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 .
Election/Restrictions
Applicant’s election with traverse of peptides of Group I, structures II-2, B-27, B-39, B-8, and B-24 of Group II, and a reverse transcriptase of Group III in the reply filed on 05/17/2026 is acknowledged. However, the species election requirements have been withdrawn.
Claims Status
Claims 1-56, 73-74 is/are cancelled and claims 77-81 is/are newly added. Claims 57-72, 75-81 is/are currently pending. Claims 57-72, 75-81 is/are under examination.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claims 57, 60, 70, 72 contain amendments which are not in black text and as a result, appear in low resolution compared to the surrounding text. For legibility, it is requested that underlining, striking through, and bracketing of claim amendments be made in black instead of gray or a different color.
Claims 58, 61, 68 are indicated as “Withdrawn”. However, the species election requirement previously presented would not have required withdrawal of any claims if maintained, as all species claims were drawn to all species, and thus, the withdrawal of any claims would have been incorrect if the species election requirement had been maintained, and are incorrect with the species election requirement withdrawn.
Claim Interpretation
The claims contain limitations preceded by the term “optional”. All claim limitations recited as “optional” are interpreted as not required. As such, prior art can be applied to teach these limitations, but does not need to be applied.
Claim Rejections - 35 USC § 112
112(b):
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.
Claim 81 is 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 81 recites the limitation "said crRNA conjugate" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 70, on which claim 81 depends, does not recite a crRNA conjugate.
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 57-72, 75-81 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.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it”).
According to the MPEP § 2163, "The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutsch land GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.")."
Claim 57 recites “crRNA conjugates” but does not describe what structures are conjugated to the crRNA. Claim 70 recites “lgRNA conjugates” but does not describe what structures are conjugated to the lgRNA. Based on claim 57 lines 3-9, the crRNA is not conjugated to the Cas protein or tracrRNA. The specification does not provide a limiting definition of a crRNA or lgRNA conjugate—i.e., what structures may be conjugated to a crRNA or lgRNA conjugate and in what fashion the structures may be conjugated. The disclosure provides examples of crRNA or lgRNA conjugates (see claims 58, 71, 77, 80), but these examples are not limiting of the scope of crRNA conjugates of claim 57 or lgRNA conjugates of claim 70. Additionally, claim 71 recites that the lgRNA conjugate “comprises one or more covalently linked nucleic acid templates”, but it is unclear whether the linkage of the nucleic acid template to the lgRNA renders the lgRNA an “lgRNA conjugate”, or if the “lgRNA conjugate” is conjugated to a different structure. Furthermore, claims 58, 77, and 80 recite that the conjugates comprise one or more covalently linked peptides, but do not describe any structural or functional features of said peptides. Paragraph [0012] describes that in some embodiments, the crRNA or lgRNA “is conjugated with peptides, aptamers, oligonucleotides, antibodies, small molecule receptor ligands such as GalNAc, biotin, cholesterol, tocopherol, lipid, or folate and etc.”, thus not providing a limiting definition of the genera of crRNA conjugates and lgRNA conjugates. Claims 58-69, 71-72, 75-81 depend on claim 57 or 70 and do not rectify the lack of written description, and thus are rejected for lack of written description.
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) 57-58, 60-69, 78-79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US20180362975A1), in view of Kelton (2016).
Regarding claim 57, Chen teaches a method of gene editing a target nucleic acid sequence in a cell, comprising delivering to said cell a Cas9 protein, or nucleic acid encoding a Cas9 protein, and a gRNA, or a nucleic acid encoding a gRNA (claim 109). Chen teaches that the gRNA may be modified by conjugation with a moiety, cap or linker at the 3’ end (paragraphs [1510]-[1519]). Chen teaches that the gRNA and the Cas9-encoding nucleic acid are delivered to cells in separate viral vectors sequentially (paragraph [1507]). Chen teaches that the gRNA is a dgRNA, comprising a crRNA and a tracrRNA on separate nucleic acid molecules (paragraph [0341]). Chen teaches that administration may be by injection (paragraph [1420]).
Regarding claim 58, Chen teaches that the gRNA molecules may be modified such that they are covalently linked to PEG (paragraphs [1511], [1546]).
Regarding claim 60, Chen teaches that the method further comprises administering a template nucleic acid (claim 109) which is integrated into the targeted nucleic acid sequence (paragraph [1037]) and which encodes a CAR gene (paragraph [0131]).
Regarding claim 61, Chen teaches that the gRNA may be 2’-O-methyl modified (II-2) (paragraph [0347]). Chen teaches that the gRNA may comprise m5Um (5,2’-0-dimethyluridine) (comprising the base B-24) (paragraph [1553]).
Regarding claim 62, Chen teaches that the crRNA comprises uracil instead of thymine (paragraph [0643]) and comprises a spacer sequence 12-20 nucleotides long which targets a sequence within a viral genome (paragraphs [0002], [0643]-[0644]).
Regarding claim 63, Chen teaches that the crRNA comprises a spacer sequence which is 12-20 nucleotides long (paragraphs [0643]-[0644]), which targets a target sequence within a host cell (paragraph [0005]), and which comprises uracil instead of thymine (paragraph [0643]).
Regarding claim 64, Chen teaches that the template nucleic acid introduces a stop codon (paragraph [117]). Chen teaches that 5’-tag-3’ is a known stop codon (paragraph [0813]), and as such, it would be obvious that 5’-tag-3’ could be used as the introduced stop codon.
Regarding claim 65, Chen teaches that the template further comprises a promoter sequence (a transcriptional cis-regulatory element) (paragraph [1037]).
Regarding claim 66, Chen teaches that the method may comprise administering multiple gRNAs comprising different targeting sequences (paragraph [1111]).
Regarding claims 67-68, Chen teaches that the Cas protein may be a Cas9 protein fused to a DNA methyltransferase (paragraph [0798]) or a Cas9 protein (claim 109).
Regarding claim 69, Chen teaches that the expression of the Cas9 protein and the gRNAs may be under the control of an enhancer sequence (paragraphs [0539], [0127]).
Regarding claim 78, Chen teaches that the sgRNA is modified to comprise 2’-fluoro-2’-deoxynucleotides (paragraphs [1563], [1547]).
Regarding claim 79, the Cas9-effector fusion protein of claim 67 is an optional limitation, and claim 79 does not require that the Cas protein of claim 67 be a Cas9-effector fusion protein—instead, claim 79 requires that if the Cas protein of claim 67 is elected to be a Cas9-effector fusion protein, that the effector protein be a reverse transcriptase. As such, Chen is not required to teach this limitation while encompassing claim 79.
However, Chen does not teach that one viral vector or mRNA comprises a nucleic acid encoding a Cas protein and a tracrRNA and that a second viral vector or mRNA encodes a crRNA.
Kelton teaches that a tracrRNA and a crRNA may be present on the same or different vectors.
Regarding claim 57, Kelton teaches that a tracrRNA and a crRNA may be present on different vectors, as an obvious alternative to these two RNAs being present on the same vector (page 441). It would have been obvious to an artisan that the nucleic acid encoding the Cas protein, the tracrRNA, and the crRNA may be present on the same vector, different vectors, or combinations thereof (e.g., the nucleic acid encoding the Cas protein may be present on the same vector as one of the tracrRNA or the crRNA, or the tracrRNA and crRNA may be present on the same vector while the Cas protein is encoded on a different vector, as described in claim 110 of Chen).
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US20180362975A1) and Kelton (2016), as applied to claim 57 above, and further in view of Cohnen (WO 2019118935 A1) and Cotta-Ramusino (US20190062734A1).
The teachings of Chen and Kelton are discussed above and render obvious the limitations of claim 57.
Regarding claim 59, Chen teaches that the method further comprises administering a template nucleic acid (claim 109) which is integrated into the targeted nucleic acid sequence (paragraph [1037]).
However, Chen does not teach that the template is covalently linked to a gRNA.
Cohnen teaches that nucleic acid templates for HDR should be covalently linked to a crRNA.
Regarding claim 59, Cohnen teaches that crRNA may be physically (covalently) linked to a donor template (page 14 lines 21-23). Cotta-Ramusino teaches that “Cas9-mediated gene editing using an exogenous template nucleic acid can proceed with increased efficiency when the gRNA and the template nucleic acid are held in close proximity by covalently or non-covalently linking the gRNA to the template nucleic acid” (paragraph [0119]). It would thus be obvious to an artisan that the method of Chen, combined with the teachings of Cohnen, should be modified such that the template nucleic acid is covalently linked to the crRNA to provide increased efficiency.
Claim(s) 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US20180362975A1) and Kelton (2016) as applied to claim 57 above, and further in view of Zhong (US20160215275A1).
The teachings of Chen and Kelton are discussed above and render obvious the limitations of claim 57.
However, Chen and Kelton do not teach that the crRNA or gRNA are covalently linked to a peptide.
Zhong teaches that crRNA and tracrRNA may be joined by a non-nucleotide linker to form an lgRNA and teaches that gRNA may be covalently linked to peptides.
Regarding claim 77, Zhong teaches that a gRNA may be conjugated to a cell-penetrating peptide, providing the benefit of “lower off-target mutation frequencies than plasmid transfection” (paragraph [0010]). It would have been obvious to modify the sgRNA of Chen or the lgRNA of the combination of Chen and Zhong with a cell-penetrating peptide to provide lower off-target mutation frequencies.
Claim(s) 70, 72, 75-76, 80-81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US20180362975A1), in view of Zhong (US20160215275A1).
Regarding claim 70, Chen teaches a method of gene editing a target nucleic acid sequence in a cell, comprising delivering to said cell a Cas9 protein, or nucleic acid encoding a Cas9 protein, and a gRNA, or a nucleic acid encoding a gRNA (claim 109). Chen teaches that the gRNA may be modified by conjugation with a moiety, cap or linker at the 3’ end (paragraphs [1510]-[1519]). Chen teaches that the gRNA and the Cas9-encoding nucleic acid are delivered to cells in separate viral vectors sequentially (paragraph [1507]). Chen teaches that the gRNA is an sgRNA (paragraph [0341]). Chen teaches that administration may be by injection (paragraph [1420]).
Regarding claim 72, Chen teaches that the method further comprises administering a template nucleic acid (claim 109) which is integrated into the targeted nucleic acid sequence (paragraph [1037]) and which encodes a CAR gene (paragraph [0131]).
Regarding claim 75, Chen teaches that the template nucleic acid introduces a stop codon (paragraph [117]). Chen teaches that 5’-tag-3’ is a known stop codon (paragraph [0813]), and as such, it would be obvious that 5’-tag-3’ could be used as the introduced stop codon.
Regarding claim 76, Chen teaches that the template further comprises a promoter sequence ( a transcriptional cis-regulatory element) (paragraph [1037]).
Regarding claim 81, Chen teaches that the sgRNA is modified to comprise 2’-fluoro-2’-deoxynucleotides (paragraphs [1563], [1547]).
However, Chen does not teach that the crRNA and tracrRNA are joined as an lgRNA (joined by a non-nucleotide linker), and instead teaches that the crRNA and tracrRNA are joined as an sgRNA. Furthermore, Chen does not teach that the gRNA comprises one or more covalently linked peptides.
Zhong teaches that crRNA and tracrRNA may be joined by a non-nucleotide linker to form an lgRNA and teaches that gRNA may be covalently linked to peptides.
Regarding claim 70, Zhong teaches that lgRNA are formed from crRNA and tracrRNA which are chemically ligated in vitro, and that such a formation of a crRNA:tracrRNA complex is preferable to sgRNA, as crRNA and tracrRNA “are more readily synthesized chemically at industrial scale, and can even be further shortened by introductions of chemical modifications at various sites, and therefore more commercially accessible” (paragraph [0012]). It would thus be obvious to an artisan to use an lgRNA instead of an sgRNA, as the lgRNA would be more readily synthesized at industrial scale.
Regarding claim 80, Zhong teaches that a gRNA may be conjugated to a cell-penetrating peptide, providing the benefit of “lower off-target mutation frequencies than plasmid transfection” (paragraph [0010]). It would have been obvious to modify the sgRNA of Chen or the lgRNA of the combination of Chen and Zhong with a cell-penetrating peptide to provide lower off-target mutation frequencies.
Claim(s) 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US20180362975A1) and Zhong (US20160215275A1), as applied to claim 70 above, and further in view of Cotta-Ramusino (US20190062734A1).
The teachings of Chen and Zhong are discussed above and render obvious the limitations of claim 70.
Regarding claim 71, Chen teaches that the method further comprises administering a template nucleic acid (claim 109) which is integrated into the targeted nucleic acid sequence (paragraph [1037]).
However, Chen does not teach that the template is covalently linked to the gRNA.
Cotta-Ramusino teaches that nucleic acid templates for HDR should be covalently linked to a gRNA.
Regarding claim 71, Cotta-Ramusino teaches that “Cas9-mediated gene editing using an exogenous template nucleic acid can proceed with increased efficiency when the gRNA and the template nucleic acid are held in close proximity by covalently or non-covalently linking the gRNA to the template nucleic acid” (paragraph [0119]). It would thus be obvious to an artisan that the method of Chen, combined with the teachings of Zhong, should be modified such that the template nucleic acid is covalently linked to the lgRNA to provide increased efficiency.
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 70-71, 76, 79-80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of copending Application No. 18218659 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending claims recite methods of directing a Cas polypeptide to a target nucleic acid using a guide RNA in one or more cells, encompassing methods of gene editing comprising the same steps (claims 1-2, 8). The copending claims recite that the gRNA is an lgRNA (claims 1-4). The copending claims recite that the gRNA is a gRNA conjugate (claim 14). The copending claims recite that the lgRNA is covalently bound to a DNA repair template (claims 11-13). The copending claims recite that the template comprises one or more transcription cis-regulatory elements (claim 13). The copending claims recite that the Cas protein is fused to a reverse transcriptase domain (claim 9). The copending claims recite that the lgRNA comprises one or more covalently linked peptides (claim 20).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 72, 75, 81 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8 of copending Application No. 18218659, as applied to claim 70 above, and further in view of Chen (US20180362975A1).
The limitations of the copending claims encompass the limitations of the instant claim 70, as described above.
However, the copending claims do not recite that the donor template encodes a CAR gene (required by claim 72). The copending claims recite that the donor template comprises a stop codon (claim 12), but does not recite the identity of the stop codon (required by claim 75). The copending claims recite that the gRNA comprises modified nucleotides (claim 23), but do not recite the types of modifications (required by claim 81).
Chen teaches a method of gene editing a target nucleic acid sequence in a cell, comprising delivering to said cell a Cas9 protein, or nucleic acid encoding a Cas9 protein, and a gRNA, or a nucleic acid encoding a gRNA (claim 109). Chen teaches that the gRNA may be modified by conjugation with a moiety, cap or linker at the 3’ end (paragraphs [1510]-[1519]). This is a provisional nonstatutory double patenting rejection.
Regarding claim 72, Chen teaches that the method further comprises administering a template nucleic acid (claim 109) which is integrated into the targeted nucleic acid sequence (paragraph [1037]) and which encodes a CAR gene (paragraph [0131]). Chen teaches that the introduction of CAR genes into cells is useful for treating diseases, including cancers (paragraph [0004]); it would have been obvious to an artisan that the donor template of the copending application could be selected from any coding sequence, and that the selection of a CAR gene would provide the claimed method with additional therapeutic utility.
Regarding claim 75, Chen teaches that the template nucleic acid introduces a stop codon (paragraph [117]). Chen teaches that 5’-tag-3’ is a known stop codon (paragraph [0813]), and as such, it would be obvious that 5’-tag-3’ could be used as the introduced stop codon in the copending claims.
Regarding claim 81, Chen teaches that the sgRNA is modified to comprise 2’-fluoro-2’-deoxynucleotides (paragraphs [1563], [1547]). Chen teaches that nucleotide modifications “can enhance the stability of the nucleic acid” (paragraph [1545); it would therefore have been obvious to use modified nucleotides in the gRNA as described by Chen in order to enhance the stability of the gRNA of the copending application.
Conclusion
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/AFRICA M MCLEOD/Examiner, Art Unit 1635
/KIMBERLY CHONG/Primary Examiner, Art Unit 1636
Prosecution Insights