DETAILED ACTION
Status of the Application
Claims 1-26 and 33-36 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A preliminary amendment filed on
A preliminary amendment filed on 10/01/2024 amending claims 3-5, 7-9, 11, 13-15, 17-20, 25-26, 33-36 and cancelling claims 27-32 and 37-39 is acknowledged.
Applicants’ election with traverse of Group I, claims 1-24 drawn in part to mRNAs that encode for a UGT1A1 polypeptide that has a 5’ UTR designed to increase the half-life of the mRNA in a communication filed on 06/29/2026 is acknowledged.
Applicants’ traverse is on the grounds that the claims of Groups II and III depend from claim 1, such that all claims of Group I, II and III require an mRNA comprising a 5’ untranslated region comprising the nucleotide sequence of SEQ ID NO: 50 and an open reading frame encoding a human uridine diphosphate glycosyltransferase 1 family, polypeptide A1 (UGT1A!) polypeptide. There is no basis to place this exact same subject matter into different restriction groups. This is found persuasive, and Group I, claims 1-24, Group II, claim 25 and Group III, claim 26, will be examined. The Examiner has demonstrated that the composition and method groups lack unity of invention, as such restriction is proper.
The requirement is still deemed proper and is therefore FINAL.
Claims 33-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 06/29/2026.
Claims 1-26 are under consideration and are being examined herein.
Priority
The instant application is a 371 national stage application of PCT/US2022/034449 filled on 06/22/2022 and claims domestic priority under 35 U.S. C. 119(e) to provisional application No.63/213,511 filed on 06/22/2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10/01/2024 and 06/29/2026 are acknowledged. The submissions 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 are objected to because Fig. 3 is illegible. It is hard to differentiate between the different lines as the The Examiner interprets this as total bilirubin 7 and 3 days before the administration of the single intravenous dose of UGT1A1-LNP. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 4 is 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.
As stated in MPEP 2111.01, during examination, the claims must be interpreted as
broadly as their terms reasonably allow. Claim 4 is directed to the mRNA of claim 1, wherein the ORF is at least 75% identical to the nucleotide sequence of SEQ ID NO: 2.
Claim 4 recites the mRNA of claim 1, wherein the ORF is at least 75% identical to SEQ ID NO:2, but the specification does not reasonably convey possession of the full breadth of mRNA encompassed by the claim. The disclosure appears to support, at most, a specific exemplified nucleotide sequence for the ORF (SEQ ID NO: 2) and does not show possession of the claimed genus. The claim encompasses a large genus of mRNA that can up to 400 nucleotide modifications within SEQ ID NO: 2
(
(
400
=
0.25
×
1599
)
; SEQ ID NO: 2 has 1599 nucleotides). Not all the possible mRNA in which the claim encompasses would encode for a protein that has the same function as human uridine diphosphate glycosyltransferase. Therefore, the specification does not reasonably convey possession of the full scope of mRNA encompassed by the claim.
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 3 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.
Claim 3 is indefinite in the recitation of “sequence of any one of SEQ ID NO: 114”. SEQ ID NO: 114 is a single sequence and the claim as written reads as a plurality of sequences. Correction is required.
Claim Rejections - 35 USC § 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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claims 1-26 are rejected under 35 U.S.C. 103 as being obvious over Martini et al. (WO2020/056239 A1, published 03/19/2020), in view of Benenato et al. (WO2021/247535 A1, with a priority date of 06/01/2020).
The applied references have a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Martini et al. teaches a mRNA comprising a 5’ UTR, an open reading frame encoding a human uridine diphosphate glycosyltransferase 1 family, polypeptide A1 (UGT1A1) polypeptide with a nucleic acid sequence with 100% sequence identity SEQ ID NO: 2 of the instant application (see claim 23 and alignment of SEQ ID NO: 2 of the instant application and SEQ ID NO: 2 of WO2020/056239 A1), a stop codon and a 3’ UTR. Martini et al. teaches the UGT1A1 polypeptide comprises 100% sequence identity to SEQ ID NO: 1 of the instant application (see claim 24 and alignment of SEQ ID NO: 1 of the instant application and SEQ ID NO: 1 of WO2020/056239 A1). Martini et al. teaches a mRNA having a 3’ UTR that has 100% sequence identity to SEQ ID NO: 114 of the instant application (see claim 31 and alignment of SEQ ID NO: 114 of the instant application and SEQ ID NO: 178 of WO2020/056239 A1). Martini et al. teaches the polynucleotide sequence comprising an mRNA encoding a UGT1A1 polypeptide with a 5’ cap and an example of the cap is Cap1 (see paragraph [0121], pg. 31). Martini et al. teaches a polynucleotide sequence comprising an mRNA encoding a UGT1A1 polypeptide with a poly-A tail region (see paragraph [0121, pg. 31). Martini et al. teaches the poly-A tails can be between 80 to approximately 250 residues long (see paragraph [0329], pg. 97). Martini et al. teaches the mRNA comprises at least one chemically modified nucleobase, sugar, backbone, or any combination thereof (see claim 38, pg. 307). Martini et al. teaches the polynucleotide wherein, the chemically modified nucleobase is selected from the group consisting of pseudouracil (Ψ), Nl-methylpseudouracil (m1Ψ), 1-ethylpseudouracil, 2-thiouracil (s2U), 4' -thiouracil, 5-methylcytosine, 5-methyluracil, 5-methoxyuracil, and any combination thereof (see claim 39, pg. 307). Martini et al. teaches in some instances, at least about 25%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least
about 80%, at least about 90%, at least about 95%, at least about 99%, or 100% of the
uracils are chemically modified to N1-methylpseudouracils (see paragraph [0021], pg. 6). Martini et al. teaches in some embodiments; the 5' terminal cap comprises Cap1 and all of the
uracils of the polynucleotide are N1-methylpseudouracils (see paragraph [0040], pg. 9). Martini et al. teaches that in some embodiments, the poly-A region is 100 nucleotides in length (see paragraph [0041], pg. 9). Martini et al. teaches a pharmaceutical composition comprising the mRNA encoding UGT1A1 polypeptide and the formulation of cells in pharmaceutically acceptable carriers (see claim 2, pg. 302, paragraph [0693], pg. 190) and a lipid nanoparticle delivery agent (see claim 21, pg. 304).
Martini et al. does not teach the poly-A region comprising A100-UCUAG-A20-inverted deoxy-thymidine.
Benenato et al. teaches an mRNA with a 5’ UTR that has 100% identity to SEQ ID NO: 50 of the instant application (see sequence alignment of SEQ ID NO: 50 of the instant application and SEQ ID NO: 50 of Benenato et al. below). Benenato et al. teaches that the mRNA has a 5’ UTR that confers an increased half-life, increased expression and/or increased activity (pg. 16, lines 20-25). Benenato et al. teaches the use of natural 5’ caps and 5’ cap analogues (see Example 6, pg. 100). Benenato et al. teaches the mRNA comprises a poly-A region approximately 80 to approximately 250 residues long (see pg. 49, Poly-A Tails). Benenato et al teaches the poly-A region having the sequence of A100-UCUAG-A20-inverted deoxythymidine (see SEQ ID NO: 211 and pg. 52, lines 15-17). Benenato et al. teaches the mRNA comprises at least one chemically modified nucleobase, e.g., N1-methylpseudouracil or 5-methoxyuracil and in certain embodiments all uracils in the mRNA are N1-methylpseudouracils (see pg. 10, lines 25-29). Benenato et al. teaches the poly-A tail is 100 nucleotides in length and all uracils of the mRNA are N1-methylpseudouracils (see pg. 49 and SEQ ID NO: 195 and claim 10). Benenato et al. teaches a lipid nanoparticle comprising the mRNA (see claims 1-13).
Benenato et al. does not teach the open reading frame encoding a human uridine diphosphate glycosyltransferase 1 family, polypeptide A1 (UGT1A1) polypeptide.
Alignment of SEQ ID NO: 2 of the instant application and SEQ ID NO: 2 of WO2020/056239 A1:
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221
725
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Alignment of SEQ ID NO: 1 of the instant application and SEQ ID NO: 1 of WO2020/056239 A1:
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784
722
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Alignment of SEQ ID NO: 114 of the instant application and SEQ ID NO: 178 of WO2020/056239 A1:
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382
735
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Claim 1 is directed to a messenger RNA (mRNA) comprising a 5' untranslated region (UTR) comprising the nucleotide sequence of SEQ ID NO:50 and an open reading frame (ORF) encoding a human uridine diphosphate glycosyltransferase 1 family, polypeptide Al (UGTlA1) polypeptide. Claim 2 is directed to the mRNA of claim 1, wherein the UGT1A1 polypeptide comprises the amino acid sequence of SEQ ID NO:1. Claim 3 is directed to the mRNA of claim 1, wherein the mRNA comprises a 3' UTR, said 3' UTR comprising a nucleotide nucleic acid sequence at least 90% identical to the nucleotide sequence of any one of SEQ ID NO:114. Claim 4 is directed to the mRNA of claim 1, wherein the ORF is at least 75% identical to the nucleotide sequence of SEQ ID NO:2. Claim 5 is directed to the mRNA of claim 1, wherein the mRNA comprises a 5' terminal cap. Claim 6 is directed to the mRNA of claim 5, wherein the 5' terminal cap comprises a m7G-ppp-Gm-AG, Cap0, Cap1, ARCA, inosine, N1-methyl-guanosine, 2'-fluoro-guanosine, 7-deaza-guanosine, 8- oxo-guanosine, 2-amino-guanosine, LNA-guanosine, 2-azidoguanosine, Cap2, Cap4, 5' methylG cap, or an analog thereof. Claim 7 is directed to the mRNA of claim 1, wherein the mRNA comprises a poly-A region. Claim 8 is directed to the mRNA of claim 7, wherein the poly-A region is at least 10 nucleotides in length. Claim 9 is directed to the mRNA of claim 7, wherein the poly-A region is 10 to 200 nucleotides in length. Claim 10 is directed to the mRNA of claim 7, wherein the poly-A region comprises A100-UCUAG- A20-inverted deoxy-thymidine. Claim 11 is directed to the mRNA of claim 1, wherein the mRNA comprises at least one chemically modified nucleobase, sugar, backbone, or any combination thereof. Claim 12 is directed to the mRNA of claim 11, wherein the at least one chemically modified nucleobase is selected from the group consisting of pseudouracil (y), N1-methylpseudouracil (mly), 1- ethylpseudouracil, 2-thiouracil (s2U), 4'-thiouracil, 5-methylcytosine, 5-methyluracil, 5- methoxyuracil, and any combination thereof. Claim 13 is directed to the mRNA of claim 11, wherein at least 25% of the uracils are chemically modified to N1-methylpseudouracils. Claim 14 is directed to the mRNA of claim 1, comprising the nucleotide sequence of SEQ ID NO: 3. Claim 15 is directed to a messenger RNA (mRNA) comprising: (i) a 5'-terminal cap; (ii) a 5' untranslated region (UTR) comprising the nucleotide sequence of SEQ ID NO:50; (iii) an open reading frame (ORF) encoding the uridine diphosphate glycosyltransferase 1 family, polypeptide Al (UGT1A1) polypeptide of SEQ ID NO:1, wherein the ORF comprises the nucleotide acid sequence of SEQ ID NO:2; (iv) a 3' UTR comprising the nucleotide sequence of SEQ ID NO:114; and (vi) a poly-A-region. Claim 16 is directed to the mRNA of claim 15, wherein the 5' terminal cap comprises a m7G-ppp-Gm- AG, Cap0, Cap1, ARCA, inosine, N1-methyl-guanosine, 2'-fluoro-guanosine, 7-deaza- guanosine, 8-oxo-guanosine, 2-amino-guanosine, LNA-guanosine, 2-azidoguanosine, Cap2, Cap4, 5' methylG cap, or an analog thereof. Claim 17 is directed to the mRNA of claim 15, wherein the poly-A region is at least 10 nucleotides in length. Claim 18 is directed to the mRNA of claim 15, wherein the poly-A region is 10 to 200 nucleotides in length. Claim 19 is directed to the mRNA of claim 15, wherein the poly-A region comprises A100-UCUAG-A20-inverted deoxy-thymidine. Claim 20 is directed to the mRNA of claim 15, wherein the mRNA comprises at least one chemically modified nucleobase, sugar, backbone, or any combination thereof. Claim 21 is directed to the mRNA of claim 20, wherein the at least one chemically modified nucleobase is selected from the group consisting of pseudouracil (y), N1-methylpseudouracil (mly), 1- ethylpseudouracil, 2-thiouracil (s2U), 4'-thiouracil, 5-methylcytosine, 5-methyluracil, 5- methoxyuracil, and any combination thereof. Claim 22 is directed to the mRNA of claim 15, comprising the nucleotide sequence of SEQ ID NO:3. Claim 23 is directed to the mRNA of claim 22, wherein the 5' terminal cap comprises Cap1 and all of the uracils of the polynucleotide are N1-methylpseudouracils. Claim 24 is directed to the mRNA of claim 23, wherein the poly-A-region is 100 nucleotides in length. Claim 25 is directed to a pharmaceutical composition comprising the mRNA of claim 1 and a pharmaceutically acceptable carrier. Claim 26 is directed to a lipid nanoparticle comprising the mRNA of claim 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mRNA construct of Martini et al. by substituting the 5’ UTR for the 5’ UTR of Benenato et al.
A person of ordinary skill in the art is motivated to substitute the 5’ UTR of Martini et al. with the 5’ UTR of Benenato et al. because Benenato et al. teaches the 5’ UTR has an increased half-life, increased expression and/or increased activity.
One of ordinary skill in the art has a reasonable expectation of success because the proposed modification is known in the art to increase the half-life, increase expression or increase activity of other mRNAs. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.disclosed,at the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 5 11, and 25-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 128, 130, and 135, 141-144 of copending Application No. 18/012,094 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, claims 128, 130 and 135 of ‘094 recites an mRNA encoding a polypeptide comprising a 5’ UTR comprising a nucleotide sequence at least 95% and 98% identical to the sequence of SEQ ID NO: 1. SEQ ID NO: 1 is a 100% match to SEQ ID NO: 50 (see alignment below). Thus, claims 128, 130 and 135 of ‘094 are drawn to the same subject matter as instant claim 1.
Alignment of SEQ ID NO: 50 of the instant application and SEQ ID NO: 1 of ‘094.
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217
733
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Regarding claim 5, claim 141 of ‘094 recites the mRNA comprises at least one 5’ cap structure. Thus claim 141 of ‘094 is drawn to the same subject matter as instant claim 5.
Regarding claim 11, claim 142 of ‘094 recites wherein the mRNA comprises at least one chemical modification. Thus claim 142 of ‘094 is drawn to the same subject matter as instant claim 11.
Regarding claim 25, claim 144 of ‘094 recites a pharmaceutical composition comprising the LNP composition of claim 143. Thus claim 144 of ‘094 is drawn to the same subject matter as instant claim 25.
Regarding claim 26, claim 143 of ‘094 recites a lipid nanoparticle composition comprising a polynucleotide of claim 128. Thus claim 143 of ‘094 is drawn to the same subject matter as instant claim 26.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALTON KIEFER, PhD whose telephone number is (571)272-1235. The examiner can normally be reached M-F 7:30-5 EST.
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/DALTON EDWARD KIEFER/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
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