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 .
DETAILED ACTION
Claims 1-15 are currently pending and a preliminary amendment to the claims filed on 12/11/2024 is acknowledged.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The two (2) information disclosure statements (IDS) submitted on 12/11/2024 and 04/30/2026 were filed before the mailing date of the instant first action on the merits. The submissions thereof are in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statements have been considered by the examiner, and signed and initialed copies thereof are enclosed herewith.
Claim Objection
Claim 5 is objected to the following minor informality:
Claim 5 recites “such, that the composition …”, but which would be better to recite “such that the composition …”. Appropriate correction is requested.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-4, 6-11 and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Each of claims 2, 4 and 6-8 lacks sufficient antecedent basis. Specifically, claim 1 does not require “the protection of S. epidermidis …” (claims 3 and 4), and not require skin bacterial of the genus Lactobacillus … (claims 6 and 7), and S. epidermis (claim 8).
Each of claims 2, 9-11 and 13 refers to dual ranges in one claim. That is, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, each of claims 2 and 13 recites the broad recitation, genus Lactobacillus, and the claims also recite L. crispatus which is the narrower statement of the range/limitation. In the same context, claims 9-11 recites the broad recitation, 0.1-10%, and those claims also recite “more preferably 0.5 to 7.5%, most preferably 0.5 to 7.5%”. Claims 2, 9-11 and 13 are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Appropriate correction is requested.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Specifically, dependent claim 14 requires “the composition comprises … ethylhexylsalicylate, bis-ethylhexyloxylphenol methoxyphenyl triazine …”, and however, base claim 13 reciting Markush format is limited to one or more UV filters selected from the group consisting of octocrylene, butyl methoxydibenzoylmethane and/or ethylhexyl triazone. That is, dependent claim 14 has a broader scope than base claim 13. Therefore, it may not be said that dependent claim 14 further limits base claim 13 in a proper manner.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mintel (IDS of 04/30/2026).
Applicant claims the below claim 1 filed on 12/11/2024:
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For examination purpose, the limitation of “for use in the treatment or prevention of dysbiosis of the skin and/or for strengthening the surface barrier of the skin after UV-radiation” of claim 1 and related uses of claims 2-4 and 6-8, is an intended use, which does not limit the scope of the claim because it merely defines a context in which the invention operates. see Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Moreover, the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Thus, "recitation of a new intended use for an old product does not make a claim to that old product patentable." In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1977). Therefore, if the prior art teaches the claimed UV filter-containing composition, the said intended use limitations are implicit, and as a result, the UV filter-containing composition of that prior art reads on the inventions of instant claims 1-4 and 6-8.
Prior Art
Mintel teaches Nivea Sun protect & moisture immediate protection & 48h moisture SPF 50+” that reads on the claimed SPF having at least 20 and the composition offers very high UVA and UVB protection, and works in balance with skin’s microbiome, a natural bacteria, acting as a skin’s natural defense system (page 1); the product contains butyl methoxydibenzoylmethane, bis-ethylhexloxyphenol methoxyphenyl triazine, ethylhexyl salicylate, ethylhexyl triazine, etc. which reads on the claimed one or more UV- filters. The composition is useful for UV protection, long lasting moisturizing and hydrating, etc. (page 2). Sine Mintel teaches their composition is useful for UV protection and keep balance skin’s microbiome, and a natural bacteria and Mintel’s composition reads on the claimed UV filter-containing composition, the claimed intended uses/properties would be implicit (instant claims 1-8).
In light of the foregoing, instant claims 1-8 are anticipated by Mintel.
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Mintel (04/30/2026) as applied to instant claims 1-8, in view of Willemin et al. (EP1745773A1).
Applicant claims as noted above.
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143).
Mintel was discussed noted above with respect to instant claims 1-8.
However, Mintel does not expressly teach the amount of UV-filters of instant claims 9-11. The deficiency is cured by Willemin.
Willemin discloses sunscreen composition comprising at least one UV radiation filtering agent, and at least one aqueous phase; Example 5 of Willemin teaches the UV filtering agent includes ethylhexyl triazone in an amount of 1% which is within the claimed range of 0.1-10%, 0.5 to 7.5% or 1 to 5% (instant claim 9), octocrylene in an amount of 2.5% which is within the claimed range of 0.1-10%, 0.5 to 7.5% or 1 to 5% (instant claim 10), and butyl methoxydibenzoylmethane in an amount of 3.5% which is within the claimed range of 0.1-10%, 0.5 to 7.5% or 1 to 5% (instant claim 11). MPEP 2144.05 “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
It would have been obvious to optimize the amount of sunscreen agent of the applied art with the claimed ranges because Willemin discloses inside ranges.
In light of the foregoing, instant claims 9-11 are obvious over Mintel in view of Willemin.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Mintel (04/30/2026) in view of Burns et al., “Ultraviolet radiation, both UVA and UVB, influences the composition of the skin microbiome”, vol. 28, no. 2, 2019, pp. 136-141 (IS of 12/11/2024); Delanghe et al., “The role of lactobacilli in inhibiting skin pathogens”, Biochemical Society Transactions (2021) 49, 617-627 (IDS of 12/11/2024); and Liu-Walsh et al. (EP3616678A1, IDS of 12/11/2024).
Applicant claims the below claims 12-13 filed on 12/11/2024:
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Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143).
Mintel teaches Nivea Sun protect & moisture immediate protection & 48h moisture SPF 50+” which offers very high UVA and UVB protection, and works in balance with skin’s microbiome, a natural bacteria, acting as a skin’s natural defense system (page 1); the product contains butyl methoxydibenzoylmethane, bis-ethylhexloxyphenol methoxyphenyl triazine, ethylhexyl salicylate, ethylhexyl triazine, etc. (page 2) which reads on the claimed one or more UV- filters and the spray product is applied to skin prior to UV exposure (page 3)(instant claims 12-14, in part).
However, Mintel does not expressly teach protecting specific bacteria Lactobacillus and S. Epidermidis from ultraviolet radiation (UVA and UVB) of instant claim 12; increase the differential abundance of bacterial of genus Lactobacillus of instant claim 13; and octocrylene as additional UV filter species of instant claim 14. The deficiencies are cured by Delanghe, Burns and Liu-Walsh.
Burns discloses ultraviolet radiation (UVR) including UVA and/or UVB influences the skin microbiome, and the study shows that alterations in the skin microbiome following UVA and/or UBV exposure wherein the Lactobacillus decreased with UVA and UVB exposure, and thus this prior art evidences UVR influences on the composition of the skin microbiome, possible effecting skin pathology in which UVR is a factor, and acne, atopic dermatitis and psoriasis associated with decreased lactobacillus by UVR (abstract and page 137).
Delanghe discloses Lactobacilli is effective against the invasion of pathogens, UV radiation, etc. (page 618); and skin infection caused by the pathogen can result in excessive inflammation, skin barrier disruption and a decrease in skin microbiome diversity (Fig. 1 and page 619), and therefore application of Lactobacilli to skin provides beneficial effects such as anti-pathogenic action and increase of microbiota diversity (pages 619-621).
Liu-Walsh discloses topical composition to increase the growth of staphylococcus epidermis on skin comprising topically applying to skin in need of treatment for eczema, acne, decreased moisturization, or other skin conditions associated with microbiota dysbiosis (abstract and [0013]); AND the composition further comprises UV filters such as octocrylene, ethylhexyl triazone, bisoctrizole (=bis-ethylhexyloxyphenol methoxphenyl triazine), octyl salicylate (=ethylhexyl salicylate), zinc oxide, etc. ([0054]). As evidenced by Burns, acne, other skin conditions associated with decreased microbiome.
It would have been obvious to further define microbiome of Mintel with Burns, Delanghe, and Liu-Wash, because Delanghe discloses Lactobacilli is effective to treat skin pathogen and UV and to increase microbiota diversity; Burns/Walsh teaches skin infection such as acne, eczema, other skin conditions associated microbiota dysbiosis associated with decreased microbiome are caused by UV exposure; and accordingly, one of the ordinary artisan would have been motivated to combine those references to protect skin and beneficial skin microbiome including Lactobacillus and S. Epidermis from UV exposure, resulting in increased microbial diversity as taught by Burns/ Delanghe/Liu-Walsh. It would be obvious to further octocrylene of Liu-Walsh to the composition of Mintel in order to enhance UV filtering activity.
In light of the foregoing, instant claims 12-14 are obvious over Mintel in view of Delanghe/ Burns/Liu-Walsh.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mintel (04/30/2026) in view of Delanghe et al., “The role of lactobacilli in inhibiting skin pathogens”, Biochemical Society Transactions (2021) 49, 617-627 (IDS of 12/11/2024); Burns et al., “Ultraviolet radiation, both UVA and UVB, influences the composition of the skin microbiome”, vol. 28, no. 2, 2019, pp. 136-141 and further in view of; Liu-Walsh et al. (EP3616678A1, IDS of 12/11/2024) and further in view of Willemin et al. (EP1745773).
Mintel in view of Delanghe/ Burns/Liu-Walsh were discussed with respect to instant claims 12-14.
However, those applied art does not expressly teach the amount of UV filters of instant claim 15. The deficiency is cured by Willemin.
Willemin discloses a sunscreen composition and UV filters are present in an amount of 0.01 to 20% which overlaps the instant range of 15-20%. MPEP 2144.05 noted above. Optimizing the amount of UV filters of the applied art with the claimed range would be obvious because the ordinary artisan would determine their amount without undue experimentation based on overlapping amount of WiIlemin.
In light of the foregoing, instant claim 15 is obvious over Mintel in view of Burns/Delanghe/Walsh and further in view of Willemin.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending application No. 18/873973.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require protection of skin bacteria Lactobacillus, L. crispatus and S.epidermis by applying a composition comprising one or more UV filters selected from octocrylene, butyl methoxydibenzoylmethane, and ethylhexyl triazone in the same amounts thereof. The difference between tem is that copending ‘973 further defines L. crispatus as L.crispatus CIP 103604. However, such definition would have been yielded no more than the predictable results. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
Conclusion
All the claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613
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