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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 07, 2025 has been entered.
Formal Matters
Applicant’s remarks along with the DECLARATION UNDER 37 CFR 1.132 by Jennifer Marsh filed on October 07, 2025 have been fully considered due to the entered request for continued examination. Claims 1-11 are pending. Claims 1-11 are under examination in the instant office action. Applicant’s arguments did not overcome the rejections set forth in the previous office action under 35 USC 103 for reasons set forth in the previous office action and herein below.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
Rejections Maintained
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-7 and 9-11 remain rejected under 35 U.S.C. 103 as being unpatentable over O’Toole (US Patent No. 7300647, IDS reference) in view of Johnson et al. (US 2006/0269501, IDS reference) and as evidenced by Sarkar et al. (Journal of Biological Chemistry, 242, 5572-5577, 1967, IDS reference) and as evidenced by Mandecki (US 4936963, previously cited).
Applicants’ claims
Applicants claim a shampoo composition and a method of inhibiting copper deposition.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
O’Toole teaches applying to the hair a hair care composition (method of use), rinsing the composition from the hair, the use of a hair conditioning compositions such as rinse-off, leave-on, or heat activated products (Col. 1 lines 2-4, and 17-21), wherein the hair care composition comprises by weight: (i) from about 0.025% to about 0.25% histidine, furthermore 0.05% to about 0.2%, and even further 0.1% to 0.15% histidine (Col. 2 66-69, Col. 25 Ex. 1); (ii) from about 2% to about 50% of one or more detersive surfactants (Col. 13 lines 30-35, 44-47). Surfactant systems useful herein can comprise one or more surfactants selected from anionic surfactants, amphoteric surfactants, nonionic surfactants, cationic surfactants and mixtures thereof and specifically for detersive anionic surfactants see column 14 and 15.; and (iii) from about 20% to about 95% of a first aqueous carrier (Col. 24 lines 38-42). O’Toole et al., also discloses a hair care composition comprising (ii) a conditioner gel matrix comprising: (1) from about 0.1% to about 20% of one or more high melting point fatty compounds (Col. 24 lines 25-33); (2) from about 0.1% to about 10% of a cationic surfactant system (Col. 13 lines 30-35, 44-47); and (3) at least 20% of a second aqueous carrier (Col. 24 line 38-42, 47). O’Toole further teaches the composition of the present invention will also preferably comprise water. When present water will generally comprise from about 25% to about 99%, preferably from about 50% to about 98%, by weight of the total composition (Col. 24 lines 38-42).
The hair care composition of the present invention may optionally comprise one or more additional benefit agents suitable for rendering the present composition more cosmetically or aesthetically acceptable or to provide them with additional usage benefits. Such conventional optional ingredients are well-known to those skilled in the art (Col. 6 lines 36-42). These include: any cosmetically acceptable ingredients such as those found in the CFTA International Cosmetic Ingredient Dictionary and Handbook. Examples of optional ingredients include: other amino acids/peptides (Col. 6 line 50), conditioning agents (silicone conditioning agents (Col. 7 line 18), cationic conditioning agents (Col. 10 line 55), quaternary ammonium compounds (Col. 13 lines 10-16), perfumes, coloring agents such as any of the FD&C or D&C dyes, bleaching agents such as hydrogen peroxide, perborate and persulfate salts, anti-dandruff agents such as zinc pyrithion (ZPT), sulfur, and selenium sulfide, and anti-microbial agents such as ketoconazole and climbazole (Col. 24 lines 61-69). O’Toole et al., teaches the use of a hair care composition to improve the strength and condition of hair. In addition, O’Toole et al., teaches a hair care composition with the same elements of the shampoo composition to include histidine (Col. 1 66-69), one or more detersive surfactants (Col. 13 lines 44-47, 60-68), and a first aqueous carrier (Col. 24 lines 38-42). O’Toole also contains the elements making up the conditioner composition to include histidine, and the ingredients comprising a gel matrix: high melting point fatty compounds, a cationic surfactant system, and an aqueous carrier. The compositions of the present invention may optionally comprise a cationic conditioning component. The cationic conditioning component may comprise any suitable cationic conditioning agent or mixtures of cationic conditioning agents. Preferred cationic conditioning agents for use herein include, but are not limited to, polymeric cationic conditioning agents. Preferably the cationic polymer conditioning agent will preferably be water soluble. The total level of cationic polymers in the compositions of the present invention is typically from about 0.001% to about 20%, more typically from about 0.005% to about 10%, preferably from about 0.01% to about 2%, by weight (column 10, lines 57-67, column 11, lines 1-65, column 12 lines 1-65, and column 13 lines 1-29). ). Suitable cationic hair conditioning polymers include, for example: polymeric quaternary ammonium salt of hydroxyethylcellulose (referred to in the industry by the Cosmetic, Toiletry, and Fragrance Association, “CTFA”, as Polyquaternium-10), such as those commercially available from Amerchol under the tradename UCARE Polymer JR-30M; copolymers of hydroxyethylcellulose and diallyldimethyl ammonium chloride (referred to in the industry by the Cosmetic, Toiletry, and Fragrance Association, “CTFA”, as Polyquaternium-4), such as those commercially available from National Starch under the tradename Celquat L-200 and Celquat H-100; copolymers of 1-vinyl-2-pyrrolidone and 1-vinyl-3-methylimidazolium salt (e.g., chloride salt) (referred to in the industry by the Cosmetic, Toiletry, and Fragrance Association, “CTFA”, as Polyquaternium-16), such as those commercially available from BASF Wyandotte Corp. (Parsippany, N.J., USA) under the LUVIQUAT tradename (e.g., LUVIQUAT FC 370); copolymers of 1-vinyl-2-pyrrolidone and dimethylaminoethyl methacrylate (referred to in the industry by CTFA as Polyquaternium-11) such as those commercially available from Gaf Corporation (Wayne, N.J., USA) under the GAFQUAT tradename (e.g., GAFQUAT 755N); cationic diallyl quaternary ammonium-containing polymers, including, for example, dimethyldiallylammonium chloride homopolymer and copolymers of acrylamide and dimethyldiallylammonium chloride, referred to in the industry (CTFA) as Polyquaternium 6 and Polyquaternium 7, respectively; and mineral acid salts of amino-alkyl esters of homo- and co-polymers of unsaturated carboxylic acids having from 3 to 5 carbon atoms, as described in U.S. Pat. No. 4,009,256 (column 13, lines 37-65). A wide variety of additional ingredients can be formulated into the present composition. These include: other hair conditioning ingredients such as panthenol, pantethine, pantotheine, panthenyl ethyl ether, and combinations thereof; other solvents such as hexylene glycol; hair-hold polymers such as those described in WO-A-94/08557; viscosity modifiers and suspending agents such as xanthan gum, guar gum, hydroxyethyl cellulose, triethanolamine, methyl cellulose, starch and starch derivatives; viscosity modifiers such as methanolamides of long chain fatty acids such as cocomonoethanol amide; crystalline suspending agents; pearlescent aids such as ethylene glycol distearate; opacifiers such as polystyrene; preservatives such as phenoxyethanol, benzyl alcohol, methyl paraben, propyl paraben, imidazolidinyl urea and the hydantoins; polyvinyl alcohol; ethyl alcohol; pH adjusting agents, such as lactic acid, citric acid, sodium citrate, succinic acid, phosphoric acid, sodium hydroxide, sodium carbonate; salts, in general, such as potassium acetate and sodium chloride; colouring agents, such as any of the FD&C or D&C dyes; hair oxidising (bleaching) agents, such as hydrogen peroxide, perborate and persulfate salts; hair reducing agents, such as the thioglycolates; perfumes; sequestering agents, such as disodium ethylenediamine tetra-acetate; anti-dandruff agents such as anti-dandruff agents such as zinc pyrithione (ZPT), sulfur, selenium sulfide, coal tar, piroctone olamine, ketoconazole, climbazole, salicylic acid; antioxidants/ultra violet filtering agents such as octylmethoxycinnamate, benzophenone-3 and DL-alpha tocopherol acetate and polymer plasticizing agents, such as glycerine, diisobutyl adipate, butyl stearate, and propylene glycol. Such optional ingredients generally are used individually at levels from about 0.001% to about 10.0%, preferably from about 0.05% to about 5.0% by weight of the composition (column 24 lines 43-67). Surfactant systems useful herein can comprise one or more surfactants selected from anionic surfactants, amphoteric surfactants, nonionic surfactants, cationic surfactants and mixtures thereof (see for list of amphoteric surfactant column 14 lines 44-67 and column 14 lines 1-33).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
O’Toole does not specifically teach the shampoo gel matrix as included in claim 1 and its contents. These deficiencies are cured by the teachings of Johnson et al.
Johnson et al. teach shampoo compositions comprise (a) from about 5% to about 50% of one or more detersive surfactants, by weight of the shampoo composition; (b) a dispersed gel network phase comprising, by weight of the shampoo composition, (i) at least about 0.05% of one or more fatty alcohols; (ii) at least about 0.01% of one or more secondary surfactants; and (iii) water; and (c) at least about 20% of an aqueous carrier, by weight of the shampoo composition; and, wherein the dispersed gel network phase has a melt transition temperature of at least about 38 oC. Recently, the use of shampoo compositions comprising a dispersed fatty alcohol gel network phase has been proposed to achieve improved wet feel and dry conditioning benefit while not interfering with cleansing efficacy (paragraph 0009). Johnson et al. also teach that shampoo compositions comprising a dispersed fatty alcohol gel network phase, wherein the dispersed fatty alcohol gel network phase has a melt transition temperature of at least about 38.degree. C., are most storage stable under standard physical stability protocols and surprisingly also deliver superior dry conditioning benefits versus shampoo compositions such as those disclosed as preferable and exemplified in Wells (paragraph 0010). The use of cetyl (16 C), stearyl (18), arachidyl (C20), and behenyl (C22) alcohols are exemplified in examples 8-14 meeting the limitations of claim 2.
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the hair care composition of O’Toole by incorporating a shampoo gel matrix as recited in claim 1 because Johnson et al. teach shampoo compositions comprise (a) from about 5% to about 50% of one or more detersive surfactants, by weight of the shampoo composition; (b) a dispersed gel network phase comprising, by weight of the shampoo composition, (i) at least about 0.05% of one or more fatty alcohols; (ii) at least about 0.01% of one or more secondary surfactants; and (iii) water; and (c) at least about 20% of an aqueous carrier, by weight of the shampoo composition; and, wherein the dispersed gel network phase has a melt transition temperature of at least about 38 oC. One of ordinary skill in the art would have been motivated to add the shampoo gel matrix in the shampoo composition of O’Toole because Johnson et al. teach that recently, the use of shampoo compositions comprising a dispersed fatty alcohol gel network phase has been proposed to achieve improved wet feel and dry conditioning benefit while not interfering with cleansing efficacy (paragraph 0009). Johnson et al. teach that shampoo compositions comprising a dispersed fatty alcohol gel network phase, wherein the dispersed fatty alcohol gel network phase has a melt transition temperature of at least about 38.degree. C., are most storage stable under standard physical stability protocols and surprisingly also deliver superior dry conditioning benefits versus shampoo compositions such as those disclosed as preferable and exemplified in Wells (paragraph 0010). A person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of O’Toole, and Johnson et al., because both references teach shampoo compositions containing similar ingredients. In the case where the claimed range of the amount of ingredients "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). Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are teach in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). With regard to the new limitation reciting the method of inhibiting copper deposition since the combination teachings of O’Toole, and Johnson et al., met the claimed structure of claim 1 inhibition of copper deposition would necessarily and innately happen. Furthermore, as it is conventionally known in the art histidine is a chelating agent for copper. The examiner to evidence that as in the previous application that went to the board provides Sarkar et al. (Journal of Biological Chemistry, 242, 5572-5577, 1967, IDS reference), asserting the fact that increased removal of copper from hair is well expected result given the teachings of the prior art reference Sarkar et al. The stability of histidine as a copper chelating agent was known before the effective filing date of the instant invention, as evidenced by Sarkar et al. (Introduction). With regard to the new claim amendment reciting a zwitterionic histidine compound, the examiner reminds Applicant that histidine at physiological pH is always zwitterionic as evidenced by Mandecki. Mandecki teaches in example 6 that Other polycationic compounds have been tested as buffer constituents for the improved resolution of DNA gels. A histidine molecule may assume one of two ionic forms at pH 7.6. Since the imidazole group has pKa =6.0, most histidine molecules in solution are zwitterions (NH3 + and COO-) with no net charge.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Toole (US Patent No. 7300647, IDS reference) in view of Johnson et al. (US 2006/0269501, IDS reference) and as evidenced by Sarkar et al. (Journal of Biological Chemistry, 242, 5572-5577, 1967, IDS reference) and as evidenced by Mandecki (US 4936963, previously cited) as applied to claims 1-7 and 9-11 above, and further in view of Dunlop et al., (US Patent No. 6451300, IDS reference).
Applicants’ claims
Applicants claim a shampoo composition and a method of inhibiting copper deposition.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
The teachings of O’Toole and Johnson et al. are described in detail as set forth above and are incorporated herein by reference.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
O’Toole does not specifically teach the pH of the claimed composition wherein the shampoo composition has a pH from about 5.25 to about 7 as recited in claim 8. This deficiency is cured by Dunlop et al.
Dunlop et al., teaches shampoo compositions that provide a combination of anti-dandruff efficacy and conditioning, and a method of cleansing and conditioning the hair which include applying to the hair and scalp an effective amount of said compositions. The anti-dandruff and conditioning shampoos comprise: (a) from about 5% to about 50%, by weight of the composition, of an anionic surfactant; (b) from about 0.01% to about 10%, by weight of the composition, of a non-volatile condition agent; (c) from about 0.1% to about 4%, by weight of the composition, of an anti-dandruff particulate; (d) from about 0.02% to about 5%, by weight of the composition, of at least one cationic polymer; from 0.005% to about 1.5%, by weight of the composition, of a polyalkylene glycol; and (f) water (abstract). Many of these compositions have been found to provide excellent hair cleansing and conditioning performance (Col. 1 lines 20-22). Dunlop et al., teaches the average molecular weight of cationic conditioning polymers suitable for use is typically from about 5,000 to about 10,000,000, preferably from about 100,000 to about 2,000,000, more preferably from about 200,000 to about 1,500,000, more preferably from about 250,000 to about 850,000, more preferably from about 350,000 to about 850,000, most preferably from about 350,000 to 500,000. The polymers have a cationic charge density typically from about 0.2 meq/g to about 7 meq/g, as measured at the pH of intended use of the shampoo composition. The pH of intended use of the shampoo composition typically ranges from about pH 3 to about pH 9, preferably from about pH 4 to about pH 7 (Col. 18 line 44-60).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the hair care compositions of O’Toole and Johnson et al. by preparing hair care compositions with pH ranges as recited in instant claim 8 because Dunlop et al. teaches hair conditioning shampoo compositions comprising substantially similar components to those of O’Toole to include anionic surfactants, conditioning agents, anti-dandruff particulates, cationic polymers, and water that (Col.1 lines 12-14). Dunlop et al. teaches that the cationic conditioning polymers agents have a charge density preferably from about 0.5 meq/g to about 0.9 meq/g as measured at the intended use of shampoo. Dunlop et al., teaches that the pH of intended use of the shampoo composition ranges from about 3 to a pH from about 9, preferably from about pH 4 to a pH from about 7 (Col. 18 line 44-60). One of ordinary skill in the art would have been motivated to alter the pH range of O’Toole to have a pH as recited because O’Toole also contains cationic polymers with a charge density preferably less than about 2.5meq/g at the pH of intended use of the shampoo composition and Dunlop et al., teaches that the pH of intended use for such a composition ranges from about pH 3 and about pH 9. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of O’Toole, Johnson et al. and Dunlop et al., because all of the references teach hair care compositions containing similar agents such as conditioning agents and cationic polymers and Dunlop et al. teaches a pH from about 3 to a pH of about 9 for hair care compositions is typically known to people skilled in the art. In the case where the claimed range of the amount of ingredients "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). Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are teach in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). With regard to the limitation reciting the method of inhibiting copper deposition since the combination teachings of O’Toole, Johnson et al., and Dunlop et al. met the claimed structure inhibition of copper deposition would necessarily and innately happen. Furthermore, as it is conventionally known in the art histidine is a chelating agent for copper. The examiner to evidence that as in the previous application that went to the board provides Sarkar et al. (Journal of Biological Chemistry, 242, 5572-5577, 1967, IDS reference), asserting the fact that increased removal of copper from hair is well expected result given the teachings of the prior art reference Sarkar et al. The stability of histidine as a copper chelating agent was known before the effective filing date of the instant invention, as evidenced by Sarkar et al. (Introduction). With regard to the limitation reciting a zwitterionic histidine compound, the examiner reminds Applicant that histidine at physiological pH is always zwitterionic as evidenced by Mandecki. Mandecki teaches in example 6 that Other polycationic compounds have been tested as buffer constituents for the improved resolution of DNA gels. A histidine molecule may assume one of two ionic forms at pH 7.6. Since the imidazole group has pKa =6.0, most histidine molecules in solution are zwitterions (NH3 + and COO-) with no net charge. Since the combination teachings of O’Toole, Johnson et al. and Dunlop et al. clearly teach a composition containing histidine at a physiological pH which will necessarily form a zwitterion.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Applicant’s Arguments
Applicant argues that O’ Toole simply presents a list of possible compounds that may be used as the “at least one other amino acid compound” of O’ Toole. Specifically, O’ Toole requires “at least one other amino acid compound selected from tryptophan compounds, histidine compounds and lysine compounds.” (O’ Toole, at Abstract; see also O’ Toole at 2:45-50). O’ Toole does not recognize the problem of copper content on the hair surface and in between the cuticle layers of hair. O’Toole further does not recognize any copper inhibition properties of the “at least one other amino acid compound” in the list of possible compounds.
The above assertions are not found persuasive because contrary to Applicant’s assertions O’Toole teaches applying to the hair a hair care composition (method of use), rinsing the composition from the hair, the use of a hair conditioning compositions such as rinse-off, leave-on, or heat activated products (Col. 1 lines 2-4, and 17-21), wherein the hair care composition comprises by weight: (i) from about 0.025% to about 0.25% histidine, furthermore 0.05% to about 0.2%, and even further 0.1% to 0.15% histidine (Col. 2 66-69, Col. 25 Ex. 1); (ii) from about 2% to about 50% of one or more detersive surfactants (Col. 13 lines 30-35, 44-47).
Applicants argue the subject Application discloses the unexpected results of combining histidine with a gel network to provide enhanced copper inhibition. As shown in Tables 2 and 3 of the subject Application, the combination of histidine and a gel matrix provided a statistically different copper inhibition result as compared to a simple surfactant, simple surfactant and just histidine, and a simple surfactant and just gel network. The subject Application at Tables 2 and 3 show the unexpected results. Applicants argue first, as clearly indicated in Table 3 of the Specification and Figure 1 and corresponding paragraph 15 of the Declaration of Jennifer Marsh (“Declaration”), gel network alone does provide copper inhibition benefits. Specifically, according to Figure 1 of the Declaration, copper levels in the hair dropped from 141.25 mg/g to 98.37 mg/g by adding a gel network to a simple surfactant shampoo. See Decl., at Fig. 1 Examples A and B; see also Decl. at 15. Therefore, it is not the histidine alone that provides copper inhibition performance. Second, Applicant respectfully submits that histidine is not a critical entity found in O’ Toole. Specifically, O’ Toole requires “a hair care composition comprising at least one tyrosine compound and at least one other amino acid compound selected from tryptophan compounds, histidine compounds, and lysine compounds.” (O’ Toole, at Abstract; see also O’ Toole at 2:45-50) (emphasis added). As such, the critical entities of O’ Toole are “at least one tyrosine compound and at least one other amino acid compound” and the “at least one other amino acid compound” could be tryptophan compounds, histidine compounds and/or lysine compounds. Id. Applicants argue Applicant respectfully submits that a person of skill in the art would not be motivated to combine O’ Toole with Johnson to arrive at claim 1. Specifically, a person of ordinary skill in the art cannot select any of the listed “at least one other amino acid compound[s]” from O’Toole and add the gel network from Johnson to arrive at claim 1. As shown in Figure 1, Examples A and C of the Declaration and discussed in corresponding paragraph 16, the addition of 0.1% lysine, a listed amino acid compound of O’Toole, to a simple shampoo composition increases the copper levels in the hair from 141.25 mg/g to 164.75 mg/g as compared to the copper levels in the hair of a simple shampoo composition alone. Further, even adding a gel network to a simple surfactant shampoo with 0.1% lysine increases the copper levels in the hair from 98.37 mg/g to 119.17 mg/g as compared to a shampoo with gel network alone. See Decl. at Figure 1, Examples B and D; see also Decl. at 16. As stated above, O’Toole fails to recognize the problem of copper levels in the hair. O’ Toole also fails to recognize the copper inhibition benefit that histidine provides or the increased copper levels that are present when lysine is added. Further, Johnson et al fails to recognize the problem of copper levels in the hair and the benefit of adding gel networks to simple shampoo compositions for copper inhibition. Since neither O’Toole nor Johnson recognize the problem of copper levels in hair, Applicant respectfully submits that a person of skill in the art would not have been motivated to modify O’ Toole by selecting only histidine from the list of possible amino acids then combine the modified O’Toole with the gel network of Johnson et al. to provide enhanced copper inhibition as claimed in the Subject Application. Thus, it is believed that independent claim 1, as well as dependent claims 2-7, 9-11 that depend therefrom are patentable under 35 U.S.C. 103 over O’ Toole in view of Johnson as evidenced by Sarkar and as evidenced by Mandecki and such indication is respectfully requested. On the contrary, evidence offered to rebut a prima facie case of obviousness need only be reasonably commensurate in scope with the claimed invention. MPEP 2145, citing, e.g., In re Kulling, 897 F.2d 1147, 1149 (Fed. Cir. 1990). The Office should not require the applicant to show unexpected results over the entire range of properties possessed by a composition. MPEP 2145, citing In re Chupp, 816 F.2d 643, 646 (Fed. Cir. 1987). An exemplary showing may be sufficient to establish a reasonable correlation between the showing and the entire scope of the claim, when viewed by a skilled artisan. MPEP 2145, citing, e.g., Chupp, 816 F.2d at 646. Applicant respectfully submits that, when viewed by a skilled artisan, the showing in Tables 2 and 3 on page 24 of the specification is reasonably commensurate in scope with the present claims. Therefore, Applicant respectfully submits that the evidence sufficiently rebuts a prima facie case of obviousness and requests that the rejection of claim 1 and its dependent claims be withdrawn.
The examiner from the data provided in the declaration do agree with applicant that a shampoo chassis with gel network show a decrease in copper levels in the hair. However, the claim is drawn to “A shampoo composition comprising:
a. about 0.025% to about 0.2% of a zwitterionic histidine compound, by
weight of the shampoo composition;
b. about 2% to about 50% of one or more detersive anionic surfactants, by
weight of the shampoo composition; and
c. a gel matrix comprising:
i. about 0.1% to about 20% of one or more fatty alcohols, by weight
of the gel matrix;
ii. about 0.1% to about 10% of one or more gel matrix surfactants, by
weight of the gel matrix; and
iii. about 20% to about 95% of an aqueous carrier, by weight of the gel
matrix;
wherein the shampoo composition inhibits copper deposition on hair and facilitates the removal of copper deposited on hair.” not to a shampoo chassis with a gel network. An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). "A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference." In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978) (emphasis in original). Where the comparison is not identical with the reference disclosure, deviations therefrom should be explained, In re Finley, 174 F.2d 130, 81 USPQ 383 (CCPA 1949), and if not explained should be noted and evaluated, and if significant, explanation should be required. In re Armstrong, 280 F.2d 132, 126 USPQ 281 (CCPA 1960) (deviations from example were inconsequential). The closest amino acid disclosed by O’ Toole to the instant invention is histidine which is recited in Applicant’s claim not lysine. It is unclear how the experiments related to lysine are applicable to the claims. Furthermore, it should be also clear that even though the inclusion of the gel network with a shampoo chassis decreased copper amount on the hair the fact that histidine is also a conventionally known copper chelator as evidenced by Sarkar cannot be ignored. One of ordinary skill in the art will still expect the composition as claimed would be able to chelate copper. Therefore the examiner maintains that the above assertions are not found persuasive because Applicant’s data is not surprising data. It is clear from Applicant’s data the high copper deposition property is due to the inclusion of the chelant histidine which is a critical entity found in the composition of O’Toole. Absent a side by side comparison experiment with O’Toole which includes histidine Applicant has not demonstrated a surprising result. As clearly indicated by Applicant a composition comprising the gel network with no chelant it does not result in a deposition of Cu which is a clear evidence it is not the gel network which is responsible rather the chelant. The examiner contends that Applicant’s alleged surprising result are insufficient to outweigh the evidence of obviousness. The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Exparte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Furthermore, to demonstrate criticality of the amount of histidine recited in claim 1 Applicant should include data outside of the ranges from each end points showing that outside of the range recited in the claims, the deposition of Cu will not occur if Applicant is arguing the specific range recited for the amount of histidine shows criticality. Applicant relying upon comparative showing to rebut prima facie case must compare his/her claimed invention with closest prior art (In re Holladay, 584 F.2d 384, 199 USPQ 516 (CCPA 1978) in the instant case O’Toole is the closest prior art which Applicant completely failed to test in a side by side analysis. With regard to the limitation reciting wherein the shampoo composition inhibits copper deposition on hair and facilitates the removal of copper deposited on hair since the combination teachings of O’Toole and Johnson et al., teach both the shampoo composition and the gel matrix, the combination teachings of the references would necessarily and innately increase the removal and/or inhibition of copper by histidine. It is clear that the combination teachings of O’Toole and Johnson et al. meets the claimed structure in claim 1 and the other dependent claims. Therefore, the intended use of the composition would necessarily or innately would be met. "[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 In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. See also MPEP § 2112.01 with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103. As a point of clarity Applicant’s data in the specification on Table 3 clearly indicates that the gel matrix by itself did not result in copper deposition proving the fact that it is the histidine that is the cause of the copper deposition. Most critically, the most crucial component histidine, which is responsible for chelating copper is clearly taught by O’Toole. O’Toole teaches applying to the hair a hair care composition (method of use), rinsing the composition from the hair, the use of a hair conditioning compositions such as rinse-off, leave-on, or heat activated products (Col. 1 lines 2-4, and 17-21). It is preferred that the histidine compound comprise from about 0.001% to about 20%, more preferably from about 0.005% to about 5%, even more preferably from about 0.01% to about 1%, by weight, of total composition, which clearly overlaps with the claimed range of histidine (column 2, lines 66-67 and column 3, lines 1-2). Additionally Example 1 of O’Toole, which is a shampoo composition also contains 0.1% of histidine which overlaps in scope with the claimed range. Furthermore, whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). It should be recognized that Applicant’s claim 1 is drawn to broader ranges of each of the ingredients in components b and c (i-iii) while the examples in the data provided in the specification, which are presented in Table 2 and 3 of the original specification are single point data. One of ordinary skill in the art cannot extrapolate the alleged surprising result data throughout the claimed ranges and the claimed generic ingredients.
The examiner also repeats herein the findings of the Patent Trial and Appeal Board on the parent application 15/478,352 with respect to Applicant’s allegations of surprising results presented in Tables 2 and 3 in the original specification. The Board took the position as follows:
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Applicant in claims 1-10 is claiming a product of matter, the intended use is not afforded any patentability weight. In response to applicant’s argument that “wherein the shampoo composition inhibits copper deposition on hair and facilitates the removal of copper deposited on hair,” a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, as described above . "[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 In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. See also MPEP § 2112.01 with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103. Even furthermore, The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) ("One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings."); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991).
Conclusion
No claims are allowed.
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/TIGABU KASSA/
Primary Examiner, Art Unit 1619