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 .
Applicants’ amendment to the claims filed on 4/16/2024 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 25-44 are pending.
Claims 1-24 are canceled.
Priority
Acknowledgement is made of this national stage entry of PCT/KR2022/015809 filed on 10/18/2022, which claims foreign priority to Republic of Korea application KR10-2021-0139473, filed on 10/19/2021. The certified copy has been filed in the present application on 4/16/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/16/2024, 11/20/2024, 11/21/2024, 12/2/2024, 5/20/2025, 12/5/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The Drawings filed on 4/16/2024 are acknowledged and accepted by the Examiner.
Claim Rejections - 35 USC § 112(b)
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 31, 40, 44 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 claims 31, 40, 44, the phrase " is further prepared" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. It is unclear what steps Applicant is claiming to represent the phrase “in further prepared.” It is not clear if the items/phrases followed by this phrase are to be considered as claim limitations. How are rebaudioside D (claim 31); rebaudioside M (claims 40, 44) further prepared? Appropriate correction is suggested. See MPEP § 2173.05(d). Appropriate correction is suggested.
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 25-27, 29-32, 34-37, 39-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al (2018, Food Chemistry, Examiner cited) {herein Chen}.
Claims 25-27, 29-32 are drawn to a method for preparing rebaudioside D, comprising: reacting rebaudioside A and sucrose synthase and uridine diphosphate (UDP)- glycosyltransferase B (UGT-B) with (i) nucleotide diphosphate to which glucose is bonded, or (ii) sucrose and nucleotide diphosphate in situ to prepare rebaudioside D.
Claims 34-37, 39-42 are drawn to a method for preparing rebaudioside M, comprising: preparing rebaudioside D in accordance with the method of claim 25; and reacting the rebaudioside D with nucleotide diphosphate to which glucose is bonded in the presence of uridine diphosphate (UDP)-glycosyltransferase A (UGT-A) to prepare rebaudioside M.
Claims 43-44 are drawn to a method for preparing rebaudioside M from rebaudioside A, comprising: reacting sucrose, nucleotide diphosphate, rebaudioside A, rebaudioside D, sucrose synthase, uridine diphosphate (UDP)-glycosyltransferase A (UGT-A) and uridine diphosphate (UDP)-glycosyltransferase B (UGT-B) in situ to prepare rebaudioside M.
With respect to claims 25-27, 29-32, 34-37, 39-40, 42-44, Chen teaches a method for preparing rebaudioside D by reacting rebaudioside A, sucrose synthase, uridine diphosphate with glucose bound, sucrose, and nucleoside diphosphate (page 286, column 1, para 1; page 286, column 2, para 1; page 287, column 1, para 1-2; column 2, para 3). The rebaudioside A is synthesized from stevioside (page 288, column 2, para 2). Glycosyltransferase uridine diphosphate glucose (UDP-glucose), of which class uridine diphosphate (UDP)- glycosyltransferase B (UGT-B) and uridine diphosphate (UDP)-glycosyltransferase A belong, catalyzes the bioconversion of rebaudioside A to rebaudioside D (page 287, column 1, para 1). Absent evidence otherwise, it is the Examiner’s position that glycosyltransferase uridine diphosphate glucose (UDP-glucose) necessarily contains the UGT-A (Instant Application SEQ ID NO: 4) and UGT-B (Instant Application SEQ ID NO: 2) since both UGT-A and UGT-B are from Stevia rebaudiana within the UDP-glucose class taught by Chen (page 286, column 2, para 2; page 287, column 1, para 1). Chen further teaches the UDP-glucose is regenerated in situ (page 286). It is the Examiner’s position that said method is performed consecutively in situ since Applicant’s definition of ‘consecutively in situ’ is ‘in situ’ (instant application specification page 14, para 5). Chen further teaches rebaudioside M2, which is an isomer of rebaudioside M, is produced from rebaudioside D (page 288, column 1, para 1). Extending the reaction time generated rebaudioside M2 from further glycosylation of rebaudioside D (abstract).
For the reasons stated herein, the teachings of Chen anticipate claims 25-27, 29-32, 34-37, 39-44.
Claims 25-27, 33, 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ‘302A (CN112760302A, Date of Publication: 2021-05-07, cited on IDS dated 5/20/2025) {herein ‘302A}.
Claims 25-27 are drawn to a method for preparing rebaudioside D, comprising: reacting rebaudioside A and sucrose synthase and uridine diphosphate (UDP)- glycosyltransferase B (UGT-B) with (i) nucleotide diphosphate to which glucose is bonded, or (ii) sucrose and nucleotide diphosphate in situ to prepare rebaudioside D.
Claim 33 is drawn to the method of claim 25, wherein the UGT-B comprises at least one selected from the group consisting of SEQ ID NO: 1 to 3.
Claim 36 is drawn to the method of claim 34, wherein the nucleotide diphosphate to which glucose is bonded is prepared by reacting sucrose and nucleotide diphosphate in the presence of a sucrose synthase.
With respect to claims 25-27, 33, 36, ‘302A teaches a method wherein rebaudioside A, sucrose synthase, sucrose substrate, UDP combined with glucose are combined to form rebaudioside D (page 3, para 10-11). Said method also consists of a glycosyltransferase StUGT capable of catalyzing rebaudioside A to rebaudioside D (page 2, para 1). Said StUGT (SEQ ID NO: 2) is 100% identical to the instant application SEQ ID NO: 1 (appendix A).
For the reasons stated herein, the teachings of ‘302A anticipates claims 25-27, 33, 36.
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.
Claims 28, 38 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (2018, Food Chemistry, Examiner cited) {herein Chen}.
Claim 28 is drawn to the method of claim 27, wherein the sucrose synthase comprises the amino acid sequence of SEQ ID NO: 5.
Claim 38 is drawn to the method of claim 34, wherein the sucrose synthase comprises the amino acid sequence of SEQ ID NO: 5.
With respect to claims 28, 38, Chen teaches a method for preparing rebaudioside D using sucrose synthase (page 286, column 1, para 1; page 286, column 2, para 1; page 287, column 1, para 1-2; column 2, para 3). Said sucrose synthase is derived from Solanum tuberosum (potatoe) (abstract). It would be obvious to one of ordinary skill in that art to substitute the sucrose synthase from Solanum tuberosum (potato) for the sucrose synthase from Oruza sativa (rice) (instant application SEQ ID NO: 5) as rice has a longer shelf-life and is easier to store, due to its smaller size. As such, purifying the sycrose synthase from the rice, compared to the potato would be more cost and time effective. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 25-30, 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. US 10,472,660 B2 which are commonly owned and have common inventors and filed before the instant application. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to a method for preparing rebaudioside A from stevioside, comprising performing in a single reaction system the following two reactions: (1) reacting sucrose and nucleotide diphosphate in the presence of a sucrose synthase to prepare nucleotide diphosphate to which glucose is bonded, and (2) reacting the nucleotide diphosphate to which glucose is bonded with stevioside in the presence of a glycosyltransferase to prepare rebaudioside A, wherein the sucrose synthase comprises the sequence of SEQ ID NO:3, wherein the glycosyltransferase comprises the sequence of SEQ ID NO: 4, and wherein the reaction system pH is in the range of pH 5.5 to 11.0 which is not patentably distinct from the instant application claims 25-30, 32 as SEQ ID NO: 3 of ‘660 is 100% identical to the instant application SEQ ID NO: 3 (appendix B) and SEQ ID NO: 4 of ‘660 is 100% identical to the instant application SEQ ID NO: 4 (appendix C).
Conclusion
Status of Claims
Claims 25-44 are pending.
Claims 1-24 are canceled.
Claims 25-44 are rejected
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Appendix A
Instant Application SEQ ID NO: 1 vs ‘302A SEQ ID NO: 2 (Result No. 1 from STIC .rag)
Query Match 100.0%; Score 2327; Length 441;
Best Local Similarity 100.0%;
Matches 441; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MATLRVLMFPWLAYGHISPFLNIAKQLADRGFLIYLCSTLINLESIIKKIPEKYSESIRF 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MATLRVLMFPWLAYGHISPFLNIAKQLADRGFLIYLCSTLINLESIIKKIPEKYSESIRF 60
Qy 61 VELHLPELPELPPHYHTTNGLPPHLNHTLHKALKMSKPNFSKILQNLKPDLVIYDILQPW 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VELHLPELPELPPHYHTTNGLPPHLNHTLHKALKMSKPNFSKILQNLKPDLVIYDILQPW 120
Qy 121 AEHVVNEQNIPAVKILTSGAALFSYFFNFLKNPGVEFPFPAIYLPKVEQVKMREMFEKEP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 AEHVVNEQNIPAVKILTSGAALFSYFFNFLKNPGVEFPFPAIYLPKVEQVKMREMFEKEP 180
Qy 181 NEEDRLAEGNMQIMLMCTSRTIEAKYLDYCTELSNWKVVPVGPPFQDPITNDVDDMELID 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 NEEDRLAEGNMQIMLMCTSRTIEAKYLDYCTELSNWKVVPVGPPFQDPITNDVDDMELID 240
Qy 241 WLGTKDENSTVFVCFGSEYFLSREDMEEVAFGLELSNVNFIWVARFPKGEEQNLEDVLPK 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 WLGTKDENSTVFVCFGSEYFLSREDMEEVAFGLELSNVNFIWVARFPKGEEQNLEDVLPK 300
Qy 301 GFLERIGERGRVLDKFAPQPRILNHPSTGGFISHCGWNSVMESLDFGVPIIAMPMHNDQP 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 GFLERIGERGRVLDKFAPQPRILNHPSTGGFISHCGWNSVMESLDFGVPIIAMPMHNDQP 360
Qy 361 INAKLIVELGVAMEIVRDDDGNIHRGEITETLKDVITGETGEILRGKVRDISKNLKSIRE 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 INAKLIVELGVAMEIVRDDDGNIHRGEITETLKDVITGETGEILRGKVRDISKNLKSIRE 420
Qy 421 EEMNAAAEELIQLCRNSNKYK 441
|||||||||||||||||||||
Db 421 EEMNAAAEELIQLCRNSNKYK 441
Appendix B
Instant Application SEQ ID NO: 5 vs ‘962 SEQ ID NO: 3 (alignment using ABSS)
PNG
media_image1.png
838
572
media_image1.png
Greyscale
Appendix C
Instant Application SEQ ID NO: 4 vs ‘962 SEQ ID NO: 4 (alignment using ABSS)
PNG
media_image2.png
510
589
media_image2.png
Greyscale
Prosecution Insights