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 .
Application Status
Applicant’s remarks, and amendments to the claims, specification, and sequence listing filed June 2, 2026 are acknowledged. Claims 1 and 103 were amended. 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Claims 31-32, 36, 38, 40, 61, 72, and 90 remain withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions.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Withdrawn Rejections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 specification resolve objections (I) and (II) to the specification described in the prior action. The amendments to the claims resolve the § 112(a) and § 112(b) rejections raised in the prior action. The aforementioned objections to the specification and rejections are withdrawn, accordingly.
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: 3 or 4 recited in instant claim 1. The first disclosure of SEQ ID NOs: 3 and 4 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 specification filed June 2, 2026 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)-(II) below (updated from objections designated (III) and (IV) in the prior action, respectively). 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).
The original disclosure sets forth SEQ ID NO: 12 as corresponding to a “Modified PspST (ST6GAL1 signal peptide), nt” (see [0249] of specification filed June 19, 2024). Relative to the original disclosure, the description of SEQ ID NO: 12 recites “Modified PspST (ST6GAL1 signal peptide-PspST-P2A-B4GALT1), nt.” The amended description is not explicitly set forth in the original disclosure. The original disclosure was also reviewed to determine whether the description has inherent support in the original disclosure.
The original disclosure appears to associate the term “PspST” with the nucleotide sequence set forth in SEQ ID NO: 11 ([0249]). The original disclosure also appears to associate the term “B4GALT1” with the nucleotide sequence set forth in SEQ ID NO: 14. The nucleotide sequence of SEQ ID NO: 12, while associated with the descriptors “PspST” and “B4GALT1,” does not comprise the sequence set forth in SEQ ID NO: 11 or SEQ ID NO: 14. See attached alignments in Appendix I.
Taken together, the amendments change the description of SEQ ID NO: 12 to a description which is neither explicitly set forth in the original disclosure, nor inherent to the SEQ ID NO based on the sequences associated with the descriptors in the original disclosure.
The original disclosure recites “In such embodiments, the first nucleic acid comprises a nucleotide sequence as set forth in SEQ ID NO: 12 or SEQ ID NO: 13” (see [051] of specification filed June 19, 2024). Relative to the original disclosure, the amended specification recites “In such embodiments, the first nucleic acid comprises 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” ([0051]).
The original disclosure sets forth that the first nucleic acid which encodes the sialyltransferase catalytic peptide comprises SEQ ID NOs: 12 or 13 ([0051]; [00158]). 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 ([0045]; [0149]-[0151]).
The original disclosure does not, however, set forth or suggest that the first nucleic acid comprises both the sialyltransferase catalytic peptide and the galactosyltransferase catalytic peptide, or (under an alternative interpretation of the amended phrase), that the first nucleic acid comprises the sialyltransferase catalytic peptide, and the galactosyltransferase catalytic peptide comprises a nucleotide sequence as set forth in SEQ ID NO: 12 or 13. Furthermore, the amended phrase is incongruent with phrases which describe the original disclosure’s scope of “first nucleic acid” and SEQ ID NOs: 12-13 (see paragraphs [0047]; [0051]; [0156]-[0158]; [0249]).
Applicant is required to cancel the new matter in the reply to this Office Action. Specifically, Applicant is required to submit a substitute specification cancelling the new matter.
Response to Remarks - Objection to the Specification
Applicant’s remarks regarding the objections to the specification have been reviewed. As described above, Applicant’s amendments to the disclosure resolve objection (I) and (II) described in the prior action. Applicant’s amendments and remarks also partially resolve the issues raised in objection (III), i.e., those related to the annotations of SEQ ID NOs: 3-4, and 13 in paragraph [0249]. Applicant’s amendments and remarks are not sufficient to resolve the issues raised in objection (III) related to SEQ ID NO: 12, because, as described above and in contrast to Applicant’s assertions, SEQ ID NO: 12 does not contain “the nucleotide sequence[] of… the PspST,” which is understood to refer to SEQ ID NO: 11, or “the nucleotide sequence[] encoding the… B4GALT1 (SEQ ID NO: 14).” Applicant’s amendments also only partially resolve the issues raised in objection (IV) in the prior action. While Applicant asserts that “the amendments have been restored” with respect to objection (IV), as described above the specification still contains a phrase which is not supported by the original disclosure.
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.
Claims 1, 3-4, 9, 12, 14, 24, 28, and 103 are 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 rejections that follow are new and necessitated by Applicant’s amendments to the claims and amendments to the disclosure to modify the sequence set forth in SEQ ID NO: 11.
Claim 1 recites a CHO cell which “expresses an exogenous sialyltransferase catalytic peptide and an exogenous galactosyltransferase catalytic peptide… expressed in a single transcript; wherein the CHO cell expresses SEQ ID NO: 3 or SEQ ID NO: 4.” Based on the disclosure, both SEQ ID NOs: 3 and 4 comprise an amino acid sequence corresponding to a sialyltransferase catalytic peptide (“PspST”) and an amino acid sequence corresponding to a galactosyltransferase catalytic peptide (“B4GALT1”), linked via an amino acid sequence corresponding to P2A ([0249]). Thus, it would appear that the previously recited “exogenous sialyltransferase catalytic peptide and [] exogenous galactosyltransferase catalytic peptide… expressed in a single transcript” may refer to SEQ ID NOs: 3 or 4 which provides these elements, such that a CHO cell need only express SEQ ID NO: 3 or 4 to meet the scope of claim 1.
However, claim 9 recites that the CHO cell comprises “a first nucleic acid encoding the exogenous sialyltransferase catalytic peptide,” “wherein the first nucleic acid comprises SEQ ID NO: 11.” The nucleic acid sequence set forth in SEQ ID NO: 11, when translated, does not correspond to the amino acid sequences set forth in either SEQ ID NO: 3 or SEQ ID NO: 4. See alignments in Appendix II. In view of claim 9, it is no longer clear whether the “exogenous sialyltransferase catalytic peptide and [] exogenous galactosyltransferase catalytic peptide… expressed in a single transcript” recited in claim 1 may correspond to the sequences set forth in SEQ ID NOs: 3 and 4. It would appear that the CHO cell of claim 1 must, at a minimum, “express SEQ ID NO: 3 or SEQ ID NO: 4,” and also express a separate “exogenous sialyltransferase catalytic peptide and [] exogenous galactosyltransferase catalytic peptide… expressed in a single transcript.” The minimum structures required of claim 1 are not clear, because it is no longer clear how or if the structures recited in claim 1 relate to one another in view of dependent claim 9. Thus, claim 1 is rendered indefinite.
Claims 3-4, 9, 12, 14, 24, 28, and 103 are rejected for depending from claim 1 and failing to remedy the indefiniteness.
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.
Claim Rejections - 35 USC § 112(d)
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 3 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. The rejection that follows is new.
Claim 3 recites that the “first nucleic acid and the second nucleic acid” encoding the catalytic peptides of claim 1, “are transcriptionally controlled by the same promoter.” The catalytic peptides of claim 1 are “expressed in a single transcript.” Based on the specification ([0045]), the first and second nucleic acid, by virtue of being expressed in a single transcript, are necessarily transcriptionally controlled by the same promoter. Therefore, claim 3 fails to further limit the subject matter of the claim upon which it depends.
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 § 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 to the claims.
Claim 1 has been amended to recite “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 CHO cell expresses SEQ ID NO: 3 or SEQ ID NO: 4.
Applicant’s remarks indicate that support for the amendments to the claims are found in [0158] and [0167] of the specification. These paragraphs disclose cells comprising a first nucleic acid comprising a nucleotide sequence as set forth in SEQ ID NO: 12 or SEQ ID NO: 13, and cells wherein the sialyltransferase catalytic peptide comprises an amino acid sequence as set forth in SEQ ID NO: 3 or 4. The paragraphs provide support for cells comprising SEQ ID NO: 3, 4, 12, or 13. The proffered paragraphs do not appear to provide support, however, for a CHO cell comprising “SEQ ID NO: 3 or SEQ ID NO: 4,” and also a separate “exogenous sialyltransferase catalytic peptide and [] exogenous galactosyltransferase catalytic peptide… expressed in a single transcript,” as interpreted herein based on the amended claims as described in paragraph 10 above. The disclosure as a whole was reviewed. No support for such a CHO cell was found. Accordingly, the newly introduced limitations fail to comply with the written description requirement.
Claims 3-4, 9, 12, 14, 24, 28, and 103 are rejected for encompassing the new matter introduced to claim 1, and failing to remedy the written description issues therein.
Conclusion
No claims are allowed.
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/JENNA L PERSONS/Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637
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