DETAILED ACTION
This action is in response to papers filed on 09/30/2025. Claims 1, 3, and 10, and 12-17 of Cross et al., 18004997 (01/10/2023) are pending: claims 2, 4-9, and 11 are canceled, claims 1 is amended, and claims 14-15 remain withdrawn. Claims 1, 3, 10, 12-13, and 16-17 are rejected. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/30/2025 has been entered.
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
This application is a 371 of PCT/EP2021/0691 72 (07/09/2021) and claims Foreign Priority to EUROPEAN PATENT OFFICE (EPO) 20185487.4 (07/13/2020).
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
In a response filed on 12/02/2025, Applicant elected Group 1, claims 1-3 and 5-15, drawn to an solid antiperspirant composition in the form of a water-in-oil emulsion comprising an aqueous phase comprising dissolved aluminum sesquichlorohydrate, an oil phase, an emulsifier, a polyol, solidifying agent wherein the polyol is glycerol, propylene glycol and or PEG oligomers having a molecular weight average from 180 to 420 and is present at a total level of at least % by weight the total composition and wherein the composition comprises an amino acid and a water-soluble calcium salt, to which the claims must be restricted. Applicant elected Group I, with traverse, based on a “existing technical relationship between a composition and method of its use, i.e., category (2) under 1.475(b)” (p. 2, Applicant’s Remarks).
The Examiner acknowledges Applicant’s traversal, but respectfully highlights that based on the prior art, the common technical feature of the instant claims lacks novelty over the prior art. Since the common technical feature is taught by the prior art, the common technical feature does not rise to the level of a special technical feature. Thus, the groups lack unity of invention a posterori, and restriction between them is proper. Accordingly, any subsequent patentably distinct invention lacks unity with the first group, see 37 CFR § 1.476 (d). Claims 14, and 15, drawn to non-elected groups, are hereby withdrawn.
Withdrawn Rejections/Objections
The following objections and/or rejections have been withdrawn:
The objection to the Specification is withdrawn in view of Applicant’s arguments (Applicant’s Remarks, at page 5).
The objection of claim 1 is withdrawn in view of Applicant’s amendment to claim 1. (Applicant’s Remarks, at page 5).
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.
Claims 1, 3, 10, 12-13, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lemoine et al., WO2009077453A1, (“Lemoine”), in view of Fawzy et al., WO 2014/187685, (“Fawzy”), and as evidenced by US Patent 9375501, and Phipps et al., (US 20110038823 A1) (“Phipps”).
Regarding claim 1, Lemoine teaches a solid antiperspirant composition in the form of a water-in-oil emulsion comprising carrier, aqueous phase, wax, emulsifier, and at least one antiperspirant (Abstract; p. 1, ll. 5-20). The solid antiperspirant composition is in the form of a solid antiperspirant stick (pp. 1, ll. 33) comprising: (i) aluminum sesquichlorohydrate (ASCH) antiperspirant active (p. 11, ll. 7-8); (ii) an oil phase (pp. 13-16); (iii) an emulsifier and (iv) a polyol (pp. 6-7; pp. 18, ll. 17-22; claims 2-4; and page 17, ll. 1-6; and (v) a solidifying agent in the form of waxes (p.10, ll. 12-22), wherein “The preferred waxes are the polyethylene waxes Performalene 400 polyethylene or Performalene 500-L polyethylene” (pp. 7-8, and p. 10, ll. 20-22).
Regarding the polyol that is glycerol, Lemoine teaches that the aqueous phase may contain solvents other than water, for instance polyols such as, for example, glycerol, and propylene glycol (p. 17 ll. 1-6: “The aqueous phase may contain solvents other than water, for instance polyols such as, for example… glycerol”); and p. 14, ll. 26). Lemoine also uses activated aluminum hydrochlorides with an amino acid (p. 10, ll. 32; p. 20, ll. 3).
Regarding the composition comprising a water-soluble calcium salt, although Lemoine uses zinc salts (p. 12, ll. 21) rather than calcium salt, the selection of one salt for another is prima facie obvious to one of ordinary skill in the art as taught by US Patent 9375501 which discloses deodorants and the use of calcium chloride or zinc chloride as the salts (claim 1).
The claimed invention differs from Lemoine in terms of the following:
Regarding the polyol being present at a total level of at least 5% by weight of the total composition, Lemoine does not teach, for example, glycerol being at least 5%.
However, to one of ordinary skill in the art, these are subjected to routine optimization depending on desirability. In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "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." This is underscored by Lemoine’s teachings on page 23, ll. 25-30 that: “Of course, those skilled in the art will take care to select the optional additional additives and/or the amount thereof in such a way that the advantageous properties of the composition according to the invention are not, or are not substantially, impaired by the addition envisaged.”.
Nonetheless, Fawzy teaches “An aqueous composition comprising basic aluminium chloride salt, water soluble calcium salt, and amino acid, characterized in that the basic aluminium chloride salt is of formula Al2OH4.4Cl1.6 to Al2OH4.9Cl1.1 and methods for making such compositions having enhanced antiperspirancy performance.” (Abstract). Said composition comprises polyols such as glycerol and propylene glycol present from 0.5% to 10% of the total composition (p. 14, ll. 6-13). Fawzy, also teaches about the polyol being glycerol on p. 14, ll. 6-8, and teaches at ll. 11-13 that: “Such components may add to the sensory properties of the composition and, when included, are typically present at from 0.5 to 10% of the total composition…”. 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). Lemoine in view of Fawzy teaches the limitation wherein the polyol being present at a total level of at least 5%.
Regarding the limitation, “wherein the oil phase constitutes from 40 to 70% by weight of the composition”.
Lemoine teaches on page 16, at lines 19-21, that the fatty phase represents from 10% to 40% by weight relative to the total weight of the composition. 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). Lemoine’s high end value of 40% overlaps with Applicant’s claimed range starting at 40%-70%. However, to one of ordinary skill in the art, these are subjected to routine optimization depending on desirability. In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "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." This is underscored by Lemoine’s teachings on page 23, ll. 25-30 that: “Of course, those skilled in the art will take care to select the optional additional additives and/or the amount thereof in such a way that the advantageous properties of the composition according to the invention are not, or are not substantially, impaired by the addition envisaged.”.
Fawzy also teaches on page 10, that the total amount of oil in the composition is preferably from 0.1 to 20% (c.f., lines 4-5), which demonstrates that to one of ordinary skill in the art, routinely optimizing the oil phase depends on desirability.
Phipps teaches a similar antiperspirant emulsion product comprising a water-in-oil emulsion having a water phase and an oil phase. The water phase comprises an activated aluminum sesquichlorohydrate (ASCH) active system and the oil phase comprises cetyl PEG/PPG-1071 dimethicone and a hydrophobic carrier.
As taught by Phipps at page 2, para. [0013], the antiperspirant emulsion product comprises a water phase in an amount of about 60 to about 85 weight percent (wt.%) of the total antiperspirant emulsion product, and an oil phase in an amount of about 15 to about 40 wt.% of the total antiperspirant emulsion product.
Given that the high end of the oil phase disclosed by Lemoine and Phipps antiperspirant emulsion product comprises about 40% of oil phase, and in the absence of evidence demonstrating the criticality of the claimed range, a prima facie case of obviousness is established. Moreover, according to MPEP § 2144.05(I), obviousness may be found where the claimed ranges do not overlap with the prior art but are merely close. Since the proportions are sufficiently similar, one skilled in the art would reasonably expect them to exhibit the same properties. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Moreover, "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).
It would have therefore been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate a solid antiperspirant composition in the form of a water-in-oil emulsion comprising: (i) aluminum sesquichlorohydrate (ASCH) antiperspirant active (p. 11, ll. 7-8); (ii) an oil phase (pp. 13-16); (iii) an emulsifier and (iv) a polyol (pp. 6-7; pp. 18, ll. 17-22; claims 2-4); and (v) a solidifying agent in the form of waxes (p.10, ll. 12-22) as disclosed by Lemoine, and further include glycerol in an amount of at least 5% (w/w) based Fawzy’s teachings, and Phipps teachings of the claimed oil phase being about 40%, and arrive at the claimed invention successfully. One of skill in the art would be motivated to do so, in the claimed amounts because, as disclosed by Fawzy, “Such components may add to the sensory properties of the composition” (p. 14, ll. 11-12). Consistent with this reasoning, the combination of ingredients making up the claimed composition are known to one of ordinary skill in the art, so much so that, that it would have been obvious to one of ordinary skill in the art to arrive at the claimed compositions yielding no more than one would expect from such an arrangement.
Moreover, as discussed above, the range disclosed for the oil phase and glycerol is within the skill of an artisan to routinely optimize and formulate in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "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." See MPEP § 2144.05, "II. Optimization of Ranges". 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); and in cases where the claimed ranges do not overlap with the prior art but are merely close. Since the proportions are sufficiently similar, one skilled in the art would reasonably expect them to exhibit the same properties. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Furthermore, regarding the amino acid, both Lemoine and Fawzy teach wherein the amino acid is glycine (for e.g., Lemoine: p. 10, ll. 32; and Fawzy: p. 6, ll. 25: “Preferred amino acids for use in the present invention are glycine, alanine, valine and praline.”), where glycine is the preferred amino acid. Taken together, the ASCH AP active is a calcium-activated ASCH glycine complex.
Claim 1 is obvious over Lemoine, in view of Fawzy, US Patent 9375501, and Phipps.
Regarding claim 3, and as applied above to claim 1, Lemoine in view of Fawzy teaches the composition of claim 1, wherein the polyol is present at a total level of at least 8% by weight of the total composition (Fawzy, p. 14, ll. 6-8 regarding polyols: “Such components may add to the sensory properties of the composition and, when included, are typically present at from 0.5 to 10% of the total composition.”). Claim 3, as is claim 1, is also obvious.
Regarding claim 10, and as disclosed by Lemoine, “The aqueous phase will preferably range from 50% to 80% by weight relative to the total weight of the composition.” (p. 16, ll. 30-32). 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). Furthermore, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "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." See MPEP § 2144.05, "II. Optimization of Ranges". Claim 10, as is claim 1, is also obvious.
Regarding claim 12, and as disclosed by Lemoine, “active agents in the cosmetics or dermatological field that can be used in the cosmetics or be used according to the invention” include, for example, a-hydroxy acids such as lactic acid, citric acid and glycolic acid, which are skin tone modifiers (p. 21, ll. 14-20). Claim 12, as is claim 1 is also obvious.
Regarding claim 13, and as disclosed by Lemoine, different oils can be used including ester and ether oils (p. 14, ll. 13-30) or mineral oils (p. 14, ll. 30-34). Claim 12, as is claim 1 is also obvious.
As stated above, it would have therefore been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate a solid antiperspirant composition in the form of a water-in-oil emulsion comprising: (i) aluminum sesquichlorohydrate (ASCH) antiperspirant active (p. 11, ll. 7-8); (ii) an oil phase (pp. 13-16); (iii) an emulsifier and (iv) a polyol (pp. 6-7; pp. 18, ll. 17-22; claims 2-4); and (v) a solidifying agent in the form of waxes (p.10, ll. 12-22) as disclosed by Lemoine, and further include glycerol in an amount of at least 5% (w/w) based Fawzy’s teachings, and arrive at the claimed invention successfully. One of skill in the art would be motivated to do so, in the claimed amounts because, as disclosed by Fawzy, “Such components may add to the sensory properties of the composition” (p. 14, ll. 11-12). Consistent with this reasoning, the combination of ingredients making up the claimed composition are known to one of ordinary skill in the art, so much so that, that it would have been obvious to one of ordinary skill in the art to arrive at the claimed compositions yielding no more than one would expect from such an arrangement.
Moreover, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "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." See MPEP § 2144.05, "II. Optimization of Ranges". 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 16-17, Lemoine’s teachings in view of Fawzy, Phipps and US Patent 9375501 as applied to claim are is discussed above. Claims 16-17 recite the limitation wherein the oil phase present in the solid antiperspirant stick composition according to claim 1 constitutes from about 40-70% by weight of the total composition. This is discussed and applied in claim 1.
Given that the high end of the oil phase disclosed by Phipps antiperspirant emulsion product comprises about 40% of oil phase, and in the absence of evidence demonstrating the criticality of the claimed range, a prima facie case of obviousness is established. Moreover, according to MPEP § 2144.05(I), obviousness may be found where the claimed ranges do not overlap with the prior art but are merely close. Since the proportions are sufficiently similar, one skilled in the art would reasonably expect them to exhibit the same properties. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Moreover, "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). Claims 16-17 are therefore also obvious.
Applicant’s Arguments
Applicant essentially contends that the Office has not presented a case as to why one would choose calcium salts would be preferred over zinc salts, as used by Lemoine, when used in combination with aluminum-containing antiperspirant actives such as ASCH (Applicant’s Remarks at page 6). Applicant also alleges unexpected results, and argues that the antiperspirant composition of the present invention provided a water-in-oil antiperspirant stick formulation exhibiting high antiperspirancy efficacy. Applicant’s Remarks at page 7. Applicant argues that none of the secondary references remedies the gap of Lemoine, or overcomes the alleged unexpected results of high antiperspiracy efficacy.
Examiner’s Response
The Examiner acknowledges the Applicant’s amendment to claim 1. Applicant’s arguments have been fully considered by the Examiner, especially in regard to the combination of Lemoine and Fawzy, and respectfully maintains that the claimed invention remains obvious for the following reasons as discussed above:
The claimed invention differs from Lemoine in terms of the following:
Regarding the polyol being present at a total level of at least 5% by weight of the total composition, Lemoine does not teach, for example, glycerol being at least 5%.
However, to one of ordinary skill in the art, these are subjected to routine optimization depending on desirability. In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "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." This is underscored by Lemoine’s teachings on page 23, ll. 25-30 that: “Of course, those skilled in the art will take care to select the optional additional additives and/or the amount thereof in such a way that the advantageous properties of the composition according to the invention are not, or are not substantially, impaired by the addition envisaged.”.
Nonetheless, Fawzy teaches “An aqueous composition comprising basic aluminium chloride salt, water soluble calcium salt, and amino acid, characterized in that the basic aluminium chloride salt is of formula Al2OH4.4Cl1.6 to Al2OH4.9Cl1.1 and methods for making such compositions having enhanced antiperspirancy performance.” (Abstract). Said composition comprises polyols such as glycerol and propylene glycol present from 0.5% to 10% of the total composition (p. 14, ll. 6-13). Fawzy, also teaches about the polyol being glycerol on p. 14, ll. 6-8, and teaches at ll. 11-13 that: “Such components may add to the sensory properties of the composition and, when included, are typically present at from 0.5 to 10% of the total composition…”. 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). Lemoine in view of Fawzy teaches the limitation wherein the polyol being present at a total level of at least 5%.
Regarding Applicant’s arguments referencing benefits such as improved “antiperspirancy efficacy”, these are not supported by any critical data over the claimed range, and is not commensurate in scope with the claims as presented.
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 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). 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.). 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. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). This is presently not the case.
Furthermore, even if Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, this cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Additionally, modifying the concentration of a known component within a composition to optimize known properties (e.g., sensory feel, antiperspiracy efficacy, residue profile, etc.), falls well within the routine skill of one of ordinary skill in the art, particularly where the prior art teaches the benefits of varying the oil content for enhanced cosmetic and/or performance effects.
Finally, Applicant’s argument that the motivation of choosing calcium salts over zinc salts when used in combination with aluminum-containing antiperspirant actives such as ASCH is not provided. This argument is not found to be persuasive because as discussed above, although Lemoine uses zinc salts (p. 12, ll. 21) rather than calcium salt, the selection of one salt for another is prima facie obvious to one of ordinary skill in the art as taught by US Patent 9375501 which discloses deodorants and the use of calcium chloride or zinc chloride as the salts (claim 1) in the formulation. US Patent 9375501 shows that calcium and zinc salts are functionally interchangeable as stabilizing or performance-modifying additives (i.e., predictable alternatives), and the choice between them depends on routine optimization based on formulation needs. A person of ordinary skill in the art would have routine motivation to evaluate either salt in an ASCH-containing formulation to optimize performance or stability. Applicant has not shown any unexpected technical difference between Zinc activated ASCH and calcium-ASCH systems. Absent such evidence, the selection of calcium chloride remains a predictable modification. Furthermore, based on the chemistry between calcium ions and aluminum, there is implicit motivation to use calcium salts over zinc salts. Accordingly, Applicant’s arguments that there is no motivation is not found to be persuasive. Additionally, obviousness does not require absolute predictability, but a reasonable expectation of success. See MPEP 2143.02. The rejection is maintained.
Conclusion
No claims are allowed.
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/C A/Examiner, Art Unit 1622 December 10, 2025
/DANAH AL-AWADI/Primary Examiner, Art Unit 1615