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 .
Restriction/Election
Applicant's election with traverse of Group III (Claims 9-12), as well as Applicant's election of Species 1A (SEQ ID NO.: 1), in the reply filed on 21 October 2025, is acknowledged. The traversal is on the grounds that no objection to unity of invention was raised at any point of the PCT phase. However, this is not found to be persuasive, because it is not a rule or requirement that the assessment with regard to unity of invention by the instant Examiner agree with those of the authorizing officer presiding over the PCT submission of the application. The examination of an application for U.S. patent eligibility is an independent evaluation not guided by the findings of the PCT authorizing officer.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-8 and 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Groups I and II, there being no allowable generic or linking claim.
Applicant timely traversed the restriction (election) requirement mailed on 21 August 2025 in the reply filed on 21 October 2025.
Status of Claims
Claims 1-8 and 13-14 show incorrect status identifiers. Applicant is reminded that claims 1-8 and 13-14 should be labeled: “(Withdrawn)”; remaining claims should be identified appropriately (MPEP 714 (II)(C)(A)) (See 37 CFR 1.121 (c)).
Appropriate correction is required.
Applicant is required to provide a new claim set showing correct status identifiers in the response to this Office Action.
Claims 1-14 are pending.
Claims 9-12 are rejected.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. §119(e) or under 35 U.S.C. §120, §121, or §365(c) is acknowledged. This application is a 371 of PCT/EP2020/087660, filed on 12/22/2020.
Applicant has complied with all of the conditions for receiving the benefit of an earlier filing date under 35 U.S.C. §120 or §365(c).
Claims 9-12 have the effective filing date of 22 December 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 22 December 2023, 20 June 2024 and 17 January 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner.
Drawings
The drawings were received on 16 June 2023. These drawings are accepted.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 demarcates each step of the method with a dash mark "-". However, steps presented in claims should be indicated with letters (such as (a), (b), etc.) or numbers (such as (i), (ii), etc. or (1), (2), etc.).
Appropriate correction is required.
Claim Interpretations
Claim 9 recites the alternative term "optionally".
Claim 9 recites: "...; and optionally recovering said 6'-sialyllactose."
In the instant case(s), the term does not render the claim language indefinite; however, the limitations cited in view of this term can be excluded in the determination of the applicability of prior art (see MPEP 2111.04 (I) and MPEP 2103 (C)). The term does not render the claim(s) indefinite, because there is no ambiguity as to which alternatives are covered by the claim. See Ex parte Wu, 10 USPQ2d 2031 (Bd. Pat. App. & Inter. 1989) (MPEP 2173.05 (h)(II)). In the instance where the list of potential alternatives can vary and ambiguity arises, then it is proper to make a rejection under 35 U.S.C. §112(b).
The MPEP states: Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See MPEP 2111.04; see also MPEP 2103(C) and 2173.05(h)…“optional elements do not narrow the claim because they can always be omitted.” MPHJ Tech. Invs., LLC v. Ricoh Ams. Corp., 847 F.3d 1363, 1379 (Fed. Cir. 2017) (citing In re Johnston, 435 F.3d 1381, 1384 (Fed. Cir. 2006)).
Claim Rejections - 35 U.S.C. § 103
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 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 of this title, 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.
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.
Claims 9-12 are rejected under 35 U.S.C. §103 as being unpatentable over Drouillard et al. (Carb. Res. 2010, 345: 1394-1399 in view of Wang et al. (Vet. Microbiol. 2011, 153: 403-406) as evidenced by STIC sequence search ((SEQ ID NO.: 1); Datasheet [online]; Downloaded on 07 November 2025, pp. 1-5).
[Drouillard et al. cited in the Restriction/Election Office Action mailed 12 August 2025.]
Drouillard et al. addresses some of the limitations of claim 9.
Regarding claim 9, pertaining to a method for producing 6'-sialyllactose in a cell; and providing a genetically engineered cell for the production of 6' -sialyllactose, wherein said cell has been genetically engineered to possess a lactose-accepting α-2,6-sialyltransferase,
Drouillard et al. shows that 6'-sialyllactose can be efficiently produced by a metabolically engineered E. coli strain expressing α-(2→6)-sialyltransferase gene ST6 from the Photobacterium sp. JT-ISH-224 (pg. 1394, column 2, para. 1).
Further regarding claim 9, pertaining to cultivating said cell in a culture medium and under conditions permissive for the production of 6'-sialyllactose,
Drouillard et al. shows that to favor the production of 6'-sialyllactose, E. coli strain DC29 was cultured with a continuous supply of lactose for 48 h (pg. 1398, column 1, para. 1; and pg. 1395, Table 1 for description of strain DC29). Cultures were carried out in 2-L reactors containing one liter of mineral culture medium. The high cell density culture consisted of three phases: an exponential growth phase, which started with the inoculation of the fermenter and lasted until exhaustion of the carbon substrate (glycerol 17.5 g/L), a 5-h fed-batch with a high glycerol feeding rate of 4.5 g/L/h, and a 25-h fed-batch phase with a lower glycerol feeding rate of 2.7 g/L/h (pg. 1398, column 2, para. 2).
Drouillard et al. does not show: 1) a lactose-accepting α-2,6-sialyltransferase which comprises an amino acid sequence that is at least 25% identical over a stretch of at least 100 amino acids to the amino acid sequence as represented by SEQ ID No. 1 [species election] [Claim 9].
Wang et al. as evidenced by STIC sequence search addresses some of the limitations of claim 9.
Regarding claim 9, pertaining to a lactose-accepting α-2,6- sialyltransferase which comprises an amino acid sequence that is at least 25% identical over a stretch of at least 100 amino acids to the amino acid sequence as represented by SEQ ID No. 1 [species election],
Wang et al. shows the capsular polysaccharide synthesis (cps) locus of Streptococcus suis. Twenty-nine open reading frames related to transcriptional regulation, glycosyl transfer, oligosaccharide repeat unit polymerization, polysaccharide transport, sialic acid synthesis and modification were identified (pg. 403, Abstract). cps2E were identified as sialic acid genes (pg. 405, column 1, last line thru column 2, lines 1-3). According to the genes involved in capsular synthesis of S. suis serotype 16, its capsule is synthesized by Wzy (oligosaccharide repeat unit polymerase)-dependent mechanism (pg. 405, column 2, para. 3 [nexus to Drouillard et al.- genes/proteins related to sialic acid and oligosaccharide synthesis]).
Wang et al. does not show that one of the identified and deposited polypeptides belonging to the cps locus is a lactose-accepting α-2,6-sialyltransferase which comprises an amino acid sequence that is at least 25% identical over a stretch of at least 100 amino acids to the amino acid sequence as represented by SEQ ID No. 1, with regard to claim 9.
STIC sequence search shows that "Result 1" describes EMBL entry# E9NQ24 as being 100% identical to the amino acid sequence of instant SEQ ID NO.: 1 [species election] (pg. 1, Query match 100.0). This Result 1 entry is associated with Wang et al. as cited above (pg. 2). The 100% query match (of instant SEQ ID NO.: 1 and E9NQ24 of Wang et al.) is shown on page 3. The EMBL deposit submission (as BAM94559.1, and cited on pg. 2, line "RN") identifies the gene/protein (E9NQ24) as a sialyltransferase (pg. 4).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the method for producing 6'-sialyllactose in a cell, comprising providing a cell engineered to possess a lactose-accepting α-2,6-sialyltransferase, as shown by Drouillard et al., by using an α-2,6-sialyltransferase which has an amino acid sequence that is at least 25% identical over a stretch of at least 100 amino acids to the amino acid sequence as represented by SEQ ID NO.: 1 [species election] [Claim 9], as shown by Wang et al. as evidenced by STIC sequence search, with a reasonable expectation of success, because Wang et al. as evidenced by STIC sequence search shows a sialyltransferase which is 100% identical to the amino acid sequence of instant SEQ ID NO.: 1 (MPEP 2143 (I)(G)).
Although the α-2,6-sialyltransferase shown by Drouillard et al. is not described as a "lactose-accepting" α-2,6-sialyltransferase, it would have been obvious to one of ordinary skill in the art to have understood that the α-2,6-sialyltransferase shown by Drouillard et al. is lactose-accepting, because the production of a sialyllactose requires the transfer of sialic acid to a substrate comprising lactose via a sialyltransferase enzyme. Drouillard et al. shows the addition of lactose to the culture medium of the described engineered cell above (pg. 1398, column 1, para. 1).
One of ordinary skill in the art would have been motivated to have made that modification, because Drouillard et al. teaches that oligosaccharides with α-(2→3) and α-(2→6) linkages are present in high concentrations in human milk and are believed to protect breast-fed infants from infections. Supplementing infant formula with synthetic human milk oligosaccharides has been considered as a way to improve infant nutrition (pg. 1394, column 1, para. 1). That is, one of ordinary skill in the art of improving the therapeutic potential of (cow-based) infant milk would have been motivated to have supplemented said infant milk with 6'-sialyllactose and other oligosaccharides identified as anti-infective agents. Drouillard et al. shows a method for improving the production yield and purity of 6'-sialyllactose (MPEP 2143 (I)(G)).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Drouillard et al. further addresses the limitations of claims 10, 11 and 12.
Regarding claim 10, pertaining to glycerol,
Drouillard et al. shows that the high cell density culture of the described engineered cell consisted of three phases: an exponential growth phase, which started with the inoculation of the fermenter and lasted until exhaustion of the carbon substrate (glycerol 17.5 g/L), a 5-h fed-batch with a high glycerol feeding rate of 4.5 g/L/h, and a 25-h fed-batch phase with a lower glycerol feeding rate of 2.7 g/L/h (pg. 1398, column 2, para. 2).
Regarding claim 11, pertaining to lactose,
Drouillard et al. shows that in the experiment with a continuous lactose supply, lactose was added at a concentration of 2 g/L and was then continuously fed at a rate of 0.52 g/L/h for 5 h, followed by a rate of 0.3 g/L/h for 42 h (pg. 1398, column 2, para. 2).
Regarding claim 12, pertaining to recovered from the bacterial cell,
Drouillard et al. shows that, after the first purification step, a cell fraction containing 6'-sialyllactose and 6-6'-disialyllactose was recovered from the intracellular fraction of a 1L culture of strain DC29. From this fraction, size exclusion chromatography was used to purify 6'-sialyllactose from 6-6'-disialyllactose (pg. 1399, column 1, last para. thru column 2, lines 1-2).
Conclusion
No claims are allowed.
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
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/SMP/Examiner, Art Unit 1651
/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651