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 .
The amendment and response filed on February 18, 2026 are received.
Claims 66, 109, 111, 1177, 123, 126, 145, 146, 157, 173, 185-187, 196, 197, 201-203, 205 and 207 are canceled.
New claims 230-238 are added.
Claims 1, 2, 5, 25, 34, and 230-238 are pending and are being examined.
Restriction/Election:
Applicant’s election without traverse of, Group I, claims 1, 2, 5, 25, 34, and 230-238, in the reply filed on 02/18/2026 is acknowledged.
Claims 66, 109, 111, 1177, 123, 126, 145, 146, 157, 173, 185-187, 196, 197, 201-203, 205 and 207, are canceled in the same reply.
Election was made without traverse in the reply filed on 02/18/2026.
Objection(s):
a)
Claim 230 is objected to because of the following informalities:
In claim 230, provide the complete form of “RebM”.
Appropriate correction is required.
b)
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
In new claim 236, provide proper antecedent basis “vessels”.
Claim Rejection - 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.
Claim 231 is 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 231 recites the limitation "biomass" in claim 1. There is insufficient antecedent basis for this limitation in the claim. Because claim 231 does not recite biomass or biomass removal.
Suggestion to obviate the rejection: provide antecedent basis.
Claim Rejection - 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 1, 2, 5, 25, 34 and 230 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mao et al. (U.S. patent No. 10,752,928) as evidenced by SEQ search results (2 Pages of PDF).
Regarding claim 1, Mao et al. disclose a method for preparing a glycosylated product, comprising: providing a bacterial cell expressing one or more recombinant UDP-dependent glycosyltransferase (UGT) enzymes, the bacterial cell having: a recombinant sucrose synthase enzyme expression, and one or more genetic modifications that increase availability of UDP-sugar; culturing the bacterial cell in the presence of a substrate for glycosylation; and recovering the glycosylated product (Method of Producing Rebaudioside M, the method include culturing a whole-cell catalyst with a culture medium including a stevioside substrate for a sufficient time to produce rebaudioside M, the whole-cell catalyst is a transformed host cell expressing an amount of UDP-glycosyltransferase (UGT76G1) and an amount of sucrose synthase (mbSUS1) and a sucrose synthase (SUS), the one whole-cell catalyst is a transformed host cell that includes at least one nucleotide sequence encoding at least one enzyme including, but not limited to, a uridine diposphoglycosyltransferase (UDP-glycosyltransferase, and separating the steviol glycoside compound from cell culture) (See for example, column 13, lines 58-67- Continued on column 14 lines 1-5, column 12 lines 46-55, column 13 lines 12-43, and column 37 lines 8-12).
Regarding claim 2, Mao et al. disclose the bacterial cell is Escherichia spp., Bacillus spp., Rhodobacter spp., Zymomonas spp., or Pseudomonas spp. (bacteria of species, Bacillus, Pseudomonas, and Rhodobacter) (See for example, column 25 lines 53-55, 58 and 60).
Regarding claim 5, Mao et al. disclose the bacterial cell expresses a recombinant sucrose synthase enzyme comprising an amino acid sequence that has at least about 70% sequence identity with one of SEQ ID NOS: 1 to 12 (See sequence search results No. 1, showing 100% sequence identity to SEQ ID NO: 1).
Regarding claim 25, Mao et al. disclose the substrates for glycosylation are provided as a plant extract or fraction thereof, or are produced synthetically or by a biosynthesis process (extracts from Stevia rebaudiana plant) (See for example, column 11 lines 39-41).
Regarding claim 34, Mao et al. disclose the substrate is provided as a stevia leaf extract or fraction thereof (extracts from Stevia rebaudiana plant) (See for example, column 11 lines 39-41).
Regarding claim 230, Mao et al. disclose the glycosylated product comprises RebM (glycosylated product Rebaudioside M) (See for example, column 13 lines 59-61).
Mao et al. therefore anticipate the claimed method for preparing a glycosylated product.
Claim Rejection - 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.
Claims 1, 2, 5, 25, 34, and 230-238 are rejected under 35 U.S.C. 103 as being unpatentable over Mao et al. (U.S. Patent No. 10,752,928) as evidenced by SEQ search results (2 Pages of PDF) as applied to claims 1, 2, 5, 25, 34 and 230 above, further in view of Prakash et al. (U.S. Patent No. 9,169,285) and Weymarn et al. (Process. Biotechnol Progress, 2003, Vol. 19, p. 815-821).
The teachings of Mao et al. with respect to the teachings of claims 1, 2, 5, 25, 34 and 230 were discussed above.
Mao et al. do no teach recovering the glycosylated product comprises: lowering the pH of the culture to below about pH 5 or raising the pH of the reaction or culture to above about pH 9, raising the temperature to at least about 50 °C; followed by biomass removal (claim 231), wherein the pH is adjusted to a pH within the range of about 2 and about 4 (claim 232), wherein the temperature is adjusted to a temperature between about 50°C and about 90°C (claim 233), temperature adjustment takes place by transfer of the culture to pre-heated harvest tanks (claim 234), biomass is removed by centrifugation, thereby preparing a clarified broth (claim 235), wherein the clarified broth is transferred directly or indirectly to one or more crystallization vessels (claim 236), prior to crystallization, glycoside products are purified by tangential flow filtration (TFF) (claim 237), and at least two crystallization steps are employed (claim 238).
However, regarding claim 231, Prakash et al. teach the recovering a glycosylated product from a preparation of solution of steviol glycosides comprises lowering the pH to below about pH 5 or raising the pH of the reaction or culture to above about pH 9, raising the temperature to at least about 50 °C (separation of steviol glycoside from a preparation of solution of steviol glycosides, at a temperature of about 5-80°C, and pH from about 6.0 to about 7.0) (See for example, column 3 lines 52-55, column 11 lines 25-34, column 14 lines 62-65, column 20 lines 23-25, column 16 lines 35-47).
Regarding claim 232, Prakash et al. teach the pH is adjusted to a pH within the range of about 2 and about 4 (pH is about 2 to about 5) (See claim 7 for example).
Regarding claim 233, Prakash et al. teach the temperature is adjusted to a temperature between about 50°C and about 90°C (at a temperature range of about 5-80°C, which is overlapping) (See for example, column 16 lines 6-9).
Regarding claim 238, Prakash et al. teach at least two crystallization steps are employed (purification by inducing crystallization, and cycle cab be repeated two times, etc.) (See for example, column 19 lines 29-35 column 20 lines 3-23).
Moreover, regarding claims 234-237, before the effective filing date of invention, Weymarn et al. teach downstream processing techniques including centrifugation to remove biomass and preparing a clarified broth and purification of a product from a culture (See for example, paragraph 2.4.), the clarified broth is transferred directly or indirectly to one or more crystallization vessels (transfer to crystallizer, etc.) (See for example, p. 818 left-hand column 2nd paragraph), and glycoside products are purified by tangential flow filtration (TFF) prior to crystallization (See for example, p. 817 left-hand column paragraph 2.2., p. 818 right-hand column paragraph 3.1.).
Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been capable of applying downstream processing techniques of recovering glycosylated product taught by the prior art (combined teachings of Prakash et al. and Weymarn et al.) to further purify the glycosylated product prepared and recovered according to the method taught by Mao et al. with a reasonable expectation of success in recovering the glycosylated product by lowering the pH of the culture to below about pH 5 or raising the pH of the reaction or culture to above about pH 9, raising the temperature to at least about 50 °C; followed by biomass removal, the pH is adjusted to a pH within the range of about 2 and about 4, the temperature is adjusted to a temperature between about 50°C and about 90°C, the temperature adjustment takes place by transfer of the culture to pre-heated harvest tanks, biomass is removed by centrifugation, thereby preparing a clarified broth, the clarified broth is transferred directly or indirectly to one or more crystallization vessels, prior to crystallization, glycoside products are purified by tangential flow filtration (TFF). Because Prakash et al. teach the recovering a glycosylated product from a preparation of solution of steviol glycosides comprises lowering the pH to below about pH 5 or raising the pH of the reaction or culture to above about pH 9, raising the temperature to at least about 50 °C, the pH is adjusted to a pH within the range of about 2 and about 4, the temperature is adjusted to a temperature between about 50°C and about 90°C, and at least two crystallization steps are employed. In addition, the temperature adjustment (claim 234), would have been obvious, the motivation for example, would be because of the heating capacity of the culturing vessel.
Conclusion(s):
No claim(s) is allowed at this time.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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