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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 8/6/24 has/have been acknowledged and is/are being considered by the Examiner.
Response to Arguments
Applicant's arguments with respect to claims 1-8 and 10-14, filed 7/2/26 have been fully considered but they are not persuasive. The Applicant argues that the claims are directed toward treatment of the gums and not the gingival sulcus. The Examiner respectfully disagrees. Wu clearly discloses that the treatment area can be the tooth and further the light is adjusted to allow for treatment of infection at various depths as clearly disclosed in cited paragraph 38.
Applicant’s arguments with respect to claim(s) 15-22 and 24-28 have been considered but are moot because the new ground of rejection based on the newly added claim limitations. Upon further consideration, a new ground(s) of rejection is made in view of Wu in view of Lindskog et al. (U.S. Pub. 2012/0116799).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 10-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu (U.S. Pub. 208/0178030).
Regarding claim 1, Wu discloses a system for treating periodontitis with photo dynamic therapy (e.g. Fig. 3, Abstract), comprising: at least one photosensitizer for application to one or more microbial infected areas within a mouth of a patient, wherein the at least one photosensitizer is configured to generate a radical oxygen species upon application of a light (e.g. ¶81); an intra-oral appliance for positioning with the mouth of the patient (e.g. 30), the intra-oral appliance comprising: a housing configured to fit within the mouth (e.g. see Figs. 4-6), at least one light emitter at least partially encased within the housing (e.g. LDF), the at least one light emitter configured to emit an effective amount of a light to the one or more microbial infected areas within the mouth (e.g. ¶37), wherein the at least one light emitter is configured to irradiate a microbial biofilm or plaque within or adjacent to a gingival sulcus within the mouth (e.g. ¶38; irradiate the teeth) based upon a location and depth of the one or microbial infected areas of localized periodontitis within or adjacent to the gingival sulcus (e.g. ¶¶21, 25, 38; irradiate the teeth based on infection with parameters for the depth of tissue), and a controller (e.g. 10) operatively coupled to the at least one emitter, the controller configured to control the at least one emitter when the housing is disposed within the mouth over a treatment period (e.g. ¶58).
Regarding claim 2, Wu further discloses wherein the at least one photosensitizer comprises synthetic photoactive compounds, natural photoactive compounds, tetra-pyrrole structures, or modified photoactive compounds (e.g. ¶81; “indocyanine green”).
Regarding claim 3, Wu further discloses wherein the sythentic photoactive compounds comprise methylene blue, toluidine blue, or indocyanine green, or combinations thereof (e.g. ¶81; “indocyanine green”).
Regarding claim 10, Wu further discloses wherein the at least one light emitter is configured to irradiate oral tissue or alveolar soft tissue within the mouth (e.g. ¶38).
Regarding claim 11, Wu further discloses wherein the at least one light emitter is configured to emit the light sufficient to generate the radical oxygen species at a wavelength ranging from about 360 nm to 820 nm (e.g. ¶38).
Regarding claim 12, Wu further discloses wherein the treatment period ranges from 1 minute to 24 hours (e.g. ¶39).
Regarding claim 13, Wu further discloses wherein the predetermined treatment period ranges from 30 seconds to 8 hours (e.g. ¶39).
Regarding claim 14, Wu further discloses wherein the controller is configured to apply the light continuously or repetitively (e.g. ¶38; [repetitively 1 to 1000 times]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 15-17 and 24-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu (U.S. Pub. 208/0178030) in view of Lindskog et al. (U.S. Pub. 2012/0116799 hereinafter “Lindskog”).
Regarding claim 15, Wu discloses a system for treating periodontitis with photo dynamic therapy (e.g. Fig. 3, Abstract), comprising: at least one photosensitizer for application to one or more microbial infected areas within a mouth of a patient, wherein the at least one photosensitizer is configured to generate a radical oxygen species upon application of a light (e.g. ¶81); an intra-oral appliance for positioning with the mouth of the patient (e.g. 30), the intra-oral appliance comprising: a housing configured to fit within the mouth (e.g. see Figs. 4-6), at least one light emitter at least partially encased within the housing (e.g. LDF), the at least one light emitter configured to emit an effective amount of a light to the one or more microbial infected areas within the mouth (e.g. ¶37), wherein the at least one light emitter is configured to irradiate a microbial biofilm or plaque within or adjacent to a gingival sulcus within the mouth (e.g. ¶38; irradiate the teeth) based upon a location and depth of the one or microbial infected areas of localized periodontitis within or adjacent to the gingival sulcus (e.g. ¶¶21, 25, 38; irradiate the teeth based on infection with parameters for the depth of tissue), and a controller (e.g. 10) operatively coupled to the at least one emitter, the controller configured to control the at least one emitter when the housing is disposed within the mouth over a treatment period (e.g. ¶58). Wu discloses treatment for periodontitis with light values for various depths, but fails to explicitly state that the system determines the location and depths for treatment. However, Lindskog teaches that it is well known in the art to determine location and depth of periodontitis pockets as taught in Paragraphs 4, 99, 125 and 132 so that they can be identified for treatment. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Wu, with the determination of infection as taught by Lindskog, since such a modification would provide the predictable results of determining the location of infection using the known methods as taught by Lindskog before applying the treatment of Wu.
Regarding claim 16, meeting the limitations of claim 15 above, Wu further discloses wherein the at least one photosensitizer comprises synthetic photoactive compounds, natural photoactive compounds, tetra-pyrrole structures, or modified photoactive compounds (e.g. ¶81; “indocyanine green”).
Regarding claim 17, meeting the limitations of claim 15 above, Wu further discloses wherein the sythentic photoactive compounds comprise methylene blue, toluidine blue, or indocyanine green, or combinations thereof (e.g. ¶81; “indocyanine green”).
Regarding claim 24, meeting the limitations of claim 15 above, Wu further discloses wherein the at least one light emitter is configured to irradiate oral tissue or alveolar soft tissue within the mouth (e.g. ¶38).
Regarding claim 25, meeting the limitations of claim 15 above, Wu further discloses wherein the at least one light emitter is configured to emit the light sufficient to generate the radical oxygen species at a wavelength ranging from about 360 nm to 820 nm (e.g. ¶38).
Regarding claim 26, meeting the limitations of claim 15 above, Wu further discloses wherein the treatment period ranges from 1 minute to 24 hours (e.g. ¶39).
Regarding claim 27, meeting the limitations of claim 15 above, Wu further discloses wherein the predetermined treatment period ranges from 30 seconds to 8 hours (e.g. ¶39).
Regarding claim 28, meeting the limitations of claim 15 above, Wu further discloses wherein the controller is configured to apply the light continuously or repetitively (e.g. ¶38; [repetitively 1 to 1000 times]).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu as applied to claims 1-3 and 10-14 above, and further in view of Pinyayev et al. (U.S. Pub. 2008/0060148 hereinafter “Pinyayev”).
Regarding claims 4-5, Wu discloses the claimed invention including the use of photosensitizers but fails to explicitly disclose all of the types of known photosensitizers. However, Pinyayev teaches that it is known to use natural, synthetic and modified photoactive compounds as set forth in Paragraphs 137 and 156 to provide known methods to activate oxygen species can be singlet oxygen, superoxide, hydroxyl radical, hydroperoxyl radical, endoperoxide or a mixture of the above to remove stains and treat disease. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Wu, with the known types of photosensitizers that include natural, synthetic and modified compounds as taught by Pinyayev, since such a modification would provide the predictable results of substituting other well-known compounds to achieve the same results as those taught by the Wu reference.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Lindskog as applied to claims 15-17 and 24-28 above, and further in view of Pinyayev et al. (U.S. Pub. 2008/0060148 hereinafter “Pinyayev”).
Regarding claims 18-19, Wu in view of Lindskog discloses the claimed invention including the use of photosensitizers but fails to explicitly disclose all of the types of known photosensitizers. However, Pinyayev teaches that it is known to use natural, synthetic and modified photoactive compounds as set forth in Paragraphs 137 and 156 to provide known methods to activate oxygen species can be singlet oxygen, superoxide, hydroxyl radical, hydroperoxyl radical, endoperoxide or a mixture of the above to remove stains and treat disease. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Wu in view of Lindskog, with the known types of photosensitizers that include natural, synthetic and modified compounds as taught by Pinyayev, since such a modification would provide the predictable results of substituting other well-known compounds to achieve the same results as those taught by the Wu reference.
Claims 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu as applied to claims 1-3 and 10-14 above, and further in view of Appeaning et al. (U.S. Pub. 2012/0100039 hereinafter “Appeaning”).
Regarding claims 6-8, Wu discloses the claimed invention including the use of photosensitizers but fails to explicitly disclose all of the types of known mechanisms for transferring oxygen. However, Appeaning teaches that it is well-known to use type 1 and type 2 mechanisms with photosensitizers as set forth in Paragraphs 13-14 to provide known methods to activate oxygen molecules in the known photosensitizers to effectively transfer electrons to enhance the cleaning and sanitizing effects of the photosensitizers. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Wu, with the known types of mechanisms as taught by Appeaning, since such a modification would provide the predictable results of using well-known mechanisms to activate oxygen molecules in the known photosensitizers to effectively transfer electrons to enhance the cleaning and sanitizing effects of the photosensitizers.
Claims 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Lindskog as applied to claims 15-17 and 24-28 above, and further in view of Appeaning et al. (U.S. Pub. 2012/0100039 hereinafter “Appeaning”).
Regarding claims 20-22, Wu in view of Lindskog discloses the claimed invention including the use of photosensitizers but fails to explicitly disclose all of the types of known mechanisms for transferring oxygen. However, Appeaning teaches that it is well-known to use type 1 and type 2 mechanisms with photosensitizers as set forth in Paragraphs 13-14 to provide known methods to activate oxygen molecules in the known photosensitizers to effectively transfer electrons to enhance the cleaning and sanitizing effects of the photosensitizers. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Wu in view of Lindskog, with the known types of mechanisms as taught by Appeaning, since such a modification would provide the predictable results of using well-known mechanisms to activate oxygen molecules in the known photosensitizers to effectively transfer electrons to enhance the cleaning and sanitizing effects of the photosensitizers.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dolgopolsky et al. (U.S. 2024/0277757) – discloses determining location and depth of infection before treatment (e.g. Paragraphs 162, 164, 166).
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 REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REX R HOLMES/ Primary Examiner, Art Unit 3796
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