DETAILED ACTION
Applicant’s arguments, filed 20 May 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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 .
Claim Objections
Claim 8 is objected to because of the following informalities: immediately prior to “emulsion forming excipients” in line 3 of the claim there should be recited --- two or more ---. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: immediately prior to “emulsion forming excipients” in line 2 of the claim there should be recited --- two or more ---. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: “emulsions” in line 2 of the claim should be recited as --- emulsion ---. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Badenoch et al. (WO 2018/170235 A1, 09/20/2018, IDS reference) (hereinafter Badenoch) in view of Huang (US 2015/0231070 A1, 08/20/2015).
Badenoch discloses compositions comprising medium chain triglycerides (MCT) (abs), such as caprylic triglyceride, in amounts of at least about 35% by wt. ([0006], [0045]); at least one surfactant, including lecithin and polyoxyl hydrogenated castor oil ([0007]); and at least one co-surfactant. The co-surfactant can be any suitable co-surfactant known in the art for facilitating surfactant activity to provide desired emulsion formation and stabilization, and may be included in amounts ranging from about 2.0 to about 10.0 wt.% ([0053]). The compositions form stable emulsions on reconstitution in water. The emulsions are stable at ambient conditions, for example, for at least about 24 hours, and have a mean droplet diameter of less than about 1000 nm, but greater than about 100 nm ([0042]).
Badenoch differs from the instant claims insofar as not explicitly disclosing wherein the co-surfactant includes sodium oleate.
Huang discloses pharmaceutically acceptable, stable nanoemulsion (abs) comprising surfactants such as lecithin ([0050]-[0051]). The nanoemulsion may also contain a co-surfactant that acts synergistically with the surfactant to alter the interfacial tension, permitting nanoemulsion formation. Suitable co-surfactants include sodium oleate. The co-surfactant may be included in an emulsion at a range of 0.01-30 w/v%, in a ratio of 10:0.1 to 0.1:10 (surfactant : co-surfactant) ([0052]-[0053]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included sodium oleate in the compositions of Badenoch since it is a known and effective co-surfactant acting synergistically to permit nanoemulsion formation as taught by Huang.
Regarding claims 1 and 6 reciting amounts of caprylic triglyceride, the claimed ranges (i.e. at least 30% by weight, or between about 30% and about 60% by weight, respectively) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. at least about 35% by weight). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, the selection of weight percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in % by weight. "[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." See MPEP § 2144.05(II)(A).
Regarding claims 1 and 10 reciting an emulsion stability time range or an average particle diameter, the claimed ranges under ambient conditions (i.e. for at least one month, or less than 0.5 µm for at least one month) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. for at least about 24 hours or between about 0.1 µm and about 1 µm). See MPEP § 2144.05(I). Moreover, in the case of claimed time period of emulsion stability, since the emulsion of Badenoch comprises substantially the same active ingredients as the claimed invention (i.e. caprylic triglyceride, lecithin, co-surfactants) in substantially the same amount, and having substantially the same mean droplet diameters as instantly claimed, one of ordinary skill in the art would reasonably conclude that the emulsion of Badenoch to reasonably possess substantially the same properties as the claimed invention, such as being stable for at least one month under ambient conditions. See MPEP § 2111.02(II).
Regarding claims 7, 8, and 9 reciting amounts or ratios of at least one surfactant, the claimed ranges (i.e. between about 1% and about 10% by weight, or at least 2.0% by weight, respectively) and ratio (i.e. 1:1 to 2:1 ratio) would have been obvious to one of ordinary skill in the art since they overlap with the ranges and ratios of the prior art (i.e. between about 2.0% and about 10.0% wt., and 3:1 to 1:1 ratio, respectively). See MPEP § 2144.05(I). Moreover, in any case, the selection of weight percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in % by weight, as well as the corresponding weight ratios. "[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." See MPEP § 2144.05(II)(A).
Regarding claims 12-13 and 15 reciting a use of the liquid pharmaceutical composition of claim 1, such limitations are merely stating a purpose or intended use of said composition, rather than any distinct definition of any of the claimed invention’s limitations that would result in a structural difference between the claimed invention and the prior art. As the claims are directed to a product, the “for” statements are interpreted as intended use. Accordingly, where the same active agent is present in the prior art as instantly claimed, the intended use is met.
Regarding claims 3, 4, and 16, Badenoch further discloses wherein the emulsions may be formed in aqueous solutions including those adjusted to a pH of 6.5.
Badenoch differs from the instant claim insofar as not explicitly disclosing wherein the pH adjusters include glycerol.
However, Huang further discloses wherein the emulsion formulation may also contain active components, pH-adjusting or tonicity modifying agents, such as glycerol ([0055]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included glycerol in the emulsion of Badenoch since it is a known and effective pH-adjusting or tonicity modifying agent as taught by Huang.
Regarding claim 11, Badenoch further discloses wherein the compositions may further comprise additional excipients such as flavor enhancers ([0036]). Although Badenoch does not explicitly disclose a solubility of the flavor enhancing agent, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at a claimed flavoring agent through routine experimentation based on the flavor desired.
Claims 1-13 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Badenoch et al. (WO 2018/170235 A1, 09/20/2018, IDS reference) (hereinafter Badenoch) in view of Huang (US 2015/0231070 A1, 08/20/2015), further in view of Seidel (EP 2111850 B1, 08/19/2015).
The disclosures of Badenoch and Huang have been discussed in detail above.
Regarding claims 1, 3, 4, 16, and 18, while Badenoch and Huang are believed to support a finding of obviousness, purely arguendo, for the purposes of complete prosecution, and for the purposes of this ground of rejection only, Badenoch and Huang will be interpreted as though it does not explicitly disclose wherein the composition comprises glycerol.
However, Seidel discloses emulsions containing one or more esters of monoglycerides and/or diglycerides as an emulsifier, generating a low interfacial tension, allowing for the formation of mechanically stable interfaces and form very stable emulsions without there being any significant coalescence (p. 3, ¶ 3; p. 3, ¶ 6). Exemplary esters including monoglycerides and/or diglycerides that are esterified with citric acid (p. 4, ¶ 6). The water phase may further comprise water-miscible liquids such as glycerol (p. 4, last ¶).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included glycerol in the emulsion of Badenoch since it is a known and effective component suitable for the water phase of emulsions as taught by Seidel.
Regarding claims 5, 17, and 18, it would have been obvious to one of ordinary skill in the art to have included a citric acid ester of monoglycerides and diglycerides since it is a known and effective surface active agent capable of stabilizing interfaces within the emulsion as taught by Seidel.
Response to Arguments
Applicant’s arguments have been considered but are moot because new rejections necessitated by Applicant’s amendment have been made.
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 1-13 and 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,559,488 B2 in view of Badenoch et al. (WO 2018/170235 A1, 09/20/2018, IDS reference) (hereinafter Badenoch), Huang (US 2015/0231070 A1, 08/20/2015), and Seidel (EP 2111850 B1, 08/19/2015).
Although the patented claims differ from the pending claims insofar as not explicitly teaching all the features of the claimed invention, these features are known in the art. As noted in the current rejections, the combined teachings of Badenoch and Huang render obvious claims 1-4, 6-13 and 15-16. Furthermore, the combined teachings of Badenoch, Huang, and Seidel render obvious claims 1-13 and 15-18.
Therefore, as claims 1-13 and 15-18 of U.S. Patent No. 11,559,488, Badenoch, Huang, and Seidel all disclose emulsions comprising surfactants and triglycerides, it would have been prima facie obvious to one of ordinary skill in the art to have modified the patented claims and to include the teachings of Badenoch, Huang, and Seidel as discussed in the rejections above, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as instantly claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See MPEP 2144.06(I).
Response to Arguments
Applicant’s arguments have been considered but are moot because new rejections necessitated by Applicant’s amendment have been made.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dang et al. (US 2020/0346174 A1, 11/05/2020), directed to a process for producing a nano-microemulsion system of plant oil triglycerides comprising a carrier of propylene glycol monocaprylate and lecithin.
Henderson (US 2008/0009467 A1, 01/10/2008, IDS reference of 11/21/2023), directed compositions comprising medium chain triglycerides.
Kocherlakota et al. (WO 2019/186444 A1, 10/03/2019, IDS reference of 05/30/2025), directed to liquid formulations having an oil phase, aqueous phase, one or more emulsifying agents, and optionally other pharmaceutical excipients, optimized for stability.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 LUCY M TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Friday 10:00 AM - 6:00 PM EST.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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