DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the claims and applicant arguments/remarks, filed 01/21/2026, is acknowledged.
Claims 1, 3-4, 7-13, 19-29 are pending in this action. Claims 2, 5-6, 14-18 have been cancelled previously. Claims 1, 4, 7-13, 19-23 have been amended. New claims 24-29 have been added. No new matter was added. Claims 1, 3-4, 7-13, 19-29 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of objection(s) and/or rejection(s) presented in this office action.
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 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
This application is a 371 of PCT/EP2019/067758, filed July 2, 2019.
Claim Objections
Claims 1, 3-4, 8, 21-23, 29 are objected to because of the following informalities:
Newly amended claim 1 comprises the typographic error “lactlate” that needs to be corrected to “lactylate”.
Claim 3 and newly amended claim 8 are identical.
Newly amended claim 4 recites the limitation “selected from the group consisting of … or mixtures thereof” needs to be corrected to “selected from the group consisting of … and mixtures thereof” for clarity (see claims 7, 12,13).
New claim 21 comprises the typographic error “according to Claim 4” that needs to be corrected to “according to claim 4”. Similar is applied to claims 22-23.
New claim 29 comprises the typographic error “present in an amount from 5 to” that needs to be corrected to “present in an amount of from 5 to” (see claims 1, 19).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(1)
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.
Claims 27, 28 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The present claims are directed to a method for improving the sun protection factor of a composition comprising one or more oil soluble UV filters, wherein the method comprises adding to said composition a mixture consisting of beeswax and sodium stearoyl lactylate (claim 27) in an amount of 1-10 wt% (claim 28).
The written description requirement for a claimed genus (here as a method of improving compositions) may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. MPEP §2163.
In the present case, three examples of specific compositions consisting of 19 constituents/compounds including beeswax and sodium stearoyl lactylate are provided (Para. 0201, 0203, 0205). Applicant shows that in said compositions the addition of beeswax and sodium stearoyl lactylate allows improving/increasing a sun protection factor. No information is provided in the instant specification how said effect can be generalized/extrapolated on other sun protection compositions, i.e., what compounds must be excluded and/or what compounds can be included in combination with beeswax and sodium stearoyl lactylate to provide an increase/improvement of sun protection factor (SPF).
The present specification provides no disclosure beyond the statement, that would have been amenable for use in the present invention, nor does it teach the specific structure, physical properties or a method of identification of compounds that can be included in claimed compositions in combination with beeswax and sodium stearoyl lactylate for providing an improvement of SPF. To this point, it is noted that a wish or plan for obtaining the chemical invention as claimed does not provide adequate written description of a chemical invention. Rather, a precise definition, such as by structure, formula, chemical name or physical properties, is required. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004).
While it is recognized that adequate written description of a limitation is not required to be stated in haec verba in the specification or claims as originally filed, adequate written support for claim limitations must arise from either an explicit or implicit suggestion by the disclosure to show that such a concept as claimed was actually in possession of applicant at the time of the invention. For the reasons provided supra, applicant has failed to provide the necessary teachings, by describing the claimed invention with all of its limitations using such descriptive means that fully set forth the claimed invention, in such a way as to reasonably convey to one skilled in the relevant art that applicant had possession of the entire genus of drugs. Therefore, it is examiner’s position that the instant specification does not provide required written description of the claimed invention.
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 1, 3-4, 7-13, 19-26, 29 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 pre-AIA the applicant regards as the invention.
Newly amended claim 1 discloses “a composition comprising an oil phase comprising beeswax and sodium stearoyl lactate, and at least one oil soluble UV filter, wherein said composition exhibit a SPF of at least 15” that is not reasonably clear. To this point, it is noted that it is well known in the field that properties of multicomponent systems (i.e., compositions) depends on compounds included as well as on concentrations and distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition. Therefore, claiming a result (i.e., a SPF) without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation. See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Further, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Furthermore, “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Similar is applied to claims 3, 8-10. Clarification is required.
Newly amended claim 4 (dependent on claim 1) recites the limitation “The composition of claim 1 further comprising” and discloses a list of UVA, UVB and broadband filters to be included into the claimed composition that is not reasonably clear. Does this claim disclose additional filters to be included into the composition of claim 1 (i.e., further comprising), OR clarify/define the compounds/filters that can be included as oil soluble filters disclosed in independent claim 1. Clarification is required.
Claim 10 (dependent on claim 1) recites the limitation "the composition exhibits a ratio of the UVA absorbance to the total UVB + UVA absorbance that is greater than or equal to 0.70" that is unclear. In the present case, it is noted that independent claim 1 does not disclose UVA absorbance and/or UVB absorbance. Therefore, it is unclear how claim 10 narrows the scope of claim 1 upon which it dependents. Clarification is required.
New claim 25 recites the limitation “substantially water-free” that is unclear. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
New claim 26 recites the limitation “UV filters comprise at least one UVA filter and at least one UVB filter” that is unclear. In the present case, it is unclear what is understood as “UV filter” – a specific compound, OR a mixture comprising UVA or UVB filleters in combination with other compounds that can be present even in large amounts (i.e., comprising). Clarification is required.
Claims 7, 11-13, 19-24, 29 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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, 3-4, 7-13, 19-29 are rejected under 35 U.S.C. 103 as being unpatentable over Graham, US 2012/0237466, in view of Winkler et al., US 2013/0251650 A1 (cited in IDS; hereinafter referred to as Winkler), and Pesaro et al., US 2016/0100574 (hereinafter referred to as Pesaro).
Graham teaches photo-filtering compositions for treatment of hair and scalp and protecting the hair and scalp from damaging UV rays (e.g., UVA, UVB), wherein said compositions can be incorporated into lotions to be used for treatment of hair and scalp (Para. 0017), and wherein said compositions may include oils and (Title; Abstract; Para. 0007, 0017):
(a) beeswax, e.g., 5 wt% (Claims 5, 6; Abstract; Para. 0007, 0019 as applied to claims 1, 3-4, 27-28);
(b) sodium stearoyl lactylate (Claims 7, 8; Para. 0044 as applied to claims 1, 3-4, 27-28);
(c) UV absorber/photo-filtering agent, e.g., butyl methoxy dibenzoylmethane, terephthalylidene dicamphor sulfonic acid, menthyl anthranilate (Claim 9; Para. 0046 as applied to claims 4, 27-28) identified in the instant application as UVA filters;
(d1) octocrylene, homosalate, octisalate, triethanolamine salicylate, 2-ethylhexyl-paramethoxycinnamate, isoamyl methoxycinnamate, phehylbenzimidazole sulfonic acid (Claim 9; Para. 0046 as applied to claims 4, 27-28) identified in the instant application as, i.e., UVB filters;
(d2) bis-ethylhexyloxyphenol methoxyphenol triazine, 2-hydroxy-4-methoxybenzophenone-5-sulfonic acid, 2-hydroxy-4-methoxybenzophenone (here as oxybenzone), benzophenone-3, sulisobenzone, benzophenone-4 (Claim 9; Para. 0046 as applied to claims 4, 27-28) identified in the instant application as broadband filters;
(vi) titanium dioxide, zinc oxide (Claims 1, 9, 17; Abstract; Para. 0007, 0046 as applied to claim 7) identified in the instant application as pigments;
(vii) sorbitan esters, e.g., sorbitan isostearate, sorbitan laurate, sorbitan oleate, sorbitan sesquioleate, sorbitan trioleate (Para. 0044 as applied to claim 13) identified in the instant application as emulsifiers.
Though Graham teaches that said compositions may include additional additives (Para. 0017), e.g., insect repellents (Para. 0047), Graham does not specifically teach the use of 1,2-alkanediol having 5-12 carbon atoms (claims 11), 4-hydroxyaxetophenone and/or o-cymen-5-ol (claim 12).
Winkler teaches compositions for the protection of skin or hair against the deleterious effects of light (Abstract), wherein said compositions may include: beeswax; sodium stearoyl lactylate; butyl methoxydibenzoylmethane (i.e., UVA filters); ethylhexyl methoxycinnamate, isoamyl p-methoxycinnamate, octocrylene, homosalate, (i.e., UVB filters); bis-ethylhexyloxyphenol methoxyphenyl triazine (i.e., a broadband filter); glyceryl oleate citrate, sorbitan esters (i.e., an emulsifier; Abstract; Para. 0135, 0136, 0156, 0162; Examples B15-B17), and also teaches that said compositions may also include suitable insect repellents, e.g., 1,2-pentanediol (Para. 0179). Winkler provides examples of compositions comprising 0.5 wt% of beeswax and less than 4 wt% of sodium stearyl lactylate (Examples B15-B17).
Pesaro teaches compositions for skin treatment (Para. 0050), wherein said compositions may include: 4-hydroxyacetophenone as an antimicrobial agent (Para. 0040), beeswax, e.g., 1 wt% of beeswax in combination with such UVB filer as tris(2-ethylhexyl)-4,4′,4″-(1,3,5-triazine-2,4,6-triyltriimino)tribenzoate (0093; 0101; Table XXXXIII); 0.1-10 wt % of acyl lactylates (here as a surfactant; Para. 052); UV-absorbing agents, UVA filters, UVB filters, broadband filters (Para. 0050, 0098, 0101; 0155-0191), e.g., methyl anthranilate, butyl methoxydibenzoyl methane (i.e., UVA filter; Para. 0155), octocrylene, 4-methylbenzylidene camphor, isoamyl-p-methoxy-cinnamate (i.e., UVB filters; Para. 0163-192; Table XXXXII); 2-hydroxy-4-methoxybenzophenone (i.e., broadband filter; Para. 0130); titanium dioxide, zinc oxide (Para. 0195-0197); sorbitan esters, stearic acid esters (i.e., emulsifiers; Para. 0073-0076); and skin moisturizing agents such as 1,2-alkanediols having 5-12 carbon atoms as 1,2-pentanediol, 1,2-hexanediol, 1,2-octanediol, 1,2-decanediol (Para. 0205).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include additional components as taught by Winkler and Pesaro into the compositions as taught by Graham, because it is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a new composition to be used for the very same purpose. (MPEP 2144.06). In the present instance, cited prior art teaches personal care compositions that can be applied to a skin and/or hair and provide UV protection. One would do so with expectation of beneficial results, because said approach would provide compositions that also can repel insects and/or moisturize the skin.
With regard to the concentrations/amounts instantly claimed, it is noted that the cited prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Pertinent prior art (see below) provides a strong support to the examiner’s position. Further, regarding the claimed properties of the disclosed compositions, it is noted that the cited prior art teaches the compositions that are substantially the same as the compositions recited by the instant claims. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2012/0128611 A1 – teaches UV filter combinations that may include: (i) butyl methoxydibenzoylmethane (i.e., UVA filter); (ii) octocrylene (i.e., UVB filters; Abstract; Para. 0085); (iii) zinc oxide (Para. 0120); (iv) [Symbol font/0x3C]2.5 wt% of sodium stearoyl lactylate (Example 16); (v) beeswax, e.g., 1 wt% (Example 17).
US 2022/0241159 A1 (priority date 04/30/2019) – teaches cosmetic compositions providing SPF of 30-100; Para. 0029), wherein said compositions may include: (i) beeswax, e.g., 1.5-3 wt% (Para. 0097, 0117, 0140); (ii) 1-10 wt% of sodium stearoyl lactylate (Para. 0038-0040); (iii) butyl methoxydibenzoylmethane/avobenzone (i.e., UVA filter); octocrylene (i.e., UVB filters; 0141); bis-ethylhexyloxyphenol methoxyphenyl triazine (i.e., a broadband filter; Claim 11; Para. 0023, 0097, 0114, 0115, 0140); (iv) zinc oxide, titanium oxide (Para. 0096, 0097, 0104).
US 2014/0030198 A1 – teaches sun-care products to protect from UV radiation (i.e., providing SPF of 15-70; Para. 0031), wherein said product/compositions may include: (i) beeswax; (ii) sodium stearoyl lactylate; (iii) butyl methoxydibenzoylmethane/avobenzone (i.e., UVA filter); octocrylene, triethanolamine salicylate (i.e., UVB filters); bis-ethylhexyloxyphenol methoxyphenyl triazine (i.e., a broadband filter; Para. 0029, 0033, 0051, 0056, 0059).
US 2009/0124576A1 (cited in IDS) - teaches cosmetic sunscreen compositions that can be applied to a skin or hair and may include: (i) beeswax; (ii) sodium stearoyl lactylate; (iii) butyl methoxydibenzoylmethane (i.e., UVA filter); ethylhexyl methoxycinnamate, isoamyl p-methoxycinnamate (i.e., UVB filters); bis-ethylhexyloxyphenol methoxyphenyl triazine (i.e., a broadband filter; Para. 0038-0055; 0065, 0069-0070; Example B3, compositions C and/or G).
Response to Arguments
Applicant's arguments, filed 01/21/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or rejections have been added to the record to address newly introduced amendments and/or to clarify the position of the examiner. Additional examiner’s comments are set forth next.
In response to applicant's arguments that Graham teaches the use of sodium stearoyl lactylate as an alternative to beeswax, rather than a complementary component, it is noted that Graham teaches the use of additional or alternative emulsifying agents (Para. 0044) as well as additional or alternative oil and waxes (Para. 0045) to be used in photo-filtering compositions for treatment of hair and scalp and protecting the hair and scalp from damaging UV rays (e.g., UVA, UVB). In the present case, the cited prior art as well as the pertinent prior art of record discloses/teaches photo-filtering compositions comprising the same compounds. One skilled in the art would have understood that properties of multicomponent systems (e.g., comprising UV filters for providing sun-protection) depend on compounds included as well as on concentrations and distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition. Therefore, it is expected that different compositions might have different properties. The determination of suitable or effective concentration/composition (e.g., for providing/controlling sun-protecting properties of compositions) can be and usually is determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Further, as stated previously, the fact that the applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). To this point, it is also noted that the Supreme Court decided (KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)) that: (i) The obviousness analysis needs not seek out precise teachings directed to the subject matter of the challenged claim and can take into account the inferences and creative steps that one of ordinary skill in the art would employ; (ii) The obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents; (iii) It is error to look only the problem the patentee was trying to solve. Any need or problem known in the field of endeavor at the time of invention and addressed by the prior art can provide a reason for combining the elements in the manner claimed; (iv) It is error to assume that one of ordinary skill in the art in attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem. Common sense teaches that familiar items may have obvious uses beyond their primary purposes, and in many cases one of ordinary skill in the art will be able to fit the teachings of multiple patents together like pieces of a puzzle (one of ordinary skill in the art is not automaton); (v) It is error to assume that a patent claim cannot be proved obvious merely by showing that the combination of elements was “obvious to try”.
Therefore, the examiner maintains the positions that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made/filed, because every element of the invention has been collectively taught by the combined teachings of the references. Applicant is advised to clarify the structure of the claimed compositions, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Applicant's amendment necessitated the new 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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