DETAILED ACTION
Claims 10 and 13-25 are cancelled.
Claims 1-9, 11-12, and 26-27 are pending
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 .
Priority
This application is a 371 of PCT/US2021/015670 filed 01/29/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/25/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
(previous objection, withdrawn) Claim 2 was previously objected to over the following informality: Claim 2 recites seborrheic dermatitis in parentheses, “(seborrheic dermatitis)”. It is unclear if this is intended to be a limitation of the claim since it is enclosed in paratheses. Applicants have amended claim 2 to remove the above informality, thereby overcoming the previous objection.
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.
(previous rejection, withdrawn) Claims 1-12 and 26-27 were previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being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 the treatment of a scalp disorder using living Yarrowia cells, does not reasonably provide enablement for the treatment of a scalp disorder using a fraction thereof, a cell lysate thereof, and/or a fermentate thereof. 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. Claim 1 recites “A skin care composition for use in the treatment of a scalp disorder, 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 fermentate thereof, wherein said composition reduces free fatty acids of said subject’s scalp and/or treat said scalp disorder”. Regarding the breadth of the claim, the structural elements recited in claim 1 include “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 fermentate thereof”. The breadth of claim 1 includes any fermentate of Yarrowia and the claims dependent upon claim 1 do not further specify any particular fermentates. The nature of the invention is predicated on the compositions ability to treat scalp disorders and reduce free fatty acids of a subjects scalp. In claim 1, the scalp disorder is not specified and may therefore be any scalp disorder. Claim 2, which depends from claim 1, specifies scalp disorders to be treated by the composition. Claims 4 is directed to the compositions ability to degrade lipids. Claims 5-7 are directed to the compositions ability to reduce growth, remove biofilm, and/or reduce biofilm formation of Malassezia species. The present disclosure provides working examples of living Yarrowia cells being used to degrade lipids and to inhibit growth of Malassezia species. However, the present disclosure does not provide working examples of Yarrowia fermentates, or lysates being used to treat a scalp disorder, degrade lipids, or to inhibit growth of Malassezia species. Based on the present disclosure, there would be an unreasonably high burden of experimentation needed to use the composition as claimed in claims 1-12, and 26-27.
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.
(previous rejection, withdrawn) Claims 1-12 and 26-27 were previously 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.
Applicants have amended claims 1, and 12 to overcome the previous indefinite rejection. Additionally, applicants have cancelled claim 10, thereby rendering to previous rejection in regards to claim 10 moot. Accordingly, the previous rejection of claims 1-12 and 26-27 is withdrawn.
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.
(previous rejection, maintained, withdrawn in regards to claims 10 and 26) Claims 1-9, and 11-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. As shown below, the claims do not integrate the judicial exception into a practical application, and do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. Claims 1-9, and 11-12 are directed to a composition of matter (step 1: yes).
Claim 1 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 fermentate thereof, wherein said composition reduces free fatty acids of said subject’s scalp and/or treat said scalp disorder”. As shown in the claim interpretation section above, and given the definition of metabolite in the instant specifications, claim 1 reads upon water. Therefore claim 1 is directed to a product of nature (step 2A: yes). Furthermore, claim 1 does not recite (a) markedly different characteristic(s)(step 2B: no). Therefore, claim 1 is not eligible subject matter under 35 U.S.C 101.
Claim 2 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.” As shown, claim 2 is also directed to a product of nature (step 2A: yes), and does not recite (a) markedly different characteristic(s)(step 2B: no). Therefore, claim 2 is not eligible subject matter under 35 U.S.C 101.
Claim 3 recites; “The skin care composition of claim 1, further comprising one or more antidandruff active agents”. As shown, claim 3 is also directed to a natural product (step 2A: yes), and does not recite (a) markedly different characteristic(s)(step 2B: no). As shown in the instant specifications, the antidandruff agent may be a natural product itself (i.e., tea tree oil, aloe vera, sulphur, etc.) (specifications filed 07/29/2022, pg. 14-15). MPEP section 2106.04(c) states “Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts”. Applicants have not demonstrated that the combination of the composition of claim 1 and the antidandruff agent of claim 3 results in an unexpected property that would constitute a markedly different characteristic (step 2B: no). Therefore, claim 3 is not eligible subject matter under 35 U.S.C. 101.
Claim 4 recites; “The skin care composition of claim 1, wherein the composition degrades lipids selected from the group consisting of palmitic acid, oleic acid, and any one combination thereof”. As shown, claim 4 is also directed to a product of nature (step 2A: yes), and does not recite (a) markedly different characteristic(s)(step 2B: no). Therefore, claim 4 is not eligible subject matter under 35 U.S.C 101.
Claim 5 recites; “The skin care composition of claim 1, wherein the composition reduces the growth of Malassezia species”. As shown, claim 5 is also directed to a product of nature (step 2A: yes), and does not recite (a) markedly different characteristic(s)(step 2B: no). Therefore, claim 5 is not eligible subject matter under 35 U.S.C 101.
Claim 6 recites; “The skin care composition of claim 1, wherein the composition removes biofilm of Malassezia species”. As shown, claim 6 is also directed to a product of nature (step 2A: yes), and does not recite (a) markedly different characteristic(s)(step 2B: no). Therefore, claim 6 is not eligible subject matter under 35 U.S.C 101.
Claim 7 recites; “ The skin care composition of claim 1, wherein the composition prevents or reduces biofilm formation of Malassezia species”. As shown, claim 7 is also directed to a product of nature (step 2A: yes), and does not recite (a) markedly different characteristic(s)(step 2B: no). Therefore, claim 7 is not eligible subject matter under 35 U.S.C 101.
Claim 8 recites; “The skin care composition of claim 1, further comprising at least one additional compound selected from the group consisting of an excipient, a preservative, a pH adjuster”. As shown, claim 8 is also directed to a product of nature (step 2A: yes), and does not recite (a) markedly different characteristic(s)(step 2B: no). Therefore, claim 8 is not eligible subject matter under 35 U.S.C 101.
Claim 9 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”. As shown, claim 9 is also directed to a product of nature (step 2A: yes), and does not recite (a) markedly different characteristic(s)(step 2B: no). Therefore, claim 9 is not eligible subject matter under 35 U.S.C 101.
Claim 11 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”. As shown, claim 11 is also directed to a product of nature (step 2A: yes), and does not recite (a) markedly different characteristic(s)(step 2B: no). Therefore, claim 11 is not eligible subject matter under 35 U.S.C 101.
Claim 12 recites; “The skin care product of claim 11, wherein said effective amount of the skin care composition is at least about 1%, 2%, 3%, 4% up to 5% on a weight basis relative to a total weight of said skin care product”. As shown, claim 12 is also directed to a product of nature (step 2A: yes), and does not recite (a) markedly different characteristic(s)(step 2B: no). Therefore, claim 12 is not eligible subject matter under 35 U.S.C 101.
For the reasons above, claims 1-9, and 11-12 are not eligible subject matter under 35 U.S.C 101. Accordingly, claims 1-9, and 11-12 are rejected.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(previous rejection, maintained, withdrawn regarding cancelled claim 10) Claims 1-3, 5-8, 11-12, and 26-27 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Castiel, US 20110014248 A1 (see form PTO-892 Notice of References Cited).
Regarding claims 1-3, Castiel teaches a skin care composition comprising at least one probiotic microorganism, a fraction thereof, and/or metabolite thereof; and an effective amount of at least one active agent selected from an antidandruff active agents and hydrating active agents (Castiel, claim 14; claim 16). Castiel further teaches that the at least one probiotic microorganism may be Yarrowia lipolytica (Castiel, [157]). Furthermore, Castiel teaches that the above skin care composition is useful for treating scalp disorders such as, dandruff, discomfort of the scalp, unbalanced ecoflora of the scalp seborrheic dermatitis (Castiel, claims 2-6).
Regarding claim 5, Castiel teaches that the above skin care composition reduces the growth/colonization of Malassezia species (Castiel, [70]; [368]; fig. 4).
Regarding claim 8, Castiel teaches that the skin care composition above comprises at least one pharmaceutical or dermatological excipient (Castiel, [68]).
Regarding claim 11, Castiel teaches that the skin care composition above comprises at least one pharmaceutical or dermatological excipient (Castiel, [68]). The dermatological excipient in this case is considered to read upon the dermatologically or skin care acceptable component, as recited in instant claim 11.
Regarding claim 12, Castiel teaches that the effective active agents of the skin care composition comprise 0.001% to 10% by weight relative to the total weight of the composition (Castiel, claim 28). The active ingredients in this case is the composition described above in regards to instant claim 1.
Regarding claim 26, Castiel teaches a method of preventing and/or treating a scalp disorder comprising administering the above skin care composition topically (Castiel, claim 10). Castiel teaches that the disorder being prevented and/or treated is a dandruff condition of the scalp (Castiel, claim 2).
Regarding claim 27, Castiel teaches that the skin care product may be a cream, gel, serum, or a lotion (Castiel, [40]). Castiel teaches that the effective active agents of the skin care composition comprise 0.001% to 10% by weight relative to the total weight of the composition (Castiel, claim 28).
Regarding claims 6 and 7, Castiel teaches that the above skin care composition reduces the growth/colonization of Malassezia species (Castiel, [70]; [368]; fig. 4). Although Castiel does not explicitly teach that the skin care composition removes, prevents, or reduces the biofilm of Malassezia species, it appears inherent that these effects would occur during the topical application of the skin care composition. Claims 6 and 7 are both dependent upon claim 1. Claims 6 and 7 do not add additional structural limitations to the composition of claim 1, but recite additional properties of the composition of claim 1. MPEP section 2112.01(I) states, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”. Furthermore, MPEP section 2112(III) states, “Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103”. As shown above, the composition taught by Castiel is substantially identical to the composition of claim 1, from which claims 6 and 7 depend. Therefore, the properties/characteristics of the composition to remove biofilm, or to prevent or reduce biofilm appear to be inherent to the above teachings of Castiel.
As shown above, the teachings of Castiel anticipate instant claims 1-3, 5, 8, 11-12, and 26-27. Accordingly, claims 1-3, 5-8, 11-12, and 26-27 are rejected.
Claim 10 was previously included in this rejection but has since been cancelled by applicants, thereby rendering the previous rejection of claim 10 moot. Accordingly, the previous rejection of claim 10 is withdrawn.
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.
(previous rejection, maintained, withdrawn regarding cancelled claim 10) Claims 1-19 11-12, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Castiel as applied to claims 1-3, 5, 8, 10-12, and 26-27 above, and further in view of Zhang1 (see form PTO-892 Notice of References Cited).
As shown above, Castiel teaches instant claims 1-3, 5, 8, 10-12, and 26-27. As shown above, Castiel teaches a generic Yarrowia lipolytica strain, a fraction thereof, and/or metabolite thereof to be used in their invention.
Regarding claim 4, Castiel does not teach that the skin care composition degrades palmitic acid, oleic acid, and any one combination thereof.
Regarding claim 9, Castiel does not teach a specific Yarrowia lipolytica strain that is used for their invention.
Zhang teaches a Yarrowia lipolytica ATCC 20362 strain, which is capable of degrading fatty acids such as palmitate/palmitic acid (Zhang, table 3). These teachings are applicable to instant claims 4 and 9.
It would have been obvious at the time of filing to combine the teachings of Zhang and Castiel. Specifically, it would have been obvious to use the Yarrowia lipolytica ATCC 20362 strain in the skin care composition and method taught by Castiel. One of ordinary skill in the art would have been motivated to combine the teachings of Castiel and Zhang because Castiel teaches that their skin care composition comprises a probiotic microorganism such as Yarrowia lipolytica. The Yarrowia lipolytica ATCC 20362 strain taught by Zhang is easily available to one of ordinary skill in the art from the American Type Culture Collection (Zhang, pg. 26, [4]). Additionally, one of ordinary skill in the art would have a reasonable expectation of success in combining the above elements of Zhang and Castiel. Zhang teaches that the Yarrowia lipolytica ATCC 20362 strain is capable of growing on fatty substrates such as fatty acids (Zhang, pg. 37, [1]). Castiel teaches that Malassezia bacteria are one of the major causes of dandruff. Castiel teaches that Malassezia cause dandruff by releasing fatty acids from sebum on the scalp which may impair the barrier function of the epidermis and give rise to inflammation (Castiel, [12]; [61]; [97]). Therefore, it would have been obvious to the ordinarily skilled artisan at the time of filing to combine the above teachings of Castiel and Zhang. Accordingly, claims 1-9, 11-12, and 26-27 are rejected.
Claim 10 was previously included in this rejection but has since been cancelled by applicants, thereby rendering the previous rejection of claim 10 moot. Accordingly, the previous rejection of claim 10 is withdrawn.
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.
(previous rejection, maintained) Claims 1-2, 5-6, 9, 11, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-9, 12, 14-16, and 18-19 of copending Application No. 18/569824 (hereby referred to as Flannery). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of Flannery recites, “A skin care composition for use in the treatment of a scalp disorder, comprising at least two microorganisms selected from the group consisting of Yarrowia lipolytica and Bacillus velezensis, and/or cell lysate thereof, and/or fermentate thereof, and/or metabolite thereof, wherein said composition reduces and/or treats said scalp disorder”. As shown in the claim interpretation section above, the composition of instant claim 1 is reasonably interpreted to be water. The metabolite of Yarrowia lipolytica and Bacillus velezensis as recited in claim 1 of Flannery is also interpreted to be water. Thus, claim 1 of Flannery anticipates instant claim 1.
Claim 2 of Flannery 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, seborrheic dermatitis, and any one combination thereof”. Instant claim 2, which is dependent upon instant claim 1, recites the same scalp disorders. Thus, claim 2 of Flannery anticipates instant claim 2.
Claim 6 of Flannery recites, “The skin care composition of claim 1, wherein the composition reduces the growth of Malassezia species”. Instant claim 5 recites “The skin care composition of claim 1, wherein the composition reduces the growth of Malassezia species”. Thus, claim 6 of Flannery anticipates instant claim 5.
Claim 7 of Flannery recites, “The skin care composition of claim 1, wherein the composition prevents or reduces biofilm formation of Malassezia species”. Instant claim 6 recites, “The skin care composition of claim 1, wherein the composition prevents or reduces biofilm formation of Malassezia species”. Thus, claim 7 of Flannery anticipates instant claim 6.
Claim 8 of Flannery recites, “The skin care composition of claim 1, further comprising a cosmetic or dermatological acceptable component”. Instant claim 11 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”. As shown above, claim 1 of Flannery anticipates instant claim 1. Instant claim 11 adds the additional element of one or more dermatologically or skin care acceptable component. Claim 8 of Flannery also teaches adding dermatological acceptable component. Thus, claim 8 of Flannery anticipates instant claim 11.
Claim 9 of Flannery recites, “The skin care composition of claim 1, wherein the Yarrowia lipolytica, and/or a cell lysate thereof, and/or fermentate thereof, and/or metabolite thereof, is selected from the group consisting of Yarrowia lipolytica ATCC 20362, Yarrowia lipolytica ATCC 9773, Yarrowia lipolytica DGCC 9975, Yarrowia lipolytica ATCC 18942, Yarrowia lipolytica ATCC 20177, Yarrowia lipolytica CBS2073, Yarrowia lipolytica Phaff#50-47, and any one combination thereof., and any one combination thereof.” Instant claim 9 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”. Thus, claim 9 of Flannery anticipates instant claim 9.
Claim 14 of Flannery recites, “A method for treating a scalp disorder in a subject in need thereof, comprising administering a skin care composition comprising at least two microorganisms selected from the group consisting of Yarrowia lipolytica and Bacillus velezensis, and/or a cell lysate thereof, and/or fermentate thereof, and/or metabolite thereof, to said subject, wherein said composition reduces and/or treats said scalp disorder”. Instant claim 1, although indefinite, also recites a method step of administering the composition to a subject in order to reduce and/or treat a scalp disorder. Thus, claim 14 of Flannery anticipates instant claim 1.
Claim 15 of Flannery recites, “The method according to claim 14, 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, seborrheic dermatitis, and any one combination thereof”. Furthermore, the specifications of Flannery state that composition may be administered topically (Flannery, pg. 40, ln 5-7). Instant claim 2 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”. As shown above, instant claim 1 also recites a method administering the composition. Thus, claim 15 of Flannery anticipates instant claim 2.
Claim 16 of Flannery recites, “The method according to claim 14, wherein said skin care composition is administered topically”. Instant claim 26 recites, “A method for treating and/or reducing a dandruff condition of the scalp in a subject in need thereof, comprising topically administering a skin care product comprising a skin care composition of claim 1 to said subject.” As shown above, the composition being administered in both instant claim 26 and claim 16 of Flannery may be water. Thus, claim 16 of Flannery anticipates instant claim 26.
Claim 18 of Flannery recites, “The method of claim 14, wherein the skin care composition is administered to the subject's skin or scalp”. Instant claim 1 recites administering the same composition (water) to the subject’s skin or scalp. Additionally, instant claim 26 also recites administering the same composition topically. It is well understood in the art that topical administration is superficial administration to the skin. Thus instant claim 18 anticipates instant claims 1 and 26.
Claim 19 of Flannery recites, “The method of claim 14, wherein the Yarrowia lipolytica, and/or a cell lysate thereof, and/or fermentate thereof, and/or metabolite thereof, is selected from the group consisting of Yarrowia lipolytica ATCC 20362, Yarrowia lipolytica ATCC 9773, Yarrowia lipolytica DGCC 9975, Yarrowia lipolytica ATCC 18942, Yarrowia lipolytica ATCC 20177, Yarrowia lipolytica CBS2073, Yarrowia lipolytica Phaff#50-47, and any one combination thereof, and any one combination thereof”. Instant claim 9 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”. As shown above, instant claim 9 is dependent upon instant claim 1 which recites a method step of administering the composition to a subject to treat a scalp disorder. Thus, claim 19 of Flannery anticipates instant claim 9.
For the reasons shown above, claims 1-2, 5-6, 9, 11, and 26 are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants argue that claim 2 has been amended, obviating the previous objection. In view of applicants amendment to claim 2, the previous objection is withdrawn as shown above.
Applicants argues the previous 112(a) rejection of claims 1-12, and 26-27. Applicant argues that non-enabled limitations have been removed from claim 1. Additionally, applicants have cited enablement support for the remaining limitations of independent claim 1 and claims dependent therefrom (specifications filed 07/29/2022, pg. 55-60, examples 6-7). In view of the amendment to claim 1, the previous 112(a) rejection of claims 1-12, and 26-27 is withdrawn, as shown above.
Applicants argue the previous 112(b) rejection of claims 1-12, and 26-27. Applicants have amended claims 1, and 12 to overcome the previous indefinite rejection. Additionally, applicants have cancelled claim 10, thereby rendering to previous rejection in regards to claim 10 moot. Accordingly, the previous rejection of claims 1-12 and 26-27 is withdrawn as shown above.
Applicants argue the previous 101 rejection of claims 1-12 and 26. Applicants argue that the claimed compositions are not directed to a product of nature but to a formulated skin care composition comprising at least one microorganism of the genus Yarrowia and/or a fraction thereof, and/or a cell lysate thereof, and/or a fermentate thereof, optionally with an excipient. Applicant argues that these compositions exhibit markedly different characteristics from naturally occurring Yarrowia. However, the examiner does not find this argument persuasive. The only structural limitations recited in independent claim 1 are “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”. The Yarrowia recited in claim 1 are not specified to be naturally or non-naturally occurring. Additionally, the specifications state “As used herein the term "skin care composition" refers to a composition comprising at least one skin care benefit agent capable of providing a skin care benefit. As used herein the term "skin care benefit agent" or "active agent" are used interchangeably, and refer to a microorganism of the genus Yarrowia and/or a fraction of said microorganism, and/or a cell lysate of said microorganism, and/or a fermentate of said microorganism, and/or a metabolite of said microorganism that can provide a skin care benefit” (specifications filed 07/29/2022, pg. 13, ln 20-28). Therefore, the limitation of “a skin care composition” as recited in claim 1 does not impart additional structural limitations beyond that of a microorganism of the genus Yarrowia and/or a fraction of said microorganism, and/or a cell lysate of said microorganism, and/or a fermentate of said microorganism, which still reads on a natural product without significantly more. This rejection is maintained in regards to claims 1-9, and 11-12. This rejection is withdrawn in regards to cancelled claim 10. This rejection is also withdrawn in regards to claim 26 in view of the amendment to claim 1 from which 26 depends.
Applicant argues the previous rejection under 102(a)(1) and 102(a)(2) of claims 1-3, 5-8, 10-12, and 26-27. Applicant argues that the present invention differs from the cited prior art of Castiel in that the present invention achieves a new effect. However, this argument is not found persuasive. As shown above, Castiel teaches a skin care composition comprising the same structural limitations as those recited in instant claims 1-3, 5-8, 10-12, and 26-27. Additionally, MPEP 2112(I) states “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977)”. Additionally, MPEP 2112(II) states “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)”. Because Castiel teaches a composition comprising the same structural limitations as those recited in the instant claims, the claimed functional limitation of are interpreted to necessarily flow from teachings of Castiel. Therefore, the previous rejection of claims 1-3, 5-8, 11-12, and 26-27 is maintained. The previous rejection regarding cancelled claim 10 is withdrawn as being moot.
Applicants argue the previous 103 rejection of claims 1-12 and 26-27. Applicants argue that Castiel does not teach the functional limitations of the instant claims. Applicant further argues that there would be no motivation to combine the teachings of Castiel and Zhang. However, the examiner does not find this argument persuasive. One of ordinary skill in the art would have been motivated to combine the teachings of Castiel and Zhang because Castiel teaches that their skin care composition comprises a probiotic microorganism such as Yarrowia lipolytica. The Yarrowia lipolytica ATCC 20362 strain taught by Zhang is easily available to one of ordinary skill in the art from the American Type Culture Collection (Zhang, pg. 26, [4]). Additionally, Castiel teaches that Malassezia cause dandruff by releasing fatty acids from sebum on the scalp which may impair the barrier function of the epidermis and give rise to inflammation (Castiel, [12]; [61]; [97]). Zhang teaches that the Yarrowia lipolytica ATCC 20362 strain is capable of growing on fatty substrates such as fatty acids (Zhang, pg. 37, [1]). Thus, one of ordinary skill would have been motivated to combine the teachings of Castiel and Zhang with a reasonable expectation of success. Accordingly, the previous rejection of claims 1-9, 11-12, and 26-27 is maintained. The previous rejection is withdrawn in regards to cancelled claim 10 as being moot.
Applicant argues the provisional double patenting rejection of claims 1-2, 5-6, 9, 11 and 26. Applicant argues that claim 1 has been amended to delete reference to a metabolite thereof. Applicant further argues that the claims of the present application are limited to compositions comprising Yarrowia alone, whereas the reference application requires a combination of Yarrowia and Bacillus velezensis. However, the examiner does not find this argument persuasive. Claim 1 presently 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…”. As shown above, claim 1, and claims dependent therefrom use the transitional phrase “comprising”. MPEP section 2111.03(I) states “The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004)”. Additionally, the instant claims do not recite a negative limitation or any exclusion of additional elements not explicitly recited in the claims. Therefore, the broadest reasonable interpretation of the instant claims read upon those cited from the reference application of Flannery. Accordingly, the previous provisional double patenting rejection is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/BENJAMIN HALL EASTON/ Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652
1 Zhang H, Damude HG, Yadav NS. Three diacylglycerol acyltransferases contribute to oil biosynthesis and normal growth in Yarrowia lipolytica. Yeast. 2012 Jan;29(1):25-38. doi: 10.1002/yea.1914. Epub 2011 Dec 20. PMID: 22189651.