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 .
Priority
Provisional application filed 09/29/2023 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/30/2024 and 05/16/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the references included have been considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because in the . A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 5 and 17-18 are objected to because of the following informalities: the (as in instant claims 5-7 and 17-18). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 5, 6, 11, 16 and 17-18 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.
Claim 5 and 6 are rejected because of the statement “a combination of two or more thereof” following the preamble, “a plurality of amino acids”. The preamble conveys there will be more than one amino acid, so the combination of two or more is confusing and appears unnecessary.
Claim 17-18 recites the limitation "the plurality of amino acids" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim, as claim 17 is dependent on claim 16, which only claims an amino acid, rather than a plurality of amino acids.
Claims 3, 5, 6, 11, 16 and 17 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 3, 5, 6, 11, 16, and 17 is improper because it should read “…is selected from the group consisting of…”. The current phrasing of the claims above do not particularly point out whether one component from the list is in the composition, or if there has to be a combination.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common 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.
Claim(s) 1-3, 5-11, 16-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thorel (FR3112475A1).
Regarding claims 1-3, 8-11, and 20, Thorel describes a cosmetic formulation that can function to protect the skin from the sun (para. [0047]). The cosmetic formulation comprises zinc oxide (i.e. mineral UV filter) and ethylhexyl methoxycrylene (see claim 9). Thorel further describes that the cosmetic composition comprises an amino acid (see claim 4) and ceramides (see claim 9).
Regarding claims 5-7 and 16-18, Thorel discloses that the amino acid in the composition can be selected from amino acids such as glycine, arginine, and taurine (see claim 4).
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.
Claim(s) 4 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Thorel (FR3112475A1) in view of Patel (WO 2020086755 A1), evidenced by Drėno et al. (Journal of the European Academy of Dermatology and Venereology, 2019, 33, 34-35), hereinafter Drėno.
While Thorel describes the claimed invention as above, it fails to disclose that the composition can contain both butyloctyl salicylate and ethylhexyl methoxycrylene, or that the composition omits titanium compounds.
Regarding claims 4 and 14, Patel teaches a sunscreen composition with a mineral UV filter and both butyloctyl salicylate and ethylhexyl methoxycrylene (see Table 1).
Regarding claims 12 and 13, Patel teaches that the sunscreen composition contains zinc oxide as the mineral UV filter, but does not comprise any titanium compounds (see Table 1). Drėno teaches that titanium dioxide has been suspected to penetrate dermal and respiratory barriers, and can cause potential risk to the consumer (see abstract, pg. 34 Drėno 2019).
Thorel and Patel are considered to be analogous to the claimed invention because they are in the same field of topical compositions that are applied to the skin for protection from the sun. Patel teaches that the butyloctyl salicylate and ethylhexyl methoxycrylene function as agents for enhancing the sun protection factor (i.e. SPF, see claim 20). As such, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to incorporate both the butyloctyl salicylate and ethylhexyl methoxycrylene taught in Patel into the composition taught in Thorel for the benefit of enhanced SPF. See MPEP § 2143(I)(a). Additionally, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to not include titanium compounds in the composition taught in Thorel, because Patel teaches a composition that does not use titanium compounds and is effective as a sunscreen (see Table 1). The skilled artisan would have expected success in omitting the titanium compounds from the topical composition taught in Thorel, because titanium compounds have potential risks to the consumer, as taught in Drėno. Further, Patel teaches that sunscreen compositions are effective without the titanium present. It would have been obvious to the person of ordinary skill in the art that not including titanium compound could decrease the potential health risk for the consumer. MPEP § 2143(I)(g).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Thorel (FR3112475A1) in view of LaRosa (US 20210093529 A1).
While Thorel teaches the claimed invention as above, it fails to disclose the specific ceramides that are utilized in the composition.
Regarding claim 15, LaRosa teaches a sunscreen composition that comprises a mineral UV filter. The composition taught in LaRosa comprises ceramides, specifically ceramide 1, ceramide 3, and ceramide 6 II (para. [1579]).
Thorel and LaRosa are considered to be analogous to the claimed invention because they are in the same field of cosmetic compositions that function as sunscreens. Thorel teaches the claimed invention as above, but does not state the specific ceramides that the composition can contain. It would have been obvious to one of ordinary skill in the art to substitute the generic ceramides in the composition taught in Thorel with the ceramide 1, ceramide 3, and ceramide 6 II as taught in LaRosa to yield predictable results. MPEP § 2143(I)(b).
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Thorel (FR3112475A1) in view of Nabi (WO 2017116465 A1).
Thorel teaches the claimed invention as above, but fails to teach the weight ratio of the amino acids in the composition.
Regarding claim 19, Nabi teaches a personal care composition that can comprise a sunscreen agent, that further comprises glycine, arginine, and taurine in a weight ratio of 1:24:45 to 1:40:69 (see claim 1). The weight ratio taught in instant claim 19 almost entirely overlaps with the range taught in Nabi, and as such it is obvious. (“[W]here 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.”) In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP § 2144.05(II).
Thorel and Nabi are considered to be analogous to the claimed invention because they are in the same field of cosmetic formulations that are effective as sunscreens. While Thorel does not disclose the weight ratio of the amino acids in the composition, Nabi teaches that a range that almost fully encompasses that of instant claim 19. The weight ratio between glycine, arginine, and taurine is an optimizable parameter, inviting one skilled in the art to experiment. It would have been obvious to one of ordinary skill in the art to incorporate the weight ratio taught in the composition of Nabi, into the composition disclosed in Thorel, because Nabi teaches that this ratio is effective in a personal care composition that can function as a sunscreen. MPEP § 2143(I)(g).
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.
Claim(s) 1-11, 14, 16-18, and 20 are rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1 and 16 of U.S. Application No. 18/318,100 (hereafter App ‘100) in view of Thorel (FR3112475A1).
Regarding claims 1-3, 9-11, and 20 of instant invention, App ‘100 describes a sunscreen composition containing zinc oxide (i.e. mineral UV filter, see claim 1). The composition disclosed in App ‘100 further comprises pongamia pinnata extract, ethylhexyl methoxycrylene, and butyloctyl salicylate (see claim 16). While App ‘100 does not disclose amino acids or ceramides in the composition, Thorel teaches these components.
Regarding claims 1, 5-9, 16-18, and 20 of instant invention, as discussed in detail above, Thorel teaches a composition for protecting the skin from the sun. The composition described in Thorel contains amino acids such as arginine, taurine, and glycine (see claim 4). Thorel describes that the amino acids function in the composition as osmolytes (see claim 4), which are known in the art to improve stability of topical formulations. As such, it would have been obvious to one of ordinary skill in the art to incorporate the amino acids taught in Thorel into App ‘100, for their benefit of functioning as osmolytes. MPEP § 2143(I)(a). Further, Thorel teaches that the composition contains ceramides (see claim 9). Ceramides are known in the art to be effective in maintaining and restoring the skin barrier. Therefore, one of ordinary skill in the art would have a reasonable expectation of success in adding ceramides of Thorel to the composition taught in App ‘100, for their benefit of restoring the skin barrier. MPEP § 2143(I)(a).
Regarding claim 4 and 14 of instant invention, App ‘100 teaches that the composition comprises pongamia pinnata extract, ethylhexyl methoxycrylene, and butyloctyl salicylate (see claim 16).
The conflicting claims of instant invention and App ‘100 differ only marginally in scope from claims 1-11, 14, 16-18, and 20 of the present application. Claims 4 and 9 of Thorel, which are discussed above in the rejections under 35 U.S.C. 102, compensate for the deficiency in the conflicting claims concerning the amino acids and ceramides in the composition.
Claim(s) 1-11, 14, 16-18, and 20 are rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1, 10, and 11 of U.S. Application No. 18/949,395 (hereafter App ‘395) in view of Thorel (FR3112475A1).
Regarding claims 1-3, 9-11, and 20 of instant invention, App ‘395 describes a composition for the skin that comprises zinc oxide and iron oxide (i.e. mineral UV filter, see claim 1), as well as amino acids (see claim 11). The composition of App ’395 further comprises butyloctyl salicylate, ethylhexyl methoxycrylene, octyldodecyl neopentanoate, Pongamia pinnata extract, or a combination of two or more thereof (see claim 10). While App ‘395 does not teach that the composition contains ceramides, Thorel teaches this component.
Regarding claims 8-9 and 20 of instant invention, as discussed above, Thorel teaches a composition that functions as a sunscreen. The composition described in Thorel contains ceramides (see claim 9). As above, ceramides are known in the art to maintain and restore the skin barrier. Therefore, one of ordinary skill in the art would have a reasonable expectation of success in adding ceramides to the composition of App ‘395, for their benefit of restoring the skin barrier. MPEP § 2143(I)(a).
Regarding claims 4 and 14 of instant invention, App ‘395 teaches that the composition comprises butyloctyl salicylate, ethylhexyl methoxycrylene, and Pongamia pinnata extract, or a combination of two or more thereof (see claim 10).
Regarding claims 5-7 and 16-18 of instant invention, App ‘395 teaches that the composition can comprise amino acids selected from glycine, arginine, taurine, and a combination of two or more thereof (see claim 11).
The conflicting claims of instant invention and App ‘395 differ only marginally in scope from claims 1-11, 14, 16-18, and 20 of the present application. Claim 9 of Thorel, which is discussed above in the rejections under 35 U.S.C. 102, compensates for the deficiency in the conflicting claims concerning the ceramides in the composition.
Claim(s) 1-11, 14, 16-18, and 20 are rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 3, 6, and 12 of U.S. Application No. 19/415,177 (hereafter App ‘177) in view of Thorel (FR3112475A1).
Regarding claims 1-3, 9-11, and 20 of instant invention, App ‘177 describes a composition that is applied to the skin and functions as a sunscreen. The composition comprises zinc oxide (i.e. mineral UV filter, see claim 3), as well as amino acids which function as skin conditioning agents (see claim 12). The composition taught in App ‘177 further comprises butyloctyl salicylate and ethylhexyl methoxycrylene (see claim 6). While App ‘177 does not teach that the composition contains ceramides, Thorel teaches this component as above.
Regarding claims 8-9 and 20 of instant invention, as above, Thorel teaches a sunscreen composition. The composition described in Thorel contains ceramides (see claim 9). As above, ceramides are known in the art to maintain and restore the skin barrier. Therefore, one of ordinary skill in the art would have a reasonable expectation of success in adding ceramides to the composition of App ‘177, for their benefit of restoring the skin barrier. MPEP § 2143(I)(a).
Regarding claims 4 and 14 of instant invention, App ‘177 teaches that the composition comprises butyloctyl salicylate and ethylhexyl methoxycrylene (see claim 6).
Regarding claims 5-7 and 16-18 of instant invention, as discussed in detail above, Thorel teaches a composition for protecting the skin from the sun. The composition described in Thorel contains amino acids such as arginine, taurine, and glycine (see claim 4). Thorel describes that the amino acids function in the composition as osmolytes (see claim 4), which are known in the art to improve stability of topical formulations. As such, it would have been obvious to one of ordinary skill in the art to incorporate the amino acids taught in Thorel into App ‘177, for their benefit of functioning as osmolytes. MPEP § 2143(I)(a).
The conflicting claims of instant invention and App ‘177 differ only marginally in scope from claims 1-11, 14, 16-18, and 20 of the present application. Claim 9 of Thorel, which is discussed above in the rejections under 35 U.S.C. 102, compensates for the deficiency in the conflicting claims concerning the ceramides and specific amino acids in the composition.
Conclusion
Claim(s) 1-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Makenna Miller whose telephone number is (571)272-9852. The examiner can normally be reached Mon-Fri 7:30-5:00 EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/M.R.M./Examiner, Art Unit 1611
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