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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim(s) 1-10, 15-18 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 2, 10, 12, 17, 18 of U.S. Patent No. 12161719. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application claim(s) is/are broader than the corresponding claim(s) in the reference patent and thus the corresponding claim(s) is/are a species of the more generic instant claim(s). It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Furthermore, they are not patentably distinct from each other because the instant application claim(s) overlap in scope with and are anticipated and/or obvious over the reference claim(s).
Regarding claim 1, U.S. Patent No. 12161719 teaches a method of treating a biological surface (claim 10 “target tissue comprises soft tissues, biofilms, saliva, skin, plaque and teeth surfaces”), the method comprising:
simultaneously directing a first light and a second light against the biological surface, the first light comprising photons with a majority energy in the range from 2.8 eV to 3.5 eV (claim 17 “first light with photons having a majority energy in the range from 3.5 eV to 2.8 eV”) and the second light comprising photons with a majority energy in the range from 1.24 eV to 2.48 eV (claim 17 “second light with photons having a majority energy in the range from 1.24 eV to 2.48 eV”).
Claim 15 is rejected under substantially the same basis as claim 1 above.
Regarding claim 2, U.S. Patent No. 12161719 teaches wherein the first light and the second light are effective to prevent or reduce microbial, viral, or fungal contamination of the biological surface (claim 1 “antimicrobial”).
Regarding claim 3, U.S. Patent No. 12161719 teaches wherein the first light and the second light are effective to prevent or reduce viral or fungal contamination of the biological surface (claim 2).
Regarding claim 4, U.S. Patent No. 12161719 teaches wherein the biological surface is selected from the group consisting of a tissue, saliva, skin, a biofilm, plaque, teeth surfaces, the mouth, and a mucous membrane of, on, or within a mammal (claim 10).
Regarding claim 5, U.S. Patent No. 12161719 teaches wherein the biological surface comprises a biofilm (claim 12).
Regarding claim 6, U.S. Patent No. 12161719 teaches wherein the biological surface is disposed on an inanimate object (claim 10; teeth surface is inanimate because teeth is inanimate).
Regarding claim 7, U.S. Patent No. 12161719 teaches wherein the energy intensity ratio between the first light and the second light is in the range of 5:1 to 0.2:1 (claim 1 “range of 3:1 to 1:3.”).
Claim 17 is rejected under substantially the same basis as claim 7 above.
Regarding claim 8, U.S. Patent No. 12161719 teaches wherein the energy intensity ratio between the first light and the second light is in the range of 3:1 to 1:3 (claim 1 “range of 3:1 to 1:3.”).
Claim 18 is rejected under substantially the same basis as claim 8 above.
Regarding claim 9, U.S. Patent No. 12161719 teaches further comprising providing at least one photosensitizer to the biological surface to treat the biological surface using photodynamic therapy with the first light, second light, and the at least one photosensitizer (claim 1 “photosensitive antibiotic”).
Regarding claim 10, U.S. Patent No. 12161719 teaches wherein the at least one photosensitizer is applied to the biological surface and thereafter the first light and the second light are simultaneously directed against the biological surface (claim 1; clam 18 “simultaneously”).
Regarding claim 16, U.S. Patent No. 12161719 teaches further comprising at least one photosensitizer which can be activated by the photons of the first light and/or the second light (claim 1 “photosensitive antibiotic”).
Claim(s) 1-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 4-5, 13, 18, 24, 29, 30, 31 of U.S. Patent No. 12263349. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application claim(s) is/are broader than the corresponding claim(s) in the reference patent and thus the corresponding claim(s) is/are a species of the more generic instant claim(s). It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Furthermore, they are not patentably distinct from each other because the instant application claim(s) overlap in scope with and are anticipated and/or obvious over the reference claim(s).
Regarding claim 1, U.S. Patent No. 12263349 teaches a method of treating a biological surface (claim 1), the method comprising:
simultaneously directing a first light and a second light against the biological surface, the first light comprising photons with a majority energy in the range from 2.8 eV to 3.5 eV and the second light comprising photons with a majority energy in the range from 1.24 eV to 2.48 eV (claim 1 “a first light with photons having a majority energy in the range from 3.17 eV to 2.95 eV and a second light with photons having a majority energy in the range from 1.56 eV to 1.45 eV”; claim 17 “the chips exhibiting emission energy in the range of 2.48 eV and 1.24 eV and in the range of 3.5 eV and 2.8 eV,”; MPEP 2131.03: A specific example in the prior art which is within a claimed range anticipates the range; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.).
Claim 15 is rejected under substantially the same basis as claim 1 above.
Regarding claim 2, U.S. Patent No. 12263349 teaches wherein the first light and the second light are effective to prevent or reduce microbial, viral, or fungal contamination of the biological surface (claims 4-5).
Regarding claim 3, U.S. Patent No. 12263349 teaches wherein the first light and the second light are effective to prevent or reduce viral or fungal contamination of the biological surface (claims 4-5).
Regarding claim 4, U.S. Patent No. 12263349 teaches wherein the biological surface is selected from the group consisting of a tissue, saliva, skin, a biofilm, plaque, teeth surfaces, the mouth, and a mucous membrane of, on, or within a mammal (claim 13).
Regarding claim 5, U.S. Patent No. 12263349 teaches wherein the biological surface comprises a biofilm (claim 13).
Regarding claim 6, U.S. Patent No. 12263349 teaches wherein the biological surface is disposed on an inanimate object (claim 13; teeth surface is inanimate because teeth is inanimate).
Regarding claim 7, U.S. Patent No. 12263349 teaches wherein the energy intensity ratio between the first light and the second light is in the range of 5:1 to 0.2:1 (claim 29 “range of 5:1 to 0.2:1.”).
Claim 17 is rejected under substantially the same basis as claim 7 above.
Regarding claim 8, U.S. Patent No. 12263349 teaches wherein the energy intensity ratio between the first light and the second light is in the range of 3:1 to 1:3 (claim 30 “range of 3:1 to 1:3.”).
Claim 18 is rejected under substantially the same basis as claim 8 above.
Regarding claim 9, U.S. Patent No. 12263349 teaches further comprising providing at least one photosensitizer to the biological surface to treat the biological surface using photodynamic therapy with the first light, second light, and the at least one photosensitizer (claim 1 “chlorhexidine”; claim 31).
Regarding claim 10, U.S. Patent No. 12263349 teaches wherein the at least one photosensitizer is applied to the biological surface and thereafter the first light and the second light are simultaneously directed against the biological surface (claim 1 “simultaneously directed”).
Regarding claim 11, U.S. Patent No. 12263349 teaches wherein at least 50% of the photons of the first light have energy corresponding to a wavelength of 390 nm to 420 nm and at least 50% of the photons of the second light have energy corresponding to a wavelength of 795 nm to 855 nm (claim 1 “a first light with photons having a majority energy in the range from 3.17 eV to 2.95 eV and a second light with photons having a majority energy in the range from 1.56 eV to 1.45 eV”; the eV ranges correspond to the recited nm wavelength ranges; claim 18 “400 to 430 nm… 780 to 830 nm”; MPEP 2131.03: A specific example in the prior art which is within a claimed range anticipates the range; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.).
Regarding claim 12, U.S. Patent No. 12263349 teaches wherein at least 50% of the photons of the first light have a majority energy from 2.95 to 3.17 eV and at least 50% of the photons of the second light have a majority energy from 1.45 eV to 1.56 eV (claim 1 “a first light with photons having a majority energy in the range from 3.17 eV to 2.95 eV and a second light with photons having a majority energy in the range from 1.56 eV to 1.45 eV,”).
Claim 19 is rejected under substantially the same basis as claim 12 above.
Regarding claim 13, U.S. Patent No. 12263349 teaches wherein the first light and the second light are each delivered to the biological surface at a dosage of from 1 to 120 J/cm2, at a power density of from 10 to 2500 mW/cm2, for a duration of 0.5 seconds to 120 minutes (claim 18).
Regarding claim 14, U.S. Patent No. 12263349 teaches wherein the first light and the second light are delivered from an optoelectionic device (claim 14; claim 17), and wherein the optoelectronic device is in the form of a mouthpiece adapted to be inserted in a mouth of a human between teeth biting surfaces (claim 24 “optoelectronic device…the shape of a mouth piece which can be inserted in a mouth of user between biting surfaces of the teeth”).
Claim 20 is rejected under substantially the same basis as claim 14 above.
Regarding claim 16, U.S. Patent No. 12263349 teaches further comprising at least one photosensitizer which can be activated by the photons of the first light and/or the second light (claim 1 “chlorhexidine”; claim 31).
Claim Rejections - 35 USC § 102
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 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) 1-6, 9-10, 13-16, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Altshuler (US 20040193235 A1; 9/30/2004).
Regarding claim 1, Altshuler teaches a method of treating a biological surface, the method comprising:
simultaneously directing a first light and a second light against the biological surface, the first light comprising photons with a majority energy in the range from 2.8 eV to 3.5 eV and the second light comprising photons with a majority energy in the range from 1.24 eV to 2.48 eV (Fig. 4; Fig. 33-34; [0086][0087]; [0117]; [0126]; [0146]; note that the recited 3.5 eV to 2.8 eV is equivalent to ~354-443 nm wavelength and the recited 1.24 eV to 2.48 eV is equivalent to ~500-1000 nm which is met by the reference.
Claim 15 is rejected under substantially the same basis as claim 1 above.
Regarding claim 2, Altshuler teaches wherein the first light and the second light are effective to prevent or reduce microbial ([0014]; [0126]; [0128]), viral ([0014]), or fungal ([0014]) contamination of the biological surface (Fig. 4; Fig. 33-34; [0014]; [0126]; [0128]).
Regarding claim 3, Altshuler teaches wherein the first light and the second light are effective to prevent or reduce viral or fungal contamination of the biological surface (Fig. 4; Fig. 33-34; [0014]; [0126]; [0128]).
Regarding claim 4, Altshuler teaches wherein the biological surface is selected from the group consisting of a tissue ([0069]; [0146] "tissue"), saliva ([0017]), skin ([0069] "cheeks or facial tissue"), a biofilm, plaque ([0004]-[0005]), teeth surfaces ([0104]; [0122]; [0126]; [0158]), the mouth (Fig. 4), and a mucous membrane ([0069] "gums"; [0146] "oral mucus") of, on, or within a mammal (Fig. 4).
Regarding claim 5, Altshuler teaches wherein the biological surface comprises a biofilm ([0004] “colorless film of bacteria”; [0005]).
Regarding claim 6, Altshuler teaches wherein the biological surface is disposed on an inanimate object (Fig. 4; [0104]; [0122]; [0126]; [0158]; teeth surface is inanimate because teeth is inanimate).
Regarding claim 9, Altshuler teaches further comprising providing at least one photosensitizer to the biological surface to treat the biological surface using photodynamic therapy with the first light, second light, and the at least one photosensitizer ([0105]-[0106]; [0117]; [0126]).
Regarding claim 10, Altshuler teaches wherein the at least one photosensitizer is applied to the biological surface and thereafter the first light and the second light are simultaneously directed against the biological surface ([0086]-[0087]; [0104]-[0106]; [0126]).
Regarding claim 13, Altshuler teaches wherein the first light and the second light are each delivered to the biological surface at a dosage of from 1 to 120 J/cm2 ([0122] "0.06-30 J/cm2), at a power density of from 10 to 2500 mW/cm2 ([0120] "1-1000 mW /cm2"), for a duration of 0.5 seconds to 120 minutes (the dosage and power density are inherently related to one another via the exposure time; [0166] "duration of one second to one hour").
Regarding claim 14, Altshuler teaches wherein the first light and the second light are delivered from an optoelectionic device, and wherein the optoelectronic device is in the form of a mouthpiece adapted to be inserted in a mouth of a human between teeth biting surfaces (Fig. 3; Fig. 4; Fig. 33-34; [0066]-[0067]).
Claim 20 is rejected under substantially the same basis as claim 14 above.
Regarding claim 16, Altshuler teaches further comprising at least one photosensitizer which can be activated by the photons of the first light and/or the second light ([0105]-[0106]; [0117]; [0126]).
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) 11-12, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Altshuler as applied to claim 1 above.
Regarding claim 11, Altshuler does not explicitly teach wherein at least 50% of the photons of the first light have energy corresponding to a wavelength of 390 nm to 420 nm and at least 50% of the photons of the second light have energy corresponding to a wavelength of 795 nm to 855 nm. However, Altshuler does teach these light ranges and the purpose of each of these wavelength ranges for specific treatment modality ([0124]; [0126]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use the instant claim's range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 12, Altshuler does not explicitly teach wherein at least 50% of the photons of the first light have a majority energy from 2.95 to 3.17 eV and at least 50% of the photons of the second light have a majority energy from 1.45 eV to 1.56 eV. However, Altshuler does teach these light ranges and the purpose of each of these wavelength ranges for specific treatment modality ([0124]; [0126]; the recited ranges in eV correspond to the wavelengths 390 nm to 420 nm and 795 nm to 855 nm as recited in claim 11 above). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use the instant claim's range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 19 is rejected under substantially the same basis as claim 12 above.
Allowable Subject Matter with Respect to 102/103
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of claim 7 and its dependent 8; and claim 17 and its dependent 18 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the energy intensity ratio between the first light and the second light is in the range of 5:1 to 0.2:1.
Conclusion
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/JONATHAN T KUO/ Primary Examiner, Art Unit 3792