DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claim Status
Applicant’s amendment of 08/07/2025 is acknowledged. Claims 1, 5-6, 9-10, and 14-16 are amended, and claims 11-13 were previously cancelled. Claims 1-10 and 14-20 are currently pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/EP2021/057314 filed on 03/22/2021 and claims foreign priority to EP20167076.7 filed on 03/31/2020 as reflected in the filing receipt dated on 01/06/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/08/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Declaration Under 37 CFR 1.132
Dr. Paul Jenkins provided a Declaration under 37 CFR 1.132, filed 08/07/2025. The Declaration meets the formal requirements. In the most relevant part, the Declaration presents the expert opinion of Dr. Paul Jenkins regarding how formulation (e.g., viscosities of liquid and foam shampoo compositions) affects piroctone availability. A Declaration is due full consideration and weight for all that it discloses. The ultimate determination of patentability must be based on consideration of the entire record based on a preponderance of the evidence standard.
The Declaration under 37 CFR 1.132 filed 08/07/2025 is insufficient to overcome the rejection of claims 1-10 and 14-20 under 35 U.S.C. 102 as being anticipated by Johnson as set forth in the last Office action for the following reasons:
The Declaration presents a scientific analysis from Dr. Jenkins describing the general behavior of piroctone within specific shampoo formulations and how formulation affects piroctone’s availability for deposition on hair or scalp. The expert opinion of Dr. Jenkins centers on the premise that “foam shampoo compositions differ substantially from liquid shampoo compositions in both physical properties and their ability to deliver piroctone” (Declaration, paragraph 13). However, no data is provided to support the assertion that piroctone delivery is more effective in liquid shampoo formulations than in foam formulations, or that the claimed viscosity could not be achieved by a foam formulation. Additionally, the Declaration fails to consider the full disclosure of Johnson presented in the Office action dated 04/09/2025. Specifically, the Examiner cited wherein Johnson teaches that the shampoo may be dispensed as a liquid form or a foam (Johnson, paragraph 0283). In view of Applicant’s amendment to the claims, the Examiner notes that Johnson expressly teaches a preferred embodiment wherein the liquid phase of the composition has a viscosity of 5,000 centipoise (same as 5,000 mPa.s.; Johnson, paragraph 0073), which lies within and thus anticipates the instantly claimed shampoo composition viscosity. Whether the composition of Johnson is in liquid or foam form, there is no indication in Johnson nor objective data in Applicant’s Declaration that suggests one of ordinary skill in the art would not be able to achieve the claimed viscosity.
Thus, the Declaration and accompanying examples from the specification (Declaration, paragraph 3) do not overcome the prior art rejections of record at this time because, in view of the totality of evidence presented, there is no structural difference between the prior art composition and the instantly claimed composition in order to patentably distinguish one from the other. As supported by Applicant’s Declaration, a liquid shampoo composition having the same ingredients and viscosity as that instantly claimed would necessarily deliver piroctone to the skin barrier and strengthen said skin barrier as claimed.
Therefore, the invention as a whole would have been anticipated by the prior art at the time the invention was made, as evidenced by Johnson, especially in the absence of objective evidence to the contrary.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence fails to outweigh the evidence of anticipation.
Withdrawn Objections and Rejections
Applicant’s amendments to the claims have overcome the previous objections to the claims. Thus, the objections are hereby withdrawn.
Applicant’s arguments regarding the previous 112(b) rejections were fully considered and found to be persuasive. Thus, the rejections are hereby withdrawn.
The previous provisional nonstatutory double patenting rejection over claims 1, 5, 7-9, 13, and 15 of copending Application No. 17/777,726 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025) is hereby withdrawn due to abandonment of the copending application on 10/23/2025.
Applicant’s amendment to the claims has prompted the new/revised grounds of rejection presented herein under 102. Applicant’s arguments insofar as they pertain to the revised grounds of rejection are addressed herein.
Applicant’s amendment to the claims has prompted the new/revised grounds of rejection presented herein under nonstatutory double patenting. Applicant’s arguments insofar as they pertain to the revised grounds of rejection are addressed herein.
Claim Interpretation
The Examiner acknowledges Applicant’s intended claim interpretation presented in the Remarks dated 08/07/2025 and the accompanying clarified claim language recited in the amended claims. As acknowledged by Applicant, the piroctone compound recited in claim 1 could be, but is not necessarily, the one mRNA biomarker/mRNA biomarker group enhancement compound. Therefore, a composition comprising piroctone olamine, which is both a piroctone compound and an mRNA biomarker/mRNA biomarker group enhancement compound, is interpreted as meeting both claim limitations because the claims do not require that the at least one mRNA biomarker/mRNA biomarker is a different compound from the piroctone compound.
The following grounds of rejection are new or modified as necessitated by Applicant’s amendment to the claims.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 and 14-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “viscosity” in line 7. However, the viscosity of a liquid is a function of temperature, as evidenced by Coker 2007 (Chapter 3, Pages 104-105, 3.3 Viscosity of Liquids; cited on PTO-892 of instant action). Because temperature directly impacts the viscosity of a liquid, one of ordinary skill in the art could not ascertain that a composition possesses the claimed viscosity without defining the temperature at which the viscosity was measured. Therefore, the metes and bounds of the claimed subject matter are indefinite.
Claims 2-10 and 14-20 are rejected by virtue of their dependency on claim 1, as they do not resolve the ambiguity in question.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10 and 14-20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
Johnson discloses a concentrated shampoo dosage of foam which delivers consumer desired dosage volume, surfactant amount, and scalp health agent in an optimal formulation (Paragraph 0001). A surfactant system provides cleaning performance to the composition (Paragraph 0030). The scalp health agent may be added to provide scalp benefits including moisturization, barrier improvement, anti-fungal, anti-microbial and anti-oxidant, anti-itch, cooling sensations, and warming sensations (Paragraph 0274). The scalp health agent can be an anti-dandruff agent selected from the group consisting of piroctone olamine, among others (Paragraph 0250). Suitable conditioning agents, which are used to provide a conditioning benefit to the hair or skin, are those conditioning agents characterized generally as silicones (Paragraph 0168).
Johnson also discloses a method of treating the hair comprising (1) providing a hair care composition, (2) dispensing the composition as a liquid form or a foam, (3), applying the composition to the hair, and (4) rinsing the composition from the hair (Paragraph 0283). During the use of a shampoo, the product is dispensed into the hand and applied to wet hair and scalp (Paragraph 0252), which reads on the application step of the method recited in instants claim 1 and 4, the shampoo composition of instant claim 1, the scalp care composition of instant claim 6, and the rinse-off composition of instant claim 16.
Johnson further discloses exemplary embodiments, wherein the amount stated reflects the weight percent of the active material within the composition (Paragraph 0291). Examples 12 and 13 (Pages 22-23, Table 4), comprise 1% of octopirox (also known as piroctone olamine as recognized in Paragraph 0256), 28% of sodium laureth sulfate (also known as sodium lauryl ether sulfate, or SLES), and 6% and 1%, respectively, of dimethicone DM5500.
The octopirox (piroctone olamine) meets the composition limitation of the method recited in instant claim 1 as evidenced by instant claim 8, wherein piroctone olamine is recited as a suitable mRNA biomarker/mRNA biomarker group enhancement compound and as evidenced by the instant specification, wherein piroctone olamine-treated cultures experienced increased expression of mRNA biomarkers associated with cornified envelope formation (Instant Specification, Page 17, Table 1). 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). Note: MPEP 2145(II). It also meets the limitation of a piroctone compound as recited in instant claim 1.
Regarding the viscosity recited in instant claim 1, Johnson expressly teaches that the disclosed shampoo may be dispensed in one of two forms: liquid or foam. While Johnson states that the composition can form a dosage stable form (Paragraph 0283), the composition is not required to be a foam. Further, Johnson discloses wherein the composition may have a liquid phase viscosity of 5,000 centipoise (Paragraph 0073, same as 5,000 mPa.s.), which lies within and thus anticipates the viscosity of instant claim 1. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention could at once envisage an embodiment wherein the shampoo composition is a liquid formulation having a viscosity of 5,000 mPa.s. Note: MPEP 2131.02. A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). Further, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990).
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the compositions of Johnson teach the same structure as recited in instant claim 1 and, therefore, the claimed property would necessarily flow from the structure when applied to the scalp in the manner taught by Johnson, as evidenced by the instant specification which states that claimed composition can enhance the health and strength of the skin/epidermal barrier (Page 1, lines 30-35). 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). Note: MPEP 2145(II). Further, Johnson recognizes that its compositions, which comprise piroctone olamine as a scalp health agent, provide scalp benefits including barrier improvement.
Regarding instant claims 2, 14, and 15, the amount of octopirox in the compositions of Johnson (1% by weight of the composition) lies within the instantly claimed ranges and, therefore, anticipates the claims.
Regarding instant claim 3, biomarkers involved in corneodesmosome formation and tight junction formation are necessarily enhanced by the octopirox of Johnson as evidenced by the instant specification, wherein piroctone olamine-treated cultures experienced increased expression of mRNA biomarkers associated with corneodesmosome formation and tight junction formation (Instant Specification, Page 17, Table 1). 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). Note: MPEP 2145(II).
Regarding instant claim 5, the recited mRNA biomarkers are necessarily enhanced by the octopirox of Johnson as evidenced by the instant specification, wherein piroctone olamine-treated cultures experienced increased expression of Desmocoln 2, Desmoglein 4, Plakophilin 1, Claudin 4, Claudin 7, Claudin 17, Claudin 25, Late cornified envelope 3A, Late cornified envelope 3C, Late cornified envelope 3B, Small proline-rich protein 2D, Claudin 1, Zona occludens 2, and Involucrin (Instant Specification, Pages 17-18, Tables 1 and 2). 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). Note: MPEP 2145(II).
Regarding instant claim 7, the octopirox of Johnson is recognized by Johnson as an anti-dandruff agent (Paragraph 0250) and, therefore, meets the claim.
Regarding instant claims 9 and 17-20, the sodium laureth sulfate (also known as sodium lauryl ether sulfate, or SLES) of the compositions of Johnson meets the claim limitations of anionic surfactant and alkyl sulphate as evidenced by instant claims 18 and 20, which state that SLES is a suitable alkyl sulphate, and by instant claim 17 which states that the anionic surfactant can comprise an alkyl sulphate.
Regarding instant claim 10, the dimethicone DM5500 of the compositions of Johnson meets the claim limitation conditioning agent as evidenced by Johnson, which discloses that silicones are suitable conditioning agents.
Response to Arguments
Applicant’s arguments submitted on 08/07/2025 with respect to rejections under 35 U.S.C. 102 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that Johnson’s teachings are limited to foam compositions. The Examiner respectfully disagrees because the prior art teaches alternative embodiments, including a liquid form. While Johnson teaches that the composition can form a stable dosage of foam, the composition is not required to be a foam. MPEP 2123(II) states, “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). As cited in the prior art rejections of record, Johnson expressly discloses a method wherein its compositions are dispensed as a liquid form. Johnson further teaches a liquid phase viscosity of 5,000 centipoise (same as 5,000 mPa.s.) and, thus, clearly discloses a preferred embodiment which reads on the structure of Applicant’s shampoo composition as claimed.
Applicant further argues the differences in behavior of foam and liquid shampoo compositions, suggesting that the availability of piroctone for deposition is different in the two forms. However, these arguments are insufficient to overcome the prior art rejection because there is no structural difference between the prior art composition and the instantly claimed composition in order to patentably distinguish one from the other. As supported by Applicant’s Declaration, a liquid shampoo composition having the same ingredients and viscosity as that instantly claimed would necessarily possess the same physical properties and, thus, deliver piroctone to the skin barrier and strengthen said skin barrier as claimed. Note: MPEP 2145. The fact that the inventor 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 Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Furthermore, the amount of piroctone deposited upon application of the composition to a skin barrier is not a claimed feature, and Johnson recognizes that its compositions, which comprise piroctone olamine as a scalp health agent, provide scalp benefits including barrier improvement. Thus, application of the prior art composition to a skin barrier would achieve the method as claimed.
In view of the foregoing, the prior art rejections above are maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 12-13, and 18 of copending Application No. 18/683945 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘945 are drawn to a method of depositing piroctone compound onto a scalp (claims 12 and 13) comprising applying the hair care composition of claim 1, wherein the hair composition comprises a piroctone compound, an anionic surfactant, and hydrocarbon oil (claim 1), onto the scalp of an individual and rinsing the scalp with water. Hydrocarbon oil reads on the conditioning agent of instant claim 10 as evidenced by the instant specification which states that the water-insoluble conditioning agent may include non-silicone oily or fatty materials such as hydrocarbon oils (Instant Specification, Page 12, Lines 10-15). App. ‘945 claims 4 and 18 recite that the anionic surfactant is sodium laureth sulphate (also known as sodium lauryl ether sulphate), and App. ‘945 claim 5 recites that the piroctone compound is piroctone olamine. Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Together, these claims read on instant claims 1, 3-8-10 and 16-20. App. ‘945 claim 6 recites that the piroctone compound is in an amount from 0.01 to 10% by weight of the total composition, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
However, App. ‘945 claims do not recite the viscosity of instant claim 1.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the combination of the claims of App. ‘945 and Johnson teach a composition with the same structure as recited in instant claim 1 and, therefore, the claimed property would necessarily flow from the structure when applied to the scalp in the manner recited in the claims of App. ‘945, as evidenced by the instant specification which states that claimed composition can enhance the health and strength of the skin/epidermal barrier (Instant Specification, Page 1, lines 30-35). Regarding instant claim 3, biomarkers involved in corneodesmosome formation and tight junction formation are necessarily enhanced by the octopirox of Johnson as evidenced by the instant specification, wherein piroctone olamine-treated cultures experienced increased expression of mRNA biomarkers associated with corneodesmosome formation and tight junction formation (Instant Specification, Page 17, Table 1). Regarding instant claim 5, the recited mRNA biomarkers are necessarily enhanced by the octopirox of Johnson as evidenced by the instant specification, wherein piroctone olamine-treated cultures experienced increased expression of Desmocoln 2, Desmoglein 4, Plakophilin 1, Claudin 4, Claudin 7, Claudin 17, Claudin 25, Late cornified envelope 3A, Late cornified envelope 3C, Late cornified envelope 3B, Small proline-rich protein 2D, Claudin 1, Zona occludens 2, and Involucrin (Instant Specification, Pages 17-18, Tables 1 and 2). 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). Note: MPEP 2145(II).
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 9, and 12-13 of U.S. Pat. No. 12,403,080 B2 (patented form of previously provisionally rejected copending Application No. 17/909725; patent published on 09/02/2025) in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of US ‘080 are drawn to a method of treating hair or scalp, comprising application of a person care composition of claim 1, wherein the composition comprises an anionic surfactant, a triglyceride oil consisting of coconut oil, and a piroctone compound (claim 1), to the hair or scalp (claim 12), wherein the composition is washed off after use (claim 13). The triglyceride oil consisting of coconut oil reads on the conditioning agent of instant claim 10 as evidenced by the instant specification, which states that conditioning agents in cosmetic compositions are water-insoluble oily materials such as triglycerides (Instant Specification, Page 11, Lines 35-36 and Page 12, Line 1). US ‘080 claims 4 and 5 recite that the anionic surfactant is an ethoxylated alkyl sulphate, specifically sodium laureth sulphate (also known as sodium lauryl ether sulphate), and claim 6 recites that the piroctone compound is piroctone olamine (claim 6). Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Together, these claims read on instant claims 1, 3-8-10 and 16-20. US ‘080 claim 9 recites that the amount of piroctone compound is from 0.1 to 5 wt%, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
However, US ‘080 claims do not recite the viscosity of instant claim 1.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of US ‘080 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 10-11 of copending Application No. 17/629908 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘908 are drawn a method of treating hair or the scalp comprising, application of a hair treatment compound of claim 1, wherein the hair treatment composition comprises sodium laureth sulphate (also known as sodium lauryl ether sulphate), a silicone, and a piroctone compound antidandruff agent (claim 1), to the hair or scalp (claim 10), and wherein the composition is washed off after use (claim 11). Silicone is a conditioning agent as evidenced by the instant specification, which states that conditioning agents used in cosmetic compositions are water-insoluble oily materials such as silicone oils (Instant Specification, Page 11, Lines 35-36 and Page 12, Line 1). App. ‘908 claim 6 recites that the piroctone compound antidandruff agent is piroctone olamine. Together, these claims read on instant claims 1, 3-10, and 16-20. App. ‘908 claim 2 recites that the amount of piroctone compound is from 0.1 to 20% by weight of the total emulsion, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
However, App. ‘908 claims do not recite the viscosity of instant claim 1.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘908 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 8-9, 11, 13, and 17 of copending Application No. 18/002636 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘636 are drawn to a method of depositing anti-dandruff agents onto scalp comprising the step of applying the hair care composition of claim 1, wherein the composition comprises a piroctone compound (claim 1), onto scalp surfaces of an individual followed by rinsing the surfaces with water (claim 13). App. ‘636 claim 3 recites that the piroctone compound is piroctone olamine, claims 8 and 17 recite that the composition further comprises an anionic surfactant that is sodium laureth sulphate (also known as sodium lauryl ether sulphate), and claim 11 recites that the composition further comprises a silicone emulsion. Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Silicone is a conditioning agent as evidenced by the instant specification, which states that conditioning agents used in cosmetic compositions are water-insoluble oily materials such as silicone oils (Instant Specification, Page 11, Lines 35-36 and Page 12, Line 1). Together, these claims read on instant claims 1, 3-10, and 16-20. App. ‘636 claim 9 recites that the amount of piroctone compound is from 0.01 to 5% by weight of the total composition, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
However, App. ‘636 claims do not recite the viscosity of instant claim 1.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘636 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 7, 9-11 of copending Application No. 17/790231 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘231 are drawn to a method of treating hair or the scalp, comprising application of the shampoo composition of claim 1, wherein the composition comprises a piroctone compound and an anionic surfactant consisting of an ethoxylated alkyl sulphate (claim 1), to the hair or scalp (claims 9 and 11), wherein the composition is washed off after use (claim 10). App. ‘231 claim 2 recites that the anionic surfactant comprises sodium laureth sulphate (also known as sodium lauryl sulphate), claim 5 recites that the piroctone compound is piroctone olamine, and claim 7 recites that the composition further comprises a silicone. Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Silicone is a conditioning agent as evidenced by the instant specification, which states that conditioning agents used in cosmetic compositions are water-insoluble oily materials such as silicone oils (Instant Specification, Page 11, Lines 35-36 and Page 12, Line 1). Together, these claims read on instant claims 1, 3-10, and 16-20. App. ‘231 claim 1 recites that the amount of piroctone compound is from 0.2 to 3 wt% of the total composition, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
However, App. ‘231 claims do not recite the viscosity of instant claim 1.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘231 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-8, and 15-17 of U.S. Patent No. 12,246,084 in view of Johnson et al. 2018 (US20180110696A1; PTO-892) in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of US ‘084 are drawn to a method of depositing anti-dandruff agents onto scalp comprising a step of applying the hair care composition of claim 1, wherein the composition comprises piroctone olamine as the anti-dandruff agent (claims 1 and 16-17), onto scalp surfaces of an individual followed by rinsing the surfaces with water (claim 15). US ‘084 claims 6-7 recite that the composition comprises a cleansing surfactant that comprises sodium lauryl ether sulphate, and claim 8 recites that the composition comprises a conditioning agent. Together, these claims read on instant claims 1, 3-10, and 16-20. US ‘084 claim 2 recites that the amount of anti-dandruff agent is from 0.01 to 10% by weight of the composition, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
However, US ‘084 claims do not recite the viscosity of instant claim 1.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of US ‘084 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 10, 12, 14, 18 of copending Application No. 18/714108 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘108 are drawn to a method of depositing piroctone compound onto a scalp (claim 14) comprising applying the hair care composition of claim 1, wherein the hair composition comprises a piroctone compound (claim 1), onto the scalp of an individual and rinsing the scalp with water. App. ‘108 claim 6 recites that the piroctone compound is piroctone olamine. Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Together, these claims read on instant claims 1, 3-8, and 16. App. ‘108 claim 10 recites that the piroctone compound is in an amount from 0.01 to 10%, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05. App. ‘108 claim 12 recites that the composition further comprises an anionic surfactant, and claim 18 recites that the anionic surfactant is sodium lauryl ether sulphate, which reads on instant claims 9 and 17-20.
The claims of App. ‘108 differ from the instant claims in that the claims of App. ‘108 do not recite the viscosity of instant claim 1, or that the composition comprises a conditioning agent as recited in instant claim 10.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘108 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding instant claim 10, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in App. ‘108 with the dimethicone DM5500 taught by Johnson. One of ordinary skill in the art would have been motivated to add a silicone conditioning agent because Johnson teaches that such agents are used in hair care compositions to provide a conditioning benefit to the hair or skin. One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the use of dimethicone DM5500 in a hair care composition also comprising piroctone olamine and sodium lauryl ether sulfate.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, and 11-12 of copending Application No. 17/787649 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘649 are drawn to a method of treating hair or scalp, comprising applying of the hair treatment composition of claim 1, wherein the composition comprises a piroctone compound and an anionic surfactant consisting of an ethoxylated alkyl sulphate surfactant (claim 1), to the hair or scalp (claim 11), and further comprising washing the composition off the hair or scalp after use (claim 12). App. ‘649 claim 6 recites that the anionic surfactant is sodium laureth sulphate (also known as sodium lauryl ether sulphate), and claim 7 recites that the piroctone compound is piroctone olamine. Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Together, these claims read on instant claims 1, 3-9, and 16-20. App. ‘649 claim 1 recites that the amount of piroctone compound is from 0.2 to 3 wt% of the total composition, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
The claims of App. ‘649 differ from the instant claims in that the claims of App. ‘649 do not recite the viscosity of instant claim 1, or that the composition comprises a conditioning agent as recited in instant claim 10.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘649 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding instant claim 10, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in App. ‘649 with the dimethicone DM5500 taught by Johnson. One of ordinary skill in the art would have been motivated to add a silicone conditioning agent because Johnson teaches that such agents are used in hair care compositions to provide a conditioning benefit to the hair or skin. One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the use of dimethicone DM5500 in a hair care composition also comprising piroctone olamine and sodium lauryl ether sulfate.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 12 of copending Application No. 18/269119 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘119 are drawn to a translucent hair care composition comprising an antidandruff agent comprising piroctone olamine (claim 1), and wherein the composition comprises less than 1% silicone compound by weight of the composition (claim 12). Piroctone olamine is an anti-dandruff active as evidenced by the instant specification, which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Silicone is a conditioning agent as evidenced by the instant specification, which states that conditioning agents used in cosmetic compositions are water-insoluble oily materials such as silicone oils (Instant Specification, Page 11, Lines 35-36 and Page 12, Line 1). Together, these claims read on the composition of instant claim 1 and the further limitations of instant claims 3, 5, and 7-8, and 10. App. ‘119 claim 4 recites that the antidandruff agent is present in an amount of 0.01 to 5% by weight of the composition, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
The claims of App. ‘119 differ from the instant claims in that the claims of App. ‘119 do not recite the application step of the method of instant claim 1, the viscosity of instant claim 1, that the skin barrier is of the scalp as recited in instant claim 4, that the composition is a scalp care composition as recited in instant claim 6, that the composition is a rinse-off or leave-on composition as recited in instant claim 16, or that the composition further comprises an anionic surfactant as recited in instant claims 9 and 17-20.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding instant claims 9 and 17-20, it would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of App. ‘119 by adding the sodium lauryl ether sulfate (SLES) taught by Johnson. One of ordinary skill in the art would have been motivated to add the SLES anionic surfactant because Johnson teaches that a surfactant system provides cleaning performance to the composition.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Further, it would have been obvious to use the method taught by Johnson to apply the composition taught by the combination of App. ‘119 claims and Johnson to the scalp and then rinse the composition from the hair, which reads on the application step of instant claim 1, the skin barrier of scalp of instant claim 4, and the scalp care composition of instant claim 6, and the rinse-off composition of instant claim 16, because Johnson teaches that the method can provide scalp benefits such as barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, application of the structure of the composition taught by the combination of the claims of App. ‘119 and Johnson meets the claim limitation for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding mRNA biomarker group of instant claim 3 and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘119 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the application and rinsing off of hair care compositions comprising piroctone olamine, a silicone conditioning agent, and sodium lauryl ether sulfate.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 14-16 of copending Application No. 18/265502 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘502 are drawn to a method of treating dandruff comprising the step of topically applying the composition of claim 1, wherein the composition comprises an anionic surfactant and piroctone olamine (claim 1), onto a desired scalp surface. App. ‘502 claim 16 recites that the anionic surfactant is sodium lauryl ether sulfate. Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Together, these claims read on instant claims 1, 3-9, and 17-20. App. ‘502 claim 10 recites that the amount of piroctone olamine is 0.1 to 10 wt%, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05. App. 502 claim 14 teaches that the composition is a shampoo.
The claims of App. ‘502 differ from the instant claims in that the claims of App. ‘502 do not recite the viscosity of instant claim 1, or that the composition further comprises a conditioning agent as recited in instant claim 10, or that the composition is a leave-on or rinse-off composition as recited in instant claim 16.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘502 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding instant claim 10, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in App. ‘502 with the dimethicone DM5500 taught by Johnson. One of ordinary skill in the art would have been motivated to add a silicone conditioning agent because Johnson teaches that such agents are used in hair care compositions to provide a conditioning benefit to the hair or skin. Further, it would have been obvious to rinse off the composition taught by the combination of App. ‘502 claims and Johnson because Johnson teaches that applying and subsequently rinsing off a shampoo composition comprising piroctone olamine, a scalp health agent, is an effective way to provide scalp benefits such as barrier improvement. Thus, the prior art teaches the missing limitation of instant claim 16.
One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the application and rinsing off of hair care compositions comprising piroctone olamine, a silicone conditioning agent, and sodium lauryl ether sulfate.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 14 of copending Application No. 18/029734 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘734 are drawn to a method of treating dandruff comprising a step of topically applying the composition of claim 1, wherein the hair care composition comprises a piroctone olamine and a silicone compound, onto a desired scalp surface (claim 14). Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Silicone is a conditioning agent as evidenced by the instant specification, which states that conditioning agents used in cosmetic compositions are water-insoluble oily materials such as silicone oils (Instant Specification, Page 11, Lines 35-36 and Page 12, Line 1). Together, these claims read on instant claims 1, 3-8, and 10. App. ‘734 claim 4 recites that the amount of piroctone olamine is 0.01 to 10 wt%, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
The claims of App. ‘734 differ from the instant claims in that the claims of App. ‘734 do not recite the viscosity of instant claim 1, that the composition further comprises an anionic surfactant as recited in instant claims 9 and 17-20, or that the composition is a leave-on or rinse-off composition as recited in instant claim 16.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘734 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding instant claims 9 and 17-20, it would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of App. ‘119 by adding the sodium lauryl ether sulfate (SLES) taught by Johnson. One of ordinary skill in the art would have been motivated to add the SLES anionic surfactant because Johnson teaches that a surfactant system provides cleaning performance to the composition. Further, it would have been obvious to rinse off the composition taught by the combination of App. ‘734 claims and Johnson because Johnson teaches that applying and subsequently rinsing off a shampoo composition comprising piroctone olamine, a scalp health agent, is an effective way to provide scalp benefits such as barrier improvement. Thus, the prior art teaches the missing limitation of instant claim 16.
One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the application and rinsing off of hair care compositions comprising piroctone olamine, a silicone conditioning agent, and sodium lauryl ether sulfate.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 15, and 17 of copending Application No. 18/022799 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘799 are drawn to a method of preventing or reducing hair fall in an individual in need thereof comprising topically applying a hair care composition comprising piroctone olamine and a silicone to the hair and/or scalp of the individual (claim 12), wherein the composition is a rinse-off composition (claim 15). Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Silicone is a conditioning agent as evidenced by the instant specification, which states that conditioning agents used in cosmetic compositions are water-insoluble oily materials such as silicone oils (Instant Specification, Page 11, Lines 35-36 and Page 12, Line 1). Together, these claims read on instant claims 1, 3-8, 10, and 16. App. ‘799 claim 17 recites that the amount of piroctone olamine is 0.05 to 5% by weight of the total composition, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
The claims of App. ‘799 differ from the instant claims in that the claims of App. ‘799 do not recite the viscosity of instant claim 1, or that the composition comprises an anionic surfactant as recited in instant claims 9 and 17-20.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘799 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding instant claims 9 and 17-20, it would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of App. ‘799 by adding the sodium lauryl ether sulfate (SLES) taught by Johnson. One of ordinary skill in the art would have been motivated to add the SLES anionic surfactant because Johnson teaches that a surfactant system provides cleaning performance to the composition. One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the application and rinsing off of hair care compositions comprising piroctone olamine, a silicone conditioning agent, and sodium lauryl ether sulfate.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7-8, 11, 15-16, and 18-19 of copending Application No. 17/793130 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘130 are drawn to a method of providing topical antimicrobial benefit on a topical surface of a human or animal body (skin barrier) comprising a step applying the topical antimicrobial composition of claim 1 (claim 11), wherein the composition comprises an antimicrobial active agent which is at least one of caprylhydroxamic acid or piroctone olamine (claim 1). Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Regarding the piroctone olamine, because the claims of App. ‘130 provide only two choices for the antimicrobial active agent, one of ordinary skill in the art could immediately envision an embodiment wherein piroctone olamine is the microbial active of choice, as evidenced by App. ‘130 claims 15 and 16. App. ‘130 claim 7 recites that the composition further comprises a carrier wherein the carrier comprises a surfactant, and claims 16 and 19 teach compositions comprising piroctone olamine that further comprise an anionic surfactant. App. ‘130 claim 8 recites that the composition is a wash-off or leave-on hair care composition. Together, these claims read on instant claims 1, 3, 5, 7-9, and 16. App. ‘130 claim 5 recites that the amount of antimicrobial active agent is 0.1 to 10 wt%, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
The claims of App. ‘130 differ from the instant claims in that the claims of App. ‘130 do not recite the viscosity of instant claim 1, that the skin barrier is of the scalp as recited in instant claim 4, that the composition is a scalp care composition as recited in instant claim 6, that the anionic surfactant is an alkyl sulphate as recited in instant claims 17-20, or that the composition further comprises a conditioning agent as recited in instant claim 10.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘130 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding instant claims 10 and 17-20, it would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of App. ‘130 by using sodium lauryl ether sulfate (SLES) as the anionic surfactant and by adding the dimethicone DM5500 taught by Johnson. One of ordinary skill in the art would have been motivated to use the SLES anionic surfactant because Johnson teaches that the surfactant system provides cleaning performance to the composition. One of ordinary skill in the art would have been motivated to add a silicone conditioning agent because Johnson teaches that such agents are used in hair care compositions to provide a conditioning benefit to the hair or skin. Further, it would have been obvious to use the method recited in the claims of App. ‘130 to apply the composition taught by the combination of App. ‘130 claims and Johnson to the scalp, which reads on the skin barrier of instant claim 4 and the scalp care composition of instant claim 6, because Johnson teaches that the method can provide scalp benefits such as barrier improvement.
One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the application and rinsing off of hair care compositions comprising piroctone olamine, a silicone conditioning agent, and sodium lauryl ether sulfate.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-10, 15, 20 of copending Application No. 17/777715 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘715 are drawn to a method of depositing anti-dandruff agents onto scalp comprising the step of applying the hair care composition of claim 1, wherein the composition comprises a silicone compound and 0.01 to 10% by weight of an anti-dandruff agent comprising piroctone olamine (claims 1 and 9-10), onto scalp surfaces of an individual followed by rinsing the surfaces with water (claim 15). App. ‘715 claim 20 recites that the anti-dandruff agent is piroctone olamine. Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Together, these claims read on instant claims 1, 3-8, 10, and 16. The amount of piroctone olamine recited in the claims of App. ‘715 overlap the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
The claims of App. ‘715 do not recite the viscosity of instant claim 1, or that the composition further comprises an anionic surfactant, as recited in instant claims 9 and 17-20.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘715 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding instant claims 9 and 17-20, it would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of App. ‘715 by adding the sodium lauryl ether sulfate (SLES) taught by Johnson. One of ordinary skill in the art would have been motivated to add the SLES anionic surfactant because Johnson teaches that a surfactant system provides cleaning performance to the composition. One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the application and rinsing off of hair care compositions comprising piroctone olamine, a silicone conditioning agent, and sodium lauryl ether sulfate.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 22 of copending Application No. 17/777721 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘721 are drawn to a method of depositing anti-dandruff agents onto scalp comprising the step of applying the hair care composition of claim 1, wherein the composition comprises an ethoxylated alkyl sulfate anionic surfactant and from 0.05 to 0.5% by weight of piroctone olamine (claim 22), onto scalp surfaces of an individual followed by rinsing the surfaces with water (claim 15). App. ‘721 claim 22 further recites that the anionic surfactant is sodium lauryl ether sulfate. Together, these claims read on instant claims 1, 3-9, and 16-20. The amount of piroctone olamine recited in the claims of App. ‘721 overlap the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
The claims of App. ‘721 differ from the instant claims in that the claims of App. ‘721 do not recite the viscosity of instant claim 1, or that the composition comprises a conditioning agent as recited in instant claim 10.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘721 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding instant claim 10, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in App. ‘721 with the dimethicone DM5500 taught by Johnson. One of ordinary skill in the art would have been motivated to add a silicone conditioning agent because Johnson teaches that such agents are used in hair care compositions to provide a conditioning benefit to the hair or skin. One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the use of dimethicone DM5500 in a hair care composition also comprising piroctone olamine and sodium lauryl ether sulfate.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-8, and 11 of copending Application No. 17/778365 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘365 are drawn to methods of preventing or alleviating the symptoms of dandruff on the scalp and/or hair comprising the step of applying a composition of claim 1, wherein the composition comprises piroctone olamine (claim 1), onto scalp and/or hair (claim 11). App. ‘365 claim 5 recites that the composition additionally comprises a surfactant, claim 6 recites that the composition is a wash-off or leave-on hair care composition, claim 7 recites that the composition is a shampoo or conditioner, and claim 8 recites that the composition is a shampoo comprising an anionic surfactant. Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Together, these claims read on instant claims 1, 3-9, and 16. App. ‘365 claim 3 recites that the amount of piroctone olamine is 0.01 to 6 wt% in the composition, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
The claims of App. ‘365 differ from the instant claims in that the claims of App. ‘365 do not recite the viscosity of instant claim 1, or that the composition further comprises a conditioning agent as recited in instant claim 10, or that the anionic surfactant is an alkyl sulphate as recited in instant claims 17-20.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘365 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding instant claims 10 and 17-20, it would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of App. ‘365 by using sodium lauryl ether sulfate (SLES) as the anionic surfactant and by adding the dimethicone DM5500 taught by Johnson. One of ordinary skill in the art would have been motivated to use the SLES anionic surfactant because Johnson teaches that the surfactant system provides cleaning performance to the composition. One of ordinary skill in the art would have been motivated to add a silicone conditioning agent because Johnson teaches that such agents are used in hair care compositions to provide a conditioning benefit to the hair or skin.
One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the application and rinsing off of hair care compositions comprising piroctone olamine, a silicone conditioning agent, and sodium lauryl ether sulfate.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 9, and 15 of copending Application No. 17/642595 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of App. ‘595 are drawn to a method of treating and/or preventing dandruff comprising the step of applying the hair care composition of claim 8, wherein the composition comprises a premix according to claim 1 comprising piroctone olamine (claim 1) mixed with co-solvent, onto hair and/or scalp of an individual (claim 15). Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Together, these claims read on instant claims 1 and 3-8. App. ‘595 claim 9 recites that the amount of piroctone olamine is from 0.01 to 10% by weight of the composition, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
The claims of App. ‘595 differ from the instant claims in that the claims of App. ‘595 do not recite the viscosity of instant claim 1, that the composition further comprises an anionic surfactant as recited in instant claims 9 and 17-20, that it further comprises a conditioning agent as recited in instant claim 10, or that the composition is a rinse-off or leave-on composition as recited in instant claim 16.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘595 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding instant claims 9-10 and 17-20, it would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of App. ‘595 by adding the sodium lauryl ether sulfate (SLES) and the dimethicone DM5500 taught by Johnson. One of ordinary skill in the art would have been motivated to use the SLES anionic surfactant because Johnson teaches that the surfactant system provides cleaning performance to the composition. One of ordinary skill in the art would have been motivated to add a silicone conditioning agent because Johnson teaches that such agents are used in hair care compositions to provide a conditioning benefit to the hair or skin. Further, it would have been obvious to use the method recited in the claims of App. ‘595 to apply the composition taught by the combination of App. ‘595 claims and Johnson to the scalp and then rinse the composition from the hair as taught by Johnson, which reads on the rinse-off composition of instant claim 16, because Johnson teaches that the method can provide scalp benefits such as barrier improvement.
One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the application and rinsing off of hair care compositions comprising piroctone olamine, a silicone conditioning agent, and sodium lauryl ether sulfate.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11-12 of copending Application No. 17/625446 in view of Johnson et al. 2018 (US20180110696A1; PTO-892).
The claims of App. ‘446 are drawn to a hair care product (claim 11) comprising the composite particle of claim 1, wherein the composite particle comprises an antidandruff agent and the antidandruff agent is piroctone olamine (claim 1). Together, the claims of App. ‘446 read on the composition of instant claim 1 and the further limitation of instant claims 3, 5, and 7-8. App. ‘446 claims 12 recites that the amount of piroctone olamine is from 0.01 to 5 wt%, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
The claims of App. ‘446 differ from the instant claims in that the claims of App. ‘446 do not recite the viscosity of instant claim 1, the application step of the method of instant claim 1, that the skin barrier is of the scalp as recited in instant claim 4, that the composition is a scalp care composition as recited in instant claim 6, that the surfactant is an anionic surfactant as recited in instant claims 9 and 17-20, that the composition further comprises a conditioning agent as recited in instant claim 10, or that the composition is a rinse-off or leave-on composition as recited in instant claim 16.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding instant claims 8-10 and 17-20, it would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of App. ‘446 by adding the sodium lauryl ether sulfate (SLES) and dimethicone DM5500 taught by Johnson. One of ordinary skill in the art would have been motivated to add the SLES anionic surfactant because Johnson teaches that a surfactant system provides cleaning performance to the composition. One of ordinary skill in the art would have been motivated to add a silicone conditioning agent because Johnson teaches that such agents are used in hair care compositions to provide a conditioning benefit to the hair or skin.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Further, it would have been obvious to use the method taught by Johnson to apply the composition taught by the combination of App. ‘446 claims and Johnson to the scalp and then rinse the composition from the hair, which reads on the application step of instant claim 1, the skin barrier of scalp of instant claim 4, the scalp care composition of instant claim 6, and the rinse-off composition of instant claim 16, because Johnson teaches that the method can provide scalp benefits such as barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, application of the structure of the composition taught by the combination of the claims of App. ‘446 and Johnson meets the claim limitation for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding mRNA biomarker group of instant claim 3 and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of App. ‘446 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the application and rinsing off of hair care compositions comprising piroctone olamine, a silicone conditioning agent, and sodium lauryl ether sulfate.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10 and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 7-8, 11, 13-14, and 16-17 of copending U.S. Patent No. 11,839,677 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of US ‘677 are drawn to topical compositions comprising an antimicrobial active which is at least one of caprylhydroxamic acid or piroctone olamine (claims 1, 3, 11, 13), wherein the carrier further comprises a surfactant (claim 7 and 16), and wherein the composition is a wash-off or leave-on hair care composition (claim 8 and 17). Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Regarding the piroctone olamine, because the claims of US ‘677 provide only two choices for the antimicrobial active agent, one of ordinary skill in the art could immediately envision an embodiment wherein piroctone olamine is the microbial active of choice. Therefore, the claims of US ‘677 read on the composition of instant claim 1 and the further limitation of instant claims 3, 5, 7-8 and 16. US ‘677 claims 5 and 14 recite that the amount of antimicrobial active is 0.01 to 10 wt%, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
The claims of US ‘677 differ from the instant claims in that the claims of US ‘677 do not recite the viscosity of instant claim 1, the application step of the method of instant claim 1, that the skin barrier is of the scalp as recited in instant claim 4, that the composition is a scalp care composition as recited in instant claim 6, that the surfactant is an anionic surfactant as recited in instant claims 9 and 17-20, or that the composition further comprises a conditioning agent as recited in instant claim 10.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding instant claims 8-10 and 17-20, it would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of US ‘677 by adding the sodium lauryl ether sulfate (SLES) and dimethicone DM5500 taught by Johnson. One of ordinary skill in the art would have been motivated to add the SLES anionic surfactant because Johnson teaches that a surfactant system provides cleaning performance to the composition. One of ordinary skill in the art would have been motivated to add a silicone conditioning agent because Johnson teaches that such agents are used in hair care compositions to provide a conditioning benefit to the hair or skin.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Further, it would have been obvious to use the method taught by Johnson to apply the composition taught by the combination of US ‘677 claims and Johnson to the scalp, which reads on the application step of instant claim 1, the skin barrier of scalp of instant claim 4, and the scalp care composition of instant claim 6, because Johnson teaches that the method can provide scalp benefits such as barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, application of the structure of the composition taught by the combination of the claims of US ‘677 and Johnson meets the claim limitation for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding mRNA biomarker group of instant claim 3 and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of US ‘677 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the application and rinsing off of hair care compositions comprising piroctone olamine, a silicone conditioning agent, and sodium lauryl ether sulfate.
Claims 1-10 and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9, and 11 of U.S. Patent No. 12,138,334 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of US ‘334 are drawn to a method of inhibiting growth of M. furfur comprising applying the composition of claim 1, wherein the composition comprises piroctone olamine (claim 1), on a desired skin surface (claim 12). Piroctone olamine is an anti-dandruff active, as evidenced by the instant specification which states that piroctone olamine is one of various anti-dandruff agents (Instant Specification, Lines 25-30). Together, these claims read on instant claims 1, 3, 5, and 7-8. US ‘334 claim 6 recites that the amount of piroctone olamine is from 0.0001 to 1, which is interpreted to be % weight of the composition as evidenced by US ‘334 claims 4 and 5. Thus, the amount overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05. US ‘334 claim 9 recites that the composition is a shampoo or a hair conditioner, which anticipates that the skin barrier is the scalp as recited in instant claim 4 and that the composition is a scalp care composition as recited in instant claim 6.
The claims of US ‘334 differ from the instant claims in that the claims of US ‘334 do not recite the viscosity of instant claim 1, that composition further comprises an anionic surfactant as recited in instant claims 9 and 17-20, that the composition further comprises a conditioning agent as recited in instant claim 10, or that the composition is a rinse-off or leave-on composition as recited in instant claim 16.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of US ‘334 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding instant claims 9-10 and 17-20, it would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of US ‘334 by adding the sodium lauryl ether sulfate (SLES) and the dimethicone DM5500 taught by Johnson. One of ordinary skill in the art would have been motivated to use the SLES anionic surfactant because Johnson teaches that the surfactant system provides cleaning performance to the composition. One of ordinary skill in the art would have been motivated to add a silicone conditioning agent because Johnson teaches that such agents are used in hair care compositions to provide a conditioning benefit to the hair or skin. Further, it would have been obvious to use the method recited in the claims of US ‘334 to apply the composition taught by the combination of US ‘334 claims and Johnson to the scalp and then rinse the composition from the hair as taught by Johnson, which reads on the rinse-off composition of instant claim 16, because Johnson teaches that the method can provide scalp benefits such as barrier improvement.
One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the application and rinsing off of hair care compositions comprising piroctone olamine, a silicone conditioning agent, and sodium lauryl ether sulfate.
Claims 1-10 and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-7, 9, and 12-13 of U.S. Patent No. 11,826,453 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of US ‘453 are drawn to a method (claim 13) of treating or reducing dandruff comprising a step of applying thereon the composition of claim 1, wherein the composition comprises the photolabile antidandruff agent piroctone olamine (claim 1). US ‘453 claims 5-7 recite that the composition further comprises an alkyl sulphate and/or an alkoxylated alkyl sulfate surfactant. Together, these claims read on instant claims 1, 3, 5, 7-9, and 17. US ‘453 claim 3 recites that the amount of photolabile antidandruff agent is 0.1 to 10 wt% in the composition, which overlaps the instantly claimed ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05. US ‘453 claims 9 and 12 recites that the composition is a shampoo or hair conditioner, respectively, which anticipate that the skin barrier is the scalp as recited in instant claim 4 and that the composition is a scalp care composition as recited in instant claim 6.
The claims of US ‘453 differ from the instant claims in that the claims of US ‘453 do not recite the viscosity of instant claim 1, that the composition further comprises a conditioning agent as recited in instant claim 10, that the alkyl sulphate anionic surfactant is one recited in instant claims 18-20, or that the composition is a rinse-off or leave-on composition as recited in instant claim 16.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of US ‘453 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding instant claims 10 and 18-20, it would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of US ‘334 by selecting sodium lauryl ether sulfate (SLES) as the alkyl sulphate anionic surfactant and by adding the dimethicone DM5500 taught by Johnson. One of ordinary skill in the art would have been motivated to use the SLES because Johnson teaches that the surfactant system provides cleaning performance to the composition. One of ordinary skill in the art would have been motivated to add a silicone conditioning agent because Johnson teaches that such agents are used in hair care compositions to provide a conditioning benefit to the hair or skin. Further, it would have been obvious to use the method recited in the claims of US ‘453 to apply the composition taught by the combination of US ‘453 claims and Johnson to the scalp and then rinse the composition from the hair as taught by Johnson, which reads on the rinse-off composition of instant claim 16, because Johnson teaches that the method can provide scalp benefits such as barrier improvement.
One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the application and rinsing off of hair care compositions comprising piroctone olamine, a silicone conditioning agent, and sodium lauryl ether sulfate.
Claims 1-10 and 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 11 of U.S. Patent No. 12,168,066 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of US ‘066 are drawn to a method of depositing an anti-dandruff agent onto scalp comprising: applying the hair composition of claim 1, wherein the hair composition comprises an anionic surfactant that is a salt of acyl glutamate and from 0.05 to 1.5% by weight of piroctone olamine and wherein the composition does not comprise other anionic surfactants in addition to the salt of acyl glutamate (claims 1 and 11), onto scalp surfaces of an individual, and rinsing the surfaces with water, wherein the anti-dandruff agent is piroctone olamine (claim 7). Together, these claims read on instant claims 1, 3-9, and 16. The amount of piroctone olamine recited in the claims of US ‘066 overlaps the ranges recited in instant claims 2, 14, and 15. In the case where the claimed ranges "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). Note MPEP 2144.05.
The claims of US ‘066 differ from the instant claims in that the claims of US ‘066 do not recite the viscosity of instant claim 1, or that the composition comprises a conditioning agent as recited in instant claim 10.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of US ‘066 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding instant claim 10, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in US ‘066 with the dimethicone DM5500 taught by Johnson. One of ordinary skill in the art would have been motivated to add a silicone conditioning agent because Johnson teaches that such agents are used in hair care compositions to provide a conditioning benefit to the hair or skin. One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the use of dimethicone DM5500 in a hair care composition also comprising piroctone olamine and sodium lauryl ether sulfate.
Claims 1-10 and 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8-9, and 12 of U.S. Patent No. 11,672,751 in view of Johnson et al. 2018 (US20180110696A1; PTO-892 of 04/09/2025).
The claims of US ‘751 are drawn to a method of depositing anti-dandruff agents onto scalp comprising: applying the hair care composition of claim 1, wherein the composition comprises an ethoxylated alkyl sulfate anionic surfactant and an anti-dandruff agent comprising zinc pyrithione, selenium sulfide, or a mixture thereof (claim 1), onto scalp surfaces of an individual and raining the scalp surfaces with water (claim 12). US ‘751 claim 6 recites that the ethoxylated alkyl sulfate anionic surfactant is sodium lauryl ether sulfate, and claims 8 and 9 recite that the anti-dandruff further comprises climbazole, piroctone olamine, or mixtures thereof. Regarding the piroctone olamine, because the claims of US ‘751 provide only two choices for the anti-dandruff agent of claim 9, one of ordinary skill in the art could immediately envision an embodiment wherein piroctone olamine is the anti-dandruff agent of choice. Therefore, the claims of US ‘751 read on instant claims 1, 3-9, and 16-20.
The claims of US ‘751 differ from the instant claims in that the claims of US ‘751 do not recite the viscosity of instant claim 1, the specific amount of piroctone olamine in the composition as recited in instant claims 2, 14, and 15, or that the composition further comprises a conditioning agent as recited in instant claim 10.
The teachings of Johnson are as set forth above and further incorporated herein.
Regarding the viscosity recited in instant claim 1, it would have been obvious to one of ordinary skill in the art to use 5,000 mPa.s., which lies within and thus renders obvious the claimed viscosity, as a starting point for routine optimization of the composition’s viscosity with a reasonable expectation of success because Johnson teaches that this viscosity is suitable for producing a piroctone olamine-containing shampoo composition with a wide range of benefits including but not limited to moisturization and barrier improvement.
Regarding the recitation “strengthening the skin barrier” recited in instant claim 1, the mRNA biomarker group of instant claim 3, and the mRNA biomarker of instant claim 5, the structure of the composition taught by the combination of the claims of US ‘751 and Johnson meets the claim limitations for the reasons discussed in detail above (see nonstatutory double patenting rejection of copending Application No. 18/683945).
Regarding instant claims 2, 14, and 15, it would have been obvious to one of ordinary skill in the art to adjust the concentration of the piroctone olamine recited in the claims of US ‘751 using 1% by weight of the composition of piroctone olamine, which overlaps the instantly claimed ranges, as a starting point for routine optimization with a reasonable expectation of success because Johnson teaches that amount of piroctone olamine is suitable for producing hair care compositions comprising sodium lauryl ether sulfate. In the case where the claimed ranges "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). Note MPEP 2144.05. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in US ‘751 with the dimethicone DM5500 taught by Johnson. One of ordinary skill in the art would have been motivated to add a silicone conditioning agent because Johnson teaches that such agents are used in hair care compositions to provide a conditioning benefit to the hair or skin. One of ordinary skill in the art would have a reasonable expectation of success because Johnson teaches the use of dimethicone DM5500 in a hair care composition also comprising piroctone olamine and sodium lauryl ether sulfate.
Response to Arguments
Applicant’s request in the Remarks filed 08/07/2025 for the double patenting rejection of record to be held in abeyance is acknowledged. However, this 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). Accordingly, the rejections will be maintained until a terminal disclaimer is filed or claims are amended to obviate the rejection.
Conclusion
No claim is allowed.
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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/SARAH C WISTNER/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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