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 .
Response to Amendment
This Office action is responsive to the preliminary amendment filed January 17, 2025. As directed by the amendment, claims 1-19 are cancelled and claims 20-34 have been added. Thus, claims 20-34 are presently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119e and/or 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 62/241,902 and 15/292,731 each fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed application do not disclose combination of applying heat to the treatment area by a heat source for a first time period and apply applying light to the treatment area by an illuminator for a second time period and/or controlling the temperature by referencing at least one thermal map. In view of these, the effective filing date of instant case is filing date of child application 15/487991 (i.e. April 14, 2017).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 26 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 26 and 34 were added by the preliminary amendment noted above, as to claim 26, the original disclosure does not disclose or provide written description in regards the first time period overlaps with the second time period, the original disclosure disclose a first time period and a second time period that follows (hence not overlapping) the first time period. As to claim 34, the original disclosure does not disclose or provide written description in regards to a rate of warming up the heat source is based on an average skin temperature of the patient.
If examiner is mistaken, Applicant is respectfully requested to cite specific section of the original disclosure that provides written description for the subject matter in question.
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 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.
Claims 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over the Applicant cited Sakamoto et al. WO 2009003173 A1 ("Sakamoto") in view of Black US 20030195592 A1.
Regarding claim 29, Sakamoto discloses a method of photodynamic treatment (Figs. 3-4, [0102]) the method comprising: applying a topical composition to a treatment area on a face, scalp, or extremity of a patient, the topical composition comprising 5-aminolevulinic acid (ALA) - ([0106]); applying heat to the treatment area by a heat source for a first time period ([0061] “Phase I …tissue heating …”, [0102], [0112] “Skin warming … during phase I…”); applying light to the treatment area by an illuminator for a second time period following the first time period ([0102], Fig. 4, [0109] “Phase II”), the illuminator comprising at least one fan ([0103] “… warming device 400 such as, e.g., fan”); and controlling a temperature within the treatment area based on temperature detected by one or more sensors (i.e. by referencing temperature from the one or more sensors), wherein controlling the temperature comprises controlling at least one of the heat source or the at least one fan to cause a predetermined increase in skin temperature of the patient ([0020] [0104] one or more sensors to detect inter alia skin temperature, and a control element or controller varying one or more parameters, [0107] and [0109] for parameters being varied based on skin temperature by controlling the cooling and/or heating devices to achieve a desired skin temperature).
Sakamoto does not explicitly disclose a thermal map associate with the temperature sensor (examiner notes: a temperature map by definition is a graphical representation of temperature across an area). However, Black teaches that it was known in the prior art to control temperature using a controller of a selected area to be within a desired temperature ([0030]) based on input of temperature or temperature map (examiner note: a temperature map is synonymous to a thermal map). Inasmuch as Black teaches the use of temperature or temperature map as an input to a controller to control temperature of a monitored area to be within a desired temperature, at the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the exercise art to substitute one for the other, In re Fout, 675 F.2d 297, 301, 213 USPQ 532, 536 (CCPA 1982), in this case, use data from the one or more sensors to generate a temperature map, to perform the same function of controlling the skin temperature in Sakamoto.
Regarding claim 30, Sakamoto in view of Black discloses the invention of claim 29 as discussed above, Sakamoto further discloses in [0107] “… monitoring characteristics of skin temperature to control the cooling/heating devices for achieving a desired skin surface temperature”, in modified Sakamoto, this process would involve correlating a target or desired skin temperature with the thermal/temperature map with at least one of volumetric flow rate or air speed (in regards to fan), or an air temperature (detected temperature).
Regarding claims 31 and 32, Sakamoto in view of Black discloses the invention of claim 29 as discussed above, Sakamoto further discloses in [0111] that phase I time (i.e. first time period) may range from 0-300 minutes (i.e. variable) and phase II time (i.e. the second time period) may range for about 1 minute to 120 minutes (i.e. variable. Additionally, the time for applying heat and/or light treatment is dependent on tolerable or target temperature of the skin and parameters associated with heat and/or light source e.g., fluence, irradiance and/or wavelength [(0109]). However, because the particular parameter of the claimed time period is affected by both a tolerable or target temperature as well as the heat source irradiance and fluence, it is a matter of optimization as being a result effective variable.
In view of these, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have used the particular time for the first time period and/or second time period as recited in claim 31 and 32 for pre-phototreatment and phototreatment in Sakamoto in view of Black, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) (MPEP 2144.05 (II-B)).
Claims 20 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto, in view Black and in view of Barolet et al. US 20080108982 A1 ("Barolet").
Regarding claim 20, all limitations are to be found in claim 29, but for the limitation controlling at least one of the heat source or the illuminator “to cause an increase in skin temperature of the patient of approximately 2oC”. See discussion in claim 29 above, the citations and discussion in claim 29 is applicable here and will not be repeated for brevity sake. In regards to “to cause an increase in skin temperature of the patient of approximately 2oC”, Sakamoto discloses in [0107] controlling the heating/cooling devices for achieving a desired skin temperature but does not specify an increase of approximately 2oC. However, Barolet teaches increasing skin temperature above 2oC (i.e. superior by 2oC) enhances production of collagen degrading enzymes that can trigger dermal collagen degradation ([0251-0252]). In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have modified the method of Sakamoto in view of Black to cause an increase of about 2oC, because Barolet teaches at temperature above/superior to 2oC, would cause or trigger dermal collagen degradation which will not be desired in Sakamoto.
Regarding claim 25, Sakamoto in view of Black and Barolet discloses the invention of claim 20 as discussed above, Sakamoto further discloses in [0107] “… monitoring characteristics of skin temperature to control the cooling/heating devices for achieving a desired skin surface temperature”, in modified Sakamoto, this would involve controlling a speed of the fan used for cooling/heating as the effect of the fan depends on a speed of the fan.
Regarding claim 26, Sakamoto in view of Black and Barolet discloses the invention of claim 20 as discussed above, since the heat source of Sakamoto is also a light source, claim 26 is broad to encompass a heat source of Sakamoto that also provides light e.g., an infrared LED or light source ([0103], [0112]) by providing both heat and light, time period associated with generation of heat read on the first time period and time period associated with when the infrared light source is turned off will read on the second time period (i.e., claim 26 is read differently from claim 20 in regards to the step of applying heat and the step of applying light), note, residual heat will be generated after the infrared light source is turned off and therefore the step of applying heat and light are distinct and the first and second time periods will overlap while being distinct.
Regarding claim 27, Sakamoto in view of Black and Barolet discloses the invention of claim 20 as discussed above, the second time period in Sakamoto (phase II) follows the first time period (phase I) as discussed above.
Claims 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto in view of Black and Barolet as applied to claim 20 above, and further in view of Applicant cited Kim KR 10-2012-0100861 (see attached machine language English Translation for references).
Regarding claims 21-24, Sakamoto in view of Black and Barolet discloses the invention of claim 20 as discussed above, the illuminator of Sakamoto in Fig. 4 comprises a plurality of light sources, a heat source and fan, but does not explicitly disclose that the illuminator comprises a plurality of panels comprising the light sources, wherein the plurality of panels comprise five panels, wherein the heat source is positioned between adjacent panels, wherein the fan is mounted to the plurality of panels.
Kim, in the same field of endeavor of photodynamic therapy ([0001]) discloses a prior art illuminator comprising five panels, each panel comprising light sources (see illustrations Figs. 1, 2, 3a, 3b) , Fig. 3a and 3b illustrate that the illuminator can be adjusted to different configurations to more conform to a body part of the patient. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have modified the illuminator of Sakamoto to comprise five panels, each panel comprising the light sources, and position the heat sources between adjacent panels and mount the fan to the five panels, because such a modification would allow the illuminator of Sakamoto to conform to better conform to different body parts of varying dimensions of a patient by allowing adjustment of different panels of the illuminator relative to the patient.
Claims 28 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto in view of Black as applied to claim 32 above (claim 33) or Sakamoto in view of Black and Barolet as applied to claim 30 above (claim 20), and further in view of Applicant cited article by Wiley et al., “Temperature-Modulated Photodynamic Therapy for the Treatment of Actinic Keratosis on the Extremities: A Pilot Study” (“Wiley”).
Regarding claims 28 and 33, Sakamoto in view of Black and Barolet or Sakamoto in view of Black discloses the invention of claim 20 and 32 respectively as discussed above, but does not explicitly disclose applying the light at a dose of approximately between 10 J/cm2 (claim 20) or approximately between 10 J/cm2 and 40 J/cm2 (claim 33). However, Wiley in the same field of photodynamic therapy using topically applied 5-ALA and a light source, teaches applying light for treatment at a dose of 10 J/cm2 (page 1094, “METHODS” ). In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have specified a dose of 10 J/cm2 as taught by Wiley for phototreatment in modified Sakamoto with reasonable expectation of success, because Wiley exemplifies that a dose of 10 J/cm2 is sufficient for phototherapy.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto in view of Black as applied to claim 29 above, and further in view of Applicant cited Lundahl et al. US 20040143308 A1 (“Lundahl”).
Regarding claim 34, Sakamoto in view of Black discloses the invention of claim 32 as discussed above but does not explicitly disclose warming up the heat source during a predetermined warm-up period. However, Lundahl in the same field of endeavor of apparatus and method for photodynamic therapy, teaches in [0097] a predetermined time period (first 2.5 minutes) to warm up a heat source used in photodynamic therapy while maintaining output irradiance within specified limits to provide optimum tube warm up. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have included a step of warming up the heat source in Sakamoto in view of Black, so as to provide optimum warm-up of the heat source in the method of Sakamoto, prior to treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797