DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/04/2025 has been entered.
Response to Amendment
The amendment filed 06/04/2025 has been entered, Claims 1-17 remain pending.
Claim Objections
Claims 15 and 17 are objected to because of the following informalities:
Claim 15 recites “The tube of claim 14…”, Claim 15 should read “The insert to a tube of claim 14…”, for proper antecedent basis;
Claim 17 recites “The tube of claim 16…”, Claim 17 should read “The filter of claim 16…”, for proper antecedent basis;
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Specifically, independent Claim 1 and 6 recites “wherein the substrate is configured to substantially conform to an interior contour of the tube”, and “the substrate is configured to flexibly and conformally engage the inner surfaces of the tube”. Independent Claim 11 recites “heat sink fins integrally formed with the filter”. The specification does not contain written description for the claimed limitations. See specification section above for detailed explanation.
Claim Rejections - 35 USC § 103
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.
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, 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaska et al. (US20070187626), hereafter Gaska, in view of Cumbie et al. (US20090143842), hereafter Cumbie.
Regarding Claim 1, Gaska discloses a tube (Fig. 3B, an endotracheal tube 32), comprising: an array of UV-C LEDs (Fig. 3B, ultraviolet diodes 42A-B; par. 28-29, configured to emit UV light in the 250-280nm range, which is UV-C) mounted to a substrate (Fig. 3B, sterilization structure 40) that is conformally installed (par. 0027, “The elongated structure can be substantially rigid or include sufficient flexibility to bend about a corner”; the flexibility renders the substrate conformal to the tube) and secured within the tube (Fig. 3B, 4, par. 0035, “the ultraviolet diodes 42A-B can be configured/operated such that substantially all locations of the interior side of endotracheal tube 32 are impinged by each of the predominant wavelengths”; the substrate 40 is configured to affect all of interior side of the tube, therefore is secured within the tube), wherein the substrate is configured to substantially conform to an interior contour of the tube (See par. 0027, 0035, Fig. 3B, 4; the substrate 40 is flexible and is configured to installed within the interior surface of the tube, see specification section above).
Gaska does not disclose wherein the UV-C LEDs are configured to emit UV-C light as a series of high frequency pulses of between 1 and 100 femtoseconds to limit the heat generated by the UV-C LEDs.
However, Cumbie discloses a device to treat infections (Cumbie Abstract, claim 11), comprising: an array of UV-C LEDs, wherein the UV-C LEDs are configured to emit UV-C light as a series of high frequency pulses of between 1 and 100 femtoseconds to limit the heat generated by the UV-C LEDs (par. 0021-0024, 0051, 0207, the UV-C LEDs are disclosed as capable of emitting pulsed UV-C light with programmable pulses of between 1 and 100 femtoseconds satisfying this limitation, see MPEP 2144.05(I)).
It would have been obvious (MPEP §2143(I)(A)) to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the known endotracheal tube comprising an array of UV-C LEDs mounted to a substrate installed within the tube and configured to emit UV-C light as a series of pulses of Gaska, with the addition of the known high frequency programmable pulses with a duration between 1 and 100 femtoseconds of Cumbie, to obtain the predictable result of: enhancing the cell penetration of the light emitted (Cumbie, 0023); delivering more instantaneous energy with the emitted light (Cumbie, 0024); enhancing the wavelength profile of the emitted light (Cumbie, 0025); and significantly increasing the two-photon absorption of the light emitted (Cumbie, 0032), all of which increase the germophobic capabilities of the light emitted with a shortened pulse duration.
Regarding Claim 2, the modified Gaska discloses the tube of claim 1, wherein the tube is an endotracheal tube (Gaska, Fig. 3B, an endotracheal tube 32).
Regarding Claim 6, Gaska discloses an insert (Fig. 3B, insert shown in drawing within a tube 32) to a tube (Fig. 3B, an endotracheal tube 32), comprising: an array of UV-C LEDs (Fig. 3B, ultraviolet diodes 42A-B; par. 28-29, configured to emit UV light in the 250-280nm range, which is UV-C) mounted to a flexible substrate (Fig. 3B, sterilization structure 40) that is configured to be removably (par. 0027, “sterilization structure 40 is inserted and/or removed from endotracheal tube 32”) inserted and conformally secured within the tube (par. 0027, “The elongated structure can be substantially rigid or include sufficient flexibility to bend about a corner”; the flexibility renders the substrate conformal to the tube; Fig. 3B, 4, par. 0035, “the ultraviolet diodes 42A-B can be configured/operated such that substantially all locations of the interior side of endotracheal tube 32 are impinged by each of the predominant wavelengths”; the substrate 40 is configured to affect all of interior side of the tube, therefore is secured within the tube), wherein the substrate is configured to flexibly and conformally engage the inner surfaces of the tube (See par. 0027, 0035, Fig. 3B, 4; the substrate 40 is flexible and is configured to installed within the interior surface of the tube, see specification section above).
Gaska does not disclose wherein the UV-C LEDs are configured to emit UV-C light as a series of high frequency pulses of between 1 and 100 femtoseconds to limit heat generation.
However, Cumbie discloses a device to treat infections (Cumbie Abstract, claim 11), comprising: an array of UV-C LEDs, wherein the UV-C LEDs are configured to emit UV-C light as a series of high frequency pulses of between 1 and 100 femtoseconds to limit heat generation (par. 0021-0024, 0051, 0207, the UV-C LEDs are disclosed as capable of emitting pulsed UV-C light with programmable pulses of between 1 and 100 femtoseconds satisfying this limitation, see MPEP 2144.05(I)).
It would have been obvious (MPEP §2143(I)(A)) to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the known endotracheal tube comprising an array of UV-C LEDs mounted to a substrate installed within the tube and configured to emit UV-C light as a series of pulses of Gaska, with the addition of the known high frequency programmable pulses with a duration between 1 and 100 femtoseconds of Cumbie, to obtain the predictable result of: enhancing the cell penetration of the light emitted (Cumbie, 0023); delivering more instantaneous energy with the emitted light (Cumbie, 0024); enhancing the wavelength profile of the emitted light (Cumbie, 0025); and significantly increasing the two-photon absorption of the light emitted (Cumbie, 0032), all of which increase the germophobic capabilities of the light emitted with a shortened pulse duration.
Regarding Claim 7, the modified Gaska discloses the insert of claim 6, wherein the tube is an endotracheal tube (Gaska, Fig. 3B, an endotracheal tube 32).
Regarding claim 12, the modified Gaska discloses the tube of claim 1, wherein the array of LEDs is configured to transmit 260 nm UV light at a given duty cycle (Cumbie, par. 0021-0023, 0053; the LEDs are disclosed as capable of being monochromatic, therefore emissive of a single wavelength including 260 nm, as well as having a programmed duty cycle of pulses and pauses between pulses).
Regarding claim 13, the modified Gaska discloses the tube of claim 12, wherein the given duty cycle comprises one "ON" pulse followed by ten "OFF" pulses (Cumbie, par. 38, 44, 48, 50, 53-54, 73, 142, 151-152, 241, 245, 248; the pulses are disclosed as programmable including pulses of light, i.e. "ON" pulses, and pauses, i.e. "OFF" pulses, the light pulses and pauses being programmable for complex patterns, including capable of being programmed to emit one light pulse followed by a pause equivalent in length to ten light pulses).
Regarding claim 14, the modified Gaska discloses the insert to a tube of claim 6, wherein the array of LEDs is configured to transmit 260 nm UV light at a given duty cycle (Cumbie, par. 0021-0023, 0053; the LEDs are disclosed as capable of being monochromatic, therefore emissive of a single wavelength including 260 nm, as well as having a programmed duty cycle of pulses and pauses between pulses;).
Regarding claim 15, the modified Gaska discloses the tube of claim 14, wherein the given duty cycle comprises one "ON" pulse followed by ten "OFF" pulses (Cumbie, par. 38, 44, 48, 50, 53-54, 73, 142, 151-152, 241, 245, 248; the pulses are disclosed as programmable including pulses of light, i.e. "ON" pulses, and pauses, i.e. "OFF" pulses, the light pulses and pauses being programmable for complex patterns, including capable of being programmed to emit one light pulse followed by a pause equivalent in length to ten light pulses;).
Claim(s) 3, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaska, in view of Cumbie, further in view of Bui (US10525156), hereafter Bui.
Regarding Claim 3, the modified Gaska discloses the tube of claim 1, but is silent on wherein the tube is a bronchoscope tube.
However, Bui teaches a tube (Fig. 5B, tube 302), comprising of an array of UV LED installed within the tube (Fig. 5B, UV light source 62 and 68 within tube 302), on wherein the tube is a bronchoscope tube (col. 10, line 56-58, “the present invention could also be used to disinfect/sterilize cystoscopes and instruments, ureteroscopes and instruments, bronchoscopes…”). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known tube of Gaska, and with the bronchoscope tube of Bui, for disinfection in bronchoscopy procedure as taught by Bui (Bui, col. 10, line 56-64).
Regarding Claim 8, the modified Gaska discloses the insert of claim 6, wherein the tube is a bronchoscope tube.
However, Bui teaches a tube (Fig. 5B, tube 302), comprising of an array of UV LED installed within the tube (Fig. 5B, UV light source 62 and 68 within tube 302), on wherein the tube is a bronchoscope tube (col. 10, line 56-58, “the present invention could also be used to disinfect/sterilize cystoscopes and instruments, ureteroscopes and instruments, bronchoscopes…”). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known tube of Gaska, and with the bronchoscope tube of Bui, for disinfection in bronchoscopy procedure as taught by Bui (Bui, col. 10, line 56-64).
Claim(s) 4, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaska, in view of Cumbie, further in view of Heatherington (WO2019156921), hereafter Heatherington.
Regarding Claim 4, the modified Gaska discloses the tube of claim 1, but is silent on wherein the tube is a nasal cannula.
However, Heatherington teaches a system of disinfecting a CPAP equipment (par.00127, generator 250 can produce UV light to sanitize the contents of interior 230 and the associated CPAP equipment), using UV light (par. 00127, “UV light is highly effective at deactivating microorganisms, including bacteria, viruses, yeasts, and molds”), wherein the CPAP equipment is a tube, and wherein the tube is a nasal cannula (par. 00115, “For example, the respiratory assembly can include a nasal cannula”). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known tube with Gaska, with the disinfection system of Heatherington, for disinfection of a nasal cannula during CPAP therapy using ultraviolet light as taught by Heatherington (Heatherington, par. 00127).
Regarding Claim 9, the modified Gaska discloses the insert of claim 6, wherein the tube is a nasal cannula.
However, Heatherington teaches a system of disinfecting a CPAP equipment (par.00127, generator 250 can produce UV light to sanitize the contents of interior 230 and the associated CPAP equipment), using UV light (par. 00127, “UV light is highly effective at deactivating microorganisms, including bacteria, viruses, yeasts, and molds”), wherein the CPAP equipment is a tube, and wherein the tube is a nasal cannula (par. 00115, “For example, the respiratory assembly can include a nasal cannula”). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known tube with Gaska, with the disinfection system of Heatherington, for disinfection of a nasal cannula during CPAP therapy using ultraviolet light as taught by Heatherington (Heatherington, par. 00127).
Claim(s) 5, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaska, in view of Cumbie, further in view of Eltorai (US20190168023), hereafter Eltorai.
Regarding Claim 5, the modified Gaska discloses the tube of claim 1, but is silent on wherein the tube is a thoracentesis needle.
However, Eltorai teaches a system of disinfection with UV light (par. 0018, “The light-emitting antimicrobial catheter… a light transmitter configured and arranged to emit light through the tube, which may be ultraviolet C (UVC) irradiation, photodynamic therapy (PDT), violet-blue light therapy, and other light-based therapies. In one embodiment, violet-blue wavelengths (from 400-500 nm) of visible spectrum light that have both antimicrobial effects and are safe to expose to human tissue”), comprising of a tube (par. 0018, “a catheter that includes a thin, flexible tube having an optically transparent wall; and a light transmitter…”), wherein the tube is a thoracentesis needle (par. 0085, “the light-emitting antimicrobial catheter described herein may be used in any number of catheters, tubes… thoracentesis devices, thoracentesis systems”; the thoracentesis device/system inherently includes a thoracentesis needle). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known tube of Gaska, with the system of Eltorai, for disinfection during thoracentesis therapy as taught by Eltorai (Eltorai, par. 0085).
Regarding Claim 10, the modified Gaska discloses the insert of claim 6, wherein the tube is a thoracentesis needle.
However, Eltorai teaches a system of disinfection with UV light (par. 0018, “The light-emitting antimicrobial catheter… a light transmitter configured and arranged to emit light through the tube, which may be ultraviolet C (UVC) irradiation, photodynamic therapy (PDT), violet-blue light therapy, and other light-based therapies. In one embodiment, violet-blue wavelengths (from 400-500 nm) of visible spectrum light that have both antimicrobial effects and are safe to expose to human tissue”), comprising of a tube (par. 0018, “a catheter that includes a thin, flexible tube having an optically transparent wall; and a light transmitter…”), wherein the tube is a thoracentesis needle (par. 0085, “the light-emitting antimicrobial catheter described herein may be used in any number of catheters, tubes… thoracentesis devices, thoracentesis systems”; the thoracentesis device/system inherently includes a thoracentesis needle). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known tube of Gaska, with the system of Eltorai, for disinfection during thoracentesis therapy as taught by Eltorai (Eltorai, par. 0085).
Claims 11, 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US20190167833), in view of Cumbie, further in view of Wang et al. (US8911670), hereafter Wang
Regarding Claim 11, Yang discloses a ventilator filter (Fig. 1, air purifier 1), comprising: an array of UV-C LEDs (Fig. 4, ultraviolet light emitting diode (LED) 221); and heat sink fins (Fig. 4, heat sink 222) and positioned directly adjacent to each UV-C LED to efficiently disperse heat (See Fig. 4, heat sink 222 are adjacent to LEDs 221, facing the direction of a filter media 4).
Yang is silent on the array of UV-C LEDs are directly mounted to the onto filter media of the ventilator filter, and the heat sink fins are integrally formed with the filter media
However, Wang teaches a filter (Abstract), comprising of an array of LEDs (Fig. 3A, LEDs 308), and a filter media (Fig. 3A, filter material 330). Wang further teaches that the UV light irradiance on the filter media can be increased by decreasing the distance between the LEDs and the filter media (col 7, line 17-31). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known ventilator filter of Yang, with the teaching of Wang, and have the array of UV-C LEDs are directly mounted to the onto filter media of the ventilator filter, to minimize the distance between the UV-C LEDs and the filter media to increase light irradiance for stronger disinfection effect as taught by Wang (col 7, line 17-31).
The modified Yang further discloses the heat sink fins are integrally formed with the filter media (Examiner Notes: Based on the prior art, the array of LEDs is directed adjacent to the filter media, Yang, Fig. 4 shows the heat sink fins being integrally formed with the LEDs 221, and the LEDs are facing the filter media 4; therefore, after the modification, the heat sink fins are integrally formed with the filter media)
The modified Yang is still silent on wherein the UV-C LEDs are configured to emit UV-C light as a series of high frequency pulses of between 1 and 100 femtoseconds to limit the heat generated by the UV-C LEDs.
However, Cumbie discloses a device to treat infections (Cumbie Abstract, claim 11), comprising: an array of UV-C LEDs, wherein the UV-C LEDs are configured to emit UV-C light as a series of high frequency pulses of between 1 and 100 femtoseconds to limit the heat generated by the UV-C LEDs (the UV-C LEDs are disclosed as capable of emitting pulsed UV-C light with programmable pulses of between 1 and 100 femtoseconds satisfying this limitation, see MPEP 2144.05(I); Cumbie par. 21-24, 51, 207, claim 11).
It would have been obvious (MPEP §2143(I)(A)) to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the known filter comprising an array of UV-C LEDs mounted to the filter and heat sink fins configured to disperse heat generated by the array of UV-C LEDs of Yang, with the addition of the known high frequency programmable pulses with a duration between 1 and 100 femtoseconds of Cumbie, to obtain the predictable result of: enhancing the cell penetration of the light emitted (Cumbie par. 0023); delivering more instantaneous energy with the emitted light (Cumbie par. 0024); enhancing the wavelength profile of the emitted light (Cumbie par. 0025); and significantly increasing the two-photon absorption of the light emitted (Cumbie par. 0032), all of which increase the germophobic capabilities of the light emitted with a shortened pulse duration.
Regarding claim 16, the modified Yang discloses the filter of claim 11, wherein the array of LEDs is configured to transmit 260 nm UV light at a given duty cycle (Cumbie, par. 0021-0023, 0053; the LEDs are disclosed as capable of being monochromatic, therefore emissive of a single wavelength including 260 nm, as well as having a programmed duty cycle of pulses and pauses between pulses).
Regarding claim 17, the modified Yang discloses the tube of claim 16, wherein the given duty cycle comprises one "ON" pulse followed by ten "OFF" pulses (Cumbie, 38, 44, 48, 50, 53-54, 73, 142, 151-152, 241, 245, 248; the pulses are disclosed as programmable including pulses of light, i.e. "ON" pulses, and pauses, i.e. "OFF" pulses, the light pulses and pauses being programmable for complex patterns, including capable of being programmed to emit one light pulse followed by a pause equivalent in length to ten light pulses).
Response to Arguments
Applicant's arguments filed 06/04/2025 have been fully considered. In the remarks, applicant argued the newly amended limitation, including the insert being conformal to the interior contour of the tube, the insert being removably insertable, and the heat sink fins being integrally formed with the filter media distinguishing the claimed invention from prior art disclosures. However, there is a lack of support and written description in the specification for the above amendments.
Specifically, arguments made in pg. 6 of Applicant’s Remark, regarding Claim 1 and 6, such as the insert being flexible, and removable are disclosed by Gaska (Gaska, par. 0027), and the heat sink fins being integrally formed with the LED is disclosed by Yang (Yang, Fig. 4). Therefore, the arguments regarding Claims 1 and 6 are not persuasive.
Applicant further argues that Claim 11 has been amended to have the LEDs directly mounted onto the filter media, which distinguish it from the prior art. This argument have been fully considered and is persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of Wang, teaching placing a LED directly on a filter media (col 7, line 17-31).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRIS HANYU GONG whose telephone number is (703)756-5898. The examiner can normally be reached M-F 8:30-4:30.
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/KRIS HANYU GONG/Examiner, Art Unit 3785
/VICTORIA MURPHY/Supervisory Patent Examiner, Art Unit 4100