DETAILED ACTION
Applicant’s response filed on December 1, 2025 to the non-Final rejection mailed on July 1, 2025 is acknowledged.
Claims 1-3, 5-12, 14-22 are pending in this 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 .
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 12/1/25 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 The rejection is herewith withdrawn. However, the claims are rendered indefinite. See modified rejection below.
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 administering heat to an affected area using a thermal delivery device to achieve a temp of about 38C to about 42C simultaneously with incubating a pharmaceutical composition comprising 10wt% to 20 wt% 5-ALA and administering a dose of light to the affected area. 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. 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, Example 10 describes treatment effect is a reduction in lesion counts persistent for 9 months. While the Examiner does not disagree that simultaneous use of heat and incubation proves significant and long-lasting lesion reduction, the prior art observes similarly treatment proved successful and acne lesions were significantly reduced after a single treatment AND clearing remained for months. The Examiner suggests, Applicant provide a comparison with the closest art of record, wherein sequential and co-administration of ALA with heat are compared. 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.
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 § 112
Claims 10-12, 14-18, 20, and 22 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “non-therapeutic” in claim is used for acne, is the accepted meaning for treatment of acne and is therapeutic. It is unclear how administration to facial acne, with a combination of i) and ii) results in a non-therapeutic method. The term is indefinite because the specification does not clearly redefine the term.
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, 5-11, 14-18, and 21-22 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, 5-11, and 14-22 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.
Claim 3 and 12 is 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.
Contact Information
The arguments are not persuasive and the rejection is made FINAL.
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 extension fee 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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/LAYLA SOROUSH/Primary Examiner, Art Unit 1622
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