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 .
This application is the national stage entry of PCT/EP2022/059965, filed 13 April 2022; and claims benefit of foreign priority document EP 21168625.8, filed 15 April 2021. This foreign priority document is not in English.
Claims 1-27 are pending in the current application and are examined on the merits herein.
Claim Objections
Claim 5 is objected to because of the following informalities: claim 5 recites “… and at least one compound selected from the group consisting of 1,1-GPS, further deoxy-disaccharide alcohols selected from the group consisting of 1,1-GPS, other deoxy-disaccharide alcohols, polysaccharides, oligosaccharides, …” This recitation can raise confusion as to whether the alternatives of polysaccharides and oligosaccharides are part of the “further deoxy-disaccharide alcohols” group or part of the “at least one compound” group. Under the broadest reasonable interpretation the terms have been interpreted as part of the broader “at least one compound” group.
Appropriate correction is required.
Claim 26 is objected to because of the following informalities: claim 26 at line 2 recites “1,6 GPS”. However, throughout the application the text “1,6-GPS” is used. For consistently the same text should be used at line 2 of claim 26.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 27 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because claim 27 recites the “Use of a 1,1-GPM- and/or 1,6-GPS-enriched isomalt composition produced by a method and/or composition according to claim 1, in products for human and/or animal consumption.” See MPEP 2173.05(q) citing In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961) providing “one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101”.
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 7, 9, 16, 18-19, and 25-27 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.
Regarding claims 7, 9, 16, 18-19, and 25-26, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For example, claim 7 recites “selective hydrogenation, in particular 1,6-GPS-selective hydrogenation”, and it is unclear if the selective hydrogenation is required to be 1,6-GPS-selective hydrogenation or if this phrase is a non-limiting example of selective hydrogenation encompassed within the scope of the claim and the claimed selective hydrogenation may be something other than 1,6-GPS-selective hydrogenation. For example, both claims 25 and 26 recite the composition “in particular producible by a method according to Claim 1”, and it is unclear if this phrase limits the claimed composition in terms of a product-by-process or if this phrase is a non-limiting example of how the composition may be produced.
Claims 25 and 26 recite the composition “in particular producible by a method according to Claim 1” (emphasis added). The term “producible” further renders the claim indefinite because it is unclear if the term “producible” means the claimed composition is produced by the method according to Claim 1 defining it as a product-by-process, or if the term “producible” means “capable of being produced” but not required to be produced by the method according to Claim 1.
Claim 27 recites the use of a 1,1-GPM- and/or 1,6-GPS-enriched isomalt composition without setting forth any steps involved in the how this use is practiced. See MPEP 2173.05(q) citing Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Claim Rejections - 35 USC § 102
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 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 26-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rapp et al. (US 6,555,146, issued 29 April 2003, cited in PTO-892).
Rapp et al. discloses improved sugar-free food products, characterized by their content in enriched mixtures of 1-O-α-D-glucopyranosyl-D-mannitol (1,1-GPM) and 6-O-α-D-glucopyranosyl-D-sorbitol (1,6-GPS) (abstract). This hydrogenated isomaltulose composition is also known as isomalt (column 7, lines 30-35). Rapp et al. discloses working example 10 of a filled hard caramel, in which the liquid filling contains a 1,6-GPS-enriched mixture, and the 1,6-GPS-enriched mixture component comprises 82% 1,6-GPS and 18% 1,1-GPM (column 13, line 35 to column 14, line 10), meeting limitations of claims 26 and interpreted as a use of the 1,6-GPS-enriched isomalt composition in a product for human consumption meeting limitations of claim 27.
Regarding claim 26 reciting “in particular producible by a method according to Claim 1”, as discussed above it is unclear if this phrase limits the claimed composition in terms of a product-by-process or if this phrase is a non-limiting example of how the composition may be produced. If this language defines the claimed composition in terms of a product-by-process, MPEP 2113 especially at I. provides “Furthermore, “[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes.” Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009).” In this case the product of Rapp et al. is made by a different process but appears to substantially identical to the claimed product, for example having the same amounts of 1,1-GPM and 1,6-GPS as claimed.
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.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Rapp et al. (US 6,555,146, issued 29 April 2003, cited in PTO-892) in view of Ueno et al. (US 6,746,541, issued 08 June 2004, cited in PTO-892) and Lovette et al. (Ind. Eng. Chem. Res., 2008, 47, p9812–9833, cited in PTO-892).
Rapp et al. discloses improved sugar-free food products, characterized by their content in enriched mixtures of 1-O-α-D-glucopyranosyl-D-mannitol (1,1-GPM) and 6-O-α-D-glucopyranosyl-D-sorbitol (1,6-GPS) (abstract). This hydrogenated isomaltulose composition is also known as isomalt (column 7, lines 30-35). Rapp et al. discloses working examples such as example 8 comprising a 1,1-GPM-enriched mixture that is 85% 1,1-GPM and 15% 1,6-GPS and forms a microcrystalline boundary layer of 1,1-GPM-dihydrate on the surface, which leads to a reduced stickiness and reduces the further water intake from the atmosphere (favorable storage behavior) (column 12, lines 30-65).
Rapp et al. does not specifically disclose the 1,1-GPM-enriched isomalt composition wherein the composition has a length-to-width ratio of the crystals contained therein of from 7.0 to 10.5 (claim 25).
Ueno et al. teaches a crystalline mixture solid composition which has almost no hygroscopicity, is easy to handle and dissolve and hardly worn by abrasion, and comprises α-D-glucopyranosyl-1,1-mannitol and α-D-glucopyranosyl-1,6-sorbitol and may further comprise α-D-glucopyranosyl-1,1-sorbitol (abstract). Ueno et al. teaches a process to obtain a high-quality powdery or granular crystalline mixture solid composition which does not require a drying step, is easy to handle and dissolve, and is hardly worn by abrasion (columns 3-4). The obtained crystalline mixture solid composition can be made powder by grinding or granule by granulation. The grinding and granulation methods are not particularly limited and commonly used grinders and granulators are used (column 4, lines 20-25).
Lovette et al. teaches in an industrial crystallization process, crystal shape strongly influences end-product quality and functionality, as well as downstream processing (page 9812, abstract) Size and shape distributions impact various solid properties, including end-use efficacy (e.g., bioavailability for pharmaceuticals, reactivity for catalytics), flowability, wettability, and adhesion. In turn, these properties impact downstream processing efficiency (e.g., filtering/drying times and the possible need for milling), as well as storage and handling. The desired size and shape distributions of a crystalline product will vary, depending on its application (page 9812, left column, paragraph 102).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Rapp et al. in view of Ueno et al. and Lovette et al. in order to select the optimal shape of the crystalline product. One of ordinary skill in the art would have been motivated to combine Rapp et al. in view of Ueno et al. and Lovette et al. with a reasonable expectation of success because both Rapp et al. and Ueno et al. are drawn to compositions comprising 1,1-GPM and 1,6-GPS, Ueno et al. teaches the advantages of a high-quality powdery or granular crystalline mixture solid composition and suggests the shape of the composition can be changed such as being made powder by grinding or granule by granulation, and Lovette et al. teaches crystal size and shape are known to affect the properties of the crystalline product, suggesting it would have been obvious to select the optimal shape of the crystalline product using known methods. See also MPEP 2144.04 at IV.B. citing In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) in which the court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. In this case the combined teachings of Rapp et al. in view of Ueno et al. and Lovette et al. suggest it would have been obvious to select the configuration or shape of the crystalline product as a matter of choice.
Allowable Subject Matter
Claims 1-4, 6, 8, 10-15, 17, and 20-24 are allowed.
Claim 5 is objected to over informalities explained above.
Claims 7, 9, 16, and 18-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is Rapp et al. (US 6,555,146, issued 29 April 2003, cited in PTO-892) in view of CN’729 (CN 101759729 A, published 30 June 2010, 6 page EPO English machine translation included, provided by Applicant in IDS filed 15 Aug 2025).
Rapp et al. teaches as above. Rapp et al. discloses improved sugar-free food products, characterized by their content in enriched mixtures of 1-O-α-D-glucopyranosyl-D-mannitol (1,1-GPM) and 6-O-α-D-glucopyranosyl-D-sorbitol (1,6-GPS) (abstract). This hydrogenated isomaltulose composition is also known as isomalt (column 7, lines 30-35). Rapp et al. discloses the method of production of the mixtures which is characterized in that hydrogenated isomaltulose is dissolved in water, crystalline hydrogenated isomaltulose is added in a quantity so that its solubility is exceeded, the formed suspension is filtered, and the 1,6-GPS-enriched filtrate is separated from the 1,1-GPM-enriched filter cake, or hydrogenated isomaltulose is mixed with water in such a ratio that the water quantity is not sufficient at the selected temperature so as to dissolve the entire quantity of isomalt mixture. For example, the total solids content of this suspension of hydrogenated isomaltulose can thereby be approximately 50-90 wt %, wherein the solids are present partially dissolved and partially undissolved (column 5, line 35 to column 6, line 65).
Rapp et al. does not specifically teach the method for producing 1,1-GPM- and/or 1,6-GPS-enriched isomalt compositions from an isomalt-containing solution characterised in that the isomalt-containing solution provided in method step a) is subjected to flash evaporation in a reactor for crystal nucleation to obtain a first isomalt-containing suspension comprising a first crystalline phase and a first liquid phase, and the first isomalt-containing suspension obtained in method step b) is subjected to a crystallisation process whereby a second isomalt-containing suspension comprising a second crystalline phase and a second liquid phase is obtained (claim 1).
Citations to CN’729 will be found in the 6 page EPO English machine translation. CN’729 teaches the invention relates to a method for producing crystals of isomalt (page 2, paragraph 1). Isomalt is a mixture of 1,1,-GPM and 1,6-GPS (page 2, paragraph 2). In the method an isomalt solution having a ketitol content above 94% is sucked into the negative pressure evaporation crystallizer to fill 10%-40% of the effective volume of the crystallizer, steam is vaporized in a negative pressure evaporation crystallizer to evaporate the isomalt solution, and seeded when the isomalt solution is supersaturated. The isomalt solution is continued to be fed into the negative pressure evaporation crystallizer while maintaining constant temperature evaporation until the crystallizer is full. When the crystal yield reaches 40-55% of the total weight of the material the negative pressure is broken, and the isomaltitol crystals are separated and dried (page 3, paragraphs 1-5).
It would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Rapp et al. in view of CN’729 in a manner that arrives that the method as claimed. Rapp et al. generally teaches separating the liquid and solid phases and regulating the composition of the liquid and the solid phases by means of adjusting the temperature. However, the combined teachings of Rapp et al. in view of CN’729 does not provide guidance for performing the additional step of flash evaporation in a reactor for crystal nucleation to obtain a first isomalt-containing suspension, and a further crystallisation process whereby a second isomalt-containing suspension is obtained. Therefore the closest prior art does not teach or fairly suggest each and every feature of the claimed method.
Conclusion
The application is not currently in condition for allowance.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693