*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 .
Applicant’s response dated October 17, 2025, is acknowledged.
Priority
This application is a 371 of PCT/JP2020/045085 filed on 12/03/2020, which claims
foreign priority in Japanese application JP2019-227456 filed on 12/17/2019.
Claim Status
Claims 1-4, 6, 7 and 13-26 are pending. Claims 20-26 were newly added where claims 20 and 26 read on the elected invention of Group I and claim 21-25 do not read the elected invention of Group I. Claims 1, 3, and 4 were amended. Claims 5 and 8-12 were canceled. Claims 6, 7, 13-19, and 21-25 are withdrawn. Claims 1-4, 20, and 26 are examined.
Claims 21-25 are withdrawn from consideration as follows.
Group VI, claims 21-24, drawn to a thickener comprising a phospholipid, a surfactin of formula II, a 1,2-diol, and water wherein the amounts of each component are expressed as ratios by mass, the thickener does not contain a polymer thickener or a content amount of a polymer thickener is less than 1 mass %, and the thickener is further defined by a range of viscosities.
Group VII, claim 25, drawn to a thickened composition comprising the thickener to Group I.
The common technical feature among Groups I-VII is the composition described in claim 1. The common technical feature is not a contribution over the prior art of record as shown in the obviousness rejections of claim 1 of Satoshi and Lu below.
Withdrawn Claim Rejections — 35 USC § 103
Rejections of claims 1-3 over Satoshi are withdrawn because claim 1 was amended to include limitations of claim 4 which are not obvious over Satoshi.
Claim Objections
Claim 1 is objected to because R1 in line 5 is a typographical error and should be R2 because the chemical structure of formula II contains the R2 variable. Appropriate correction is required.
New Claim Rejections – 35 USC § 112
Necessitated by Amendment
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.
Claim 26 is 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. Claim 26 further defines the thickener according to claim 1 by requiring that said phospholipid is the only lipid-based component in said thickener. This limitation is new matter because it is not supported in the application as filed. The specification only teaches phospholipids in the composition, however these teachings are not sufficient to provide support for excluding lipid-based components that are not a phospholipid. The mere absence of a limitation is not sufficient to provide support for excluding the limitation. Based on the application as filed, there is no indication that applicant contemplated excluding any non-phospholipid lipids from the invention.
Per MPEP 2173.05(i) states “Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). In describing alternative features, the applicant need not articulate advantages or disadvantages of each feature in order to later exclude the alternative features. See Inphi Corporation v. Netlist, Inc., 805 F.3d 1350, 1356-57, 116 USPQ2d 2006, 2010-11 (Fed. Cir. 2015). The mere absence of a positive recitation is not basis for an exclusion. However, a lack of literal basis in the specification for a negative limitation may not be sufficient to establish a prima facie case for lack of descriptive support. Ex parte Parks, 30 USPQ2d 1234, 1236 (Bd. Pat. App. & Inter. 1993). "Rather, as with positive limitations, the disclosure must only 'reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.' ... While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure." Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013, 2022 USPQ2d 569 (Fed. Cir. 2022) (quoting Ariad Pharm. Inc. v. Eli Lilly & Co., 589 F.3d 1336, 1351, 94 USPQ2d 1161, 1172). Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. See MPEP § 2163 - § 2163.07(b) for a discussion of the written description requirement of 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph.
New Claim Rejections — 35 USC § 103
Necessitated by Amendment
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.
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.
Claims 1-4 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Satoshi (JP 2018024639 A Published February 15, 2018 — English language machine translation appended thereto — of record in PTO-892 dated 05/12/2025) and Lu (US 2016/0030324 Al Published February 4, 2016).
The claims encompass a thickener.
Satoshi teaches a cosmetic composition comprising (A) a mannosylerythritol lipid, (B) a phospholipid, and (C) a polyhydric alcohol (Abstract), where the phospholipid (B) is present in a concentration of 50-80% and may be used in a combination of two or more and comprises phosphatylethanolamine and examples thereof include natural lecithin and examples of polyhydric alcohol (C) include 1,2-octanediol (page 3 of the translation). Satoshi teaches that barrier function of skin prevents the penetration of active ingredients used in cosmetics and skin external preparations, and that attempts have been made to improve the permeability by encapsulating the active ingredient in liposomes (pages 1-2 in the Background section). Satoshi further teaches that the compositions contain anti-inflammatory agents and anti-aging agents, among others (page 14).
Satoshi does not teach the compound of formula II.
The teachings of Lu are related to a surfactin, which is a cycloaliphatic peptide made of 7 amino acids, wherein said surfactin has various functions including anti-ageing, anti-wrinkle, increasing skin permeation of cosmetic products, foaming agent, and emulsifier (Abstract). One aspect provides a composition for improving skin penetration by using surfactin, wherein the composition comprises surfactin, and pharmaceutically acceptable vehicle, excipients, diluents, and adjuvants, and wherein the surfactin is a cycloaliphatic peptide having 7 amino acids (L)Glu- (L)Leu-(D)Leu-(L) Val-(L)Asp-(D)Leu-(L)Leu linked to a beta-hydroxy fatty acid and the distribution of the fatty acids at the fatty acid end of the surfactin are as follows: (1) iso-Cl3>3%; (2)C13>0.65%; (3) iso-Cl4> 17%; ( 4) Cl4<41 %; and (5) iso-Cl 5<11 %. The enhanced skin penetration composition further comprises at least one of the following ingredients: alcohols, esters, complex polysaccharides, nut oils, and vitamins; wherein the alcohol comprises at least one of the following: Cl6-18 alcohols, butanediol, pentanediol, octanediol, glycerin, hexadecanol, stearyl alcohol, 1-docosanol and propylene glycol (paragraph 0048).
The teachings of Satoshi and Lu are related to compositions intended for cosmetic use and application to skin and it would have been obvious to have combined them because they are in the same field of endeavor.
Regarding claim 1, it would have been prima facie obvious to a person of ordinary skill I the art before the effective filing date of the claimed invention to have formed a composition comprising a phospholipid, a biosurfactant, 1,2-octanediol, and an anti-wrinkle agent or an anti-ageing agent, with a reasonable expectation of success because Satoshi teaches a cosmetic composition comprising (A) a mannosylerythritol lipid, (B) a phospholipid, and (C) a polyhydric alcohol, where the phospholipid (B) is present in a concentration of 50-80% and may be used in a combination of two or more comprising phosphatylethanolamine and examples thereof include natural lecithin and examples of polyhydric alcohol (C) include 1,2-octanediol (page 3 of the translation), and wherein the composition further comprises an antiwrinkle or antiaging agent.
It would have been obvious to have selected surfactin (L)Glu-(L)Leu-(D)Leu-(L) Val-(L)Asp-(D)Leu-(L)Leu linked to a beta-hydroxy fatty acid and having the distribution of the fatty acids at the fatty acid end of the surfactin are as follows: (1) iso-C13>3%; (2)C13>0.65%; (3) iso-Cl4>17%; ( 4) Cl4<41 %; and (5) iso-C15<11 % and used it as the anti-wrinkle agent or an anti-aging agent, with a reasonable expectation of success because Lu teaches said surfactin is known in the art as an anti-wrinkle agent and an anti-aging agent. The selection of a known material based on its suitability for its intended purpose supports obviousness. Furthermore, one of skill in the art would have been motivated to include said surfactin in Satoshi’s composition because the surfactin is known as a penetration enhancer and Satoshi recognized the importance of a cosmetic composition to have a sufficient permeability of the skin. Thus, the surfactin would have improved Satoshi’s composition.
The claimed compound of formula II is obvious over (L)Glu-(L)Leu-(D)Leu-(L) Val- (L)Asp-(D)Leu-(L)Leu linked to a beta-hydroxy fatty acid, when X is leucine and R2 is a mixture of C13-C15.
Satoshi’s composition modified by Lu contains the same elements as claimed and it could have been used as a thickener, absent evidence to the contrary.
The “wherein” clause at the end of the claim describes a property of the claimed thickener. The prior art composition contains the same components as claimed and it would have been reasonable to expect the prior art composition to have the same properties as claimed composition when placed under identical conditions, including thickening a liquid composition as claimed. A composition and its properties are inseparable.
Combining prior art elements according to known methods to obtain predictable results supports obviousness.
Regarding claim 2, it would have been obvious to have modified the composition by adding a trihydric alcohol such as glycerin, with a reasonable expectation of success because Satoshi teaches that examples of component (C) include polyhydric alcohols such as 1,2- octanediol and trihydric alcohols such as glycerin (page 3). It would have been obvious to have used a mixture of alcohols as component (C) because does not limit component C to a single alcohol and under broadest reasonable interpretation of Satoshi mixtures of alcohols would have been obvious.
Regarding claim 3, it would have been obvious to have formed the composition to contain components A and B in a concentration of 2-30 wt. % and component C in a concentration of 70-98 wt. %, with a reasonable expectation of success because Satoshi teaches said concentration ranges as suitable (Abstract). It would have been obvious to have varied the concentration of each component A and B in a range of up to 30 wt. % as long as the combined concentration of the two falls in the range of 2-30 wt. % because Satoshi does not limit the concentration of each component A and B, but requires their combination to be 2-30 wt. %. Therefore, lecithin would have been present in a concentration of up to 30 wt. %. Similarly, it would have been obvious to have varied the concentration of each alcohol in a concentration of up to 98 wt. % as long as the combined concentration falls in the range of 70-98 wt. % because Satoshi does not limit the concentration of each individual alcohol, but requires the total alcohol content to fall in the range of 70-98 wt. %. Lecithin would have been present in a concentration of up to 30 wt. % and the trihydric alcohol such as glycerin would have been present in a concentration of up to 98 wt. %. The claimed range of weight ratios of polyol to the biosurfactant (1-20):1 is obvious because it overlaps with the prior art range of weight ratios of the trihydric alcohol to lecithin (up to 98):(up to 30). The specification was reviewed and there is no evidence that the claimed combination of components and the claimed range of weight ratios are critical.
Regarding claim 4, Satoshi’s composition modified by Lu does not contain a polymeric thickener. Satoshi does not require the presence of a polymeric thickener in the composition.
Regarding claim 20, it would have been obvious to have formulated the composition with a solvent because Satoshi teaches that the composition contains additional components such as solvents (first full paragraph on page 5 of the translation).
Response to Arguments
Applicant’s arguments submitted in the remarks dated October 17, 2025, were fully considered but are not persuasive for the following reasons.
Applicant’s argument that it would not be obvious to replace MEL in Satoshi with the claimed compound of formula II, is not persuasive because the rejection is not based on replacing MEL with the compound of formula II.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Applicant’s argument that the proposed modification of Satoshi by adding the compound of formula II to Satoshi’s composition is based on hindsight, is not persuasive because all limitation and motivation to combined are present in the cited references. The compound of formula II is known in the art as a penetration enhancer, an anti-wrinkle agent, and an anti-aging agent. Satoshi teaches adding a penetration enhancer, an anti-wrinkle agent, or an anti-aging agent to the composition. In view of these teachings it would have been obvious to select the compound of formula II as taught by Lu and used it in Satoshi’s composition because the selection of a known material based on its suitability for its intended purpose supports obviousness.
Applicant’s argument that Satoshi’s composition is not described as a thickening composition is not sufficient to obviate the grounds of rejection because Satoshi’s composition modified by Lu contains the same components as claimed and it would have been reasonable to expect the prior art composition to have thickening properties when placed under the same conditions as instantly claimed composition. The Office does not have the means to test prior art products in order to determine whether or not they have the same properties as instantly claimed products. Prior art composition meets all of the structural limitations of the claimed composition and it would have been reasonable to expect the prior art composition and claimed composition to have the same properties when tested under the same conditions.
In response to applicant's argument that Satoshi does not teach that the composition has a thickening effect and Lu does not teach thickening action, the fact that the inventor 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. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). As explained above, Satoshi’s composition modified in view of Lu contains the same components as claimed. Examiner’s reason for combining prior art references does not have to be the same as applicant’s reason in order for an obviousness rejection to be proper.
Applicant’s argument that the claimed invention produces unexpected results is not persuasive because applicant has not met the requirements set forth in MPEP 716.02.
It is not clear why the applicant considers the observed results unexpected. The different compositions were made using different alcohols, thus it would have been reasonable to expect the different compositions to have different properties because they have different chemical compositions. There is no reference on the record that would have led a person of ordinary skill in the art to believe that compositions made from different alcohols would have the same thickening properties. Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected.
The table uses terms excellent, bad, and separated to describe thickening properties of the various compositions. It is unknown if the results are of statistical and practical significance because the differences between the three adjectives cannot quantified. Applicant presented one result for each composition and statistical analysis cannot be determined based on a single example. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance."
The data in the Table show excellent thickening property for two specific compositions. Applicant did not provide any evidence to show that the data obtained for the two examples can be extrapolated to the entire breadth of the claims. Therefore, the claims are not commensurate in scope with examples that produced the asserted unexpected results. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range.
An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness.
Applicant’s arguments related to claims 21-25 were considered however claims 21-25 are withdrawn from consideration for reasons described above.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alma - Pipic whose telephone number is (571)270-7459. The examiner can normally be reached M-F 9:00am-5:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more
information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALMA PIPIC/
Primary Examiner, Art Unit 1617