Prosecution Insights
Last updated: April 19, 2026
Application No. 17/909,669

LAMELLAR GEL-CONTAINING COMPOSITION, EMULSIFIED COMPOSITION, AND COMPOSITION FOR EXTERNAL-USE SKIN PREPARATION

Final Rejection §103§DP
Filed
Sep 06, 2022
Examiner
LEE, SIN J
Art Unit
1613
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Shiseido Company Ltd.
OA Round
2 (Final)
69%
Grant Probability
Favorable
3-4
OA Rounds
3y 0m
To Grant
94%
With Interview

Examiner Intelligence

Grants 69% — above average
69%
Career Allow Rate
716 granted / 1039 resolved
+8.9% vs TC avg
Strong +26% interview lift
Without
With
+25.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
59 currently pending
Career history
1098
Total Applications
across all art units

Statute-Specific Performance

§101
0.3%
-39.7% vs TC avg
§103
46.3%
+6.3% vs TC avg
§102
18.9%
-21.1% vs TC avg
§112
20.2%
-19.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1039 resolved cases

Office Action

§103 §DP
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 canceled claims 3-7 and 10-20. Due to the terminal disclaimer filed by applicant, previous double patenting rejection over claims of U.S. Patent No. 10,898,426 B2 is hereby withdrawn. In view of the amendment, previous 112(b) rejection on claims 1-20 is hereby withdrawn. In view of the amendment, previous 102(a)(1) or 102(a)(2) rejection over Miyahara et al’932 and previous 102(a)(1) or 102(a)(2) over Miyahara et al’833 are hereby withdrawn. Thus, applicant’s argument concerning those 102(a)(1)/102(a)(2) rejections is now moot. 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. Claim Rejections - 35 USC § 103 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. 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) 1, 2, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over MIYAHARA et al (US 2019/0029932 A1) in view of Yu (CN 110037981 A and its English translation). Miyahara teaches ([0013]) a composition for external skin care use and a-gel (instant lamellar gel) composition using a a-gel forming composition consisting only of polyoxyethylene surfactants without containing higher alcohols and higher fatty acids. Miyahara teaches that its composition has a high skin moisturizing effect and does not have a problem of the over-time stability, such as crystal deposition and a viscosity increase over time. Specifically, in Table 10, Miyahara teaches an oil-in-water (O/W) type emulsified serum composition containing the following ingredients: PNG media_image1.png 480 571 media_image1.png Greyscale In the composition shown above, polyoxyethylene (8 mol) distearate (present in the amount of 0.5 wt.%) teaches instant first nonionic surfactant of formula [Chem. 1] shown in claim 1 as well as instant polyethylene glycol distearate of claim 2 (with instant k being 8) (see [0038]-[0040] of present specification). With respect to instant second nonionic surfactant having an HLB of from 7 to 15, Miyahara’s composition shown above does not include instant second nonionic surfactant of formula [Chem.3], [Chem.4] or [Chem.5]. However, Miyahara teaches ([0086]) that its composition can further contain (in addition to the essential components) components typically used in cosmetics products, and among examples of such additional components, Miyahara teaches ([0086], [0089]-[0090]) nonionic surfactants (lipophilic or hydrophilic). Miyahara further teaches ([0090]) POE-sorbitan fatty acid esters, such as POE-sorbitan monostearate, among examples of hydrophilic nonionic surfactants (in [0090], Miyahara also teaches POE-glyceryl monostearate (instant second nonionic surfactant of [Chem..4]) among other examples of hydrophilic nonionic surfactants). Furthermore, as evidenced by Yu (see 5th paragraph on pg.5 of English translation), polysorbate 60 (another name for POE (20) sorbitan monostearate) is known to enhance the function of emulsifier extensibility and lubricity. Since Miyahara already teaches that POE-sorbitan monostearate (a hydrophilic nonionic surfactant) can be used in its composition as one of the additional components, and since it is known in the art (as evidenced by Yu) that polysorbate 60 enhances the function of emulsifier extensibility and lubricity, it would have been obvious to one skilled in the art to further include polysorbate 60 (POE (20) sorbitan monostearate) in Miyahara’s composition shown above with a reasonable expectation of enhancing the function of emulsifier extensibility and lubricity. Polysorbate 60 (POE (20) sorbitan monostearate) meets instant second nonionic surfactant of [Chem.5] (see [0054]-[0055] of present specification) and has an HLB of 14.9 (see [0119] of present specification). With respect to instant content of the second nonionic surfactant (0.05-60% by mass relative to the composition), Miyahara teaches ([0069]) that its external skin care composition can contain nonionic surfactants in the total amount of 0.1-20%. Since the components (1), (2) and (3) of the composition shown above (in Table 10) are all nonionic surfactants, and since the sum of the amounts for those components is 6.5% by mass, this gives up to 13.5% by mass relative to the composition for the amount of polysorbate 60 (instant second nonionic surfactant). Such range overlaps with instant range (0.05-60% by mass) for the content of the second nonionic surfactant relative to the composition, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). With respect to instant limitation as to the content of the second nonionic surfactant being 0.5 to 4 parts by mass per 1 part by mass of the first nonionic surfactant, since there is going to be up to 13.5% by mass of polysorbate 60 (instant second nonionic surfactant of [Chem.5]) and 0.5% by mass of polyoxyethylene (8 mol) distearate (instant first nonionic surfactant of [Chem.1]), this gives up to 27 parts by mass for the content of instant second nonionic surfactant per 1 part by mass of the first nonionic surfactant. Such range overlaps with instant range (0.5-4 parts by mass) for the content of the second nonionic surfactant per 1 part by mass of the first nonionic surfactant, this rendering instant range prima facie obvious. In re Wertheim, supra. The above composition is free of higher aliphatic alcohol and free of higher fatty acid having at least 16 carbon atoms, thus meeting instant limitation “a content by percentage of higher aliphatic alcohols and/or higher fatty acids having at least 16 carbon atoms is 1% by mass or less relative to the mass of the composition”. The ion exchange water included in the above composition teaches instant water, and Squalane included in the composition teaches instant oily component of claims 8 (see [0066] and [0070] of present specification). With respect to instant limitation “the lamellar gel phase has a higher eutectic point and higher melting enthalpy than a lamellar gel phase formed solely from any one of the second nonionic surfactants represented by Chem.3 to Chem.5”, since Miyahara in view of Yu teaches all of instant components of claim 1, it is the Examiner’s position that the lamellar gel phase of Miyahara’s O/W emulsified serum composition shown in Table 10 further containing polysorbate 60 (as modified by the teaching of Yu) would inherently have a higher eutectic point and enthalpy of fusion than a lamellar gel phase formed solely from any one of instant second nonionic surfactants represented by Chem.3 to Chem.5 as instantly recited. Thus, Miyahara in view of Yu renders obvious instant claims 1, 2, 8 and 9 (since Miyahara’s O/W emulsified serum composition (for an external-use skin preparation) shown in Table 10 as modified by Yu’s teaching contains instant composition of claim 1, an oily component (squalane) and water, such composition teaches instant emulsified composition of claim 8 wherein the oily component or the water is emulsified by the lamellar gel phase). Claim(s) 1, 2, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over MIYAHARA et al (US 2019/0350833 A1) in view of Yu (CN 110037981 A and its English translation). Miyahara teaches ([0013]) a composition for external skin care use and a-gel (instant lamellar gel) composition using a a-gel forming composition consisting only of polyoxyethylene surfactants without containing higher alcohols and higher fatty acids. Miyahara teaches that its composition has a high skin moisturizing effect and does not have a problem of the over-time stability, such as crystal deposition and a viscosity increase over time. Specifically, Miyahara teaches (see Table 9 in [0114]) an oil-in-water (O/W) type emulsified serum composition containing the following ingredients: PNG media_image2.png 535 475 media_image2.png Greyscale In the composition shown above, polyoxyethylene (6 mol) distearate (present in the amount of 0.2 wt.%) teaches instant first nonionic surfactant of formula [Chem. 1] shown in claim 1 as well as instant polyethylene glycol distearate of claim 2 (with instant k being 6) (see [0038]-[0040] of present specification). With respect to instant second nonionic surfactant having an HLB of from 7 to 15, Miyahara’s composition shown above does not include instant second nonionic surfactant of formula [Chem.3], [Chem.4] or [Chem.5]. However, Miyahara teaches ([0073]) that its composition can further contain (in addition to the essential components) components typically used in cosmetics products, and among examples of such additional components, Miyahara teaches ([0073] and [0077]-[0078]) nonionic surfactants (lipophilic or hydrophilic). Miyahara further teaches ([0078]) POE-sorbitan fatty acid esters, such as POE-sorbitan monostearate, among examples of hydrophilic nonionic surfactants (in [0078], Miyahara also teaches POE-glyceryl monostearate (instant second nonionic surfactant of [Chem..4]) among other examples of hydrophilic nonionic surfactants). Furthermore, as evidenced by Yu (see 5th paragraph on pg.5 of English translation), polysorbate 60 (another name for POE (20) sorbitan monostearate) is known to enhance the function of emulsifier extensibility and lubricity. Since Miyahara already teaches that POE-sorbitan monostearate (a hydrophilic nonionic surfactant) can be used in its composition as one of the additional components, and since it is known in the art (as evidenced by Yu) that polysorbate 60 enhances the function of emulsifier extensibility and lubricity, it would have been obvious to one skilled in the art to further include polysorbate 60 (POE (20) sorbitan monostearate) in Miyahara’s composition shown above with a reasonable expectation of enhancing the function of emulsifier extensibility and lubricity. Polysorbate 60 (POE (20) sorbitan monostearate) meets instant second nonionic surfactant of [Chem.5] (see [0054]-[0055] of present specification) and has an HLB of 14.9 (see [0119] of present specification). With respect to instant content of the second nonionic surfactant (0.05-60% by mass relative to the composition), Miyahara teaches ([0057]) that its external skin care composition can contain nonionic surfactants in the total amount of 0.1-20%. Since the components (2), (3) and (4) of the composition shown above (in Table 9) are all nonionic surfactants, and since the sum of the amounts for those components is 1.0% by mass, this gives up to 19% by mass relative to the composition for the amount of polysorbate 60 (instant second nonionic surfactant). Such range overlaps with instant range (0.05-60% by mass) for the content of the second nonionic surfactant relative to the composition, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). With respect to instant limitation as to the content of the second nonionic surfactant being 0.5 to 4 parts by mass per 1 part by mass of the first nonionic surfactant, since there is going to be up to 19% by mass of polysorbate 60 (instant second nonionic surfactant of [Chem.5]) and 0.2% by mass of polyoxyethylene (6 mol) distearate (instant first nonionic surfactant of [Chem.1]), this gives up to 95 parts by mass for the content of instant second nonionic surfactant per 1 part by mass of the first nonionic surfactant. Such range overlaps with instant range (0.5-4 parts by mass) for the content of the second nonionic surfactant per 1 part by mass of the first nonionic surfactant, thus rendering instant range prima facie obvious. In re Wertheim, supra. The above composition is free of higher aliphatic alcohol and free of higher fatty acid having at least 16 carbon atoms, thus meeting instant limitation “a content by percentage of higher aliphatic alcohols and/or higher fatty acids having at least 16 carbon atoms is 1% by mass or less relative to the mass of the composition”. The ion exchange water included in the above composition teaches instant water, and liquid paraffin included in the composition shown above teaches instant oily component of claim 8 (see [0066] and [0070] of present specification). With respect to instant limitation “the lamellar gel phase has a higher eutectic point and higher melting enthalpy than a lamellar gel phase formed solely from any one of the second nonionic surfactants represented by Chem.3 to Chem.5”, since Miyahara in view of Yu teaches all of instant components of claim 1, it is the Examiner’s position that the lamellar gel phase of Miyahara’s O/W emulsified serum composition shown in Table 9 above further containing polysorbate 60 (as modified by the teaching of Yu) would inherently have a higher eutectic point and enthalpy of fusion than a lamellar gel phase formed solely from any one of instant second nonionic surfactants represented by Chem.3 to Chem.5 as instantly recited. Thus, Miyahara in view of Yu renders obvious instant claims 1, 2, 8 and 9 (since Miyahara’s O/W emulsified serum composition (for an external-use skin preparation) shown in Table 9 as modified by Yu’s teaching contains instant composition of claim 1, an oily component (liquid paraffin) and water, such composition teaches instant emulsified composition of claim 8 wherein the oily component or the water is emulsified by the lamellar gel phase). Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov . Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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 . /SIN J LEE/ Primary Examiner, Art Unit 1613 March 6, 2026
Read full office action

Prosecution Timeline

Sep 06, 2022
Application Filed
Aug 14, 2025
Non-Final Rejection — §103, §DP
Nov 18, 2025
Response Filed
Mar 07, 2026
Final Rejection — §103, §DP (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
69%
Grant Probability
94%
With Interview (+25.5%)
3y 0m
Median Time to Grant
Moderate
PTA Risk
Based on 1039 resolved cases by this examiner. Grant probability derived from career allow rate.

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