Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-12 are pending and under examination.
Election/Restrictions
Applicant’s election without traverse of claims 1-12 in the reply filed on 02/04/2026 is acknowledged. Claims 13-22 have been cancelled.
Claim Objections
Claims 2, 5, and 11 are objected to because of the following informalities:
In claim 2, line 4, the extraneous word “one” between “any” and “combination” should be removed so that the claim recites: and any combination thereof.
In claim 5, line 3, a second parenthesis should be added after “(BSP”.
In claim 11, line 6, the word “or” after “antiparasitic shampoo” should be removed and a comma should be added so that the claim recites: an antiparasitic shampoo, a medicated shampoo…
Appropriate correction is required.
Claim Interpretation
Page 16 of the instant specification defines “fermentate” as a composition produced by living microorganisms in a nutrient medium. Therefore, it is interpreted that “fermentate” is any product produced by a microorganism.
“Fermentate supernatant” is interpreted to mean a supernatant obtained from a fermentation reaction.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a skin care composition comprising a fermentate of two microorganisms selected from Yarrowia lipolytica and Bacillus velezensis. This judicial exception is not integrated into a practical application because, under BRI, a fermentate is considered any product produced by a microorganism in a nutrient media, therefore, a fermentate is naturally occurring, as interpreted in the instant disclosure, and the claims do not include any additional elements other than the naturally occurring fermentate.
Prong 1 - Statutory category: Here, the claimed invention is either a composition of matter or a manufacture. Under 35 USC 101, the claimed invention must be “any new and useful process, machine, manufacture, or composition of matter.” The invention falls under one of the statutory categories (composition of matter) identified in 35 USC 101.
Prong 2A – Judicial exception: Here, the claimed invention is a composition or a manufactured product but is directed to the judicial exception, specifically a law of nature or a natural phenomenon (product of nature). Even a composition of matter or a manufacture may not be patent eligible if it falls under a judicial exception. The three judicial exception categories are: enumerated abstract idea, law of nature, and natural phenomenon (product of nature). Nature based products include both naturally occurring as well as non-naturally occurring products that have characteristics that are not markedly different from a natural occurring counterpart and fall within the judicial exception.
Here, the composition comprises a naturally occurring fermentate, i.e., product produced by a microorganism, is therefore directed to products of nature and fall within the judicial exception category.
Prong 2B: Judicial Exception/Significantly More: The “significantly more” analysis is a determination whether a claim is eligible if the claims recite additional elements that integrate the judicial exception into a practical application. Integration requires an additional element in the claim to apply, rely on, or use the judicial exception in a manner than imposes a meaningful limit on the judicial exception. Claims 1-12 are drawn to compositions comprising naturally occurring fermentates with no additional elements. These limitations do not recite any meaningful additional limitations, modifications or transformations that indicate that the composition comprises anything other than a naturally occurring fermentate, and there is no information to suggest that the microorganisms producing said fermentates have been genetically modified by the applicant (i.e., it is interpreted that they are naturally occurring). Therefore, the claims do not recite any limitations significantly more than the judicial exception.
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 1-12 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.
Claim 1 recites: A skin care composition for use in the treatment of a scalp disorder, comprising at least a fermentate of two microorganisms selected from the group consisting of Yarrowia lipolytica and Bacillus velezensis. The claim language leads to multiple interpretations and is therefore considered indefinite. “Two microorganisms” may be interpreted to mean two or more microorganism cells of either the Yarrowia lipolytica species or the Bacillus velezensis species, or it may be interpreted to mean two microorganism strains which are Yarrowia lipolytica and Bacillus velezensis. To obviate the rejection, the phrase may be amended to recite: A skin care composition…comprising at least a fermentate of Yarrowia lipolytica and Bacillus velezensis.
Claim 1 also recites: wherein said composition reduces and/or treats said scalp disorder. The term “reduces” leads to multiple interpretations and is therefore considered indefinite. The meaning of “reduces a scalp disorder” is not expressly defined in the instant specification and a search of the prior art does not evidence common usage of the phrase in the art of scalp disorders. The phrase could be interpreted to mean that the composition eliminates the cause of the scalp disorder, or it could be interpreted to mean that the composition reduces symptoms associated with the scalp disorder.
Claims 2-12 are also rejected as they depend from claim 1.
Claim 5 recites a fermentate supernatant of about 0.1% to 10% by weight.
The term “about” is a term of approximation which renders the claim indefinite. The range that is encompassed by the term “about” is not defined by the claim, and the specification does not provide the upper and lower limits of the range encompassed by the term “about”. One of ordinary skill in the art would not be reasonably be apprised of the scope of the invention. It is therefore unclear what amount of fermentate supernatant is within approximation as required by the claim.
Claim 10 requires a B. velezensis strain with a 16S ribosomal RNA sequence that is at least 97% sequence identity to a 16S ribosomal RNA sequence of B. velezensis strain E04, H02, or F03. The claim does not recite any sequence identifier for the 16S rRNA sequences. That is, claim 10 does not set forth any SEQ ID NO: for the 16S rRNA sequences. Therefore, the claim is indefinite. To obviate the rejection, Applicant may amend the claim to include SEQ ID NOs for each 16S rRNA sequence of each B. velezensis strain.
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 1-12 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention.
Claims 1-12 are drawn to a skin care composition for use in treating a scalp disorder comprising a fermentate, i.e., any product produced by Y. lipolytica or B. velezensis.
MPEP 2163.05 II states “the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. 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) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that ‘only describe[d] one type of structurally similar antibodies’ that ‘are not representative of the full variety or scope of the genus.’). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us].’”
The instant specification describes testing fermentates under very specific growth conditions using specific strains of Y. lipolytica and B. velezensis (Example 1). The specification does not provide adequate written description support for all Y. lipolytica and B. velezensis strains under all growth conditions. The instant specification does not disclose a correlation between the structural properties of the fermentate and the claimed function to be maintained, i.e., treatment of a scalp disorder. Therefore, the disclosed species are not representative of the entire genus of claimed fermentates. One of ordinary skill in the art cannot reasonably predict all possible fermentates produced by all Y. lipolytica and B. velezensis strains under all growth conditions that are capable of treating a condition of the scalp.
Castiel teaches use of an effective amount of at least one probiotic microorganism and/or a metabolite thereof for preventing and/or treating dandruff disorders of the scalp (Abstract). Castiel teaches that a microorganism that may be suitable for the invention may be Yarrowia lipolytica (para. [0156]-[0157]). KR ‘178 teaches a cosmetic composition comprising a Bacillus amyloliquefaciens subsp. plantarum extract, i.e., a fermentate (para. [0010], para. [0019]), which is a taxonomic synonym for Bacillus velezensis. However, neither Castiel nor KR ‘178 disclose structures of all fermentates produced by Y. lipolytica and B. velezensis that are capable of treating a scalp disorder.
In summary, neither the instant specification, nor the prior art, discloses a structure-function relationship between fermentate structure and the claimed function of treating a scalp disorder. One of ordinary skill in the art cannot reasonably predict what cell culture conditions may be modified to generate a functional fermentate capable of treating a scalp disorder. Based on the instant disclosure, those skilled in the art would not conclude that the applicant was in possession of all claimed variants.
Claim Rejections - 35 USC § 102
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, 2, 6-8, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Castiel et al., (US 2011/0014248 A1).
Claim 1 recites: a skin care composition…comprising at least a fermentate of two microorganisms selected from the group consisting of Yarrowia lipolytica and Bacillus velenzensis. Under BRI, it is interpreted that the claim requires any product produced by at least two microorganism cells of either Y. lipolytica or B. velenzensis.
Regarding claim 1, Castiel teaches use of an effective amount of at least one probiotic microorganism and/or a metabolite thereof for preventing and/or treating dandruff disorders of the scalp (Abstract). Castiel teaches that a microorganism that may be suitable for the invention may be Yarrowia lipolytica (para. [0156]-[0157]). Castiel defines metabolite as any substance derived from the metabolism of the microorganisms (para. [0141]), therefore, a metabolite is considered a fermentate as defined by the instant disclosure.
Regarding claim 2, Castiel teaches that the disorder may be dandruff of the scalp (Abstract).
Regarding claims 6-7, Castiel teaches that the composition may be used for preventing and/or treating skin infections of the scalp by Malassezia sp. (para. [0070]). Castiel teaches that dandruff may be caused by colonization of the skin or hair follicles by Malassezia sp. (para. [0006]). Therefore, it is interpreted that the composition of Castiel reduces Malassezia growth and biofilm formation. It is of note that the limitations of claims 6 and 7 are considered intended use of the composition of claim 1. During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. See MPEP 2111.02 II. Because Castiel teaches a composition that is structurally identical to the composition of the instant invention, i.e., a product produced by a microorganism which may be Y. lipolytica, the composition of Castiel meets the limitations of the instant claims.
Regarding claim 8, Castiel teaches that the composition may comprise an additional cosmetic active agent being chosen from antidandruff active agents (Abstract).
Regarding claim 11, Castiel teaches that the composition may be a hair lotion, a shampoo, a conditioner, a detangler, a hair gel, etc. (para. [0300]).
Regarding claim 12, Castiel teaches that the composition may be a topical composition (para. [0300]).
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 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Castiel et al., (US 2011/0014248 A1) as applied to claim 1 above, and further in view of KR 102019178 B1, herein after referred to as KR '178, as evidenced by NCBI Taxonomy Browser-Bacillus velezensis (Schoch CL, et al. NCBI Taxonomy: a comprehensive update on curation, resources and tools. Database (Oxford). 2020).
Regarding claim 3, Castiel teaches that a microorganism that may be suitable for dandruff treatment may be Yarrowia lipolytica (para. [0156]-[0157]). Castiel teaches that the microorganism may be in the form of a culture supernatant (para. [0185]). Castiel does not teach a Bacillus velezensis supernatant.
However, KR ‘178 teaches a cosmetic composition comprising a Bacillus amyloliquefaciens subsp. plantarum extract, i.e., a fermentate (para. [0010], para. [0019]), which is a taxonomic synonym for Bacillus velezensis, as evidenced by NCBI Taxonomy browser (p. 1). KR’178 teaches that the Bacillus extract may be a supernatant (para. [0020]
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to add the B. amyloliquefaciens subsp. plantarum supernatant of KR ‘178 to a composition for the treatment of a dandruff disorder of the scalp comprising a Yarrowia lipolytica supernatant, as taught by Castiel. One of ordinary skill in the art would have been motivated to do so because KR ‘178 teaches that B. amyloliquefaciens subsp. plantarum extracts have antimicrobial activity (para. [0012]) and Castiel teaches that a microorganism of the Bacillus genus may be added to the cosmetic composition (para. [0224]). One of ordinary skill in the art would have had a reasonable expectation of success because Castiel and KR ‘178 are in the same field of endeavor of cosmetic composition development. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)
Regarding claims 4 and 5, Castiel teaches a skin care composition comprising two microorganisms, each at 5% by weight (Example 5), i.e., a ratio of 1:1, which falls within the ratio and concentration ranges of the instant claims. It would have been obvious to one of ordinary skill in the art to add a Bacillus amyloliquefaciens subsp. plantarum supernatant as taught by KR ‘178 to a composition comprising a Y. lipolytica supernatant at the concentrations taught by Castiel.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Castiel et al., (US 2011/0014248 A1) as applied to claim 1 above, and further in view of Zhang et al., (Three diacylglycerol acyltransferases contribute to oil biosynthesis and normal growth in Yarrowia lipolytica. Yeast. 2012 Jan;29(1):25-38).
See discussion of Castiel above. Castiel does not teach any of the Y. lipolytica strains of instant claim 9.
However, Zhang teaches Yarrowia lipolytica strain ATCC 20362 (Table 3).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to substitute Yarrowia lipolytica strain ATCC 20362 as taught by Zhang, for the Yarrowia lipolytica to treat a dandruff disorder of the scalp, as taught by Castiel. One of ordinary skill in the art would have been motivated to do so because Zhang teaches that Yarrowia lipolytica strain ATCC 20362 is capable of degrading fatty acids (Table 3), which cause dandruff as taught by Castiel (para. [0012]). One of ordinary skill in the art would have had a reasonable expectation of success because both Castiel and Zhang are in the same field of endeavor of Yarrowia lipolytica culture methods.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Castiel et al., (US 2011/0014248 A1) as applied to claim 1 above, and further in view of KR 102019178 B1, herein after referred to as KR '178, as evidenced by NCBI Taxonomy Browser-Bacillus velezensis (Schoch CL, et al. NCBI Taxonomy: a comprehensive update on curation, resources and tools. Database (Oxford). 2020) and Toledo et al., (US 10596209 B2).
Castiel does not teach the use of B. velezensis or teach a bacterial strain having a 16S ribosomal RNA sequence with at least 97% sequence identity to the 16S ribosomal RNA sequences of the recited B. velezensis stains. The 16S ribosomal RNA sequence of CBS147469 is instant SEQ ID NO:1, the 16S ribosomal RNA sequence of CBS147473 is instant SEQ ID NO:2, and the 16S ribosomal RNA sequence of CBS1474781 is instant SEQ ID NO:3.
KR ‘178 teaches a cosmetic composition comprising a Bacillus amyloliquefaciens subsp. plantarum extract, i.e., a fermentate (para. [0010], para. [0019]), which is a taxonomic synonym for Bacillus velezensis, as evidenced by NCBI Taxonomy browser (p. 1). KR ‘178 does not teach that the B. velezensis strain has a 16S ribosomal RNA sequence with at least 97% sequence identity to the 16S ribosomal RNA sequences of the recited B. velezensis stains.
Toledo teaches a sequence, SEQ ID NO:10, with 100% sequence identity to instant SEQ ID NO:1 (see alignment attached to this Office action).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to add B. velezensis, as taught by KR ‘178, with a 16 ribosomal RNA sequence as taught by Toledo, to the composition to treat a dandruff disorder of the scalp, taught by Castiel. One of ordinary skill in the art would have been motivated to do so because KR ‘178 teaches that B. amyloliquefaciens subsp. plantarum, i.e., B. velezensis extracts, have antimicrobial activity (para. [0012]) and can be used in cosmetic compositions (para. [0010]), Toledo teaches that SEQ ID NO:10 is the 16 ribosomal RNA sequence of DP10, which is B. velezensis, (Table 7), and Castiel teaches that a microorganism of the Bacillus genus may be added to a cosmetic composition for the treatment of dandruff (para. [0224]). One of ordinary skill in the art would have had a reasonable expectation of success because Castiel, KR ‘178, and Toledo are in the same field of endeavor of probiotic composition development.
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, 2, 6, 8, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 8, and 10 of copending Application No. 18/254,961 in view of Castiel et al., (US 2011/0014248 A1).
This is a provisional nonstatutory double patenting rejection.
Claim 1 of ‘961 recites: A skin care composition for use in treatment of a scalp disorder, comprising an effective amount of a Bacillus velezensis fermentate, and/or metabolite thereof, wherein said composition reduces and/or treats said scalp disorder. Castiel teaches use of an effective amount of at least one probiotic microorganism and/or a metabolite thereof for preventing and/or treating dandruff disorders of the scalp (Abstract). Castiel teaches that a microorganism that may be suitable for the invention may be Yarrowia lipolytica (para. [0156]-[0157]). Castiel defines metabolite as any substance derived from the metabolism of the microorganisms (para. [0141]), therefore, a metabolite is considered a fermentate as defined by the instant disclosure.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to add the Yarrowia lipolytica fermentate of Castiel to the skin care composition of ‘961, as Castiel teaches that Y. lipolytica is a suitable microorganism for the treatment of scalp disorders.
Claim 2 of ‘961 recites: The skin care composition of claim 1, wherein the scalp disorder is selected from the group consisting of a dandruff condition of the scalp (seborrheic dermatitis), unbalanced ecoflora of the scalp, discomfort of the scalp, tinea versicolor, dry skin, irritated skin, or any one combination thereof.
Claim 4 of ‘961 recites: The skin care composition of claim 1, wherein the composition reduces the growth of Staphylococcus species and/or Malassezia species.
Claim 5 of ‘961 recites: The skin care composition of claim 1, wherein the composition removes biofilm of Malassezia species and/or Staphylococcus species.
Claim 8 of ‘961 recites: A skin care composition comprising an effective amount of the skin care composition of any one of claims 1-6 and one or more dermatologically or skin care acceptable component.
Claim 10 of ‘961 recites: The skin care product of claim 8, wherein the product is formulated for topical administration.
Instant claim 1 is unpatentable over claim 1 of ‘961 in view of Castiel because both claims require a skin care composition for the treatment of a scalp disorder comprising a Bacillus velezensis fermentate while Castiel teaches a skin care composition for the treatment of a scalp disorder that may comprise a Yarrowia lipolytica fermentate.
Instant claim 2 is unpatentable over claim 2 of ‘961 in view of Castiel because both claims require that the scalp disorder is selected from dandruff, seborrheic dermatitis, unbalanced ecoflora of the scalp, discomfort of the scalp, tinea versicolor, dry skin, or irritated skin.
Instant claim 6 is unpatentable over claim 4 of ‘961 in view of Castiel because both claims require that the composition reduces the growth of Malassezia species.
Instant claim 8 is unpatentable over claim 8 of ‘961 in view of Castiel because both claims require that the skin care composition comprises a dermatological acceptable carrier. Castiel teaches that the composition may comprise an additional cosmetic active agent (Abstract).
Instant claim 12 is unpatentable over claim 10 of ‘961 in view of Castiel because both claims require that the product is formulated for topical administration.
Claims 1, 2, and 6-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 7, 9, and 11 of copending Application No. 17/796,433 in view of KR 102019178 B1, herein after referred to as KR '178.
This is a provisional nonstatutory double patenting rejection.
Claim 1 of ‘433 recites: A skin care composition for use in the treatment of a scalp disorder in a subject, the composition comprising an effective amount of at least one microorganism of the genus Yarrowia and/or a fraction thereof, and/or a cell lysate thereof, and/or a fermentate thereof, wherein said composition, reduces free fatty acids of said subject's scalp and/or treat said scalp disorder. KR ‘178 teaches a cosmetic composition that may comprise a Bacillus amyloliquefaciens subsp. plantarum supernatant, i.e., a Bacillus velezensis fermentate.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to add the Bacillus velezensis fermentate of KR ‘178 to the skin care composition of ‘433, as KR ‘178 teaches that Bacillus velezensis possesses antimicrobial activity.
Claim 2 of ‘433 recites: The skin care composition of claim 1, wherein the scalp disorder is selected from the group consisting of a dandruff condition of the scalp, unbalanced ecoflora of the scalp, discomfort of the scalp, tinea versicolor, dry skin, irritated skin, or any one combination thereof.
Claim 5 of ‘433 recites: The skin care composition of claim 1, wherein the composition reduces the growth of Malassezia species.
Claim 7 of ‘433 recites: The skin care composition of claim 1, wherein the composition prevents or reduces biofilm formation of Malassezia species.
Claim 9 of ‘433 recites: The skin care composition of claim 1, comprising at least one microorganism of the genus Yarrowia and/or a fraction thereof, and/or a cell lysate thereof, and/or fermentate thereof, and/or metabolite thereof, selected from the group consisting of Yarrowia lipolytica ATCC 20362, Yarrowia lipolytica ATCC 9773, Yarrowia lipolytica ATCC 18942, Yarrowia lipolytica ATCC 20177, Yarrowia lipolytica CBS2073, Yarrowia lipolytica Phaff#50-47, or any one combination thereof.
Claim 11 of ‘433 recites: A skin care product comprising an effective amount of the skin care composition of claim 1 and one or more dermatologically or skin care acceptable component.
Instant claim 1 is unpatentable over claims 1 and 9 of ‘433 in view of KR ‘178 because both claims require a skin care composition for the treatment of a scalp disorder comprising a Yarrowia lipolytica fermentate while KR ‘178 teaches a cosmetic composition that may comprise a Bacillus amyloliquefaciens subsp. plantarum supernatant, i.e., a Bacillus velezensis fermentate.
Instant claim 2 is unpatentable over claim 2 of ‘433 in view of KR ‘178 because both claims require that the scalp disorder is selected from dandruff, unbalanced ecoflora of the scalp, discomfort of the scalp, tinea versicolor, dry skin, or irritated skin.
Instant claim 6 is unpatentable over claim 5 of ‘433 in view of KR ‘178 because both claims require that the composition reduces the growth of Malassezia species.
Instant claim 7 is unpatentable over claim 7 of ‘433 in view of KR ‘178 because both claims require that the composition prevents or reduces biofilm formation of Malassezia species.
Instant claim 8 is unpatentable over claim 11 of ‘433 in view of KR ‘178 because both claims require that the skin care composition comprises a dermatological acceptable component. KR ‘178 teaches that the composition is a cosmetic composition, therefore it is considered that said composition may contain a cosmetic acceptable component.
Instant claim 9 is unpatentable over claim 9 of ‘433 in view of KR ‘178 because both claims require a Yarrowia lipolytica strain selected from the group consisting of Yarrowia lipolytica ATCC 20362, Yarrowia lipolytica ATCC 9773, Yarrowia lipolytica ATCC 18942, Yarrowia lipolytica ATCC 20177, Yarrowia lipolytica CBS2073, Yarrowia lipolytica Phaff#50-47, or any one combination thereof.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571) 272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657