DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16 March 2026 has been entered.
Status of Application
The amendments and response filed 16 March 2026 are acknowledged and have been considered in their entireties. Claims 58-63, 65-66 and 69 are cancelled; claim 74 is new. Thus, claims 48-57, 64, 67-68 and 70-74 are pending and subject to examination on the merits.
Withdrawal of Previous Objections/Rejections
The rejection of claim(s) 48 and 67-68 under 35 U.S.C. 102(a)(2) as being anticipated by Vroom et al. (US 2018/0223264 – cited previously; with an effectively filed date of 02 February 2017) is withdrawn in view of the amendments to require 97% sequence identity to SEQ ID NOs: 3, 7, 9 and 13; and 97% for the encoding nucleic acids.
The rejection of claims 48-57 and 64-73 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mao et al. (US 11098315 - cited previously) is withdrawn in view of the 35 U.S.C. 102(b)(2)(C) statement (See p. 6, Remarks).
The rejection of claim(s) 48-57 and 64-73 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mao et al. (US 10724062 - cited previously) is withdrawn in view of the 35 U.S.C. 102(b)(2)(C) statement (See p. 7, Remarks).
The rejection of claim(s) 48-57 and 64-73 under 35 U.S.C. 102(a)(2) as being anticipated by Mao et al. (US 10883130 - cited previously) is withdrawn in view of the 35 U.S.C. 102(b)(2)(C) statement (See p. 8, Remarks).
New Rejection - 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 48-57 and 64-74 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mao et al. (US 11680281 - cited herein).
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Applicants should note, any 102(b)(2)(C) statement MUST adhere to the following criteria. Per MPEP 717.02(a)(I) - 102(b)(2)(C) - “The statement should either be on or begin on a separate sheet and must not be directed to other matters (37 CFR 1.4(c)). The statement must be signed in accordance with 37 CFR 1.33(b)” Failure to follow this criteria will result in a deficient statement and maintenance of the rejection of record.
Mao et al. teach a nucleic acid of SEQ ID NO: 4, encoding UGT76G1 (their SEQ ID NO: 3), which has 100% sequence identity to instant SEQ ID NO: 3 (See Supplemental Content, 20250211_143658_us-17-697-043-3.rai file, Result #1; Duplicates) and instant SEQ ID NO: 4 (See Supplemental Content, 20250211_143652_us-17-697-043-4.rni file, Result #1/Duplicates), and which further comprises making substitutions in the nucleic acids encoding said enzymes resulting in various mutant UGT76G1’s of L6A, T90A and/or L185A – See Table 2 and Examples 1-4; and claims 1-5.
Maintained Rejection(s)
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 48-57 and 64-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10724062. Although the claims at issue are not identical, they are not patentably distinct from each other because the overlap in scope to such an extent to be obvious variations of one another.
The instant claims in their broadest are drawn to a nucleic acid encoding a recombinant polypeptide having at least 97% identity to SEQ ID NOs: 3, 7, 9, 13 and which has a substitution as position 6, 90 and/or 185 or which is encoded by nucleic acids having at least 97% identity to SEQ ID NO: 4, 6, 8, 10, 14. Dependent claims recite that the polynucleotides are in recombinant cells such as those that are bacterial or plants. It is noted that instant SEQ ID NO: 7 differs from SEQ ID NO: 3 by having two substitutions at L6A + L185G; and instant SEQ ID NO: 9 by having three substitutions at L6A + T90A + L185G and differs from instant SEQ ID NO: 13 by a single mutation, e.g. L6A.
The claims to the ‘062 patent are drawn to methods of making a steviol glycoside by utilizing a UDP-glycosyltransferase comprising an enzyme having at least 80% identity to SEQ ID NO: 3, which has 100% sequence identity to instant SEQ ID NO: 3 (See SCORE, .rai file, Result #1 under Duplicates). Said SEQ ID NO: 3 also has 99.4% identity to instant SEQ ID NO: 7 (See SCORE, .rai file, Result #4); and also 99.2% identity to instant SEQ ID NO: 9 (See SCORE, .rai file, Result #4); - dependent claim 13 recites that SEQ ID NO: 3 of claim 12 has a substitution of at least a position selected from 6, 90 and 185, among others.
Thus, the difference in the claims is that the claims to the ‘062 patent utilize the encoded amino acid of instant SEQ ID NO: 3 (see claims 12-13). It is obvious to those skilled in the art that proteins are generally encoded by nucleic acids. In addition, in properly construing the scope of the claims the ‘062 patent, it clear that this interpretation is consistent with that of the ‘062 patent.
Claims 48-57 and 64-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11441165. Although the claims at issue are not identical, they are not patentably distinct from each other because the overlap in scope to such an extent to be obvious variations of one another.
The instant claims in their broadest are drawn to a nucleic acid encoding a recombinant polypeptide having at least 97% identity to SEQ ID NOs: 3, 7, 9, 13 and which has a substitution as position 6, 90 and/or 185 or which is encoded by nucleic acids having at least 97% identity to SEQ ID NO: 4, 6, 8, 10, 14. Dependent claims recite that the polynucleotides are in recombinant cells such as those that are bacterial or plants. It is noted that instant SEQ ID NO: 7 differs from SEQ ID NO: 3 by having two substitutions at L6A + L185G; and instant SEQ ID NO: 9 by having three substitutions at L6A + T90A + L185G and differs from instant SEQ ID NO: 13 by a single mutation, e.g. L6A.
The claims to the ‘165 patent are drawn to methods of making a steviol glycoside by utilizing a UDP-glycosyltransferase comprising an enzyme having at least 95% identity to SEQ ID NO: 7, 11 or 13 and 97% identity to SEQ ID NO: 15, wherein said sequences have 99.2% identity to instant SEQ ID NO: 3 (See .rai file, Result #5); SEQ ID NO: 11 also has 99.2% identity to instant SEQ ID NO: 9 and 99.4% to instant SEQ ID NO: 7 (See .rai files, Results 8) and 99.8% identity to instant SEQ ID NO: 13 (See .rai file, Result #6).
Thus, the difference in the claims is that the claims to the ‘165 patent utilize the encoded amino acid of instant SEQ ID NO: 3 (see claim 1). It is obvious to those skilled in the art that proteins are generally encoded by nucleic acids. In addition, in properly construing the scope of the claims the ‘165 patent, it clear that this interpretation is consistent with that the ‘165 patent.
Claims 48-57 and 64-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-49 of U.S. Patent No. 11098315. Although the claims at issue are not identical, they are not patentably distinct from each other because the overlap in scope to such an extent the claims of the ‘315 patent would necessarily anticipated the instant claims.
The instant claims in their broadest are drawn to a nucleic acid encoding a recombinant polypeptide having at least 97% identity to SEQ ID NOs: 3, 7, 9, 13 and which has a substitution as position 6, 90 and/or 185 or which is encoded by nucleic acids having at least 97% identity to SEQ ID NO: 4, 6, 8, 10, 14. Dependent claims recite that the polynucleotides are in recombinant cells such as those that are bacterial or plants. It is noted that instant SEQ ID NO: 7 differs from SEQ ID NO: 3 by having two substitutions at L6A + L185G; and instant SEQ ID NO: 9 by having three substitutions at L6A + T90A + L185G and differs from instant SEQ ID NO: 13 by a single mutation, e.g. L6A.
The claims to the ‘315 patent are drawn to a recombinant host cell transformed with a polynucleotide that encodes a mutant enzyme comprising SEQ ID NO: 3, wherein a mutation occurs at least one position selected from 3, 6, 90, 91, 93, 181, 183, 184, 185, 350, 389, 410, 418, 450, 451, 452, and 454.
It is noted, SEQ ID NO: 4, which encodes SEQ ID NO: 3 in the ‘043 patent has the following percent identities with the instantly claimed sequences: 100% to instant SEQ ID NO: 4 (See .rni file, Result #3); 99.4% to instant SEQ ID NO: 8 (See .rni file, Result #6); 99.3% to instant SEQ ID NO: 10 (See .rni file, Result #6); and 99.7% to instant SEQ ID NO: 14 (See .rni file, Result #4). Also SEQ ID NO: 3 of the ‘043 patent has 100% identity to instant SEQ ID NO: 3 (See .rai file, Result #1); 99.4% identity to instant SEQ ID NO: 7 (.rai file, Result #6); 99.2 % identity to instant SEQ ID NO: 9 (.rai file, Result # 6) and 99.8% identity to instant SEQ ID NO: 13 (.rai file, Result #4).
Thus, the claims differ by specifically reciting that the polynucleotide encodes a mutant enzyme at positions 3, 6, 90, 91, 93, 181, 183, 184, 185, 350, 389, 410, 418, 450, 451, 452, and/or 454. However, the instant claims recite a percent identity (80% or 95%) great enough to allow for several substitutions as well as claiming the exact same substitutions in instant SEQ ID NO: 7 and 9 and 13 (See SCORE, .rai files). Thus, it can be said that the claims of ‘315 would necessarily anticipate the instant claims and the claims are not patentably distinct because the entire scope of the examined claim falls within the scope, and would be anticipated by, the claims of the ‘315 patent. Anticipation Analysis MPEP 804(II)(B)(1):
“The claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by 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, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993). This type of nonstatutory double patenting situation arises when the claim being examined is, for example, generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim.”
Applicant’s Remarks and Examiner’s Rebuttal:
Applicant’s have asked the Non-Statutory Double Patenting rejections be held in abeyance until such time that allowable claims are identified.
The Examiner acknowledges this request, however, said rejections are not suspended and are maintained.
New NSDP Rejection
Claims 48-57 and 64-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11680281. Although the claims at issue are not identical, they are not patentably distinct from each other because the overlap in scope to such an extent to be obvious variations of one another.
The instant claims in their broadest are drawn to a nucleic acid encoding a recombinant polypeptide having at least 97% identity to SEQ ID NOs: 3, 7, 9, 13 and which has a substitution as position 6, 90 and/or 185 or which is encoded by nucleic acids having at least 97% identity to SEQ ID NO: 4, 6, 8, 10, 14. Dependent claims recite that the polynucleotides are in recombinant cells such as those that are bacterial or plants. It is noted that instant SEQ ID NO: 7 differs from SEQ ID NO: 3 by having two substitutions at L6A + L185G; and instant SEQ ID NO: 9 by having three substitutions at L6A + T90A + L185G and differs from instant SEQ ID NO: 13 by a single mutation, e.g. L6A.
The claims to the ‘281 patent are drawn to methods of making rebaudioside M by utilizing a UDP-glycosyltransferase comprising an enzyme having at least 90% identity to SEQ ID NO: 1 or 3, wherein SEQ ID NO: 3 has 100% sequence identity to instant SEQ ID NO: 3 (See Supplemental Content, 20250211_143658_us-17-697-043-3.rai file, Result #1; Duplicates)). Said SEQ ID NO: 3 also has 99.4% identity to instant SEQ ID NO: 7 (See Supplemental Content, .rai file, Result #4); and also 99.2% identity to instant SEQ ID NO: 9 (See Supplemental Content, .rai file, Result #4); - dependent claims 4 and 5 recites that SEQ ID NO: 3 has a substitution of at least a position one amino acid selected from 6, 90 and 185, among others; and specific substitutions of (i) W3L, (ii) L6A or L6G, (iii) T90A or T90G, (iv) S91G or S91L, (v) V93A or V93G, (vi) S181G, (vii) F183V, F183A, or F183G, (viii) G184A, (ix) L185A, (x) G350A, (xi) L389V, (xii) S410G, (xiii) H418V, (xiv) T450A or T450G, (xv) K451A, (xvi) D452A, and (xvii) K454L or K454V.
Thus, the difference in the claims is that the claims to the ‘281 patent utilize the encoded amino acid of instant SEQ ID NO: 3. It is obvious to those skilled in the art that proteins are generally encoded by nucleic acids. In addition, in properly construing the scope of the claims the ‘281 patent, it clear that this interpretation is consistent with that of the ‘281 patent – See MPEP 804(II)(B)(1).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached on M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 20 March 2026