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 .
This is the ninth Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 22 July 2026 has been entered.
Status of the Claims
Applicant amended claim 1 and cancelled claims 6-7. Claims 2-5, 8-13, and 32 were previously cancelled by Applicant. Claims 1, 14-31, and 33-38 are pending and under consideration.
Status of the Rejections
The rejection of claims 1, 14-31, 33-34, and 38 under 35 U.S.C. 103 as being unpatentable over Jayaswal (US 2016/0279048 A1), as evidenced by Bailey (US 2006/0120988 A1), is maintained. Applicant’s arguments are considered in paragraphs 23-32 of this Office action.
The rejection of claims 35-37 under 35 U.S.C. 103 as being unpatentable over Jayaswal (US 2016/0279048 A1) in view of Bailey (US 2006/0120988 A1) is maintained.
The provisional rejection of claims 1, 14-31, and 33-38 on the ground of non-statutory obviousness-type double patenting as being unpatentable over the claims of co-pending Application No. 15/962,327 in view of Jayaswal (US 2016/0279048 A1) is maintained.
Claim Rejections - 35 U.S.C. 103
The following is a quotation of 35 U.S.C. 103, which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 14-31, 33-34, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Jayaswal (US 2016/0279048 A1), as evidenced by Bailey (US 2006/0120988 A1).
Jayaswal is directed to hair care compositions that comprise a combination of cationic deposition polymers (para. [0001]).
In Table 1, which is located immediately below paragraphs [0091] and [0100], Jayaswal discloses ten exemplary hair care formulations. Example 10, which is especially relevant to the claims of the present application, comprises 14 wt% sodium laureth sulfate (anionic surfactant), 0.5 wt% climbazole (soluble antidandruff agent), and 0.15 wt% hydroxypropyltrimonium chloride HD1 (cationic polymer). Regarding limitation (a) of claim 1 of the present application, the examiner notes that sodium laureth sulphate is the only species of anionic alkyl sulfate or alkyl ether sulfate included in Example 10 of Jayaswal. Therefore, the concentration range recited in limitation (a) is satisfied.
In paragraph [0087], Jayaswal identifies HD1 as “a high charge density (HD) cationic guar made by Rhodia which has a molecular weight of 1,200,000 g/mol and a cationic charge density of 1.4 meq/g” (emphasis added). The molecular weight of HD1 is overlapped by the corresponding range recited in claim 1, at line 2 of limitation (c). MPEP § 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”). However, the charge density of HD1 is below the minimum of the corresponding range recited in claim 1, which is 1.7 meq/g. See line 3 of limitation (c). Nevertheless, Jayaswal more broadly discloses that “[t]he first cationically-modified guar polymer suitably has a charge density of at least 1.2 meq per gram, preferably from 1.3 to 1.8 meq per gram.” (Emphasis added) Para. [0043]. Both the foregoing broader ranges are overlapped by the corresponding range recited in claim 1, which requires a charge density of 1.7 to 2.2 meq/g. MPEP § 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”). It is important to recognize that “[a] reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.” MPEP § 2123(I); see also MPEP § 2123(II) (“Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.”).
Regarding the “deposition efficiency” functional limitation recited in Applicant’s claim 1, the examiner notes that Jayaswal discloses, in paragraph [0005], that “the hair care composition of the present invention demonstrates unaffected deposition efficiency of antidandruff actives onto scalp which indicates it can also be used for antidandruff purposes.” Moreover, Bailey evidences that cationic guar assists in depositing water-soluble antidandruff agents onto the scalp (paras. [0034] and [0030]-[0032]). This provides a sound basis for the examiner’s position that the deposition efficiency functional limitation is satisfied. MPEP § 2112(V) (“once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant”).
Therefore, claims 1, 15-16, 18-22, and 27-28 are prima facie obvious.
Regarding claim 14, Jayaswal discloses that the “n” value of the sodium laureth sulphate is from 1 to 3 (para. [0072]).
Regarding claim 17, Example 10 comprises 1.6 wt% cocoamidopropyl betaine (Table 1), which is an amphoteric or zwitterionic surfactant (para. [0075]).
Regarding claims 23-24, Example 10 comprises 0.6 wt% carbomer, which is an acrylic acid polymer (Table 1).
Regarding claims 25-26, Jayaswal discloses that “[s]uitable antidandruff agents include compounds selected from azole based antifungal agents, octopirox, metal pyrithione salts, selenium sulfide and mixtures thereof” (para. [0079]). The examiner notes that octopirox is a tradename for piroctone olamine (INCI).
Regarding claims 29-31 and 33-34, Example 10 comprises 1.0 wt% zinc pyrithione (Table 1).
Regarding claim 38, under the principle of broadest reasonable interpretation, the phrase “having branched alkyl chains” modifies the “alkyl ether sulfates” only. It does not further modify or otherwise limit the “alkyl sulfates,” which are recited earlier in the Markush group of limitation (a). MPEP § 2111 (“During patent examination, the pending claims must be ‘given their broadest reasonable interpretation consistent with the specification.’”). With this in mind, the examiner notes that Jayaswal identifies sodium lauryl sulphate as a preferred anionic surfactant (para. [0070]). In the alternative, Jayaswal teaches as follows, in regard to the anionic alkyl sulfates and anionic alkyl ether sulfates defined in paragraph [0071]: “Most preferably R2 has 12 to 14 carbon atoms, in a linear rather than branched chain.” Emphasis added. Thus, Jayaswal teaches that branched anionic alkyl sulfates and anionic alkyl ether sulfates are suitable. MPEP § 2144.07 (the selection of a known material based on its suitability for its intended use supports prima facie obviousness). It is important to acknowledge that “[a] reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.” MPEP § 2123(I); see also MPEP § 2123(II) (“Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.”). The charge density of HD1 in Example 10 of Jayaswal is 1.4 meq/g (para. [0087]), which is close enough to the minimum charge density of 1.5 meq/g recited in limitation (c) of claim 38 to establish prima facie obviousness. MPEP § 2144.05(I) (“Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”). Applicant is referred above, to paragraphs 13-15 of this Office action, for a detailed discussion of Example 10 that addresses the remaining limitations recited in claim 38, which are recited also in claim 1.
Response to Applicant’s Arguments
The arguments raised by Applicant on pages 5-6 of the Reply filed 22 July 2026 are considered below:
First, Applicant argues: “However, a ‘mere overlap’ is insufficient to establish obviousness, particularly when the claimed, narrower range, particularly at its lower bound, yields unexpected and superior results. A person of ordinary skill in the art would not have been motivated to select a specific charge density of at least 1.7 meq/g from a broader, preferred range that largely falls below this value, without a reasonable expectation of achieving the enhanced deposition efficiency of the present invention.” Reply, page 5. As explained below, the foregoing argument is not persuasive.
The principles set forth in MPEP § 2144.05(I) and MPEP § 2123 control the Patent Office’s analysis, and those principles have been properly applied above, in paragraph 14 of this Office action and also in paragraph 14 of the previous Office action (22 April 2026). If anything, Applicant is implicitly asserting that the Patent Office needs anticipatory art (i.e., prior art suitable for advancing a proper rejection under 35 U.S.C. 102) to make a proper obviousness rejection under 35 U.S.C. 103. As stated in the previous Office action, there simply is no support in the law for that assertion.
Second, Applicant argues as follows: “The claimed deposition efficiency of from about 1.6X to about 2.3X is not merely ‘unaffected’ or generally ‘assisted’ deposition, but a quantifiable and significant improvement over a control composition. The specification provides explicit experimental data showing ‘increased deposition efficiencies of 1.4X to 2.2X that of their respective controls’ for compositions falling within the claimed parameters. This unexpected result is achieved by the specific combination of cationic polymer MW and CD, which was not taught or suggested by the prior art.” Reply, page 6. As explained below, the foregoing argument is not persuasive.
The data and other evidence set forth on pages 48-49 of Applicant’s specification, as originally filed, is not persuasive because neither the control composition (Example 16) nor Example 17 is adequately representative of the closest prior art, which is Example 10 of Jayaswal, as previously identified by the examiner. MPEP § 716.02(e) (the claimed subject matter must be compared with the closest prior art to be effective to rebut a prima facie case of obvious). For example, Applicant’s control composition (Example 16) does not even comprise a cationic polymer, in contrast to the closest prior art. Furthermore, Example 18 focuses exclusively on polyquaternium-10, which is a quaternary ammonium salt of hydroxyethyl cellulose. That lone species of cationic polymer does not provide an adequate basis for concluding that all other cationic polymers would behave in the same manner. MPEP § 716.02(d) (“Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the ‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.’”). In the interest of compact prosecution, Applicant is reminded yet again that the elected species of cationic polymer is guar, not hydroxyethyl cellulose, and Example 10 of Jayaswal is focused on guar.
Applicant’s Example 17 does comprise a guar, specifically, guar hydroxypropyltrimonium chloride marketed by Ashland Specialty Ingredients under the tradename N-Hance BF-17. However, the charge density (CD) of that guar is 1.5 meq/g, which lies below the minimum charge density of 1.7 meq/g recited in limitation (c) of claim 1. Moreover, its molecular weight (800,000 g/mol) lies below the minimum of “about 1,000,000” g/mol recited in limitation (c) of claim 1. Id. Consequently, Example 17 is not commensurate in scope with the claimed invention and, therefore, does not meaningfully support Applicant’s evidentiary assertions. MPEP § 716.02(d) (“Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the ‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.’”).
Regarding the “deposition efficiency” functional limitations recited respectively in claims 1 and 38, it is worth emphasizing that Jayaswal discloses: “Moreover, the hair care composition of the present invention demonstrates unaffected deposition efficiency of antidandruff actives onto scalp which indicates it can also be used for antidandruff purposes.” (Emphasis added) Para. [0005]. More importantly, Bailey evidences that cationic guar assists in depositing water-soluble antidandruff agents onto the scalp (para. [0034]) and even identifies Octopirox (piroctone olamine) and climbazole as exemplary water-soluble antidandruff agents. Para. [0030]. This is noteworthy because, as discussed above in the §103 rejection, Example 10 of Jayaswal comprises both (i) cationic guar having a molecular weight of 1,200,000 g/mol and a cationic charge density of 1.4 meq/g and (ii) climbazole.
The foregoing disclosure and evidence continue to provide a sound basis for the Patent Office’s position that the deposition efficiency functional limitations recited in claims 1 and 38 are satisfied. MPEP § 2112(V) (“once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant”); see also Office action (12 January 2023) at para. 17. Interestingly, they also urge Applicant to show that its asserted results concerning deposition efficiency are genuinely unexpected relative to the prior art. MPEP § 716.02(c)(I) (“Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness.”), citing In re Nolan, 553 F.2d 1261, 1267 (CCPA 1977).
It remains Applicant’s burden to show, inter alia, there is a critical difference between (i) the charge density of the cationic guar in Example 10 of Jayaswal and (ii) the charge density of the cationic polymer, as recited respectively in claims 1 and 38. MPEP § 2144.05(III)(A) (“‘The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.’”), quoting In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990). “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.” MPEP § 716.02(d)(II), citing In re Hill, 284 F.2d 955 (CCPA 1960).
The §103 rejection is maintained.
* * *
Claims 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Jayaswal (US 2016/0279048 A1), as applied above to claims 1, 14-31, 33-34 and 38, in view of Bailey (US 2006/0120988 A1).
Although Jayaswal provides that the hair care formulations disclosed therein can further comprise a pH adjusting agent (para. [0082]), Jayaswal is silent regarding the pH of those formulations. Consequently, Jayaswal does not expressly satisfy the pH range limitations recited in claims 35-37. As explained below, Bailey compensates for this deficiency.
Bailey is directed to hair treatment compositions comprising an anti-dandruff agent that is in solution, where the compositions have benefits in terms of perceived mildness by users and deposition of anti-dandruff agents (abstract).
In Example 1 (para. [0133]), Bailey teaches a shampoo formulation that comprises: 14 wt% sodium lauryl ether sulphate (anionic surfactant), 1 wt% climbazole (soluble antidandruff agent), and 0.2 wt% Jaguar C17. Example 1 of Bailey has a pH of 6.5 (para. [0133]).
In paragraph [0035], Bailey teaches as follows: “The pH of the compositions of the invention is preferably in the range of from 5 to 8, more preferably in the range of from 6 to 7 e.g., 6.5. The pH of the compositions of the invention can be adjusted using alkaline agents (such as sodium hydroxide, for example) or acidic agents (such as citric acid) as is well-known in the art.” Emphasis added.
Before the effective filing date of the claimed invention, the teachings of Bailey would have motivated a person having ordinary skill in the art to select a desired pH of 5 to 8 (preferably 6 to 7) for Example 10 of Jayaswal and achieve that desired pH by adding pH-adjusting agents thereto, as needed, such as those taught in paragraph [0035] of Bailey. The foregoing modification would have been made with a reasonable expectation of success given the substantial similarity between the hair care formulations of Jayaswal (Example 10) and Bailey (Example 1). Therefore, claims 35-37 are prima facie obvious. MPEP § 2144.05(I).
Double Patenting (Non-Statutory)
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 obviousness-type 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR1.321(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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 eTerminalDisclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/ eTD-info-I.jsp.
Claims 1, 14-31, and 33-38 are provisionally rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1-9, 13-17, and 19-48 of co-pending Application No. 15/962,327 (as amended on 08 June 2026) in view of Jayaswal (US 2016/0279048 A1).
The conflicting claims (the claims of the ’327 application) differ only marginally in scope from the claims of the present application. For example, compare conflicting claims 1, 3, and 4 to claims 1, 18, and 19 of the present application. Paragraph [0043] of Jayaswal, which is discussed above in the rejections under 35 U.S.C. 103, compensates for the deficiency in the conflicting claims concerning the molecular weight and charge density of the cationic polymer.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not yet been patented.
Conclusion
Claims 1, 14-31, and 33-38 are rejected.
No claim is allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
06 August 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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