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
Application Status
This application is a CON of US patent application 16/903,369, filed on 12/05/2022.
Claims 16, 21-22, 28, 33-34 and 35 are currently pending in this patent application.
In response to a previous Office action, a Final Rejection Office action (mailed on 11/24/2025), Applicants filed a response and an amendment on 05/19/2026, amending claim 16, is acknowledged.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/19/2025 has been entered.
Applicants' arguments filed on 05/19/2025 have been fully considered and are deemed persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claims 16, 21-22, 28, 33-34 and 35 are present for examination.
Priority
Acknowledgement is made of applicants claim for priority of US patent applications 16/903,369, filed on 06/16/2020, now US patent 11542537, 15/694,524, filed on 09/01/2017, now US patent 10683526, 14/287,837, 371, filed on 5/27/2014, now US patent 9752174, and CIP of US patent application 15/400,325, filed on 01/06/2017, and Provisional applications 61/827,922, filed on 05/28/2013 and 61/939,855, filed on 02/14/2014.
Withdrawn-Claim Rejections - 35 USC § 102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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
MPEP-2131 Anticipation — Application of 35 U.S.C. 102 [R-08.2017]
A claimed invention may be rejected under 35 U.S.C. 102 when the invention is anticipated (or is "not novel") over a disclosure that is available as prior art. To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation. See, e.g., MPEP § 2114, subsections II and IV.
"A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). "When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art." Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001) Note that, in some circumstances, it is permissible to use multiple references in a 35 U.S.C. 102 rejection. See MPEP § 2131.01.
MPEP-2131.01 Multiple Reference 35 U.S.C. 102 Rejections [R-11.2013]
Normally, only one reference should be used in making a rejection under 35 U.S.C. 102. However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to:
(A) Prove the primary reference contains an "enabled disclosure;"
(B) Explain the meaning of a term used in the primary reference; or
(C) Show that a characteristic not disclosed in the reference is inherent.
The previous rejection of Claims 16, 21-22, 28, 33-34 and 35 are rejected under 35 U.S.C. 102(a)(1/2) based upon a public use or sale or other public availability of the invention as anticipated by Mikkelsen et al. (Methods for improved production of rebaudioside D and rebaudioside M, WO 2014/122227 A2, publication 08/14/2014, claim priority of US Provisional application 61/761,490, filed on 02/06/2013, pd), as evidenced by Prakash et al. (Isolation and characterization of a novel rebaudioside M isomer from a bioconversion reaction of rebaudioside A and NMR comparison studies of rebaudioside M isolated from Stevia rebaudiana Bertoni and Stevia rebaudiana Morita. Biomolecules (03312014), 4: 374-389), is withdrawn in view of Applicants amendment of the claims and persuasive arguments.
New-Claim Rejections - 35 U.S.C. § 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
According to MPEP 2143:
“Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield
predictable results;
(B) Simple substitution of one known element for another to obtain predictable
results;
(C) Use of known technique to improve similar devices (methods, or products)
in the same way;
(D) Applying a known technique to a known device (method, or product) ready
for improvement to yield predictable results;
(E) “ Obvious to try ” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in
either the same field or a different one based on design incentives or other market
forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art
reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.”
Claim 17, 21-23, 25-26, and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Mikkelsen et al. (Methods for improved production of rebaudioside D and rebaudioside M, WO 2014/122227 A2, publication 08/14/2014, claim priority of US Provisional application 61/761,490, filed on 02/06/2013, see IDS), and Prakash et al. (Isolation and characterization of a novel rebaudioside M isomer from a bioconversion reaction of rebaudioside A and NMR comparison studies of rebaudioside M isolated from Stevia rebaudiana Bertoni and Stevia rebaudiana Morita. Biomolecules (03312014), 4: 374-389see, PTO892).
The Broadest Reasonable Interpretation (BRI) of Claim 16 (newly amended limitations are underlined), which is directed to a consumable product comprising a target steviol glycoside composition having a content of greater than 90% by weight on a dry weight basis of rebaudioside D2 (reb D2), or reb M2, wherein the product is selected from the group consisting of a food, a beverage, a pharmaceutical composition, a tobacco product, a nutraceutical composition, an oral hygiene composition, and a cosmetic composition.
** As an initial matter, the provisional application 61/861,528, filed on 08/02/2013 has support for reb A, and D, and provisional applications 61/881,166, filed on 09/23/2013, has support for reb A and D of claim 16, and 61/921,635 filed on 12/30/2013 (EFD) has support for Reb M, reb D2 and reb M2 of claim 16.
Regarding claims 16, 21, 22, 28, 33-34 and 35, Mikkelsen et al. teach (abstract, para 7, 47, 302, 339-341, 356-357, Fig. 1, 10, 11, 12, Example 7, Table 16, and claims 1-117) a recombinant biosynthesis of steviol glycosides including reb A (reb A), reb D, reb E and reb M from stevioside or steviol, and a composition including food products beverages comprising said steviol glycosides, in particular the biosynthesis of reb D and reb M by using recombinant cells (para 7). Mikkelsen et al. also teach a method of producing Rebaudioside D (reb D) and Rebaudioside M (reb M), comprising: (a) culturing a recombinant cell in a culture medium, under conditions wherein genes encoding a UGT85C2 polypeptide; a UGT74G1 polypeptide; a UGT76G1 polypeptide; a UGT91d2 polypeptide; or a EUGT11 (similar enzyme UGTSL2 having same function) polypeptide, wherein UGT stands for UDP-glucosyltransferase (UDP-glycosyltransferase) are expressed; and (b) synthesizing Reb D, Reb M, in the cell, wherein the culture medium comprises steviol or stevioside as feedstock; and (c) isolating Reb D and/or Reb M (para 47, 187, 209, 305, Fig. 1), wherein the recombinant cell is Saccharomyces cerevisiae (para 37, 39), i.e., recombinant S. cerevisiae host cell EFSC 3841 comprising: (a) a gene encoding a polypeptide UGT85C2, UGT74G1, UGT76G1, UGT91d2 and UGT EUGT11 (synonym: UGTSL2), an UDP-glycosyl transferase (UDP-glucosyl transferase enzymes (see, para 2, 14, 15, 307, 356, 357, Fig. 1, 11 and Table 16, Example 7).
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Mikkelsen et al. do not teach target steviol glycoside composition having a content of greater than 90% by weight on a dry weight basis of rebaudioside D2 (reb D2), or reb M2.
However, Prakash et al. teach isolation and characterization of a novel rebaudioside M isomer from a bioconversion reaction of rebaudioside A and NMR comparison studies of rebaudioside M isolated from Stevia rebaudiana Bertoni and Stevia rebaudiana Morita, and Prakash et al. also teach a minor product, rebaudioside M2 (reb M2), from the bioconversion reaction of rebaudioside A (reb A) to rebaudioside D (reb D), was isolated and the complete structure of the novel steviol glycoside was determined, and Rebaudioside M2 (2) is considered an isomer of rebaudioside M, and contains a relatively rare 1,6 sugar linkage, and it was isolated and characterized with NMR (1H, 13C, COSY, HSQC-DEPT, HMBC, 1D-TOCSY, and NOESY) and mass spectral data. Prakash et al. further teach that numerous NMR spectroscopy studies of rebaudioside M, rebaudioside D, and mixture of rebaudioside isomers led to the discovery that SG17 which was previously reported in literature, is a mixture of rebaudioside D, rebaudioside M, and possibly other related steviol glycosides (see, abstract, Title, Scheme 1, Fig 2, and .
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Prakash et al. clearly teach isolation and characterization of a novel rebaudioside M isomer from a bioconversion reaction of rebaudioside A and NMR comparison studies of rebaudioside M isolated from Stevia rebaudiana Bertoni and Stevia rebaudiana Morita, and Prakash et al. also teach a minor product, rebaudioside M2 (reb M2), from the bioconversion reaction of rebaudioside A (reb A) to rebaudioside D (reb D).
Therefore, it would have been obvious to one of ordinary skill in the art to arrive at the claimed invention as a whole before the effective filing date of the invention was made by combining the teachings of Mikkelsen et al., and Prakash et al. isolation and characterization of a novel rebaudioside M isomer from a bioconversion reaction of rebaudioside A and NMR comparison studies of rebaudioside M isolated from Stevia rebaudiana Bertoni and Stevia rebaudiana Morita, and Prakash et al. also teach a minor product, rebaudioside M2 (reb M2), from the bioconversion reaction of rebaudioside A (reb A) to rebaudioside D (reb D) as taught by Prakash et al. and modify Mikkelsen et al., a consumable product comprising a target steviol glycoside composition having a content of greater than 90% by weight on a dry weight basis of rebaudioside D2 (reb D2), or reb M2, wherein the product is selected from the group consisting of a food, a beverage, a pharmaceutical composition, a tobacco product, a nutraceutical composition, an oral hygiene composition, and a cosmetic composition to arrive the claimed invention.
One of ordinary skilled in the art would have been motivated to make a composition comprising rebaudioside D2 (reb D2), or/and reb M2, which are in fact a plant-based sweetener, without any calorie, which is therapeutically as an antidiabetic sugar, clinically, pharmaceutically and financially beneficial.
One of ordinary skilled in the art would have a reasonable expectation of success because Mikkelsen et al., and Prakash et al. could successfully produce reb D2 , or/and reb M2, and isolate and highly purified said reb D2 , or/and reb M2 of a composition.
Thus, the above references render the claims prima facie obvious to one of ordinary skill in the art.
New-Double Patenting Rejections (Provisional)
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b)
Claims 16, 21-22, 28, 33-34 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34, 36-37, 39-40, and 42 of co-pending Application No. 18/155,002 (USPGPUB US20230413865A1, publication 12/28/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are of overlapping scope.
Claims 16-18, 22, 33-34 and 35 of the instant application are drawn to a consumable product comprising a target steviol glycoside composition having a content of greater than 90% by weight on a dry basis of rebaudioside D2 (reb D2) or rebaudioside M2 (reb M2), wherein the product is selected from the group consisting of a food, a beverage, a pharmaceutical composition, a tobacco product, a nutraceutical composition, an oral hygiene composition, and a cosmetic composition, wherein the target steviol glycoside is reb D2, wherein the composition is selected from the group consisting of beverages; natural juices; refreshing drinks; carbonated soft drinks; diet drinks; zero calorie drinks; reduced calorie drinks and foods; yogurt drinks; instant juices; instant coffee; powdered types of instant beverages; canned products; syrups; fermented soybean paste; soy sauce; vinegar; dressings; mayonnaise; ketchups; curry; soup; instant bouillon; powdered soy sauce; powdered vinegar; types of biscuits; rice biscuit; crackers; bread; chocolates; caramel; candy; chewing gum; jelly; pudding; preserved fruits and vegetables; fresh cream; jam; marmalade; flower paste; powdered milk; ice cream; sorbet; vegetables and fruits packed in bottles; canned and boiled beans; meat and foods boiled in sweetened sauce; agricultural vegetable food products; seafood; ham; sausage; fish ham; fish sausage; fish paste; deep fried fish products; dried seafood products; frozen food products; preserved seaweed; preserved meat; tobacco and medicinal products, wherein the target steviol glycoside is reb M2, wherein the consumable product further comprising at least one additive selected from the group consisting of carbohydrates, polyols, amino acids and their corresponding salts, poly-amino acids and their corresponding salts, sugar acids and their corresponding salts, nucleotides, organic acids, inorganic acids, organic salts including organic acid salts and organic base salts, inorganic salts, bitter compounds, flavorants and flavoring ingredients, astringent compounds, proteins or protein hydrolysates, surfactants, emulsifiers, flavonoids, alcohols, polymers and combinations thereof, and at least one functional ingredient selected from the group consisting of saponins, antioxidants, dietary fiber sources, fatty acids, vitamins, glucosamine, minerals, preservatives, hydration agents, probiotics, prebiotics, weight management agents, osteoporosis management agents, phytoestrogens, long chain primary aliphatic saturated alcohols, phytosterols and combinations thereof, as well as one of Mogroside V, Luo Han Guo, allulose, allose, D-tagatose, erythritol and combinations thereof.
The claims 34, 36-37, and 39 of the co-pending application are drawn to a method for producing a highly purified rebaudioside M composition, comprising the steps of: (a) providing a starting composition comprising an organic compound with at least one carbon atom, wherein said starting composition is selected from the group consisting of stevioside A, rebaudioside B2, rebaudioside M3, (b) providing a biocatalyst, the biocatalyst containing uridine diphosphate glycosyltransferases (UDP-glycosyltransferases), wherein the UDP-glycosyltransferase comprises an amino acid sequence selected from the group consisting of the amino acid sequence set forth in SEQ ID NO: 11 uridine diphosphate-glycosyltransferase 76G1 (“UGT76G1”), an amino acid sequence having at least 95% amino-acid sequence identity with the amino acid sequence set forth in SEQ ID NO: 11, the amino acid sequence set forth in SEQ ID NO: 9 uridine diphosphate-glycosyltransferase of Solanum lycoperiscum origin (“UGTSL2”) and an amino acid sequence having at least 95% amino-acid sequence identity with the amino acid sequence set forth in SEQ ID NO: 9, and further providing an enzyme with β-glucosidase activity from Trichoderma reesei or Aspergillus niger; (c) contacting the UDP-glycosyltransferases and the enzyme with β-glucosidase activity with a medium comprising the starting composition to produce a composition comprising at least rebaudioside M; and (d) separating rebaudioside M from the medium to provide a highly purified rebaudioside M composition, wherein rebaudioside M is separated from the medium using crystallization, separation by membranes, centrifugation, extraction, chromatographic separation or a combination of such methods, wherein the highly purified rebaudioside M composition comprises rebaudioside M in an amount of at least 95% by weight on a dry weight basis, and the composition further comprising providing an enzyme with β-glucosidase activity for hydrolysis of rebaudioside D2 or rebaudioside M2.
Claims of the instant application listed above cannot be considered patentably distinct over claims 34, 36-37, and 39 of the reference patent application when there are specifically recited embodiments that would either anticipate to claims 16-18, 22, 33-34 and 35 of the instant application or alternatively render them obvious. Alternatively, claims 16-18, 22, 33-34 and 35 cannot be considered patentably distinct over the claims 34, 36-37, and 39 of co-pending Application No. 18/155,002 of the reference co-pending application when there is specifically disclosed embodiment in the reference co-pending application that falls within the scope of claims 16-18, 21-22, and 33-35 of the instant application, i.e. there is substantially overlapping scope between the claimed invention and the teachings of the reference. One having ordinary skill in the art would have been motivated to do this because that embodiment is disclosed as being a preferred embodiment within the claims 4, 36-37, and 39 of co-pending Application No. 18/155,002.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
New-Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 16, 21-22, 28, 33-34 and 35 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over at least claims 1-4 of US patent 9752174 B2, patent granted on 09/05/2017, IDS).
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 16, 21-22, 28, 33-34 and 35 are directed to a consumable product comprising a target steviol glycoside composition having a content of greater than 90% by weight on a dry basis of rebaudioside D2 (reb D2) or rebaudioside M2 (reb M2), wherein the product is selected from the group consisting of a food, a beverage, a pharmaceutical composition, a tobacco product, a nutraceutical composition, an oral hygiene composition, and a cosmetic composition, wherein the target steviol glycoside is reb D2, wherein the composition is selected from the group consisting of beverages; natural juices; refreshing drinks; carbonated soft drinks; diet drinks; zero calorie drinks; reduced calorie drinks and foods; yogurt drinks; instant juices; instant coffee; powdered types of instant beverages; canned products; syrups; fermented soybean paste; soy sauce; vinegar; dressings; mayonnaise; ketchups; curry; soup; instant bouillon; powdered soy sauce; powdered vinegar; types of biscuits; rice biscuit; crackers; bread; chocolates; caramel; candy; chewing gum; jelly; pudding; preserved fruits and vegetables; fresh cream; jam; marmalade; flower paste; powdered milk; ice cream; sorbet; vegetables and fruits packed in bottles; canned and boiled beans; meat and foods boiled in sweetened sauce; agricultural vegetable food products; seafood; ham; sausage; fish ham; fish sausage; fish paste; deep fried fish products; dried seafood products; frozen food products; preserved seaweed; preserved meat; tobacco and medicinal products, wherein the target steviol glycoside is reb M2, wherein the consumable product further comprising at least one additive selected from the group consisting of carbohydrates, polyols, amino acids and their corresponding salts, poly-amino acids and their corresponding salts, sugar acids and their corresponding salts, nucleotides, organic acids, inorganic acids, organic salts including organic acid salts and organic base salts, inorganic salts, bitter compounds, flavorants and flavoring ingredients, astringent compounds, proteins or protein hydrolysates, surfactants, emulsifiers, flavonoids, alcohols, polymers and combinations thereof, and at least one functional ingredient selected from the group consisting of saponins, antioxidants, dietary fiber sources, fatty acids, vitamins, glucosamine, minerals, preservatives, hydration agents, probiotics, prebiotics, weight management agents, osteoporosis management agents, phytoestrogens, long chain primary aliphatic saturated alcohols, phytosterols and combinations thereof, as well as one of Mogroside V, Luo Han Guo, allulose, allose, D-tagatose, erythritol and combinations thereof.
The claims 1-4 of the US patent 9752174 B2 disclose a method for preparing reb D2 comprising: a. contacting a starting composition comprising reb A with UDP-glucosyltransferase, to produce a composition comprising reb D2; and b. isolating the composition comprising reb D2, wherein the method of claim 1, further comprising purifying the composition comprising reb D2 to provide reb D2 having a purity greater than about 95% by weight on an anhydrous basis, and said method further comprising a process of preparing reb M2 comprising: a. contacting a starting composition comprising reb D2 with UDP-glucosyltransferase to produce a composition comprising reb M2; and b. isolating the composition comprising reb M2, wherein the method further comprising purifying the composition comprising reb M2 to provide reb M2 having a purity greater than about 95% by weight on an anhydrous basis.
Claims of the instant application listed above cannot be considered patentably distinct over claims 1-4 of the reference patent application when there are specifically recited embodiments that would either anticipate to claims 16-18, 22, 33-34 and 35 of the instant application or alternatively render them obvious. Alternatively, claims 16-18, 22, 33-34 and 35 cannot be considered patentably distinct over the claims 1-4 of the reference patent 9752174 B2. The reference patent, when there is specifically disclosed embodiment in the reference patent that falls within the scope of claims 16-18, 21-22, and 33-35 of the instant application, i.e. there is substantially overlapping scope between the claimed invention and the teachings of the reference. One having ordinary skill in the art would have been motivated to do this because that embodiment is disclosed as being a preferred embodiment within the claims 1-4 of the US patent 9752174 B2.
One of ordinary skilled in the art would have a reasonable expectation of success because the reference patent could successfully make a consumable product comprising reb D2 and reb M2 from steviol glycoside.
Claims 16, 21-22, 28, 33-34 and 35 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over at least claims 1-4 of US patent 11653679 B2, patent granted on 09/05/2017).
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 16, 21-22, 28, 33-34 and 35 are directed to a consumable product comprising a target steviol glycoside composition having a content of greater than 90% by weight on a dry basis of rebaudioside D2 (reb D2) or rebaudioside M2 (reb M2), wherein the product is selected from the group consisting of a food, a beverage, a pharmaceutical composition, a tobacco product, a nutraceutical composition, an oral hygiene composition, and a cosmetic composition, wherein the target steviol glycoside is reb D2, wherein the composition is selected from the group consisting of beverages; natural juices; refreshing drinks; carbonated soft drinks; diet drinks; zero calorie drinks; reduced calorie drinks and foods; yogurt drinks; instant juices; instant coffee; powdered types of instant beverages; canned products; syrups; fermented soybean paste; soy sauce; vinegar; dressings; mayonnaise; ketchups; curry; soup; instant bouillon; powdered soy sauce; powdered vinegar; types of biscuits; rice biscuit; crackers; bread; chocolates; caramel; candy; chewing gum; jelly; pudding; preserved fruits and vegetables; fresh cream; jam; marmalade; flower paste; powdered milk; ice cream; sorbet; vegetables and fruits packed in bottles; canned and boiled beans; meat and foods boiled in sweetened sauce; agricultural vegetable food products; seafood; ham; sausage; fish ham; fish sausage; fish paste; deep fried fish products; dried seafood products; frozen food products; preserved seaweed; preserved meat; tobacco and medicinal products, wherein the target steviol glycoside is reb M2, wherein the consumable product further comprising at least one additive selected from the group consisting of carbohydrates, polyols, amino acids and their corresponding salts, poly-amino acids and their corresponding salts, sugar acids and their corresponding salts, nucleotides, organic acids, inorganic acids, organic salts including organic acid salts and organic base salts, inorganic salts, bitter compounds, flavorants and flavoring ingredients, astringent compounds, proteins or protein hydrolysates, surfactants, emulsifiers, flavonoids, alcohols, polymers and combinations thereof, and at least one functional ingredient selected from the group consisting of saponins, antioxidants, dietary fiber sources, fatty acids, vitamins, glucosamine, minerals, preservatives, hydration agents, probiotics, prebiotics, weight management agents, osteoporosis management agents, phytoestrogens, long chain primary aliphatic saturated alcohols, phytosterols and combinations thereof, as well as one of Mogroside V, Luo Han Guo, allulose, allose, D-tagatose, erythritol and combinations thereof.
The claims 1-4 of the US patent 11653679 B2 disclose a method for producing a highly purified target steviol glycoside composition, comprising the steps of: (a) providing a starting composition comprising steviol glycosides; (b) providing a recombinant microorganism E. coli, the recombinant microorganism containing uridine diphosphate glycosyltransferases (UDP-glycosyltransferases), wherein the UDP-glycosyltransferase comprises an amino acid sequence selected from the group consisting of the amino acid sequence set forth in SEQ ID NO: 11 (“UGT76G1”), an amino acid sequence having greater than 95% amino-acid sequence identity with the amino acid sequence set forth in SEQ ID NO: 11, the amino acid sequence set forth in SEQ ID NO: 9 (“UGTSL2”) and an amino acid sequence having greater than 95% amino-acid sequence identity with the amino acid sequence set forth in SEQ ID NO: 9, and further providing an enzyme with β-glucosidase activity from Trichoderma reesei or Aspergillus niger; (c) contacting the recombinant microorganism and the enzyme with β-glucosidase activity with a medium comprising the starting composition to produce a composition comprising a target steviol glycoside, wherein the target steviol glycoside is selected from the group consisting of rebaudioside A (“reb A”), rebaudioside D (“reb D”), rebaudioside D2 (“reb D2”), rebaudioside M (“reb M’), rebaudioside M2 (“reb M2”), rebaudioside I (“reb”’), and combinations thereof; and (d) separating the target steviol glycoside from the medium to provide a highly purified target steviol glycoside composition, wherein the enzyme with β-glucosidase activity is for the hydrolysis of reb D2 and/or reb M2, wherein the target steviol glycoside is separated from the medium using crystallization, separation by membranes, centrifugation, extraction, chromatographic separation or a combination of such methods, wherein the highly purified target steviol glycoside composition comprises the target steviol glycoside in an amount greater than 95% by weight on a dry weight basis.
Claims 16-18, 22, 33-34 and 35 of the instant application listed above cannot be considered patentably distinct over claims 1-4 of the reference patent application when there are specifically recited embodiments that would either anticipate to claims 16-18, 22, 33-34 and 35 of the instant application or alternatively render them obvious. Alternatively, claims 16-18, 22, 33-34 and 35 cannot be considered patentably distinct over the claims 1-4 of the reference patent 11653679 B2. The reference patent, when there is specifically disclosed embodiment in the reference patent that falls within the scope of claims 16-18, 21-22, and 33-35 of the instant application, i.e. there is substantially overlapping scope between the claimed invention and the teachings of the reference. One having ordinary skill in the art would have been motivated to do this because that embodiment is disclosed as being a preferred embodiment within the claims 1-4 of the US patent 11653679 B2.
One of ordinary skilled in the art would have a reasonable expectation of success because the reference patent could successfully make a consumable product comprising reb D2 and reb M2 from steviol glycoside.
Claims 16, 21-22, 28, 33-34 and 35 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over at least claims 1-2, 4, and 5-6 of US patent 10683526 B2, patent granted on 06/16/2020, see IDS).
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 16, 21-22, 28, 33-34 and 35 are directed to a consumable product comprising a target steviol glycoside composition having a content of greater than 90% by weight on a dry basis of rebaudioside D2 (reb D2) or rebaudioside M2 (reb M2), wherein the product is selected from the group consisting of a food, a beverage, a pharmaceutical composition, a tobacco product, a nutraceutical composition, an oral hygiene composition, and a cosmetic composition, wherein the target steviol glycoside is reb D2, wherein the composition is selected from the group consisting of beverages; natural juices; refreshing drinks; carbonated soft drinks; diet drinks; zero calorie drinks; reduced calorie drinks and foods; yogurt drinks; instant juices; instant coffee; powdered types of instant beverages; canned products; syrups; fermented soybean paste; soy sauce; vinegar; dressings; mayonnaise; ketchups; curry; soup; instant bouillon; powdered soy sauce; powdered vinegar; types of biscuits; rice biscuit; crackers; bread; chocolates; caramel; candy; chewing gum; jelly; pudding; preserved fruits and vegetables; fresh cream; jam; marmalade; flower paste; powdered milk; ice cream; sorbet; vegetables and fruits packed in bottles; canned and boiled beans; meat and foods boiled in sweetened sauce; agricultural vegetable food products; seafood; ham; sausage; fish ham; fish sausage; fish paste; deep fried fish products; dried seafood products; frozen food products; preserved seaweed; preserved meat; tobacco and medicinal products, wherein the target steviol glycoside is reb M2, wherein the consumable product further comprising at least one additive selected from the group consisting of carbohydrates, polyols, amino acids and their corresponding salts, poly-amino acids and their corresponding salts, sugar acids and their corresponding salts, nucleotides, organic acids, inorganic acids, organic salts including organic acid salts and organic base salts, inorganic salts, bitter compounds, flavorants and flavoring ingredients, astringent compounds, proteins or protein hydrolysates, surfactants, emulsifiers, flavonoids, alcohols, polymers and combinations thereof, and at least one functional ingredient selected from the group consisting of saponins, antioxidants, dietary fiber sources, fatty acids, vitamins, glucosamine, minerals, preservatives, hydration agents, probiotics, prebiotics, weight management agents, osteoporosis management agents, phytoestrogens, long chain primary aliphatic saturated alcohols, phytosterols and combinations thereof, as well as one of Mogroside V, Luo Han Guo, allulose, allose, D-tagatose, erythritol and combinations thereof.
The claims 1-2, 4-5 and 6 of the US patent 10683526 B2 disclose a method for producing highly purified target steviol glycoside rebaudioside M2, comprising the steps of:
a. providing an aqueous solution comprising a starting composition comprising steviol glycosides; b. providing a microorganism selected from the group consisting of E. coli, Saccharomyces species, Aspergillus species, Pichia species, Bacillus species, and Yarrowia species; said microorganism comprising at least one exogenous gene-encoded steviol biosynthesis enzyme selected from the group consisting of: geranylgeranyl diphosphate synthase, copalyl diphosphate synthase, kaurene synthase, kaurene oxidase, kaurenoic acid 13-hydroxylase, steviol synthetase, deoxyxylulo se 5-phosphate synthase, D-1-deoxyxylulose 5-phosphate reductoisomerase, 4-diphosphocytidyl-2-C-methyl-D-erythritol synthase, 4-diphosphocytidyl-2-C-methyl-D-erythritol kinase, 4-diphosphocytidyl-2-C-methyl-D-erythritol 2,4-cyclodiphosphate synthase, 1-hydroxy-2-methyl-2(E)-butenyl 4-diphosphate synthase, 1-hydroxy-2-methyl-2(E)-butenyl 4-diphosphate reductase, acetoacetyl-CoA thiolase, truncated HMG-CoA reductase, mevalonate kinase, phosphomevalonate kinase, mevalonate pyrophosphate decarboxylase, and cytochrome P450 reductase, and a combination thereof;
said microorganism further comprising an exogenous gene-encoded uridine diphosphate (UDP)-glycosyltransferases capable of adding at least one glucose unit to the steviol glycoside to provide the target steviol glycoside; said microorganism further optionally comprising an exogenous gene-encoded UDP-glucose recycling enzymes; and c. contacting the microorganism with a medium containing the starting composition to produce a medium comprising at least one target steviol glycoside, the method further comprising the step of: d. separating the target steviol glycoside from the medium to provide a highly purified target steviol glycoside composition, wherein the target steviol glycoside is produced within a cell or in the medium and is separated using crystallization, separation by membranes, centrifugation, extraction, chromatographic separation or a combination thereof, and wherein the UDP-glycosyltransferase (UGT) is selected from the group consisting of: UGT of Solanum lycoperiscum origin (UGTSL); UGTSL2; UGTSL produced in Saccharomyces cerevisiae (UGTSL Sc); UGT74G1; UGT85C2; UGT76G1; UGT91D2; and isolated nucleic acid molecules that code for UGTSL, UGTSL2, UGTSL Sc, UGT74G1, UGT85C2, UGT76G1, or UGT91D2.
Claims of the instant application listed above cannot be considered patentably distinct over claims 1-2, 4-5 and 6 of the reference patent application when there are specifically recited embodiments that would either anticipate to claims 16-18, 22, 33-34 and 35 of the instant application or alternatively render them obvious. Alternatively, claims 16-18, 22, 33-34 and 35 cannot be considered patentably distinct over the claims 12, 4-5 and 6 of the reference patent 10683526 B2. The reference patent, when there is specifically disclosed embodiment in the reference patent that falls within the scope of claims 16-18, 21-22, and 33-35 of the instant application, i.e. there is substantially overlapping scope between the claimed invention and the teachings of the reference. One having ordinary skill in the art would have been motivated to do this because that embodiment is disclosed as being a preferred embodiment within the claims 1-2, 4-5 and 6 of the US patent 10683526 B2.
One of ordinary skilled in the art would have a reasonable expectation of success because the reference patent could successfully make a consumable product comprising reb M2 from steviol glycoside.
Claims 16, 21-22, 28, 33-34 and 35 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over at least claims 1-5 of US patent 11312984 B2, patent granted on 04/26/2022).
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 16, 21-22, 28, 33-34 and 35 are directed to a consumable product comprising a target steviol glycoside composition having a content of greater than 90% by weight on a dry basis of rebaudioside D2 (reb D2) or rebaudioside M2 (reb M2), wherein the product is selected from the group consisting of a food, a beverage, a pharmaceutical composition, a tobacco product, a nutraceutical composition, an oral hygiene composition, and a cosmetic composition, wherein the target steviol glycoside is reb D2, wherein the composition is selected from the group consisting of beverages; natural juices; refreshing drinks; carbonated soft drinks; diet drinks; zero calorie drinks; reduced calorie drinks and foods; yogurt drinks; instant juices; instant coffee; powdered types of instant beverages; canned products; syrups; fermented soybean paste; soy sauce; vinegar; dressings; mayonnaise; ketchups; curry; soup; instant bouillon; powdered soy sauce; powdered vinegar; types of biscuits; rice biscuit; crackers; bread; chocolates; caramel; candy; chewing gum; jelly; pudding; preserved fruits and vegetables; fresh cream; jam; marmalade; flower paste; powdered milk; ice cream; sorbet; vegetables and fruits packed in bottles; canned and boiled beans; meat and foods boiled in sweetened sauce; agricultural vegetable food products; seafood; ham; sausage; fish ham; fish sausage; fish paste; deep fried fish products; dried seafood products; frozen food products; preserved seaweed; preserved meat; tobacco and medicinal products, wherein the target steviol glycoside is reb M2, wherein the consumable product further comprising at least one additive selected from the group consisting of carbohydrates, polyols, amino acids and their corresponding salts, poly-amino acids and their corresponding salts, sugar acids and their corresponding salts, nucleotides, organic acids, inorganic acids, organic salts including organic acid salts and organic base salts, inorganic salts, bitter compounds, flavorants and flavoring ingredients, astringent compounds, proteins or protein hydrolysates, surfactants, emulsifiers, flavonoids, alcohols, polymers and combinations thereof, and at least one functional ingredient selected from the group consisting of saponins, antioxidants, dietary fiber sources, fatty acids, vitamins, glucosamine, minerals, preservatives, hydration agents, probiotics, prebiotics, weight management agents, osteoporosis management agents, phytoestrogens, long chain primary aliphatic saturated alcohols, phytosterols and combinations thereof, as well as one of Mogroside V, Luo Han Guo, allulose, allose, D-tagatose, erythritol and combinations thereof.
The claims 1-5 of the US patent 11312984 B2 disclose a method for producing target steviol glycoside rebaudioside D2 (reb D2) comprising the steps of a. providing an aqueous solution comprising a starting composition comprising steviol glycosides and wherein the steviol glycosides comprise rebaudioside A (reb A); b. providing a microorganism selected from the group consisting of E. coli, Saccharomyces species, Aspergillus species, Pichia species, Bacillus species, and Yarrowia species; said microorganism comprising at least one enzyme selected from the group consisting of: geranylgeranyl diphosphate synthase, copalyl diphosphate synthase, kaurene synthase, kaurene oxidase, kaurenoic acid 13-hydroxylase (KAH), steviol synthetase, deoxyxylulose 5-phosphate synthase (DXS), D-1-deoxyxylulose 5-phosphate reductoisomerase (DXR), 4-diphosphocytidyl-2-C-methyl-D-erythritol synthase (CMS), 4-diphosphocytidyl-2-C-methyl-D-erythritol kinase (CMK), 4-diphosphocytidyl-2-Cmethyl-D-erythritol 2,4-cyclodiphosphate synthase (MCS), 1-hydroxy-2-methyl-2(E)butenyl 4-diphosphate synthase (HDS), 1-hydroxy-2-methyl-2(E)-butenyl 4-diphosphate reductase (HDR), acetoacetyl-CoA thiolase, truncated HMG-CoA reductase, mevalonate kinase, phosphomevalonate kinase, mevalonate pyrophosphate decarboxylase, cytochrome P450 reductase, and a combination thereof; said microorganism further comprising a UDP-glycosyltransferase capable of adding at least one glucose unit to the steviol glycoside to provide the target steviol glycoside;
said microorganism further optionally comprising a UDP-glucose recycling enzyme;
c. contacting the microorganism with a medium containing the starting composition to transform rebaudioside A to rebaudioside D2 to produce a medium comprising rebaudioside D2; and
d. purifying the rebaudioside D2 from the medium to provide a highly purified rebaudioside D2 composition, wherein the UDP-glycosyltransferase is selected from the group consisting of UGT91D2, UGTSL2, UGT76G1, or UGT76G1 containing one or more point mutations selected from S42A, F46I, I190L, S274G, I295M, K303G, F314S, K316R, K393R, V394I, I407V, N409K, N409R, Q425E, Q432E, S447A and S456, wherein the highly purified rebaudioside D2 composition has a rebaudioside D2 purity greater than about 95% by weight on a dry basis, the method further comprising: e. contacting the reb D2 with an enzyme selected from the group consisting of enzymes capable of transforming reb D2 to reb M2, UDP-glucose, and optionally UDP-glucose recycling enzymes to produce a composition comprising reb M2; and f. isolating, and optionally, purifying the composition comprising reb M2, wherein reb M2 has a purity greater than about 95% by weight on an anhydrous basis.
Claims of the instant application listed above cannot be considered patentably distinct over claims 1-5 of the reference patent application when there are specifically recited embodiments that would either anticipate to claims 16-18, 22, 33-34 and 35 of the instant application or alternatively render them obvious. Alternatively, claims 16-18, 22, 33-34 and 35 cannot be considered patentably distinct over the claims 1-5 of the reference patent 11312984 B2. The reference patent, when there is specifically disclosed embodiment in the reference patent that falls within the scope of claims 16-18, 21-22, and 33-35 of the instant application, i.e. there is substantially overlapping scope between the claimed invention and the teachings of the reference. One having ordinary skill in the art would have been motivated to do this because that embodiment is disclosed as being a preferred embodiment within the claims 1-5 of the US patent 11312984 B2.
One of ordinary skilled in the art would have a reasonable expectation of success because the reference patent could successfully make a consumable product comprising reb M2 from steviol glycoside.
Conclusion
Status of the claims:
Claims 16, 21-22, 28, 33-34 and 35 are rejected.
Applicant's amendments (see, substantial claims amendment of claim 16), necessitated the new ground(s) of rejection presented in this Office action.
Applicants must respond to the objections/rejections in each of the sections in this Office action to be fully responsive in prosecution. 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F, at 9:00-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Iqbal H. Chowdhury, PhD.
Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656
Prosecution Insights