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
Applicant's election with traverse of Group I, claims 1-15 and 21-22 in the reply filed on 11/17/2025 is acknowledged. The traversal is on the ground(s) that the two groups share a common special technical feature that defines over the prior art which will be established during prosecution.
This is not found persuasive because as set forth in Rule 13.1 of the Patent Cooperation Treaty (PCT), "the international application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept.” Moreover, as stated in PCT Rule 13.2, "where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features." Furthermore, Rule 13.2 defines "special technical features" as "those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art." A lack of unity of invention determination begins with a consideration of the claims in light of the description and drawings. Lack of unity of invention may be directly evident “a priori,” or before considering any prior art when no special technical feature is common to each of the independent claims. Alternatively, lack of unity of invention may only become evident “a posteriori,” or after considering the claims in relation to the prior art.
The common technical feature of Groups I-II is a composition comprising benzoyl peroxide, azelaic acid, a strontium salt, methylsulfonylmethane (MSM) and a dermatologically acceptable carrier, formulated as one or more dosage forms, wherein at least one dosage form comprises both benzoyl peroxide and azelaic acid.
Rosman et al. (WO2019198067) teach topical formulations which comprise methylsulfonylmethane and strontium, see paragraph [0001]. The strontium can take the form of strontium chloride hexahydrate, see paragraphs [0055] and [0079]. Rosman et al. teach that one or more additional active agents can be added including azelaic acid, see paragraphs [0034]-[0035]. The strontium can be present from 0.1-10% by weight, see paragraphs [0043]-[0045] and [0065]. The azelaic acid can be applied at 25% by weight, see paragraph [0078]. The topical formulation can be formulated as a cream, see paragraphs [0058]-[0059].
Rosman does not teach the presence of benzoyl peroxide at a with their azelaic acid formulation wherein benzoyl peroxide is from 0.1-30% w/w and wherein propylene glycol is present as a permeation enhancer. Guy Webster (Combination of Azelaic Acid Therapy for Acne Vulgaris) teaches that azelaic acid plus benzoyl peroxide gives a greater efficacy and higher patient ratings for acne, see abstract and discussion sections. Benzoyl peroxide is taught at 4% concentration but is silent to the units, see abstract. Jerry Zhang (United States Patent Publication 2009/0209604) Zhang teaches topical compositions which comprise benzoyl peroxide, vitamins, and at least one dicarboxylic acid including azelaic acid, see claim 1 and 3. The combination therapy reduces side effects and has enhanced therapeutic efficacy, see paragraph [0008]. Benzoyl peroxide can comprise from 2-10% by weight, see paragraphs [0021] and claim 1-2 and 14-15. The topical composition comprises propylene glycol as a penetration enhancer, see paragraph [0047]. Based on the prior art, of ordinary skill in the art would have combined azelaic acid with benzoyl peroxide from 2-10% by weight and to provide greater efficacy against acne than administering each alone. Thus, the common technical feature of the instant claims lacks novelty over the prior art. Since the common technical feature is taught by the prior art, the common technical feature does not rise to the level of a special technical feature. Thus, the groups lack unity of invention a posteriori and restriction between them is proper. Accordingly, any subsequent patentably distinct invention lacks unity with the first group, see 37 CFR § 1.476 (d)
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election without traverse of the species: strontium chloride hexahydrate, benzoyl peroxide, azelaic acid, MSM, sulfur as the additional active, and propylene glycol as the penetration enhancer in the reply filed on 11/17/2025 is acknowledged.
Claims 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/17/2025.
Claims 1-15 and 21-22 are under current examination, strontium chloride hexahydrate, benzoyl peroxide, azelaic acid, MSM, sulfur as the additional active, and propylene glycol as the penetration enhancer.
Information Disclosure Statements
Information Disclosure Statements (IDS) filed on 06/27/2024 and 04/01/2025 have been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Claim Objections
Claim 12 is objected to because of the following informalities: For readability of the claim and claim language consistency, claim 12 should recite “further comprising” since the claim is adding additional ingredients to the cosmetic product or medicament of claim 11. Note that this is consistent with claim 9 which recites further comprising with addition of at least one additional active ingredient.
Claim 13 is objected to because of the following informalities: For readability of the claim and claim language consistency, claim 13 should recite “further comprising” since the claim is adding propylene glycol to the cosmetic product or medicament of claim 11.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)-indefinite
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 and 21-22 are 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The recitation in claim 1 is interpreted wherein all of the dosage forms of the composition comprise benzoyl peroxide, azelaic acid, strontium salt, methylsulfonylmethane, and a dermatologically acceptable carrier. In the present instance, the recitation in claim 1 of at least one dosage form comprises both benzoyl peroxide and azelaic acid recites the broad recitation, and the claim also recites a composition comprising benzoyl peroxide, azelaic acid, a strontium salt, methylsulfonylmethane and a dermatologically acceptable carrier which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Therefore, the additional recitation of wherein at least one dosage form comprises both benzoyl peroxide and azelaic acid renders the scope of the claim indefinite. Claims 2-15 and 21-22 are rejected since they require all the limitations of claim 1 and do not rectify the indefinite issue of claim 1.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the recitation in claim 4 of at least one of is interpreted as allowing one or more ranges recited by the claim and thus the claim recites the broad recitation of about 2.5-10% by w/w, about 8 to 15% w/w, and the claim also recites from about 5 to about 10% w/w, about 5% w/w or about 10% w/w which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Therefore, it is unclear what the amount of benzoyl peroxide should be present because the claim recites at least one which allows for multiple broader rages and the narrower values recited by claim 4.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the recitation in claim 6 of at least one of is interpreted as allowing for one or more ranges recited by the claim and thus the claim recites the broad recitation of about 0.5% to about 25% w/w, with a broader range of from about 5 to about 30% w/w, from about 10% to about 25% w/w, from about 15 to about 35% w/w, and the claims also recite from about 15% w/w or about 25% w/w which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. It is therefore unclear what the amount of azelaic acid should be present to meet the claim because the claim recites at least one which allows for a broader rage and then the narrower values recited by claim 6.
.
Claim Rejections - 35 USC § 103
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 1-6, 8, 11-15 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Rosman et al. (WO2019198067) in view of Jerry Zhang (United States Patent Publication 2009/0209604) and Guy Webster (Combination of Azelaic Acid Therapy for Acne Vulgaris).
Rosman et al. teach topical formulations which comprise methylsulfonylmethane and strontium, see paragraph [0001]. The strontium can take the form of strontium chloride hexahydrate, see paragraphs [0055] and [0079]. Rosman et al. teach that one or more additional active agents can be added including azelaic acid and retinol, see paragraphs [0034]-[0035]. The strontium can be present from 0.1-10% by weight, with 5% by weight strontium chloride being exemplified, see paragraphs [0043]-[0045] and [0065]. The azelaic acid can be applied at 25% by weight, see paragraph [0078]. The topical formulation can be formulated as a cream, see paragraphs [0058]-[0059]. The topical formulations can treat acne or rosacea, see paragraphs [0036], [0028] and [0030].
Rosman et al. do not teach the presence of benzoyl peroxide with their azelaic acid formulation wherein benzoyl peroxide is from 0.1-30% w/w and wherein propylene glycol is present as a permeation enhancer.
Webster teaches that azelaic acid plus benzoyl peroxide gives a greater efficacy and higher patient ratings for acne, see abstract, pages 2-3 and discussion sections. Benzoyl peroxide is taught at 4% concentration but is silent to the units, see abstract.
Webster does not expressly teach a range of from about 2-10% w/w benzoyl peroxide or the presence of propylene glycol.
However, Zhang teaches topical compositions which comprise benzoyl peroxide, vitamins, and at least one dicarboxylic acid including azelaic acid, see claim 1 and 3. The combination therapy reduces side effects and has enhanced therapeutic efficacy, see paragraph [0008]. Benzoyl peroxide can preferably comprise from 2-10% by weight (w/w), see paragraphs [0021], [0023] and claim 1-2 and 14-15. The topical composition comprises propylene glycol as a penetration enhancer, see paragraph [0047].
It would have been prima facie obvious to combine the azelaic acid taught by Rosman et al. with benzoyl peroxide from 2-10% by weight and to include propylene glycol with the topical formulation of Rosman.
One of ordinary skill in the art would have been motivated to combine benzoyl peroxide with the azelaic acid of Rosman because benzoyl peroxide with azelaic acid is taught to provider greater efficacy against acne than administering each alone, and per the teachings of Zhang, benzoyl peroxide can be combined with azelaic acids in amounts from 2-10% by weight for topical formulations including for the treatment of acne. One of ordinary skill in the art would have been motivated to incorporate propylene glycol in order to enhance penetration of the topical formulation.
There would have been a reasonable expectation of success because Rosman et al., Zhang and Webster teach topical formulations including for the treatment of acne which comprise azelaic acid.
With respect to claim 15, as Rosman et al., in view of Zhang and Webster arrives at a cream composition comprising azelaic acid, MSM, strontium chloride hexahydrate and benzoyl peroxide, the physical and/or chemically stability would be the natural result of the cream formulation having a combination of the same ingredients absent evidence to the contrary, see Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019).
Claim(s) 7 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Rosman et al. (WO2019198067), Jerry Zhang (United States Patent Publication 2009/0209604) and Guy Webster (Combination of Azelaic Acid Therapy for Acne Vulgaris) as applied to claims 1-6, 8, 11-15 and 21 above and further in view of Tamarkin et al. (United States Patent Publication 2021/0069335).
Rosman et al. do not teach homogenous (i.e. uniform) distribution of the azelaic acid and/or benzoyl peroxide.
Zhang teaches that micronized benzoyl peroxide can be made by mixing until a uniform gel is formed with azelaic acid being added uniformly, see examples 1-2 suggesting that both benzoyl peroxide and azelaic acid should be uniform.
However, Zhang does not teach benzoyl peroxide and azelaic acid as a homogenous distribution wherein both are micronized particles.
Tamarkin et al. teach that micronized active agents that are homogenized can assist in the delivery to the skin or mucosal surfaces, see paragraph [0338]. Compositions that remain uniform do not precipitate thus are stable, see paragraph [0153]. Examples of active agents include azelaic acid and/or benzoyl peroxide, see paragraphs [0089], [0114] and [0406]
It would have been prima facie obvious to provide the azelaic acid and benzoyl peroxide of the modified Rosman et al. as homogenously distributed micronized particles.
One of ordinary skill in the art would have been motivated to do so to maintain stability and assist with delivery to mucosal surfaces given Tamarkin teaches that micronized homogenized particles aide in delivery to skin surfaces and do not precipitate.
Claim(s) 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Rosman et al. (WO2019198067) Jerry Zhang (United States Patent Publication 2009/0209604) and Guy Webster (Combination of Azelaic Acid Therapy for Acne Vulgaris) as applied to claims 1-6, 8, 11-15 and 21 above, and further in view of Weinberger et al. (United Stated Patent Publication 2021/0238131-filed 4/16/22).
The teachings of Rosman et al. in view of Zhang and Webster are discussed above.
Rosman et al., Zhang and Webster do not expressly teach the addition of sulfur (elected species) as an additional compound.
Weinberger et al. teach pharmaceutical compositions which treat dermatological disorders comprising azelaic acid, see abstract. Examples of dermatological disorders include acne and rosacea, see paragraphs [0024] and [0029]. Topical agents which treat acne include benzoyl peroxide which kills bacteria with salicylic acid and sulfur, see paragraphs [0007] and [0044].
It would have been prima facie obvious to include sulfur with the topical formulation of Rosman.
One of ordinary skill in the art would have been motivated to do so because Weinberger teaches that benzoyl peroxide and sulfur are an effective cosmetic active agents useful in treating acne. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) . In the instant case, it would have been obvious to add sulfur to the acne treating composition taught by Rosman et al. because sulfur and benzoyl peroxide are taught as useful anti-acne actives together.
There would have been a reasonable expectation of success because Rosman et al. teach that one or more additional cosmetic active ingredients can be present in the composition, and Weinberger teaches that one more active compounds including sulfur, benzoyl peroxide and azelaic acid treat dermatological conditions including acne (see paragraph [0044]).
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 1-15 and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-10 of U.S. Patent No. 11918666 in view of Zhang United States Patent Publication 2009/0209604)and Tamarkin et al. (United States Patent Publication 2021/0069335).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Both the instant claims and those of Patent ‘666 claim topical compositions which comprise strontium salt including strontium chloride hexahydrate together with methylsulfonylmethane (MSM). Both the topical composition of Patent ‘666 and the instant claims can further comprise at least one active ingredient including benzoyl peroxide and sulfur. Both Patent ‘666 and those of the instant claims include azelaic acid. The strontium salt of Patent ‘666 can be present from 5-10% by weight with MSM at 10-5% w/w. The benzoyl peroxide of the instant claims can be present from 0.1-30% by weight or from 2.5-10% w/w, which overlaps thus is obvious over the 0.1-20% by weight of Patent ‘666 at claim 9. The azelaic acid of the instant claims can be present from about 0.5-25% w/w which overlaps the 0.1-40% w/w recited in claim 9 of Patent ‘666.
The difference between the instant claims and that of Patent ‘666 is the homogenous distribution of azelaic acid and/or benzoyl peroxide micronized particles.
Zhang teaches that micronized benzoyl peroxide can be made by mixing until a uniform gel is formed with azelaic acid being added uniformly, see examples 1-2 suggesting that both benzoyl peroxide and azelaic acid should be uniform.
Zhang does not teach benzoyl peroxide and azelaic acid as a homogenous distribution wherein both are micronized particles.
Tamarkin et al. tech that micronized active agents that are homogenized can assist in the delivery to the skin or mucosal surfaces, see paragraph [0338]. Compositions that remain uniform do not precipitate thus are stable, see paragraph [0153]. Examples of active agents include azelaic acid and/or benzoyl peroxide, see paragraphs [0089], [0114] and [0406]
It would have been obvious to make azelaic acid and benzoyl acid of Patent ‘666 as homogenously distributed micronized particles.
One of ordinary skill in the art would have been motivated to do so to maintain stability and assist with delivery to mucosal surfaces.
Conclusion
Currently, no claims are allowed and all claims are rejected.
Correspondence
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619