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 .
Priority
This application claims benefit of priority to foreign applications PCTEP2021051479 filed 01/22/2021 and EP21185379.1 filed 07/13/2021. This application is also a 371 of PCT/EP2022/051295 filed 01/21/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed 07/19/2023 has been acknowledged and considered.
Drawings
The Drawings filed 07/19/2023 are accepted by the Examiner.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-11, in the reply filed on 12/24/2025 is acknowledged. The traversal is on the ground(s) that “the Office seems to have selected one of over 100,000 UniProt entries for ‘sugar efflux transporter’ for its basis that no special technical effect is present. Furthermore, the Office fails to interpret the claim as a whole.” This is not found persuasive for the same reasons stated in the Requirement for Restriction mailed 11/06/2025. As stated on Pages 4- 5 of the Restriction Requirement mailed 11/06/2025, the technical feature of Groups I and III is the genetically modified cell of claim 1. Meaning, all of the limitations present in claim 1 that make up the genetically modified cell are part of the technical feature, including the polypeptide of SEQ ID NO: 1 or a homologue thereof, a sialyl-transferase and a biosynthetic pathway for making a sialate sugar nucleotide. The genetically modified cell as claimed does not make a contribution over the prior art in view of Jennewein et al. (US 20180305724 A1, 10/25/2018) (Of Record) in view of UniProt (A0A380PXT8_YERFR, 11/07/2018) (Of Record) because the combination of Jennewein et al. and UnitProt renders the genetically modified cell obvious for the same reasons stated in the Restriction Requirement mailed 11/06/2025.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election of (a) 3’-SL, (b) α-2,3-sialyltransferase, (c) the collection of gene NeuB (SEQ ID NO: 12), NeuC (SEQ ID NO: 14) and NeuA (SEQ ID NO: 16) and (d) PglpF (SEQ ID NO: 5) in the reply filed on 12/24/2025 is acknowledged. Because applicant 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 § 818.01(a)). More specifically, Applicant did not state whether the elections of species were made with or without traverse.
In the reply filed 12/24/2025, Applicant added new claims that would have been subjected to a species election requirement. New claims 18-19 both contain multiple species of sialyltransferases, with claim 18 being directed to specific α-2,6-sialyltransferases and claim 19 being directed to specific α-2,3-sialyltransferases. As an α-2,3-sialyltransferase was elected as the specific sialyl transferase in the reply filed 12/24/2025, new claim 18 is being withdrawn. However, new claim 19 recites multiple species of α-2,3-sialyltransferases and is subject to an Election of Species.
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
During a telephone conversation with Thomas Campbell on 03/02/2026 a provisional election of AAC44541.1 as the specific α-2,3-sialyltransferase was made without traverse. Affirmation of this election must be made by Applicant in replying to this Office action.
Amendments and Claim Status
In the reply filed 12/24/2025, Applicant amended claims 1-5 and 7-14, cancelled claims 15-16 and added new claims 17-20. New claims 17-19 are encompassed by Group I and new claim 20 is encompassed by Group III. Therefore, claims 12-14 and 20 are withdrawn due to not being encompassed by the elected group. Additionally, claim 18, directed to an α-2,6-sialyltransferase, is withdrawn as it is not encompassed by the election of species.
Claims 1-14 and 17-20 are currently pending.
Claims 12-14, 18 and 20 are withdrawn by the Examiner as the are not encompassed by the elections.
Claims 1-11, 17 and 19 are under examination.
Claim Objections
Claims 1-5 and 7-11 are objected to because of the following informalities: It appears the amended portions of claims 1-5 and 7-11 are in a color other than black because the amended portions are unclear and hard to read while the unamended portions of the claim are clear and legible. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: Claim 5 recites “the a-2,3-sialyl-transferase …” in line 2. The claim should recite “the α-2,3-sialyl-transferase,” as in the first letter should be the Greek symbol for alpha, not a lowercase A.
Claim 7 is objected to because of the following informalities: Claim 7 is missing a comma after “The genetically modified cell according to claim 1”. Appropriate correction is required
Claim 8 is objected to because of the following informalities: Claim 8 recites “encoding a major MFS polypeptide” in lines 3-4. The ‘M’ in MFS stands for major. Thus, the major recited before MFS polypeptide is redundant and unnecessary. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: Claim 10 recites “comprises the amino acid sequence of SEQ ID NO: 5, 6 or 7”. However, SEQ ID NOs: 5-7 are nucleic acid sequences, not amino acid sequences. Appropriate correction is required. The claim is being examined as if the claim reads “comprises the nucleic acid sequence of SEQ ID NO:5 …”.
Claim Rejections - 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 5 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 5 recites the limitation "wherein the a-2,3-sialyl-transferase comprises …" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 1, the claim from which claim 5 depends, does not recite an ‘a-2,3-sialyl-transferase,’ only a sialyl-transferase. Thus, claim 5 lacks antecedent basis.
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 9 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 9 recites “the genetically modified cell according to claim 8, wherein the regulatory element regulates the expression of the MFS polypeptide of SEQ ID NO: 1, or a functional homologue thereof with an amino acid sequence which is at least 90% identical to SEQ ID NO: 1”. Claim 8, the claim from which claim 9 depends, recites “the genetically modified cell according to claim 1, wherein the cell further comprises a nucleic acid sequence comprising a regulatory element for the regulation of the expression of the heterologous nucleic acid sequence encoding a major MFS polypeptide”. The heterologous nucleic acid sequence encoding a major facilitator superfamily polypeptide in claim 1 is SEQ ID NO: 1, or a functional homologue thereof with an amino acid sequence at least 90% identical to SEQ ID NO: 1. Therefore, claim 9, which encompasses all of the limitations of claim 8 and claim 1, fails to further limit the subject matter of the claim upon which it depends because the limitation of the regulatory element regulating the expression of the MFS polypeptide of SEQ ID NO: 1 was present in claim 8.
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.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1-11, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (WO 2019123324 A1, 06/27/2019) (IDS Reference of 07/19/2023, 108 Pages) in view of Jennewein et al. (US 20180305724 A1, 10/25/2018) (Of Record) and UniProt (A0A380PXT8_YERFR, 11/07/2018) (Of Record), as evidenced by GenBank (AF400048.1, 07/23/2016)
Regarding claims 1-2, 4, 11 and 17, Pederson et al. disclose recombinant production of biological molecules in host cells and nucleic acid constructs that allow the modification of expression of desired genes wherein the constructs can be used to produce human milk oligosaccharides (HMOs) (See entire document, Abstract). More specifically, Pederson et al. disclose the sialylated HMO 3’-sialyllactose (3’-SL) can be produced by an engineered bacteria comprising an exogenous nucleic acid molecule encoding for an α(2,3) sialyltransferase (Page 56, Lines 19-21). An exogenous nucleic acid molecule encoding for an α(2,3) sialyltransferase reads on a heterologous nucleic acid sequence encoding a sialyl-transferase. The exogenous sialyltransferase gene utilized for 3’-SL production may be obtained from any available source, e.g., those described from Neisseria meningitidis and Neisseria gonorrhoeae, including specific examples listed in Table 5 (Page 56, Lines 21-24). A specific example from Table 5 includes NST from N. meningitidis MC58 with accession number AAC44541.1 (Table 5). AAC44541.1 is the elected α-2,3-sialyltransferase.
Furthermore, the bacterium (e.g., E. coli) also comprises a sialic acid synthesis capability. For example, the bacterium comprises a sialic acid synthesis capability through provision of an exogenous UDP-GlcNAc 2-epimerase (e.g., neuC of Campylobacter jejuni (GenBank AAK91727.1; GL 15193223) or equivalent (e.g. neuC of E.coli S88 (GenBank YP _002392936.1; GI: 218560023), a Neu5Ac synthase (e.g., neuB of C. jejuni (Gen Bank AAK91726.1; Gl:15193222) or equivalent, (e.g. Flavobacterium limnosediminis sialic acid synthase, Gen Bank GL559220424), and/or a CMP-Neu5Ac synthetase (e.g., neuA of C. jejuni (GenBank AAK91728.1; Gl:15193224) or equivalent, (e.g. Vibrio brasiliensis CMP-sialic acid synthase, GenBank GI: 493937153).
Bacteria producing sialylated HMO's comprise one or more exogeneous sialyltransferases, which are encoded by the coding DNA of an expression cassette of the invention that is present in the host cells either as plasmid-borne or genome-integrated. Preferably, at least one of the one or more sialyltransferase-coding DNA sequences is operably linked to a glp promoter described herein, preferably PglpF. Non-limited examples of useful sialyltranferases are listed in Table 5 (Page 58, Lines 8-22).
The sialic acid synthesis capability from the genes disclosed above, which produces CMP-Neu5AC, reads on a biosynthetic pathway for making a sialate sugar nucleotide. In a specific embodiment, Pederson et al. disclose plasmid MAP1214 comprising MDO PglpF-NeuA PglpF-neuB PglpF-neuC PglpF-nst (Table 6). The MDO portion of plasmid MAP1214 represents the background strain which is Escherichia coli K12 DH1 (Page 61, Line 15).
Pederson et al. additionally disclose the construct of the invention may encode an enzyme or a sugar transporter protein which are normally expressed by the host bacterial cell that naturally comprises in its genome genes encoding said enzyme or sugar transporter protein (Page 28, Lines 24-27).
Pederson et al. do not disclose a heterologous nucleic acid sequence encoding a MFS polypeptide of SEQ ID NO: 1 or a functional homologue thereof that shares 90% sequence identity to instant SEQ ID NO: 1.
However, Jennewein et al. disclose a method for the production of oligosaccharides in genetically modified bacterial host cells (See entire document, Abstract), specifically human milk oligosaccharides (Paragraph [0016]). The genome of the often used fermentation model organism E. coli encodes more than 500 distinct transporter proteins (Paragraph [0006]). The E. coli transport protein SetA was even described to transfer the human milk oligosaccharide 3-fucosyllactose, resulting in an improved production of said compound during fermentation of a recombinant E. coli strain overexpressing setA (Paragraph [0011]).
Additionally, UniProt discloses A0A380PXT8_YERFR, a sugar efflux transporter protein with gene name setA, that shares 98.7% sequence identity to instant SEQ ID NO. 1. Sequence alignment provided below wherein Qy represents instant SEQ ID NO: 1 and Db represents A0A380PXT8_YERFR disclosed by UniProt.
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Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the setA gene disclosed by UniProt in the genetically modified cell of Pederson et al. motivated by the desire to create a genetically modified cell capable of producing HMOs at a high level because Jennewein et al. disclose the use of setA in a recombinant cell resulted in the improved production of an HMO and the setA disclosed by UniProt was a known and effective setA protein disclosed by the prior art.
Regarding claim 3, it appears, absent evidence to the contrary, that the presence of the specific MFS polypeptide would inherently provide this effect. Therefore, the genetically modified cell of Pederson et al./UniProt meets this limitation.
Regarding claims 5 and 19, it appears as though SEQ ID NO: 3 and AAC44541.1 refer to the same sequence. The instant Specification states the gene that is genomically integrated is a gene encoding a α-2,3-sialyltransferase, for example, NST of Neisseria meningitidis (Genbank protein accession number AAC44541.1 or SEQ ID NO: 3) (Page 22, Lines 31-33). Thus, it appears as though SEQ ID NO: 3 and AAC44541.1 refer to the same sequence. As discussed above regarding claim 1, Pederson et al. disclose a specific example of an α(2,3) sialyltransferase from Table 5 being NST from N. meningitidis MC58 with accession number AAC44541.1.
Regarding claim 6, as discussed above regarding claim 1, Pederson et al. disclose the bacterium comprises a sialic acid synthesis capability wherein that capability is provided via nueA from C. jejuni with GenBank accession number AAK91728.1, nueB from C. jejuni with GenBank accession number AAK91726.1 and nueC from C. jejuni with GenBank accession number AAK91727.1 (Page 58, Lines 6-15). It is noted the instant Specification states CMP-Neu5Ac synthesis enzymes are neuBCA genes (Page 40, Line 1). The Specification further states neuBCA is a gene cluster consisting of neuA, neuB and neuC (Page 15, Lines 15-18). Thus, the disclosure of Pederson et al. of the bacterium comprising a sialic acid synthesis capability wherein that capability is provided via nueA from C. jejuni with GenBank accession number AAK91728.1, nueB from C. jejuni with GenBank accession number AAK91726.1 and nueC from C. jejuni with GenBank accession number AAK91727.1, reads on a biosynthetic pathway for making a sialate sugar nucleotide wherein the sialate sugar nucleotide is CMP-Neu5Ac.
Regarding claim 7, as discussed above regarding claim 1, Pederson et al. disclose the bacterium comprises a sialic acid synthesis capability wherein that capability is provided via nueA from C. jejuni with GenBank accession number AAK91728.1, nueB from C. jejuni with GenBank accession number AAK91726.1 and nueC from C. jejuni with GenBank accession number AAK91727.1 (Page 58, Lines 6-15).
GenBank accession number AAK91728.1 (nueA) refers to a protein ID of an amino acid sequence that has been translated from a nucleic acid sequence. The nucleic acid sequence encoding protein AAK91728.1 shares 100% sequence identity to instant SEQ ID NO: 16. A sequence alignment has been provided below where Qy represents instant SEQ ID NO: 16 and Db represents the nucleic acid sequence encoding the amino acid sequence of protein AAK91728.1.
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GenBank accession number AAK91726.1 (nueB) refers to a protein ID of an amino acid sequence that has been translated from a nucleic acid sequence. The nucleic acid sequence encoding protein AAK91726.1 shares 100% sequence identity to instant SEQ ID NO: 12. A sequence alignment has been provided below where Qy represents instant SEQ ID NO: 12 and Db represents the nucleic acid sequence encoding the amino acid sequence of protein AAK91726.1.
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GenBank accession number AAK91727.1 (neuC) refers to a protein ID of an amino acid sequence that has been translated from a nucleic acid sequence. The nucleic acid sequence encoding protein AAK91727.1 shares 100% sequence identity to instant SEQ ID NO: 14. A sequence alignment has been provided below where Qy represents instant SEQ ID NO: 14 and Db represents the nucleic acid sequence encoding the amino acid sequence of protein AAK91727.1.
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Thus, the disclosure of Pederson et al. of proteins AAK91727.1, AAK91726.1 and AAK91728.1 reads on instant SEQ ID NOs: 12, 14 and 16 because, as shown above, these proteins are encoded by the nucleic acid sequences represented by SEQ ID NOs: 12, 14 and 16. Additionally, as discussed above, these proteins were inserted into a plasmid, plasmid MAP1214 comprising MDO PglpF-NeuA PglpF-neuB PglpF-neuC PglpF-nst (Table 6), wherein the MDO portion of plasmid MAP1214 represents the background strain which is Escherichia coli K12 DH1 (Page 61, Line 15). To be inserted into a plasmid, the nucleic acid sequence encoding the amino acid sequence would have to be used. Thus, the disclosure of Pederson et al. reads on this limitation.
Regarding claims 8 and 9, it is noted the instant specification states “the term, a “regulatory element” or “promoter” or “promoter region” or “promoter element” is a nucleic acid sequence that is recognized and bound by a DNA dependent RNA polymerase during initiation of transcription” (Page 25, Lines 26-28). Thus, it appears a ‘regulatory element’ is another word for a promoter. As discussed above, Pederson et al. disclose the use of the glp promoter, PglpF (Page 58, Lines 19-20).
Pederson et al. do not specifically disclose the promoter PglpF is utilized for the regulation of the MFS polypeptide.
However, as disclosed above, Pederson et al. disclose the use of the PglpF promoter before all utilized sequences in plasmid MAP1214. Plasmid MAP1214 comprises MDO PglpF-NeuA PglpF-neuB PglpF-neuC PglpF-nst (Table 6).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the PglpF promoter to regulate the expression of the MFS polypeptide as well as it was already being used to effectively control the expression of other polypeptides of the invention.
Regarding claim 10, see 112b above. Pederson et al. disclose a PglpF promoter from E. coli that shares 100% sequence identity to instant SEQ ID NO: 5 which is a nucleic acid sequence. A sequence alignment is provided below wherein Qy represents instant SEQ ID NO: 5 and Db represents the sequence disclosed by Pederson et al.
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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 1-11, 17 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 19 and 23 of U.S. Patent No. 9758803 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘803 is drawn to the production of a sialylated oligosaccharide in Escherichia coli bacterium, wherein said sialylated oligosaccharide comprises 3’-sialyllactose (3’-SL) and the method utilizes an exogenous sialyl-transferase comprising an α(2,3) sialyl-transferase, a sialic acid synthesis capability and a functional lactose permease gene. Claim 6 of ‘803 corresponds to instant claims 6-7. Claim 7 of ‘803 corresponds to instant claim 5. Claim 23 of ‘803 corresponds to instant claim 2.
The claims of ‘803 anticipate the instant claims.
Claims 1, 3, 8-11 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 17/759,276 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘276 are drawn to a genetically modified cell capable of producing one or more Human Milk Oligosaccharides wherein the cell comprises a major facilitator superfamily polypeptide of SEQ ID NO: 1. SEQ ID NO: 1 of ‘276 shares 100% sequence identity to instant SEQ ID NO: 1. Claims 3-5 of ‘276 correlate to instant claims 8-10 and claim 6 of ‘276 correlates to instant claims 11 and 17.
The claims of ‘276 anticipate the instant claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-11, 17 and 19 are rejected.
No claims are allowed.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653