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 .
Status of Application
Receipt of the Preliminary Amendment filed on April 29,2024 is acknowledged.
Claims 1-21 and 26 are pending in this application.
Claims 2-21 have been amended. Claim 26 is new.
All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on November 16, 2023 is acknowledged. A signed copy is attached to this office action.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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.
Claim 10 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.
Regarding claim 10, the claim recites “said aqueous phase”. There is insufficient antecedent basis for this limitation in the claim. While claim 1 recites an oil in water emulsion, an aqueous phase is not explicitly recited, therefore there the recitation of “said aqueous phase” does not have antecedent basis. It is suggested the claim be amended to recite “the aqueous phase”.
Claim Rejections - 35 USC § 102
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.
Claims 1-5, 7-8, 10-11, 15-17, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Emoto (US 6,458,395).
Emoto discloses gelatinous food products formed from a gel of an emulsified mixture comprising 10 to 50 wt. % of total solid content on a dry weight basis and 50 to 90 wt. % of water, the solid content contains 30 to 90 wt. % of saccharide, 5 to 40 wt. % of lipid, 2 to 60 wt. % of protein, 0.2 to 5 wt. % of organic acid, 0.2 to 5 wt. % of organic acid salt, 0.2 to 5 wt. % of emulsifying agent and 0.2 to 5 wt. % of gelling agent, the food product having a pH of 3.3 to 4 and being a composite of an isoelectric gel of the protein and a heat-soluble gel formed with the gelling agent (abstract).
Example 4 discloses:
Sucrose 5 parts (14)
Dextrin 15 parts (41.9) (plant based polysaccharide)
Enzyme-decomposed soybean protein 5 parts (14) (plant based protein)
Soybean isolate 5 parts (14) (plant based protein).
MCT 4 parts (11.2) (oil)
Egg yolk lecithin 0.2 parts (0.6)
Water 64.2 parts
Gluconic acid 0.8 parts (2.2)
Sodium ascorbate 0.3 parts (0.8)
Carrageenan 0.3 parts (0.8)
Agar 0.2 parts (0.6)
Total 100 parts
Multivitamin preparation 0.2 parts
Magnesium sulfate 0.1 parts
Potassium chloride 0.1 parts
Sodium secondary phosphate 0.1 parts
Total 0.5 parts
Regarding claim 2-4, as noted above, the gel of Example 4 comprises soybean protein, a plant based protein.
Regarding claim 5, as noted above, the gel of Example 4 comprises dextrin, a plant based polysaccharide.
Regarding claim 7, it is noted that dextrin is a starch or starch derivative.
Regarding claim 8, as noted above, agar is present in the amount of 0.2 parts.
Regarding claim 10, as noted above, water is present in the amount of 64.2 parts.
Regarding claim 11, as noted above, the gel comprises sucrose, which is common table sugar.
Regarding claims 15-17, as noted above, the gel comprises multivitamins, which are considered pharmaceutically and nutraceuticals active agents.
Regarding claim 26, as noted above, the formulation comprising soybean protein.
Emoto, therefore, anticipates the rejected claims.
Claims 1-5, 7, 11, 15-17, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kondo et al. (WO 2017170528), as evidenced by Dhar et al. (Electro-viscoelasticity of agarose based electrorheological fluids, Phys. Fluids 33, 013101 (2021).
Kondo discloses Carotenoid-containing particles comprise carotenoids dispersed in an agar gel comprising cyclodextrin and/or vegetable protein (abstract).
The method of preparation includes preparing an oil-in-water emulsified composition by dispersing an oil phase containing carotenoid in an aqueous phase containing agar and cyclodextrin and/or a vegetable protein, and cooling and solidifying the oil-in-water type emulsified composition into droplets (description).
Regarding claim 2, as noted above, the protein is disclosed to be a vegetable protein, which is, therefore, plant-based.
Regarding claims 3-4 and 26, the plant protein included soy protein, wheat protein, rice protein, pea protein and corn protein, used either alone or in combination.
Regarding claims 5, 7, and 11, excipients, including binders such as celluloses, sugar, sugar alcohols, and starches can be added.
Regarding claims 15-17, as noted above, carotenoids are added, which are pharmaceutically and nutraceutical active agents. Additional antioxidants, such as vitamin E and ascorbic acid (Vitamin C) can be added.
It is noted that agar gel particles exhibit viscoelasticity, as evidenced by Dhar.
Kondo, therefore, anticipates the rejected claims.
Claim Rejections - 35 USC § 103
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, 5-7, 9-16, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Seternes et al (US 2011/0268770).
Seternes discloses an oral pharmaceutical composition in unit dose form, each unit dose comprising a statin within a unitary carrier body, said body comprising a soft, chewable, gelled oil- in- water emulsion, one or both of the oil phase and the water phase whereof comprises a physiologically tolerable omega-3 acid ester (abstract).
By soft and chewable it is meant that the gelled emulsion is preferably readily deformable rather than rigid while yet being self-supporting, i.e. that it will not flow like a viscous liquid, and that it may be readily fragmented upon chewing, i.e. so that it need not be swallowed whole. Typically, such a gelled emulsion may be compressed at least substantially reversibly, i.e. elastically (paragraph 0019).
Gelling agents include proteins and polysaccharides (paragraph 0031).
Examples of proteins include gelatins, alginates, and carrageen’s (paragraph 0031).
Typical polysaccharides used as gelling agents include agars and plant based polysaccharides (paragraph 0035). The carrageenan family, which includes iota- and kappa-carrageenan’s, is a family of linear sulphated polysaccharides produced from red algae (paragraph 0037). It is noted that kappa-carrageenan is hydrophobically modified.
Regarding claims 5-6, as noted above, typical polysaccharides used as gelling agents include agars and plant based polysaccharides (paragraph 0035). The carrageenan family, which includes iota- and kappa-carrageenan’s, is a family of linear sulphated polysaccharides produced from red algae (paragraph 0037). It is noted that kappa-carrageenan is hydrophobically modified.
Regarding claim 7, cellulose derivatives can also be used as an emulsion stabilizer, examples include hydroxy methyl propyl cellulose (paragraph 0040).
Regarding claim 9, sweeteners including glycerol can be included (paragraph 0043).
Regarding claims 10 and 14, Example 1 discloses preparation of an emulsion with a weight ratio of 45:55 oil phase to aqueous phase.
Regarding claims 11-12, Example 1 discloses 36% xylitol and 14% sorbitol, a sugar alcohol.
Regarding claim 13, the oil can be a physiologically tolerable oil, such as a vegetable oil (paragraph 0012). Oils from plant seeds, algae and shirt are preferred (paragraph 0029). Example 5 discloses sunflower oil.
Regarding claims 15 and 16, as noted above, the composition comprises a physiologically tolerable omega-3 acid ester, which is considered a pharmaceutically/nutraceutical active agent.
Regarding claim 18, as noted above, the oral compoisition is disclosed to be a unit dose form.
Regarding claim 19, the dosage forms consist of a core of gelled emulsion. Less preferably, the core is coated (paragraph 0026). Therefore, it is the position of the Examiner that the preferred embodiment comprises an uncoated core.
Regarding claims 20-21, the dose units are blister packed and accordingly it is especially desirable to use the blistered layer of the blister packaging as the mold. The blister pack can then be foil sealed. The use of oxygen-impermeable foil packaging is especially preferred, e.g. as both laminate of a blister pack or as a single dose unit containing sachet. Oxygen-impermeable foils, e.g. metal/plastics laminates, are well known in the food and pharmaceuticals industries (paragraph 0051). Seternes does not disclose the mold is coated with a release control agent, therefore, it is the position of the Examiner that the mold would be uncoated.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have followed the guidance of Seternes to arrive at the instantly claimed composition. While Seternes does not exemplify agar in his gelled composition, he does disclose it as a suitable alternative, therefore, the skilled artisan would have a reasonable expectation that the emulsion would gel and maintained the same functionality as the exemplified embodiment. Applicants’ attention is directed to MPEP 2123 which discloses "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Fabry (US 2006/0093559) which discloses chewing gum composition with vegetal additives (abstract).
It is noted that chewing gum is considered a viscoelastic solid.
The chewing gum comprises encapsulated microcapsules comprising an oil in water emulsion gel matrix comprising agar (paragraph 0063-0065).
David et al. (BR 112020022809) which discloses a gel including water, a gelling agent and/or a polyvalent ionic gelled polymeric gelling agent and a pH adjuster.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615