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
Applicant’s preliminary amendment filed on 17 September 2024 is entered. Claims 1, 3-8, and 10 are amended, and claims 11-18 are new.
Claims 1-18 are pending and under examination.
Priority
Acknowledgment is made of Applicant’s claim for priority to the filing date of DKPA 2021 00835 filed 25 August 2021, DKPA 2022 00503 filed 31 May 2022, and PCT/EP2022/073726 filed 25 August 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 25 August 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02 May 2024 is being considered by the examiner.
Claim Objections
Claims 1, 5-7, 9-12, and 14-15 are objected to because of the following informalities:
Claim 1. The word “active” in lines 2, 4, and 7 should be corrected to “actives” to match the plural phrase “two or more” immediately before it.
Claim 1. The conjugation for the word “is” on line 8 should be corrected to “are” since the subject is plural.
Claim 5. The indefinite article “a” should be added before the word “metabolism”.
Claim 6. The word “at” is missing before the word “least” on line 1 of the claim.
Claim 7. The plural word “bacteriocins” should be in the singular due to the singular indefinite article “a” before it.
Claim 7. The word “hereof” at the end of the claim should be corrected to “thereof”.
Claim 7 recites improper Markush group language “selected from a bacteriocins, an organic acid, a cell wall material, or a combination thereof.” The terminal “or” should be corrected to “and”.
Claim 9. The genus name “Malassezia” on line 3 should be italicized to conform with standard nomenclature.
Claim 10 recites improper Markush group language “selected from the group consisting of an anionic surfactant, a nonionic surfactant, an amphoteric surfactant, or a combination thereof.” The terminal “or” should be corrected to “and”.
Claim 11. The “is” on line 4 should be corrected to “are” since the subject is plural.
Claim 12. A comma should be added before the words “wherein” on lines 2 and 3. An “and” should be added before the last “wherein” on line 3.
Claim 14. The word extraneous “wherein” should be deleted.
Claim 15. The conjugation for the word “comprising” should be corrected to “comprises”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 recites the limitation “two or more active of the one or more isolated probiotic bacterial strains.” It is unclear what the term “active” means. This term is neither defined in the specification nor a commonly used or known to one of ordinary skill in the art. It is uncertain whether the limitation requires that the probiotic bacterial strains are in an active form (i.e. actively replicating), or the term is referring to active materials derived from the probiotic bacterial strains, as disclosed in the specification (p. 3, line 5).
Claims 1 and 11 recite the term “an acceptable carrier.” It is unclear what features of a carrier are required for the carrier to be considered “acceptable”. The claims do not recite any limitations which define what is meant by the term “acceptable”, and the disclosure lacks any special definition which would allow one of ordinary skill in the art to understand whether a given carrier is “acceptable” and ascertain the metes and the bounds of the claimed invention.
Claim 2 recites that the composition of claim 1 comprises nucleic acid and/or nucleotides. It is unclear whether the composition of claim 1 further comprises nucleic acid and/or nucleotides, or the nucleic acid and/or nucleotides are the “two or more actives” in claim 1.
Claims 2-10 and 15-18 are dependent on claim 1, and claims 12-14 are dependent on claim 11, so those dependent claims are indefinite for the same reasons.
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 1-9 and 11-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a product of nature without significantly more.
Claims 1-9 and 11-18 are drawn to the statutory category of a composition of matter (Step 1: Yes).
Claim 1 recites a composition comprising one or more isolated probiotic strains, two or more actives of the probiotic strains, or a combination thereof, and an acceptable carrier. The BRI of claim 1’s composition includes a composition comprising naturally occurring probiotic strains or products produced by those natural strains together with a natural occurring carrier, all in the form of a powder. Many probiotic strains commensurate in scope with the invention are isolated from natural medium, as evidenced by the specification (Specification pg. 10 last para.), and there are many naturally occurring carriers, such as water, natural botanical juices, natural oils, etc. as evidenced by the specification (Specification pg. 16 last para.). Claim 1’s limitation that the pH of the composition is below 6.5 does not render the composition markedly different from that found in nature, unless it can be shown that the claimed pH range is non-natural and grants the composition markedly different properties from the natural counterpart. This same logic applies to claim 4, which recites that the composition of claim 1 has a pH below 5.5.
Claim 2 recites that the composition of claim 1 comprises nucleic acid and/or nucleotides. Nucleic acids are the principal components present in naturally occurring in DNA and RNA biological macromolecules.
Claim 3 recites that the composition of claim 1 does not comprise plant and/or fiber material. The composition’s lack of plant and/or fiber material does not render the whole markedly different from the natural counterpart.
Claims 5 and 6 recite product-by-process language which describe how the claimed products are produced. MPEP §2113(I) states that product-by-process claims are not limited by the manipulations of the process, only by the implied structure of the steps. Claim 5 recites that the two or more actives of the probiotic strains in claim 1 are produced by the metabolism of the probiotic strains. Claim 6 recites that the two actives of claim 1 are produced by a single probiotic strain. The steps of claims 5 and 6 do not recite any implied structure beyond what was claimed in claim 1, so they recite the same product of nature recited in claim 1.
Claim 7 recites that the actives of claim 1 are selected from a bacteriocin, an organic acid, a cell wall material, or a combination thereof. The BRI of the “cell wall material” includes the natural components that make up the cell walls of the natural probiotic. It is widely known that probiotic bacteria, such as the Lactobacillus and Bifidobacterium species, produce bacteriocins, organic acids, and cell walls, as evidenced by the abstract of Alvarez et al. (Bacteriocins of lactic acid bacteria: extending the family, Appl Microbiol Biotechnol (2016) 100:2939–2951).
Claim 11 recites a composition comprising one or more viable probiotic bacterial strains and an acceptable carrier, in the form of a powder. The BRI of claim 11’s composition includes a composition comprising naturally occurring probiotic strains together with a natural occurring carrier, all in the form of a powder. Many probiotic strains commensurate in scope with the invention are isolated from natural medium, as evidenced by the specification (Specification pg. 10 last para.), and there are many naturally occurring carriers, such as water, natural botanical juices, natural oils, etc. as evidenced by the specification (Specification pg. 16 last para.). The powder form of the composition does not add markedly different characteristics to the composition because it merely changes the form with which the composition takes. The same compositional elements are contained within the claimed powder, thus claim 11’s composition recites a product of nature.
Claim 12 recites the composition of claim 11 comprises viable probiotics in at least a concentration of 103 CFU/g. A specific concentration of naturally occurring probiotics within claim 11’s composition does not add any markedly different characteristics which would differentiate claim 11’s composition from its natural counterpart.
Claim 13 recites the composition of claim 11 is a dry-shampoo. The claim does not recite any components or structural characteristics of the dry-shampoo form that would render the whole non-natural or otherwise markedly different from the natural counterpart.
Claim 15 recites that the composition of claim 1 comprises viable probiotic bacteria in a concentration of 103 to 1013 CFU/g. Claim 16 recites the composition of claim 1 comprises a pH range of 3.5-5.5. A specific concentration of naturally occurring probiotics within claim 1’s composition does not add any markedly different characteristics which would differentiate claim 1’s composition from its natural counterpart. Likewise, the pH range of a composition does not render the composition markedly different from that found in nature, unless it can be shown that the claimed pH range is non-natural and grants the composition markedly different properties from the natural counterpart.
Claim 17 recites the composition of claim 2 comprises a pH value below 5.5, and claim 18 recites that the composition of claim 3 comprises a pH value below 5.5. The pH range of a composition does not render the composition markedly different from that found in nature, unless it can be shown that the claimed pH range is non-natural and grants the composition markedly different properties from the natural counterpart.
Claims 1, 8-9, 11-12, and 14 recite limitations which are interpreted as being intended uses or capabilities of the claimed compositions, but do not add any new structural limitations to the composition. Thus, if the composition itself is directed to a product of nature, then these claims also recite a product of nature. Claim 1 recites the probiotic strains are capable of inhibiting fungal proliferation, which is an intended capabilities of the probiotic strain, not a structural limitation. Claims 8-9 recite that the composition of claim 1 for the prevention and/or treatment of mycoses and/or dandruff, which is an intended use of the composition, not a structural limitation. Claim 11 recites the probiotic strains are capable of inhibiting fungal proliferation, which is an intended capabilities of the probiotic strain, not a structural limitation. Claim 12 recites that the composition of claim 11 is for the treatment of dandruff and/or mycosis, which is an intended use of the composition, not a structural limitation. Claim 14 recites the composition of claim 11 is for scalp treatment, skin treatment, and diaper rash, which are intended uses of the composition, not structural limitations.
Therefore, the instant invention recites a judicial exception of a product of nature (Step 2A Prong One: Yes).
The judicial exception is not integrated into a practical application, and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are directed to compositions of matter, and do not recite any active steps that limit the composition to being used in a practical application, or to otherwise include additional elements that would amount to significantly more than the product of nature.
As mentioned above, claims 8-9 recite that the composition of claim 1 for the prevention and/or treatment of mycoses and/or dandruff, claim 12 recites that the composition of claim 11 is for the treatment of dandruff and/or mycosis, and claim 14 recites the composition of claim 11 is for scalp treatment, skin treatment, and diaper rash. These limitations are intended uses of the claimed compositions, not active method steps of applying the compositions for a specific therapeutic purpose.
Therefore, the instant invention is directed to the judicial exception of a product of nature (Step 2A Prong Two: No), and does not include any additional elements that amount to significantly more than the recited judicial exception of a product of nature, and so the instant invention is not patent eligible subject matter under 35 USC §101 (Step 2B: No).
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.
(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.
Claim interpretation
Claims 1, 8-9, 11-12, and 14 recite limitations which are interpreted as being intended uses or capabilities of the claimed compositions, but do not add any new structural limitations to the composition. Claim 1 recites the probiotic strains are capable of inhibiting fungal proliferation, which is not a structural limitation. Claims 8-9 recite that the composition of claim 1 for the prevention and/or treatment of mycoses and/or dandruff, which is an intended use of the composition, not a structural limitation. Claim 11 recites the probiotic strains are capable of inhibiting fungal proliferation, which is not a structural limitation. Claim 12 recites that the composition of claim 11 is for the treatment of dandruff and/or mycosis, which is an intended use of the composition, not a structural limitation. Claim 14 recites the composition of claim 11 is for scalp treatment, skin treatment, and diaper rash, which are intended uses of the composition, not structural limitations. Thus, if a composition in the prior art teaches all of the structural limitations of the claimed compositions, those limitations will be considered to be anticipated.
Claims 1-10 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zapka et al. (US 20170281660 A1, published 05 October 2017), as evidenced by Alvarez et al. (Bacteriocins of lactic acid bacteria: extending the family, Appl Microbiol Biotechnol (2016) 100:2939–2951).
Regarding claims 1, 3-4, and 16-18, Zapka teaches a topical composition comprising an active ingredient, including probiotics, prebiotics, or synbiotic, and at least one carrier (Zapka claims 1 and 15). The pH of the composition can be between 2.5 and 9.0 (Zapka claim 27).
Regarding claim 2, probiotic microorganisms comprise DNA genomes that comprise nucleic acids and/or nucleotides, thus Zapka’s composition which comprises probiotic microorganisms also comprises nucleic acids and nucleotides.
Regarding claims 5-6, the claims recite product-by-process language which describe how the claimed products are produced. MPEP §2113(I) states that product-by-process claims are not limited by the manipulations of the process, only by the implied structure of the steps. 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. Claim 5 recites that the two or more actives of the probiotic strains in claim 1 are produced by the metabolism of the probiotic strains. Claim 6 recites that the two actives of claim 1 are produced by a single probiotic strain. The processes of claims 5 and 6 do not recite any implied structure beyond what was claimed in claim 1, so are anticipated for the same reasons.
Regarding claim 7, Zapka teaches their composition comprises probiotic bacteria and derivatives or byproducts thereof (Zapka [25] and claim 5). It is widely known that probiotic bacteria, including the Lactobacillus and Bifidobacterium species discussed in Zapka produce bacteriocins, organic acids, and cell walls, as evidenced by Alvarez (Alvarez abstract). Therefore, derivatives and byproducts of Zapka’s probiotics comprise bacteriocins, organic acids, cell wall materials, and combinations thereof.
Regarding claims 8-9, as described above, claims 8-9 recite intended uses of the composition of claim 1, but do not add any new structural limitations to the composition. Since Zapka teaches all of the structural limitations of the claimed composition, claims 8-9 are considered to be anticipated.
Regarding claim 10, Zapka teaches the topical composition may be in the form of a shampoo, and may have a pH between 2.5 to 9.0, and also may comprise surfactants like anionic surfactant sodium lauryl sulfate, non-ionic surfactant polysorbate-polyethylenesorbitan-monolaurate, and amphoteric surfactant lecithin (Zapka [30]-[31] and [44]).
Claims 11 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lorenz et al. (US 20180360739 A1, published 20 December 2018).
Regarding claims 11 and 13, Lorenz teaches a dry shampoo composition comprising a probiotic and a carrier, which can be in the form of a powder (Lorenz [9], [46], and [61]).
Regarding claim 14, as described above, the claim recites that the composition of claim 11 is for scalp treatment, skin treatment, and diaper rash, which are interpreted as being intended uses of the claimed composition, but do not add any new structural limitations to the composition. Since Lorenz teaches all of the structural limitations of the claimed composition, claim 14 is considered to be anticipated.
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lorenz as applied to claims 11 and 13-14 above, and further in view of Shemesh (US 20200190463 A1, published 18 June 2020).
Lorenz does not teach their composition comprises viable probiotics in a concentration of 103 CFU/g.
Shemesh teaches a probiotic composition comprising 103 to 1015 CFU/g of the composition (Shemesh [181]), and that the probiotic composition may be in the form of a powder (Shemesh [198]).
MPEP §2144.05(II)(A) states “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
It would have been obvious for one of ordinary skill in the art to optimize the concentration of viable probiotic bacteria in the composition of Lorenz using the concentrations in Shemesh’s probiotic composition as a starting point. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to maximize the benefits of Lorenz’s composition with the minimum amount of viable probiotics.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Zapka as applied to claims 1-10 and 16-18 above, and further in view of Shemesh (US 20200190463 A1, published 18 June 2020).
Zapka does not teach their composition comprises viable probiotics in a concentration of 103 to 1013 CFU/g.
Shemesh teaches a probiotic composition comprising 103 to 1015 CFU/g of the composition (Shemesh [181]), and that the probiotic composition may be in the form of a powder (Shemesh [198]).
MPEP §2144.05(II)(A) states “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
It would have been obvious for one of ordinary skill in the art to optimize the concentration of viable probiotic bacteria in the composition of Lorenz using the concentrations in Shemesh’s probiotic composition as a starting point. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to maximize the benefits of Zapka’s composition with the minimum amount of viable probiotics.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER M DURYEE whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/Alexander M Duryee/Examiner, Art Unit 1657 /LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
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