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 .
Continued Examination Under 37 CFR 1.114
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. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 7, 2025 has been entered.
Improper Amended Claim Notation
The amendments to the claims filed November 7, 2025 do not comply with the requirements of 37 CFR 1.121(c) because claim 1, which is amended, is identified as “Previously Presented.” Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c)(2), which states that “All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims.”
Application Status
In the interest of compact prosecution, the Examiner will consider the claim listing on its merits. Examiner reserves the right to send a PTOL-324 Notice of Non-Compliant Amendment in the event of more severe deficiencies, which may result in loss of patent term.
Correctly annotated, claim 1 reads “1. (Currently Amended) A CHO cell for expressing a sialylated glycoprotein, wherein the cell constitutively and/or controllably expresses an exogenous sialyltransferase catalytic peptide and an exogenous galactosyltransferase catalytic peptide, wherein the exogenous sialyltransferase catalytic peptide and the exogenous galactosyltransferase catalytic peptide are expressed in a single transcript; wherein the single transcript encodes SEQ ID NO: 03 or SEQ ID NO: 04
Applicant’s remarks, and amendments to the claims, specification, and sequence listing filed November 7, 2025 are acknowledged. Claims 1, 90, and 103 were amended, and claims 7 and 102 were cancelled. Claims 1, 3-4, 9, 12, 14, 24, 28, 31-32, 36, 38, 40, 61, 72, 90, and 103 are pending.
Restriction/Election
Claims 31-32, 36, 38, 40, 61, 72, and 90 remain withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions. Claims 1, 3-4, 9, 12, 14, 24, 28, and 103 are under examination herein.
Withdrawn Rejections
The amendments to the claims resolve the § 112(b) rejections raised in the prior action. The amendments to claim 1 to require that the cell comprise a single transcript encoding SEQ ID NO: 03 or 04 are sufficient to overcome the § 103 rejections over He, Hombu, Wang (2020), Tsukamoto, and UniProt, and the aforementioned in view of Wang (2018). None of the previously cited prior art, or the prior art reviewed in the updated search, teach or suggest a cell comprising the sequences of SEQ ID NO: 03 or 04. The aforementioned rejections are withdrawn.
Applicant’s remarks and amendments to the claims have been thoroughly reviewed, but are not found persuasive to place the claims in condition for allowance for the reasons that follow. Any rejection or objection not reiterated herein has been overcome by amendment.
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, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
A thorough review of the disclosures of the prior-filed provisional applications, Application No. 63/581,389, filed September 8, 2023 and Application No. 63/639,286, filed April 26, 2024, failed to uncover support for SEQ ID NOs: 03 or 04 recited in instant claim 1. The first disclosure of SEQ ID NOs: 03 and 04 is in the instant application, filed June 19, 2024. Because all claims under examination require the limitations of instant claim 1, the effective filing date of all claims under examination is June 19, 2024.
Objection to the Specification – New Matter
The amendment filed November 7, 2025 is objected to under 35 USC 132(a) because it introduces new matter into the disclosure. 35 USC 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is described in (I)-(IV) below. The amendments do not appear to be mere rephrasing where the same meaning remains intact, or correction of obvious errors which would be recognized by the skilled artisan, and for which the appropriate correction would also be recognized. See MPEP 2163.07(I)-(II).
Based on Applicant’s remarks, the sequence listing has been amended to “replace SEQ ID NO: 11 with the partial sequence of SEQ ID NO: 12, encoding the variant… [t]his partial sequence corresponds to the 105th to 505th amino acids of the originally filed SEQ ID NO: 03 (Table B) or 114th to 514th amino acids of the originally filed SEQ ID NO: 04 (Table C) that corresponds to SEQ ID NO: 02.”
No such partial sequence of SEQ ID NO: 12 corresponding to partial sequences of SEQ ID NO: 03 or 04 is set forth in the original disclosure. In addition, SEQ ID NO: 11 is disclosed as the sequence of a reference gene in the original disclosure (“the first nucleic acid comprises a nucleotide sequence exactly the same as a reference gene; for example, the first nucleic acid might comprise a nucleotide sequence as set forth in SEQ ID NO: 10 or SEQ ID NO: 11,” [0051]). Thus, this amendment to the sequence listing substitutes the sequence of a reference gene, with a partial sequence of SEQ ID NO: 12 which is not set forth in the original disclosure, and which encodes a variant based on Applicant’s remarks (“the partial sequence of SEQ ID NO: 12, encoding the variant”).
The sequence disclosed in the specification as SEQ ID NO: 11 has also been amended in paragraph [0249] as described immediately above.
The deficiencies of the original disclosure described above for the sequence listing also apply for this amendment to the specification.
The descriptions of SEQ ID NO: 03, SEQ ID NOs: 04 and 13, and SEQ ID NO: 12 in the specification are amended to recite “Modified PspST (ST6GAL1 signal peptide-PspST-P2A-B4GALT1),” “Modified PspST (B4GALT1 signal peptide-PspST-P2A-B4GALT1),” and “Modified PspST (ST6GAL1 signal peptide-PspST-P2A-ST6GAL1),” respectively, in paragraph [0249].
As shown above, the original disclosure sets forth that SEQ ID NOs: 03-04, and 12-13 correspond to a “Modified PspST” comprising a “B4GALT1” or “ST6GAL1 signal peptide” ([0249]). The amended descriptions are not explicitly set forth in the original disclosure. The original disclosure was also reviewed to determine whether the descriptions have inherent support in the original disclosure.
The original disclosure uses the term “PspST” generically throughout; the term does not appear to correspond to any specific amino acid or nucleotide sequence (see at least paragraphs [0049]; [0051]). SEQ ID NOs: 03-04, and 12-13 set forth specific PspST amino acid and nucleotide sequences, but are associated with the generic descriptor “PspST” in the amendments. The original disclosure clearly associates the term “B4GALT1” with the amino acid sequence of SEQ ID NO: 05, and the nucleotide sequence of SEQ ID NO: 14 ([0249]). The nucleotide sequence of SEQ ID NO: 13, while associated with the descriptor “B4GALT1” in the amendments, does not comprise the sequence of SEQ ID NO: 14. The original disclosure also clearly associates the term “ST6GAL1” with the amino acid sequence of SEQ ID NO: 01, and the nucleotide sequence of SEQ ID NO: 10 ([0249]). The nucleotide sequence of SEQ ID NO: 12, while associated with the descriptor “ST6GAL1” in the amendments, does not comprise the sequence of SEQ ID NO: 10. Finally, the original disclosure clearly associates the term “P2A” with the amino acid sequence of SEQ ID NO: 06, and the nucleotide sequence of SEQ ID NO: 19 ([0249]). The nucleotide sequence of SEQ ID NO: 13, while being associated with the descriptor “P2A” in the amendments, does not comprise the sequence of SEQ ID NO: 19. See attached alignments.
Taken together, the amendments change the description of the SEQ ID NOs to descriptions which are neither explicitly set forth in the original disclosure, or inherent to the SEQ ID NOs based on the sequences associated with the descriptors in the original disclosure.
The specification has also been amended to 1) add the sentence “In certain embodiments, the single transcript encodes SEQ ID NO: 03 or SEQ ID NO: 04” in paragraph [0047], 2) strike the sentence “Yet in certain embodiments, the sialyltransferase catalytic peptide comprises an amino acid sequence as set forth in SEQ ID NO: 03 or SEQ ID NO: 04” from paragraph [0049], and 3) modify the sentence “In such embodiments, the single transcript expressing the sialyltransferase catalytic peptide and the galactosyltransferase catalytic peptide comprises a nucleotide sequence as set forth in SEQ ID NO: 12 or SEQ ID NO: 13” in paragraph [0051].
The original disclosure sets forth on multiple occasions that the sialyltransferase catalytic peptide comprises SEQ ID NOs: 3 or 4 ([0049]; [0167]), and the first nucleic acid which encodes the sialyltransferase catalytic peptide comprises SEQ ID NOs: 12 or 13 ([0051]; [00158]). Indeed, as described immediately above, the original disclosure sets forth that SEQ ID NOs: 03-04, and 12-13 correspond to a “Modified PspST” ([0249]). Based on the original disclosure, the skilled artisan would understand that the sialyltransferase catalytic peptide and first nucleic acid encoding the sialyltransferase catalytic peptide correspond to SEQ ID NOs: 03-04, and 12-13, respectively. The original disclosure also describes that the sialyltransferase catalytic peptide and galactosyltransferase catalytic peptide are encoded by a first nucleic acid and second nucleic acid, respectively, which may be expressed as a “single transcript” ([0045]; [0149]-[0151]).
The original disclosure does not, however, set forth or suggest that the “single transcript” corresponds to SEQ ID NOs: 03-04, or 12-13 as set forth in the amendments. The amendments, therefore, alter the scope of the “single transcript,” in a manner which does not appear to be a simple rephrasing, or correction of an obvious error in the specification. Furthermore, the amended phrases are incongruent with phrases still present in the disclosure which correspond to the original disclosure’s scope of “single transcript,” “first nucleic acid,” and “sialyltransferase catalytic peptide” (see paragraphs [0149]-[0151]; [0158]; [0167]).
Applicant is required to cancel the new matter in the reply to this Office Action. Specifically, Applicant is required to submit I) a replacement sequence listing which includes SEQ ID NOs: 11 and 12 as they appear in the original disclosure, and II) a substitute specification cancelling the new matter.
Claim Rejections - 35 USC § 112(a) – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-4, 9, 12, 14, 24, 28, and 103 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection necessitated by Applicant’s amendments.
MPEP 608.04(a) states that “If the new matter has been entered into the claims or affects the scope of the claims, the claims affected should be rejected under 35 U.S.C. 112(a)… on the ground that it recites elements without support in the original disclosure.”
Claim 1 has been amended to recite “wherein the single transcript encodes SEQ ID NO: 03 or SEQ ID NO: 04.” As described in paragraph 7(IV) above, the original disclosure does not provide support for a single transcript encoding SEQ ID NOs: 03 or 04 as set forth in the amendments.
Claim 9 recites “wherein the first nucleic acid comprises SEQ ID NO: 11.” As described in paragraphs 7(I) and 7(II), as amended, SEQ ID NO: 11 (i.e., a partial sequence of SEQ ID NO: 12) does not find support in the original disclosure.
Claim 103 has been amended to recite “wherein the single transcript comprises SEQ ID NO: 12 or SEQ ID NO: 13.” As described in paragraph 7(IV) above, the original disclosure does not provide support for a single transcript comprising SEQ ID NOs: 12 or 13 as set forth in the amendments.
Dependent Claims
Claims 3-4, 12, 14, 24, and 28 are rejected for depending from claim 1 and failing to remedy the deficiencies above.
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 103 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. The rejection that follows is new and necessitated by Applicant’s amendments to the claims.
Claim 1 recites that “the single transcript,” which expresses the exogenous sialyltransferase catalytic peptide and the exogenous galactosyltransferase catalytic peptide, “encodes SEQ ID NO: 03 or SEQ ID NO: 04.” Claim 103 recites that “the single transcript comprises SEQ ID NO: 12 or SEQ ID NO: 13.” Translating the nucleotide sequence of SEQ ID NO: 12 results in an amino acid sequence 100% identical to instant SEQ ID NO: 03, but only 90% identical to SEQ ID NO: 04. Translating the nucleotide sequence of SEQ ID NO: 13 results in an amino acid sequence with less than 50% identity to either of SEQ ID NOs: 03 or 04. See attached alignments.
Because only one of the nucleotide sequences clearly corresponds to an amino acid sequence encoded by the single transcript (i.e., SEQ ID NO: 12 to SEQ ID NO: 03), it is not clear how the features of SEQ ID NOs: 12 or 13 correspond to SEQ ID NOs: 03 or 04, or whether correspondence between the nucleotide sequences the single transcript must “comprise” and the amino acid sequences the single transcript must “encode” is even intended. As such, the structural features of the CHO cells encompassed by claim 103 are unclear. Specifically, it is not clear whether the claim encompasses CHO cells with a single transcript I) comprising SEQ ID NO: 12 which encodes SEQ ID NO: 03, or portions of SEQ ID NO: 04, or II) comprising SEQ ID NO: 13, which encodes portions of SEQ ID NOs: 03 and 04, or III) encoding SEQ ID NO: 03 or 04, and separately, comprising the nucleotide sequences of SEQ ID NOs: 12 or 13, or some combination of the aforementioned options.
Response to Remarks - 35 USC§ 112(b)
Applicant's arguments with respect to the§ 112(b) rejections raised in the prior action have been considered but are moot because the rejections above are new, and necessitated by Applicant's amendments to the claims.
Allowable Subject Matter
The prior art reviewed during examination does not teach or suggest a CHO cell which expresses SEQ ID NO: 03 or SEQ ID NO: 04. As described in the prior action (paragraph 14), SEQ ID NOs: 03 and 04 correspond to fusion proteins comprising a variant Photobacterium sp. JT-ISH-224 beta-galactoside alpha-2,6-sialyltransferase and human beta-1,4-galactosyltransferase connected by a ribosomal shifting peptide sequence. While the prior art renders obvious a fusion protein comprising a variant Photobacterium alpha-2,6-sialyltransferase connected to a human beta-1,4-galactosyltransferase by a ribosomal shifting peptide (i.e., P2A), the prior art does not teach or suggest any fusion proteins comprising the additional features of SEQ ID NOs: 03 or 04. Specifically, the prior art does not teach or suggest a fusion protein comprising the aforementioned elements and I) ~ 90 N-terminal amino acids of a human beta-galactoside alpha-2,6-sialyltransferase and a "GGGGS" linker (SEQ ID NO: 03), or II) ~ 90 N-terminal amino acids of the human beta-1,4-galactosyltransferase corresponding to SEQ ID NO: 05 and a "GGGGS" linker (SEQ ID NO: 04). Thus, a CHO cell expressing SEQ ID NOs: 03 or 04 is free of the prior art reviewed during examination.
Conclusion
No claims are allowed.
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/JENNA L PERSONS/Examiner, Art Unit 1637
/Soren Harward/Primary Examiner, TC 1600