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 I (a method) and the species of a culture product in the reply filed on 18 June 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)).
Claim Status
The amended claim set filed 18 June 2026 is acknowledged. Claims 1-7 and 11-12 are currently pending. Of those, claims 11-12 are currently amended, claims 1-7 were amended by preliminary amendment, and no claims are new. Claims 8-10 are cancelled. Claims 1-7 and 11-12 will be examined on the merits herein.
The amended claim set filed 18 June 2026 does not comply with 37 C.F.R. 1.121 because it does not mark the changes relative to the previous claim set. The previous claim set, filed 18 Oct 2024, is a re-filing of the original claim set and is also non-compliant because it does not include the claim amendments from the claim set filed 25 April 2024. It appears that the re-filing of the original claim set on 18 Oct 2024 was in error because the amended claim set filed 18 June 2026 marks claim amendments relative to the amended claim set filed 25 April 2024. The claim set filed 18 June 2026 will be examined despite the error because the intended claim text is clear. See MPEP 714.C.E.
References to the Specification
The instant specification does not include paragraph numbers. To avoid ambiguity if future amendments to the specification change the page and line numbers where information is located, in this action references to the specification will use paragraph numbers from the Pre-Grant Publication US-20250049699-A1 (PTO-892).
Priority
The application claims priority to KR10-2021-0144906 (filed 27 Oct 2021) and is a 371 of PCT/KR2022/016509 (filed 26 Oct 2022). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The non-English priority document cannot be evaluated for supporting the instant claims. Therefore, the effective filing date used for searching the art for all claims is 26 Oct 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 25 April 2024 and 18 June 2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies of these statements are attached with this action. A copy of the WO-2021162145-A1 reference was not identified in the 25 April 2024 submission, but is attached with this action.
Drawings/Specification
The drawings and specification are objected to because the drawings do not show all features as described in the specification. Specifically, [0199-0200] and [0202] refer to colors in the figures (red, blue) but the submitted drawings are black-and-white images.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) and/or an amendment to the specification to obviate this objection are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. The hyperlink is found at [0203]. The required correction is to delete the http:// to remove the link, but to leave the remaining website name.
Claim Objections
Claim 3 is objected to because of the following informalities: (1) Grammar of the phrase “comprise-the”. If the hyphen marks deleting the space between the two words, then the space should be re-added to the sentence. If the hyphen is part of the text of the claim, it should be deleted and replaced with a space. (2) Grammar of the phrase “or a gene encoding the same”, but the claim requires six objects (1-6) so the term “gene” should be plural. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: the limitation “powder” is duplicated in the list. Appropriate correction is required.
Claim Interpretation
Claims 5-6 each recite “the skin improvement”. This term has antecedent basis in both the subject population of claim 1 and the effect that is observed in claim 1 in the preamble. There is no rejection because the antecedent basis of the term is clear, but applicant is warned of the interpretation in case they wanted these claims to limit only the subject population or only the effect.
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 1-7 and 12 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.
Regarding claim 1, the claim recites “wherein the Cutibacterium sp. strain comprises (a) an Lrp/AsnC family transcriptional regulator or a gene encoding the same, and (b) a lactococcin 972 family bacteriocin or a gene encoding the same.” The boundaries of the proteins in (a) and (b) are indefinite in view of disagreement over whether C. acnes strain ATCC 11828 comprises these proteins or not. The instant specification teaches that this strain does not comprise these proteins (see below). However, the Japanese Patent Office determined that the C. acnes strain ATCC 11828 does comprise the claimed Lrp/AsnC family transcriptional regulator and lactococcin 972 family bacteriocin proteins (see below). Therefore, the claim terms “Lrp/AsnC family transcriptional regulator” and “lactococcin 972 family bacteriocin” are indefinite because those of ordinary skill in the art (the inventors, the Japanese Patent Office examiner) cannot determine the boundaries of the claim scope (which bacterial strains comprise these proteins). This is also a rejection of dependent claims 2-7 and 12 because they depend from claim 1 and do not obviate this grounds of rejection. Claim 11 is not rejected because it requires the use of specific bacterial strains comprising the claimed proteins.
Excerpt from instant specification, pg. 64-65.
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Excerpt from “Office Action issued in corresponding Japanese Patent Application No. 2024-525398, dated March 18, 2025” (filed in IDS on 18 June 2025), pg. 2.
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Regarding claim 2, the claim recites “at least one protein selected from the group consisting of the following (1) to (6)” but the options (1) to (6) recite protein names “or a gene encoding the same”. The claim is indefinite because the options do not correspond with their description, rendering the claim boundary unclear. In the interest of compact prosecution, in this action, the claim will be interpreted as if it read “… strain does not comprise at least one protein or gene selected from the group consisting of the following (1) to (6):” and then listed the options of proteins or genes.
Regarding claim 3, similarly to claim 2, the claim recites “does not comprise-the following (1) to (6) or a gene encoding the same”, but the options (1) to (6) recite protein names “or a gene encoding the same”. The recitation of “a gene encoding the same” separate from the following (1) to (6) implies that (1) to (6) are not genes, but the listed options do include genes. The claim is indefinite because the options do not correspond with their description, rendering the claim boundary unclear. In the interest of compact prosecution, in this action, the claim will be interpreted as if it read “… strain does not comprise the following (1) to (6):” and then listed the options of proteins or genes.
Regarding claim 7, the term “sensitive skin improvement” is a relative term which renders the claim indefinite. The term “sensitive” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree or type of “improvement”, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One of ordinary skill in the art at the time of filing would not be able to clearly determine when the intended use was completed without being able to clearly determine what degree and types of sensitivity are included within the claim for improvement.
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.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods using publicly available Cutibacterium that are not required to be specific deposited strains, does not reasonably provide enablement for using the Cutibacterium sp. strains deposited under Accession number KCCM13032P, KCCM13033P, KCCM13034P, KCCM13035P, KCCM13036P and KCCM13037P. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
It is apparent that Cutibacterium sp. strains deposited under Accession number KCCM13032P, KCCM13033P, KCCM13034P, KCCM13035P, KCCM13036P and KCCM13037P is required to practice the full scope of the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the strains.
The process disclosed in the specification to isolate these strains does not appear to be repeatable, and the full scope of the invention will not work with commonly available material because claim 11 requires that the specific deposited strains be used. It is noted that Applicants have deposited biological material but there is no indication in the specification as to public availability. Therefore, a deposit at a recognized depository may be made to obviate this rejection.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
Claims 1-7 and 11-12 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.
MPEP 2163 states:
An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). … A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)
Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate").
What is claimed: The instant claims are drawn to methods for skin improvement, comprising the elected species of administering a culture product of a Cutibacterium sp. strain into a subject in need of the skin improvement, wherein the Cutibacterium sp. strain comprises (a) an Lrp/AsnC family transcriptional regulator or a gene encoding the same, and (b) a lactococcin 972 family bacteriocin or a gene encoding the same. Dependent claims 2-4 define additional genes which must be present or absent in the Cutibacterium sp. strain. Dependent claim 11 requires specific deposited strains be used.
Dependent claims 5-7 require additional functions that the composition must be capable of: “the skin improvement is at least one selected from the group consisting of skin wrinkle improvement, skin elasticity improvement, skin aging prevention, skin moisturizing improvement, skin moisture supply, and skin nutrition supply”, “wherein the skin improvement is at least one selected from the group consisting of scalp protection, hair loss prevention, hair moisture supply, and hair nutrition supply”, and “wherein the cosmetic composition for skin improvement is a cosmetic composition for sensitive skin improvement”, respectively.
Finally, claim 12 limits the formulation of the culture product to being “administered in any one formulation selected from the group consisting of solution, suspension, emulsion, paste, gel, cream, powder, ointment, patch, cosmetic water, essence, gel, lotion, mask, pack, powder, capsule and spray.”
The instant specification defines the term “culture product” as “In the present description, “culture product” of a Cutibacterium sp. strain may mean a product obtained by culturing a Cutibacterium sp. strain.” [0083]. The specification further provides examples to demonstrate the breadth of the term: “The culture product of the Cutibacterium sp. strain may be in a form in which the strain (microbial cell) is removed, or in a form in which the strain is not removed… The culture product may be a whole culture product of the Cutibacterium sp. strain, a diluted solution, a concentrate, a dried matter (e.g., lyophilizate, etc.), a lysate, and/or a fraction thereof, and the concentrate may be obtained by centrifuging or evaporating the culture product, and the dried matter may be obtained by drying the culture product using a dryer and the like, and the lyophilizate may be obtained by freeze-drying the culture product using a freeze-dryer and the like, and the lysate may be obtained by physically treating or sonicating the strain or culture product, and the fraction may be obtained by applying the culture product, lysate and the like to a method of centrifugation, chromatography, and the like. The culture product may be a solid phase (solid, for example, dried matter), a liquid phase (liquid), or a mobile phase, but not limited thereto.” [0083-0085]. Therefore, the breadth of “culture products” that can be applied in the method includes cultures comprising bacteria, cell-free supernatants, but also culture fractions and purified products. The specification also describes a broad range culture products based on their molecular weight [0090-0092, 0095-0099].
The claimed culture product is also a product-by-process; it is defined by its method of being made and specifically by the strain that was used to make it. MPEP 2113 states: “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).”
Structures correlated with the claimed function: The broad description of potential culture products at [0083-0099] does not disclose which of these products are useful in the claimed method to obtain the claimed skin improvement results. In contrast to the breadth discussed elsewhere in the specification, the examples only generate two different culture products: a cell-free supernatant and a less than 3 kDa fraction of said supernatant. C. acnes is grown in RCM broth or vegetable broth for 48 hours, and a cell-free supernatant was generated by centrifuging to remove cells [0192], adjusting the pH to 7, and then filtering through a 0.22 μm pore size filter [0194]. Also in an example, the culture product was additionally filtered to 3 kDa or less through a 3 kDa amicon filter [0193].
The examples show that the cell-free supernatant culture product modulates macrophage immune response [Example 3, Figure 3-4], inhibits the growth of acne-causing C. acnes (ATCC 6919) [Example 4, Figure 5], inhibit biofilm formation of S. epidermidis [Example 5, Figure 6], are non-toxic [Example 6, Figure 7, Example 10, Figure 14], improve wound healing [Example 7], improves expression of skin genes used as indicators for “skin barrier (Filaggrin) improvement” and “moisturizing (Aquaporin-3) improvement” [0254] [Example 9, Figures 12-13] and did not harm collagen secretion [Example 10, Figure 15]. The < 3 kDa fraction was shown to be non-toxic [Example 10, Figure 14], and did not harm collagen secretion [Example 10, Figure 15].
The specification states that for the intended use of “skin wrinkle improvement” (claim 5), major causes include a collapsed barrier in skin dermal layers, moisture loss and reduced collagen production [0254], and that Example 9 was used to show the cell free supernatant composition is capable of the intended use of skin wrinkle improvement. Similarly, the Example 9 measurement of Aquaporin-3 was used to show the cell free supernatant composition is capable of the intended use of skin moisture supply (claim 5). Similarly, collagen and moisture levels are related to skin elasticity [0254].
The specification states that sensitive skin improvement (claim 7) includes improvement of the immune response and inflammatory response [0112], so Example 3 was used to show the cell free supernatant composition is capable of the intended use of “a cosmetic composition for sensitive skin improvement.”
The specification does not explain how the composition improves skin nutrition supply (claim 5), and does not explain which compositions are suitable for this use. The specification does not explain how the composition performs scalp protection, hair loss prevention, hair moisture supply, or hair nutrition supply (claim 6), and does not explain which compositions are suitable for these uses. Instead, the specification asserts without proof that the method is capable of the outcome.
In summary, the specification discloses a broad scope of culture products. However, the specification only measures the functions of cell-free supernatants and for the less than 3 kDa fraction of the supernatant, and only demonstrates a structure-function correlation for the functions of “skin improvement” (claim 1), “skin wrinkle improvement, skin elasticity improvement, skin aging prevention, skin moisturizing improvement, skin moisture supply” (claim 5, in part), and “is a cosmetic composition for sensitive skin improvement” (claim 7).
Representativeness of the disclosed species within the claimed genus: Li et al. (US-20210137997-A1; PTO-892) discloses “culture products”, beyond cell-free supernatants, from Propionibacterium acnes (now Cutibacterium acnes) [0004]. Li describes extraction of porphyrins by extracting the culture in ethyl acetate and acetic acid [0108] to obtain the soluble fraction, and describes isolation of deoR RNA by lysing the cells and purifying the RNA fraction [0111]. Li also teaches that these different fractions have different effects on the skin; Li teaches that one should administer a topical or oral composition comprising a nucleic acid encoding deoR [0009], but that porphyrins are a group of pro-inflammatory metabolites important in acne development [0026]. Additionally, Bijl et al. (CN1229440A; PTO-892) teaches that Propionibacterium acnes (now Cutibacterium acnes) can be used to in a fermentation method to produce vitamin B12 [pg. 3 par. 5], which can be administered subjects in the form of animal feed, human food additives, or cosmetic products [pg. 5 par. 3-4].
Li and Bijl do not teach the specific strains and genes that are discussed in the claims. However, porphyrins and vitamin B12 each have defined chemical structures, which would not differ based on the strain that was used to produce them. Also, there is no evidence that the deoR RNA sequence and structure would be different in the claimed strains rather than in the disclosed strains because the deoR gene is not excluded from the claimed species. Therefore, these compositions fall within the scope of the claimed “culture products” because the structure of the composition is identical despite the different strain used to make it.
Therefore, Li and Bijl provide evidence, in addition to the broad description in the specification, that there is substantial variation in the claimed genus of “culture products”. Li also demonstrates that the specification’s example species are not representative of the whole genus either in terms of structure (a cell-free supernatant comprising many different molecules is not representative of a purified sample that comprises only a few molecules) or function (the claimed functions are not shared across the “culture product” structures as broadly claimed, and some culture products have the opposite of the claimed effect).
Conclusion: When evaluating the specification in the context of the prior art at the time of filing, one having ordinary skill in the art at the time of filing would have concluded that the specification demonstrated possession of cell-free supernatants comprising the less than 3 kDa fraction that are capable of the intended uses of “skin improvement” (claim 1), “skin wrinkle improvement, skin elasticity improvement, skin aging prevention, skin moisturizing improvement, skin moisture supply” (claim 5, in part), and “is a cosmetic composition for sensitive skin improvement” (claim 7), but have not demonstrated possession of the breadth of culture products claimed and have not demonstrated possession of a method performing all the claimed functions. Therefore, claims 1-7 and 11-12 are rejected for failing to demonstrate possession of the claimed invention.
Claims 1-7 and 11-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods of administering cell-free supernatants comprising the less than 3 kDa fraction that are capable of the intended uses of “skin improvement” (claim 1), “skin wrinkle improvement, skin elasticity improvement, skin aging prevention, skin moisturizing improvement, skin moisture supply” (claim 5, in part), and “is a cosmetic composition for sensitive skin improvement” (claim 7), does not reasonably provide enablement for methods of using any culture product or methods that achieve all of the claimed functions of claims 1 and 5-7. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01. Although all factors were considered, the Wands factors that were most relevant for this decision are discussed in detail below.
The breadth of the claims and the nature of the invention: The breadth of the claims was discussed above in par. 28-32. Briefly, the method uses a broad range of culture products, defined by their method of making and specifically the strain used to make them. The nature of the invention requires the administration be capable of a variety of in vivo effects for skin improvement. Being enabled for administering the claimed culture product is insufficient to enable the method.
The amount of direction provided by the inventor and the existence of working examples: The teachings of the specification related to the culture products are discussed above in par. 31 and 33. The teachings of the working examples are discussed above in 33-37. Briefly, the specification teaches a broad range of culture products but does not disclose which ones are useful in the claimed method. The examples test cell-free supernatants and a less than 3 kDa fraction of the supernatant, and do not perform experiments to test whether these products are capable of all of the claimed functions.
The state of the prior art and the level of predictability in the art: The teachings of the art were discussed above in par. 39-40. Briefly, the art teaches that the culture products include purified small molecules (vitamins) and large molecules (proteins and mRNA) whose structure does not change despite being produced in a different strain. The art also teaches that not all culture products are suitable for the claimed uses; some culture products are pro-inflammatory and promote acne development. Therefore, the art teaches that the effect of the culture product is unpredictable when applied to a person.
The quantity of experimentation needed to make or use the invention: The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success and without undue experimentation. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004). The instant specification is not enabling because one cannot follow the guidance presented therein, or within the art at the time of filing, and practice the claimed method without first making a substantial inventive contribution.
It is known that not all culture products are capable of use in the method, but the instant specification does not provide guidance on how to determine which culture products are useable. So, a person of ordinary skill in the art would have to perform multiple further experiments in in vivo models or in vitro models known to be correlated with the claimed outcomes for a representative sample of the claimed culture products in order to determine which culture products can be used with a reasonable expectation of success to achieve the claimed outcomes. The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of successfully achieving the functions listed in claims 1 and 5-7. However, the specification does enable methods of administering cell-free supernatants comprising the less than 3 kDa fraction that are capable of the intended uses of “skin improvement” (claim 1), “skin wrinkle improvement, skin elasticity improvement, skin aging prevention, skin moisturizing improvement, skin moisture supply” (claim 5, in part), and “is a cosmetic composition for sensitive skin improvement” (claim 7). Therefore, claims 1-7 and 11-12 are rejected under 35 U.S.C. §112(a) or 35 U.S.C. §112, first paragraph, for failing to meet the enablement requirement.
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 1-4, 7, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bijl et al. (CN1229440A; hereafter Bijl; PTO-892) as evidenced by Brescoll et al. (2015; hereafter Brescoll; PTO-892).
Regarding claims 1-4 and 11, Bijl teaches that Propionibacterium acnes (now Cutibacterium acnes) can be used to in a fermentation method to produce vitamin B12 [pg. 3 par. 5], which can be purified into a “culture product” and administered subjects in the form of animal feed, human food additives, or cosmetic products [pg. 3 par. 3, pg. 5 par. 3-4].
Bijl does not teach the specific strains and genes that are discussed in the claims. However, vitamin B12 has defined chemical structures, which would not differ based on the strain that was used to produce them. MPEP 2113 states: “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).”
Regarding the functions in claims 1 and 7, Brescoll provides evidence that vitamin B12 administration is inherently capable of treating dermatological diseases (pg. 31 col. 1 par. 3) (i.e. skin improvement) and is inherently capable of suppressing “the cytokine production of T lymphocytes, which may initiate the inflammatory events of atopic dermatitis” (pg. 31 col. 1 par. 3) (i.e. composition for sensitive skin improvement, note that instant specification [0112] provides evidence that improved inflammatory response is an example of sensitive skin improvement). A multiple reference 102 rejection is proper to “show that a characteristic not disclosed in the reference is inherent”, see MPEP 2131.01. In this case, the Brescoll reference is used to show the dermatological benefits that inherently occur after Bijl’s disclosure that vitamin B12 is administered to a person in need thereof via food or cosmetics.
Regarding claim 12, the “vitamin B12-containing compositions can be used as or used for human food additive product and/or is incorporated into cosmetic products such as shampoo or bath” [pg. 5 par. 4]. Shampoo is in the form of a solution, ointment, gel and/or solution.
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.
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 1-7 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (US-20210252054-A1, published 19 Aug 2021; PTO-892) in view of Bijl et al. (CN1229440A; hereafter Bijl; PTO-892).
Regarding claims 1, 5-7, and 12, Chang teaches “vitamin supplement compositions formulated for administration to patients, particularly improved vitamin compositions formulated for use in cosmetic or therapeutic applications. The compositions may be used to slow aging process [i.e. skin aging prevention] and promote wellness including treating a vitamin deficiency, skin conditions [i.e. skin improvement], improving skin appearance, wound healing and scar prevention and hair loss [i.e. hair loss prevention].” [Abstract]. “[A]dministration of a composition provided herein may improve skin elasticity, skin regeneration [i.e. sensitive skin improvement], metabolism, smoothness and/or softness of skin (i.e., making the skin feel smoother and softer following treatment); the overall appearance of skin; evening out skin tone and texture; clarity and/or radiance of skin; making the skin look younger; and making wrinkles appear softer and/or less prominent.” [0008] Specifically, Chang teaches an aqueous solution comprising cobalamin (vitamin B12) [0011].
Chang does not teach that the vitamin B12 is an administration of a culture product of a Cutibacterium sp. strain, wherein the Cutibacterium sp. strain comprises (a) an Lrp/AsnC family transcriptional regulator or a gene encoding the same, and(b) a lactococcin 972 family bacteriocin or a gene encoding the same, as in claim 1, or the strains of claims 2-4 or claim 11.
Regarding claims 1-4 and 11, Bijl teaches that Propionibacterium acnes (now Cutibacterium acnes) can be used to in a fermentation method to produce vitamin B12 [pg. 3 par. 5], which can be purified into a “culture product” and administered subjects in the form of animal feed, human food additives, or cosmetic products [pg. 3 par. 3, pg. 5 par. 3-4]. Bijl teaches the advantage that “This method is easy to operate on an industrial scale and are beneficial to the environment, because it does not need to use organic solvent or cyanide.” [pg. 3 par. 3].
Bijl does not teach the specific strains and genes that are discussed in the claims. However, vitamin B12 has defined chemical structures, which would not differ based on the strain that was used to produce them. MPEP 2113 states: “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).”
Regarding claim 12, the “vitamin B12-containing compositions can be used as or used for human food additive product and/or is incorporated into cosmetic products such as shampoo or bath” [pg. 5 par. 4]. Shampoo is in the form of a solution, ointment, gel and/or solution.
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to improve the Chang method of improving skin by administering vitamin compositions comprising vitamin B12 by producing vitamin B12 as a Cutibacterium acnes culture product via the fermentation method of Bijl, thereby arriving at the claimed invention, because Bijl teaches that their vitamin B12 production method has the advantages of being easy to operate and beneficial for the environment. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” The modification could have been made with a reasonable expectation of success because it only requires swapping one vitamin B12 composition with another, and Bijl states that their vitamin B12 product can be used in a cosmetic product.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the prior art (Chang) teaches a method that only differs from the claimed invention by the substitution of a single component (i.e. substitution of the vitamin B12 used); the substituted element (i.e. the vitamin B12 product) was already known and already shown to be produced as a Cutibacterium sp. culture product and to function as a vitamin B12, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of substituting one vitamin B12 for another with a reasonable expectation of success (i.e. the substitution of the element would lead to predictable results). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Double Patenting
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 1-7, and 11-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 13, and 16 of copending Application No. 18/705,390 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because in view of the side by side comparison below of the limitations of claimed method of instant application and the method of copending Application No. 18/705,390.
Claims of copending application No.18705390:
Claims of instant application No.18704774:
1. A method for preventing, alleviating or treating inflammatory skin disease, comprising administering a Cutibacterium sp. strain, a culture product of the strain, or a combination thereof into a subject in need of preventing, alleviating or treating the inflammatory skin disease, wherein the Cutibacterium sp. strain comprises (a) an Lrp/AsnC family transcriptional regulator or a gene encoding the same, and (b) a lactococcin 972 family bacteriocin or a gene encoding the same.
1. A method for skin improvement, comprising administering a Cutibacterium sp. strain, a culture product of the strain, or a combination thereof, into a subject in need of the skin improvement, wherein the Cutibacterium sp. strain comprises (a) an Lrp/AsnC family transcriptional regulator or a gene encoding the same, and(b) a lactococcin 972 family bacteriocin or a gene encoding the same.
2. The method according to claim 1, wherein the Cutibacterium sp. strain does not comprise at least one protein selected from the group consisting of the following (1) to (6) or a gene encoding the same:(1) beta-glucuronidase or a gene encoding the same, (2) 2-isopropylmalate synthase or a gene encoding the same, (3) 3-isopropylmalate dehydratase or a gene encoding the same, (4) type I-E CRISPR-associated protein Cse1/CasA or a gene encoding the same, (5) type I-E CRISPR-associated protein Cas7/Cse4/CasC or a gene encoding the same, and (6) CRISPR-associated helicase/endonuclease Cas3 or a gene encoding the same.
2. The method according to claim 1, wherein the Cutibacterium sp. strain does not comprise at least one protein selected from the group consisting of the following (1) to (6) or a gene encoding the same: (1) beta-glucuronidase or a gene encoding the same, (2) 2-isopropylmalate synthase or a gene encoding the same, (3) 3-isopropylmalate dehydratase or a gene encoding the same, (4) type I-E CRISPR-associated protein Cse1/CasA or a gene encoding the same, (5) type l-E CRISPR-associated protein Cas7/Cse4/CasC or a gene encoding the same, and (6) CRISPR-associated helicase/endonuclease Cas3 or a gene encoding the same.
3. The method according to claim 1, wherein the Cutibacterium sp. strain does not comprise the following (1) to (6) or a gene encoding the same:(1) beta-glucuronidase or a gene encoding the same, (2) 2-isopropylmalate synthase or a gene encoding the same, (3) 3-isopropylmalate dehydratase or a gene encoding the same, (4) type I-E CRISPR-associated protein Cse1/CasA or a gene encoding the same, (5) type I-E CRISPR-associated protein Cas7/Cse4/CasC or a gene encoding the same, and (6) CRISPR-associated helicase/endonuclease Cas3 or a gene encoding the same.
3. The method according to claim 1, wherein the Cutibacterium sp. strain does not comprise-the following (1) to (6) or a gene encoding the same: (1) beta-glucuronidase or a gene encoding the same, (2) 2-isopropylmalate synthase or a gene encoding the same, (3) 3-isopropylmalate dehydratase or a gene encoding the same, (4) type I-E CRISPR-associated protein Cse1/CasA or a gene encoding the same, (5) type l-E CRISPR-associated protein Cas7/Cse4/CasC or a gene encoding the same, and (6) CRISPR-associated helicase/endonuclease Cas3 or a gene encoding the same.
4. The method according to claim 1, wherein the Cutibacterium sp. strain comprises a 16S rRNA gene of SEQ ID NO: 8.
4. The method according to claim 1, wherein the Cutibacterium sp. strain comprises a 16S rRNA gene of SEQ ID NO: 8.
5. The method according to claim 1, wherein the skin improvement is at least one selected from the group consisting of skin wrinkle improvement, skin elasticity improvement, skin aging prevention, skin moisturizing improvement, skin moisture supply, and skin nutrition supply.
6. The method according to claim 1, wherein the inflammatory skin disease is at least one selected from the group consisting of hair loss, rosacea, erythema nodosum, erythema multiforme, keratosis pilaris, psoriasis, eczema, atopic dermatitis and acne.
6. The method according to claim 1, wherein the skin improvement is at least one selected from the group consisting of scalp protection, hair loss prevention, hair moisture supply, and hair nutrition supply.
1. A method for preventing, alleviating or treating inflammatory skin disease, comprising administering a Cutibacterium sp. strain, a culture product of the strain, or a combination thereof into a subject in need of preventing, alleviating or treating the inflammatory skin disease, wherein the Cutibacterium sp. strain comprises (a) an Lrp/AsnC family transcriptional regulator or a gene encoding the same, and (b) a lactococcin 972 family bacteriocin or a gene encoding the same.
7. The method according to claim 1, wherein the cosmetic composition for skin improvement is a cosmetic composition for sensitive skin improvement.
16. The method according to claim 1, wherein the Cutibacterium sp. Strain is deposited under Accession number KCCM13032P, KCCM13033P, KCCM13034P, KCCM13035P, KCCM13036P or KCCM13037P.
11. The method according to claim 1, wherein the Cutibacterium sp. strain is deposited under Accession number KCCM13032P, KCCM13033P, KCCM13034P, KCCM13035P, KCCM13036P or KCCM13037P.
13. the method according to claim 1, wherein the Cutibacterium sp. strain, the culture product of the strain, or the combination thereof is administered as a food or feed composition.
12. The method according to claim 1, wherein the Cutibacterium sp. strain, or the culture product of the strain, or the combination thereof is administered in any one formulation selected from the group consisting of solution, suspension, emulsion, paste, gel, cream, powder, ointment, patch, cosmetic water, essence, gel, lotion, mask, pack, powder, capsule and spray.
In addition, regarding claim 5, the claimed properties of “at least one selected from the group consisting of skin wrinkle improvement, skin elasticity improvement, skin aging prevention, skin moisturizing improvement, skin moisture supply, and skin nutrition supply” are inherent to the claimed method using a supernatant culture product from the deposited strains, i.e. the claimed method taught by claims 1-6, 13, and 16 of copending Application No. 18/705,390. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The instant specification provides evidence that the same product is capable of these effects when used in the same way as in copending Application No. 18/705,390, so the additional intended uses are anticipated by the copending claims. Regarding instant claim 7, the instant specification gives an example that an improvement in inflammatory response is an example of sensitive skin improvement [0112].
Therefore, in view of the above side by side comparison of claimed methods, the method as disclosed by claims 1-6, 13 and 16 of copending Application No. 18/705,390 anticipates or makes obvious the claimed method as disclosed by claims 1-7 and 11-12 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
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