DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election with traverse of Group I in the reply filed on 6/26/2026 is acknowledged. The traversal is on the ground(s) that there would be undue search burden. This is not found persuasive because search burden is not a criteria to demonstrate lack of unity for national state applications. The claims lack unity for the reasons set forth in the restriction mailed 4/8/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/26/2026.
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statement filed 1/7/2025 is acknowledged.
Claim Rejections - 35 USC § 103
3. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Shen (WO 0010512 A2) in view of Franklin et al. (US 20160136066) and Zijun Li (US Patent 7087220).
Shen (WO 0010512 A2), published 03/02/2000, cited in IDS dated 01/07/2025) teaches compositions comprising enhanced efficacy antiperspirant salts stabilized by inclusion of calcium and an amino acid or a hydroxy acid (See entire document, e.g., Abstract). A preferred salt is aluminum-zirconium chlorohydrate which includes the penta-chlorohydrate form (e.g., Page 7 Lines 30-34). Preferred calcium salts include calcium chloride (i.e., a suitable calcium salt having a solubility in water of 10 g/L or greater of the instant claims; see claim 9) (e.g., Page 8 Lines 32-33). The most preferred amino and/or hydroxy acid is glycine, and the amino and/or hydroxy acid may be included as part of the antiperspirant salt complex such as, for example, Al-Zr-Gly salts (e.g. aluminum-zirconium tetrachlorohydrate-gly), wherein the glycine content of the salts may be adjusted (e.g., Page 9 Lines 22-24, 30-34). The composition will comprise in percent by weight about 18% to about 45% antiperspirant salt, about 20% to about 80% water, an amino acid or a hydroxy acid in an amount to provide an acid:Al+Zr weight ratio of about 2:1 to about 1:20, and a soluble calcium salt in an amount to provide a Ca:Al+Zr weight ratio of about 1:1 to about 1:28 (e.g., Page 10 Lines 13-19). The compositions may be formulated as oil-in-water and water-in-oil emulsions (e.g., Example 7 on Page 19 Line 30-Page 20 Line 3). The compositions comprise fragrance (ex 8). Claim 9 recites that the aluminum-zirconium complex is heat activated by the water-soluble calcium salt for at least 30 min at a temperature of at least 50° C. This is regarded as a product by process claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe. It must be noted that the recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed.Cir. 1997) MPEP § 2111.02. The compositions may contain ethanol (Example 8).
Shen et al. does not explicitly teach the molar ratio of aluminum to calcium ratio from 1.3 to 60 and molar ratio of aluminum to glycine from 1.5 to 25.
Franklin et al. (US 20160136066) (hereinafter Franklin et al.) teach molar ratio of calcium to aluminum from 1:20 to 1:5 (para 0031-0032). The molar ratio of amino acid to aluminum is at least 1:4 (para 0030). Franklin et al. teach calcium to aluminum molar ratio and/or amino acid to aluminum molar ratio lead to compositions of higher Band III content (vide infra) and, in general, higher antiperspirancy performance. It will be noted that higher Band III content is generally indicative of higher antiperspirancy performance (para 0033). A preferred amino acid is glycine (para 0034). Franklin et al. teach in order for the antiperspirant to become activated, it is important to have sufficient amino acid present relative to the amount of aluminum present. The molar ratio of amino acid to aluminum is at least 1:20, preferably at least 1:10 and most preferably at least 1:5. It is not advantageous to have the amino acid concentration in excess of the aluminum concentration; hence, the molar amino acid to aluminum is preferably from 1:20 to 1:1, more preferably from 1:10 to 1:1 and most preferably from 1:5 to 1:1 (para 0029). In order for the antiperspirant to become activated, it is important to have sufficient calcium present relative to the amount of aluminum present. The molar ratio of calcium to aluminum is at least 1:40, preferably at least 1:30 and more preferably at least 1:20. It is not advantageous to have the calcium concentration in excess of the aluminum concentration, indeed it is preferred that the calcium concentration is no more than half that of the aluminum concentration and more preferred that it is no more than a fifth of said concentration. For the preferred molar ratio of calcium to aluminum of at least 1:20, it is independently preferred that this ratio is no greater than 1:2 and more preferred that it is no greater than 1:5 (para 0025).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to optimize the molar ratio of aluminum to calcium and optimize the molar ratio of aluminum to glycine. One would have been motivated to do so as taught by Franklin et al, doing so allows for the antiperspirant to become activated.
Shen et al. does not teach pH as claimed. Zijun Li (US Patent 7087220) teach that products with a lower pH tend to increase the irritancy potential of the actives. The pH is at least 3.5. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the pH of the antiperspirant composition be of at least 3.5. One would have been motivated to do so because a lower pH tend to increase the irritancy potential of the active ingredients.
DOUBLE PATENTING
4. 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 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 7-13 of copending Application No. 18571916. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to antiperspirant compositions containing an aluminium-zirconium pentachlorohydrex-glycine complex and 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 2-7. The differences being that the ‘916 reference discloses an aqueous and oil phase where the instant application is an aqueous form however, the instant application does disclouse inclusions of oils and antiperspirant compositions can be in aqueous form or in emulsion forms as taught by WO 0010512 A2 .
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
CORRESPONDENCE
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANAH AL-AWADI/ Primary Examiner, Art Unit 1615
Prosecution Insights