3DETAILED ACTION
Claims 1, 3-6, 9, 11, 14, 20-21, 24-26, 33-34, 38, and 40-42 are pending. Of these, claims 24-26, 33-34, 38, and 40-42 are withdrawn as directed to a nonelected invention. Therefore, claims are 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/7/26 was filed prior to the mailing date of a first Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
Status of the Rejections
The 103 rejection is revised in view of the amendment, except for the rejection of claim 9 which is withdrawn and replaced with a new rejection incorporating the teachings of a new secondary reference and which was necessitated by the amendment.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-6, 9, 11, 14, and 20-21 are rejected under 35 U.S.C. 103 as unpatentable over Takeuchi et al. (EP 1 287 813; of record in IDS in view of Takeuchi et al. (EP 1 547 576; of record in IDS; hereinafter “Takeuchi’576”) Franklin et al. (WO 94/14409; of record), and Lesniak et al. (US Pat. Pub. 2018/0235858; published 8.23.2018; of record).
As to claims 1, 3-6, 9, 11, 14, and 20-21, Takeuchi discloses in Example 2 an antiperspirant personal care roll-on composition comprising an odor-reducing agent consisting of a fragrance and further comprising PPG-15 stearyl ether (an “emollient comprising a non-volatile ether compound” that comprises an ether of stearyl alcohol of claims 1 and 3-4), and an emulsifier mixture comprising steareth-2 in the amount of 3 wt% and steareth-20 in the amount of 1.80% which is a weight ratio of about 1.67, which is within the about 1.1:1.0 to 3.0:1.0 range for the emulsifier mixture recited by claim 1, and which is a total amount of emulsifier of 4.8%, which is within the about 4.7 to about 10.0 wt% range recited by claim 1. The composition is free of cyclomethicone (claim 1) volatile compounds (claim 5), dimethicone (claim 6), phenoxyethanol (claim 6), talc (claim 11), potassium alum (claim 14), butylated hydroxytoluene (claim 20), and antioxidant (claim 21). While the Example 2 composition comprises the fragrance in the amount of 1.2% which is above the ranges recited by claims 1 and 9, the broader teachings of Takeuchi disclose that the fragrance may be used in amounts of 0.05-4.0%, which encompasses the ranges of claims 1 and 9 (paragraphs 40-41). While the Example 2 composition comprises the PPG-15 stearyl ether in the amount of 3%, which is slightly below the 4%-9% range recited by claim 1, the broader teachings of Takeuchi disclose that it may be present in the amount of 1-6 wt%, which overlaps the range of claim 1 (paragraph 37). While the Example 2 composition comprises aluminum chlorohydrate as an antiperspirant active, the broader teachings of Takeuchi are that the antiperspirant active may comprise other compounds such as inorganic or organic salts of zirconium or zinc (paragraph 29). Takeuchi further teaches that in addition to a roll-on, the composition may take other forms such as a stick (paragraph 2) and also teaches that the composition may include preservatives (paragraph 44).
Regarding claims 9 and 20-21, Takeuchi does not require the use of phenoxyethanol, butylated hydroxytoluene, or antioxidant in the composition.
As to claims 1, 3-6, 9, 11, 14, and 20-21, Takeuchi does not further expressly disclose that the Example 2 composition comprises calcium silicate (claim 1) nor a preservative comprising a blend of sodium benzoate, lactic acid, and sodium lactate within the ranges recited by claim 1, or that it is free of aluminum chlorohydrate (claim 14), nor that the emulsifier mixture comprises stereath-2 in combination with steareth-21 as opposed to steareth-20 as taught by Takeuchi.
Takeuchi ’576 discloses a personal care composition in the form of a topical stick, the composition comprising fragrance (identified by the present specification as an odor-reducing agent that is not an aluminum compound at paragraph 23), PPG14-BE (i.e, PPG-14 butyl ether, which is a non-volatile ether emollient,) stearyl alcohol (an “emulsifier”), and calcium silicate (Example 2-A at paragraph 76). Takeuchi teaches that the calcium silicate functions as a filler (paragraph 53).
Franklin discloses deodorant compositions comprising an emulsifier combination of steareth-21 and steareth-2 (Example 14).
Lesniak discloses preservative systems based upon organic acids for inclusion in personal care products, the preservative system comprising citric acid, lactic acid, benzoic acid, and gluconic acid, in free or salt form (paragraph 6). Lesniak also expressly discloses benzoic acid and lactic acid preservatives in the form of their sodium salts (i.e., sodium benzoate and sodium lactate)(paragraphs 3 and 12). The personal care product comprises each of the organic acid or salts thereof preservatives in the amount of 0.01 to 5 wt% (paragraphs 31-32), which encompasses the ranges recited by claim 1. Lesniak teaches that the preservative system is advantageous because it does not require the use of parabens, triclosan, and other traditional antimicrobial agents, and presents a low risk to consumer health and the environment (paragraph 6).
As to claims 1, 3-6, 9, 11, 14, and 20-21, 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 composition of Takeuchi by incorporating calcium silicate as a filler, because Takeuchi ’576 teaches that the composition may be in the form of a stick and Takeuchi ’813 expressly teaches that calcium silicate is useful as a filler to form personal care compositions in the form of a stick, such that the skilled artisan reasonably would have expected that calcium silicate could be used as a filler to form the Takeuchi product as a stick product. Such a combination is merely the combining of prior art elements according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
It further would have been prima facie obvious to incorporate a preservative system comprising sodium benzoate, lactic acid, and sodium lactate in amounts within the ranges recited by claim 1, because Takeuchi teaches that its personal care composition further may comprise preservatives, and Lesniak teaches that these ingredients are useful in combination in such amounts as preservatives in personal care products and that they impart preservative properties to the product without the use of parabens, triclosan, and other traditional antimicrobial agents, and thereby advantageously present a low risk to consumer health and the environment
It further would have been prima facie obvious to It further would have been prima facie obvious to use stereath-2 in combination with steareth-21 as opposed to steareth-20 as the mixture of emulsifiers, because Franklin expressly teaches that this combination is a known alternative to the use of steareth-2 and steareth-20 as an emulsifier mixture in an deodorant composition, such that the skilled artisan reasonably would have expected that it could be used as the emulsifier mixture in the Takeuchi deodorant composition. Such a modification is merely the simple substitution of one known element for another according to known methods to achieve predictable results, which is prima facie obvious. MPEP 2143.
Additionally, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious).
Here, the steareth-21 recited by the claims is a homolog of the steareth-20 disclosed by Takeuchi, as it varies only by the presence of 21 polyethylene glycol units instead of 20. Therefore, the skilled artisan reasonably would have expected that both compounds would have similar emulsifying abilities and that either would be suitable for use in the Takeuchi deodorant composition.
Regarding claim 14, it further would have been prima facie obvious to select an antiperspirant other than aluminum chlorohydrate such as an inorganic or organic salt of zirconium or zinc, because Takeuchi expressly teaches that such salts are also suitable for use as antiperspirants in the compositions disclosed therein.
Response to Applicant’s Arguments
Applicant asks which odor-reducing agent in the prior art references read on the claimed limitation “odor-reducing agent consisting of fragrances but free of aluminum.” Applicant asserts that Takeuchi’813 fails to fairly suggest replacing all of the odor reducing agents with fragrance only.
In response and as discussed in the rejection, Takeuchi’813 discloses that the composition comprises a “fragrance,” which is an odor reducing agent that is aluminum free, and while Example 2 of the reference also contains an aluminum antiperspirant, the broader teaching of Takeuchi’813 disclose that antiperspirants that do not contain aluminum also may be used instead of an aluminum-containing antiperspirant as discussed in the rejection. Additionally, modifying the prior art to arrive at the claimed invention does not require replacing all odor reducing agents with fragrance only. Base claim 1 recites open-ended “comprising” language in the preamble, which allows for the presence of additional odor reducing agents that are not a fragrance.
With respect to the previously argued alleged presence of unexpected results, Applicant argues that the claimed formulation is not required to exhibit superiority in all characteristics. In response, the Office agrees that a claimed formulation is not required to exhibit superiority in all characteristics, but, as discussed above, there is no evidence of any practical significance of the moderate improvement in phase separation.
Applicant argues that Takeuchi ‘813 does not use the specific emulsifier mixture nor the specific preservative blend of sodium benzoate, lactic acid, and sodum lactate, nor the amount of the PPG 15 stearyl ether and fragrance that is recited by claim 1. Applicant argues these deficiencies are not remedied by the secondary references, because both Takeuchi’576 and Franklin use an aluminum compound while the claimed composition is free of aluminum, and also do not disclose the claimed emulsion mixture or preservative system. Lesniak is said not to suggest claim 1 as a whole comprising a composition comprising fragrance in the recited amount and that is free of aluminum compounds.
In response, the teachings of a reference are not limited to its examples. While Example 2 of Takeuchi’813 comprises amounts of the fragrance and ether of stearyl alcohol that differ from the claimed amounts and which comprises an aluminum compound, the broader teachings of Takeuchi are that the antiperspirant active may comprise other compounds such as inorganic or organic salts of zirconium or zinc instead of aluminum as discussed in the rejection, and that the stearyl ether may be present in the amount of 1-6 wt% and the fragrance in the amount of of 0.05-4.0%, which overlaps the claimed ranges as discussed in the rejection. as discussed in the rejection. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. MPEP 2123. Additionally, the rejection rely on Lesniak for a motivation to select the claimed preservative mixture. Additionally, while Applicant has pointed out to deficiencies of each reference in failing to disclose one or more claim elements, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. MPEP 2145 IV. Here, the combination of cited references, considered together, disclose or suggest all elements of the claims as discussed in the rejection.
Applicant argues that Takeuchi’813 and the cited secondary references fail to fairly suggest the unexpected effects of low rate of phase separation and low absolution separation as shown by inventive composition 1 in Table 2A. Applicant asserts that claim 1 as amended distinguishes composition 1 in Table 2A from other compositions by the unique combination of ingredients along with their respective amounts and ratios. Applicant further argues that compositions 2 and 4 in Table 2A are close to Example 2 of Takeuchi’813, such that claim 1 should demonstrate unexpected results over Example 2 of Takeuchi’813 with regards to rate of phase separation and absolute separation
In response, in situations where the Applicants are relying upon unexpected results to rebut a prima facie case of obviousness, Applicants bear the burden to establish that the results are unexpected and significant. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). See MPEP 716.02(b).
Additionally, whether unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110C and 130C. The court affirmed the rejection of claims 1-7 and 9-10 because the term "elevated temperatures" encompassed temperatures as low as 60C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.). MPEP 70602(d).
Table 2A and Table 4 are reproduced below:
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216
500
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224
512
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158
536
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142
544
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Paragraph 54 of the specification as published states that Example 1 shows the lowest rate of phase separation of all test samples as demonstrated in the last column of Table 4 (i.e., a value of 0.01580 at a G-force of 2128). Composition 9 shows the worst performance with a value of 0.10290, which is about 6.5X the value for Example 1. Examples 2 and 4, however, show values of 0.02170 and 0.02290, which are only 1.47X and 1.45X the values of Example 1, and as such are much closer to Example 1 than Example 9 in terms of phase separation. Additionally, Table 4 shows that the Example 2 composition actually has a lower phase separation value than the Example 1 composition at a G-force of 1630. There is no evidence of record that the moderate improvement in phase separation between Example 1 and Examples 2/4 is of any practical significance, especially since the improvement does not appear at all G-forces that were tested. Therefore, Applicant has not bet the burden of establishing the differences in rate of phase separation depicted in the working examples is of statistical and practical significance.
New Rejection
Claim 9 is rejected under 35 U.S.C. 103 as unpatentable over Takeuchi et al. (EP 1 287 813; of record in IDS in view of Takeuchi et al. (EP 1 547 576; of record in IDS; hereinafter “Takeuchi’576”) Franklin et al. (WO 94/14409; of record), and Lesniak et al. (US Pat. Pub. 2018/0235858; published 8.23.2018) as applied to claims 1, 3-6, 9, 11, 14, and 20-21 above, and further in view of Hilliard, Jr. et al. (US Pat. Pub. 2019/0358134; filed 12.8.17).
The teachings of Takeuchi, Takeuchi’576, Franklin, and Lesniak are relied upon as discussed above. Takeuchi further teaches that the PPG-15 stearyl ether is present in the amount of 1.0-6.0 wt% (paragraph 37), which slightly below the 6.27% amount recited by claim 9, the glycerin in the amount of 0.25-5 wt% (paragraph 27) which encompasses the amount of claim 9, and the two steareth emulsifiers in the amount of 1-4 wt% (paragraph 23) and 1-6 wt% (paragraph 37), which in combination reads on the 6.77 wt% for both steareth emulsifiers recited by claim 9. Takeuchi’576 further teaches that the calcium silicate is used in the amount of 0.02-10% (paragraph 53) which encompasses the amount of claim 9. Lesniak teaches amounts of 0.01-5 wt% for each of the lactic acid, sodium lactate, and sodium benzoate as discussed in the base rejection supra, which reads on the amounts of claim 9. Additionally, 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). These references do not, however, further expressly disclose the presence of caprylyl glycol in the amount of about 0.511% as recited by claim 9.
Hilliard discloses antiperspirant/deodorant compositions (Abstract), and teaches that the compositions may comprise capryl glycol as an additional deodorizing agent such as capryl glycol (synonym of “caprylyl glycol”) in the amount of 0.01-4 wt%, which reads on the amount recited by claim 9 (paragraph 51).
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 composition of Takeuchi, Takeuchi’576, Franklin, and Lesniak as combined supra by incorporating caprylyl glycol in the claimed amount, because Hilliard teaches that this compound is useful in deodorant compositions in such amounts because it imparts additional deodorizing properties to the composition. Additionally, 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.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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