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 .
Examiner contacted Attorney on 5/14/2026 regarding claim set dated 11/18/2025. Said claim set does not belong to the instant application. Attorney also notified Examiner that the drawings dated 11/18/2025 do not belong to the instant application. Attorney agreed to look into having the claim set and drawings dated 11/18/2025 removed or submitting a document requesting the claim set and drawings dated 11/18/2025 be expunged.
Applicants’ amendment to the claims filed on 10/25/2023 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-3, 10, 13-16, 19-21, 23-24, 26, 28, 31-35 are pending.
Claims 4-9, 11-12, 17-18, 22, 25, 27, 29-30 are canceled.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-3, 10, 13-16, 19-21, 23-24, 26, 28) in the reply filed on 4/10/2026 is acknowledged.
Claims 4-9, 11-12, 17-18, 22, 25, 27, 29-30 were cancelled by prior amendment.
Claims 31-35 stands withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-3, 10, 13-16, 19-21, 23-24, 26, 28 are pending and examined on the merits.
Priority
Acknowledgement is made of this national stage entry of PCT/US2021/054636 filed on 10/12/2021, which claims domestic priority to U.S. provisional application 63/183,545, filed on 5/3/2021, which claims domestic priority to U.S. provisional application 63/091,880, filed on 10/14/2020, which claims domestic priority to U.S. provisional application 63/090,685, filed on 10/12/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/20/2023, 9/25/2023, 11/20/2023, 3/7/2024, 5/8/2024, 7/18/2024, 9/19/2024, 12/10/2024, 2/26/2025, 5/6/2025, 7/3/2025, 9/29/2025, 11/18/2025, 2/23/2026, 4/16/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The Drawings filed on 4/11/2023, 11/18/2025 are acknowledged and accepted by the Examiner.
Claim Rejections - 35 USC § 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 21 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.
Regarding claim 21, the recitation of "-" in lines 2-3 of claim 21 renders the claim indefinite because it is unclear whether the limitations following the recitation is part of the claimed invention. See MPEP § 2173.05(d). It is unclear what Applicant means by “-.” Appropriate correction is suggested.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 24, 26, 28 are rejected under 35 U.S.C. 102a1 as being anticipated by Olson et al (WO2019152609A1, Date of Publication: August 8, 2019, Examiner cited) {herein Olson}.
Claims 1, 24, 26, 28 are drawn to a CRISPR/Cas-based base editing system for altering an RNA splice site encoded in the genomic DNA of a subject, the CRISPR/Cas-based base editing system comprising a fusion protein and at least one guide RNA (gRNA),wherein the fusion protein comprises a Cas protein and a base-editing domain, and wherein the at least one gRNA targets a sequence comprising at least one of SEQ ID NOs: 21-23 or 43 or a complement or a fragment thereof and/or the gRNA comprises a sequence selected from SEQ ID NOs: 24-26 or 44 or a complement or a fragment thereof.
With respect to claims 1, 24, 26, 28, Olson teaches a CRISPR/Cas based base editing system with guide RNA (gRNA) for altering an RNA splice site (page 2, lines 1-9). Said system is cloned into a vector and propagated in cells (Fig. 4A-4F). Absent evidence otherwise, it is the Examiner’s position that CRISPR/Cas is a fusion protein as Olson teaches said complex is routinely engineered as fusion proteins to expand their capabilities. Additionally, it is well-known in the art that CRISPR/Cas contains a base editing domain as said construct is engineered as a tool to correct genetic disorders (page 8, lines 28-32). Furthermore, said gRNA comprises the instant application SEQ ID NO: 21 targeting DNA (appendix A and page 19, lines 10).
For the reasons stated herein, the teachings of Olson anticipates claims 1, 24, 26, 28.
Claims 2-3 are rejected under 35 U.S.C. 102a1 as being anticipated by Liu et al (WO2018027078A1, Date of Publication: 08 February 2018, Examiner cited) {herein Liu}.
Claims 2-3 are drawn to a CRISPR/Cas-based base editing system for altering an RNA splice site encoded in the genomic DNA of a subject, the CRISPR/Cas-based base editing system comprising a fusion protein and at least one guide RNA (gRNA),wherein the fusion protein comprises a Cas protein and a base-editing domain, and wherein the base-editing domain comprises a polypeptide selected from SEQ ID NOs: 45-52 and/or is encoded by a polynucleotide comprising a sequence selected from SEQ ID NOs: 53-60.
With respect to claims 2-3, Liu teaches a CRISPR/Cas based base editing system with guide RNA (gRNA) for altering an RNA splice site (para 00225). Liu further teaches fusion proteins comprising a Cas9 domain and an adenosine deaminase domain, for example, an engineered deaminase domain capable of deaminating an adenosine in DNA (para 0006). In some embodiments, the fusion protein comprises one or more of a nuclear localization sequence (NLS), an inhibitor of inosine base excision repair (e.g., dISN), and/or a linker (para 0006). Said gRNA comprises the instant application SEQ ID NO: 45 which is comprised of an adenosine deaminase (appendix B, Liu claim 110). The CRISPR/Cas comprises the instant application SEQ ID NO: 27 (appendix C, Liu claim 170).
For the reasons stated herein, the teachings of Liu anticipates claims 2-3.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 10, 21, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al (WO2019152609A1, Date of Publication: August 8, 2019, Examiner cited) {herein Olson} as applied to claims 1, 24, 26, 28 in view of Liu et al (WO 2018/027078 A1, Date of Publication: 08 February 2018, Examiner cited {herein Liu}.
Claim 10 is drawn to the CRISPR/Cas-based base editing system claim 1, wherein the Cas protein comprises a Cas9, and wherein the Cas9 comprises at least one amino acid mutation which eliminates the nuclease activity of Cas9.
Claim 21 is drawn to the CRISPR/Cas-based base editing system of claim 1, wherein the fusion protein comprises the structure: NH2-[ABE]-[Cas protein]- COOH or NH2-[Cas protein l-[ABEl-COOH, and wherein each instance of "-" comprises an optional linker and wherein "ABE" is a base-editing domain.Claims 23 is drawn to the CRISPR/Cas-based base editing system of claim 1, wherein the fusion protein further comprises a nuclear localization sequence (NLS).
The teachings of Olson as applied to claims 1, 24, 26, 28 are set forth in the 102a1 rejection above.
However, Olson does not teach the product of claim 10, wherein the Cas protein comprises a Cas9, and wherein the Cas9 comprises at least one amino acid mutation which eliminates the nuclease activity of Cas9 (claim 10). Olson does not teach the product of claim 21, wherein the fusion protein comprises the structure: NH2-[ABE]-[Cas protein]- COOH or NH2-[Cas protein l-[ABEl-COOH, and wherein each instance of "-" comprises an optional linker and wherein "ABE" is a base-editing domain. Olson does not teach the product of claim 23, wherein the fusion protein further comprises a nuclear localization sequence (NLS).
With respect to claim 10, Liu teaches a fusion protein comprised a nuclease inactive Cas9 domains (para 00311). Said cas9 may be comprised of one of more mutations (para 00429).
With respect to claims 21, 23, Liu teaches the fusion protein comprises the structure:
NH2- [adenosine deaminase]- [napDNAbp] -COOH (para 00308). Said fusion protein is also comprised of a nuclear localization sequence (NLS) (para 00323).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Olson et al of a CRISPR/Cas base editing system with guide RNA (gRNA) for altering an RNA splice site (page 2, lines 1-9) or combine the teachings of Liu et al of a fusion protein comprised of a nuclease inactive Cas9 domain (para 00311). Said Cas9 may be comprised of one of more mutations (para 00429).
One of ordinary skill in the art would be motivated to either use the teachings of Olson et al. by itself or combine the teachings of Liu because Liu provides Olson the motivation to utilize a nuclease inactive Cas9 as said Cas9 would not cause double strand breaks in the DNA, thereby reducing the safety risks of chromosomal rearrangements and deletions. Olson in view of Liu would have a reasonable expectation of success that utilizing the inactive Cas9 protein would allow for precise base editing without causing permanent, potentially dangerous double-strand breaks (DSBs) in the DNA. Additionally, said Cas9 mutant would provide Olson with more insight on mechanisms for correcting or mitigating disease-causing mutations, especially since DMD is associated with more than 3000 different mutations in the X-linked dystrophin gene (Olson: page 2, para 1).
One of skill in the art would have a reasonable expectation of success to make and use the claimed Cas9 protein because Olson provides the basic Cas9 protein and its uses and methods of making it. Whereas, Liu provides a fusion protein comprised of nuclease inactive Cas9 domains (para 00311). Said Cas9 may be comprised of one of more mutations (para 00429). Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 13 are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al (WO2019152609A1, Date of Publication: August 8, 2019, Examiner cited {herein Olson} as applied to claims 1, 24, 26, 28 in view of Zhang et al (US 2014/0186919 A1, Date of Publication: Jul. 3, 2014, Examiner cited) {herein Zhang}.
Claim 13 is drawn to the CRISPR/Cas-based base editing system of claim 1, wherein the Cas protein comprises an amino acid sequence of SEQ ID NO: 4 or 5.
The teachings of Olson as applied to claims 1, 24, 26, 28 are set forth in the 102a1 rejection above.
However, Olson does not teach the product of claim 13, wherein the Cas protein comprises an amino acid sequence of SEQ ID NO: 4 or 5.
With respect to claim 13, Zhang teaches a CRISPR/Cas system wherein the Cas is 100% identical to the instant application SEQ ID NO: 4 (appendix D; para 0102).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Olson et al of a CRISPR/Cas base editing system with guide RNA (gRNA) for altering an RNA splice site (page 2, lines 1-9) or combine the teachings of Zhang et al of a CRISPR/Cas system wherein the Cas is 100% identical to the instant application SEQ ID NO: 4 (appendix D; para 0102).
One of ordinary skill in the art would be motivated to either use the teachings of Olson et al. by itself or combine the teachings of Zhang because Zhang provides the motivation for Olson to use a Cas9 protein comprised of instant application SEQ ID NO: 4 as said Cas9 protein converts Cas9 into a catalytically null mutant which is useful for generic DNA binding (para 0102). One of ordinary skill in the art knowing the benefit of Cas9 proteins in base-editing based on the teachings Olson in view of Zhang
would have a reasonable expectation of success that utilizing the catalytically inactive Cas9 protein would allow for precise base editing without causing permanent, potentially dangerous double-strand breaks (DSBs) in the DNA. Additionally, said Cas9 mutant would provide Olson with more insight on mechanisms for correcting or mitigating disease-causing mutations, especially since DMD is associated with more than 3000 different mutations in the X-linked dystrophin gene (page 2, para 1).
One of skill in the art would have a reasonable expectation of success to make and use the claimed fusion Cas9 protein because Olson provides the basic Cas9 protein and its uses and methods of making it. Whereas, Zhang provides a CRISPR/Cas system wherein the Cas is 100% identical to the instant application SEQ ID NO: 4 (appendix D; para 0102). Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 14-16, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al (WO2019152609A1, Date of Publication: August 8, 2019, Examiner cited) {herein Olson} as applied to claims 1, 24, 26, 28 in view of Gao et al (WO 2018/086623 A1, Date of Publication: 17 May 2018, Examiner cited) {herein Gao}.
Claim 14 is drawn to the CRISPR/Cas-based base editing system of claim 1, wherein the base-editing domain further comprises (i) a cytidine deaminase domain and (ii) at least one uracil glycosylase inhibitor (UGI) domain.
Claim 15 is drawn to the CRISPR/Cas-based base editing system of claim 14, wherein the cytidine deaminase domain comprises an apolipoprotein B mRNA-editing enzyme, catalytic polypeptide- like (APOBEC) deaminase.
Claim 16 is drawn to the CRISPR/Cas-based base editing system of claim 14, wherein the cytidine deaminase domain comprises an APOBEC 1 deaminase.
Claim 19 is drawn to the CRISPR/Cas-based base editing system of claim 14, wherein the at least one UGI domain comprises the amino acid sequence of SEQ ID NO: 20 or an amino acid sequence encoded by the polynucleotide sequence of SEQ ID NO: 6 or SEQ ID NO: 18.
Claim 20 is drawn to the CRISPR/Cas-based base editing system of claim 14, wherein the base-editing domain comprises one UGI domain or two UGI domains.
The teachings of Olson as applied to claims 1, 24, 26, 28 are set forth in the 102a1 rejection above.
However, Olson does not teach the product of claim 14, wherein the base-editing domain further comprises (i) a cytidine deaminase domain and (ii) at least one uracil glycosylase inhibitor (UGI) domain. Olson does not teach the product of claim 16, wherein the cytidine deaminase domain comprises an APOBEC 1 deaminase. Olson does not teach the product of claim 19, wherein the at least one UGI domain comprises the amino acid sequence of SEQ ID NO: 20 or an amino acid sequence encoded by the polynucleotide sequence of SEQ ID NO: 6 or SEQ ID NO: 18. Olson does not teach the product of claim 20, wherein the base-editing domain comprises one UGI domain or two UGI domains.
With respect to claims 14-16, 19-20, Gao teaches a base editing domain comprising a APOBEC1 cytidine deaminase and a uracil glycosylase inhibitor (UGI) (Gao: claims 1-3, 7). It is known by those of ordinary skill in the art that APOBEC1 is a cytidine deaminase enzyme that primarily edits messenger RNAs (specifically apolipoprotein B mRNA) by converting cytidine to uridine (C-to-U). Absent evidence otherwise, it is the Examiner’s position that the teaching by Gao of ‘a uracil glycosylase inhibitor (UGI) (Gao: claims 1-3, 7)’ is the same as recited ‘one UGI domain’ as the term ‘a’ is well-understood to be singular tense. Gao further teaches that said UGI domain is comprised of an amino acid sequence that is 100% identical to SEQ ID NO: 20 (appendix E; Gao claim 7).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Olson et al of a CRISPR/Cas base editing system with guide RNA (gRNA) for altering an RNA splice site (page 2, lines 1-9) or combine the teachings of Gao et al of a base editing domain comprising a APOBEC1 cytidine deaminase and a uracil glycosylase inhibitor (UGI) (Gao: claims 1-3, 7).
One of ordinary skill in the art would be motivated to either use the teachings of Olson et al. by itself or combine the teachings of Gao because Gao provides the motivation for Olson to try using a CRISPR/Cas system equipped with a cytidine deaminase domain (a Cytosine Base Editor or CBE) combined with a uracil glycosylase inhibitor (UGI) to treat DMD as the cytidine deaminase domain (APOBEC1) acts as an editor that converts a targeted Cytosine (C) to a Uracil (U) on single-stranded DNA (Gao: page 13, para 1-3) within the DMD gene. One of ordinary skill in the art knowing the benefit of the CRISPR/Cas system in gene editing based on the teachings Olson in view of Gao would have a reasonable expectation of success that utilizing a base-editing domain comprised of a cytidine deaminase domain and at least one uracil glycosylase inhibitor domain would significantly increase the efficiency and accuracy of the desired C-to-T conversion, leading to higher levels of restored dystrophin protein. Furthermore said construct would allow for targeted, efficient, and safer editing of the dystrophin gene by permanently modifying bases to skip mutated exons, directly addressing the underlying genetic cause of DMD (Gao: page 13, para 1-3).
One of skill in the art would have a reasonable expectation of success to make and use the claimed fusion Cas9 protein because Olson provides the basic Cas9 protein and its uses and methods of making it. Whereas, Gao provides the teaching of a base editing domain comprising a APOBEC1 cytidine deaminase and a uracil glycosylase inhibitor (UGI) (Gao: claims 1-3, 7). Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Non-Statutory 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 1-3, 10, 13-16, 19-21, 23-24, 26, 28 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 7, 20, 22 of U.S. Patent Application No. 17603243 which are commonly owned and have common inventors and filed before the instant application. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to a CRISPR/Cas-based base editing system for altering an RNA splice site encoded in the genomic DNA of a subject, wherein the instant application and U.S. Patent Application No. US 17603243 comprises fusion proteins and Cas proteins that are 100% identical (appendix F) (instant application claims 1-3, 10, 13-16, 19-20, 28 and U.S. Patent Application No. 17603243 claim 1). Additionally, both U.S. Patent Application No. 17603243 and the instant application are drawn to a fusion protein that comprises the structure: NH2-[ABE]-[Cas protein]- COOH or NH2-[Cas protein l-[ABEl-COOH, and wherein each instance of "-" comprises an optional linker and wherein "ABE" is a base-editing domain (instant application claim 21 and U.S. Patent Application No. 17603243 claim 20), of which are not patentably distinct from one another. Furthermore, both U.S. Patent Application No. 17603243 and the instant application are drawn to a fusion protein further comprising a nuclear localization sequence (NLS) domain (instant application claim 23 and U.S. Patent Application No. 17603243 claim 22) and an isolated polynucleotide encoding the CRISPR/Cas-based base editing system domain (instant application claim 24 and U.S. Patent Application No. 17603243 claim 7), of which are not patentably distinct from one another.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Status of Claims
Claims 4-9, 11-12, 17-18, 22, 25, 27, 29-30 were cancelled by prior amendment.
Claims 31-35 stands withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-3, 10, 13-16, 19-21, 23-24, 26, 28 are pending and examined on the merits.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Appendix A
Instant Application SEQ ID NO: 21 vs Olson et al SEQ ID NO: 2493 (STIC search result no. 88 .rng)
Query Match 100.0%; Score 20; Length 40;
Best Local Similarity 100.0%;
Matches 20; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TGGTATCTTACAGGAACTCC 20
||||||||||||||||||||
Db 8 TGGTATCTTACAGGAACTCC 27
Appendix B
Instant Application SEQ ID NO: 45 vs (WO2018027078A1) Liu et al SEQ ID NO: 64 (STIC search result No. 1)
Query Match 100.0%; Score 872; Length 166;
Best Local Similarity 100.0%;
Matches 166; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 SEVEFSHEYWMRHALTLAKRAWDEREVPVGAVLVHNNRVIGEGWNRPIGRHDPTAHAEIM 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 SEVEFSHEYWMRHALTLAKRAWDEREVPVGAVLVHNNRVIGEGWNRPIGRHDPTAHAEIM 60
Qy 61 ALRQGGLVMQNYRLIDATLYVTLEPCVMCAGAMIHSRIGRVVFGARDAKTGAAGSLMDVL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ALRQGGLVMQNYRLIDATLYVTLEPCVMCAGAMIHSRIGRVVFGARDAKTGAAGSLMDVL 120
Qy 121 HHPGMNHRVEITEGILADECAALLSDFFRMRRQEIKAQKKAQSSTD 166
||||||||||||||||||||||||||||||||||||||||||||||
Db 121 HHPGMNHRVEITEGILADECAALLSDFFRMRRQEIKAQKKAQSSTD 166
Appendix C
Instant application SEQ ID NO: 27 vs Liu SEQ ID NO: 702 (STIC search result no. 1 .rag)
Query Match 100.0%; Score 9121; Length 1775;
Best Local Similarity 100.0%;
Matches 1775; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MSEVEFSHEYWMRHALTLAKRAWDEREVPVGAVLVHNNRVIGEGWNRPIGRHDPTAHAEI 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MSEVEFSHEYWMRHALTLAKRAWDEREVPVGAVLVHNNRVIGEGWNRPIGRHDPTAHAEI 60
Qy 61 MALRQGGLVMQNYRLIDATLYVTLEPCVMCAGAMIHSRIGRVVFGARDAKTGAAGSLMDV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 MALRQGGLVMQNYRLIDATLYVTLEPCVMCAGAMIHSRIGRVVFGARDAKTGAAGSLMDV 120
Qy 121 LHHPGMNHRVEITEGILADECAALLSDFFRMRRQEIKAQKKAQSSTDSGGSSGGSSGSET 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LHHPGMNHRVEITEGILADECAALLSDFFRMRRQEIKAQKKAQSSTDSGGSSGGSSGSET 180
Qy 181 PGTSESATPESSGGSSGGSSEVEFSHEYWMRHALTLAKRALDEREVPVGAVLVLNNRVIG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 PGTSESATPESSGGSSGGSSEVEFSHEYWMRHALTLAKRALDEREVPVGAVLVLNNRVIG 240
Qy 241 EGWNRAIGLHDPTAHAEIMALRQGGLVMQNYRLIDATLYVTFEPCVMCAGAMIHSRIGRV 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 EGWNRAIGLHDPTAHAEIMALRQGGLVMQNYRLIDATLYVTFEPCVMCAGAMIHSRIGRV 300
Qy 301 VFGVRNAKTGAAGSLMDVLHYPGMNHRVEITEGILADECNALLCYFFRMPRQVFNAQKKA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 VFGVRNAKTGAAGSLMDVLHYPGMNHRVEITEGILADECNALLCYFFRMPRQVFNAQKKA 360
Qy 361 QSSTDSGGSSGGSSGSETPGTSESATPESSGGSSGGSDKKYSIGLAIGTNSVGWAVITDE 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 QSSTDSGGSSGGSSGSETPGTSESATPESSGGSSGGSDKKYSIGLAIGTNSVGWAVITDE 420
Qy 421 YKVPSKKFKVLGNTDRHSIKKNLIGALLFDSGETAEATRLKRTARRRYTRRKNRICYLQE 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 YKVPSKKFKVLGNTDRHSIKKNLIGALLFDSGETAEATRLKRTARRRYTRRKNRICYLQE 480
Qy 481 IFSNEMAKVDDSFFHRLEESFLVEEDKKHERHPIFGNIVDEVAYHEKYPTIYHLRKKLVD 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 IFSNEMAKVDDSFFHRLEESFLVEEDKKHERHPIFGNIVDEVAYHEKYPTIYHLRKKLVD 540
Qy 541 STDKADLRLIYLALAHMIKFRGHFLIEGDLNPDNSDVDKLFIQLVQTYNQLFEENPINAS 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 STDKADLRLIYLALAHMIKFRGHFLIEGDLNPDNSDVDKLFIQLVQTYNQLFEENPINAS 600
Qy 601 GVDAKAILSARLSKSRRLENLIAQLPGEKKNGLFGNLIALSLGLTPNFKSNFDLAEDAKL 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 GVDAKAILSARLSKSRRLENLIAQLPGEKKNGLFGNLIALSLGLTPNFKSNFDLAEDAKL 660
Qy 661 QLSKDTYDDDLDNLLAQIGDQYADLFLAAKNLSDAILLSDILRVNTEITKAPLSASMIKR 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 QLSKDTYDDDLDNLLAQIGDQYADLFLAAKNLSDAILLSDILRVNTEITKAPLSASMIKR 720
Qy 721 YDEHHQDLTLLKALVRQQLPEKYKEIFFDQSKNGYAGYIDGGASQEEFYKFIKPILEKMD 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 YDEHHQDLTLLKALVRQQLPEKYKEIFFDQSKNGYAGYIDGGASQEEFYKFIKPILEKMD 780
Qy 781 GTEELLVKLNREDLLRKQRTFDNGSIPHQIHLGELHAILRRQEDFYPFLKDNREKIEKIL 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 GTEELLVKLNREDLLRKQRTFDNGSIPHQIHLGELHAILRRQEDFYPFLKDNREKIEKIL 840
Qy 841 TFRIPYYVGPLARGNSRFAWMTRKSEETITPWNFEEVVDKGASAQSFIERMTNFDKNLPN 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 TFRIPYYVGPLARGNSRFAWMTRKSEETITPWNFEEVVDKGASAQSFIERMTNFDKNLPN 900
Qy 901 EKVLPKHSLLYEYFTVYNELTKVKYVTEGMRKPAFLSGEQKKAIVDLLFKTNRKVTVKQL 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 EKVLPKHSLLYEYFTVYNELTKVKYVTEGMRKPAFLSGEQKKAIVDLLFKTNRKVTVKQL 960
Qy 961 KEDYFKKIECFDSVEISGVEDRFNASLGTYHDLLKIIKDKDFLDNEENEDILEDIVLTLT 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 KEDYFKKIECFDSVEISGVEDRFNASLGTYHDLLKIIKDKDFLDNEENEDILEDIVLTLT 1020
Qy 1021 LFEDREMIEERLKTYAHLFDDKVMKQLKRRRYTGWGRLSRKLINGIRDKQSGKTILDFLK 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 LFEDREMIEERLKTYAHLFDDKVMKQLKRRRYTGWGRLSRKLINGIRDKQSGKTILDFLK 1080
Qy 1081 SDGFANRNFMQLIHDDSLTFKEDIQKAQVSGQGDSLHEHIANLAGSPAIKKGILQTVKVV 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 SDGFANRNFMQLIHDDSLTFKEDIQKAQVSGQGDSLHEHIANLAGSPAIKKGILQTVKVV 1140
Qy 1141 DELVKVMGRHKPENIVIEMARENQTTQKGQKNSRERMKRIEEGIKELGSQILKEHPVENT 1200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 DELVKVMGRHKPENIVIEMARENQTTQKGQKNSRERMKRIEEGIKELGSQILKEHPVENT 1200
Qy 1201 QLQNEKLYLYYLQNGRDMYVDQELDINRLSDYDVDHIVPQSFLKDDSIDNKVLTRSDKNR 1260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1201 QLQNEKLYLYYLQNGRDMYVDQELDINRLSDYDVDHIVPQSFLKDDSIDNKVLTRSDKNR 1260
Qy 1261 GKSDNVPSEEVVKKMKNYWRQLLNAKLITQRKFDNLTKAERGGLSELDKAGFIKRQLVET 1320
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1261 GKSDNVPSEEVVKKMKNYWRQLLNAKLITQRKFDNLTKAERGGLSELDKAGFIKRQLVET 1320
Qy 1321 RQITKHVAQILDSRMNTKYDENDKLIREVKVITLKSKLVSDFRKDFQFYKVREINNYHHA 1380
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1321 RQITKHVAQILDSRMNTKYDENDKLIREVKVITLKSKLVSDFRKDFQFYKVREINNYHHA 1380
Qy 1381 HDAYLNAVVGTALIKKYPKLESEFVYGDYKVYDVRKMIAKSEQEIGKATAKYFFYSNIMN 1440
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1381 HDAYLNAVVGTALIKKYPKLESEFVYGDYKVYDVRKMIAKSEQEIGKATAKYFFYSNIMN 1440
Qy 1441 FFKTEITLANGEIRKRPLIETNGETGEIVWDKGRDFATVRKVLSMPQVNIVKKTEVQTGG 1500
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1441 FFKTEITLANGEIRKRPLIETNGETGEIVWDKGRDFATVRKVLSMPQVNIVKKTEVQTGG 1500
Qy 1501 FSKESILPKRNSDKLIARKKDWDPKKYGGFDSPTVAYSVLVVAKVEKGKSKKLKSVKELL 1560
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1501 FSKESILPKRNSDKLIARKKDWDPKKYGGFDSPTVAYSVLVVAKVEKGKSKKLKSVKELL 1560
Qy 1561 GITIMERSSFEKNPIDFLEAKGYKEVKKDLIIKLPKYSLFELENGRKRMLASAGELQKGN 1620
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1561 GITIMERSSFEKNPIDFLEAKGYKEVKKDLIIKLPKYSLFELENGRKRMLASAGELQKGN 1620
Qy 1621 ELALPSKYVNFLYLASHYEKLKGSPEDNEQKQLFVEQHKHYLDEIIEQISEFSKRVILAD 1680
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1621 ELALPSKYVNFLYLASHYEKLKGSPEDNEQKQLFVEQHKHYLDEIIEQISEFSKRVILAD 1680
Qy 1681 ANLDKVLSAYNKHRDKPIREQAENIIHLFTLTNLGAPAAFKYFDTTIDRKRYTSTKEVLD 1740
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1681 ANLDKVLSAYNKHRDKPIREQAENIIHLFTLTNLGAPAAFKYFDTTIDRKRYTSTKEVLD 1740
Qy 1741 ATLIHQSITGLYETRIDLSQLGGDSGGSPKKKRKV 1775
|||||||||||||||||||||||||||||||||||
Db 1741 ATLIHQSITGLYETRIDLSQLGGDSGGSPKKKRKV 1775
Appendix D
Instant application SEQ ID NO: 4 vs Zhang et al SEQ ID NO: 195 (STIC search result No. 1 .rag)
Query Match 100.0%; Score 7003; Length 1368;
Best Local Similarity 100.0%;
Matches 1368; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MDKKYSIGLAIGTNSVGWAVITDEYKVPSKKFKVLGNTDRHSIKKNLIGALLFDSGETAE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MDKKYSIGLAIGTNSVGWAVITDEYKVPSKKFKVLGNTDRHSIKKNLIGALLFDSGETAE 60
Qy 61 ATRLKRTARRRYTRRKNRICYLQEIFSNEMAKVDDSFFHRLEESFLVEEDKKHERHPIFG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ATRLKRTARRRYTRRKNRICYLQEIFSNEMAKVDDSFFHRLEESFLVEEDKKHERHPIFG 120
Qy 121 NIVDEVAYHEKYPTIYHLRKKLVDSTDKADLRLIYLALAHMIKFRGHFLIEGDLNPDNSD 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 NIVDEVAYHEKYPTIYHLRKKLVDSTDKADLRLIYLALAHMIKFRGHFLIEGDLNPDNSD 180
Qy 181 VDKLFIQLVQTYNQLFEENPINASGVDAKAILSARLSKSRRLENLIAQLPGEKKNGLFGN 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VDKLFIQLVQTYNQLFEENPINASGVDAKAILSARLSKSRRLENLIAQLPGEKKNGLFGN 240
Qy 241 LIALSLGLTPNFKSNFDLAEDAKLQLSKDTYDDDLDNLLAQIGDQYADLFLAAKNLSDAI 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 LIALSLGLTPNFKSNFDLAEDAKLQLSKDTYDDDLDNLLAQIGDQYADLFLAAKNLSDAI 300
Qy 301 LLSDILRVNTEITKAPLSASMIKRYDEHHQDLTLLKALVRQQLPEKYKEIFFDQSKNGYA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 LLSDILRVNTEITKAPLSASMIKRYDEHHQDLTLLKALVRQQLPEKYKEIFFDQSKNGYA 360
Qy 361 GYIDGGASQEEFYKFIKPILEKMDGTEELLVKLNREDLLRKQRTFDNGSIPHQIHLGELH 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 GYIDGGASQEEFYKFIKPILEKMDGTEELLVKLNREDLLRKQRTFDNGSIPHQIHLGELH 420
Qy 421 AILRRQEDFYPFLKDNREKIEKILTFRIPYYVGPLARGNSRFAWMTRKSEETITPWNFEE 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 AILRRQEDFYPFLKDNREKIEKILTFRIPYYVGPLARGNSRFAWMTRKSEETITPWNFEE 480
Qy 481 VVDKGASAQSFIERMTNFDKNLPNEKVLPKHSLLYEYFTVYNELTKVKYVTEGMRKPAFL 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 VVDKGASAQSFIERMTNFDKNLPNEKVLPKHSLLYEYFTVYNELTKVKYVTEGMRKPAFL 540
Qy 541 SGEQKKAIVDLLFKTNRKVTVKQLKEDYFKKIECFDSVEISGVEDRFNASLGTYHDLLKI 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 SGEQKKAIVDLLFKTNRKVTVKQLKEDYFKKIECFDSVEISGVEDRFNASLGTYHDLLKI 600
Qy 601 IKDKDFLDNEENEDILEDIVLTLTLFEDREMIEERLKTYAHLFDDKVMKQLKRRRYTGWG 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 IKDKDFLDNEENEDILEDIVLTLTLFEDREMIEERLKTYAHLFDDKVMKQLKRRRYTGWG 660
Qy 661 RLSRKLINGIRDKQSGKTILDFLKSDGFANRNFMQLIHDDSLTFKEDIQKAQVSGQGDSL 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 RLSRKLINGIRDKQSGKTILDFLKSDGFANRNFMQLIHDDSLTFKEDIQKAQVSGQGDSL 720
Qy 721 HEHIANLAGSPAIKKGILQTVKVVDELVKVMGRHKPENIVIEMARENQTTQKGQKNSRER 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 HEHIANLAGSPAIKKGILQTVKVVDELVKVMGRHKPENIVIEMARENQTTQKGQKNSRER 780
Qy 781 MKRIEEGIKELGSQILKEHPVENTQLQNEKLYLYYLQNGRDMYVDQELDINRLSDYDVDH 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 MKRIEEGIKELGSQILKEHPVENTQLQNEKLYLYYLQNGRDMYVDQELDINRLSDYDVDH 840
Qy 841 IVPQSFLKDDSIDNKVLTRSDKNRGKSDNVPSEEVVKKMKNYWRQLLNAKLITQRKFDNL 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 IVPQSFLKDDSIDNKVLTRSDKNRGKSDNVPSEEVVKKMKNYWRQLLNAKLITQRKFDNL 900
Qy 901 TKAERGGLSELDKAGFIKRQLVETRQITKHVAQILDSRMNTKYDENDKLIREVKVITLKS 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 TKAERGGLSELDKAGFIKRQLVETRQITKHVAQILDSRMNTKYDENDKLIREVKVITLKS 960
Qy 961 KLVSDFRKDFQFYKVREINNYHHAHDAYLNAVVGTALIKKYPKLESEFVYGDYKVYDVRK 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 KLVSDFRKDFQFYKVREINNYHHAHDAYLNAVVGTALIKKYPKLESEFVYGDYKVYDVRK 1020
Qy 1021 MIAKSEQEIGKATAKYFFYSNIMNFFKTEITLANGEIRKRPLIETNGETGEIVWDKGRDF 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 MIAKSEQEIGKATAKYFFYSNIMNFFKTEITLANGEIRKRPLIETNGETGEIVWDKGRDF 1080
Qy 1081 ATVRKVLSMPQVNIVKKTEVQTGGFSKESILPKRNSDKLIARKKDWDPKKYGGFDSPTVA 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 ATVRKVLSMPQVNIVKKTEVQTGGFSKESILPKRNSDKLIARKKDWDPKKYGGFDSPTVA 1140
Qy 1141 YSVLVVAKVEKGKSKKLKSVKELLGITIMERSSFEKNPIDFLEAKGYKEVKKDLIIKLPK 1200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 YSVLVVAKVEKGKSKKLKSVKELLGITIMERSSFEKNPIDFLEAKGYKEVKKDLIIKLPK 1200
Qy 1201 YSLFELENGRKRMLASAGELQKGNELALPSKYVNFLYLASHYEKLKGSPEDNEQKQLFVE 1260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1201 YSLFELENGRKRMLASAGELQKGNELALPSKYVNFLYLASHYEKLKGSPEDNEQKQLFVE 1260
Qy 1261 QHKHYLDEIIEQISEFSKRVILADANLDKVLSAYNKHRDKPIREQAENIIHLFTLTNLGA 1320
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1261 QHKHYLDEIIEQISEFSKRVILADANLDKVLSAYNKHRDKPIREQAENIIHLFTLTNLGA 1320
Qy 1321 PAAFKYFDTTIDRKRYTSTKEVLDATLIHQSITGLYETRIDLSQLGGD 1368
||||||||||||||||||||||||||||||||||||||||||||||||
Db 1321 PAAFKYFDTTIDRKRYTSTKEVLDATLIHQSITGLYETRIDLSQLGGD 1368
Appendix E
Instant Application SEQ ID NO: 20 vs Gao et al (SEQ ID NO: 15 STIC search result no. 1 .rag)
Query Match 100.0%; Score 418; Length 83;
Best Local Similarity 100.0%;
Matches 83; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TNLSDIIEKETGKQLVIQESILMLPEEVEEVIGNKPESDILVHTAYDESTDENVMLLTSD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 TNLSDIIEKETGKQLVIQESILMLPEEVEEVIGNKPESDILVHTAYDESTDENVMLLTSD 60
Qy 61 APEYKPWALVIQDSNGENKIKML 83
|||||||||||||||||||||||
Db 61 APEYKPWALVIQDSNGENKIKML 83
Appendix F
Instant Application SEQ ID NO: 27/4 vs US Patent Application No. 17603243 SEQ ID NO: 4 (ABSS Sequence Alignment)
PNG
media_image1.png
698
642
media_image1.png
Greyscale
PNG
media_image2.png
924
688
media_image2.png
Greyscale
PNG
media_image3.png
138
664
media_image3.png
Greyscale
Prosecution Insights