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 .
Claim Status
The amended claim set filed on 31 December 2024 is acknowledged. Claims 33-44 and 46-53 are currently pending. Of those, claims 33-44 and 46-53 are amended. Claim 53 is new, and no claims are withdrawn. Claims 1-32 and 45 are cancelled. Claims 33-44 and 46-53 will be examined on the merits herein.
Response to Amendment
The Applicants’ arguments filed 31 December 2024 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 4 October 2024 will be referred to “NFOA”.
Objection(s) and Rejection(s) Withdrawn
The objections to claims 33, 40-44, and 50 are withdrawn in view of the amendments to the claims.
The objection to and rejection under 35 U.S.C. 103 of claim 45 are moot because the claim is cancelled.
The rejections of claims 38, 44, and 52 under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims.
The double patenting rejections over applications 17/754,430 and 17/754,431 are withdrawn because the ‘430 and ‘431 applications are abandoned.
Objection(s) Maintained
Claims 39 and 51 remain objected to for the following informalities:
In claim 39, the phrase “as thickener” should contain an article and read “as a thickener”, and
In claim 51, the list of alternatives should contain an “or” preceding the term “rosacea”.
Appropriate correction is required.
Applicant has not pointed to any errors or deficiencies in the objections presented in the NFOA. Applicant is reminded that in order to be fully responsive, Applicant must distinctly and specifically point out the supposed errors in the Action and must reply to every ground or objection and rejection in the prior Office Action. See MPEP 714.02 and 37 CFR 1.111(b).
Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103
Claims 33-38, 41-44, and 46-52 remain rejected and claim 53 is newly rejected under 35 U.S.C. 103 as being unpatentable over Pätzold and Güell (WO 2018/073651 A1, cited in IDS; herein “Pätzold”) in view of Stadler et al. (DE 10-2008-062398 A1; herein “Stadler”; translation provided, but original document used for citations) as evidenced by Keen and Hassan (2016, Indian Dermatol Online J; herein “Keen”) and Epstein, H (2009, Handbook of Cosmetic Science and Technology; herein “Epstein”) for the reasons of record and the reasons herein.
Applicant argues (Remarks, pg. 10-11) that Pätzold does not provide a reason to use an emollient other than those disclosed therein and that Stadler does not provide a reason to use one or both of dicaprylyl carbonate and ethylhexyl cocoate as an emollient in a composition according to Pätzold because there are many emollients disclosed by Stadler and neither are employed in any of the example compositions of Stadler.
This argument has been carefully considered but is not persuasive. Regarding the argument that Pätzold lacks motivation to use another emollient, MPEP 2145(X)(A) states: “there is no requirement that an ‘express, written motivation to combine must appear in prior art references before a finding of obviousness.’ Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004).” 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). As is set forth in the previous 103 rejection, Stadler teaches an “improved” emulsion and thickening system and teaches that their emollients make the skin supple and smooth and make skin care compositions last linger and improves texture (para. 3, 10, and 19). Thus, Stadler provides motivation to use its emulsion composition over that of Pätzold.
Regarding the argument that dicaprylyl carbonate and ethylhexyl cocoate are only two of many emollients disclosed by Stadler, MPEP 2131.02(II) states: “when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that "the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’ as that term is used in [pre-AIA ] 35 U.S.C. 102(a), in that publication."). Id. at 1718.” In this case, Stadler clearly teaches dicaprylyl carbonate and ethylhexyl cocoate as emollients; thus, the limitation “one or both of dicaprylyl carbonate and ethylhexyl cocoate as an emollient” is taught by Stadler. Furthermore, MPEP(II) states: “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971)…. Furthermore, ‘[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….’ In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).”
Kerkhoven and KSR both clearly show that combining known compositions to yield predictable results, due to their shared purpose or other reasons, is obvious. The combination of the Pätzold skin composition with the Statler skin composition emollients does not become less obvious just because the field of emollients is well researched and many functional emollients are known to the art to have predictable results at the time of filing.
Applicant argues (Remarks, pg. 11-12) that the conclusion that one would be motivated to use dicaprylyl carbonate and/or ethylhexyl cocoate based on the disclosure of Stadler can only be made with the benefit of hindsight.
This argument has been fully considered but is not persuasive. 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). In this case, dicaprylyl carbonate and ethylhexyl cocoate were known in the art, before the effective filing date of the instant claims, as emollients beneficial in skin care compositions. One of ordinary skill in the art would have had a reasonable expectation of using one or both of dicaprylyl carbonate and ethylhexyl cocoate as emollients in combination with the composition of Pätzold because Pätzold teaches that their composition may comprise emollients, thereby arriving at the composition of claim 33.
Applicant argues (Remarks, pg. 12) that the emollients recited in claim 33 have been found to be surprisingly compatible with the live C. acnes strains and points to pg. 6 of the instant specification and supplementary data in the Remarks as evidence.
This argument has been carefully considered but is not found persuasive. Regarding the allegation of unexpected results on pg. 6 of the specification, the section referenced in the Remarks does not specify a particular composition/formulation or specify what emollients are in the composition with the surprising properties. The data presented in the specification (e.g., Examples 1-3) and the drawings (e.g., FIGs. 2-3 and 5) does not show that the increase in viability is consistently higher in compositions comprising dicaprylyl carbonate and/or ethylhexyl cocoate compared to compositions without dicaprylyl carbonate and ethylhexyl cocoate (note that the scales on FIGs. 2 and 3 are different, so Formulations 12-13 did not achieve greater activation than formulations without dicaprylyl carbonate and ethylhexyl cocoate). Furthermore, the data does not demonstrate that the difference in reactivation is statistically significant. MPEP 716.02(b) states: “The evidence relied upon should establish ‘that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.’ Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992)” Thus, the allegation of unexpected results is not persuasive.
Regarding the data from supplementary experiments that is presented in the Remarks, Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel’s arguments in place of evidence in the record. Any evidence submitted to traverse the rejection or objection on a basis not otherwise provided for must be by way of an oath or declaration (see 37 CFR 1.132).
The following rejection has been amended to reflect the claim amendments.
Regarding claims 33 and 46-47, Pätzold teaches a skin care composition for topical administration to the skin comprising live Propionibacterium acnes (i.e., Cutibacterium acnes) strains (pg. 1, para. 5) and may comprise emollients (pg. 40, para. 1). The live C. acnes bacteria may be freeze-dried prior to mixing with other components to form a composition (pg. 45, para. 1). Pätzold also teaches that skin care composition comprises C. acnes of single-locus sequence typing (SLST) strains D1, A5, C1 (SEQ ID NO. 25 on pg. 23), C3, H1, H2, H3, K1, K2, K4, K6, F8, K9, L1, and F4 (pg. 2 and pg. 19, para. 5, and Table 1), including a composition wherein the C. acnes strain is SLST type C3 and/or K8 strains and further comprising SLST type A5 and/or F4 strains (pg. 2, para. 1-2).
Regarding claims 41-42 and 44, the skin care composition may further comprise antioxidants (pg. 41, para. 2), ethyl alcohol (i.e., ethanol) (pg. 36, para. 2) or other preservatives (pg. 42, para. 2), and citrate buffer to adjust the pH of the composition (pg. 37, para. 5).
Regarding claim 48, the concentration of each C. acnes strain in the skin care composition is at least 5% of the composition, i.e., at least 0.5% (pg. 2, para. 5).
Regarding claim 49, the skin care composition comprises 104–109 CFU/mL of each live C. acnes strain (pg. 4, para. 1), which anticipates the claimed range of 104 –1011 CFU/mL.
Regarding claims 50-52, the skin care composition is in the form of a gel, cream, ointment, or lotion (pg. 2, para. 8), and is capable of treating or preventing acne, oily skin, progressive macular hypomelanosis, atopic eczema, atopic dermatitis, and rosacea, as well as improving the appearance of the skin, maintaining healthy skin in a subject (pg. 3, para. 2), and/or modulating sebum production (pg. 11, para. 4) in a subject.
Regarding claim 53, Pätzold teaches that the composition may optionally comprise talc, i.e., does not require talc be present in the composition (pg. 42, para. 3). Pätzold does not teach a composition comprising any of paraffinum liquidum, octyldodecanol, polymethylsilsesquioxane, CarbomerTM, alkyl acrylate crosspolymer, ascorbic acid, benzethonium chloride, caprylyl/capryl glucoside, and glyceryl caprylate.
However, Pätzold does not teach dicaprylyl carbonate or ethylhexyl cocoate as emollients as in instant claim 33, tocopherol and/or tocopheryl acetate as antioxidants as in instant claim 41, or PEG-40 hydrogenated castor oil as a solubilizer as in instant claim 43.
Regarding claims 33-38, Stadler teaches an improved emulsion and thickening system for cosmetic and dermatological compositions comprising at least one emollient, such as ethylhexyl cocoate and/or dicaprylyl carbonate (para. 20); this means either substance may be used as an emollient or both may be used with or without other emollients in the composition. Each emollient or emollient combination may be present in amounts of 3-15% (w/w) based on the weight of the total composition (para. 21). The purpose of the emollient(s) in the composition is to make the skin supple and smooth (para. 19). Stadler teaches the ingredients make skin care compositions last longer and improve the composition’s texture (para. 3, 10, 19).
Regarding claim 41, Stadler teaches the composition for the skin comprising one or more of tocopherol (i.e., Vitamin E; para. 154) and tocopheryl acetate (para. 157).
Regarding claim 43, Stadler teaches the composition for the skin comprising PEG-40 hydrogenated castor oil (para. 14) as a solubilizer.
Regarding claim 53, Stadler teaches that octyldodecanol (para. 20), talc (para. 43, section (i)), carbomer (para. 4-5), ascorbic acid (para. 153), and benzethonium chloride (para. 43, section (b)) are optional elements of the emulsion composition, i.e., not required to be present in the composition. Stadler also does not teach a composition comprising any of paraffinum liquidum, polymethylsilsesquioxane, alkyl acrylate crosspolymer, caprylyl/capryl glucoside, and glyceryl caprylate. So Stadler teaches compositions for the skin that are free of any of paraffinum liquidum, octyldodecanol, talc, polymethylsilsesquioxane, carbomer, alkyl acrylate crosspolymer, ascorbic acid, benzethonium chloride, caprylyl/capryl glucoside, and glyceryl caprylate.
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to combine the skin care composition of Pätzold with the skin care compositions of Stadler, thereby arriving at the claimed invention.
The person of ordinary skill in the art would have been motivated to combine the teachings because skin care compositions require a unique balance of substances in order to have an effective shelf-life and temperature stability, while also feeling good on the skin to the user (Stadler, para. 2). Emollients are used in skin care or cosmetic products for the beneficial effect of making the skin supple and smooth (Stadler, para. 19) and they have been used in treatments for atopic dermatitis (Pätzold, pg. 34, para. 3). Solubilizers (i.e., emulsifier) add stability to the composition by allowing otherwise immiscible components of the composition to mix; this means separation of the components is less likely, allowing for longer shelf-life of the composition (Stadler, para. 3 and 10). The composition of Pätzold is intended for continuous use on a subject (pg. 43, para. 4 – pg. 44, para. 1) for cosmetic use or prevention or treatment of skin conditions (pg. 3, para. 2 and 11, para. 4), so longevity of the composition and pleasant feel on the skin would be beneficial for such a product. Therefore, the combination is also desirable. See MPEP 2144(II).
The person of ordinary skill in the art would have had a reasonable expectation of successfully making the claimed composition because all of the elements and their functions in skin care compositions are well known in the art. Pätzold suggests the use of one or more emollients and one or more antioxidants in their composition comprising C. acnes (pg. 40, para. 1 and pg. 41, para. 2). Tocopherol, i.e., Vitamin E, and its derivatives are widely used in skin care products (as evidenced by Keen, Abstract). Dicaprylyl carbonate and ethylhexyl cocoate are emollients used in compositions to soften skin and are commercially available under trade names such as CETIOL® and CRODAMOL®, respectively (Stadler, para. 19-20). When combining several substances with different structural properties affecting solubility, a solubilizer (e.g., PEG-40 hydrogenated castor oil) may be used to ensure the mixing of immiscible substances (see Stadler, para. 1-3, as evidenced by Epstein; pg. 121, para. 3, pg. 122, para. 2, and pg. 125, para. 3). Therefore, the combination leads to expected results because each element performs the same function as it does individually. The compositions of Pätzold (pg. 1, para. 5) and Stadler (para. 2-3) are both made for the purpose of topical administration to the skin. From MPEP 2144.06(I): “‘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)….”
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., C. acnes strains, emollients, antioxidants, preservatives, a solubilizer, and a pH adjuster) were known in the art. In addition, combining these elements yields a composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art.
Regarding the relative amounts of dicaprylyl carbonate and ethylhexyl cocoate in claims 34-37, the amounts of the same ingredients taught by Stadler (3-15% w/w) anticipates the broader range of claims 34 and 36 (0.05-25.0% w/w), but is broader than the narrower range recited in claims 35 and 37 (7.5-10% w/w). However, it would be obvious to one of ordinary skill in the art to optimize the relative amounts of the emollient needed for the specific composition claimed. It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). In the instant claims 35 and 37, the claimed range (7.5-10% w/w) is only somewhat narrower than the range in the prior art (3-15% w/w), and there is no evidence that the claimed range has different properties or is critical to the structure or function of the composition (see MPEP 2144.05(I)). The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II). Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Therefore, the invention of claims 33-38, 41-44, and 46-53 is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 33-44 and 46-53 remain rejected under 35 U.S.C. 103 as being unpatentable over Pätzold (WO 2018/073651 A1) in view of Stadler (DE 10-2008-062398 A1) as applied to claims 33-38, 41-44, and 46-52 above, and further in view of Hentrey et al. (WO 2016/173824 A1, translation provided; herein "Hentrey") and Panzieri and Santus (US 2011/0081401 A1; herein “Panzieri”) for the reasons of record and the reasons herein.
Applicant argues (Remarks, pg. 15) that claims 39 and 40 are dependent claims and patentable for at least the reasons set forth in the arguments to the rejection of claim 33 over Pätzold in view of Stadler and that Hentrey and Panzieri do not cure the deficiencies of Pätzold and Stadler.
This argument has been fully considered but is not persuasive. Independent claim 33 remains rejected over Pätzold and Stadler, as is set forth above. Furthermore, Hentrey and Panzieri are not relied upon in this rejection to cure the alleged deficiencies of Pätzold and Stadler, so the argument is not persuasive.
The following rejection has been amended to reflect the claim amendments.
The combination of Pätzold and Stadler is set forth above and teaches all limitations of claims 33-38, 41-44, and 46-52.
The combination does not teach a composition comprising Chondrus crispus extract and/or hydroxypropyl starch phosphate as a thickener, as in instant claim 39, or distarch phosphate and/or tapioca starch as a filler, as in instant claim 40.
Regarding claims 39-40, Hentrey teaches compositions for the skin comprising Chondrus crispus extract and tapioca starch (see “Examples” tables on pg. 11-13). Hentrey teaches that tapioca starch led to “further improved dispersibility” and improved sensory characteristics of the composition (pg. 5).
Regarding claim 39, Panzieri teaches that Chondrus crispus extract is used as a thickener in cosmetic products because it contains polysaccharides with structuring properties, so it can enhance viscosity and stability (para. 10) and may be used in combination with other skin care ingredients (e.g., emollients, emulsifiers, etc.) to improve appearance of skin (para. 42, 79-82).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to modify the composition of Pätzold and Stadler by adding Chondrus crispus extract and tapioca starch as taught by Hentrey and Panzieri, thereby arriving at the claimed invention. The combination of Pätzold and Stadler is a skin care composition beneficial to the skin, which comprises C. acnes and an emollient. Hentrey and Panzieri teach Chondrus crispus extract as beneficial to the skin on its own and with tapioca starch as beneficial additions to skin care compositions. From MPEP 2144.06(I): “‘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)….” Accordingly, each and every element is taught in the prior art and the combination has a beneficial result (see MPEP 2144(II)); however, the combination amounts to no more than a predictable use of prior art elements according to their established functions.
The person of ordinary skill in the art would have been motivated to combine the elements because tapioca starch improved the sensory characteristics of the composition taught by Hentrey (pg. 5). Chondrus crispus extract provides benefits, like improving the appearance of skin, as well as structural components to thicken the composition (Panzieri, para. 10), which contributes to the improved applicability, texture, and feel of the composition (Stadler, para. 4). Each of these substances may be used to further improve the combination of Pätzold and Stadler. Therefore the combination is also desirable (see MPEP 2144(II)).
The person of ordinary skill in the art would have had a reasonable expectation of success of combining tapioca starch and Chondrus crispus extract with the combination of Pätzold and Stadler because each element is well known in the art as beneficial to skin care compositions (Hentrey, pg. 5 and Panzieri, para. 10) and capable of being combined with other common skin care ingredients without impacting the performance of other active ingredients (Hentrey, “Examples” tables on pg. 11-13 and Panzieri, para. 42). Therefore, the combination leads to expected results because each element performs the same function as it does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., C. acnes strains, emollients, thickeners, fillers, antioxidants, preservatives, a solubilizer, and/or a pH adjuster) were known in the art. In addition, combining these elements yields a composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art.
Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Double Patenting
Response to Arguments
The applicant requested that these rejections be held in abeyance. The applicant is reminded that a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer. Such a response is required even when the nonstatutory double patenting rejection is provisional. See MPEP 804.I.B.1.
The following rejections have been amended to reflect the claim amendments.
17/754,426
Claims 33-44 and 46-52 remain provisionally rejected and claim 53 is newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-37 and 39-53 of copending Application No. 17/754,426 ('426) in view of Stadler (DE 10-2008-062398 A1). This is a provisional nonstatutory double patenting rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the '426 claims disclose a skin care composition, wherein the composition is suitable for topical application to skin and comprises: (a) lyophilized and/or spray dried live bacteria of at least one strain of Cutibacterium acnes (C. acnes); and (b) one or more of: dicaprylyl carbonate and/or ethylhexyl cocoate as emollient; Chondrus crispus extract and/or hydroxypropyl starch phosphate as thickener; distarch phosphate and/or tapioca starch as filler; tocopherol and/or tocopheryl acetate as antioxidant; one or more of ethanol, phenoxyethanol, caprylyl glycol, methylpropanediol as preservative; and PEG-40 hydrogenated castor oil as solubilizer (‘426, claim 33).
The skin care composition further comprises citric acid/citrate buffer as a pH adjuster (‘426, claim 44). The at least one strain of C. acnes comprises at least one of single-locus sequence typing (SLST) type strains D1, A5, C1, C3, H1, H2, H3, K1, K2, K4, K6, K8, K9, L1, F4 (‘426, claims 45-47). The concentration of each type of C. acnes strain present in the composition is at least 0.5% (w/v) of the skin care composition (‘426, claim 48) or present in an amount of from 104 to 1011 CFU/ml (‘426, claim 49). The composition is present in the form of at least one of a gel, a cream, an ointment or a lotion (‘426, claim 50). The composition is capable of treating or preventing one or more of acne, oily skin, progressive macular hypomelanosis, dandruff, atopic eczema, atopic dermatitis, rosacea in a subject (‘426, claim 51) or of improving an appearance of skin of a subject and/or of modulating a sebum production of skin cells of a subject and/or of maintaining healthy skin of a subject (‘426, claim 52).
Regarding instant claim 53, the ‘426 claims do not teach a skin care composition comprising any of paraffinum liquidum, octyldodecanol, talc, polymethylsilsesquioxane, carbomer, alkyl acrylate crosspolymer, ascorbic acid, benzethonium chloride, caprylyl/capryl glucoside, and glyceryl caprylate (‘426 claims 33-37 and 39-53).
The ‘426 claims do not disclose the relative amounts of dicaprylyl carbonate and/or ethylhexyl cocoate as in instant claims 34-37, or limit the composition to only use dicaprylyl carbonate and ethylhexyl cocoate as emollients as in instant claim 38.
Stadler teaches compositions for the skin comprising at least one emollient, such as ethylhexyl cocoate and/or dicaprylyl carbonate (para. 20); this means either substance may be used as an emollient or both may be used with or without other emollients in the composition. Each emollient or emollient combination may be present in amounts of 3-15% (w/w) based on the weight of the total composition (para. 21).
It would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the instant invention to have used the relative amounts of dicaprylyl carbonate and/or ethylhexyl cocoate taught by Stadler and further optimize the amounts to be appropriate for the specific claimed composition to arrive at the instant invention with a reasonable expectation of success. One would be motivated to do so in order to optimize the amount of ethylhexyl cocoate and/or dicaprylyl carbonate in the claimed composition to maximize the benefit of the emollient used, such as the effect of smoothing the skin (Stadler, para. 19).
It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985)). See MPEP 2144.05.01. The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
In the interest of space, the other, highly similar rejections are presented in an abbreviated form. The table lays out the support for each limitation of the instant claims (see row labels on the left of the table) in the claims of each co-pending application (see column headers at the top of the table).
‘428
‘432
‘129
33 preamble
33
29
1
33(a)
33
29, 40
1, 18-19
33(b)
39
34
7
39
33
35
8
40
33
36
9
41
41
38
10
42
42
37
1-6
43
43
29
11
44
44
39
--
46
46
41
1, 18-19
47
47
42-43
12
48
48
44
13
49
49
45
14
50
50
46
15
51
51
47
16
52
52-53
48
17
53
33-44, 46-53
29-48
1-20
17/754,428
Claims 33-44 and 46-52 remain provisionally rejected and claim 53 is newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-44 and 46-53 of copending Application No. 17/754,428 (‘428) as applied to claims 33 and 39-52, further in view of Stadler (DE 10-2008-062398 A1). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The teachings of ‘428 relevant to claims 33, 39-44 and 46-53 are presented in the table above.
‘428 does not disclose the relative amounts of dicaprylyl carbonate and/or ethylhexyl cocoate, or limit the composition to only use dicaprylyl carbonate and ethylhexyl cocoate as emollients, the same as application ‘426 above. The teachings of Stadler and the rationale for combining are the same as presented in application ‘426.
17/754,432
Claims 33-44 and 46-52 remain provisionally rejected and claim 53 is newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-48 of copending Application No. 17/754,432 (‘432) as applied to claims 33 and 39-52, further in view of Stadler (DE 10-2008-062398 A1). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The teachings of ‘432 relevant to claims 33, 39-44, and 46-53 are presented in the table above.
‘432 does not disclose the relative amounts of dicaprylyl carbonate and/or ethylhexyl cocoate, or limit the composition to only use dicaprylyl carbonate and ethylhexyl cocoate as emollients, the same as application ‘426 above. The teachings of Stadler and the rationale for combining are the same as presented in application ‘426.
US 12,409,129 B2
Claims 33-44 and 46-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending U.S. Patent No. 12,409,129 (‘129) as applied to claims 33 and 39-52, in view of Stadler (DE 10-2008-062398 A1) and further in view of Pätzold (WO 2018/073651 A1).
The teachings of ‘129 relevant to claims 33, 39-43, and 46-53 are presented in the table above.
‘129 does not disclose the relative amounts of dicaprylyl carbonate and/or ethylhexyl cocoate, or limit the composition to only use dicaprylyl carbonate and ethylhexyl cocoate as emollients, the same as application ‘426 above. The teachings of Stadler and the rationale for combining are the same as presented in application ‘426.
‘129 does not disclose a buffer based on citric acid and citrate as a pH adjuster as in instant claim 44.
Pätzold teaches a skin care composition comprising citrate buffer to adjust the pH of the composition (pg. 37, para. 5).
Therefore, it would have been prima facie obvious, before the effective filing date of the instant invention, to a person of ordinary skill in the art to modify the skin care composition of ‘129 and Stadler by adding the citrate buffer taught by Pätzold with a reasonable expectation of success. One would be motivated to do so in order to stabilize the pH of the composition (Pätzold, pg. 37, para. 4) to protect the C. acnes, which need a certain range of environmental pH to survive (Pätzold, pg. 37, para. 4 and pg. 65, para. 4). Accordingly, each and every element is taught in the prior art and the combination has a beneficial result (see MPEP 2144(II)); however, the combination amounts to no more than a predictable use of prior art elements according to their established functions.
New Rejection(s)
Claim Rejections - 35 USC § 112(b)
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.
Claim 53 is newly 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.
Claim 53 contains the trademark/trade name CARBOMERTM. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify polyacrylic acid and, accordingly, the identification is indefinite.
Double Patenting
In the interest of space, the new, highly similar double patenting rejections are presented in an abbreviated form. The table lays out the support for each limitation of the instant claims (see row labels on the left of the table) in the claims of each co-pending application (see column headers at the top of the table).
‘624
‘559
‘289
33 preamble
1
1
1
33(a)
1, 13-15
1
1, 13-15
33(b)
8
7
7
39
9
8
8
40
10
9
1-6
41
11
1-6
9
42
1-7
10
10
43
12
11
11
44
--
12
12
46
14
13
14
47
15
14
15
48
16
15
16
49
17
16
17
50
18
17
18
51
20
18
19
52
19
--
20
53
1-20
1-20
1-20
19/297,624
Claims 33-44 and 46-53 are newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/297,624 (‘624) in view of Stadler (DE 10-2008-062398 A1) and further in view of Pätzold (WO 2018/073651 A1). This is a provisional nonstatutory double patenting rejection.
The teachings of ‘624 relevant to claims 33, 39-43, and 46-53 are presented in the table above.
‘624 does not disclose the relative amounts of dicaprylyl carbonate and/or ethylhexyl cocoate, or limit the composition to only use dicaprylyl carbonate and ethylhexyl cocoate as emollients, the same as application ‘426 above. The teachings of Stadler and the rationale for combining are the same as presented in application ‘426.
‘624 does not disclose a buffer based on citric acid and citrate as a pH adjuster as in instant claim 44. The teachings of Pätzold and the rationale for combining are the same as presented for US 12,409,129.
19/351,559
Claims 33-44, 46-51, and 53 are newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/351,559 (‘559) in view of Stadler (DE 10-2008-062398 A1). This is a provisional nonstatutory double patenting rejection.
The teachings of ‘559 relevant to claims 33, 39-43, and 46-53 are presented in the table above.
‘559 does not disclose the relative amounts of dicaprylyl carbonate and/or ethylhexyl cocoate, or limit the composition to only use dicaprylyl carbonate and ethylhexyl cocoate as emollients, the same as application ‘426 above. The teachings of Stadler and the rationale for combining are the same as presented in application ‘426.
19/371,289
Claims 33-44 and 46-53 are newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/371, 289 (‘289) in view of Stadler (DE 10-2008-062398 A1). This is a provisional nonstatutory double patenting rejection.
The teachings of ‘289 relevant to claims 33, 39-43, and 46-53 are presented in the table above.
‘289 does not disclose the relative amounts of dicaprylyl carbonate and/or ethylhexyl cocoate, or limit the composition to only use dicaprylyl carbonate and ethylhexyl cocoate as emollients, the same as application ‘426 above. The teachings of Stadler and the rationale for combining are the same as presented in application ‘426.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645