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 .
DETAILED ACTION
This application is a continuation of 16/799522 filed on 2/24/2020, which claims domestic benefit from US provisional application 62/059498 filed on 10/03/2014. Applicant’s amendments filed November 3, 2025 are acknowledged. Claims 1-28, 31-32, 36-37, and 42 are canceled, and claims 29-30, 35, 38, 40-41, and 43 are amended. Currently claims 29-30, 33-35, 38-41, and 43-48 are pending and under examination.
The previous objections to the specification and claims, and 112(b) rejection in the Non-Final office action mailed May 2, 2025 are withdrawn due to Applicant’s amendments to the specification and claims filed November 3, 2025.
Specification
(maintained) The abstract of the disclosure is objected to because Applicant did not correctly submit the abstract in proper form. The corrected abstract of the disclosure must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(maintained) Claims 29-30, 33, 38, and 43-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 29, 33, 38, and 43 recite a sucrose synthase is either fused to the HV1 or used in combination with HV1 in the reaction. The breadth of the claims broadly encompasses any type of sucrose synthase, such as isoforms, that are derived from many different groups of plants such as monocots, eudicots, and gymnosperms, as disclosed by Stein et al. (Frontiers in Plant Science, 2019, vol. 10, article 95, pgs. 1-14, cited in PTO-892 mailed 5/2/2025). The Specification defines suitable sucrose synthase as an Arabidopsis sucrose synthase 1; an Arabidopsis sucrose synthase 3; and a Vigna radiate sucrose synthase. A particularly suitable sucrose synthase domain can be, for example, Arabidopsis sucrose synthase 1, AtSUS1 having the amino acid sequence SEQ ID NO: 7, and are the only species whose complete structure is disclosed. While the genus encompasses a large number of variants that have the same activity as sucrose synthase enzymes in kind and the genus encompasses a large number of variants that have a different structure, the specification does not describe the complete structure of a representative number of species of the large genus of sucrose synthase enzyme variants/species/isoforms or functional equivalents thereof.
Next, then, it is determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics (i.e., other than nucleotide sequence or amino acid sequence), specific features and functional attributes that would distinguish different members of the claimed genus. In the instant case, the only other identifying characteristic of sucrose synthase is that it is a glycosyltransferase, and its systematic name of this enzyme class is NDP-glucose:D-fructose 2-alpha-D- glucosyltransferase, as well as known by other names such as: UDP glucose-fructose glucosyltransferase, sucrose synthetase, sucrose-UDP glucosyltransferase, sucrose- uridine diphosphate glucosyltransferase, and uridine diphosphoglucose-fructose glucosyltransferase. Additionally, the specification gives examples of use, such as it can be coupled with the UGT to generate UDP-glucose in Example 2, and also catalyzes the chemical reaction between NDP-glucose and D- fructose to produce NDP and sucrose. Such broad limitations cannot be an identifying characteristic for the claimed diverse genus of sucrose synthases (variants/species/isoforms) since by Applicant’s definition of a sucrose synthase or functional equivalent thereof, all members of the claimed genus will have that characteristic.
Applicant’s attention is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, "Written Description" Requirement (MPEP2163).
In conclusion, Applicant’s disclosure of the species of sucrose synthase of the claimed broad genus is not deemed sufficient to reasonably convey to one skilled in the art that Applicant was in possession of the claimed broad genus at the time the application was filed. Thus, it is concluded that the written description requirement is not satisfied for the claimed genus.
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.
(maintained) Claims 29-30 and 33-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7 of prior U.S. Patent No. 9908913. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claims 29-30, Claims 1 and 7 of ‘913 is drawn to a method of synthesizing rebaudioside E from rubusoside, the method comprising preparing a reaction mixture comprising rubusoside, substrates sucrose, UDP and/or UDP-glucose, and a HV1 UDP-glycosyltransferase according to SEQ ID NO: 5; incubating the reaction mixture to produce Reb E, wherein glucose covalently couples to rubusoside to produce Reb KA. The HV1 according to SEQ ID NO: 5 of ‘913 has 100% sequence identity to instant SEQ ID NO: 5. Furthermore, the reaction mixture in ‘913 comprises all of the limitations of the instant reaction mixture, wherein Reb KA would inherently be produced as a precursor to Reb E, thus anticipates the claims. Note also that the reaction mixture encompassed in instant claim 29 and patent claim 1 have a "comprising" limitation.
Regarding instant claims 33-34, claims 2-4 of ‘913 further include a sucrose synthase (SUS), specifically said SUS is Arabidopsis thaliana sucrose synthase I (AtSUS1), which clearly anticipates the claims.
Regarding instant claim 35, the claims of ‘913 do not recite the AtSUS1 has a particular amino acid sequence, however the patent discloses AtSUS1 is SEQ ID NO: 7, which has 100% sequence identity to the instant SEQ ID NO: 7 (col. 55, Table 2). Therefore, Atsus1 is defined in ‘913 as being SEQ ID NO:7 (col. 43, lines 46-49).
(maintained) Claims 44-46 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7 of U.S. Patent No. 9908913 in view of Richman et al. (The Plant Journal (2005) 41, pgs. 56–67, cited in PTO-892 mailed 5/2/2025).
As discussed above, claims 29-30 and 33-35 are anticipated by ‘913. The claims of ‘913 do not recite the reaction mixture is performed in vitro, nor that the HV1 is expressed in a host organism, such as E. coli. However Richman teaches expression of recombinant glycosyltransferases in E. coli hosts, wherein the enzyme is isolated and reacted to form rubusoside in vitro (pg. 65, col. 2, para 1; pg. 66, col. 1, para 1). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the method recited in ‘913 and conduct the reaction in vitro, as well as utilize a host cell, such as E. coli, for expression of the UGT as taught by Richman with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to utilize a host organism for efficient enzyme expression, and further use the enzyme in an in vitro reaction to produce the desired products as disclosed in Richman.
(maintained) Claims 29-30, 33-35, 45, and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-10, 12, and 20-25 of prior U.S. Patent No. 10752928 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claims 29-30, claims 7-10 and 12 of ‘928 recite a method of producing a steviol glycoside by incubating a whole cell catalyst composition outlined in claims 1-4, and 6 of ‘928 in a culture medium comprising a steviol glycoside substrate, sucrose, UDP and/or UDP-glucose for period such that said starting steviol glycoside substrate is converted to the desired steviol glycoside in the culture medium. Claims 20-23 of ‘928 recite the steviol glycoside substrate is rubusoside, and produces rebaudioside KA. Claim 1 of ‘928 recite a whole cell catalyst composition for production of a steviol glycoside comprising a nucleotide sequence encoding a HV1-GCW61 fusion protein wherein the nucleotide sequence is at least 80% identical to SEQ ID NO: 2. SEQ ID NO: 1 encoded by SEQ ID NO: 2 of ‘928 has 100% sequence identity to instant SEQ ID NO: 5. Therefore, the elements of the composition comprise the same limitations to be used in the instant methods.
Regarding instant claims 33-35, claims 1-4, 6-10 and 12 of ‘928 recites the whole-cell catalyst further comprises a nucleotide sequence encoding a sucrose synthase (SUS), wherein the SUS is AtSUS1 and is encoded by a nucleotide sequence SEQ ID NO: 12. SEQ ID NO: 11 encoded by SEQ ID NO: 12 of ‘928 has 84% sequence identity to instant SEQ ID NO: 7. Therefore, the elements of the composition comprise the same limitations to be used in the instant methods, and would be obvious variants of one another.
Regarding instant claims 45 and 47, claims 1, 4, 7, 12, and 25 of ‘928 recite the enzymes are expressed in a transformed Pichia pastoris, which is in essence a species of host organism and yeast cell, thus clearly anticipating these claims.
In conclusion, the claims of the instant application are directed to a method of making rebaudioside KA from rubusoside by the action of an UDP-glycosyltransferase selected from HV1 UDP-glycosyltransferase in the presence of sucrose to produce rebaudioside KA. The claimed methods are indistinguishable as both require the limitations set forth in the instant application, note the instant reaction mixtures encompassed in claim 29 has a "comprising" limitation. Therefore, instant claims 29-30, 33-35, 45, and 47 are clearly anticipated by ‘928.
Allowable Subject Matter
Claims 39-41 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Regarding the Double Patenting Rejections, Applicant requests these be deferred until allowable subject matter has been determined (Remarks p. 7). A request to defer a rejection is not a proper response to a rejection. Rather, a request to hold a
matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see 37 CFR 1.111(b) and MPEP §714.02). Thus, the double patenting rejections of record have been maintained as no response to these rejections has been filed by applicant at this time.
Conclusion
THIS ACTION IS MADE FINAL. 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 JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571) 272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657