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 .
Receipt is acknowledged of the Request for Continued Examination (RCE) under 1.114, the Amendment and Response, all filed 2/23/26.
Claims 1, 2, 10, 11, 14, 15, and 17-24 are pending and have been examined on the merits. Claims 3-9, 12, 13, and 16 were previously cancelled.
Withdrawn Rejections
The 103(a) rejections of claims 1, 2, 10, 11, 14, 15, 17, 18, and 20-23 over Markosyan et al. (US 2014/0030381) have been withdrawn due to the amendment to claim 1.
The 103(a) rejection of claim 19 over Markosyan et al. (US 2014/0030381) and in further view of Markosyan et al. (US 2013/0287894) “Mark II” and (US 2013/0287894) has been withdrawn due to the amendment to the claim 1.
The 103(a) rejection of claim 24 over Markosyan et al. (US 2014/0030381) and in further view of Katta et al. (US 2010/0330257) has been withdrawn due to the amendment to the claim 1.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/23/26 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 14/254,653, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The new limitation of the increase in water solubility is not recited in parent application. However, provisional application 62/114,134 discloses an increase in water solubility. Therefore regarding the limitation the priority date is 2/10/15.
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 1, 2, 10, 11, 14, 15, and 17-24 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.
The recitation of step a. in claim 1 is confusing. It seems to indicate that step a. either requires rebaudioside M or a mixture of rebaudioside M, and rebaudioside D, starch, α-amylase, and cyclomaltodextrin glucanotransferase (CGTase), However, if rebaudioside M (reb M) is provided alone, subsequent steps of providing glucosylated rebaudioside M derivative, and separation of amylase and CGTase cannot take place because step a. does not necessarily require the inclusion of the starch and enzymes with reb M, since as recited reb M as the only ingredient in the starting composition. The claim should be rewritten to recite providing a starting composition comprising rebaudioside M, starch, α-amylase, and cyclomaltodextrin glucanotransferase (CGTase) or a mixture of rebaudioside M, and rebaudioside D, starch, α-amylase, and cyclomaltodextrin glucanotransferase (CGTase). Claims 2, 10, 11, 14, 15, 17-24 are rejected based on their dependency upon claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 10, 11, 14, 15, 17, 18, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Markosyan et al. (US 2014/0030381) in view of Wang et al. Molecules August 2014 “Cucurbitane Glycosides Dervied from Mogroside IIE:…”.
Regarding Claim 1: Markosyan discloses a method of making glucosyl stevia/glucosyl stevioside compositions having greater than 95% purity [abstract]. Markosyan discloses using starch and steviol glycosides such as Reb X (Reb M) as starting materials [0023; 0025; 0036]. Markosyan discloses subjecting the Reb X to enzymatic transglucosylation via cyclodextrin glycosyltransferase (CGTase) in the presence of starch, resulting in the formation of α-1, 4-glucosyl derivatives [0026]. Markosyan discloses additionally treating the α-1, 4-glucosyl derivatives with β-amylase or other enzymes to form α-1, 4-glucosyl derivatives with a desired degree of polymerization [0026; 0039]. Markosyan discloses that the additional enzyme can be an amylase (interpreted as α-amylase) [0054; claim 2]. Markosyan discloses inactivating the enzymes which is equivalent to removal of the enzymes, and discloses ion exchange and membrane filtration [0059]. Markosyan discloses further treating with glucoamylase and incubating at 5-125°C [0053; 0054].
Markosyan does not explicitly speak to the water solubility of the α-1, 4-glucosyl derivatives obtained after treatment of rebaudioside with CGTase and amylase.
Wang discloses CGTase as a versatile enzyme and discloses its ability to improve the taste and water solubility of stevioside and rebaudioside [pg. 12678; 2.1.].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art that CGTase treated steviosides of Markosyan would have had an increase in solubility since Wang discloses the increase in water solubility and improvement in taste following treatment of rebaudioside with CGTase.
Regarding Claim 2: Markosyan as modified discloses as discussed above in claim 1. Markosyan also discloses purification methods via desalting, or decolorizing using activated carbon or membrane filtration [0021].
Regarding Claims 10 and 11: Markosyan as modified discloses as discussed above in claim 1. Markosyan discloses an enzyme which is a biocatalyst [abstract].
Regarding Claim 14: Markosyan discloses as discussed above in claim 1. Markosyan discloses a flavor composition which can comprise orange, fruity, banana, grape, pear, pineapple, bitter almond, cola, cinnamon, sugar, cotton candy, and vanilla flavors [0063].
Regarding Claim 15: Markosyan discloses as discussed above in claim 1 and further discloses food ingredients including flavors, acidulants, organic and amino acids, coloring agents, bulking agents, modified starches, gums, texturizers, preservatives, antioxidants, emulsifiers, stabilizers, thickeners, gelling agents [0064].
Regarding Claims 17 and 18: Markosyan discloses a Reb M composition and discloses including in cosmetics and pharmaceuticals [abstract].
Further regarding the process steps of claim 1, since there is no evidence that the recited process produces a product that is materially different from what is disclosed in the prior art, claim 17 and 18 have been considered regarding its disclosure of a cosmetic and a pharmaceutical comprising a Reb M composition.
“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 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 art was made by a different process.” In re Thorpe, 777 F.2d 695, 698.
Regarding Claim 20: Markosyan discloses as discussed above in claim 19. Markosyan discloses a flavor composition which can comprise orange, fruity, banana, grape, pear, pineapple, bitter almond, cola, cinnamon, sugar, cotton candy, and vanilla flavors [0063].
Further regarding the process steps of claim 1, since there is no evidence that the recited process produces a product that is materially different from what is disclosed in the prior art, claim 20 has been considered regarding its disclosure of a cosmetic and a pharmaceutical comprising a Reb M composition.
“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 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 art was made by a different process.” In re Thorpe, 777 F.2d 695, 698.
Regarding Claims 21 and 22: Markosyan discloses a Reb M composition and discloses including in cosmetics and pharmaceuticals [abstract].
Further regarding the process steps of claim 1, since there is no evidence that the recited process produces a product that is materially different from what is disclosed in the prior art, claim 21 and 22 have been considered regarding its disclosure of a cosmetic and a pharmaceutical comprising a Reb M composition.
“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 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 art was made by a different process.” In re Thorpe, 777 F.2d 695, 698.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Markosyan et al. (US 2014/0030381) and Wang et al. Molecules August 2014 “Cucurbitane Glycosides Dervied from Mogroside IIE:…” as applied to claim 1 above and in further view of Markosyan et al. (US 2013/0287894) “Mark II” and (US 2013/0287894).
Regarding Claim 19: Markosyan discloses as discussed in claim 1. Markosyan also discloses the formation of crystals and further drying the crystals [0055]. Markosyan discloses purifying to >95% [abstract].
Mark II discloses additionally treating the glucosyl Reb composition with an enzyme that is hydrolytic and can be glucoamylase. Mark II discloses crystallizing [0078]. Mark II discloses compositions with 97% purity [Ex. 1].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Markosyan to include treating to increase the level of purity as in Mark II in order to achieve a Rebaudioside of higher purity.
Although Markosyan and Mark II do not explicitly disclose a purity of 99% one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by the references overlap the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Markosyan et al. (US 2014/0030381) and Wang et al. Molecules August 2014 “Cucurbitane Glycosides Dervied from Mogroside IIE:…” as applied to claim 1 above and in further view of Katta et al. (US 2010/0330257).
Regarding Claim 24: Markosyan discloses discussed above in claim 1. Markosyan does not explicitly disclose treating at between 50 to 70°C.
Katta discloses treating a liquified starch with glucoamylase at 55°C [0035; 0043].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Markosyan to include the glucoamylase treatment step at 55°C as in Katta in order to provide temperature at which the enzyme can be active.
Response to Arguments
The 103(a) rejections of claims 1, 2, 10, 11, 14, 15, 17, 18, and 20-23 over Markosyan et al. (US 2014/0030381) have been withdrawn due to the amendment to claim 1.
The 103(a) rejection of claim 19 over Markosyan et al. (US 2014/0030381) and in further view of Markosyan et al. (US 2013/0287894) “Mark II” and (US 2013/0287894) has been withdrawn due to the amendment to the claim 1.
The 103(a) rejection of claim 24 over Markosyan et al. (US 2014/0030381) and in further view of Katta et al. (US 2010/0330257) has been withdrawn due to the amendment to the claim 1.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Prakash et al. (Feb 2014 Foods vol 3 pages 162-175) “Development of Next Generation Stevia Sweetener Rebaudioside M” discloses Reb M as suitable as a natural non-caloric sweetener [abstract; Intro]. Prakash discloses Reb M as slightly soluble in water and ethanol [pg. 165 2.2].
Leemhuis et al. “Engineering of cyclodextrin glucanotransferases and the impact for biotechnological applications” Applied Microbiology Biotechnology 2010 vol. 85 pages 823-835, Leemhuis discloses cyclodextrin glucanotransferases as useful in the food industry, in the glycosylation of stevioside for the reduction of bitter taste and further discloses that it may increase the water solubility of steviosides [abstract; pg. 830. 1st full paragraph].
Miyake (US 4,219,571) Miyake discloses a method of making a sweetener from steviosides [abstract]. Miyake discloses that steviosides generally have low water solubility [col. 2, lines 1-11]. Miyake discloses subjecting steviosides and starch to enzymatic treatments with enzymes including CGTase [col. 2, lines 15-30; col. 4, lines 61-66]. Miyake discloses an increase in water solubility [col. 2, lines 32-37]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
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/Felicia C Turner/Primary Examiner, Art Unit 1793
