DETAILED ACTION
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 .
CONTINUING DATA
This application is a 371 of PCT/EP2021/074914 09/10/2021
PCT/EP2021/074914 has PRO 63/076,529 09/10/2020
FOREIGN APPLICATIONS
EP 20202294.3 10/16/2020
Claims 1-15 are pending.
Claim Interpretation
The claims recite increasing the differential abundance of P. marcusii in the skin microbiome by administering to a body in need thereof or supplying carotenoids to skin in need thereof. The specification does not define who the subject in need actually is, but the specification states that carotenoids exert benefits of skin homeostasis, and that P. marcusii produces carotenoids and is a hydrocarbons degrader. Thus, the subjects in need thereof are interpreted to at least include subjects which need the skin benefits exerted by carotenoids and subjects which need protection from environmental pollution.
Claim Objections
Claim 7 is objected to because of the following informalities: claim 7 recites “according to claims 5,” which perhaps should read “according to claim 5.” Appropriate correction is required.
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.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because a “use” is not one of the four categories of patent eligible subject matter. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). MPEP 2173.05(q).
Claim Rejections - 35 USC § 112
Claims 6, 9-11, 13-15 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites a broad range directed to amount of saccharide isomerate, and then recites “preferably” and “most preferably” narrower ranges. Claim 9 recites a broad limitation “at least one” followed by “preferably several.” Claim 10 recites the broad limitation “body skin” followed by the narrower limitation “preferably the torso.” Claims 11 and 15 each recite a broad limitation “coryneforms” followed by the narrower limitation “preferably of B. casie.” Claim 13 recites a broad limitation “carotenoids” followed by the narrower limitation “preferably astaxanthin.”
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 9 recites the limitation “several.” “Several” is not defined in the specification. The limitation is indefinite because the ordinary definition of “several” varies. For example, the Merriam-Webster dictionary defines several as a) more than one, or b) more than two but fewer than many. The Cambridge dictionary defines several as “some; an amount that is not exact but is fewer than many.” The Merriam-Webster dictionary then defines “many” as “being one of a large but indefinite number.” Thus, the ordinary definition of “several” might be as low as two, or might require more than two, but is less than one of a large but indefinite number. It is unclear how many soaps and/or surfactants are required by “several.”
Claim 10 depends from claim 1 and recites applying the rinse-off composition. Claim 1 does not recite a rinse-off composition, so there is insufficient antecedent basis for this limitation in the claim. It is unclear whether a rinse-off composition is actually required in claim 10 or not.
Claim 14 is drawn to a use of saccharide isomerate, but does not recite any active steps. Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. MPEP 2173.05(q).
Claim 15 depends from claim 13 and recites the “use according to claim 13.” Claim 13 is drawn to a method, not a “use,” so there is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, claim 15 will be treated as though it recites the method according to claim 13.
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.
Claim(s) 1-6 and 11-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chadwick (US 2019/0365629 A1, December 5, 2019).
Chadwick teaches methods of reducing the appearance of fine lines and wrinkles and protecting against pollution, comprising administering saccharide isomerate. See abstract. The compositions comprising saccharide isomerate are topical compositions. See paragraph [0121], for example. The composition in Example 3 contains 1.0% by weight saccharide isomerate, which falls within the effective range 0.01 to 10 wt% disclosed in the current specification and recited in current claim 6.
The limitation “to increase the differential abundance of P. marcusii in the skin microbiome” is a purpose or intended use, which must be evaluated to determine whether the the recited purpose or intended use results in a manipulative difference between the claimed invention and the prior art. If so, the recitation serves to limit the claim. In this instance, the subject in need of increasing the differential abundance of P. marcusii in the skin microbiome is the same subject disclosed in the prior art (that is, a subject in need of reducing wrinkles or protecting against pollution). Likewise, the subject in need of supplying carotenoids is the same subject disclosed in the prior art (that is, a subject in need of reducing wrinkles). The prior art administers the same compound to the same subject in the same amount as required by the current claims, and so the claims are anticipated.
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. See MPEP 2112.02. In this instance, the claims recite the same “use” but the use is directed to a result or property of the composition.
The ”wherein” clauses in claims 11 and 15 are not given weight because they simply express the intended result of the process steps positively recited. Alternatively, the results recited in the “wherein” clauses are inherent results of the Chadwick method because Chadwick administers the same compound, in the same amount, to the same patient population.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chadwick (US 2019/0365629 A1, December 5, 2019).
Chadwick teaches as set forth above, a method comprising administering the same compound to the same subject in the same amount as is claimed, which inherently has the same result. The examples disclosed by Chadwick are not rinse-off compositions.
Chadwick also teaches that the compositions can be used as a rinse-off composition which is applied to the skin and rinsed with water. A rinse-off composition can be a skin cleanser, shampoo, or soap. Paragraph [0019]. Compositions can also contain any or all of a pH adjuster, a moisturizing agent [0016], a surfactant [0013], or chelating agents such as EDTA [0059]. The most basic composition contains saccharide isomerate, sodium carrageenan, sea salt, and sodium hyaluronate (claim 1).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare a rinse-off composition containing saccharide isomerate because Chadwick teaches rinse-off compositions. It would have been obvious to include water, soap or surfactant, moisturizer, a chelating agent and a pH adjusting agent because it is suggested by Chadwick.
The language “wherein the detergent rinse-off composition consists essentially of” will be construed as equivalent to “comprising” absent a clear indication in the specification or claims or what the basic and novel characteristics actually are. If an applicant contends that additional materials in the prior art excluded by “consisting essentially of,” applicant has the burden of showing that the introduction of additional components would materially change the characteristics of the claimed invention. In Chadwick’s composition, the sea salt + sodium carrageenan is used to increase hyaluronic acid and ceramides [0050]. Sodium hyaluronate increases skin moisturization, reduces roughness, etc. [0051]. The claimed composition can also include moisturizing agents (paragraph [0044] and claim 9), so the examiner has found no basis to conclude that inclusion of components which increase HA and thus moisturization would change the characteristics of the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693