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 amendment of 04/13/2026 is acknowledged. Claims 2-6, 8, and 14-17 are amended, and claims 1, 7, 9-13, and 18-20 are cancelled. Claims 2-6, 8, and 14-17 are currently pending.
Election/Restrictions
An election of invention/species was required in the instant application as detailed in the Office action dated 07/28/2025. Applicant’s cancellation of claims 9-13 and 18-20 has rendered moot the restriction between the inventions of Groups I and II. Thus, the restriction requirement is hereby withdrawn. The species election requirement is maintained. Accordingly, claims 2-6, 8, and 14-17 are examined on the merits herein.
The Examiner notes that in searching for Applicant’s elected species, art was previously found that reads on an additional species of the instantly claimed sphingolipid of general formula I. To expedite prosecution, the species election was extended in the Office action dated 12/16/2025 to include sphingolipids taught in Oh et al. (Arch. Dermatol. Res., vol. 308, p. 563-574; published: 07/11/2016; PTO-892 of 12/16/2025) and subsequently the art was applied in the rejections. The same art and species election extension are applied in the rejections presented herein.
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.
Previous Rejections/Objections
Applicant’s arguments filed 04/13/2026 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Objections
Claims 2-6, 8, and 14-17 objected to because of the following informalities:
Claims 2-4, 8, and 14-17 each recite the limitation “Claim 5”, which is inappropriately capitalized and should read “claim 5”.
Claims 5 and 6 each recite the limitation “Formula I”, which is inappropriately capitalized and should read “formula I”.
Appropriate correction is required.
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.
Claims 16 and 17 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 16 and 17 each recite the limitation “based on a total of a cosmetic formulation”. It is unclear whether “a cosmetic formulation” (1) refers to a formulation comprising the sphingolipid recited in claim 5, in which case the claim does not explicitly recite that the cosmetic formulation is applied to the skin, so it is unclear how the sphingolipid is applied to the skin at the claimed concentration, or (2) refers to any cosmetic formulation, in which case it is unclear how one of ordinary skill in the art could readily ascertain the metes and bounds of the concentration of sphingolipid applied to the skin in the instant method. Furthermore, the recitation “a total” makes it unclear whether the concentration of sphingolipid is relative to one of several possible total weights, volumes, etc. present within a cosmetic formulation or whether the cosmetic formulation has only a singular total weight, volume, etc. Therefore, the scope of each claim is indefinite. For the purposes of compact prosecution in the prior art rejections below, the Examiner is interpreting each claim to mean that the sphingolipid is applied to the skin in the form of a cosmetic formulation comprising the sphingolipid and that the recited amount represents the concentration of sphingolipid relative to the (i.e., singular) total weight of the cosmetic formulation.
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.
New Matter Rejection
Claims 8, 16, and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Per the amendment filed on 04/13/2026, claim 8 now recites the limitation “applying at least one UV light protection filter substance”, and claims 16 and 17 recite that the sphingolipid is applied in an amount of “0.02% by weight to 1.50% by weight” [claim 16] or “0.05% by weight to 0.50% by weight” [claim 17] based on a total weight of a cosmetic formulation. However, the instant disclosure does not provide support for the limitations, or the full scope of the limitations, as recited in the amended claims. Regarding claim 8, the instant specification and claims as originally filed do not disclose support for applying a UV light protection filter substance to the skin, or any substrate. Regarding claims 16 and 17, the instant specification and claims as originally filed do not provide support for the entirety of the scope encompassed by the claim limitations and only provide support for applying specific species of the sphingolipid (e.g., hydroxybutyroyl phytosphingosine, 6-hydroxyhexanoyl phytosphingosine, and 2-hydroxy-3,3-dimethyl-hydroxybutyroyl sphinganine) to the skin at a single concentration (e.g., 0.1% w/w).
If Applicant believes this rejection is in error, Applicant must disclose where in the specification support for the entire scope of the amendment(s) and/or new claims can be found. As a result, claims 8, 16, and 17 represent new matter.
Claim Interpretation
Regarding the limitation “exposing said skin to oxygen and UV radiation” recited in claims 5 and 6: Applicant’s instant disclosure only provides support for the limitation to the extent that the skin of a test subject is naturally exposed to oxygen in the air and UV radiation from the sun following application of the claimed sphingolipid to the skin [see pg. 15-17, ex. 7]. Thus, the limitation is interpreted as necessarily occurring following the application of the claimed sphingolipid to any subject with skin.
Regarding the term “optionally” recited in claims 5, 6, 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 method step of “applying” recited in claim 8: The Examiner notes that the claim does not require that the UV light filter protection substance is applied to the skin or any particular substrate. Thus, the claim is interpreted broadly to mean that any application of the substance is sufficient to meet the claim.
Regarding the term “cosmetic formulation” recited in claims 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 2-3, 5-6, 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 of 12/16/2025) as evidenced by Fisher Scientific (webpage, https://www.fishersci.com/; archived: 11/22/2015; PTO-892 of 12/16/2025) and Genomatica (Brontide Safety Data Sheet, p. 1-5; revised: 08/18/2020; PTO-892 of 12/16/2025).
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; fig. 1].
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Regarding the sphingolipid of claims 2-3, 5-6, and 14-15: Oh’s C16 ω-OH-phytoceramide reads on a non-elected 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 the method steps of claims 5 and 6: Oh teaches that the forearms of human volunteers were treated with C16 ω-OH-phytoceramide every 6 hours for 48 hours [pg. 566, “Measurement of SC cohesion”], which reads on the claimed step of “applying a sphingolipid of the general formula I…to skin”. Regarding the claimed step of “exposing said skin to oxygen and UV radiation”, as discussed above under “Claim Interpretation”, exposure of the skin to oxygen in the air and UV radiation from the sun necessarily occurs following application of the sphingolipid to the skin of a human subject (e.g., sunlight through a window, walking outside, etc.). This rationale is supported by Applicant’s own example 7, which teaches that the claimed sphingolipid is applied to the forearm of a test subject and discloses no specific UV radiation and oxygen exposure step other than what must inherently occur [instant spec., pg. 15-17]. Because the human volunteers of Oh were evaluated over 48 hours, an ordinarily skilled artisan would reasonably conclude that the skins of the volunteers were necessarily exposed to UV radiation and oxygen like the test subjects of the instant application. Thus, 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. Since the structure of the sphingolipid of Oh is capable of performing the intended use, and the prior art further discloses the same application step as claimed, wherein the skin is necessarily exposed to UV radiation and oxygen, the prior art meets the claim. Note: MPEP 2111.02.
Regarding claims 16 and 17: Oh teaches that C16 ω-OH-phytoceramide is applied to human skin in the form of a formulation comprising 500 µg C16 ω-OH-phytoceramide in 100 µl of vehicle of pure liposome, wherein the liposome comprises: 6% lecithin; 10% 1,3-butylene glycol; and 84% distilled water [pg. 565, l. col.; pg. 566, l. col.]. The liposome is sufficient to read on the instantly claimed cosmetic formulation because all ingredients are safe for cosmetic use. 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 [pg. 1]. The density of 1,3-butylene glycol is 1.004 – 1.006 g/cm3 (also written as g/mL) as evidenced by Genomatica [pg. 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.
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 2-6 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Oh et al. (Arch. Dermatol. Res., vol. 308, p. 563-574; published: 07/11/2016; PTO-892), as applied to claims 2-3, 5-6, and 14-17 above, and further 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 of 12/16/2025) and 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 as evidenced by Fisher Scientific and Genomatic teaches the invention(s) of claims 2-3, 5-6, and 14-17 as discussed in detail above and further incorporated herein. However, Oh does not expressly teach application of Applicant’s elected species of sphingolipid, which is the hydroxybutyroyl phytosphingosine recited in claim 4.
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; claims].
Regarding claim 4: Park further 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 [pg. 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, e.g., hydroxybutyroyl phytosphingosine, (carbons numbered below on Applicant’s elected structure for clarity).
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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)).
Park further teaches that its phytosphingosine derivatives can be used to prepare liposomes [pg. 3, ADVANTAGEOUS-EFFECTS; claims] and discloses formulations wherein the liposome comprises a phytosphingosine derivative and hydrogenated soybean lecithin [pg. 5, ex. 2].
Based on the teachings of Oh and Park, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Oh by substituting the C16 ω-OH-phytoceramide with the hydroxybutyroyl phytosphingosine taught by Park to yield the predictable result of a cosmetic formulation that maintains the integrity and moisturization of the lipid-based skin barrier when applied to skin. There is a reasonable expectation of success because both references teach that phytosphingosine derivatives are useful for this purpose and can be formulated into liposomes comprising lecithin [Park, pg. 2, BACKGROUND-ART; Oh, pg. 563-564, “Introduction”]. Further, 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 [see Park, pg. 5, ex. 2, wherein 16-hydroxyhexadecanoic phytosphingosine is structurally equivalent to Oh’s C16 ω-OH-phytoceramide]. 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 2-6, 8, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Oh et al. (Arch. Dermatol. Res., vol. 308, p. 563-574; published: 07/11/2016; PTO-892 of 12/16/2025) 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 of 12/16/2025), as applied to claims 2-6 and 14-17 above, and further in view of Friedman (US20150202139A1; published: 07/23/2015; PTO-892 of 12/16/2025) and as evidenced by Fisher Scientific (webpage, https://www.fishersci.com/; archived: 11/22/2015; PTO-892 of 12/16/2025) and Genomatica (Brontide Safety Data Sheet, p. 1-5; revised: 08/18/2020; PTO-892 of 12/16/2025).
The combination of Oh and Park as evidenced by Fisher Scientific and Genomatica teaches the invention(s) of claims 2-6 and 14-17 as discussed in detail above and further incorporated herein.
The combination of Oh and Park 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 [0005]. In light of the moisturizing properties of phytosphingosine derivatives, as taught by both Oh and Park, 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 [0049-0056] to prevent additional insult to the skin stemming from daily exposure to the sun [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 [0093-0095; table 2].
Response to Arguments
Applicant’s arguments submitted on 04/13/2026 with respect to rejections under 35 U.S.C. 103 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that the cited art, alone or in combination, fails to disclose or suggest the instant methods as claimed. Specifically, Applicant argues that Oh et al. teaches that UVB irradiation is followed by application of phytoceramide and thus does not suggest a method of applying to skin and exposure to oxygen and UV irradiation. This argument was not found to be persuasive. As discussed in detail above, exposure of the skin to oxygen in the air and UV radiation from the sun necessarily occurs within following application of the sphingolipid to the skin of a human subject as taught by Oh. This rationale is supported by Applicant’s own example 7, which teaches that the claimed sphingolipid is applied to the forearm of a test subject and discloses no specific UV radiation and oxygen exposure step other than what must inherently occur [instant spec., pg. 15-17]. Because the human volunteers of Oh were evaluated over 48 hours, an ordinarily skilled artisan would reasonably conclude that the skins of the volunteers were necessarily exposed to UV radiation and oxygen like the test subjects of the instant application. Thus, the prior art reads on the claimed methods.
Applicant further argues that Park et al. does not suggest a method of applying a sphingolipid to the skin and exposure to oxygen and UV radiation and even assuming arguendo that Park et al. does suggest such, Applicant argues there is no disclosure or suggestion of any protective effects from skin damage or aging induced by UV radiation. This argument was not found to be persuasive. The protective effects argued by Applicant 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. Since the structure of the sphingolipid of Oh, or the sphingolipid taught by the combination of Oh and Park, is capable of performing the intended use, and the prior art further discloses the same application step as claimed, wherein the skin is necessarily exposed to UV radiation and oxygen, the prior art meets the claim. Note: MPEP 2111.02.
Taken together, the prior art anticipates or renders obvious all elements of Applicant’s instantly claimed methods and elected species of sphingolipid. Therefore, the prior art rejections of record are maintained.
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 2-8 and 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,939,612 B2 in view of Oh et al. (Arch. Dermatol. Res., vol. 308, p. 563-574; published: 07/11/2016; PTO-892 of 12/16/2025), 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 of 12/16/2025), and Friedman (US20150202139A1; published: 07/23/2015; PTO-892 of 12/16/2025).
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 claims 5 and 6 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.
The claims of US ‘612 do not explicitly recite the methods of instant claims 5 and 6, or the further 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 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 recited in the claims of US ‘612 claims as a lecithin-based liposome according to known methods and then apply the liposome formulation to the skin of a human using the method of Oh because Oh teaches the usefulness of ceramide derivatives delivered as liposomes in maintaining the integrity and moisturization of the lipid-based skin barrier. Regarding the claimed step of “exposing said skin to oxygen and UV radiation”, as discussed above under “Claim Interpretation”, exposure of the skin to oxygen in the air and UV radiation from the sun necessarily occurs following application of the sphingolipid to the skin of a human subject (e.g., sunlight through a window, walking outside, etc.). This rationale is supported by Applicant’s own example 7, which teaches that the claimed sphingolipid is applied to the forearm of a test subject and discloses no specific UV radiation and oxygen exposure step other than what must inherently occur [instant spec., pg. 15-17]. Thus, the method taught by the combination of US ‘612 claims and Oh reads on the instantly 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. Since the structure of the sphingolipid recited in the claims of US ‘612 is capable of performing the intended use, and the prior art further discloses the same application step as claimed, wherein the skin is necessarily exposed to UV radiation and oxygen, the method taught by the combination of US ‘612 claims and Oh meets the claim. Note: MPEP 2111.02.
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 used in the method taught by the combination of US ‘612 claims and Oh 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, pg. 3, ADVANTAGEOUS-EFFECTS].
Regarding claim 8: In light of the moisturizing properties of phytosphingosine derivatives, as taught by both Oh and Park, 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 to prevent additional insult to the skin stemming from daily exposure to the sun.
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.
Response to Arguments
Applicant’s arguments submitted on 04/13/2026 with respect to rejections on the grounds of non-statutory double patenting have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that the claims of US ‘612 are directed to a cosmetic formulation, not a method of applying to skin. This argument was not found persuasive in view of the prior art, specifically Oh et al., which teaches that cosmetic formulations comprising sphingolipids within the scope recited in the claims of US ‘612 are known to be applied to the skin.
Regarding Applicant’s assertion that the obviousness-type double patenting rejection is improper and must be withdrawn, Applicant does not specifically point out how the rejection is improper. 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 this case, applying to the skin the cosmetic formulation recited in the reference claims would have been prima facie obvious in view of the prior art for the reasons discussed above. Therefore, the double patenting rejection is proper and hereby maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new/revised ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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