DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30 March 2026, has been entered.
Status of the Claims
Amendments to the Claims and Arguments/Remarks filed 30 March 2026, in response to the Office Correspondence dated 02 February 2026, are acknowledged.
The listing of Claims filed 30 March 2026, have been examined. Claims 1-14 are pending. Claims 1-3, 6, and 9 are amended and are supported by the originally-filed disclosure. No claims are canceled and no new claims have been added.
Response to Amendment
The applicant states that the amendments are supported by the originally filed specification, including paragraphs ¶[0040]-[0042], and Fig. 1, and therefore no new matter has been introduced. The examiner agrees that amended claim 1 does not introduce new matter. The present amendment adopts substantially the structural language previously identified by the prior Office Correspondence, namely, a core comprising the active substance and amphiphilic natural protein surfactant, an inner pullulan film surrounding the core, and an outer jelly coat film comprising a gelled anionic natural polymer. Accordingly, the prior rejection of claims 1-14 under 35 U.S.C. § 112(b) set forth in the previous Office Correspondence is withdrawn.
The applicant also contends that the prior written description and indefiniteness issues concerning claim 9 have been overcome by amendment. The applicant’s position is persuasive. Claim 9 no longer employs the previously criticized conditional formulation (“when”), and now affirmatively recites both a narrowed lipid carbon chain range of 13-21 carbon atoms and a defined gel particle size range of 30-100 µm. The amended language is consistent with the disclosure in paragraphs ¶[0052], ¶[0086], and Experimental Example 4. Accordingly, the prior 35 U.S.C. § 112(a) rejection of claim 9 is withdrawn and the prior objection to claim 9 for redundancy is withdrawn.
Although the prior § 112 rejections have been overcome, further examination of the amended claims reveals new issues requiring rejection under 35 U.S.C. § 112(b), as detailed below.
Claim Rejections - 35 USC § 112(b)
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 Applicant regards as his invention.
Claims 1-14 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, regards as the invention.
Amended claim 1 recites, “An oil-in-water emulsion composition comprising: gel particles dispersed in a water phase…”. The claim, however, does not distinctly identify what constitutes the dispersed oil phase of the oil-in-water emulsion. The claim further recites that the gel particles comprise a core comprising an active substance and amphiphilic natural protein surfactant; an inner pullulan film; and an outer jelly coat film. Ambiguity is created by “oil-in-water emulsion composition” versus “gel particles dispersed in a water phase”.
The language leaves unresolved whether the core itself constitutes the oil phase, the gel particles collectively constitute the dispersed oil phase, or the gel particles are separate particulate entities suspended in the aqueous phase independent of the oil-in-water emulsion structure. An oil-in-water emulsion ordinarily requires a dispersed oil phase and continuous aqueous phase. The claim presently does not clearly identify the phase identity of the recited “core” or “gel particles,” and therefore the structural meaning of “oil-in-water emulsion” remains uncertain. A person of ordinary skill in the art would not be able to determine with reasonable certainty the physical structure required by the claim (see Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014)).
Claim 1 broadly recites “an active substance.” Although dependent claims 10-12 provide exemplary subclasses, independent claim 1 imposes no limitation as to whether the active substance is hydrophobic or hydrophilic, whether it is solid or liquid, whether it is oil-soluble, or whether it forms the oil phase of the emulsion. Because claim 1 simultaneously requires an “oil-in-water emulsion composition,” yet does not define whether the active substance is oil-phase material, the metes and bounds remain uncertain. Claims 2-14 depend directly or indirectly from claim 1 and therefore incorporate the indefiniteness of claim 1.
To overcome this rejection, by clarifying the structural phase relationship, for example by reciting that the core comprises an oil phase containing the active substance, and that the gel particles constitute dispersed oil-containing particles within the continuous aqueous phase. An example of a revised claim that may be considered is: “An oil-in-water emulsion composition comprising a continuous aqueous phase and gel particles dispersed in the continuous aqueous phase, wherein each gel particle comprises: (a) a core comprising an active substance and an amphiphilic natural protein surfactant disposed; (b) an inner film comprising pullulan surrounding the core; and (c) an outer jelly coat film surrounding the inner film and comprising a gelled anionic natural polymer, wherein the anionic natural polymer is gelled by a gelling agent; and wherein the core constitutes a portion of the dispersed oil phase of the oil-in-water emulsion composition.” All of these features are expressly described in paragraphs ¶[0005], ¶[0040], ¶[0041], and embodiment ¶[0093].
Allowable Subject Matter
Claims 1-14 are allowable over the prior art.
The following is a statement of reasons for the indication of allowable subject matter. Three designated prior art references have been analyzed for determining allowable subject matter in the current patent application claims:
Baek et al. (KR20070071225A; 04 July 2007), describes oil-in-water emulsion compositions containing pullulan as thickener, peroxide as an active substance, and amphiphilic protein surfactants such as carrageenan and pectin (Abstract; ¶[0012]-[0015]; ¶[0028]). Baek et al. teaches a cosmetic or pharmaceutical composition (¶[0003]) with a water phase comprising gel particles (¶[0021]-[0025]) wherein the gel particles comprised in an inner film/polymeric shell (¶[0021] and ¶[0024]), and the inner film comprises a lipid (oil and fatty material) having 6-30 carbon atoms in the hydrophobic tail (¶[0028]); an outer jelly coat comprising an anionic natural polymer polysaccharides (¶[0022] and ¶[0024]) and ionic crosslinking gelling agent (¶[0036]); an oil phase comprises a range overlapping with 0.1-10 wt% active substance that is a solid hydrophobic oil-soluble liquid or mixture comprising an oil (¶[0028], ¶[0033], and ¶[0038]).
Baek et al. does not explicitly teach an inner film comprising pullulan and an amphiphilic natural protein surfactant in the inner film selected from zein, hordein, secalin, kafirin, gliadin, oryzin, avenin, an outer jelly coat film, an anionic natural polymer that is a vegetable polysaccharide, selected from pectin, alginic acid, hyaluronic acid, starch, dextran, carrageenan, cellulose, agarose, agar, salts or wherein the gelling agent is specifically selected from CaCl₂, CaCO₃, CaO, CaSO₄ or an average particle size 1-2000 µm or 30-100 µm.
While Baek et al. discloses the use of these protein surfactants in emulsion systems, it does not teach or suggest the specific structural arrangement of gel particles with distinct inner and outer films as claimed, nor the calcium-based outer gelling agent or the use of an inner hydrophobic/oil active substance (0.1-10%). The reference focuses on surfactant properties rather than the layered gel particle architecture that characterizes the current invention.
Wudao (CN104610758A; 13 May 2015), relates to emulsion compositions with natural polymers and active substances. Wudao teaches An oil-in-water emulsion cosmetic composition (¶[0006]) having an oil phase and water phase (¶[0048]), a water phase comprises gel particles (¶[0042]), an explicit outer jelly coat film comprising an anionic natural polymer selected from vegetable polysaccharides pectin, alginic acid, hyaluronic acid, starch, dextran, carrageenan, cellulose, agarose, agar, salts (¶[0023]-[0026]) and a calcium gelling agent selected from CaCl₂, CaCO₃, CaO, CaSO₄ (¶[0031]-[0034]), an oil phase comprising an active substance (¶[0048]), and an average particle size encompassing the instant claimed range of 1-2000 µm and 30-100 µm, wherein this exact size range not explicit but is considered a result-effective variable (¶[0042]).
Wudao does not explicitly teach wherein the composition is a pharmaceutical composition, gel particles comprising an inner film with the inner film comprising pullulan, a lipid having 6-30 carbon atoms in the hydrophobic tail, and a amphiphilic natural protein surfactant selected from zein, hordein, secalin, kafirin, gliadin, oryzin, avenin or 0.1-10 wt% of an active substance that is a solid hydrophobic, oil-soluble liquid, or mixture comprising an oil.
Wudao discloses various anionic natural polymers including carrageenan, alginate, and pectin, but fails to teach the specific combination with pullulan in a layered structure with amphiphilic natural protein surfactants located specifically in the inner film. The reference is designated for food packaging use rather than encapsulation of inner hydrophobic/oil active substances (0.1-10%) and focuses on formulation aspects rather than the structural details that are central to the current claims.
Mannino et al. (WO2004091578A2; 28 October 2004), is the closest identified prior art. It discloses emulsion compositions with gel particles comprising various biopolymers. Mannino et al., teaches an oil-in-water pharmaceutical emulsion composition (O/W dispersions; page 10, lines 1-15) with an oil phase and a water phase (page 7, lines 1-20), wherein the water phase comprises gel particles comprising an inner pullulan film (page 3, lines 5-15 and page 6, lines 10-25; supplying the gap in Baek et al.), an amphiphilic natural protein surfactant selected from zein, hordein, secalin, kafirin, gliadin, oryzin, avenin in the inner film (page 9, lines 5-20; protein emulsifiers- specific proteins not explicitly listed by are considered obvious equivalents and obvious substitution), the inner film further comprises a lipid with a 6-30 carbon atom hydrophobic tail (page 7; carbon range implicit routine selection), an outer jelly coat film/coat (page 8, lines 5-25), and an oil phase comprises active substance, wherein the active substance is solid hydrophobic, oil-soluble liquid, or mixture (page 7, lines 1-20).
Mannino et al., does not explicitly teach wherein the composition is a cosmetic composition, the outer jelly coat comprises anionic natural polymer is a vegetable polysaccharide selected from pectin, alginic acid, hyaluronic acid, starch, dextran, carrageenan, cellulose, agarose, agar, salts and gelling agent selected from CaCl₂, CaCO₃, CaO, CaSO₄, the average particle size is1-2000 µm or 30-100 µm, or the oil-soluble liquid active substance comprises oil at a concentration of 0.1-10 wt% active substance.
Mannino et al., teaches the use of polysaccharides like pullulan as a stabilizer/ aggregation inhibitor integrated into the particle and anionic polymers such as alginate, pectin or lipid phosphatidylserine (C14-22 hydrophobic tail) for forming encapsulation structures for various active substances broadly including drugs or nutrients but not explicitly as solid hydrophobic and oil-soluble actives in nature or specify their location relative to a pullulan layer, teaches lipid components but does not teach modulating particle size by varying lipid chain length, discusses lipid-to-drug ratios but not disclose active substances in the 0.1-10 wt.% range, and does not explicitly teach the use to form a structured film for emulsion stabilization. The reference uses calcium ions for precipitation but not specifically as a gelling agent for an anionic polymer coat and zein is listed which serves as an amphiphilic natural protein surfactant without disclosing placement in the layered structure as specifically within an inner pullulan film. However, it does not specifically disclose the unique dual-layer structure with an inner film containing pullulan and an outer jelly coat film with an anionic natural polymer as a unified layered structure as claimed in the current application. The reference teaches a cochleate layered structure and primarily focuses on encapsulation techniques without the specific combination of components claimed in the instant application.
No single reference explicitly discloses a pullulan inner film with a calcium-crosslinked anionic outer jelly coat and cereal-derived amphiphilic protein expressly listing specific protein species such as zein, gliadin, etc., with an exact particle size sub-range of 30–100 µm in one embodiment.
Based on thorough analysis of the prior art references, claims 1-14 contain allowable subject matter as the specific structural combination of elements has not been taught or suggested in the cited references. The unique arrangement of components produces emulsion stability and active substance encapsulation that are not achieved by the prior art references either individually or in combination. The specific arrangement of pullulan in the inner film combined with an anionic polymer jelly coat provides enhanced protection of active ingredients against degradation that is not achieved by either polymer alone. The localization of amphiphilic protein surfactants in the inner film allows for modulated release kinetics of active substances that is not taught in the prior art.
Any comments considered necessary by the applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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