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 Amendments
This Office Action is responsive to the amendment filed 03 November 2025. As per the amendment: Claims 1-12 and 21-23 remain withdrawn, claims 24-25 remain cancelled, and no claims have been amended, cancelled, or added. Thus, claims 13-20 are presently pending and under examination.
Response to Arguments
Applicant's arguments filed 03 November 2025 have been fully considered but they are not persuasive. Applicant argues that Cumbie cannot properly be combined with Yang or Tanaka to arrive at the independent claim 12, as Cumbie teaches away from generating heat while using germicidal light to inactivate and/or kill the organisms or cells that cause infections and other disorders. Applicant, specifically cites paragraph [0155] of Cumbie which states “it may be desirable to filter out infrared and other wavelengths to decrease the heat generated during treatment. Thus, light can be precisely tuned to maximum effectiveness while minimizing undesirable side effects from unwanted wavelengths of light” (emphasis added).
Thus, in response to applicant’s argument, the examiner recognizes that "the nature of the teaching is highly relevant and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) and that "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) ("a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.") (internal quotations omitted) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)); and Schwendimann v. Neenah, Inc., 82 F.4th 1371, 1381, 2023 USPQ2d 1173 (Fed. Cir. 2023) (See MPEP 2145(X)(D)1. and MPEP 2143.01(I)). In this case, although Cumbie discloses that it is desirable to filter out infrared and other wavelengths to decrease the heat generated during treatment, Cumbie also discloses “a pulse xenon lamp (XPL) capable of providing pulsed full spectrum light from approximately 180 nm to more than 1600 nm…It appears, therefore, that UVC applied to nails with a low pressure mercury lamp is able to inactivate organisms that cause nail infections and clear the infection. It also appears that pulsed, broad spectrum germicidal light is even more efficacious in curing nail infections…Thus, while treatment with UVC alone successfully treated nail infections, treatment with broad spectrum light pulsed germicidal light had the unexpected result of being more efficacious at much lower doses.” ([0065]-[0084]) along with other advantages of using a wide spectrum of light that includes infrared wavelengths of light ([0122]-[0123])
Additionally, Cumbie inherently discloses “wherein the IR second electromagnetic radiation increases a temperature of the infectious cells or organisms on or within the living species.”, as a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Thus, since Cumbie teaches the anti-infective radiation device that is able to generate the recited intensities of light and direct that light towards the lighting species, Cumbie’s device would also be able to result in an increase in temperature of the infectious cells or organisms on or within the living species. Therefore, claims 13-14, 16, and 18-20 remain as rejected under 35 USC 103 as shown in detail below.
No specific arguments were presented for previous 35 U.S.C. 103 rejection of dependent claims 15 and 17, nor specifically with respect to the previously cited reference: Estes.
Therefore, claims 15 and 17 remain rejected as described in detail below.
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) 13-14, 16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cumbie et al. (US 2011/0178510 A1, previously cited), hereinafter Cumbie in view of Yang, Yuchong, et al. "Supramolecular radical anions triggered by bacteria in situ for selective photothermal therapy." Angewandte Chemie 129.51 (2017): 16457-16460., hereinafter Yang (previously cited), or alternatively Tanaka et al. (US Patent 8,347,881 B2, previously cited), hereinafter Tanaka.
Regarding claim 13, Cumbie discloses an anti-infective radiation device (Abstract: “apparatus to prevent and treat infection and disorders using germicidal light to inactivate and/or kill organisms or cells that cause infections and other disorders”) comprising:
at least one lighting device (Figure 1: device 100, combination of lamps and sources 110, 112) configured to provide a first output energy of at least one antimicrobial first electromagnetic radiation wavelength(s) within a range of 100nm - 450nm ([0067] “Fifteen subjects received treatment using Prototype B. Each treatment irradiated the target nail with 3.87 mw/cm.sup.2 of UVC from 240 to 280 nm for 8 minutes for 4 sessions each spaced one week apart.”, [0067]-[0072] “In addition to the UVC wavelengths of interest, the lamp also provided the following dosages of light during each treatment lasting 8 minutes: Far UV from 180 nm to 240 nm, UVC from 240 nm to 280nm, 280 nm to 320 nm, UVA from 320 nm to 400 nm, Visible light from 400 nm to 750 nm”) and a second output energy of at least one IR second electromagnetic radiation wavelength(s) within a range of 700 nm - 1200 nm ([0067], [0072]-[0074] “In addition to the UVC wavelengths of interest, the lamp also provided the following dosages of light during each treatment lasting 8 minutes: visible light from 400 nm to 750 nm, infrared from 750 nm to 880 nm, infrared above 880 nm”),
wherein the at least one lighting device is configured to be directed towards an exterior of a living species and/or integrated and/or placed within an interior of a living species (Figure 1: diagrammatic view of a light according to an embodiment of the present invention for use in treating skin or nail, Figure 2: diagrammatic view of a light according to an embodiment of the present invention for use in treating an internal orifice, wherein the at least one lighting device is configured to project at least one of the first or second electromagnetic radiation wavelength(s) directly onto and/or through one or more layers of living species tissue so that the electromagnetic radiation wavelength(s) reach near or directly onto unwanted infectious living cells or organisms on or within the living species ([0047] “FIG. 1, includes irradiating a target tissue 104, such as a skin or nail, with light 106. The procedure uses specific types and levels of light having a germicidal electromagnetic radiation component to take advantage of the previously unrecognized ability of radiation to penetrate tissues and other matter sufficiently to inactivate organisms and undesirable cells without unduly harming the host (e.g., human or animal patient).”, [0051] “The treatment device may also contain very small lamps 114 (FIG. 2) capable of being inserted in small spaces 116 or directly on the surface to be treated.”) ,
wherein the antimicrobial first electromagnetic radiation damages or kills unwanted infectious cells or organisms on or within the living species ([0030]-[0032] describes that the UV wavelengths have germicidal properties and leads to inactivation of organisms, [0024] “UVC light has the ability to inactivate organisms by damaging the organism's genetic material, which in turn prevents it from reproducing.”).
Although Cumbie does not explicitly teach these ranges, it would be obvious to one of ordinary skill in the art to use values within these ranges because Cumbie’s ranges are shown to effective and they overlap heavily with applicant’s ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233.
Cumbie fails to disclose wherein the IR second electromagnetic radiation increases a temperature of the infectious cells or organisms on or within the living species.
However, Yang teaches wherein the IR second electromagnetic radiation increase a temperature of the infectious cells or organisms on or within the living species (pg. 1, Column 1: “locally increasing temperature (> 50 ֯ C) by photothermal agents can lead to the death of the microbes by denaturation of their proteins”, pg. 2, Column 2, “Under NIR irradiation (808 nm), the temperature of the CPPDI aqueous solution increased greatly in the presence of E. Coli (Figure 2a). It could be risen up to 65 ֯ C in 30 minutes”)
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cumbie to incorporate the teachings of Yang to have the IR second electromagnetic radiation increase a temperature of the infectious cells or organisms on or within the living species, as these prior art references are directed to using radiation to regulate infectious organisms. One would be motivated to do this as heat as increasing the temperature can lead to death of the microbes by denaturation of their proteins, as recognized by Yang (pg. 1, Column 1).
Alternatively, Tanaka teaches pneumostoma device where when in contact with a target tissue of the pneumostoma the IR second electromagnetic radiation increase a temperature of the infectious cells or organisms on or within the living species (Column 27, lines 8-28: “the surface of the pneumostoma treatment device is then heated to raise the temperature of the target tissue (e.g. by electrical heating, laser heating, or by circulating a heated medium). Other methods of thermotherapy include application of focused ultrasound, infrared light, radio or microwave-frequency radiation to the target tissue to induce the desired temperature rise in the target tissue. For example, thermotherapy treatment device may direct energy at the tissue to heat the target tissue…the temperature and duration of the heat treatment are selected to affect physical characteristics of tissues, reduce cell proliferation and/or treat infection but not to kill tissues of the pneumostome”).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cumbie to incorporate the teachings of Tanaka to have the IR second electromagnetic radiation increase a temperature of the infectious cells or organisms on or within the living species, as these prior art references are directed to devices that can be placed internally and provide disinfection using radiation. One would be motivated to do this as heating the tissue can reduce cell proliferation and/or treat infection, as recognized by Tanaka (Column 27, lines 26-27).
Regarding claim 14, Cumbie in view of Yang (alternatively Tanaka) teaches the anti-infective radiation device of Claim 13 (as shown above). Cumbie further teaches wherein the at least one lighting device is integrated into a medical device ([0208] “Germicidal light could also be introduced using a light guide to the throat to treat yeast infections, which often occur when food and breathing tubes are inserted. Specially designed breathing and food tubes could transmit the light (and are claimed as part of this invention) or the light could be introduced using a separate instrument”).
Regarding claim 16, Cumbie in view of Yang (alternatively Tanaka) teaches the anti-infective radiation device of Claim 13 (as shown above). Cumbie doesn’t explicitly teach the device further comprising at least one LED, however, Cumbie does disclose “One possible source of light that becomes much more attractive because of this discovery is the use of UV emitting LEDs” ([0087]).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have replace Cumbie’s lamp with LEDs, because they have shown to have a great potential in treating infections, as recognized by Cumbie ([0087]).
Regarding claim 18, Cumbie in view of Yang (alternatively Tanaka) teaches the anti-infective radiation device of Claim 13 (as shown above). Cumbie further discloses wherein the output energy of at least one of the antimicrobial first electromagnetic radiation wavelength(s) or the IR second electromagnetic radiation wavelength(s) is configured to be focused or concentrated on a specific infected area of the living species ([0051] “Light can also be concentrated and transmitted via a light guide 118 this permitting high doses to be precisely applied to the area to be treated”).
Regarding claim 19, Cumbie in view of Yang (alternatively Tanaka) teaches the anti-infective radiation device of Claim 13 (as shown above). Cumbie further discloses wherein the output energy of at least one of the first antimicrobial electromagnetic radiation wavelength(s) or the IR second electromagnetic radiation wavelength(s) is configured to be pulsed ([0052] “For example, the light can be pulsed to achieve an improvement in efficacy of three order of magnitude or more”, [0059] “One way to substantially increase the penetrating power of UVC and other forms of germicidal radiation is to administer the light in the form of very short, high intensity pulses”).
Regarding claim 20, Cumbie in view of Yang (alternatively Tanaka) teaches the anti-infective radiation device of Claim 13 (as shown above). Cumbie further teaches wherein the output energy of at least one of the antimicrobial first electromagnetic radiation wavelength(s) or the IR second electromagnetic radiation wavelength(s) is configured to be used with a drug therapy ([0180] “The longer waves of UVA penetrate the skin more deeply than UVB and require a photosensitizing agent to be effective in treating psoriasis, psoralen, a drug taken orally, but can be applied topically or by immersion. The combined photosensitizer and UVA energy inhibit DNA synthesis in skin cells and suppress the skin cell proliferation of psoriasis”).
Claim(s) 15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cumbie in view of Yang as applied to claim 13 above, and further in view of Estes et al. (US Patent 11,357,998 B2, previously cited), hereinafter Estes.
Regarding claim 15, Cumbie in view of Yang (alternatively Tanaka) teaches the anti-infective radiation device of Claim 13 (as shown above). Cumbie and Yang, alone or in combination, fail to teach wherein the at least one lighting device is integrated into a wearable medical device.
However, Estes teaches a wearable ultraviolet light phototherapy device that can act as a hand-held disinfection device (Abstract, Column 2, line 57-59), wherein the at least one lighting device is integrated into a wearable medical device (Column 2, line 38-59: “The wearable ultraviolet light phototherapy devices can take the form of any of a number of wearable articles that can be worn, held, placed, arranged, disposed, attached, etc., on a body part of a patient that has a need for phototherapy such as a human being or even an animal.”, Figure 1: wearable ultraviolet light phototherapy device 10, ultraviolet light emitting source 20)
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cumbie and Yang to incorporate the teachings of Estes to have the at least one lighting device integrated into a wearable medical device, as these prior art references are directed to applying radiation for disinfection. One would be motivated to do this to deliver radiation to a specific part of the body (Column 2, lines 38-59) and allows for hands-free easy use.
Regarding claim 17, Cumbie in view of Yang (alternatively Tanaka) teaches the anti-infective radiation device of Claim 13 (as shown above). Cumbie and Yang, alone or in combination, fail to teach wherein the output energy of at least one of the antimicrobial first electromagnetic radiation wavelength(s) or the IR second electromagnetic radiation wavelength(s) is configured to be set by a user or operator of the anti-infective radiation device.
However, Estes teaches wherein the output energy of at least one of the antimicrobial first electromagnetic radiation wavelength(s) or the IR second electromagnetic radiation wavelength(s) is configured to be set by a user or operator of the anti-infective radiation device (Column 4, lines 1-10: “the wearable ultraviolet light phototherapy devices of the various embodiments can further include a control module coupled to the ultraviolet light emitting source(s) to control the operation thereof. For example, the control module can direct the ultraviolet light emitting source(s) to deliver a predetermined amount of ultraviolet radiation into the body part of a patient at a peak wavelength in the aforementioned UV-B range. The control module can determine the predetermined amount of ultraviolet radiation as a function of the patient's susceptibility to ultraviolet radiation.”, Column 4, lines 17-26: “An input component can be coupled to the control module that permits entry of information relating to any of the aforementioned factors. For example, users of the wearable ultraviolet light phototherapy devices of the various embodiments can enter information that pertains to the general patient parameters. In addition, the input component can be used in other capacities. For example, a user can utilize the input component to manually adjust the predetermined amount of ultraviolet radiation delivered by the ultraviolet light emitting source to another amount.”)
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cumbie and Yang to incorporate the teachings of Estes to have the output energy of at least one of the antimicrobial first electromagnetic radiation wavelength(s) or the IR second electromagnetic radiation wavelength(s) is configured to be set by a user or operator of the anti-infective radiation device, as these prior art references are directed to applying radiation for disinfection. One would be motivated to do this in order to deliver specific amount and pattern of radiation as necessary and to be deliver radiation based on patient’s susceptibility, as recognized by Estes (Column 4, lines 1-47).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Fewkes et al. (US Patent 11,213,695 B2) teaches an illuminated bandage and method of disinfecting a wound (Abstract) wherein infrared (IR) light can be used as an additional heat source for accelerating the photochemical processes (Column 2, lines 42-58).
THIS ACTION IS MADE FINAL. 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 ATTIYA SAYYADA HUSSAINI whose telephone number is (703)756-5921. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on 5712724156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792