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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/26/2026 has been entered.
Claims 1, 3, 4, 7, and 11 were amended in the claim set filed 01/26/2026. It is noted that the amendments to the claims filed on 01/26/2026 do not comply with the requirements of 37 CFR 1.121(c) because not all amended text is properly marked. For example, a comma was added to the preamble of instant claim 3, which is not properly marked in the amended claim set. Additionally, claim 1 has been amended to recite “said DNA” at lines 6-7 instead of “said polynucleotide,” but these deletions and additions are also not properly marked. The Examiner notes that the claim set filed 11/20/2025 was not entered into the application file, as indicated in the advisory action mailed 12/05/2025. Therefore, the last claim set entered into the application file was filed 08/04/2025 and all amendments should reflect that claim set. However, in the interest of compact prosecution, the amendments to the claims have been entered.
Claims 6 and 8-10 were canceled in the claim set filed 01/26/2026.
Claim 12 was added in the claim set filed 01/26/2026.
Accordingly, claims 1, 3, 4, 7, 11, and 12 are pending and under consideration.
Information Disclosure Statement
Receipt of an information disclosure statement on 02/09/2026 is acknowledged. The signed and initialed PTO-1449 has been mailed with this action.
Status of Prior Objections/Rejections
RE: Claim Objections
►Claim 3 was previously objected to for minor grammatical informalities.
The amendments to claim 3 have obviated the basis of the prior objection. The objection of record is hereby withdrawn.
RE: Claim Rejections - 35 USC § 112
►Claim 1 was previously 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 amendments to claim 1 have obviated the basis of the rejection of record. The rejection of record is hereby withdrawn.
RE: Claim Rejections - 35 USC § 103
►Claims 1, 3-4, and 7-10 were previously rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/132129 A1 (hereinafter Rothwell) in view of WO 03/052071 (hereinafter Glazer; previously cited), as evidenced by Aggarwal, 1995 (previously cited).
►Claims 6 and 11 were previously rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/132129 A1 (hereinafter Rothwell) in view of WO 03/052071 (hereinafter Glazer; previously cited), as evidenced by Aggarwal, 1995 (previously cited), as applied to claims 1 and 10 above, and further in view of Wang et al., 2015 (previously cited).
The cancellation of claims 8-10 renders the rejection thereof moot.
Applicant has traversed the rejection of record, asserting that the cited art does not teach or suggest the method of amended instant claim 1 (from which all other claims directly or indirectly depend) as set forth in the prior action.
In response, while it is found persuasive that the claim amendments have necessitated new grounds of rejection as compared to that which was set forth in the prior action, Applicant’s arguments themselves are not found persuasive.
The Examiner notes that while Applicant has asserted that both Rothwell and Glazer are drawn exclusively to intracellular methods of generating ssDNA, Glazer also discloses therapeutic delivery of nucleic acid constructs for targeted genomic recombination, thereby activating, inactivating, or altering the activity and function of the target gene (page 4, lines 21-27; Examples 3 and 4). Thus, while Glazer does not disclose all of the amended claim limitations, Glazer is explicitly drawn to delivery of nucleic acid constructs for targeted genomic recombination/insertion, as instantly claimed. Therefore, it is not found persuasive that amended claim 1 is non-obvious over any combination that includes Glazer, as Glazer is explicitly drawn to delivery of nucleic acid constructs for targeted genomic recombination/insertion. Additionally, it cannot reasonably be considered that the Examiner utilized improper hindsight reasoning to arrive at the conclusion that Glazer discloses delivery of nucleic acid constructs for targeted genomic recombination/insertion when Glazer explicitly discloses such subject matter (see Examples 3 and 4).
Furthermore, regarding Applicant’s assertion that there is no disclosure in Glazer for the combination of the donor DNA being part of the loop of a stem-loop structure, this is not found persuasive. As set forth above, Glazer is explicitly drawn to delivery of nucleic acid constructs for targeted genomic recombination, which is depicted in Figure 2. Figure 2 of Glazer illustrates targeted integration of SEQ ID NO: 5, which corresponds to the ssDNA loop released from MboII digestion of the stem-loop structure of SEQ ID NO: 6, as depicted in Figures 1C and 1D.
While the Examiner acknowledges that Glazer does not specify that the structure taught therein is a closed circular structure, this deficiency is cured by Rothwell, which discloses the advantages associated with covalently closing single-stranded circular and double-stranded DNA molecules for use as therapeutic agents (page 47, lines 3-10; set forth in greater detail below).
Thus, while new grounds of rejection necessitated by amendment are set forth below, it is not found persuasive that the disclosures of Glazer and Rothwell do not collectively disclose the instantly claimed method.
New/Maintained Grounds of Objection/Rejection
Claim Rejections - 35 USC § 101 and 35 USC § 112(b)
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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.
MPEP § 2173.05(q) “Use” Claims, states:
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph...
"Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid."
Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim.
It is appropriate to reject a claim that recites a use but fails to recite steps under 35 U.S.C. 101 and 35 U.S.C. 112(b) if the facts support both rejections.
Claims 1, 3, 4, 7, and 11-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim does not fall within at least one of the four categories of patent eligible subject matter because the claims are “use” claims that do not purport to claim a process, machine, manufacture, or composition of matter. As noted above, MPEP § 2173.05(q) states that "use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. While instant claim 1 recites “a method of providing a linear single stranded donor template to a cell for genome editing,” the rest of the claim body is drawn to “the use of a delivery vector,” wherein the delivery vector is further structurally defined. No active steps for the delivery and/or utilization of said delivery vector are recited.
Dependent claims 3, 4, 7, and 11-12 also do not recite any active method steps and are instead drawn to further limitations of the nucleic acid delivery vector itself. Given that dependent claims 3, 4, 7, and 11-12 do not recite any active method steps, they inherit the rejection of independent claim 1, as set forth above.
Claims 1, 3, 4, 7, and 11-12 are also 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.
Claim 1 is indefinite because it is a “use” claim that attempts to claim a process without setting forth any steps involved in the process. As noted above, MPEP § 2173.05(q) states that attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Furthermore, as set forth above, while instant claim 1 recites “a method of providing a linear single stranded donor template to a cell for genome editing,” the rest of the claim body is drawn to “the use of a delivery vector,” wherein the delivery vector is further structurally defined. No active steps for the delivery and/or utilization of said delivery vector are recited.
Dependent claims 3, 4, 7, and 11-12 also do not recite any active method steps and are instead drawn to further limitations of the nucleic acid delivery vector itself. Given that dependent claims 3, 4, 7, and 11-12 do not recite any active method steps, they inherit the rejection of independent claim 1, as set forth above.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 11 and 12 are drawn a method of providing a linear single stranded donor template to a cell for genome editing comprising the use of a delivery vector, wherein the delivery vector comprises a recognition sequence for a guided nuclease, such as Cas9 or a variant thereof. The rejected claims thus comprise a set of guided nucleases, including Cas9 and variants thereof, all species of which must function to recognize and cleave a duplex in the instantly claimed delivery vector.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof. The specification describes cleavage of the instantly claimed delivery vector with Cas9 (Examples 1 and 2). No description is provided of cleavage of the instantly claimed delivery vector with any other guided nucleases or variants thereof.
Even if one accepts that the examples described in the specification meet the claim limitations of the rejected claims with regard to structure and function, the examples are only representative of duplex target recognition and cleavage with CRISPR nucleases such as Cas9 guided by their associated guide RNAs. The results are not necessarily predictive of duplex target recognition and cleavage with any guided nuclease or variant thereof. Thus, it is impossible for one to extrapolate from the few examples described herein those guided nucleases that would necessarily meet the structural/functional characteristics of the rejected claims.
The prior art does not appear to offset the deficiencies of the instant specification in that it does not describe a set of guided nucleases and variants thereof that are capable of recognizing and cleaving a target sequence in the duplex region of the instantly claimed nucleic acid delivery vector. As is known to those of skill in the art, while Cas9 is the most well-known guided nuclease (disclosed at page 10, line 27 of the instant specification), other identified CRISPR guided nucleases include Cas12a and Cas13a (disclosed at page 12, lines 1-10 of the instant specification). Other CRISPR guided nucleases include species such as Cas12b (reviewed in Wu et al., 2018: see Table 1). However, these CRISPR nucleases are all structurally and mechanistically distinct. As reviewed in Wu et al., 2018, CRISPR-Cas systems may be divided into class 1 and class 2 systems, wherein class 1 systems use crRNA-binding cascade complexes composed of multiple subunits that associate with a nuclease (Cas3 or Cas10) and class 2 systems use a single multidomain protein for both guide binding and target cleavage (page 642, column 1, paragraph 3-column 2, paragraph 1). Class 2 CRISPR-Cas system may be further divided into types II, V, and VI, wherein type II includes Cas9, type V includes Cas12a and Cas12b, and type VI includes Cas13a and Cas13b (page 642, column 2, paragraph 2). As shown in Table 1 of Wu et al., 2018, Cas9, Cas12a, and Cas12b are all structurally and mechanistically distinct, with differences in tracrRNA requirements, PAM sequence, seed length, type of cleavage performed, and required spacer length. Furthermore, Cas13 nucleases are known to target RNA rather than DNA (page 642, column 2, paragraph 2). Given that the instantly claimed nucleic acid delivery vector is explicitly recited to be formed from DNA at claim 1, one of ordinary skill in the art would not expect Cas13 nucleases to cleave the instantly claimed nucleic acid delivery vector duplex, as is encompassed by the language of instant claim 11. Both the instant specification and prior art are silent as to any methodology that would facilitate Cas13-mediated cleavage of the instantly claimed DNA-based nucleic acid delivery vector duplex.
While instant claim 12 narrows the claimed guided nuclease to Cas9 or variants thereof, suitable variants are not defined either in the specification or in the prior art. Cas9 variants are known in the art, but these variants are not necessarily capable of performing the requisite function of recognizing and cleaving a targeted duplex in the instantly claimed nucleic acid delivery vector. For example, dCas9 is a catalytically inactive dead Cas9 that does not cleave its targeted sequence, and Cas9n is a nickase variant that nicks only one DNA strand rather than generating a double-stranded break (reviewed in Wu et al., 2018: see page 644, column 1, paragraph 2). While these species are Cas9 variants, as instantly claimed, they are not functionally compatible with the instantly claimed invention. Neither the instant specification nor the prior art discloses methods by which these or other Cas9 variants are capable of recognizing and cleaving a targeted duplex in the instantly claimed nucleic acid delivery vector such that the linear, single stranded DNA donor is released from said delivery vector.
Therefore, the skilled artisan would have reasonably concluded applicants were not in possession of the claimed invention for claims 11 and 12.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 4, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over WO 03/052071 (hereinafter Glazer; of record) in view of WO 2016/132129 A1 (hereinafter Rothwell; of record), as evidenced by Aggarwal, 1995 (hereinafter Aggarwal; of record).
With regard to amended claim 1, which recites “a method of providing a linear single stranded donor template to a cell for genome editing, comprising the use of a delivery vector, wherein the delivery vector is a synthetic nucleic acid delivery vector comprising a closed circular single stranded DNA, said vector comprising:
a duplex formed a first section and a third section of said DNA, said sections including sequences which are complementary;
a loop formed from a second section of said DNA, said section separating the first and third sections;
wherein said duplex includes a recognition sequence for a targeted nuclease, wherein said vector delivers a linear single stranded DNA, wherein said single stranded DNA is present within the second section and wherein said linear single stranded DNA is a donor template,”
as previously set forth, Glazer discloses means for delivery of providing large quantities of donor DNA for recombination (page 4, lines 1-3), including methods for intracellularly generating single stranded DNA molecules that can induce a chromosomal event such as recombination, wherein said recombination may provide a functional copy of a mutated target gene (page 4, lines 5-7; page 4, lines 23-30). Such single stranded DNA molecules are known to mediate targeted genome modification via induced recombination (page 2, line 25-page 3, line 2) and are therefore useful for gene therapy (page 3, lines 10-12). Glazer explicitly discloses that the single stranded DNA molecules taught therein are recombined into a target chromosomal sequence (page 14, lines 4-5; Example 4) and further that such nucleic acids and/or the vectors to generate them intracellularly may be delivered via a variety of mechanisms, including liposomal delivery (page 14, lines 30-31) and viral vector delivery (page 15, lines 9-10). The single stranded DNA molecules taught in Glazer include that shown in Figure 1C, which has a double stranded stem-single stranded loop structure (page 5, lines 29-31; Figure 1C) and reads on the instantly claimed structure. This nucleic acid structure is further processed by cleavage with MboII to yield a linear ssDNA product of interest released from within the loop (page 6, lines 7-9; page 18, lines 24-25; Figure 1D). As is known to those of ordinary skill in the art, restriction enzymes such as MboII are by definition highly specific in acting exclusively on their recognition sites (reviewed in Aggarwal: see page 11, column 1, paragraph 2), meaning the MboII disclosed in Glazer reads on the instantly claimed targeted nuclease acting on a recognition sequence for purposes of releasing the therapeutic, linear, single stranded DNA within the construct taught therein and instantly claimed. Furthermore, as set forth above, Glazer discloses that the nucleic acid constructs taught therein are for targeted insertion into the genome, as instantly claimed, and that such constructs may be delivered (i.e. via liposomes) or produced intracellularly following delivery via a viral vector. Thus, Glazer discloses a method of providing a linear single stranded donor template to a cell for genome editing, wherein said linear single stranded donor template is provided within a nucleic acid construct that may be delivered via liposomal delivery of said nucleic acid construct, as instantly claimed. However, Glazer does not specify that this structure is a closed circular structure.
This deficiency is cured by Rothwell. Rothwell discloses that single-stranded circular DNA molecules have particularly utility as therapeutic agents when they are closed structures, as the covalently closed structure prevents attack by enzymes such as exonucleases (page 47, lines 3-6). Therefore, someone of ordinary skill in the art would be motivated by the disclosure of Rothwell to covalently close the structure disclosed to be delivered for purposes of inserting a donor construct at a target site in the genome of Glazer, as set forth in greater detail below.
With regard to amended claim 3, which recites “the method [of claim 1] provides a linear single stranded donor template to a cell for gene editing,” as set forth above, Glazer explicitly discloses that the single stranded DNA molecules taught therein are recombined into a target chromosomal sequence (page 14, lines 4-5; Example 4; Figure 2). Such target chromosomal sequences include the locus for TK genes (Example 3). Thus, Glazer discloses a method of providing a linear single stranded donor template to a cell for gene editing, as instantly claimed. Specifically, digestion of the stem-loop structure with MboII as set forth above releases the ssDNA loop of SEQ ID NO: 5 (Figure 1), which then inserts into the targeted gene locus as shown in Figure 2. Thus, it is considered that Glazer discloses each and every additional limitation of amended claim 3.
With regard to amended claim 4, which recites “the linear single stranded DNA [of the method of claim 1] has a free 5’ and 3’ end once released from the delivery vector,” as depicted in Figures 1C-1D of Glazer, digestion with MboII yields ssDNA with 5’ and 3’ ends that are recombined into a target site in the genome, as depicted in Figure 2 of Glazer. Furthermore, given that the structure of Figure 1C of Glazer in view of Rothwell is identical to the instantly claimed structure and is processed in the same manner as is instantly claimed, both the structure of Glazer/Rothwell and the instantly claimed structure must have free 5’ and 3’ ends once released from the delivery vector construct carrying the template sequence (see MPEP § 2114 and § 2173.05(g)).
With regard to amended claim 7, which recites “the method of claim 1, wherein the nuclease binds to the recognition sequence without a guide,” as set forth above, Glazer discloses that cleavage of the stem-loop structure taught therein with MboII yields a linear ssDNA product released from the sequence of interest contained in the loop (page 6, lines 7-9; page 18, lines 24-25; Figure 1D). Additionally, as is known to those of skill in the art, restriction endonucleases, by definition, are highly specific in acting on their recognition sites without the assistance of a guide (reviewed in Aggarwal: see page 11, column 1, paragraph 2). Thus, it is considered that Glazer discloses each and every additional limitation of amended claim 7.
Given that Glazer discloses delivery (i.e. via liposomes) of nucleic acid constructs taught therein (including that of Figure 1C, which reads on the instantly claimed construct with the exception of it being a closed circular structure) for release of ssDNA for targeted genome integration (i.e. for therapeutic purposes), and that Rothwell discloses that covalently closed circular ssDNA structures are more better suited to in vivo use due to being less vulnerable to attack by exonucleases, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the nucleic acid construct delivered as in Glazer to be a covalently closed circular structure (as disclosed in Rothwell) to predictably deliver a covalently closed circular ssDNA structure with a duplex formed from a first and third section and a loop formed from a second section such that the ssDNA loop is released via MboII digestion for targeted genome integration (i.e. at the TK locus as disclosed in Glazer). One would have been motivated to make such a modification in order to receive the expected benefit of delivering therapeutic nucleic acid constructs that are not vulnerable to attack by exonucleases and that are capable of integrating into the genome at a targeted site.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over WO 03/052071 (hereinafter Glazer; of record) in view of WO 2016/132129 A1 (hereinafter Rothwell; of record), as evidenced by Aggarwal, 1995 (hereinafter Aggarwal; of record) as applied to claim 1 above, and further in view of Wang et al., 2015 (hereinafter Wang; of record).
The combined disclosures of Glazer and Rothwell (as evidenced by Aggarwal) are described above and applied as before. However, these disclosures do not teach the [guided nuclease (i.e. Cas9) of instant claims 11 and 12.
With regard to amended claim 11 and new claim 12, which respectively recite the “nuclease [of the method of claim 1] is a guided nuclease,” such as “Cas9 or a variant thereof,” as set forth above, Glazer anticipates the method of amended instant claim 1. However, Glazer only discloses the use of targeted nucleases such as restriction enzyme MboII (Figures 1C and 1D). This deficiency is cured by Wang. Wang discloses that Cas9 can be used like a restriction enzyme to cleave DNA without the limitations of the more commonly used restriction enzymes (page 170, column 1, paragraph 1). Per Wang, Cas9 is a guided nuclease that can be programmed as desired to cleave almost anywhere with high stringency (abstract), as opposed to cleavage by restriction enzymes, the activity of which is constrained by their defined recognition sequences, which may themselves be present multiple times in a large vector (page 161, column 1, paragraph 1-page 161, column 2, paragraph 1). This usage of Cas9 confers several advantages to researchers, including speed and convenience (page 170, column 1, paragraph 1).
Given the disclosed success of Wang in programming Cas9 to assume the role traditionally performed by restriction enzymes, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to cleave the duplex stem of the circularized structure disclosed by Glazer and Rothwell with Cas9 (as disclosed in Wang) rather than the restriction enzymes disclosed in Glazer to predictably cleave the duplex DNA stem to release the single-stranded loop with flexible sequence targeting and high stringency. One would have been motivated to make such a modification in order to receive the expected benefit of cleaving the duplex DNA stem (to release the single-stranded loop for targeted genome integration) with greater targeted sequence flexibility and high stringency, thereby delivering the single-stranded loop for targeted genome integration, as disclosed in Examples 3 and 4 of Glazer.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sarah E Allen whose telephone number is (571)272-0408. The examiner can normally be reached M-Th 8-5, F 8-12.
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/SARAH E ALLEN/ Examiner, Art Unit 1637
/Jennifer Dunston/ Supervisory Patent Examiner, Art Unit 1637