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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/09/2026 has been entered.
Response to Amendment
The Amendment filed 04/09/2026 has been entered. Applicant’s amendments are in response to in the Final Office Action mailed 11/10/2025 (note the new Examiner for this Application, where continuity of rationale will continue as much as possible, but style may slightly differ due to process specific practices). Furthermore, with regard to the approach to the Application within this Office Action, “there is nothing unusual, certainly, about an examiner changing his viewpoint as to the patentability of claims as the prosecution of a case progresses, and so long as the rules of Patent Office practice are duly complied with an applicant has no legal ground for complaint because of such change in view. The life of a patent solicitor has always been a hard one. In re Ruschig, 154 USPQ 118, 120-21 (CCPA 1967).” In this case, the difference in search and interpretation of the Prior Art has led to a modified approach to the instant claim set.
Applicant’s claims have been amended in the following manner: independent claim 1 has been cancelled, and replaced by new independent claim 12, whereby the compound formula (compared to the previous claim set) has been effectively narrowed to Pal-GH (i.e., supported in Applicant’s Specification by [0075-0114]).
The following objections/rejections are withdrawn: 112(b) (due to cancellation of claim 1, that contained the term “possibly”).
The Examiner further acknowledges the following:
Claims 11-12 are pending.
Claims 11-12 are presented for examination and rejected as set forth below.
Claim Objections
Claim 11 is in improper form and must be objected to. 37 CFR § 1.75: One or more claims may be presented in dependent form, referring back to and further limiting another claim or claims in the same application. Claim 11 refers to claim 12. That is not referring back. See also MPEP 608.01(m). Appropriate correction is required.
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Imoto (US 20170042783A1) in view of Ringenbach (US20190099362A1) and Laville (US20160331676A1).
Applicant’s claims are directed to Pal-GH (i.e., whereby the Specification states “a free form of N-palmitoyl-Gly-His (hereinafter may be referred to simply as "Pal-GH")” at [0075] in Applicant’s Specification), wherein the sucrose ester is selected from the group consisting of sucrose laurate, sucrose myristate, sucrose palmitate, and sucrose stearate, and wherein the composition is in the form of a liquid. Note that the phrase of “can form a film on the surface of skin or hair” is an intended use, where a film-forming ability of the composition only provides patentable weight.
Imoto discloses a thickened composition, comprising a lipid peptide-type compound (Imoto – claim 1) that is highly safe for living organisms, and highly useful particularly in applications such as cosmetics materials [0025].
Regarding claim 12: Imoto teaches Pal-GH (i.e., free form of N-palmitoyl-Gly-His) in preferred embodiments [0117-0123] in combination with a polyhydric alcohol, and stearic acid (abstract). Furthermore, Imoto teaches that the composition may be a solution (i.e., liquid) comprising a non-ionic surfactant ([0072]) such as sucrose fatty acid esters ([0072]).
In summary, Imoto teaches a composition comprising Pal-GH and sucrose fatty acid esters that may be in liquid form. However, Imoto does not teach that the sucrose (fatty acid) ester is selected from the group consisting of sucrose laurate, sucrose myristate, sucrose palmitate, and sucrose stearate (instant claim 12).
Ringenbach teaches a cosmetic treatment comprising a physiologically acceptable medium ([0040]) such as an aqueous or hydro-alcoholic solution ([0041]) and lipophilic derivatives of peptides, preferably palmitoyl derivatives such as the dipeptide N-Palmitoyl-beta-Ala-His (i.e., a lipidic peptide compound) ([0058]). Additionally, Formulation Example 2 comprises sucrose stearate (reads on instant claim 12).
Laville teaches a composition comprising sucrose esters (abstract) in a variety of topical formulations (Laville – claim 6) and inclusive of thickeners [0073], whereby the sucrose esters (i.e., C1-C22), such as sucrose monolaurate (aka sucrose laurate) [0020], exhibit interesting biochemical and biological activities on the skin, skin appendages and mucous membranes mainly to improve moisturizing, the barrier function of the epidermis, and to prevent and/or combat the signs of skin ageing [0015], in addition to their already known function as surface active agents [0017]. Laville also teaches that film-forming agents (i.e., incorporated into topical compositions [0075]) can rebuild the cutaneous barrier to tackle problems of skin dryness and ageing [0014].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to select the sucrose stearate, as taught by Ringenbach, as the sucrose fatty acid ester generally taught by Imoto [0072], because it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Furthermore, Laville motivates inclusion of sucrose esters such as sucrose monolaurate (aka, sucrose laurate) into cosmetic compositions for the skin benefitting properties of sucrose esters as a class (i.e., mainly to improve moisturizing, the barrier function of the epidermis, and to prevent and/or combat the signs of skin ageing) [0015], whereby Imoto teaches moisturizers and tactile-feel enhancers [0069-0070] to benefit the skin [0001-0002, 0069].
Claim 11-12 is rejected under 35 U.S.C. 103 as being unpatentable over Imoto (US20170042783A1), Ringenbach (US20190099362A1), and Laville (US20160331676A1), as applied to claim 12, and further in view of Ranade (US20100266648A1) and Miyamoto (US20110183913).
As discussed above, combined Prior Art make obvious the limitations of claim 12. However, they do not teach film characteristics of a surface roughness, and the average surface roughness is 3 nm to 500 nm (instant claim 11).
Ranade teaches compositions and methods for imparting super-hydrophobic properties to cosmetics, which can be used to significantly improve water repellency compared to traditional cosmetics (abstract). Ranade discloses compositions with nano-scale (1 nm to about 1,000 nm) surface roughness (i.e., structure) on a film, which imparts water repellency by providing protuberances on which water droplets may sit, thereby minimizing contact of the water with the surface at large, i.e., reducing surface adhesion ([0044]). With regard to the numerical range of the surface roughness, note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)).
Miyamoto additionally teaches that lipid peptide gelators (i.e., the lipid dipeptide of formula (1) (abstract) compares to lipid dipeptide of Formula (1) of Imoto (abstract)) that are capable of forming films ([0081, 0109, 0135, 0335-0339], Miyamoto - claim 24). Miyamoto further teaches that Pal-GH (palmitoyl-Gly-His) is preferred because it can form a gel in a wide variety of mediums including such mediums, and thus mediums can be selected from a much wider range [0099].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of the combined Prior Art to have a film with a surface roughness of 3-500 nm as taught by Ranade and Miyamoto, because that would impart superhydrophobic films to skin, hair, and nails to achieve water-resistant, self-cleaning and/or long-wear properties [0015], whereby Imoto [0001-0007, 0069], Ringenbach [0001-0004] and Laville [0014-0017, 0075] are interested in cosmetic application to skin and hair. Laville also teaches that film-forming agents (i.e., incorporated into topical compositions [0075]) can rebuild the cutaneous barrier to tackle problems of skin dryness and ageing [0014]. Finally, Miyamoto teaches Pal-GH is capable of forming films.
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 11-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of co-pending Application No. 17/789444 (reference application) in view of Imoto (US20170042783A1), Ringenbach (US20190099362A1), and Laville (US20160331676A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the pending and copending claims both recite a composition comprising substantially the same lipidic peptide compound, including overlapping film surface features. However, the instant claim further narrows the lipid peptide to Pal-GH, and specific sucrose esters.
The additional limitations of the instant claim set are addressed by the secondary references (i.e., Imoto teaches the Pal-GH species, and Ringenbach/Laville teach the sucrose ester species) according to the motivations provided in the 103 rejection above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 11-12 (Nissan Chemical Corp) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 Patent No. US9265833B2 (Nissan Chemical Corp), in view of over Imoto (US20170042783A1), Ringenbach (US20190099362A1), Laville (US20160331676A1), Ranade (US20100266648A1) and Miyamoto (US20110183913).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets recite a composition comprising a lipid peptide compound. However, the instant claim further narrows the lipid peptide to Pal-GH, specific sucrose esters, and film surface features.
The additional limitations of the instant claim set are addressed by the secondary references according to the motivations provided in the 103 rejection above.
Claims 11-12 (Nissan Chemical Corp) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 Patent No. US10071044B2 (Nissan Chemical Corp), in view of over Imoto (US20170042783A1), Ringenbach (US20190099362A1), Laville (US20160331676A1), Ranade (US20100266648A1) and Miyamoto (US20110183913).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets recite a composition comprising a lipid peptide compound. However, the instant claim further narrows the lipid peptide to Pal-GH, specific sucrose esters, and film surface features.
The additional limitations of the instant claim set are addressed by the secondary references according to the motivations provided in the 103 rejection above.
Response to Arguments
Applicants arguments, see pg 3-5, filed 04/09/2026, with respect to the 103 rejection of claims 1 and 11 under rejection have been fully considered but they are not persuasive. The 103 rejection has been modified with respect to amendments made to the claim set and new added independent claim 12.
Due to modification of the independent claim 12 (i.e., that now specify the species “Pal-GH”, as compared to previous independent claim 1), the arguments based on the narrowed limitation of Pal-GH are considered moot. However, arguments of substance will be responded to, when possible.
On page 3, Applicant discusses changes made in response to the 112(b), in which the changes were found acceptable to withdraw the 112(b), due to removal of the term “possibly”.
On page 3, Applicant suggests the combined Prior Art does not teach all limitations of the instant claim scope. All elements of each prior art reference need not read on the claimed invention, rather, the proper test for obviousness is what the combined teachings would have suggested to a person of ordinary skill in the art. In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). Note, that the 103 and non-statutory double patenting rejections address all limitations of the claim scope as obvious based on the combined Prior Art (see rejections above for the teaching of limitations and rationale for combining Prior Art).
On page 3, Applicant suggests “superior results throughout the wealth of comparative data” but does not provide an explanation of superiority compared to the combined Prior Art. To counteract an obviousness rejection: “[A]ppellants have the burden of explaining the data…they proffer as evidence of non-obviousness.” Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Thus, there is no specific argument of unexpected results, in which, the Examiner is able to respond to and/or discuss (i.e., “superior results throughout the wealth of comparative data” is not specific enough).
On page 4, Applicant argues that the behavior of surfactants varies by type without specifically describing how this argument pertains to the instant claim scope, and also without referring to the objective evidence to support this argument (especially in relation to the surfactants of the instant application). Thus, Applicant has not provided evidence of the specific unpredictability of the art to challenge the obviousness of the modification. Furthermore, this general per se type of argumentation (without specifically applying the argument to the patentability of the claim scope) is not persuasive to demonstrate non-obviousness. It is understood that sucrose fatty acid esters are surface-active compounds as taught by Imoto [0072].
On page 4, Applicant argues the references do not specify Pal-GH, which has been addressed above, as being a moot point, due to the modification made to the independent claim scope.
On page 5, Applicant concludes.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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/R.P./Examiner, Art Unit 1614 5/28/26
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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