DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment received on 09/16/2026 is acknowledged. Claims 18 has been amended.
Response to Arguments
Applicant submits through a declaration by applicant analysis of HPLC traces in the figures of the instant application. This analysis shows that that in Figure 2, 55.51% of Reb B is glucosylated and 44.49% is not modified, and that following precipitation of unreacted Reb B the mixture is 82.38% glucosylated and 17.62% unmodified. These traces provide implicit support for these relative concentrations of glycosylated Reb B to unmodified Reb B. This does not provide description for the scope of “is greater than 50% of the sum of the glucosyl rebaudioside B derivatives and the unmodified rebaudioside B”. The rejection has been updated to reflect this.
Further in light of the amendment to the claims double patenting rejections are made below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims have been amended to recited the limitation “containing one or more α-1,4,-glucosyl residues attached to glycosidic residues of C-13 position of rebaudioside B is greater than 50% of the sum of the glucosyl rebaudioside B derivatives and the unmodified rebaudioside B.” The specification as originally filed contains no literal written support for the limitation “greater than 50% of the sum of the glucosyl rebaudioside B derivatives”. The specification provides the following description regarding the ratio of products, “The unreacted steviol glycoside was precipitated from reaction mixture…(Page 4 Ling 20-25)” and “…The mixture was held under moderate agitation for 24 hrs, which resulted in precipitation of unreacted reb B. The precipitated reb B was separated by filtration and the pH of filtrate containing mainly α-1,4-glucosyl derivatives (C13) was adjusted to 5.0-7.0, preferably 6.0-6.5. (Page & Ln 28-31)”. However as evidenced by the analysis of figure 2 provided by the Declaration submitted on 09/16/2025, a concentration of ~55% modified to unmodified RebB residues can be achieved without a step or precipitating Reb B starting material using known enzymes. The declaration provides that Figure 2 and Figure 3 disclose embodiments in which compositions having 55.51% and 82.38% modified glucosyl Reb B can be obtained. The specification does not appear to provide any further embodiments or concentrations. The specification does not provide further discussion of the ratio of modified to total Reb B compounds, nor does it provide any discussion of how ratios may be controlled or achieved, See MPEP 2163.05 (III).
It is the Examiner' s position that applicant only provided adequate written description to show possession of a glucosyl Reb B compositions having a ratio of 55.51% glucosyl modified Reb B to total Reb B and a composition of 82.38% glucosyl modified Reb B to total Reb B. As applicant has provided no other description by which one skilled in the art would have found them to have possession of other concentrations in the range of “greater than 50%”.
Double Patenting
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 double patenting rejection is appropriate where the claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No 9474296. Although the claims at issue are not identical, they are not patentably distinct from each other because the process claimed in ‘296 matches the process steps which are disclosed in the instant specification to produce the products having the ratio of products instantly claimed. The product resulting from the process of ‘296 will result in the derivative structure claimed. The product itself is a food product and will also comprise rebaudioside B.
The instant claims are thus rendered obvious by the claims of ‘296.
Claims 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No 11678685. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘685 claims a product by process and The process used will result in the derivative structure claimed and ratios claimed. ‘685 further claims formulations of the glucosyl rebaudioside B product (Claims 2-4) in sweetening compositions matching the limitations as claimed.
The claims of ‘685 thus render obvious the instant claims.
Claims 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 8257948. Although the claims at issue are not identical, they are not patentably distinct from each other because the steviol glycoside used in the process of ‘948 can be Reb B as disclosed in the specification. Further the reaction steps in the instant application which produce the trace of Figure 2 fall within the scope steps claimed in ‘948 and thus the process of ‘948 will produce a product having greater than 50% modified Reb B. The product itself is a food product and will also comprise rebaudioside B.
The claims of ‘948 thus render obvious the claims of the instant application.
Claims 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 8318459. Although the claims at issue are not identical, hey are not patentably distinct from each other because the steviol glycoside used in the process of ‘459 can be Reb B as disclosed in the specification. Further the reaction steps in the instant application which produce the trace of Figure 2 fall within the scope steps claimed in ‘459 and thus the process of ‘459 will produce a product having greater than 50% modified Reb B. The product itself is a food product and will also comprise rebaudioside B.
The claims of ‘948 thus render obvious the claims of the instant application.
Claims 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 8669077. Although the claims at issue are not identical, they are not patentably distinct from each other because the steviol glycoside used to produce the product by process in the claims of ‘077 can be Reb B, as disclosed in the specification. The reaction steps in the instant application which produce the trace of Figure 2 fall within the scope steps to produce the product claimed in ‘077 and thus the process of ‘077 will produce a product having greater than 50% modified Reb B. The product itself is a food product and will also comprise rebaudioside B. ‘077 further claims the limitations of the instantly claimed formulations using the sweetener product (Claims 2-4).
The claims of ‘077 thus render obvious the claims of the instant application.
Claims 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 8735101. Although the claims at issue are not identical, hey are not patentably distinct from each other because the steviol glycoside used in the process of ‘101 can be Reb B as disclosed in the specification. Further the reaction steps in the instant application which produce the trace of Figure 2 fall within the scope steps claimed in ‘101 and thus the process of ‘101 will produce a product having greater than 50% modified Reb B. The product itself is a food product and will also comprise rebaudioside B.
The claims of ‘101 thus render obvious the claims of the instant application.
Claims 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 8911971. Although the claims at issue are not identical, they are not patentably distinct from each other because the steviol glycoside used to produce the product by process in the claims of ‘971 can be Reb B, as disclosed in the specification. The reaction steps in the instant application which produce the trace of Figure 2 fall within the scope steps to produce the product claimed in ‘971 and thus the process of ‘971 will produce a product having greater than 50% modified Reb B. The product itself is a food product and will also comprise rebaudioside B. ‘971 further claims the limitations of the instantly claimed formulations using the sweetener product (Claims 17-20).
The claims of ‘971 thus render obvious the claims of the instant application.
Claims 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 8647844. Although the claims at issue are not identical, they are not patentably distinct from each other because the steviol glycoside used to produce the product by process in the claims of ‘844 can be Reb B, as disclosed in the specification. The reaction steps in the instant application which produce the trace of Figure 2 fall within the scope steps to produce the product claimed in ‘844 and thus the process of ‘844 will produce a product having greater than 50% modified Reb B. The product itself is a food product and will also comprise rebaudioside B. ‘844 further claims the limitations of the instantly claimed formulations using the sweetener product (Claims 2-7).
The claims of ‘844 thus render obvious the claims of the instant application.
Claims 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 8993269. Although the claims at issue are not identical, they are not patentably distinct from each other because the steviol glycoside used to produce the product by process in the claims of ‘269 can be Reb B, as disclosed in the specification. The reaction steps in the instant application which produce the trace of Figure 2 fall within the scope steps to produce the product claimed in ‘269 and thus the process of ‘269 will produce a product having greater than 50% modified Reb B. The product itself is a food product and will also comprise rebaudioside B. ‘269 further claims the limitations of the instantly claimed formulations using the sweetener product (Claims 22-25).
The claims of ‘269 thus render obvious the claims of the instant application.
Claims 18-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-8 of USP 9706792. Although the claims at issue are not identical, they are not patentably distinct from each other because the steviol glycoside used to produce the product by process in the claims of ‘792 can be Reb B, as disclosed in the specification. The reaction steps in the instant application which produce the trace of Figure 2 fall within the scope steps to produce the product claimed in ‘792 and thus the product produced by ‘792 will produce a product having greater than 50% modified Reb B. The product itself is a food product and will also comprise rebaudioside B. ‘792 further claims the limitations of the instantly claimed formulations using the sweetener product (Claims 2-8).
The claims of ‘792 thus render obvious the claims of the instant application.
Claims 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of USP 9392799. Although the claims at issue are not identical, t they are not patentably distinct from each other because the steviol glycoside used to produce the product by process in the claims of ‘799 can be Reb B, as disclosed in the specification. The reaction steps in the instant application which produce the trace of Figure 2 fall within the scope steps to produce the product claimed in ‘799 and thus the process of ‘799 will produce a product having greater than 50% modified Reb B. The product itself is a food product and will also comprise rebaudioside B.
The claims of ‘799 thus render obvious the claims of the instant application.
Claims 18-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of USP 9615599. Although the claims at issue are not identical, they are not patentably distinct from each other because the steviol glycoside used to produce the product by process in the claims of ‘599 can be Reb B, as disclosed in the specification. The reaction steps in the instant application which produce the trace of Figure 2 fall within the scope steps to produce the product claimed in ‘599 and thus the process of ‘599 will produce a product having greater than 50% modified Reb B. The product itself is a food product and will also comprise rebaudioside B. ‘599 further claims the limitations of the instantly claimed formulations using the sweetener product (Claims 16-19).
The claims of ‘599 thus render obvious the claims of the instant application.
Claims 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of USP 10729163. Although the claims at issue are not identical, they are not patentably distinct from each other because the steviol glycoside used in the modified steviol glycoside of ‘163 can be Reb B as disclosed in the specification. And the ratios claimed fall within the range of greater than 50% modified Reb B. The product itself is a food product and will also comprise rebaudioside B.
The claims of ‘163 thus render obvious the claims of the instant application.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES Z CONSTANTINE whose telephone number is (571)270-5533. The examiner can normally be reached Mon-Fri 9-5.
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/CHARLES Z CONSTANTINE/ Examiner, Art Unit 1657
/ROBERT J YAMASAKI/ Primary Examiner, Art Unit 1657