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 .
Formal Matters
Receipt of Applicant’s response dated 05/28/2026 is acknowledged.
Claims 1, 4, and 7-14 are pending.
Restriction/Election
Applicant's election with traverse of Group I, claims 1, 4, and 7-13, in the reply filed on 05/28/2026 is acknowledged.
The traversal is on the grounds that there exists a technical relationship between a composition and method of its use and that the claims have been deemed novel and inventive in the international stage.
This is not found persuasive because, firstly, prosecution of the instant application is conducted independently of prosecution at the international stage and, therefore, the argument regarding the claims having been deemed novel and inventive in the international stage is not relevant to prosecution of the instant case. Secondly, per PCT Rule 13.1, the international application shall relate to a group of inventions so linked as to form a single general inventive concept or a “unity of invention” (see MPEP 1850). Per PCT Rule 13.2, “unity of invention” is fulfilled by defining a special technical feature that is shared amidst the claimed inventions. The Rule further specifies that “[t]he expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.” Lack of unity of invention may be directly evident “a priori,” or before considering any prior art when no special technical feature is common to each of the independent claims. Alternatively, lack of unity of invention may only become evident “a posteriori,” or after considering the claims in relation to the prior art. By a posteriori analysis, the claimed invention still lacks unity of invention because the special technical feature lacks inventive step in the art as demonstrated by the teaching of Doering et al (US 2017/0281517 A1, published 10/05/2017, cited in IDS dated 09/19/2024) in view of Shen (US 6,042,816 A, published 03/28/2000) discussed in the instant Office action below (See rejection under 35 USC 103 below).
The requirement is still deemed proper and is therefore made FINAL.
Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 4, and 7-13 are under consideration in the instant Office action.
Priority
This application is a 371 of PCT/EP2022/068455 filed 07/04/2022, claiming priority to EPO 21184310.7 filed 07/07/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) filed 09/19/2024 and 01/07/2025 have been considered by the Examiner. A signed copy of each IDS is included with the present Office Action.
Regarding the IDS dated 09/19/2024, Foreign reference 16 has been lined through because this regards a duplicate copy of WO2009044381 which is already cited as Foreign reference 2 in the IDS dated 09/19/2024.
Regarding the IDS dated 01/07/2025, AU2017262451 which is cited as Foreign reference 2, has been lined through because there is no corresponding document in the file. Instead, a duplicate copy of WO2017194268 which is cited as Foreign reference 25 on the IDS dated 09/19/2024 was uploaded to the file.
Claim Objections
Claims 1 and 7-8 are objected to because of the following:
The word “and” should be added at the end of line 7 of claim 1 for grammatical correctness; and
The recitation of “the aluminium-zirconium-glycine complex” in each of claims 7 and 8 should be amended to “the aluminium-zirconium penta-chlorohydrex-glycine complex” in order to improve claim readability and consistency.
Appropriate correction is required.
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, 4, and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Doering et al (US 2017/0281517 A1, published 10/05/2017, cited in IDS dated 09/19/2024) in view of Shen (US 6,042,816 A, published 03/28/2000).
Doering et al teach cosmetic agents comprising at least one specific non-ionic polyurethane polymer, at least one emulsifier having an HLB value from 1 to 6, at least one emulsifier having an HLB value from 10 to 17, at least one sweat-inhibiting and/or deodorizing active substance, and optionally further ingredients, in a cosmetically acceptable carrier (See entire document, e.g., [0012]-[0014], [0027]).
Doering et al teach that use of these non-ionic polyurethane polymers leads to a thickening of the cosmetic agents (e.g., [0040]).
Doering et al teach a list of preferred sweat-inhibiting active substances including aluminum-zirconium salts such as aluminum zirconium pentachlorohydrex glycine, teach that the aluminum-zirconium salt may be “activated”, teach that the activated salt is also referred to as antiperspirant active substances “with enhanced activity”, and teach that the activated aluminum-zirconium salt can be stabilized additionally with a water-soluble strontium salt and/or with a water-soluble calcium salt and preferably stabilized in particular by amino acids including glycine (e.g., [0055], [0058]-[0059], [0062]).
Doering et al teach that the cosmetic agents can be present in forms including emulsions (O/W or W/O emulsions) and solid compositions (e.g., [0071]).
Doering et al teach that the at least one sweat-inhibiting and/or deodorizing active substance is present in the aqueous phase of the cosmetic agent (e.g., [0090]-[0091]).
Doering et al do not teach how the aluminum-zirconium salt is activated, do not teach a molar ratio of aluminum to glycine nor a molar ratio of aluminum to calcium, do not teach examples of suitable water-soluble calcium salts, and do not teach a fragrance as an optional further ingredient.
These deficiencies are made up for in the teaching of Shen.
Shen teaches a method of preparing an enhanced (i.e., activated) aluminum-zirconium antiperspirant salt that involves heating an aqueous solution of the aluminum-zirconium antiperspirant salt in the presence of a soluble calcium salt and a water soluble amino acid or hydroxy acid at a temperature and for a time sufficient to convert the salt to an enhanced antiperspirant salt, which is typically at about 40 °C to about 100 °C and typically for about 2 to about 120 hours (See entire document, e.g., Col. 4 Lines 51-58, Col. 10 Lines 56-63).
Shen teaches a list of preferred soluble calcium salts including calcium chloride and teaches a list of preferred water soluble amino and/or hydroxy acids including glycine, wherein glycine is most preferred (e.g., Col. 6 Lines 21-22, 28, 45-48, 60-62). The amino and/or hydroxy acid need not be separately added to the composition but may be included as part of the antiperspirant salt complex such as, for example, Al--Zr--Gly salts (e.g., Col. 7 Lines 3-7). The amount of calcium salt utilized should be that amount which provides a Ca:Al+Zr weight ratio of about 1:1 to about 1:28, preferably about 1:2 to about 1:25 (e.g., Col. 6 Lines 34-37). The amount of amino acid or hydroxy acid utilized should be that amount which provides an acid:Al+Zr ratio of about 2:1 to about 1:20, preferably about 1:1 to about 1:10, and most preferably about 1:2 to about 1:7 (e.g., Col. 6 Lines 62-66).
Shen teaches that the stabilized, enhanced antiperspirant salts may be formulated into topical compositions including creams, gels, and sticks and that aqueous solutions of these stabilized antiperspirant salts may be directly utilized in oil-in-water and water-in-oil emulsions (e.g., Col. 13 Lines 56-61).
Shen exemplifies an antiperspirant gel composition which comprises a fragrance and comprises the stabilized, enhanced aluminum-zirconium antiperspirant salt in the water phase (e.g., Col. 14 Lines 5-23).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, based on the teachings of Doering et al and Shen, to provide a cosmetic agent composition comprising at least one specific non-ionic polyurethane polymer, at least one emulsifier having an HLB value from 1 to 6, at least one emulsifier having an HLB value from 10 to 17, at least one sweat-inhibiting and/or deodorizing active substance being activated aluminum zirconium pentachlorohydrex glycine stabilized by a water-soluble calcium salt being calcium chloride, and a fragrance, in a cosmetically acceptable carrier, wherein the composition may be an O/W emulsion or a W/O emulsion, wherein the aluminum zirconium pentachlorohydrex glycine is activated by heating an aqueous solution of the aluminum zirconium pentachlorohydrex glycine in the presence of the calcium chloride and the glycine at about 40 °C to about 100 °C for about 2 to about 120 hours, wherein the stabilized, activated aluminum zirconium pentachlorohydrex glycine is present in the aqueous phase, wherein the Ca:Al+Zr weight ratio is about 1:1 to about 1:28, and preferably about 1:2 to about 1:25, wherein the glycine:Al+Zr weight ratio is about 2:1 to about 1:20, preferably about 1:1 to about 1:10, and most preferably about 1:2 to about 1:7, and wherein the cosmetic agent composition may be formulated as a solid such as a stick.
One of ordinary skill in the art would have been motivated to use the method of enhancement (i.e., activation) taught by Shen because Doering et al teach that the aluminum-zirconium salt may be “activated” and that the activation leads to enhanced activity, however, do not provide a teaching regarding a method for said activation. One of ordinary skill in the art would have been motivated to use calcium in an amount that results in a Ca:Al+Zr weight ratio of about 1:1 to about 1:28, and preferably about 1:2 to about 1:25, and motivated to use glycine in an amount that result in a glycine:Al+Zr weight ratio of about 2:1 to about 1:20, preferably about 1:1 to about 1:10, and most preferably about 1:2 to about 1:7, because Doering et al teach that the activated aluminum-zirconium salt can be stabilized additionally with a water-soluble strontium salt and/or with a water-soluble calcium salt and preferably stabilized in particular by amino acids including glycine, however, do not provide a teaching regarding what molar ratios should be used. One of ordinary skill in the art would have been motivated to add a fragrance to the cosmetic agent composition of Doering et al because Shen et al teach incorporation of fragrance to a composition comprising a stabilized, enhanced aluminum-zirconium antiperspirant salt and Doering et al teach the compatibility of the cosmetic agent composition with further ingredients. One of ordinary skill in the art would have been motivated to formulate the cosmetic agent composition, in the form of an oil-in-water emulsion or a water-in-oil emulsion, as a solid such as a stick because Doering et al teach compatibility of the composition comprising the stabilized, activated aluminum-zirconium salt with forms including an oil-in-water emulsion, a water-in-oil emulsion, and a solid and Shen et al teach compatibility of the composition comprising the stabilized, enhanced antiperspirant salt with forms including a cream, a gel, a stick, an oil-in-water emulsion, and a water-in-oil emulsion. There would have been a reasonable expectation of success in looking to the above teachings of Shen to modify the above teachings of Doering et al because of the similarities of the subject matter, e.g., each of the compositions of Doering et al and Shen regard antiperspirant/sweat-inhibiting compositions comprising activated/enhanced aluminum-zirconium salt stabilized by a water-soluble calcium salt.
Regarding the requirement of the instant claims that the composition comprise a thickening agent, the at least one specific non-ionic polyurethane polymer in the cosmetic agent composition of Doering et al in view of Shen meets this limitation because of the thickening property of the non-ionic polyurethane polymer taught by Doering et al (see supra).
Regarding the requirement of the instant claims that the aqueous phase has a pH of 3.5 to 4.1, the activated aluminum zirconium pentachlorohydrex glycine stabilized by calcium chloride being present in the aqueous phase in the composition of Doering et al in view of Shen being the same as the aluminium-zirconium penta-chlorohydrex-glycine complex and calcium salt having a solubility in water of 10 g/L or greater in the composition being present in the aqueous phase in the composition of instant claim 1, meets this limitation because, as evidenced by Page 25, specifically Table 10, of the instant specification, an inventive emulsion composition comprising an aqueous phase of aluminium-zirconium penta-chlorohydrex-glycine complex and calcium chloride dihydrate exhibits a pH of 3.74 ± 0.02.
Regarding the ranges required by the instant claims, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)). 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)).
Thus, the composition of Doering et al and Shen renders obvious instant claims 1, 4, and 7-13.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, and 7-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, and 8-13 of copending Application No. 18/572,086 (hereafter ‘086) in view of Doering et al (as cited above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claims 1, 4, and 7-13 recite an emulsion antiperspirant (AP) composition comprising: an aqueous phase; an oil phase; and an emulsifier; wherein the aqueous phase comprises an aluminium-zirconium penta-chlorohydrex-glycine complex and a calcium salt having a solubility in water of 10 g/L or greater, wherein the molar ratio of aluminium to glycine is from 2 to 6 and the molar ratio of aluminium to calcium is from 2 to 7, wherein the aqueous phase has a pH of 3.5 to 4.1, wherein the aluminium-zirconium-glycine complex is heat activated by the calcium salt, wherein the aluminium-zirconium-glycine complex is heat activated by the calcium salt for at least 30 mins, at a temperature of at least 50 °C, wherein the calcium salt is calcium chloride, the composition being an oil-in-water emulsion, the composition being a water-in-oil emulsion, comprising a thickening agent and which is in the form of a solid stick or soft solid, and comprising a fragrance.
Claims 1-3, 5-6, and 8-13 of ‘086 recite an antiperspirant composition manufactured by a method of manufacture of an aluminium-zirconium (Al/Zr) antiperspirant active comprising: heating in aqueous solution: an aluminium-zirconium penta-chlorohydrex-glycine complex, and a calcium salt having a solubility in water of 10 g/L or greater measured at 20° C and 1 atmosphere pressure, wherein a molar ratio of aluminium to calcium is from 1.3 to 60, wherein the molar ratio of aluminium to glycine is from 1.5 to 25, wherein the aqueous solution has a pH of from 3.5 to 4.1, wherein the molar ratio of aluminium to calcium is from 1.8 to 20, wherein the aqueous solution is heated to 50° C or above for 30 minutes or longer, wherein a resulting aqueous solution is subsequently spray-dried to give a solid particulate antiperspirant active, wherein the solid particulate antiperspirant active is subsequently mixed with a carrier oil and structuring agent to form a solid stick or soft solid composition, wherein the calcium salt is calcium chloride, wherein a resulting Al/Zr antiperspirant active is subsequently mixed with a fragrance or an emollient oil, and wherein a resulting Al/Zr antiperspirant active in aqueous solution is emulsified with a fragrance and/or an emollient oil with shear and an emulsifier.
Claims 1-3, 5-6, and 8-13 of ‘086 do not recite the composition being an oil-in-water emulsion or a water-in-oil emulsion.
These deficiencies are made up for in the teaching of Doering et al, which has been discussed supra.
It would have been prima facie obvious to one of ordinary skill in the art to formulate the antiperspirant composition of the claims of ‘086 as an oil-in-water emulsion or as a water-in-oil emulsion because Doering et al teach the compatibility of a similar composition with forms including an oil-in-water emulsion and a water-in-oil emulsion (see teaching of Doering et al supra).
Thus, claims 1-3, 5-6, and 8-13 of ‘086 in view of Doering et al render obvious instant claims 1, 4, and 7-13.
Conclusion
No claims are allowable.
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/K.E.O./Examiner, Art Unit 1619
/NICOLE P BABSON/Primary Examiner, Art Unit 1619
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