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 .
DETAILED ACTION
Application Status
This application is a CON of 16/946,689, filed on 10/29/2024, which claim benefit of US Provisional patent applications 62/730,890, filed on 09/13/2018, and 62/870,472, filed on 07/03/2019.
Claims 1-14 are currently pending in this patent application.
The amendment of the claims and response filed on 08/10/2026 is acknowledged.
Election/Restriction
Applicant's election without traverse of Group I, Claims 1-13, drawn to a variant Cas12 protein, comprising: a nuclease (NUC) lobe, a recognition (REC) lobe, and a modified bridge helix (BH) region joining the NUC lobe and the REC lobe, the variant Cas12 protein having increased DNA cleavage selectivity relative to a corresponding wild type Cas12 protein, wherein the modified BH region increases the DNA cleavage selectivity of the variant Cas12 protein relative to the DNA cleavage selectivity of the corresponding wild type Cas12 protein, and wherein the modified BH region comprises at least one amino acid substitution relative to the corresponding wild type Cas12 protein, and wherein the at least one amino acid substitution in the modified BH region comprises a substitution in any one or more of amino acid positions 631, 632, 644, 645, 654, 655, and 656, wherein said amino acid positions are numbered relative to a Alicyclobacillus acidoterrestrisstrain ATCC 49025Cas12b (AaCas12b) protein set forth in of the amino acid sequence SEQ ID NO:4, and wherein the variant Cas12b protein has at least 90% identity to SEQ ID NO:4, and a single mutation at position 644, and a double mutation at positions 644 and 645 in the response filed on 08/10/2026 is acknowledged.
Applicants request for rejoinder of method claims is noted. However, current claims of elected Group I are not allowable at this time. When Group I would be allowable, rejoinder request would be evaluated at that time.
The requirement is still deemed proper and is therefore made FINAL.
Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-13 are present for examination.
Priority
Acknowledgement is made of applicants claim for priority of US patent Application 16/949,689, filed on 07/01/202202083, US Provisional patent applications 62/730,890, filed on 09/13/2018, and 62/870,472, filed on 07/03/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/29/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is considered by the examiner. The signed copy of IDS is enclosed herewith.
Drawings
Drawings submitted on 10/24/2024 are accepted by the Examiner.
Double Patenting Rejection
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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-13 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over at least claims 1-6 of U.S. Patent 11459552 B2, granted on 10/04/2022.
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-13 of the instant application disclose a variant Cas12 protein, comprising: a nuclease (NUC) lobe, a recognition (REC) lobe, and a modified bridge helix (BH) region joining the NUC lobe and the REC lobe, the variant Cas12 protein having increased DNA cleavage selectivity relative to a corresponding wild type Cas12 protein, wherein the modified BH region increases the DNA cleavage selectivity of the variant Cas12 protein relative to the DNA cleavage selectivity of the corresponding wild type Cas12 protein, and wherein the modified BH region comprises at least one amino acid substitution relative to the corresponding wild type Cas12 protein, and wherein the at least one amino acid substitution in the modified BH region comprises a substitution amino acid positions 631, 632, 644, 645, 654, 655, and 656, wherein said amino acid positions are numbered relative to a Cas12b (AaCasl2b) protein set forth in of the amino acid sequence SEQ ID NO:4, and wherein the variant Cas12b protein has at least 90% identity to SEQ ID NO:4, wherein the at least one amino acid substitution in the modified BH region is selected from the group consisting of ala, arg, asn, asp, cys, glu, gln, gly, his, ile, leu, lys, met, phe, pro, ser, thr, trp, tyr, and val, wherein the at least one amino acid substitution in the modified BH region is selected from the group consisting of (1) Leu 631and/or Arg 632 mutated to Pro 631 and/or Pro 632, (2) Gln 644 and/or Leu 645 mutated to Pro 644 and/or Pro 645, (3) Leu 654 and/or Leu 655 mutated to Pro 654 and/or Pro 655, and (4) Leu 655 and/or Val 656 mutated to Pro 655 and/or Pro 656, wherein at least one pair of substitutions selected from the group consisting of (a) substitutions in amino acid positions 631 and 632, (b) substitutions in amino acid positions 644 and 645, (c) substitutions in amino acid positions 654 and 655, and (d) substitutions in amino acid positions 655 and 656, wherein each substitution of the at least one pair of substitutions is independently selected from the group consisting of ala, arg, asn, asp, cys, glu, gln, gly, his, ile, leu, lys, met, phe, pro, ser, thr, trp, tyr, and val, in particular substitutions at position 654 and position 655, wherein the substitutions in position 654 and position 655 are independently selected from the group consisting of ala, arg, asn, asp, cys, glu, gln, gly, his, ile, leu, lys, met, phe, pro, ser, thr, trp, tyr, and val, wherein substitutions at position 655 and position 656.
Claims 1-6 of US patent 11459552 B2 disclose a variant Cas12 protein, comprising: a nuclease (NUC) lobe, a recognition (REC) lobe, and a modified bridge helix (BH) region joining the NUC lobe and the REC lobe, the variant Cas12 protein having increased DNA cleavage selectivity relative to a corresponding wild type Cas12 protein, wherein the modified BH region increases the DNA cleavage selectivity of the variant Cas12 protein relative to the DNA cleavage selectivity of the corresponding wild type Cas12 protein, and wherein the modified BH region comprises at least one amino acid substitution relative to the corresponding wild type Cas12 protein, and wherein the at least one amino acid substitution in the modified BH region comprises a substitution in any one or more of amino acid positions 956, 957, 961, 962, 969, and 970, wherein said amino acid positions are numbered relative to a Cas12a (FnCas12a) protein set forth in of the amino acid sequence SEQ ID NO:1, and wherein the variant Cas12a protein has at least 90% identity to SEQ ID NO:1, wherein the at least one amino acid substitution in the modified BH region is selected from the group consisting of ala, arg, asn, asp, cys, glu, gln, gly, his, ile, leu, lys, met, phe, pro, ser, thr, trp, tyr, and val, wherein at least a pair of substitutions are in amino acid positions 956 and 957, (b) substitutions in amino acid positions 961 and 962, and (c) substitutions in amino acid positions 969 and 970, and wherein the at least one amino acid substitution in the modified BH region comprises a substitution in amino acid positions 943, 944, 948, 949, 956, and 957, wherein said amino acid positions are numbered relative to AsCas12a) protein set forth in of the amino acid sequence SEQ ID NO:3, and wherein the variant Cas12a protein has at least 90% identity to SEQ ID NO:3, wherein the variant Cas12 protein comprising at least a pair of substitutions selected from the group consisting of (a) substitutions in amino acid positions 943 and 944, (b) substitutions in amino acid positions 948 and 949, and (c) substitutions in amino acid positions 956 and 957, wherein the at least one amino acid substitution in the modified BH region is selected from the group consisting of ala, arg, asn, asp, cys, glu, gln, gly, his, ile, leu, lys, met, phe, pro, ser, thr, trp, tyr, and val.
The above indicated claims of the reference patents while not totally identical to the instant claims, are indeed product claim of a variant Cas12 protein, comprising: a nuclease (NUC) lobe, a recognition (REC) lobe, and a modified bridge helix (BH) region joining the NUC lobe and the REC lobe, the variant Cas12 protein having increased DNA cleavage selectivity relative to a corresponding wild type Cas12 protein, wherein the modified BH region increases the DNA cleavage selectivity of the variant Cas12 protein relative to the DNA cleavage selectivity of the corresponding wild type Cas12 protein, and wherein the modified BH region comprises at least one amino acid substitution relative to the corresponding wild type Cas12 protein, and wherein the at least one amino acid substitution in the modified BH region comprises a substitution in any one or more of amino acid positions 956, 957, 961, 962, 969, and 970, The portion of the claims and the in the reference patents, while drawn to the actual product as claims in the instant application, includes several embodiments that would anticipate the invention claimed in the instant application. Claims of the instant application listed above cannot be considered patentably distinct over claims of the reference patents when there are specifically recited and embodiments that would either anticipate to claims 1-13 of the instant application or alternatively render them obvious. Alternatively, claims 1-13 cannot be considered patentably distinct over claims 1-6 of the reference patents when there is specifically disclosed embodiment in the instant application that falls within the scope of claims 1-6 of US patent 11459552 B2, i.e. there is substantially overlapping scope between the claimed invention and the teachings of the reference. One having ordinary skill in the art would have been motivated to do this because that embodiment is disclosed as being a preferred embodiment within the claims 1-6 of US patent 11459552 B2.
Note: The present application claims priority as a CON to the parent application 16/946,689 of US patent 11459552 B2, and thus negating safe harbor from non-statutory ODP rejections since the present claims are drawn to a same claimed invention of a variant Cas12 protein, comprising: a nuclease (NUC) lobe, a recognition (REC) lobe, and a modified bridge helix (BH) region joining the NUC lobe and the REC lobe, the variant Cas12 protein having increased DNA cleavage selectivity relative to a corresponding wild type Cas12 protein, from what was examined in the parent. Thus, as discussed above, the presently claimed of a variant Cas12 protein, comprising: a nuclease (NUC) lobe, a recognition (REC) lobe, and a modified bridge helix (BH) region joining the NUC lobe and the REC lobe, the variant Cas12 protein having increased DNA cleavage selectivity relative to a corresponding wild type Cas12 protein, is patentably indistinct from and not protected by the safe harbor from, the claim to the a variant Cas12 protein, comprising: a nuclease (NUC) lobe, a recognition (REC) lobe, and a modified bridge helix (BH) region joining the NUC lobe and the REC lobe, the variant Cas12 protein having increased DNA cleavage selectivity relative to a corresponding wild type Cas12 protein molecules in the parent patent.
Conclusion
Status of the claims:
Claims 1-13 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F, at 9:00-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Iqbal H. Chowdhury, Ph.D.
Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656
Prosecution Insights