0161] in some non-limiting embodiments or aspects, when medication source device 206 is paired with smart device 104, visual indicator 210 of medication source device 206 and visual indicator 252 of smart device 104 are configured to provide a same type of visual output (e.g., a same color of light from a multi-colored LED, a same pattern of light, etc.). For example, and referring again to FIG. 2A, medication source device 206a may be paired with smart device 104n and each of medication source device 206a and smart device 104n may output a first color of light (e.g., red light), medication source device 206b may be paired with smart device 104a and each of medication source device 206b and smart device 104a may output a second color of light (e.g., green light), medication source device 206n may be paired with smart device 104b and each of medication source device 206n and smart device 104b may output a third color of light (e.g., blue light), and/or the like. One or more position sensors (e.g., a position sensor configured to detect movement of smart device 104, etc.); one or more RBG color sensors; one or more mechanical switches; one or more flow sensors (e.g., an ultrasonic flow sensor, a thermal flow sensor, etc.); or any combination thereof).
Regarding claim 15, Brand discloses the method of claim 11, further comprising: communicating, with communication circuitry, the set of images to an external computing device, wherein the external computing devices includes the at least one processor (see claim 1, also pages 5, 9, paragraphs, [0078] and [0143], clause 16. The method of clause 15, further comprising: transmitting, with “communication circuitry”, the force signal to a remote computing system. Referring now to FIG. 1, FIG. 1 is a diagram of an example environment 100 in which devices, systems, methods, and/or products described herein, may be implemented. As shown in FIG. 1, environment 100 includes medication source system 102, smart device 104, communication network 106, central computing system 108, and terminal/mobile computing system 110. Systems and/or devices of environment 100 can interconnect via wired connections, wireless connections, or a combination of wired and wireless connections).
Regarding claim 17, Brand discloses the method of claim 11, wherein providing, with the at least one processor, the indication of whether the medical device is connected to the needleless connector includes: generating, with the at least one processor, a message including at least: (i) the indication of whether the medical device is connected to the needleless connector, and (ii) an identifier of the medical device or of the needleless connector; and communicating, with communication circuitry, the message to an external computing device (see claim 1, also page 8, paragraph, [0135] as used herein, the terms “communication” and “communicate” may refer to the reception, receipt, transmission, transfer, provision, and/or the like of information (e.g., data, signals, messages, instructions, commands, and/or the like). For one unit (e.g., a device, a system, a component of a device or system, combinations thereof, and/or the like) to be in communication with another unit means that the one unit is able to directly or indirectly receive information from and/or transmit information to the other unit. This may refer to a direct or indirect connection that is wired and/or wireless in nature. Additionally, two units may be in communication with each other even though the information transmitted may be modified, processed, relayed, and/or routed between the first and second unit. For example, a first unit may be in communication with a second unit even though the first unit passively receives information and does not actively transmit information to the second unit. As another example, a first unit may be in communication with a second unit if at least one intermediary unit (e.g., a third unit located between the first unit and the second unit) processes information received from the first unit and communicates the processed information to the second unit. In some non-limiting embodiments or aspects, a message may refer to a network packet (e.g., a data packet and/or the like) that includes data. It will be appreciated that numerous other arrangements are possible).
With regard to claims 6, 10, 11, 16 and 21 the arguments analogous to those presented above for claims 1, 2, 3, 4, 5, 7, 9, 12, 13, 14, 15 and 17 are respectively applicable to claims 6, 10, 11, 16 and 21.
Allowable Subject Matter
Claims 8, 18, 19, 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Seyed Azarian whose telephone number is (571) 272-7443. The examiner can normally be reached on Monday through Thursday from 6:00 a.m. to 7:30 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Matthew Bella, can be reached at (571) 272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEYED H AZARIAN/Primary Examiner, Art Unit 2667
August 3, 2026
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