DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 March 2026 has been entered.
Response to Amendment
3. The amendment filed 19 March 2026 has been received and considered for examination. Claims 1-4, 6-8, 10, 12-20 and 22 are presently pending, with claims 12-13 withdrawn from consideration and claims 1-4, 6-8, 10, 14-20 and 22 being examined herein.
4. All rejections from the previous Office action are withdrawn in view of Applicant’s amendment.
5. New grounds of rejection under 35 U.S.C. 112(b) and 35 U.S.C. 103 are necessitated by the amendments, as detailed below.
Claim Rejections - 35 USC § 112
6. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 6-8, 10, and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
8. Regarding claim 6, it is unclear whether the limitation “a body” is the same body or a different body than the one introduced in the list of alternatives at the end of amended claim 1, which is understood as a highly reflective component positioned external to the UV-transmissive portion. This uncertainty leads to indefiniteness regarding the limitation “the body supports a circuit” as it is unclear what structure is doing the supporting.
9. Claims 7-8 and 10 are indefinite by virtue of their dependence on indefinite claim 6.
10. Regarding claim 10, it is unclear whether the limitation “a shroud” is the same shroud or a different shroud than the one introduced in the list of alternatives at the end of amended claim 1, which leads to further indefiniteness regarding what structure is supporting the circuit.
11. Regarding claim 22, the claim has indefinite scope due to its dependence on cancelled claim 21. For the purpose of examination, the claim is treated as dependent on claim 20.
Claim Rejections - 35 USC § 103
12. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
13. Claims 1, 2, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Wegener et al (US 20190192844 A1) in view of McDonald (US 6030578 A).
14. Regarding claim 1, Wegener discloses an ultra-violet (UV) light sterilizable (sterilization energy source may comprise a UVC emitter, par 0040; apply sterilization energy to the chamber, par 0051) fluid-guiding element (once the chamber and corresponding surfaces have been sterilized, fluid communication may be opened between chambers, par 0052; FIGS. 3-7) for bioprocessing applications (fluid contained therein…may comprise biological materials, par 0041) which is configurable to form a part of a normally closed fluid system (create and maintain sterile fluid pathways between two closed fluidic circuits, par 0023), at least a portion of the element being formed from a material which is transmissive to UV light (connector portions 357 and 457 may comprise a substantially UVC-transparent material, par 0051), said at least one portion of the element including one or more surfaces configured to contact and guide fluids (FIG. 6A, interior surfaces 362, 459, 460, 461 etc. contact fluid, pars 0045-0049) within the closed system in use (FIG. 6B, once the chamber 416 and corresponding surfaces 411a, 361, 461 have been sterilized, fluid communication may be opened between chambers, par 0052), the element further including at least one UV light emitting diode (the sterilization energy source may comprise a UVC emitter e.g., LED, pars 0040 and 0051) mounted (device providing the sterilization energy source 300 may comprise a mold configured to receive the connector, par 0053) in, on, or adjacent the at least one portion (FIG. 4, UVC source 300) and having sufficient light output to sterilise at least the one or more surfaces (sterilization energy to sterilize connector surfaces, pars 0050-0051). Wegener also teaches at least one void in the closed fluid system (opening 211 and opening 215 come together to form enclosed chamber 216, par 0039) and by teaching that the surfaces 59a, 61, 159a, 161, 211a, 215a of the void previously open to the atmosphere may be sterilized using the UV light (par 0040), Wegener establishes that the void may harbor microorganisms as in the claimed apparatus, though microorganisms harbored are considered as a material worked upon by the sterilizing apparatus and accordingly not given patentable weight. See MPEP 2115.
Wegener does not specifically teach wherein the element additionally comprises a highly reflective external surface, shroud, body, or housing configured to reflect UV light into the at least one void in the closed fluid system.
McDonald teaches an analogous sterile transfer coupling assembly (Abstract, FIGS. 1-4) wherein provision of a reflector 29 behind the UV sources 26 ensures that the UV light is reflected into the chamber of the sterile coupling (col 5 lines 27-52), this reflector depicted in FIG. 1 as a reflective external surface, shroud, body, or housing configured to reflect UV light into analogous voids within a sterile coupling assembly, which could include interior recesses of docking assembly 23, seal 27, and/or chamber 1 (col 5 lines 41-59 and col 6 lines 4-11).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, include behind the UV light source of Wegener a reflective external surface, shroud, body, or housing configured to reflect UV light into the at least one void as taught by McDonald, because this would predictably ensure that UV light is reflected into the chamber to sterilize the surfaces of the coupling in a similar manner and involves combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).
15. Regarding claim 2, Wegener as modified by McDonald teaches the fluid-guiding element of claim 1, wherein the at least one UV light emitting diode emits light of a wavelength of about 100 to about 280 nanometres (UVC emitter, e.g., LED, Wegener par 0040; apply sterilization energy to the chamber, in which sterilization energy source comprises UVC, Wegener par 0051).
16. Regarding claim 4, Wegener as modified by McDonald teaches the fluid-guiding element of claim 1, wherein the material for the connector portions 357 and 457 is glass or a quartz glass (Wegener par 0051), or is a polypropylene (PP) or a polymethyl methacrylate (PMMA) (Wegener par 0051), or a polydimethylsiloxane (PDMS), a polyimide (PI), or a fluorinated PI, or a combination of said materials (and/or quartz glass, Wegener par 0051).
17. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener et al (US 20190192844 A1) and McDonald (US 6030578 A) as applied to claim 1 above, and further in view of Runge et al (US 20080105830 A1).
Regarding claim 3, Wegener as modified by McDonald teaches the fluid-guiding element of claim 1, wherein the connector portion would comprise a material with high permeability to the sterilization energy, e.g., quartz glass (Wegener par 0051). The combination does not specifically teach wherein the material transmits 5% or more of the UV light per mm light propagation distance, more than about 10% per mm, or more than about 20% per mm.
Runge teaches an ultraviolet gas discharge lamp (Title, Abstract) for sterilization (par 0066) that can employ different quartz materials to transmit different wavelengths (par 0041). As shown in FIG. 2, the preferred quartz material, Suprasil, transmits over 80% of UV light between 180-280 nm, and the other quartz types also demonstrate an ability to transmit light at the desired wavelengths. Example wall thicknesses of 1 mm and 1.3 mm are given (par 0041), thus these materials are capable of transmitting more than about 20% of the UV light per mm propagation distance.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use as the material for the UV-transmissive connector portion of modified Wegener a quartz glass material with substantially high transmissivity of more than 20% of the UV light per mm propagation distance as taught by Runge, as this would predictably provide adequate UV transmission so that the interior surfaces and fluid can be sterilized with the germicidal radiation and involves simple substitution of one known element for another to obtain predictable results. See MPEP 2143(I)(B).
18. Claims 6, 7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Wegener et al (US 20190192844 A1) and McDonald (US 6030578 A) as applied to claim 1 above, and further in view of Asano (US 20180099061 A1) and Yang (US 20110049391 A1).
19. Regarding claim 6, Wegener as modified by McDonald teaches the fluid-guiding element of claim 1, wherein the element includes a body having one or more surfaces configured to contact and guide fluids (Wegener FIG. 6A, body 362 contacts and guides fluid, Wegener pars 0048-0050). Wegener teaches that the LED is located proximally to the UV-transmissive body (Wegener FIG. 4) but is silent regarding necessary electrical connections for the UV LED thus does not teach wherein the body supports a circuit for operating the at least one UV light emitting diode.
Asano teaches an analogous sterilization apparatus wherein ultraviolet light from the UV-LEDs 32 is transmitted through the light guide 20 (pars 0029-0030, FIG. 1) and into a fluid to sterilize the fluid (FIG. 3, 60; par 0024). The UV-LEDs are provided on the upper surface 23 (par 0030, FIGS. 1-3, 32) and are described as having “electrical power for turning the light source on” (par 0039), but Asano is silent regarding the structure of any circuitry for powering the UV-LEDs.
Yang teaches an ultraviolet light sanitizing storage container (Abstract) having an ultraviolet LED that protrudes downward from a circuit board (par 0019). The circuitry is provided within an extension of the body (FIGS. 2-4) and comprises a battery (par 0014) and a push button switch (par 0014), the circuitry supported in the top cover 20 by a retaining member 40 (par 0016, FIGS. 3-4). Yang teaches that the volume of the circuit board is reduced to the minimum as a benefit for transportability (par 0008).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the UV light source of Wegener with UV-LEDs mounted to the surface of the light guide material as taught by Asano, the UV-LEDs having compact circuitry with a battery and a push-button switch supported within an extension of the body as taught by Yang, because this mounting configuration would predictably provide reliable battery power and on-off control for the UV-LEDs, with the advantage of a small profile that can reasonably fit on small fluid guiding connectors (Yang par 0008) with minimal UV light escaping to the environment (Asano pars 0037-0038), the modification involving combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).
20. Regarding claim 7, Wegener as modified by McDonald, Asano and Yang teaches the fluid-guiding element of claim 6, wherein the circuit is provided within an extension of the body (Yang FIGS. 2-4, circuit board 30 fully contained within top cover 20).
21. Regarding claim 10, Wegener as modified by McDonald, Asano and Yang teaches the fluid-guiding element of claim 6, and Yang teaches that the circuit board 30 is fixed in the top cover 20 by a retaining member 40 (par 0016, FIGS. 3-4), thus the circuit is supported by a shroud that is distinct from the body which also supports the circuit as required by claim 6 to read upon further including a shroud for support supporting said circuit.
22. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener et al (US 20190192844 A1), McDonald (US 6030578 A), Asano (US 20180099061 A1) and Yang (US 20110049391 A1) as applied to claim 6 above, and further in view of Bonutti et al (US 20150209457 A1).
Regarding claim 8, Wegener as modified by Proulx, Asano and Yang teaches the fluid-guiding element of claim 6, wherein the circuit comprises a push to make switch, a UV LED, and a battery (Yang par 0014; FIGS. 1-2, button 21 pushes switch 32, UV LED 31, battery 33). The combination does not explicitly teach that this circuit includes a current limiting resistor.
Bonutti teaches a UVC disinfection system (Abstract; par 0026) powered by a battery (par 0026) and using an LED driver circuit (par 0006, FIG. 2) that controls the intensity of the ultraviolet LED array by a current limiting resistor in series with the LED (par 0027).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include in series with the LED in the circuit of modified Wegener a current limiting resistor as taught by Bonutti, because this would predictably provide the ability to control the intensity of the LED array (Bonutti par 0027) and protect the LED from excessive current damage and involves combination of prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).
23. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener et al (US 20190192844 A1) in view of McDonald (US 6030578 A) and McCool (US 4523968 A).
Regarding claim 14, Wegener teaches an ultra-violet (UV) light sterilizable (sterilization energy source may comprise a UVC emitter, par 0040; apply sterilization energy to the chamber, par 0051) fluid-guiding element (once the chamber and corresponding surfaces have been sterilized, fluid communication may be opened between chambers, par 0052; FIGS. 3-7) for bioprocessing applications (fluid contained therein…may comprise biological materials, par 0041) which is configurable to form a part of a normally closed fluid system (create and maintain sterile fluid pathways between two closed fluidic circuits, par 0023), at least a portion of the element being formed from a material which is transmissive to UV light (connector portions 357 and 457 may comprise a substantially UVC-transparent material, par 0051), said at least one portion of the element including one or more surfaces configured to contact and guide fluids (FIG. 6A, interior surfaces 362, 459, 460, 461 etc. contact fluid, pars 0045-0049) within the closed system in use (FIG. 6B, once the chamber 416 and corresponding surfaces 411a, 361, 461 have been sterilized, fluid communication may be opened between chambers, par 0052), the element further including at least one UV light emitting diode (the sterilization energy source may comprise a UVC emitter e.g., LED, pars 0040 and 0051) mounted (device providing the sterilization energy source 300 may comprise a mold configured to receive the connector, par 0053) in, on, or adjacent the at least one portion (FIG. 4, UVC source 300) and having sufficient light output to sterilise at least the one or more surfaces (sterilization energy to sterilize connector surfaces, pars 0050-0051).
Wegener also teaches at least one void in the closed fluid system (opening 211 and opening 215 come together to form enclosed chamber 216, par 0039) and by teaching that the surfaces 59a, 61, 159a, 161, 211a, 215a of the void previously open to the atmosphere may be sterilized using the UV light (par 0040), Wegener establishes that the void may harbor microorganisms as in the claimed apparatus, though microorganisms harbored are considered as a material worked upon by the sterilizing apparatus and accordingly not given patentable weight. See MPEP 2115.
Wegener does not specifically teach wherein the element additionally comprises a highly reflective external surface, shroud, body, or housing configured to reflect UV light into the at least one void in the closed fluid system.
McDonald teaches an analogous sterile transfer coupling assembly (Abstract, FIGS. 1-4) wherein provision of a reflector 29 behind the UV sources 26 ensures that the UV light is reflected into the chamber of the sterile coupling (col 5 lines 27-52), this reflector depicted in FIG. 1 as a reflective external surface, shroud, body, or housing configured to reflect UV light into analogous voids within a sterile coupling assembly, which could include interior recesses of docing assembly 23, seal 27, and/or chamber 1 (col 5 lines 41-59 and col 6 lines 4-11).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, include behind the UV light source of Wegener a reflective external surface, shroud, body, or housing configured to reflect UV light into the at least one void as taught by McDonald, because this would predictably ensure that UV light is reflected into the chamber to sterilize the surfaces of the coupling in a similar manner and involves combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).
Wegener teaches that one open end of a tube may be coupled to form a hermetic seal with the sterilizable connector by a variety of suitable methods, including by clamping or fit molding (par 0033). Wegener does not teach the specific structure wherein the element comprises at least one inner clamp and one outer clamp, wherein the outer clamp is configured to slide axially over the inner clamp along the tube, and wherein a locking force is generated by the axial slide of the outer clamp towards the same direction as the open end of the tubing.
McCool teaches a similar fitting assembly for sterile fluid tubing (Abstract, col 1 line 53 to col 2 line 18) having at least one inner clamp (collar 34, cover FIG. 5) and one outer clamp (die 50, cover FIG. 5), wherein the outer clamp is configured to slide axially over the inner clamp along the tube (moving the fitting 22 with the tube 24…into the die 50, col 4 lines 5-32; FIGS. 4-5, outer clamp 50 over inner clamp 34), and wherein a locking force is generated by the movement of the outer clamp towards the same direction as the open end of the tubing (as fitting 22 moves further into the die 50, the collar 34 becomes slightly extruded longitudinally or distally and is tightly clamped against the outer surface of the end of tube 24, col 4 lines 5-32).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to connect the tubing sealably to the connector of Wegener using at least one inner clamp and one outer clamp slid and locked together as taught by McCool, because this connection would predictably provide a similar fluid-tight, mechanically strong connection between the connector fitting and the tube as taught by McCool (col 4 lines 5-32) and involves simple substitution of one known element for another to obtain predictable results. See MPEP 2143(I)(B).
24. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener et al (US 20190192844 A1), McDonald (US 6030578 A), and McCool (US 4523968 A) as applied to claim 14 above, and further in view of Asano (US 20180099061 A1) and Yang (US 20110049391 A1).
Regarding claim 15, Wegener as modified by McDonald and McCool teaches the fluid-guiding element of claim 14, wherein the element includes a body having one or more surfaces configured to contact and guide fluids (Wegener FIG. 6A, body 362 contacts and guides fluid, Wegener pars 0048-0050). The combination teaches that the LED is located proximally to the UV-transmissive body (Wegener FIG. 4) but does not teach wherein the body supports a circuit for operating the at least one UV light emitting diode.
Asano teaches an analogous sterilization apparatus wherein ultraviolet light from the UV-LEDs 32 is transmitted through the light guide 20 (pars 0029-0030, FIG. 1) and into a fluid to sterilize the fluid (FIG. 3, 60; par 0024). The UV-LEDs are provided on the upper surface 23 (par 0030, FIGS. 1-3, 32) and are described as having “electrical power for turning the light source on” (par 0039), but Asano is silent regarding the structure of any circuitry for powering the UV-LEDs.
Yang teaches an ultraviolet light sanitizing storage container (Abstract) having an ultraviolet LED that protrudes downward from a circuit board (par 0019). The circuitry is provided within an extension of the body (FIGS. 2-4) and comprises a battery (par 0014) and a push button switch (par 0014). Yang teaches that the volume of the circuit board is reduced to the minimum as a benefit for transportability (par 0008).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the UV light source of Wegener to comprise UV-LEDs mounted to the surface of the light guide material as taught by Asano, the UV-LEDs having compact circuitry with a battery and a push-button switch as taught by Yang, because this circuitry would predictably provide reliable battery power and on-off control for the UV-LEDs, with the advantage of a small profile that can reasonably fit on small fluid guiding connectors (Yang par 0008) in a mounting configuration that would predictably provide adequate UV illumination of the fluid guiding element with minimal UV light escaping to the environment (Asano pars 0037-0038), the modifications involving combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).
25. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener et al (US 20190192844 A1), McDonald (US 6030578 A), McCool (US 4523968 A), Asano (US 20180099061 A1) and Yang (US 20110049391 A1) as applied to claim 15 above, and further in view of Bonutti et al (US 20150209457 A1).
Regarding claim 16, Wegener as modified above teaches the fluid-guiding element of claim 15, wherein the circuit comprises a push to make switch, a UV LED, and a battery (Yang par 0014; FIGS. 1-2, button 21 pushes switch 32, UV LED 31, battery 33). The combination does not explicitly teach that this circuit includes a current limiting resistor.
Bonutti teaches a UVC disinfection system (Abstract; par 0026) powered by a battery (par 0026) and using an LED driver circuit (par 0006, FIG. 2) that controls the intensity of the ultraviolet LED array by a current limiting resistor in series with the LED (par 0027).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include in series with the LED in the circuit of modified Wegener a current limiting resistor as taught by Bonutti, because this would predictably provide the ability to control the intensity of the LED array (Bonutti par 0027) and protect the LED from excessive current damage and involves combination of prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).
26. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener et al (US 20190192844 A1) in view of McDonald (US 6030578 A) and Minkus (US 20140276375 A1).
Regarding claim 17, Wegener teaches an ultra-violet (UV) light sterilizable (sterilization energy source may comprise a UVC emitter, par 0040; apply sterilization energy to the chamber, par 0051) fluid-guiding element (once the chamber and corresponding surfaces have been sterilized, fluid communication may be opened between chambers, par 0052; FIGS. 3-7) for bioprocessing applications (fluid contained therein…may comprise biological materials, par 0041) which is configurable to form a part of a normally closed fluid system (create and maintain sterile fluid pathways between two closed fluidic circuits, par 0023), at least a portion of the element being formed from a material which is transmissive to UV light (connector portions 357 and 457 may comprise a substantially UVC-transparent material, par 0051), said at least one portion of the element including one or more surfaces configured to contact and guide fluids (FIG. 6A, interior surfaces 362, 459, 460, 461 etc. contact fluid, pars 0045-0049) within the closed system in use (FIG. 6B, once the chamber 416 and corresponding surfaces 411a, 361, 461 have been sterilized, fluid communication may be opened between chambers, par 0052), the element further including at least one UV light emitting diode (the sterilization energy source may comprise a UVC emitter e.g., LED, pars 0040 and 0051) mounted (device providing the sterilization energy source 300 may comprise a mold configured to receive the connector, par 0053) in, on, or adjacent the at least one portion (FIG. 4, UVC source 300) and having sufficient light output to sterilise at least the one or more surfaces (sterilization energy to sterilize connector surfaces, pars 0050-0051).
Wegener also teaches at least one void in the closed fluid system (opening 211 and opening 215 come together to form enclosed chamber 216, par 0039) and by teaching that the surfaces 59a, 61, 159a, 161, 211a, 215a of the void previously open to the atmosphere may be sterilized using the UV light (par 0040), Wegener establishes that the void may harbor microorganisms as in the claimed apparatus, though microorganisms harbored are considered as a material worked upon by the sterilizing apparatus and accordingly not given patentable weight. See MPEP 2115.
Wegener does not specifically teach wherein the element additionally comprises a highly reflective external surface, shroud, body, or housing configured to reflect UV light into the at least one void in the closed fluid system.
McDonald teaches an analogous sterile transfer coupling assembly (Abstract, FIGS. 1-4) wherein provision of a reflector 29 behind the UV sources 26 ensures that the UV light is reflected into the chamber of the sterile coupling (col 5 lines 27-52), this reflector depicted in FIG. 1 as a reflective external surface, shroud, body, or housing configured to reflect UV light into analogous voids within a sterile coupling assembly, which could include interior recesses of docking assembly 23, seal 27, and/or chamber 1 (col 5 lines 41-59 and col 6 lines 4-11).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, include behind the UV light source of Wegener a reflective external surface, shroud, body, or housing configured to reflect UV light into the at least one void as taught by McDonald, because this would predictably ensure that UV light is reflected into the chamber to sterilize the surfaces of the coupling in a similar manner and involves combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).
Although Wegener teaches that the channel may have outer threads configured to mate with corresponding inner threads of the connector portions (pars 0047 and 0049) and that connector segments may be configured such that the outer surface of one segment forms a threaded fit with the other segment (par 0050), Wegener does not teach a threaded screw cap.
Minkus teaches analogous sterilizable tubing connections (FIGS. 6B-6C) wherein a threaded cap can thread onto the sterile transfer lines (par 0122) in order to seal and maintain the threaded end in a sterilized condition (pars 0104-0107).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the threaded connection of Wegener with a threaded screw cap as taught by Minkus, because this would predictably close the tubing end and maintain sterility in a similar manner and involves combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).
27. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener et al (US 20190192844 A1), McDonald (US 6030578 A), and Minkus (US 20140276375 A1) as applied to claim 17 above, and further in view of Asano (US 20180099061 A1) and Yang (US 20110049391 A1).
Regarding claim 18, Wegener as modified by McDonald and Minkus teaches the fluid-guiding element of claim 17, wherein the element includes a body having one or more surfaces configured to contact and guide fluids (Wegener FIG. 6A, body 362 contacts and guides fluid, pars 0048-0050). Wegener teaches that the LED is located proximally to the UV-transmissive body (Wegener FIG. 4) but does not teach wherein the body supports a circuit for operating the at least one UV light emitting diode.
Asano teaches an analogous sterilization apparatus wherein ultraviolet light from the UV-LEDs 32 is transmitted through the light guide 20 (pars 0029-0030, FIG. 1) and into a fluid to sterilize the fluid (FIG. 3, 60; par 0024). The UV-LEDs are provided on the upper surface 23 (par 0030, FIGS. 1-3, 32) and are described as having “electrical power for turning the light source on” (par 0039), but Asano is silent regarding the structure of any circuitry for powering the UV-LEDs.
Yang teaches an ultraviolet light sanitizing storage container (Abstract) having an ultraviolet LED that protrudes downward from a circuit board (par 0019). The circuitry is provided within an extension of the body (FIGS. 2-4) and comprises a battery (par 0014) and a push button switch (par 0014). Yang teaches that the volume of the circuit board is reduced to the minimum as a benefit for transportability (par 0008).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the UV light source of Wegener with UV-LEDs mounted to the surface of the light guide material as taught by Asano, the UV-LEDs having compact circuitry with a battery and a push-button switch as taught by Yang. This mounting configuration would predictably provide adequate UV illumination of the fluid guiding element with minimal UV light escaping to the environment (Asano pars 0037-0038). The circuitry would predictably provide reliable battery power and on-off control for the UV-LEDs, with the advantage of a small profile that can reasonably fit on small fluid guiding connectors (Yang par 0008).
28. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener et al (US 20190192844 A1), McDonald (US 6030578 A), Minkus (US 20140276375 A1), Asano (US 20180099061 A1) and Yang (US 20110049391 A1) as applied to claim 18 above, and further in view of Bonutti et al (US 20150209457 A1).
Regarding claim 19, Wegener as modified above teaches the fluid-guiding element of claim 18, wherein the circuit comprises a push to make switch, a UV LED, and a battery (Yang par 0014; FIGS. 1-2, button 21 pushes switch 32, UV LED 31, battery 33). The combination does not explicitly teach that this circuit includes a current limiting resistor.
Bonutti teaches a UVC disinfection system (Abstract; par 0026) powered by a battery (par 0026) and using an LED driver circuit (par 0006, FIG. 2) that controls the intensity of the ultraviolet LED array by a current limiting resistor in series with the LED (par 0027).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include in series with the LED in the circuit of modified Wegener a current limiting resistor as taught by Bonutti, because this would predictably provide the ability to control the intensity of the LED array (Bonutti par 0027) and protect the LED from excessive current damage and involves combination of prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).
29. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener et al (US 20190192844 A1) in view of BRITA GmbH (DE 202011000504 U1, references made with respect to the English machine translation), McDonald (US 6030578 A), Asano (US 20180099061 A1) and Yang (US 20110049391 A1).
Regarding claim 20, Wegener teaches an ultra-violet (UV) light sterilizable (sterilization energy source may comprise a UVC emitter, par 0040; apply sterilization energy to the chamber, par 0051) fluid-guiding element (once the chamber and corresponding surfaces have been sterilized, fluid communication may be opened between chambers, par 0052; FIGS. 3-7) for bioprocessing applications (fluid contained therein…may comprise biological materials, par 0041) which is configurable to form a part of a normally closed fluid system (create and maintain sterile fluid pathways between two closed fluidic circuits, par 0023), at least a portion of the element being formed from a material which is transmissive to UV light (connector portions 357 and 457 may comprise a substantially UVC-transparent material, par 0051), said at least one portion of the element including one or more surfaces configured to contact and guide fluids (FIG. 6A, interior surfaces 362, 459, 460, 461 etc. contact fluid, pars 0045-0049) within the closed system in use (FIG. 6B, once the chamber 416 and corresponding surfaces 411a, 361, 461 have been sterilized, fluid communication may be opened between chambers, par 0052), the element further including at least one UV light emitting diode (the sterilization energy source may comprise a UVC emitter e.g., LED, pars 0040 and 0051) mounted (device providing the sterilization energy source 300 may comprise a mold configured to receive the connector, par 0053) in, on, or adjacent the at least one portion (FIG. 4, UVC source 300) and having sufficient light output to sterilise at least the one or more surfaces (sterilization energy to sterilize connector surfaces, pars 0050-0051). Wegener further teaches wherein the element includes a body having one or more surfaces configured to contact and guide fluids (Wegener FIG. 6A, body 362 contacts and guides fluid, Wegener pars 0048-0050).
Wegener also teaches at least one void in the closed fluid system (opening 211 and opening 215 come together to form enclosed chamber 216, par 0039) and by teaching that the surfaces 59a, 61, 159a, 161, 211a, 215a of the void previously open to the atmosphere may be sterilized using the UV light (par 0040), Wegener establishes that the void may harbor microorganisms as in the claimed apparatus, though microorganisms harbored are considered as a material worked upon by the sterilizing apparatus and accordingly not given patentable weight. See MPEP 2115.
Wegener does not specifically teach wherein the element additionally comprises a highly reflective external surface, shroud, body, or housing configured to reflect UV light into the at least one void in the closed fluid system.
McDonald teaches an analogous sterile transfer coupling assembly (Abstract, FIGS. 1-4) wherein provision of a reflector 29 behind the UV sources 26 ensures that the UV light is reflected into the chamber of the sterile coupling (col 5 lines 27-52), this reflector depicted in FIG. 1 as a reflective external surface, shroud, body, or housing configured to reflect UV light into analogous voids within a sterile coupling assembly, which could include interior recesses of docking assembly 23, seal 27, and/or chamber 1 (col 5 lines 41-59 and col 6 lines 4-11).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, include behind the UV light source of Wegener a reflective external surface, shroud, body, or housing configured to reflect UV light into the at least one void as taught by McDonald, because this would predictably ensure that UV light is reflected into the chamber to sterilize the surfaces of the coupling in a similar manner and involves combining prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).
Wegener teaches embodiments wherein the sterilizable element comprises a valve (valve 59/159, FIGS. 3-5, pars 0035-0037) for controlling fluid flow between the sterilizing chamber and the opening of the connector segment (par 0035). Wegener does not teach that this valve would be a ball valve.
Brita teaches a self-sterilizing dispenser device (pars 0006-0012) featuring a valve made of UV-permeable and UV-resistant material (par 0035) wherein the valve can be designed as a ball valve (par 0035). The UV radiation is directed to the interior of the valve to reduce the spread of germs and contamination in any dead spaces in the valve and downstream (pars 0016-0017) providing the fluid shutoff capability (par 0006) while preventing microbial contamination within even the hardest to reach spaces of the transparent valve body (par 0011).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the valve of the sterilizable element of Wegener with a UV-permeable ball valve as taught by Brita, because this would predictably provide a UV-sterilizable closeable connection in the same manner as Brita and would involve simple substitution of one known element for another to obtain predictable results. See MPEP 2143(I)(B).
Although Wegener teaches that the LED is located proximally to the UV-transmissive body (Wegener FIG. 4), the combination does not teach wherein the body supports a circuit for operating the at least one UV light emitting diode, wherein the circuit is provided within an extension of the body.
Asano teaches an analogous sterilization apparatus wherein ultraviolet light from the UV-LEDs 32 is transmitted through the light guide 20 (pars 0029-0030, FIG. 1) and into a fluid to sterilize the fluid (FIG. 3, 60; par 0024). The UV-LEDs are provided on the upper surface 23 (par 0030, FIGS. 1-3, 32) and are described as having electrical power for turning the light source on (par 0039), but Asano is silent regarding the structure of any circuitry for powering the UV-LEDs.
Yang teaches an ultraviolet light sanitizing storage container (Abstract) having an ultraviolet LED that protrudes downward from a circuit board (par 0019). The circuitry is provided within an extension of the body (FIGS. 2-4) and comprises a battery (par 0014) and a push button switch (par 0014). Yang teaches that the volume of the circuit board is reduced to the minimum as a benefit for transportability (par 0008).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the UV light source of modified Wegener with UV-LEDs mounted to the surface of the light guide material as taught by Asano, the UV-LEDs having compact circuitry with a battery and a push-button switch as taught by Yang. This mounting configuration would predictably provide adequate UV illumination of the fluid guiding element with minimal UV light escaping to the environment (Asano pars 0037-0038). The circuitry would predictably provide reliable battery power and on-off control for the UV-LEDs, with the advantage of a small profile that can reasonably fit on small fluid guiding connectors (Yang par 0008).
30. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener (US 20190192844 A1), Brita (DE 202011000504 U1), McDonald (US 6030578 A), Asano (US 20180099061 A1) and Yang (US 20110049391 A1) as applied to claim 20 above, and further in view of Bonutti et al (US 20150209457 A1).
Regarding claim 22, Wegener as modified above teaches the fluid-guiding element of claim 20, wherein the circuit comprises a push to make switch, a UV LED, and a battery (Yang par 0014; FIGS. 1-2, button 21 pushes switch 32, UV LED 31, battery 33). The combination does not explicitly teach that this circuit includes a current limiting resistor.
Bonutti teaches a UVC disinfection system (Abstract; par 0026) powered by a battery (par 0026) and using an LED driver circuit (par 0006, FIG. 2) that controls the intensity of the ultraviolet LED array by a current limiting resistor in series with the LED (par 0027).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include in series with the LED in the circuit of modified Wegener a current limiting resistor as taught by Bonutti, because this would predictably provide the ability to control the intensity of the LED array (Bonutti par 0027) and protect the LED from excessive current damage and involves combination of prior art elements according to known methods to yield predictable results. See MPEP 2143(I)(A).
Response to Arguments
31. Applicant’s arguments, see Remarks filed 19 March 2026, with respect to the rejections of claims 1-4, 6-8, 10, 14-20, and 22 under 35 U.S.C. 112(b) and 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made over Wegener in view of McDonald to address the newly recited limitation requiring wherein the element additionally comprises a highly reflective external surface, shroud, body, or housing configured to reflect UV light into at least one void in the closed fluid system which harbors microorganisms.
32. In response to Applicant’s argument that a skilled artisan would find no reason to modify the disclosure of Asano because Asano teaches an open fluid system instead of a closed fluid system, the Examiner would like to clarify that the disclosure of Asano is not being modified, the base device of Wegener is. Asano teaches the UV source adjacency as a slight modification to the UV source location in Wegener, and Asano expounds upon internal reflection mechanisms that would be present within the connector of Wegener in this obvious mounting configuration, as the fluid guiding element is constructed of similar UV-transmissive materials. Further, the disclosure of Asano is directed toward a similar problem in that it kills microorganisms on or near UV-transmissive surfaces. It is immaterial where the microorganisms could come from, as the microorganisms are treated as a material worked upon by the sterilization device and thus carry no patentable weight, see MPEP 2115.
Conclusion
33. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Talbert whose telephone number is (703)756-5538. The examiner can normally be reached Mon-Fri 8:00-5:00 Eastern Time.
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/ERIC TALBERT/Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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