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 .
Status of the Claims
Claims 1-20 are pending and under current examination.
All rejections not reiterated have been withdrawn.
A terminal disclaimer is on file for US Patent Nos. 10,933,046; 10,945,987; 11,628,155; 11,865,100; 11,877,997; 11,541,026; 11,986,456; and 12295935, which issued from US Application No. 18/123,702.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-12 of U.S. Patent No. 9,687,465 (cited in the IDS filed 03/31/2024); and
claims 1-16 of U.S. Patent No. 11,426,378 (cited in the IDS filed 03/31/2024);
in view of Nicholson et al. (J Am Acad Dermatol Vol 57 No 2, pages 213-221; publication year: 2007; of record).
Inter alia, the claims of the ‘465 and ‘378 patents embrace a method for treating rosacea, including erythematotelengietatic, papulopustular, phymatous, or ocular rosacea (the ‘465 specification indicates that the term “rosacea” embraces at least erythematotelengietatic and papulopustular rosacea: col 1, lines 15-20 “characterized by telangiectatic erythema, dryness of the skin, papules and pustules”), comprising topically applying to the skin of a rosacea patient a composition comprising as the sole active ingredient 2.5 - 10 % by weight encapsulated and/or microencapsulated benzoyl peroxide in an extended release formulation (claim 1 of the ‘465 application indicates that the BPO shows an extended release profile “60% w/h” dissolution rate) in a cream or emulsion, which would contain a fatty or oily phase, once daily for 12 weeks and measuring the outcome (see col 4, lines 15-19 of the ‘465 patent, which indicates by an example method that the term “administering” embraces treatment of at least 12 weeks, moreover, it would have been prima facie obvious for one having ordinary skill at the effective filing date of the instant invention to determine the length of time required to see an effect of the BPO used to treat rosacea as this is the objective of the method).
The claims of the cited patents do not measure outcome using PAPSS or PAPI as required by the instant claims.
Nicholson discloses an instrument for measuring rosacea patient quality of life as assessed by the patient (title, abstract). Nicholson discloses that rosacea, of each subtype erythematotelengietatic, papulopustular persistent, phymatous, and ocular, significantly affects quality of life for patients (page 213, right col). Nicholson discloses further that pharmaceutical companies developing new treatments could benefit from an instrument to measure patient-reported therapeutic impact over time. Nicholson discloses that objective clinical parameters of skin disease are often poorly correlated with quality of life impact and most physicians underestimate the impact of skin disease on quality of life (page 214, left col). Nicholson’s quality of life instrument evaluates factors associated with symptoms, functioning, and emotion (page 214, left col) and some specific metrics include appearance of skin (which the examiner interprets to include redness, as this is a hallmark feature of rosacea), flushes, skin irritation, burning or stinging, embarrassment, frustration, and sensitive skin (table 1).
It would have been prima facie obvious at the effective filing date of the instant invention to evaluate the efficacy of the patented methods by measuring the patient’s perception of quality of life as disclosed by Nicholson. The artisan of ordinary skill would have been motivated to do so in order to more accurately capture the efficacy of the treatment as deemed by the patient. The ultimate goal of any treatment is to improve quality of life for the patient. In view of Nicholson, one having ordinary skill in the art would have recognized that the patient’s evaluation of quality of life often does not align with a physician’s objective evaluation of symptoms. The skilled artisan would have had a reasonable expectation of success because this would merely require administering Nicholson’s questionnaire to the patient and because Nicholson indicates that reliability of the survey in accurately capturing changes in quality of life was high (abstract).
With regard to the phrases “Patient Assessment of Papulopustular Rosacea Signs and Symptoms (PAPSS)” as recited in instant claim 1 and “Patient Assessment of Papulopustular Rosacea Impacts (PAPI)” as recited in instant claim 11, the instant specification discloses PAPSS to be measuring burning, redness, and bumps and discloses PAPI to be measuring embarrassment, self-consciousness, and frustration (see page 8 of the instant specification). Nicholson’s quality of life instrument measures appearance of skin (which the examiner interprets to include redness, as this is a hallmark feature of rosacea), flushes, skin irritation, burning or stinging, embarrassment, frustration, and sensitive skin. As Nicholson’s instrument evaluates the same factors, the examiner considers a step of measuring a PAPSS or PAPI to be prima facie obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 21-47 of U.S. Patent No. 9,868,103;
claims 1-11 of U.S. Patent No. 10,653,899 (cited in the IDS filed 03/31/2024);
claims 1-14 of U.S. Patent No. 11,865,208;
claims 1-8 of U.S. Patent No. 12,070,629;
claims 1-32 of U.S. Patent No. 12,257,348; and
claims 1-4 of U.S. Patent No.12,156,946
in view of Sertchook et al. (US 2017/0281571; publication date: 10/05/2017; cited in the IDS filed 09/30/2020) and further in view of Nicholson et al. (J Am Acad Dermatol Vol 57 No 2, pages 213-221; publication year: 2007; of record).
Inter alia, the claims of the ‘103, ‘899, ‘208, ‘629, ‘348, and ‘946 patents embrace a method for treating rosacea, comprising topically applying a composition (i.e. a carrier) comprising encapsulated and/or microencapsulated benzoyl peroxide (see col 4, line 14 of the ‘208 patent and col 18, line 30 of the ‘946 patent where it is disclosed that the claimed compositions may be used to treat rosacea).
The examiner has relied upon the specification to delineate the scope of the invention embraced by the ‘208 and ‘946 patents, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797.
Although no other active agent is listed, the claims of the ‘103, ‘899, ‘208, ‘629, ‘348, and ‘946 patents do not specify that benzoyl peroxide is the sole active agent, nor do the recite a dosing schedule.
Sertchook discloses a method of treatment of rosacea and a composition for topical use for treating rosacea and symptoms and conditions of rosacea (title abstract). The composition is administered topically to the skin (0019) in a physiologically acceptable medium (i.e. a carrier; 0042). The composition contains from about 2.5 to 5 weight % of benzoyl peroxide (BPO) as the single pharmaceutical active agent in the composition (0018). In example methods, a clinical trial is disclosed wherein the composition is applied once daily for 12 weeks and a 1% or 5% BPO gel is compared to vehicle alone (0185). Sertchook reports outcomes of the clinical trial using the Investigator Global Assessment (IGA). Patients were assessed specifically for inflammatory lesions (papules and pustules) at screening, baseline, weeks 4, 8, and 12, and for erythema, and telangiectasia at baseline and weeks 4, 8, and 12 (end of study).
It would have been prima facie obvious at the effective filing date of the instant invention to deliver benzoyl peroxide in the ‘103, ‘899, ‘208, ‘629, ‘348, and ‘946 method as the sole active agent to treat rosacea. One having ordinary skill in the art would have recognized this as a suitable substance for single agent treatment of rosacea in view of Sertchook who discloses that 12 weeks of treatment with a composition containing from 2.5-10 % BPO alone can reduced symptoms of rosacea, specifically papulopustular rosacea (see example method). Sertchook discloses further that encapsulated compositions can provide extended release of BPO. It would have been prima facie obvious to follow the dosing regimen of once daily for 12 weeks because Sertchook discloses this to be effective in an example method.
The claims of the patents do not measure outcome using PAPSS or PAPI as required by the instant claims.
Nicholson discloses an instrument for measuring rosacea patient quality of life as assessed by the patient (title, abstract). Nicholson discloses that rosacea, of each subtype erythematotelengietatic, papulopustular persistent, phymatous, and ocular, significantly affects quality of life for patients (page 213, right col). Nicholson discloses further that pharmaceutical companies developing new treatments could benefit from an instrument to measure patient-reported therapeutic impact over time. Nicholson discloses that objective clinical parameters of skin disease are often poorly correlated with quality of life impact and most physicians underestimate the impact of skin disease on quality of life (page 214, left col). Nicholson’s quality of life instrument evaluates factors associated with symptoms, functioning, and emotion (page 214, left col) and some specific metrics include appearance of skin (which the examiner interprets to include redness, as this is a hallmark feature of rosacea), flushes, skin irritation, burning or stinging, embarrassment, frustration, and sensitive skin (table 1).
It would have been prima facie obvious at the effective filing date of the instant invention to evaluate the efficacy of the ‘899 method by measuring the patient’s perception of quality of life as disclosed by Nicholson. The artisan of ordinary skill would have been motivated to do so in order to more accurately capture the efficacy of the treatment as deemed by the patient. The ultimate goal of any treatment is to improve quality of life for the patient. In view of Nicholson, one having ordinary skill in the art would have recognized that the patient’s evaluation of quality of life often does not align with a physician’s objective evaluation of symptoms. The skilled artisan would have had a reasonable expectation of success because this would merely require administering Nicholson’s questionnaire to the patient and because Nicholson indicates that reliability of the survey in accurately capturing changes in quality of life was high (abstract).
With regard to the phrases “Patient Assessment of Papulopustular Rosacea Signs and Symptoms (PAPSS)” as recited in instant claim 1 and “Patient Assessment of Papulopustular Rosacea Impacts (PAPI)” as recited in instant claim 11, the instant specification discloses PAPSS to be measuring burning, redness, and bumps and discloses PAPI to be measuring embarrassment, self-consciousness, and frustration (see page 8 of the instant specification). Nicholson’s quality of life instrument measures appearance of skin (which the examiner interprets to include redness, as this is a hallmark feature of rosacea), flushes, skin irritation, burning or stinging, embarrassment, frustration, and sensitive skin. As Nicholson’s instrument evaluates the same factors, the examiner considers a step of measuring a PAPSS or PAPI to be prima facie obvious.
With regard to claims 6 and 15, the composition may be a suspension (0044).
With regard to claims 7 and 16, Sertchook discloses treating papulopustular rosacea (0034).
With regard to claims 8 and 17, the composition may be a cream or emulsion, which would have a fatty or oily phase (0043).
With regard to claims 9 and 18, the composition provides extended release (figure 3; “the controlled release of the pharmaceutical active agent was slow enough to allow for controlled and slow release of the pharmaceutical active agent over a prolonged period of time” 0024). The controlled release is achieved by coating the BPO (0073). One having ordinary skill in the art would have expected the encapsulated (i.e. coated) BPO of the ‘899 patent to also provide extended release.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41, 42, 45-47, and 59 of copending Application No. 12/525,331 Sertchook et al. (US 2017/0281571; publication date: 10/05/2017; cited in the IDS filed 09/30/2020) and further in view of Nicholson et al. (J Am Acad Dermatol Vol 57 No 2, pages 213-221; publication year: 2007; of record).
Inter alia, the claims of the ‘331 application embrace a method for treating rosacea, comprising topically applying a composition (i.e. a carrier) comprising encapsulated and/or microencapsulated benzoyl peroxide.
Although no other active agent is listed, the claims of the ‘331 application do not specify that benzoyl peroxide is the sole active agent, nor do the recite a dosing schedule.
Sertchook discloses a method of treatment of rosacea and a composition for topical use for treating rosacea and symptoms and conditions of rosacea (title abstract). The composition is administered topically to the skin (0019) in a physiologically acceptable medium (i.e. a carrier; 0042). The composition contains from about 2.5 to 5 weight % of benzoyl peroxide (BPO) as the single pharmaceutical active agent in the composition (0018). In example methods, a clinical trial is disclosed wherein the composition is applied once daily for 12 weeks and a 1% or 5% BPO gel is compared to vehicle alone (0185). Sertchook reports outcomes of the clinical trial using the Investigator Global Assessment (IGA). Patients were assessed specifically for inflammatory lesions (papules and pustules) at screening, baseline, weeks 4, 8, and 12, and for erythema, and telangiectasia at baseline and weeks 4, 8, and 12 (end of study).
It would have been prima facie obvious at the effective filing date of the instant invention to deliver benzoyl peroxide in the ‘331 method as the sole active agent to treat rosacea. One having ordinary skill in the art would have recognized this as a suitable substance for single agent treatment of rosacea in view of Sertchook who discloses that 12 weeks of treatment with a composition containing from 2.5-10 % BPO alone can reduced symptoms of rosacea, specifically papulopustular rosacea (see example method). Sertchook discloses further that encapsulated compositions can provide extended release of BPO. It would have been prima facie obvious to follow the dosing regimen of once daily for 12 weeks because Sertchook discloses this to be effective in an example method.
The claims of the ‘331 application do not measure outcome using PAPSS or PAPI as required by the instant claims.
Nicholson discloses an instrument for measuring rosacea patient quality of life as assessed by the patient (title, abstract). Nicholson discloses that rosacea, of each subtype erythematotelengietatic, papulopustular persistent, phymatous, and ocular, significantly affects quality of life for patients (page 213, right col). Nicholson discloses further that pharmaceutical companies developing new treatments could benefit from an instrument to measure patient-reported therapeutic impact over time. Nicholson discloses that objective clinical parameters of skin disease are often poorly correlated with quality of life impact and most physicians underestimate the impact of skin disease on quality of life (page 214, left col). Nicholson’s quality of life instrument evaluates factors associated with symptoms, functioning, and emotion (page 214, left col) and some specific metrics include appearance of skin (which the examiner interprets to include redness, as this is a hallmark feature of rosacea), flushes, skin irritation, burning or stinging, embarrassment, frustration, and sensitive skin (table 1).
It would have been prima facie obvious at the effective filing date of the instant invention to evaluate the efficacy of the ‘331 method by measuring the patient’s perception of quality of life as disclosed by Nicholson. The artisan of ordinary skill would have been motivated to do so in order to more accurately capture the efficacy of the treatment as deemed by the patient. The ultimate goal of any treatment is to improve quality of life for the patient. In view of Nicholson, one having ordinary skill in the art would have recognized that the patient’s evaluation of quality of life often does not align with a physician’s objective evaluation of symptoms. The skilled artisan would have had a reasonable expectation of success because this would merely require administering Nicholson’s questionnaire to the patient and because Nicholson indicates that reliability of the survey in accurately capturing changes in quality of life was high (abstract).
With regard to the phrases “Patient Assessment of Papulopustular Rosacea Signs and Symptoms (PAPSS)” as recited in instant claim 1 and “Patient Assessment of Papulopustular Rosacea Impacts (PAPI)” as recited in instant claim 11, the instant specification discloses PAPSS to be measuring burning, redness, and bumps and discloses PAPI to be measuring embarrassment, self-consciousness, and frustration (see page 8 of the instant specification). Nicholson’s quality of life instrument measures appearance of skin (which the examiner interprets to include redness, as this is a hallmark feature of rosacea), flushes, skin irritation, burning or stinging, embarrassment, frustration, and sensitive skin. As Nicholson’s instrument evaluates the same factors, the examiner considers a step of measuring a PAPSS or PAPI to be prima facie obvious.
With regard to claims 6 and 15, the composition may be a suspension (0044).
With regard to claims 7 and 16, Sertchook discloses treating papulopustular rosacea (0034).
With regard to claims 8 and 17 the composition may be a cream or emulsion (0043).
With regard to claims 9 and 18, the composition provides extended release (figure 3; “the controlled release of the pharmaceutical active agent was slow enough to allow for controlled and slow release of the pharmaceutical active agent over a prolonged period of time” 0024). The controlled release is achieved by coating the BPO (0073). One having ordinary skill in the art would have expected the encapsulated (i.e. coated) BPO of the ‘331 application to also provide extended release.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 08/28/2025 have been fully considered but they are not persuasive.
On pages 6-15 of the remarks, Applicant traverses the double patenting rejections as follows:
Throughout pages 6-15, Applicant describes the limitations of the cited patents or copending applications, the teachings of Nicholson, and/or the teachings of Sertchook and describes the limitations not taught be each reference in isolation. Applicant asserts there would have been no reason to combine these references.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the instant case, these arguments are not persuasive because they do not address the reasoning underlying the obviousness conclusion in each rejection. For example, in applications or patents directed to compositions comprising benzoyl peroxide in which an intended use other than treatment of rosacea is either recited in the claims or mentioned in the specification, Applicant asks “why would one consider at the effective filing date of the instant application to interpret that claims of [the cited patent or application] may be used for treating rosacea?” The answer to this question was laid out in the rejections in each instance. In each case, one having ordinary skill in the art would have recognized the claims of the cited applications or patents to embrace a composition suitable for rosacea treatment in view of the cited prior art.
Throughout pages 6-15, Applicant argues that Nicholson merely discloses a general survey instrument for assessing patient quality of life without suggesting that benzoyl peroxide treatment would achieve the specific quantifiable thresholds recited in the present claims.
This argument does not address the reasoning underlying the obviousness conclusion. As explained in each of the rejections above that cite Nicholson to address limitations requiring an improvement in PAPI or PAPSS, with regard to the phrases “Patient Assessment of Papulopustular Rosacea Signs and Symptoms (PAPSS)” as recited in instant claim 1 and “Patient Assessment of Papulopustular Rosacea Impacts (PAPI)” as recited in instant claim 11, the instant specification discloses PAPSS to be measuring burning, redness, and bumps and discloses PAPI to be measuring embarrassment, self-consciousness, and frustration (see page 8 of the instant specification). Nicholson’s quality of life instrument measures appearance of skin (which the examiner interprets to include redness, as this is a hallmark feature of rosacea), flushes, skin irritation, burning or stinging, embarrassment, frustration, and sensitive skin. As Nicholson’s instrument evaluates the same factors, the examiner considers a step of measuring a PAPSS or PAPI to be prima facie obvious. With regard to expectation of success, (1) the efficacy seen with prior art methods is sufficient to provide a reasonable expectation of success that the claimed efficacy in terms of patient’s self-assessment; (2) the methods rendered obvious by the cited patents/applications in combination with the cited prior art are sufficiently similar to those instantly claimed to support an inherency argument (see detailed discussion in the examiner’s response to traversal of the obviousness rejections, below); and (3) it would have been obvious to adjust dose, excipients, and schedule to achieve an outcome that the patient considered favorable because such is the objective of treatment. Also, with regard to the argument that in some claims a treatment duration of 52 weeks is recited, as explained in the rejection, it would be obvious to measure patient reported outcome, and the achieved outcome is necessarily an inherent result of carrying out the claimed method steps.
In several locations Applicant points to allegedly unexpected clinical outcomes not suggested by the copending applications or patents.
Please see the full discussion below: These arguments are not persuasive because Applicant has not met the burden to overcome an obviousness rejection with a persuasive showing of unexpected results.
With regard to the argument on page 14 that the ‘382 claims are directed to a process of coating benzoyl peroxide, the examiner notes that the application also claims the product, the coated particles of benzoyl peroxide. The instant claims are considered an obvious variant of the ‘382 invention because it would have been obvious to use these particles in a method of treating rosacea as laid out in the rejection.
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.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sertchook et al. (US 9,687,465; issue date: 06/27/2017; cited in the IDS filed 03/31/2024) in view of Nicholson et al. (J Am Acad Dermatol Vol 57 No 2, pages 213-221; publication year: 2007; cited in the IDS filed 03/31/2024).
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Toledano et al. (US 9,868,103; issue date: 01/16/2019) n view of Sertchook et al. (US 2017/0281571; publication date: 10/05/2017; cited in the IDS filed 09/30/2020) and further in view of Nicholson et al. (J Am Acad Dermatol Vol 57 No 2, pages 213-221; publication year: 2007; of record).
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Toledano et al (US 20100016443; publication date: 01/21/2010; PGPub of copending Application No. 12/,525,331; cited in the IDS filed 03/31/2024) in view of Sertchook et al. (US 2017/0281571; publication date: 10/05/2017; cited in the IDS filed 03/31/2024) and further in view of Nicholson et al. (J Am Acad Dermatol Vol 57 No 2, pages 213-221; publication year: 2007; cited in the IDS filed 03/31/2024).
In each rejection above, the claims are rejected as obvious under 35 USC 103 exactly as set forth in the double patenting rejection above.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sertchook et al. (US 2017/0281571; publication date: 10/05/2017; cited in the IDS filed 03/31/2024) in view of Nicholson et al. (J Am Acad Dermatol Vol 57 No 2, pages 213-221; publication year: 2007; cited in the IDS filed 03/31/2024).
Sertchook discloses a method of treatment of rosacea and a composition for topical use for treating rosacea and symptoms and conditions of rosacea (title abstract). The composition is administered topically to the skin (0019) in a physiologically acceptable medium (i.e. a carrier; 0042). The composition contains from about 2.5 to 5 weight % of benzoyl peroxide (BPO) as the single pharmaceutical active agent in the composition (0018). In example methods, a clinical trial is disclosed wherein the composition is applied once daily for 12 weeks and a 1% or 5% BPO gel is compared to vehicle alone (0185). Sertchook reports outcomes of the clinical trial using the Investigator Global Assessment (IGA). Patients were assessed specifically for inflammatory lesions (papules and pustules) at screening, baseline, weeks 4, 8, and 12, and for erythema, and telangiectasia at baseline and weeks 4, 8, and 12 (end of study).
Sertchook does not disclose measuring a Patient Assessment of Papulopustular Rosacea Signs and Symptoms (PAPSS) as required by instant claim 1 or measuring a Patient Assessment of Papulopustular Rosacea Impacts (PAPI) as required by instant claim 11.
Nicholson discloses an instrument for measuring rosacea patient quality of life as assessed by the patient (title, abstract). Nicholson discloses that rosacea, of each subtype erythematotelengietatic, papulopustular persistent, phymatous, and ocular, significantly affects quality of life for patients (page 213, right col). Nicholson discloses further that pharmaceutical companies developing new treatments could benefit from an instrument to measure patient-reported therapeutic impact over time. Nicholson discloses that objective clinical parameters of skin disease are often poorly correlated with quality of life impact and most physicians underestimate the impact of skin disease on quality of life (page 214, left col). Nicholson’s quality of life instrument evaluates factors associated with symptoms, functioning, and emotion (page 214, left col) and some specific metrics include appearance of skin (which the examiner interprets to include redness, as this is a hallmark feature of rosacea), flushes, skin irritation, burning or stinging, embarrassment, frustration, and sensitive skin (table 1).
It would have been prima facie obvious at the effective filing date of the instant invention to evaluate the efficacy of Sertchook’s method by measuring the patient’s perception of quality of life as disclosed by Nicholson. The artisan of ordinary skill would have been motivated to do so in order to more accurately capture the efficacy of the treatment as deemed by the patient. The ultimate goal of any treatment is to improve quality of life for the patient. In view of Nicholson, one having ordinary skill in the art would have recognized that the patient’s evaluation of quality of life often does not align with a physician’s objective evaluation of symptoms. The skilled artisan would have had a reasonable expectation of success because this would merely require administering Nicholson’s questionnaire to the patient and because Nicholson indicates that reliability of the survey in accurately capturing changes in quality of life was high (abstract).
With regard to the phrases “Patient Assessment of Papulopustular Rosacea Signs and Symptoms (PAPSS)” as recited in instant claim 1 and “Patient Assessment of Papulopustular Rosacea Impacts (PAPI)” as recited in instant claim 11, the instant specification discloses PAPSS to be measuring burning, redness, and bumps and discloses PAPI to be measuring embarrassment, self-consciousness, and frustration (see page 8 of the instant specification). Nicholson’s quality of life instrument measures appearance of skin (which the examiner interprets to include redness, as this is a hallmark feature of rosacea), flushes, skin irritation, burning or stinging, embarrassment, frustration, and sensitive skin. As Nicholson’s instrument evaluates the same factors, the examiner considers a step of measuring a PAPSS or PAPI to be prima facie obvious.
With regard to claims 1 and 11, the examiner notes that the claimed method evaluates response using a Patient Assessment of Papulopustular Signs and Symptoms and a Patient Assessment of Papulopustular Impacts, but the claimed method is not limited to patients having the papulopustular manifestation of rosacea. Although this patient population is not required in the method delimited in the instant claims, the examiner also notes that Sertchook discloses treating patients having papulopustular rosacea (0034).
With regard to the intended outcomes recited in claim 1 of a decrease in PAPSS is at least about 30% after treatment with said pharmaceutical composition for about 2 weeks compared with a decrease of about 20 % after 2-week treatment with vehicle alone and claim 11 of a decrease in PAPI is at least about 35% after treatment with said pharmaceutical composition for about 2 weeks compared with a decrease of about 23% after treatment with vehicle alone, all of the active method steps recited in the instant claims are disclosed by Sertchook. Specifically, Sertchook discloses steps of topically administering to a patient suffering from rosacea a composition comprising BPO as the sole pharmaceutically active agent and containing BPO at 5% by weight in a pharmaceutically acceptable carrier for 12 weeks. The claimed invention differs from Sertchook only in the method of measuring the outcome of treatment, as noted above. As all of the active method steps disclosed by Sertchook fall within the scope of the instant claims, the examiner considers the requisite outcome to be inherent. Moreover, the intent of Sertchook is to treat the rosacea, and BPO is disclosed to be effective for this purpose. It also would have been prima facie obvious to optimize dose, timing of administration, and vehicle to maximize efficacy and minimize side effects. Specifically it would have been obvious to seek an amount and dosing schedule of BPO that would be effective without causing irritation, and to select a vehicle that reduces inflammation and irritation by testing several doses, and administration schedules and by including inactive ingredients in the vehicle that are known to be soothing to skin. Sertchook evaluates two different doses and reports improvement in mean IGA at the 1% dose and the 5% dose over vehicle control (0195 and figure 1), thus there appears to be a relationship between dose and efficacy, although not for all measures: the 1% gel was comparable to the 5% gel in terms of mean inflammatory lesion count (figure 2). Sertchook also discloses that BPO has been associated with irritation and intolerance (e.g. 0015 and 0036), therefore one of ordinary skill would have been aware that there are dose-limiting toxicities associated with BPO, in addition to the direct correlation between percent BPO and overall IGA shown in figure 1. Sertchook also explains the following (0024):
It has been found by the inventors of the present application that a composition comprising BPO, having dissolution rate of less than about 80%/h provides a safer and more effective treatment of rosacea with respect to the tolerance and adverse effect as compared with compositions having similar amount of pharmaceutical active agent with faster dissolution. It was shown by the inventors of the application that as the dissolution rate of BPO is lowered to less than 80%/h the treatment of a chronic skin disease such as rosacea, including its symptoms and conditions associated therewith, was dramatically improved since the controlled release of the pharmaceutical active agent was slow enough to allow for controlled and slow release of the pharmaceutical active agent over a prolonged period of time, releasing an amount of BPO able to treat the disease, symptoms and/or conditions associated with rosacea, but on the other hand not allowing for intolerance or adverse effects to appear.
In view of this disclosure, one having ordinary skill in the art would have reasonably expected to be also able to optimize BPO release rate in order to maximize efficacy (whether in terms of the IGA reported by Sertchook, or in terms of a patient evaluation of symptoms and impact as disclosed by Nicholson). Finally, Sertchook discloses adding the “calmative” class of excipients (0041), which one having ordinary skill would have recognized could have been included in the composition to reduce the irritating effect of BPO. Thus, the examiner also considers it prima facie obvious to have optimized the treatment protocol to achieve the intended outcomes recited in the claims.
With regard to claims 2, 3 12, 13, and 19, these claims recite intended outcomes of the claimed method, specifically that the decrease in PAPSS is at least about 40% after treatment with said pharmaceutical composition for about 4 weeks compared with a decrease of less than about 40% after 4-week treatment with vehicle alone (claim 2); the decrease in PAPSS is from about 50% to about 65% after treatment with said pharmaceutical composition for at least about 8 weeks compared with a decrease from about 25% to about 40% after 8-week treatment with vehicle alone (claim 3); the decrease in PAPI is from about 60% to about 70% after treatment with said pharmaceutical composition for at least about 8 weeks compared with a decrease of about 35% after 8-week treatment with vehicle alone (claim 12); and an average decrease in the PAPI after treatment with said pharmaceutical composition for at least about 8 weeks is approximately about 1.2 to two times an average decrease in the PAPI after 8-week treatment with vehicle alone (claim 19). Claims 2, 3, 12, 13, and 19 are considered inherent and also obvious for reasons analogous to the analysis set forth above for the intended outcomes of claims 1 and 11.
With regard to claims 4 and 13, as noted above, in certain embodiments BPO is the sole pharmaceutical active ingredient in the composition.
With regard to claims 5 and 14, as noted above, an example composition contains 5% BPO.
With regard to claims 6 and 15, the composition may be a suspension (0044).
With regard to claims 7 and 16, Sertchook discloses treating papulopustular rosacea (0034).
With regard to claims 8 and 17 , the composition may be a cream or emulsion, which would have a fatty or oily phase (0043).
With regard to claims 9 and 18, the composition provides extended release (figure 3; “the controlled release of the pharmaceutical active agent was slow enough to allow for controlled and slow release of the pharmaceutical active agent over a prolonged period of time” 0024). The controlled release is achieved by coating the BPO (0073).
With regard to claim 10, as noted above, in view of Nicholson, one having ordinary skill in the art would have found it obvious to measure the patient’s assessment of appearance of skin (which the examiner interprets to include redness, as this is a hallmark feature of rosacea), flushes, skin irritation, burning or stinging.
With regard to claim 20, as noted above, in view of Nicholson, one having ordinary skill in the art would have found it obvious to measure the patient’s assessment of embarrassment and frustration.
Response to Arguments
Applicant's arguments and the declaration, both filed 08/28/2025, have been fully considered but they are not persuasive.
The examiner notes that the declaration filed 08/28/2025 is a copy of the declaration filed in parent application no. 16794923. The examiner’s response is the same and is replicated here:
Response to Declaration:
With regard to Declarant’s assertion of unexpected results on pages 2-4, please see the discussion of the burden on Applicant to overcome an obviousness rejection with a persuasive showing of unexpected results in the “Response to Arguments” section below.
On pages 6-7 of the declaration, Declarant argues that one of ordinary skill in the art would have understood that an improvement in IGA relative to baseline may not correlate with an improvement in PAPSS after only about 2 weeks and one having ordinary skill would have understood that a percent change in mean inflammatory lesion count would not necessarily correlated with improvement in PAPPS. Applicant argues that none of the Sertchook publications cited in the obviousness rejection of the instant claims describes any outcome of BPO on PAPSS therefore one of ordinary skill in the art would not consider, envisage, or even contemplate the methods described in Sertchook to result in a percentage decrease in PAPSS of at least about 30% after about 2 weeks compared with a decrease of about 20% after 2-week treatment with a vehicle alone as recited in claim 1. On pages 8-9, analogous arguments are presented with respect to claim 11.
These arguments ignore the express rationales set forth in the rejection and discussed in more detail below underlying the inherency conclusion with regard to effect on PAPSS or PAPI and also the obviousness conclusion with respect to optimizing BPO release rate from Sertchook’s extended release formulation to maximize treatment efficacy and minimize negative side effects of the composition. The claimed invention differs from Sertchook’s disclosure only in terms of the method used to measure outcomes of treatment. As these methods were known in the art, the claims are considered prima facie obvious. See further discussion of this point in the Response to Arguments section below. See also Persion Pharmaceuticals LLC v. Alvogen Malta Operations LTD, 945 F.3d 1184, 2019 U.S.P.Q.2d 494084 (Fed. Cir. 2019), Court Opinion (12/27/2019).
On pages 7 and 8, Declarant argues that one of ordinary skill would have understood that topical administration of BPO was associated with skin irritation and this would not reduce and in fact could increase erythema in a rosacea subject.
This argument is discussed in detail in the Response to Arguments section below. Briefly, Sertchook appreciated the problem with BPO exposure and skin irritation and in fact, Sertchook’s extended release BPO formulation solves this problem by slowing release of BPO such that effective but non-irritating concentrations of BPO are achieved on the surface of the skin for a duration sufficient to treat symptoms of rosacea without causing unwanted side effects such as inflammation.
On pages 9-11 Declarant presents analogous arguments with respect to the Toledano publications. On page 13, Declarant describes the teachings of Nicholson and argues that the active method steps recited in the instant claims regarding application of BPO to treat rosacea are not taught by Nicholson.
Toledano ‘927, Toledano ’899 and Toledano ‘985 are not cited under 35 USC 103 against the instant claims. Shevachman is also not cited against the instant claims.
With regard to Toledano ‘443, Declarant argues that Toledano ‘443 teaches BPO as an anti-acne agent and therefore the instant claims, directed to methods of treating rosacea erythema, are non-obvious.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On pages 13-14, Declarant argues that Applicant’s important discovery occurred after many years of clinical studies at the cost of tens of millions of dollars.
Cost incurred by Applicant and duration of research are not factors under evaluation in an obviousness analysis under 35 USC 103. See MPEP 2143 and 2144.
Response to Arguments:
On pages 16-19, Applicant reiterates arguments that were presented in the declaration filed 08/28/2025:
Applicant argues that Sertchook describes response as measured by the IGA and one would not have expected a response measured by IGA to translate to the claimed response on PAPI or PAPSS and Sertchook does not teach the claimed self-reported improvements. Applicant argues that one having ordinary skill would not have considered the features of claims 1 and 11 to be present in Sertchook/Sertchook does not describe results at 2 weeks, and that inherency cannot be relied upon to support an obviousness conclusion. On page 19, Applicant argues that one having ordinary skill would have recognized BPO as causing irritation, citing the declaration, which in turn cites Sparavinga and Leyden.
This is not persuasive because the above is a mere assertion and fails to address the specific explanation provided in the rejection supra as to how each and every element of the claimed invention is taught in the prior art. No traversal of the examiner’s rationale underlying the inherency conclusion with respect to intended outcomes not overtly taught by Sertchook has been put forth and accordingly the examiner maintains the opinion that the preponderance of the evidence supports the inherency conclusion for the reasons detailed above. All active treatment steps recited in the claims are taught by Sertchook to include the identity of the BPO formulation used. Based solely upon what one would have known as of the instant effective filing date, it would have been obvious to measure the efficacy of Sertchook’s BPO formulation using methodology falling within the scope of the terms “a PAPSS” or “a PAPI” for the reasons detailed in the rejection. The claimed intended outcome of the regimen is considered inherent because all of the steps to treat rosacea with the same formulation as claimed are disclosed by Sertchook, absent evidence to the contrary. Specifically, Sertchook discloses steps of topically administering to a patient suffering from mild to severe rosacea a composition comprising BPO as the sole pharmaceutically active agent and containing BPO at 5% by weight in a pharmaceutically acceptable carrier for 12 weeks. The claimed invention differs from Sertchook only in the method used to test the outcome of treatment, as noted above. As all of the active method steps disclosed by Sertchook fall within the scope of the instant claims, the examiner considers the requisite outcome to be inherent.
Sertchook also explains the following (0024):
It has been found by the inventors of the present application that a composition comprising BPO, having dissolution rate of less than about 80%/h provides a safer and more effective treatment of rosacea with respect to the tolerance and adverse effect as compared with compositions having similar amount of pharmaceutical active agent with faster dissolution. It was shown by the inventors of the application that as the dissolution rate of BPO is lowered to less than 80%/h the treatment of a chronic skin disease such as rosacea, including its symptoms and conditions associated therewith, was dramatically improved since the controlled release of the pharmaceutical active agent was slow enough to allow for controlled and slow release of the pharmaceutical active agent over a prolonged period of time, releasing an amount of BPO able to treat the disease, symptoms and/or conditions associated with rosacea, but on the other hand not allowing for intolerance or adverse effects to appear.
In view of the foregoing disclosure it is the composition disclosed by Sertchook, providing delayed release of BPO, that allows for avoidance of the negative side effects when BPO is applied in high amounts and concomitant patient compliance. Because the composition disclosed by Sertchook appears to be identical to the claimed composition, the application ste