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 .
Claim Objections
Claim 1 is objected to because of the following informalities: the claim includes a period in the middle of the text following the word “thereof”. MPEP 608.01(m) details that “[e]ach claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5, 8, 12-14, 16, 20, and 31-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
Claim 1, from which all the remaining claims also depend or refer, is drawn to an extended release composition comprising: lipid multiparticulate particles, and an active agent present in an amount of about 50% to about 80% by weight based on a total weight of the lipid multiparticulate particles, the lipid multiparticulate particles comprising a lipid matrix, wherein the lipid matrix comprises a wax, a lecithin, an orange oil, and does not contain a low flow excipient, wherein the low flow excipient includes a fatty alcohol, a fatty acid, a fatty acid ester of glycols and poly glycols, a fatty acid ester of polyglycerol, a fatty acid esters of glycerol (glycerides), or a combination thereof wherein the active agent is dispersed within the lipid matrix, the active agent comprising ascorbic acid or a derivative thereof, and wherein the active agent is released from the lipid multiparticulate particles over a period of time from about 1 hour to about 20 hours after ingestion. The claim recites orange oil as a required component of the lipid matrix and subsequently recites that the matrix does not contain a low flow point excipient. While a listing of low flow excipients is recited, the listing is drafted with the term “includes” which is open claim language. Therefore the recitation embraces the recited options and any other excipient that would be considered a “low flow” excipient based upon the disclosure. The instant specification at paragraph 45 states that “[b]y ‘low flow point’ excipient, such as a glyceride, is meant that the melting point of the excipient, such as a glyceride, is less than 50⁰C”. Orange oil is an excipient that is liquid at ambient conditions, given that it is an oil. The Material Safety Data Sheet for orange oil states that its melting point is -89°C to -96.9°C which is well below 50⁰C and therefore qualifies it as a low flow point excipient (see Orange Oil Material Safety Data Sheet 2007, page 3 – previously cited). The specification explicitly states that the recitation “low flow” excipient means the melting point of the excipient is less than 50⁰C, thus orange oil is a low flow excipient. Since claim 1 requires an ingredient that it also excludes, the composition limitations are contradictory and it cannot be made. Accordingly, the instant claims do not comply with the enablement requirement of §112.
Relevant Prior Art
Iida et al. teach an oral composition with vitamin C (ascorbic acid) and/or a vitamin C fatty acid ester derivative as the main active component for humans or as a feed additive (see abstract and paragraphs 1 and 20-21). The composition contains lipophilic provitamin C compounds that stabilize the vitamin C against oxidative decomposition as well as a natural oil at 1 to 45 wt%, a food natural emulsifier at 0.2 to 5 wt% , and an antioxidant that are all beneficial to the efficacy of the vitamin C (see paragraphs 9 -10, 14, and 16). The provitamin C has its own bioactivity in addition to its functionality as a stabilizer (see paragraph 27-28). Iida et al. detail orange oil and olive oil amongst a short list of envisioned oils to (see paragraph 14). The additional antioxidant is envisioned to include carotenoids (see paragraph 16). The vitamin C is present at 10 to 95 wt% and preferably present at 60-85 wt% (see paragraph 10). The composition is formulated for oral administration via its inclusion with known diluents and carriers and is envisioned in various multiparticulate forms such as granules and powders (see paragraphs 18-20). Iida et al. detail an example with 65 wt% vitamin C combined with 25 wt% provitamin C compounds, 3 wt% olive oil, 3 wt% tocopherol acetate as an antioxidant (second nutraceutical), 1 wt% natural emulsifier (surfactant) and 4 wt% organic acid (see paragraph 31). Iida et al. teach that the emulsifier could also be a polyoxyethylene sorbitan monooleate (polysorbate) (see paragraph 22).
Iijima et al. (JP-2698921 – English translation relied upon for citations) teach the protection of physiologically active substances for animal feed or veterinary substances by producing a granulate of the active with a water insoluble binder (see pages 2-3). The binder melts at 50 to 80⁰C and is envisioned as candelilla wax, hardened oils, and fats (see page 5). Stirring granulation techniques include the binder at 10 to 40 wt% (see page 6). Iijima et al. detail in example 5 with ascorbic acid as the active granulated via stirring technique where the ascorbic acid is dispersed in wood wax and heated to 80⁰C while stirring, then chopped into particles (multiparticulates) that collect on a mesh 16 to mesh 24 (about 700 to 1200 mm) (see page 8)
Suzuki et al. (WO – 2016136285 – English translation relied upon for citations) teach a pulverized lipid preparation (multiparticulate particles) of an ascorbic acid fatty acid ester derivative dispersed in a lipid matrix that is a fat which melts at 60 to 90⁰C for oral administration in food or beverages (see page 2 and pages 5-6). The ratio of fat to ascorbic acid derivative 1/99 to 60/40 and the particle are sized at 50 to 1000 mm and more narrowly 100 to 500 mm (see page 6). They detail fat as extremely hardened fats such as hydrogenated animal or vegetable fats (see page 5). The multiparticulate particles are also envisioned to include antioxidant and food emulsifier where lecithin is envisioned as the latter for improving water dispersibility (see pages 7-8).
If the negative proviso of claim 1 were modified to permit the presence of the orange oil that is positively recited, the prior art cited here and of record would be sufficient to render this claim and several others obvious.
Response to Arguments
Applicant's arguments filed December 15, 2025 have been fully considered. In light of the amendment to the claims, the rejection under 35 UC 112 (d) is hereby withdrawn. The arguments directed toward the remaining rejection are not persuasive.
The applicant argues that the definition for low flow excipient quoted from the specification is not a definition for the term and does not apply to all excipients. They argue that it only applies to the exemplary categories of excipients that fall under its temperature constraint. This is unpersuasive because the specification states in paragraph 48, “[b]y "low flow point" excipient, such as a glyceride, is meant that the melting point of the excipient, such as a glyceride, is less than 50⁰C.” The phrase “such as” indicates an example and generic terminology in the claims is not limited to the examples provided in the specification. While the specification and amended claim 1 provide additional examples of the categories of excipients “generally” envisioned or “included” as “low flow” excipients, they do not limit the scope of the term (see MPEP 2111.01(II)). Since orange oil has a melting point well below 50⁰C, it is a “low flow” excipient according to the disclosure and is excluded from the composition of claim 1, based on its negative proviso. Thus the claimed composition that excludes low flow excipients cannot also comprise orange oil and therefore cannot be made.
Conclusion
No claim is allowed.
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.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615