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 Status of the Application Claims 150-169 are pending and are currently under examination. Information Disclosure Statement The submission of the Information Disclosure Statement s are in compliance with 37 CFR 1.97. The information disclosure statement s ha ve been considered by the examiner and signed copies have been placed in the file. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 150-169 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more. Regarding claims 150-159 and 1 68 , the claims are drawn to a composition comprising a nuclease comprising a single RuvC active site wherein the amino terminus (N terminus) does not begin with the amino acid sequence “MIS” and a recombinant guide RNA. The specification describes nucleases as Cas12J as comprising RuvC domains (0107) which are highly conserved domains in naturally occurring Cas12 and Cas9 nucleases (0681). The specification describes the Cas12J proteins in Fig. 6A-6R, which includes SEQ ID NO s : 120 and 126 o f Fig. 6R, are naturally occurring Cas12J proteins ( 00105 ) . The naturally occurring sequence s do not begin with MIS. The specification defines “recombinant” as meaning that “a particular nucleic acid (DNA or RNA) is the product of various combinations of cloning, restriction, polymerase chain reaction (PCR) and/or ligation steps resulting in a construct having a structural coding or non-coding sequence distinguishable from endogenous nucleic acids found in natural systems.” See (0062). However, no specific differences from a natural counterpart are required by the claims, and the structural differences are not necessarily significant when comparing the structure of the “recombinant” products to their natural counterparts . Regarding Step 1 in the analysis of Subject Matter Eligibility (MPEP 2106), the claims recites a composition of matter which is appropriate subject matter for a patent. Regarding Step 2A prong 1, the claims recite a natural phenomenon because the Cas12J polypeptide and the guide RNA naturally occur in a bacteriophage and they do not have markedly different characteristics from those found in nature . Regarding Step 2A prong 2 and 2B, there are no additional elements recited in claim 1 50 which either integrate the judicial exception into a practical application or transform the claim into significantly more than the judicial exception. Thus the claims simply recites naturally occurring proteins and RNA found in bacteriophage without markedly different characteristics. Moreover, post-filing art teaches that the CRISPR-CasΦ (or Cas12J) system is naturally present in bacteriophage, which naturally contact cells and targets the genes of competing phages or phage hosts in cells (Pausch et al. Science, Vol. 369, pages 333-337, 2020, cited on the IDS filed 06/05/2024 ). Thus, the claimed method reads on the natural phenomenon of a bacteriophage, which encodes Cas12J of SEQ ID NO s : 120 or 126 or closely related ortholog #3 , for example, and a guide RNA capable of infecting a cell and targeting a host cell gene or phage gene in the cell. Regarding claim 16 2 , the claim recites a composition of claim 1 61 comprising a lipid. Given the broadest reasonable interpretation of a lipid, which could be a natural lipids that is naturally found in bacteriophage, this does not integrate the judicial exception into a practical application or transform the claim into significantly more than the judicial exception. Regarding claims 16 0, 161, 163 and 164, the claims recite the nuclease comprises nickase activity, is encoding by a mRNA and the composition is present in a viral vector or does not comprise a tracrRNA and therefor the composition is still drawn to a naturally occurring nuclease and guide RNA , there are no additional elements that integrate the judicial exception into a practical application and further the mRNA and viral vector do not transform the claim into significantly more than the judicial exception. Regarding claim s 165 and 166 , the claims recite the nuclease has been engineered to have reduced nuclease activity therefor is still drawn to a naturally occurring polypeptide and RNA and there are no additional elements that integrate the judicial exception into a practical application and further the engineering do not transform the claim into significantly more than the judicial exception. Regarding claim 169, the claims recite a kit comprising the nuclease and the guide RNA is still drawn to a naturally nuclease and the guide RNA and there are no additional elements that integrate the judicial exception into a practical application and further the engineering do not transform the claim into significantly more than the judicial exception. Therefore, the instant claims are directed to a natural product that are not markedly different from its natural protein and RNA in a bacteriophage, is not integrated into a practical applicant, does not include elements that amount to significantly more that the natural product itself and therefore do not qualify as patent eligible subject matter under 35 USC § 101 . Claim Rejections - 35 USC § 102 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. 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. Claim(s) 150- 160, 162-167 and 169 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cheng et al. (US 2020/0299659 – cited on IDS 06/05/2024 ; having an effectively filed date of May 16, 2018) as evidenced by Pausch et al. ( Science, Vol. 369, pages 333-337, 2020, cited on the IDS filed 06/05/2024 ) . Regarding claim 150 , 156 , 161 and 1 69 , Cheng et al. teach compositions for editing nucleic acids comprising recombinant CRISPR-Cas nucleases and their respective recombinant guide crRNA or nucleic acids encoding the nuclease or guide RNA (See paragraph 0009, 0027, 0127). Chen g et al. teach a Cas nuclease of SEQ ID NO: 318 (which is 721 amino acids) has 100% sequence identity to SEQ ID NO: 120 shown in Fig 6M as Cas12J ( See SCORE, 20210608_085700_us-17-229-272-120.rapbm file, Result #1 in patent family Application 17229272 an attached file showing alignment ). Chen g et al. the CRISPR associate protein comprises a RuvC domain (claim 63) and the amino acid terminu s does not begin with MIS. Regarding the kit of claim 169, the claim merely recites CRISPR-Cas nucleases and recombinant guide crRNA and thus the limitation is taught. Regarding claim 151, Chen g et al. teach the gRNA comprises a repeat sequence and a spacer sequence (0009). Regarding claim 152, Chen g teach a nuclear localization signal fused to the nuclease (see 0113). Regarding claim 153, Chen g et al. teach said Cas nuclease system further comprises an exogenous DNA or RNA donor template (See paragraph 0187). Regarding claims 154 and 155, Chen g et al. teach the composition can be used in in therapeutic applications to target various human target genes (0186-0191). Regarding claims 15 7, Chen g et al. teach the target sequence is DNA to cleave one strand or teach targeting viral sequences (0017) (which can be double stranded DNA) (0195). Regarding claim s 158 and 159, the instant specification establishes that nuclease is a Cas12J which is a synonym for Casϕ (See paragraph 0096). The evidentiary reference of Pausch et al. establishes that Casϕ’s inherently recognize T-rich PAM sequences such as TTN (See p. 1, middle column, 1 st full paragraph and Figure 1C. In addition, said enzyme is inherently is a divalent cation dependent enzyme which comprises a Mg 2+ for activity cation (See Figure 3B) as such said composition would contain said divalent cation. Regarding claim 160, Chen g et al. teach enzyme is a nickase or rendered catalytically inactive through mutation (See paragraphs 0027, 0114-0115). Regarding claim 162 and 164 , Chen g et al. teach the Cas nuclease system is formulated for therapeutic delivery in liposomes (e.g. excipients), plasmids or vectors or nanoparticles (See paragraphs 200-204). Regarding claim 163, Chen g et al. teach the CRIPR-Cas system optionally has a tracrRNA and thus inherently tea c h the system does not have a tracrRNA (0020). Regarding claims 165 and 166, Chen et al. teach the nuclease can comprise modifications to reduce nuclease activity (0093). Regarding claim 167, Chen g et al. teach the heterologous polypeptide such as DNA modifying domains is fused to either the N- or C-terminus of the Cas nuclease (See paragraphs 0094-0095). Thus Chen g et al. anticipates the instant claims. 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 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. The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Claims 167 and 168 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 2020/0299659 cited on IDS 06/05/2024 having an effectively filed date of May 16, 2018) as evidenced by Pausch et al. ( Science, Vol. 369, pages 333-337, 2020, cited on the IDS filed 06/05/2024 ) and in view of Komor et al. ( "Programmable editing of a target base in genomic DNA without double-stranded DNA cleavage." Nature 533.7603 (2016): 420-424 ) . The claims are relied upon as above. Chen et al. do not teach the nuclease is specifically fused to a deaminase . Komor et al. teach increasing the efficiency of homology-directed repair (HDR). HDR by fusing a deaminase to a Cas9 nuclease that allowed for more efficient gene correction using the CRISPR/Cas system (see introduction). Komor et al. teach the development of base editing advances both the scope and effectiveness of genome editing (see page 423 last paragraph). It would have been obvious to one of ordinary skill in the art to fuse a heterologous peptide, such as deaminase, to the nuclease of Chen g et al. to allow for more efficient gene correction. Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed. Claim 161 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 2020/0299659 cited on IDS 06/05/2024 having an effectively filed date of May 16, 2018) as evidenced by Pausch et al. ( Science, Vol. 369, pages 333-337, 2020, cited on the IDS filed 06/05/2024 ) and in view of Chen et al . (US Patent Application Publication No. 2016/0298134 A1). The claims are relied upon as above. Chen g et al. do not teach the nuclease is encoded by a mRNA . However, Chen . et al teach it is within the skill of one in the art to contact a cell with mRNA encoding a Cas polypeptide (e.g., paragraphs [0006], [0013], [0014], [0064] and [0067]). It would have been obvious to use mRNA as the nucleic acid in the composition of the instant claims in order to provide a specific form of nucleic acid for the composition, where the nucleic is known to be suitable for introduction into a cell for expression of a Cas polypeptide . Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed. Claim Rejections - 35 USC § 112 The following is a quotation 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 35 U.S.C. 112 (pre-AIA), first paragraph: 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. Written Description Claims 150-169 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated: To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966; Regents of the University of California v. Eli Lilly & Co. , 43 USPQ2d 1398. The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc ., 935 F.2d at 1563-64, 19 USPQ2d at 1117. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial Structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed structure, and v. Correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. Moreover, the written description requirement for a genus may be satisfied through sufficient description of a representative number of species by “…disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function al and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” Thus when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The claims are drawn to a genus of nucleases comprising a single RuvC active site capable of cleaving DNA and binding crRNA wherein the amino acid terminus does not begin with MIS and a genus of recombinant guide RNA with the function of cleaving DNA . The specification describes the identification of Cas12J sequences by analyzing publicly available sequence data for the presence of TnpB superfamily members (e.g., paragraph [00715]) and Figs. 6 and 7 show 18 of these described sequences. The specification describes ribonucleoproteins (RNPs) comprising a Cas12J polypeptide and a guide RNA (e.g., paragraph [0095]) and discloses the presence of a RuvC domain (e.g., paragraph [00108]). No description is provided of the vast number of nucleases comprising a single RuvC active domain capable of both cleaving DNA and binding crRNA wherein the amino acid terminus does not begin with the amino acid sequences MIS. With regard to PAM recognition, the disclosure provides an analysis for three of the disclosed Cas12J polypeptides, where two of the three polypeptides are capable of recognizing PAMs with the claimed consensus sequence of 5’-NTTN-3’. The specification discloses a nuclease that uses a PAM sequence on the non-complementary strand of 5’-VTTR-3’, where V is G, A or C, and where R is A or G (e.g., paragraph [00212]). This consensus sequence excludes T at the first position from the 5’ end, and excludes C or T at the fourth position from the 5’ end (i.e., TTTC and TTTT are excluded). The specification discloses a nuclease that uses a PAM sequence on the non-complementary strand of 5’-TBN-3’, where B it T, C or G (e.g., paragraph [00213]). This consensus falls within the scope of 5’NTTN-3’ when B is T (i.e., 5’-NTBN-3’ is 5’-NTTN-3’) [00213] . Further, t he specification discloses that ortholog #3 uses a PAM sequence on the non-complementary strand of 5’-NTTN-3’ (e.g., paragraph [00214]). No description is provided of the PAM recognition sequences of other guide sequence encompassed by the claims [00214] . The specification and claims do not indicate what distinguishing characteristics of the nuclease and a recombinant guide DNA as described in the specification that are concisely shared by the members of the broad genus that would convey to one of skill in the art that these dsRNA represent the entire genus . A review of the specification shows that it provides no description or guidance that would allow one of skill to distinguish the functional species of the recited structural genus from the non-functional members without empirical determination. The prior art does not appear to provide written description to support the broad genus. The prior art of Koonin et al. ( "Diversity, classification and evolution of CRISPR-Cas systems." Current opinion in microbiology 37 (2017): 67-78 ) teach there are numerous different Cas proteins from numerous different organisms (see Figure 1). Koonin et al. illustrates each has different structures based on the different class systems (see Figure 1 and Figure 3). Koonin et al. do not describe these different Cas proteins as having a RuvC active site and an amino acid terminus as claimed. The prior art teaches that the PAM sequence recognized by a Cas protein, such as Cas9, must be determined experimentally for each protein variant (Karvelis et al. Methods, Vol. 121-122, pages 3-8, March 24, 2017; e.g., Abstract). The prior art teaches that orthologs of a single type of Cas protein, such as Cas9, do not all share a common PAM sequence (Seebeck et al. US Patent Application Publication No. 2019/0249200 A1; e.g., Table A and Fig. 1). Since the disclosure and the prior art fail to describe the common attributes and characteristics concisely identifying members of the proposed genus, and because the claimed genus is highly variant comprising a vast number of Cas proteins and different guide RNA , one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus claimed. "A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus" (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) ( emphasis added ). Further, “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin , 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester , 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar , 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention . The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed. ” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder , 736 F.2d 1516, 1521,222 USPQ 369,372-372 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the entire scope of the claimed invention. Therefore, the skilled artisan would have reasonably concluded applicants were not in possession of the claimed invention for claims 150-169. 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp . Claims 150-169 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 30 of Patent No. 11,578,313 ( Patent313 ) in view of Chen et al (US Patent Application Publication No. 2016/0298134 A1) and Komor et al. ( "Programmable editing of a target base in genomic DNA without double-stranded DNA cleavage." Nature 533.7603 (2016): 420-424 ) . Although the claims at issue are not identical, they are not patentably distinct from each other. Both the instant claims and claims of Patent313 are drawn to a composition comprising a nuclease having a RuvC active site and a guide RNA and wherein PAM is 5’-NTTN-3’, wherein T is thymine and N is any nucleotid e capable of cleaving a target nucleic acid. The claims of Patent313 does not specify that the nucleic acid encoding the polypeptide is messenger RNA (mRNA ) or teach a fused heterologous polypeptide. Chen et al teach it is within the skill of the art to contact a cell with mRNA encoding a Cas polypeptide (e.g., paragraphs [0006], [0013], [0014], [0064] and [0067]). It would have been obvious to use mRNA as the nucleic acid in the composition of Patent313 in order to provide a specific form of nucleic acid for the composition, where the nucleic is known to be suitable for introduction into a cell for expression of a Cas polypeptide. Komor et al. teach increasing the efficiency of homology-directed repair (HDR). HDR by fusing a deaminase to a Cas9 nuclease that allowed for more efficient gene correction using the CRISPR/Cas system (see introduction). Komor et al. teach the development of base editing advances both the scope and effectiveness of genome editing (see page 423 last paragraph).It would have been obvious to one of ordinary skill in the art to fuse a heterologous peptide, such as deaminase, to the nuclease of Patent313. to allow for more efficient gene correction. Claims 150-169 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of Patent 11,377,646 ( Patent646 ) in view of Chen et al (US Patent Application Publication No. 2016/0298134 A1) and Komor et al. ( "Programmable editing of a target base in genomic DNA without double-stranded DNA cleavage." Nature 533.7603 (2016): 420-424 ) . Although the claims at issue are not identical, they are not patentably distinct from each other. Both the instant claims and claims of Patent646 are drawn to a composition comprising a nuclease having a RuvC active site and a guide RNA and wherein PAM is 5’-NTTN-3’, wherein T is thymine and N is any nucleotid e capable of cleaving a target nucleic acid. The claims of Patent646 does not specify that the nucleic acid encoding the polypeptide is messenger RNA (mRNA ) or teach a fused heterologous polypeptide of a deaminase . Chen et al teach it is within the skill of the art to contact a cell with mRNA encoding a Cas polypeptide (e.g., paragraphs [0006], [0013], [0014], [0064] and [0067]). It would have been obvious to use mRNA as the nucleic acid in the composition of Patent646 in order to provide a specific form of nucleic acid for the composition, where the nucleic is known to be suitable for introduction into a cell for expression of a Cas polypeptide. Komor et al. teach increasing the efficiency of homology-directed repair (HDR). HDR by fusing a deaminase to a Cas9 nuclease that allowed for more efficient gene correction using the CRISPR/Cas system (see introduction). Komor et al. teach the development of base editing advances both the scope and effectiveness of genome editing (see page 423 last paragraph). It would have been obvious to one of ordinary skill in the art to fuse a heterologous peptide, such as deaminase, to the nuclease of Patent646 to allow for more efficient gene correction. Claims 150-169 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of Patent 11,530,398 (Patent398) in view of Chen et al (US Patent Application Publication No. 2016/0298134 A1) and Komor et al. ( "Programmable editing of a target base in genomic DNA without double-stranded DNA cleavage." Nature 533.7603 (2016): 420-424 ) . Although the claims at issue are not identical, they are not patentably distinct from each other. Both the instant claims and claims of Patent398 are drawn to a composition comprising a nuclease having a RuvC active site and a guide RNA and wherein PAM is 5’-NTTN-3’, wherein T is thymine and N is any nucleotid e capable of cleaving a target nucleic acid. The sequences of Patent398 are encompassed in the nuclease and guide RNA as instantly claimed. The claims of Patent398 does not specify that the nucleic acid encoding the polypeptide is messenger RNA (mRNA ) or teach a fused heterologous polypeptide. Chen et al teach it is within the skill of the art to contact a cell with mRNA encoding a Cas polypeptide (e.g., paragraphs [0006], [0013], [0014], [0064] and [0067]). It would have been obvious to use mRNA as the nucleic acid in the composition of Patent 398 in order to provide a specific form of nucleic acid for the composition, where the nucleic is known to be suitable for introduction into a cell for expression of a Cas polypeptide. Komor et al. teach increasing the efficiency of homology-directed repair (HDR). HDR by fusing a deaminase to a Cas9 nuclease that allowed for more efficient gene correction using the CRISPR/Cas system (see introduction). Komor et al. teach the development of base editing advances both the scope and effectiveness of genome editing (see page 423 last paragraph). It would have been obvious to one of ordinary skill in the art to fuse a heterologous peptide, such as deaminase, to the nuclease of Patent 398 to allow for more efficient gene correction. Claims 150-169 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of Patent 12,312,616 (Patent616) in view of Chen et al (US Patent Application Publication No. 2016/0298134 A1) and Komor et al. ( "Programmable editing of a target base in genomic DNA without double-stranded DNA cleavage." Nature 533.7603 (2016): 420-424 ) . Although the claims at issue are not identical, they are not patentably distinct from each other. Both the instant claims and claims of Patent616 are drawn to a composition comprising a nuclease having a RuvC active site and a guide RNA and wherein PAM is 5’-NTTN-3’, wherein T is thymine and N is any nucleotid e capable of cleaving a target nucleic acid. The sequences of Patent616 are encompassed in the nuclease and guide RNA as instantly claimed. The claims of Patent616 does not specify that the nucleic acid encoding the polypeptide is messenger RNA (mRNA ) or teach a fused heterologous polypeptide. Chen et al teach it is within the skill of the art to contact a cell with mRNA encoding a Cas polypeptide (e.g., paragraphs [0006], [0013], [0014], [0064] and [0067]). It would have been obvious to use mRNA as the nucleic acid in the composition of Patent616 in order to provide a specific form of nucleic acid for the composition, where the nucleic is known to be suitable for introduction into a cell for expression of a Cas polypeptide. Komor et al. teach increasing the efficiency of homology-directed repair (HDR). HDR by fusing a deaminase to a Cas9 nuclease that allowed for more efficient gene correction using the CRISPR/Cas system (see introduction). Komor et al. teach the development of base editing advances both the scope and effectiveness of genome editing (see page 423 last paragraph). It would have been obvious to one of ordinary skill in the art to fuse a heterologous peptide, such as deaminase, to the nuclease of Patent398 to allow for more efficient gene correction. Claims 150-169 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of Patent 12,365,887 (Patent887) evidenced by Cheng et al. (US 2020/0299659 – cited on IDS 06/05/2024; having an effectively filed date of May 16, 2018) in view of Chen et al (US Patent Application Publication No. 2016/0298134 A1) and Komor et al. ( "Programmable editing of a target base in genomic DNA without double-stranded DNA cleavage." Nature 533.7603 (2016): 420-424 ) . Although the claims at issue are not identical, they are not patentably distinct from each other. Both the instant claims and claims of Patent887 are drawn to a composition comprising a nuclease and a guide RNA and wherein PAM is 5’-NTTN-3’, wherein T is thymine and N is any nucleotid e capable of cleaving a target nucleic acid. The sequences of Patent887 are encompassed in the nuclease and guide RNA as instantly claimed. Patent887 do not specifically teach the unease has a RuvC active site. As evidenced by Cheng et al. teach a Cas nuclease of SEQ ID NO: 318 (which is 721 amino acids) has 100% sequence identity to SEQ ID NO: 120 shown in Fig 6M as Cas12J (See SCORE, 20210608_085700_us-17-229-272-120.rapbm file, Result #1 in patent family Application 17229272 an attached file showing alignment ). Cheng et al. the CRISPR associate protein comprises a RuvC domain (claim 63). The claims of Patent887 does not specify that the nucleic acid encoding the polypeptide is messenger RNA (mRNA ) or teach a fused heterologous polypeptide. Chen et al teach it is within the skill of the art to contact a cell with mRNA encoding a Cas polypeptide (e.g., paragraphs [0006], [0013], [0014], [0064] and [0067]). It would have been obvious to use mRNA as the nucleic acid in the composition of Patent616 in order to provide a specific form of nucleic acid for the composition, where the nucleic is known to be suitable for introduction into a cell for expression of a Cas polypeptide. Komor et al. teach increasing the efficiency of homology-directed repair (HDR). HDR by fusing a deaminase to a Cas9 nuclease that allowed for more efficient gene correction using the CRISPR/Cas system (see introduction). Komor et al. teach the development of base editing advances both the scope and effectiveness of genome editing (see page 423 last paragraph). It would have been obvious to one of ordinary skill in the art to fuse a heterologous peptide, such as deaminase, to the nuclease of Patent887 to allow for more efficient gene correction Claims 150-169 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 4 of Patent 1 1,685,909 (Patent 909 ) evidenced by Cheng et al. (US 2020/0299659 – cited on IDS 06/05/2024; having an effectively filed date of May 16, 2018) in view of Chen et al (US Patent Application Publication No. 2016/0298134 A1) and Komor et al. ( "Programmable editing of a target base in genomic DNA without double-stranded DNA cleavage." Nature 533.7603 (2016): 420-424 ) . Although the claims at issue are not identical, they are not patentably distinct from each other. Both the instant claims and claims of Patent909 are drawn to a composition comprising a nuclease and a guide RNA and wherein PAM is 5’-NTTN-3’, wherein T is thymine and N is any nucleotid e capable of cleaving a target nucleic acid. The sequences of Patent909 are encompassed in the nuclease and guide RNA as instantly claimed. Patent909 do not specifically teach the unease has a RuvC active site. As evidenced by Cheng et al. teach a Cas nuclease of SEQ ID NO: 318 (which is 721 amino acids) has 100% sequence identity to SEQ ID NO: 120 shown in Fig 6M as Cas12J (See SCORE, 20210608_085700_us-17-229-272-120.rapbm file, Result #1 in patent family Application 17229272 an attached file showing alignment ). Cheng et al. the CRISPR associate protein comprises a RuvC domain (claim 63) . The claims of Patent909 does not specify that the nucleic acid encoding the polypeptide is messenger RNA (mRNA ) or teach a fused heterologous polypeptide. Chen et al teach it is within the skill of the art to contact a cell with mRNA encoding a Cas polypeptide (e.g., paragraphs [0006], [0013], [0014], [0064] and [0067]). It would have been obvious to use mRNA as the nucleic acid in the composition of Patent 909 in order to provide a specific form of nucleic acid for the composition, where the nucleic is known to be suitable for introduction into a cell for expression of a Cas polypeptide. Komor et al. teach increasing the efficiency of homology-directed repair (HDR). HDR by fusing a deaminase to a Cas9 nuclease that allowed for more efficient gene correction using the CRISPR/Cas system (see introduction). Komor et al. teach the development of base editing advances both the scope and effectiveness of genome editing (see page 423 last paragraph). It would have been obvious to one of ordinary skill in the art to fuse a heterologous peptide, such as deaminase, to the nuclease of Patent 909 to allow for more efficient gene correction Claims 150-169 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 70-176, 178-189 of Patent Application No. 17,225,866 ( APP866 ) in view of Chen et al (US Patent Application Publication No. 2016/0298134 A1) and Komor et al. ( "Programmable editing of a target base in genomic DNA without double-stranded DNA cleavage." Nature 533.7603 (2016): 420-424 ) . Although the claims at issue are not identical, they are not patentably distinct from each other. C laims of APP866 are drawn to a composition comprising a nuclease having a RuvC active site and a guide RNA and wherein PAM is 5’-NTTN-3’, wherein T is thymine and N is any nucleotid e capable of cleaving a target nucleic acid. The sequences of APP866 are encompassed in the nuclease and guide RNA as instantly claimed. The instant claims re drawn to a composition comprising a nuclease having a RuvC active site and a guide RNA and wherein PAM is 5’-NTTN-3’, wherein T is thymine and N is any nucleotid e capable of cleaving a target nucleic acid and it would have been obvious to use the composition of the instant claims in the methods of APP866. The claims of APP866 do not specify that the nucleic acid encoding the polypeptide is messenger RNA (mRNA ) or teach a fused heterologous polypeptide. Chen et al teach it is within the skill of the art to contact a cell with mRNA encoding a Cas polypeptide (e.g., paragraphs [0006], [0013], [0014], [0064] and [0067]). It would have been obvious to use mRNA as the nucleic acid in the composition of APP866 in order to provide a specific form of nucleic acid for the composition, where the nucleic is known to be suitable for introduction into a cell for expression of a Cas polypeptide. Komor et al. teach increasing the efficiency of homology-directed repair (HDR). HDR by fusing a deaminase to a Cas9 nuclease that allowed for more efficient gene correction using the CRISPR/Cas system (see introduction). Komor et al. teach the development of base editing advances both the scope and effectiveness of genome editing (see page 423 last paragraph). It would have been obvious to one of ordinary skill in the art to fuse a heterologous peptide, such as deaminase, to the nuclease of APP866 to allow for more efficient gene correction This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 150-169 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 150-169 of Patent Application No. 17,990,074 ( APP074 ) evidenced by Cheng et al. (US 2020/0299659 – cited on IDS 06/05/2024; having an effectively filed date of May 16, 2018). Although the claims at issue are not identical, they are not patentably distinct from each other. Both the instant claims and claims of APP074 are drawn to a composition comprising a nuclease having a RuvC active site and a guide RNA and wherein PAM is 5’-NTTN-3’, wherein T is thymine and N is any nucleotid e capable of cleaving a target nucleic acid. The sequences of APP074 are encompassed in the nuclease and guide RNA as instantly claimed. The instant claims and claims of APP074 are drawn to a composition comprising a nuclease having a RuvC active site and a guide RNA and wherein PAM is 5’-NTTN-3’, wherein T is thymine and N is any nucleotid e capable of cleaving a target nucleic acid and it would have been obvious to use the composition of the instant claims in the methods of APP074. Each further claim the nucleic acid encoding the polypeptide is messenger RNA (mRNA ) or teach a fused heterologous polypeptide. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 150-169 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 150-169 of Patent Application No. 18,313,914 ( APP914 ) as evidenced by Cheng et al. (US 2020/0299659 – cited on IDS 06/05/2024; having an effectively filed date of May 16, 2018). Although the claims at issue are not identical, they are not patentably distinct from each other. Both the instant claims and claims of APP914 are drawn to a composition comprising a nuclease and a guide RNA and wherein PAM is 5’-NTTN-3’, wherein T is thymine and N is any nucleotid e capable of cleaving a target nucleic acid. APP914 do not specifically teach the unease has a RuvC active site. As evidenced by Cheng et al. teach a Cas nuclease of SEQ ID NO: 318 (which is 721 amino acids) has 100% sequence identity to SEQ ID NO: 120 shown in Fig 6M as Cas12J (See SCORE, 20210608_085700_us-17-229-272-120.rapbm file, Result #1 in patent family Application 17229272 an attached file showing alignment ). Cheng et al. the CRISPR associate protein comprises a RuvC domain (claim 63) The instant claims and claims of APP914 are drawn to a composition comprising a nuclease having a RuvC active site and a guide RNA and wherein PAM is 5’-NTTN-3’, wherein T is thymine and N is any nucleotid e capable of cleaving a target nucleic acid and it would have been obvious to use the composition of the instant claims in the methods of APP914. Each further claim the nucleic acid encoding the polypeptide is messenger RNA (mRNA ) or teach a fused heterologous polypeptide. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Kimberly Chong at FILLIN "Phone number" \* MERGEFORMAT (571)272-3111 . The examiner can normally be reached Monday thru Friday between M-F 8:00am-4:30pm . If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public. For more information about the PAIR system, see http://pair-direct.uspto.gov. For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199. /KIMBERLY CHONG/ Primary Examiner Art Unit 1636