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 .
1. Claims 2-25 as filed on November 27, 2024 are pending and under consideration.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
2. 37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete for the Sequence Listing filed 11/27/2024.
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, 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.
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.
3. Claims 2-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,970,546 B2 (Rabuka et al. Apr. 30, 2024) in view of US 2020/0239594 A1 (Bamdad et al. July, 30, 2020, IDS), “Bamdad”.
The ‘546 claims are drawn to:
1. An antibody or fragment thereof that specifically binds to Mucin-1 (MUC-1), wherein the antibody or fragment thereof comprises: a heavy chain complementarity determining region 1 (HCDR1), a heavy chain complementarity determining region 2 (HCDR2), and a heavy chain complementarity determining region 3 (HCDR3) as set forth in a variable heavy (VH) chain comprising the amino acid sequence of SEQ ID NO: 1; and a light chain complementarity determining region 1 (LCDR1), a light chain complementarity determining region 2 (LCDR2), and a light chain complementarity determining region 3 (LCDR3) as set forth in a variable light (VL) chain comprising the amino acid sequence of any one of SEQ ID NOs: 2, 3, or 4.
2. The antibody or fragment thereof according to claim 1, comprising: a VH chain comprising: an HCDR1 comprising the amino acid sequence DHTMEI (SEQ ID NO: 17); an HCDR2 comprising the amino acid sequence YFYPRDDSTNYNEKFKG (SEQ ID NO: 18); and an HCDR3 comprising the amino acid sequence GLRYALDY (SEQ ID NO: 9); and a VL chain comprising: a) an LCDR1 comprising the amino acid sequence RASSSVSSSYLY (SEQ ID NO: 10), an LCDR2 comprising the amino acid sequence GTSNLAS (SEQ ID NO: 11), and an LCDR3 comprising the amino acid sequence HQYAWSPPT (SEQ ID NO: 12); or b) an LCDR1 comprising the amino acid sequence RASSSVGSSNLY (SEQ ID NO: 13), an LCDR2 comprising the amino acid sequence RSTKLAS (SEQ ID NO: 14), and an LCDR3 comprising the amino acid sequence HQYRWSPPT (SEQ ID NO: 15; or c) an LCDR1 comprising the amino acid sequence RASSSVSSSYLY (SEQ ID NO: 10), an LCDR2 comprising the amino acid sequence GTSNLAS (SEQ ID NO: 11), and an LCDR3 comprising the amino acid sequence HQYSWSPPT (SEQ ID NO: 16).
3. The antibody or fragment thereof according to claim 1, wherein the VH chain comprises an amino acid sequence having at least 80% identity to the amino acid sequence set forth in SEQ ID NO: 1.
4. The antibody or fragment thereof according to claim 3, wherein the VL chain comprises an amino acid sequence having at least 80% identity to the amino acid sequence set forth in any one of SEQ ID NO: 2, 3, or 4.
5. The antibody or fragment thereof according to claim 1, comprising: (i) an HCDR1 comprising the amino acid sequence DHTMH (SEQ ID NO: 17), an HCDR2 comprising the amino acid sequence YFYPRDDSTNYNEKFKG (SEQ ID NO: 18), an HCDR3 comprising the amino acid sequence GLRYALDY (SEQ ID NO: 9), an LCDR1 comprising the amino acid sequence RASSSVSSSYLY (SEQ ID NO: 10), an LCDR2 comprising the amino acid sequence GTSNLAS (SEQ ID NO: 11), and an LCDR3 comprising the amino acid sequence HQYAWSPPT (SEQ ID NO: 12), as per Kabat definition; or (ii) an HCDR1 comprising the amino acid sequence GYTFTDH (SEQ ID NO: 7), an HCDR2 comprising the amino acid sequence YPRDDS (SEQ ID NO: 8), an HCDR3 comprising the amino acid sequence GLRYALDY (SEQ ID NO: 9), an LCDR1 comprising the amino acid sequence RASSSVSSSYLY (SEQ ID NO: 10), an LCDR2 comprising the amino acid sequence GTSNLAS (SEQ ID NO: 11), and an LCDR3 comprising the amino acid sequence HQYAWSPPT (SEQ ID NO: 12), as per Chothia definition; or (iii) an HCDR1 comprising the amino acid sequence GYTFTDHT (SEQ ID NO: 34), an HCDR2 comprising the amino acid sequence FYPRDDST (SEQ ID NO: 44), an HCDR3 comprising the amino acid sequence ARGLRYALDY (SEQ ID NO: 45), an LCDR1 comprising the amino acid sequence SSVSSSY (SEQ ID NO: 33), an LCDR2 comprising the amino acid sequence GT, and an LCDR3 comprising the amino acid sequence HQYAWSPPT (SEQ ID NO: 12), as per IMGT definition.
6. The antibody or fragment thereof according to claim 1, comprising: (i) an HCDR1 comprising the amino acid sequence DHTMH (SEQ ID NO: 17), an HCDR2 comprising the amino acid sequence YFYPRDDSTNYNEKFKG (SEQ ID NO: 18), an HCDR3 comprising the amino acid sequence GLRYALDY (SEQ ID NO: 9), an LCDR1 comprising the amino acid sequence RASSSVGSSNLY (SEQ ID NO: 13), an LCDR2 comprising the amino acid sequence RSTKLAS (SEQ ID NO: 14), and an LCDR3 comprising the amino acid sequence HQYRWSPPT (SEQ ID NO: 15), as per Kabat definition, or (ii) an HCDR1 comprising the amino acid sequence GYTFTDH (SEQ ID NO: 7), an HCDR2 comprising the amino acid sequence YPRDDS (SEQ ID NO: 8), an HCDR3 comprising the amino acid sequence GLRYALDY (SEQ ID NO: 9), an LCDR1 comprising the amino acid sequence RASSSVGSSNLY (SEQ ID NO: 13), an LCDR2 comprising the amino acid sequence RSTKLAS (SEQ ID NO: 14), and an LCDR3 comprising the amino acid sequence HQYRWSPPT (SEQ ID NO: 15), as per Chothia definition; or (iii) an HCDR1 comprising the amino acid sequence GYTFTDHT (SEQ ID NO: 34), an HCDR2 comprising the amino acid sequence FYPRDDST (SEQ ID NO: 44), an HCDR3 comprising the amino acid sequence ARGLRYALDY (SEQ ID NO: 45), an LCDR1 comprising the amino acid sequence SSVGSSN (SEQ ID NO: 46), an LCDR2 comprising the amino acid sequence RS, and an LCDR3 comprising the amino acid sequence HQYRWSPPT (SEQ ID NO: 15), as per IMGT definition.
7. The antibody or fragment thereof according to claim 1, comprising: (i) an HCDR1 comprising the amino acid sequence DHTMH (SEQ ID NO: 17), an HCDR2 comprising the amino acid sequence YFYPRDDSTNYNEKFKG (SEQ ID NO: 18); an HCDR3 comprising the amino acid sequence GLRYALDY (SEQ ID NO: 9), an LCDR1 comprising the amino acid sequence RASSSVSSSYLY (SEQ ID NO: 10), an LCDR2 comprising the amino acid sequence GTSNLAS (SEQ ID NO: 11), and an LCDR3 comprising the amino acid sequence HQYSWSPPT (SEQ ID NO: 16), as per Kabat definition or (ii) an HCDR1 comprising the amino acid sequence GYTFTDH (SEQ ID NO: 7), an HCDR2 comprising the amino acid sequence YPRDDS (SEQ ID NO: 8), an HCDR3 comprising the amino acid sequence GLRYALDY (SEQ ID NO: 9), an LCDR1 comprising the amino acid sequence RASSSVSSSYLY (SEQ ID NO: 10), an LCDR2 comprising the amino acid sequence GTSNLAS (SEQ ID NO: 11), and an LCDR3 comprising the amino acid sequence HQYSWSPPT (SEQ ID NO: 16), as per Chothia definition; or (iii) an HCDR1 comprising the amino acid sequence GYTFTDHT (SEQ ID NO: 34), an HCDR2 comprising the amino acid sequence FYPRDDST (SEQ ID NO: 44), an HCDR3 comprising the amino acid sequence ARGLRYALDY (SEQ ID NO: 45), an LCDR1 comprising the amino acid sequence SSVSSSY (SEQ ID NO: 33), an LCDR2 comprising the amino acid sequence GT, and an LCDR3 comprising the amino acid sequence HQYSWSPPT (SEQ ID NO: 16), as per IMGT definition.
8. The antibody or fragment thereof according to claim 1, wherein the antibody is a humanized antibody or a chimeric antibody.
9. The antibody or fragment thereof according to claim 1, wherein the antibody or fragment thereof is selected from the group consisting of: an IgG, Fv, single chain antibody, scFv, Fab, F(ab′)2, or Fab′.
10. The antibody or fragment thereof according to claim 9, wherein the antibody is an IgG1 or a bispecific antibody.
11. The antibody or fragment thereof according to claim 1, wherein the antibody or fragment thereof is detectably labeled.
12. The antibody or fragment thereof according to claim 1, wherein the antibody or fragment thereof comprises a covalently linked lipid or fatty acid moiety.
13. The antibody or fragment thereof according to claim 1, wherein the antibody or fragment thereof is linked to a contrast agent.
14. The antibody or fragment thereof according to claim 1, wherein the antibody or fragment thereof is immobilized on a solid support.
15. The antibody or fragment thereof according to claim 1, wherein the antibody or fragment thereof comprises a constant region comprising an amino acid sequence of a sulfatase motif.
16. The antibody or fragment thereof according to claim 1, wherein the antibody or fragment thereof comprises a constant region comprising an amino acid sequence of a sulfatase motif, and wherein the sulfatase motif is modified to comprise a 2-formylglycine (fGly) moiety.
17. A pharmaceutical composition comprising: a. the antibody or fragment thereof according to claim 1; and b. a pharmaceutically acceptable carrier.
18. The pharmaceutical composition of claim 17, further comprising a T cell activator.
19. The pharmaceutical composition of claim 18, wherein the T cell activator is selected from the group consisting of: an immune checkpoint inhibitor, a cytokine, and an antagonist of an inhibitory immune receptor.
20. The pharmaceutical composition of claim 17, wherein the antibody or fragment thereof is encapsulated in a liposome.
21. The antibody or fragment thereof according to claim 1, wherein the VH chain comprises the amino acid sequence as set forth in SEQ ID NO: 1, and wherein the VL chain comprises the amino acid sequence as set forth in any one of SEQ ID NO: 2, SEQ ID NO: 3, or SEQ ID NO: 4.
22. The antibody or fragment thereof according to claim 21, wherein the antibody or fragment thereof comprises a constant region comprising an amino acid sequence of a sulfatase motif.
23. The antibody or fragment thereof according to claim 22, wherein the sulfatase motif is modified to comprise a 2-formylglycine (fGly) moiety.
The amino acid sequence of a sulfatase motif heterologous amino sequence fused to the antibody.
The ‘546 claims do not teach nucleic acid encoding the antibodies or cells comprising the nucleic acids.
Bamdad teaches making antibodies to MUC1* and nucleic acids encoding the antibodies. See abstract and ¶¶ 0008-0026.
Bamdad teaches once a monoclonal or single species of antibody has been identified, one can determine the sequence of the antibody or its variable regions. This enables many forms of protein engineering and recombinant DNA technology which can be used for example to make antibody derivatives, including but not limited to single chain, bispecific, diabodies, and antibody-chemical fusions or antibody-protein fusions. The antibody sequences can be used to make an unlimited supply of a reproducible, single species antibody. See ¶¶ 0007, 0409, 0410, and 0429.
Bamdad teaches production of antibodies and antibody variants can be carried out in a wide variety of cells from different organisms. Vectors and cells available for antibody synthesis are numerous and well known to those skilled in the art. See ¶¶ 0433.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of the ‘546 claims and Bamdad identify and make the nucleic acids encoding the antibodies of the ‘546 claims because Bamdad teaches once a monoclonal or single species of antibody has been identified one can determine the sequence of the antibody or its variable regions for genetic engineering and antibody production. Thus, one would have been motivated to identify and make the nucleic acids encoding the antibodies of the ‘546 claims to make recombinant forms of the antibodies and to produce the antibody for use from cells expressing the nucleic acids.
4. Claims 2-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-62 of co-pending Application No. 18/291,500 (US 2025/0152724 A1) in view of US 2020/0239594 A1 (Bamdad et al. July, 30, 2020, IDS), “Bamdad”.
This is a provisional nonstatutory double patenting rejection.
The ‘500 claims teach:
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and W2 is an anti-MUC1 antibody.
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45. The conjugate of claim 1, wherein the fGly′ residue is positioned in a heavy chain CH.sub.3 region of the anti-MUC1 antibody.
46. The conjugate of claim 1, wherein the anti-MUC1 antibody competes for binding to MUC1 with an anti-MUC1 antibody comprising: a variable heavy chain (VH) chain comprising heavy chain CDRs1-3 (HCDRs1-3) of a VH chain having the sequence: EVQLVQSGAEVKKPGATVKISCKVSGYTFTDHTMHWIKQRPGKGLEWMGYFYPRDDSTN YNEKFKGRVTLTADKSTDTAYMELSSLRSEDTAVYYCARGLRYALDYWGQGTLVTVSS (SEQ ID NO:1); and a variable light chain (VL) chain comprising light chain CDRs1-3 (LCDRs1-3) of a VL chain having the sequence: TABLE-US-00017 (SEQ ID NO: 2) EIVLTQSPATLSLSPGERATLSCRASSSVSSSYLYWYQQKPGQAPRLWI YGTSNLASGVPARFSGSGSGTDYTLTISSLEPEDAAVYYCHQYAWSPPT FGQGTKLEIK; (SEQ ID NO: 3) EIVLTQSPATLSLSPGERATLSCRASSSVGSSNLYWYQQKPGQAPRLWI YRSTKLASGVPARFSGSGSGTDYTLTISSLEPEDAAVYYCHQYRWSPPT FGQGTKLEIK; or (SEQ ID NO: 4) EIVLTQSPATLSLSPGERATLSCRASSSVSSSYLYWYQQKPGQAPRLWI IGTSNLASGVPARFSGSGSGTDYTLTISSLEPEDAAVYYCHQYSWSPPT FGQGTKLEIK.
47. The conjugate of claim 1, wherein the anti-MUC1 antibody comprises: a variable heavy chain (VH) chain comprising heavy chain CDRs1-3 (HCDRs1-3) of a VH chain having the sequence: EVQLVQSGAEVKKPGATVKISCKVSGYTFTDHTMHWIKQRPGKGLEWMGYFYPRDDSTN YNEKFKGRVTLTADKSTDTAYMELSSLRSEDTAVYYCARGLRYALDYWGQGTLVTVSS (SEQ ID NO:1); and a variable light chain (VL) chain comprising light chain CDRs1-3 (LCDRs1-3) of a VL chain having the sequence: (SEQ ID NO: 2) EIVLTQSPATLSLSPGERATLSCRASSSVSSSYLYWYQQKPGQAPRLWI YGTSNLASGVPARFSGSGSGTDYTLTISSLEPEDAAVYYCHQYAWSPPT FGQGTKLEIK; (SEQ ID NO: 3) EIVLTQSPATLSLSPGERATLSCRASSSVGSSNLYWYQQKPGQAPRLWI YRSTKLASGVPARFSGSGSGTDYTLTISSLEPEDAAVYYCHQYRWSPPT FGQGTKLEIK; or (SEQ ID NO:4) EIVLTQSPATLSLSPGERATLSCRASSSVSSSYLYWYQQKPGQAPRLWI IGTSNLASGVPARFSGSGSGTDYTLTISSLEPEDAAVYYCHQYSWSPPT FGQGTKLEIK.
48. The conjugate of claim 1, wherein the VH polypeptide comprises an amino acid sequence having at least 80% identity to the amino acid sequence set forth in SEQ ID NO:1.
49. The conjugate of claim 46, wherein the VL polypeptide comprises an amino acid sequence having at least 80% identity to the amino acid sequence set forth in SEQ ID NO:2, 3, or 4.
50. The conjugate of claim 46, wherein: the HCDR1 comprises the amino acid sequence DHTMH (SEQ ID NO:17); the HCDR2 comprises the amino acid sequence YFYPRDDSTNYNEKFKG (SEQ ID NO:18); the HCDR3 comprises the amino acid sequence GLRYALDY (SEQ ID NO:9); the LCDR1 comprises the amino acid sequence RASSSVSSSYLY (SEQ ID NO:10); the LCDR2 comprises the amino acid sequence GTSNLAS (SEQ ID NO:11); and the LCDR3 comprises the amino acid sequence HQYAWSPPT (SEQ ID NO:12), as per Kabat definition.
51. The conjugate of claim 46, wherein: the HCDR1 comprises the amino acid sequence DHTMH (SEQ ID NO:17); the HCDR2 comprises the amino acid sequence YFYPRDDSTNYNEKFKG (SEQ ID NO:18); the HCDR3 comprises the amino acid sequence GLRYALDY (SEQ ID NO:9); the LCDR1 comprises the amino acid sequence RASSSVGSSNLY (SEQ ID NO:13); the LCDR2 comprises the amino acid sequence RSTKLAS (SEQ ID NO:14); and the LCDR3 comprises the amino acid sequence HQYRWSPPT (SEQ ID NO:15), as per Kabat definition.
52. The conjugate of claim 46, wherein: the HCDR1 comprises the amino acid sequence DHTMH (SEQ ID NO:17); the HCDR2 comprises the amino acid sequence YFYPRDDSTNYNEKFKG (SEQ ID NO:18); the HCDR3 comprises the amino acid sequence GLRYALDY (SEQ ID NO:9); the LCDR1 comprises the amino acid sequence RASSSVSSSYLY (SEQ ID NO:10); the LCDR2 comprises the amino acid sequence GTSNLAS (SEQ ID NO:11); and the LCDR3 comprises the amino acid sequence HQYSWSPPT (SEQ ID NO:16), as per Kabat definition.
The ‘500 claims do not teach nucleic acid encoding the antibodies or cells comprising the nucleic acids.
Bamdad teaches making antibodies to MUC1* and nucleic acids encoding the antibodies. See abstract and ¶¶ 0008-0026.
Bamdad teaches once a monoclonal or single species of antibody has been identified, one can determine the sequence of the antibody or its variable regions. This enables many forms of protein engineering and recombinant DNA technology which can be used for example to make antibody derivatives, including but not limited to single chain, bispecific, diabodies, and antibody-chemical fusions or antibody-protein fusions. The antibody sequences can be used to make an unlimited supply of a reproducible, single species antibody. See ¶¶ 0007, 0409, 0410, and 0429.
Bamdad teaches production of antibodies and antibody variants can be carried out in a wide variety of cells from different organisms. Vectors and cells available for antibody synthesis are numerous and well known to those skilled in the art. See ¶¶ 0433.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of the ‘500 claims and Bamdad identify and make the nucleic acids encoding the antibodies of the ‘500 claims because Bamdad teaches once a monoclonal or single species of antibody has been identified one can determine the sequence of the antibody or its variable regions for genetic engineering and antibody production. Thus, one would have been motivated to identify and make the nucleic acids encoding the antibodies of the ‘500 claims to make recombinant forms of the antibodies and to produce the antibody for use from cells expressing the nucleic acids.
Conclusion
5. No claims allowed.
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached M-F 8:30-5:30 Eastern Time.
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/PETER J REDDIG/Primary Examiner, Art Unit 1646
