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 .
Information Disclosure Statements
Information Disclosure Statements (IDS) filed on 04/27/2026 and 06/03/2026 have been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Status of the Claims
Claims 1-15 and 21-22 are under current examination to strontium chloride hexahydrate, benzoyl peroxide, azelaic acid, MSM, sulfur as the additional active, and propylene glycol as the penetration enhancer.
Applicants' amendment/remarks filed on 04/27/2026 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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]. The combination of Strontium and MSM in Rosman et al. can be used in a formulation and/or product comprising an active cosmetic ingredient, or used prior or post the use of a topical cosmetic product . When the combination is not part of the product and is applied before or after the product, the combination should be used in close proximity timewise in order to have the desired effect of reducing irritation, see paragraph [00025]. Therefore, the cosmetic product which can further contain azelaic acid can be administered encompassing more than one dosage form in Rosman et al.
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. Patent ‘666 can be formulated as more than one dosage form as evidenced by the claims. Claim 12 of Patent ‘666 for example is a cleanser formulation while claim 8 includes a rejuvenating or peeling formulation.
The difference between the instant claims and that of Patent ‘666 is the homogenous distribution of azelaic acid and/or benzoyl peroxide micronized particles and wherein the composition is formulated as more than one dosage form wherein at least one dosage form comprises both benzyl peroxide and azelaic acid.
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.
Response to remarks
Applicants argue that compositions comprising benzoyl peroxide and azelaic acid that are advantageous in feasibility, stability and efficacy compared to known compositions with these ingredients with respect to alleviation of side effects.
Examiner respectfully submits that it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Here, the prior art 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, thus the prior art recognizes the advantages of a combination treatment.
Applicants argue that the efficacy of a cosmetic product in the treatment of acne is not disclosed in Rosman and benzoyl peroxide is not disclosed or implied. Applicants argue that there is no specific disclosure in Rosman to provide a second active agent.
Examiner respectfully disagrees that a treatment of acne is not disclosed in Rosman because paragraph [0030] expressly teaches for use in products for treatment of acne, see paragraph [0030]. Rosman further teaches that at least one additional cosmetic ingredient can be added to the formulation, see paragraph [0033] and claim 5, thus it is clear from the teachings of Rosman that one or more than one cosmetic ingredients can be applied with their formulation containing MSM and strontium salts.
Applicants argue that Webster does not address incorporating benzoyl peroxide into Rosman’s MSN/strontium low pH propylene glycol vehicle and avoiding the side effects of administering BPO and AZA. Applicants argue that placing BPO with Rosman’s system lacks an enabling pointer given BPOs documented side effects. Applicants argue that Webster does not address the Rosman excipient system and does not supply the missing motivation or expectation of success needed to modify Rosman’s anti-acne formulations in the claimed way which avoids skin damage when administering AZA and BPO together. Applicants argue that BPO is naturally instable in the presence of certain acidic substances.
Examiner respectfully submits that Rosman recognizes that it is the combination of strontium with MSM that reduce side effects/irritations of cosmetic products and that their invention due to those ingredients enables more efficacious products without side effects, see paragraph [0026]. One of ordinary skill in the art would have combined BPO and AZA because Zhang expressly teaches their combination in treatment of acne and Webster suggests that these two actives together are more efficacious than using either alone. It is not Webster alone which provides the benzoyl peroxide, rather Zhang teaches anti-acne products which combine both. The skin irritation could be avoided by the combination because the Rosman reference explicitly teaches that MSM and strontium reduce irritation and development of erythema., see claim 11, paragraphs [0002], [0021]-[0026], [0032] and [0041].Examiner respectfully submits that BPO is taught to be combined for a topical formulation in Zhang with azelaic acid. There is no disclosure of the formulation being degraded or unstable. Furthermore, like the prior art which combines both, the instant claims require a dosage form that combines azelaic acid with benzoyl peroxide, thus is also an acid with benzoyl peroxide.
Applicants argue that one of ordinary skill in the art would not add BPO to Rosman containing propylene glycol due to the reaction as it is volatile thus discouraging the reaction of Rosman and Webster. Applicants note that BPO decomposes rapidly in propylene glycol compared with other vehicles.
Examiner notes that Rosman is silent to the addition of propylene glycol. Nevertheless, the propylene glycol of Zhang is not added as a solvent or carrier vehicle to BPO, rather the cosmetic formulation adds propylene glycol to obtain suitable moisturization properties. The polyols which are added are preferably propylene glycol to the composition which already contains benzoyl peroxide. Furthermore, the instant claims (claim 11) do not limit the propylene glycol from being away from the benzoyl peroxide as the cosmetic product can further comprise propylene glycol.
Applicants argue that neither MSM or strontium salts are disclosed in Zhang whereas the instant invention requires BPO, azelaic acid and strontium salt and dermatologically acceptable carrier. Applicants argue there is no motivation in Zhang to replace vitamin B3 with MSM or introduce strontium salt and MSM with BPO and azelaic acid. The cited document focuses on enhancing skin barrier and anti-inflammatory effects via vitamin B3 using specific vehicles, thus Applicants argue the use of hindsight reasoning to arrive at the combination.
Regarding Applicants’ argument that Zhang does not disclose MSM or strontium salts, Roseman already teaches the combination of MSM and strontium salts. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here, 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. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicants argue that Zhang and the present application address different technical problems as while Zhang primarily addresses acne treatment using BPO plus dicarboxylic acid plus vitamin B3 improves tolerability via specific solvent systems, the present application addresses a more complex problem namely reducing irritation commonly associated with application of BPO and azelaic acid and enhancing tolerability while maintaining or improving efficacy. The introduction of strontium and MSM is directed to this distinct problem. Thus, the combination of BPO plus azelaic acid plus strontium plus MSM provides improved skin tolerability and reduced irritation without comprising antimicrobial/keratolytic activity compared to BPO plus AZA systems devoid of the strontium and MSM. The combination provides for synergistic keratolytic and anti-bacterial effects for BPO and AZA enabled by the presence of strontium plus MSM. Applicants argue the effect of co-application of MSM and strontium in treating rosacea, acne, seborrhea with BPO and azelaic acid is demonstrated in Example 2 for the improved irritation and redness of side effects. The improved tolerability and enhanced efficacy provided by the instant claimed composition go beyond what would be expected from a sequential administration of known components and may be indicative of synergism.
Examiner respectfully submits that it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Here, the prior art 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, thus the prior art recognizes the advantages of combining both. Furthermore, Rosman acknowledges that the combination of strontium plus MSM does reduce irritation that can be caused by skin treating compositions not limited to ones that contain azelaic acid, see abstract and paragraph [0038], [0041], and example II. The combination of MSM and Strontium yields a synergistic effect, see paragraph [0071] of Rosman.
Applicants argue that while Zhang requires specific vehicles with alkanediols, the instant claimed composition does not require such carries.
Examiner respectfully submits that the instant claims do not exclude the presence of additional ingredients in view of the “comprising” claim language. he transitional t erm "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). The instant claims are not limited to azelaic acid, benzoyl peroxide and MSM and strontium.
With regards to Webster, Applicants argue that Webster does not disclose a single integrated composition comprising benzoyl peroxide and azelaic acid as such as combination has skin irritation problems. Applicants argue that Webster is silent to the inclusion of MSM or strontium salts, and Webster does not address the problem of inflammation, nociceptor activation or sensory irritation associated with topical application of such agents. Applicants argue that the combination with Rosman lacks an enabling disclosure and reasonable expectation of success.
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). Here, it is the combination of Rosman with Zhang and Webster that arrive at the instantly claimed invention. Zhang expressly teaches a combination of benzoyl peroxide together with azelaic acid in a topical composition. The Rosman references expressly teaches that MSM and strontium salts help reduce irritation of skin with application of other cosmetic actives including azelaic acid. 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. When the reference relied on makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP § 716.07. In addition, objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Furthermore, the instant claims do not require a single composition having MSM, strontium salt and benzoyl peroxide and azelaic acid because claim 1 recites that there can be more than one dosage form meaning that the product does not necessarily have to be administered all in one.
Applicants argue that to arrive at the claimed invention the rejection requires selectively combining elements from multiple references each directed to different compositions and solving different technical problems without any teaching or suggestion in the art that a combination would be desirable. Applicants argue that to arrive at the claimed compositions, a POSITA must extract azelaic acid form Rosman, combine with benzoyl peroxide of Webster or Zhang and incorporate penetration enhancers from Zhang and further include strontium salts and MSM but such a construction is hindsight reasoning.
Examiner respectfully disagrees that there would be no motivation or suggestion to combine the references because Rosman already teaches MSM, strontium salt and the inclusion of azelaic acid while recognizing that the cosmetic composition containing both MSM and strontium can reduce skin irritation. Benzoyl peroxide and azelaic acid are known in the prior art to be desirable in the treatment of acne with improved efficacy when combined versus use of either alone per the teachings of Webster. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicants argue that there is no teaching in the Rosman reference that combing both benzoyl peroxide and azelaic acid would maintain stability and improve tolerability.
Examiner respectfully submits that the Rosman reference discloses formulations in which irritation of skin is reduced by combining strontium and MSM thus providing for improved tolerability of other cosmetic actives such as azelaic acid. One of ordinary skill in the art per the teachings of Zhang would have combined benzoyl peroxide with azelaic acid in order to help treat acne. The Zhang references formulates topical compositions which combine azelaic acid and benzoyl peroxide into one formulation and neither Rosman nor Zhang teach their formulations as being degraded or unstable, thus the topical formulation of Rosman and Zhang are necessarily stable.
With regards to Tamarkin, Applicants argue that the application is directed to foam gel, and composition vehicles with rheology modification not to a formulation strategy requiring benzoyl peroxide and azelaic acid to be homogenously distributed. The reference does not present benzoyl peroxide and azelaic acid a micronized pair much less as homogenously distributed particles. Tamarkin only lists these actives as a part of a broad laundry list disclosure of optional actives, there is no concentrate teaching that these two actives should both be micronized and uniformly dispersed together. Tamarkin discloses general stability/breakability of foams and gels for controlled release to skin or mucosal surfaces which is a different delivery concept to claims 7 and 22. Applicants argue that at most Tamarkin taches that micronization of certain actives may affect rheology. The limitation is not a mere restatement of uniform gel mixing; a formulation can be uniform without the actives being micronized and homogenously distributed. The applicants argue that the reference therefore lacks motivation.
Examiner respectfully submits that Applicants arguments are unpersuasive because Tamarkin expressly teaches that “the active agent is micronized, which can assist in delivery into the skin, mucosal membrane and body cavity surfaces and also aid homogenous distribution within the formulation.” This is advantageous because compositions which are uniform (i.e. homogenous) can remain uniform without separation which is of high importance in a pharmaceutical product. 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 (i.e. homogenous). Micronized particles per the teaches of Tamarkin are advantageous in assisting with delivery to the skin and aids in homogenous distribution. Thus, there is at least motivation in Tamarkin to provide actives as a microparticle which aids in homogenous distribution.
Applicants argue that Weinberger utilizes arginine/modified arginine/arginine salts to enhance penetration of actives such as azelaic acid and salicylic acid topical formulations thus there would be no motivation to replace arginine with propylene glycol as a penetration enhancer. Applicants argue that sulfur and benzoyl peroxide are only mentioned in Weinberger as optional components from a broad list of possible topical actives. Applicants argue that the examiners conclusion that sulfur and benzoyl peroxide treat acne is not supported by the cited references and relies on generalized rationale. Applicants argue that Weinberger does not teach incorporation into a formulation having benzoyl peroxide, azelaic acid, a strontium salt and MSM as presently claimed nor does Weinberg address the stability or tolerability of such single compositions. Applicants argue that the prior art fails to recognize or address the specific problem solved by the present invention nor does the art provide motivation to combine all of the claimed components into a single formulation. Applicants argue that Rosman’s generic teaching of inclusion of cosmetic actives is too broad to render obvious the inclusion of sulfur with the claimed multi-active system.
Examiner respectfully submits that Rosman makes it known that further actives can be added to their cosmetic product and Rosman is inclusive of acne treating formulations. 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 include sulfur with Rosman 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. Applicants have not provided any evidence to the contrary why it would not have been prima facie obvious to provide an acne formulation further comprising sulfur. Regarding the fact that Weinberger does not teach a single product having benzoyl peroxide, azelaic acid, strontium and MSM, it is the combined references that arrive at the inclusion of sulfur with Rosman’s cosmetic product and not the teachings of Weinberger alone. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Examiner further notes that since both arginine salts and propylene glycol both function as penetration enhancers one of ordinary skill in the art could have utilized arginine or propylene glycol for its properties of penetration enhancement. However, examiner notes that the obviousness with Weinberger does not rely on the replacement of propylene glycol for arginine, rather Weinberger renders it prima facie obvious to include sulfur with the acne formulation of Rosman since sulfur is a known anti-acne compound and per the teachings of Rosman, their composition is useful in treatment of acne.
With regards to the Double Patenting rejection, the Applicants argue that the amended to the claims are inventive over patent ‘666 and the relevance of the Zhang and Tamarkin teachings are discussed above for the same reasons apply to the Double Patenting.
Examiner respectfully submits that for the same reasons discussed above, the Double Patenting rejections have been maintained and modified to address the amendment to the claims. Examiner notes that Patent ‘666 teaches more than one dosage form as the formulation comprising MSM, strontium salt, azelaic acid and benzoyl peroxide can be formulated as a peeling formulation, as a whitening formulation and as an anti-aging formulation and a cleaning formulation per claims 7-12. Each of these separate compositions can constitute a separate dosage form. Notably paragraph [0038] of the instant application states that The term “dosage form”, as used in the context of the present disclosure, sometimes also interchangeably with the term “unit dose”, refers to a pharmaceutical and/or cosmetic composition in a form in which it is intended to be used (applied, administered) and/or marketed. Thus, an anti-acne and a cleaning formulation are inclusive of separate dosage forms.
With regard to the lack of unity invention, as previously noted, the restriction requirement is still deemed proper and was made final.
Conclusion
Applicant’s arguments/remarks are considered unpersuasive. 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).
Currently, no claims are allowed and all claims are rejected.
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.
Correspondence
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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