DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/22/2025 has been entered.
Response to Amendment
Applicant’s response of 08/22/2025 has been received and entered into the application file. Claims 1, 6, 10-11, 15, and 24-25 are pending in this 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, 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, 6, 10-11, 15, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over McMillan et al. (US 8858970 B2, 2014) and Goodman et al. (US 4,623,398).
McMillan teaches carrier and delivery systems for active molecular compounds; in particular aqueous dispersions for delivery of active molar compounds (Abstract). In some embodiments, the dispersion is configured for topical administration to a subject. In some embodiments, the hydrophilic submicron particle substrate comprises a hydrophilic clay. The hydrophilic clay comprises one or more of smectite, laponite and bentonite clays. In some embodiments, the quaternary ammonium compound comprises benzethonium chloride. In some embodiments, the active agent comprises one or more of an antimicrobial, an analgesic, an anti-fungal, an anti-inflammatory (Col 4, lines 5-19). In some embodiments, a dispersed phase comprises a hydrophilic particle substrate having electrically charged binding sites (Col 7, lines 1-3). McMillan discloses methods of making an antimicrobial carrier system: adding a humectant such as glycerin to deionized water to form an aqueous suspension; uniformly mixing a hydrophilic clay and a quaternary compound to form a hydrophilic clay-quaternary ammonium compound combination; combining the aqueous suspension and the hydrophilic clay-quaternary ammonium compound combination to obtain a suspension (Col 14, lines 35-45). McMillan discloses that dispersions provide significant advantages over administration of active agents via other carriers and/or systems, including: reduction of toxicity of active ingredients, extended time of activity for active ingredients, time release characteristics, controlled release of active ingredients, increased active ingredient loads of up to 200% of ion exchange capacity or greater (Col 14, lines 13-20). In some embodiments, a dispersion has a continuous aqueous phase containing particulate material held in suspension by small particle size, e.g., sub-micron (Col 7, lines 58-60).
McMillan does not specifically mention filtering.
Goodman et al. teach an organo-clay composition prepared by mixing a quaternary ammonium compound with an aqueous suspension of a smectite clay (Abstract). Goodman et al. teach a process for preparing an organo-clay comprising mixing an aqueous suspension of a clay of the smectite group with a quaternary ammonium compound, subjecting the mixing at high shear for a time sufficient to dissipate in the mixture, dewatering the product (column 1, lines 35-50). Furthermore, Goodman et al. teach organo-clays A, B and C were prepared as dispersions of benzyl methyl di-hydrogenated tallow ammonium chloride by pouring molten quaternary ammonium compound into water. In each case the suspension of the organo-clay was then filtered on a Buchner funnel (column 3, lines 9-15, 56-60). One of ordinary skill in the art recognizes that a Buchner funnel porosity is about 25-50 μm.
Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined the dispersion taught by McMillan and filtering said dispersion to achieve certain particle size suitable for injection. This is taking some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Regarding claim 6, McMillan discloses how the dispersions would have reduced toxicity of active ingredients as discussed above.
Regarding claims 10-11, active ingredients are discussed above.
Regarding claim 15, particle size is discussed above.
Regarding claims 24-25, one of ordinary skill in the art would contemplate various routes of administration for a delivery system of active ingredients.
Response to Arguments
Applicant’s arguments filed 08/22/2025 have been fully considered but they are not persuasive.
On pages 4-5, applicant argues that the combination of McMillan and Goodman fails to teach or suggest the claim step of mixing said dispersion with glycerin and water to make a suspension. Compositions made by the methods of the presently claimed invention differ at least in being an even suspension and non-toxic.
However, as discussed above, in some embodiments, a dispersed phase comprises a hydrophilic particle substrate having electrically charged binding sites (Col 7, lines 1-3). McMillan discloses methods of making an antimicrobial carrier system: adding a humectant such as glycerin to deionized water to form an aqueous suspension; uniformly mixing a hydrophilic clay and a quaternary compound to form a hydrophilic clay-quaternary ammonium compound combination (dispersion); combining the aqueous suspension and the hydrophilic clay-quaternary ammonium compound combination (dispersion) to obtain a suspension (Col 14, lines 35-45).
McMillan teaches mixing glycerin and water then mixing with hydrophilic clay and a quaternary compound. The examiner cannot determine why the compositions of instant application would yield something different. Goodman teaches filtering which removes toxicity. The applicant could submit surprising or unexpected results to distinguish from prior arts – why the suspension of presently claimed invention is different and how (Is it a certain concentration of laponite clay or benzethonium chloride? Is it the way it is mixed?).
The applicant argues that the specific ratios of components yield a non-toxic suspension. McMillan discloses the dispersions of the present invention provide reduced toxicity of active ingredients (col 14, lines 15-16). The examiner also cannot determine the critical ranges of each ingredient within the composition – for example 0.05-0.5% of said dispersion, 1-10% glycerin, and 89-98.9% of water. There are no comparative studies conducted that would have prevented one of ordinary skills to routinely arrive at such ranges.
The applicants did not amend any claims and have provided the same arguments which the examiner responded to in the Final Rejection mailed on 05/01/2025.
Conclusion
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 JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615