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 .
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 9, 10, 11, 12, 15, and 20 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.
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, Claims 9-12, 15 and 20 recite either the broad recitation of Thaumatin or one of the claimed Thaumatins, and the claim also recites “preferably Thaumatin II”, or recite the broad recitation of one of the claimed Rebaudiosides, and also recites “preferably the Rebaudioside is selected from Reb A and Reb M”, which is the narrower statement of the range/limitation. The claim(s) 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.
Claim Rejections - 35 USC § 102
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 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, 15, and 20 are rejected under 35 U.S.C. 102a1 as being anticipated by Melisheva (RU 2503267), made of record by Applicant.
A machine translation of the RU document is used in the following rejection, and has been made of record by the Examiner.
Regarding amended Claims 8, 10, 15, 20, Melisheva teaches a sweetener or flavor modifying composition comprising thaumatin and at least one rebaudioside, where the rebaudioside is rebaudioside A (machine translation, Paragraphs 9-11). Since Melisheva teaches the thaumatin and the rebaudioside A in a composition, Melisheva is deemed to teach the claimed “kit of parts” comprising as a first part a thaumatin and as a second part the at least one rebaudioside.
Claims 8, 10, 15, and 20 are rejected under 35 U.S.C. 102a1 as being anticipated by Yoshinaka et al. (USPA 2010/0267847), made of record by Applicant.
Regarding amended Claims 8, 10, 15, 20, Yoshinaka teaches a sweetener or flavor modifying composition comprising thaumatin and at least one rebaudioside, where the rebaudioside is rebaudioside A (Paragraphs 41, 42, 79 and 193). Since Yoshinaka teaches the thaumatin and the rebaudioside A in a composition, Yoshinaka is deemed to teach the claimed “kit of parts” comprising as a first part a thaumatin and as a second part the at least one rebaudioside.
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.
Claims 1-5, 7-12, 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshinaka et al. (USPA 2010/0267847), made of record by Applicant, in view of Firsov et al. (2016).
Regarding amended Claims 1-3, 8, 9, 10, 15, Yoshinaka teaches a sweetener composition comprising thaumatin and rebaudioside A, where the thaumatin together with rebaudioside A and mogroside V can produce a sweetener having an excellent and more sugar-like sweetness quality (Paragraph 79). Yoshinaka does not specifically teach where the thaumatin is thaumatin II of greater than 90% purity, or where the thaumatin II is not isolated from Thaumatococcus danielli.
Firsov teaches that thaumatin is a supersweet protein from the fruit of the African plant katemfe (Thaumatococcus danielli) that has high water solubility, heat and acidic pH stability and taste properties like those of carbohydrate sweeteners and teaches that thaumatin is present in the above fruit or plant in five variants, with the two main ones being thaumatin I and II (Page 1, Column 1, Paragraph 1), and teaches that thaumatin II has best the best studied variant of thaumatin (Page 1, Column 2, Paragraph 1). Firsov teaches that the manufacture of thaumatin from the fruit of the T. danielli plant is limited and teaches of preparing recombinant thaumatin II by producing thaumatin in tomatoes as an expressed protein and comparing it to the native thaumatin from the plant (Page 2, Column 1, Paragraph 1). Firsov teaches that the recombinant thaumatin II having a purity of 93% (Table 1) had a taste that was indistinguishable from the native protein obtained from T. danielli and may be a safe and low-cost alternative to thaumatin from natural sources for use in the pharmaceutical and food industries. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the thaumatin in Yoshinaka to have been thaumatin II having the claimed purity and not from T. danielli in light of the teaching of Firsov that recombinant thaumatin II having 93% purity can be used as a sweetener in foods in place of natural sources of thaumatin as a low-cost and safe alternative.
Regarding amended Claims 4, 5, 7, 11, 12, 14, as set forth above, Yoshinaka in view of Firsov teach a sweetener composition comprising rebaudioside A and thaumatin, and as motivated by Firsov, where the thaumatin is thaumatin II, and teaches the sweetener composition comprises rebaudioside A and mogroside V in a weight ratio of 95:5 to 60:40 (Yoshinaka, Paragraph 82) and teaches the thaumatin is added to the combination of rebaudioside A and mogroside V in an amount of up to 3 parts by mass per total 100 parts of the rebaudioside A and mogroside A contained in the sweetener, and that by using thaumatin in combination with the mogroside V, the sweetness quality of rebaudioside A can be further improved and a sweetness quality similar to sugar can be obtained (Yoshinaka, Paragraphs 89-92) and teaches when thaumatin is added the linger sweetness can be further reduced in the sweetener composition and the bitterness was masked, so that the sweetness quality became closer to that of sugar (Yoshinaka, Paragraph 193). Yoshinaka also teaches that the total amount of rebaudioside A, mogroside V and thaumatin in the sweetener can be suitably adjusted so that it falls within the range up to 100% by weight (Paragraph 97).
Regarding the claimed percentages of about 2 to about 5% by weight thaumatin II and about 95-98% rebaudioside A, or about 3% thaumatin II and about 97% rebaudioside A, or about 2% thaumatin II and about 98% rebaudioside A, while the prior art does not specifically teach the relative percentages of the two claimed sweeteners in the sweetness composition, the following points are noted: Yoshinaka teaches up to 3 parts thaumatin per 100 total parts of rebaudioside A and mogroside V and teaches a ratio of rebaudioside A to mogroside that can be 95:5 (Paragraphs 82-92). Therefore, where the total of rebaudioside A and mogroside is 100%, this would give 3% thaumatin, and since rebaudioside A can be at 95%, this would provide for thaumatin at 2.85% by weight of the amount of rebaudioside A. Since the amount of rebaudioside A, mogroside V and thaumatin can be 100%, and Yoshinaka teaches adjusting the amounts of the sweeteners in order to provide a total of 100%, this would result in slightly less than 95% rebaudioside A, slightly less than 5% mogroside V and slightly less than 3% thaumatin by weight, while keeping the ratios as disclosed by Yoshinaka. Since Yoshinaka teaches the sensory benefits of adding a small amount of thaumatin to a sweetener composition comprising a majority of rebaudioside A, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have optimized the amount of the sweeteners in the sweetener composition in order to minimize bitterness, minimize lingering sweetness and provide a sweetener composition that has a sweetness that more closely resembles that of sugar.
Furthermore, it has been found that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. See MPEP 2144.05 I. Given the guidelines and ratios taught by Yoshinaka, it would have been well within the skill of one of ordinary skill in the art to have adjusted the percentages of the rebaudioside A, mogroside V and thaumatin in order to maximize the functional benefits of the thaumatin in the sweetener composition and provide a desirable sweetness to the sweetener composition that more closely resembles sugar.
Where "the difference between the claimed invention and the prior art is some range or other variable within the claims...Applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir.1990). MPEP 2144.05 III. In addition, where general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges in the percentage of thaumatin and rebaudioside A involves only routine skill in the art. MPEP 2144.05 II.
Lastly, the exact percentages of thaumatin and rebaudioside A is deemed to be a result effective variable with regard to the preparation of a sweetener composition that has minimizes undesirable characteristics and produces a sweetness similar to that of sugar. It would require routine experimentation to determine the optimum value of a result effective variable, such as the claimed amount of thaumatin and rebaudioside A, in the absence of a showing of criticality in the claimed percentage of thaumatin and rebaudioside A. In re Boesch, 205 USPQ 215 (CCPA 1980), In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). One of ordinary skill in the art would have been motivated by Yoshinaka to have adjusted the percentages of the rebaudioside A, mogroside V and thaumatin in order to maximize the functional benefits of the thaumatin in the sweetener composition and provide a desirable sweetness to the sweetener composition that more closely resembles sugar.
Regarding amended Claim 16, Yoshinaka in view of Firsov teach a method of manufacturing a reduced calorie product comprising adding the composition to a food or beverage product, as Yoshinaka in view of Firsov teach the sweetener composition includes high intensity sweeteners and the desirability of non or low-calorie high intensity sweeteners added to foods and beverages that have a sweetness that is similar to that of sugar (Yoshinaka, Paragraphs 5, 95-100 and Examples 2 and 5). Therefore, the claimed method of manufacturing a reduced calorie product would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, in light of the teachings of Yoshinaka in view of Firsov.
Regarding amended Claims 17-19, Yoshinaka in view of Firsov teach a sweetener composition orally administered that is a food or beverage that has an added total content of rebaudioside A and mogroside V in the range of 10ppm to 5,000 ppm, where the composition further includes up to 3 parts by mass of thaumatin per total 100 parts by mass of rebaudioside A and mogroside V (Yoshinaka, Claims 6-9), where the total use level overlaps with or includes the claimed ranges and amount. While the prior art does not specifically teach the total use level of the claimed sweetener including rebaudioside A, mogroside V and thaumatin, the following points are noted: Yoshinaka teaches up to 3 parts thaumatin per 100 total parts of rebaudioside A and mogroside V and teaches a ratio of rebaudioside A to mogroside that can be 95:5 (Paragraphs 82-92). Therefore, where the total of rebaudioside A and mogroside is 100%, this would give 3% thaumatin, and since rebaudioside A can be at 95%, this would provide for thaumatin at 2.85% by weight of the amount of rebaudioside A. Since the amount of rebaudioside A, mogroside V and thaumatin can be 100%, and Yoshinaka teaches adjusting the amounts of the sweeteners in order to provide a total of 100%, this would result in slightly less than 95% rebaudioside A, slightly less than 5% mogroside V and slightly less than 3% thaumatin by weight, while keeping the ratios as disclosed by Yoshinaka. Therefore, one of ordinary skill in the art would have reasonably expected that adjusting the amounts of the three disclosed sweeteners in the sweetener composition would result in a use level close to the disclosed range of 10 ppm to 5,000 ppm. Since Yoshinaka teaches the sensory benefits of adding a small amount of thaumatin to a sweetener composition comprising a majority of rebaudioside A, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have optimized the amount of the sweeteners in the sweetener composition in order to minimize bitterness, minimize lingering sweetness and provide a sweetener composition that has a sweetness that more closely resembles that of sugar.
Where "the difference between the claimed invention and the prior art is some range or other variable within the claims...Applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir.1990). MPEP 2144.05 III. In addition, where general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges in the use level of the sweetener composition involves only routine skill in the art. MPEP 2144.05 II.
Lastly, the claimed food or beverage comprising the claimed use level in ppm of the sweetener composition is deemed to be a result effective variable with regard to the preparation of a sweetener composition that has minimized undesirable characteristics and produces a sweetness similar to that of sugar. It would require routine experimentation to determine the optimum value of a result effective variable, such as the claimed ppm of the use level of the sweetener composition in food and beverage, in the absence of a showing of criticality in the claimed use level of the sweetener composition. In re Boesch, 205 USPQ 215 (CCPA 1980), In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). One of ordinary skill in the art would have been motivated by Yoshinaka to have adjusted the amounts of the rebaudioside A, mogroside V and thaumatin in order to maximize the functional benefits of the thaumatin in the sweetener composition and provide a desirable sweetness to the sweetener composition that more closely resembles sugar.
Regarding amended Claim 20, since Yoshinaka in view of Firsov teach the thaumatin and the rebaudioside A in a composition, as set forth above, Yoshinaka is deemed to teach the claimed “kit of parts” comprising as a first part a thaumatin and as a second part the at least one rebaudioside.
Claims 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshinaka et al. (USPA 2010/0267847), made of record by Applicant, in view of Firsov et al. (2016), and further in view of Prakash et al. (USPA 2017/0295827).
Regarding amended Claims 6 and 13, Yoshinaka in view of Firsov are taken as cited above in the rejection of Claims 1 and 8, and teach the sweetener or flavor modifying composition comprising Thaumatin or Thaumatin II and at least one rebaudioside such as Rebaudioside A, as set forth above, but do not specifically teach Rebaudioside M as the rebaudioside.
Prakash teaches beverages including sweeteners enhancers and high potency sweeteners (Paragraph 2), and teaches that the rebaudiosides including rebaudioside A, C, D, M, etc. are all considered sweetness enhancers and high potency sweeteners that can be included in the disclosed beverages (Paragraphs 10-11, and 26).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the sweetener or flavor modifying composition of Yoshinaka in view of Firsov to have comprised rebaudioside M as the at least one rebaudioside in an amount as taught by Yoshinaka in view of Firsov in light of the teachings of Prakash and the well known use of other rebaudiosides such as rebaudioside M as a sweetness enhancer and high potency sweetener. It is prima facie obvious to substitute one composition for another that is taught in the prior art to be used for the same purpose, when their equivalency is established or acknowledged by the prior art. See MPEP 2144.06 II.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNA A WATTS whose telephone number is (571)270-7368. The examiner can normally be reached Monday-Friday. 9am-4:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached at 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JENNA A. WATTS
Primary Examiner
Art Unit 1791
/JENNA A WATTS/Primary Examiner, Art Unit 1791 12/5/2025