DETAILED ACTION
Notice of Pre-AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Application
The amendments, response and Affidavit filed under 37 CFR 1.131, all filed 24 September 2025 are acknowledged and have been considered in their entireties. Claims 27-32 are canceled and claim 37 is new. Thus, claims 26 and 33-37 are pending and subject to examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted 24 September 2025 has been considered, see initialed and signed PTO/SB08.
Terminal Disclaimer
The terminal disclaimer filed on 24 September 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent 10760064 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawal of Previous Rejections
Claims 26-36 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Zhang et al. (US 2014/0186958 – cited on IDS 12/02/2019; with priority to US Provisional 61/736,527 (December 2012) is withdrawn in view of the Declaration filed under 37 C.F.R. 1.131 on 24 September 2025 and also Applicants remarks which do establish support in the Declaration that the dCas9 and mutants as claimed are supported in said Declaration and supporting evidence/laboratory notebook and the Maeder et al. reference (Nat. Methods, 2013, 10(10), 977-979 – cited as ref 574 on IDS filed 11/13/2024). This now effectively establishes that the invention as claimed was invented and reduced to practice prior to 12 December 2012, the earliest priority date of Zhang et al. As such, the rejection is withdrawn.
It is noted, even if said documentation were not enough, as noted by Applicants, MPEP 715.02 notes that even if every element is not fully supported by the Declaration, it can still overcome the rejection if the differences are obvious to one skilled in the art (See Remarks, p. 6, middle paragraph). Here the mutations as claimed were well known in the art prior to the effective filing date of the claimed invention as evidenced by Jinek et al., Science, 2012, 337:816-821 – cited on IDS and provided as Appendix B in response of 10/19/2018. As such, since the Declaration is deemed fully supportive now, both 35 U.S.C. 103(a) rejections are withdrawn as noted above.
The rejection of claims 26-36 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 19-22 of U.S. Patent No. 9944912 in view of Zhang et al. (US 2014/0186958 – cited on IDS), is withdrawn for the same reasons recited above regarding Zhang et al.
The rejection of claims 26-36 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7 and 10-11 of U.S. Patent No. 10119133 in view of Zhang et al. (US 2014/0186958 – cited on IDS), is withdrawn for the same reasons recited above regarding Zhang et al.
The rejection of claims 26-36 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 15-19 of U.S. Patent No. 11634731 in view of Zhang et al. (US 2014/0186958 – cited on IDS), is withdrawn for the same reasons recited above regarding Zhang et al.
The rejection of claims 26-36 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 16-19 of U.S. Patent No. 10808233 in view of Zhang et al. Zhang et al. (US 2014/0186958 – cited on IDS), is withdrawn for the same reasons recited above regarding Zhang et al.
The rejection of claims 26-36 on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11220678 in view of Zhang et al. Zhang et al. (US 2014/0186958 – cited on IDS), is withdrawn for the same reasons recited above regarding Zhang et al.
The rejection of claims 26-36 on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11859220 in view of Zhang et al. (US 2014/0186958 – cited on IDS), is withdrawn for the same reasons recited above regarding Zhang et al.
The rejection of claims 26-36 on the ground of nonstatutory double patenting as being unpatentable over claims 7-16 of U.S. Patent No. 10844403 in view of Zhang et al. (US 2014/0186958 – cited on IDS), is withdrawn for the same reasons recited above regarding Zhang et al.
The rejection of claims 26-36 on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 24-31 of U.S. Patent No. 11624058 in view of Zhang et al. (US 2014/0186958 – cited on IDS), is withdrawn for the same reasons recited above regarding Zhang et al.
The rejection of claims 26-36 on the ground of nonstatutory double patenting as being unpatentable over claims 31-37 and 49-58 of copending Application No. 18507709 (reference application), is withdrawn for the same reasons recited above regarding Zhang et al.
The rejection of claims 26-36 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10760064, is withdrawn in view of the terminal disclaimer as noted above.
Maintained Rejection(s)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 26 and 33-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 22-27 of U.S. Patent No. 9512446. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims to the ‘446 patent anticipate and/or render obvious the instant claims.
The instant claims in their broadest are drawn to a mammalian cell expressing a fusion protein comprising a catalytically inactive S. pyogenes Cas9 protein linked to a heterologous functional domain, wherein the catalytically inactive Cas9 protein comprises mutations at D10 and H840, and wherein the heterologous functional domain is VP64, the order of the fusion protein (claim 33), said fusion comprises linkers and/or nuclear localization sequence or epitope tag (claim 34), the kind of epitope tag selected from c-myc, Hisx6 and FLAG (claim 35) and the fusion protein is expressed from a vector in said cell (claim 36).
The claims to the ‘446 patent in their broadest are drawn to an isolated Streptococcus pyogenes Cas9 (SpCas9) protein with mutations at one or both of Q695 and Q926 in SEQ ID NO: 1, and optionally wherein the SpCas9 protein is fused to one or more of a nuclear localization sequence, cell penetrating peptide sequence, and/or affinity tag (claim 1); with dependent claims 6-7 reciting the SpCas9 further comprises mutations that decrease nuclease activity selected from (i) D10A or D10N; and (ii) H840A, H840N or H840Y. Dependent claim 8-10 recites the fusion protein further comprises an activation domain, selected from VP64 or NF-kB p65. Dependent claims 22-24 recites the fusion protein is encoded by nucleic acid within a vector and expressed in a host cell. While the ‘446 patent claims do not recite what type of host cell comprises the fusion protein(s), consistent with MPEP 804(II)(B)(1), upon construing the scope of the claims and specifically the scope of “host cell” consistent with specification of the ‘446 patent, it is clear that the host cells encompass mammalian and human host cells (See Examples utilizing human cells and See Col. 5, lines 48-53).
Claims 26 and 33-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 23-30 of U.S. Patent No. 10093910. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims to the ‘910 patent anticipate and/or render obvious the instant claims.
The instant claims in their broadest are drawn to a mammalian cell expressing a fusion protein comprising a catalytically inactive S. pyogenes Cas9 protein linked to a heterologous functional domain, wherein the catalytically inactive Cas9 protein comprises mutations at D10 and H840, and wherein the heterologous functional domain is VP64, the order of the fusion protein (claim 33), said fusion comprises linkers and/or nuclear localization sequence or epitope tag (claim 34), the kind of epitope tag selected from c-myc, Hisx6 and FLAG (claim 35) and the fusion protein is expressed from a vector in said cell (claim 36).
The claims to the ‘910 patent in their broadest are drawn to an isolated Streptococcus pyogenes Cas9 (SpCas9) protein that has at least 95% sequence identity to SEQ ID NO: 1, with mutations at one or both of Q695 and Q926, and wherein the protein retains the ability to interact with a guide RNA and target DNA (claim 1), with dependent claim 2 reciting the protein is further fused to a NLS sequence, etc.; dependent claims 7-8 recites the SpCas9 further comprises mutations that decrease nuclease activity selected from (i) D10A or D10N; and (ii) H840A, H840N or H840Y. Dependent claim 9-11 recites SpCas9 is in a fusion protein that further comprises an activation domain, selected from VP64 or NF-kB p65. Dependent claims 23-25 recites the fusion protein is encoded by nucleic acid within a vector and expressed in a host cell. While the ‘910 patent claims do not recite what type of host cell comprises the fusion protein(s), consistent with MPEP 804(II)(B)(1), upon construing the scope of the claims and specifically the scope of “host cell” consistent with specification of the ‘910 patent, it is clear that the host cells encompass mammalian and human host cells (See Examples utilizing human cells and See Col. 5, lines 45-51).
Claims 26 and 33-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 23-27 of U.S. Patent No. 10633642. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims to the ‘642 patent anticipate and/or render obvious the instant claims.
The instant claims in their broadest are drawn to a mammalian cell expressing a fusion protein comprising a catalytically inactive S. pyogenes Cas9 protein linked to a heterologous functional domain, wherein the catalytically inactive Cas9 protein comprises mutations at D10 and H840, and wherein the heterologous functional domain is VP64, the order of the fusion protein (claim 33), said fusion comprises linkers and/or nuclear localization sequence or epitope tag (claim 34), the kind of epitope tag selected from c-myc, Hisx6 and FLAG (claim 35) and the fusion protein is expressed from a vector in said cell (claim 36).
The claims to the ‘642 patent in their broadest are drawn to a Streptococcus pyogenes Cas9 (SpCas9):single guide RNA (sgRNA) complex comprising a SpCas9 protein with mutations at one or both of Q695 and Q926 in SEQ ID NO: 1, and a sgRNA (claim 1), with dependent claim 2 reciting the protein is further fused to a NLS sequence, etc.; dependent claims 7-8 recites the SpCas9 further comprises mutations that decrease nuclease activity selected from (i) D10A or D10N; and (ii) H840A, H840N or H840Y. Dependent claim 9-11 recites SpCas9 is in a fusion protein that further comprises an activation domain, selected from VP64 or NF-kB p65. Dependent claims 23-24 recites the fusion protein is encoded within a vector and expressed in a host cell. While the ‘642 patent claims do not recite what type of host cell comprises the fusion protein(s), consistent with MPEP 804(II)(B)(1), upon construing the scope of the claims and specifically the scope of “host cell” consistent with specification of the ‘642 patent, it is clear that the host cells encompass mammalian and human host cells (See Examples utilizing human cells and See Col. 5, lines 53-60).
Claims 26 and 33-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 27-33 of U.S. Patent No. 9926545. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims to the ‘545 patent anticipate and/or render obvious the instant claims.
The instant claims in their broadest are drawn to a mammalian cell expressing a fusion protein comprising a catalytically inactive S. pyogenes Cas9 protein linked to a heterologous functional domain, wherein the catalytically inactive Cas9 protein comprises mutations at D10 and H840, and wherein the heterologous functional domain is VP64, the order of the fusion protein (claim 33), said fusion comprises linkers and/or nuclear localization sequence or epitope tag (claim 34), the kind of epitope tag selected from c-myc, Hisx6 and FLAG (claim 35) and the fusion protein is expressed from a vector in said cell (claim 36).
The claims to the ‘545 patent in their broadest are drawn to an isolated variant Streptococcus pyogenes Cas9 (SpCas9) protein, comprising an amino acid sequence that has at least 90% sequence identity to SEQ ID NO: 1, with a mutation at D1135 and optionally at one or more of the following positions: G1104, S1109, L1111, S1136, G1218, N1317, R1335, T1337, wherein the isolated variant SpCas9 protein can interact with a guide RNA and a target DNA (claim 1), with dependent claims 4-5 reciting the SpCas9 further comprises mutations that decrease nuclease activity selected from (i) D10A or D10N; and (ii) H840A, H840N or H840Y. Dependent claim 13-15 recites SpCas9 is in a fusion protein that further comprises an activation domain, selected from VP64 or NF-kB p65. Dependent claim 27 recites the fusion protein is expressed in a host cell. While the ‘545 patent claims do not recite what type of host cell comprises the fusion protein(s), consistent with MPEP 804(II)(B)(1), upon construing the scope of the claims and specifically the scope of “host cell” consistent with specification of the ‘545 patent, it is clear that the host cells encompass mammalian and human host cells (See Examples utilizing human cells and See Col. 4, lines 16-25).
Claims 26 and 33-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 24-35 of U.S. Patent No. 10479982. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims to the ‘982 patent anticipate and/or render obvious the instant claims.
The instant claims in their broadest are drawn to a mammalian cell expressing a fusion protein comprising a catalytically inactive S. pyogenes Cas9 protein linked to a heterologous functional domain, wherein the catalytically inactive Cas9 protein comprises mutations at D10 and H840, and wherein the heterologous functional domain is VP64, the order of the fusion protein (claim 33), said fusion comprises linkers and/or nuclear localization sequence or epitope tag (claim 34), the kind of epitope tag selected from c-myc, Hisx6 and FLAG (claim 35) and the fusion protein is expressed from a vector in said cell (claim 36).
The claims to the ‘982 patent are drawn to an isolated variant Streptococcus pyogenes (SpCas9) protein comprising an amino acid sequence that has at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 1, with an amino acid mutation at G1218 and optionally at one or more of the following positions: G1104, S1109, L1111, E1219, D1135, N1317, R1335, T1337, wherein the isolated variant SpCas9 protein can interact with a guide RNA and a target DNA (claim 1). Dependent claims 5-6 recite the SpCas9 further comprises mutations that decrease nuclease activity selected from (i) D10A or D10N; and (ii) H840A, H840N or H840Y. Dependent claim 10-12 recites SpCas9 is in a fusion protein that further comprises an activation domain, selected from VP64 or NF-kB p65. Dependent claims 24-29 recites the variant protein is expressed in a host cell. While the ‘982 patent claims do not recite what type of host cell comprises the fusion protein(s), consistent with MPEP 804(II)(B)(1), upon construing the scope of the claims and specifically the scope of “host cell” consistent with specification of the ‘982 patent, it is clear that the host cells encompass mammalian and human host cells (See Examples utilizing human cells and See Col. 4, lines 1-57; Examples).
Claims 26 and 33-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 23-35 of U.S. Patent No. 11286468.
The instant claims in their broadest are drawn to a mammalian cell expressing a fusion protein comprising a catalytically inactive S. pyogenes Cas9 protein linked to a heterologous functional domain, wherein the catalytically inactive Cas9 protein comprises mutations at D10 and H840, and wherein the heterologous functional domain is VP64, the order of the fusion protein (claim 33), said fusion comprises linkers and/or nuclear localization sequence or epitope tag (claim 34), the kind of epitope tag selected from c-myc, Hisx6 and FLAG (claim 35) and the fusion protein is expressed from a vector in said cell (claim 36).
The claims to the ‘468 patent are drawn An Streptococcus pyogenes Cas9 (SpCas9) protein, comprising an amino acid sequence that has at least 80% sequence identity to the amino acid sequence of SEO ID NO: 1, with mutations at all six of the following positions: D1135, S1136, G1218, E1219, R1335, and T1337, wherein the mutations are LRSVQL, LRKIQK, LRSVQK, LWKIQK, VRKIQK, IRAVQL, GRKIQK, SWRVW, SWKVLK, TAHFKV, MWVHLN, KRRCKV, VRAVQL, SRMHCK, GWKLLR, GWKOQK, VAKLLR, VAKIQK, VAKILR, GRKILR, VRKLLR, IRAVQL, MQKSER, VRKSER, ICKSER, LRSVER, MQSVQL, ICCCER, LWRWA, WMQAYG, LWRSEY, MCSFER, LWMREQ, FMQWVN, YCSWVG, MCAWCG, FMQWVR, MRARKE, LRLSAR, KWMMCG, AWNFQV, LWTTLN, CWCQCV, AEEQQR, GWEKVR, NRAVNG, LRSYLH, VQDAQR, GWRQSK, AWLCLS, KWARW, VKMAKG, QRKTRE, LCRQQR, CWSHQR, SRTHTQ, or LWEVIR. Dependent claims 2-3 recite the SpCas9 further comprises mutations that decrease nuclease activity selected from (i) D10A or D10N; and (ii) H840A, H840N or H840Y. Dependent 4-6 recite the encoded SpCas9 is further fused to a heterologous functional domain such as a transcriptional activation domain of VP64 or NF-kB p65. Independent claim 23 recite the variant SpCas9 of claim 1 encoded by a nucleic acid and that said nucleic acid is in vector, and in a mammalian host cell.
While the claims do not specifically recite that the fusion protein of claims 2-7 are found mammalian host cells, it would be an obvious variation that will be given the method claims are intended to utilize said variant SpCas9 in altering the genome of a cell, including mammalian cells.
Applicant’s Response and Examiner’s Rebuttal:
Applicant’s traverse the remaining non-statutory double patenting rejections of record.
Applicant’s first argument on pp. 11-12 can be distilled down to it is in appropriate to make non-statutory double patenting rejections over patents which have issued but which have later patent term filing dates than the current application.
The Examiner acknowledges this but does not find it convincing. The only consideration of filing dates, patent term dates notably are not taken into consideration, is relevant only when the rejection is a provisional rejection, e.g. directed to the matters as defined in MPEP 803. However, when rejection is non-provisional, and the rejection is thus made over an issued patent, then the relevant factors are governed as in MPEP 804, where there is no consideration of filing dates or patent term dates.
A. Applicant’s response directed to the ‘466 patent on pp. 12-13 is acknowledged and have been considered in their entirety. Applicant’s assert the Office has not established any evidence or other reasoning for support the rejection based on the claims.
The Examiner disagrees. Applicant’s only point to the independent claim to suggest the subject matter is not overlapping. However, as clearly detailed in the rejection, when the dependent claims are combined with the independent claim (e.g. claims 1 and 6-10, 22-24), then they reach the independent claim which includes a host cell encoding the mutant(s) and fusions. It is entirely permissible to have additional species/elements (E.g. the Q695 and Q926 mutations) of the patented claims, so long as the combination arrives at the elements of the examined claims. In addition, and as noted in the rejection itself, it is also entirely permissible to establish the meaning of a term a claim (e.g. here what is meant encompassed by host cell). This is consistent with MPEP 804(II)(B)(1) and upon construing the scope of the claims and specifically the scope of “host cell” consistent with specification of the ‘446 patent, it is clear that the host cells encompass mammalian and human host cells (See Examples utilizing human cells and See Col. 5, lines 48-53).
B. Applicant’s response directed to the ‘910 patent on p.13 is acknowledged and have been considered in their entirety. Applicant’s assert the Office has not established that based on the claims that there is an overlap of subject matter.
The Examiner has considered this but as above, both the combination of the claims and the interpretation of the meaning of a claim term (e.g. again here host cell), results in directly overlapping/obvious subject matter. As detailed in the rejection, when the dependent claims are combined with the independent claim (e.g. claims 1 and 7-8, 9-11 and 23-25), then they reach the independent claim which includes a host cell encoding the mutant(s) and fusions. It is entirely permissible to have additional species/elements (E.g. the Q695 and Q926 mutations) of the patented claims, so long as the combination arrives at the elements of the examined claims. In addition, and as noted in the rejection itself, it is also permissible to establish the meaning of a term a claim (e.g. here what is meant/encompassed by “host cell”). This is consistent with MPEP 804(II)(B)(1) and upon construing the scope of the claims and specifically the scope of “host cell” consistent with specification of the ‘910 patent, it is clear that the host cells encompass mammalian and human host cells (See Examples utilizing human cells and See Col. 5, lines 45-51).
C. Applicant’s response directed to the ‘642 patent on pp.13-14 is acknowledged and have been considered in their entirety. Applicant’s assert the Office has not established that based on the claims that there is an overlap of subject matter.
The Examiner has considered this but as above, both the combination of the claims and the interpretation of the meaning of a claim term (e.g. again here host cell), results in directly overlapping/obvious subject matter. As detailed in the rejection, when the dependent claims are combined with the independent claim (e.g. claims 1 and 7-8, 9-11 and 23-24), then they reach the independent claim which includes a host cell encoding the mutant(s) and fusions. It is entirely permissible to have additional species/elements (E.g. the Q695 and Q926 mutations) of the patented claims, so long as the combination arrives at the elements of the examined claims. In addition, and as noted in the rejection itself, it is also permissible to establish the meaning of a term a claim (e.g. here what is meant/encompassed by “host cell”). This is consistent with MPEP 804(II)(B)(1) and upon construing the scope of the claims and specifically the scope of “host cell” consistent with specification of the ‘642 patent, it is clear that the host cells encompass mammalian and human host cells (See Examples utilizing human cells and See Col. 5, lines 53-60).
D. Applicant’s response directed to the ‘545 patent on p. 14-15 is acknowledged and have been considered in their entirety. Applicant’s assert the Office has not established that based on the claims that there is an overlap of subject matter.
The Examiner has considered this but as above, both the combination of the claims and the interpretation of the meaning of a claim term (e.g. again here host cell), results in directly overlapping/obvious subject matter. As detailed in the rejection, when the dependent claims are combined with the independent claim (e.g. claims 1 and 4-5, 13-15 and 27), then they reach the independent claim which includes a host cell encoding the mutant(s) and fusions. It is entirely permissible to have additional species/elements (E.g. the G1104, S1109, L1111, S1136, G1218, N1317, R1335, T1337 mutations) of the patented claims, so long as the combination arrives at the elements of the examined claims. In addition, and as noted in the rejection itself, it is also permissible to establish the meaning of a term a claim (e.g. here what is meant/encompassed by “host cell”). This is consistent with MPEP 804(II)(B)(1) and upon construing the scope of the claims and specifically the scope of “host cell” consistent with specification of the ‘545 patent, it is clear that the host cells encompass mammalian and human host cells (See Examples utilizing human cells and See Col. 4, lines 16-25).
F. Applicant’s response directed to the ‘982 patent on p. 15 is acknowledged and have been considered in their entirety. Applicant’s assert the Office has not established that based on the claims that there is an overlap of subject matter.
The Examiner has considered this but as above, both the combination of the claims and the interpretation of the meaning of a claim term (e.g. again here host cell), results in directly overlapping/obvious subject matter. As detailed in the rejection, when the dependent claims are combined with the independent claim (e.g. claims 1 and 5-6, 10-12 and 24-29), then they reach the independent claim which includes a host cell encoding the mutant(s) and fusions. It is entirely permissible to have additional species/elements (E.g. the G1104, S1109, L1111, S1136, G1218, N1317, R1335, T1337 mutations) of the patented claims, so long as the combination arrives at the elements of the examined claims. In addition, and as noted in the rejection itself, it is also permissible to establish the meaning of a term a claim (e.g. here what is meant/encompassed by “host cell”). This is consistent with MPEP 804(II)(B)(1) and upon construing the scope of the claims and specifically the scope of “host cell” consistent with specification of the ‘982 patent, it is clear that the host cells encompass mammalian and human host cells (See Examples utilizing human cells and See Col. 4, lines 1-57).
J. Applicant’s response directed to the ‘468 patent on p. 17-18 is acknowledged and have been considered in their entirety. Applicant’s assert the Office has not established that based on the claims that there is an overlap of subject matter.
The Examiner has considered this but as above, both the combination of the claims and the interpretation of the meaning of a claim term (e.g. again here host cell), results in directly overlapping/obvious subject matter. As detailed in the rejection, when the dependent claims are combined with the independent claim (e.g. claims 1 and 2-6, and 23), then they reach the independent claim which includes a host cell encoding the mutant(s) and fusions. It is entirely permissible to have additional species/elements (E.g. the D1135, S1136, G1218, E1219, R1335 and T1337 mutations) of the patented claims, so long as the combination arrives at the elements of the examined claims, wherein given. As noted, the claims of the ‘468 recite mammalian cells comprising the SpCas9 mutants, and the fusion proteins are not specifically incorporated into the claims reciting mammalian cells, it would nonetheless be an obvious variation to combine patented claims to arrive at the specific mammalian cells comprising the fusion protein.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 05 December 2025
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