DETAILED ACTION
Claims 5, 9-10, and 12-17 are pending and under consideration on the merits.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Rejections
The 112(b) rejection is withdrawn in view of the amendment.
The 102 rejection is withdrawn in view of the amendment.
The 103 is revised in view of the amendment and expanded to include newly added claims, and a new 103 rejection is applied to newly added claims incorporating the teachings of a new secondary reference, Carter et al.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6, 9-10, 12-13, and 16 are rejected under 35 U.S.C. 103 as unpatentable over Suzuki et al. (US Pat. Pub. 2019/0133897; of record) in view of Calaor (“Is a Hair Essence the Missing Product in Your Hair-Care Routine?”)(dated 4.15.2016)(of record).
As to claims 6, 9-10, 12-13, and 16, Suzuki discloses a hair care composition (a “scalp and hair care product” of claim 5) such as a hair conditioner (paragraph 132) comprising an N-fatty acyl amino acid-based surfactant or salt thereof, wherein the amino acid may be, for example, glutamic, alanine, methyl beta alanine, or cysteine (claim 5), the composition further comprising a polyhydric alcohol and water as solvents (claim 5)(paragraphs 11-18, 25, 27, 41, 51, 53, 55). The composition further may comprise an oily starting material such as a higher aliphatic alcohol such as stearyl alcohol or cetanol (“cetyl alcohol”) or vegetable oil (a “hair care oil” of claim 5)(paragraphs 104 and 106). Example 10, Table 9 shows a specific embodiment of a hair conditioner (claim 9) comprising 0.1 wt% N-stearoyl-L-glutamic acid (a C18 surfactant of claim 1), 0.20 wt% N-lauroyl-L-arginine, and 8 wt% of a 25 wt% solution of N-octanoyl-L-lysine (i.e., 2 wt% of the surfactant) as the fatty acyl amino acid based surfactants (which totals to 2.3 wt% total amino acid surfactant which is within the range of claim 5), 8 wt % glycerol as the polyhydric alcohol solvent, cetanol (i.e.,“cetyl alcohol,” which is a C16 higher aliphatic alcohol of claim 5) in the amount of 6 wt%, which is within the range of claim 5, and water to balance as the solvent. The Example 10 hair conditioner of Suzuki further comprises jojoba oil (a “hair care oil” of claim 5), paraoxybenzoate as preservative, and citric acid to q.s. as a pH regulator. The broader teachings of Suzuki also disclose that the oil may be squalane as recited by claim 13 (paragraph 106). Additionally, while only the N-stearoyl-L-glutamic acid of Example 10 is within the carbon chain length of 18 or more as required by claim 1 and it is present in the amount of 0.1% which is outside the 0.8 to 5% range of claim 1, the broader teachings of Suzuki discloses that the long chain acyl amino acid based surfactants are present in the amount of 0.1-7 wt% (paragraph 103), which allows for the amount of the N-stearoyl-L-glutamic acid to be increased from 0.1% to 0.8% so as to be within the scope of claim 1, resulting in the total amount of acyl amino acid based surfactant in the Example 10 composition to be 3wt%, which is within the 0.1-7 wt% range taught by Suzuki. The composition further may comprise a chelating agent as recited by claim 5 (paragraph 104) such as ethylenediaminetetraacetic acid (paragraph 108).
Regarding claim 10, Suzuki additionally discloses a method of preparing the composition of Example 10 comprising dissolving the oil and emulsifier by stirring at a temperature of 80 degrees Celsius (which is within the range of claim 10), adding a long carbon chain fatty acyl amino acid based surfactant and stirring, cooling to 45 degrees Celsius (which is slightly below the range of claim 10), and adding the pH adjuster (paragraphs 241-247).
Regarding claim 12, Suzuki expressly teaches that the surfactant, such as the C18 acyl glutamic surfactant of Example 10, may be in the form of a sodium salt (paragraph 59).
As to claims 6, 9-10, 12, and 16, Suzuki does not further disclose that the composition comprises an essence as recited by claim 5 nor that the squalane and citric acid are used in amounts within the ranges of claims 13 and 16, nor that the method of making the composition comprises adding a chelating agent or essence as recited by the method of claim 10. Additionally, the order of addition of ingredients differs from the claim 10 method.
Calaor discloses that hair essence is a serum-like moisturizer that helps to hydrate and nourish the hair so it becomes silky and shiny (see 1st through 3rd paragraphs).
As to claims 6, 9-10, 12-13, and 16, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Suzuki Example 10 hair care composition by incorporating an essence, because Calaor teaches that essence helps to hydrate and nourish the hair so it becomes silky and shiny, such that the skilled artisan would have been motivated to incorporate essence into the Suzuki hair care composition so that the composition will impart silky and shiny properties to the hair upon application.
Regarding claim 10, it further would have been prima facie obvious to modify the method of making the hair care composition as taught by Suzuki by incorporating the steps of adding chelator and an essence, because the broader teachings of Suzuki expressly teach that the compositions taught therein may contain a chelating agent, and because Calaor teaches that essence helps to hydrate and nourish the hair so it becomes silky and shiny, such that the skilled artisan would have been motivated to incorporate essence into the Suzuki hair care composition so that the composition will impart silky and shiny properties to the hair upon application.
Regarding the order of steps recited by claim 10, the differences relative to the order of steps in the Suzuki process do not render the claim nonobvious because the differences do not produce new or unexpected results based upon the evidence of record. A change in the sequence of adding ingredients in a process claim is prima facie obvious in the absence of new or unexpected results. See Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
Regarding the difference in temperature in the cooling step between claim 10 and the Suzuki method, it would have been well within the purview of the skilled artisan to vary the temperature to arrive at the optimal temperature that will properly dissolve the ingredients to be added. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 13 and 16, it further would have been prima facie obvious to optimize an amount of squalane and citric acid to be within the recited ranges, because Suzuki teaches that squalane serves as an oily starting base for the composition such that its amount is a result effective variable that will affect its ability to impart oily base functionality to the hair composition and that citric acid is a pH adjuster such that its amount is a result effective variable that will affect its ability to impart an appropriate pH to the composition, and there would have been a reasonable expectation of success in arriving at the claimed range because of the similarity between the Suzuki composition and the claimed composition are similar hair care compositions comprising an acyl amino acid based surfactant and fatty alcohols such that the skilled artisan would have been optimizing a composition very similar to the claimed composition. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Applicant’s Arguments
Applicant argues that Suzuki Example 10 composition does not contain a chelating agent, and the fact that the broader disclosure of Suzuki mentions chelating agents while omitting them from Example 10 demonstrates that Suzuki did not consider a chelator to be necessary for achieving their goal of stability.
In response, it would have been obvious to include a chelator because Suzuki expressly teaches doing so, and the fact that Example 10 does not include a chelator does not render inclusion of a chelator non-obvious, because disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. MPEP 2123. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Applicant argues that the claims require that the surfactant have a chain length of at least 18 carbons, while Example 10 of Suzuki includes a C8 surfactant, and there allegedly is no reason to modify this composition to exclude shorter chain surfactants or to focus solely on C18 and longer chains.
In response, the rejection does not require a motivation to exclude surfactants having a chain length of less than C18, because the claim language nowhere excludes the presence of shorter chain length surfactants.
Applicant argues that Calaor discloses hair essences as standalone products, and therefore teaches away from incorporating an essence within an emulsion system such as Example 10 of Suzuki, and there is no reasonable expectation of success that adding an essence would yield a stable and effective hair repair product.
In response, Suzuki expressly teaches that a wide variety of additional additives generally found in skin, hair, or cleansing compositions may be incorporated into the compositions taught therein, one of which is a moisturizer (paragraph 104), and Calaor teaches that the essence serves as a moisturizer, such that the skilled artisan reasonably would have expected that essence could be incorporated into the Suzuki composition. The Office notes that a prima facie case of obviousness does not require absolute predictability; only a reasonable expectation of success is required. MPEP 2145.
Applicant argues that there is no motivation in the prior art to discard the C8 surfactant of Suzuki Example 10, drastically increase the amount of the C18 surfactant, and shift the functional focus of the formulation from Suzuki’s stability driven composition to a repair-driven system built around high levels of C18+ anionic surfactants as in the present invention. Applicant argues that such modifications would render the prior art unsatisfactory for its intended purpose of providing a stable creamy composition since Suzuki teaches that compositions containing the C8 surfactant showed good stability in both low and high temperatures.
In response, the Office again notes that the C8 surfactant needn’t be discarded because the claims do not exclude the presence of a C8 surfactant, and further that the broader teachings of Suzuki teach total ranges for the surfactant that would allow the amount of the C18 surfactant of Example 10 to be increased to be within the claimed ranges as discussed in the revised rejection. Regarding the functional focus of the Suzuki compositions versus that of the claimed invention, It is not necessary that the prior art suggest the claimed combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below).
Applicant argues that test example 2 of the present specification demonstrates unexpectedly superior results by showing inventive compositions that have average to excellent hair care performance even though the prior art as discussed in the background of the invention teaches away from using anionic surfactants for primary hair repair, instead focusing on cationic surfactants which are known to be irritating to the scalp. Applicant claims to have identified a non-cationic system that provides hair repair while being gentle on the scalp.
In response, this argument is not persuasive because evidence of unexpected results must compare the claimed invention with the closest prior art. MPEP 716.02(e). Here, the closest prior art currently of record is Suzuki, and there is no evidence of record showing that the claimed composition possesses unexpectedly superior results relative to the Suzuki compositions.
Applicant argues that the specific ranges recited by the claims are critical for achieving the desired balance of hair care efficacy and scalp gentleness and that the skilled artisan would not arrive at these ranges without the benefit of Applicant’s insight. Applicant asserts that Tables 1-3 demonstrates the criticality of the claimed ranges by showing that all 18 successful examples fall within a surfactant range of 0.8 to 5 wt%, while Example 10 of Suzuki possesses a C18+ surfactant level below this range (i.e., 0.1 wt%), and that while the present specification does not include comparative examples with C18+ surfactant levels below 0.8%, the absence of any working example below this level coupled with the consistent success of examples within the range, demonstrates that the inventors identified this specific threshold as critical. Applicant claims to have identified and solved a problem not recognized by the prior art, by recognizing that long carbon chain fatty acyl amino acid based anionic surfactants, when combined with higher aliphatic alcohols in specific ratios, can assemble into structures that mimic the hair’s natural protective layer and provide effective repair while being gentle on the scalp.
In response, and as acknowledged by Applicant, the specification does not include comparative examples with C18+ surfactant levels below 0.8%. Therefore, there is no actual evidence of record that C18+ surfactant levels below 0.8% would have markedly inferior results and would not solve the problem of providing effective hair repair while being gentle on the scalp. Applicant’s assertion that the absence in the present specification of any working examples below this level is evidence that 0.8% is a critical threshold is attorney argument that cannot replace actual evidence of record. Nor does there appear to be any evidence of record that the presence of higher aliphatic alcohols in specific ratio with respect to the surfactants is necessary to solve the problem of providing effective hair repair while being gentle on the scalp as suggested by Applicant.
New Rejection
Claims 14-15 and 17 are rejected under 35 U.S.C. 103 as unpatentable over Suzuki et al. (US Pat. Pub. 2019/0133897) in view of Calaor (“Is a Hair Essence the Missing Product in Your Hair-Care Routine?”)(dated 4.15.2016) as applied to claims 6, 9-10, 12-13, and 16 above, and further in view of Carter et al. (US Pat. Pub. 2013/0280193).
The teachings of Suzuki and Calaor are relied upon as discussed above. The broader teachings of Suzuki also disclose that the preservative may be phenoxyethanol as recited by claim 15 (paragraph 114). Suzuki also discloses a range for the surfactant as discussed above that encompasses the range for the alanine surfactant recited by claim 17. Suzuki and Calaor do not, however, further expressly disclose that the EDTA chelator is in the form of its disodium salt (claims 14 and 17), or that the preservative comprises benzyl alcohol (claims 15 and 17) and polydimethylsiloxane (claim 17), and wherein all of the ingredients are present in the amounts recited by claim 17.
Carter discloses hair care compositions such as conditioners comprising a preservative such as benzyl alcohol, and a chelator such as EDTA-2Na (paragraph 188), and a silicone conditioner such as polydimethylsiloxane (paragraphs 54-55 and 60).
Regarding claims 14-15 and 17, it would have been prima facie obvious to modify the hair care composition of Suzuki and Calaor as combined supra by selecting the disodium form of EDTA as the type of EDTA chelator, and further to incorporate benzyl alcohol and polydimethylsiloxane, because Carter teaches that EDTA-2Na is a suitable type of EDTA for use as a chelator in a hair care composition, and that benzyl alcohol and polydimethylsiloxane are useful in hair care compositions for their preserving and conditioning properties, such that the skilled artisan reasonably would have expected they could be used for this purpose in the Suzuki composition. It further would have been prima facie obvious to select amounts of the cetyl alcohol and stearyl alcohol and squalane (taught by Suzuki as an oily starting base for the hair care composition), citric acid (taught by Suzuki as a pH regulator), water (taught by Suzuki as a solvent), polydimethylsiloxane (taught by Carter as a conditioner), EDTA-2Na (taught by Suzuki and Carter as a chelator), benzyl alcohol (taught by Carter as a preservative), phenoxyethanol (taught by Suzuki as a preservative, and essence (taught by Calaor as a moisturizer), because the prior art teaches these ingredients as having the functionalities as discussed above for a hair care composition such that the amounts of these ingredients would have been recognized as result effective variables for achieving these functionalities, and there would have been a reasonable expectation of arriving at the claimed amounts because the skilled artisan would have been optimizing the amounts of these ingredients for the same functionality in the same type of composition (i.e., hair care composition) as the claimed invention. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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