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 .
Claim Status
In the amendment filed 17th, September, 2026, Applicant cancelled claim 7
Claims 1-3, 8, 12, 16-18, 20-21, 24, 26, 28-29, 32-34, 36, 38-39, 47, 49 and 51-58 are pending.
Claims 18, 20-21, 26, 28-29, 32-34, 36, 38-39, 47, 49 and 51-58 are withdrawn.
Claims 1-3, 8, 12, 16-17 and 24 are under examination.
Examiner’s Remark
Claim 24 appears to have been amended to remove the periods before the end of the claim and add parentheses (e.g. from “a.” to “(a)”). All claims being currently amended must be presented with markings to indicate the changes that have been made relative to the immediate prior version. See MPEP § 714(II)(c) and (f). Amendments which fail to comply with the requirements of 37 CFR 1.121 are considered noncompliant. As it is clear in the record that claim 24 has been amended this way to overcome the previous rejection of record and encompasses a correction of informalities (see remarks pg. 13 “Objections to the claims”) and does not affect the claim scope, claim 24 is examined as written for the sake of compact prosecution.
Species Rejoinder
The species election requirement between Cas protein sequence, as set forth in the Lack of Unity mailed on 19th, March, 2026, has been reconsidered in view of the prior art.
SEQ ID NO:8, drawn to a previously non-elected species is no longer withdrawn from consideration.
In view of the above noted withdrawal of the species election requirement, applicant is advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement or species election is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Withdrawn Objections to Specification
Browser-Executable Code
The objection to the specification due to embedded hyperlinks and/or other form of browser-executable code as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Moot Claim Objections
The objection to claim 7 due to informalities as set forth in the previous office action is moot in view of the cancellation the claim.
Withdrawn Claim Objections
The objection to claims 12 and 24 due to informalities as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
New Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8 is missing a conjunction before the last wherein clause.
Appropriate correction is required.
Moot Claim Rejections - 35 USC § 101
The rejection of claim 7 under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more as set forth in the previous office action is moot in view of the cancellation of the claim.
Withdrawn Claim Rejections - 35 USC § 101
The rejection of claims 1-3, 8 and 17 under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Moot Claim Rejections - 35 USC § 112(a)
Written Description
The rejection of claim 7 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 as set forth in the previous office action is moot in view of the cancellation of the claim.
Claim Rejections - 35 USC § 112(a)
Written Description
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 1-3, 8, 12, 16-17 and 24 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.
The purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the 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. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997).
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 a disclosure of a representative number of species to describe the complete structure of the claimed genus and/or disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof.
Scope of the Claims
Instant claims encompass the following genera which present written description requirement issues.
comprises the amino acid sequence of SEO ID NO: 7 or SEO ID NO: 8 “and is no more than 800 amino acids” (claim 1 and dependents)
SEQ ID NO: 7 is 611 amino acids in length and therefore this limitation encompasses 189 amino acids as part of the sequence that are not defined by the claim. These could be on either side of SEQ ID NO: 7 and encompass any one of the 20 standard amino acid or no amino acid for shorter sequences. To illustrate the breadth of this genus, an estimation can be made using the 20 standard amino acids that this encompasses up to 2 x 21189 (20 amino acids or no amino acid is 21 options for 189 positions. On either side of SEQ ID NO:7 this is then twice as many options) possible structurally and functionally distinct polypeptides
SEQ ID NO: 8 is 625 amino acids in length and therefore this limitation encompasses 175 amino acids as part of the sequence that are not defined by the claim. These could be on either side of SEQ ID NO: 8 and encompass any one of the 20 standard amino acid or no amino acid for shorter sequences. To illustrate the breadth of this genus, an estimation can be made using the 20 standard amino acids that this encompasses up to 2 x 21175 (20 amino acids or no amino acid is 21 options for 175 positions. On either side of SEQ ID NO:8 this is then twice as many options) possible structurally and functionally distinct polypeptides.
As such, this limitation encompasses an enormously broad number of structurally and functionally distinct polypeptides.
“the N-terminal X domain comprises the amino acid sequence of SEQ ID NO: 13 or SEQ ID NO: 14 and “is no more than 70 amino acids in length” (claim 3).
SEQ ID NO: 13 is 34 amino acids in length and therefore this limitation encompasses 36 amino acids as part of the sequence that are not defined by the claim. These could be on either side of SEQ ID NO: 13 and encompass any one of the 20 standard amino acid or no amino acid for shorter sequences. To illustrate the breadth of this genus, an estimation can be made using the 20 standard amino acids that this encompasses up to 2 x 2136 (20 amino acids or no amino acid is 21 options for 36 positions. On either side of SEQ ID NO: 13 this is then twice as many options.) possible structurally and functionally distinct polypeptides.
SEQ ID NO: 14 is 42 amino acids in length and therefore this limitation encompasses 28 amino acids as part of the sequence that are not defined by the claim. These could be on either side of SEQ ID NO: 14 and encompass any one of the 20 standard amino acid or no amino acid for shorter sequences. To illustrate the breadth of this genus, an estimation can be made using the 20 standard amino acids that this encompasses up to 2 x 2128 (20 amino acids or no amino acid is 21 options for 28 positions. On either side of SEQ ID NO: 13 this is then twice as many options.) possible structurally and functionally distinct polypeptides.
As such, this limitation encompasses an enormously broad number of structurally and functionally distinct polypeptides.
The Cas protein is “no more than 700 amino acids in length” (claim 8)
Because this depends on claim 1, this limitation already also requires that the sequence comprises SEQ ID NO:7 or 8.
SEQ ID NO: 7 is 611 amino acids in length and therefore this limitation encompasses 89 amino acids as part of the sequence that are not defined by the claim. These could be on either side of SEQ ID NO: 7 and encompass any one of the 20 standard amino acid or no amino acid for shorter sequences. To illustrate the breadth of this genus, an estimation can be made using the 20 standard amino acids that this encompasses up to 2 x 2189 (20 amino acids or no amino acid is 21 options for 89 positions. On either side of SEQ ID NO:7 this is then twice as many options) possible structurally and functionally distinct polypeptides
SEQ ID NO: 8 is 625 amino acids in length and therefore this limitation encompasses 75 amino acids as part of the sequence that are not defined by the claim. These could be on either side of SEQ ID NO: 8 and encompass any one of the 20 standard amino acid or no amino acid for shorter sequences. To illustrate the breadth of this genus, an estimation can be made using the 20 standard amino acids that this encompasses up to 2 x 2175 (20 amino acids or no amino acid is 21 options for 75 positions. On either side of SEQ ID NO:8 this is then twice as many options) possible structurally and functionally distinct polypeptides.
As such, this limitation encompasses an enormously broad number of structurally and functionally distinct polypeptides.
Disclosure of Structure and Disclosure of Species
N-Terminal X Domains
Regarding the N-Terminal X domains, Applicant discloses X domains in Table 1 which includes full length sequences of SEQ ID NO: 7-11.
Applicant discloses specific X domains of SEQ ID NO: 13 and 14 which have a length of 34 and 42 amino acids respectfully.
It is noted that SEQ ID NO:7 comprises SEQ ID NO: 13.
In total, Applicant discloses 7 sequences that can be considered X domains.
Cas Proteins No more than 700 or 800 amino acids in length
Regarding the Cas Proteins No more than 700 or 800 amino acids in length, Applicant discloses SEQ ID NO: 7, which is 611 amino acids in length and SEQ ID NO: 8 which is 625 amino acids in length.
In total, Applicant discloses 2 sequences which are Cas Proteins no more than 700, or 800 amino acids in length.
Structure/Function Correlation and Functional Characteristics
It is well known in the art that even a single amino acid change can affect the function of a protein, such as through a nonsense mutation that cause the protein to misfold and abrogate function. Therefore, Applicant’s claims, which encompass unfathomably large numbers of structurally distinct polypeptides also encompass unfathomably large numbers of functionally distinct polypeptides and domains.
Written Description – Conclusion
Therefore, the examiner concludes there is insufficient written description support for the instantly claimed genera.
Regarding the N-terminal X domains, Applicant discloses only 7 specific X domain sequences, which is not representative of the unfathomably larger genus of N-terminal X domains no more than 70 amino acids lengths that encompass structurally and functionally distinct polypeptide sequences and domains.
Regarding the Cas proteins no more than 700 or 800 amino acids in length, Applicant discloses only 2 sequences that are no more than 700 or 800 amino acids in length. This is not representative of the unfathomably large genus of Cas proteins no more than 700, or 800 amino acids in length, and otherwise meet instant claims, which encompasses structurally and functionally distinct polypeptides and Cas proteins.
There is no description of the structure/function correlation that would allow one of ordinary skill in the art to reasonably ascertain which substitutions, deletions or insertions can be performed. As such, one of ordinary skill in the art could not envision all the embodiments that fall outside of the description provide by the specification and the art.
Response to Arguments
Applicant’s arguments, filed 17th, September, 2026, have been fully considered but are not found persuasive.
Applicant argues “Claim 1 instead requires that the Cas protein comprise the amino acid sequence of SEQ ID NO: 7 or SEQ ID NO: 8. Support is at Table 1, which sets out both sequences in full at 611 and 625 amino acids respectively”
Applicant argues “Claim 8 is amended to recite a Cas protein of no more than 700 amino acids in length. Support is at paragraph [0055] and at Table 1, which discloses SEQ ID NO: 7 at 611 amino acids
and SEQ ID NO: 8 at 625 amino acids, both within the recited limit” (pg. 15-16).
In response, the two specific full length sequences disclosed in table 1 are not sufficient to support the full breadth of the large genus of structurally and functionally distinct polypeptides for the reason set forth above.
Applicant argues “Support is at paragraph [0067], which sets out both X domains in full, the cA2-l X domain as SEQ ID NO: 13 at 34 amino acids and the cA2-2 X domain as SEQ ID NO: 14 at 42 amino acids, and at Table 1 (continued), which places them at residues 1 to 34 of SEQ ID NO: 7 and residues 1 to 42 of SEQ ID NO: 8. Support for the recited length is at paragraph [0068]” (pg. 15-16).
In response, the two specific full length sequences of SEQ ID NO: 13 and 14 are not sufficient to support the full breadth of the large genus of structurally and functionally distinct polypeptides for the reason set forth above.
Withdrawn Claim Rejections - 35 USC § 112(b)
The rejection of claims 12 and 17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Moot Claim Rejections - 35 USC § 102
The rejection of claim 7 under 35 U.S.C. 102 (a)(1) as being anticipated by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) as evidenced by NCBI Reference Sequence: WP_033888930.1 (accessed at: https://www.ncbi.nlm.nih.gov/protein/WP_033888930.1?report=genbank&log$=protalign&blast_rank=15&RID=2JWM2JTA014) as set forth in the previous office action is moot in view of the cancellation of the claim.
The rejection of claim 7 = under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (WO-2020191102-A1: Published 24th, September, 2020 with priority to U.S. Provisional application 62/820,109 filed on 18th, March, 2019; see IDS filed 20th, April, 2023; henceforth “Zhang1”) as set forth in the previous office action is moot in view of the cancellation of the claim.
The rejection of claim 7 under 35 U.S.C. 102 (a)(1) as being anticipated by Maianti et al. (WO-2018/165631-A1; henceforth “Maianti”) as evidenced by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) as set forth in the previous office action is moot in view of the cancellation of the claim.
The rejection of claim 7 under 35 U.S.C. 102 (a)(1) as being anticipated by Jaskula-Ranga et al. (WO-2018009534-A1; henceforth “Jaskula-Ranga”) as evidenced by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) as set forth in the previous office action is moot in view of the cancellation of the claim.
Withdrawn Claim Rejections - 35 USC § 102
The rejection of claims 1-3 and 17 under 35 U.S.C. 102 (a)(1) as being anticipated by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) as evidenced by NCBI Reference Sequence: WP_033888930.1 (accessed at: https://www.ncbi.nlm.nih.gov/protein/WP_033888930.1?report=genbank&log$=protalign&blast_rank=15&RID=2JWM2JTA014) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claims 1-2 and 8 under 35 U.S.C. 102 (a)(1) as being anticipated by Harrington et al. (Science. 2018 Nov 16;362(6416):839-842. Epub 2018 Oct 18.) as evidenced by (Nat Commun. 2026 Jan 28;17(1):2126.; henceforth “Ganguly”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claims 1-3, 8, 12, 16 and 24 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (WO-2020191102-A1: Published 24th, September, 2020 with priority to U.S. Provisional application 62/820,109 filed on 18th, March, 2019; see IDS filed 20th, April, 2023; henceforth “Zhang1”) as set forth in the previous office action is withdrawn in view of Applicant’s filing of a Declaration under 37 C.F.R. 1.130 indicating that the subject matter was a disclosure by Inventor.
The rejection of claims 1-3, 8, 12, 17 and 24 under 35 U.S.C. 102 (a)(1) as being anticipated by Maianti et al. (WO-2018/165631-A1; henceforth “Maianti”) as evidenced by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claims 1-3, 7, 12, and 16-17 under 35 U.S.C. 102 (a)(1) as being anticipated by Jaskula-Ranga et al. (WO-2018009534-A1; henceforth “Jaskula-Ranga”) as evidenced by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Response to Declaration under 37 C.F.R. 1.130
The Declaration under 37 C.F.R. 1.130 filed on 17th, September, 2026 is sufficient to overcome the rejection of claims 1-3, 8, 12, 16 and 24 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (WO-2020191102-A1: Published 24th, September, 2020 with priority to U.S. Provisional application 62/820,109 filed on 18th, March, 2019; see IDS filed 20th, April, 2023; henceforth “Zhang1”) as set forth in the previous office action.
Moot Non-Statutory Double Patenting
The rejection of claim 7 on the ground of nonstatutory double patenting as being unpatentable over the cited claims of the issued US patents listed below, as evidenced by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) and NCBI Reference Sequence: WP_033888930.1 (accessed at: https://www.ncbi.nlm.nih.gov/protein/WP_033888930.1?report=genbank&log$=protalign&blast_rank=15&RID=2JWM2JTA014) because they claim a composition comprising a Cas protein or Cas effector protein in the identified claims that meets the structural requirements of instant claims or make obvious the instant claims as set forth in the previous office action is moot in view of the cancellation of the claim.
Withdrawn Non-Statutory Double Patenting
The rejection of claims 1-3 and 17 on the ground of nonstatutory double patenting as being unpatentable over the cited claims of the issued US patents listed below, as evidenced by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) and NCBI Reference Sequence: WP_033888930.1 (accessed at: https://www.ncbi.nlm.nih.gov/protein/WP_033888930.1?report=genbank&log$=protalign&blast_rank=15&RID=2JWM2JTA014) because they claim a composition comprising a Cas protein or Cas effector protein in the identified claims that meets the structural requirements of instant claims or make obvious the instant claims as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claim 8 on the ground of nonstatutory double patenting as being unpatentable over the cited claims of the issued US patents listed below, as evidenced by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) and NCBI Reference Sequence: WP_033888930.1 (accessed at: https://www.ncbi.nlm.nih.gov/protein/WP_033888930.1?report=genbank&log$=protalign&blast_rank=15&RID=2JWM2JTA014) and further evidenced by Harrington et al. (Science. 2018 Nov 16;362(6416):839-842. Epub 2018 Oct 18.), because they claim a composition comprising a Cas protein or Cas effector protein in the identified claims that meets the structural requirements of instant claims or make obvious the instant claims as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claims 12 and 24 on the ground of nonstatutory double patenting as being unpatentable over the cited claims of the issued US patents listed above, as evidenced by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) and NCBI Reference Sequence: WP_033888930.1 (accessed at: https://www.ncbi.nlm.nih.gov/protein/WP_033888930.1?report=genbank&log$=protalign&blast_rank=15&RID=2JWM2JTA014) as applied to claim 1 above, and in further view of Maianti et al. (WO-2018/165631-A1; henceforth “Maianti”) because they claim a composition comprising a Cas protein or Cas effector protein in the identified claims that meets the structural requirements of instant claims or make obvious the instant claims as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claim 16 on the ground of nonstatutory double patenting as being unpatentable over the cited claims of the issued US patents listed above, as evidenced by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) and NCBI Reference Sequence: WP_033888930.1 (accessed at: https://www.ncbi.nlm.nih.gov/protein/WP_033888930.1?report=genbank&log$=protalign&blast_rank=15&RID=2JWM2JTA014) as applied to claim 1 above, and in further view of Jaskula-Ranga et al. (WO-2018009534-A1; henceforth “Jaskula-Ranga”) because they claim a composition comprising a Cas protein or Cas effector protein in the identified claims that meets the structural requirements of instant claims or make obvious the instant claims as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
U.S. Patents and specifically identified conflicting claims that claim a Cas protein and were previously cited in non-statutory double patenting rejections:
US Patent No:
12644111 (claims 1, 14 and 18)
12618101 (claims 1 and 11)
12595478 (claims 4, 18, 20, 22)
12559786 (claim 30)
12534714 (claim 1)
12529042 (claims 1-2)
12522807 (claim 1)
12467925 (claims 1 and 18-19)
12435320 (claims 1, 23 and 29)
12431216 (claim 1)
12421507 (claims 1 and 16-19)
12415000 (claim 1)
12410416 (claims 1, 16 and 21)
12350368 (claim 9)
12351837 (claim 8)
12297436 (claim 1)
12252705 (claim 1)12227742 (claim 1)
12221636 (claims 6-8)
12215318 (claims 1, 15 and 23)
12188059 (claim 1)
12110490 (claim 1)
12054755 (claim 1)
11965159 (claim 16)
11913044 (claims 14-15)
11898142 (claims 1-2)
11866697 (claim 22)
11840711 (claim 1)
11788083 (claim 1)
11767528 (claim 1)
12297433 (claim 1)
11730826 (claim 1)
11732274 (claims 20-23)
11633732 (claim 1)
11618928 (claim 1)
11618896 (claim 1)
11597919 (claim 11)
11578312 (claim 20)
11530425 (claim 1)
12146152 (claims 1 and 6)
11453865 (claims 1-2)
11697808 (claims 1-2)
12385024 (claim 1)
11453907 (claim 1)
11639523 (claim 1)
12522863 (claim 4)
11795452 (claim 1)
12509680 (claim 1)
12570972 (claims 1, 25 and 27)
12624354 (claims 1 and 25)
11384344 (claim 1)
12559774 (claims 18-19 and 24-26)
11286478 (claim 1)
12344838 (claim 9)
11180751 (claim 1)
11174515 (claim 1)
11091798 (claim 1)
11634755 (claim 1)
11773432 (claim 1)
12091709 (claim 18)
12371737 (claim 1)
11060115 (claims 1 and 3)
11773412 (claim 1)
11021740 (claim 1)
12630867 (claim 1)
10954514 (claims 12-13)
10876100 (claims 1 and 25)
12123032 (claims 1, 8 , 10 and 12)
10851357 (claims 1 and 21)
12553065 (claim 1)
10696986 (claim 1)
10377998 (claim 1)
10266886 (claims 1 and 9)
12037639 (claim 1)
9790490 (claims 1-4)
8993233 (claim 43)
8906616 (claim 1)
8889356 (claim 24)
8932814 (claim 25)
8865406 (claim 24)
8889418 (claims 1 and 23)
8895308 (claim 25)
8795965 (claim 26)
8871445 (claim 26)
8697359 (claim 15)
8771945 (claim 26)
8945839 (see IDS filed 29th, September, 2026;claim 21)
12473543 (claims 10-11)
12435330 (claims 6-9)
11912985 (claim 1)
10494621 (claims 1-3)
Moot Provisional Non-Statutory Double Patenting
The provisional rejection of claim 7 on the ground of nonstatutory double patenting as being unpatentable over the cited claims of the co-pending Applications listed below, as evidenced by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) and NCBI Reference Sequence: WP_033888930.1 (accessed at: https://www.ncbi.nlm.nih.gov/protein/WP_033888930.1?report=genbank&log$=protalign&blast_rank=15&RID=2JWM2JTA014) because they claim a composition comprising a Cas protein or Cas effector protein in the identified claims that meets the structural requirements of instant claims or make obvious the instant claims as set forth in the previous office action is moot in view of the cancellation of the claim.
Withdrawn Provisional Non-Statutory Double Patenting
The provisional rejection of claims 1-3 and 17 on the ground of nonstatutory double patenting as being unpatentable over the cited claims of the co-pending Applications listed above, as evidenced by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) and NCBI Reference Sequence: WP_033888930.1 (accessed at: https://www.ncbi.nlm.nih.gov/protein/WP_033888930.1?report=genbank&log$=protalign&blast_rank=15&RID=2JWM2JTA014) because they claim a composition comprising a Cas protein or Cas effector protein in the identified claims that meets the structural requirements of instant claims or make obvious the instant claims as set forth in the previous office action is withdrawn in view of Applicant’s amendments. The provisional rejection of claim 8 on the ground of nonstatutory double patenting as being unpatentable over the cited claims of the co-pending Applications listed below, as evidenced by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) and NCBI Reference Sequence: WP_033888930.1 (accessed at: https://www.ncbi.nlm.nih.gov/protein/WP_033888930.1?report=genbank&log$=protalign&blast_rank=15&RID=2JWM2JTA014) and further evidenced by Harrington et al. (Science. 2018 Nov 16;362(6416):839-842. Epub 2018 Oct 18.), because they claim a composition comprising a Cas protein or Cas effector protein in the identified claims that meets the structural requirements of instant claims or make obvious the instant claims as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The provisional rejection of claims 12 and 24 on the ground of nonstatutory double patenting as being unpatentable over the cited claims of the co-pending Applications listed above, as evidenced by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) and NCBI Reference Sequence: WP_033888930.1 (accessed at: https://www.ncbi.nlm.nih.gov/protein/WP_033888930.1?report=genbank&log$=protalign&blast_rank=15&RID=2JWM2JTA014) as applied to claim 1 above, and in further view of Maianti et al. (WO-2018/165631-A1; henceforth “Maianti”) because they claim a composition comprising a Cas protein or Cas effector protein in the identified claims that meets the structural requirements of instant claims or make obvious the instant claims as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The provisional rejection of claim 16 on the ground of nonstatutory double patenting as being unpatentable over the cited claims of the co-pending Applications listed above, as evidenced by Nishimasu et al. (Cell. 2014 Feb 13;156(5):935–949.; henceforth “Nishimasu”) and NCBI Reference Sequence: WP_033888930.1 (accessed at: https://www.ncbi.nlm.nih.gov/protein/WP_033888930.1?report=genbank&log$=protalign&blast_rank=15&RID=2JWM2JTA014) as applied to claim 1 above, and in further view of Jaskula-Ranga et al. (WO-2018009534-A1; henceforth “Jaskula-Ranga”) because they claim a composition comprising a Cas protein or Cas effector protein in the identified claims that meets the structural requirements of instant claims or make obvious the instant claims as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
U.S. Co-pending Applications and specifically identified conflicting claims that claim a Cas protein and were previously cited in provisional non-statutory double-patenting rejections.
Applications which list Feng Zhang as an Inventor:
19/677,353 (claim 1; claims filed 14th, May, 2026)
19/563,393 (claims 1 and 8; claims filed 28th, April, 2026)
19/388,533 (claims 1, 21-22, 24, 28, 30, 34, 71, 75, 83, 86, 105, 127, 137, 140; claims filed 5th, January, 2026)
19/361,664 (claim 31; claims filed 8th, April, 2026)
19/348,206 (claim 1; claims filed 12th, January, 2026)
19/342,889 (claims 1 and 24; claims filed 29th, September, 2025)
19/330,290 (claim 1 and 20; claims filed 16th, September, 2025)
19/307,262 (claim 2, 16 and 19-20; claims filed 25th, February, 2026)
19/287,917 (claim 1, 18, 21, 24, 61, 64, 67; claims filed 7th, October, 2025)
19/262,704 (claims 24, 39, 41-42; claims filed 20th, November, 2025)
19/260,968 (claims 9 and 20; claims filed 23rd, February, 2026)
19/221,936 (claim 2 and 26; claims filed 9th, January, 2026)
19/089,389 (claims 1, 15 and 17; claims field 2nd, June, 2025)
19/053,983 (claims 157-158, 162; claims filed 1st, October, 2025)
19/043,619 (claims 8 and 26; claims filed 10th, April, 2025)
19/028,841 (claims 2 and 20-21; claims filed 27th, April, 2025)
19/029,037 (claims 2 and 20-21; claims filed 27th, April, 2025)
19/025,663 (claim 1; claims filed 16th, January, 2025)
19/016,260 (claims 1, 14, 20-22; claims filed 31st, March, 2025)
18/932,763 (claims 7-8, 32-33; claims filed 13th, January, 2025)
18/905,630 (claims 105, 119, 121-122; claims filed 26th, February, 2025)
18/889,942 (claims 90 and 95; claims filed 24th, March, 2025)
18/772,681 (claim 1; claims filed 6th, March, 2025)
18/726,514 (claims 19 and 39; claims filed 27th, January, 2025)
18/717,020 (claims 1, 7-8, 21, 27, 40; claims filed 19th, December, 2024)
18/712,779 (claims 1 and 22; claims filed 6th, December, 2024)
18/701,358 (claims 1 and 13; claims filed 5th, November, 2024)
18/235,760 (claim 62; claims filed 20th, February, 2024)
18/317,248 (claims 64-67; claims filed 9th, February, 2024)
18/107,108 (claim 41; claims filed 4th, August, 2024)
17/910,497 (claim 1; claims filed 3rd, March, 2026)
17/640,016 (claims 1 and 11; claims filed 12th, May, 2026)
17/638,355 (claims 1, 15, 20-21; claims filed 13th, February, 2026)
17/612,245 (claims 1 and 26; claims filed 24th, March, 2026)
17/321,872 (claim 1; claims filed 11th, May, 2026)
16/973,061 (claim 71; claims filed 8th, May, 2026)
16/631,879 (claim 1; claims filed 21st, April, 2026)
16/617,560 (claim 1; claims filed 26th, March, 2026)
16/450,852 (claim 16, claims filed 5th, June, 2026)
18/965,935 (claims 1 and 4-17; claims filed 26th, March, 2026)
18/726,460 (claims 27, 33 and 56; claims filed 21st, January, 2025)
18/276,471 (claims 2-3, 14 and 23-25; claims filed 17th, April, 2026)
18/272,158 (claims 21 and 48; claims filed 22nd, April, 2026)
18/270,854 (claims 8, 10-14, 17; claims filed 19th, March, 2026)
18/269,813 (claims 1 and 34; claims filed 13th, March, 2026)
17/801,815 (claims 1-2, 18 and 60; claims filed 6th, April, 2026)
17/742,503 (claim 29, claims filed 24th, October, 2022)
17/742,127 (claims 1-2; claims filed 7th, October, 2022)
17/763,907 (claims 7 and 98-99; claims filed 2nd March, 2026)
17/612,504 (claims 1 and 41-44; note that claim 1 also specifically meets instant claim 8 because the cas protein is between 600-750 amino acids in size; claims filed 2nd, January, 2026)
16/961,820 (claim 1; claims filed 16th, March, 2026)
16/955,380 (claim 1; claims filed 29th, April, 2026)
16/954,032 (claim 1; claims filed 26th, January, 2026)
16/772,269 (claim 1; claims filed 18th, February, 2026)
16/626,396 (claims 23, 66 and 69; claims filed 6th, February, 2026)
17/831,745 (claim 31; claims filed 17th, February, 2026)
18/349,707 (claim 51; claims filed 28th, January, 2026)
18/334,074 (claim 1; claims filed 29th, May, 2026)
17/798,248 (claims 19 and 21; claims filed 18th, March, 2026)
17/793,115 (claims 1, 33, 40 and 43; claims filed 24th, February, 2026)
17/786,168 (claim 1; claims filed 21st, January, 2026)
17/776,269 (claims 1, 48, 56; claims filed 9th, January, 2026)
17/761,641 (claims 30, 73, 83; claims filed 30th, January, 2026)
17/439,063 (claim 1; claims filed 4th, March, 2025)
17/273,999 (claims 16, 25-27, 31-33; claims filed 22nd, January, 2026)
17/264,340 (claims 4, 8 and 17; claims filed 21st, April, 2026)
18/248,252 (claims 4, 19, 23; claims filed 27th, January, 2026)
17/928,355 (claims 1, 21; claims filed 26th, May, 2026)
17/785,070 (claims 7-11; claims filed 4th, May, 2026)
17/761,292 (claims 1, 24, 27, 31, 42, 44-45, 48; claims filed 1st, May, 2026)
17/254,886 (claim 41; claims filed 27th, April, 2026)
16/756,134 (claims 1, 46-47; claims filed 26th, May, 2026)
16/095,207 (claims 1-2; claims filed 26th, May, 2026)
15/330,876 (claims 1, 30 and 40; claims filed 18th, May, 2020)
14/738,398 (claim 1; claims filed 26th, March, 2022)
17/773,104 (claims 1, 14, 34; claims filed 4th, June, 2026)
18/480,647 (claim 1; claims filed 18th, March, 2026). A notice of allowance as mailed on 31st, March, 2026. When the Patent issues this rejection will no longer be provisional.
17/495,219 (claim 1; claims filed 13th, April, 2026) A notice of allowance as mailed on 24th, April, 2026. When the Patent issues this rejection will no longer be provisional.
17/246,466 (claims 83 and 104; claims filed 9th, March, 2026). A notice of allowance as mailed on 23rd, March, 2026. When the Patent issues this rejection will no longer be provisional.
17/265,910 (claims 1, 17, 22, 42, 48, 64-65; claims filed 26th, March, 2026). A notice of allowance as mailed on 26th, May, 2026. When the Patent issues this rejection will no longer be provisional.
16/623,799 (claim 1; claims filed 17th, April, 2026). A notice of allowance as mailed on 28th, April, 2026. When the Patent issues this rejection will no longer be provisional.
18/109,550 (claim 31; claims filed 21st, July, 2025)
16/938,110 (claim 60; claims filed 8th, July, 2025)
16/906,580 (claim 30; claims filed 8th, July, 2025)
16/535,043 (claims 47 and 63; claims filed 4th, May, 2023)
15/967,495 (claims 61-63; claims filed 30th, June, 2021)
15/230,025 (claim 1; claims filed 31st, March, 2020)
15/230,161 (claims 10-11; claims filed 10th, December, 2021)
15/160,710 (claim 1; claims filed 27th, January, 2021)
Applications which list Soumya Kannan as an Inventor:
16/617,560 (claim 1; claims filed 26th, March, 2026) (also lists Zhang as inventor above)
17/638,355 (claims 1, 15, 20-21; claims filed 13th, February, 2026) (also lists Zhang as inventor above)
19/016,260 (claims 1, 14, 20-22; claims filed 31st, March, 2025) (also lists Zhang as inventor above)
19/388,533 (claims 1, 21-22, 24, 28, 30, 34, 71, 75, 83, 86, 105, 127, 137, 140; claims filed 5th, January, 2026) (also lists Zhang as inventor above)
19/563,393 (claims 1 and 8; claims filed 28th, April, 2026) (also lists Zhang as inventor above)
18/965,935 (claims 1 and 4-17; claims filed 26th, March, 2026) (also lists Zhang as inventor above)
17/264,340 (claims 4, 8 and 17; claims filed 21st, April, 2026) (also lists Zhang as inventor above)
17/776,269 (claims 1, 48, 56; claims filed 9th, January, 2026) (also lists Zhang as inventor above)
17/793,115 (claims 1, 33, 40 and 43; claims filed 24th, February, 2026) (also lists Zhang as inventor above)
17/761,292 (claims 1, 24, 27, 31, 42, 44-45, 48; claims filed 1st, May, 2026) (also lists Zhang as inventor above)
17/801,815 (claims 1-2, 18 and 60; claims filed 6th, April, 2026) (also lists Zhang as inventor above)
16/623,799 (claim 1; claims filed 17th, April, 2026). A notice of allowance as mailed on 28th, April, 2026. When the Patent issues this rejection will no longer be provisional. (also lists Zhang as inventor above)
Applications which list Han Altae-Tran as an Inventor:
17/638,355 (claims 1, 15, 20-21; claims filed 13th, February, 2026) (also lists Zhang and Kannan as inventors above)
19/016,260 (claims 1, 14, 20-22; claims filed 31st, March, 2025) (also lists Zhang and Kannan as inventors above)
19/388,533 (claims 1, 21-22, 24, 28, 30, 34, 71, 75, 83, 86, 105, 127, 137, 140; claims filed 5th, January, 2026) (also lists Zhang and Kannan as inventors above)
19/563,393 (claims 1 and 8; claims filed 28th, April, 2026) (also lists Zhang and Kannan as inventors above)
17/612,504 (claims 1 and 41-44; note that claim 1 also specifically meets instant claim 8 because the cas protein is between 600-750 amino acids in size; claims filed 2nd, January, 2026) (also lists Zhang as inventor above)
18/965,935 (claims 1 and 4-17; claims filed 26th, March, 2026) (also lists Zhang and Kannan as inventors above)
17/776,269 (claims 1, 48, 56; claims filed 9th, January, 2026) (also lists Zhang and Kannan as inventors above)
17/793,115 (claims 1, 33, 40 and 43; claims filed 24th, February, 2026) (also lists Zhang and Kannan as inventors above)
17/761,292 (claims 1, 24, 27, 31, 42, 44-45, 48; claims filed 1st, May, 2026) (also lists Zhang and Kannan as inventors above)
17/785,070 (claims 7-11; claims filed 4th, May, 2026) (also lists Zhang as inventor above)
17/801,815 (claims 1-2, 18 and 60; claims filed 6th, April, 2026) (also lists Zhang and Kannan as inventors above)
Although the claims in the cited co-pending Applications above are not identical, they are not patentably distinct for the reasons stated below.
Examiner’s Remark
SEQ ID NO: 7 is free of the prior art.
SEQ ID NO: 8 is free of the prior art.
Because SEQ ID NO: 7-8 are free of the prior art, claims 1-3, 8, 12, 16-17 and 24 are free of the prior art. However, these claims are not allowable because they are rejected under 35. U.S.C. 112 (a) above and because claim 8 is objected to above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
No claim is allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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