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 Objections
Claims 2 and 3 are objected to because of the following informalities:
-In claim 2, the term “Thamatococcus Daniellii” should read “Thaumatococcus daniellii”.
-In claim 3, the term “whereas” should read “wherein”.
Appropriate correction is required.
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, 9, 12-14 and 16-19 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.
Regarding claim 3, the recitation “whereas the Mogrosides” renders the claim indefinite because there is no antecedent basis for the term “the Mogrosides.” Claim 1 from which claim 3 depends from requires “at least one Mogroside.”
Regarding claims 5-7, the term “the Thaumatin” in line 4 renders the claim indefinite because there is no antecedent basis for the term. Claim 1, from which claims 5-7 depend, requires Thaumatin II.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance:
-claim 9 recites the broad recitation “Thaumatin”, and the claim also recites “preferably the Thaumatin is Thaumatin II” which is the narrower statement of the range/limitation.
-claims 12-14 and 19 recite the broad recitation “Thaumatin”, and the claim also recites “preferably “Thaumatin II” which is the narrower statement of the range/limitation.
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claims 16 and 17, the recitation “A food, beverage, nutritional product, cosmetic product, or pharmaceutical product comprising adding the sweetener or flavor modifying composition of claim 1 at a use level between about 1 ppm and about 1000 ppm” (or in claim 17, of about 500 ppm) renders the claim indefinite. Claims 16 and 17 are directed to a composition and not a method of making. Are the claims intended to be product-by-process claims wherein the food, beverage, nutritional product, cosmetic product, or pharmaceutical product is made by a process comprising adding between about 1 ppm to about 1000 ppm (or in claim 17 about 500 ppm) of the sweetener or flavor modifying composition of claim 1 to the food, beverage, nutritional product, cosmetic product, or pharmaceutical product ? In the alternative, does Applicant merely intend to claim a food, beverage, nutritional product, cosmetic product, or pharmaceutical product comprising about 1 ppm to about 1000 ppm (or as in claim 17 about 500 ppm) of the sweetener or flavor modifying composition of claim 1?
Regarding claim 18, the recitation “A food, beverage, nutritional product, cosmetic product or pharmaceutical product comprising adding the sweetener or flavor modifying composition of claim 1” renders the claim indefinite because the claim is direct to a composition and not a method. Does Applicant intend to claim a food, beverage, nutritional product, cosmetic product or pharmaceutical product made by a process of adding the sweetener or flavor modifying composition of claim 1 to a food, beverage, nutritional product, cosmetic product or pharmaceutical product?
Drawings
The drawings are objected to because in Figure 1, the total sweetness perception values on the Y-axis contain commas instead of decimal points (e.g., “0,5” should be written as “0.5”) . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 8, 10 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gelin et al. (US 2010/0310751).
Regarding claims 8 and 10, Gelin et al. disclose a sweetener composition comprising: (a) Mogroside V; and (b) thaumatin (i.e., the extract of the fruit of the Katemfe fruit – Abstract, .
Regarding claim 19, Gelin et al. disclose a sweetener composition comprising: (a) Mogroside V; and (b) thaumatin (i.e., the extract of the fruit of the Katemfe fruit). Since Gelin et al. disclose the thaumatin and Mogroside V in a composition, Gelin et al. necessarily discloses the claimed “kit of parts” comprising as a first part a thaumatin and as a second part the at least one Mogroside.
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.
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.
Claims 11-13 is rejected under 35 U.S.C. 103 as being unpatentable over Gelin et al. (US 2010/0310751).
Regarding claims 11-13, Gelin et al. disclose all of the claim limitations as set forth above. Gelin et al. disclose the ratio of Mogroside V to thaumatin ranges from 6000:1 to 1:40. It would have been obvious to one of ordinary skill in the art to have selected any ratio within the claimed range including a ratio of 98:2 with a reasonable expectation of success. 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).
Claims 1-6, 9 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gelin et al. (US 2010/0310751) in view of Firsov et al. (“Purification and characterization of recombinant supersweet protein thaumatin II from tomato fruit”, Protein Expression and Purification, 123, (2016), pp. 1-5).
Regarding claims 1-3, Gelin et al. disclose a sweetener composition comprising: (a) Mogroside V; and (b) thaumatin (i.e., the extract of the fruit of the Katemfe fruit – Abstract, .
Gelin et al. is silent with respect to thaumatin II of greater than 90% purity.
Firsov et al. teach thaumatin is a supersweet protein from the fruit of the African plant katemfe (Thaumatococcus danielli) and has high water solubility, heat and acidic pH stability and taste properties like those of carbohydrate sweeteners (p. 1/C1/Introduction). Firsov et al. teach that thaumatin is present in the fruit of T. danielli in five variants; two main ones- thaumatin I and II, and three minor ones- thaumatin a, b and c (p. 1/C1/Introduction). Firsov et al. teach the manufacture of thaumatin from the fruit of the T. danielli plant is limited and teach preparing recombinant thaumatin II by producing thaumatin in tomatoes as an expressed protein and comparing it to the native thaumatin from the plant (p. 2/C1). Firsov et al. teach the recombinant thaumatin II, having a purity of 93%, had a taste that was indistinguishable from the native protein obtained from T. danielli. (p. 4/Table 1). Firsov et al. teach the recombinant thaumatin II may be a safe and low-cost alternative to thaumatin from natural source for use in the pharmaceutical and food industries (p. 3/C2/Conclusion).
Gelin et al. and Firsov et al. are combinable because they are concerned with the same field of endeavor, thaumatin as a sweetener. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to have used the thaumatin II, having a purity of 93%, as taught by Firsov et al. for the thaumatin in the sweetener composition of Gelin et al. as a low cost and safe alternative with a taste indistinguishable from native protein obtained from T. danielli.
Regarding claims 4-6, modified Gelin et al. disclose all of the claim limitations as set forth above. Gelin et al. disclose the ratio of Mogroside V to thaumatin ranges from 6000:1 to 1:40. It would have been obvious to one of ordinary skill in the art to have selected any ratio within the claimed range including a ratio of 98:2 with a reasonable expectation of success. 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).
Regarding claim 9, Gelin et al. disclose all of the claim limitations as set forth above. Gelin et al. is silent with respect to thaumatin II.
Firsov et al. teach thaumatin is a supersweet protein from the fruit of the African plant katemfe (Thaumatococcus danielli) and has high water solubility, heat and acidic pH stability and taste properties like those of carbohydrate sweeteners (p. 1/C1/Introduction). Firsov et al. teach that thaumatin is present in the fruit of T. danielli in five variants; two main ones- thaumatin I and II, and three minor ones- thaumatin a, b and c (p. 1/C1/Introduction). Firsov et al. teach the manufacture of thaumatin from the fruit of the T. danielli plant is limited and teach preparing recombinant thaumatin II by producing thaumatin in tomatoes as an expressed protein and comparing it to the native thaumatin from the plant (p. 2/C1). Firsov et al. teach the recombinant thaumatin II, having a purity of 93%, had a taste that was indistinguishable from the native protein obtained from T. danielli. (p. 4/Table 1). Firsov et al. teach the recombinant thaumatin II may be a safe and low-cost alternative to thaumatin from natural source for use in the pharmaceutical and food industries (p. 3/C2/Conclusion).
Gelin et al. and Firsov et al. are combinable because they are concerned with the same field of endeavor, thaumatin as a sweetener. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to have used the thaumatin II, having a purity of 93%, as taught by Firsov et al. for the thaumatin in the sweetener composition of Gelin et al. as a low cost and safe alternative with a taste indistinguishable from native protein obtained from T. danielli.
Regarding claim 15, modified Gelin et al. disclose all of the claim limitations as set forth above. Gelin et al. disclose a method of making a reduced sugar tea beverage comprising the steps of adding the sweetener composition of claim 1 to a beverage base ([0057]-[0063]/Example 3).
Regarding claims 16 and 18, modified Gelin et al. disclose all of the claim limitations as set forth above. Gelin et al. disclose a foodstuff comprising the sweetener of claim 1 (the sweetening composition is preferably provided in a beverage or foodstuff – Abstract,[0037]- [0038], [0040], claim 10).
Gelin et al. disclose the concentration of the sweetener composition in a beverage or foodstuff ranges from 5.05 to 320 ppm ([0038], claim 10). 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).
Regarding claim 17, modified Gelin et al. disclose all of the claim limitations as set forth above. Gelin et al. disclose a foodstuff comprising the sweetener of claim 1 (the sweetening composition is preferably provided in a beverage or foodstuff – Abstract,[0037]- [0038], [0040], claim 10).
While Gelin et al. disclose the concentration of the sweetener composition in a beverage or foodstuff ranges from 5.05 to 320 ppm ([0038], claim 10), the reference is silent with respect to a concentration of 500 ppm. However, given Gelin et al. disclose the sweetening composition can be used to replace sugar and is found to provide a substantially similar taste profile to sugar, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have adjusted, in routine processing, the amount of added sweetener composition to obtain a foodstuff or beverage with a desired level of sweetness.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gelin et al. (US 2010/0310751) in view of Firsov et al. (“Purification and characterization of recombinant supersweet protein thaumatin II from tomato fruit”, Protein Expression and Purification, 123, (2016), pp. 1-5) as applied to claim 1, and further in view of Pawer et al. (“Sweeteners from plants-with emphasis on Stevia rabaudiana (Bertoni) and Siraitia grosvenorii (Swingle)”, Anal Bioanl Chem, 405, (2013), pp. 4397-4407).
Regarding claim 7, modified Gelin et al. disclose all of the claim limitations as set forth above. While Gelin et al. disclose the ratio of Mogroside V to thaumatin ranges from 6000:1 to 1:40., the reference does not disclose the mogroside siamenoside I. Note, Gelin et al. disclose an extract of the fruit of one or more plants from Cucurbitaceae family comprising 20 wt% to 100 wt% based on the total weight of the extract, of Mogroside V ([0018]-[0019]).
Pawer et al. teach plant-derived compounds are increasingly used as natural sweeteners (Abstract). Pawer et al. teach sweet tasting fruit, luo han guo, from the Cucurbitaceae family. Pawer et al. teach Mogrosides IV and V are the main sweet cucurbitane-type triterpene glycosides of the fruit (p. 4403/C1). Pawer et al. teach that several other cucurbitane-type triterpene glycosides have been identified in the fruit including siamenoside I which is reported to have a sweetness of 563 relative to that of sucrose (p. 4403/C1).
Given Gelin et al. disclose an extract of the fruit of one or more plants from Cucurbitaceae family wherein the extract comprises from 20 wt% to 100 wt% Mogroside V, since Pawer et al. teach siamenoside I is one of the cucurbitaine-type triterpene glycosides identified in an extract of luo han guo which has a sweetness of 563 relative to that of sucrose, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have used siamenoside I in place of mogroside V in the sweetening composition of Gelin et al. because it has a greater sweetness intensity.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Gelin et al. (US 2010/0310751) in view of Pawer et al. (“Sweeteners from plants-with emphasis on Stevia rabaudiana (Bertoni) and Siraitia grosvenorii (Swingle)”, Anal Bioanl Chem, 405, (2013), pp. 4397-4407).
Regarding claim 14, Gelin et al. disclose all of the claim limitations as set forth above. While Gelin et al. disclose the ratio of Mogroside V to thaumatin ranges from 6000:1 to 1:40., the reference does not disclose the mogroside siamenoside I. Note, Gelin et al. disclose an extract of the fruit of one or more plants from Cucurbitaceae family comprising 20 wt% to 100 wt% based on the total weight of the extract, of Mogroside V ([0018]-[0019]).
Pawer et al. teach plant-derived compounds are increasingly used as natural sweeteners (Abstract). Pawer et al. teach sweet tasting fruit, luo han guo, from the Cucurbitaceae family. Pawer et al. teach Mogrosides IV and V are the main sweet cucurbitane-type triterpene glycosides of the fruit (p. 4403/C1). Pawer et al. teach that several other cucurbitane-type triterpene glycosides have been identified in the fruit including siamenoside I which is reported to have a sweetness of 563 relative to that of sucrose (p. 4403/C1).
Given Gelin et al. disclose an extract of the fruit of one or more plants from Cucurbitaceae family wherein the extract comprises from 20 wt% to 100 wt% Mogroside V, since Pawer et al. teach siamenoside I is one of the cucurbitaine-type triterpene glycosides identified in an extract of luo han guo which has a sweetness of 563 relative to that of sucrose, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have used siamenoside I in place of mogroside V in the sweetening composition of Gelin et al. because it has a greater sweetness intensity.
Claims 1-3, 8-10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Galindo et al. (EP 2 428 122 – IDS filed February 14, 2024).
Regarding claims 1, 3 and 8-10, Galindo et al. disclose a sweetening composition comprising thaumatin II (use of one of the various thaumatin proteins -thaumatin I, II, III, a, b, c, or mixtures thereof –[0005]), gymnemic acid and a sweetening agent ([0009]-[0012],[0017]).
Galindo et al. disclose the thaumatin II is pure (i.e., greater than 90% purity- [0038]).
Galindo et al. disclose the sweetening agent is selected from the list of: (i) natural sweeteners such as Momordica grosvenori (mogrosides IV or V), Stevia, rebaudioside A, brazzein, glycyrrhyzic acid and its salt, curculin, monellin, phyllodulcin, rubusosides, mabinlin, dulcoside A, dulcoside B, siamenoside, monatin and its salt, thaumatin, hernandulcin, phyllodulcin, glycyphyllos, phlorizin, trilobatin, baiyunoside, osladin, polypodoside A, pterocaryoside A, pterocaryoside B, mukurozioside, phlomisoside I, periandrin I, abrusoside A, cyclocarioside I, erythritol, and/or other natural polyols such as maltitol, mannitol, lactitol, sorbitol, inositol, isomalt, xylitol, glycerol, propylene glycol, threitol, galactitol, reduced isomalto-oligosaccharides, palatinose, reduced xylo-oligosaccharides, reduced gentio-oligosaccharides, reduced maltose syrup and/or reduced glucose syrup, and/or (ii) artificial sweeteners, such as aspartame, cyclamate, sucralose, acesulfame K, neotame, saccharin, and/or neohesperidin dihydrochalcone; and at least one sweet taste improving carbohydrate comprising sucrose, fructose, glucose, maltose, lactose, mannose, galactose, ribose, rhamnose, trehalose, tagatose, or high fructose corn syrup. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have chose any of the additional sweeteners, including Mogroside V and arrive at the present invention with a reasonable expectation of success.
Regarding claim 2, Galindo et al. disclose all of the claim limitations as set forth above. Galindo et al. disclose thaumatin extracted from Thaumatococcus danelli ([0005]). However, even though product-by process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability does not depend on its method of production, If the product in the product-by-process claims is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP §2113).
Regarding claim 15, Galindo et al. disclose all of the claim limitations as set forth above. Galindo et al. disclose a method of making an edible food product comprising the step of adding the sweetening composition of claim 1 into the composition of the edible food product ([0034]).
Conclusion
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/ Primary Examiner, Art Unit 1759
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