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
Applicant’s election of Group III, claims 9-17, as well as SEQ ID NO: 1 following claim amendments in the reply filed on 11/10/2025 is acknowledged; in said amendment applicants’ have cancelled claims 1-5, amended claims 6-7 and 9-12 and added new claims 13-17. Because applicants’ did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). Amended Claims 6-17 are pending in this application; Group III, claims 9-17, as well as SEQ ID NO: 1 reading on the elected invention is now under consideration for examination; and claims 6-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Priority
Acknowledgment is made of applicants’ claim for foreign priority under 35 U.S.C. 119(a)-(d). This application is a 371 of PCT/KR2021/019767 filed on 12/23/2021 and claims the priority date of Korea application 10-2020-0182517 filed on 12/23/2020; however, no English translation of said foreign priority application has been provided. Therefore, the priority date for instant claims under consideration is deemed to be the filing date of 371 of PCT/KR2021/019767 filed on 12/23/2021.
Information disclosure statement
The information disclosure statements (IDS) submitted on 06/12/2023, 10/10/2024 and 11/04/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statements are considered and initialed by the examiner.
Objections-Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. The specification contains hyperlinks to various site domains, for example, line 11, page 15 of the instant application. Applicants’ are required to thoroughly scrutinize the specification and delete all embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01. Appropriate correction is required.
Double Patenting rejection
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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
Amended Claims 9-17 are provisionally rejected on the ground of nonstatutory double patenting over: (i) amended claims 1-4 and 7-17 (dated 06/21/2024) of co-pending Application No. 18/722,755 (US 2025/0154549 A1); and (ii) amended claims 1-3, 7-8, 11, 13-18, 21-23 and 25-29 (dated 06/21/2024) of co-pending Application No. 18/722,905 (US 2025/0051818 A1). This is a provisional double patenting rejection because the patentably indistinct claims have not in fact been patented.
The subject matter claimed in the instant application is fully disclosed in the referenced co-pending applications and would be covered by any patent granted on those co-pending applications, since the referenced co-pending applications and the instant application are claiming common subject matter, as follows: The recited reference claims (i) amended claims 1-4 and 7-17 (dated 06/21/2024) of co-pending Application No. 18/722,755; and (ii) amended claims 1-3, 7-8, 11 and 13-18 (dated 06/21/2024) of co-pending Application No. 18/722,905, also encompass a genus of enzyme proteins having an amino acid sequence that has at least 92% of amino acid sequence identity with of SEQ ID NO: 1 (see provided sequence alignments; said reference polypeptides have 100% sequence identity to SEQ ID NO: 1 of the instant application), and having uridine diphosphate-glycosyltransferase (UDP-glucosyltransferase) activity of transferring glucose to steviol glycosides… and method of use as claimed in claims 9-17 herein, “a method for producing steviol glycosides, comprising reacting, in the presence of a glucose donor, at least one selected from the group consisting of an enzyme protein, a recombinant microorganism expressing the enzyme protein, cells of the microorganism, cell lysates of the microorganism, cultures of the microorganism, and extracts thereof, with a substrate, wherein the enzyme protein comprises an amino acid sequence having at least 92% sequence identity to SEQ ID NO: 1, and has uridine diphosphate-glycosyltransferase (UDP-glucosyltransferase) activity of transferring glucose to steviol glycosides…, examiner takes the position that the method claims of the instant application is a different form/version of expression of the reference polypeptides and encoding polynucleotides of the cited co-pending reference applications claims and falls entirely within the scope of co-pending amended claims in co-pending reference applications.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
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.
Claim 13 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 pre-AIA the applicant regards as the invention.
Claim 13 is indefinite in the recitation of “derived”. The metes and bounds of the term “derived” is not clear in the context of the claim. It is not clear to the examiner what are the structures encompassed in “derived”? or is a representative member of a genus/merely exemplary. Furthermore, in claim 13 is indefinite in the recitation of “derived”; as written, one cannot determine if the term refers to ‘functions of several real variables” or ‘structural variables’ of claimed “derived” polypeptides (unlimited structures or structurally undefined molecules or functionally variable molecules and the extent of variability is unclear). The metes and bounds of the claim is unclear. For examination purposes, no patentable weight will be given to the terms. It is not clear to the examiner as to what the phrase “derived” means in the context of the above claims, is this synonymous with “obtained from specific source or having specific structures? or does it include natural and man-made variants of unlimited/undefined structures thereof from any source? Examiner suggests amending the claims to recite ”obtained from…”. Clarification and correction required.
Claim Rejections: 35 U.S.C. 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 16 recites “…wherein the gene is encoded by an amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 3, or SEQ ID NO: 5” and depends from independent claim 9; said independent claim 9 recites “…at least 92% of amino acid sequence identity with of SEQ ID NO: 1”; in claim 16, SEQ ID NO: 5 has 90.1% amino acid sequence identity to SEQ ID NO: 1 and 68.3% amino acid sequence identity to SEQ ID NO: 3 and depends from claim 9 and does not further limit independent claim 9. Dependent claim 16 broadens the scope of independent claim 9.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of pre-AIA 35 U.S.C. 112, 4th paragraph, are related to matters of form, non-compliance with pre-AIA 35 U.S.C. 112, 4th paragraph, renders the claim unpatentable just as non-compliance with other paragraphs of 35 U.S.C. 112 would. See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92, 79 USPQ2d 1583, 1589-90 (Fed. Cir. 2006) (holding a dependent claim in a patent invalid for failure to comply with pre-AIA 35 U.S.C. 112, 4th paragraph). Therefore, if a dependent claim does not comply with the requirements of 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, the dependent claim should be rejected under pre-AIA 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as unpatentable rather than objecting to the claim. See also MPEP § 608.01(n),subsection III, “Infringement Test” for dependent claims.
Claim Rejections: 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
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.
Claims 9-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Zhao et al., (US 11,091,743 B2) and further in view of Mao et al., (US 9,522,929) and Rossello M., (UniProtKB/TrEMBL Accesion#A0A3B6IL54 disclose a naturally occurring glycosyltransferase having 100% sequence identity to SEQ ID NO: 1 obtained from Triticum aestivum).
Claims 9-17 of the instant application as interpreted are directed to a method of producing steviol glycosides comprising a genus of polypeptides comprising an enzyme protein having an amino acid sequence that has at least 92% of amino acid sequence identity with of SEQ ID NO: 1, and an uridine diphosphate-glycosyltransferase (UDP-glucosyltransferase) activity of transferring glucose to steviol glycosides, a recombinant microorganism comprising a gene encoding said glycosyltransferase, wherein the enzyme protein has an activity of converting 40% by weight or more of rebaudioside A to rebaudioside D… and wherein the enzyme protein comprises the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 3, or SEQ ID NO: 5 (also see 35 U.S.C. 112(b) and 35 U.S.C. 112(d) rejections above for claims interpretation).
Zhao et al., (US 11,091,743 B2) disclose a glycosyltransferases having 100% sequence identity to SEQ ID NO: 3 and SEQ ID NO: 5 of the instant invention (see provided sequence alignments) and method of use; said reference glycosyltransferase has an activity of converting rebaudioside A to rebaudioside D and production of steviol glycosides (see Abstract; Figs. 1A-B, 2B-C; col. 23, lines 26-67 to col. 24, lines 1-11; col. 26, lines 34-67 to col. 27, lines 1-30; and entire document); transformed recombinant host cells/cell strains E. coli, Pichia and Saccharomyces (col. 25 to col. 26, lines 1-33); and said reference transformed recombinant host cells produce >100% or 1000-fold or more of steviol glycosides (col. 39 to col. 40, lines 1-48).
The disclosure of Zhao et al., (US 11,091,743 B2) as applied to claims 9-17 is described in the rejection above. However, Zhao et al., is silent regarding wherein the enzyme protein is derived from Triticum aestivum (as in claims 9 and 13) and wherein said reference polypeptides having the amino acid sequence of SEQ ID NO: 1 (as in claims 9 and 16).
Regarding claims 9, 13 and 16, analogous art teach the structural and functional information of the instant application:
Mao et al., (US 9,522,929) also disclose a glycosyltransferase having 100% sequence identity to SEQ ID NO: 3 of the instant invention (see provided sequence alignments) and method of use for converting rebaudioside A to rebaudioside D/steviol glycoside in transformed recombinant E. coli host cells (see Abstract; Figs. 1C & 3-8; col. 24, lines 5-20; Example 2, cols. 35-36; Example 1, cols, 34-35; and entire document).
Rossello M., (UniProtKB/TrEMBL Accesion#A0A3B6IL54) disclose a naturally occurring glycosyltransferase having 100% sequence identity to SEQ ID NO: 1 obtained from Triticum aestivum.
Therefore, it would have been obvious to a person of ordinary skill in the art to combine and modify the teachings of Zhao et al., and employ the glycosyltransferase polypeptides of Mao et al., and Rossello M., that teach structural and functional elements involved in the enhanced production of steviol glycosides i.e., converting rebaudioside A to rebaudioside D to generate a genetically modified recombinant microbial/host cell comprising recombinant proteins involved in the biochemical pathway of converting rebaudioside A to rebaudioside D and producing steviol glycosides; said genetic modification in said recombinant host cell involving enhancing the activities of enzymes/proteins/functional elements that are involved in the synthesis of precursors/intermediate products and the enhanced production of final product i.e., converting rebaudioside A to rebaudioside D and producing steviol glycosides. Motivation to generate such a modified microorganism derives from the fact that steviol glycoside/rebaudioside D is a commercial product of importance and useful in the preparation of fine chemicals, agrochemicals, pharmaceuticals, food industry (Mao et al., and Zhao et al.,). The expectation of success is high, because the combined teachings of Zhao et al., Mao et al., and Rossello M., teach genetically modified recombinant microbial/host cells comprising recombinant enzymes/proteins/functional elements and the entire pathway for the enhanced production of glycosides i.e., converting rebaudioside A to rebaudioside D and producing steviol glycosides; said references also provide the structural and functional elements of the instant invention (Teaching, Suggestion and Motivation).
Given this extensive teaching in prior art (Zhao et al., Mao et al., and Rossello M.,) i.e., a method of producing steviol glycosides comprising a genus of polypeptides comprising an enzyme protein having an amino acid sequence that has at least 92% of amino acid sequence identity with of SEQ ID NO: 1, and an uridine diphosphate-glycosyltransferase (UDP-glucosyltransferase) activity of transferring glucose to steviol glycosides, a recombinant microorganism comprising a gene encoding said glycosyltransferase, wherein the enzyme protein has an activity of converting 40% by weight or more of rebaudioside A to rebaudioside D… and wherein the enzyme protein comprises the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 3, or SEQ ID NO: 5 (also see 35 U.S.C. 112(b) and 35 U.S.C. 112(d) rejections above for claims interpretation), as taught by the instant invention and as claimed in claims 9-17 is not of innovation but of ordinary skill in the art and the expectation of success is extremely high i.e., “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at, 82 USPQ2d at 1397”.
Therefore, claims 9-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Zhao et al., (US 11,091,743 B2) and further in view of Mao et al., (US 9,522,929) and Rossello M., (UniProtKB/TrEMBL Accesion#A0A3B6IL54 disclose a naturally occurring glycosyltransferase having 100% sequence identity to SEQ ID NO: 1 obtained from Triticum aestivum).
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652