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 .
DETAILED ACTION
Claims 1, 3-5, 7, 9, 10, 15-17, 19, 21, 22, 29, 30, 33-37, 45 and 55 are currently pending in a Response dated 02/17/2026. Claims 10 and 15-16 have been withdrawn. Accordingly, claims 1, 3-5, 7, 9, 17, 19, 21, 22, 29, 30, 33-37, 45 and 55 are being examined at this time.
Withdrawn rejections:
Applicant's amendments and arguments filed 02/17/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
New Grounds of Rejections --- as necessitated by amendment
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
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 1, 3-5, 7, 9, 17, 19, 21, 22, 29, 30, 33-37, 45 and 55 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “at least 60% of at least one polymer”. However, it appears that the limitation of “at least 60%” is not supported by the specification including Examples 1-4, 11 and 12. For example, Example 4 discloses 20g of composite microcapsules comprising 50% omega-3 algal oil were prepared with 30% ethyl cellulose and 20% shellac. Here, “ethyl cellulose” reads on the claimed shell material.
If applicant disagrees, please provide supportive location and proper explanation.
The remaining claims are also rejected due to the rejection of base claim 1.
Claim 1 is 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 1 recites “the shell comprises at least 60% of at least one polymer”, but it fails to specify the basis for the claimed percentage. It is unclear whether the recited “at least 60%” refers to (i) the amount of polymer relative to the total weight of the shell, or (ii) the amount of polymer relative to the total weight of the microcapsule, or some other basis. The specification does not provide a clear definition or consistent usage resolving this ambiguity. Because multiple reasonable interpretations exist, the metes and bounds of the claim is indefinite. Applicant is required to amend the claim to clearly define the basis for the percentage.
For examination purpose, “the shell comprises at least 60% of at least one polymer” is seen as “the shell comprises any amount of at least one shell polymer based on the total weight of the shell,” until applicant clarifies.
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.
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.
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.
Claims 1, 3-5, 7, 9, 17, 19, 21, 22, 29, 30 and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Kvitnitsky et al. (EP2913103A1, IDS of 09/02/2022).
Applicant claims the below claim 1 filed on 02/07/2026:
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For examination purpose, the limitation of “designed to deliver a composition to the gastrointestinal tract” is not structurally limiting, but an intended use because it is an intended use it merely defines a context in which the invention operates. See Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Moreover, the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Thus, "recitation of a new intended use for an old product does not make a claim to that old product patentable." In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1977). Thus, if the prior art teaches the claimed microcapsule containing a core containing at least one active substance and a polymer shell, it reads on the claimed microcapsule.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical microcapsule research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02); and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143).
Kvitnitsky discloses single- and multi-layer microcapsules comprising an inner core made of an encapsulated active ingredient and a shell made of a wall-forming polymer (e.g., [0047] and claim 1 of prior art), and microencapsulation is suitable for e.g., food supplements (e.g., [0007]) which reads on the claimed food-grade microcapsules, and for oral hygiene and oral care, macrolide antibiotics can topically be used (e.g., [0024], [0114] and claim 13 of prior art); the active ingredient having biological activity includes one or more odor agent, color agent, and may also include non-active ingredients such as an anti-oxidant, a plasticizer, a carrier, etc.(e.g., [0037]) and the active substant can be sensitive to oxidation (e.g., [0051]), and its specific example includes vitamins such as vitamin F, a mixture of unsaturated fatty acids that oxidizes rapidly when incorporated in cosmetic formulation (e.g., [0073]) which reads the claimed elected species of active ingredient, natural extract (e.g., grape seed extract GSE) or plant oil such as evening primrose oil (e.g., [0075]-[0080]) which reads on the claimed active substance; the encapsulated active ingredient prevents oxidative degradation (e.g., [0076]); the microcapsules comprises wall-forming polymer includes ethyl cellulose (e.g., [0095]) which reads on the claimed shell material; and Example 1 discloses encapsulation of retinol palmitate (vitamin A) for oral hygiene wherein 3g retinol, 1g antioxidant, 6g plasticizer and 10g ethyl cellulose solution in 140 ml ethyl acetate and thus the amount of ethyl cellulose polymer in the total weight of shell reads on the claimed amount, and further the polymer amount would be optimized (instant claims 1, 3, 5, 7, 9, 22 and 34-35); the microcapsule enables controlled release of the active ingredient which reads on the claimed prolonged release profile, delayed release profile, sustained release profile (e.g., [0007] and [0017])(instant claim 4); the amount of active ingredient is 25±1% α-tocopherol, 14±0.2% linolenic and linoleic free fatty acids α-tocopherol (e.g., [0073]), 7% of Rutin ([0074]), 6% of GSE ([0076]) in which the prior art amount of active ingredient overlaps the instant range of at least 5%. MPEP 2144.05: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). (instant claim 17); the microcapsule containing an active substance masks an original odor, color or taste of the substance ([0023]) (instant claim 19); as the shell material, polysaccharide gum such as an alkali metal alginate can also be used ([0012])(instant claim 21); the microcapsule has a size of 20-40 microns which is within the instant range of 10-400 microns(instant claim 29); the inner and outer polymer shells are both polymer-plasticizer or polymer-mineral shells and the polymer of the inner core microcapsule and of the outer shells may be identical or different ([0092]-[0093]) (instant claim 30); and the microcapsules and the microcapsule-containing composition is provided in the form of cream, paste, oral hygiene, etc. ([0038]) (instant claim 33).
In light of the foregoing, instant claims 1, 3-5, 7, 9, 17, 19, 21, 22, 29, 30, and 33-35 are obvious over Kvitnitsky.
Claims 1 and 21 (other species of shell material), 36, 37, 45 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Kvitnitsky et al. (EP2913103A1, IDS of 09/02/2022) in view of Kolar et al. (JP2009/519980A, IDS of 09/02/2022, citation is obtained from its corresponding US2007/0141211A1).
However, Kvitnitsky does not expressly teach other species of instant claims 1 and 21, and various types of food products of instant claims of 36, 37, 45 and 55. The deficiency is cured by Kolar.
Kolar discloses a microcapsule comprises core and shell wall encapsulated the core material wherein the core includes a phospholipid and a oxidation material such as unsaturated fatty acid including omega-3- fatty acid, omega-6-fatty acid, and an omega-9 fatty acid (claims 1 and 5 of prior art) that has fish odors ([0004]) and the said fatty acid materials reads on the claimed elected species of polyunsaturated fatty acids, and the core further includes antioxidant (claim 12 of prior art); the wall material is water impermeable (claim 14 of prior art) wherein the shell wall material comprises polysaccharides such as cellulose, hemicellulose, gum, chitosan ([0052]) and the examples of cellulose include methylcellulose, ethylcellulose, hydroxyethylcellulose, carboxymethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, sulfonated cellulose, cellulose acetate, cellulose acetate phthalate, cellulose acetate trimelitate, cellulose ethyl phthalate, and viscose ([0056]) (instant claims 1 and 21 – other species); and the said encapsulation does not impart offensive tastes or odors to the foods from the oxidation of the fatty acids or other oxidizable materials ([0019]); the microcapsule has a size of 10nm to 500 microns ([0059]) or between about 0.1 and about 60 microns ([0063]) which overlaps the instant range of 10-400 microns. MPEP2144.05 noted above; and the microcapsule is contained in food products and thus, the food products contain an edible material and a microcapsule ([0076]) including milk, drinks, fruit and vegetable drinks which reads on the vegan food, dairy product ([0078]), nutritional drinks, energy drinks ([0079]), and pet food ([0082]) which reads on vegan or vegetarian raw material. (instant claims 36, 37, 45, and 55).
It would have been obvious to modify microcapsules for the food supplement of Kvitnitsky with various shell materials and types of food products of Kolar as a matter of choice or design, and thus such selection would have yielded no more than the predictable results of obtaining wide range of food-grade products containing microcapsules with various polymeric shells.
In light of the foregoing, instant claims 1, 21, 36, 37, 47 and 55 are obvious over Kvitnitsky in view of Kolar.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that newly added limitation of “microcapsule designed to deliver a composition to the gastrointestinal (GI) tract” of instant claim 1 is an intended use and thus is not structurally limiting.
The Examiner responds that Kvitnitsky discloses microcapsule containing macrolide antibiotics for oral hygiene and thus, even when the microcapsule is topically applied to the gums, significant amounts can be swallowed or absorbed systemically, ultimately delivering the composition to the GI. The claimed invention does not require the microcapsule should be orally applied.
Applicant argues that the applied art does not teach a shell comprising at least 60% of at least one polymer.
The Examiner replies that Kvitnitsky and Kolar both teaches same shell materials (see [0095] of Kvitnitsky and [0056] of Kolar); and Kvitnitsky teaches ethyl cellulose amount in e.g., Example 1. Thus, in microencapsulation, shell must be structurally continuous and that typically require the polymer to be the major component and therefore it would have been obvious to a POSITA to select a polymer (e.g., ethyl cellulose or other cellulose derivatives) as the primary polymer shell component and to obtain its concentration to at least 60% based on the shell weight in order to form a robust, continuous shell and achieve predictable encapsulation and release properties.
In light of the foregoing, applicant’s arguments are not persuasive.
Conclusion
All examined claims are rejected.
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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613