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 .
DETAILED ACTION
A fifth 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 30, 2026 has been entered.
Claims 9-14, 16, 17, 29, 31 and 32 are pending.
Claims 1-8, 15, 18-28 and 30 are cancelled.
Claim 29 is currently amended.
Claims 9-14, 16 and 17 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 29, 31 and 32 as filed on March 30, 2026 are under consideration.
This action is made FINAL.
Withdrawn Objections / Rejections
In view of the amendment of the claims, all previous claim objections are withdrawn.
Applicant’s arguments 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 29, 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Salama et al. (WO 2022/190086, filed March 7, 2022 and claiming priority to March 7, 2021, of record).
Salama teaches preservative compositions comprising a zinc (divalent transition metal) compound inclusive of zinc gluconate and an organic acid and/or a salt thereof inclusive of benzoic acid, dehydroacetic acid, sorbic acid or/and salicylic acid (title; abstract; paragraphs [012]-[013], [044]; claims, in particular claims 1-3, 7 and 18), as required by instant claim 31. Salicylic acid is also an antibiofilm agent (claim 12). The compositions may comprise 15 to 95 wt% of the organic acid and/or the salt thereof (paragraph [007]; claim 4). The compositions may comprise 0.5 to 95 wt% of the zinc compound (paragraph [008]; claim 5). The compositions may comprise 1 to 80 wt% of the antibiofilm agent (claim 14). Salama exemplifies an embodiment of a preservative comprising 42% benzoic acid, 10% zinc gluconate and 20% salicylic acid (Table 6).
Salama does not specifically teach or exemplify an embodiment of composition falling entirely within the claimed ranges, however, the broader teachings of Salama render obvious compositions consisting of 0.5 to 95 wt% of a zinc compound inclusive of zinc gluconate and 15 to 95 wt% of an organic acid and/or a salt thereof inclusive of benzoic acid and salicylic acid and 1 to 80 wt% of an antibiofilm agent inclusive of salicylic acid. Because the ranges taught by Salama overlap the instantly claimed ranges, a prima facie case of obviousness exists. See MPEP 2144.05 and 2144.07.
Regarding the consisting of transitional phrase of claim 29, because the compositions of Salama at broadest require nothing more than an organic acid and a zinc compound (e.g., claims 1, 4-7, 18) or an antibiofilm agent inclusive of salicylic acid and a zinc compound (e.g., claim 2), the compositions of Salama meet the claim.
Regarding the intended use recitations of the wherein clause of claim 29 and of claim 32, a 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. See MPEP 2111.02. Nonetheless, Salama teaches the preservative compositions are suitable for personal care products (abstract; claims).
Claims 29, 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Beerse et al. (US 6,294,186, published September 25, 2001, IDS reference filed July 6, 2022) in view of Salama et al. (WO 2022/190086, filed March 7, 2022 and claiming priority to March 7, 2021, of record).
Beerse teaches antimicrobial compositions comprising a benzoic acid analog and a metal salt (title). The compositions comprise a dermatologically acceptable carrier (abstract; claims, in particular claim 1; columns 8-19). The carrier may comprise from about 50 to 99.99 wt% of the compositions (column 8, lines 15-27).
The benzoic acid analog is selected from salicylic acid or/and benzoic acid (column 6, lines 24-26 and 53-59). The acid analog may be added directly to the compositions or the acid may be formed in situ upon topical application (column 6, lines 53-59). The compositions comprise about 0.01 to 20 wt% of the benzoic acid analog (column 6, lines 27-32). Beerse exemplifies embodiments comprising salicylic acid and sodium benzoate (column 49, Examples 6 and 7) and embodiments comprising salicylic acid and benzoic acid (column 53, Example 21).
The metal salts comprise metals inclusive of inter alia zinc (divalent transition metal) and salts inclusive of gluconates (title; column 6, line 60 through column 7, line 60), as required by instant claim 31. The compositions comprise about 0.001 to 20 wt% of the metal ion of the metal salt.
Although Beerse teaches antimicrobial compositions comprising a benzoic acid analog and a metal salt (title), the compositions of Beerse further comprise a carrier (e.g., claim 1; columns 8-19).
Beerse does not specifically teach or exemplify an embodiment consisting (only) of a preservative system consisting of about 1.5 to 63 wt% salicylic acid, about 26 to 63 wt% of benzoic acid or a salt thereof and about 30 to 95 wt% of one or more divalent transition metal salts / zinc gluconate as required by claims 29, 31 and 32.
This deficiency is made up for in the teachings of Salama.
The teachings of Salama have been described supra.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the antimicrobial component of the compositions of Beerse require only (consist only of) the benzoic acid analog inclusive of salicylic acid and benzoic acid and the metal salt inclusive of zinc salts inclusive of zinc gluconate, and it would have been obvious to include the acid(s) in amounts ranging from 15 to 95 wt% and the metal / zinc salt(s) from 0.5 to 95 wt% in the antimicrobial component of the compositions of Beerse because such is taught by Salama as an effective preservative composition sans carrier.
Regarding the intended use recitations of the wherein clause of claim 29 and of claim 32, a 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. See MPEP 2111.02. Nonetheless, Beerse teaches the compositions are formulated for personal care applications (paragraph bridging columns 3-4) as does Salama.
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant’s argument at page 6 of the Remarks that the compositions of Salama require an antibiofilm agent (e.g., maltol or pyrones) is acknowledged but not found persuasive because (1) only the embodiment of composition consistent with claim 2 requires an antibiofilm agent and (2) antibiofilm agents include salicylic acid as set forth in claim 12 (see also claim 7 of the priority document) and as set forth in the narrative of the rejection.
Applicant’s citation to claim 1 of Salama as requiring an organic acid to zinc ratio between 10:1 and 4:1 and statement that claim 29 allows for up to 95 wt% zinc is acknowledged but not found persuasive because (1) the antibiofilm embodiment is that of claim 2 which allows for a ratio of the antibiofilm agent (e.g., salicylic acid) to the zinc compound from 2:1 to 1:5 and (2) Applicant is not in possession of compositions comprising 95 wt% zinc because the compositions of claim 29 minimally require 27.5 wt% organic acids. 100 – 27.5 = 72.5. Claim 29 encompasses a multitude of inoperable / mathematically impossible embodiments. Applicant’s further argument that Salama teaches away from prioritizing the acid concentration is unpersuasive because Salama embraces a multitude of compositions including those which “prioritize” the organic acids or/and antibiofilm agents (e.g., claims).
Applicant’s rehashed citation to the data within the instant specification remains unpersuasive for reasons of record. The statement that salicylic acid and benzoic acid alone “failed” is unpersuasive because the specification actually states (e.g., page 19):
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the amounts or/and ratios of salicylic acid and benzoic acid in the compositions of Table 2 were not strong enough to reduce E. faecalis. However, Salama is in possession of compositions comprising zinc compounds in combination with organic acids as instantly claimed. Salama also expressly teaches the compositions thereof are suitable for inter alia cleaning in infants during diaper changes (e.g., paragraph [003]) and are suitable for inter alia inhibiting gram positive bacteria (e.g., paragraph [025]). Beerse is also in possession of compositions comprising benzoic acid analogs in combination with metal ions (e.g., title) which provide previously unseen effectiveness against gram positive bacteria (e.g., abstract). Applicant’s further argument that secondary considerations overcome prima facie obvious and allegation that the Examiner has dismissed the data within the instant specification is unpersuasive because evidence is weighed. In other words, each piece of rebuttal evidence should not be evaluated for its ability to knockdown the prima facie case. See MPEP 716.01, in particular section (d). See also MPEP 716.02. Applicant’s allegation that a preservative system that causes emulsion separation or discoloration is undesirable is unpersuasive because no pending claim is drawn to an emulsion, let alone the substantially undefined emulsions of Table 2, and because the alleged discoloration due to copper (e.g., page 19):
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is hardly unexpected and is embraced by the embodiments of the instant claims which comprise copper. Applicant’s argument of “criticality” is unpersuasive because a demonstration of criticality requires evidence. See MPEP 716.02(d). Said evidence requires testing both inside and outside the claimed range in a manner commensurate in scope with that which is claimed. See also MPEP 2144.05. "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It is not seen how optimizing a known preservative to knock down a known bacteria is anything other than routine.
Applicant’s argument at page 7 that Beerse does not provide motivation to adopt the specific “consisting of” system instantly claimed is unpersuasive because Beerse is in possession of a genus of compositions comprising benzoic acid analogs in combination with metal ions (e.g., title) inclusive of compositions as instantly claimed.
Therefore, the rejections of record are properly maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gans et al. (US 5,648,389) teaches compositions comprising (a) an antimicrobial selected from the group inclusive of benzoic acid, (b) a hydroxy acid selected from the group inclusive of salicylic acid and (c) a zinc compound (title; abstract; claims, in particular 1, 2, 8-10).
Rennie et al. (US 2004/0234457) teaches compositions comprising an organic acid selected from the group inclusive of salicylic acid or/and benzoic acid and comprising a metal compound selected from the group inclusive of gluconates or/and pidolates such as zinc gluconate (title; abstract; claims, in particular 1-3; paragraphs [0037], [0038]).
Nonninger et al. (US 2010/0221486) teaches biocidal compositions comprising at least one nanoscale metal oxide of the transition elements inclusive of zinc oxide and at least one organic biocidal agent inclusive of food preservatives inclusive of benzoic acid or/and salicylic acid (title; abstract; claims, in particular 1, 2, 11; paragraph [0017]).
Chang et al. (US 2021/0121382) teaches personal care composition preservation level optimization in compositions comprising about 0.02 to 0.25 wt% salicylate salts or acids and from about 0.2 to 0.25 wt% benzoate salts or acids, wherein the weight ratio of the salicylate(s) to the benzoate(s) is about 1:1 to 12.5 to 1; the compositions may further comprise zinc or/and copper pyrithione (title; abstract; claims; paragraphs [0003], [0011], [0026]-[0029], [0181]).
Meyer et al. (WO 00/61099, as evidenced by the Google translation) teaches aqueous cosmetic products which contain acidic active substances with preservative properties selected from inter alia benzoic acid or/and salicylic acid (title; abstract; claims; paragraph bridging pages 2 and 3).
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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