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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/07/2025 has been entered.
Response to Arguments
Applicant’s arguments in combination with amendments, see Remarks and Claims, filed 10/24/2025, with respect to the rejection(s) of claim(s) under 35 USC 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 Therefore, the rejection has been withdrawn.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 the following:
Claim(s) 1, 10-12, 15, 20, 22-25, 27-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190282826 A1 to Bellini.
Claim(s) 14 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellini (20190282826).
Claim(s) 2-4, 7-9, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellini in view of US Pat Pub No. 20040068305 granted to Bansal et al. (previously presented).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellini in view of US 5079262 A to Kennedy.
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, 10-12, 15, 20, 22-25, 27-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190282826 A1 to Bellini.
Regarding claim 1. (Previously presented) Bellini discloses an illumination device for photodynamic therapy (para 0049, 0053 “system 100” considered to be the overall device), the illumination device comprising two or more electromagnetic radiation emitting units (para 0053-0054 “a plurality of light emitting devices 300,”), the two or more electromagnetic radiation emitting units each comprising at least one electromagnetic radiation source (para 0054 “each lamp 300 comprises light source 320”), the electromagnetic radiation source being configured to generate radiation for the irradiation of a region of an irradiation object in an illumination session (para 0054 “emit light for the phototherapy treatment on the subject 200”), wherein the irradiation object is to be arranged at a predetermined object location (para 0054 “the light emitted by the light source 320 of one lamp 300 irradiates an area 220 which intersects a treatment site”), wherein the predetermined object location is arranged at a distance relative to a radiation output area of the two or more electromagnetic radiation emitting units through which the radiation generated by the at least one electromagnetic radiation source exits the two or more electromagnetic radiation emitting units during operation of the illumination device (para 0108 “each lamp 300 include a distance measurer 372 to measure a distance Cs between the light-emitting side 302 of the lamp 300 and the subject 200”, fig. 3 5), wherein the illumination device comprises a location or distance monitoring system (para 0107 “control system 330”), wherein the location or distance monitoring system comprises at least two distance sensors (para 0108 “distance measurer 372 of each lamp” since there are a plurality of lamps, there will be a plurality of distance measurers), wherein each of the two or more electromagnetic radiation emitting units comprises at least one of the at least two distance sensors, wherein the distance of the irradiation object from each of the two or more electromagnetic radiation emitting units is measured by the at least one of the at least two distance sensors of the respective electromagnetic radiation emitting unit (para 0108 “each lamp 300 include a distance measurer 372 to measure a distance Cs between the light-emitting side 302 of the lamp 300 and the subject 200”, fig. 3, 5, para 0110), and wherein the illumination device is configured such that each of the two or more electromagnetic radiation emitting units: is operated in a low-intensity mode when the distance of the electromagnetic radiation emitting unit to the irradiation object lies within an irradiation range around a nominal distance (para 0112 “the central controller 175 may be configured to decrease the intensity of the light emitted by one or more of the lamps 300 or to substantively turn off one or more of the lamps 300 in response to one or more of the distances Cs being unsuitable”), the low-intensity mode being a mode in which the radiation intensity emitted by the electromagnetic radiation emitting unit is smaller than a nominal radiation intensity used during the illumination session, is automatically switched from the low-intensity mode into a no-intensity mode when the distance of the electromagnetic radiation emitting unit to the irradiation object leaves the irradiation range (para 0112 “the central controller 175 may be configured to decrease the intensity of the light emitted by one or more of the lamps 300 or to substantively turn off one or more of the lamps 300 in response to one or more of the distances Cs being unsuitable”), the no-intensity mode being a mode in which the electromagnetic radiation emitting unit does not emit radiation (para 0111-0112 “control system 330 of each lamp configured to control the emission of light by the lamp based on the distance [] to substantively turn off one or more of the lamps 300 in response to one or more of the distances Cs being unsuitable”).
Regarding claim 10. (Previously presented) Bellini discloses the illumination device according to claim 1, wherein at least one electromagnetic radiation emitting unit of the two or more electromagnetic radiation emitting units comprises a unit housing which defines an outer edge of the at least one electromagnetic radiation emitting unit (fig. 7, para 0087 “housing 312”).
Regarding claim 11. (Currently amended) Bellini discloses the illumination device according to claim 10, wherein at least one electromagnetic radiation emitting unit of the two or more electromagnetic radiation emitting units comprises a plurality of radiation source carriers (para 0085), each radiation source carrier being provided with a plurality of electromagnetic radiation sources (para 0089 “each light source 320 is made up of many light-emitting diodes (LEDs) 322 1-322 L”), and wherein the radiation source carrier closest to the outer edge is oriented such that a main radiation direction (V) of the electromagnetic radiation sources on this radiation source carrier is outwardly offset from a main radiation direction (V) of the electromagnetic radiation sources on another radiation source carrier further away from the outer edge (fig. 3, 18-19, para 0059 “The lamps 300 thus may be rotated, pivoted, tilted, laterally shifted or displaced with respect to one another in order to adjust the orientation of the lamps 300 to direct light emitted by the lamps 300 toward the one or more anatomical features of the subject 200”).
Regarding claim 12. (Previously presented) Bellini discloses the illumination device according to claim 1, wherein at least one electromagnetic radiation emitting unit of the two or more electromagnetic radiation emitting units comprises one continuous radiation source carrier common for all electromagnetic radiation sources of the at least one electromagnetic radiation emitting unit (fig. 3, 7, 18-19), or wherein the at least one electromagnetic radiation emitting unit comprises a plurality of radiation source carriers, each radiation source carrier being provided with a plurality of electromagnetic radiation sources, at least two radiation source carriers being arranged angled relative to one another (fig. 19), wherein the radiation source carriers are fixed in their relative position to one another, or movable relative to one another (para 0059 “The lamps 300 thus may be rotated, pivoted, tilted, laterally shifted or displaced with respect to one another in order to adjust the orientation of the lamps 300 to direct light emitted by the lamps 300 toward the one or more anatomical features of the subject 200”).
Regarding claim 15. (Previously presented) Bellini discloses the illumination device according to claim 1, wherein the two or more electromagnetic radiation emitting units are movably connected to one another (para 0058-0059 “The lamps 300 thus may be rotated, pivoted, tilted, laterally shifted or displaced with respect to one another in order to adjust the orientation of the lamps 300”).
Regarding claim 20. (Previously presented) Bellini discloses the illumination device according to claim 1, wherein the location or distance monitoring system is configured to adjust the operation of the illumination device or to call for an adjustment of the operation of the illumination device by using one of, an arbitrary combination of, or all of the following measures: varying the distance between the respective electromagnetic radiation emitting unit and the irradiation object, and/or adjusting the radiation power emitted by the respective electromagnetic radiation emitting unit, and/or adjusting a duration of the illumination session (para 0058-0060, 0111-0112, 0140).
Regarding claim 22. (Previously presented) Bellini discloses a method for treating a skin disease comprising the following steps: a) applying a pharmaceutical substance to the surface of the skin in a region which is to be treated, b) arranging the skin region to be treated in a predetermined object location of the illumination device according to claim 1, and c) irradiating the skin region to be treated with the illumination device (para 0053-0054, “a photoactivatable composition 600”, para 0066-0070 discussing applying the photoactivatable composition).
Regarding claim 23. (Previously presented) Bellini discloses a method for operating the illumination device according to claim 1, comprising the steps of: a) providing a measurement signal which is indicative for a distance between the respective electromagnetic radiation emitting unit and the radiation object, and b) generating an operation signal as a function of the measurement signal, said operation signal being configured to cause the illumination device to adjust the operation of the illumination device or to call for an adjustment of the operation of the illumination device (para 0108-0112).
Regarding claim 24. (Original) Computer program product comprising machine-readable instructions, which, when loaded and executed on a processor, are configured to cause the illumination device to execute the method of claim 23 (para 0062, 0103 “general-purpose processor executing program code stored in the memory portion 364”).
Regarding claim 25. (Previously presented) Bellini discloses a non-transitory computer-readable medium having stored thereon the computer program product according to claim 24 (para 0103 “general-purpose processor executing program code stored in the memory portion 364”).
Regarding claim 27. (Previously presented) Bellini discloses the illumination device of claim 1, further comprising a feedback system configured to provide feedback in order to assist in keeping the irradiation object at the predetermined object location (para 0111 “notification, such as a textual message (e.g., “lamp too close”, “lamp too far”, “lamp properly positioned”, or the like), a graphical icon (e.g., an arrow pointing towards or away from a human representation), and/or another message, may be conveyed on the display 190 connected to the central controller 175”).
Regarding claim 28. (Previously presented) Bellini discloses the illumination device of claim 1, further comprising a user interface, wherein the user interface is configured to indicate for each electromagnetic radiation emitting unit of the two or more electromagnetic radiation emitting units the distance to the irradiation object and/or if the distance has to be increased or reduced in order to come into the irradiation range (para 0111 “notification, such as a textual message (e.g., “lamp too close”, “lamp too far”, “lamp properly positioned”, or the like), a graphical icon (e.g., an arrow pointing towards or away from a human representation), and/or another message, may be conveyed on the display 190 connected to the central controller 175”).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 14 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellini (20190282826).
Regarding claim 14. (Previously presented) Bellini discloses the illumination device according to claim 1, wherein the at least one radiation source is an optoelectronic component, and wherein the emission spectrum of the optoelectronic component has a peak wavelength in one of the following ranges: 635 nm ± 4 nm, 542 nm ± 4 nm, 506 nm ± 4 nm, 417 nm ± 5 nm (para 0094). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 21. (Previously presented) Bellini discloses the Illumination device according to claim 20, wherein, when the respective electromagnetic radiation emitting unit is switched on, it is, by default, in the no-intensity mode and only the location or distance monitoring system is operable (para 0058-0059, 0111-0112 “control system 330 of each lamp configured to control the emission of light by the lamp based on the distance [] to substantively turn off one or more of the lamps 300 in response to one or more of the distances Cs being unsuitable”). .
Regarding claim 26. (Previously presented) Bellini discloses an illumination device for photodynamic therapy (para 0049, 0053 “system 100” considered to be the overall device), the illumination device comprising two or more electromagnetic radiation emitting units (para 0053-0054 “a plurality of light emitting devices 300,”), the two or more electromagnetic radiation emitting units each comprising at least one electromagnetic radiation source (para 0054 “each lamp 300 comprises light source 320”), the electromagnetic radiation source being configured to generate radiation for the irradiation of a region of an irradiation object in an illumination session (para 0054 “emit light for the phototherapy treatment on the subject 200”), wherein the irradiation object is to be arranged at a predetermined object location (para 0054 “the light emitted by the light source 320 of one lamp 300 irradiates an area 220 which intersects a treatment site”), wherein the predetermined object location is arranged at a distance relative to a radiation output area of the two or more electromagnetic radiation emitting units through which the radiation generated by the at least one electromagnetic radiation source exits the two or more electromagnetic radiation emitting units during operation of the illumination device (para 0108 “each lamp 300 include a distance measurer 372 to measure a distance Cs between the light-emitting side 302 of the lamp 300 and the subject 200”, fig. 3 5), wherein each of the two or more electromagnetic radiation emitting units comprises a plurality of electromagnetic radiation sources arranged on a respective common radiation source carrier (e.g., para 0085, fig. 7; 0140, connecting members 157”), wherein the illumination device comprises a location or distance monitoring system (para 0107 “control system 330”, fig 4, etc.), wherein the location or distance monitoring system is configured to monitor the location and/or the distance of the irradiation object from each of the two or more electromagnetic radiation emitting units, wherein the location or distance monitoring system comprises a distance sensor arranged on the radiation source carrier of each of the two or more electromagnetic radiation emitting units (para 0108 “distance measurer 372 of each lamp” since there are a plurality of lamps, there will be a plurality of distance measurers); and wherein the illumination device is configured such that each of the two or more electromagnetic radiation emitting units (para 0108 “each lamp 300 include a distance measurer 372 to measure a distance Cs between the light-emitting side 302 of the lamp 300 and the subject 200”, fig. 3, 5, para 0110), is operated in a low-intensity mode when the distance of the electromagnetic radiation emitting unit to the irradiation object lies within an irradiation range around a nominal distance (para 0112 “the central controller 175 may be configured to decrease the intensity of the light emitted by one or more of the lamps 300 or to substantively turn off one or more of the lamps 300 in response to one or more of the distances Cs being unsuitable”), the low-intensity mode being a mode in which the radiation intensity emitted by the electromagnetic radiation emitting unit is smaller than a nominal radiation intensity used during the illumination session, is automatically switched from the low-intensity mode into a no-intensity mode when the distance of the electromagnetic radiation emitting unit to the irradiation object leaves the irradiation range (para 0112 “the central controller 175 may be configured to decrease the intensity of the light emitted by one or more of the lamps 300 or to substantively turn off one or more of the lamps 300 in response to one or more of the distances Cs being unsuitable”), the no-intensity mode being a mode in which the electromagnetic radiation emitting unit does not emit radiation (para 0111-0112 “control system 330 of each lamp configured to control the emission of light by the lamp based on the distance [] to substantively turn off one or more of the lamps 300 in response to one or more of the distances Cs being unsuitable”).
Bellini shows the distance sensor in a schematic figure 13 but fails to explicitly disclose it to be located offset of a geometric center of the radiation source carrier when viewed in plan view. However, the repositioning or the exact position of the sensor is understood to be a design choice. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice
Claim(s) 2-4, 7-9, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellini in view of US Pat Pub No. 20040068305 granted to Bansal et al. (hereinafter “Bansal” – previously presented).
Regarding claim 2. (Previously presented) Bellini discloses the illumination device according to claim 1, wherein at least one electromagnetic radiation emitting unit of the two or more electromagnetic radiation emitting units comprises a plurality of electromagnetic radiation sources arranged on a common radiation source carrier (see rejection of claim 1, para 0085, fig. 7; 0140, connecting members 157”), but fails to disclose wherein an occupancy density of the radiation source carrier with the plurality of electromagnetic radiation sources is smaller in a center region of the radiation source carrier than in peripheral regions of the radiation source carrier outside the center region.
Bansal, from a similar field of endeavor, teaches a similar phototherapy system and device having a plurality of Light sources arranged to take a number of different non-uniform forms to achieve the goal of even exposure on the subject's skin (para 0025, see fig. 9b, which shows a smaller density in a center region than in peripheral). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Bellini with the teachings of Bansal to provide the predictable result of even exposure on the subject’s skin.
Regarding claim 3. (Previously presented) Bellini as modified by Bansal renders obvious the illumination device according to claim 2, wherein the plurality of electromagnetic radiation sources are arranged in a one- or two- dimensional pattern on the radiation source carrier, or wherein the radiation source carrier is an elongate carrier with a main direction of extension defining a longitudinal direction (L) (Bellini, figs 3, 18-19; Bansa, fig. 8-9d).
Regarding claim 4. (Previously presented) Bellini as modified by Bansal renders obvious the illumination device according to claim 3, wherein the pattern is irregular, or wherein the pattern is symmetrical relative to one axis or two axis, which are perpendicular (Bansa, fig. 8-9d).
Regarding claim 7. (Previously presented) Bellini as modified by Bansal renders obvious the illumination device according to claim 2, wherein the plurality of electromagnetic radiation sources on the radiation source carrier are grouped into a plurality of groups, wherein the electromagnetic radiation sources of each group are arranged in a regular group pattern, and wherein at least two groups of the plurality of groups have different group patterns (Bansal fig. 9a, shows an embodiment wherein the radiation sources can be grouped into three groups, wherein the middle group (marked 1) has a pattern that is different from the two groups on the two sides (marked 2 and 3). see marked figure below).
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Regarding claim 8. (Previously Presented) Bellini as modified by Bansal renders obvious the illumination device according to claim 7, wherein at least two groups of the plurality of groups have the same group pattern (Bansal fig. 9a, see marked 2 and 3 in the marked figure above; see rejection of claim 7).
Regarding claim 9. (Previously presented) Bellini as modified by Bansal renders obvious the illumination device according to claim 8, wherein a first group with a first group pattern is arranged between a second group and a third group, when seen in plan view of the radiation source carrier, and wherein the second and the third group have the same group pattern and the first group has a different group pattern (Bansal fig. 9a, see marked 1 is between marks 2 and 3 in the marked figure above; see rejection of claim 7).
Regarding claim 17. (Previously presented) Bellini as modified by Bansal renders obvious the illumination device according to claim 2, wherein the at least two distance sensors arranged on the radiation source carrier of the two or more electromagnetic radiation emitting units (para 0108 “distance measurer 372 of each lamp” since there are a plurality of lamps, there will be a plurality of distance measurers), even though Bellini fails to explicitly disclose it to be located offset of a geometric center of the radiation source carrier when viewed in plan view, the repositioning or the exact position of the sensor is understood to be a design choice. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice
Regarding claim 18. (Previously presented) Bellini as modified by Bansal renders obvious the illumination device according to claim 17, wherein the illumination device is configured to compensate for distance or location variations of the irradiation object from the respective electromagnetic radiation emitting unit and/or the predetermined object location in order to maintain a predetermined radiation dose during the illumination session (para 0108-0112).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellini in view of US 5079262 A to Kennedy.
Regarding claim 29. (New) Bellini discloses the method for treating a skin disease according to claim 22, but fails to disclose wherein the pharmaceutical substance comprises 5-aminolevulinic acid.
Kennedy, from a similar field of endeavor, teaches that it is known to administer 5-aminolevulinic acid to the patient in an amount sufficient to induce synthesis of protoporphyrin IX in the leisons, followed by exposure of the treated lesion to a photoactivating light in the range 350-640 nm to treat malignant and non-malignant tissue abnormalities and lesions of the skin, conjunctives, respiratory, digestive and vaginal mucosa (abstract, Col 3, lines 40-46, col 4, lines 3-8, etc.). it would have been obvious before the filing date of the claimed invention to modify the disclosure of Bellini with the teachings of Kennedy to provide the predictable result of treating various tissue abnormalities.
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796