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 .
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.
Status of Claims
In the amendment filed on December 30th, 2025, claims 1, 6, 8 and 16 have been amended, claims 3, 4, 9 and 18 have been cancelled and no new claim has been added. Therefore, claims 1, 2,5-8, 10-17, 19 and 20 are pending for examination.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/30/2025 has been entered.
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) 1, 2, 6, 7, 16, 17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tieck et al. (US 9744290 B2) in view of Mott (US 202200063883 A1) and Miglioli et al. (US 20020014962 A1)
In regards to claim 1, Tieck teaches a container, comprising a container identifying element that is unique to the container, wherein the container identifying element is adapted to correspond to a matching database identification code that is associated with data stored in a database(Column 40, lines 21-31;Column 81, lines 20-30),i.e.
A reservoir unit system for an infusion pump device according to an embodiment of the present invention includes a reservoir container having a neck portion and an interior volume for containing an infusion medium, where the neck portion has a port opening through which infusion media may be received into the interior volume of the reservoir, and where the neck portion has a flow channel with a first opening to the interior volume of the reservoir container and a second opening for connection in flow communication with a tubing.[Col 40, ln 21-31]
In certain embodiments, the processing electronics 62 coupled to the transceiver 68 may access, e.g., via a wired or wireless connection, directly or via another device(s), a database (e.g., on the Internet) to verify the authenticity of one or more of the base, reservoir, and/or cap using the serial number (unique ID, etc.) obtained from the base, reservoir, and/or cap, respectively, to confirm that such unit is authentic and genuine.[Col 81, ln 20-30]
This indicates wireless communication using processing electronics of a transceiver linked to a database to match an Identification code to what is stored within the database. Tieck further teaches the data comprises the type and quantity of fluid within the container. (Column 5, lines 33-37; Column 78, lines 25-40; Column 84, lines 30-38), i.e.
In particular embodiments, the one or more characteristics includes one or more of: a type or identity of a manufacturer of the reservoir or the cap; a size of the reservoir or the cap; a type or concentration of infusion media in the reservoir; a volume amount of infusion media in the reservoir[Col 5, ln 33-37]
the processing electronics 62 determines and sets operational settings for one or more of: pumping rate (amount of fluid pumped per unit time), pumping time period (amount of time of pumping), pumping power (amount of fluid pressure), priming (filling) the infusion set tubing 52, priming (filling) the infusion set needle or cannula 56, detecting an occlusion in the fluid path from the reservoir 1 to the infusion set needle or cannula 56, handling an occlusion (pumping time, pressure, or program for dislodging, compensating for, or otherwise handling an occlusion).[Col 78, ln 25-40]
In further embodiments, one or more wireless or wired communication devices is provided on the infusion pump device 30 (or other delivery device) and is configured and controlled to transmit volume information relating to the volume of infusion fluid remaining in or dispensed from the reservoir 1 (or other information corresponding to detected parameters or associated characteristics) for display on another electronic device separate from or located remote from the infusion pump device 30. [Col 84, ln 30-38]
Tieck fails to teach a tamper resistant mechanism disposed on the container, wherein the tamper resistant mechanism comprises a non-permanent memory connected to an electronic circuit, wherein a passcode is stored in the non- permanent memory. Mott on the other hand teaches a tamper resistant mechanism disposed on the container, wherein the tamper resistant mechanism comprises a non-permanent memory connected to an electronic circuit, wherein a passcode is stored in the non- permanent memory (Paragraphs 14, 96), i.e.
alternatively, this embodiment might include a keypad coupled to the smart module, such that one can gain authorized access to the container by entering a passcode. The keypad might be numerical, alphanumerical, alphabetical, or even non-alphanumerical symbols and include any number of keys deemed to be appropriate to the application. The smart module would accept an ‘open’ command when the keypad receives the appropriate passcode or selection pattern, and direct the locking mechanism of the cap to unlock and allow access to the container. [P-14]
If the operating device 108 maintains a log over time, it would be possible to provide additional features such as keeping track of when the cap 100 was last opened or closed; whose thumbprint, device 108, or code was used to open the cap 100 most recently; and maintain an ongoing history of input device readings. With this kind of remote support, the smart module 202 need only provide regular updates of current status, rather than store such information in the smart module memory 202F. This seems like the optimal option, though an embodiment wherein the smart module 202 includes the memory 202F and CPU 202A to keep such a record locally may also be preferred, particularly in an embodiment less dependent on the operating device 108. In step 10.20, having determined that the input is not a request for opening the cap 100, the smart module 202 next determines whether the input being received indicates something that should be reported urgently instead of simply logged as data. Some examples might be sensor input data that indicates an attempt at tampering with the container 102 [P-96]
Here, the circuit is integrated into the cap, thereby, the electrical connection between the cap and the electronic circuit is one entity, since there is no definitive structural configuration disclosed.
Furthermore, Motts disclosed cap is configured to open or close the container to selectively gain access to the content within the container (in this case scenario, fluid)
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Motts’ teaching with Tieck’s teaching in order to enable and log authorized opening as well as log tampered openings of the container.
Tieck modified via Mott teaches a cap, cover over an opening, or valve disposed on the container; and an electrical connection between the electronic circuit and the cap, cover, or valve, (Paragraph 96, Mott)
If the operating device 108 maintains a log over time, it would be possible to provide additional features such as keeping track of when the cap 100 was last opened or closed; whose thumbprint, device 108, or code was used to open the cap 100 most recently; and maintain an ongoing history of input device readings. With this kind of remote support, the smart module 202 need only provide regular updates of current status, rather than store such information in the smart module memory 202F. This seems like the optimal option, though an embodiment wherein the smart module 202 includes the memory 202F and CPU 202A to keep such a record locally may also be preferred, particularly in an embodiment less dependent on the operating device 108. In step 10.20, having determined that the input is not a request for opening the cap 100, the smart module 202 next determines whether the input being received indicates something that should be reported urgently instead of simply logged as data. Some examples might be sensor input data that indicates an attempt at tampering with the container 102 [P-96]
Tieck modified fails to teach breaking the electrical connection causes the electronic circuit to erase the non-permanent memory.
Miglioli on the other hand teaches breaking the electrical connection causes the electronic circuit to erase the non-permanent memory, wherein an electrical contact located on the closure member (such as the cap, cover) the electrical pathway located to interrupt the electrical connection between the electronic circuit and the closure member in response to actuating the closure member to open the container (Paragraphs 4, 7)
an intrusion detection mechanism having a metallic cover for protecting an encryption circuitry and a memory in which the encryption key is stored. The metallic cover has a top and a bottom side which are secured together by a screw. The screw merely functions to cause a switch arm to depress a switch button when the mechanism is in the desired, assembly mode. When the security screw is rotated, a circuit is activated (by opening of the button), the attempt to open the cover is detected and a destruct circuit is enabled which causes the memory to be erased. A drawback of this method is that the electromechanical switch utilized is subject to hot and cold temperatures, dampness and other deteriorating environmental conditions which can adversely affect the switch's level of performance, especially after prolonged exposure to such conditions. Furthermore, a failure of the circuit itself may be caused by oxidation of the circuitry at various portions thereof as a result of such prolonged exposure.[P-4]
According to another aspect of the invention, there is provided an electrical assembly which includes an electronic device including an electrical circuit having sensitive information as part thereof, a tamper resistant enclosure, the electronic device being positioned within the enclosure, the enclosure including a first cover for being positioned substantially on a first side of the electronic device, a second cover for being positioned substantially on the opposite side of the electronic device from the first side, a plurality of fixing components passing through the first cover for securing the first cover to the second cover, the fixing elements adapted for passing through the electronic device and forming a part of the electrical circuit of the electronic device when the first cover is secured to the second cover, and a detector for detecting the interruption of the electrical circuit caused by at least the partial removal of at least one of the fixing elements.[P-7]
Here, we see Miglioli teach an analogous disclosure is which an electrical contact located on the closure member (cover) the electrical pathway located to interrupt the electrical connection between the electronic circuit and the closure member in response to actuating the closure member to open the container; by opening of the cover and attempting an opening of the cover of the container vessel, the interruption of the electrical connection of the circuitry of the cover on the container, results in the destruction of the circuit and the erasing of the memory of the said circuit.
Miglioli’s teaching is directed to protecting against tampering of a container for an electronic device such that the circuitry is placed between the opening mechanism/cover and the actual container of the protected device. The same system may obviously be translated to a casing/container of another device or substance, such that the same security mechanism may be applicable.
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Miglioli’s teaching with Tieck modified’s teaching or circuitry disruption of the opening of a cover/cap of a container in order to effectively delete or reset the memory of the lid.
In regards to claim 2, Tieck modified teaches the container identifying element is selected from the group consisting of a barcode, a VR code, a decimal code, an alphanumeric code, an RFID tag, and a combination thereof. (Column 18, lines 58-67; Column 28, lines 50-55; Column 81, lines 20-30), i.e.
In further embodiments: (a) the at least one RF detectable feature includes a radio frequency identification (RFID) tag that is attached to a housing of the cap to the reservoir or on a plunger within the reservoir, (b) the at least one RF detectable feature includes a passive RF device that receives power through inductive coupling with the RF sensor, (c) the at least one RF detectable feature includes an RF detectable device having a directional antenna or an antenna with at least one RF shield or wave guide configured to direct RF signals to or from the antenna [Col18, ln 58-67]
in further embodiments, the at least one optically detectable feature includes: (a) at least one surface of the cap or the reservoir that has at least one of a material, coating, surface contour or pattern, ribs, grooves, undulations, roughness, abrasions, apertures, detents or an attached article, that inhibits or changes optical reflective characteristics of the at least one surface of the cap; (b) a bar code, matrix code or other optically detectable pattern that represents encoded information; or (c) an adhesive-backed tag that adheres to the cap and that has an outer surface configured to alter an optical signal in an optically detectable manner. [Col 28, ln 50-55]
In certain embodiments, the processing electronics 62 coupled to the transceiver 68 may access, e.g., via a wired or wireless connection, directly or via another device(s), a database (e.g., on the Internet) to verify the authenticity of one or more of the base, reservoir, and/or cap using the serial number (unique ID, etc.) obtained from the base, reservoir, and/or cap, respectively, to confirm that such unit is authentic and genuine.[Col 81, ln 20-30]
In regards to claim 6, Tieck fails to teach comprising a locking mechanism adapted to lock the container within a fluid delivery device having a user interface, wherein the locking mechanism is disabled by entry of the passcode into the user interface. Mott on the other hand teaches teach comprising a locking mechanism adapted to lock the container within a fluid delivery device having a user interface, wherein the locking mechanism is disabled by entry of the passcode into the user interface (Paragraph 10), i.e.
the cap may restrict access to the container by requiring a biometric scan, such as a thumbprint or retina, to match a preset one; may have a keypad and require a passcode; have a touch screen that can be programmed to require a certain authentication that can be entered via the touchscreen; or may be remotely operated by a device such as a computer or smartphone, allowing the sealed container to remain close to someone whose access should be limited but not allowing this person to actually access the contents until the container is unlocked by someone else who need not be present to do so.[P-10]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Motts’ teaching with Tieck’s teaching in order to enable an increased level of security, regarding authorized access to the container.
In regards to claim 7, Tieck teaches an extending portion that extends from an end of the container, wherein the extending portion further comprises a needle that extends from an end of the extending portion (Column 215, lines 3-10), i.e.
The transfer guard 1060 also includes a fluid channel formed of one or more hollow needle or tube structures 1068 arranged to connect in fluid communication with the reservoir 1 and the vial 1062 or other container, when the port end of the reservoir 1 and the port end of the vial 1062 or other container are received in the first and second enclosures 1064 and 1066, respectively. [Col 215, ln 3-10]
In regards to claim 16, Tieck teaches a container, comprising a container identifying element that is unique to the container, wherein the container identifying element is adapted to correspond to a matching database identification code that is associated with data stored in a database(Column 40, lines 21-31;Column 81, lines 20-30),i.e.
A reservoir unit system for an infusion pump device according to an embodiment of the present invention includes a reservoir container having a neck portion and an interior volume for containing an infusion medium, where the neck portion has a port opening through which infusion media may be received into the interior volume of the reservoir, and where the neck portion has a flow channel with a first opening to the interior volume of the reservoir container and a second opening for connection in flow communication with a tubing.[Col 40, ln 21-31]
In certain embodiments, the processing electronics 62 coupled to the transceiver 68 may access, e.g., via a wired or wireless connection, directly or via another device(s), a database (e.g., on the Internet) to verify the authenticity of one or more of the base, reservoir, and/or cap using the serial number (unique ID, etc.) obtained from the base, reservoir, and/or cap, respectively, to confirm that such unit is authentic and genuine.[Col 81, ln 20-30]
This indicates wireless communication using processing electronics of a transceiver linked to a database to match an Identification code to what is stored within the database.
Tieck further teaches the data comprises the type and quantity of fluid within the container. (Column 5, lines 33-37; Column 78, lines 25-40; Column 84, lines 30-38), i.e.
In particular embodiments, the one or more characteristics includes one or more of: a type or identity of a manufacturer of the reservoir or the cap; a size of the reservoir or the cap; a type or concentration of infusion media in the reservoir; a volume amount of infusion media in the reservoir[Col 5, ln 33-37]
the processing electronics 62 determines and sets operational settings for one or more of: pumping rate (amount of fluid pumped per unit time), pumping time period (amount of time of pumping), pumping power (amount of fluid pressure), priming (filling) the infusion set tubing 52, priming (filling) the infusion set needle or cannula 56, detecting an occlusion in the fluid path from the reservoir 1 to the infusion set needle or cannula 56, handling an occlusion (pumping time, pressure, or program for dislodging, compensating for, or otherwise handling an occlusion).[Col 78, ln 25-40]
In further embodiments, one or more wireless or wired communication devices is provided on the infusion pump device 30 (or other delivery device) and is configured and controlled to transmit volume information relating to the volume of infusion fluid remaining in or dispensed from the reservoir 1 (or other information corresponding to detected parameters or associated characteristics) for display on another electronic device separate from or located remote from the infusion pump device 30. [Col 84, ln 30-38]
Tieck fails to teach a tamper resistant mechanism disposed on the container, wherein the tamper resistant mechanism comprises a non-permanent memory connected to an electronic circuit, wherein a passcode is stored in the non-permanent memory. Mott on the other hand teaches a tamper resistant mechanism disposed on the container, wherein the tamper resistant mechanism comprises a non-permanent memory connected to an electronic circuit, wherein a passcode is stored in the non- permanent memory (Paragraphs 14, 96),i.e.
alternatively, this embodiment might include a keypad coupled to the smart module, such that one can gain authorized access to the container by entering a passcode. The keypad might be numerical, alphanumerical, alphabetical, or even non-alphanumerical symbols and include any number of keys deemed to be appropriate to the application. The smart module would accept an ‘open’ command when the keypad receives the appropriate passcode or selection pattern, and direct the locking mechanism of the cap to unlock and allow access to the container. [P-14]
If the operating device 108 maintains a log over time, it would be possible to provide additional features such as keeping track of when the cap 100 was last opened or closed; whose thumbprint, device 108, or code was used to open the cap 100 most recently; and maintain an ongoing history of input device readings. With this kind of remote support, the smart module 202 need only provide regular updates of current status, rather than store such information in the smart module memory 202F. This seems like the optimal option, though an embodiment wherein the smart module 202 includes the memory 202F and CPU 202A to keep such a record locally may also be preferred, particularly in an embodiment less dependent on the operating device 108. In step 10.20, having determined that the input is not a request for opening the cap 100, the smart module 202 next determines whether the input being received indicates something that should be reported urgently instead of simply logged as data. Some examples might be sensor input data that indicates an attempt at tampering with the container 102 [P-96]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Motts’ teaching with Tieck’s teaching in order to enable and log authorized opening as well as tampered openings of the container
Tieck modified via Mott teaches a cap, cover over an opening, or valve disposed on the container; and an electrical connection between the electronic circuit and the cap, cover, or valve, (Paragraph 96, Mott)
If the operating device 108 maintains a log over time, it would be possible to provide additional features such as keeping track of when the cap 100 was last opened or closed; whose thumbprint, device 108, or code was used to open the cap 100 most recently; and maintain an ongoing history of input device readings. With this kind of remote support, the smart module 202 need only provide regular updates of current status, rather than store such information in the smart module memory 202F. This seems like the optimal option, though an embodiment wherein the smart module 202 includes the memory 202F and CPU 202A to keep such a record locally may also be preferred, particularly in an embodiment less dependent on the operating device 108. In step 10.20, having determined that the input is not a request for opening the cap 100, the smart module 202 next determines whether the input being received indicates something that should be reported urgently instead of simply logged as data. Some examples might be sensor input data that indicates an attempt at tampering with the container 102 [P-96]
Tieck modified fails to teach breaking the electrical connection causes the electronic circuit to erase the non-permanent memory.
Miglioli on the other hand teaches breaking the electrical connection causes the electronic circuit to erase the non-permanent memory, wherein an electrical contact located on the closure member (such as the cap, cover) the electrical pathway located to interrupt the electrical connection between the electronic circuit and the closure member in response to actuating the closure member to open the container (Paragraphs 4)
an intrusion detection mechanism having a metallic cover for protecting an encryption circuitry and a memory in which the encryption key is stored. The metallic cover has a top and a bottom side which are secured together by a screw. The screw merely functions to cause a switch arm to depress a switch button when the mechanism is in the desired, assembly mode. When the security screw is rotated, a circuit is activated (by opening of the button), the attempt to open the cover is detected and a destruct circuit is enabled which causes the memory to be erased. A drawback of this method is that the electromechanical switch utilized is subject to hot and cold temperatures, dampness and other deteriorating environmental conditions which can adversely affect the switch's level of performance, especially after prolonged exposure to such conditions. Furthermore, a failure of the circuit itself may be caused by oxidation of the circuitry at various portions thereof as a result of such prolonged exposure.[P-4]
According to another aspect of the invention, there is provided an electrical assembly which includes an electronic device including an electrical circuit having sensitive information as part thereof, a tamper resistant enclosure, the electronic device being positioned within the enclosure, the enclosure including a first cover for being positioned substantially on a first side of the electronic device, a second cover for being positioned substantially on the opposite side of the electronic device from the first side, a plurality of fixing components passing through the first cover for securing the first cover to the second cover, the fixing elements adapted for passing through the electronic device and forming a part of the electrical circuit of the electronic device when the first cover is secured to the second cover, and a detector for detecting the interruption of the electrical circuit caused by at least the partial removal of at least one of the fixing elements.[P-7]
Here, we see Miglioli teach an analogous disclosure is which an electrical contact located on the closure member (cover) the electrical pathway located to interrupt the electrical connection between the electronic circuit and the closure member in response to actuating the closure member to open the container; by opening of the cover and attempting an opening of the cover of the container vessel, the interruption of the electrical connection of the circuitry of the cover on the container, results in the destruction of the circuit and the erasing of the memory of the said circuit.
Miglioli’s teaching is directed to protecting against tampering of a container for an electronic device such that the circuitry is placed between the opening mechanism/cover and the actual container of the protected device. The same system may obviously be translated to a casing/container of another device or substance, such that the same security mechanism may be applicable.
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Miglioli’s teaching with Tieck modified’s teaching or circuitry disruption of the opening of a cover/cap of a container in order to effectively delete or reset the memory of the lid.
In regards to claim 17, Tieck modified teaches the container identifying element is selected from the group consisting of a barcode, a VR code, a decimal code, an alphanumeric code, an RFID tag, and a combination thereof. (Column 18, lines 58-67; Column 28, lines 50-55; Column 81, lines 20-30, Tieck), i.e.
In further embodiments: (a) the at least one RF detectable feature includes a radio frequency identification (RFID) tag that is attached to a housing of the cap to the reservoir or on a plunger within the reservoir, (b) the at least one RF detectable feature includes a passive RF device that receives power through inductive coupling with the RF sensor, (c) the at least one RF detectable feature includes an RF detectable device having a directional antenna or an antenna with at least one RF shield or wave guide configured to direct RF signals to or from the antenna [Col18, ln 58-67]
in further embodiments, the at least one optically detectable feature includes: (a) at least one surface of the cap or the reservoir that has at least one of a material, coating, surface contour or pattern, ribs, grooves, undulations, roughness, abrasions, apertures, detents or an attached article, that inhibits or changes optical reflective characteristics of the at least one surface of the cap; (b) a bar code, matrix code or other optically detectable pattern that represents encoded information; or (c) an adhesive-backed tag that adheres to the cap and that has an outer surface configured to alter an optical signal in an optically detectable manner. [Col 28, ln 50-55]
In certain embodiments, the processing electronics 62 coupled to the transceiver 68 may access, e.g., via a wired or wireless connection, directly or via another device(s), a database (e.g., on the Internet) to verify the authenticity of one or more of the base, reservoir, and/or cap using the serial number (unique ID, etc.) obtained from the base, reservoir, and/or cap, respectively, to confirm that such unit is authentic and genuine.[Col 81, ln 20-30]
In regards to claim 20, Tieck modified via Mott teaches a locking mechanism adapted to lock the container within a fluid delivery device having a user interface, wherein the locking mechanism is disabled by entry of the passcode into the user interface (Paragraph 10), i.e.
the cap may restrict access to the container by requiring a biometric scan, such as a thumbprint or retina, to match a preset one; may have a keypad and require a passcode; have a touch screen that can be programmed to require a certain authentication that can be entered via the touchscreen; or may be remotely operated by a device such as a computer or smartphone, allowing the sealed container to remain close to someone whose access should be limited but not allowing this person to actually access the contents until the container is unlocked by someone else who need not be present to do so.[P-10]
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tieck et al. (US 9744290 B2) in view of Mott (US 202200063883 A1) and Miglioli et al. (US 20020014962 A1) as applied above in claim1, in further view of Fulkerson et al. (CN 103476486 A).
In regards to claim 5, Tieck fails to teach a set of splines or pins extending therefrom, wherein the set of splines or pins is indicative of the type of fluid disposed within the container. Fulkerson on the other hand teaches a set of splines or pins extending therefrom, wherein the set of splines or pins is indicative of the type of fluid disposed within the container (Paragraph 384, 436), i.e.
the hot fluid flow measuring device 5601 further comprises a series of contact portions 5611, 5612 and 5613. operatively, when fluid (e.g., blood, dialysate or other fluid) during dialysis flow when passing through the fluid flow path 5603, which is in first contact part embedded in the plastic path of 5611. the contact part 5611 contacts with the electric power source, the power source in one embodiment is on the machine front door 5620 on the pin 5621. power supply or pin in the dialysis machine controller controls 5610. power source to provide electrical stimulation to the contact part 5611, electrical stimulation acts to sine wave method based on micro-heating contact part. [P-384]
possible implementation of conductance sensor for manifold is integrated is used as electrical leads with contact dialysate liquid conductivity cell. technical details of one exemplary conductivity cell shown in FIG. 57. Referring to FIG. 57, conductivity cell 5700 comprising a constant current of small fluid applied to bias the pin 5701. sensing pins 5702 detect voltage in the fluid, wherein the magnitude depends on the fluid conductance and temperature voltage detected. temperature used is placed close to the conductivity cell 5700 of the thermistor 5703 to measure. one can selectively, temperature can be disclosed by the above means is measured. As known the sensing pin 5702 of the measured temperature and voltage value, the conductivity of the fluid can be measured.[P-436]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Fulkerson’s teaching with Tieck’s teaching in order to enable the measurement of the voltage within the fluid.
Claim(s) 8, 10 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mott (US 202200063883 A1) in view of Miglioli et al. (US 20020014962 A1)
In regards to claim 8, Mott teaches a container, comprising a tamper resistant mechanism disposed on the container, wherein the tamper resistant mechanism comprises a non-permanent memory connected to an electronic circuit, wherein a passcode is stored in the non-permanent memory (Paragraphs 9, 14, 96),i.e.
in most embodiments, the invented device fits in place of a cap or lid having a standardized size and shape, such as a prescription medicine bottle cap, a jar lid, or a gallon jug lid, to name only three examples of lids having well-known standardized shapes and sizes. Accordingly, the overall shape and size of the invented device may vary depending upon the cap size and shape standard being adhered to. Non-standard cap sizes and shapes are also included within the scope of the invention, but may be less useful (i.e. perhaps only slightly more useful than an ordinary cap that doesn't fit any available containers) without a container in mind that the cap is meant to fit onto.[P-9]
alternatively, this embodiment might include a keypad coupled to the smart module, such that one can gain authorized access to the container by entering a passcode. The keypad might be numerical, alphanumerical, alphabetical, or even non-alphanumerical symbols and include any number of keys deemed to be appropriate to the application. The smart module would accept an ‘open’ command when the keypad receives the appropriate passcode or selection pattern, and direct the locking mechanism of the cap to unlock and allow access to the container. [P-14]
If the operating device 108 maintains a log over time, it would be possible to provide additional features such as keeping track of when the cap 100 was last opened or closed; whose thumbprint, device 108, or code was used to open the cap 100 most recently; and maintain an ongoing history of input device readings. With this kind of remote support, the smart module 202 need only provide regular updates of current status, rather than store such information in the smart module memory 202F. This seems like the optimal option, though an embodiment wherein the smart module 202 includes the memory 202F and CPU 202A to keep such a record locally may also be preferred, particularly in an embodiment less dependent on the operating device 108. In step 10.20, having determined that the input is not a request for opening the cap 100, the smart module 202 next determines whether the input being received indicates something that should be reported urgently instead of simply logged as data. Some examples might be sensor input data that indicates an attempt at tampering with the container 102 [P-96]
Furthermore, Motts disclosed cap is configured to open or close the container to selectively gain access to the content within the container (in this case scenario, fluid)
Mott teaches a cap, cover over an opening, or valve disposed on the container; and an electrical connection between the electronic circuit and the cap, cover, or valve, (Paragraph 96, Mott)
If the operating device 108 maintains a log over time, it would be possible to provide additional features such as keeping track of when the cap 100 was last opened or closed; whose thumbprint, device 108, or code was used to open the cap 100 most recently; and maintain an ongoing history of input device readings. With this kind of remote support, the smart module 202 need only provide regular updates of current status, rather than store such information in the smart module memory 202F. This seems like the optimal option, though an embodiment wherein the smart module 202 includes the memory 202F and CPU 202A to keep such a record locally may also be preferred, particularly in an embodiment less dependent on the operating device 108. In step 10.20, having determined that the input is not a request for opening the cap 100, the smart module 202 next determines whether the input being received indicates something that should be reported urgently instead of simply logged as data. Some examples might be sensor input data that indicates an attempt at tampering with the container 102 [P-96]
Mott fails to teach breaking the electrical connection causes the electronic circuit to erase the non-permanent memory.
Miglioli on the other hand teaches breaking the electrical connection causes the electronic circuit to erase the non-permanent memory, wherein an electrical contact located on the closure member (such as the cap, cover) the electrical pathway located to interrupt the electrical connection between the electronic circuit and the closure member in response to actuating the closure member to open the container (Paragraphs 4, 7)
an intrusion detection mechanism having a metallic cover for protecting an encryption circuitry and a memory in which the encryption key is stored. The metallic cover has a top and a bottom side which are secured together by a screw. The screw merely functions to cause a switch arm to depress a switch button when the mechanism is in the desired, assembly mode. When the security screw is rotated, a circuit is activated (by opening of the button), the attempt to open the cover is detected and a destruct circuit is enabled which causes the memory to be erased. A drawback of this method is that the electromechanical switch utilized is subject to hot and cold temperatures, dampness and other deteriorating environmental conditions which can adversely affect the switch's level of performance, especially after prolonged exposure to such conditions. Furthermore, a failure of the circuit itself may be caused by oxidation of the circuitry at various portions thereof as a result of such prolonged exposure.[P-4]
According to another aspect of the invention, there is provided an electrical assembly which includes an electronic device including an electrical circuit having sensitive information as part thereof, a tamper resistant enclosure, the electronic device being positioned within the enclosure, the enclosure including a first cover for being positioned substantially on a first side of the electronic device, a second cover for being positioned substantially on the opposite side of the electronic device from the first side, a plurality of fixing components passing through the first cover for securing the first cover to the second cover, the fixing elements adapted for passing through the electronic device and forming a part of the electrical circuit of the electronic device when the first cover is secured to the second cover, and a detector for detecting the interruption of the electrical circuit caused by at least the partial removal of at least one of the fixing elements.[P-7]
Here, we see Miglioli teach an analogous disclosure is which an electrical contact located on the closure member (cover) the electrical pathway located to interrupt the electrical connection between the electronic circuit and the closure member in response to actuating the closure member to open the container; by opening of the cover and attempting an opening of the cover of the container vessel, the interruption of the electrical connection of the circuitry of the cover on the container, results in the destruction of the circuit and the erasing of the memory of the said circuit.
Miglioli’s teaching is directed to protecting against tampering of a container for an electronic device such that the circuitry is placed between the opening mechanism/cover and the actual container of the protected device. The same system may obviously be translated to a casing/container of another device or substance, such that the same security mechanism may be applicable.
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Miglioli’s teaching Mott’s teaching or circuitry disruption of the opening of a cover/cap of a container in order to effectively delete or reset the memory of the lid.
In regards to claim 10, Mott modified via Miglioli teaches a power storage element (Paragraph 15, Miglioli).
FIG. 3 shows the tamper detection circuit according to a preferred embodiment of the present invention. A voltage Va is constantly supplied at point 301. The supply can be provided either by a battery or by a system power supply. Four comparators 303 monitor the circuit. Each comparator 303 has one input (+) fixed at a reference voltage (Vref) and a second input (-) connected to one of the circular pads 219. In normal operational conditions, when the package is closed and circular pads 219 are forced to a low level (ground) by means of the above mentioned circuit (star washer 221, standoff 223 and external cover 215), the comparators' output is inactive (i.e. no tamper is detected). If one of the screws 201 is removed and internal cover 205 (together with device 209) is lifted, the corresponding circular pad(s) 219 lose the connection to ground and the negative (-) input of the corresponding comparator goes to a high level, causing the comparator to trigger the erasing circuit. Another event which can cause the activation of the comparator is the removing of the battery or the interruption of the power supply. The reaction in this case is the same as described above and the sensitive information is destroyed because the security of the system cannot be guaranteed any longer.
In regards to claim 14, Mott modified teaches a locking mechanism adapted to lock the container within a fluid delivery device having a user interface, wherein the locking mechanism is disabled by entry of the passcode into the user interface (Paragraph 10, Mott), i.e.
the cap may restrict access to the container by requiring a biometric scan, such as a thumbprint or retina, to match a preset one; may have a keypad and require a passcode; have a touch screen that can be programmed to require a certain authentication that can be entered via the touchscreen; or may be remotely operated by a device such as a computer or smartphone, allowing the sealed container to remain close to someone whose access should be limited but not allowing this person to actually access the contents until the container is unlocked by someone else who need not be present to do so.[P-10]
Claim(s) 11, 12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mott (US 20220063883 A1) in view of Miglioli et al. (US 20020014962 A1) as applied above in claim 8, in further view of Tieck et al. (US 9744290 B2).
In regards to claim 11, Mott modified fails to teach a container identifying element that is unique to the container, wherein the container identifying element is adapted to correspond to a matching database identification code that is associated with data stored in a database, wherein the data comprises the type and quantity of fluid within the container. Tieck on the other hand teaches a container identifying element that is unique to the container, wherein the container identifying element is adapted to correspond to a matching database identification code that is associated with data stored in a database, wherein the data comprises the type and quantity of fluid within the container(Column 5, lines 33-37; Column 78, lines 25-40; Column 84, lines 30-38), i.e.
In particular embodiments, the one or more characteristics includes one or more of: a type or identity of a manufacturer of the reservoir or the cap; a size of the reservoir or the cap; a type or concentration of infusion media in the reservoir; a volume amount of infusion media in the reservoir[Col 5, ln 33-37]
the processing electronics 62 determines and sets operational settings for one or more of: pumping rate (amount of fluid pumped per unit time), pumping time period (amount of time of pumping), pumping power (amount of fluid pressure), priming (filling) the infusion set tubing 52, priming (filling) the infusion set needle or cannula 56, detecting an occlusion in the fluid path from the reservoir 1 to the infusion set needle or cannula 56, handling an occlusion (pumping time, pressure, or program for dislodging, compensating for, or otherwise handling an occlusion).[Col 78, ln 25-40]
In further embodiments, one or more wireless or wired communication devices is provided on the infusion pump device 30 (or other delivery device) and is configured and controlled to transmit volume information relating to the volume of infusion fluid remaining in or dispensed from the reservoir 1 (or other information corresponding to detected parameters or associated characteristics) for display on another electronic device separate from or located remote from the infusion pump device 30. [Col 84, ln 30-38]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Tieck’s teaching with Mott modified’s teaching in order to effectively validate by way of the database, authorized access to the container.
In regards to claim 12, Mott modified via Tieck teaches the container identifying element is selected from the group consisting of a barcode, a VR code, a decimal code, an alphanumeric code, an RFID tag, and a combination thereof. (Column 18, lines 58-67; Column 28, lines 50-55; Column 81, lines 20-30, Tieck)
In further embodiments: (a) the at least one RF detectable feature includes a radio frequency identification (RFID) tag that is attached to a housing of the cap to the reservoir or on a plunger within the reservoir, (b) the at least one RF detectable feature includes a passive RF device that receives power through inductive coupling with the RF sensor, (c) the at least one RF detectable feature includes an RF detectable device having a directional antenna or an antenna with at least one RF shield or wave guide configured to direct RF signals to or from the antenna [Col18, ln 58-67]
in further embodiments, the at least one optically detectable feature includes: (a) at least one surface of the cap or the reservoir that has at least one of a material, coating, surface contour or pattern, ribs, grooves, undulations, roughness, abrasions, apertures, detents or an attached article, that inhibits or changes optical reflective characteristics of the at least one surface of the cap; (b) a bar code, matrix code or other optically detectable pattern that represents encoded information; or (c) an adhesive-backed tag that adheres to the cap and that has an outer surface configured to alter an optical signal in an optically detectable manner. [Col 28, ln 50-55]
In certain embodiments, the processing electronics 62 coupled to the transceiver 68 may access, e.g., via a wired or wireless connection, directly or via another device(s), a database (e.g., on the Internet) to verify the authenticity of one or more of the base, reservoir, and/or cap using the serial number (unique ID, etc.) obtained from the base, reservoir, and/or cap, respectively, to confirm that such unit is authentic and genuine.[Col 81, ln 20-30]
In regards to claim 15, Mott modified fails to teach an extending portion that extends from an end of the container, wherein the extending portion further comprises a needle that extends from an end of the extending portion. Tieck on the other hand teaches an extending portion that extends from an end of the container, wherein the extending portion further comprises a needle that extends from an end of the extending portion (Column 215, lines 3-10)
The transfer guard 1060 also includes a fluid channel formed of one or more hollow needle or tube structures 1068 arranged to connect in fluid communication with the reservoir 1 and the vial 1062 or other container, when the port end of the reservoir 1 and the port end of the vial 1062 or other container are received in the first and second enclosures 1064 and 1066, respectively. [Col 215, ln 3-10]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Tieck’s teaching with Mott’s teaching in order to administer the medical fluid from the reservoir to administering component in an authorized setting.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mott (US 20220063883 A1) in view of Miglioli et al. (US 20020014962 A1)) as applied above in claim 8, in further view of in view of Fulkerson et al. (CN 103476486 A).
In regards to claim 13, Mott modified fails to teach a set of splines or pins extending therefrom, wherein the set of splines or pins is indicative of the type of fluid disposed within the container. Fulkerson on the other hand teaches a set of splines or pins extending therefrom, wherein the set of splines or pins is indicative of the type of fluid disposed within the container (Paragraph 384, 436), i.e.
the hot fluid flow measuring device 5601 further comprises a series of contact portions 5611, 5612 and 5613. operatively, when fluid (e.g., blood, dialysate or other fluid) during dialysis flow when passing through the fluid flow path 5603, which is in first contact part embedded in the plastic path of 5611. the contact part 5611 contacts with the electric power source, the power source in one embodiment is on the machine front door 5620 on the pin 5621. power supply or pin in the dialysis machine controller controls 5610. power source to provide electrical stimulation to the contact part 5611, electrical stimulation acts to sine wave method based on micro-heating contact part. [P-384]
possible implementation of conductance sensor for manifold is integrated is used as electrical leads with contact dialysate liquid conductivity cell. technical details of one exemplary conductivity cell shown in FIG. 57. Referring to FIG. 57, conductivity cell 5700 comprising a constant current of small fluid applied to bias the pin 5701. sensing pins 5702 detect voltage in the fluid, wherein the magnitude depends on the fluid conductance and temperature voltage detected. temperature used is placed close to the conductivity cell 5700 of the thermistor 5703 to measure. one can selectively, temperature can be disclosed by the above means is measured. As known the sensing pin 5702 of the measured temperature and voltage value, the conductivity of the fluid can be measured.[P-436]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Fulkerson’s teaching with Mott’s teaching in order to enable the measurement of the voltage within the fluid.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tieck et al. (US 9744290 B2) in view of Mott (US 20220063883 A1) as applied above in claim 16, in further view of Fulkerson et al. (CN 103476486 A)
In regards to claim 19, Tieck modified fails to teach a set of splines or pins extending therefrom, wherein the set of splines or pins is indicative of the type of fluid disposed within the container. Fulkerson on the other hand teaches a set of splines or pins extending therefrom, wherein the set of splines or pins is indicative of the type of fluid disposed within the container (Paragraph 384, 436), i.e.
the hot fluid flow measuring device 5601 further comprises a series of contact portions 5611, 5612 and 5613. operatively, when fluid (e.g., blood, dialysate or other fluid) during dialysis flow when passing through the fluid flow path 5603, which is in first contact part embedded in the plastic path of 5611. the contact part 5611 contacts with the electric power source, the power source in one embodiment is on the machine front door 5620 on the pin 5621. power supply or pin in the dialysis machine controller controls 5610. power source to provide electrical stimulation to the contact part 5611, electrical stimulation acts to sine wave method based on micro-heating contact part. [P-384]
possible implementation of conductance sensor for manifold is integrated is used as electrical leads with contact dialysate liquid conductivity cell. technical details of one exemplary conductivity cell shown in FIG. 57. Referring to FIG. 57, conductivity cell 5700 comprising a constant current of small fluid applied to bias the pin 5701. sensing pins 5702 detect voltage in the fluid, wherein the magnitude depends on the fluid conductance and temperature voltage detected. temperature used is placed close to the conductivity cell 5700 of the thermistor 5703 to measure. one can selectively, temperature can be disclosed by the above means is measured. As known the sensing pin 5702 of the measured temperature and voltage value, the conductivity of the fluid can be measured.[P-436]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Fulkerson’s teaching with Tieck’s teaching in order to enable the measurement of the voltage within the fluid.
Response to Arguments
The examiner has addressed applicant’s amendments above under new grounds of rejection.
Conclusion
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/ANTHONY D AFRIFA-KYEI/Examiner, Art Unit 2686
/BRIAN A ZIMMERMAN/Supervisory Patent Examiner, Art Unit 2686