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 .
Applicants' arguments, filed 09/12/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 103—Previous
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.
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.
Claim(s) 1, 5, 8-14, 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pramanik et al., (WO 2020/030414, cited in IDS) in view of Thong et al., (US 5,955,065).
Pramanik et al. teaches “AN ANTIPERSPIRANT COMPOSTION” (Ti.) comprising “a complex of a zinc salt with a β amino acid in an anhydrous carrier” (Abstract), “wherein the molar ratio of zinc salt to β amino alcohol is from 1:0.5 to 1:3” (p. 2, lines 5-7), “preferably in the range of 1:1 to 1:3” (p. 5, line 30).
The preferred β amino alcohol “is chosen from mono ethanol amine, diethanol amine, triethanol amine or 2-amino-1-butanol” (p. 2, lines 9-10).
The preferred anhydrous carrier “is ethanol or propanol preferably ethanol” (p. 6, lines 12-13) and further a “polyhydric alcohol” such as “glycerol, propylene glycol, glycerol or xylitol” (p. 6, lines 22-27).
It should be noted here that the amount of anhydrous carrier has not been delineated by the prior art; however, the artisan would have been motivated to provide an amount of carrier suitable for manufacturing the breath of antiperspirant forms, such as stick, soft solid, roll-on, aerosol. Accordingly, "[W]here 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" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)).
The preferred zinc salts include “chloride, formate, acetate, propionate, gluconate or citrate of zinc” (p. 3, lines 27-28).
Method of use comprises “the step of applying a composition as claimed in the first aspect on to the desired skin surface” (p. 2, lines 12-14).
“The pH of the composition is preferably in the range of 5 to 8” (p. 6, line 1).
“The complex is preferably prepared by a process comprising the steps of (i) dissolving the β amino alcohol in a volatile alcohol; and (ii) dissolving therein the zinc salt” (p. 6, lines 7-8), as per claim 13.
Pramanik et al. does not teach calcium chloride.
Thong et al. teaches antiperspirant compositions containing calcium salts (Ti), wherein the “amount of water soluble calcium salt in the composition will typically fall within about 0.5 to about 15% by weight” (col. 3, lines 33-36).
“The more preferred calcium salts are calcium chloride and calcium nitrate, with calcium chloride being the most preferred” (col. 4, lines 55-56).
Thong et al. further teaches, “The compositions with calcium chloride will exhibit improved thermal efficacy compared to similar composition without calcium chloride” (col. 6, lines 18-20).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add calcium chloride to the antiperspirant composition of Praminik et al. since calcium chloride is known in the art to be added to antiperspirant compositions, as taught by Thong et al. The artisan would have been further motivated to add calcium chloride for the advantage of improving thermal efficacy compared to similar compositions without calcium chloride, as taught by Thong et al.
Response to Arguments
The affidavit of Satyajit Samadder, filed on 09/12/2025, is acknowledged. Affiant provided experimental data alleged to “demonstrate the unexpected and surprising criticality of the claimed anhydrous solvent mixture in claim 1” (p. 2, paragraph 5).
Affiant submits Table 5 showing 6 total samples i.e. Example C to G and Example 5. Affiant admits, “Each example in Table 5 is a new sample not previously described in the present application as originally filed” (Id. paragraph 2). According to Affiant: “The results demonstrate that compositions according to the claimed invention (1.e., Example 5) having an anhydrous solvent comprising a mixture of ethanol and propylene glycol in accordance with pending claim | unexpectedly provide good antiperspirant activity as illustrated by the percentage flow rate reduction values in Table 5. The comparative examples (outside of the scope of the invention), i.e., Examples C through G, which comprised glycerol and/or ethanol as the anhydrous solvent, did not exhibit this benefit, giving much lower percentage flow rate reduction” (p. 3, paragraph 8).
Initially, there is no statement in the instant specification in reference to secondary considerations, such as unexpected or surprising results.
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. In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) (MPEP 716.02(c)).
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) (MPEP 716.02(b)).
In this case, affiant does not indicate what was reasonably expected from the combination prior to experimentation such that the results are truly unexpected. There is also no evidence that the experiments were performed in triplicate to reduce impact of random errors, improve accuracy and reliability, and validate results. The PFRR results of formula 5 in view of the comparative example C, on its face, do not appear to be statistically significant.
It is well settled, that there must be demonstration of a difference between the claimed invention and the closest prior art. In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.”). Due to the absence of tests comparing affiant's claimed invention with those of the closest prior art, i.e. Example 1 Pramanik et al., affiant's assertions of unexpected results constitute mere argument.
Moreover, affiant’s results are not a difference in kind from the results shown in the prior art from the same combination of ingredients. Again, the prior art teaches combining a zinc salt with a β amino alcohol in an anhydrous solvent, for the purpose of preventing perspiration. Affiant’s results demonstrate the reasonable expectation of the artisan, i.e., that the combination of zinc salt with a β amino alcohol in an anhydrous solvent, including ethanol, propylene glycol, and calcium chloride, would have been useful for reducing perspiration.
The artisan would have reasonably been expected to optimize combinations of antiperspirant and anhydrous solvent for purpose of improving antiperspirant efficacy of Pramanik et al. See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
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. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." Compare In re Wagner, 371 F.2d 877, 884, 152 USPQ 552, 560 (CCPA 1967) (differences in properties cannot be disregarded on the ground they are differences in degree rather than in kind); Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) ("we generally consider a discussion of results in terms of ‘differences in degree’ as compared to ‘differences in kind’ . . . to have very little meaning in a relevant legal sense").
In this case, affiant’s results, showing marked improvement over results with other combinations of anhydrous solvents and agents known to benefit antiperspirants constitute a difference in degree from what is expected from the combination rather than a difference in kind, as required for a demonstration of unexpected results.
Even if applicant’s data supported an unexpected result, the instant claims are not commensurate in scope with those data. 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" (see MPEP 716.02(d) quoting In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)). While applicant’s embodiments require specific combinations of ingredients, the instant claim provide a generalized recitation of ingredients.
In the recent remarks, Applicant additionally argues, “Thong expressly teaches away from including higher than 2% by weight of lower alkanol such as ethanol by weight of the carrier vehicle” and “it is only in hindsight could a person of ordinary skill in the art expect that the combination of calcium salt, particularly calcium chloride, with an aluminum-based antiperspirant salt would provide a similar benefit in a composition having a complex of a zinc salt with a β amino alcohol” (p. 7-8).
However, “Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
In this case, Thong was used to provide motivation for adding calcium chloride to the antiperspirant of Pramanik et al. The primary reference, Praminik et al. provides sufficient motivation to add the claimed anhydrous solvents.
Further, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Here, the office relies solely on the prior art for providing motivation to combine anhydrous solvents like ethanol and other agents like calcium chloride to the antiperspirant of Pramanik et al.
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.
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Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612