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 .
Response to Restriction and Status of Claims
Applicant’s election with traverse of the invention of Group I (Claims 1-11 and 16-20), drawn to methods for preparing a solid delivery system, in the reply filed 09/04/2026, is acknowledged by the Examiner. The Examiner maintains the Unity of Invention restriction requirement as the claimed invention is not above prior arts cited in the previous office action and as described in the rejection herein. As set forth in the previous Office Action, the shared technical feature lacks novelty or inventive step because McIver et al. (US 2002/187223 A1, cited in the International Written Opinion), hereinafter McIver, has taught the technical feature. McIver discloses the preparation of a granular delivery system comprising a flavor or fragrance ingredient or composition distributed as droplets throughout a matrix of polymeric carriers, wherein said carriers comprise at least a carbohydrate material and from 1 to 7% of pre-hydrated agar agar; and also teaches the method of making the composition comprising blending the flavor/fragrance with the matrix comprising carbohydrate, extruding, cooling, cutting and pulverizing, washing, and optionally drying ([0049]; Claims 1 and 12; Examples 1-4). The flavor or fragrance component include natural extract e.g. lemon, orange, lime, essential oils of herbs etc. ([0036], Example 3). The instant Specification ([0007], [0021]) requires the same extracts/oils taught by the prior art. McIver also teaches adding soya lecithin emulsifier agent (Examples 1-2 and 5; [0038]).
As the technical feature was known in the art at the time of the invention, this cannot be considered a special technical feature. Therefore, the technical feature claim elements are expressly taught or are rendered obvious by McIver. The technical feature is not above the prior arts, and therefore is not a special technical feature.
Applicant’s traversal based on no undue burden on the Examiner has been fully and carefully considered, but fails to be persuasive. Applicant is reminded that the instant application is a National Stage (371) entry of PCT Application No. PCT/US2019/028721, and the requirement for restriction between inventions presented in a National Stage (371) application is proper when it is shown that the inventions or groups of inventions and/or species fail to relate to a single general inventive concept because they lack the same or corresponding special technical features. See PCT Rules 13.1 and 13.2. See MPEP 1850 (II) discussion on “a posteriori” vs. “a priori”. As such, the requirement is maintained and is considered FINAL. A rejoinder will be issued when examined elected claims are found allowable.
Claims 1-20 are pending. Claims 12-15 are withdrawn pursuant to 37 C.F.R. 1.142(b) as being drawn to non-elected subject matter. The claims corresponding to the elected subject matter are Claims 1-11 and 16-20, and are herein acted on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/11/2026 and 08/21/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements were considered by the Examiner.
Claim Objections
Claim 7 is objected to because of the following informalities:
The name of essential oils in Claim 7 should not be capitalized. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 5 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 is indefinite for reciting “water content”. There is insufficient antecedent basis for this limitation in the claim. Claim 3 depends from Claim 1, however, Claim 1 does not refer to any water content. Therefore, the claim is indefinite and rejected. See MPEP § 2173.05(d).
Claim 5 is indefinite for reciting “consisting of” and “derivatives”. The recitation of “derivatives” in Claim 5 refers to derivatives of sucrose, glucose, lactose, levulose etc. The Merriam Webster Online Dictionary (online, 2009) defines “derivative” to mean: “a chemical substance related structurally to another substance and theoretically derivable from it". It is unclear which chemical substance are theoretically possible that one can use in this invention. Furthermore, Wermuth (Drug Discovery Today, 2006, 11(7/8), 348-354) teaches that small changes in chemical structure can lead to different chemical activity (see page 349, last paragraph right column; Figure 2, page 350; and Table 1, page 353, for example). In other words, without more disclosure as to which 'derivatives' might work in this invention the metes and bounds of the claim are unclear, and does not comply with the “consisting of” transitional phrase.One skilled in the art would not be able to ascertain what derivatives are included within the “consisting of” language. Therefore, Claim 5 is ambiguous and indefinite.
Claim 17 recites “wherein step b) occurs within 60 minutes of adding the high-terpene content essential oil”, which lacks antecedent basis. Claim 17 depends from Claim 16, which does not have any step b). Therefore, it is unclear what step b) is being referred to. The Examiner cannot ascertain what method step is involved in “step b)” that would require occurrence within 60 minutes, however, for compact prosecution, the Examiner will interpret “step b)” to mean step b) in Claim 1, i.e. the extrusion step.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-4, 7, and 11 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by McIver et al. (US 2002/0187223 A1; Of record), hereinafter McIver, as evidenced by Fahlbusch et al. ("Flavors and fragrances." Ullmann’s Encyclopedia of Industrial Chemistry. 2003), hereinafter Fahlbusch.
Regarding Claim 1, McIver discloses a granular delivery system prepared by combining at least a carbohydrate material with agar agar to make a matrix capable of providing controlled release of an active flavoring or perfuming ingredient (Abstract; Claim 1). McIver discloses the process of making a delivery system comprising:
combining and blending a flavor or fragrance ingredient or composition with a matrix comprising an aqueous solution of at least a carbohydrate material, from 1 to 7% of prehydrated agar agar, and optionally an emulsifier, under temperature and stirring conditions useful to produce a uniform melt thereof;
extruding the uniform melt through a die;
chopping, cutting, grinding or pulverising the material obtained as it exits the die or after cooling the melt; and
optionally drying (Claim 12).
Therefore, steps a)-d) and f) are taught by McIver. Regarding the claimed washing step e), McIver also teaches the washing step [0049].
Regarding the claimed high-terpene content essential oil, McIver teaches orange oil in Examples 3 and 5; Orange oil contains >90% terpene as evidences by Fahlbusch (p. 166, R. Col., item 7).
Regarding Claim 2, McIver teaches heating the mixture of matrix carbohydrate material, agar-agar and active ingredient to a temperature comprised between 90 and 130° C., the mixture being then subsequently extruded trough a die and the molten mass being chopped as it exits the die and before it is cooled to solidify [0055]. McIver expressly teaches admixing 81.50% maltodextrin syrup, 16% fragrance, which reads on the essential oil, 1% lecithin, and 1.5% agar-agar in water, and heated to 123 ˚C, anticipating the claim (Example 2).
Regarding Claim 3, McIver teaches first mixing agar agar with water to form a slurry, which is added to a syrup comprising sucrose, maltodextrin and water, and the resulting mixture heated to 123 ˚C, anticipating the step a1 (Example 1). The cinnamic aldehyde, which reads on the essential oil, and emulsifier were mixed with the syrup, thereby anticipating step a2). Because cinnamic aldehyde is an essential oil from cinnamon, Claim 7 is also anticipated.
Regarding Claim 4, the Examiner calculates the water to be ~7% of the granular delivery system in Example 2, and is within the claimed range.
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Example 2 Formulation Table
Regarding Claim 5, McIver teaches maltodextrin in the granular delivery system in Example 2, anticipating the claim.
Regarding Claim 6, McIver reads on the feature of at least 70% maltodextrin relative to the weight of the carbohydrate matrix in Example 2. As such, Claims 18-19 are also anticipated.
Regarding Claim 8, by Examiner’s calculation, the amount of fragrance in the Example 2 formulation is ~11%, which is within the claimed range.
Regarding Claim 9-10, McIver teaches soya lecithin at ~7% relative to the weight of the cinnamic aldehyde , by Examiner’s calculation, anticipating the claims (Example 1).
Claim Rejections - 35 USC § 103
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.
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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over McIver, as applied to Claim 1 above.
Regarding Claim 16, McIver teaches all the features in the anticipation rejection supra, but does not exemplify a temperature between 110°C and 120°C. However, McIver has taught the suitable heating temperature to be between 90°C and 130°C, and teaches water as plasticizer ([0050], [0055]). McIver also gave examples using 123°C, which is close to the claimed range (Examples 1 and 2). 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. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05.
Claims 11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over McIver, as applied to Claim 1 above, in view of Tritthart, T. (WO 2005/074699 A2, machine translated in IP.com), hereinafter Tritthart.
Regarding Claim 11, McIver teaches flavor and fragrance composition, but does not expressly teach them together (Title; Examples 1 and 2; Claims 11-12).
Tritthart is in the same field and relates the method for encapsulating substances in a matrix containing sugar, sugar alcohols, sugar substitutes or the mixtures thereof by extrusion using an extruder having one or more temperature zones (Abstract).
Tritthart teaches that the substances to be encapsulated may be combinations of active ingredients inter alia fragrances and flavors (Claim 14). Tritthart teaches a combination of alpha-pinene, 1,8-cineol and eucalyptus oil (p. 21, Sample 2-7).
McIver teaches flavor or fragrance to be present in its system. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Tritthart with that of McIver, and combine different active essential oils, fragrances and flavors in the solid delivery system with reasonable expectations of success. The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983). See also Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick, 464 F.3d 1356, 1368, 80 USPQ2d 1641, 1651 (Fed. Cir. 2006). In the instant case, McIver and Tritthart provides examples of delivery systems comprising flavor and fragrance essential oils.
Regarding Claim 17, Tritthart teaches extrusion and solidification within the first minute after it left the extruder (pp. 21-22, Example 2). Tritthart comprehends the need for short dwell time ensuring short heat exposure of sensitive substances (p. 12, 9th paragraph). Only with a sufficiently high viscosity is a mass carried by the screw in the extruder and the dispersibility with the following homogeneous composition of the extrudate is ensured, with the sensitive substances homogeneously distributed and enclosed at the same time or solid solutions of active pharmaceutical ingredients are formed in the matrix (p. 13, 4th paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Tritthart into the method of McIver and use a short extrusion dwell time and fast solidification, e.g. within a minute after leaving the extruder, to ensure short heat exposure of sensitive substances per the teaching of Tritthart.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over McIver, as applied to Claim 1 above, in view of Tritthart, and Kirkendall (“Encapsulated hop oil”, 2021. Cited in the IDS).
Regarding Claim 20, McIver does not teach hop oil.
Tritthart teaches preferred substances for encapsulation include essential oils including orange oil, hop oil etc. (p. 3, 3rd paragraph).
Kirkendall provides the motivation for encapsulating hop oils. Kirkendall relates that encapsulated hop oils are free-flowing granules consisting of hop oil trapped in a dense carbohydrate matrix (p. 1, last paragraph). Kirkendall teaches that hops impart aroma and bitterness to beer, but are traditionally bulky to store and susceptible to oxidation (p. 2, 1st paragraph). Hop oil extract helps solve this issue, and encapsulation of hop oil provides a longer shelf life at ambient temperature (p. 2, 2nd and 3rd paragraphs). Furthermore, encapsulated hop oil allow for innovation in flavor and sustainable hopping process (p. 3, 3rd paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to encapsulate hop oil using the method of McIver because Kirkendall has taught that encapsulation of hop oil in carbohydrate matrix provides a longer shelf life at ambient temperature, allow for innovation in flavor and sustainable hopping process.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached M-F, 10-6 EST.
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/JANICE Y SILVERMAN/Examiner, Art Unit 1792
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