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 .
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 3,5-7 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.
It is unclear how the steviol glycoside in claim 3 can comprise 300-600ppm Reb A when claim 1 recites 40-60wt%(400,000-600,000ppm). Therefore, claim 3 does not properly limit the composition of claim 1. It appears that the amounts in ppm in claim 3 represent the amounts of each rebaudioside component in a beverage or other food composition and the percentages in claim 1 represent the amounts of each rebaudioside based on the total amount of sweetener. However, this is not clarified in the claims.
Claims 5-7 have similar issues.
The applicant argues that claims 3,5-7 are clear because the term “wt%” means the % of the weight of the particular anhydrous rebaudioside of the weight of all anhydrous rebaudiosides in the formulation”. However, this is not the basis for the 112 rejection. The issue is that independent claim 1 recites a large amount of Reb A, specifically 40-60wt%, which equates to 400,000-600,000ppm. Claim 3 then recites a concentration of 300-600ppm, which is way outside of the 400,000-600,000ppm recited in claim 1.
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.
Claim(s) 1,9-11,24,29-33,42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang(CN109349596) in view of Prakash(2018/0263269).
Regarding claim 1, Wang teaches a stevia glycoside formulation consisting essentially of Reb A, Reb D, and Reb M. Wang teaches that sweetener I comprises Reb D and Reb M in a ratio of 1.5-9:1 and sweetener II comprises sweetener I and reb A in a ratio of 4 to 6:4 to 6(p.1). Therefore, assuming a 4:6 ratio of sweetener I to reb A and an 8:1 ratio of Reb D to Reb M, the composition would 60% reb A, 32% Reb D, and 8% Reb M.
Wang is silent on the presence of reb E. However, Prakash discloses a steviol glycoside composition used to impart sweetness (para [0396] - "The steviol glycoside compositions and sweetener compositions of the present invention can be used to impart sweetness or to enhance the flavor of consumables.") and a formulation comprising Reb D, Reb M, Reb A, Reb N, Reb 0, and Reb E (para [0011] - "The steviol glycoside composition of the present invention has a total steviol glycoside content of about 95% by weight or greater and contains (a) a major component comprising rebaudioside M and rebaudioside D and (b) a minor component comprising rebaudioside A, rebaudioside N, rebaudioside O and rebaudioside E.
Prakash does not specifically disclose a steviol glycoside formulation comprises15-30 wt% rebaudioside E (Reb E). Since Prakash discloses a steviol glycoside composition comprising Reb D, Reb M, Reb A, and Reb E, it would have been obvious to one of ordinary skill in the art to modify the glycoside composition of Wang to include a minor amount, e.g. 15-30 wt.% Reb E as taught in Prakash since this would allow use as a sweetener with a specific sweetness or flavor profile, as determined through routine testing.
Wang teaches 32% Reb D and not 10-17 wt% as claimed. However, it would have been obvious to one of ordinary skill in the art to adjust the amount of Reb D in Wang since this would allow use as a sweetener with a specific sweetness or flavor profile, as determined through routine testing.
Regarding claim 9, Wang in view of Prakash does not specifically teach that the at least one rebaudioside is made by a genetically modified microbe. However, it is noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.
Therefore, absent evidence of criticality regarding the presently claimed process and given that Wang in view of Prakash meets the requirements of the claimed sweetener, Wang in view of Prakash clearly meets the requirements of the present claims.
Regarding claims 10,11,24,29,30-33,42, Wang does not specifically teach that the steviol glycoside is included in a food composition. However, Prakash teaches that the stevia composition can be included in a food composition in order to provide the desired sweetness to the food composition([0260]). The food composition can further complain common ingredients such as additives, sweeteners, antioxidants such as tocopherols, chelating agents for use as a preservative, and moisture( [116, 178,261 328]). It would have been obvious to include the sweetener composition of Wang in a food composition with common food ingredients such as additives, sweeteners, antioxidants such as tocopherols, chelating agents for use as a preservative, and moisture in order to provide the desired amount of sweetness to a composition. It would have been obvious to adjust the amount of the common food additives depending on the nature of the composition, as determined by routine experimentation.
Wang does not specifically teach the amounts of each rebaudioside component in ppm in the food product. However, it would have been obvious to adjust the amounts of rebaudiosides in the final product depending on the sweetness desired.
Claim(s) 3,5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang(CN109349596) in view of Prakash(2018/0263269) further in view of Prakash(US2017/0275666).
Regarding claims 3,5-7, Wang does not specifically teach the amounts of each rebaudioside component in ppm. As stated in the 112(b) rejection above, it is unclear if this amount is based on just the sweetener components, or of a larger composition such as a food. As such, it would have been obvious to adjust the amounts of rebaudiosides in the final product depending on the sweetness desired.
Wang does not specifically teach the presence of Reb I. However, Prakash ‘666 teaches a Rebaudioside I sweetening composition that can be mixed with other stevia extracts such as Reb A, Reb D, Reb M, and Reb E([104]). Reb I can be included in an amount of 50ppm when added to a consumable([0111]). It would have been obvious to include Reb I in the stevia composition of Prakash ‘269 in an amount of 50ppm when added to a consumable as taught in Prakash ’666, since this would allow use as a sweetener with a specific sweetness or flavor profile, as determined through routine testing.
Response to Arguments
Applicant's arguments filed 12/4/2025 have been fully considered but they are not persuasive.
The applicant argues that claims 3,5-7 are clear because the term “wt%” means the % of the weight of the particular anhydrous rebaudioside of the weight of all anhydrous rebaudiosides in the formulation”. However, this is not the basis for the 112 rejection. The issue is that independent claim 1 recites a large amount of Reb A, specifically 40-60wt%, which equates to 400,000-600,000ppm. Claim 3 then recites a concentration of 300-600ppm, which is way outside of the 400,000-600,000ppm recited in claim 1. Therefore, the 112 rejection is maintained.
The applicant argues that the references do not teach the claimed combination of stevia glycosides. However, Wang teaches a stevia glycoside formulation consisting essentially of Reb A, Reb D, and Reb M. Wang teaches that sweetener I comprises Reb D and Reb M in a ratio of 1.5-9:1 and sweetener II comprises sweetener I and reb A in a ratio of 4 to 6:4 to 6(p.1). Prakash further renders obvious the inclusion of Reb E in the claimed amounts(see rejection above). As such, the applicant has not shown that the combination of steviol glycoside components provided unexpected results.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KATHERINE D LEBLANC/Primary Examiner, Art Unit 1791