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
Status of the Claims
1. Claims 1-17 are the original claims filed on 9/7/2023. Claims 1-17 are the pending claims.
Priority
2. USAN 18/463,194, filed 09/07/2023, is a Divisional of 17/172,790, filed 02/10/2021, now abandoned, 17/172,790, is a Divisional of 16/098,479, filed 11/02/2018, now U.S. Patent # 10954302, 16/098,479, is a National Stage entry of PCT/US2017/031791, International Filing Date: 05/09/2017, PCT/US2017/ 031791 Claims Priority from Provisional Application 62/333,643, filed 05/09/2016. The priority filing date of 05/09/2016 is granted for this application.
Information Disclosure Statement
3. As of 2/26/2026, a total of four (4) IDS are filed: 9/7/2023; 9/7/2023; 5/22/2024; and 9/24/2024. The corresponding initialed and dated 1449 form is considered and of record.
Objections
Specification
4. The disclosure is objected to because of the following informalities:
a) The use of the term, i.e., Tris, Xenomouse, UniProt, MiSeq, CellTiter-Glo, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
b) The specification contains a typographical error for OptEIA and CellTiter-Glo.
Appropriate correction is required.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
5. Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10954302.
In the restriction/election of species of 5/29/2020 for parent U.S. Patent No. 10954302 (USAN 16/098,479), Group I is drawn to both an antibody and a nucleotide encoding the antibody thereof.
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The instant claims fall 1-9 fall under original Group I and the reference patent is not afforded safe harbor protection under 35 USC 121. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim sets are drawn to a nucleic acid/ polynucleotide encoding the anti-PDL-1 antibody comprising the VH/VL CDR1-3.
As regards claim 1, the reference claims are as follows:
Ref 19. A polynucleotide encoding a heavy chain or a light chain of the antibody or antigen-binding fragment of claim 1.
Ref 1. An isolated anti-PD-L1 antibody, or an antigen-binding fragment thereof, comprising a heavy chain variable region (VH) and a light chain variable region (VL), wherein the antibody or antigen-binding fragment thereof comprises: (i) an HVR-H1 comprising the sequence of GFSLTSYDIS (SEQ ID NO: 4); (ii) an HVR-H2 comprising the sequence of VIWTGVGTN (SEQ ID NO: 5); and (iii) an HVR-H3 comprising the sequence of DPYYYGMDY (SEQ ID NO: 6); (iv) an HVR-L1 comprising the sequence of RASQDISIWLS (SEQ ID NO: 1); (v) an HVR-L2 comprising the sequence of KASNLHT (SEQ ID NO: 2); and (vi) an HVR-L3 comprising the sequence of LQSQSFPRT (SEQ ID NO: 3); and wherein the anti-PD-L1 antibody is capable of binding to human and cynomolgus monkey PD-L1.
As regards claims 2-5, the reference claims are as follows:
Ref 2. The anti-PD-L1 antibody or an antigen-binding fragment thereof of claim 1, comprising a VH having at least 90% sequence identity to SEQ ID NO: 45 and a VL having at least 90% sequence identity to SEQ ID NO: 46.
Ref 16. The antibody or antigen-binding fragment thereof of claim 1, wherein the VH comprises the amino acid sequence SEQ ID NO: 45 and the VL comprises the amino acid sequence SEQ ID NO: 46.
Ref 17. The antibody or antigen-binding fragment thereof of claim 1, wherein the VH comprises the amino acid sequence SEQ ID NO: 37 and the VL comprises the amino acid sequence SEQ ID NO: 44.
AS regards claims 6-8, the reference claims are as follows:
Ref 10. The antibody or antigen-binding fragment of claim 1, wherein the antibody is an IgG, IgM, IgA, IgD, or IgE isotype.
Ref 11. The antibody or antigen-binding fragment of claim 10, wherein the antibody is an IgM isotype.
None of the original patent ref claims are drawn to a vector, host cell or methods of producing the antibody of instant claims 9-30 and all of which find original written description support in US Provisional 62/333,643. However, all of instant claims 9-30 comprise a polynucleotide encoding the anti-PD-L1 antibody and ref patent claims are thus overlapping with the instant claims.
As regards claim 9, a vector is construed as polynucleotide under ref claims 1 and 19.
AS regards claim 10, a host cell comprising a polynucleotide is construed as polynucleotide under ref claims 1 and 19.
As regards claims 11-30, a method for producing the anti-PD-L1 antibody comprising a polynucleotide via a host cell is construed under ref claims 2-17:
Ref 2. The anti-PD-L1 antibody or an antigen-binding fragment thereof of claim 1, comprising a VH having at least 90% sequence identity to SEQ ID NO: 45 and a VL having at least 90% sequence identity to SEQ ID NO: 46.
Ref 3. The antibody or antigen-binding fragment according to claim 1, which is a chimeric antibody or a humanized antibody.
Ref 4. The anti-PD-L1 antibody or antigen-binding fragment thereof of claim 1, comprising a VH having at least 90% sequence identity to the sequence of any one of SEQ ID NOS: 36, 37, 38, 39, 40, 41 or 42 and a VL having at least 90% sequence identity to any one of SEQ ID NOS: 43 or 44.
Ref 5. The antibody or antigen-binding fragment thereof of claim 4, wherein the VH comprises the sequence of SEQ ID NO: 36, 37, 38, 39, 40, 41 or 42 and the VL comprises SEQ ID NO: 43 or 44.
Ref 6. The antibody or antigen-binding fragment of claim 1, which is bispecific.
Ref 7. The antibody or antigen-binding fragment of claim 6, wherein the bispecific antibody or antigen-binding fragment binds to a PD-L1 protein and a cell surface protein.
Ref 8. The antibody or antigen-binding fragment of claim 7, wherein the cell surface protein is selected from the group consisting of: CD20, EGFR, HER2, CTLA-4, TIM3, LAG3, VISTA and TIGIT.
Ref 9. The antibody or antigen-binding fragment of claim 1, wherein the antigen-binding fragment is selected from the group consisting of: Fab, Fab′, F(ab).sub.2, F(ab′).sub.2, Fv, and scFv.
Ref 10. The antibody or antigen-binding fragment of claim 1, wherein the antibody is an IgG, IgM, IgA, IgD, or IgE isotype.
Ref 11. The antibody or antigen-binding fragment of claim 10, wherein the antibody is an IgM isotype.
Ref 12. The antibody or antigen-binding fragment of claim 11, wherein the antibody comprises a J-chain.
Ref 13. The antibody or antigen-binding fragment of claim 12, wherein the J-chain is a modified J-chain comprising an extraneous binding moiety.
Ref 14. The antibody or antigen-binding fragment according to claim 10, wherein the antibody is an IgA isotype, wherein the antibody is a subclass selected from the group consisting of: IgA1 and IgA2, and wherein the antibody comprises a J-chain.
Ref 15. The antibody or antigen-binding fragment of claim 1, which is a PD-L1 antagonist.
Ref 16. The antibody or antigen-binding fragment thereof of claim 1, wherein the VH comprises the amino acid sequence SEQ ID NO: 45 and the VL comprises the amino acid sequence SEQ ID NO: 46.
Ref 17. The antibody or antigen-binding fragment thereof of claim 1, wherein the VH comprises the amino acid sequence SEQ ID NO: 37 and the VL comprises the amino acid sequence SEQ ID NO: 44.
Conclusion
6. No claims are allowed.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643