DETAILED CORRESPONDENCE
Application Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s amendment to the claims filed on 06/22/2026 in response to the Non-Final Rejection mailed on 03/23/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
3. Claims 3, 37-48, and 69-72 are cancelled.
New claims 77-82 are added.
4. Claims 51, 59-65, 67-68, 73-82 are pending.
5. New claims 77-82 are drawn to methods that are dependent upon claim 65, which has been withdrawn pursuant to 37 CFR 1.142(b). Accordingly, new claims 77-82 are also withdrawn with claims 65 and 67-68 pursuant to 37 CFR 1.142(b).
6. Applicant’s remarks filed on 06/22/2026 in response to the Non-Final Rejection mailed on 03/23/2026 have been fully considered and are deemed not persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Information Disclosure Statement
7. The IDS filed on 04/14/2026 has been considered by the examiner and a copy of the Form PTO/SB/08 is attached to the office action.
Claim Rejections - 35 USC § 103
8. The rejection of claims 51, 59-64, and 73-76 under 35 U.S.C. 103 as being unpatentable over Hollands et al. (WO 2019/209241 A1, priority to 04/23/2018; cited on IDS filed on 12/21/2023) in view of Yardeni et al. (Research in Microbiology, 2018; cited on PTO-892 mailed on 12/04/2025), and Philippe et al. (WO 2019/099649 A1; priority to 11/20/2017; cited on PTO-892 mailed on 12/04/2025) as evidenced by Genbank MDFA_ECOLI (Genbank, 2018; cited on PTO-892 mailed on 12/04/2025) is maintained for the reasons of record and the reasons set forth below.
9. With respect to claim 51, Hollands et al. teach a host cell genetically modified for production of fucosyllactose, wherein the host cell comprises one nucleic acid sequence coding for a fucosyltransferase that transfers GDP-fucose to a lactose acceptor to synthesize fucosyllactose and the cell further comprises expression of a heterologous membrane protein to enhance fucosyllactose transport wherein the membrane protein is a Sugar porter or a SWEET transporter (porter protein not belonging to the SET family) [see Abstract; Figure 1; p. 2-3].
With respect to claim 53, Hollands et al. teach a host cell genetically modified for production of fucosyllactose, wherein the host cell comprises one nucleic acid sequence coding for a fucosyltransferase that transfers GDP-fucose to a lactose acceptor to synthesize fucosyllactose and the cell further comprises expression of a heterologous membrane protein to enhance fucosyllactose transport wherein the membrane protein is a Sugar porter or a SWEET transporter [see Abstract; Figure 1; p. 2-3].
With respect to claim 59, Hollands et al. teach the host cell wherein the membrane protein is a transporter protein involved in transport of compounds across the outer membrane of the cell wall [see Abstract; p. 2-3].
With respect to claim 60, Hollands et al. teach the host cell wherein the cell is cultured under suitable conditions (interpreted as stably) [see p. 3].
With respect to claim 61, Hollands et al. teach the host cell wherein the cell is selected from a microbial cell [see p. 3].
With respect to claim 62, Hollands et al. teach wherein the cell is an Escherichia coli cell [see p. 18].
With respect to claim 63, Hollands et al. teach host cell wherein the host cell comprise modification to improve the efficiency of production of fucosyllactose including improvements to carbon flux such as knocking out pathways that compete for key intermediates of the present fucosyllactose pathway [see p. 25, lines 10-16].
With respect to claim 64, Hollands et al. teach the host cell wherein the fucosyllactose is 2’-fucosyllactose [see Abstract].
With respect to claim 73, Hollands et al. teach a host cell genetically modified for production of fucosyllactose, wherein the host cell comprises one nucleic acid sequence coding for a fucosyltransferase that transfers GDP-fucose to a lactose acceptor to synthesize fucosyllactose and the cell further comprises expression of a heterologous membrane protein to enhance fucosyllactose transport wherein the membrane protein is a Sugar porter or a SWEET transporter (porter protein not belonging to the SET family) [see Abstract; Figure 1; p. 2-3]. Hollands et al. teach host cell wherein the host cell comprise modification to improve the efficiency of production of fucosyllactose including improvements to carbon flux such as knocking out pathways that compete for key intermediates of the present fucosyllactose pathway [see p. 25, lines 10-16].
With respect to claims 74-75, Hollands et al. teach a host cell further modified to express one or more genes encoding enzyme of the de novo synthesis of GDP-fucose [see Example 8].
With respect to claim 76, Hollands et al. teach the host cell further comprises introduction and/or overexpression of a lactose permease [see Example 8].
However, Hollands et al. does not explicitly teach the host cell of claims 51 and 73, wherein the membrane protein is selected from the group consisting of the specific membrane proteins recited in claims 51 and 73.
Yardeni et al. teach that E. coli MdfA is a member of a large group of secondary multidrug transporters that has the ability to interact with chemically unrelated drugs to drive efflux of compounds that are not only structurally, but also electrically, different [see Abstract; p. 455]. Evidentiary reference Genbank is cited to demonstrate that E. coli MdfA comprises an amino acid sequence that is 100% identical to the amino acid sequence of SEQ ID NO: 2 [see alignment attached as APPENDIX A].
Phillipe et al. teach genetically modified host cells, including E. coli, designed for producing sweetener compounds, steviol glycosides, and efflux of said compounds out of the host cells be expressing a transporter such as MdfA [see Abstract; p. 2, p. 6, lines 3-17]. Phillipe et al. also teach that suitable transporters include E. coli transporters sharing at least 50% identity to bcr, emrD, emrE, mdfA, mdtD, mhpT, setA, ydhC, yhhS, yjhB, and ynfM [see claim 34].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Hollands et al., Yardeni et al. and Phillipe et al. according to the teachings of Yardeni et al. and Phillipe et al. to use the bcr, emrD, emrE, mdfA, mdtD, mhpT, setA, ydhC, yhhS, yjhB, and ynfM transporters Yardeni et al. and Phillipe et al. in the host cells of Hollands et al. because Hollands et al. teach genetically modified host cells expressing an efflux porter membrane protein such as a sugar transporter or setA for the efflux of fucosyllactose. Yardeni et al. teach that E. coli MdfA is a multidrug transporter with broad specificity for a variety of structurally different compounds and Phillipe et al. teach that bcr, emrD, emrE, mdfA, mdtD, mhpT, setA, ydhC, yhhS, yjhB, and ynfM are obvious variants of transporters that can be heterologously expressed for the efflux of sweetener compounds such as steviol glycosides. One of ordinary skill in the art would have had a reasonable expectation of success and a reasonable level of predictability to combine the teachings of Hollands et al., Yardeni et al., and Phillipe et al. because Yardeni et al. acknowledges that MdfA has a broad specificity for the efflux of compounds and Phillipe et al. acknowledges that bcr, emrD, emrE, mdfA, mdtD, mhpT, setA, ydhC, yhhS, yjhB, and ynfM can be heterologously expressed in host cells for the efflux of sweeteners. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Applicants’ remarks filed on 06/22/2026 have been fully considered by the examiner; however, they are found to be not persuasive for the reasons already of record and the reasons set forth below.
Regarding applicants’ remarks that there is no reasonable expectation of success that an MdfA would successfully export fucosyllactose, MPEP 2143 states “[t]he Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. In Ball Aerosol v. Ltd. Brands, 555 F.3d 984, 89 USPQ2d 1870 (Fed. Cir. 2009), the Federal Circuit offered additional instruction as to the need for an explicit analysis. The Federal Circuit explained that the Supreme Court’s requirement for an explicit analysis does not require record evidence of an explicit teaching of a motivation to combine in the prior art.” The examiner maintains the position, that Hollands et al. identifies sugar transporters such as setA, Sugar porters and SWEET transporters as suitable for the export of fucosyllactose [see bottom of p. 2]. Yardeni et al. teach the broad substrate specificity of MdfA and Phillipe et al. teach several suitable transporters considered to be obvious variants for the export of sweetener compounds such as steviol glycosides that include SWEET, MDR, ABC family and MFS family such as bcr, emrD, emrE, mdfA, mdtD, mhpT, setA, ydhC, yhhS, yjhB, and ynfM. Given that fucosyllactose and steviol glycosides are both sweetener compounds and given that setA has already been established as a suitable transporter for fucosyllactose as taught by Hollands et al. and Phillipe et al. considers bcr, emrD, emrE, mdfA, mdtD, mhpT, setA, ydhC, yhhS, yjhB, and ynfM as obvious variants, one of ordinary skill in the art would have a reasonable expectation of success and reasonable level of predictability that these transporters could also be used for the export of fucosyllactose. This analysis is consistent with the KSR approach of “combining prior art elements according to known methods to yield predictable results” and “simple substitution of one known element for another to obtain predictable results” [see MPEP 2143A and B].
Regarding applicants’ remarks that the rejections do not establish that the membrane protein is capable of transporting fucosyllactose out of a cell, this argument is found to be not persuasive as it was already established from Philippe et al. that MdfA could export compounds out of the cell into the cell culture medium [see Philippe et al. p. 2-3].
Conclusion
10. Status of the claims:
Claims 51, 59-65, 67-68, 73-82 are pending.
Claims 65, 67-68, and 77-82 stand withdrawn pursuant to 37 CFR 1.142(b).
Claims 51, 59-64, and 73-76 are rejected.
No claims are in condition for an allowance.
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 PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656
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