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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/14/2026 has been entered.
Priority
As noted in the previous actions, the priority date for the instant claims is the afforded an effective filing date of 06/05/2017 via the parent (CON) application 16/307359 which claims priority to national stage (371) PCT/US2017/035931.
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 25 and 26 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 instant specification has been reviewed but no support for the precise ranges of the components listed are found. If support is present, clear indication of where the support is found is requested.
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 27 and 28 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.
Claim 27 is directed to a method of making the composition of claim 1, however there is no mention of rebaudioside A or stevioside and their glycosylated derivatives which are required to be present in the composition of claim 1. It appears that the method of claim 27 is directed to making only the component of the composition that comprises rebaudioside B, steviolbioside and their glycosylated derivatives. It appears that the claimed composition is directed to the embodiment where rebaudioside A and stevioside are glycosylated resulting in a composition of rebaudioside A, stevioside and their glycolylates, is combined with a composition of rebaudioside A and stevioside are base-treated and glycosylated to convert to rebaudioside B, steviolbioside and their glycosylates. The method steps of claim 27 appear to be directed to the manner in which the second composition is formed (base-treated and glycosylated). The combined composition also appears to correspond to examples SG95 G combined with 15% SG95 B-G listed in Table 7 of the instant specification where 20% of the SG95 G solution is base-treated and recombined with the original SG95 G which has not been base-treated (pages 46-47). If this assessment is accurate, it is suggested to amend the claim to clearly indicate that the process of claim 27 is directed to making one component of claim 1. It may also benefit the claims to clearly indicate that the two components listed in claim 1 are separate components (such as setting apart by labeling as “a)” and “b)”. As currently worded, it is not clear if the entire composition is made by the process claimed rather than only part of the composition is made in the manner claimed prior to combining with the glycosylated only portion. The same issue arises with claim 28.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 1-6, 9-20, and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0006906 (Jackson) in view of EP 2868209 (Schafer) and US 2013/0136838 (Miguel) and US 2015/0030725 (Markosyan).
Jackson discloses a sweetener comprising glycosylated steviol glycoside and a rebaudioside for use in foods and beverages (abstract). Jackson discloses glycosylated Reb A, stevioside, Reb B, and glycosylated steviolbioside [0117, 0127, claims 1 and 10]. Jackson does not expressly give an example of these four in combination. However, Schafer discloses a composition of steviol glycosides comprising a mixture of 30-50wt% Reb A, 5-10wt% Reb B, 5-10wt% Reb C, 20-30 wt% Reb D, 15-25 wt% stevioside, and 1-5wt% steviolbioside (claim 3). The total of Reb A and stevioside is 45-75 wt% and the total of Reb B and steviolbioside is 6-15 wt%. These ranges overlap the claimed ranges and present a prima facie case for obviousness. Based upon the disclosure of Schafer, it would have been obvious to select Reb A, Reb B, stevioside and steviolbioside since this combination is expressly disclosed as useful as a sweetener by Schafer.
Miguel teaches a natural sweetener blend comprising a first composition selected from steviol glycosides including Reb A and a second composition selected from steviolbioside, Reb B and steviolmonoside (claim 1). The ratio of the first composition to second composition is 99:1 to 75:25. Example 6 is a sweetener blend comprising Reb A: Reb B: steviolbioside in a ratio of 78:11:11. Miguel teaches that glucosylated steviol glycosides (GSGs) may be added as an additional sweetener [0049, 0110, 0133].
Markosyan teaches glucosyl stevia compositions prepared from steviol glycosides and that the glycosylation provides glucosyl derivatives with superior taste characteristics and can be used as sweetness enhancers (abstract). The steviol glycosides are selected from the group consisting of rebaudioside B, steviolbioside, steviolmonoside, as well as other steviol glycosides found in Stevia rebaudiana Bertoni plant and mixtures thereof [0018]. It would have been obvious to one of ordinary skill to add the glucosylated derivatives of Reb B and steviolbioside to the sweetener blend of Miguel which contains Reb B and steviolbioside since Miguel expressly stated that glycosylated steviol glycosides may be added to the blends as additional sweeteners and Markosyan expressly teaches that the glycosylated derivatives may be uses as sweetness enhancers. It would have been obvious to one of ordinary skill to select the combination of glycosylated Reb B and glycosylated steviolbioside in combination with Reb B and steviolbioside based upon the teaching in Migel of Reb B and steviolbioside and Reb A as a select combination and in the glycosylated Reb B and steviolbioside taught by Markosyan as useful sweetener enhancers.
Jackson states in [0119] that glycosylated and non-glycosylated steviol glycosides can be combined and [0118, 120] discloses that these combinations can provide sweetener compositions with increased solubility.
Regarding the amounts of claim 1, Jackson that the steviol glycosides (non-glycosylated) can be 1-99wt% of the composition [0121] and the glycosylated steviol glycosides can be 1-99wt% of the composition [0120]. Schafer discloses the relative amounts of the non-glycosylated individual components. Moreover, Example 6 of Miguel discloses 74wt% Reb A and 11wt% each Reb B and steviolbioside, thus the total amount of steviol glycosides is at least 85wt%. Further, the combined amount of Reb B and steviobioside is 22wt%. It would have been obvious to one of ordinary skill to adjust the amounts of each of the glycosylated and non-glycosylated compounds to adjust the desired sweetness. Overall, the composition has more than 85wt% steviol glycosides whether glycosylated or not glycosylated and Jackson teaches that the glycosylated steviol glycoside derived from Reb B is about 0-10wt% [0123] and Markosyan in Example 6 discloses Reb B and steviolbioside of 11wt% each which is indicative of what one of ordinary skill in the art could use as direction as to the level of ordinary skill for useful amounts for combination with other sweeteners.
Regarding claims 2-4, 15, 16, 25 and 26, as stated above the combination suggests using the four claimed compounds together and the amounts disclosed in the art overlap or are suggested and further that one of ordinary skill would find it obvious to vary the amounts depending upon the desired sweetness and also the solubility of the mixtures [see Jackson 0010-0011]. Further, Miguel teaches that some Stevia sweeteners contain a mixture of steviol glycosides and stevia sweeteners that contain a mixture of steviol glycosides often present taste properties that are objectionable to the consumer [0005] and that although rebaudioside A and stevioside are known to be among the sweetest steviol glycosides, these compounds actually exhibit unpleasant off-notes (e.g., bitter tastes, licorice tastes, sweetness linger and strong aftertastes) [0006]. Miguel also states that compared to natural sweeteners such as rebaudioside A or stevioside alone, the natural sweetener blends exhibit decreased sweetness linger (aftertaste), decreased bitterness, decreased astringency, a more sugar-like sweet temporal profile, a more sugar-like taste quality or some combination thereof [0057]. Thus, it is known in the art that blends of sweeteners at varying amounts will affect the aftertaste, solubility, bitterness etc. as well as the overall sweetness. Absent a showing of unexpected results, one of ordinary skill would have found it obvious to vary the amounts of the compounds with the expectation of adjusting the properties of the blend accordingly. Moreover, Jackson teaches an overlapping range for the amounts of glycosylated and non-glycosylated compounds and Miguel and Markosyan suggest the selection of Reb B and steviolbioside.
Regarding claims 5, 6, 9-14, 19, and 20, Jackson discloses additional components including bulking agents such as maltose and glucose [0107]. Jackson further teaches starch (tapioca) which would yield maltodextrins upon reaction. Jackson also suggests using Reb A and Reb B in combination [0211-0213], thus one of ordinary skill would have found it obvious to use Reb A in addition to Reb B as this combination is suggested in the prior art. Moreover, Miguel teaches in Example 6 the combination of Reb A, Reb B and steviolbioside.
Regarding claim 17, Jackson teaches the use of the sweetener in a food or beverage (abstract, 0012).
Regarding claim 18, Jackson teaches in [0018] that the blend can be used “alone” or in combination.
Regarding claims 27 and 28, these claims are product by process and are not seen to impart a structural distinction from the composition of Jackson as modified above. The time, pH and temperature as well as the enzyme is not seen to provide a patentable distinction to the final product formed.
Response to Arguments
The amendments overcome the issues references in the advisory action mailed 04/03/2026. A new 112(b) rejection is made above for claims 27 and 28. A new rejection under 112(a) is also made above for claims 25 and 26 as no clear support has been found for the ranges of the components listed in the claims. New art of EP 2868209 (Schafer) demonstrates the combination of Reb A, stevioside, Reb B, and steviolbioside is known.
Regarding the 103, rejection the affidavit filed 04/14/2026 has been considered. The affidavit was originally filed in the parent application 16/307359 and is directed to the same subject matter described in the specification. It is noted that Table 3 on page 7 of the affidavit appears to transpose “B-G” in the 5th line of data (SG95 G with 20% SG95 B-G) as when compared to Table 7 on page 47 of the instant specification indicates that the SG95 material is G-B, meaning it is glycosylated first followed by base-treating. The values of 3.8 (liking) and 2.0 (off-flavor) are identical. The newly added example of Pilot Plant 15-27 is not clearly understood since there appears to be a range of the material added (74-85% and 15-27%) and yet there is a single data result. Table 3 also states “750 or 1000 ppm total in water” but there is no indication as to whether each example is 750 or 1000. The affidavit states that the data is pulled from Tables 6 and 7 of the instant specification, but no examples are at 750 ppm. Thus, the data is not entirely clear.
Overall, the data is not persuasive of unexpected results. Currently, the claims are directed to a composition having 50-95wt% rebaudioside A, stevioside and their glycosylates (first component) and 5-50wt% rebaudioside B, steviolbioside and their glycosylates (second component). The data relied upon provides an example with 15wt% or 20wt% of what appears to be the second component and 85wt% of the first component (SG95 G with 15 or 20wt% B-G or G-B in Table 7 or Table 3 of the affidavit). These compositions are compared to SG95 G alone or combined with Reb B since neither of these are commensurate with the current claims. The data points of 15 and 20wt% are not representative of the scope of the claimed range of 5-50% and the comparison outside of the range is simple 0% (no G-B or B-G present). Notably, the data for SG95G with 4% Reb B is only slightly worse than SG95G with 20% G-B as there is an identical liking (3.8) and off flavor is 2.2 vs. 2.0 (lower is better). Thus, only SG95 G with 15% SG95 B-G appears to have a significant difference with a liking of 4.4 and off flavor of 1.8.
The affidavit provides data in Tables 1 and 2 but the concentration of 1500ppm is not reflective of the claimed composition and the amount of the composition used (1500 vs 1000 vs 500ppm) appears to have an effect on its liking rank. See Tables 6 and 7 of the instant specification where the concentration (ppm) has an effect on the liking and off-flavor results. The data from Tables 1 and 2 also appear to show an improvement at a 50/50 ratio of the two components of the composition, but this ratio is not commensurate with the entire scope of the claims. As discussed above, Table 3 of the affidavit, in combination with Tables 6 and 7 from the specification, give points at what appear to be 15wt%, 20wt% and 50wt% and outside the range at 0wt% for the second component (RebB etc.) but the results for 20wt% are only slightly better than SG95B with 4% RebB.
The affidavit provides an explanation that tests were performed with 5%, 7.5%, and 10% inclusion of the RebB component at 1500ppm. As noted above, the amount of sweetener is seen to affect the results and such a limitation is not present in the claims. Moreover, there is no data chart provided and only an explanation in prose. Thus, no comparison of the results can be made.
Applicant argues that Jackson, Miguel and Markosyan do not disclose a composition enriched in RebB and glycosylated RebB and/or steviolbioside and glycosylated steviolbioside. However, Jackson discloses the inclusion of RebB and steviolbioside as a choice among components and Miguel expressly discloses a ratio of RebA:RebB:steviolbioside as well as the further inclusion of glycosylated steviolbioside and Markosyan discloses that glycosylation provides superior taste. Thus, the art is seen to obviate the components and their glycosylates.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO 2016/074761 discloses an embodiment comprising component a) having 10 to 20 % by weight of stevioside, 5 to 15 % by weight of Rebaudioside A and at least 50 % by weight of glucosylated steviol glycosides, based on the total weight of component a) and wherein the glucosylated steviol glycoside is glucosylated stevioside, glucosylated Rebaudisoide A, glucosylated rebaudioside C, glucosylated dulcoside, glucosylated rubusoside, glucosylated steviolbioside, glucosylated rebaudioside B, glucosylated rebaudioside D, glucosylated rebaudioside E and glucosylated rebaudioside F with various degrees of glucosylation or mixtures thereof. WO 2012/177727 discloses a sweetener with a blend of Reb A and Reb B.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1723
/Jennifer McNeil/Primary Examiner, Art Unit 1723
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