DETAILED ACTION
Notice of Pre-AIA or AIA Status
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 present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/24/2025 has been entered.
Claim Status
Applicant’s amendment of 10/24/2025 is acknowledged. Claims 18, 21-23, 33, and 36 are amended; claims 1-17, 19-20, 34-35, and 37 are cancelled; and claims 38-39 are new. Claims 18, 21-33, 36 and 38-39 are currently pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/KR2021/001717 filed on 02/09/2021 and claims foreign priority to KR10-2020-0018621 filed on 02/14/2020 and KR10-2021-0015590 filed on 02/03/2021 as reflected in the filing receipt dated on 07/21/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/24/2025 and 11/21/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Withdrawn Objections and Rejections
Applicant’s amendments to the claims have overcome the previous objections to the claims. Thus, the objections are hereby withdrawn.
Applicant’s amendments to the claims have overcome/rendered moot the previous 112(b) rejections. Thus, the rejections are hereby withdrawn.
In view of Applicant’s amendment and introduction of new claims, the previous rejections under 103 and on the grounds of nonstatutory double patenting have been withdrawn in favor of the new/revised grounds of rejection presented herein. Applicant’s arguments insofar as they pertain to the revised grounds of rejection are addressed herein.
Claim Objections
Claims 18, 21, 23-26, 28, 33, 36, and 38-39 are objected to because of the following informalities:
Claims 18, 21, 23-25, 28, 33, 36, and 38-39 each recite at least one bacterial genus or species (e.g., Lactobacillus, Bifidobacterium, Staphylococcus epidermis, Staphylococcus aureus, etc.), which should be italicized.
Claims 21 (line 3), 36 (line 4), and 39 (line 3) each recite the term “Strain”, which is inappropriately capitalized. The claims should recite “strain”.
Claim 23 recites the limitation “comprising inulin, beta-glucan, maltodextrin, the beer-derived yeast extract, the truffle-derived yeast extract, a Lactobacillus ferment lysate, and a Bifidobacterium ferment lysate as active ingredients”. Because claim 23 depends from claim 18, which already recites comprising inulin, beta-glucan, maltodextrin, the beer-derived yeast extract, the truffle-derived yeast extract, and a fermentation lysate of a strain belonging to the genus Lactobacillus, the Examiner recommends amending the claim to recite “further comprising a Bifidobacterium ferment lysate as an active ingredient”, which removes redundant limitations already recited in the parent claim.
Appropriate correction is required.
Applicant is advised that should claim 21 be found allowable, claim 23 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). In this case, both claims recite a cosmetic composition requiring the same ingredients (i.e., inulin, beta-glucan, maltodextrin, a beer-derived yeast extract, a truffle-derived yeast extract, a Lactobacillus ferment lysate, and a Bifidobacterium ferment lysate. Therefore, the resulting formulations would be identical in composition and, thus, have the same properties.
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.
Claims 21-22, 36, and 39 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.
Claims 21 (line 4), 36 (line 4), and 39 (line 3) each recite the limitation “the fermentation lysate of the second bacterial strain”. There is insufficient antecedent basis for this limitation in the claims. None of claims 21, 36, and 39 recite a fermentation lysate of the second bacterial strain, and each depends from claims 18, 33, and 38, respectively, which recite a fermentation lysate of a strain belonging to the genus Lactobacillus but do not recite a fermentation lysate of a second bacterial strain. Therefore, it is unclear to which fermentation lysate of a second bacterial strain the claims refer.
Claim 22 recites the limitation “wherein the bacterial strain fermentation product is one or more selected from the group consisting of a ferment lysate and a ferment filtrate”. However, the claim depends from claim 18, which requires that the bacterial strain fermentation product is a fermentation lysate. Because claim 22 improperly broadens the scope of the parent claim, the claim is indefinite.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18, 21-33, 36, and 38-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification discloses microorganisms, such as Saccharomyces cerevisiae, which meet the written description and enablement provisions of 35 USC 112, first paragraph. However, claims 18, 33, and 38 are directed to encompass beer-derived yeast extracts and truffle-derived yeast extracts, which only correspond in some undefined way to specifically instantly disclosed microorganisms. In the case of truffle-derived yeast extracts, Applicant’s specification does not even disclose from which microorganism the yeast extract may be derived. Only the specifically disclosed microorganisms meet the written description provision of 35 USC § 112, first paragraph. The broadly claimed yeast extracts, however, do not due to lacking chemical structural information for what they are and, as recited, their potential chemical structures are highly variant and encompass a myriad of possibilities. The specification provides no guidance as to determine compounds which fulfill this description, especially since extraction methods, and thus their obtained products, vary. The specification provides insufficient written description to support the broad genus encompassed by the claim.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
With the exception of the above specifically disclosed chemical structures, the skilled artisan cannot envision the detailed chemical structure of the encompassed derivatives, analogs, etc., regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
Therefore, the full breadth of the claims does not meet the written description provision of 35 USC § 112, first paragraph. The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
Claims 21-32 are rejected by virtue of their dependency on claim 18, as they do not resolve the written description deficiency.
Claim 36 is rejected by virtue of its dependency on claim 33, as it does not resolve the written description deficiency.
Claim 39 is rejected by virtue of its dependency on claim 38, as it does not resolve the written description deficiency.
Claim Rejections - 35 USC § 112(d)
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 26-32 are 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.
Claims 26-32 each recite intended uses of the composition of claim 18 without reciting any features that further limit the actual structure of the composition. Therefore, the claims fail to further limit the subject matter of the claim upon which they depend.
Claims 28 and 31-32 are further rejected by virtue of their dependency on claims 27 and 30, respectively, as they also fail to further limit the structure of the composition recited in the parent claims.
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 Interpretation
In view of the written description deficiencies described above, wherein the exact structures of the claimed beer-derived yeast extract and truffle-derived yeast extract cannot be clearly determined from Applicant’s disclosure, the Examiner is interpreting the limitation beer-derived yeast extract to mean any extract obtained from brewer’s yeast, e.g., Saccharomyces cerevisiae, and the limitation truffle-derived yeast extract to mean any extract obtained from a yeast isolated from any known truffle species.
The Examiner notes that the inclusion of the recitation “suitable” in claims 26-27, 29, and 31-32 does not impart further structural limitations to the intended use claims. If the prior art structure is capable of performing the intended uses, then it meets the claim. As such, this recitation is not given patentable weight because it does not materially affect the composition. Note: MPEP 2111.02.
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 18, 22, 26-33, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over J. Dai et al. 2020 (CN110755321A; published: 02/07/2020; PTO-892 of 03/13/2025) in view of Andre-Frei et al. 2018 (WO2018051021A1; PTO-892 of 03/13/2025), Figueroa et al. 2015 (WO2015061798A2; published: 04/30/2015; PTO-892 of 03/13/2025), Zacchi et al. 2003 (Annals of Microbiology, vol. 53, p. 275-282; published: 2003; PTO-892 of 03/13/2025), and MyChelle (webpage, <https://www.mychelle.com/pages/ingredients>; archived: 05/30/2019; PTO-892 of instant action).
J. Dai teaches a composition for skin care cosmetics, as well as a preparation method and use of the skin care product for rapid soothing and repairing (Paragraphs 0002 and 0041). More specifically, the composition comprises: 1-5% β-glucan and 0.1-5% lactobacillus fermentation lysate by mass among other ingredients, such as tamarind seed polysaccharide, patchouli leaf extract, silanediol salicylate, rhodiola rosea root extract, etc. (Paragraph 0011).
Regarding the composition of claims 18, 33, and 38: Beta-glucan and lactobacillus ferment lysate read on the same as instantly claimed.
Regarding claim 22: Lactobacillus ferment lysate reads on the instantly claimed ferment lysate.
Regarding the active method step of claim 33: J. Dai teaches that an experimental group of subjects with sensitive skin applied the composition to the right side of the face (Paragraph 0043), which reads on the active method step of applying the composition to the skin.
Regarding the active method step of claim 38: J. Dai teaches that other components of the composition, such as patchouli leaf extract, are known to quickly relieve skin and scalp irritation (Paragraph 0024). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the composition to the scalp specifically in order to relieve irritation.
However, J. Dai does not expressly teach that the composition comprises a beer-derived yeast extract, a truffle-derived yeast extract, inulin, or maltodextrin as recited in claims 18, 33, and 38.
Andre-Frei teaches the cosmetic or dermatological use of a Saccharomyces cerevisiae yeast (brewer’s yeast) extract to increase the commensal microbial flora in the skin and/or mucous membranes by increasing the ratio of the content of the Staphylococcus epidermidis strain, which is found on healthy skin, relative to the Staphylococcus aureus strain, which induces inflammation (Paragraphs 0002-0004). Compositions comprising the extract are intended for use on any area of the skin, including the scalp (Paragraph 0013), and may contain other ingredients that are active on the cutaneous microbial flora and/or active on the skin’s barrier function, including inulin-based products (Paragraph 0043).
Figueroa teaches that in living skin, lipids play a role in the formation and maintenance of both the permeability and antimicrobial barriers (Page 1, lines 20-23). Yeast, such as Debaryomyces hansenii, can be used to produce lipids economically, for example, for use in cosmetic or medical methods and compositions (Page 2, lines 10-12 and Page 7, lines 14-20), wherein the compositions may be used for topical administration and provide enhanced transdermal penetration and delivery (Page 2, lines 15-25). Figueroa notes that useful yeasts are found in various locations and environments throughout the world, and optimal growth conditions and generation of whole yeast and/or yeasts for lipid yeast extract from any particular species of yeast may be determined by those of skill in the art (Page 8, lines 5-10).
Zacchi teaches five strains of yeast species (Cryptococcus albidus, Cryptococcus humicolus, Debaryomyces hansenii, Rhodotorula mucilaginosa, and Saccharomyces paradoxus) that can be isolated from the surface of mature truffles of the species Tuber aestivum (Page 277 and Table 2).
MyChelle teaches that maltodextrin is a binding agent sourced from rice that also increases the skin rejuvenating properties of active ingredients in a formula (Page 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of J. Dai to further include the Saccharomyces cerevisiae yeast extract and inulin taught by Andre-Frei, the truffle-derived yeast extract taught by Figueroa and Zacchi, and the maltodextrin taught by MyChelle for the reasons discussed below.
Regarding the beer-derived yeast extract and inulin recited in claims 18, 33, and 38: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of J. Dai by adding the Saccharomyces cerevisiae yeast extract and inulin taught by Andre-Frei as an active ingredients because the reference teaches that both ingredients are known to improve the microbial flora inhabiting the skin and enhance the skin barrier function, which reduces manifestations of sensitive skin.
Regarding the truffle-derived yeast extract recited in claims 18, 33, and 38: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of J. Dai by adding the Debaryomyces hansenii-derived lipid yeast extract taught by Figueroa as an active ingredient to improve the skin’s antimicrobial barriers and to enhance the transdermal penetration and delivery of the composition. Additionally, it would have been obvious to one of ordinary skill in the art to isolate the Debaryomyces hansenii from the surface of mature Tuber aestivum truffles, as taught by Zacchi, with a reasonable expectation of success because Figueroa teaches that the yeasts of its disclosure are found in various locations and environments throughout the world and are an economic source for lipid production.
Regarding the maltodextrin recited in claims 18, 33, and 38: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of J. Dai by adding the maltodextrin taught by MyChelle as an active ingredient in order to increase the skin rejuvenating properties of other active ingredients in the composition.
One of ordinary skill in the art would reasonably expect success in modifying the composition of J. Dai with the prior art teachings as proposed because J. Dai explicitly teaches that the purpose of its compositions is to combine plant herbal extracts, fungal extracts, and fermentation products to soothe skin, repair the skin barrier, and balance the skin environment (Paragraph 0054), and all proposed additional ingredients are known in the prior art to be safe and useful for the same purpose of repairing the skin barrier and/or soothing skin. In further support, J. Dai permits that the contents of the composition may be modified and substituted as obvious to those skilled in the art (Paragraph 0054).
It is noted that the recitations “cosmetic” and “for skin improvement” in independent claim 18, “for improving the microbial flora inhabiting the skin” in claim 26, “for promoting growth of beneficial bacteria inhabiting the skin or suppressing growth of harmful bacteria” in claim 27, “for any one of skin soothing, skin wrinkle amelioration, and skin elasticity improvement” in claim 29, “for any one of scalp soothing, scalp oil improvement, hair loss prevention, and hair growth” in claim 31, “for improving microbial flora inhabiting the scalp” in claim 32, “for improving skin”, “cosmetic”, “for skin improvement”, “for improving microbial flora inhabiting the skin”, “skin soothing”, “skin wrinkle amelioration”, and “skin elasticity improvement” in claim 33, and “for improving scalp”, “cosmetic”, “for scalp improvement”, “for improving microbial flora inhabiting the scalp”, “scalp soothing”, “scalp oil improvement”, “hair loss prevention”, and “hair growth promotion” in claim 38 are intended uses of the claimed composition and/or intended outcomes of applying the composition as claimed. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the structure of the composition taught by the combination of J. Dai, Andre-Frei, Figueroa, Zacchi, and MyChelle is capable of performing the intended uses and/or achieving the intended outcomes when practicing the active method step of applying the composition as claimed, then it meets the claims. Note: MPEP 2111.02.
The Examiner further notes that claims 28 and 30 depend from claims 27 and 30, respectively, which are directed toward intended uses of the claimed composition that do not impart further structural limitations to the composition. As such, the claims are not given patentable weight because they do not materially affect the composition. Still, the Examiner notes that combined references clearly support that the prior art composition is capable of promoting the growth of Staphylococcus epidermis and/or suppressing the growth of Staphylococcus aureus and is also suitable for use on the scalp.
Claims 18, 21-23, 26-33, 36, and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over J. Dai et al. (CN110755321A; published: 02/07/2020; PTO-892 of 03/13/2025), Andre-Frei et al. (WO2018051021A1; PTO-892 of 03/13/2025), Figueroa et al. (WO2015061798A2; published: 04/30/2015; PTO-892 of 03/13/2025), Zacchi et al. (Annals of Microbiology, vol. 53, p. 275-282; published: 2003; PTO-892 of 03/13/2025), and MyChelle (webpage, <https://www.mychelle.com/pages/ingredients>; archived: 05/30/2019; PTO-892 of instant action), as applied to claims 18, 22, 26-33, and 38 above, and further in view of Gan et al. (US20160158143A1; published: 06/09/2016; PTO-892 of instant action).
The combination of J. Dai, Andre-Frei, Figueroa, Zacchi, and MyChelle teaches the invention(s) of claims 18, 22, 26-33, and 38 as discussed in detail above and further incorporated herein.
However, the prior art combination does not expressly teach that the composition further comprises a Bifidobacterium ferment lysate as recited in claims 21, 23, 36, and 39.
Gan teaches topical skin compositions comprising a lysate of a fermentation product of Bifidobacterium, e.g. bifida ferment lysate, which can enhance skin smoothness by suppressing protein-destructive enzymes and immune suppressive biochemicals and can reduce redness caused by irritation of the skin (Paragraph 0014).
Regarding the fermentation lysate of a Bifidobacterium sp. strain, e.g. Bifidobacterium ferment lysate, recited in claims 21, 23, 36, and 39: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by the combination of J. Dai, Andre-Frei, Figueroa, Zacchi, and MyChelle by adding the Bifidobacterium ferment lysate taught by Gan as an active ingredient to achieve the added benefits of improving skin smoothness and reducing redness.
Regarding the limitation “has probiotic characteristics” as recited in claims 21, 36, and 39: Applicant defines “probiotics” as microorganisms that exist in the human body to have beneficial effects on human health and the actions thereof, and also includes all the metabolites such as dead cells, extracts, and fermented products of the microorganisms (Instant Specification, Page 2). Because Gan teaches that Bifidobacterium ferment lysate enhances the health of skin, under broadest reasonable interpretation, the ingredient necessarily has probiotic characteristics.
An ordinarily skilled artisan would reasonably expect success in modifying the prior art composition as proposed because Gan teaches the ingredient is known in the art to be used in topical compositions for skin improvement, and J. Dai notes that multiple fermentation products may be used to achieve the intended effects of rapid soothing and enhancing the skin’s immune function (Paragraph 0054).
Claims 18, 21-33, 36, and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over J. Dai et al. (CN110755321A; published: 02/07/2020; PTO-892 of 03/13/2025), Andre-Frei et al. (WO2018051021A1; PTO-892 of 03/13/2025), Figueroa et al. (WO2015061798A2; published: 04/30/2015; PTO-892 of 03/13/2025), Zacchi et al. (Annals of Microbiology, vol. 53, p. 275-282; published: 2003; PTO-892 of 03/13/2025), MyChelle (webpage, <https://www.mychelle.com/pages/ingredients>; archived: 05/30/2019; PTO-892 of instant action), and Gan et al. (US20160158143A1; published: 06/09/2016; PTO-892 of instant action), as applied to claims 18, 21-23, 26-33, 36, and 38-39 above, and further in view of Y. Dai (CN109846787A; published: 06/07/2019; PTO-892 of 03/13/2025) and Cosmetic Ingredient Review (published: 08/18/2014; PTO-892 of 03/13/2025).
The combination of J. Dai, Andre-Frei, Figueroa, Zacchi, MyChelle, and Gan teaches the invention(s) of claims 18, 21-23, 26-33, 36, and 38-39 as discussed in detail above and further incorporated herein.
Andre-Frei further teaches that Saccharomyces cerevisiae extract is particularly useful at a concentration of 0.01 to 3.0% of the total weight of the composition (Paragraph 0062).
Figueroa further teaches that yeast lipid extract is particularly useful at a concentration of at least 0.1% w/w of the composition (Page 2, lines 28-30).
Gan further teaches that Bifidobacterium ferment lysate is particularly useful at a concentration of 0.1 to 2% by weight of the formulation (Paragraph 0015).
However, the prior art combination does not expressly teach that all ingredients are present in the amounts recited in claims 24 and 25.
Y. Dai teaches a cosmetic composition and application thereof for achieving structural repair of the skin and improving skin tissue architecture. Among other ingredients, the composition comprises inulin and fructose, which are prebiotics that activate the growth of beneficial bacteria on the skin and inhibit the growth of pathogenic bacteria. Preferably, inulin is present in 0.09 – 4.5 parts by weight of the composition (Claim 4).
Cosmetic Ingredient Review teaches that when maltodextrin, which is prepared as a white powder or concentrated solution by partial hydrolysis of corn starch, potato starch, or rice starch (Page 4, Method of Manufacture), is used for dermal contact, it is generally used at a concentration of 0.00001 – 4% (Page 42, Table 2, Maltodextrin).
Regarding claim 24: The prior art teaches that any amount of β-glucan between 1 to 5% by mass (J. Dai), Lactobacillus fermentation lysate between 0.1 to 5% by mass (J. Dai), Saccharomyces cerevisiae-derived yeast extract between 0.01 to 3.0% by weight (Andre-Frei), inulin between 0.09 to 4.5 parts by weight (Y. Dai), maltodextrin between 0.00001 to 4% (Cosmetic Ingredient Review), Debaryomyces hansenii-derived lipid yeast extract of at least 0.1% w/w (Figueroa), and Bifidobacterium ferment extract between 0.1 to 2% by weight (Gan) is suitable for producing a cosmetic composition for skin improvement. While Cosmetic Ingredient Review is silent on the concentration unit for maltodextrin, the reference teaches that maltodextrin is available as a powder. It would be obvious to one of ordinary skill to use the ingredient in powder form, whereby the concentration would be measured by weight percentage. Together, it would have been obvious to one of ordinary skill in the art to adjust the amount of each ingredient within the prior art ranges, which overlap in amounts ranging from 1 to 2% by weight, to arrive at an optimal weight ratio of active ingredients within the composition.
Additionally, it is generally noted that differences in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here 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). Given that Applicant did not point out the criticality of the active ingredient concentrations of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum concentration. NOTE: MPEP 2144.05.
Regarding claim 25: Although the claim only requires that one of the active ingredients of the Markush group is in an amount of 0.00001 to 10 wt% with respect to 100 wt% of the cosmetic composition, all concentration ranges of ingredients taught by the prior art, as discussed above, overlap or lie within the instantly claimed range. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
An ordinarily skilled artisan would reasonably expect success in modifying the prior art composition as proposed because all ingredients and concentrations are known in the art to be safe and useful for the same purpose of repairing the skin barrier and/or soothing skin.
Response to Arguments
Applicant’s arguments submitted on 10/24/2025 with respect to rejections under 35 U.S.C. 103 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that the claimed composition is not obvious in view of the cited references and alleges that the prior art does not teach this combination of features. This argument was not found to be persuasive in view of J. Dai, Andre-Frei, Figueroa, Zacchi, and MyChelle, which together teach all features of the instantly claimed composition as discussed in detail in the prior art rejections of record. The Examiner notes that 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).
Applicant further argues that the claimed combination of features demonstrates a remarkable and unpredictable effect in improving the skin’s microbial balance, which could not have been readily derived from the prior art. This argument was not found to be persuasive in view of the cited references, wherein several ingredients of the claimed composition, such as beer-derived yeast extract and inulin, are well-established in the prior art for the roles in activating the growth of beneficial bacteria, including Applicant’s instantly claimed Staphylococcus epidermis, on the skin and inhibiting the growth of pathogenic bacteria, including Applicant’s instantly claimed Staphylococcus aureus (see, for example, Andre-Frei and Y. Dai). Therefore, the effect Applicant argues was unforeseeable from the properties of the individual components is clearly expected based on the prior art teachings.
Applicant further argues that the combination of ingredients in Applicant’s Preparation Example 7, which comprises inulin, beta-glucan, maltodextrin, any beer-derived yeast extract, any truffle-derived yeast extract, Lactobacillus ferment lysate, and Bifidobacterium ferment lysate at 10 g each (Instant Specification, Pages 16-17), i.e., each ingredient at a concentration of ~14.3 wt.%, demonstrates true synergy which could not have been reasonably expected by a skilled person through a simple combination of known ingredients. However, the data which Applicant relies upon for the argument of unexpected results is not commensurate in scope with the claims with which the evidence is offered to support. First, Applicant’s Preparation Example 7 includes Bifidobacterium ferment lysate, which is not a required feature of independent claim 18, and thus it is not clear that the claimed combination would achieve the same effect as Applicant’s Preparation Example 7.
Further, it is not clear that the claimed combination would achieve the same effect when the ingredients are present at any concentration, as broadly permitted by independent claim 18. Even in the claimed composition’s most limited form (for example, instant claim 25), it is not clear from Applicant’s data that a composition requiring only one (or more) of the ingredients to be present in an amount of 0.0001 wt.% to 10 wt.% would achieve the same effect as Applicant’s Preparation Example 7, wherein each ingredient is present at a concentration of ~14.3 wt.%, which lies outside of the claimed range.
Moreover, even if Applicant’s data were commensurate in scope with the claims, Applicant fails to demonstrate that the alleged unpredictable synergistic effect is statistically significant compared to individual and/or various combinations of ingredients at the same concentration, or compared to the closest prior art. Regarding the results shown in Applicant’s Table 7, the individual ingredients were each implemented at a concentration of 1% (Instant Specification, Page 20), which the Examiner is interpreting to mean 1 wt.% based on the weight of the composition, and various combinations of three ingredients were implemented at 10 g each (i.e., each ingredient at a concentration of ~33.3 wt.%). Therefore, it is not clear that the alleged synergism observed from the combination in Preparation Example 7 is truly unexpected and significantly more compared to the expected effect of the composition’s individual components, or whether the observed difference is actually due to differences in concentrations.
Applicant further argues that claims 33 and 38 are directed to specific uses that are not taught or suggested in the cited references. This argument was not found to be persuasive in view of the cited references, which teach the instantly claimed active step of applying to the skin a composition for soothing the skin and repairing the skin. Additionally, J. Dai specifically teaches that ingredients in the composition are useful for relieving scalp irritation and, as such, it would have also been obvious to apply the composition to the scalp in particular. Regarding the specific uses recited in claims 33 and 38, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the structure of the composition taught by the combination of prior art is capable of performing the intended uses and/or achieving the intended outcomes when applied to the skin or scalp as claimed, then it meets the claims. Note: MPEP 2111.02.
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, all claimed ingredients and active method steps were known in the art prior to the effective filing date of the claimed invention to be safe and useful for the same purpose of repairing the skin barrier and/or soothing skin, as discussed in detail in the prior art rejections of record. As such, an ordinarily skilled artisan would be sufficiently motivated to combine the ingredients as proposed and apply them to the skin, including the scalp, to achieve these art-established benefits.
In view of the foregoing, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of objective evidence to the contrary. Therefore, the prior art rejections of record are maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 18, 22, 26-33, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,496,320 B2 (patented form of previously provisionally rejected copending Application No. 18/032,893; patent published on 12/16/2025) in view of J. Dai et al. 2020 (CN110755321A; published: 02/07/2020; PTO-892 of 03/13/2025), Andre-Frei et al. 2018 (WO2018051021A1; PTO-892 of 03/13/2025), Figueroa et al. 2015 (WO2015061798A2; published: 04/30/2015; PTO-892 of 03/13/2025), Zacchi et al. 2003 (Annals of Microbiology, vol. 53, p. 275-282; published: 2003; PTO-892 of 03/13/2025), and MyChelle (webpage, <https://www.mychelle.com/pages/ingredients>; archived: 05/30/2019; PTO-892 of instant action).
The claims of US ‘320 recite a cosmetic composition comprising a lysate of Lactobacillus pentosus NIFSLG-1 strain or a culture supernatant of the strain, as an active ingredient, and a cosmetically acceptable carrier ingredient, wherein the active ingredient is present in an amount effective for promoting skin collagen synthesis, improving skin wrinkles, alleviating skin inflammation, promoting skin brightening, promoting skin regeneration, improving skin elasticity, calming skin, improving skin moisturization, promoting proliferation of Staphylococcus epidermidis on the skin, or inhibiting proliferation of Staphylococcus aureus on the skin (Claim 1).
The claims of US ‘320 differ from the instant claims in that they do not specify that the Lactobacillus lysate is a fermentation lysate, or that the composition further comprises the polysaccharides, beer-derived yeast extract, or truffle-derived yeast extract recited in instant claims 18, 33, and 38. Further, the claims of US ‘320 do not recite the further limitations of instant claims 21-25, or the methods of instant claims 33, 36, or 38-39.
The teachings of J. Dai, Andre-Frei, Figueroa, Zacchi, and MyChelle are as set forth above and further incorporated herein.
Regarding the fermentation/ferment lysate and beta-glucan recited in instant claims 18, 22, 33, and 38: It would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of US ‘320 by using a fermentation lysate as the lysate of Lactobacillus pentosus and by further including beta-glucan because J. Dai teaches that this form of Lactobacillus lysate together with beta-glucan is particularly useful for alleviating skin inflammation and calming the skin.
Regarding the beer-derived yeast extract and inulin recited in instant claims 18, 22, 33, and 38: It would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of US ‘320 by adding the Saccharomyces cerevisiae yeast extract and inulin taught by Andre-Frei as an active ingredients because the reference teaches that both ingredients are known to improve the microbial flora inhabiting the skin and enhance the skin barrier function, which reduces manifestations of sensitive skin.
Regarding the truffle-derived yeast extract recited in claims 18, 33, and 38: It would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of US ‘320 by adding the Debaryomyces hansenii-derived lipid yeast extract taught by Figueroa as an active ingredient to improve the skin’s antimicrobial barriers and to enhance the transdermal penetration and delivery of the composition. Additionally, it would have been obvious to one of ordinary skill in the art to isolate the Debaryomyces hansenii from the surface of mature Tuber aestivum truffles, as taught by Zacchi, with a reasonable expectation of success because Figueroa teaches that the yeasts of its disclosure are found in various locations and environments throughout the world and are an economic source for lipid production.
Regarding the maltodextrin recited in claims 18, 33, and 38: It would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of US ‘320 by adding the maltodextrin taught by MyChelle as an active ingredient in order to increase the skin rejuvenating properties of other active ingredients in the composition.
Regarding the active method steps of claims 33 and 38: It would have been obvious to one of ordinary skill in the art to apply the composition taught by the combination of US ‘320 claims, J. Dai, Andre-Frei, Figueroa, Zacchi, and MyChelle to the skin or scalp using the method taught by J. Dai in order to impart benefits, such as promoting skin collagen synthesis, improving skin wrinkles, alleviating skin inflammation, promoting skin brightening, promoting skin regeneration, improving skin elasticity, calming skin, improving skin moisturization, promoting proliferation of Staphylococcus epidermidis on the skin, or inhibiting proliferation of Staphylococcus aureus on the skin, to the user.
One of ordinary skill in the art would reasonably expect success in modifying the composition of recited in the claims of US ‘320 with the prior art teachings as proposed because all ingredients are known in the prior art to be safe and useful for the same purpose of alleviating skin inflammation, soothing the skin, and/or promoting proliferation of Staphylococcus epidermidis on the skin, or inhibiting proliferation of Staphylococcus aureus on the skin.
It is noted that the recitations “cosmetic” and “for skin improvement” in claim 18, “for improving the microbial flora inhabiting the skin” in claim 26, “for promoting growth of beneficial bacteria inhabiting the skin or suppressing growth of harmful bacteria” in claim 27, “for any one of skin soothing, skin wrinkle amelioration, and skin elasticity improvement” in claim 29, “for any one of scalp soothing, scalp oil improvement, hair loss prevention, and hair growth” in claim 31, “for improving microbial flora inhabiting the scalp” in claim 32, “for improving skin”, “cosmetic”, “for skin improvement”, “for improving microbial flora inhabiting the skin”, “skin soothing”, “skin wrinkle amelioration”, and “skin elasticity improvement” in claim 33, and “for improving scalp”, “cosmetic”, “for scalp improvement”, “for improving microbial flora inhabiting the scalp”, “scalp soothing”, “scalp oil improvement”, “hair loss prevention”, and “hair growth promotion” in claim 38 are intended uses of the claimed composition and/or intended outcomes of applying the composition as claimed. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the structure of the composition taught by the combination of US ‘320 claims, J. Dai, Andre-Frei, Figueroa, Zacchi, and MyChelle is capable of performing the intended uses and/or achieving the intended outcomes when practicing the active method step of applying the composition as claimed, then it meets the claims. Note: MPEP 2111.02.
The Examiner further notes that claims 28 and 30 depend from claims 27 and 30, respectively, which are directed toward intended uses of the claimed composition that do not impart further structural limitations to the composition. As such, the claims are not given patentable weight because they do not materially affect the composition. Still, the Examiner notes that combined references clearly support that the prior art composition is capable of promoting the growth of Staphylococcus epidermis and/or suppressing the growth of Staphylococcus aureus and is also suitable for use on the scalp.
Claims 18, 21-23, 26-33, 36, and 38-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,496,320 B2 (patented form of previously provisionally rejected copending Application No. 18/032,893; patent published on 12/16/2025) in view of J. Dai et al. 2020 (CN110755321A; published: 02/07/2020; PTO-892 of 03/13/2025), Andre-Frei et al. 2018 (WO2018051021A1; PTO-892 of 03/13/2025), Figueroa et al. 2015 (WO2015061798A2; published: 04/30/2015; PTO-892 of 03/13/2025), Zacchi et al. 2003 (Annals of Microbiology, vol. 53, p. 275-282; published: 2003; PTO-892 of 03/13/2025), and MyChelle (webpage, <https://www.mychelle.com/pages/ingredients>; archived: 05/30/2019; PTO-892 of instant action), as applied to claims 18, 22, 26-33, and 38 above, and further in view of Gan et al. (US20160158143A1; published: 06/09/2016; PTO-892 of instant action).
The combination of US ‘320 claims, J. Dai, Andre-Frei, Figueroa, Zacchi, and MyChelle teaches the invention(s) of claims 18, 22, 26-33, and 38 as discussed in detail above and further incorporated herein.
However, the combination of US ‘320 claims and prior art does not expressly teach that the composition further comprises a Bifidobacterium ferment lysate as recited in claims 21, 23, 36, and 39.
The teachings of Gan are as set forth above and further incorporated herein.
Regarding the fermentation lysate of a Bifidobacterium sp. strain, e.g. Bifidobacterium ferment lysate, recited in claims 21, 23, 36, and 39: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by the combination of US ‘320 claims, J. Dai, Andre-Frei, Figueroa, Zacchi, and MyChelle by adding the Bifidobacterium ferment lysate taught by Gan as an active ingredient to achieve the added benefits of improving skin smoothness and reducing redness.
Regarding the limitation “has probiotic characteristics” as recited in claims 21, 36, and 39: Applicant defines “probiotics” as microorganisms that exist in the human body to have beneficial effects on human health and the actions thereof, and also includes all the metabolites such as dead cells, extracts, and fermented products of the microorganisms (Instant Specification, Page 2). Because Gan teaches that Bifidobacterium ferment lysate enhances the health of skin, under broadest reasonable interpretation, the ingredient necessarily has probiotic characteristics.
An ordinarily skilled artisan would reasonably expect success in modifying the composition taught by the combination of US ‘320 claims and prior art as proposed because Gan teaches the ingredient is known in the art to be used in topical compositions for skin improvement.
Claims 18, 21-33, 36, and 38-39 are rejected are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,496,320 B2 (patented form of previously provisionally rejected copending Application No. 18/032,893; patent published on 12/16/2025) in view of J. Dai et al. (CN110755321A; published: 02/07/2020; PTO-892 of 03/13/2025), Andre-Frei et al. (WO2018051021A1; PTO-892 of 03/13/2025), Figueroa et al. (WO2015061798A2; published: 04/30/2015; PTO-892 of 03/13/2025), Zacchi et al. (Annals of Microbiology, vol. 53, p. 275-282; published: 2003; PTO-892 of 03/13/2025), MyChelle (webpage, <https://www.mychelle.com/pages/ingredients>; archived: 05/30/2019; PTO-892 of instant action), and Gan et al. (US20160158143A1; published: 06/09/2016; PTO-892 of instant action), as applied to claims 18, 21-23, 26-33, 36, and 38-39 above, and further in view of Y. Dai (CN109846787A; published: 06/07/2019; PTO-892 of 03/13/2025) and Cosmetic Ingredient Review (published: 08/18/2014; PTO-892 of 03/13/2025).
The combination of US ‘320 claims, J. Dai, Andre-Frei, Figueroa, Zacchi, MyChelle, and Gan teaches the invention(s) of claims 18, 22, 26-33, and 38 as discussed in detail above and further incorporated herein.
However, the combination of US ‘320 claims and prior art does not expressly teach that all ingredients are present in the amounts recited in claims 24 and 25.
The teachings of Y. Dai and Cosmetic Ingredient Review are as set forth above and further incorporated herein.
Regarding claim 24: The prior art teaches that any amount of β-glucan between 1 to 5% by mass (J. Dai), Lactobacillus fermentation lysate between 0.1 to 5% by mass (J. Dai), Saccharomyces cerevisiae-derived yeast extract between 0.01 to 3.0% by weight (Andre-Frei), inulin between 0.09 to 4.5 parts by weight (Y. Dai), maltodextrin between 0.00001 to 4% (Cosmetic Ingredient Review), Debaryomyces hansenii-derived lipid yeast extract of at least 0.1% w/w (Figueroa), and Bifidobacterium ferment extract between 0.1 to 2% by weight (Gan) is suitable for producing a cosmetic composition for skin improvement. While Cosmetic Ingredient Review is silent on the concentration unit for maltodextrin, the reference teaches that maltodextrin is available as a powder. It would be obvious to one of ordinary skill to use the ingredient in powder form, whereby the concentration would be measured by weight percentage. Together, it would have been obvious to one of ordinary skill in the art to adjust the amount of each ingredient within the prior art ranges, which overlap in amounts ranging from 1 to 2% by weight, to arrive at an optimal weight ratio of active ingredients within the composition.
Additionally, it is generally noted that differences in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here 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). Given that Applicant did not point out the criticality of the active ingredient concentrations of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum concentration. NOTE: MPEP 2144.05.
Regarding claim 25: Although the claim only requires that one of the active ingredients of the Markush group is in an amount of 0.00001 to 10 wt% with respect to 100 wt% of the cosmetic composition, all concentration ranges of ingredients taught by the prior art, as discussed above, overlap or lie within the instantly claimed range. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
An ordinarily skilled artisan would reasonably expect success in modifying the prior art composition as proposed because all ingredients and concentrations are known in the art to be safe and useful for the same purpose of repairing the skin barrier and/or soothing skin.
Response to Arguments
Applicant’s request in the Remarks filed 10/24/2025 for the double patenting rejections of record to be held in abeyance is acknowledged. However, this request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02). Accordingly, the rejections will be maintained until a terminal disclaimer is filed or claims are amended to obviate the rejections.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616