DETAILED ACTION
Status of the Application
Claims 42-51 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 cancelling claims 1-41 and adding claims 42-51 as submitted in a communication filed on 4/30/2025 is acknowledged.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See page 42, paragraph [0145], two instances. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01.
Priority
Acknowledgment is made of a claim for domestic priority under 35 U.S.C. 119(e) to provisional application No. 62/745,239 filed on 10/12/2018, 62/745,238 filed on 10/12/2018, 62/745,246 filed on 10/12/2018, and 62/745,240 filed on 10/12/2018.
Acknowledgment is made of a claim for foreign priority under 35 U.S.C. 119(a)-(d) to EUROPEAN PATENT OFFICE (EPO) 18181680.2 filed on 07/04/2018, EUROPEAN PATENT OFFICE (EPO) 18174707.2 filed on 05/29/2018, EUROPEAN PATENT OFFICE (EPO) 18172625.8 filed on 05/16/2018, EUROPEAN PATENT OFFICE (EPO) 18162683.9 filed on 03/19/2018, and EUROPEAN PATENT OFFICE (EPO) 18162681.3 filed on 03/19/2018. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Acknowledgment is made of a claim for domestic priority under 35 U.S.C. 120 or 121 to US application No. 16/982,433 filed on 09/18/2020, which is the US national application which entered the national stage from PCT/US2019/023044 filed on 5/19/2019.
Upon performing a sequence search and a cursory review of the specification of the provisional applications to which the instant application claims priority, it has been found that SEQ ID NO: 3 and SEQ ID NO: 4 were first disclosed in PCT/US2019/023044 filed on 5/19/2019.
Drawings
The drawings submitted on 1/10/2025 have been reviewed and are accepted by the Examiner for examination purposes.
Claim Rejections - 35 USC § 102 (AIA )
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)(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 42-46, 48, 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheng et al. (WO 2020/112908 published 6/4/2020, claims priority to application No. 62/772,278, effective filing date 11/28/2018).
Claims 42-46, 48, 50 are directed in part to (i) a synthetic RNA-guided nuclease (sRGN) that comprises an amino acid sequence at least 95% identical to SEQ ID NO: 3 or SEQ ID NO: 4, wherein said sRGN further comprises one or more nuclear localization signals, (ii) a composition comprising the sRGN of (i), and (iii) a composition that comprises the sRGN of (i) and a guide RNA capable of hybridizing to a target nucleic acid, wherein the sRGN of (i) and the guide RNA can form a complex.
Cheng et al. teach a sRGN that comprises an amino acid sequence which is 97.35% identical to SEQ ID NO: 3 (SEQ ID NO: 1; page 3, paragraph [0011]) and a sRGN that comprises an amino acid sequence which is 100% identical to SEQ ID NO: 4 (SEQ ID NO: 39; page 19, paragraph [0067]; page 47, paragraph [0145]). See alignments below. The protein of SEQ ID NO: 39 has the SV40 nuclear localization signal PKKKRKV (page 74, sequence 39, amino acids 3-9, GST-v1). Cheng et al. teach that the sRGN can comprise nuclear localization signals (page 3, paragraph [0010]). Cheng et al. teach CRISPR/Cas system that comprise a guide RNA which has a spacer that hybridizes to a target nucleic acid of interest and forms a ribonucleoprotein complex with the sRGN (page 21, paragraphs [0073]-[0074]). Cheng et al. teach the delivery of lipid-based nanoparticles that comprise nucleic acids encoding the sRGN and a guide RNA to cells and the successful editing of a target gene (page 46, paragraph [0143]). Since the nucleic acids in the nanoparticles had to be expressed to observe the editing of the target gene, the cells of Cheng et al. after delivery of the nanoparticles comprise a composition comprising the sRGN complexed with the guide RNA. In the absence of the specific components of a pharmaceutical composition, the intracellular contents of the cell after delivery of the nanoparticles are deemed a pharmaceutical composition which comprises water (pharmaceutically acceptable carrier). Therefore, the teachings of Cheng et al. anticipate the instant claims as written/interpreted.
SEQ ID NO: 3
BHV54910
ID BHV54910 standard; protein; 1057 AA.
XX
AC BHV54910;
XX
DT 23-JUL-2020 (first entry)
XX
DE Staphylococcus sp. Cas9 protein (Gib11SpaCas9-1), SEQ ID 1.
XX
KW Cas9 protein; cardiovascular disease; cardiovascular-gen.; drug delivery;
KW factor viii deficiency; genetic-disease-gen.; nanotechnology;
KW therapeutic.
XX
OS Staphylococcus lugdunensis.
OS Staphylococcus pasteuri.
OS Staphylococcus microti.
OS Staphylococcus hyicus.
XX
CC PN WO2020112908-A2.
XX
CC PD 04-JUN-2020.
XX
CC PF 26-NOV-2019; 2019WO-US063456.
XX
PR 28-NOV-2018; 2018US-0772278P.
XX
CC PA (CASE-) CASEBIA THERAPEUTICS LLP.
XX
CC PI Cheng CJ, Scharenberg A, Wang K, Sane S;
XX
DR WPI; 2020-491643/051.
DR N-PSDB; BHV54916, BHV54922.
XX
CC PT Lipid-based nanoparticle composition for delivering nucleic acid molecule
CC PT into cell, and for editing genome of cell, comprisesnucleic acid molecule
CC PT comprising nucleotide sequence encoding site-specific endonuclease, and
CC PT lipid moieties.
XX
CC PS Claim 9; SEQ ID NO 1; 100pp; English.
XX
CC The present invention relates to a novel lipid-based nanoparticle (LNP)
CC composition, useful for a delivering nucleic acid molecule into a cell.
CC The LNP composition comprises a nucleic acid molecule containing a
CC nucleotide sequence encoding a site-specific endonuclease of SEQ ID NO: 1
CC -6 (see BHV54910-BHV54915); and lipid moieties selected from amino
CC lipids, ionizable lipids, neutral lipids, polyethylene glycol (PEG)
CC lipids, helper lipids and cholesterol or cholesterol derivatives. The
CC invention further claims: (1) a method for delivering a nucleic acid
CC molecule into a cell; and (2) a method for editing a genome of the cell.
CC The LNP composition is useful for: delivering a nucleic acid molecule
CC into a target cell, which is useful for editing a genome of the cell; and
CC treating disease such as hemophilia A (HemA) or cardiovascular disease.
XX
SQ Sequence 1057 AA;
Query Match 97.7%; Score 5355; Length 1057;
Best Local Similarity 97.4%;
Matches 1029; Conservative 18; Mismatches 10; Indels 0; Gaps 0;
Qy 1 MNQKFILGLDIGITSVGYGLIDYETKNIIDAGVRLFPEANVENNEGRRSKRGSRRLKRRR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MNQKFILGLDIGITSVGYGLIDYETKNIIDAGVRLFPEANVENNEGRRSKRGSRRLKRRR 60
Qy 61 IHRLERVKLLLTEYDLINKEQIPTSNNPYQIRVKGLSEILSKDELAIA LLHLAKRRGIHN 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 IHRLERVKLLLTEYDLINKEQIPTSNNPYQIRVKGLSEILSKDELAIA LLHLAKRRGIHN 120
Qy 121 VDVAADKEETASDSLSTKDQINKNAKFLESRYVCELQKERLENEGHVRGVENRFLTKDIV 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VDVAADKEETASDSLSTKDQINKNAKFLESRYVCELQKERLENEGHVRGVENRFLTKDIV 180
Qy 181 REAKKIIDTQMQYYPEIDETFKEKYISLVETRREYFEGPGQGSPFGWNGDLKKWYEMLMG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 REAKKIIDTQMQYYPEIDETFKEKYISLVETRREYFEGPGQGSPFGWNGDLKKWYEMLMG 240
Qy 241 HCTYFPQELRSVKYAYSADLFNALNDLNNLIIQRDNSEKLEYHEKYHIIENVFKQKKKPT 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 HCTYFPQELRSVKYAYSADLFNALNDLNNLIIQRDNSEKLEYHEKYHIIENVFKQKKKPT 300
Qy 301 LKQIAKEIGVNPEDIKGYRITKSGTPEFTSFKLFHDLKKVVKDHAILDDIDLLNQIAEIL 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 LKQIAKEIGVNPEDIKGYRITKSGTPEFTSFKLFHDLKKVVKDHAILDDIDLLNQIAEIL 360
Qy 361 TIYQDKDSIVAELGQLEYLMSEADKQSISELTGYTGTHSLSLKCMNMIIDELWHSSMNQM 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 TIYQDKDSIVAELGQLEYLMSEADKQSISELTGYTGTHSLSLKCMNMIIDELWHSSMNQM 420
Qy 421 EVFTYLNMRPKKYELKGYQRIPTDMIDDAILSPVVKRTFIQSINVINKVIEKYGIPEDII 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 EVFTYLNMRPKKYELKGYQRIPTDMIDDAILSPVVKRTFIQSINVINKVIEKYGIPEDII 480
Qy 481 IELARENNSDDRKKFINNLQKKNEATRKRINEIIGQTGNQNAKRIVEKIRLHDQQEGKCL 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 IELARENNSDDRKKFINNLQKKNEATRKRINEIIGQTGNQNAKRIVEKIRLHDQQEGKCL 540
Qy 541 YSLESIPLEDLLNNPNHYEVDHIIPRSVSFDNSYHNKVLVKQSENSKKSNLTPYQYFNSG 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 YSLESIPLEDLLNNPNHYEVDHIIPRSVSFDNSYHNKVLVKQSENSKKSNLTPYQYFNSG 600
Qy 601 KSKLSYNQFKQHILNLSKSQDRISKKKKEYLLEERDINKFEVQKEFINRNLVDTRYATRE 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 KSKLSYNQFKQHILNLSKSQDRISKKKKEYLLEERDINKFEVQKEFINRNLVDTRYATRE 660
Qy 661 LTNYLKAYFSANNMNVKVKTINGSFTDYLRKVWKFKKERNHGYKHHAEDALIIANADFLF 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 LTNYLKAYFSANNMNVKVKTINGSFTDYLRKVWKFKKERNHGYKHHAEDALIIANADFLF 720
Qy 721 KENKKLKAVNSVLEKPEIETKQLDIQVDSEDNYSEMFIIPKQVQDIKDFRNFKFSHRVDK 780
|||||||||||||||||||||||||||||||||||||||||||||||||||||:||||||
Db 721 KENKKLKAVNSVLEKPEIETKQLDIQVDSEDNYSEMFIIPKQVQDIKDFRNFKYSHRVDK 780
Qy 781 KPNRQLINDTLYSTRMKDEHDYIVQTITDIYGKDNTNLKKQFNKNPEKFLMYQNDPKTFE 840
||||||||||||||| || |||||| ||| |||| |||||:|:||||||||:||:|||
Db 781 KPNRQLINDTLYSTRKKDNSTYIVQTIKDIYAKDNTTLKKQFDKSPEKFLMYQHDPRTFE 840
Qy 841 KLSIIMKQYSDEKNPLAKYYEETGEYLTKYSKKNNGPIVKKIKLLGNKVGNHLDVTNKYE 900
|| :|||||::||||||||:|||||||||||||||||||| :| :|||:|:|||||::::
Db 841 KLEVIMKQYANEKNPLAKYHEETGEYLTKYSKKNNGPIVKSLKYIGNKLGSHLDVTHQFK 900
Qy 901 NSTKKLVKLSIKNYRFDVYLTEKGYKFVTIAYLNVFKKDNYYYIPKDKYQELKEKKKIKD 960
:|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 SSTKKLVKLSIKNYRFDVYLTEKGYKFVTIAYLNVFKKDNYYYIPKDKYQELKEKKKIKD 960
Qy 961 TDQFIASFYKNDLIKLNGDLYKIIGVNSDDRNIIELDYYDIKYKDYCEINNIKGEPRIKK 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 TDQFIASFYKNDLIKLNGDLYKIIGVNSDDRNIIELDYYDIKYKDYCEINNIKGEPRIKK 1020
Qy 1021 TIGKKTESIEKFTTDVLGNLYLHSTEKAPQLIFKRGL 1057
|||||||||||||||||||||||||||||||||||||
Db 1021 TIGKKTESIEKFTTDVLGNLYLHSTEKAPQLIFKRGL 1057
SEQ ID NO: 4
RESULT 2
BHV54948
ID BHV54948 standard; protein; 1082 AA.
XX
AC BHV54948;
XX
DT 23-JUL-2020 (first entry)
XX
DE LNP composition preparation related fusion protein (GST3-v1), SEQ ID 39.
XX
KW Cas9 protein; Nucleoplasmin; cardiovascular disease; cardiovascular-gen.;
KW drug delivery; factor viii deficiency; fusion protein;
KW genetic-disease-gen.; nanotechnology; therapeutic.
XX
OS Macaca mulatta polyomavirus 1.
OS Staphylococcus lugdunensis.
OS Staphylococcus pasteuri.
OS Staphylococcus microti.
OS Staphylococcus hyicus.
OS Chimeric.
OS Synthetic.
OS Unidentified.
XX
CC PN WO2020112908-A2.
XX
CC PD 04-JUN-2020.
XX
CC PF 26-NOV-2019; 2019WO-US063456.
XX
PR 28-NOV-2018; 2018US-0772278P.
XX
CC PA (CASE-) CASEBIA THERAPEUTICS LLP.
XX
CC PI Cheng CJ, Scharenberg A, Wang K, Sane S;
XX
DR WPI; 2020-491643/051.
DR N-PSDB; BHV54947.
XX
CC PT Lipid-based nanoparticle composition for delivering nucleic acid molecule
CC PT into cell, and for editing genome of cell, comprisesnucleic acid molecule
CC PT comprising nucleotide sequence encoding site-specific endonuclease, and
CC PT lipid moieties.
XX
CC PS Example 2; SEQ ID NO 39; 100pp; English.
XX
CC The present invention relates to a novel lipid-based nanoparticle (LNP)
CC composition, useful for a delivering nucleic acid molecule into a cell.
CC The LNP composition comprises a nucleic acid molecule containing a
CC nucleotide sequence encoding a site-specific endonuclease of SEQ ID NO: 1
CC -6 (see BHV54910-BHV54915); and lipid moieties selected from amino
CC lipids, ionizable lipids, neutral lipids, polyethylene glycol (PEG)
CC lipids, helper lipids and cholesterol or cholesterol derivatives. The
CC invention further claims: (1) a method for delivering a nucleic acid
CC molecule into a cell; and (2) a method for editing a genome of the cell.
CC The LNP composition is useful for: delivering a nucleic acid molecule
CC into a target cell, which is useful for editing a genome of the cell; and
CC treating disease such as hemophilia A (HemA) or cardiovascular disease.
CC The present sequence is a fusion protein containing nucleoplasmin nuclear
CC localization signal (NLS) peptide, Gly-Ser linker peptide, Staphylococcus
CC sp. Cas9 protein and SV40 NLS peptide, which is useful for preparing LNP
CC composition for editing a genome of the cell.
XX
SQ Sequence 1082 AA;
Query Match 100.0%; Score 5494; Length 1082;
Best Local Similarity 100.0%;
Matches 1057; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MNQKFILGLDIGITSVGYGLIDYETKNIIDAGVRLFPEANVENNEGRRSKRGSRRLKRRR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 10 MNQKFILGLDIGITSVGYGLIDYETKNIIDAGVRLFPEANVENNEGRRSKRGSRRLKRRR 69
Qy 61 IHRLERVKLLLTEYDLINKEQIPTSNNPYQIRVKGLSEILSKDELAIA LLHLAKRRGIHN 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 70 IHRLERVKLLLTEYDLINKEQIPTSNNPYQIRVKGLSEILSKDELAIA LLHLAKRRGIHN 129
Qy 121 VDVAADKEETASDSLSTKDQINKNAKFLESRYVCELQKERLENEGHVRGVENRFLTKDIV 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 130 VDVAADKEETASDSLSTKDQINKNAKFLESRYVCELQKERLENEGHVRGVENRFLTKDIV 189
Qy 181 REAKKIIDTQMQYYPEIDETFKEKYISLVETRREYFEGPGQGSPFGWNGDLKKWYEMLMG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 190 REAKKIIDTQMQYYPEIDETFKEKYISLVETRREYFEGPGQGSPFGWNGDLKKWYEMLMG 249
Qy 241 HCTYFPQELRSVKYAYSADLFNALNDLNNLIIQRDNSEKLEYHEKYHIIENVFKQKKKPT 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 250 HCTYFPQELRSVKYAYSADLFNALNDLNNLIIQRDNSEKLEYHEKYHIIENVFKQKKKPT 309
Qy 301 LKQIAKEIGVNPEDIKGYRITKSGTPEFTSFKLFHDLKKVVKDHAILDDIDLLNQIAEIL 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 310 LKQIAKEIGVNPEDIKGYRITKSGTPEFTSFKLFHDLKKVVKDHAILDDIDLLNQIAEIL 369
Qy 361 TIYQDKDSIVAELGQLEYLMSEADKQSISELTGYTGTHSLSLKCMNMIIDELWHSSMNQM 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 370 TIYQDKDSIVAELGQLEYLMSEADKQSISELTGYTGTHSLSLKCMNMIIDELWHSSMNQM 429
Qy 421 EVFTYLNMRPKKYELKGYQRIPTDMIDDAILSPVVKRTFIQSINVINKVIEKYGIPEDII 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 430 EVFTYLNMRPKKYELKGYQRIPTDMIDDAILSPVVKRTFIQSINVINKVIEKYGIPEDII 489
Qy 481 IELARENNSDDRKKFINNLQKKNEATRKRINEIIGQTGNQNAKRIVEKIRLHDQQEGKCL 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 490 IELARENNSDDRKKFINNLQKKNEATRKRINEIIGQTGNQNAKRIVEKIRLHDQQEGKCL 549
Qy 541 YSLESIPLEDLLNNPNHYEVDHIIPRSVSFDNSYHNKVLVKQSENSKKSNLTPYQYFNSG 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 550 YSLESIPLEDLLNNPNHYEVDHIIPRSVSFDNSYHNKVLVKQSENSKKSNLTPYQYFNSG 609
Qy 601 KSKLSYNQFKQHILNLSKSQDRISKKKKEYLLEERDINKFEVQKEFINRNLVDTRYATRE 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 610 KSKLSYNQFKQHILNLSKSQDRISKKKKEYLLEERDINKFEVQKEFINRNLVDTRYATRE 669
Qy 661 LTSYLKAYFSANNMDVKVKTINGSFTNHLRKVWRFDKYRNHGYKHHAEDALIIANADFLF 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 670 LTSYLKAYFSANNMDVKVKTINGSFTNHLRKVWRFDKYRNHGYKHHAEDALIIANADFLF 729
Qy 721 KENKKLQNTNKILEKPTIENNTKKVTVEKEEDYNNVFETPKLVEDIKQYRDYKFSHRVDK 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 730 KENKKLQNTNKILEKPTIENNTKKVTVEKEEDYNNVFETPKLVEDIKQYRDYKFSHRVDK 789
Qy 781 KPNRQLINDTLYSTRMKDEHDYIVQTITDIYGKDNTNLKKQFNKNPEKFLMYQNDPKTFE 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 790 KPNRQLINDTLYSTRMKDEHDYIVQTITDIYGKDNTNLKKQFNKNPEKFLMYQNDPKTFE 849
Qy 841 KLSIIMKQYSDEKNPLAKYYEETGEYLTKYSKKNNGPIVKKIKLLGNKVGNHLDVTNKYE 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 850 KLSIIMKQYSDEKNPLAKYYEETGEYLTKYSKKNNGPIVKKIKLLGNKVGNHLDVTNKYE 909
Qy 901 NSTKKLVKLSIKNYRFDVYLTEKGYKFVTIAYLNVFKKDNYYYIPKDKYQELKEKKKIKD 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 910 NSTKKLVKLSIKNYRFDVYLTEKGYKFVTIAYLNVFKKDNYYYIPKDKYQELKEKKKIKD 969
Qy 961 TDQFIASFYKNDLIKLNGDLYKIIGVNSDDRNIIELDYYDIKYKDYCEINNIKGEPRIKK 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 970 TDQFIASFYKNDLIKLNGDLYKIIGVNSDDRNIIELDYYDIKYKDYCEINNIKGEPRIKK 1029
Qy 1021 TIGKKTESIEKFTTDVLGNLYLHSTEKAPQLIFKRGL 1057
|||||||||||||||||||||||||||||||||||||
Db 1030 TIGKKTESIEKFTTDVLGNLYLHSTEKAPQLIFKRGL 1066
Claim Rejections - 35 USC § 103 (AIA )
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 of this title, 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.
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 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.
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.
Claims 47, 49, 51 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (WO 2020/112908 published 6/4/2020, claims priority to application No. 62/772,278, effective filing date 11/28/2018).
Cheng et al. further teach that homology directed repair requires a donor molecule to template repair of a target molecule and that in some situations, the donor polynucleotide integrates into the target DNA (page 11, paragraph [0046]). Cheng et al. discloses the intended use of mice to evaluate the integration of the FVIII gene into the albumin locus (page 50, paragraph [0152]). Cheng et al. teach lipid-based nanoparticles comprising mRNAs encoding the sRGN and guide RNAs (page 45, Example 2). Cheng et al. teach the use of kits with reagents and instructions according to the manufacturer with defined protocols (page 45, first four lines).
Claims 47, 49, 51 are directed in part to the composition of claim 46 as described above, wherein the composition further comprises a donor polynucleotide, or wherein said composition is formulated in a liposome or a lipid nanoparticle, and a kit that comprises the sRGN of claim 42 as described above, a guide RNA and instructions for targeting, editing, modifying or manipulating a target DNA.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to (i) add a donor polynucleotide to the composition that comprises the sRGN and gRNA of Cheng et al., (ii) include the composition of Cheng et al. in a liposome or a lipid nanoparticle, or (iii) include the composition of Cheng et al. in a kit with instructions. A person of ordinary skill in the art is motivated to (i) add a donor polynucleotide to the composition that comprises the sRGN and gRNA of Cheng et al., for the benefit of including a molecule that would be required in homology directed repair so that the desired editing is achieved, (ii) include the composition of Cheng et al. in a liposome or a lipid nanoparticle for the benefit of aiding the delivery of the composition to a cell through its membrane, and (iii) include the composition of Cheng et al. in a kit with instructions to allow one of skill in the art to have the required components in a single item for facilitating targeting, cleaving and editing the desired target nucleic acid. One of ordinary skill in the art has a reasonable expectation of success at (i) adding a donor polynucleotide to a composition that comprises a sRGN and gRNA, (ii) including the composition of Cheng et al. in a liposome or a lipid nanoparticle, or (iii) include the composition of Cheng et al. in a kit with instructions because all that is required is including a nucleic acid to the composition, using a well known method to deliver a composition to a cell, and place all the required components in a single item (kit), which is a commonly used form of placing components for an assay, as evidenced by Cheng et al. 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.
Conclusion
No claim is in condition for allowance.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DELIA M RAMIREZ, Ph.D., whose telephone number is (571) 272-0938. The examiner can normally be reached on Monday-Friday from 8:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert B. Mondesi, can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/DELIA M RAMIREZ/Primary Examiner, Art Unit 1652
DR
September 17, 2026
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