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 .
Claim Status
Claims 20-39 are rejected.
No claims are allowed.
Maintained Claim Rejections - 35 USC § 103
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.
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.
Claims 20-39 are rejected under 35 U.S.C. 103 as being unpatentable over Agostino et al., (US 2013/0220358 A1, Aug. 29, 2013) (hereinafter Agostino) as evidenced by PubChem (hydroxyethyl-3,4- methylenedioxyaniline, accessed July 10, 2025) (hereinafter PubChem hydroxyethyl-3,4- methylenedioxyaniline) and PubChem (2-amino-5-ethylphenol, accessed July 10, 2025) (hereinafter 2-amino-5-ethylphenol).
Agostino discloses non-diluted and diluted hair colouring compositions that include a dye component comprising at least one oxidative dye precursor and/or an alkalizing agent. Oxidative dye precursors are usually classified either as primary intermediates (also known as developers) or couplers (also known as secondary intermediates). The total amount of oxidative dye precursors ranges up to 12%. Various couplers may be used with primary intermediates in order to obtain different shades. Suitable primary intermediates include p-aminophenol (i.e., at least one oxidation base). Suitable couplers include, but are not limited to, 2-amino-5-ethylphenol, hydroxyethyl-3,4-methylenedioxyaniline, and mixtures thereof ([0032]). The hair colouring compositions may contain from 0.01% to 5% by weight of a chelant and salts thereof. The term “salts thereof” means all salts comprising the same functional structure as the chelant they are referring to and includes alkali metal. The chelant may be present in the dye component ([0040]). Chelants include N,N-Dicarboxymethyl-L-glutamic acid ([0046]). The hair colouring compositions may comprise polyalkylsiloxane oils (i.e., silicone oil) as a conditioning agent present in the dye component ([0067] and [0068]). The hair colouring compositions may comprise ceramides and surfactants in the dye component ([0036]). Surfactants suitable for use can be selected from anionic, nonionic and mixtures thereof ([0071]). The dye component of the non-diluted and diluted hair colouring compositions may optionally comprise an alkalizing agent, such as monoethanolamine (i.e., an alkanolamine) ([0033]). The non-diluted and diluted hair colouring compositions comprise a developer component (i.e., oxidizing composition) comprising an oxidizing agent, such as urea peroxide ([0031]). The compositions may be utilized in a variety of packaging and dispensing devices that come in the form of separate devices which may be used independently or in combination with one another. Typically, the hair colouring or bleaching components are contained within separate single or multi compartment containers so that the components can be stored separately from one another before use. The components are then mixed together by a mixing means and then applied to the consumer's hair by an application means. ([0099]). The developer component, the dye component and a dilutant component may be provided as separate containers in a kit ([0100]).
Agostino discloses hair colouring compositions containing 2-amino-5-ethylphenol ([0032]), hydroxyethyl-3,4-methylenedioxyaniline ([0032]), and N,N-Dicarboxymethyl-L-glutamic acid ([0046]). Together these would provide a composition as claimed instantly. The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
Regarding the limitation of claim 20 reciting at least one oxidation coupler chosen from hydroxyethyl-3,4- methylenedioxyaniline of formula (III)
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, the hydroxyethyl-3,4- methylenedioxyaniline of Agostino has the structure
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, as evidenced by PubChem hydroxyethyl-3,4- methylenedioxyaniline (page 3, 2D Structure), which is the same as formula (III).
Regarding the limitation of claim 20 reciting at least one oxidation coupler chosen from 2-amino-5-ethylphenol of formula (II)
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,
the 2-amino-5-ethylphenol of Agostino has the structure,
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, as evidenced by PubChem 2-amino-5-ethylphenol (bottom of page 2 - top of page 3, 2D Structure), which is the same as formula (II).
Regarding the limitation of claim 26 reciting the weight ratio of the total amount of oxidation base(s) to the total amount of oxidation coupler(s) chosen from hydroxyethyl- 3,4-methylenedioxyaniline(s) of formula (I), addition salts thereof, solvates thereof, solvates of their salts thereof and oxidation coupler(s) chosen from 2-amino-5- ethylphenol(s) of formula (II), addition salts thereof, solvates thereof, solvates of their salts thereof ranges from 0.1:1 to 10:1, as discussed above, Agostino teaches that oxidative dye precursors include 2-amino-5- ethylphenol and hydroxyethyl-3,4-methylenedioxyaniline and wherein a total amount of oxidative dye precursors ranges up to 12% is present. Thus, one of ordinary skill in the art would have selected an amount of 2-amino-5- ethylphenol and an amount of hydroxyethyl-3,4-methylenedioxyaniline from this range. The amounts selected would have led to a ratio between the two components that overlaps with the claimed ratio. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Regarding claim 36, as discussed above, Agostino teaches that the developer component comprises the chemical oxidizing agent, the dye component comprises the oxidation couplers (i.e., hydroxyethyl-3,4-methylenedioxyaniline and 2-amino-5-ethylphenol), and the chelant (i.e., N,N-dicarboxymethyl glutamic acid) may be present in the dye component. Further, The developer component, the dye component and the dilutant component may be provided as separate containers in the kit. Accordingly, it would have been within the capabilities of one of ordinary skill in the art to formulate the dye component of Agostino to comprise the oxidation couplers and chelant and provide it separately in a kit, making the dye component free or substantially free of any chemical oxidizing agent.
Response to Applicant’s Arguments
Applicant argues that Agostino discloses 44 different optional couplers and hundreds of possible chelants as opposed to the instant claims which require the two distinct oxidation couplers hydroxyethyl-3,4-methylenedioxyaniline and 2-amino-5-ethylphenol and the distinct chelant N,N-dicarboxymethyl-L-glutamic acid.
Applicant’s argument has been fully considered but found not to be persuasive. Selecting from a listing of possible solutions is obvious to try when choosing from a finite number of identified, predictable solutions. See MPEP(I). The lists of couplers and chelants disclosed by Agostino are finite lists of possible couplers and chelants, respectively, that would be suitable for use in hair dye compositions. As discussed above, Agostino teaches hydroxyethyl-3,4-methylenedioxyaniline and 2-amino-5-ethylphenol as possible couplers and N,N-Dicarboxymethyl-L-glutamic acid as a possible chelant. Thus, one would have reasonably selected hydroxyethyl-3,4-methylenedioxyaniline and 2-amino-5-ethylphenol as couplers and N,N-Dicarboxymethyl-L-glutamic acid as a chelant in a hair dye composition according to the teachings of Agostino.
Further, “a reference that “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989).” As discussed above, Agostino teaches hydroxyethyl-3,4-methylenedioxyaniline and 2-amino-5-ethylphenol as possible couplers and N,N-Dicarboxymethyl-L-glutamic acid as a possible chelant. Thus, one would have reasonably selected hydroxyethyl-3,4-methylenedioxyaniline and 2-amino-5-ethylphenol as couplers and N,N-Dicarboxymethyl-L-glutamic acid as a chelant in a hair dye composition according to the teachings of Agostino.
It was agreed upon during the interview 01/26/2026 that the unexpected results submitted in Applicant's Remarks dated 1/9/2026 would likely overcome the prior art rejection of the non final office action dated 9/9/2025, however, an updated prior art search will be performed to determine the allowability of the instant claims. Upon execution of an update prior art search and consideration it was found that the unexpected results submitted in Applicant's Remarks dated 1/9/2026 would not be unexpected to one of ordinary skill in the art as discussed below.
Applicant argues that the claimed combination of three compounds leads to unexpected results that are significantly better than those obtained from any combination of two of the compounds. Applicant cites the results disclosed in instant Table 3 demonstrating a ΔE value of 0.53 for the inventive mixture which is less than the ΔE values for the comparative mixtures 1 and 2, which are 2.95 and 2.86, respectively, and lower ΔE values represent improved selectivity and uniform coloration, which is not taught by Agostino.
Applicant’s argument has been fully considered but found not to be persuasive. As noted in the instant specification on page 44, line 14, ΔE is a measure of color difference and represents color selectivity of the composition. As discussed above, Agostino teaches that 2-amino-5-ethylphenol and hydroxyethyl-3,4-methylenedioxyaniline are couplers. Agostino discloses in paragraph [0032] wherein various couplers may be used with primary intermediates in order to obtain different shades. Thus, it would have been obvious to one of ordinary skill in the art that each mixture in instant Table 3 comprising a coupler would have a ΔE. Although, Comparative mixture 2 and Comparative mixture 1 have similar ΔE values, the Examiner is not persuaded that a mixture comprising both of the couplers in Comparative mixture 2 and Comparative mixture 1 would be expected to have a similar ΔE as the comparative mixtures and that when the ΔE is different it is unexpected. As evidenced by Chan et al., (US 5,344,463 A, Sept. 06, 1994) (hereinafter Chan), whether to use coupler (I) alone or in combination with other couplers will depend on the shade of the color desired (col 3, lines 64-67). Thus, one of ordinary skill in the art would reasonably expect that combining two couplers together would produce a shade different from when one coupler is used. Therefore, one of ordinary skill in the art would reasonably expect for Invention mixture comprising both 2-amino-5-ethylphenol and hydroxyethyl-3,4-methylenedioxyaniline as couplers to have a ΔE different than Comparative mixture 2 comprising just 6-2-amino-5-ethylphenol as the coupler and a ΔE different than Comparative mixture 1 comprising just hydroxyethyl-3,4-methylenedioxyaniline as the coupler. Applicant has not shown wherein a mixture comprising two other couplers may have a similar ΔE value compared to two mixtures each comprising one of those two couplers.
Further, as evidenced by Marsh (US 2009/0119852 A1, March 17, 2009) (hereinafter Marsh), couplers are used with other couplers to generate specific color effects or to stabilize the color ([0024]). Thus, one of ordinary skill in the art would reasonably expect that combining two couplers together would produce a color effect and stability, both different from when one coupler is used. Therefore, one of ordinary skill in the art would reasonably expect for the inventive mixture comprising both 2-amino-5-ethylphenol and hydroxyethyl-3,4-methylenedioxyaniline as couplers to have a selectivity, which is a coloring effect, different than Comparative mixture 2 comprising just 6-2-amino-5-ethylphenol as the coupler and a selectivity different than Comparative mixture 1 comprising just hydroxyethyl-3,4-methylenedioxyaniline as the coupler. Applicant has not shown wherein a mixture comprising two other couplers may have a similar selectivity compared to two mixtures each comprising one of those two couplers.
As such, Applicant's showing does not appear to be unexpected.
Further, purely arguendo, even if Applicant's showing is unexpected, the independent claim is not commensurate in scope with Applicant's showing. As noted in instant Table 1, the inventive mixture comprises tetrasodium glutamate diacetate as the representative N,N-Dicarboxymethylglutamic acid salt. However, the claims recite N,N-dicarboxymethylglutamic acid and all of its salts and mixtures thereof. One of ordinary skill in the art would not reasonably expect tetrasodium glutamate diacetate to be reasonably representative of N,N-dicarboxymethylglutamic acid and all of its salts because different N,N-dicarboxymethylglutamic acid salts have different solubilities that would affect the final color produced by the composition. Also, the independent claim does not recite amounts. As noted in instant Table 1, the inventive composition comprises 2.1 mmol of each coupler and 0.1% of the tetrasodium glutamate diacetate. Chan teaches that the proportions and amounts of the several constituents in the hair dye composition will depend on the nature and amount of the dye components, the tonal impression to be created, and the color of the hair to be dyed (col 3, lines 60-64). Thus, one would not reasonably expect any or all amounts of couplers and any or all amounts of N,N-dicarboxymethylglutamic and its salts and mixtures thereof to produce the same or similar ΔE values.
For the foregoing reasons the rejection is maintained.
Maintained 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 20-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-24 and 26-38 of copending Application No. 18/268,065 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite the addition of 6-hydroxybenzomorpholine of formula (II)) and thus read on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 20-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/257,841(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims recite at least one oxidation coupler chosen from 2-amino-5-ethylphenol of formula (II), addition salts thereof, solvates thereof, solvates of its salts thereof, or mixtures of two or more thereof.
However, Agostino discloses non-diluted and diluted hair colouring compositions that include a dye component comprising at least one oxidative dye precursor and/or an alkalizing agent. Oxidative dye precursors are usually classified either as primary intermediates (also known as developers) or couplers (also known as secondary intermediates. Various couplers may be used with primary intermediates in order to obtain different shades. Suitable couplers include, but are not limited to 6-hydroxybenzomorpholine, 2-amino-5-ethylphenol, hydroxyethyl-3,4-methylenedioxyaniline, and mixtures thereof ([0032]). The hair colouring compositions invention may contain a chelant. The presence of redox metals such as copper, iron, and calcium in tap water used by consumers, may affect the color chemistry of oxidative hair dyes. The presence of chelants may limit this effect ([0040]). Chelants include N,N-Dicarboxymethyl-L-glutamic acid ([0046]).
Generally, 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. The copending claims disclose wherein the composition comprises oxidation couplers. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 2-amino-5-ethylphenol of formula (II) into the composition of the pending claims since it is a known and effective oxidation coupler as taught by Agostino.
Claims 20-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. US 12,290,586 B2 in view of Agostino et al., (US 2013/0220358 A1, Aug. 29, 2013) (hereinafter Agostino). Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims recite at least one oxidation coupler chosen from 2-amino-5-ethylphenol of formula (II), addition salts thereof, solvates thereof, solvates of its salts thereof, or mixtures of two or more thereof and one or more compounds chosen from N,N-dicarboxymethylglutamic acid, its salts and mixtures thereof.
However, Agostino discloses non-diluted and diluted hair colouring compositions that include a dye component comprising at least one oxidative dye precursor and/or an alkalizing agent. Oxidative dye precursors are usually classified either as primary intermediates (also known as developers) or couplers (also known as secondary intermediates. Various couplers may be used with primary intermediates in order to obtain different shades. Suitable couplers include, but are not limited to 6-hydroxybenzomorpholine, 2-amino-5-ethylphenol, hydroxyethyl-3,4-methylenedioxyaniline, and mixtures thereof ([0032]). The hair colouring compositions invention may contain a chelant. The presence of redox metals such as copper, iron, and calcium in tap water used by consumers, may affect the color chemistry of oxidative hair dyes. The presence of chelants may limit this effect ([0040]). Chelants include N,N-Dicarboxymethyl-L-glutamic acid ([0046]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to formulate the pending claims to comprise one or more compounds chosen from N,N-dicarboxymethylglutamic acid, its salts and mixtures thereof because the presence of chelants in hair colouring compositions may limit the effect of redox metals in the color chemistry of oxidative hair dyes, as taught by Agostino.
Generally, 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. The copending claims disclose wherein the composition comprises oxidation couplers. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 2-amino-5-ethylphenol of formula (II) into the composition of the pending claims since it is a known and effective oxidation coupler as taught by Agostino.
Response to Applicant’s Arguments
Applicant requests that the double patenting rejections be held in abeyance until allowable subject matter is indicated, at which time applicant will consider the propriety of filing a Terminal Disclaimer.
Applicant’s argument has been fully considered but found not to be persuasive since an appropriate terminal disclaimer has not been filed at this time.
For the foregoing reasons the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.J.K./Examiner, Art Unit 1614
/TRACY LIU/Primary Examiner, Art Unit 1614