DETAILED ACTION
Amendments made June 9, 2026 have been entered.
Claims 1-13 and 26-30 are pending.
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 .
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.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 8-12 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joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention has been withdrawn in light of applicant’s amendments made June 9, 2026.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Note: “A continuous melt granulation mixture” is one suitable for “continuous melt granulation in an extruder or any other suitable apparatus. See instant specification page 7 lines 10-11.
The rejection of claims 10 and 12 under 35 U.S.C. 103 as being unpatentable over Upadhye et al (US 10,786,459) in view of Kiippers et al (US 4203997) has been withdrawn in light of applicant’s amendments made June 9, 2026 which require the filler is limited to inulin.
Claims 1-9, 11, 13 and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Upadhye et al (US 10,786,459) in view of Kiippers et al (US 4203997).
Upadhye et al (Upadhye) teaches a dry granulation mixture with high active loads comprising:
At least one active ingredient selected from the group including ascorbic acid which is a nutritional supplement, and thus, would have been obvious to select for its nutritional benefits;
A carrier selected from the group including polyols, which also function as binders, wherein the carrier, and thus polyol/binder, has a melting point not exceeding the melting point of the active ingredient; and
0-40% fillers and dilutants selected from the group including sorbitol, and cellulose which is a polysaccharide filler having a melting point of 500-518F (260-270C) (abstract, column 3 lines 42-52, column 12 lines 51-53, column 13 line 38, column 14 lines 40-44, column 16 lines 27-40, and claim 15).
Upadhye is not specific to the mixture as comprising at least 50% active ingredient and less than 5% water as recited in claim 1, or 50-80% ascorbic acid, 5-15% of a binder with the claimed melting point, and less than 2% water as recited in claim 8, or 65-75% ascorbic acid as recited in claim 26.
Regarding the mixture as comprising less than 5% water as recited in claim 1, preferably less than 2% water as recited in claim 8, although Upadhye is not specific to a moisture content, as Upadhye teaches of a dry composition, wherein liquid binders and solvents are not added to the mixture (abstract and column 3 lines 42-48), one of ordinary skill in the art would find it obvious to form the product of Upadhye in a dry manner, and thus a moisture content within the claimed ranges of less than 5%, including less than 2% are considered at least obvious over the teachings of the prior art. The position is further supported as Kiipers teaches a dry base mixture comprising ascorbic acid as an active ingredient contains a maximum of 0.1% water (abstract and column 3 lines 18-25), and wherein it would have been obvious to use a known dry product moisture content wherein non was disclosed.
Regarding the mixture as comprising at least 50% active ingredient as recited in claim 1, or to the active ingredient as 50-80% ascorbic acid and to 5-15% of a binder with the claimed melting point as recited in claim 8, or 65-75% ascorbic acid as recited in claim 26, although Upadhye is not specific to the amount of active ingredient in the mixture, as Upadhye teaches the mixture facilitates the production of high load granules (column 3 lines 47-48), the teachings of the prior art would have made obvious a mixture with a high load, such as over 50% active ingredient and thus 50% or less other ingredients, including the carrier/polyol binder. Furthermore, as Upadhye teaches that the ratio of the active ingredient to the carrier is about 99:1 to 1:1 (column 15 lines 46-53; equating to about 50-99% active), wherein no other ingredients are required (all), the teachings of Upadhye further make obvious a mixture comprising: about 1-50% carrier including a polyol/binder with the disclosed melting point, and about 50-99% active ingredient, including ascorbic acid which is disclosed by Upadhye for its nutritional properties.
Regarding the melting temperature of the active ingredient as higher than the melting point of the binder, and the melting temperature of the binder as lower than the melting point of the filler as recited in claim 1, and to the sugar alcohol as sorbitol as recited in claim 30, as discussed above, Upadhye teaches a dry active mixture comprising a carrier selected from the group including polyols which also function as binders, with a melting point not exceeding the melting point of the active ingredient. Upadhye also teaches the filler as cellulose which is a polysaccharide (column 16 lines 34-40). Upadhye is not explicit to a desired polyol for use.
Kiipers teaches that when binding a mixture of ascorbic acid, 5-9% polyol is advantageously used, preferably sorbitol as the desired binder, i.e. carrier of the active (abstract, column 3 lines 18-25 and 56-61). Thus, it would have been particularly obvious to include about 5-9% sorbitol in the ascorbic acid active mixture of Upadhye as it was a preferred binder for said material as taught by Kiipers. As cellulose, i.e. a filler, has a melting point of 500-518F (260-270C), sorbitol, i.e. a binder, has a melting point of 230F, and ascorbic acid, i.e. an active ingredient, has a melting point of about 374F, the composition of the prior art encompasses the claimed limitations.
Regarding the mixture as a continuous melt granulation mixture as recited in claim 1, as noted above, the term “a continuous melt granulation mixture” is one suitable for “continuous melt granulation in an extruder or any other suitable apparatus (see instant specification page 7 lines 10-11). The term does not reflect a product which has been melted, but rather a composition or mixture which is capable of being treated with continuous melt granulation. Although Upadhye teaches that melting is not required for formation of the product (column 12 lines 41-43), as the prior art teaches of a mixture with an overlapping composition, including the same main three components with the same melting temperatures, the product of the prior art would be capable of being treated in the manner claimed. A product and its properties cannot be separated. The position is further supported as Upadhye teaches that the mixture can be treated in the same type of apparatus, i.e. an extruder (abstract).
Regarding claims 4-7, as discussed above Upadhye teaches at least one active ingredient selected from the group including ascorbic acid which is a nutritional supplement, and thus, would have been selected for its nutritional benefits. Ascorbic acid as taught by Upadhye is natural, and thus not a synthetic drug, is a water-soluble micronutrient, and a water-soluble vitamin.
Regarding the ratio of filler and binder as from 4:1 to 1:1 as recited in claim 9, preferably 3:1 to 1:1 as recited in claim 27, or 2:1 to 1:1 as recited in claim 28, or 2:1 as recited in claim 29, as discussed above the teachings of Upadhye at least make obvious a mixture comprising: an active, up to 50% binder, and 0-40% fillers. Additionally, Upadhye specifically teaches 0-50% binder (column 16 lines 27-34). Thus, the teachings of Upadhye encompass a filler to binder ratio overlapping the claimed range. Furthermore, it would have been obvious to adjust the amount of each respective ingredient, and thus the resulting ratio depending on the intensity of the related function, i.e. filling or binding.
The prior art discloses overlapping ranges of composition. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Upadhye et al (US 10,786,459) in view of Kiippers et al (US 4203997), further in view of Harel et al (US 2019/0194259).
As discussed above Upadhye teaches a dry mixture with a filler and high active loads of bioactive materials, wherein it would have been obvious for the binder to be sorbitol in view of Kippers.
Upadhye is silent to the filler as inulin as recited in claims 10 and 12.
Harel et al (Harel) teaches formulations for embedding bioactive materials, including vitamins, in a protective dry matrix include stabilizers to provide structural stability and/or physical and chemical protective benefits, wherein the stabilizers are selected from the group including inulin (abstract and paragraphs 3, 10-12, and 71-72). As Harel teaches that the materials are in dry powder form (paragraph 18) and that the stabilizer is included from 0.1-10% dry weight (paragraph 12), the teachings of Harel encompass the stabilizer as from 0.1-10% total weight.
It would have been obvious for the active containing mixture of Upadhye to comprise 0.1-10% inulin to provide structural stability and/or physical and chemical protective benefits in view of Harel.
Response to Arguments
Applicant's arguments filed June 9, 2026, regarding the remaining rejections have been fully considered but they are not persuasive.
Applicant argues that Upadhye does not teach a continuous melt granulation mixture because the mixture of the prior art is processed with dry granulation. This argument is not convincing as it is not commensurate in scope with the claims. As noted above, the term “a continuous melt granulation mixture” is one suitable for “continuous melt granulation in an extruder or any other suitable apparatus (see instant specification page 7 lines 10-11). The term does not reflect a product which has been melted, but rather a composition or mixture which is capable of being treated with continuous melt granulation. Although Upadhye teaches that melting is not required for formation of the product (column 12 lines 41-43), as the prior art teaches of a mixture with an overlapping composition, including the same main three components with the same melting temperatures, the product of the prior art would be capable of being treated in the manner claimed. A product and its properties cannot be separated. The position is further supported as Upadhye teaches that the mixture can be treated in the same type of apparatus, i.e. an extruder (abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US9675557 shows solid particles comprising 8-70% fat soluble actives, 1-80% water, and 1-80% auxiliary agents including sorbitol.
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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KELLY BEKKER
Primary Patent Examiner
Art Unit 1792
/KELLY J BEKKER/Primary Patent Examiner, Art Unit 1792
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