DETAILED ACTION
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
Receipt of the Response and Amendment after Non-Final Office Action filed 08/18/2026 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims and/or persuasive remarks: (1) the objections to the drawings and claims 2-4, 7-8, and 10 have been withdrawn; and (2) the 35 U.S.C. §112(b) rejections of claims 3 and 6-9 have been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-23
Withdrawn claims: 11-21
Previously cancelled claims: None
Newly cancelled claims: None
Amended claims: 2-4, 6-10
New claims: 22-23
Claims currently under consideration: 1-10, 22-23
Currently rejected claims: 1-10, 22-23
Allowed claims: None
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 1-2 and 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Galindo (US 2013/0183427; IDS citation).
Regarding claims 1, 5, 6, 7, 8, and 9, Galindo teaches a sweetener composition comprising gymnemic acid, thaumatin, and brazzein [0009], [0017]-[0018], wherein the concentration of gymnemic acid is 0.5-500 ppm [0015] and the ratio of gymnemic acid to thaumatin is 6-8 parts gymnemic acid to 1 part thaumatin [0012]. From these disclosures, Galindo at least suggests that the concentration of thaumatin in the composition may be from 0.06 ppm to 83 ppm. The combined weight of thaumatin and gymnemic acid comprises up to 583 ppm of the composition so that the composition may comprise 999,417 ppm of other ingredients such as brazzein. Therefore, the composition of Galindo may comprise brazzein in an amount from greater than 0 ppm to an amount of 999,417 ppm, thereby providing amounts of thaumatin and brazzein in the thaumatin and brazzein portion of the composition that encompass the ranges recited in present claims 1, 5, 6, 7, 8, and 9.
It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.I.
Regarding claim 2, Galindo teaches the invention as described above in claim 1, including the thaumatin may be selected from thaumatin I, thaumatin II, thaumatin A, and thaumatin B [0005].
Regarding claim 4, Galindo teaches the invention as described above in claim 1. Galindo does not teach that the thaumatin is not isolated from Thaumatococcus daniellii. However, it is noted that claim 4 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113.I. Since the structure and functionality of naturally-occurring thaumatin isolated from Thaumatococcus daniellii is the same as the structure and functionality of thaumatin not isolated Thaumatococcus daniellii, the thaumatin of Galindo renders the claimed thaumatin obvious.
Regarding claim 10, Galindo teaches the invention as described above in claim 1, including the composition may contain thaumatin, gymnemic acid, and brazzein [0009], [0018]. Gymnemic acid is not a protein at all and thus, is not a protein originating from organisms belonging to either the Thaumatococcus or Pentadiplandra genus. Therefore, the composition contains 0 wt.% of any proteins originating from organisms belonging to either the Thaumatococcus or Pentadiplandra genus excluding thaumatin or brazzein as presently claimed.
Claims 3 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Galindo (US 2013/0183427; IDS citation) as applied to claim 1 above, in view of Prakash (WO 2020/205978; previously cited).
Regarding claims 3, 22, and 23, Galindo teaches the invention as described above in claim 1, including that the sweetener composition comprises thaumatin and brazzein [0009], [0017]-[0018]. Galindo also teaches that the thaumatin may be thaumatin I or thaumatin II [0005] as recited in present claims 3, 22, and 23.
Galindo does not teach that the brazzein is type 3 brazzein as recited in present claims 3 and 23.
However, Prakash teaches a sweetener composition comprising brazzein (page 2, lines 1-3). Prakash teaches that the composition may further comprise thaumatin (page 20, lines 28-29; page 21, lines 14-19). Prakash teaches that the brazzein may be type 3 brazzein (corresponding to the minor form of wild-type brazzein) or type 1 brazzein (corresponding to a naturally-occurring variant of the minor form brazzein being the major form of brazzein) (page 11, line 26- page 12, line 3).
It would have been obvious for a person of ordinary skill in the art to have modified the brazzein of Galindo to be type 3 brazzein as taught by Prakash. Since Galindo teaches that the sweetener composition comprises thaumatin and brazzein [0009], [0017]-[0018], but does not disclose a type of brazzein to include in a sweetener composition comprising thaumatin and brazzein, a skilled practitioner would have been motivated to consult an additional reference such as Prakash to determine a suitable type of brazzein, thereby rendering the claimed type 3 brazzein obvious.
Response to Arguments
Objections to Drawings: Applicant provided replacement drawings which fully address the objection. Therefore, the objection is withdrawn.
Claim Objections: Applicant amended claims 2-4, 7-8, and 10 to fully address the objections. Therefore, the objections are withdrawn.
Claim Rejections – 35 U.S.C. §112(b) of claims 3 and 6-9: Applicant amended claims 3 and 6-9 to fully address the rejections. Therefore, the rejections are withdrawn.
Claim Rejections – 35 U.S.C. §103 of claims 1-2 and 4-10 over Galindo: Applicant’s arguments have been fully considered and are considered unpersuasive.
Applicant argued that a skilled practitioner would not have understood that the disclosure of Galindo discloses a sweetener composition comprising 0.5-500 ppm gymnemic acid, 0.06-83 ppm thaumatin, and up to 999,917 ppm of brazzein. Applicant argued that claim 16 of Galindo discloses a multitude of sweeteners that may be added to the composition comprising gymnemic acid and thaumatin, wherein the multitude of sweeteners includes brazzein. Applicant argued that Galindo does not disclose any actual examples using any of the multitude of further sweeteners, let alone any examples comprising thaumatin and brazzein. Applicant stated that while Galindo discloses that, while the composition of Galindo may contain 583 ppm of a combined content of thaumatin and gymnemic acid, the assumption that the remaining 999,917 ppm of the composition comprises other ingredients such as brazzein is inaccurate and would not have been done by a skilled practitioner since a skilled practitioner would have been more likely to consider diluents, carbohydrate sweeteners, or natural sweeteners other than brazzein as comprising the balance of the composition (Applicant’s Remarks, page 10, 1st paragraph under the heading “The Rejections of the Claims Under 35 U.S.C. § 103 Should Be Withdrawn” - page 12, 2nd paragraph; page 13, 4th paragraph – page 14, 1st paragraph).
However, a skilled practitioner prior to the time of filing of the present application would have been able to determine that the composition of Galindo may comprise up to 999,417 ppm (the 999,917 ppm written in the previous Office Action is the result of a typo) of other ingredients since arriving at such a number merely involves math which existed prior to the filing of the present invention. The term “ppm” means parts per million so that in using the term “ppm” to describe the make-up of the composition, Galindo discloses that the weight of the composition is divided into one million parts. Of those one million parts, Galindo discloses that 0.5-500 of the one million parts are made up of gymnemic acid [0015]. Galindo also discloses that composition further comprises thaumatin and that the ratio of gymnemic acid to thaumatin in the composition is 6-8 parts gymnemic acid to 1 part thaumatin [0012]. From these disclosures, Galindo suggests that the concentration of thaumatin in the composition may be from 0.06 ppm to 83 ppm. The combined weight of thaumatin and gymnemic acid comprises 0.56-583 ppm of the composition of Galindo. Since the composition of Galindo necessarily comprises one million parts and Galindo discloses that gymnemic acid and thaumatin comprise 0.56-583 of those one million parts, the composition of Galindo necessarily requires at least an additional 999,417 parts in order to meet the required one million parts. Therefore, the composition of Galindo requires at least one additional ingredient.
In disclosing brazzein as being a further component of the composition in [0017]-[0018], Galindo at least suggests that the remainder of the composition may comprise wholly or partly of brazzein. As such, the composition may comprise brazzein in an amount of 999,417 parts if brazzein is the only further component of the composition containing thaumatin and gymnemic acid; or the composition may comprise brazzein in an amount of less than 999,417 parts if brazzein is not the only further component of the composition. Furthermore, the present claims merely require the amount of thaumatin and brazzein to be based on the combined weight of thaumatin and brazzein only, not based on the weight of the entire composition. Therefore, a skilled practitioner does not need for the entire 999,417 parts of the composition of Galindo to comprise solely of brazzein. For example, the composition of Galindo may contain 10 ppm gymnemic acid, 50 ppm thaumatin, 500 ppm brazzein, and 999,440 ppm of other ingredients, thereby providing a composition comprising 91 wt.% brazzein and 9 wt.% thaumatin based on the combined weight of brazzein and thaumatin, which falls within the concentration recited in present claim 1.
In response to Applicant’s assertion that Galindo does not disclose any actual examples using any of the multitude of further sweeteners, let alone any examples comprising thaumatin and brazzein, “[d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).” MPEP 2123.II. Galindo broadly discloses brazzein as being an ingredient that may be present in the composition. Therefore, Galindo does not teach away from including brazzein in the composition.
In response to Applicant’s assertions that a skilled practitioner would have been more likely to consider diluents, carbohydrate sweeteners, or natural sweeteners other than brazzein as comprising the balance of the composition, Applicant has not provided any reasoning as to why this would be the case, especially wherein Galindo expressly states that the composition may comprise brazzein.
Applicant then argued that the present invention relates to a low-calorie sweetener composition having good organoleptic properties characterized by a particular ratio of thaumatin and brazzein. Applicant argued that the present invention demonstrates in Examples 1 and 3-4 of the present specification surprising and unexpected technical effects of no lingering aftertaste and synergistic sweetness that was not derivable for a skilled practitioner prior to the time of filing (Applicant’s Remarks, page 12, 3rd paragraph – page 13, 3rd paragraph; page 14, 2nd -3rd paragraphs).
However, the Examiner points out that the Examples of the present specification only tested compositions containing 18.9 wt.% thaumatin and 81.1 wt.% brazzein based on the combined weight of thaumatin and brazzein, which is only one value within the claimed ranges of thaumatin and brazzein in present claim 1 and outside of the ranges recited in present claims 5-9. “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range.” MPEP §716.02(d). The asserted unexpected results are not shown to occur over the entire claimed range recited in present claim 1 or shown to occur at any point of the ranges recited in present claims 5-9. As such, the asserted unexpected results are not commensurate in scope with the claimed invention.
Applicant then argued that Galindo teaches gymnemic acid as a necessary component to avoid lingering aftertaste when using thaumatin as a sweetener so that a skilled practitioner consulting Galindo would have always added gymnemic acid to the composition (Applicant’s Remarks, page 14, 4th paragraph – page 15, 3rd paragraph).
However, the present claims do not exclude any ingredients from the composition so that the inclusion of gymnemic acid in a composition as disclosed by Galindo is permissible.
Since the prior art has been shown to render the present claims obvious and Applicant’s arguments have been shown to be unpersuasive, the rejections of the claims are maintained as written herein.
Claim Rejections – 35 U.S.C. §103 of claim 3 over Galindo and Prakash: Applicant’s arguments have been fully considered and are considered unpersuasive.
Applicant argued that Prakash does teach the surprising and unexpected technical effects of no lingering aftertaste and synergistic sweetness of compositions comprising thaumatin and brazzein in the ratio of claim 1 (Applicant’s Remarks, page 15, 4th paragraph – page 16, 3rd paragraph).
However, the Examiner points out that the Examples of the present specification only tested compositions containing 18.9 wt.% thaumatin and 81.1 wt.% brazzein based on the combined weight of thaumatin and brazzein, which is only one value within the claimed ranges of thaumatin and brazzein in present claim 1, from which claim 3 depends. “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range.” MPEP §716.02(d). The asserted unexpected results are not shown to occur over the entire claimed range recited in present claim 1. As such, the asserted unexpected results are not commensurate in scope with the claimed invention.
Since the prior art has been shown to render the present claims obvious and Applicant’s arguments have been shown to be unpersuasive, the rejections of the claims are maintained as written herein.
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 Kelly Kershaw whose telephone number is (571)272-2847. The examiner can normally be reached Monday - Thursday 9:00 am - 4:00 pm.
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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.
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/K.P.K./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
