DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application has a priority date of 31 May 2018 as no additional claims of priority have been made.
Examiner’s Note
Applicant's amendments and arguments filed on 20 February 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 22 July 2026, it is noted that claims 1, 9, 11-12, 14-16, 25-27, 29, and 34 have been amended. Support can be found throughout the specification. No new matter has been added.
Election/Restrictions
Applicant has previously elected Group I, drawn to a cleansing composition and has previously elected the following species:
Decylglucoside (alkyl polyglucoside)
Cocamidopropyl betaine (amphoteric surfactant)
Polyquaternium-10 (conditioning agent)
Status of the Claims
Claims 1, 8-9, 11-16, 24-29, and 31-39 are pending.
Claim 24 is withdrawn.
Claims 1, 8-9, 11-16, 25-29, and 31-39 are rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 8-9, 11-16, 25-29, and 31-39 stand rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US 8,574,561) in view of Ananthapadmanabhan et al. (US 2013/0150338) in view of Zhao et al. (US 2017/0165165).
Patel teaches an aqueous composition containing an anti-dandruff agent, at least two surfactants chosen from amphoteric and zwitterionic surfactants, a viscosity modifying agent, and a conditioning agent wherein the composition is free of sulfate-containing surfactants and wherein the composition can be used as a shampoo (col 2, lns 15-28; col 12, lns 51-52). The choice of surfactants can include alkyl polyglucosides, PEG fatty esters, coco betaine (col 7, lns 12-43). Additional surfactants include nonionic surfactants such as decyl glucoside (col 10, ln 4) and anionic surfactants chosen from compounds in the classes of taurates, isethionates, and lauryl sarcosinate (col 10, lns 34-48). The surfactants may be present in amounts ranging from 0.1-45 wt% of the total weight of the composition (col 10, lns 59-64). The conditioning agent can be a cationic polymer such as polyquaternium-10 and be included in about 0.025-3 wt% (col 8, lns 23-67). Regarding the viscosity modifier, said agent can be selected from gums such as gum Arabic and xanthan (col 12, lns 6-21) or carbomers (col 4, ln 59- col 5, ln 3) and can be present in the range of from 0.01-2 wt% (col 5, lns 8-10). The aqueous medium can comprise water in about 5-95 wt% and can also comprise polyol alcohols (col 9, lns 1-26).
Patel does not teach the isethionates as acyl isethionates. Patel does not teach the composition further comprising glycerin.
Ananthapadmanabhan teaches that a surfactant system including fatty acyl isethionate (i.e. sodium cocoyl isethionate) and an alkyl glycinate provides an improvement to the condition of the skin stratum corneum barrier and improves anti-dandruff shampoos [0124-0125].
Zhao teaches polyols such as glycerin add elasticity to damaged hair fibers and result in hair that is less sensitive to environmental changes [0025]. In addition, glycerin can result in more segregated micelles that transport onto the hair surface quicker and thus result in improved soil removal [0026]. Zhao further teaches that a consumer preference is for a haircare product to have a viscosity in the range of 1,000-15,000 cps, which results in enough viscosity that the product does not run off the hand after dispensing but not too much viscosity that it is difficult to spread [0027].
It would have been prima facie obvious to prepare the aqueous composition of Patel containing an anti-dandruff agent, at least two surfactants chosen from amphoteric and zwitterionic surfactants, a viscosity modifying agent, and a conditioning agent wherein the composition is free of sulfate-containing surfactants and wherein the composition can be used as a shampoo. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been obvious to have selected various combinations of surfactants and hair care agents from within Patel, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
The resulting shampoo composition would have been obvious to prepare comprising an anti-dandruff agent, a mixture of surfactants (0.1-45 wt%) comprising sodium cocoyl isethionate, alkyl glycinate, alkyl polyglucosides, PEG fatty esters, coco betaine, decyl glucoside, lauryl sarcosinate, a polyquaternium-10 conditioning agent (0.025-3 wt%), thickening agents such as gum Arabic and/or carbomers (0.1-2 wt%), and a solvent system of water (up to 95%) and polyols such as glycerin. Regarding the inclusion of glycerin as the polyol and sodium cocoyl isethionate as the isethionate of Patel, generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
Regarding the concentrations of each surfactant, Patel teaches that the total amount thereof can be up to 45 wt%, thus the individual amounts of each included surfactant can be in the range of from 0.1-45 wt% as well, which overlaps with the ranges of the instant claims. 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). MPEP 2144.05 (I).
It is noted that the composition of Patel is free of sulfate-containing anionic surfactants and further does not require the inclusion of glycerolated alcohols or polyarylsiloxanes. Furthermore, it would have been obvious to adjust the amount of thickening agents to achieve a viscosity in the desired range of from 1,000-15,000 cpa. 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). MPEP 2144.05 (I).
The resulting shampoo composition renders obvious instant claims 1, 8-9, 11-16, 25-29, and 31-39.
Response to Arguments
Applicant's arguments filed 22 July 2026 have been fully considered but they are not persuasive. The Applicant argues, on pages 8-10 of their remarks, that the cited references do not teach the claimed amounts of acyl isethionate and alkyl polyglucoside. The Applicant specifically points out that Patels range, which encompasses the claimed range, does not provide a reason to narrow to the specifically claimed range. The Applicant further identifies the ranges provided in the secondary references as not teaching the claimed amounts.
In response, 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). MPEP 2144.05 (I). Since the prior art teaches a broad range of each agent that encompasses or overlaps with the claimed range, the resulting claimed range would have been prima facie obvious. The Applicant has not provided convincing evidence of an unexpected result to overcome the broad ranges in the prior art. To be sure, the instant claims are broad to wide ranges of surfactants and selections thereof. The Appellant has shown, in the Xavier Declaration, that the one documented inventive composition is stable as compared to similar, but not identical, compositions with modified surfactant amounts. It is noted that the comparative examples comprise a variety of different agents than the inventive composition and thus a 1:1 comparison is not possible. These data do not clearly identify an unexpected result nor are the claims commensurate in scope with the data. It is reminded that any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected (see MPEP 716.02). Moreover, there is a fundamental requirement that must be met before secondary considerations can carry the day. "For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention." Wyers v. Master Lock Co., 616 F.3d 1231, 1246 [95 USPQ2d 1525] (Fed. Cir. 2010) (quotation omitted). Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention. Takai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 [97 USPQ2d 1673] (Fed. Cir. 2011) ("If commercial success is due to an element in the prior art, no nexus exists."); Ormco Corp., 463 F.3d at 1312 ("[l]f the feature that creates the commercial success was known in the prior art, the success is not pertinent."); In re Woodruff, 919 F.2d 1575, 1578 [16 USPQ2d 1934] (Fed. Cir. 1990).
The Applicant argues, on pages 10-12 of their remarks, that the claimed amounts would not have resulted from routine optimization. The Applicant specifically points to Patel and asserts that the reference does not require either surfactant class nor does it teach a critical result of using isethionate or polyglucoside. In addition, the Applicant states that the secondary references also do not teach a critical result with the inclusion of the surfactants.
In response, the above rejection does not rely on routine optimization or result-effective variable in order to render obvious the claimed invention. Rather, it would have been obvious to prepare the composition of Patel based on the combination of known elements within the disclosure. The Applicant is reminded that the teachings of KSR are actually an endorsement and expansion of the flexible and expansive approach to obviousness, which clearly invites continued reliance on such broad and flexible analyses concerning the utility of selecting alternative embodiments of components providing art-recognized utility, with no substantial change in the overall utility of a composition so formulated. See KSR International Co. v. Teleflex, Inc., 82 USPQ2d 1385, 1395-96 (U.S.2007) (“the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”; “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious”; “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions” exemplified by the holdings of cases such as Merck v. Biocraft. That being said, regarding the inclusion of glycerin as the polyol and sodium cocoyl isethionate as the isethionate of Patel, generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
The Applicant argues, on pages 13-16 of their remarks, that the Xavier Declaration demonstrates the significance of the claimed quantitative combination and unexpected stability. The Applicant provides experimental data showing that by increasing various surfactant components of the composition in Xavier (US2016/095804), the comparative compositions 1A, 1B, 2A, and 2B were all unstable or too thick for use, as compared to the inventive composition.
In response, Xavier has been withdrawn as prior art based on the argument that there is no reason to increase the amount of surfactant over the typical value of 20 wt%. Regarding the data provided in the Xavier Declaration, these data provide evidence that in some situations an increase in the surfactant amount of the prior art composition will result in an unstable formulation. However, the instant claims are broad to wide ranges of surfactants and selections thereof. The Appellant has shown that the one documented inventive composition is stable as compared to similar, but not identical, compositions with modified surfactant amounts. These data do not clearly identify an unexpected result nor are the claims commensurate in scope with the data. It is reminded that any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected (see MPEP 716.02). Moreover, there is a fundamental requirement that must be met before secondary considerations can carry the day. "For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention." Wyers v. Master Lock Co., 616 F.3d 1231, 1246 [95 USPQ2d 1525] (Fed. Cir. 2010) (quotation omitted). Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention. Takai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 [97 USPQ2d 1673] (Fed. Cir. 2011) ("If commercial success is due to an element in the prior art, no nexus exists."); Ormco Corp., 463 F.3d at 1312 ("[l]f the feature that creates the commercial success was known in the prior art, the success is not pertinent."); In re Woodruff, 919 F.2d 1575, 1578 [16 USPQ2d 1934] (Fed. Cir. 1990). Therefore, the data in the Xavier Declaration does not amount to unexpected results that are sufficient in overcoming the pending obviousness rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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 ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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