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 1-13, 15-20, 23, 24, 26-40, 43, and 45 have been canceled. Claims 42 and 44 previously were withdrawn. Accordingly, claims 14, 21, 22, 25, and 41 remain pending and under examination. The claim set filed 11/20/2025 has been entered and is under examination.
Withdrawn Objection
The objection to claim 41 is withdrawn in view of Applicant’s amendment to the claim. Applicant’s argument to this effect is persuasive.
Response to Arguments
Applicant’s arguments filed 10/29/2025 (hereafter, “Remarks”) have been fully considered and are addressed as follows. Regarding the previously issued rejections of claims 14, 22, 25, and 41 under 35 U..C. 103 as being unpatentable over Roszell in view of Walden, Tamarkin, and Won, as well as the rejection of claim 21 further in view of Berinstein, Applicant traverses; Applicant’s arguments are addressed in detail below. Applicant’s delineation of the background of the state of the art as outlined on pages 3 and 4 of Remarks is noted.
Applicant asserts that the claimed formulations are distinctive, novel and inventive and provide very high efficacy with low side effects and good tolerance; Applicant further argues “synergy” and a once-daily regimen with reduced irritation. In reply, the examiner has evaluated the data in the tables on page 2 of Remarks as supported in the specification as filed, and what the data appear to demonstrate is relative efficacy according to active agent employed. Taking into account the standard deviation information, a conclusion of synergism or unexpected results is not supported by the data in the record. In other words, the evidence supports that the known topical acne benefit agents demonstrate effectiveness, to different quantitative amounts, where “success” is measured by sebaceous secretion as a function of time. Nevertheless, while this information provides rationale for selecting the known agents for topical application, the data are not of practical and statistical significance in support of evidence of nonobviousness in the record. Moreover, the data do not appear to illustrate criticality of the ranges and combinations of agents in combined ranges commensurate in scope with the claim.
Applicant argues that the cited references do not supply comparative human data showing “this magnitude” of sebo-suppression and clinical efficacy for a dual-retinoid plus antibacterial/bactericide regimen in an aqueous system. In reply, it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. In the instant case, one reasonably would have suggested success in combining anti-acne formulation components known in the art, even if the prior art does not explicitly suggest sebum reduction as a measured function of a method of using the claimed formulation. Further, as to Applicant’s reference to reduced irritation, this appears to be an argument which is not supported by evidence of unexpected results in the record.
On page 4 of Remarks, Applicant paraphrases segments of the specification as filed and concludes that the combination of elements claimed represent an important step forward in the art. In reply, Applicant’s delineation of the state of the art is appreciated, however this delineation is not sufficient to establish long-felt need as evidence of nonobviousness.
Applicant continues on pages 4 and 5 of Remarks, describing features of the claimed invention. However, allegations of “enhanced efficiency” and purported benefits do not appear to constitute evidence in the record.
Applicant argues that “a skilled formulator would see Roszell, Walden, and Tarmarkin as advocating fundamentally different and mutually undermining vehicle paradigms since Walden prefers oil carriers for retinoids and allegedly would not find motivation to shift to an aqueous vehicle for isotretinoin as in Roszell. Applicant contrasts Roszell’s aqueous system versus Tamarkin’s waterless or substantially non-aqueous foam and characterizes Tamarkin as teaching hydrophilic vehicles to degenerate tetracyclines. Applicant asserts that putting Tamarkin’s waterless foam concepts into Roszell’s hydrated system would negate Roszell’s need for hydration. Applicant concludes that one would not have been motivated to combine 13-cis-retinoic acid with Roszell on account of a vehicle mis-match and that there would have been no reasonable expectation of success for doing so. In reply, 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 is maintained that Roszell teaches a polymer for a controlled, prolonged release of an anti-acne agent formulation, and Won provides motivation and a reasonable expectation of success for adding Won’s active agent and polymer bead features in order to provide particular controlled release properties from a known polymer carrier for controlled delivery of a known anti-acne agent. It is noted that Roszell’s formulations are aqueous and may be in the form of an emulsion which comprises for instance water and a hydrophobic or oily or non-polar component. Therefore, one reasonably would have expected success from incorporating polar and nonpolar (aqueous and emollient, for instance) components in a single formulation based on Roszell’s disclosure as a whole.
Applicant argues that Tamarkin teaches away from water and that Walden teaches oil-based non-aqueous systems as superior for retinoids and away from aqueous aesthetics wherein Roszell does not suggest water elimination or an oil foam. Applicant notes that Won’s polymeric system is used alone in a powder or largely in non-aqueous vehicles and that the instant invention includes a polymeric system in water; Applicant concludes that one would not be motivated to combine Won’s polymeric system with Roszell’s aqueous vehicle.
In reply, Roszell teaches emulsions. Tamarkin and Walden’s oil components would have gone into the oil phase of Roszell’s emulsion, with hydrophilic, polar, and/or water-soluble active agents going into the aqueous phase of Roszell’s emulsion, reasonably being expected to maintain known benefits upon topical application based on the stable emulsion and bead structure of Won providing phase separation in pores. Walden considered as a whole also encompasses emulsions (see Walden claim 6). Tamarkin includes emulsion formulations (see [0208]). Won teaches immiscible phases to be combined using he polymeric delivery system (see column 2, lines 51-54). Therefore, the relevance of all cited references is maintained, and any single reference’s teaching of a preferred embodiment is not considered to teach away from other embodiments or the disclosure as a whole.
Maintained Rejections, Modified As Necessitated by Amendments filed 11/20/2025
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 14, 22, 25, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over WO2008/051461A2 (hereafter, “Roszell”) in view of US 2006/0177392A1 (hereafter, “Walden”), US 2010/0310476A1 (hereafter, “Tamarkin” et al), and US 5,145,675 (hereafter, “Won”).
The instant claims are drawn to a formulation containing 13-cis-retinoic acid in concentrations from 0.005% to 0.15% and another retinoid with keratolytic therapeutic action in acne in a cosmetically acceptable aqueous vehicle and containing antioxidants and preservatives suitable to protect retinoids against oxidation. The “other retinoid” is limited to being an all-trans-retinoic acid in a concentration of from 0.025% to 0.1% and the antibiotic to tetracycline in a concentration from 1 to 5%. The structural components included in the claim 1 are interpreted to be 13-cis--retinoic acid, another specified retinoid, water, vehicle, antioxidants, and preservatives, as further specified in the claims. The claims further recite at least one active ingredient to be included in a slow-release porous polymeric system as further specified in the claims, limited to particle size, pore diameter, and pore volume characteristics wherein said polymeric system is composed of ethylene glycol dimethacrylate. As to the new claim language “wherein the formulation is administered daily”, this language is not considered to further limit the structure otherwise addressed herein since this pertains to a method of use and not the product or properties of the claimed formulation itself.
Roszell teaches acne treatment compositions including an anti-acne component which may include clindamycin, retinoic acid, salicylic acid, benzoyl peroxide, sulphacetamide, adapalene, or mixtures thereof (see page 14, lines 2-10). The formulations may include water and are therefore considered aqueous and to have one or more active ingredients in aqueous phase (see page 15, lines 29-33; see also Roszell claim 10) and are for topical application including for instance emollient agents and are therefore considered “cosmetically acceptable” as in claim 14 (see paragraph bridging pages 19 and 20). Roszell names vitamin E among emollients which is also an antioxidant for instance (see page 19, line 24 and page 21, lines 16-33)(“antioxidants” as in claim 14). Roszell includes preservatives (see page 20, line 26 – page 21, line 4)(limitation of claim 14). Roszell does specify the retinoic acid component generally to be included in an amount between about 0.05 wt% and 12 wt% (see Roszell claim 3 in particular)(overlapping range of claim 14-17). Roszell teaches the formulations may be both aqueous and in the form of an emulsion. Further regarding claim 22, Roszell teaches benzoyl peroxide as an anti-acne component which may be included (page 15, line 9 for instance) for instance in an amount between about 5 to 12% (see page 15, line 25).
Roszell teaches retinoic acid for instance as the anti-acne functional component to be included alone or in a combination with other anti-acne components (see Roszell claim 2), however Roszell does not specify the instantly claimed combination of 13-cis-retinoic acid and another retinoid which has instantly been elected to be all trans retinoic acid. It is noted that Roszell does teach the retinoic acid component to be provided in an amount of about 0.05 to about 0.1% by weight (see page 15, line 22), a range overlapping and/or including the instantly claimed ranges with respect to each the 13-cis-retinoic acid species of retinoic acid and the all-trans-retinoic acid species of retinoic acid/”the other retinoid” as in claim 14).
Walden cures this deficiency. Walden teaches acne compositions for topical application. Walden teaches that the retinoid component of his acne compositions may consist of one or more of isomers of retinol including all-trans-retinol and 13-cis-retinol among others (see [0027]) with all-transretinol being preferred (see also Walden claim 7).
Both Roszell and Walden are directed to acne-treating formulations. It would have been prima facie obvious to one of ordinary skill in the art to substitute a combination of all-trans-retinol and 13-cis-retinol at least as “obvious to try” from the finite combinations of retinoid active agents taught by Walden in place of Roszell’s anti-acne retinoic acid component in general, and to further perform routine optimization procedures as to the amounts of these components upon use in combination where one reasonably would have expected success from a starting point of a total amount of retinoic acid within Roszell’s recommended range of 0.05 to 0.1% by weight. One would have been motivated to do so based on Walden’s state-of-the art teaching with regard to acne active agents which are topical retinoids (see [0014]) and subsequently based on routine optimization of known equivalents as taught by Walden and recommended amounts of known equivalents as specified by Walden.
Roszell teaches a polymer may be included in the acne treatment composition to provide a desired controlled, prolonged release rate (see page 15, line 9).
As to claims 25 and 41, all formulation components have been addressed above, and the severe inflammatory acne reference pertains only to a method of use and the administration schedule also pertains only to a method of use. Wherein the cited references are directed to anti-acne formulations, it is the examiner’s position that the formulations addressed above may be applied and/or used according to the intended use encompassed in claims 25 and 41.
Further regarding the tetracycline component of claim 14, the teachings of Roszell and Walden have been delineated above. Neither of these teaches tetracycline as instantly elected (antibiotic). Tamarkin cures this deficiency.
Tamarkin teaches topical formulations for treating various conditions including acne (see abstract in particular; see also [0003]) including acne vulgaris, inflammatory acne and various other skin conditions (see [0133]). Tamarkin recommends tetracycline such as doxycycline or minocycline for the treatment of acne (see [0429], [0430], [0431]) wherein the antibiotic may be included in an amount of about 0.1% to about 10% by weight of a total topical formulation (see Tamarkin claim 1), a range including the instantly claimed range of 1 to 5%.
Roszell, Walden, and Tamarkin are all directed to anti-acne compositions such as those including an anti-biotic agent. It would have been prima facie obvious to one of ordinary skill in the art to add a tetracycline as taught by Tamarkin to a formulation of Roszell and Walden, with a reasonable expectation of success. One would have been motivated to do so based on Tamarkin’s teaching of desirable antibiotic efficacy in topical anti-acne formulations in a concentration overlapping with the claimed concentration. See MPEP 2144 regarding overlapping ranges of each component.
As to the polymer system recited in claim 14, Roszell teaches a polymer component to provide sustained release of the anti-acne component (see abstract, in particular), however Roszell does not specify porosity, particle size, or pore diameter and volume characteristics of the sustained release polymer. Won cures this deficiency.
Won teaches products for the controlled release of active substances upon topical application. The active agents are retained as impregnants inside pores of porous solid particles or microspheres wherein the pores comprise a continuous open network permitting outward diffusion of the impregnants at a controlled rate depending on pore size (see abstract, in particular). The polymers may be in the form of beads typically in the range of 5 to 100 microns and usually about 20 microns for instance (see last sentence in column 2)(a value within the range of 10 to 25 micrometers as recited in claim 14) and have a total pore volume in the range of 0.1 to 2.0 cc/g usually 0.3 to 1 cc/g (range overlapping range in at end of claim 14) and average pore diameters ranging preferably from about 0.003 to 1 micron (see column 3, lines 45-52), a range within the parameters of claim 14 which are noted not to numerically limit a pore diameter in the last line of claim 14. Won recommends acne treatment agents such as benzoyl peroxide and salicylic acid among active agents (column 18, lines 1-7); Won describes the loading of impregnated beads in an aqueous phase (see column 5, first full paragraph). Won specifies that the controlled release of the active substance provided by the polymeric delivery system affords a prolonged activity of the substance on the skin (“slow-release…” as in claim 14 as newly recited). Further limitations of claim 22 have been addressed above in regard to claim 14.
Further regarding the claim language “loaded” as recited three lines from the end of claim 14, it is noted that this language is directed to a process of making the claimed formulation [product] and not the product itself and is therefore not considered to distinguish over the prior art which as outlined above appears to have the same or substantially the same structure (and function) as instantly claimed.
Roszell, Walden, Tamarkin, and Won are all directed to formulations which may include anti-acne agents for topical application. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to incorporate at least benzoyl peroxide in porous microbead carrier having controlled (“slow”) release properties as taught by Won for the controlled delivery of at least benzoyl peroxide as taught by Roszell, with a reasonable expectation of success. One would have been motivated to do so to the specification of Won as a specific direction to Roszell’s generally disclosed polymeric controlled delivery vehicle. One would have been motivated to do so to provide desirable controlled rate delivery of an active substance such as benzoyl peroxide as taught by Won using the polymer beads sized and having pore volume and diameter characteristics taught by Won, with a reasonable expectation of success.
Further regarding the particular inclusion of ethylene glycol dimethacrylate in a porous polymeric system as in claim 14, Won further teaches ethylene glycol dimethacrylate as instantly elected as a polymer bead material component (see column 6, lines 32-35) and further specifies this compound among particularly preferred polymer delivery systems (see column 6, lines 62 and 65-66). See also examples and Table 5.1 for instance. Further regarding the size parameters claimed, Won teaches the pore volume to be in the range of 0.01 cc/g to about 4.0 cc/g, pore diameter int eh range of 0.001 to about 3.0 microns, and bead diameter in the range of from about 10 to 40 microns (see claims 5-7 of Won in particular), features overlapping the ranges recited in claim 14.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over WO2008/051461A2 (hereafter, “Roszell”) in view of US 2006/0177392A1 (hereafter, “Walden”), US 2010/0310476A1 (hereafter, “Tamarkin” et al), and US 5,145,675 (hereafter, “Won”) as applied to claims 14, 22, 25, and 41 above, and further in view of US2005/0169948 A1 (hereafter, “Bernstein”).
The teachings of Roszell, Walden, Tamarkin, and Won have been delineated above. While, as noted above, these teach an antibiotic which is tetracycline, these do not specify erythromycin as in claim 21.
Bernstein cures this deficiency. Bernstein teaches compositions for topical treatment of acne vulgaris or acne rosacea. Bernstein teaches clindamycin and erythromycin to be equivalents with retinoic acid and other chemical agents known in the art to be beneficial to acne vulgaris or acne rosacea (see [0005]).
Roszell, Walden, Tamarkin, Won, and Bernstein are directed to formulations for treating acne and/or topical application. It would have been prima facie obvious to substitute erythromycin as taught by Bernstein for Roszell’s clindamycin (see Roszell claim 2 and page 15, line 23). It is noted that Tamarkin generally discloses erythromycin among a long list of antibiotic benefit agents (see [0105]), however Roszell and Bernstein in particular are provided for motivation or selecting erythyromycin tetracycline. One would have been motivated to do so based on Bernstein’s disclosure of clindamycin and erythromycin as equivalent known acne treatment agents.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AUDREA B CONIGLIO/ Primary Examiner, Art Unit 1617