DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Status
Claims 1-20 are pending and under current examination in this application.
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 1-3, 5-12, and 14-19 are rejected under 35 U.S.C. § 103 as being unpatentable over Cannell et al. (US-20080085249-A1; published 10 April 2008, hereinafter referred to as “Cannell”) in view of Emiko et al. (JP-4592095-B2; published 01 December 2010, hereinafter referred to as “Emiko”).
Cannell teaches a hair color-removing composition formed by combining a first composition containing a sulfur reducing agent and a second composition containing an oxidizing agent (¶[0005], ¶[0007], ¶[0017], ¶[0029], and ¶[0041]). Specifically, Cannell discloses that acceptable sulfur reducing agents include thiolactic acid and thiosalicylic acid, as per the limitations of instant claims 2, 11, and 19 (¶[0019]). Furthermore, the reference teaches that water is a primary solvent, satisfying the at least one solvent limitation of instant claims 1, 10 and 19 (¶[0040] and the water content in ¶[0057], Examples A-D). Cannell discloses the addition of anionic surfactants in the composition (¶[0037]-[0039]; see also ¶[0057], Example A, which includes the anionic surfactant sodium C14-16 olefin sulfonate), as per the limitation of instant claim 8, and includes the organic amine monoethanolamine (¶[0024], and ¶[0057], Examples A-C). These additional components are conventional in hair compositions and would be obvious to include for formulation stability and wetting.
Cannell also discloses that the pH of the final color-removing composition is between 0-5 (¶[0042]). Overlapping with the pH range of about 1-6 of instant claims 9 and 19. In the absence of evidence of criticality or unexpected results at the instant claimed pH range of 6, adjusting the pH to the ranges of the instant claims is considered obvious from the teachings of Cannell. Cannell further teaches methods of using the composition to remove artificial (oxidative) dye from hair, as recited in instant claims 10 and 18 (¶[0047] and ¶[0048]). The method step of applying the composition for a period of time of at least 5 minutes is taught in ¶[0053], encompassing the instant claim 17 range of about 5-45 minutes.
The weight percentage ranges for the hair-color removing agent (i.e., sulfur reducing agent) as claimed in instant claims 3 and 12 are not explicitly listed by Cannell. However, Cannell teaches that the sulfur reducing agent can be present in the first composition in amounts from about 1-90%, and that in the final mixed composition, the amount is about half of the individual composition ranges, placing the final mixture's reducing agent content within a broad range that overlaps with or encompasses the instant claimed range of about 0.5-20% (¶[0023] and ¶[0045]). Cannell also teaches the use of thiolactic acid in compositions at 4-15% in Example C and 3.75% in Example A (¶[0057]), which is within the instant claim 19 range of from about 1-15% by weight, relative to the total weight of the composition. Determining an appropriate and effective concentration range for an active agent within this broad effective range provided by Cannell is thus a matter of routine optimization within the ordinary skill of a formulator in the art.
Cannell states that its compositions can contain a wide variety of optional additives as, “…can also comprise any additive usually used in the field under consideration”, including moisturizers and cosmetic and dermatological active agents, referencing U.S. patent application publication no. 20040170586 (¶[0033]), which states additional additive ingredients be found in the International Cosmetic Ingredient Dictionary and Handbook (9th ed. 2002) (US20040170586A1, ¶[0455]), wherein these substances may be selected variously by the person skilled in the art and the amount thereof, in order to prepare a composition which has the desired properties, for example, consistency or texture (US20040170586A1, ¶[0456] and ¶[0458]) and wherein, “These additives may be present in the composition in a proportion from 0% to 20% (such as from 0.01% to 20%) relative to the total weight of the composition…” (US20040170586A1, ¶[0458]). Hyaluronic acid is a well-known and conventional moisturizing agent and cosmetic active in hair care compositions and The International Cosmetic Ingredient Dictionary and Handbook (9th ed., 2002) certainly includes entries for the widely recognized cosmetic humectant and viscosity-increasing agent hyaluronic acid (page 706, Section 3; hyaluronic acid is listed with its primary function as a skin-conditioning agent) and sodium hyaluronate (page 1336, Section 3). However, Cannell does not explicitly disclose the inclusion of hyaluronic acid or a salt thereof in its hair color-removing compositions.
Instant claims 5 and 14 also require a range of about 0.1-10 wt. % of the total composition as hyaluronic acid. Determining an effective and safe concentration range for such a conventional moisturizer additive, such as hyaluronic acid, from the 0-20% range taught by the reference citation is a matter of routine experimentation within the ordinary skill of a formulator. Furthermore, the instant claimed range is conventional for such cosmetic moisturizers and does not represent an inventive step over Cannell which includes the addition of such optional components. One of ordinary skill in the art would have been able to arrive at these conventional ranges through routine optimization to achieve the desired conditioning effect. Inclusion of hyaluronic acid to provide a moisturizing or conditioning benefit within the instant claimed range would have been an obvious and predictable modification to the color-removing composition taught by Cannell.
Emiko is directed to hair color and removal compositions (left on for 5-30 minutes; page 2, last 2 lines). It teaches the use of hair treatment agents, like humectants, and establishes hyaluronic acid as a conventional moisturizing and conditioning agent known in the art and used in hair care compositions, such as the hair color and removal compositions of Emiko (page 3, lines 2 and lines 5-6).
Emiko also clearly provides the motivation to include conventional hair treatment moisturizing and aesthetic-improving agents in other hair color and removal compositions, such as that of Cannell, by stating, “However, the hair decoloring agent…there is a concern about hair damage…and there is also a risk of hair damage…There's a problem.” (page 1, last 3 lines- page 2, first 2 lines). To mitigate this problem, Emiko teaches the optional use of various humectants, including hyaluronic acid, to improve aesthetics by providing hydration and reducing damage perception.
It would have been prima facie obvious to one of ordinary skill in the art in the art at the time of the invention seeking to improve the conditioning properties or mitigate potential dryness from the chemical treatment or reduce potential hair damage from a color-removing treatment, such as that of Cannell, to incorporate the common effective cosmetic moisturizer hyaluronic acid. There is a reasonable expectation that adding this common cosmetic ingredient would successfully provide a conditioning benefit. Therefore, modifying the color-removing composition of Cannell by adding hyaluronic acid or its salt as a moisturizing agent to provide improved moisturization and conditioning benefits, as taught by the Emiko, to arrive at the instant invention as claimed without inventive ingenuity.
The combination of a known hair-color removing agent and hyaluronic acid would have been a predictable use of these materials within the art because hyaluronic acid was widely used for conditioning/feel in hair compositions. Further, the inclusion of all other well-known, conventional hair care ingredients at standard concentration ranges claimed for the instant invention would itself have been obvious to one of ordinary skill in the art seeking to formulate a stable, usable, and aesthetically pleasing product. A person of ordinary skill would have had a reasonable expectation of success in combining these known elements to achieve predictable results.
Claims 1, 4, 10, 13, 19 and 20 are rejected under 35 U.S.C. § 103 as being unpatentable over Cannell et al. (US-20080085249-A1; published 10 April 2008, hereinafter referred to as “Cannell”) in view of Emiko et al. (JP-4592095-B2; published 01 December 2010, hereinafter referred to as “Emiko”) and in further view of Asada (US-20090276964-A1; published 12 November 2009).
Cannell and Emiko teach the limitations of instant claims 1, 10 and 19, as described above, from which instant claims 4, 13 and 20 depend, respectively, however do not explicitly teach the composition comprising at least one keto acid and/or salt thereof ranging from about 0.1-20% by weight, relative to the total weight of the composition.
Cannell states that its compositions can contain a wide variety of optional additives as, “…can also comprise any additive usually used in the field under consideration”, referencing U.S. patent application publication no. 20040170586 (¶[0033]), which states additional additive ingredients be found in the International Cosmetic Ingredient Dictionary and Handbook (9th ed. 2002) (US20040170586A1, ¶[0455]), wherein these substances may be selected variously by the person skilled in the art and the amount thereof, in order to prepare a composition which has the desired properties, for example, consistency or texture (US20040170586A1, ¶[0456] and ¶[0458]) and wherein, “These additives may be present in the composition in a proportion from 0% to 20% (such as from 0.01% to 20%) relative to the total weight of the composition…” (US20040170586A1, ¶[0458]). The International Cosmetic Ingredient Dictionary and Handbook (9th ed., 2002) includes entries for keto acids such as pyruvic acid, (page 1268, section 3; pyruvic acid is listed as an ingredient functioning as a buffering agent and skin-conditioning agent; in addition to lactic acid, etc.) used in cosmetic formulations, thus effectively teaching the limitations of instant claims 4, 13, 19 and 20.
In addition, keto acids, such as α-oxocarboxylic acid, is disclosed by Asada as known to be used in dye remover composition to prevent the discoloration the hair due to air oxidation after the destaining treatment (¶[002]. The reference teaches this as a known solution to a known problem of post-treatment discoloration in the field of color removal.
Instant claim 20 recites a composition containing a keto acid and an organic amine, which is a combination of two optional ingredients each individually suggested by the prior art, and their combination is merely the predictable result of routine formulation.
It would have been obvious to a person of ordinary skill, aware of the problem of hair discoloration after color stripping, to incorporate the known solution of using a keto acid as taught by Asada into the obvious color-removing composition of the Cannell and Emiko to prevent this undesirable side effect. The inclusion of a keto acid and the determination of a workable concentration range for it, constitutes routine formulation activity. The instant claimed concentration ranges for the keto acid of about 0.1-20% are typical and would be reached through routine optimization, particularly given this exact range is specifically specified in the specification reference cited by Cannell (i.e., US-20040170586-A1, ¶[0458]). There is no evidence that the specific inclusion of a keto acid, within the claimed broad range, imparts any unexpected or non-obvious property to the composition. Therefore, it would have been obvious to include such as an optional ingredient.
Claim Rejections – Nonstatutory 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).
Claims 1-20 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of co-pending US Application No. 18/084,396, claims 1-20 of co-pending US Application No. 18/084,403, claims 1-20 of co-pending US Application No. 18/084,404, claims 1-20 of co-pending US Application No. 18/084,402, claims 1-20 of co-pending US Application No. 18/626,294, claims 1-20 of co-pending US Application No. 18/626,306, claims 1-20 of co-pending US Application No. 18/626,281, claims 1-20 of co-pending US Application No. 18/626,290, claims 1-20 of co-pending US Application No. 18/626,300, claims 1-20 of co-pending US Application No. US18/626,307, and claims 1-20 of co-pending US Application No. 18/626,312. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are also rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of US Patent Application No. 17/936,431.
Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlines below.
All of these rejections stem from an equivalent single common inventive concept that the assignee is attempting to patent multiple times with minor variations. The core of the single common inventive concept is an acidic (i.e., pH 1-6), aqueous (i.e., solvent as water or aqueous vehicles) artificial or oxidative hair dye removing cosmetic composition based on a defined set of thiol-based reducing agents, specifically thiosalicylic and/or thiolactic acid. The listed co-pending applications and patent claim a variation of this single common core inventive concept and discloses and claims species within the single common inventive concept. The instant application and co-pending applications or patent attempt to claim multiple obvious variants of single common core inventive concept already claimed by the common assignee. Allowing these claims would permit an unjustified extension of the patent term for what is, in substance, a single core invention in the same field, for the same purpose with an identical inventive concept.
The instant application claims would have been obvious if the co-pending applications or patent were prior art. The primary point of distinction of the instant application from the cited co-pending application and patent references is the explicit recitation of hyaluronic acid or a salt thereof. However, hyaluronic acid is a well-known cosmetic polymer and conditioning agent, routinely employed in hair and skin compositions for moisturizing and feel benefits. Its inclusion represents a predictable substitution or addition of a known cosmetic excipient to an otherwise unchanged hair-color removal composition. The differences between the instant claims and the cited references are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art of cosmetic chemistry. The substitution or addition of hyaluronic acid, a well-known conditioning, hydrating, and stabilizing agent, to the previously invented thiol-based color-removing systems represents an obvious variation that does not produce a patentably distinct invention.
Variations in inclusion of optional/additional conventional cosmetic auxiliaries (e.g., surfactants, organic amines, organic acids, Lewis acids, amino acids, keto acids, fatty compounds, amino-sulfonic acids, thickening agents, chelators, emulsifiers, clays, etc.), concentration ranges and species optimizations of the broader hair-color removing composition are features that are expressly disclosed, inherently suggested or obvious variants of the single inventive concept directed to hair-color removal using thiol-based reducing systems formulated as cosmetic compositions in the cited co-pending applications and patent references and represent routine optimization or formulation choices that would have been obvious to a person of ordinary skill in the art. The method claims merely apply the non-patentably distinct compositions and include identical or substantially identical methods to the co-pending application and patent references (e.g., a method for removing artificial or oxidative hair color by applying such compositions to keratinous hair fibers, optionally allowing a residence time and rinsing). These claims do not impart patentable distinctness over the cited co-pending applications and patent reference inventions.
To overcome this rejection, the Applicant may file a terminal disclaimer in compliance with 37 C.F.R. § 1.321, disclaiming any patent term extending beyond the expiration of the earlier patent(s) and agreeing to common ownership for the life of the patent, amend the claims to establish patentable distinctness over the cited references, or provide arguments that defeat the central premise of the rejection, proving that the requirement for hyaluronic acid transforms the core invention in a non-obvious and unexpected way that is not simply a variation specifying a specific composition constituent (e.g., chelators, emulsifiers, Lewis acids, or amino acids) (e.g., technical argument about hyaluronic acid's unique, non-obvious mechanism in this context and comparative experimental data showing the instant composition's unexpected and superior properties versus all of the cited species (thiol acid alone, thiol acid + chelator, thiol acid + emulsion, etc.).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615