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 .
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.
Claim Status
Applicant’s preliminary amendment of 07/05/2023 is acknowledged. Claims 1-13 are amended, and claims 14-20 are new. Claims 1-20 are currently pending.
Priority
The instant application is a 371 of PCT/EP2022/050107 filed on 01/05/2022 and claims foreign priority to EP21150361.0 filed on 01/06/2021 as reflected in the filing receipt dated on 11/20/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/05/2023, 11/17/2023, 07/25/2025, and 09/10/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-8 and 14-17 in the reply filed on 09/08/2025 is acknowledged. The traversal is on the ground(s) that the Examiner has not explained why the identified claims fail to share a single inventive concept or why they are considered patentably distinct. Applicant further traverses the requirement for election of species, arguing that no prior art, technical analysis, or reasoning has been provided to show that the species are patentably distinct.
This is not found persuasive because in national stage applications submitted under 35 U.S.C. 371, a showing of lack of unity under 37 CFR §1.475 is required for proper restriction of claims. See MPEP 1893.03(d). Such a showing has been made. The groups of inventions and species do not relate to a single general inventive concept because they do not share a special technical feature in view of Kawana et al., as discussed in detail in the Requirement for Restriction/Election dated 07/28/2025, or in view of either Oh et al. or Park et al. as discussed in detail in the prior art rejections below. Unity of invention analysis (not an independent and distinct analysis) is applicable in national stage applications submitted under 35 U.S.C. 371.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-20 are pending in the application. Claims 9-13 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/08/2025. Accordingly, claims 1-8 and 14-17 are being examined on the merits herein.
The Examiner notes that the elected species for B, C, D, and E as defined in Applicant’s reply filed 09/08/2025 are not readable on the elected Group I invention since Group I is the end product, and the species B, C, D, and E are relevant to the starting materials. Thus, the elected species for B, C, D, and E are not applicable for the elected invention of the Group I compound, and not are considered for the purpose of the instant Office action.
Claim Interpretation
Regarding the term “optionally” recited in claims 1 and 14: The Examiner notes that interruption of the hydrocarbon radical by at least one -O- is not a required feature of the claim.
Regarding the term “cosmetic formulation” recited in claims 7, 8, 16, and 17: The Examiner is interpreting a combination of the claimed sphingolipid with any additional ingredient(s) as sufficient to meet the claim limitation so long as the ingredient(s) is/are safe for cosmetic use.
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.
Claims 1-3, 5-7, and 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oh et al. (Arch. Dermatol. Res., vol. 308, p. 563-574; published: 07/11/2016; PTO-892) as evidenced by Fisher Scientific (webpage, https://www.fishersci.com/; archived: 11/22/2015) and Genomatica (Brontide Safety Data Sheet, p. 1-5; revised: 08/18/2020).
Oh, throughout the reference, teaches that UVB-irradiated skins have lowered levels of omega-hydroxyceramides (ω-OH-Cer), which play a crucial role in maintaining the integrity of the skin barrier, and that treatment with a synthetic C16 ω-OH-phytoceramide (structure shown below) can improve epidermal homeostasis (Abstract and Fig. 1).
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Regarding claims 1-3: Oh’s C16 ω-OH-phytoceramide reads on a species of a sphingolipid of formula I wherein: R1 is a hydrocarbon radical having 14 carbon atoms that is substituted at the ω-position with -OH; R2 and Y are each H; and X is CH2-HCOH.
Regarding claims 5 and 6: Oh teaches that C16 ω-OH-phytoceramide is topically applied to the dorsal skin of hairless mouse (Page 566, L. Col.). Because the claimed methods each comprise only one active step of “applying the sphingolipid of Claim 1 to skin”, the prior art reads on the claimed methods. The recitations “for therapy or prophylaxis of cell damage induced by UV radiation” in claim 5 and “for the prevention of skin ageing caused by UV radiation” in claim 6 are intended uses of the claimed sphingolipid. 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. In the instant case, the only active step is the application of Applicant’s sphingolipid to the skin. Since the prior art expressly teaches this active step, it inherently performs Applicant’s method as claimed. Note: MPEP 2111.02.
Regarding claim 7: Oh teaches a formulation wherein a liposome comprises C16 ω-OH-phytoceramide, lecithin, 1,3-butylene glycol, and distilled water (Page 565, L. Col.). The liposome is sufficient to read on the instantly claimed cosmetic formulation because all ingredients are safe for cosmetic use.
Regarding claim 14: Oh’s C16 ω-OH-phytoceramide reads on the instantly claimed sphingolipid species wherein R1 is a hydrocarbon radical having 14 carbon atoms that is substituted with -OH.
Regarding claim 15: Oh’s C16 ω-OH-phytoceramide reads on the instantly claimed sphingolipid species wherein R2 is H.
Regarding claims 16 and 17: Oh teaches a formulation wherein 500 µg C16 ω-OH-phytoceramide is added to 100 µl of vehicle of pure liposome comprising: 6% lecithin; 10% 1,3-butylene glycol; and 84% distilled water (Page 565, L. Col. and Page 566, L. Col.). A skilled artisan would appreciate that the density of water is ~1 g/mL. The density of lecithin is 1.03 g/mL as evidenced by Fisher Scientific (Page 1). The density of 1,3-butylene glycol is 1.004 – 1.006 g/cm3 (also written as g/mL) as evidenced by Genomatica (Page 2). Because the vehicle comprises ingredients which each have densities of ~1 g/mL (also written as ~1000 µg/µl), 100 µl of vehicle equates to 100,000 µg. Therefore, 500 µg C16 ω-OH-phytoceramide in 100 µl of vehicle equates to an amount of 0.5% by weight based on the total cosmetic formulation, which lies within and thus anticipates the claimed ranges.
Claims 1-4, 7, and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (WO2013081226A1; published: 06/06/2013; original document and translated abstract were cited in IDS of 09/10/2025; full translation relied upon for the following rejection is cited in PTO-892).
Claims 1-3, 5-7, and 14-17 were rejected above as being anticipated by Oh as discussed in detail above. Claims 1-3, 7, and 14-15 are further rejected herein to demonstrate that Applicant’s elected species of sphingolipid, the hydroxybutyroyl phytosphingosine of claim 4, is also anticipated by the prior art.
Park, throughout the reference, teaches novel omega hydroxy acid derivatives of phytosphingosine comprising an amide bond between the carboxyl group of an omega hydroxy acid and the amine group of phytosphingosine (Abstract and Claims).
Regarding claims 1-3: Park teaches that the term “omega hydroxy acid” refers to linear aliphatic organic acid have n carbon atoms, wherein: the carboxylic acid is at the 1-position and the hydroxy group is at the n-position; n may be 4 or more; and the omega hydroxy acid may be a saturated fatty acid containing only single bonds (Page 3, BEST-MODE). Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention could at once envisage a phytosphingosine derivative comprising an amide bond between the amine of phytosphingosine and the carboxyl group of a saturated omega hydroxy acid having an n of 4, which reads on Applicant’s elected species of a sphingolipid of formula I (carbons numbered below on Applicant’s elected structure for clarity), wherein: R1 is a hydrocarbon radical having 2 carbon atoms that is substituted at the ω-position with -OH; R2 and Y are each H; and X is CH2-HCOH.
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Note: MPEP 2131.02. A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage' the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)).
Regarding claim 4: The species of Park’s phytosphingosine derivative comprising a saturated omega hydroxy acid having an n of 4 reads on Applicant’s elected species of hydroxybutyroyl phytospingosine.
Regarding claim 7: Park teaches that its phytosphingosine derivatives can be used to prepare liposomes (Page 3, ADVANTAGEOUS-EFFECTS and Claims) and discloses formulations wherein the liposome comprises a phytosphingosine derivative and hydrogenated soybean lecithin (Page 5, Example 2). The liposome is sufficient to read on the instantly claimed cosmetic formulation because lecithin is safe for cosmetic use.
While the exemplified embodiment of Park comprises 16-hydroxyhexadecanoic phytosphingosine (structure shown below), which reads on a nonelected species of Applicant’s claims 1-3 and 7, one of ordinary skill in the art before the effective filing date of the claimed invention could at once envisage an embodiment wherein Park’s phytosphingosine derivative comprising a saturated omega hydroxy acid having an n of 4 is combined with lecithin to form a liposome.
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Regarding claim 14: Both 16-hydroxyhexadecanoic phytospingosine and Park’s phytosphingosine derivative comprising a saturated omega hydroxy acid having an n of 4 read on the instantly claimed sphingolipid species wherein R1 is a hydrocarbon radical having 14 or 2 carbon atoms, respectively, that is substituted with -OH.
Regarding claim 15: Both 16-hydroxyhexadecanoic phytospingosine and Park’s phytosphingosine derivative comprising a saturated omega hydroxy acid having an n of 4 read on the instantly claimed sphingolipid species wherein R2 is H.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (WO2013081226A1; published: 06/06/2013; original document and translated abstract were cited in IDS of 09/10/2025; full translation relied upon for the following rejection is cited in PTO-892), as applied to claims 1-4, 7, and 14-15 above, and further in view of Oh et al. (Arch. Dermatol. Res., vol. 308, p. 563-574; published: 07/11/2016; PTO-892) as evidenced by Fisher Scientific (webpage, https://www.fishersci.com/; archived: 11/22/2015) and Genomatica (Brontide Safety Data Sheet, p. 1-5; revised: 08/18/2020).
Claims 1-3, 5-7, and 14-17 were rejected above as being anticipated by Oh as discussed in detail above. Claims 5-6 and 16-17 are further rejected herein to demonstrate that the claims as they relate to Applicant’s elected species of sphingolipid are also obvious over the prior art.
Park teaches the invention(s) of claims 1-4, 7, and 14-15 as discussed in detail above and further incorporated herein.
Park does not expressly teach the application step of claims 5 and 6, or the amount of sphingolipid recited in claims 16 and 17.
The teachings of Oh are as set forth above and further incorporated herein. The Examiner notes that the C16 ω-OH-phytoceramide of Oh is structurally equivalent to the 16-hydroxyhexadecanoic phytosphingosine of Park (see structures cited above).
Regarding claims 5 and 6: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply Park’s liposome formulation, which contains lecithin and a phytosphingosine derivative comprising a saturated omega hydroxy acid having an n of 4, to the skin using the method of Oh because both Park and Oh teach the usefulness of ceramide derivatives in maintaining the integrity and moisturization of the lipid-based skin barrier (Park, page 2, BACKGROUND-ART; Oh, Pages 563-564, Introduction). Because the claimed methods each comprise only one active step of “applying the sphingolipid of Claim 1 to skin”, the prior art reads on the claimed methods. The recitations “for therapy or prophylaxis of cell damage induced by UV radiation” in claim 5 and “for the prevention of skin ageing caused by UV radiation” in claim 6 are intended uses of the claimed sphingolipid. 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. In the instant case, the only active step is the application of Applicant’s sphingolipid to the skin. Since the prior art expressly teaches this active step, it inherently performs Applicant’s method as claimed. Note: MPEP 2111.02.
Regarding claims 16 and 17: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manipulate the concentration of the phytosphingosine derivative comprising a saturated omega hydroxy acid having an n of 4 using 0.5% by weight based on the total cosmetic formulation, which lies within and thus renders obvious the claimed ranges, because Oh teaches that this amount of ω-OH-phytoceramide is effective in maintaining skin barrier function.
One of ordinary skill in the art would have a reasonable expectation of success in modifying the prior art as proposed because Park recognizes a phytoshingosine derivative comprising a saturated omega hydroxy acid having an n of 4 as a suitable alternative species to the C16 ω-OH-phytoceramide of Oh. A skilled artisan would expect that applying a lecithin-based liposome formulation containing another suitable phytosphingosine derivative, according to known methods, would yield the predictable result of maintaining skin barrier function.
Claims 1-8 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (WO2013081226A1; published: 06/06/2013; original document and translated abstract were cited in IDS of 09/10/2025; full translation relied upon for the following rejection is cited in PTO-892) in view of Oh et al. (Arch. Dermatol. Res., vol. 308, p. 563-574; published: 07/11/2016; PTO-892), as applied to claims 1-7 and 14-17 above, and further in view of Friedman (US20150202139A1; published: 07/23/2015; PTO-892) as evidenced by Fisher Scientific (webpage, https://www.fishersci.com/; archived: 11/22/2015) and Genomatica (Brontide Safety Data Sheet, p. 1-5; revised: 08/18/2020).
The combination of Park and Oh teaches the invention(s) of claims 1-7 and 14-17 as discussed in detail above and further incorporated herein.
The combination of Park and Oh does not expressly teach that the cosmetic formulation additionally comprises at least one UV light protection filter substance recited in claim 8.
Friedman, throughout the reference, teaches formulations for skincare, wherein antioxidants, moisturizers, and humectants are present as liposomes to achieve more effective delivery to the particular skin area being treated (Abstract).
Regarding claim 8: Friedman teaches the usefulness of combined moisturizing/sunscreen compositions that are applied directly to the skin to combat ageing of the skin, sunburn of the skin, and numerous damaging effects resulting from exposure to the sun (Paragraph 0005). In light of the moisturizing properties of phytosphingosine derivatives, as taught by both Park and Oh, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to enhance the liposomal formulation taught by the combination of prior art above by further including at least one organic/chemical or inorganic/physical UV filter ingredient taught by Friedman (Paragraphs 0049-0056) to prevent additional insult to the skin stemming from daily exposure to the sun (Paragraph 0019).
One of ordinary skill in the art would have a reasonable expectation of success in modifying the prior art as proposed because Friedman teaches the compatibility of UV filter ingredients with liposomal moisturizers and specifically acknowledges ceramides as suitable moisturizing agents (Paragraph 0093-0095 and Table 2).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 and 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. US 11,939,612 B2 in view of Park et al. (WO2013081226A1; published: 06/06/2013; original document and translated abstract were cited in IDS of 09/10/2025; full translation relied upon for the following rejection is cited in PTO-892), Oh et al. (Arch. Dermatol. Res., vol. 308, p. 563-574; published: 07/11/2016; PTO-892), and Friedman (US20150202139A1; published: 07/23/2015; PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US ‘612 recite a sphingolipid of the general formula I, which reads on all features of the instantly claimed sphingolipid of the general formula I of instant claim 1 wherein Y is -H. The only difference is that substitution of the R1 component with at least one hydroxyl group in the claims of US ‘612 is optional rather than a required feature. Therefore, the alternative embodiment wherein the at least one hydroxyl group is included in the structure reads on the instantly claimed sphingolipid.
Regarding instant claims 2-3 and 15: Because US ‘612 claim 1 recites only five options for the R2 component including -H, recites a structure wherein the instantly claimed Y component is -H, and recites only three options for the X component including CH2-HCOH, one of ordinary skill in the art could immediately envisage an embodiment wherein R2 is -H and X is CH2-HCOH, which reads on the instantly claimed structures.
Regarding instant claim 7: The claims of US ‘612 recite the sphingolipid of general formula I as an ingredient in a cosmetic formulation.
The claims of US ‘612 do not explicitly recite the limitations of instant claims 4-8 or 14.
The teachings of Park, Oh, and Friedman are as set forth above and further incorporated herein.
Regarding claims 4 and 14: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a radical of a saturated omega hydroxy acid having an n of 4 as the R1 component and CH2-HCOH as the X component of the sphingolipid of the general formula I recited in US ‘612 claim 1 because Park teaches that a phytosphingosine derivative having this structure is useful in preparing formulations with much higher stability than conventional than conventional ceramides or lipids (Park, Page 3, ADVANTAGEOUS-EFFECTS).
Regarding claims 5 and 6: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the cosmetic formulation taught by the combination of US ‘612 claims and Park as a lecithin-based liposome according to known methods and then apply the liposome formulation to the skin using the method of Oh because both Park and Oh teach the usefulness of ceramide derivatives delivered as liposomes in maintaining the integrity and moisturization of the lipid-based skin barrier (Park, page 2, BACKGROUND-ART; Oh, Pages 563-564, Introduction). Because the claimed methods each comprise only one active step of “applying the sphingolipid of Claim 1 to skin”, the combination of US ‘612 claims and prior art reads on the claimed methods. The recitations “for therapy or prophylaxis of cell damage induced by UV radiation” in claim 5 and “for the prevention of skin ageing caused by UV radiation” in claim 6 are intended uses of the claimed sphingolipid. 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. In the instant case, the only active step is the application of Applicant’s sphingolipid to the skin. Since the combination of US ‘612 claims and prior art expressly teaches this active step, it inherently performs Applicant’s method as claimed. Note: MPEP 2111.02.
Regarding claim 8: In light of the moisturizing properties of phytosphingosine derivatives, as taught by both Park and Oh, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to enhance the liposomal formulation taught by the combination of US ‘612 claims and prior art above by further including at least one organic/chemical or inorganic/physical UV filter ingredient taught by Friedman (Paragraphs 0049-0056) to prevent additional insult to the skin stemming from daily exposure to the sun (Paragraph 0019).
One of ordinary skill in the art would have a reasonable expectation of success in modifying the claims of US ‘612 as proposed because the structure of sphingolipid taught by the prior art is a species of the sphingolipid recited in the claims of US ‘612, and a skilled artisan would expect that applying a lecithin-based liposome formulation containing a known phytosphingosine derivative and a known UV filter, according to known methods, would yield the predictable result of maintaining skin barrier function.
Claims 1-2, 5-8, and 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-12 of U.S. Patent No. US 11,155,842 B2 in view of Eckstein et al. (US20190300917A1; published: 10/03/2019; IDS of 11/17/2023) and Friedman (US20150202139A1; published: 07/23/2015; PTO-892).
The claims of US ‘842 recite a sphingolipid of the general formula I, wherein the acyl donor of the R1 component is an ester based on a polyol having up to 6 carbons, preferably a glycerol ester.
While the claims of US ‘842 do not explicitly recite species of the sphingolipid of instant claims 1-2, said species and limitations of claims 5-8 and 14-15 are obvious in view of the teachings of Eckstein and Friedman.
The teachings of Friedman are as set forth above and further incorporated herein.
Eckstein teaches, throughout the reference, a process for preparing sphingolipids, compositions comprising sphingolipids, and further components for the use of the compositions (Abstract).
Regarding claims 1-2 and 14-15: Eckstein teaches sphingolipids having the same structure as that recited in the claims of US ‘842 (Paragraphs 0025-0034). Specifically, Eckstein teaches only five options for the R2 component including -H, only three options for the X component including CH2-HCOH, and that the acyl donor of the R1 component may be a glycerol ester having an acyl group chain length of 6-30 carbon atoms, such as those derived from 12-hydroxystearic acid (Paragraphs 0037-0040), which reads on instantly the instantly claimed sphingolipid wherein R1 is a hydrocarbon radical having 16 carbon atoms that is substituted with -OH and Y is -H. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2143 KSR International Co. v. Teleflex Inc., 550 US 398, 82 USPQ 2d 1385 (2007).
Regarding claims 5-7: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate sphingolipid recited in the claims of US ‘842 as composition that is subsequently applied to skin because Eckstein teaches that applying compositions comprising the sphingolipids taught by the combination of US ‘842 claims and Eckstein to the skin provides benefits such as moisturization and fortification of the skin barrier (Paragraphs 0091-0094 and 0113-0117). Because the claimed methods each comprise only one active step of “applying the sphingolipid of Claim 1 to skin”, the combination of US ‘842 claims and prior art reads on the claimed methods. The recitations “for therapy or prophylaxis of cell damage induced by UV radiation” in claim 5 and “for the prevention of skin ageing caused by UV radiation” in claim 6 are intended uses of the claimed sphingolipid. 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. In the instant case, the only active step is the application of Applicant’s sphingolipid to the skin. Since the combination of US ‘842 claims and prior art expressly teaches this active step, it inherently performs Applicant’s method as claimed. Note: MPEP 2111.02.
Regarding claim 8: In light of the moisturizing properties of sphingolipids, as taught by Eckstein, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to enhance the composition taught by the combination of US ‘842 claims and prior art above by further including at least one organic/chemical or inorganic/physical UV filter ingredient taught by Friedman (Paragraphs 0049-0056) to prevent additional insult to the skin stemming from daily exposure to the sun (Paragraph 0019).
One of ordinary skill in the art would have a reasonable expectation of success in modifying the claims of US ‘842 as proposed because the structure of sphingolipid taught by the prior art is a species of the sphingolipid recited in the claims of US ‘842, and a skilled artisan would expect that applying a composition containing a sphingolipid and UV filter, according to known methods, would yield the predictable result of maintaining skin barrier function.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616