DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 17, 2026 has been entered.
Claims 1-3, 5-9, 19, 21, and 23-30 are currently pending and are examined on the merits herein.
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 .
Application Priority
This application filed 06/30/2022 is a Continuation of 16/631,205 filed 01/15/2020 which is a national stage entry PCT/US18/42505, Filing Date: 7/17/2018, claims priority to PRO 62/534,973, filed 07/20/2017 and PRO 62/533,558 filed 07/17/2017.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 4/2/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Response to Arguments
Applicant’s arguments over the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph of claims 10-12, 14-18, 20, and 22 is persuasive in view of amendments made to the claim. The rejection is herewith withdrawn.
Applicants’ arguments with respect to 35 U.S.C. 103 as being unpatentable Barolet (US 2009/0247932), in view of Nucci, et al. "Treatment of anogenital condylomata acuminata with topical photodynamic therapy: report of 14 cases and review." International Journal of Infectious Diseases 14 (2010): e280-e282 is not persuasive. The rejection is herewith maintained.
Applicant argues reargues the Barolet reference teaches the treatment substance is applied after irradiating the sub-epidermal layer and after treatment with IR radiation 5-ALA was applied and attributes clinical improvements due to pre-treatment with IR. Further Applicant points to Example 10, Fig 17, and Table 1 stating simultaneous use of heat and incubation proves significant and long-lasting lesion reduction.
In response, the Examiner points out that absent a comparison with the closest prior art, it is obvious co-administration of the ALA, and heat together at the same time, sequentially, or administering heat before or after ALA to achieve therapeutic effects is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. Furthermore, the Examiner’s contention is that the “significant and long-lasting lesion reduction” is similarly taught in Barolet. Specifically, Example 4 teaches a long-lasting lesion reduction.
Applicants’ arguments with respect to 35 U.S.C. 103 as being unpatentable Barolet (US 2009/0247932), in view of Maisch, et al. "Fluorescence induction of protoporphyrin IX by a new 5‐aminolevulinic acid nanoemulsion used for photodynamic therapy in a full‐thickness ex vivo skin model." Experimental Dermatology 19.8 (2010): e302-e305 is not persuasive. The rejection is herewith maintained. Applicant' s argument over the rejections depends on the validity of the previous arguments which were not found persuasive.
Applicants’ arguments with respect to 35 U.S.C. 103 as being unpatentable Barolet (US 2009/0247932), as applied to claims 1-2, 7-11, and 16-18 above, and further in view of Nucci, et al. "Treatment of anogenital condylomata acuminata with topical photodynamic therapy: report of 14 cases and review." International Journal of Infectious Diseases 14 (2010): e280-e282 above of claim(s) 5-6 and 14-15 is not persuasive. Applicant' s argument over the rejections depends on the validity of the previous arguments which were not found persuasive.
Applicants’ arguments with respect to 35 U.S.C. 103 as being unpatentable Barolet (US 2009/0247932) and Nucci, et al. "Treatment of anogenital condylomata acuminata with topical photodynamic therapy: report of 14 cases and review." International Journal of Infectious Diseases 14 (2010): e280-e282/ Maisch, et al. "Fluorescence induction of protoporphyrin IX by a new 5‐aminolevulinic acid nanoemulsion used for photodynamic therapy in a full‐thickness ex vivo skin model." Experimental Dermatology 19.8 (2010): e302-e305, as applied to claims 1-2, 5-11, and 14-18 above, and further in view of Willey et al. (" Ultra fast thermal PDT for facial AKS: Proof of concept study." International Journal of Infectious Diseases 14 (2010): e280-e282. Lasers in Surgery and Medicine, (March 2017) Vol. 49, Supp. Supplement 28, pp. 52. Abstract Number: 147) is not persuasive. Applicant' s argument over the rejections depends on the validity of the previous arguments which were not found persuasive.
Applicants’ arguments with respect to 35 U.S.C. 103 as being unpatentable Barolet (US 2009/0247932) and Nucci, et al. "Treatment of anogenital condylomata acuminata with topical photodynamic therapy: report of 14 cases and review." International Journal of Infectious Diseases 14 (2010): e280-e282/ Maisch, et al. "Fluorescence induction of protoporphyrin IX by a new 5‐aminolevulinic acid nanoemulsion used for photodynamic therapy in a full‐thickness ex vivo skin model." Experimental Dermatology 19.8 (2010): e302-e305, as applied to claims 1-2, 5-11, and 14-18 above is not persuasive. Applicant' s argument over the rejections depends on the validity of the previous arguments which were not found persuasive.
The rejections are as below:
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 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 1-2, 5-9, 19, 21, 23-24, and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Barolet (US 2009/0247932), in view of Nucci, et al. "Treatment of anogenital condylomata acuminata with topical photodynamic therapy: report of 14 cases and review." International Journal of Infectious Diseases 14 (2010): e280-e282.
Barolet teaches a method of treating facial acne in a subject in need thereof ([0081]-[0082]) treating patients with cystic acne on the face, comprising (i) administering heat to an affected area of the subject's skin using a thermal delivery device to achieve a temperature of between about 38 and about 42°C for a suitable time ([0081]-[0082]), treating the face with radiant IR (CW LEDs emitting (a), 970 nm, irradiance 50 mW/cm, total fluence 45 J/cm ) for 15 minute to raise the temperature to 42 °C); (ii) incubating a pharmaceutical composition comprising at least one photosensitizing agent for an incubation period of less than about 14 hours to provide an incubated pharmaceutical composition ( [0083]) - applying 5-ALA, a photosensitizing agent, on the treated surface and incubating for 60 minutes); (iii) administering a therapeutically effective dose of the incubated pharmaceutical composition to the affected area for a suitable time period ([0083]) - after incubation, the surface treated with the 5-ALA is irradiated with a LED source of red light for about 30 minutes, (the incubated composition remains on the surface for 30min); (iii) administering a suitable dose of red light to the affected area, thereby treating the facial acne ([0083]) - after incubation, the surface treated with the 5-ALA is irradiated with a LED source of red light;( [0083]; [0087]) the treatment reduces cystic acne lesions [0087]. The limitation of claim 2 is met by Barolet’s teaching of an incubation time is less than about 10 hours ([0083] - applying 5-ALA, a photosensitizing agent, on the treated surface and incubated for 60 minutes). The limitation of claim 7 is met by Barolet’s teaching of [0083] applying 5-ALA, a photosensitizing agent, on the treated surface and incubated for 60 minutes). The limitation of claims 12 and 15 is met by Barolet teaching of [0083] after incubation, the surface treated with the 5-ALA is irradiated with a LED source of red light with wavelength of 630nm. The limitation of claim 14 is met by Barolet teaching a method wherein the dose of the red light is about 37 J/cm ([0081]-[0082]) - total fluence 45 J/cm. Regarding Claim 16, Barolet teaches the method of claim 1, wherein an acne lesion count is reduced by greater than about 30% as a result of treatment ( [0081]; [0082]) treating patients with cystic acne on the face; [0085] for patients pretreated with IR radiation, the number of lesions before treatment was 49.7 ± 13.7, and the number of lesions after treatment was 12 ± 2.3, i.e. the percentage decrease of the lesion count has a range of 73.1%-77.4%). Regarding Claim 26, Barolet teaches the method of claim 1, wherein the acne is severe acne [0085] - our dual (manual and digital) lesion count analysis, a statistically significant decrease in the number of cystic lesions was observed on the pre-treated versus control side one month after PDT for most patients.
Barolet fails to specify the gel and 20% ala.
Nucci, et al. is solely used for its teachings that ALA- in amounts of 16–20% gel formulation in PDT have been safely and successfully effective.
It would have been obvious at the time of filing to administer 20% gel formulation of 5-ALA in PDT. The motivation comes from the teaching that ALA-PDT can be considered a highly effective and the best results are likely to be achieved with a 16–20% gel formulation of 5-ALA and red light. Therefore, a skilled artisan would have reasonable expectation of successfully achieving similar results.
It would have been obvious at the time of filing that the amount of time to achieve a temperature of between about 38 and about 42°C would differ. The motivation comes from the teaching that administering heat to an affected area of the subject's skin using a thermal delivery device to achieve a temperature of between about 38 and about 42°C for a suitable time. Therefore, a skilled artisan would have reasonable expectation of successfully administering heat to an affected area of the subject's skin using a thermal delivery device to achieve a temperature of between about 38 and about 42°C for a suitable time.
Claims 1-2, 5-9, 19, 21, 23-24, and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Barolet (US 2009/0247932), in view of Maisch, et al. "Fluorescence induction of protoporphyrin IX by a new 5‐aminolevulinic acid nanoemulsion used for photodynamic therapy in a full‐thickness ex vivo skin model." Experimental Dermatology 19.8 (2010): e302-e305.
Barolet teaches a method of treating facial acne in a subject in need thereof ([0081]-[0082]) treating patients with cystic acne on the face, comprising (i) administering heat to an affected area of the subject's skin using a thermal delivery device to achieve a temperature of between about 38 and about 42°C for a suitable time ([0081]-[0082]), treating the face with radiant IR (CW LEDs emitting (a), 970 nm, irradiance 50 mW/cm, total fluence 45 J/cm ) for 15 minute to raise the temperature to 42 °C); (ii) incubating a pharmaceutical composition comprising at least one photosensitizing agent for an incubation period of less than about 14 hours to provide an incubated pharmaceutical composition ( [0083]) - applying 5-ALA, a photosensitizing agent, on the treated surface and incubating for 60 minutes); (iii) administering a therapeutically effective dose of the incubated pharmaceutical composition to the affected area for a suitable time period ([0083]) - after incubation, the surface treated with the 5-ALA is irradiated with a LED source of red light for about 30 minutes, (the incubated composition remains on the surface for 30min); (iii) administering a suitable dose of red light to the affected area, thereby treating the facial acne ([0083]) - after incubation, the surface treated with the 5-ALA is irradiated with a LED source of red light;( [0083]; [0087]) the treatment reduces cystic acne lesions [0087]. The limitation of claim 2 is met by Barolet’s teaching of an incubation time is less than about 10 hours ([0083] - applying 5-ALA, a photosensitizing agent, on the treated surface and incubated for 60 minutes). The limitation of claim 7 is met by Barolet’s teaching of [0083] applying 5-ALA, a photosensitizing agent, on the treated surface and incubated for 60 minutes). The limitation of claims 12 and 15 is met by Barolet teaching of [0083] after incubation, the surface treated with the 5-ALA is irradiated with a LED source of red light with wavelength of 630nm. The limitation of claim 14 is met by Barolet teaching a method wherein the dose of the red light is about 37 J/cm ([0081]-[0082]) - total fluence 45 J/cm. Regarding Claim 16, Barolet teaches the method of claim 1, wherein an acne lesion count is reduced by greater than about 30% as a result of treatment ( [0081]; [0082]) treating patients with cystic acne on the face; [0085] for patients pretreated with IR radiation, the number of lesions before treatment was 49.7 ± 13.7, and the number of lesions after treatment was 12 ± 2.3, i.e. the percentage decrease of the lesion count has a range of 73.1%-77.4%). Regarding Claim 26, Barolet teaches the method of claim 1, wherein the acne is severe acne [0085] - our dual (manual and digital) lesion count analysis, a statistically significant decrease in the number of cystic lesions was observed on the pre-treated versus control side one month after PDT for most patients.
Barolet fails to specify nanoemulsion, the amounts of the 5-ALA.
Maisch is solely used for its teachings of PDT and penetration of 5-aminolevulinic acid (5-ALA) contained in a nanoemulsion-based formulation BF-200 ALA (10% 5-ALA-hydrochloride).
It would have been obvious at the time of filing to administer 10% 5-ALA as a nanoemulsion-based formulation in PDT. The motivation comes from the teaching that 5-aminolevulinic acid (5-ALA) nanoemulsion-based formulation BF-200 ALA (10%5-ALA-hydrochloride) in combination with PDT achieved penetration. Therefore, a skilled artisan would have reasonable expectation of successfully achieving similar results.
It would have been obvious at the time of filing that the amount of time to achieve a temperature of between about 38 and about 42°C would differ. The motivation comes from the teaching that administering heat to an affected area of the subject's skin using a thermal delivery device to achieve a temperature of between about 38 and about 42°C for a suitable time. Therefore, a skilled artisan would have reasonable expectation of successfully administering heat to an affected area of the subject's skin using a thermal delivery device to achieve a temperature of between about 38 and about 42°C for a suitable time.
Claims 3 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Barolet (US 2009/0247932) and Nucci, et al. "Treatment of anogenital condylomata acuminata with topical photodynamic therapy: report of 14 cases and review." International Journal of Infectious Diseases 14 (2010): e280-e282/ Maisch, et al. "Fluorescence induction of protoporphyrin IX by a new 5‐aminolevulinic acid nanoemulsion used for photodynamic therapy in a full‐thickness ex vivo skin model." Experimental Dermatology 19.8 (2010): e302-e305, as applied to claims 1-2, 5-11, and 14-18 and 21-22 above, and further in view of Willey et al. (" Ultra fast thermal PDT for facial AKS: Proof of concept study." International Journal of Infectious Diseases 14 (2010): e280-e282. Lasers in Surgery and Medicine, (March 2017) Vol. 49, Supp. Supplement 28, pp. 52. Abstract Number: 147).
Barolet is as discussed above.
Barolet fails to specify the sodium acetate warming mask.
Willey, et al. teaches 5% ALA was applied to facial skin followed by a warming mask for 20 minutes prior to exposure to 10 J/cm2 blue light. The warming mask is comprised of a sodium acetate liquid emits heat upon crystallization that consistently heats skin to approximately 40 C for 20 minutes.
It would have been obvious at the time of filing to administer ALA in PDT while using a warming mask is comprised of a sodium acetate liquid. The motivation comes from the teaching a sodium acetate liquid emits heat upon crystallization that consistently heats skin to approximately 40 C. Therefore, a skilled artisan would have reasonable expectation of successfully achieving similar results.
Conclusion
No claims allowed.
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/LAYLA SOROUSH/Primary Examiner, Art Unit 1622
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