DETAILED ACTION
The present application is a national stage entry of PCT/EP2022/073486, filed 23 August 2022, which claims priority to EP21192709.0, filed 24 August 2021.
The preliminary amendment filed 08 July 2026 is acknowledged. Claims 13-30 are pending in the current application and are examined on the merits herein.
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 .
Election/Restrictions
Applicant’s election of Group II, directed toward a method of treatment, in the reply filed on 09 July 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election of a mixture of 2’FL and DFL in the reply filed on 08 July 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
To expedite prosecution of the present application the election of species is hereby withdrawn.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 25, 27 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kosnicki et al. (WO 2022/211798, cited in PTO-892).
Kosnicki et al. teach a personalized skin care composition comprising a cultured composition comprising a milk sample acquired from breast milk; and a skin sample acquired from a healthy skin area of a subject; and optionally an additive (claim 1). The baby formula comprises human milk oligosaccharides, prebiotics, probiotics, and combinations thereof (claim 5). The composition can be used to treat various skin conditions including acne, eczema, and rash (para [0092]). The composition can be applied as a liquid to the affected skin area (para [0090]). The composition can be applied as a rinse or applied as a wipe (i.e. leave-on; para [0113]). The composition is intended to mimic the healthy skin microbiome of the subject (para [0037]).
Kosnicki et al. teach diet affects intestinal microbiota composition, and human milk oligosaccharides (HMOs) and beneficial microbes in breast milk may promote the colonization of intestinal microbes (para [0006]). Non-limiting examples of HMOs that may promote the colonization of intestinal microbes includes 2’-fucosyllactose (2’-FL) and lacto-N-tetraose (LNT) (para [0026]). Additionally, healthy skin sample can be used in combination with the HMOs (para [0029]-[0039]). The subject may be any human subject of any age (para [0041]). Culturing the milk sample and the skin sample may allow beneficial microorganisms present in the skin sample to proliferate (para [0049]).
Kosnicki et al. disclose administering to an individual at least one HMO selected from 2’-FL and lacto-N-tetraose to positively affect the skin microbiome of an individual.
Thus, the disclosure of Kosnicki et al. anticipates claims 25, 27 and 30 of the present application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 13, 16, 19, 25, 27 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Kosnicki et al. (cited above) in view of Dreno et al. (American Journal of Clinical Dermatology, 2020, vol. 21, suppl 1., pp.518-524, cited in IDS submitted 20 February 2024).
Kosnicki et al. teach as discussed above.
Kosnicki et al. do not expressly disclose contacting C. acnes (present claim 13).
Dreno et al. teach “the role of Cutibacterium acnes in the pathophysiology of acne has recently undergone a paradigm shift: rather than C. acnes hyperproliferation, it is the loss of balance between the different C. acnes phylotypes, together with a dysbiosis of the skin microbiome, which results in acne development.” (abstract). Dreno et al. teach a predominance of C. acnes phylotype IA1 has been observed (abstract). Other bacteria, mainly Staphylococcus epidermis, are also involved in acne. “S. epidermis and C. acnes interact and are critical for the regulation of skin homeostasis.”. Dreno et al. teach the gut microbiome is also involved in acne, through interaction with the skin microbiome. Future treatments will leave commensal strains intact, while targeting pathogenic ones.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to contact C. acnes with a composition comprising at least one human milk oligosaccharide.
The ordinary artisan would have known from Dreno et al. that C. acnes dysbiosis is the pathological cause of acne development. From Kosnicki et al., the ordinary artisan would have known human milk oligosaccharides including 2’-FL and LNT are useful for the treatment of skin conditions including acne, by mimicking the microbiome of a healthy subject. Accordingly, it would have been obvious to contact C. acnes with a composition comprising 2’-FL and LNT.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 13, 14, 16, 19, 25, 27 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Kosnicki et al. and Dreno et al. as applied to claims 13, 16, 19, 25, 27 and 30 above, and further in view of Dekany et al. (US Patent Application Publication No. 2016/0113952, cited in PTO-892).
Kosnicki et al. teach as discussed above.
Kosnicki et al. do not expressly disclose administering difucoysllactose (DFL), (present claim 14).
Dreno et al. teach as discussed above.
Dekany et al. teach a synthetic mixture of oligosaccharides for treating a microbiota of a mammal, to reduce or eliminate the activity and/or the proportion of a microbe that is associated with the development of a disease or unhealthy condition, wherein the microbiota is a skin microbiota (abstract). The composition may include difucosyllactose (DFL), 2’-FL and LNT (see claims 6 and 7). The mixture can be used to treat acne (para [0080]). Additional alternative saccharides include sialylated oligosaccharides, including 3’-SL and 6’-SL (claim 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to contact C. acnes with a composition comprising at least one human milk oligosaccharide, including DFL.
In addition to the reasons above, the ordinary artisan would have been further motivated to administer HMOs including DFL, 2’-FL and LNT, because they are all known HMOs that can be used to treat dysbiosis including skin dysbiosis conditions such as acne.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 15, 19, 26, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Kosnicki et al., Dreno et al. and Dekany et al. as applied to claims 13, 14, 16, 19, 25, 27 and 30 above, and further in view of Geun et al. (KR20190067499, original and Espacenet machine translation, cited in PTO-892).
Kosnicki et al. teach as discussed above.
Kosnicki et al. do not expressly disclose the composition comprises 0.01 to 10 wt.-% at least one HMO (present claims 15 and 26).
Dreno et al. teach as discussed above.
Dekany et al. teach as discussed above.
Geun et al. teach the use of 3’-sialyllactose (3’-SL) and 6’-sialyllactose (6’-SL) for improving acne (abstract). They’re representative human milk oligosaccharides, are known to have a prebiotic effect and antibacterial effect (para [0009]). The total content of 3’-SL and 6’-SL present in the cosmetic composition preferably ranges from 1 to 10 wt.% (para [0046]). The cosmetic can be in the form of a solution (para [0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the HMOs of the prior art in an amount ranging from 1 to 10 wt.%., because in the same field of endeavor of treating acne with HMOs, Geun et al. teach a cosmetic composition comprising 1 to 10 wt.% HMOs is preferred.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 17, 18, 20-24, 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Kosnicki et al., Dreno et al. and Dekany et al. as applied to claims 13, 14, 16, 19, 25, 27 and 30 above, and further in view of Richter et al. (US20210251885, cited in IDS submitted 20 February 2024).
Kosnicki et al. teach as discussed above.
Kosnicki et al. do not expressly disclose wherein the composition comprises at least 40 wt.% water (present claims 17, 18, 28 and 29). Kosnicki et al. do not expressly disclose at least one non-pathogenic C. acnes strain (present claims 20-24).
Dreno et al. teach as discussed above.
Dekany et al. teach as discussed above.
Richter et al. teach a cosmetic product comprising two spatially separated chambers, the first chamber being a lyophilizate from C. acnes strains C1, C3, D1, A5, H1, H2, H3, K1, K2, K5, K6, K8, K9, L1 and/or F4, and the second chamber contains water (claim 26). The lyophilizate preferably comprises C3 and/or K8 which is combined with strains A5 and/or F4 (claims 41-43). The C3 and K8 C. acnes strains are present in equal proportions (claim 42). Richter et al. teach using the cosmetic composition for treating acne (claim 45). (claim 19). The cosmetic comprises 1-10% by weight lyophilizate and 90-99% by weight water (para [0048]). The composition reduces the concentration and inhibits the growth of acne-causing bacteria on the skin (para [0013]-[0014]). The acne is first disinfected prior to application of the C. acnes strains (para [0056]).
According to MPEP 2144.06: “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).
Combining known therapies into a single therapy is a commonly applied method for identifying improved therapeutic outcomes with minimal adverse effect for the patient because each monotherapy is already known to be effective. Here, HMOs including 2’FL and LNT were taught to have a positive effect on the microbiome for treating acne, while C. acnes strains C3, K8, A5 and F4 were particularly effective in treating C. acnes. Thus, the skilled artisan would have been motivated to combine the two therapies wherein they each modulate the skin microbiome to treat C. acnes.
With respect to the order of steps, the ordinary artisan would have been motivated to apply the composition comprising HMOs prior to the C. acnes strains, because Richter et al. suggest modulating the microbiome on the skin (by way of applying a disinfectant) prior to treatment with the desirable C. acnes strains. As taught by Kosnicki et al. and Dekany et al., HMOs modulate and correct dysbiosis, including skin dysbiosis. Thus, similar to Richter et al., the ordinary artisan would have been motivated to first treat skin dysbiosis with the HMOs, and then apply the beneficial bacteria.
The amount of water to be used in combination with the C. acnes strains reads on the amounts recited in present claims 17 and 28.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
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