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 .
Claim Objections
Claims 33-38 are objected to because of the following informalities: no numeric value is recited for the energy dose. Appropriate correction is required.
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) 20-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2010/0331927 to Cottrell et al. (Cottrell) in view of US Pre-Grant Publication 2014/0330196 to Ingman et al. (Ingman).
Regarding claim 20, Cottrell teaches a phototherapy system including an irradiation light source (202) for irradiating an affected area (Fig. 2A, TARGET LESION) administered with a phototherapeutic agent (photosensitizer, see e.g. paragraph 21) with therapeutic light (from 202), a sensor (212), and a controller (222, see paragraph 31, “computer-controlled”), the controller configured to control irradiation (at 706) based on measured intensity (measured at 702), and to provide a visual output of the affected tissue (Fig. 2C). Cottrell also teaches that 20 J/cm2 is a threshold of interest (paragraph 45, “90% PpIX bleaching occurring at around 20J/cm2”) in at least some therapeutic modes. Cottrell does not specifically teach a warning at any particular threshold. Ingman teaches another phototherapy device generally, and particularly teaches that warnings may be provided to the user (paragraph 164, “warnings, error messages”) to inform the user of the status of the system. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a warning to the user of the system of Cottrell in order to inform the user of the status of the system. Since 20 J/cm2 is a known threshold in the system of Cottrell as noted above, it would have been obvious to provide a warning at that threshold in order to indicate the status of the treatment, e.g. that 90% bleaching was complete.
Regarding claim 21, Cottrell teaches irradiation in a first period (at 706). Cottrell further teaches irradiating again in a second period (722), which is done with a new irradiance (calculated at 720) if the tissue properties have left an acceptable range (as determined at 716), and that the measured tissue property is fluorescence intensity (paragraph 53). As such, the first period may include the 20 J/cm2 threshold.
Regarding claims 22, Cottrell teaches displaying real-time information based on measured light intensity (paragraph 32), control of irradiation (see Fig. 7), and measurement of energy does (710).
Regarding claim 23, Cottrell teaches displaying information on light intensity in all periods (paragraph 32), control of irradiation and white light (paragraph 31), image display (e.g. Fig. 2C), measurement in all periods (at 702, 704), and ending therapy upon dose completion (710 and 714).
Regarding claim 24, Cottrell teaches displaying information on light intensity in all periods (paragraph 32), control of irradiation by therapeutic and white light (paragraph 31), image display (e.g. Fig. 2C), measurement in all periods (at 702, 704), and ending therapy upon dose completion (710 and 714). Cottrell does not specifically teach a warning at any particular threshold. Ingman teaches another phototherapy device generally, and particularly teaches that warnings may be provided to the user (paragraph 164, “warnings, error messages”) to inform the user of the status of the system. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a warning upon dose completion as taught by Ingman.
Regarding claim 25, Cottrell teaches a range of possible doses, including from 20-200 J/cm2, based on different treatment regimen (see e.g. paragraph 45). The dose of 100 J/cm2 falls within this range and is therefore considered obvious (MPEP 2144.05).
Regarding claim 26, Cottrell teaches an image sensor (212, producing image as in Fig. 3D at 3 nm resolution as discussed in paragraph 33).
Regarding claim 27, Cottrell teaches a phototherapy device comprising a sensor (212), an irradiation source (202), a controller (222), control of irradiation (as shown in Fig. 7), and measurement of irradiation energy (at 702, 704). Cottrell also teaches that 20 J/cm2 is a threshold of interest (paragraph 45, “90% PpIX bleaching occurring at around 20J/cm2”) in at least some therapeutic modes. Cottrell does not specifically teach a warning at any particular threshold. Ingman teaches another phototherapy device generally, and particularly teaches that warnings may be provided to the user (paragraph 164, “warnings, error messages”) to inform the user of the status of the system. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a warning to the user of the system of Cottrell in order to inform the user of the status of the system. Since 20 J/cm2 is a known threshold in the system of Cottrell as noted above, it would have been obvious to provide a warning at that threshold in order to indicate the status of the treatment, e.g. that 90% bleaching was complete.
Regarding claim 28, Cottrell teaches irradiation in a first period (at 706). Cottrell further teaches irradiating again in a second period (722), which is done with a new irradiance (calculated at 720) if the tissue properties have left an acceptable range (as determined at 716), and that the measured tissue property is fluorescence intensity (paragraph 53). As such, the first period may include the 20 J/cm2 threshold.
Regarding claim 29, Cottrell teaches displaying real-time information based on measured light intensity (paragraph 32), control of irradiation (see Fig. 7), and measurement of energy does (710).
Regarding claim 30, Cottrell teaches displaying information on light intensity in all periods (paragraph 32), control of irradiation and white light (paragraph 31), image display (e.g. Fig. 2C), measurement in all periods (at 702, 704), and ending therapy upon dose completion (710 and 714).
Regarding claim 31, Cottrell teaches displaying information on light intensity in all periods (paragraph 32), control of irradiation by therapeutic and white light (paragraph 31), image display (e.g. Fig. 2C), measurement in all periods (at 702, 704), and ending therapy upon dose completion (710 and 714).
Regarding claim 32, Cottrell teaches an image sensor (212, producing image as in Fig. 3D at 3 nm resolution as discussed in paragraph 33).
Regarding claim 33, Cottrell teaches a phototherapy method including irradiating a lesion with an irradiation source (202), measuring the intensity of the light at that location (via 212), controlling by a controller (222) the irradiation based on the light intensity, and measuring (e.g. at 702) the dose. Cottrell also teaches that 20 J/cm2 is a threshold of interest (paragraph 45, “90% PpIX bleaching occurring at around 20J/cm2”) in at least some therapeutic modes. Cottrell does not specifically teach a warning at any particular threshold. Ingman teaches another phototherapy device generally, and particularly teaches that warnings may be provided to the user (paragraph 164, “warnings, error messages”) to inform the user of the status of the system. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a warning to the user of the system of Cottrell in order to inform the user of the status of the system. Since 20 J/cm2 is a known threshold in the system of Cottrell as noted above, it would have been obvious to provide a warning at that threshold in order to indicate the status of the treatment, e.g. that 90% bleaching was complete.
Regarding claim 34, Cottrell teaches irradiation in a first period (at 706). Cottrell further teaches irradiating again in a second period (722), which is done with a new irradiance (calculated at 720) if the tissue properties have left an acceptable range (as determined at 716), and that the measured tissue property is fluorescence intensity (paragraph 53). As such, the first period may include the 20 J/cm2 threshold. Cottrell does not specifically teach a warning at any particular threshold. Ingman teaches another phototherapy device generally, and particularly teaches that warnings may be provided to the user (paragraph 164, “warnings, error messages”) to inform the user of the status of the system. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a warning to the user of the system of Cottrell in order to inform the user of the status of the system. Since 20 J/cm2 is a known threshold in the system of Cottrell as noted above, it would have been obvious to provide a warning at that threshold in order to indicate the status of the treatment, e.g. that 90% bleaching was complete.
Regarding claim 35, Cottrell teaches displaying information on light intensity in all periods (paragraph 32).
Regarding claim 36, Cottrell teaches displaying information on light intensity in all periods (paragraph 32), control of irradiation by therapeutic and white light (paragraph 31), image display (e.g. Fig. 2C), measurement in all periods (at 702, 704), and ending therapy upon dose completion (710 and 714). Cottrell does not specifically teach a warning at any particular threshold. Ingman teaches another phototherapy device generally, and particularly teaches that warnings may be provided to the user (paragraph 164, “warnings, error messages”) to inform the user of the status of the system. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a warning upon dose completion as taught by Ingman.
Regarding claim 37, Cottrell teaches displaying information on light intensity in all periods (paragraph 32), control of irradiation by therapeutic and white light (paragraph 31), image display (e.g. Fig. 2C), measurement in all periods (at 702, 704), and ending therapy upon dose completion (710 and 714). Cottrell does not specifically teach a warning at any particular threshold. Ingman teaches another phototherapy device generally, and particularly teaches that warnings may be provided to the user (paragraph 164, “warnings, error messages”) to inform the user of the status of the system. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a warning upon dose completion as taught by Ingman.
Regarding claim 38, Cottrell teaches an image sensor (212, producing image as in Fig. 3D at 3 nm resolution as discussed in paragraph 33).
Response to Arguments
Applicant’s arguments, see page 8, filed 22 December 2025, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 and/or 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Cottrell in view of Ingman as discussed above.
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.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 2 April 2026