DETAILED ACTION
This is an initial Office action for non-provisional application 18/873493 filed December 10, 2024, which is a 371 of PCT/EP2023/065164 filed June 7, 2023, which claims foreign priority to EP22179303.7 filed June 15, 2022.
Claim Status: Claims 1-15 are pending. Claims 3-5, 7-10 and 14-15 are amended.
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 . 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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 2 should recite “…said method comprising a step of applying to an external surface of a human body with…”
Claim 10, line 2 should recite “…wherein the amount of the ethylhexyl salicylate in the sunscreen composition is selected in the range from 0.1 wt.%...”
Claim 15, line 3 should recite “…the ethylhexyl salicylate in the sunscreen composition is selected in the range from 0.1 wt.% to 20 wt.%, preferably…”
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 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to neither a “product’ nor a “process" but rather embraces or overlaps two different statutory classes set forth in 35 U.S.C. 101 which is drafted so as to set forth the statutory classes in the alternative only (MPEP 2173.05(p) (II)). In the instant case, claim 11 appears to embrace or overlap a product (a preparation with octocrylene, ethylhexyl salicylate and/or butyl methoxydibenzoylmethane) and a process for using the product (a method for use in the prevention or treatment of acne).
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 3, 8-11, and 13-15 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 3, 8-10 and 13-15 recite 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, claims 8-10 and 13-15 recite a broad amount range of octocrylene, butyl methoxydibenzoylmethane and/or ethylhexyl salicylate followed by narrower amount ranges of octocrylene, butyl methoxydibenzoylmethane and/or ethylhexyl salicylate. Further, claim 3 recites a broad reduction in survival rate followed by narrower reductions in survival rate. 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 11 is drawn to a preparation with octocrylene, ethylhexyl salicylate and/or butyl methoxydibenzoylmethane and a process for using the product (a method for use in the prevention or treatment of acne). A single claim that claims both a product and a method of using the product is ambiguous (MPEP 2173.05(p) (II)). For the purpose of examination on the merits and application of the prior art, claim 11 will be interpreted as being drawn to a product comprising octocrylene, ethylhexyl salicylate and/or butyl methoxydibenzoylmethane.
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 11-13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kunin (US 2009/0246156; cited in IDS dated 12/10/24).
Regarding claims 11-12, Kunin teaches antiacne sunscreen compositions comprising avobenzone (butyl methoxydibenzoylmethane) and octisalate (ethylhexyl salicylate) (paragraph 0008). Thus, Kunin et al anticipate compositions comprising one or more UV filters selected from octocrylene, ethylhexyl salicylate and butyl methoxydibenzoylmethane. Regarding the limitations directed to “for use in the prevention or treatment of acne”, it should be noted that this statement is intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, Kunin teaches its compositions are for acne treatment but regardless there is no structural differences between the compositions recited in the instant claims and the composition of Kunin and thus, the compositions of Kunin would also be capable of treating and preventing acne.
Regarding claims 13 and 15, the compositions of Kunin comprise 3 wt.% butyl methoxydibenzoylmethane and 5 wt.% ethylhexyl salicylate (paragraph 0012-0013). Such amounts fall within the ranges set forth in claims 13 and 15.
Claims 11-12 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nadau et al (CA 2803523; cited in IDS dated 12/10/24).
Regarding claims 11-12, Nadau et al teach topical compositions used to treat acne comprising at least one UVA/UVB sunscreen (abstract; whole document). Nadau et al exemplify a formulation with 5 wt.% ethylhexyl salicylate and 3 wt.% octocrylene (pp. 5-6, see example 1). Thus, Nadau et al anticipate compositions comprising one or more UV filters selected from octocrylene, ethylhexyl salicylate and butyl methoxydibenzoylmethane. Regarding the limitations directed to “for use in the prevention or treatment of acne”, it should be noted that this statement is intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, Nadau et al teach its compositions are for acne treatment but regardless there is no structural differences between the compositions recited in the instant claims and the composition of Nadau et al and thus, the compositions of Nadau et al would also be capable of treating and preventing acne.
Regarding claims 14-15, Nadau et al exemplify a formulation with 5 wt.% ethylhexyl salicylate and 3 wt.% octocrylene (pp. 5-6, see example 1). Such amounts fall within the ranges set forth in claims 14-15.
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.
Claims 1-4, 7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Mukherjee et al (US 2021/0386835; cited in IDS dated 12/10/24).
Regarding claim 1, Mukherjee et al teach a method and a composition to prevent or treat acne by selective inhibition of Propionibacterium acnes (also known as cutibacterium acnes or C. acnes) bacteria (abstract; whole document, paragraph 0023). The method involves applying a composition on to a desired skin surface to reduce or eliminate P. acnes on the skin (paragraph 0071). The compositions comprise P. acnes phage-derived endolysins or nucleic acid molecules encoding the same; an essential oil compound and can preferably include sunscreens (claim 1, paragraphs 0049-0050). Such sunscreens include octocrylene and ethylhexyl salicylate and can be present in an amount of 0.01-15% by weight and most preferably 0.5 to 7.5% by weight (paragraph 0050).
Although Mukherjee et al teach the method of reducing C. acnes on skin of a person in need thereof that comprises applying to skin with C. acnes a composition, the composition does not explicitly incorporate UV filters selected from octocrylene, ethylhexyl salicylate and butyl methoxydibenzoylmethane.
However, it would have been obvious to an artisan of ordinary skill before the effective filing date to incorporate a sunscreen, such as octocrylene or ethylhexyl salicylate in the compositions of Mukherjee et al. One would have been motivated to do so since such sunscreens are conventional, and it would have been obvious to incorporate materials applied to the skin that block harmful ultraviolet light. In KSR v. Telefex, 82 USPQ2d 1385, 1397 (U.S. 2007), the Supreme Court has held that when there is market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person has good reason to pursue known options within his or her technical grasp. The court has reasoned a reasonable expectation of success in the art by stating that reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle. Sinclair & Carroll Co., 325 U.S. at 335, 65 USPQ at 301.
Regarding claims 2-4 directed to the protection of S. epidermidis, reduction in the survival rate of C. acnes, and the survival rate of S. epidermidis; Mukherjee et al render obvious the method of reducing C. acnes on skin to a human in need thereof by applying a topical composition selected from octocrylene, ethylhexyl salicylate and butyl methoxydibenzoylmethane, and thus, the “wherein” limitations in claims 2-4, would naturally result from the teachings of Mukherjee et al. See MPEP 2112.02. Claim scope is not limited by claim language that does not require further steps to be performed, or by claim language that does not limit a claim to a particular structure. Such language is not considered limiting when it simply expresses the intended result of a process step positively recited. See, e.g., Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329 (Fed. Cir. 2005), quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003).
Regarding claim 7 directed to “for treating or preventing dysbiosis of the skin after UV radiation”, Mukherjee et al render obvious the method of reducing C. acnes on skin to a human in need thereof with a composition selected from octocrylene, ethylhexyl salicylate and butyl methoxydibenzoylmethane, and thus, the treatment and prevention of dysbiosis of the skin after UV radiation would naturally result from the teachings of Mukherjee et al. See MPEP 2112.02. Claim scope is not limited by claim language that does not require further steps to be performed, or by claim language that does not limit a claim to a particular structure. Such language is not considered limiting when it simply expresses the intended result of a process step positively recited. See, e.g., Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329 (Fed. Cir. 2005), quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003).
Regarding claims 9-10, Mukherjee et al teach its sunscreens include octocrylene and ethylhexyl salicylate present in an amount most preferably of 0.5 to 7.5% by weight (paragraph 0050). Such amounts fall within the amounts recited in claims 9-10.
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Mukherjee et al (US 2021/0386835; cited in IDS dated 12/10/24) as applied to claims 1-4, 7 and 9-10 and in further view of Camargo et al (US 2022/0160735; cited in IDS dated 12/10/24).
The disclosure of Mukherjee et al is discussed above.
Mukherjee et al do not teach its sunscreens exhibit an SPF of at least 20 or the presence of butyl methoxydibenzoylmethane in the amount of 0.1 wt.% to 10 wt.% of the composition.
Camargo et al teach anti-acne sunscreen compositions comprising salicylic acid, a UV filter system and a stabilizing polymer system (abstract, whole document). Suitable UV filters include butyl methoxybenzoylmethane (paragraph 0065) and the compositions are desired to have high SPF ranging from 30-90 (paragraphs 0017, 0032).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to formulate the compositions of Mukherjee et al with a SPF of at least 20 as taught in Camargo et al. One would have been motivated to do so with a reasonable expectation of success to ensure stronger protection against UV rays. Further, a skilled artisan would have been motivated to include butyl methoxybenzoylmethane as taught in Carmargo et al in a UV filter amount taught in Mukherjee et al because it is a conventional UV filter and it would have been obvious to select a different UV filter for the same intended purpose. In KSR v. Telefex, 82 USPQ2d 1385, 1397 (U.S. 2007), the Supreme Court has held that when there is market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person has good reason to pursue known options within his or her technical grasp. The court has reasoned a reasonable expectation of success in the art by stating that reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle. Sinclair & Carroll Co., 325 U.S. at 335, 65 USPQ at 301.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mukherjee et al (US 2021/0386835; cited in IDS dated 12/10/24) as applied to claims 1-4, 7 and 9-10 and in further view of Heidl et al (US 2020/0308222; cited in IDS dated 12/10/24).
The disclosure of Mukherjee et al is discussed above.
Mukherjee et al do not teach a method of reducing C. acnes on skin of a person in need thereof wherein the C. acnes is the strain, C. acnes ATCC 11827.
Heidl et al teach topical compositions comprising novel tetrapeptides that function as antimicrobial agents to treat acne (abstract, whole document, claims). Heidl et al teach its peptides are tested against the specific strain of C. acnes, ATCC 11827 (paragraph 0154).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to reduce C. acnes on the skin of a person in need thereof in which the C. acnes strain is C. acnes ATCC 11827. One would have been motivated do so since Heidl et al teach C. acnes ATCC 11827 is a known strain of C. acnes that can be reduced by applying compositions to skin.
Conclusion
Claims 1-15 are rejected. No claims are allowed.
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/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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