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 .
Election/Restrictions
Claims 3-4, 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/28/2026.
Applicant’s election without traverse of species A (brain tumor/cancer is pituitary tumor) in the reply filed on 7/28/2026 is acknowledged.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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, 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang (US 20060149342 A1; 7/6/2006).
Regarding claim 1, Huang teaches a method for treating or slowing progression of a tumor, comprising administering to the oral cavity of a subject in need thereof an effective amount of light (Fig. 5-6; [0002]; [0004]; [0006]; [0015]-[0016]; [0029]).
Regarding claim 9, Huang teaches wherein the method reduces the subject's tumor load or the prolactin level in the subject's blood (see regarding claim 1 above). Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex Parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993).
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) 2, 5-7, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang as applied to claim(s) 1, 9 above, in view of Frost (US 9180308 B1; 11/10/2015), and further in view of Dees (US 20110097280 A1; 4/28/2011).
Regarding claim 2, Huang does not teach wherein the tumor is a brain tumor. However, Frost teaches in the same field of endeavor (Abstract; Fig. 2) applying light treatment through oral cavity to brain (Fig. 2-3; Fig. 6; Col. 1 lines 33-36 “brain”; Col. 1 lines 40-60). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Huang to include this feature of targeting brain as taught by Frost because “illumination in areas where there are already holes in the skull results in more efficient coupling of light to the cells” (Col. 1 lines 40-60).
The combination of Huang and Frost does not teach treating brain tumor. However, Dees teaches in the same field of endeavor (Abstract; [0005]) treating brain tumor with light/photodynamic treatment ([0005] “tumor…direct illumination of the site, or by delivery of light energy to internal locations”; [0081] “pituitary gland”; [0082] “include treatment for: Hyperplasia, Dysplasia and Neoplasia, Cancer…Pituitary Gland”; claim 45 “disease of…pituitary gland…including hyperplasia…neoplasia, cancer”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Huang and Frost to target brain tumor/cancer as taught by Dees because this can be treated by light treatment ([0005]).
Regarding claim 5, in the combination of Huang, Frost, and Dees, Dees teaches wherein the brain tumor is a pituitary tumor ([0005] “tumor…direct illumination of the site, or by delivery of light energy to internal locations”; [0081] “pituitary gland”; [0082] “include treatment for: Hyperplasia, Dysplasia and Neoplasia, Cancer…Pituitary Gland”; claim 45 “disease of…pituitary gland…including hyperplasia…neoplasia, cancer”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Huang and Frost to target brain tumor/cancer as taught by Dees because this can be treated by light treatment ([0005]).
Regarding claim 6, in the combination of Huang, Frost, and Dees, Dees teaches wherein the pituitary tumor is a pituitary adenoma ([0005] “tumor…direct illumination of the site, or by delivery of light energy to internal locations”; [0081] “pituitary gland”; [0082] “include treatment for: Hyperplasia, Dysplasia and Neoplasia, Cancer…Pituitary Gland”; claim 45 “disease of…pituitary gland…including hyperplasia…neoplasia, cancer”; hyperplasia and neoplasia read on “adenoma”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Huang and Frost to target brain tumor/cancer as taught by Dees because this can be treated by light treatment ([0005]).
Regarding claim 7, in the combination of Huang, Frost, and Dees, Dees teaches wherein the tumor is brain cancer ([0005] “tumor…direct illumination of the site, or by delivery of light energy to internal locations”; [0081] “pituitary gland”; [0082] “include treatment for: Hyperplasia, Dysplasia and Neoplasia, Cancer…Pituitary Gland”; claim 45 “disease of…pituitary gland…including hyperplasia…neoplasia, cancer”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Huang and Frost to target brain tumor/cancer as taught by Dees because this can be treated by light treatment ([0005]).
Regarding claim 10, Huang teaches wherein the method reduces the subject's tumor load in the subject’s blood (see regarding claim 1 above). Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex Parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993).
Huang does not teach the method reduces the subject’s prolactin level in the subject's blood. However, Frost teaches in the same field of endeavor (Abstract; Fig. 2) applying light treatment through oral cavity to brain (Fig. 2-3; Fig. 6; Col. 1 lines 33-36 “brain”; Col. 1 lines 40-60). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Huang to include this feature of targeting brain as taught by Frost because “illumination in areas where there are already holes in the skull results in more efficient coupling of light to the cells” (Col. 1 lines 40-60).
The combination of Huang and Frost does not teach treating pituitary gland tumor/cancer which would reduce the subject’s prolactin level in the subject's blood. However, Dees teaches in the same field of endeavor (Abstract; [0005]) treating pituitary gland tumor/cancer with light/photodynamic treatment ([0005] “tumor…direct illumination of the site, or by delivery of light energy to internal locations”; [0081] “pituitary gland”; [0082] “include treatment for: Hyperplasia, Dysplasia and Neoplasia, Cancer…Pituitary Gland”; claim 45 “disease of…pituitary gland…including hyperplasia…neoplasia, cancer”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Huang and Frost to target pituitary gland tumor/cancer as taught by Dees because this can be treated by light treatment ([0005]).
The combination of Huang, Frost, and Dees then inherently teaches reducing the subject’s tumor load and the prolactin level in the subject’s blood. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex Parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993).
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang as applied to claim(s) 1 above, in view of Frost (US 9180308 B1; 11/10/2015), and further in view of Streeter (US 20110060266 A1; 3/10/2011; cited in IDS).
Regarding claim 11, Huang teaches wherein the administering is intra-orally administering light and the intra-orally administered light (Fig. 5-6):
(a) is administered to the subject's maxilla and the subject's mandible (Fig. 5-6).
Huang does not teach
(b) has a wavelength of about 850 nm;
(c) has a power density of about 65 mW/cm2.
Note that Huang teaches that light of appropriate wavelength and light intensity is to be used to treat ([0004]; [0006]).
However, Frost teaches in the same field of endeavor (Abstract; Fig. 2)
(b) has a wavelength of about 850 nm (Col. 7 lines 20-25 “500-1100 nm…630-1000 nm”);
(c) has a power density of about 65 mW/cm2 (Col. 3 lines 18-23 “5 mW to 20 W”).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Huang to include this feature of targeting brain as taught by Frost because “illumination in areas where there are already holes in the skull results in more efficient coupling of light to the cells” (Col. 1 lines 40-60) and these parameters are effective for treatment (Col. 3 lines 18-23; Col. 7 lines 20-25). 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.
The combination of Huang and Frost does not teach
(d) has an energy density of about 20 J/cm2.
However, Streeter teaches in the same field of endeavor (Abstract; [0032] “brain”; [0111] “brain tumors”; [0262] “brain tumors”; [0268] “cancer”; [0038] "2 mW/cm2 to about 50 mW/cm2"; [0101]; [0107]; [0304] “teeth/gums”) that energy density is a results effective variable (([0101]; [0107]; [0246]-[0248]; [0318]; [0328], the reference teaches adjusting the various time periods of light exposure in addition to power per unit area to obtain the desired result) and thus it would be obvious to utilize the recited range via routine optimization; MPEP 2144.05. Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Huang and Frost to include these parameters as taught by Streeter because this is effective for treating brain tissue (Abstract; [0318]). Thus, 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.
The combination of Huang, Frost, and Streeter does not teach
(e) is administered to each of the maxilla and the mandible for about 5 minutes to about 10 minutes per day three times per week for a period of three months.
However, the combination of Huang, Frost, and Streeter teaches that this is a results effective variable in that the appropriate amount of light is used to treat over time (Huang [0004]; [0006]; Frost Col. 3 lines 18-23; Col. 7 lines 20-25; Col. 7 lines 65-66 “prescribed period of time”; Streeter [0318]; [0328]-[0330]). and thus it would be obvious to utilize the recited range via routine optimization; MPEP 2144.05. Thus, 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. Further, as an initial matter, merely replicating the treatment step one or more additional times would have been obvious to one of ordinary skill in the art, at least until the desired outcome was achieved. For example, in Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009), the Federal Circuit held that mere repetition of a known procedure until success is achieved was merely the logical result of common sense application of the maxim "try, try again." (see MPEP 2143).
Regarding claim 12, the combination of Huang, Frost, and Streeter teaches further comprising administering light to the subject's skin (Streeter Fig. 1; Fig. 3; Fig. 8B-8C; [0040]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Huang, Frost, and Streeter to include this feature because this can additionally treat brain tissue ([0040]).
Regarding claim 13, the combination of Huang, Frost, and Streeter teaches wherein the light administered to the subject's skin:
(a) is administered to the subject's forehead (Streeter Fig. 15; [0040] “region of skin that is either adjacent an area of the brain in which treatment is desired”);
(b) has a wavelength ranging from about 660-670 nm (Streeter [0019];
(c) has a power density of about 88 mW/cm2 (Streeter [0038]).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Huang and Frost to include these parameters as taught by Streeter because this is effective for treating brain tissue (Abstract; [0318]).
The combination of Huang, Frost, and Streeter does not teach
(d) has an energy density of about 40 J/cm2.
However, Streeter teaches that energy density is a results effective variable (([0101]; [0107]; [0246]-[0248]; [0318]; [0328], the reference teaches adjusting the various time periods of light exposure in addition to power per unit area to obtain the desired result) and thus it would be obvious to utilize the recited range via routine optimization; MPEP 2144.05. Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Huang and Frost to include these parameters as taught by Streeter because this is effective for treating brain tissue (Abstract; [0318]). Thus, 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.
The combination of Huang, Frost, and Streeter does not teach
(e) is administered for about 15 minutes per day three times per week for a period of three months.
However, the combination of Huang, Frost, and Streeter teaches that this is a results effective variable in that the appropriate amount of light is used to treat over time (Huang [0004]; [0006]; Frost Col. 3 lines 18-23; Col. 7 lines 20-25; Col. 7 lines 65-66 “prescribed period of time”; Streeter [0318]; [0328]-[0330]). and thus it would be obvious to utilize the recited range via routine optimization; MPEP 2144.05. Thus, 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. Further, as an initial matter, merely replicating the treatment step one or more additional times would have been obvious to one of ordinary skill in the art, at least until the desired outcome was achieved. For example, in Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009), the Federal Circuit held that mere repetition of a known procedure until success is achieved was merely the logical result of common sense application of the maxim "try, try again." (see MPEP 2143).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
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