DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/31/2025 has been entered.
Election/Restrictions
Applicant’s election of Group II of claims 12-22 in the reply filed on November 1, 2024 were acknowledged in the office action mailed 12/19/2024. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election was treated as an election without traverse (MPEP § 818.01(a)). This election is deemed FINAL.
Claims 1-11 and 23-28 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 1, 2024.
Claims 31-32 and 35-36 read on claims that were withdrawn in a prior action as being drawn to nonelected inventions. Claims 31-32 were considered to belong to Group I and claims 35-36 were considered to belong to Group III of the restriction requirement mailed on 11/01/2024 and were accordingly withdrawn from consideration with the office action mailed 04/03/2025.
Claims Status
Claim 24 is/are cancelled. Claims 1-23 and 25-36 is/are currently pending with claims 1-11, 23, 25-32, and 35-36 is/are withdrawn. Claims 12-22 and 33-34 is/are under examination.
Claim Interpretation
Claim 16 recites the limitation “configured to perform a single-stranded cut” (lines 1-2). The broadest reasonable interpretation includes that the system performs multiple single-stranded cuts, such as in a double-stranded cut.
Claims 17-18 recite the limitations “single-stranded cut is in the encoding strand” and “single-stranded cut is in the template strand”. Whether D10A or H840A Cas9 cleaves the template or encoding strand of the mutant allele depends on which strand of the mutant allele the gRNA hybridizes. Therefore, the broadest reasonable interpretation is that any Cas9 or Cas9 variant with at least one functional nuclease domain is capable of cleaving an encoding strand or a template strand.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-22 and 34-35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “near” in claim 12 is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “near” indicates a degree of physical separation or distance that, without further definition, could range from 0 nucleotides to infinite nucleotides in a nucleic acid molecule. The claims do not indicate a range of distances that could be considered “near” or “far”; the specification does not teach a range of distances that could be considered “near” or “far”. An artisan would not be able to determine the metes and bounds of the term “near” in claim 12. Claims 13-22 and 34-35 depend on claim 12 but do not clarify this indefiniteness, and thus are also rejected for indefiniteness.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 12-22 and 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grunwald (2019), in view of Diao (2015, of record). This is a new grounds of rejection.
Regarding claim 12, Grunwald teaches a method of performing homologous chromosome template repair (HTR) in a cell, comprising: contacting a mutant allele (an allele not comprising a cassette insertion, constituting a “mutant” with the allele comprising the cassette as the reference) with a gene editing system configured to cut the mutant allele at or near a mutation in the mutant allele but not cut a homologous allele without the mutation; cutting the mutant allele at or near the mutation in the mutant allele; using the homologous allele as a template for homology-directed repair (HDR); and repairing the mutation in the mutant allele (Fig. 1, wherein the mutant allele is the Tyrchinchilla allele, and the homologous allele is the TyrCopyCat allele, and wherein the Tyr4a gRNA can only target Cas9 to the Tyrchinchilla allele based on the design of the gRNA). Grunwald teaches that the gene editing system comprises a cassette comprising: a gene encoding a guide RNA and a first reporter gene (mCherry) at a first end of the cassette (Fig. 1). Grunwald teaches that repair causes a non-fluorescent phenotypic change (albinism) (Fig. 1, the repair causes a disruption in the Tyr (tyrosinase) gene, which causes albinism, see page 105).
Regarding claims 13-18, Grunwald teaches that the gene editing system further comprises a Cas9 endonuclease (see Title; Fig. 1). The Cas9 endonuclease is configured to cut a single-stranded cut of either the encoding or the template strand of the mutant allele (Fig. 1).
Regarding claim 19, Grunwald teaches that the gene editing system is introduced into the cell (page 105 and Fig. 1).
Regarding claim 20, Grunwald teaches that the mutation creates an endonuclease recognition site in the mutant allele (see Fig. 1: Tyr4a gRNA can only hybridize to Tyrchinchilla allele).
Regarding claims 21-22, Grunwald teaches that the cell is a mammalian (chinchilla) cell (page 105, Fig. 1), and can be a somatic cell (Fig. 1: all cells in the genetically-engineered chinchilla are modified).
Regarding claim 34, Grunwald teaches that the repair results in an observable pigmentation defect (albinism) (page 105; Fig. 1).
However, Grunwald does not teach that the gene editing system cassette comprises a strong splice acceptor at a second end of the cassette, a nucleic acid encoding a T2A self-cleavage peptide adjacent to the strong splice acceptor, and a second, different reporter gene adjacent to the nucleic acid coding for the T2A self-cleavage peptide, as required by claim 12, or that the second reporter gene is a fluorescent reporter gene.
Regarding claim 12, Diao teaches an exogenous cassette integrated into an allele, the cassette comprising, from 5’ to 3’, a strong splice acceptor site, a nucleic acid sequence encoding a T2A self-cleaving peptide, a first reporter gene, and a second reporter gene (Fig. 4A). Diao also teaches that the “MiMIC” cassette can be introduced into an intron using a CRISPR/Cas system (see Abstract).
Regarding claim 35, Diao teaches that the second reporter gene Gal4 drives expression of a fluorescent reporter (page 1411; Fig. 4A). It would have been obvious to an artisan that Gal4 could be replaced with a fluorescent reporter gene. Such a substitution would simplify the gene editing system by eliminating the requirement for a second exogenous cassette, comprising a fluorescent reporter operably linked to a Gal4-driven promoter.
Grunwald teaches that the gene editing system cassette is inserted into an exon in order to disrupt function of the gene and produce a non-fluorescent phenotypic change. Grunwald also teaches that this exon is part of a gene which contains introns (Fig. 1). Based on the teachings of Diao, it would have been obvious to an artisan at the time of filing that the cassette of Grunwald could be modified to include a strong splice acceptor site in order to insert the cassette into an intron instead of an exon while maintaining the disruption to the Tyr gene. Insertion of the cassette into an exon or an intron would be obvious variants, so long as the disruption to the target gene Tyr were maintained. Furthermore, it would have been obvious to an artisan that a dual-reporter system possible with Diao could indicate both presence of the cassette (through the first reporter gene at the 3’ end of the cassette) and proper site-specific insertion of the cassette into the target allele in the step of introducing the cassette into the cell (through the second reporter gene at the 5’ end of the cassette), as expression of the second reporter gene, as described by Diao, is dependent on the second reporter gene being in-frame relative to the target allele and expression of the first reporter gene is independent of insertion site (see Fig. 4). It would have been obvious to an artisan at the time of filing to improve the cassette of Grunwald by adding a second reporter gene, a splice acceptor site, and a nucleic acid encoding a self-cleaving peptide as described in Diao, as such an improvement would provide additional control over the introduction and integration of the cassette into a cell.
Response to Arguments
Applicant’s arguments with respect to claim(s) 12-22 and 34-35 filed 07/03/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The previous rejection, now withdrawn, did not address a gRNA present in the gene editing system cassette. Applicant argues that the addition of a gRNA in the gene editing system cassette overcomes the art applied in the withdrawn rejection, as none teach a guide RNA in a donor cassette or gene editing system cassette, as required by claim 12. The references used in the withdrawn rejection have not been applied in the present rejection to teach the presence of a guide RNA.
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.
17/600,820:
Claims 12-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 9, and 14-15 of copending Application No. 17/600,820 (~820) in view of Prat (2020) and Diao (2015).
The copending claims recite a method of performing HDR in a cell, comprising: contacting a “non-preferred” allele with a “cleavage-resistant preferred allele of the same gene” (near the “mutation” which renders the non-preferred allele cleavage-sensitive); cutting the mutant allele at or near the “mutation”; using the homologous allele as a template for HDR; and repairing the mutation in the mutant allele (replacing the non-preferred allele), wherein the gene editing system comprises a cassette comprising a gene encoding a guide RNA (claims 1-2).
The claims of the copending application recite all the required limitations of the instant claims except for the following: a mechanism by which the Cas9-gRNA gene editing system discriminates and selectively targets and cleaves the target sequence and spares the preferred homologous sequence; a gene editing system which further comprises a gene editing cassette comprising a first reporter gene at a first end of the cassette, a strong splice acceptor at a second end of the cassette, a nucleic acid encoding a T2A self-cleaving peptide, and a second reporter gene; that the second reporter gene comprises a fluorescent reporter gene; and wherein the repair results in an observable pigmentation defect.
Prat teaches a mechanism by which a Cas9-gRNA gene editing system discriminates and selectively targets and cleaves a target sequence and spares a homologous preferred sequence.
Regarding claim 20, Prat teaches a gRNA design, wherein the PAM endonuclease recognition site is next to a mutation, resulting in selective targeting and cleavage of sequences with the mutation, and sparing of homologous sequences lacking the mutation (page 684).
Prat teaches that a guide RNA is designed to recognize a sequence wherein the PAM endonuclease recognition site next to the mutation site (page 684). Prat teaches that the Cas9 gene editing system is intolerant to mismatches between the gRNA and target sequence adjacent the PAM site (page 684). With such a gRNA design, the Cas9-gRNA system can selectively target and cleave a specific variant of a polymorphic gene or sequence. It would be obvious to a person of ordinary skill in the art at the time of filing that the gRNA design of Prat could be applied to the methods of ~820 in order to accomplish the claimed sequence variant specificity, wherein a target sequence is preferentially cleaved and its preferred allele is spared.
Diao teaches a gene editing system cassette, wherein the cassette comprises: a first reporter gene at one end of the cassette, a strong splice acceptor at the other end of the cassette, a nucleic acid encoding a T2A self-cleaving peptide adjacent to the splice acceptor, and a second reporter gene adjacent to the T2A-coding nucleic acid.
Regarding claim 12, Diao teaches a gene editing system cassette, wherein the cassette comprises: a first reporter gene at one end of the cassette, a strong splice acceptor at the other end of the cassette, a nucleic acid encoding a T2A self-cleaving peptide adjacent to the splice acceptor, and a second reporter gene adjacent to the T2A-coding nucleic acid (see Graphical Abstract, Figs. 1A, 4A).
Regarding claim 33, Diao teaches that the second reporter gene (named in Daio the primary transgene) can be any desired transgene (see Fig. 1 caption). As Diao teaches that the first reporter gene is a fluorescent reporter gene (Fig. 4), it would be obvious to a person of ordinary skill in the art at the time of filing that this second reporter gene could also be a fluorescent reporter gene, in the case that the activity of Gal4 (the transgene used by Diao) were not desired (for example, if what was desired was evidence of insertion of this gene editing cassette into a target locus without the additional undesired activity of a transcriptional activator like Gal4 at other locations in a cell’s genome, a fluorescent reporter would serve as a suitable substitute).
Regarding claim 34, Diao teaches that the gene editing cassette is inserted into a cell’s genome, specifically inserted into an intron the pburs gene in D. melanogaster (page 1418). The pburs gene encodes a subunit of the hormone Bursicon, which causes cuticle tanning (melanization) (see Honegger 2008). Diao further teaches that when inserted into the pburs gene, the gene editing cassette causes the truncation of the pburs gene, which will by the nature of the protein encoded by the pburs gene cause an observable pigmentation defect as the melanizing protein is not expressed (Fig. 1A). The method of repair of claim 12 comprises contacting a mutant allele with the gene editing system comprising this gene editing cassette.
The system taught by the combination of the copending application and Prat does not comprise a robust reporting system which would be used to indicate the successes of multiple components of the gene editing system without affecting survival (claims 10-12 of the copending application recite a mechanism by which survival is used to select for gene editing success). The cassette of Diao comprises multiple mechanisms by which a person might determine the success of the gene editing system without affecting survival. The fluorescent reporter(s) inserted into a target sequence are used to show whether the system as a whole successfully contacted a cell’s genome. The insertion through homologous recombination (as in Diao, see page 1411) into a gene responsible for pigmentation changes and causing the truncation of this gene with successful insertion would allow a person of ordinary skill in the art to determine if the transgene were inserted into the desired genomic location for stable, long-term expression of the reporter (in other words, determining if the design of the gene editing system were adequate for properly directing insertion in a site-specific manner). The addition of the cassette of Diao to the invention of the copending application would be obvious to a person of ordinary skill in the art at the time of filing, as this would provide easy-to-measure markers for successful contact of the gene editing system with a genome or cell, particularly if the allele targeted for repair does not produce an obvious phenotype, without affecting survival—allowing for evaluation of unsuccessful editing events.
This is a provisional nonstatutory double patenting rejection.
US 11091780 B2:
Claims 12-14, 16-20, 22, 33-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-4 of U.S. Patent No. 11091780 B2 (~780) in view of Prat (2020) and Rong (2003) and Diao (2015).
~780 recites all the required limitations of the instant claims—including a gene editing system cassette comprising a sequence encoding a guide RNA (claim 1)—except for the following: that the gene editing system is configured to selectively cleave a mutant allele, or the target allele, while sparing a homologous allele, as required by claim 12, and a mechanism by which this selective cleavage could be achieved; that the homologous chromosome can be used as a repair template; a gene editing system which further comprises a gene editing cassette comprising a first reporter gene at a first end of the cassette, a strong splice acceptor at a second end of the cassette, a nucleic acid encoding a T2A self-cleaving peptide, and a second reporter gene; that the second reporter gene comprises a fluorescent reporter gene; and wherein the repair results in an observable pigmentation defect.
Prat teaches a mechanism by which a Cas9-gRNA gene editing system discriminates and selectively targets and cleaves a target sequence and spares a homologous preferred sequence (required for claims 12 and 20).
Regarding claim 12, Prat teaches a Cas-gRNA system which selectively cleaves a target mutant allele and spares a homologous allele (abstract; page 684).
Regarding claim 20, Prat teaches a gRNA design, wherein the PAM endonuclease recognition site is next to a mutation, resulting in selective targeting and cleavage of sequences with the mutation, and sparing of homologous sequences lacking the mutation (page 684).
Prat teaches that a guide RNA is designed to recognize a sequence wherein the PAM endonuclease recognition site next to the mutation site (page 684). Prat teaches that the Cas9 gene editing system is intolerant to mismatches between the gRNA and target sequence adjacent the PAM site (page 684). With such a gRNA design, the Cas9-gRNA system can selectively target and cleave a specific variant of a polymorphic gene or sequence. It would be obvious to a person of ordinary skill in the art at the time of filing that the gRNA design of Prat could be applied to the methods and compositions of ~780 in order to increase target sequence specificity and thereby reduce off-target cleavage and off-target effects.
Furthermore, Rong teaches that the endogenous homologous chromosome is a template used by cells to repair double-stranded breaks during HDR, as required by claim 12.
Regarding claim 12, Rong teaches that the endogenous homologous chromosome is a template used by cells to repair double-stranded breaks during HDR, and that HDR is a known pathway by which cells repair double-stranded breaks (abstract).
Both ~780 and Prat utilize exogenous donor nucleic acids as template sequences for DNA repair. Moreover, neither references the use of the endogenous homologous gene or chromosome as the template sequence for repair, nor do either teach that HDR mediates DNA break repair. However, Rong teaches that at the time of filing, it was known that the endogenous homologous chromosome is a suitable template for HDR, and that HDR is a known and common pathway by which cells repair double-stranded DNA breaks. Rong renders obvious to a person of ordinary skill in the art at the time of filing that the combination of ~780 and Prat, as discussed above, could be further enhanced by utilizing the endogenous homologous chromosome as a template where possible (for example, in cases of heterozygosity), as in Rong, instead of an exogenous donor sequence, thereby reducing the quantity of exogenous constructs that must be designed, produced, and introduced into a cell and thus reducing associated costs.
Diao teaches a gene editing system cassette, wherein the cassette comprises: a first reporter gene at one end of the cassette, a strong splice acceptor at the other end of the cassette, a nucleic acid encoding a T2A self-cleaving peptide adjacent to the splice acceptor, and a second reporter gene adjacent to the T2A-coding nucleic acid.
Regarding claim 12, Diao teaches a gene editing system cassette, wherein the cassette comprises: a first reporter gene at one end of the cassette, a strong splice acceptor at the other end of the cassette, a nucleic acid encoding a T2A self-cleaving peptide adjacent to the splice acceptor, and a second reporter gene adjacent to the T2A-coding nucleic acid (see Graphical Abstract, Figs. 1A, 4A).
Regarding claim 33, Diao teaches that the second reporter gene (named in Daio the primary transgene) can be any desired transgene (see Fig. 1 caption). As Diao teaches that the first reporter gene is a fluorescent reporter gene (Fig. 4), it would be obvious to a person of ordinary skill in the art at the time of filing that this second reporter gene could also be a fluorescent reporter gene, in the case that the activity of Gal4 (the transgene used by Diao) were not desired (for example, if what was desired was evidence of insertion of this gene editing cassette into a target locus without the additional undesired activity of a transcriptional activator like Gal4 at other locations in a cell’s genome, a fluorescent reporter would serve as a suitable substitute).
Regarding claim 34, Diao teaches that the gene editing cassette is inserted into a cell’s genome, specifically inserted into an intron the pburs gene in D. melanogaster (page 1418). The pburs gene encodes a subunit of the hormone Bursicon, which causes cuticle tanning (melanization) (see Honegger 2008). Diao further teaches that when inserted into the pburs gene, the gene editing cassette causes the truncation of the pburs gene, which will by the nature of the protein encoded by the pburs gene cause an observable pigmentation defect as the melanizing protein is not expressed (Fig. 1A). The method of repair of claim 12 comprises contacting a mutant allele with the gene editing system comprising this gene editing cassette.
The system taught by the combination of ~780 and Prat and Rong does not comprise a robust reporting system which would be used to indicate the successes of multiple components of the gene editing system. The cassette of Diao comprises multiple mechanisms by which a person might determine the success of the gene editing system without affecting survival. The fluorescent reporter(s) inserted into a target sequence are used to show whether the system as a whole successfully contacted a cell’s genome. The insertion through homologous recombination (as in Diao, see page 1411) into a gene responsible for pigmentation changes and causing the truncation of this gene with successful insertion would allow a person of ordinary skill in the art to determine if the transgene were inserted into the desired genomic location for stable, long-term expression of the reporter (in other words, determining if the design of the gene editing system were adequate for properly directing insertion in a site-specific manner). The addition of the cassette of Diao to the invention of the ~780 would be obvious to a person of ordinary skill in the art at the time of filing, as this would provide easy-to-measure markers for successful contact of the gene editing system with a genome or cell, particularly if the allele targeted for repair does not produce an obvious phenotype.
Response to Arguments
Applicant's arguments filed 07/03/2025 have been fully considered but they are not persuasive. Applicant argues that the copending application, issued claims, and Prat, Diao, and Rong do not suggest or teach that the donor allele or “preferred allele” comprises a sequence encoding a guide RNA. However, as discussed above, the copending and issued claims do recite that the donor or “preferred” allele comprise at least one sequence encoding a guide RNA. As such, the applicant’s arguments are not considered persuasive, and the above non-statutory double patenting rejections are maintained.
Conclusion
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/AFRICA M MCLEOD/ Examiner, Art Unit 1635
/RAM R SHUKLA/ Supervisory Patent Examiner, Art Unit 1635