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 .
Election/Restrictions
Newly submitted claims 11-19 are directed to the non-elected species, per the Applicants response to the Restriction requirement (See response dated 12/02/2025). Accordingly, claims 11-19 are withdrawn from consideration as being directed to a non-elected invention.
Claim Status
Applicant’s claim amendments filed 08 April 2026 are acknowledged.
Claims 1-9 & 11-19 are pending.
Claims 11-19 are new.
Claim 10 is cancelled.
Claims 1-9 are amended.
Claims 3, 4, 6, 8, 9 & 11-19 are withdrawn.
Claims 1, 2, 5 & 7 are under consideration.
Examination is to the extent of the following species:
1) At least one surfactant- anionic surfactant which is sulfate surfactant; and
2) Further care component-protein hydrolysate.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Withdrawn Objections/Rejections
The objection to claim 1 is withdrawn due to amendments which delete language permitting combinations of a combination to be added.
The objection to claim 1 for being internally inconsistent is withdrawn due to amendments which delete the recitation of “the percentages by weight of the at least one surfactant comprising the anionic surfactant, amphoteric surfactant, nonionic or combinations thereof are added”.
The rejection of claim 5 under 35 USC 112(b) is withdrawn due to amendments which remove the parenthetical expressions.
The rejection of claim 7 under 35 USC 112(b) due to improper Markush language is withdrawn due to claim amendments.
New & Maintained Rejections
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.
Claim 5 is 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 recites “wherein the at least one surfactant is an anionic surfactant selected from the group consisting of alkylethersulfates…”. It is unclear whether the species of anionic surfactant selected “from the group consisting of alkylether sulfates…” are the only ones that can meet the amount of 3.0 to 20 wt.%” recited by claim 1. Are the amounts of amphoteric, and nonionic surfactant excluded from the calculation from which the recited amount of 3.0 to 20 wt.% is to be achieved?
What Applicant appears to be trying to do is limit the species of anionic surfactant is selected from. If this is Applicant’s intention, a recitation of “The cosmetic agent according to claim 1 wherein the anionic surfactant is selected from the group consisting of alkylether sulfates…” would obviate the rejection.
Response to Arguments
Applicant does not respond to the outstanding rejection (reply, pg. 7).
Because Applicant did not amend the claim as suggested in the prior office action mailed 05 January 2026, nor did Applicant specifically traverse this rejection, the rejection is maintained.
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.
Claims 1, 2, 5 & 7 are rejected under 35 U.S.C. 103 as being unpatentable over Hasebe (US 2006/0165636; Published: 07/27/2006; previously cited) in view of Alpha-Hydroxy Acids (https://web.archive.org/web/20200929033755/https://www.acnesupport.org.uk/treatment/treatment-1/; Published: 09/29/2020; previously cited).
With regard to claims 1, 2, 5 & 7, Hasebe in Prescription Example 4 teaches a shampoo comprising 4.0% POE (3) sodium lauryl ether sulfate (i.e. a C12 alkyl group and 3 ethylene oxide) and 0.2 soy-protein hydrolysate [0096]. With regard to claim 2, the combined amount of POE (3) sodium lauryl ether sulfate (anionic surfactant) and lauryl amido propyl betaine (amphoteric surfactant) is 9%. With regard to claims 1 & 2, Hasebe teaches inclusion of lactobionic acid as the bioactive ingredient which has useful bioactivity to hair ([0030] & [0046]). Hasebe teaches inclusion of citric acid in an amount of 1.5% in the Prescription Example 4 shampoo [0096].
Hasebe does not teach the amount of lactobionic acid for inclusion in a shampoo.
In the related field of skin care, Alpha-Hydroxy Acids teaches citric and lactobionic acid are both examples of alpha-hydroxy acids (pg. 2). Alpha-Hydroxy Acids teaches alpha-hydroxy acids are commonly found in 2% to 10% concentrations in products you leave on your skin and in higher concentrations in products that you wash off the skin (pg. 2). Alpha-Hydroxy Acids teaches lactobionic acid is a gentler chemical exfoliator and is not as likely to cause skin irritation as other alpha-hydroxy acids and salicylic acid (pg. 2). Alpha-Hydroxy Acids teaches exfoliating with alpha-hydroxy acids, such as lactobionic acid, is a way of removing trapped skin cells, oil and other-follicle blocking substances from skin (pg. 2).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Here, at least rationale (G) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing to have modified Hasebe’s Prescription Example 4 shampoo by substituting Hasebe’s citric acid with Hasebe’s lactobionic acid in an amount of 1.5% to greater than 10% as suggested by the combined teachings of Hasebe and Alpha-Hydroxy Acids because citric acid and lactobionic acid are both alpha-hydroxy acids but lactobionic acid is a gentler chemical exfoliator and is less likely to cause skin irritation than other alpha-hydroxy acids as taught by Alpha-Hydroxy Acids. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to remove hair follicle blocking substances from the scalp/skin with an alpha-hydroxy acid that is gentler than other alpha-hydroxy acids in amounts which are art recognized as suitable for rinse off products with shampoo being a rinse-off product as suggested by the combined teachings of Hasebe and Alpha-Hydroxy Acids.
With regard to the recited amount of lactobionic acid, “a range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case.” Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004).
With regard to the amount of the at least one surfactant/anionic surfactant/ POE (3) sodium lauryl ether sulfate, and the combined amount of the combination of POE (3) sodium lauryl ether sulfate and lauryl amido propyl betaine, the combined teachings of Hasebe and Alpha-Hydroxy Acids teach these parameters with values that overlap or fall within the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
Applicant argues the Hasebe and Alpha-Hydroxy Acids references individually (reply, pg. 8-11).
This is not persuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Hasebe teaches lactobionic acid as a suitable bioactive agent for use in their invention which may be a shampoo. Alpha-Hydroxy Acids teaches lactobionic acid as an alpha-hydroxy acid suitable for removing trapped skin cells, oil and other-follicle blocking substances (pg. 2). One would understand the follicle that is being blocked is a hair follicle.
Applicant argues Hasebe requires use of γ-polyglutamic acid and teaches inclusion of a bioactive agent but does not guide the ordinary skilled artisan to any particular bioactive agent (reply, pg. 8 & 9). Applicant further argues Hasebe doesn’t recognize lactobionic acid as an alpha-hydroxy acid; the ordinary skilled artisan would have been motivated to substitute Hasebe’s citric acid with other alpha-hydroxy acids recognized by Hasebe instead of using lactobionic acid (reply, pg. 9-10).
This is not persuasive. With regard to Applicant’s arguments pertaining to γ -polyglutamic acid, the claims use the term “comprising” which is an open ended transitional phrase which permits inclusion of unrecited reagents (See MPEP 2111.03). With regard to Applicant’s arguments pertaining to selection of lactobionic acid as the bioactive agent, Hasebe teaches lactobionic acid as a suitable bioactive agent for use in their invention. Alpha-Hydroxy Acids provides motivation for selection of lactobionic acid because it is a gentler chemical exfoliator and is not as likely to cause skin irritation as other alpha-hydroxy acids while removing follicle blocking substances from skin (pg. 2).
Applicant argues their invention is in a different field of endeavor than that of Alpha-Hydroxy Acids. Applicant’s invention is drawn to prevention or reduction of a damaging effect on keratin fibers while Alpha-Hydroxy Acids is drawn to acne treatments (reply pg. 10). This is not persuasive. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below). In the instant case, Alpha-Hydroxy Acids recognizes lactobionic acid is a gentler chemical exfoliator than other alpha-hydroxy acids and salicylic acid (pg. 2).
Applicant argues the new dependent claims 11-17 are allowable (reply, pg. 11).
This is not persuasive. New claims 11-17 are withdrawn as they are drawn to non-elected species. Claim 1, from which they ultimately depend, is not in condition for allowance.
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 1-7 & 11-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,933,005 (hereinafter ‘005; Issued: 03/02/2021; previously cited) in view of Alpha-Hydroxy Acids (https://web.archive.org/web/20200929033755/https://www.acnesupport.org.uk/treatment/treatment-1/; Published: 09/29/2020; previously cited).
Both the instant claims and the ‘005 recites inclusion of citric acid/alpha hydroxy acid in an amount of 0.5 wt.%, C14-16 α - olefin sulfonate (anionic surfactant) in an amount of 6 wt.% and 8 wt %; sodium methyl cocoyl taurate (anionic surfactant) in an amount of 2 wt.%; cocoamidopropyl betaine/amphoteric surfactant in amount of 5 wt.% or disodium cocoamphodiacetate (amphoteric surfactant) in an amount of 4 wt.%; cocoamide MEA (nonionic surfactant) in an amount of 0.3 wt.%; and hydrolyzed keratin/a protein hydrolysate. The ‘005 recites inclusion of hydrolyzed keratin, panthenol, Guar hydroxypropyltrimonium chloride, sodium chloride, perfume, and nicotinamide. The ‘005 recites inclusion of citric acid in an amount of 0.5%. The ‘005 does not teach inclusion of lactobionic acid. The teachings of Alpha-Hydroxy Acids is described above. In brief, Alpha-Hydroxy Acids teaches citric acid and lactobionic acid are both alpha hydroxy acids (AHAs) that are chemical exfoliators which remove hair follicle blocking substances but lactobionic acid is more gentle and is not as likely to cause skin irritation. It would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the hair shampoo composition recited by the ‘005 patent by adding 1.5-9.5% lactobionic acid as suggested by Alpha-Hydroxy Acids because citric acid and lactobionic acid are both chemical exfoliating AHAs. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to remove hair follicle blocking substances from the skin/scalp with less irritation as taught by Alpha-Hydroxy Acids. The pending claims are therefore an obvious variant of the conflicting, patented claims.
Claims 1, 2, 4, 6 & 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 & 7 of U.S. Patent No. 10,722,440 (hereinafter ‘440; Issued: 07/28/2020; previously cited) in view of Alpha-Hydroxy Acids (https://web.archive.org/web/20200929033755/https://www.acnesupport.org.uk/treatment/treatment-1/; Published: 09/29/2020; previously cited).
Both the instant claims and the ‘440 recites inclusion of a hair composition which comprises sodium laureth sulfate about 5 to about 15% by weight, cocoamidopropyl betaine about 2 to about 10% by weight, 0.4 PEG-40 hydrogenated castor oil (nonionic surfactant), PEG-7 glyceryl cocoate, preservatives, sodium chloride (i.e. NaCl) and citric acid 0.2 wt.%. The ‘440 patent does not recite inclusion of lactobionic acid. The teachings of Alpha-Hydroxy Acids are described above. It would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the hair shampoo composition recited by the ‘440 patent by adding 1.8-9.5% lactobionic acid as suggested by Alpha-Hydroxy Acids because citric acid and lactobionic acid are both chemical exfoliating AHAs but lactobionic acid is less likely to cause irritation. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to remove hair follicle blocking substances from the skin/scalp with less irritation as taught by Alpha-Hydroxy Acids. The pending claims are therefore an obvious variant of the conflicting, patented claims.
Claims 1-4, 6, 11-14 & 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 & 7-13 of U.S. Patent No. 10,835,467 (hereinafter ‘467; Issued: 11/17/2020; previously cited) in view of Alpha-Hydroxy Acids (https://web.archive.org/web/20200929033755/https://www.acnesupport.org.uk/treatment/treatment-1/; Published: 09/29/2020; previously cited) and Hasebe (US 2006/0165636; Published: 07/27/2006;previously cited).
Both the instant claims and the ‘467 recites a hair composition/base shampoo which comprises sodium laureth sulfate in an amount of from 2.5 to 3.75 wt.%, cocoamidopropyl betaine in an amount from 6 to 15% by weight, nonionic surfactants including PEG-7 glyceryl cocoate in an amount from 7.5 to 15 wt.%, and citric acid in an amount from 0.25 wt.%. The ‘467 patent does not recite inclusion of lactobionic acid or the amount of ethylene oxide units in the sodium laureth sulfate. The teachings of Alpha-Hydroxy Acids are described above. Hasebe in Prescription Example 4 teaches a shampoo comprising 4.0% POE (3) sodium lauryl ether sulfate (i.e. a C12 alkyl group and 3 ethylene oxide; [0096]). It would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the hair shampoo composition recited by the ‘467 patent by adding lactobionic acid in an amount of 0.25-9.75% as suggested by Alpha-Hydroxy Acids because citric acid and lactobionic acid are both chemical exfoliating AHAs. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to remove hair follicle blocking substances from the skin/scalp with less irritation as taught by Alpha-Hydroxy Acids. It also would have been prima facie obvious to the ordinary skilled artisan to the ordinary skilled artisan before the effective filing date to have modified the hair shampoo composition recited by the ‘467 by substituting the generically recited sodium lauryl sulfate with POE (3) sodium lauryl ether sulfate as taught by Hasebe because sodium laureth sulfate and POE (3) sodium lauryl ether sulfate are both suitable for use with shampoos. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to provide a shampoo with a species of sodium lauryl sulfate which is art recognized as suitable for shampoos. The pending claims are therefore an obvious variant of the conflicting, patented claims.
Response to Arguments
Applicant argues that filing a terminal disclaimer is premature because no claims have been allowed (reply, pg. 11).
This is not persuasive. Since Applicant’s representative has taken no action, the rejections are maintained.
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 LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David J Blanchard can be reached at 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LORI K MATTISON/Examiner, Art Unit 1619
/NICOLE P BABSON/Primary Examiner, Art Unit 1619
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