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 .
Response to Arguments
Applicant's arguments filed 08/12/2025 have been fully considered but they are not persuasive.
Applicant first argues that Tang and May are inappropriate to combine as Tang’s device is used for UV-C sterilization within a body cavity and May is used for color mixing in a cavity. This is unpersuasive, as both device are combined LED/optical fiber light devices directed to controlling light intensity in a cavity (Tang Para. 0030, abstract of May). While the intended usage of the light is different, both devices have similar enough needs that one of ordinary skill would find it obvious to combine, and find the combination a simple substitution of one known way of controlling the intensity with another.
Applicant next argues that using an individual LED per fiber system would require different power, control, and thermal management, and that this would ‘fundamentally alter Tang’s operation’. However, Applicant does not describe why or how this would be the case, or what components would be fundamentally altered, so the argument is moot.
Applicant finally argues on Pg. 8 of Applicant’s remarks that the usage of the one LED per fiber system. However, these benefits are not inherent to the one LED per fiber system, but made possible through that system and further components (control systems, dosage designs, etc). These further components are not provided in the claim language, and therefore the arguments are unpersuasive.
For these reasons, previous Non-Final rejections are maintained. The Examiner has added new prior art rejections to newly added claims as necessary, as well as 112(a) rejections to Claims 10 and 12 and a 112(b) rejection to Claim 13.
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.
Claim 10 is 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. A mechanical control system using a handle and cable-actuated mechanism is not disclosed in Applicant’s Specification or Drawings. Using handles on a flexible circuit board is disclosed in Para. 0010-0011 of Applicant’s Specification, none are disclosed in usage with a nasopharynx device, nor are any handle systems disclosed in usage with a cable actuation system. One of ordinary skill would not be aware of the constructional aspects of the device or how the cable actuation would control the movement of the device. As there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art (see MPEP 2173.06).
Claim 12 is 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. Applicant’s Specification does not describe a tissue temperature sensor, nor any monitoring capabilities for temperature sensing. Temperature sensors are disclosed for the working space of vaccine creation (Para. 0089, Para. 0114), and Para. 0008 broadly discloses temperature detection in or out of an LED device, but none directed to either the placement of the sensor, or the usage of tissue temperature monitoring. One of ordinary skill would not be aware of what type of sensor was used, i.e. is it a contact sensor, non-contact, etc., or how the monitoring would occur.
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.
Claim 13 recites the limitation "the distal ends". There is insufficient antecedent basis for this limitation in the claim.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7-9, 11, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20150126976 awarded to Tang et al, hereinafter Tang, in view of U.S. Patent 8772691 awarded to May et al, hereinafter May.
Regarding Claims 7-8 and 14, Tang teaches a system comprising: at least three UV-C (Para. 0055) fiber optics (Fig. 13a, showing 3 optical fibers 1320, Para. 0039, “FIGS. 13A and 13B are block diagrams that illustrate cross-sectional views of example tubular members 200, according to embodiments. FIG. 3A is a block diagram that illustrates an axial cross-sectional view 1300 of an example tubular member 200, according to an embodiment, in which more than one optical fiber or bundle 1320 are embedded within the tubular body 225 of a tubular member 200”) a UV-C fiber optic combiner for combining said at least three UV-C fiber optics into a single fiber optic (fiber bundle, Para. 0041, “In some embodiments, the optical fiber 240 may have a diameter from about 50 microns to about 500 microns. In other embodiments, the diameter of the optical fiber 240 is about 50 microns to about 250 microns. In some cases the optical fiber may be in the form of a bundle of optical fibers wrapped together. In such embodiments, the one or more optical fibers 240 contained in the tubular member 200 may be in the form of one or more optical fiber bundles. The optical fibers within fiber bundles may be of different lengths and diameters and exhibit different leakage rates of UV light. Because the rate of light leakage may be controlled by using diffusive optical fibers, the combination of multiple optical fibers (e.g., fiber bundles) having different lengths and different rates of light leakage enables precise control of UV light illumination along the length of the tubular member 200”); and an instrument operable to carry said single fiber optic into, and through, a nasopharynx/cavity of a human body, wherein the position of the leading end of said instrument is able to be mechanically controlled as the leading end moves into, and through, said nasopharynx (Para. 0011, “The treatment method comprises inserting a distal end and a portion of a tubular member into a body cavity, duct or vessel of a subject, passing a liquid or a solid object through a lumen contained in the tubular member, and transmitting a UV light through the UV illumination coupler to illuminate at least a portion of the longitudinal interior space with sufficient dose of UV light to inactivate a therapeutically effective amount of infective agents”, Para. 0031, “It should be understood that the methods and apparatuses described herein may be used in a wide range of applications requiring the transmission and directionally-selective irradiation of UV light. These may include, for example, non-urinary processes and apparatuses such as peritoneal dialysis systems, gastrointestinal tubes (such as nasogastric tubes”). Tang does not teach wherein each of said at least three UV-C fiber optics receive light from a separate UV-C LED.
However, in the art of LED devices, May teaches wherein each LED is matched with an optical fiber (Col. 11, Lines 45-67, “The system 50 includes a control circuit 21 and power source 23, as in the earlier embodiments. In the system 50, the radiant energy sources comprises LEDs 59 of three different wavelengths, e.g. to provide Red, Green and Blue light respectively. The sources may also include one or more additional LEDs 61, either of a different color or for use as `sleepers,` similar to the example of FIGS. 3 and 4. In this example (FIG. 5), the cover plate 63 of the cavity 51 has openings into which are fitted the light emitting distal ends of optical fibers 65. The proximal light receiving ends of the fibers 65 are coupled to receive light emitted by the LEDs 59 (and 61 if provided). In this way, the LED sources 59, 61 may be separate from the chamber 51, for example, to allow easier and more effective dissipation of heat from the LEDs. The fibers 65 transport the light from the LED sources 59, 61 to the cavity 51. The cavity 51 integrates the different colors of light from the LEDs as in the earlier examples and supplies combined light out through the aperture 53. The deflector, in turn, directs the combined light to a desired field. Again, the intensity control by the circuit 21 adjusts the amount or intensity of the light of each wavelength provided by the LED sources and thus controls the spectral characteristic of the combined light output”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tang by May, i.e. by transmitting the individual LED light to the fiber bundle of Tang using optical fibers as in May, for the predictable purpose of simply substituting one known method of transmitting energy with another.
Regarding Claim 9, Tang modified by May makes obvious the system of Claim 7. Tang further teaches wherein each UV-C LED is configured to emit light at a wavelength between 250 nm and 290 nm (Para. 0055, “about 250 nm and about 280 nm”).
Regarding Claim 11, Tang modified by May makes obvious the system of Claim 7. Tang modified by May further teaches wherein the system further comprises a processor configured to independently control the intensity of each UV-C LED (Tang Para. 0052 and 0053 states that multiple UV sources, such as LEDs, can be used and the intensity of the LEDs controlled).
Regarding Claim 13, Tang modified by May makes obvious the system of Claim 8, wherein the UV-C fiber optic combiner is configured to align the distal ends of the at least three UV-C fiber optics within a common ferrule (Figs 7a/7b shows the fibers contained in a solitary bundle).
Regarding Claim 15, Tang modified by May makes obvious the system of Claim 8. Tang does not teach wherein the system further comprises heat sinks thermally coupled to each UV-C LED to dissipate heat away from the fiber coupling interface.
However, May teaches the usage of heat sinks to dissipate the heat from LEDs (Col. 9, Lines 31-36, “For example, the LED support ring 227 may be constructed of aluminum, to provide the necessary structural support and to act as a heat sink to wick away a substantial portion of the heat generated by the attached LEDs 209. Although not shown, ventilation or other cooling elements may also be provided”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tang by May, i.e. by using heat sinks on the LEDs to dissipate any heat produced, for the predictable purpose of combining known prior art elements to improve the similar devices in the same way.
Regarding Claim 16, Tang modified by May makes obvious the system of Claim 8. Tang further teaches wherein the mechanically controllable leading end is repositionable along at least two independent axes (Tang Para. 0031 teaches the various body cavity catheter systems that would require positioning along two axes, such as the gastrointestinal and intravenous catheters, “Also, many embodiments are described to include specific mechanical and electrical, as well as specific materials employed in these components”)
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20150126976 awarded to Tang et al, hereinafter Tang, in view of U.S. Patent 8772691 awarded to May et al, hereinafter May, further in view of U.S. Patent Publication 20210128938 awarded to Stasko, hereinafter Stasko.
Regarding Claim 12, Tang modified by May makes obvious the system of Claim 7. Tang does not teach a temperature sensor adjacent to the leading end to monitor tissue temperature during UV-C delivery.
However, in the art of intra-nasal treatments (Para. 0044), Stasko teaches the usage of a temperature sensor to monitor the LED treatment of tissue (Para. 0317, “Temperature during operation is monitored with the temperature sensor 524. If an excess temperature condition is detected, then the microcontroller 502 may take appropriate action to reduce current supplied by the LED driver circuit(s) 510 to the LED array(s) 520. Operation”) to prevent damage and discomfort (Para. 0279).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tang by Stasko, i.e. by using a temperature sensor to monitor tissue temperature, for the predictable purpose of increasing the safety of the device of Tang as in the device of Stasko.
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 Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Kish, can be reached at (571)-272-5554. The fax number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/JLM/
Examiner, Art Unit 3792
/JAMES M KISH/Supervisory Patent Examiner, Art Unit 3792