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
Applicant's election with traverse of Group I (claims 1-8) in the reply filed on 02 December 2025 is acknowledged. The traversal is on the ground(s) that lack of unity is only in relation to independent claims and not dependent claims. Claim 9 is a dependent claim. This is not found persuasive because claim 9 is drawn to a separate statutory category of invention (i.e. a method of use) and the technical feature shared between the composition claims (i.e. claim 1) and the method of use claim (i.e. claim 9) is not a special technical feature for the reasons set forth in the office action mailed 16 April 2025.
The requirement is still deemed proper and is therefore made FINAL.
Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 02 December 2025.
Applicant's election with traverse of:
1) At least one surfactant- anionic surfactant such as a sulfate surfactant; and
2) Further care component-protein hydrolysate in the reply filed on 02 December 2025 is acknowledged. The traversal is on the ground(s) that lack of unity is only in relation to independent claims and not dependent claims. Claims 3, 4, 6, and 8 depend from independent claim 1. This is not found persuasive because the species lack unity of invention because they are not so linked to form a single inventive concept under PCT Rule 13.1.
Claims 3, 4, 6 & 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the election requirement in the reply filed on 02 December 2025.
Claim Status
Applicant’s claim amendments filed 27 October 2023 are acknowledged.
Claims 1-9 are pending.
Claim 10 is cancelled.
Claims 1-9 are amended.
Claims 3, 4, 6, 8 & 9 are withdrawn.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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 27 October 2023 has been fully considered by the examiner. A signed and initialed copy of each IDS is included with the instant Office Action.
Objections/Rejections
Claim 1 is objected to because of the following informalities:
Claim 1 has issues with general readability. First, the recitation of the percentages by weight of the at least one surfactant comprising …combinations thereof” permits combinations of a combination to be added which doesn’t make sense.
Claim 1 is also internally inconsistent, reciting “0.01 to 40 wt% of at least one surfactant comprising an anionic surfactant, amphoteric surfactant, nonionic surfactant or combinations thereof”. This permits just one species of anionic surfactant, amphoteric surfactant, or nonionic surfactant in an amount of 0.01 to 40 wt.% to meet the limitations of the claim without the total amount of anionic surfactants, amphoteric surfactant and non-ionic surfactants being added. However, 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” (emphasis added) requires all species in these three genera to be added to meet the claim limitations.
Further, the recitation of “the percentages by weight of the at least one surfactant comprising the anionic surfactant, amphoteric surfactant, nonionic surfactants, or combinations thereof are added” is an unnecessarily verbose way of reciting “the total amount of the at least one surfactant comprising the anionic surfactant, amphoteric surfactant, and nonionic surfactants”.
Applicant may wish to consider whether an amendment to recite “wherein the percentage is the total amount by weight of the at least one surfactant comprising the anionic surfactant, amphoteric surfactant, and/or non-ionic surfactant” would obviate the objection and resolve the above readability issues.
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 5 & 7 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 contains the parenthetical expressions of “alkyl(ether)sulfates” and “alkyl(ether)sulfonates”. In the English language, parenthetical expressions are asides which are digressions from the main topic. As such it is unclear whether applicant is claiming alkyl sulfates, alkyl ether sulfates or both. It is also unclear whether Applicant is claiming alkyl sulfonates, alkyl ether sulfonates, or both.
Applicant may wish to consider whether an amendment to remove the parenthesis encompassing the word “ether” would obviate the rejection.
Claim 5 recites “wherein the at least one surfactant is an anionic surfactant selected from the group consisting of alkyl(ether)sulfates…”. It is unclear whether the species of anionic surfactant selected “from the group consisting of alkyl(ether) sulfates…” are the only ones that can meet the amount of 0.01 to 40 wt.%” recited by claim 1. Are the amounts of amphoteric, and nonionic surfactant excluded from the calculation from which the recited amount of 0.01 to 40 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 alkyl(ether) sulfates…” would obviate the rejection.
Claim 7 is rejected under 35 USC 112(b) for using improper Markush language. Claim 7 recites “a further care component selected from the group comprising a protein hydrolysate, a protein, a proteolipid, a cationic polymer, or combinations thereof” (emphasis added). MPEP 2173.05(h) states “[a] Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196”.
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) in view of Alpha-Hydroxy Acids (https://web.archive.org/web/20200929033755/https://www.acnesupport.org.uk/treatment/treatment-1/; Published: 09/29/2020).
With regard to claims 1 b), 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 claims 1 a) & 2, the combined amount of anionic, amphoteric and nonionic surfactant is 26%. With regard to claims 1 a) & 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.
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, the combined teachings of Hasebe and Alpha-Hydroxy Acids teach this parameter with a value that overlaps or falls 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).
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 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) in view of Alpha-Hydroxy Acids (https://web.archive.org/web/20200929033755/https://www.acnesupport.org.uk/treatment/treatment-1/; Published: 09/29/2020).
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 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 ‘006 patent by substituting the citric acid with 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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 & 7 of U.S. Patent No. 10,722,440 (hereinafter ‘440; Issued: 07/28/2020 ) in view of Alpha-Hydroxy Acids (https://web.archive.org/web/20200929033755/https://www.acnesupport.org.uk/treatment/treatment-1/; Published: 09/29/2020).
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, 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 substituting the citric acid with 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 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) in view of Alpha-Hydroxy Acids (https://web.archive.org/web/20200929033755/https://www.acnesupport.org.uk/treatment/treatment-1/; Published: 09/29/2020) and Hasebe (US 2006/0165636; Published: 07/27/2006).
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 substituting the citric acid with 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. 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.
Conclusion
No claims are allowed.
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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/LORI K MATTISON/Examiner, Art Unit 1619
/NICOLE P BABSON/Primary Examiner, Art Unit 1619