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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-13, drawn to an active ingredient mixture.
Group II, claim(s) 14-18 and 25, drawn to a granule.
Group III, claim(s) 19, drawn to continuous melt granulation.
Group IV, claim(s) 20-24, drawn to a method of making granules.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: Groups I-IV lack unity of invention because even though the inventions of these groups require the technical feature of the mixture of claim 1, this technical feature is not a special technical feature as it does not make a contribution over the prior art. See the rejection of claim 1 below.
During a telephone conversation with Bryan Davidson on February 24, 2026 a provisional election was made with traverse to prosecute the invention of Group I, claims 1-13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-25 have been withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 8-12 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 8-12 recite the broad recitation of a range, and the claims also recite “preferably” followed by a narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1-13 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 (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.
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, 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, 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% polyol 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, 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 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, 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pubchem shows that the melting pointe of sorbitol is 230F, and the melting point of cellulose is 500-518C.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELLY BEKKER whose telephone number is (571)272-2739. The examiner can normally be reached Monday-Friday 8am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KELLY BEKKER
Primary Patent Examiner
Art Unit 1792
/KELLY J BEKKER/Primary Patent Examiner, Art Unit 1792