Notice of Pre-AIA or AIA Status
The present application, 18298882, (US PG-Pub 20240024515), filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-4, 6, 8-10, 12, 15-17, 19-23, 25, 27, 29 are pending.
Election/Restrictions
Applicant's election with traverse of the species elections, in the reply filed on 01/07/2026 is acknowledged. The traversal is on the ground(s) that all members of the Markush Groups are few or closely related such that a search and examination of the entire claim can be made without serious burden.
This is not found persuasive because the Markush group that was formerly present in claim 10 is now amended to not claim the claim 10 (ii)(a)-(ii)(h) and 16 (a)-(h) elements, in the alternative and so are not considered to be Markush Groups. Applicant’s amendment has rendered moot the requirement for election of species, mailed 10/07/2025. It is noted that the conjunction “or” is still found in claim 10 between claim section (i) and (ii), however both of these claim 10 sections have been examined.
Priority
The filing receipt, mailed 2/9/2024, states that this application, 18298882, was filed 4/11/2023, and claims foreign priority benefit of United Kingdom GB2205317.7, filed 4/11/2022 and United Kingdom GB2212566.0, filed 8/30/2022. Neither of these two certified foreign priority documents, United Kingdom GB2205317.7, filed 4/11/2022 and United Kingdom GB2212566.0, filed 8/30/2022, have been received.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/24/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
Required response – Applicant must provide:
The Specification at pp. 13-14, should provide a SEQ ID NO for the nucleotide sequences which are within the nucleotide/amino acid sequence rules, but not provided a sequence identifier.
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 22, as originally filed, in line 1, states: “between about 88 to about 1014.” However, this limitation does not appear to be found in the Specification, which should be amended to provide antecedent basis for the originally filed claim 22.
Claim Rejections - 35 USC § 112
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.
1. Claim 22 is 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.
Claim 22, lines 2-3, states the language: “the lentiviral vector is administered at a dose of between about 88 to about 1014 transducing units (TU), preferably a dose of between about 106 to about 1012 TU, . . . .” The Amendment to the Claims and Arguments, filed 1/7/2024, do not point, with particularity, when support for this new amendment is to be found. Furthermore, the newly added language is not indicated, such as by bracketing.
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.
2. Claims 6, 12, 17, 19, 22, 23, 25, 27, 29 are 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.
2a. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c)-(d). In the present instance, claims 6, for example, recites the broad recitation codon-optimised plasmids, and the claim also recites pGM691 which is a narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Description of examples and preference is properly set forth in the specification rather than in a single claim. If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim.
Claim 6 states the language “preferably” (line 2), “most preferably” (lines 3-4); Claim 12 states the language “preferably” (lines 2 and 4); Claim 17 states the language “preferably” at line 3; claim 22 states the language “preferably” at line 3; claim 23 states the language “preferably” at line 3; claim 25 states the language “preferably” at line 3; claim 29 states the language “preferably” at line 2.
2b. Claim 27 twice states the language “compared with treatment with the lentiviral vector alone.” This language is unclear and appears problematic in regards to antecedent basis. There is no definition as to what “lentiviral vector alone” encompasses, because it is uncertain as to how the “lentiviral vector alone” of the instant claim and the “lentiviral vector”, not alone, of claims differ. The intended result of claim 27 appears to be predicated on whether the patient to be treated has a class I CFTR mutation or a class II CFTR mutation, and not by a lentiviral vector in an undefined combination, compared to some other lentiviral vector, as seems to be implied in claim 27.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claim(s) 1-4, 12, 17, 19, 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alton, US 10,704,061, McCray, US 20230174600 A1.
Alton, US 10,704,061, throughout the patent, abstract, and claims, states: “This invention relates to lentiviral gene transfer vectors pseudotyped with hemagglutinin-neuraminidase (HN) and fusion (F) proteins from a respiratory paramyxovirus, comprising a promoter and a transgene; and methods of making the same. The present invention also relates to the use of said vectors in gene therapy, particularly for the treatment of respiratory tract diseases such as Cystic Fibrosis (CF)”; at reference claims 1, 4 and 11. A lentiviral vector pseudotyped with hemagglutinin-neuraminidase (HN) and fusion (F) proteins from a respiratory paramyxovirus, wherein said lentiviral vector comprises a hybrid human CMV enhancer/EF1a (hCEF) promoter and a transgene, and wherein the lentiviral vector lacks an intron positioned between said promoter and said transgene. Alton at claim 4, claims the vector comprising CFTR.
Alton, at reference claim 3, claims a SIV, as in instant claim 2; and at reference claim 4, claims a Sendai virus, (see, also col. 9, lines 63-67), as in instant claim 2 and at e.g., col. 10, lines 49-58, as in claim 3; at, e.g., col.s 11-12, lines 41-14, and reference claim 1 describes an hCEF promoter, as in instant claims 1 and 4. Alton, at e.g., para col. 6, lines 4-11 provide schedules for administration of lentiviral vector. Alton provide appropriate dosages of the lentiviral vectors of the invention, as in claim 22, and states at col 15, lines 34-42:
The lentiviral vectors of the invention may be administered in any dosage appropriate for achieving the desired therapeutic effect. Appropriate dosages may be determined by a clinician or other medical practitioner using standard techniques and within the normal course of their work. Non-limiting examples of suitable dosages include 1×10.sup.8 transduction units (TU), 1×10.sup.9 TU, 1×10.sup.10 TU, 1×10.sup.11 TU or more.
Alton at col 15, lines 34-42.
Alton does not teach or claim a CFTR modulator, as in claim 1.
McCray, 20230174600 teaches at para [0133], [0136], [0142], CFTR modulators , such as ivacaflor in combination with one or more additional therapeutic agents, including lentiviral vectors; at para [0168], describe pseudotyped lentiviral vectors. McCray at para [0135] teaches Cystic fibrosis and divided into classes based on mutation, such as Class I, Class II, Class III, Class IV and CV, reading on claims 19, 20. McCray, at e.g., para [0017]-[0018], [0043]; teaches administration of lentiviral vectors orally or by inhalation, reading on claim 21.
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have combined a CFTR modulator into a lentiviral vector pseudotyped with hemagglutinin-neuraminidase (HN) and fusion (F) proteins from a respiratory paramyxovirus, wherein said lentiviral vector comprises a cystic fibrosis transmembrane conductance regulator (CFTR) transgene.
One of ordinary skill in the art would have motivated to have combined a CFTR modulator pseudotyped lentiviral vector with fusion (F) proteins from a paramyxovirus comprising CFTR transgene with a CFTR modulator because both the vector and the CFTR modulator function to treat cystic fibrosis. Thus they are taught to be useful for the same purpose, in order to form a third composition to be used for the same purpose. See, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980); MPEP 2144.06.
2. Claim(s) 6, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alton, US 10,704,061, McCray, 20230174600 A1, as applied to claims 1-4, 12, 17, 20-22, above, and further in view of Gill, US 2022027382, (17681647 foreign priority document, GB 26 Feb 2021, Application number 2102832.9).
Alton, US 10,704,061, and McCray, 20230174600 A1, are relied upon above. However, Alton and McCray do not teach or suggest CF treatment methods comprising codon-optimized plasmids, as in claim 6; lentiviral vectors that are vGM058, vGM195, or vGM244, as in claim 7.
Gill, US 20220273821, (claiming benefit of foreign priority document, GB 26 Feb 2021, Application number 2102832.9, see e.g., p. 1), throughout the publication, abstract and, e.g., para [0208], teaches pseudotyped lentiviral vectors to respiratory-involved disease, as in instant claim 6. Gill states:
[0208] A modified pDNA2a plasmid was designed to (i) reduce the homology between the partial gagpol nucleotide sequence in pGM326 and the non-codon optimised gagpol sequence of pGM297; (ii) to codon-optimise the gagpol genes for increased gagpol protein expression; (iii) to reduce the theoretical risk of generating replication-competent lentivirus (RCL) during manufacture or clinical use; and (iv) to eliminate gagpol expression dependency on Rev. A comparison of pGM297 with the modified pDNA2a (pGM691) is shown in FIGS. 5B-5D, with the changes annotated.
Gill teaches lentivirus vector that is vGM195, as in instant claim 8, and states:
[0144] In a specific embodiment relating to CFTR, the five plasmids are characterised by FIGS. 2A-2F, thus pDNA1 is the pGM326 plasmid of FIG. 2A or the pGM830 plasmid of FIG. 2B, pDNA2a is the pGM691 plasmid of FIG. 2C, pDNA2b is the pGM299 plasmid of FIG. 2D, pDNA3a is the pGM301 plasmid of FIG. 2E and pDNA3b is the pGM303 plasmid of FIG. 2F, or variants thereof any of these plasmids (as described herein). In this embodiment, the final CFTR containing retroviral/lentiviral vector may be referred to as vGM195 (see the Examples). The pGM691 plasmid and the vGM195 vector are preferred embodiments of the invention.
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have combined CF treatment methods comprising codon-optimized plasmids, as in claim 6; lentiviral vectors that are vGM058, vGM195, or vGM244, as in claim 7 a lentiviral vector pseudotyped with hemagglutinin-neuraminidase (HN) and fusion (F) proteins from a respiratory paramyxovirus, wherein said lentiviral vector comprises a cystic fibrosis transmembrane conductance regulator (CFTR) transgene.
One of ordinary skill in the art would have motivated to have combined methods comprising codon-optimized plasmids, as in claim 6; lentiviral vectors that are vGM058, vGM195, or vGM244, as in claim 7, because Gill teaches codon-optimised gagpol genes for increased gagpol protein expression and to reduce the theoretical risk of generating replication-competent lentivirus (RCL) during manufacture or clinical use and so are preferred.
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 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,704,061 in view of McCray, 20230174600 A1.
1. Claim(s) 1-4, 12, 17, 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alton, US 10,704,061, McCray, US 20230174600 A1.
Alton, US 10,704,061, throughout the patent, abstract, and claims, states: “This invention relates to lentiviral gene transfer vectors pseudotyped with hemagglutinin-neuraminidase (HN) and fusion (F) proteins from a respiratory paramyxovirus, comprising a promoter and a transgene; and methods of making the same. The present invention also relates to the use of said vectors in gene therapy, particularly for the treatment of respiratory tract diseases such as Cystic Fibrosis (CF)”; at reference claims 1, 4 and 11. A lentiviral vector pseudotyped with hemagglutinin-neuraminidase (HN) and fusion (F) proteins from a respiratory paramyxovirus, wherein said lentiviral vector comprises a hybrid human CMV enhancer/EF1a (hCEF) promoter and a transgene, and wherein the lentiviral vector lacks an intron positioned between said promoter and said transgene. Alton at claim 4, claims the vector comprising CFTR.
Alton, at reference claim 3, claims a SIV, as in instant claim 2; and at reference claim 4, claims a Sendai virus, (see, also col. 9, lines 63-67), as in instant claim 2 and at e.g., col. 10, lines 49-58, as in claim 3; at, e.g., col.s 11-12, lines 41-14, and reference claim 1 describes an hCEF promoter, as in instant claims 1 and 4. Alton, at e.g., para col. 6, lines 4-11 provide schedules for administration of lentiviral vector. Alton provide appropriate dosages of the lentiviral vectors of the invention, as in claim 22, and states at col 15, lines 34-42:
The lentiviral vectors of the invention may be administered in any dosage appropriate for achieving the desired therapeutic effect. Appropriate dosages may be determined by a clinician or other medical practitioner using standard techniques and within the normal course of their work. Non-limiting examples of suitable dosages include 1×10.sup.8 transduction units (TU), 1×10.sup.9 TU, 1×10.sup.10 TU, 1×10.sup.11 TU or more.
Alton at col 15, lines 34-42.
Alton does not teach or claim a CFTR modulator, as in claim 1.
McCray, 20230174600 teaches at para [0133], [0136], [0142], CFTR modulators , such as ivacaflor in combination with one or more additional therapeutic agents, including lentiviral vectors; at para [0168], describe pseudotyped lentiviral vectors. McCray at para [0135] teaches Cystic fibrosis and divided into classes based on mutation, such as Class I, Class II, Class III, Class IV and CV, reading on claims 19, 20. McCray, at e.g., para [0017]-[0018], [0043]; teaches administration of lentiviral vectors orally or by inhalation, reading on claim 21.
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have combined a CFTR modulator into a lentiviral vector pseudotyped with hemagglutinin-neuraminidase (HN) and fusion (F) proteins from a respiratory paramyxovirus, wherein said lentiviral vector comprises a cystic fibrosis transmembrane conductance regulator (CFTR) transgene.
One of ordinary skill in the art would have motivated to have combined a CFTR modulator pseudotyped lentiviral vector with fusion (F) proteins from a paramyxovirus comprising CFTR transgene with a CFTR modulator because both the vector and the CFTR modulator function to treat cystic fibrosis. Thus they are taught to be useful for the same purpose, in order to form a third composition to be used for the same purpose. See, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980); MPEP 2144.06.
Allowable Subject Matter
1. Claims 9, 10, 15 and 16 appear to be free of the prior art. The examined prior art does not teach or fairly suggest a nucleic acid sequence of SEQ ID NO: 16, as in claim 9. The examined prior art does not appear to teach or fairly suggest a method for treating CF with a vector that has each of SEQ ID NO: 19, 23-30.
2. Claims 9, 10 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
1. The prior art made of record and not relied upon is related to applicant's disclosure. Doudna, WO2020102709; and Yoshida, 2018, Vol. 92, Issue 5, e02094-17, pages 1 to 22, Haynes, WO2011056899 and Shibata R., J. Virol. 64:307-312(1990).
2. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark L Shibuya whose telephone number is (571)272-0806. The examiner can normally be reached M-F, 9AM-4:30PM.
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, James (Doug) Schultz, can be reached at (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MARK L. SHIBUYA
Primary Patent Examiner
Art Unit 1631
/MARK L SHIBUYA/Primary Patent Examiner, Art Unit 1631