DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 104-107, 109-116, 118-120 and 122 are pending in this application.
Applicant’s amendment to the claims filed 08/06/2025 is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Applicant’s remarks filed on 08/06/2025 in response to the non-final rejection mailed on 03/07/2025 is acknowledged and has been fully considered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election
The elected subject matter is
Group I, corresponding to claims 104-107, 109-116, 118-120 and 122, drawn to the technical feature of an engineered nuclease system comprising (i) an endonuclease comprising a RuvC_III domain and an HNH domain derived from an uncultivated microorganism and is a class 2, type II Cas endonuclease, and (ii) an engineered guide ribonucleic acid structure; a nucleic acid; and a vector,
Species A42) the RuvC_III domain comprises a sequence with at least 70% or 80% identity to SEQ ID NO: 87,
Species B43) the endonuclease comprises SEQ ID NO: 43 or a variant having at least 80% identity thereto,
Species C43) the HNH domain comprises a sequence with at least 80% identity to SEQ ID NO: 131,
Species D11) the tracr ribonucleic acid sequence comprises a sequence with to about 60 to 90 consecutive nucleotides of SEQ ID NO: 148, and
Species E10) the PAM sequence is SEQ ID NO: 158,
elected without traverse in the reply filed 04/15/2024.
Claims 104-107, 109-116, 118-120 and 122 are being examined on the merits only to the extent they read on the elected subject matter.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 08/06/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Claim Objections
Claims 104-105, 109, 116, 119-120 and 122 are objected to for the phrase “having … sequence identity to SEQ ID NO”. In the interest of improving claim form, Applicant should consider an amendment to recite “sharing … sequence identity with SEQ ID NO”.
Claim 107 is objected to for the phrase “has … sequence identity to”. In the interest of improving claim form, Applicant should consider an amendment to recite “shares … sequence identity with”.
Claim 110 is objected to for the phrase “a protospacer adjacent motif (PAM) sequence selected from the nucleic acid sequence of SEQ ID NO: 158”. In the interest of improving claim form, Applicant should consider an amendment to recite “a protospacer adjacent motif (PAM) sequence comprising the nucleic acid sequence of SEQ ID NO: 158”.
Claim 111 is objected to for the phrase “said engineered guide ribonucleic acid structure comprises one ribonucleic acid polynucleotide comprising said guide ribonucleic acid sequence and said tracr ribonucleic acid sequence”. In the interest of improving claim form, Applicant should consider an amendment to recite “said engineered guide ribonucleic acid structure comprises one ribonucleic acid polynucleotide, wherein the one ribonucleic acid polynucleotide comprises said guide ribonucleic acid sequence and said tracr ribonucleic acid sequence”.
Claim Rejections - 35 USC § 112(a)
The rejection of claims 104, 106-107, 109-115, 119 and 122 under 35 U.S.C. 112(a) as failing to comply with the written description requirement, and
the rejection of claims 104, 106-107, 109-115, 119 and 122 under 35 U.S.C. 112(a) for the specification not enabling any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims
are withdrawn in view of the amendment to claims 104, 119 and 122 to recite “wherein the HNH domain comprises a sequence having at least 80% sequence identity to SEQ ID NO: 131” and Applicant’s remarks that this limitation provides adequate structure for the engineered nuclease system and limits the scope of the claimed engineered nuclease system, and therefore one of skill in the art would reasonably conclude that the applicant was in possession of the claimed invention and could make and use the invention in a manner reasonably correlated with the scope of the claims.
Claim Rejections - 35 USC § 101
Claims 104-107, 109-110, 112-113, 115-116 and 118-120 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Applicant’s attention is directed to the "Guidance for Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products”, released on December 16, 2014.
The instant rejection is maintained from the previous Office Action and any newly recited portions are necessitated by claim amendment.
Claims 104-107, 109-110, 112-113, 115-116 and 118
Claim Interpretation: Given a broadest reasonable interpretation, the claimed nuclease system is considered to encompass a combination of naturally-occurring products, e.g., an endonuclease comprising RuvC_III and HNH domains and a guide RNA comprising a guide RNA and a tracrRNA. Regarding the limitations of “an engineered nuclease system”, “an engineered guide ribonucleic acid structure” in recited in the claims, the limitations are considered to be a product-by-process limitations (see MPEP 2113), as the processes of engineering the nuclease system and the process of engineering the guide ribonucleic acid do not impart any structural characteristics such that one of skill in the art would recognize either the guide ribonucleic acid or the nuclease system to be markedly different from its naturally occurring counterpart.
Patent Eligibility Analysis Step 1: The claims are drawn to a composition of matter, which is a statutory category of invention.
Patent Eligibility Analysis Step 2A Prong 1: Regarding the interpretation of the claimed nuclease system as encompassing a combination of the naturally-occurring products, e. g., an endonuclease comprising RuvC_III and HNH domains and a guide RNA comprising a guide RNA and a tracrRNA, the claims recite a combination of naturally-occurring products, which is a law of nature or natural phenomena (natural products). NCBI Accession No. MEE0951869 (3 pages, 01/31/2024; cited on the attached Form PTO-892; herein “N2”) discloses a type II Cas9 endonuclease from the gut bacterium Paludibacteraceae that shares >96% sequence identity with SEQ ID NO: 131 [see Appendix A] and >98% sequence identity with SEQ ID NO: 87 [see Appendix B], which are understood correspond to a class 2, type II Cas endonuclease with HNH and RuvC_III domains. Considering that Shmakov et al. (Nat Rev Microbiol, 2017, 15(3):169-182; cited on the IDS submitted 05/20/2022; herein referred to Shmakov) discloses other class 2, type II Cas9 endonucleases containing RuvC_III and HNH domains from the organism Legionella pneumophila str. Paris [Figure 1], that CRISPR-Cas systems naturally involve a CRISPR RNA (crRNA, also known as guide RNA in the art) that binds both the endonuclease and DNA polynucleotide target [p 2, para 1], and that type II CRISPR loci encode trans-acting CRISPR RNA (tracrRNA) essential for pre-crRNA processing and target recognition in type II systems [p 3, para 2], there is no indication in the specification or the prior art of record that the claimed system of an endonuclease comprising a RuvC_III domain and an HNH domain having at least 80% sequence identity to SEQ ID NO: 131, and a guide RNA comprising a guide RNA and a tracrRNA has any characteristics (structural, functional, or otherwise) that are different from either the disclosed system, or the individual components as each occurs in nature. In this case, the claimed system does not have markedly different characteristics from what occurs in nature and is considered to be a “product of nature” exception. Accordingly, the claimed system is considered to be directed to a judicial exception.
Patent Eligibility Analysis Step 2A Prong 2: There are no additional elements recited in claims 104 and 110 beyond the judicial exception.
Claims 105-107, 109, 112-113, 115-116 and 118 recite additional elements regarding: the sequence homology of the system components such as the endonuclease (claims 105, 107, 116 and 118) and the guide RNA (claim 109); the type of endonuclease (claim 106); and the arrangement and components of the nucleic acid (claims 112-113 and 115). There is no indication in the specification or the prior art of record that the system of an endonuclease comprising RuvC_III and HNH domains and a guide RNA comprising a guide RNA and a tracrRNA with these additional elements recited in the claims have any characteristics (structural, functional, or otherwise) that are different from the individual endonuclease comprising RuvC_III and HNH domains and guide RNA as each occurs in nature. In this case, the claimed composition does not have markedly different characteristics from what occurs in nature and is considered to be a “product of nature” exception. Accordingly, the claimed composition is considered to be directed to a judicial exception.
Patent Eligibility Analysis Step 2B: The claims recite only the product of nature or a combination of products of nature without more and do not include any additional elements that could add significantly more to the judicial exception.
As such, the claims do not qualify as eligible subject matter. For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
Claims 119-120
Claim Interpretation: Given a broadest reasonable interpretation, the claimed nucleic acid is considered to encompass a naturally-occurring product, e.g., a nucleic acid encoding the class 2, type II Cas endonuclease of N2 comprising a RuvC_III domain and an HNH domain sharing at least 70% sequence identity with SEQ ID NO: 87 and at least 80% sequence identity with SEQ ID NO: 131, respectively. Regarding the limitation of “an engineered nucleic acid sequence” recited in claim 119, the limitation is considered to be a product-by-process limitation (see MPEP 2113), as the process of engineering a nucleic acid does not impart any meaningful structural characteristics such that one of skill in the art would recognize the nucleic acid is markedly different from its naturally occurring counterpart.
Patent Eligibility Analysis Step 1: The claims are drawn to a composition of matter, which is a statutory category of invention.
Patent Eligibility Analysis Step 2A Prong 1: Regarding the interpretation of the claimed nucleic acid as encompassing a naturally-occurring product, e. g., a nucleic acid encoding the class 2, type II Cas endonuclease of N2 comprising a RuvC_III domain and an HNH domain sharing at least 70% sequence identity with SEQ ID NO: 87 and at least 80% sequence identity with SEQ ID NO: 131, respectively, the claims recite a naturally-occurring product, which is a law of nature or natural phenomena (natural products). Considering the class 2, type II Cas endonuclease disclosed by N2, and that Shmakov discloses a class 2, type II Cas9 endonuclease containing RuvC_III and HNH domains from the organism Legionella pneumophila str. Paris [Figure 1], and wherein [Figure 1] depicts a locus that is understood to correspond to nucleic acid organization, there is no indication in the specification or the prior art of record that the claimed system of a nucleic acid encoding an endonuclease comprising a RuvC_III domain and an HNH domain, wherein said endonuclease is a class 2, type II Cas endonuclease has any has any characteristics (structural, functional, or otherwise) that are different from the disclosed nucleic acid as it occurs in nature. In this case, the claimed nucleic acid does not have markedly different characteristics from what occurs in nature and is considered to be a “product of nature” exception. Accordingly, the claimed composition is considered to be directed to a judicial exception.
Patent Eligibility Analysis Step 2A Prong 2:
Claim 119 recites the additional element that the nucleic acid is optimized for expression in an organism, however as N2 discloses a class 2, type II Cas endonuclease from the gut bacterium Paludibacteraceae comprising a RuvC_III domain and an HNH domain with the sequence limitations of the claim, the nucleic acid encoding said endonuclease is considered to be optimized for expression in the organism Paludibacteraceae of N2.
Claim 120 recites the additional elements of limitations on amino acid sequence encoded by the nucleic acid, wherein N2 discloses a nucleic acid encoding the class 2, type II Cas endonuclease of N2 comprising an HNH domain and a RuvC_III domain, wherein the RuvC_III domain shares at least 70% sequence identity with SEQ ID NO: 87. Therefore, there is no indication in the specification or the prior art of record that the nucleic acid encoding an endonuclease comprising a RuvC_III domain and an HNH domain with these additional elements recited in the claims has any characteristics (structural, functional, or otherwise) that are different from the nucleic acid as it occurs in nature. In this case, the claimed nucleic acid does not have markedly different characteristics from what occurs in nature and is considered to be a “product of nature” exception. Accordingly, the claimed nucleic acid is considered to be directed to a judicial exception.
Patent Eligibility Analysis Step 2B: The claims recite only the product of nature or a combination of products of nature without more and do not include any additional elements that could add significantly more to the judicial exception.
As such, the claims do not qualify as eligible subject matter. For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
Response to Remarks: beginning p 8 of Applicant’s response to rejections under 35 USC 101; Applicant in summary contends the claims recite “an engineered nuclease system” the comprises “an engineered guide ribonucleic acid structure” which distinguishes the system from naturally occurring systems; Applicant further contends the specification states the guide RNA “may be programmed to bind to a sequence of nucleic acid site-specifically” which allows the claimed system to target and bind differently from natural nucleic acid systems, which constitutes a markedly different characteristic from the naturally occurring counterpart system; Applicant further contends the limitations of claims 111 and 114 are components of the nucleic acid that do not occur in nature; Applicant further contends the limitation of “an engineered nucleic acid sequence optimized for expression in an organism” in claim 119 is the result of human intervention, and is a markedly different characteristic than the naturally occurring counterpart nucleic acid.
Applicant’s remarks regarding claims 111 and 114 are acknowledged and these claims have been removed from the rejection above.
Applicant’s remarks regarding other claims are considered and found not convincing. Regarding the recitation of “an engineered nuclease system” the comprises “an engineered guide ribonucleic acid structure”, these limitations are considered to be product-by-process limitations, as the method of engineering imparts no structural characteristics on the recited product of the nuclease system and guide RNA such that one of skill in the art would recognize these products as markedly different from their naturally occurring counterparts.
Regarding the guide RNA which “may be programmed to bind to a sequence of nucleic acid site-specifically” as cited from the specification Applicant asserts to allow the claimed system to target and bind differently from natural nucleic acid systems, this is not a feature recited in the claims. Rather, the claims recite the guide RNA hybridizes to a target DNA sequence, which encompasses naturally occurring guide RNA as disclosed by Shmakov.
Regarding the phrase “an engineered nucleic acid sequence optimized for expression in an organism” in claim 119, the limitation of “an engineered nucleic acid sequence is considered a product-by-process limitation, as the method of engineering imparts no structural characteristics on the recited product of the nucleic acid sequence such that one of skill in the art would recognize the nucleic acid sequence as markedly different from its naturally occurring counterpart. Additionally, the limitation “optimized for expression in an organism” is not considered an element introduced by the hand of man as asserted by Applicant, as the endonuclease disclosed by N2 from the organism Paludibacteraceae is considered to be encoded by a nucleic acid in the organism’s genome as taught by Shmakov, and that nucleic acid is considered to be optimized for expression in the organism.
Claim Rejections - 35 USC § 103
The rejection of claims 104, 106-107, 110-113 and 119 under 35 U.S.C. 103 as being unpatentable over Shmakov et al. (Nat Rev Microbiol, 2017, 15(3):169-182; cited on the IDS submitted 05/20/2022; herein referred to Shmakov) in view of Nowak et al. (Nucleic Acids Res, 2016, 44(20):9555-9564; cited on the Form PTO-892 mailed 02/16/2024; herein referred to as Nowak) and evidentiary references GenBank Accession No. CAH11307.1 (2 pages, 02/27/2015; cited on the Form PTO-892 mailed 03/07/2025; herein referred to as GB1) and NCBI Accession No. WP_127108862.1 (2 pages, 10/07/2019; cited on the Form PTO-892 mailed 03/07/2025; herein referred to as N1),
the rejection of claims 105, 116, 118 and 120 under 35 U.S.C. 103 as being unpatentable over Shmakov and Nowak, and further in view of UniProt Accession No. A0A3B9GP86 (1 page, 01/16/2019; cited on the Form PTO-892 mailed 03/07/2025; herein referred to as U1),
the rejection of claim 110 under 35 U.S.C. 103 as being unpatentable over Shmakov and Nowak, and further in view of Sontheimer et al. (WO 2019/094791, priority to US 16/186352 filed 11/09/2018; cited on the Form PTO-892 mailed 03/07/2025; herein referred to as Sontheimer),
the rejection of claims 114 and 122 under 35 U.S.C. 103 as being unpatentable over Shmakov and Nowak, and further in view of Xu et al. (Cell Mol Life Sci, 2015, 72:383; cited on the Form PTO-892 mailed 03/07/2025; herein referred to as Xu), and
the rejection of claim 115 under 35 U.S.C. 103 as being unpatentable over Shmakov and Nowak, and further in view of Paix et al. (PNAS, 2017, 114:e10745; cited on the Form PTO-892 mailed 03/07/2025; herein referred to as Paix)
are withdrawn in view of the amendment to claims 104, 119 and 122 to recite “wherein the HNH domain comprises a sequence having at least 80% sequence identity to SEQ ID NO: 131”, as the prior art of record does not teach or suggest “an engineered nuclease system comprising an endonuclease comprising a RuvC_III domain and an HNH domain, wherein the endonuclease is derived from an uncultivated microorganism, wherein said HNH domain comprises a sequence having at least 80% sequence identity with SEQ ID NO: 131, and wherein said endonuclease is a class 2, type II Cas endonuclease, and an engineered guide ribonucleic acid structure that forms a complex with said endonuclease, wherein said engineered guide ribonucleic acid structure comprises a guide ribonucleic acid sequence that hybridizes to a target deoxyribonucleic acid sequence and a tracr ribonucleic acid sequence that binds to said endonuclease” as recited in claim 104. Additionally, the prior art of record does not teach or suggest “a nucleic acid comprising an engineered nucleic acid sequence optimized for expression in an organism, wherein said nucleic acid encodes an endonuclease comprising a RuvC_III domain and an HNH domain, wherein said endonuclease is a class 2, type II Cas endonuclease, wherein said HNH domain comprises a sequence having at least 80% sequence identity to SEQ ID NO: 131, and wherein said endonuclease is derived from an uncultivated microorganism” as recited in claim 119.
Double Patenting
The rejection of claims 104, 106-107, 110, 112-115 and 119 on the ground of nonstatutory double patenting as being unpatentable over claim 1, 12-13, and 19-20 of U.S. Patent No. 11,946,039 (cited on the Form PTO-892 mailed 03/07/2025) in view of Shmakov and evidentiary references GB1 and N1,
the rejection of claims 105, 116, 118 and 120 on the ground of nonstatutory double patenting as being unpatentable over claim 1, 12-13, and 19-20 of U.S. Patent No. 11,946,039 in view Shmakov as applied to claims 104, 106-107, 110, 112-115 and 119 above, and further in view of U1,
the rejection of claim 110 on the ground of nonstatutory double patenting as being unpatentable over claim 1, 12-13, and 19-20 of U.S. Patent No. 11,946,039 in view of Shmakov as applied to claims 104, 106-107, 110, 112-115 and 119 above, and further in view of Sontheimer,
the rejection of claim 111 on the ground of nonstatutory double patenting as being unpatentable over claim 1, 12-13, and 19-20 of U.S. Patent No. 11,946,039 in view of Shmakov as applied to claims 104, 106-107, 110, 112-115 and 119 above, and further in view of Nowak,
the rejection of claim 122 on the ground of nonstatutory double patenting as being unpatentable over claim 1, 12-13, 19-20 of U.S. Patent No. 11,946,039 in view of Shmakov as applied to claims 104, 106-107, 110, 112-115 and 119 above, and further in view of Xu,
the rejection of claims 104 and 110-115 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7-9 and 11 of U.S. Patent No. 10,982,200 (cited on the Form PTO-892 mailed 03/07/2025),
the rejection of claims 106-107 and 119 the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7-9 and 11 of U.S. Patent No. 10,982,200 in view of Shmakov and evidentiary references GB1 and N1,
the rejection of claims 105, 116, 118 and 120 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7-9 and 11 of U.S. Patent No. 10,982,200 in view of Shmakov as applied to claims 104, 106-107, 110-115 and 119 above, and further in view of U1,
the rejection of claim 110 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7-9 and 11 of U.S. Patent No. 10,982,200 as applied to claims 104, and 110-115 above, and further in view of Sontheimer,
the rejection of claim 113 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7-9 and 11 of U.S. Patent No. 10,982,200 in view of Shmakov as applied to claims 104, 106-107, 110-115 and 119 above, and further in view of Nowak,
the rejection of claim 122 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7-9 and 11 of U.S. Patent No. 10,982,200 in view of Shmakov as applied to claims 104, 106-107, 110-115 and 119 above, and further in view of Xu,
the rejection of claims 104 and 110-115 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-8 and 10 of U.S. Patent No. 10,913,941 (cited on the Form PTO-892 mailed 03/07/2025),
the rejection of claims 106-107 and 119 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-8 and 10 of U.S. Patent No. 10,913,941 in view of Shmakov and evidentiary references GB1 and N1,
the rejection of claims 105, 116, 118 and 120 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-8 and 10 of U.S. Patent No. 10,913,941 in view of Shmakov as applied to claims 104, 106-107, 110-115 and 119 above, and further in view of U1,
the rejection of claim 110 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-8 and 10 of U.S. Patent No. 10,913,941 as applied to claims 104, and 110-115 above, and further in view of Sontheimer,
the rejection of claim 113 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-8 and 10 of U.S. Patent No. 10,913,941 in view of Shmakov as applied to claims 104, 106-107, 110-115 and 119 above, and further in view of Nowak,
the rejection of claim 122 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-8 and 10 of U.S. Patent No. 10,913,941 in view of Shmakov as applied to claims 104, 106-107, 110-115 and 119 above, and further in view of Xu,
the provisional rejection of claim 104 on the ground of nonstatutory double patenting as being unpatentable over claim 23 of copending Application No. 18/335,481,
the provisional rejection of claims 106-107, 110, 112 and 119 on the ground of nonstatutory double patenting as being unpatentable over claim 23 of copending Application No. 18/335,481 in view of Shmakov and evidentiary references GB1 and N1,
the provisional rejection of claims 105, 116, 118 and 120 on the ground of nonstatutory double patenting as being unpatentable over claim 23 of copending Application No. 18/335,481 in view of U1,
the provisional rejection of claim 110 on the ground of nonstatutory double patenting as being unpatentable over claim 23 of copending Application No. 18/335,481 as applied to claim 104 above, and further in view of Sontheimer,
the provisional rejection of claims 111 and 113 on the ground of nonstatutory double patenting as being unpatentable over claim 23 of copending Application No. 18/335,481 in view of Nowak,
the provisional rejection of claims 114 and 122 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 23 of copending Application No. 18/335,481 in view of Xu,
the provisional rejection of claims 115 on the ground of nonstatutory double patenting as being unpatentable over claim 23 of copending Application No. 18/335,481 in view of Paix,
the provisional rejection of claims 104, 106-107, 110, 112 and 119 on the ground of nonstatutory double patenting as being unpatentable over claims 106-107 of copending Application No. 18/488,520 in view of Shmakov and evidentiary references GB1 and N1,
the provisional rejection of claims 105, 116, 118 and 120 on the ground of nonstatutory double patenting as being unpatentable over claims 106-107 of copending Application No. 18/488,520 in view of Shmakov as applied to claims 104, 106-107, 110, 112 and 119 above, and further in view of U1,
the provisional rejection of claim 110 on the ground of nonstatutory double patenting as being unpatentable over claims 106-107 of copending Application No. 18/488,520 in view of Shmakov as applied to claims 104, 106-107, 110, 112 and 119 above, and further in view of Sontheimer,
the provisional rejection of claims 111 and 113 on the ground of nonstatutory double patenting as being unpatentable over claims 106-107 of copending Application No. 18/488,520 in view of Shmakov as applied to claims 104, 106-107, 110, 112 and 119 above, and further in view of Nowak,
the provisional rejection of claims 114 and 122 on the ground of nonstatutory double patenting as being unpatentable over claims 106-107 of copending Application No. 18/488,520 in view of Shmakov as applied to claims 104, 106-107, 110, 112 and 119 above, and further in view of Xu,
the provisional rejection of claim 115 on the ground of nonstatutory double patenting as being unpatentable over claims 106-107 of copending Application No. 18/488,520 in view of Shmakov as applied to claims 104, 106-107, 110, 112 and 119 above, and further in view of Paix,
the provisional rejection of claims 104, 106-107, 110, 112-114 and 119 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14-16 and 25 of copending Application No. 17/841,082 in view of Shmakov and evidentiary references GB1 and N1,
the provisional rejection of claim 110 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14-16 and 25 of copending Application No. 17/841,082 in view of Shmakov as applied to claims 104, 106-107, 110, 112-114 and 119 above, and further in view of Sontheimer,
the provisional rejection of claim 111 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14-16 and 25 of copending Application No. 17/841,082 in view of Shmakov as applied to claims 104, 106-107, 110, 112-114 and 119 above, and further in view of Nowak,
the provisional rejection of claims 115 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14-16 and 25 of copending Application No. 17/841,082 in view of Shmakov as applied to claims 104, 106-107, 110, 112-114 and 119 above, and further in view of Paix,
the provisional rejection of claims 104, 106-107, 110-112, 114-115 and 119 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-10, and 12 of copending Application No. 17/402,426 in view of Shmakov and evidentiary references GB1 and N1,
the provisional rejection of claims 105, 116, 118 and 120 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-10, and 12 of copending Application No. 17/402,426 in view of Shmakov as applied to claims 104, 106-107, 110-112, 114-115 and 119 above, and further in view of U1,
the provisional rejection of claim 113 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-10, and 12 of copending Application No. 17/402,426 in view of Shmakov as applied to claims 104, 106-107, 110-112, 114-115 and 119 above, and further in view of Nowak,
the provisional rejection of claim 122 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-10, and 12 of copending Application No. 17/402,426 in view of Shmakov as applied to claims 104, 106-107, 110, 112-114 and 119 above, and further in view of Xu,
the provisional rejection of claims 104 and 110-115 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-10, and 12 of copending Application No. 17/193,173,
the provisional rejection of claims 106-107 and 119 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-10, and 12 of copending Application No. 17/193,173 in view of Shmakov,
the provisional rejection of claims 105, 116, 118 and 120 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-10, and 12 of copending Application No. 17/193,173 in view of U1,
the provisional rejection of claim 110 on the ground of nonstatutory double patenting as being unpatentable claims 1, 8-10, and 12 of copending Application No. 17/193,173 as applied to claims 104 and 110-115 above, and further in view of Sontheimer,
the provisional rejection of claim 122 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/193,173 in view of Xu,
the provisional rejection of claims 104, 106-107, 110-113 and 119 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 82 of copending Application No. 18/660722 in view of Shmakov, Nowak, and evidentiary references GB1 and N1,
the provisional rejection of claims 105, 116, 118 and 120 on the ground of nonstatutory double patenting as being unpatentable over claim 82 of copending Application No. 18/660722, Shmakov and Nowak as applied to claims 104, 106-107, 110-113 and 119 above, and further in view of U1,
the provisional rejection of claim 110 on the ground of nonstatutory double patenting as being unpatentable over claim 82 of copending Application No. 18/660722, Shmakov and Nowak as applied to claims 104, 106-107, 110-113 and 119 above, and further in view of Sontheimer,
the provisional rejection of claims 114 and 122 on the ground of nonstatutory double patenting as being unpatentable over claim 82 of copending Application No. 18/660722, Shmakov and Nowak as applied to claims 104, 106-107, 110-113 and 119 above, and further in view of Xu,
the provisional rejection of claim 115 on the ground of nonstatutory double patenting as being unpatentable over claim 82 of copending Application No. 18/660722, Shmakov and Nowak as applied to claims 104, 106-107, 110-113 and 119 above, and further in view of Paix,
the provisional rejection of claims 104, 106-107, 110-113 and 119 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/646380 in view of Shmakov, Nowak, and evidentiary references GB1 and N1,
the provisional rejection of claims 105, 116, 118 and 120 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/646380, Shmakov and Nowak as applied to claims 104, 106-107, 110-113 and 119 above, and further in view of U1,
the provisional rejection of claim 110 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/646380, Shmakov and Nowak as applied to claims 104, 106-107, 110-113 and 119 above, and further in view of Sontheimer,
the provisional rejection of claims 114 and 122 on the ground of nonstatutory double patenting as being unpatentable o over claim 1 of copending Application No. 18/646380, Shmakov and Nowak as applied to claims 104, 106-107, 110-113 and 119 above, and further in view of Xu,
the provisional rejection of claim 115 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/646380, Shmakov and Nowak as applied to claims 104, 106-107, 110-113 and 119 above, and further in view of Paix,
the provisional rejection of claims 104 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/669712,
the provisional rejection of claims 106-107, 110-113 and 119 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/669712 as applied to claim 104 above, and further in view of Shmakov and evidentiary references GB1 and N1,
the provisional rejection of claims 105, 116, 118 and 120 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/669712 as applied to claim 104 above, and further in view of U1,
the provisional rejection of claim 110 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/669712 as applied to claim 104 above, and further in view of Sontheimer, and
the provisional rejection of claim 115 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/669712 as applied to claim 104 above, and further in view of Paix
are withdrawn in view of the amendment to instant claims 104, 119 and 122 to recite “wherein the HNH domain comprises a sequence having at least 80% sequence identity to SEQ ID NO: 131”.
Examiner Comment
The subject matter recited in claims 104, 119 and 122 of “said HNH domain comprises a sequence having at least 80% sequence identity with SEQ ID NO: 131” is considered free of the prior art of record.
The closest prior art is considered to be Shmakov et al. (Nat Rev Microbiol, 2017, 15(3):169-182; cited on the IDS submitted 05/20/2022) which discloses a class 2, type II Cas endonuclease that is a Cas9 endonuclease comprising and RuvC_III domain and HNH domain [Figure 1] and that CRISPR-Cas systems involve a CRISPR RNA (crRNA, also known as guide RNA in the art) that binds both the endonuclease and DNA polynucleotide target [p 2, para 1]. Shmakov further discloses that type II CRISPR loci also encode trans-acting CRISPR RNA (tracrRNA) essential for pre-crRNA processing and target recognition in type II systems [p 3, para 2]. Shmakov does not teach or suggest an HNH domain that comprises a sequence having at least 80% sequence identity with SEQ ID NO: 131.
Conclusion
Status of the Application:
Claims 104-107, 109-116, 118-120 and 122 are pending.
Claims 104-107, 109-110, 112-113, 115-116 and 118-120 are rejected.
Claims 111 and 114 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 122 is objected to for informal matters.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOSEPH R SPANGLER/
Examiner
Art Unit 1656
/David Steadman/Primary Examiner, Art Unit 1656
APPENDIX A
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SEQUENCE ALIGNMENT OF SEQ ID NO: 131 AND NCBI ACCESSION NO. MEE0951869
APPENDIX B
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SEQUENCE ALIGNMENT OF SEQ ID NO: 87 AND NCBI ACCESSION NO. MEE0951869