DETAILED ACTION
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. Applicant’s Request for Continued Examination, Amendment and Arguments/Remarks received on 19 May 2026 have been entered. Claims 2-16 were previously pending in the application. No claims have been cancelled, and no new claims have been added by Applicant. Claims 2-16 are currently pending in the application. Claim 2 is an independent claim.
The following election of species remains in effect in the instant application:
1) B4galt2 is additionally inactivated.
Claims 5-13 remain withdrawn from consideration as being directed to a nonelected species, there being no allowable generic or linking claim.
Claims 2-4 and 14-16 are currently pending and under examination in the instant application. An action on the merits follows.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
The present application is a DIV of U.S. Application No. 15/534,735, filed 09 June 2017, now U.S. Patent No. 10,858,671, which is a 371 pf PCT/DK2015/050391, filed 11 December 2015, claims priority to U.S. Provisional Application Nos. 62/091,056, filed 12 December 2014, and 62/193,403, filed 16 July 2015.
Thus, the earliest possible priority for the instant application is 12 December 2014.
Information Disclosure Statement
The information disclosure statement filed 19 May 2026 has been considered by the Examiner. Examiner notes the filing of IDS Size Fee assertions for the IDS filed 19 May 2026, as required under 37 CFR 1.98, indicating that no IDS size fee is required under 37 CFR 1.17(v) at this time.
37 CFR 1.821-1.825
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2), see for example specification filed 19 August 2025 page 134 lines 18-19 and 32; page 135 lines 1, 15, 16; Table 4 on pages 140-150; and Table 5 on pages 150-151. However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below and on the Notice to Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures which is attached to this communication.
Specifically, specification page 134 lines 18-19 and 32; page 135 lines 1, 15, 16; Table 4 on pages 140-150; and Table 5 on pages 150-151 disclose amino acid and/or nucleotide sequences but do not include any sequence identifiers. If the unidentified sequences of specification page 134 lines 18-19 and 32; page 135 lines 1, 15, 16; Table 4 on pages 140-150; and Table 5 on pages 150-151 are included in the submitted sequence listing, Applicant must amend the claims and specification and/or drawings to comply with the sequence identification requirements. Alternatively, if the unidentified sequences of specification page 134 lines 18-19 and 32; page 135 lines 1, 15, 16; Table 4 on pages 140-150; and Table 5 on pages 150-151 are not included in the presently submitted sequence listing, Applicant must submit an updated sequence listing in compliance with 37 CFR 1.821(c)-(d) and 37 CFR 1.825(b). See also the attached Notice to Comply.
APPLICANT IS GIVEN A THREE MONTH EXTENDABLE PERIOD WITHIN WHICH TO COMPLY WITH THE SEQUENCE RULES, 37 CFR 1.821-1.825. Failure to comply with these requirements will result in ABANDONMENT of this application under 37 CFR 1.821 (g). Extension of time may be obtained by filing a petition accompanied by the extension fee under the provisions of 37 CFR 1.136. In no case may an applicant extend the period for response beyond the six month statutory period. Applicant is requested to return a copy of the attached Notice to Comply with the response.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, including into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The use of the terms “Jupiter C4”, “Coomassie”, and “EX-CELL CHO CD Fusion serum” on page 129; “2100-Bioanalyser”, “Illumina HiSeq 2000 System” on page 130; “TOPO” on page 131; “Zeocin” on page 132; “Coomassie”, “SysBioware”, “OrbiTrap”, and “EASY-Spray” on page 133; “ComposR” on page 134; “MilliQ”, “NuPage”, “HiMark HMW”, “SimplyBlue SafeStain”, “Coomassie”, “GelQuant”, “Zorbax 300SB-C3” on pages 136-137, which is/are a trade name(s) or a mark(s) used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Note that the specification has not been inspected sufficiently to identify all instances of trade names and/or marks used in commerce. It is Applicant’s responsibility to ensure complete compliance.
Claim Objections
The objection to amended independent claim 2 for a typographical error is withdrawn in view of the amendment to claim 2.
Amended independent claim 2 is newly objected to because of the following informalities: amended independent claim 2 recites, “wherein the galactosylation genes, beta-1,4-galactosyltransferase 1 (B4galt1) and beta-1,4-galactosyltransferase 3 (B4galt3) are inactivated in the cell” in lines 1-3, which appears to either have an extra comma after “genes” or be missing a comma after “(B4galt3)”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
The rejection of amended and previously presented claims 2-4 and 14-16 under 35 U.S.C. 103 as being unpatentable over Lin et al. (WO2015/134488A1: Priority to 03/04/2014), in view of Rossomando et al. (WO2013013013A2) and Lo et al. 1998, Glycobiology, 8(5), 577-526, is maintained. Applicant's amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
Applicant amended to claims to address minor typographical errors and issues of indefiniteness which have not altered the scope of the claim to overcome a finding of obviousness under 35 U.S.C. 103 over Lin in view of Rossomando and Lo.
Applicant argues that the abolished galactosylation resulting from specific KO of B4galt1 and B4galt3 alone as shown in Figures 1D, 17, 21A, 22, and 36 is surprising and unpredictable, and that even though a single knockout of B4galt1 is able to completely abolish IgG galactosylation, IgG’s represent a unique case wherein IgGs have a galactosylation site that is less exposed, leading to less complex galactosylation. As such, KO of B4galt1/3 is therefore not needed for a complete loss of galactosylation in IgGs specifically, but that this observation does not mean that the B4galt1/3 KO combination is not relevant for resulting in complete loss of galactosylation for other proteins. As such, the skilled person could not have had a reasonable expectation of success in arriving at the presently claimed invention.
However, this is not agreed.
As discussed in the prior action, the data presented in Figures 1D, 17, 21A, 22, and 36 present galactosylation data for two different proteins- EPO and IgG in CHO cells, wherein whereas loss of galactosylation of EPO in CHO cells or CHO-GS cells was maximal with a double mutation of B4galt1/3 KO (Figure 1D), complete loss of galactosylation of an IgG in CHO cells was achieved with the single KO of B4galt1 (Figure 22). Therefore, the data presented for IgG, which Applicant asserts is an exemption to the general applicability of the claimed invention, represents one of only two examples provided by the Applicant. As such, the data presented in the disclosure provides only one example of a protein whose galactosylation is decreased more in the B4galt1/3 double knockout compared to single B4galt1 knockdown, which is not representative of all possible non-IgG proteins nor convincing evidence that IgG represents the exception. Note additionally that the claimed invention merely recites a mammalian cell comprising the B4galt1/3 double inactivation and does not claim any particular targets for loss of galactosylation, IgG or otherwise. Further, claim 16 recites wherein the cell further comprises EPO, an IgG antibody, a protein involved in hemostasis, or a coagulation factor. Accordingly, the claims indicate the relevance of the IgG protein for the instant invention and do not suggest that the IgG target presented in the data should be considered as an irrelevant edge case.
As also discussed in the prior action, the scope of the claims as written is not commensurate with the data presented as evidence of unexpected results in that independent claim 1 recites a mammalian cell wherein the galactosylation genes B4galt1 and B4galt3 are inactivated in the cell. Therefore, the claims as written and elected are distinct from the evidence used to support the assertion of surprising and unexpected results in that the evidence as presented includes the KO of B4galt1 alone or the double KO of B4galt1 and B4galt3 only in CHO cells or CHO-GS cells and only for EPO and a single IgG target. Again, as discussed above and in the prior action, the evidence as presented actually shows a complete loss of galactosylation with just the deletion of B4galt1 in the absence of further inactivation of B4galt3 for the IgG target in CHO cells (Figure 22), which represents half of the total of two targets tested.
Further, the loss of galactosylation resulting from knocking out B4galt1/3 would not have been unexpected in view of the teachings of the prior art. As discussed in the prior action, Lin teaches that galactosyltransferases, such as B4galT1/2/3/4/5/6/7, add a galactose residue in a beta 1,4 linkage to a GlcNAc residue of an N-linked glycan [0035]. Lin also teaches cell lines in which all copies of at least one of the galactosyltransferase genes are inactivated [0035].
Additionally, Lo teaches that B4galT1 and B4galt3 are highly expressed in a wide range of human tissue types, whereas B4galt5 is lowly expressed in a wide range of human tissue types, and B4galt2, B4galt4, and B4galt6 are only expressed in a few human tissue types tested, which Lo teaches is consistent with observations in mice [column 12 ¶ 3-4, Figure 6]. Therefore, an ordinarily skilled artisan would expect that the degree of loss of galactosylation from combinations of B4galt genes would depend on the cell type used, and the corresponding expression levels of the B4galt genes within the utilized cell types in the absence of B4galt gene inactivation. Further, given that B4galt1 and B4galt3 are the highest expressing B4galt variants, and that they are the 2 most ubiquitously expressed B4galt variants, an ordinarily skilled artisan at the time of filing the instant application would have expected that inactivation of both B4galt1 and B4galt3 would result in nearly complete loss of galactosylation in mammalian cell lines with a reasonable expectation of success.
As such, Applicant’s arguments do not overcome a finding of obvious under 35 U.S.C. 103 over Lin, Rossomando, and Lo, and the rejection of record is maintained.
Double Patenting
The provisional rejection of amended and previously presented claims 2-4 and 14-16 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, 19, 21-23, and 67-68 of copending Application No. 16/300,196, hereafter referred to as the ‘196 application, is withdrawn in view of the ‘196 application now being abandoned.
Conclusion
No claim is allowed.
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DR. KATIE L. PENNINGTON
Examiner
Art Unit 1634
/KATIE L PENNINGTON/Examiner, Art Unit 1634
Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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