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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/05/2026 has been entered.
Response to Amendment
The response filed 06/05/2026 has been entered. Applicant’s response is in response to in the Final Office Action mailed 02/05/2026 (note the new Examiner for this Application, where continuity of rationale will continue as much as possible, but style may slightly differ due to process specific practices). Furthermore, with regard to the approach to the Application within this Office Action, “there is nothing unusual, certainly, about an examiner changing his viewpoint as to the patentability of claims as the prosecution of a case progresses, and so long as the rules of Patent Office practice are duly complied with an applicant has no legal ground for complaint because of such change in view. The life of a patent solicitor has always been a hard one. In re Ruschig, 154 USPQ 118, 120-21 (CCPA 1967).” In this case, the difference in search and interpretation of the Prior Art has led to a modified approach to the instant claim set, while attempting to be consistent with the previous round of prosecution.
Applicant’s claims have been amended in the following manner: the instant claim set has not been amended compared to the previous claim set. However, a new reference of Tom Thumb is incorporated to address the unexpected result argument and provide a new ground of rejection. Furthermore, new ODP rejections are founded on the basis of the discovery of related patents.
The following objections/rejections are withdrawn: none.
The Examiner further acknowledges the following:
Claims 20-39 are pending.
Claims 20-39 are presented for examination and rejected as set forth below.
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 20-39 are rejected under 35 U.S.C. 103 as being unpatentable over Agostino (US 2013/0220358 A1), as evidenced by PubChem (2026).
Applicant’s claims are directed to a composition comprising: a first oxidation coupler chosen from hydroxyethyl-3,4-methylenedioxyaniline of formula (I) and a second oxidation coupler different from the first oxidation coupler and chosen from 2-amino-5-ethylphenol of formula (II), and at least at least one compound chosen from N,N-dicarboxymethyl glutamic acid. Note that the “first” and “second” are not interpreted in a manner of order of addition, because the there is no instruction to consider it in this manner, in a product-by-process interpretation.
Agostino teaches hair dye compositions and methods, comprising oxidative dye primary intermediates and couplers (in the free bases or salt form) [0032], that produce different color shades and intensity of dyed hair [0032, 0115-0131].
Regarding claim 20: Agostino teaches hair dye compositions comprising the oxidative dye precursor 2-(benzo[d][1,3]dioxol-5-ylamino)ethanol (also known as hydroxyethyl-3,4-methylenedioxyaniline, as evidenced by entry #20 of PubChem) (reads on formula I) [0032] and 2-amino-5-ethylphenol (reads on formula II) [0032], and N,N-Dicarboxymethyl-L-glutamic acid (aka GLDA) [0046].
Regarding claims 21-22 and 26: Agostino teaches 0.1% to 10% oxidative dye precursors, whereby the oxidative dye precursors are known as primary intermediates and/or couplers [0032], and various couplers can be used with primary intermediates to obtain different shades (i.e., providing motivation to combine two oxidative dyes in a method of hair dyeing) [0032], including non-vibrant (i.e., duller) shades including blonde, brown, black [0025], or alternately vibrant shades including red, violet, copper. Because the total amount of dyes ranges up to 12%, the use of each dye in the instant ratios is obvious [0032].
Regarding claims 23-25: Agostino names ortho- or para-phenylenediamines [0032], ortho- or para-aminophenols, etc. [0032], in 0.1% to 10% [0032].
Regarding claims 27-28: Agostino teaches N,N-Dicarboxymethyl-L-glutamic acid (aka GLDA) [0046], as a chelant in an amount of 0.01% to 5% [0040].
Regarding claims 29-31: Agostino teaches diluent fatty alcohols (reads on liquid and/or solid fatty substances, because the Art recognizes fatty alcohols as liquid or solid at room temperature, depending on carbon structure, unsaturation, branching, etc.) [0035].
Regarding claims 32-33: Agostino teaches surfactants [0035], including anionic or nonionic [0071].
Regarding claims 34-35: Agostino teaches bases, as buffering agents or pH modifiers [0039]. Agostino teaches monoethanolamine, 2-amino-2-methyl-1-propanol, etc., which are alkanolamines [0039].
Regarding claims 36-37: Agostino teaches an oxidizing agent (Agostino – claim 1). In a separate embodiment, Agostino also teaches “the non-diluted and diluted hair coloring compositions of the invention may comprise air oxidation or auto oxidation hair colorants”, and therefore would not require an oxidizing agent in this case (instant claim 36).
Regarding claims 38-39: Agostino teaches a kit carrying all required hair coloring components previously described above [0094-0113]. The kit describes an instruction method for dyeing hairs ([0107], Agostino – claims 1 and 14)).
In summary, Agostino teaches the elements and desirability for the components for the instant composition (and methods/kits), as described above, and thus, its obviousness. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Thus, Agostino teaches the combination of art-known elements (i.e., hair dye components) according to their disclosed beneficial properties (i.e., dying hair different shades and intensities) with the resultant product nothing more than one would expect from their combination (i.e., dyed hair).
Claims 20-39 are rejected under 35 U.S.C. 103 as being unpatentable over Agostino (US 2013/0220358 A1), as evidenced by PubChem (2026), as applied to claims 20-39, and in further view of Tom Thumb (2019).
As discussed above, Agostino teaches the obviousness of the instant composition.
Tom Thumb further provides a specific composition/kit/method embodiment (i.e., Clairol’s Nice N Easy hair coloring product), where the two instant dyes (hydroxyethyl-3,4-methylenedioxyaniline and 2-amino-5-ethylphenol) are combined with a chelant (i.e., trisodium ethylenediamine disuccinate, which is functionally equivalent to the instant N,N-Dicarboxymethyl-L-glutamic acid (GLDA); see Agostino at [0040-0046] for a discussion of chelants and functionally-equivalent chelant species) to demonstrate beneficial hair dyeing (pg 2-3). Tom Thumb shows a visual demonstration of hair coloring uniformity (i.e., so much so that the product is commercially for sale), and also describes excellent blending of complementary tones (pg 2-3).
Thus, Tom Thumb demonstrates an embodiment that specifically pairs the two instant oxidation couplers, rendering their combination for hair dyeing as obvious.
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 coloring 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 coloring 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 20-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over the below patents, in view of Agostino (US 2013/0220358 A1) and Tom Thumb (2019):
Claims 1-20 of US11213471B2
Claims 1-14 of US11324682B2
Claims 1-20 of US11730688B2
Claims 1-19 of US12290586B2
Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims recite 2-amino-5-ethylphenol or hydroxyethyl-3,4-methylenedioxyaniline, as an oxidation dye (i.e., intermediate and/or coupler) for hair fibers.
However, Agostino discloses non-diluted and diluted hair coloring 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 coloring 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]).
Tom Thumb further provides a specific embodiment, where the two instant dyes (hydroxyethyl-3,4-methylenedioxyaniline and 2-amino-5-ethylphenol ) are combined with a chelant to demonstrate uniform hair coloring, as shown in the reference images (pg 2-3.
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 coloring compositions may limit the effect of redox metals in the color chemistry of oxidative hair dyes, as taught by Agostino and Tom Thumb.
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 and Tom Thumb.
Response to Arguments
Applicants arguments, see pg 7-17, filed 06/05/2026, with respect to the 103 rejection of claims 20-39 under rejection have been fully considered, but they are not persuasive. The 103 rejection has been modified with respect to the arguments made (especially, where Applicant clarifies the proposed unexpected results).
On page 8-9, Applicant argues that the results of the instant invention are not predictable, thereby requesting withdrawal of the obviousness rejection. Note that: with regard to reasonable expectation of success: “Applicants are reminded that obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness).” Furthermore, in terms of obviousness, Applicant has not provided evidence that unpredictability of the art to challenge the obviousness of the modification. Finally, the art teaches the elements and motivations for combining the instant claim limitations (especially, the two instant dyes and the chelant of instant claim 20).
On page 9-10, Applicant argues that the combination of ingredients applied in the obviousness analysis is pulled from various lists/locations of the references. In the case obviousness: it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985). Thus, the appropriate rationale for combining and arriving at the instant embodiment is made obvious by the rationale of the 103 rejection above.
On page 10-12, Applicant argues on the proper interpretation of the unexpected results, stating that the oxidative dye combination results in more uniform coloration across the hair strand. The rationale for the unexpected effect of a resulting “more selective” hair coloration (i.e., more homogeneous or uniform hair coloration across the strand), that is based on the combination of the instant “first” and “second” oxidation couplers of claim 20, is not persuasive.
With regard to this, Tom Thumb (2019) teaches Clairol’s Nice N Easy hair coloring product, which contains a hair coloring composition that incorporates the combination of 2-Amino-5-Ethylphenol HCl (i.e., the instant “second” oxidation coupler of claim 20) and Hydroxyethyl-3,4-Methylenedioxyaniline HCl (i.e., the instant “first” oxidation coupler of claim 20) (plus a chelator of trisodium ethylenediamine disuccinate, which is functionally equivalent to the instant N,N-Dicarboxymethyl-L-glutamic acid (GLDA); see Agostino at [0040-0046] for a discussion of chelants and functionally-equivalent chelant species) into the permanent color cream (i.e., analogous to Applicant’s kit comprising a first compartment containing the two instant dyes in claim 39).
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The Nice N Easy hair coloring product demonstrates uniform hair coloring on the back of the package (see below).
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Thus, the combination of the instant “first” and “second” oxidation couplers of claim 20, is expected to produce uniform coloration, as demonstrated by Tom Thumb. Note, that “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property, which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In this case, the Applicant demonstrates a measurable uniformity of the oxidative dye combination, whereby the hair dye combination has already been used in a hair coloring product by Clairol, and Tom Thumb shows a visual demonstration of hair coloring uniformity (i.e., so much so that the product is commercially for sale), and also describes excellent blending of complementary tones (pg 2-3). Without further clarification, the arguments related to an unexpected result against the Prior Art are not persuasive.
On page 12-15, Applicant discusses the meaning of the delta E “selectivity”, which is now better understood by the Office, and addressed in the section above, on the basis of the Tom Thumb reference.
On page 15-16, Applicant argues that the claims are commensurate in scope with the data demonstrating unexpected results. Additionally, Applicant argues that different salt forms and/or pH do not affect final color produced by the composition, because of the equilibration of species. The Examiner generally agrees with Applicant’s logic, regarding salt forms and/or pH, in relation to coloration performance.
However, Applicant’s data is still not persuasive in light of the Tom Thumb reference teachings, and the discussion above. Tom Thumb teaches the Clairol Nice N Easy embodiment combining the two critical instant oxidation dyes (i.e., 2-Amino-5-Ethylphenol HCl and Hydroxyethyl-3,4-Methylenedioxyaniline HCl) that would expectedly demonstrate the improved color homogeneity property discussed by Applicant (as demonstrated in the visual results of hair by Tom Thumb), rendering this argument about salt forms and/or pH moot. Furthermore, Tom Thumb teaches the Clairol Nice N Easy that incorporates a chelant (i.e., trisodium ethylenediamine disuccinate, which is functionally equivalent to the instant N,N-Dicarboxymethyl-L-glutamic acid (GLDA) of claim 20; see Agostino at [0040-0046] for a discussion of chelants and functionally-equivalent chelant species) to demonstrate beneficial hair dyeing (pg 2-3). Thus, a PHOSITA would expect the color homogeneity resulting from the combination of ingredients of instant claim 20, to be similar to the Clairol Nice N Easy embodiment of the Tom Thumb reference.
On page 16, Applicant concludes. However, the claims remain under rejection.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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/R.P./Examiner, Art Unit 1614 7/27/2026
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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