Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim amendments filed 9/5/2025 are acknowledged. Claims 24, 28-48, and 50-53 remain pending.
Response to Arguments
Arguments filed 9/5/2025 have been considered.
The applicant first argues that cap 101 in Burapachaisri simply covers the body 103 and does not have an aperture configured to accept a luminal connection port as claimed. The examiner agrees. The previous rejection mapped element 101 to the claimed body structure (recited as not mating with the luminal connection port) and element 103 to the claimed adapter cap (which the applicant says is configured to accept the luminal connection port).
The applicant’s main argument appears to be that since the reference calls 101 a cap and 103 a body that the rejection cannot map 101 to the claimed body and 103 to the claimed cap. The examiner disagrees. Both cap and body are broad enough terms that either can be considered a body or a cap. What the reference chooses to call the body or the cap does not prevent the previously used claim mapping.
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.
Claims 24, 28, 29, 31-33, 50, and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burapachaisri et al. (US 2017/0232123) in view of Kohler (US 2008/0095661), Bak (US 2012/0321509), and Levenson et al. (US 2010/0324505).
With regards to claim 24, Burapachaisri et al. teaches a sterilization device (fig 1) comprising a body (101) with at least a battery and a light source (in aperture 107); and an adapter cap (body 103); wherein the adapter cap is inserted into a luminal connection port (has male luer connector 113 which inserts into a port of a catheter) (abstract; fig 1.; and para [0024]-[0028], [0046]). The body and the adapter cap are connected in a manner so that only the adapter cap includes an aperture configured to accept a luminal connection port (element 101 sits on top of element 103 and element 103 is the element that mates with the luminal connection port; see citations above and remarks filed 9/5/2025).
Burapachaisri et al. teaches an indicator light (visible light LED to indicate UV light is on and a visible light LED to indicate battery level) and teaches that it is in communication with a microcontroller (para [0056]-[0058]). Burapachaisri et al. teaches that the microcontroller can be located in the body (cap 101) (para [0048]). It is not clear from Burapachaisri et al. where the indicator light is. A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have placed the indicator light as part of the body motivated by an expectation of successfully indicating information to the user and in order to have the light easily communicate with the controller (closer; less wire). Further, placing the indicator light anywhere on the device that it is visible to the user would result in the predictable result of successfully indicating information to the user.
Burapachaisri et al. does not teach an RFID chip in the adapter cap as claimed. Kohler teaches a modular sterilization device and teaches using RFID tags in various components that communicate with a controller in the device to ensure proper assembly of the device (correct component and useable life left on light source etc.) and to store and transmit data about the sterilizing light source to the controller (para [0024]-[0025]; para [0099]; abstract). A person having ordinary skill in the art would have found it obvious to have installed a RFID tag in the adapter cap that communicates with the control unit in the body in order to ensure proper assembly of the device and transmit data on the UV light source of the cap to the control unit.
The combination does not teach that the adapter cap has a lens. Bak teaches a sterilizer for medical devices with a lumen including luer connecters (abstract; fig 1). Bak teaches that a lens can be used with the UV LED in order to help focus and direct the light (para [0118]). A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have added a lens to the adapter cap in order to help focus and direct the UV light as desired.
The combination does not teach that the body has an optical sensor. Levenson teaches a UV decontamination device and teaches using a light sensor in order to determine the intensity of light emitted towards the target and generate an alarm if the intensity is too low for too long (para [0025]. A person having ordinary skill in the art would have found it obvious to have added an optical sensor to the device of Burapachaisri in any location including the body where the sensor can measure the UV light emitted towards the target in order to be able to alert a user when the UV light intensity is not as desired.
With regards to claim 28, Burapachaisri et al.as discussed above teaches powering a UV LED to sterilize catheter luer connections using batteries. Burapachaisri et al. is silent as to the voltage of the battery source. Thus it is necessary and therefore obvious to look to the prior art for known battery voltage for powering a UV LED for sterilizing connectors. Bak teaches using a power source of 6V to power a UV LED to sterilize catheter connections (abstract; para [0160]; see whole document). A person having ordinary skill in the art would have found it obvious to have made the battery power supply be a 6V supply motivated by an expectation of successfully powering the UV LED to sterilize catheter connections.
With regards to claim 29, the adapter cap is inserted into a luminal connection port (has male luer connector 113 which inserts into a port of a catheter) (abstract; fig 1.; and para [0024]-[0028], [0046]). The luer connector is threaded and can connect to a connection port via threads (para [0028]).
With regards to claim 31, Burapachaisri et al. teaches that the light source is a light emitting diode (para 0030]).
With regards to claim 32, Burapachaisri et al. teaches that the light source can emit UVC light (para [0030]).
With regards to claim 33, Burapachaisri et al. teaches having the light emit either narrow or broad spectrum in the UVC range (100-280nm). Burapachaisri et al. does not specify 275nm specifically. A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have used any of the wavelengths within the taught effective band including 275nm motivated by an expectation of successfully providing germicidal action.
With regards to claim 50, the claim recites “a focal length” to describe a distance between the light and the adapter cap. It does not specify the focal length relative to the lens or even the focal length of an optical system int eh claimed device. Thus, taken broadly it can be any length. Additionally, a person having ordinary skill in the art would have found it obvious to have sized the device as desired in order to achieve a device sized to effectively treat the desired connectors and take up the desired space. Additionally, it would be obvious to position the light relative to the lens as desired in order to achieve the desired focusing of light on the target.
With regards to claim 51, a person having ordinary skill in the art would have found it obvious to have sized the device as desired in order to achieve a device sized to effectively treat the desired connectors and take up the desired space. Additionally, it would be obvious to position the light relative to the lens as desired in order to achieve the desired focusing of light on the target.
Claims 30 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burapachaisri et al. (US 2017/0232123), Kohler (US 2008/0095661), Bak (US 2012/0321509), and Levenson et al. (US 2010/0324505) as applied to claim 24 above and further in view of Ma (US 2013/0323120).
With regards to claim 30, Burapachaisri et al. does not teach that the indicator light turns green after the luminal connection port is sterilized. Ma teaches a needless connector sterilizer using UV light (abstract). Ma teaches using a status indicator light that turns green to indicate a complete treatment (para [0037]). A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have used an indicator light that turns green when the sterilization is complete in order to inform the user that sterilization is completed.
With regards to claim 34, Ma teaches a needless connector sterilizer using UV light (abstract). Ma teaches that varying the power of a UV light source affects the time needed to achieve the desired sterilization (para [0048]). A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have optimized the power of the UV light source in order to achieve the desired sterilization within the desired time frame.
Claims 35, 36, 38, 39, 41, 45-47, 52, and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burapachaisri et al. (US 2017/0232123), Sharavara et al. (US 2014/0038305), Bak (US 2012/0321509), and Levenson et al. (US 2010/0324505).
With regards to claim 35, Burapachaisri et al. teaches a sterilization device (fig 1) comprising a body (101) with at least a battery and a light source (in aperture 107); and a threaded adapter cap (body 103); wherein the adapter cap is inserted into a luminal connection port (has male luer connector 113, threads, which inserts into a port of a catheter) (abstract; fig 1.; and para [0024]-[0028], [0046]). (element 101 sits on top of element 103 and element 103 is the element that mates with the luminal connection port; see citations above and remarks filed 9/5/2025).
Burapachaisri et al. teaches an indicator light (visible light LED to indicate UV light is on and a visible light LED to indicate battery level) and teaches that it is in communication with a microcontroller (para [0056]-[0058]). Burapachaisri et al. teaches that the microcontroller can be located in the body (cap 101) (para [0048]). It is not clear from Burapachaisri et al. where the indicator light is. A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have placed the indicator light as part of the body motivated by an expectation of successfully indicating information to the user and in order to have the light easily communicate with the controller (closer; less wire). Further, placing the indicator light anywhere on the device that it is visible to the user would result in the predictable result of successfully indicating information to the user.
Burapachaisri et al. teaches an interlocking circuit that uses a sensor switch to detect whether the body (101) is attached to the adapter cap (103) (para [0048]-[0054]). This controls the operation of the UV light in the body (101) to operate when connected to the adapter cap (103) (para [0048]-[0054]; table 1). The interlocking circuit thus is connected to the adapter cap when in use.
Burapachaisri et al. does not teach that the adapter cap has a clear substrate that irreversibly changes color to indicate that sterilization has been completed. Sharavara et al. teaches that an irreversibly color changing compound can be bound to a clear substrate to indicate exposure to an amount of UV light (para [0020] and [0024]; para [0090]). Sharavara et al. teaches this to be useful in verifying UV exposure in disinfection (para [0180]). The adapter cap is inserted into the connection port and it is desirable to be sterile. Thus a person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have added a clear substrate that irreversibly changes colors to the adaptor cap in order to indicate that the desired UV exposure of the adaptor cap surface has occurred.
The combination does not teach that the adapter cap has a lens. Bak teaches a sterilizer for medical devices with a lumen including luer connecters (abstract; fig 1). Bak teaches that a lens can be used with the UV LED in order to help focus and direct the light (para [0118]). A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have added a lens to the adapter cap in order to help focus and direct the UV light as desired.
The combination does not teach that the body has an optical sensor. Levenson teaches a UV decontamination device and teaches using a light sensor in order to determine the intensity of light emitted towards the target and generate an alarm if the intensity is too low for too long (para [0025]. A person having ordinary skill in the art would have found it obvious to have added an optical sensor to the device of Burapachaisri in any location including the body where the sensor can measure the UV light emitted towards the target in order to be able to alert a user when the UV light intensity is not as desired.
With regards to claim 36, Burapachaisri et al.as discussed above teaches powering a UV LED to sterilize catheter luer connections using batteries. Burapachaisri et al. is silent as to the voltage of the battery source. Thus it is necessary and therefore obvious to look to the prior art for known battery voltage for powering a UV LED for sterilizing connectors. Bak teaches using a power source of 6V to power a UV LED to sterilize catheter connections (abstract; para [0160]; see whole document). A person having ordinary skill in the art would have found it obvious to have made the battery power supply be a 6V supply motivated by an expectation of successfully powering the UV LED to sterilize catheter connections.
With regards to claim 38, Burapachaisri et al. teaches that the light source can emit UVC light (para [0030]).
With regards to claim 39, Burapachaisri et al. teaches having the light emit either narrow or broad spectrum in the UVC range (100-280nm). Burapachaisri et al. does not specify 275nm specifically. A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have used any of the wavelengths within the taught effective band including 275nm motivated by an expectation of successfully providing germicidal action.
With regards to claim 41, Burapachaisri et al. teaches a switch and/or at least one sensor for activating the sterilization (para [0051]-[0054]).
With regards to claim 45, Sharavara et al. teaches that the color change can be used to determine exposure to different wavelengths of UV light and for different exposure times (para [0020]).
With regards to claim 46, the combination results in the clear substrate changing colors when exposed to UV light (UV light changes the color).
With regards to claim 47, the interlocking cap is attached to the adapter cap which turns on a safety feature (the UV light in the body 101 only works when connected which is a safety feature; turns on the switch to the light where the switch is a safety feature as it controls the light).
With regards to claim 52, the claim recites “a focal length” to describe a distance between the light and the adapter cap. It does not specify the focal length relative to the lens or even the focal length of an optical system in the claimed device. Thus, taken broadly it can be any length. Additionally, a person having ordinary skill in the art would have found it obvious to have sized the device as desired in order to achieve a device sized to effectively treat the desired connectors and take up the desired space. Additionally, it would be obvious to position the light relative to the lens as desired in order to achieve the desired focusing of light on the target.
With regards to claim 53, a person having ordinary skill in the art would have found it obvious to have sized the device as desired in order to achieve a device sized to effectively treat the desired connectors and take up the desired space. Additionally, it would be obvious to position the light relative to the lens as desired in order to achieve the desired focusing of light on the target.
Claim 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burapachaisri et al. (US 2017/0232123), Sharavara et al. (US 2014/0038305), Bak (US 2012/0321509), and Levenson et al. (US 2010/0324505) as applied to claim 35 above and further in view of Kohler (US 2008/0095661).
With regards to claim 48, Burapachaisri et al. does not teach an RFID chip as claimed. Kohler teaches a modular sterilization device and teaches using RFID tags in various components that communicate with a controller in the device to ensure proper assembly of the device (correct component and useable life left on light source etc.) and to store and transmit data about the sterilizing light source to the controller (para [0024]-[0025]; para [0099]; abstract). A person having ordinary skill in the art would have found it obvious to have installed a RFID tag in various components including the interlocking circuit/cap that communicates with the control unit in the body in order to ensure proper assembly of the device and transmit data (such as from the sensor unit etc.) to the control unit.
The combination results in the interlocking circuit to allow the interlocking circuit cap to communicate with the body.
Claims 37, 40, and 42-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burapachaisri et al. (US 2017/0232123), Sharavara et al. (US 2014/0038305), Bak (US 2012/0321509), and Levenson et al. (US 2010/0324505) as applied to claim 35 above and further in view of Ma (US 2013/0323120).
With regards to claim 37, Burapachaisri et al. does not teach that the indicator light turns green after the luminal connection port is sterilized. Ma teaches a needless connector sterilizer using UV light (abstract). Ma teaches using a status indicator light that turns green to indicate a complete treatment (para [0037]). A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have used an indicator light that turns green when the sterilization is complete in order to inform the user that sterilization is completed.
With regards to claim 40, Ma teaches a needless connector sterilizer using UV light (abstract). Ma teaches that varying the power of a UV light source affects the time needed to achieve the desired sterilization (para [0048]). A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have optimized the power of the UV light source in order to achieve the desired sterilization within the desired time frame.
With regards to claims 42-44, that the sterilization occurs in less than 10 second, less than 5 seconds, and is a 7-log reduction is all intended use. It is taken that the device of the combination is capable of such use. Additionally, Ma teaches a needless connector sterilizer using UV light (abstract). Ma teaches that varying the power of a UV light source affects the time needed to achieve the desired sterilization (para [0048]). Ma further teaches that desired sterilization can occur in 5 secs or less (defines disinfect as the removal of all infectious microorganisms; para [0050] and [0021]). Thus time is a result effective variable that effects the desired sterilization achieved. A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have optimized the power of the UV light source in order to achieve the desired sterilization within the desired time frame. A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have reduced sterilization time by modifying the system (such as UV power/intensity) in order to quickly render the connector unit sterile and ready for use quickly. A person having ordinary skill in the art at the time the invention was effectively filed would have found it obvious to have optimized the time for applying UV light in order to achieve the desired sterilization.
The combination results in a device capable of causing sterilization in less than about 5 seconds and achieving a 7-log reduction if desired.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONALD R SPAMER whose telephone number is (571)272-3197. The examiner can normally be reached Monday to Friday from 9-5.
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/DONALD R SPAMER/Primary Examiner, Art Unit 1799