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 .
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 1-6, 9-17, 19, 20, 25-28 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 1 has been amended to claim “A composition comprising”… “and wherein the composition is present in a food beverage…” It is not clear if claim 1 is directed to “a composition” or to “A food, beverage, cosmetic or pharmaceutical product comprising a composition”. For instance, claim 17 is directed to “A food, beverage, cosmetic or pharmaceutical product comprising i) the composition of claim 1 as a sweetening or flavor modifying ingredient and ii) at least one additional food, beverage, cosmetic or pharmaceutical ingredient. If claim 1 is a food, beverage, cosmetic or pharmaceutical product that has the composition present, the preamble should resemble claim 17 rather than “A composition”. Dependent claims are included, as is claim 17, in the rejection.
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%. 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 Miguel 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 steviolbioside 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. In sum, it would have been obvious to optimize the amounts of each of the components discussed above as one of ordinary skill is aware of their effect on taste, sweetness and sweeter enhancement. Optimization of the amounts of these known flavoring materials is considered to be within the level of ordinary skill as explained by the references.
Regarding the amount of the composition to be added to a food or beverage, Schafer discloses optimizing flavor by adding 0.0001-2wt% of the mixture for oral intake which is considered addition to food or beverage. This amount overlaps the claimed range. Furthermore, one of ordinary skill would have found it obvious to vary the amount of flavoring depending upon the food or beverage to which the material is added as well as the desired taste profile desired.
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 112(b) rejection of claims 27 and 28 are overcome by applicant’s amendments. The rejections are withdrawn. However, a new 112(b) is made above in light of the amendment to claim 1.
The 112(a) new matter rejection of claims 25 and 26 is maintained. Applicant cites several pages of the PCT Application PCT/US2017/035931 for support of the ranges in these claims. Pages 8 and 9 refer to starting material such as of RebB in amounts of at least 50, 60, 70, 80 or 90% on a dry basis weight. The next sentence after that cited by applicant also refers to the starting steviol glycoside comprised of at least 50, 60, 70, 80 or 90 RebA on a dry weight basis. The next sentence states that the starting steviol glycoside may be comprised of at least 50, 60, 70, 80 or 90% stevioside on a dry weight basis. The next citation by applicant (page 9, lines 6-9) states the starting steviol glycoside composition may be comprised of at least 10, 20, 30, 40, 50, 60 70, 80 or 90 % steviolbioside on a dry weight basis. It appears applicant is relying on the ranges of starting material that comprise only RebB and steviolbioside. Next applicant points to page 13 and the glycosylation reaction stopping once 60-85% of the starting steviol glycosided have reacted leaving 15-40% unreacted. However, the ranges of starting material of RebB and steviolbioside cited by applicant are not in combination and it is not clear what specific range combination is relied upon to reach the claimed ranges. It is not clear that the specific ranges of the claims were in applicant’s possession at the time of filing since there is no indication of a specific combination of amounts of these two materials as a starting material.
Applicant also cites Table 3, however no clear description of Table 3 is found in the instant specification. Further, Table 3 is in the section that describes an example where the starting material used comprises RebA and stevioside (Example 1) which appears to be directed to an embodiment where RebA converts to RebB. In contrast, the sections pointed to by applicant discussed above on pages 8 and 9 of the PCT are directed to using a starting material comprising RebB, not RebA.
Applicant also points to several claims of the PCT, which are generally cumulative to the citations of the specification.
In sum, the original specification includes broad citations of starting materials and glycosylation reactions, but there is no citation provided that supports the specific ranges of RebB, glycosylated RebB, steviolbioside, and glycosylated steviolbioside as claimed. The response points to broad ranges, but no specificity is provided or found that indicates possession at the time of filing.
Regarding the 103 rejection, the rejection above is maintained for reasons of record.
Overall, the data is not persuasive of unexpected results. Currently, the claims are directed to a composition having 80-85w% rebaudioside A, stevioside and their glycosylates (first component) and 15-20wt% 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). Note that Table 7 on page 47 refers to B-G whereas the paragraph that describes the samples refers to 20% G-B (also on page 47). It is not clear if these are in reference to the same materials as the notation order of G-B and B-G seem to be different based upon Table 6 which includes both citations. However, the paragraph bridging pages 42-43 describe SG95 B-G and SG95 G-B in what appear to be identical terms. The record would benefit from clarifying the notation of the materials used.
The combination of SG95 G and 15 or 20 wt% SG95 B-G (or G-B) appears to be based upon Example 4. The instant specification states on page 46 that SG95 G is glycosylated SG 95 steviol glycoside mixture containing about 60wt% RebA and about 25wt% stevioside with a dextrin:steviol glycoside wt ratio of 2:1. SG95 B-G (or G-B) is described in Example 3 (as referenced in Example 4) as containing about 60wt% RebA and about 30wt% stevioside. Thus, SG95 G with 15% SG95 G-B (or G-B) is 85% SG95G and 15% SG95 B-G. In example 4, these materials are described as the starting materials which are subsequently treated with CGTase resulting in glycosylation and what appears to be changing at least some of the materials to RebB and steviolbioside and their glycosylates as well as glycosylates of RebA and stevioside. The difficulty is that there is no description of the amounts of conversion to RebB and steviolbioside. In other words, the amounts of the starting materials are indicated, but the amounts after glycosylation and treatment with CGTase are not indicated. Thus, it is not clear that the examples are commensurate. As best understood, the order of G-B or B-G indicates the order of treatment of base treated (B) and glycosylation (G).
Also, it is not entirely clear if SG95G with 20% G-B is a mixture of SG95G and 20% SG95 G-B in the same way SG95G -15% SG95 B-G is described. The specification states the following:
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222
596
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And Table 7:
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338
634
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As seen above, the 20% G-B does not appear to be referencing the same starting material as 15% SG95 B-G. Rather, it appears to indicate 20% of the material is base treated after glycosylation. The same issues holds regardless of 15% SG95 or 20% G-B, in that there is no clear indication of the amounts of RebA, RebB, stevioside, steviolbioside and their glycosylates in the product after treatment. Moreover, there is a difference in whether the material is G-B or B-G and the 20% is associated with G-B whereas 15% is B-G.
These compositions are compared to SG95 G alone or combined with Reb B since neither of these are commensurate with the current claims.
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.
As noted above, the order of G-B or B-G appears to be of importance. For instance, page 29-30 appear to indicate the mixture of a glycosylated glycoside composition that has been base treated and then glycosylated (component a-akin to SG95 B-G) in combination with a steviol glycoside composition that has not been base treated prior to glycosylation (component b-akin to S95G-G). Based upon Table 7, it is the combination of the 15% SG95 B-G (base treated and then glycosylated) and SG95 G (no base treatment prior to glycosylation) that results in the highest liking (4.4) at 1000 ppm and lowest off-flavor (1.8). As currently written, the claims are not commensurate with the scope of the B-G vs G-B or G and as explained above, the examples do not clearly convey the final amounts in the formed products.
Also, claim 1 and 17 include addition of the composition to cosmetics. However, the data is directed to flavor. It is not clear how a cosmetic would be commensurate with a material that is tested for flavor.
Finally, example 4 includes dextrin in the composition, but this is not commensurate with the claims.
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 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
