DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Claims 17, 19-22, 25-26, 28 and 30-37, 41 and 43 are pending. Claims 1-16, 18, 23-24, 27, 29, 38-40 and 42 have been cancelled. The previous 112 rejection has been withdrawn in view of applicant’s amendments to the claims. The previous 103 rejections have been modified in view of applicant’s amendments to the claims.
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.
Claim 17, 21-22, 25-26, 28, 30-32, 35-37, 41 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Prakash (US 2007/0128311 A1).
Regarding claims 17, 21 and 41; Prakash discloses a natural high potency sweetener (NHPS) composition comprising at least one NHPS and at least one sweet taste improving composition including carbohydrates and other sweet taste improving additives or combinations thereof [0007]. Prakash discloses NHPS’s include thaumatin [0048] and the steviol glycosides rebaudioside A and rebaudioside B [0048] and [0068]. Prakash discloses the carbohydrate may be glucose [0083].
Prakash does not disclose a preferred embodiment comprising rebaudioside A, rebaudioside B, glucose and thaumatin. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected rebaudioside A, rebaudioside B and thaumatin as the NHPS and glucose as the carbohydrate of Prakash since Prakash discloses all four ingredients as appropriate for inclusion in the natural high potency sweetener composition. One would expect that all four sweetener components, when combined, would yield the predictable results of a combined sweetener composition.
Regarding the claim limitation of a blended composition, Prakash discloses the NHPS composition may be a dry-blend tabletop NHPS formulation [0900], which meets the claim limitation of a blended composition.
Prakash discloses the NHPS’s may be used individually or in combination with other NHPS’s as long as the combined effect does not adversely affect the taste of the sweetener composition, such as a steviol glycoside combination [0068]. Prakash discloses rebaudioside A is present in the steviol glycoside combination from about 50% to 99.5% of the combination of high potency sweeteners and rebaudioside B is present from about 1-8% of the combination of high potency sweeteners [0069] and [0070]. The quantity of rebaudioside A disclosed by Prakash overlaps with the claimed range of rebaudioside A of 40-80%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
Prakash discloses rebaudioside B is present from about 1-8% of the combination of high potency sweeteners [0070]. The quantity of rebaudioside B disclosed by Prakash is close to the claimed range of 10-17%. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.. MPEP 2144.05 I.
Alternatively, Prakash discloses a quantity RebB recited in the previous paragraph, which falls outside the claimed range. However, it is known in the art that the quantity of RebB is a result effective variable, changing the quantity of RebB in the composition with alter the sweetness and the calorie content of the composition. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the product disclosed by the prior art by normal optimization procedures known in the art.
Prakash also discloses the carbohydrate, glucose, be included in the NHPS composition from 1000-100,000 ppm (0.1-10%) [0122]. Prakash does not disclose the amount of carbohydrate relative to the steviol glycoside combination.
Regarding the amount of carbohydrate relative to the steviol glycoside combination, Prakash discloses a quantity glucose recited in the previous paragraph, but does not recite a concentration of glucose relative to the steviol glycoside combination. However, it is known in the art that the quantity of glucose is a result effective variable, the more glucose the higher the calorie content and sweetness. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the product disclosed by the prior art by normal optimization procedures known in the art.
Prakash does not disclose the amount of thaumatin in the composition, however Prakash does disclose that those of ordinary skill in the art will appreciate the sweetener composition can be customized to obtain the desired calorie content [0079] and the NHPS’s (including rebaudioside A, rebaudioside B and thaumatin) may be used individually or in combination with other NHPS’s as long as the combined effect does not adversely affect the taste of the sweetener composition, such as a steviol glycoside combination [0068]. Therefore, Prakash discloses a of mixture rebaudioside A, rebaudioside B, thaumatin and a carbohydrate which may be glucose [0083]. The disclosure of this mixture is considered to include all possible ratios of rebaudioside A, rebaudioside B and glucose to thaumatin, including the instantly claimed ratios.
Additionally, regarding the ratio of the steviol glycoside composition to the thaumatin of claims 17, 21 and 41 Prakash does not recite a concentration of thaumatin. However, it is known in the art that the quantity of all the claimed sweeteners is a result effective variable, the higher the concentration of the sweeteners the sweeter the resulting composition will be. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the product disclosed by the prior art by normal optimization procedures known in the art.
In summary, applicant claims a formula for making a nutritional composition that uses or eliminates common ingredients, and does not amount to invention in the constantly developing art of preparing food because there is no specific showing that establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected and useful function. It is long and commonly known that the object of people skilled in cooking (e.g. cooks, chefs, bakers, food scientists) is to use or eliminate common ingredients to formulate food that is palatable/nutritional. Such an act, the formulation or creation of a food recipe, is not patentable because it does not make a scientific advancement in the field unless a new/novel reaction, coaction or cooperative relationship is made evident by such a creation. In other words, the act of making food or food recipes that taste good/nutritional, even if the combination of the ingredients is not known or has not been done before, is not patentable subject just because it was done.
Further, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered a point of fact situation of this specific instant case.
At page 234, the Court stated as follows: This court has taken the position that new recipes or formulas for food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected and useful function. In re Benjamin D. White, 17 C.C.P.A. (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Regarding claim 25, Prakash discloses a natural high potency sweetener (NHPS) composition comprising at least on NHPS and at least one sweet taste improving composition including carbohydrates and other sweet taste improving additives or combinations thereof [0007]. Prakash discloses the sweet taste improving additive may be inorganic acid salts [0096].
Regarding claim 26, Prakash discloses the inorganic salt is present in the NHPS composition from about 25 ppm-5,000 ppm (0.0025-0.5%). Prakash does not disclose the amount of salt relative to the steviol glycoside combination.
Regarding the amount of salt of the steviol glycoside composition, Prakash discloses a quantity of salt recited in the previous paragraph, but does not recite a concentration of salt relative to the steviol glycoside combination. However, it is known in the art that the quantity of salt is a result effective variable, the more salt, saltier the resulting composition will be. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the product disclosed by the prior art by normal optimization procedures known in the art. The previous discussion regarding In re Levin, 84 USPQ 232, applies here as well.
Regarding claim 28, Prakash discloses a natural high potency sweetener (NHPS) composition comprising at least on NHPS and at least one sweet taste improving composition including carbohydrates and other sweet taste improving additives or combinations thereof [0007]. Prakash discloses the carbohydrate may be glucose, tagatose, galactose, rhamnose, sucrose, ribulose, fructose, threose, arabinose, xylose, lyxose, allose, altrose, mannose, idose, erythrose, gulose, talose, erythrulose, xylulose, pricose, turanose, fucose, sorbose or ribose [0083].
Regarding claim 30, 31 and 32; Prakash discloses the inorganic acid salt may be sodium chloride, potassium chloride (alkali metal halides), magnesium chloride (metal halide) [0096].
Regarding claim 43, Prakash also discloses the carbohydrate, glucose, be included in the NHPS composition from 1000-100,000 ppm (0.1-10%) [0122]. Prakash does not disclose the amount of carbohydrate relative to the steviol glycoside combination.
Regarding the amount of carbohydrate relative to the steviol glycoside combination, Prakash discloses a quantity glucose recited in the previous paragraph, but does not recite a concentration of glucose relative to the steviol glycoside combination. However, it is known in the art that the quantity of glucose is a result effective variable, the more glucose the higher the calorie content and sweetness. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the product disclosed by the prior art by normal optimization procedures known in the art.
Regarding claim 22, Prakash discloses the blended composition of claim 17 as detailed above. Prakash discloses the NHPS composition may be used to sweeten an orally ingestible composition [0045].
Regarding claim 35, Prakash discloses the orally ingestible composition sweetened with the NHPS may be general condiments [0046] or the NHPS may comprise a table top sweetener (sweetener composition) [0896].
Regarding claim 36, Prakash discloses the orally ingestible composition sweetened with the NPHS may be cold confections, general sugar confections, chewing gum (chewing compositions), cereal products, cakes (baked goods), ice bream (dairy products) and beverages such as colas and powdered soft drinks (beverages and beverage products) [0046].
Regarding claim 37, Prakash discloses a natural high potency sweetener (NHPS) composition comprising at least one NHPS and at least one sweet taste improving composition including carbohydrates and other sweet taste improving additives or combinations thereof [0007]. Prakash discloses NHPS’s include thaumatin [0048] and the steviol glycosides rebaudioside A and rebaudioside B [0048] and [0068]. Prakash discloses the carbohydrate may be glucose [0083].
Prakash does not disclose a preferred embodiment comprising rebaudioside A, rebaudioside B, glucose and thaumatin. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected rebaudioside A, rebaudioside B and thaumatin as the NHPS and glucose as the carbohydrate of Prakash since Prakash discloses all four ingredients as appropriate for inclusion in the natural high potency sweetener composition. One would expect that all four sweetener components, when combined, would yield the predictable results of a combined sweetener composition.
Regarding the claim limitation of a blended composition, Prakash discloses the NHPS composition may be a dry-blend tabletop NHPS formulation [0900], which meets the claim limitation of producing a blended composition.
Prakash discloses the NHPS’s may be used individually or in combination with other NHPS’s as long as the combined effect does not adversely affect the taste of the sweetener composition, such as a steviol glycoside combination [0068]. Prakash discloses rebaudioside A is present in the steviol glycoside combination from about 50% to 99.5% of the combination of high potency sweeteners and rebaudioside B is present from about 1-8% of the combination of high potency sweeteners [0069] and [0070]. The quantity of rebaudioside A disclosed by Prakash overlaps with the claimed range of rebaudioside A of 40-80%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
Prakash discloses rebaudioside B is present from about 1-8% of the combination of high potency sweeteners [0070]. The quantity of rebaudioside B disclosed by Prakash is close to the claimed range of 10-17%. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.. MPEP 2144.05 I.
Alternatively, Prakash discloses a quantity RebB recited in the previous paragraph, which falls outside the claimed range. However, it is known in the art that the quantity of RebB is a result effective variable, changing the quantity of RebB in the composition with alter the sweetness and the calorie content of the composition. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the product disclosed by the prior art by normal optimization procedures known in the art.
Prakash also discloses the carbohydrate, glucose, be included in the NHPS composition from 1000-100,000 ppm (0.1-10%) [0122]. Prakash does not disclose the amount of carbohydrate relative to the steviol glycoside combination.
Regarding the amount of carbohydrate relative to the steviol glycoside combination, Prakash discloses a quantity glucose recited in the previous paragraph, but does not recite a concentration of glucose relative to the steviol glycoside combination. However, it is known in the art that the quantity of glucose is a result effective variable, the more glucose the higher the calorie content and sweetness. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the product disclosed by the prior art by normal optimization procedures known in the art.
Prakash does not disclose the amount of thaumatin in the composition, however Prakash does disclose that those of ordinary skill in the art will appreciate the sweetener composition can be customized to obtain the desired calorie content [0079] and the NHPS’s (including rebaudioside A, rebaudioside B and thaumatin) may be used individually or in combination with other NHPS’s as long as the combined effect does not adversely affect the taste of the sweetener composition, such as a steviol glycoside combination [0068]. Therefore, Prakash discloses a of mixture rebaudioside A, rebaudioside B, thaumatin and a carbohydrate which may be glucose [0083]. The disclosure of this mixture is considered to include all possible ratios of rebaudioside A, rebaudioside B and glucose to thaumatin, including the instantly claimed ratios.
Additionally, regarding the ratio of the steviol glycoside composition to the thaumatin Prakash does not recite a concentration of thaumatin. However, it is known in the art that the quantity of all the claimed sweeteners is a result effective variable, the higher the concentration of the sweeteners the sweeter the resulting composition will be. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the product disclosed by the prior art by normal optimization procedures known in the art.
Prakash does not disclose the order of combining the rebaudioside A, rebaudioside B, glucose and thaumatin. However, selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results and selection of any order of mixing ingredients is prima facie obvious. MPEP 2144.04 IV. C.
Regarding the claim language “for improving the taste profile of a steviol glycoside composition,” this language is deemed to be an intended use so far as the process is concerned. In process claims, a claimed intended use must result in a manipulative difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the NHPS of Prakash is identical to that of the presently claimed in terms of process, it meets the intended use of the claimed method. Additionally, Prakash discloses the NHPS with at least one sweet taste improving composition imparts a more sugar like taste and the composition has an improved flavor profile [0043].
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Prakash (US 2007/0128311 A1) as applied to claim 17 above, and further in view of Putter (US 2013/0136839 A1).
Regarding claims 19 and 20, Prakash discloses the NHPS composition of claim 17 as discussed above.
Prakash does not disclose the quantity of thaumatin in the NHPS composition.
Putter, in the field of sweetener compositions, disclose a sweetener composition comprising a sweetener and at least one flavoring [0013]-[0015]. Putter discloses the sweetener may be rebaudioside A, rebaudioside B or thaumatin [0072]. Putter discloses the sweetener composition comprises at least one additional sweetener which can be glucose (carbohydrate) [0081]. Putter discloses that in some embodiments the sweetener composition comprises 0.5-7.0 wt% thaumatin [0744], which falls within the claim 19 range of 0.02-10 wt% and overlaps with the claim 20 range of 0.1-2 wt%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the NHPS composition of Prakash, which comprises thaumatin, with the thaumatin content of Putter since both are drawn to sweetener compositions comprising thaumatin, rebaudioside A and B and a carbohydrate (glucose). One would have expected this combination to yield the predictable results of providing a sweetener composition acceptable for consumption.
Claims 33 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Prakash (US 2007/0128311 A1) as applied to claim 17 above, and further in view of Markosyan (EP 2,486,806 A1, 2012).
Regarding claim 33, Prakash discloses a natural high potency sweetener (NHPS) composition comprising thaumatin, glucose and the steviol glycosides rebaudioside A and rebaudioside B as discussed in the claim 17 rejection above.
Prakash does not disclose the rebaudioside A and rebaudioside B have been subject to or are products of an alkaline hydrolysis reaction.
Markosyan, in the field of Stevia based compositions, discloses a process by which rebaudioside A is dispersed in an alkaline solution, incubated from 10-150oC for 0.5-48 hrs which results in rebaudioside A being hydrolyzed to rebaudioside B with a molar yield conversion to rebaudioside B of about 5-100% [0030]. Markosyan discloses the resulting glycoside mixtures can be used “as-is” as well as recovering rebaudioside B as a pure ingredient [0022]. Markosyan also discloses the resulting products can be used as sweeteners [0034] and in combinations with other sweeteners such as glucose (carbohydrate sweetener) [0036] and [0037].
Markosyan discloses a sample produced by this method of alkaline hydrolysis in Example 1, which yields 84% rebaudioside A and 16% rebaudioside B [0041] and is subsequently freeze dried (Example 5, [0045]). The product of Example 5, when used to sweeten a beverage, results in no bitterness or aftertaste (p6, Table 1, Example 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the alkaline hydrolysis products of Markosyan’s method as the source of rebaudioside A and B in the NHPS product of Prakash because Markosyan discloses the alkaline hydrolysis products result in no bitterness or aftertaste in the final food product.
Regarding claim 34, Prakash does not disclose the first steviol glycoside which is subject to alkaline hydrolysis is one of RA20, RA30, RA40, RA50, RA60, RA80, RA90, RA97 OR RA99.
Markosyan, in the field of Stevia based sweeteners, discloses the starting material for the alkaline hydrolysis process (detailed in the claim 33 rejection) is a commercially available rebaudioside A which contains about 95-100% rebaudioside A along with other steviol glycosides [0027]. The specification indicates that the acronym "RAx" refers to a stevia composition containing rebaudioside A in amount of > x% and < (x+10)% [0031], therefore RA90 contains 90-100% rebaudioside A. Therefore the 95-100% rebaudioside starting material of Markosyan falls within the claimed range of RA90, which contains 90-100% rebaudioside A.
Markosyan discloses the resulting glycoside mixtures after alkaline hydrolysis of rebaudioside A can be used “as-is” as well as recovering rebaudioside B as a pure ingredient [0022]. Markosyan also discloses the resulting products can be used as sweeteners [0034] and in combinations with other sweeteners such as glucose (carbohydrate sweetener) [0036] and [0037].
Markosyan discloses a sample produced by this method of alkaline hydrolysis in Example 1, which yields 84% rebaudioside A and 16% rebaudioside B [0041] and is subsequently freeze dried (Example 5, [0045]). The product of Example 5, when used to sweeten a beverage, results in no bitterness or aftertaste (p6, Table 1, Example 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the rebaudioside A from 95-100% starting materials of Markosyan’ s method as the source of the rebaudioside A and B in the NHPS product of Prakash because Markosyan discloses the alkaline hydrolysis products result in no bitterness or aftertaste in the final food product.
Response to Arguments
Applicant's arguments filed 25 September 2025 have been fully considered. To the extent they apply to the above rejection they are not persuasive.
Applicant argues the key differentiator versus Prakash is the addition of small amounts of thaumatin (i.e. in a 1000:1 to 5:1 ratio) to the steviol glycoside composition of claim 17. Prakash only mentions thaumatin three times amongst very long lists - see [0004], [0048]and [0911], and none of the examples in Prakash contain thaumatin. It is true that there are other differences (between Prakash and the instant claims), e.g. the fact that none of the Prakash examples contain glucose, and that [0070] of Prakash teaches a RB range of 1-8 wt. %, but the unexpected technical effect of the present invention, as recited in claim 17, resides in the addition of thaumatin. Claim 17 is amended to ensure that it is tightly commensurate in scope with the data provided in the specification, i.e. such that the RA, RB and glucose ranges closely match the data points provided in Examples 11, 21, 22 and 23. It is not that that the addition of thaumatin in small amounts to RA/RB/glucose compositions outside the claimed RA/RB/glucose ranges would not also demonstrate the unexpected technical effect (in which case such thaumatin containing compositions outside of the claimed ranges would also be inventive), but simply that the applicant presently has no additional evidence to demonstrate that this is the case. Just because the applicant is presently unable to demonstrate the unexpected technical effect in relation to RA, RB and glucose ranges outside of those presently claimed, and hence unable to claim broader ranges, should not prevent the applicant from claiming compositions within the RA, RB and glucose ranges for which the criticality of the thaumatin addition to the technical effect has been demonstrated. Remarks pp5-7.
This argument is not persuasive. While claim 17 has been amended to more closely ensure that it is commensurate in scope with the claims, there is still not enough data over the range or outside the claimed range to support unexpected results. The data provided in examples 11, 21, 22 and 23 (see Table A in the Remarks, p7) only uses 2 different data points for the quantities of Reb A, Reb B and glucose. The two data points of 77.46 wt% and 40.25 wt% RebA are not sufficient to support claims of unexpected results over the range of 40-80 wt% RebA. The two data points of 16.5 wt% and 10.58 wt% are not sufficient to support claims of unexpected results over the range of 10-17 wt% RebB. The two data points of 3.7 wt% and 6.12 wt% are not sufficient to support claims of unexpected results over the range of 3-7 wt% glucose. There appears to be no data presented outside the claimed range in order to show criticality of the claimed range.
Two data points is not enough data for one of ordinary skill in the art to draw any conclusions about the trend in the data or the limits on the supposed unexpected effects of the sweeteners. See MPEP 716.02 (d) II, To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
Since Prakash discloses the combination of RA, RB, glucose and thaumatin as a sweetening combination and varying the levels of the sweeteners in the combination is known in the art to vary the sweetness and calorie content of the composition (result effective variables), Applicant’s ability to provide data to demonstrate the technical effect in relation to RA, RB and glucose ranges relative to the claimed amount of thaumatin is essential in order to distinguish the instant claims from the prior art. Without a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range, unexpected results cannot be established.
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.
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/C.L.G./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793