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 .
Status of Claims
Receipt of Applicant’s response, dated 08/25/2025, is acknowledged.
Claims 1-7, 9-11, and 13-22 are pending.
Claims 8 and 12 are canceled.
Claims 14-22 are new.
Claims 1-7, 9-10, and 13 are amended.
Claims 1-7, 9-11, and 13-22 are under consideration in the instant Office action.
REJECTIONS WITHDRAWN
Claim Rejections - 35 USC § 112(b)
The indefiniteness rejections of claims 9-10 set forth in the Office action dated 06/16/2025 are hereby withdrawn in light of Applicant’s amendments to the claims.
Double Patenting
The provisional nonstatutory double patenting rejection over copending Application No. 17/787,649 set forth in the Office action dated 06/16/2025 is hereby withdrawn in light of Applicant’s amendments to the claims and in favor of the new grounds of rejection set forth below.
MAINTAINED GROUNDS OF REJECTION
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.
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 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al (US 2019/0000735 A1, published 1/3/2019, cited in IDS dated 10/10/2022).
Kelly et al teach hair care compositions, referring to products for and/or methods relating to treating hair, including shampooing (e.g., [0015]).
The hair care composition comprises a 2-pyridinol-N-oxide material and an iron chelator, the combination providing a high anti-fungal efficacy (e.g., [0003]). The 2-pyridinol-N-oxide material may be 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone monoethanolamine salt (e.g., [0041]), which is synonymous with piroctone olamine (e.g., [0132]). The hair care composition may contain from about 0.1% to about 10% of the 2-pyridinol N-oxide material (e.g., [0042]).
The hair care composition can be a shampoo composition (e.g., [0065]). The shampoo composition delivers consumer desired shampooing in addition to scalp anti-dandruff efficacy benefit (e.g., [0065]). The shampoo composition is applied to the hair and then rinsed from the hair using water (e.g., [0067]).
The shampoo composition may comprise one or more detersive surfactants, which provides cleaning performance to the composition. The one or more detersive surfactants in turn may comprise an anionic surfactant, amphoteric or zwitterionic surfactants, or mixtures thereof (e.g., [0069]). The concentration of the detersive surfactant component in the shampoo composition should be sufficient to provide the desired cleaning and lather performance, and generally ranges from about 2 wt % to about 50 wt % (e.g., [0070]).
Anionic surfactants suitable for use in the compositions are the alkyl and alkyl ether sulfates, and exemplary anionic surfactants for use in the shampoo composition include sodium laureth sulfate, and specifically as, sodium lauryl ether sulfate (SLE3S) (i.e., sodium laureth sulfate 3EO) (e.g., [0071]-[0072], [0132]). Suitable amphoteric or zwitterionic surfactants for use in the shampoo composition herein include those which are known for use in shampoo or other personal care cleansing, such as betaines, e.g., cocoamidopropyl betaine (e.g., [0073], [0075], [0132]). Concentrations of such amphoteric or zwitterionic surfactants range from about 0.5 wt % to about 20 wt % (e.g., [0073]).
The shampoo composition may optionally comprise one or more additional components known for use in hair care or personal care products, provided that the additional components are physically and chemically compatible with the essential components described herein, or do not otherwise unduly impair product stability, aesthetics or performance (e.g., [0117]), wherein suitable additional components include natural cationic deposition polymers and synthetic cationic deposition polymers (i.e., cationic polymers) (e.g., [0118]).
The hair care compositions may comprise one or more conditioning agents, i.e., materials that are used to give a particular conditioning benefit to hair (e.g., [0120]). Suitable conditioning agents include silicones (e.g., [0120], [0122]).
The hair care composition of Kelly et al, specifically a shampoo composition, comprising:
piroctone olamine as the 2-pyridinol-N-oxide material present from about 0.1% to about 10%;
an iron chelator;
detersive surfactant comprising a) sodium laureth sulfate 3EO as the anionic surfactant and b) cocoamidopropyl betaine as the amphoteric or zwitterionic surfactant, wherein b) is present from about 0.5 wt % to about 20 wt % and a) + b) (i.e., total detersive surfactant) is present from about 2 wt % to about 50 wt %;
a cationic polymer; and
a silicone
renders obvious the shampoo composition of instant claims 1-7 and 9-11.
The aforementioned shampoo composition of Kelly et al comprises the detersive surfactant, which comprises sodium laureth sulfate 3EO as the anionic surfactant and cocoamidopropyl betaine as the amphoteric or zwitterionic surfactant, from about 2 wt % to about 50 wt % which renders obvious the limitation of a total cleansing surfactant level being from 6 to 12 wt % of instant claim 1. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
The detersive surfactant, which comprises sodium laureth sulfate 3EO as the anionic surfactant and cocoamidopropyl betaine as the amphoteric or zwitterionic surfactant, being present from about 2 wt % to about 50 wt % and cocoamidopropyl betaine as the amphoteric or zwitterionic surfactant being present from about 0.5 wt % to about 20 wt % renders obvious the limitation of a ratio of ethoxylated anionic surfactant to amphoteric surfactant being from 3:1 to 4:1 of instant claim 1 (e.g., the shampoo composition of Kelly et al comprising 4 wt% detersive surfactant and 1 wt% cocoamidopropyl betaine has a weight ratio of sodium laureth sulfate 3EO to cocoamidopropyl betaine of 3:1).
The shampoo composition of Kelly et al. comprising sodium laureth sulfate 3EO as the anionic surfactant renders obvious the shampoo compositions of instant claim 2 in which the anionic surfactant consists of sodium laureth sulfate and of instant claim 3 in which the ethoxylated alkyl sulfate is sodium laureth sulfate 3EO.
The shampoo composition of Kelly et al comprising piroctone olamine as the 2-pyridinol-N-oxide material present from about 0.1% to about 10% renders obvious the shampoo composition of instant claim 1, which requires a total level of piroctone compound being from 0.2 to 3 wt%. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
Regarding instant claim 11, per MPEP 2111.02, a recitation of the preamble must result in structural difference to limit the claim. Where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation (Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997). “A method of enhancing the deposition of a piroctone compound” is a statement in the preamble that does not structurally limit the claim and merely recites the purpose of applying the shampoo composition to the hair or scalp. The active method steps of applying the shampoo composition to hair and rinsing are taught by Kelly et al (Kelly et al teach a shampoo composition referring to methods relating to treating/shampooing hair, applying the composition to the hair and then rinsing from the hair using water; see supra) and therefore Kelly et al teach the same method as instant claim 11 which would necessarily enhance the deposition of piroctone olamine.
The specific combination of features claimed is disclosed within the broad generic ranges taught by Kelly et al but such “picking and choosing” within several variables does not necessarily give rise to anticipation (Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989)). Where, as here, the reference does not provide any motivation to select this specific combination of variables of a shampoo composition, anticipation cannot be found.
That being said, however, 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.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 U.S.C. 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ” (KSR at 1741). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton” (Id. at 1742).
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have selected various combinations of various disclosed ingredients of a shampoo composition from within the prior art disclosure of Kelly et al, to arrive at the composition of the instant claims “yielding no more than one would expect from such an arrangement.”
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al (as cited above) as applied to claims 1-7 and 9-11 above, and further in view of Back et al (WO 2019/228988 A1, published 12/5/2019, cited in Notice of References Cited dated 12/11/2024).
The shampoo composition of Kelly et al is discussed supra.
Kelly et al do not teach the piroctone compound being a diethanolamine salt and/or a triethanolamine salt of piroctone acid of instant claim 13.
This deficiency is made up for in the teaching of Back et al.
Back et al teach compositions including a shampoo composition (e.g., Page 69 Lines 32-33). Back et al teach that piroctone olamine, which is used in the treatment of fungal infections, is the monoethanolamine salt of 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2(1 H)-pyridone (e.g., Page 1 Lines 28-31), that that monoethanolamine is not desired by consumers in consumer products because of the risk of the presence of nitrosamines, and that there is a need for more efficacious preserving and anti-fungal substances (as alternative to monoethanolamine) that meet present performance requirements as well as modern consumer desires and expectations (Page 3 Lines 8-19). Back et al teach that by using the diethanolamine or triethanolamine salts of piroctone acid rather than the monoethanolamine salt, there is less potential for nitrosamines while providing a preserving and anti-fungal activity (Page 9 Lines 10-14).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute piroctone olamine in the shampoo composition of Kelly et al with the diethanolamine salt and/or the triethanolamine salt of piroctone acid. One of ordinary skilled in the art would have been motivated to do so because of the advantages offered by Back et al of using the diethanolamine salt and/or the triethanolamine salt rather than the monoethanolamine salt, i.e., reduced potential of the presence of nitrosamines while providing the desired preserving and anti-fungal activity. There would have been a reasonable expectation of success because 1) the shampoo composition of Kelly et al is taught as compatible with an olamine salt of piroctone acid and 2) Back et al teach that the diethanolamine salt and/or the triethanolamine salt of piroctone acid exhibit anti-fungal activity, which is a desired feature of the shampoo composition of Kelly et al.
Thus, the modified shampoo composition of Kelly et al in view of Back et al comprising diethanolamine salt and/or the triethanolamine salt of piroctone acid renders obvious the shampoo composition of instant claim 13.
NEW GROUNDS OF OBJECTION/REJECTION
Claim Objections
Claim 1 is objected to because of the following:
In line 2 of claim 1, “of the total composition” should be added following “0.2 to 3 wt %” in order to improve claim readability and consistency; and
In line 3 of claim 1, a semicolon should be added following “thereof” in order to improve claim readability and consistency (See claim 14).
Appropriate correction is required.
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.
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 14 and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al (as cited above) as evidenced by Proj et al (Comput. Struct. Biotechnol. J., (2022), 20, 5420–5429).
The hair care composition and the methods relating to treating/shampooing hair of Kelly et al have been discussed supra.
Kelly et al also teach that examples of the suitable iron chelators include, but are not limited to, diethylenetriaminepentaacetic acid (DTPA) (i.e., a compound that modifies viscosity as evidenced by Proj et al; See Fig. 5(C) on Page 5427 of Proj et al) (e.g., [0031]).
Kelly et al also teach that the shampoo composition comprises a first aqueous carrier which may be water, or a miscible mixture of water and organic solvent, and in one aspect may comprise water with minimal or no significant concentrations of organic solvent, except as otherwise incidentally incorporated into the composition as minor ingredients of other components (e.g., [0079]).
Kelly et al also teach that examples of silicones as suitable conditioning agents are dimethicones, dimethiconols, cyclic silicones, methylphenyl polysiloxane, and modified silicones with various functional groups such as amino groups, quaternary ammonium salt groups, aliphatic groups, alcohol groups, carboxylic acid groups, ether groups, epoxy groups, sugar or polysaccharide groups, fluorine-modified alkyl groups, alkoxy groups, or combinations of such groups (e.g., [0120], [0122]).
The hair care composition of Kelly et al, specifically a shampoo composition, comprising:
piroctone olamine as the 2-pyridinol-N-oxide material present from about 0.1% to about 10%;
diethylenetriaminepentaacetic acid (DTPA) (i.e., a compound that modifies viscosity, as evidenced by Proj et al, supra) as the iron chelator;
detersive surfactant comprising a) sodium laureth sulfate 3EO as the anionic surfactant and b) cocoamidopropyl betaine as the amphoteric or zwitterionic surfactant, wherein b) is present from about 0.5 wt % to about 20 wt % and a) + b) (i.e., total detersive surfactant) is present from about 2 wt % to about 50 wt %;
water as aqueous carrier;
a cationic polymer; and
silicones, e.g., dimethicones, dimethiconols, cyclic silicones, methylphenyl polysiloxane, and modified silicones with various functional groups such as amino groups, quaternary ammonium salt groups, aliphatic groups, alcohol groups, carboxylic acid groups, ether groups, epoxy groups, sugar or polysaccharide groups, fluorine-modified alkyl groups, alkoxy groups, or combinations of such groups as the one or more conditioning agents,
renders obvious the shampoo composition of instant claims 14 and 16-22.
The shampoo composition of Kelly et al comprises the detersive surfactant, which comprises sodium laureth sulfate 3EO as the anionic surfactant and cocoamidopropyl betaine as the amphoteric or zwitterionic surfactant, from about 2 wt % to about 50 wt % which renders obvious the limitation of a total cleansing surfactant level being from 3 to 20 wt % of instant claim 14. The shampoo composition of Kelly et al comprising piroctone olamine as the 2-pyridinol-N-oxide material present from about 0.1% to about 10% renders obvious the limitation of the piroctone compound being present from 0.01 to 5 wt % of instant claim 17. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
The detersive surfactant, which comprises sodium laureth sulfate 3EO as the anionic surfactant and cocoamidopropyl betaine as the amphoteric or zwitterionic surfactant, being present from about 2 wt % to about 50 wt % and cocoamidopropyl betaine as the amphoteric or zwitterionic surfactant being present from about 0.5 wt % to about 20 wt % renders obvious the limitation of the ratio of ethoxylated anionic surfactant to amphoteric surfactant being from 2:1 to 6:1 of instant claim 14 (e.g., the shampoo composition of Kelly et al comprising 4 wt% detersive surfactant and 1 wt% cocoamidopropyl betaine has a weight ratio of sodium laureth sulfate 3EO to cocoamidopropyl betaine of 3:1).
The shampoo composition of Kelly et al comprising sodium laureth sulfate 3EO as the anionic surfactant renders obvious the shampoo composition of instant claim 18 in which the anionic surfactant consists of sodium laureth sulfate and of instant claim 19 in which the ethoxylated alkyl sulfate is sodium laureth sulfate 3EO.
The specific combination of features claimed is disclosed within the broad generic ranges taught by Kelly et al but such “picking and choosing” within several variables does not necessarily give rise to anticipation (Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989)). Where, as here, the reference does not provide sufficient specificity for the combination of variables of a shampoo composition, anticipation cannot be found.
That being said, however, 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.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 U.S.C. 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ” (KSR at 1741). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton” (Id. at 1742).
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have selected various combinations of various disclosed ingredients of a shampoo composition from within the prior art disclosure of Kelly et al, to arrive at the composition of the instant claims “yielding no more than one would expect from such an arrangement.”
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al (as cited above) as evidenced by Proj et al (as cited above) as applied to claims 14 and 16-22 above, and further in view of Back et al (as cited above).
The shampoo composition of Kelly et al is discussed supra.
Kelly et al do not teach the piroctone compound being a diethanolamine salt and/or a triethanolamine salt of piroctone acid required by instant claim 15.
This deficiency is made up for in the teaching of Back et al.
Back et al teach compositions including a shampoo composition (e.g., Page 69 Lines 32-33). Back et al teach that piroctone olamine, which is used in the treatment of fungal infections, is the monoethanolamine salt of 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2(1 H)-pyridone (e.g., Page 1 Lines 28-31), that that monoethanolamine is not desired by consumers in consumer products because of the risk of the presence of nitrosamines, and that there is a need for more efficacious preserving and anti-fungal substances (as alternative to monoethanolamine) that meet present performance requirements as well as modern consumer desires and expectations (Page 3 Lines 8-19). Back et al teach that by using the diethanolamine or triethanolamine salts of piroctone acid rather than the monoethanolamine salt, there is less potential for nitrosamines while providing a preserving and anti-fungal activity (Page 9 Lines 10-14).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute piroctone olamine in the shampoo composition of Kelly et al with the diethanolamine salt and/or the triethanolamine salt of piroctone acid. One of ordinary skilled in the art would have been motivated to do so because of the advantages offered by Back et al of using the diethanolamine salt and/or the triethanolamine salt rather than the monoethanolamine salt, i.e., reduced potential of the presence of nitrosamines while providing the desired preserving and anti-fungal activity. There would have been a reasonable expectation of success because 1) the shampoo composition of Kelly et al is taught as compatible with an olamine salt of piroctone acid and 2) Back et al teach that the diethanolamine salt and/or the triethanolamine salt of piroctone acid exhibit anti-fungal activity, which is a desired feature of the shampoo composition of Kelly et al.
Thus, the modified shampoo composition of Kelly et al in view of Back et al comprising diethanolamine salt and/or the triethanolamine salt of piroctone acid renders obvious the shampoo composition of instant claim 15.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 9-11, and 13-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-8, 10-12, 15-17, and 19-24 of copending Application No 17/787,649 (hereafter Application ‘649).
This is a provisional nonstatutory double patenting rejection.
Claim 1 of ‘649 recites a personal cleansing composition comprising: i) 0.2 to 3 wt% of the total composition of a piroctone compound; ii) 5 to 15 wt% of the total composition of a cleansing surfactant comprising: an amphoteric surfactant; and an anionic surfactant consisting of an ethoxylated alkyl sulphate surfactant having an average degree of ethoxylation of 2 or greater, wherein the weight ratio of ethoxylated alkyl sulphate to amphoteric surfactant is from 2:1 to 4:1; iii) 0.05 to 2 wt% of the total composition of a cationic polymer in which the cationic polymer is polyquaternium 6. Claim 2 of ‘649 recites the weight ratio of ethoxylated alkyl sulphate to amphoteric surfactant is from 3:1 to 4:1. Claims 3, 15, and 20 of ‘649 recite the total cleansing surfactant level is less than 11 wt%, less than 10 wt%, and from 6 to 12 wt%, respectively, of the total composition. Claim 4 of ‘649 recites the amphoteric surfactant is cocamidopropyl betaine. Claim 6 of ‘649 recites the anionic surfactant is sodium laureth sulphate (3EO). Claim 7 of ‘649 recites the piroctone compound is piroctone olamine. Claim 8 of ‘649 recites the composition further comprising a silicone. Claim 10 of ‘649 recites the composition is a shampoo. Claim 11 of ‘649 recites a method of treating hair or the scalp, comprising applying of a hair treatment composition according to claim 1, to the hair or scalp. Claim 12 of ‘649 recites the method further comprising washing the composition off the hair or scalp after use. Claims 16-17 of ‘649 recite the anionic surfactant has an average degree of ethoxylation of 2.5 or greater and 3 or greater, respectively. Claim 19 of ‘649 recites the piroctone compound is selected from piroctone acid, a primary, secondary or tertiary olamine salt of piroctone acid, and mixtures thereof. Claim 21 of ‘649 recites a personal cleansing composition consisting of: i) 0.01 to 5 wt% of the total composition of a piroctone compound; ii) 3 to 20 wt% of the total composition of a cleansing surfactant comprising: an amphoteric surfactant; an anionic surfactant consisting of an ethoxylated alkyl sulphate surfactant having an average degree of ethoxylation of 2 or greater; and optionally a non-ionic surfactant; wherein the weight ratio of ethoxylated alkyl sulphate to amphoteric surfactant is from 2:1 to 6:1;iii) 0.05 to 2 wt% of the total composition of a cationic polymer in which the cationic polymer is polyquaternium 6; iv) optionally an additional cationic polymer; a suspending agent, conditioning agent, fragrance, dye, pigment, pH adjusting agent, pearlescer, opacifier, viscosity modifier, preservative, natural hair nutrients, and mixtures thereof; and v) water. Claim 22 of ‘649 recites the piroctone compound is selected from piroctone acid, a primary, secondary or tertiary olamine salt of piroctone acid, and mixtures thereof. Claim 23 of ‘649 recites the anionic surfactant has an average degree of ethoxylation of 2.5 or greater. Claim 24 of ‘649 recites the amphoteric surfactant is cocodimethyl sulphopropyl betaine, lauryl betaine, coco betaine, cocamidopropyl betaine or sodium cocoamphoacetate.
The shampoo compositions and the methods of instant claims 1-7, 9-11, and 13-22 are not patentably distinct from the shampoo compositions and the methods of the aforementioned claims of ‘649.
Response to Applicant’s Arguments
Applicant’s arguments filed on 08/25/2025 have been considered.
Applicant argues that with the amendments to the claims and the newly added claims, the instant claims are patentable over Kelly et al and Kelly et al further in view of Back et al, and states that the transitional phrase “consisting of” in new claim 14 limits hair treatment compositions to those containing the specifically listed/claimed ingredients, for which the compositions of Kelly et al include additional ingredients (e.g., an iron chelator). Applicant argues the claimed compositions exhibit unexpectedly improved piroctone deposition due to an anionic surfactant consisting of an ethoxylated alkyl sulphate and the total level of anionic surfactant having an average degree of ethoxylation of 3 or greater and a total cleansing surfactant level from 6 to 12 wt percent of the total composition, which beneficially improve the deposition of piroctone compounds, especially piroctone acid or piroctone olamine, onto the surface of scalp and/or hair during the washing process and, importantly, the claimed compositions also improve the deposition onto the hair and/or scalp without adversely affecting the cleansing and conditioning performance. Applicant points to the Examples to demonstrate that Applicant's composition comprising an anionic surfactant consisting of an ethoxylated alkyl sulphate having an average degree of ethoxylation of 3 exhibits a significantly higher deposition of a piroctone compound onto the surface of hair during washing as compared to comparative compositions in which the average degree of ethoxylation is 1 or 2. Applicant argues that Kelly et al provide no teaching or suggestion to include an anionic surfactant consisting of an ethoxylated alkyl sulphate having an average degree of ethoxylation of 3 or greater, nor to include the claimed amount of cleansing surfactant, let alone any indication that such inclusion would be important or beneficial for increasing piroctone compound deposition.
The above arguments have been fully considered by the Examiner but are not found persuasive because, firstly, as can be seen in the new grounds of rejection under 35 USC 103 above, the compositions and methods taught by Kelly et al and the compositions taught by Kelly et al further in view of Back et al do render obvious the amended and newly added claims. Specifically, the exemplified iron chelators of Kelly et al are compounds that modify the viscosity of a fluid and, therefore, the composition of Kelly et al renders obvious the composition of newly added claim 14 (See above rejection and evidence for more details). The arguments regarding unexpected results have been fully considered by the Examiner but are not found persuasive because Example 1, which is argued as ‘Applicant’s composition’, is not commensurate in scope with either the composition of instant claim 1 or instant claim 14, i.e., Example 1 requires specific percentages to the tenth of a weight percent of each ingredient which are not required by either instant claim 1 or instant claim 14 and requires ingredients not required by either instant claim 1 or instant claim 14. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness 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). The argument regarding the lack of a teaching or suggestion by Kelly et al to include an anionic surfactant consisting of an ethoxylated alkyl sulphate having an average degree of ethoxylation of 3 or greater or to include the claimed amount of cleansing surfactant, let alone any indication that such inclusion would be important or beneficial for increasing piroctone compound deposition has been fully considered by the Examiner but is not found persuasive because the art needs to provide ‘a motivation’ and not the same motivation as Applicant or necessarily recognize the same problem/solution as Applicant. "In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls." KSR Int'l Co. v. Teleflex lnc., 550 U.S. 398,419 (2007). Instead, "any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed." Id. at 420. Further, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). "The fact that appellant 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." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant requests the provisional nonstatutory double patenting rejection over copending Application No. 17/787,649 be held in abeyance until such time as the claims at issue are deemed otherwise allowable.
The above argument has been fully considered by the Examiner but is not found persuasive because a request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP 37 CFR 1.111(b) and 714.02). Thus, because no action regarding this rejection has been taken by Applicant at this time, the provisional nonstatutory double patenting rejection over copending Application No. 17/787,649 has been made again as a new ground of rejection in light of Applicant’s amendments to the claims.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/K.E.O./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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