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 .
DETAILED ACTION
Priority
This application is a continuation under 35 U.S.C. § 120 of U.S. Application 18/512,730, filed November 17, 2023, which claims benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 63/538,540 filed September 15, 2023, U.S. Provisional Application No. 63/460,506 filed April 19, 2023, and U.S. Provisional Application No. 63/426,597 filed November 18, 2022, that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 07/25/2025 is acknowledged. Claims 21-40 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/06/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Drawings
The drawing filed on 09/06/2024 is acknowledged and accepted by the Examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-24, 32-33 and 36-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gupta et al. “Gupta” (WO2022069577, publication date April 7, 2022; and international filing date September 29, 2021: IDS of record dated 09/06/2024).
The claims are directed to a self-amplifying RNA (saRNA) comprising: (a) a plurality of modified nucleotides, wherein at least 25% cytidines of the saRNA are modified, and the modified nucleotides are selected from 5-hydroxymethylcytidine and 5-methylcytidine, and (b) at least one cargo of interest.
Regarding claims 21-24 and 39-40, Gupta discloses self-amplifying RNA (saRNA) comprising at least 25% modified nucleotides (p. 10, para 2 Preferred embodiments of polynucleotides include ... self-amplifying RNA; p. 26, para 1 Any number (e.g., all, some, or none) of nucleobases, nucleosides, or nucleotides may be an analog of a canonical species, substituted, modified, or otherwise non-naturally occurring; p. 28, para 1 wherein the mRNA is modified with at least 50% m5C and 50% i or m1 i , preferably at least 75% m5C; p. 34, para 2), wherein the modified nucleotides comprise a pyrimidine nucleoside phosphate with a moiety on carbon 5 of the pyrimidine, wherein the moiety is selected from the group consisting of methyl, ethyl, propyl, trifluoromethyl, hydroxymethyl, hydroxyethyl, and hydroxypropyl functional
groups (p. 26, para 1, a nucleobase may be selected from the non-limiting group consisting of adenine, guanine, uracil, cytosine, 7-methylguanine, 5-methylcytosine, 5- hydroxymethylcytosine ... 5-methyluridine, deoxyadenosine, deoxyguanosine, deoxycytidine, deoxyuridine, and thymidine) or an analog thereof and may include one or more substitutions or modifications including but not limited to
alkyl, aryl, halo, oxo, hydroxyl, alkyloxy, and/or thio substitutions), and at least one cargo of interest (p. 2, para 2 a delivery vector which comprises a polynucleotide cargo coding for a fusion protein, wherein translation of the polynucleotide cargo ... importantly, the fusion protein comprises a protein of interest (POI); p. 39, para 1 As in the example above, the POI and the RNA drug molecule (i.e. the mRNA,
the self-amplifying RNA, the shRNA, or the mi RNA) can be encoded for by a single polynucleotide (for instance a DNA plasmid or any other form of polynucleotide which is capable of coding for both a protein in the form of a POI and an RNA molecule, for instance in the form of an mRNA).
Regarding claims 32-33 and 37, Gupta discloses wherein the saRNA expresses the cargo at a level greater than or equal to that of a corresponding saRNA with less than 25% modified nucleotides (p. 27, para 1 top. 28, para 1 As above mentioned, various nucleotide modifications are preferably incorporated into the mRNA to modify it for increased translation ... Among these mRNA modifications, m5C and ip are the most preferred as they reduce the immunogenicity of mRNA as well as increase the translation 1 efficiency in vivo. In preferred embodiments of the present invention, the composition herein comprises a non-viral delivery vector such as an LNP or a liposome comprising a modified mRNA as the polynucleotide cargo, wherein the mRNA is modified with at least 50% m5C ... even more preferably 100% modification using m5C).
Regarding claim 36, Gupta discloses the saRNA in a pharmaceutical composition comprising a carrier (p 13 first para).
Regarding claim 38, Gupta discloses a cell comprising the saRNA (p 12 last para).
Therefore, the cited prior art anticipates the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C.
103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 25-31 and 34-35 are rejected under 35 U.S.C. 103(a) as being unpatentable over Gupta et al. “Gupta” (WO2022069577, publication date April 7, 2022; and international filing date September 29, 2021: IDS of record dated 09/06/2024) as applied to claims 21 and 23 above, in view of Mols et al. “Mols” (WO2022157153, publication date July 28, 2022; and international filing date January 18, 2022: IDS of record dated 09/06/2024) and further in view of Kitada et al. “Kitada” (WO2022150712, publication date July 14, 2022; and international filing date January 10, 2022: IDS of record dated 09/06/2024). The teachings of Gupta are outlined above and incorporated herein.
The claims are directed to the saRNA of claim21, wherein the saRNA comprises: (a) a 5’ cap; (b) non-structural protein 1 (nsp1), non-structural protein 2 (nsp2), non-structural protein 3 (nsp3), and/or non-structural protein 4 (nsp4), each derived from at least one virus; (c) a subgenomic promoter (SGP) derived from at least one virus; (d) 5’ untranslated region (UTR) derived from at least one virus;(e) the at least one cargo of interest; (f) a 3’ unstranslated region (UTR) derived from at least one virus; and (g) a poly-A tail.
Regarding claims 25 and 27-31, Mols discloses a self-amplifying RNA (saRNA) (p. 36, In 9-11 provided a nucleic acid encoding a HSV2 Fe receptor or an immunogenic fragment or variant thereof for the use described herein wherein:- the nucleic acid is a RNA molecule (e.g. a self replicating RNA molecule); p. 78, In 14-15 "Most preferably, the RNA is a self-amplifying RNA molecule") comprising from 5' to 3': (a) al least one non-structural protein derived from at least one virus (p. 83, In 20-21 the self-replicating RNA comprises or consists of a VEEV TC-83 replicon encoding from 5' to 3' viral nonstructural proteins 1-4 (nsPl-4), followed by a subgenomic promoter, and a construct (or insert) encoding the gEgl heterodimer); (b) a subgenomic promoter (SGP) derived from at least one virus (p. 83, In 20-21 the self-replicating RNA comprises ...followed by a subgenomic promoter; p. 81, In 11-13 "suitably the 26S subgenomic promoter"); and (c) at least one cargo of interest (p. 83, In 21-25 and a construct (or insert) encoding the gEgl heterodimer); wherein the saRNA comprises modified nucleotides, wherein the modified nucleotides are selected from the group consisting of 5-methylcytidine, 5- methyluridine, 5-hydroxymethyluridine, and 5-hydroxymethylcytidine (p. 79, In 21 to p. 80, In 1 O Modified nucleobases which can be incorporated into modified nucleosides and nucleotides and be present in RNA molecules include: m5C (5 -methylcytidine), m5U (5 -methyluridine) ... chm5U (5-(carboxyhydroxymethyl)uridine)); ... hm5C (5 -hydroxymethylcytidine)); and wherein the initiating nucleotide of the saRNA is methylated at the 2'0 position of the ribose (Cap1) (p. 79, In 7-10 The 5' cap of the RNA molecule may be further modified by a 2 '-O-Methyltransferase which results in the generation of a cap 1 structure (m7Gppp [m2 '-0] N), which may further increase translation efficacy).
Mols does not specifically teach the saRNA comprises at least 25% modified nucleotides.
Kitada, however, teaches a self-amplifying RNA (saRNA) comprising at least one cargo of interest to be expressed in a cell (para [0041] In certain aspects, the polynucleotide is a self-amplifying replicon RNA; [0049] a method of producing an IL-12 protein, comprising contacting a cell with any of the isolated polynucleotides), wherein the saRNA comprises at least 25% modified nucleotides (para [0065] rlL- 12-encoding repRNA modified to comprise different amounts of modified nucleoside triphosphates (modNTPs): (i) 0% modNTP (i.e., non-modified repRNA) (closed circle); (ii) 25% modNTP (closed square); (iii) 37.5% modNTP (closed triangle); or (iv) 50% modNTP (closed inversed triangle)), and wherein the initiating nucleotide comprises an adenosine or adenosine analog (para [0179].
Accordingly, it would have been obvious to one of ordinary skill in the art to have applied the elements of the saRNA expression constructs taught by Kitada to the saRNA expression constructs of Mols, including the percent of modified nucleotides, and stabilized initiation nucleotides. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to optimize stability and translation efficacy of the resulting saRNA expression constructs for in vivo expression of a given protein.
Regarding claim 26, Mols discloses the saRNA further comprising at least one 5' conserved sequence element (CSE) and/or at least one 3' conserved sequence elements (CSE) derived from at least one virus (p. 81, In 15-20 In a preferred embodiment, the encoded HSV1 or HSV2 FcR or immunogenic fragment or variant thereof and its binding partner or fragment thereof are separated by an internal ribosomal entry site (IRES) sequence. In a preferred embodiment, the IRES sequence is an IRES EV71 sequence. In a preferred embodiment, the IRES sequence comprises or consists of the sequence shown in SEQ ID NO: 127).
Regarding claims 34 and 35, Mols discloses a self-amplifying RNA (saRNA) (p. 78, In 14-15 "Most preferably, the RNA is a self-amplifying RNA molecule") comprising from 5' to 3':(a) at least one non-structural protein derived from at least one virus (p. 83, In 20-21 the self-replicating RNA comprises or consists of a VEEV TC-83 replicon encoding from 5' to 3' viral nonstructural proteins 1-4 (nsP1-4), followed by a subgenomic promoter, and a construct (or insert) encoding the gEgl heterodimer); (b) a subgenomic promoter (SGP) derived from at least one virus (p. 83, In 20-21 the self-replicating RNA comprises ... followed by a subgenomic promoter; p. 81, In 11-13 "suitably the 26S subgenomic promoter"); and (c) at least one cargo of interest (p. 83, In 21-22 and a construct (or insert) encoding the gEgl heterodimer). The saRNA is considered to be the same as the saRNA of the instant invention, thus, the properties of the saRNA (i.e. a suppression of innate immune activation compared to a corresponding saRNA with less than 75%-100% modified cytidines) would have the same functional characteristics. In this regard, The MPEP states that “the express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. "The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness." In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983)” (see MPEP 2112). section 2112(II) of the MPEP states that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004)(“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.”); Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1348-49 (Fed. Cir. 1999) (“Because sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known.”).
Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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 Langi, 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
on line using web-screens. An eTerminal Disclaimer that meets all requirements is autoprocessed
and approved immediately upon submission. For more information about eTerminal
Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-30, 32-33 and 36-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 24-27 of U.S. Patent No. 12115217. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another.
The patented claims are directed to:
1. A self-amplifying RNA (saRNA) comprising at least 25% modified nucleotides, wherein the modified nucleotides comprise a pyrimidine nucleoside phosphate with a moiety on carbon 5 of the pyrimidine, wherein the moiety is selected from the group consisting of methyl, ethyl, propyl, trifluoromethyl, hydroxymethyl, hydroxyethyl, and hydroxypropyl functional groups, and at least one cargo of interest (instant claim 21).
2. The saRNA of claim 1, wherein the modified nucleotides comprise 5-methylcytidine, 5-methyluridine, 5-hydroxymethyluridine, 5-hydroxymethylcytidine or a combination thereof (instant claims 21 and 24).
3. The saRNA of claim 1, wherein the saRNA expresses the cargo at a level greater than or equal to that of a corresponding saRNA with less than 25% modified nucleotides (instant claims 32 and 33).
4. The saRNA of claim 1, wherein the level of substitution of the modified nucleotides is: 25%-50%; 51%-75%; 75%-99%; 99.1%-99.9%; or 100% (instant claims 22-23).
5. The saRNA of claim 1, wherein the initiating nucleotide comprises:
(a) an adenosine or adenosine analog, and wherein the initiating nucleotide of the saRNA is methylated at the 2′O position of the ribose (Cap1);
(b) an adenosine or adenosine analog, and wherein the initiating nucleotide and the subsequent nucleotide of the saRNA are both methylated at the 2′O position of the ribose (Cap2);
(c) a guanosine or guanosine analog, and wherein the initiating nucleotide of the saRNA is methylated at the 2′O position of the ribose (Cap1); or
(d) a guanosine or guanosine analog, and wherein the initiating nucleotide and the subsequent nucleotide of the saRNA are both methylated at the 2′O position of the ribose (Cap2) (instant claim 25).
6. The saRNA of claim 1 comprising from 5′ to 3′:
(a) a 5′ cap;
(b) non-structural protein 1 (nsp1), non-structural protein 2 (nsp2), non-structural protein 3 (nsp3), and/or non-structural protein 4 (nsp4), each derived from at least one virus;
(c) a subgenomic promoter (SGP) derived from at least one virus;
(d) 5′ untranslated region (UTR) derived from at least one virus;
(e) the at least one cargo of interest;
(f) a 3′ untranslated region (UTR) derived from at least one virus; and
(g) a poly-A tail (instant claim 25).
7. The saRNA of claim 1, further comprising at least one 5′ conserved sequence element (CSE) and/or 3′ at least one conserved sequence element (CSE) derived from at least one virus (instant claim 26).
8. The saRNA of claim 6, wherein the at least one virus is an alphavirus (instant claim 27).
9. The saRNA of claim 6, wherein the at least one virus is selected from the group consisting of: Venezuela Equine Encephalitis Virus (VEEV), Semliki Forest Virus (SFV), Sindbis Virus (SIN), Chikungunya Virus (CHIKV), Eastern Equine Encephalitis Virus (EEEV), Mayaro Virus (MAYV), Getah Virus (GETV), Ross River Virus (RRV), Una Virus (UNAV), Middleburg Virus (MIDV), O'anyong nyong virus (ONNV), Barmah Forest Virus (BFV), Mucambo Virus (MUCV), Tonate Virus (TONV), Everglades Virus (EVEV), Rio Negro Virus (RNV), Turnip Rosette Virus (TROV), Highlands J Virus (HJV), Western Equine Encephalitis Virus (WEEV), Fig Mosaic Emaravirus (FMV), Aura Virus (AURAV), Kunjin Virus (KUN), Measles virus (MV), Coronavirus (CoV), Rabies virus (RABV), and Vesicular Stomatitis virus (VSV) (instant claim 28).
10. The saRNA of claim 1, wherein the cargo comprises a chimeric antigen receptor (CAR) comprising an extracellular domain that specifically binds to an antigen of interest (instant claim 29 and 30).
11. The saRNA of claim 10, wherein the antigen of interest for the CAR is selected from the group consisting of: CD19, CD22, CD30, b-cell maturation antigen (BCMA), disialoganglioside GD2, human estrogen receptor 2 (HER2), G protein-coupled receptor 87 (GPR87), Fibroblast Activator Protein (FAP), CD20, receptor tyrosine kinase-like orphan receptor 1 (ROR1), carcinoembryonic antigen (CEA), mesothelin (MSLN), prostate-specific membrane antigen (PSMA), epidermal growth factor receptor variant III (EGFRvIII), Interleukin 13 receptor alpha 2 (IL13Rα2), and natural killer group 2 member D (NKG2D) (instant claim 30).
12. The saRNA of claim 10, wherein the CAR is selected from the group consisting of:
(a) a conventional CAR;
(b) an ON-CAR;
(c) an OFF-CAR system;
(d) an ON/OFF-CAR;
(e) an inhibitory CAR; or
(f) a split, universal, programmable and reconfigurable (SUPRA) CAR system (instant claim 30).
13. The saRNA of claim 1, wherein the cargo comprises a ligand, a cell surface receptor, a transcription factor, a cytokine, a chemokine, an enzyme, and/or an antibody or fragment thereof (instant claim 30).
14. The saRNA of claim 13, wherein the antibody is a bispecific antibody (instant claim 30).
15. The saRNA of claim 1, wherein the cargo comprises a bispecific T cell engager (BiTE) (instant claim 30).
16. The saRNA of claim 1, wherein the cargo comprises at least one non-coding RNA selected from the group consisting of siRNA, shRNA, and microRNA (instant claim 30).
17. The saRNA of claim 1, wherein the cargo comprises at least one vaccine-associated antigen comprising at least one protein encoded by a genome of a virus (instant claim 30).
18. The saRNA of claim 17, wherein the virus is selected from the group consisting of: Rift valley fever, Crimean-Congo haemorrhagic fever, Lassa fever, Chikungunya Virus (CHIKV), Nipah Virus (NiV), respiratory syncytial virus (RSV), Ebola virus, Marburg virus, West Nile virus, Venezuela equine encephalitis, yellow fever virus, Japanese encephalitis virus, western equine encephalitis virus, eastern equine encephalitis, cytomegalovirus (CMV), human immunodeficiency virus (HIV), influenza virus, Zika virus, middle eastern respiratory syndrome coronavirus (MERS-CoV), severe acute respiratory syndrome coronavirus (SARS-CoV), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), human papillomavirus (HPV), herpes virus, rotavirus, varicella-zoster virus (VZV), dengue virus, hepatitis A virus, hepatitis B virus, rubella virus, poliovirus, and rabies virus (instant claim 28).
24. A self-amplifying RNA (saRNA) comprising from 5′ to 3′:
(a) a 5′ cap;
(b) non-structural protein 1 (nsp1), non-structural protein 2 (nsp2), non-structural protein 3 (nsp3), and/or non-structural protein 4 (nsp4), each derived from at least one virus;
(c) a subgenomic promoter (SGP) derived from at least one virus;
(d) a 5′ untranslated region (UTR) derived from at least one virus;
(e) at least one cargo of interest;
(f) a 3′ untranslated region (UTR) derived from at least one virus; and
(g) a poly-A tail (instant claim 25).
25. A nucleic acid, vector, or cell encoding or comprising the saRNA of claim 1 (instant claims 37 and 38).
26. A pharmaceutical composition comprising the saRNA of claim 1 and a pharmaceutically acceptable carrier (instant claim 36).
27. A method of expressing at least one cargo of interest in a cell, the method comprising contacting the cell with the saRNA of claim 1 (instant claim 39).
There is no patentable difference between the claimed composition and the patented composition in that the U.S. Patent No. 12115217 discloses an saRNA comprising: (a) a 5’ cap; (b) non-structural protein 1 (nsp1), non-structural protein 2 (nsp2), non-structural protein 3 (nsp3), and/or non-structural protein 4 (nsp4), each derived from at least one virus; (c) a subgenomic promoter (SGP) derived from at least one virus; (d) 5’ untranslated region (UTR) derived from at least one virus;(e) the at least one cargo of interest; (f) a 3’ unstranslated region (UTR) derived from at least one virus; and (g) a poly-A tail. Moreover, The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
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