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 .
Claims 17-18 have been cancelled.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-13, and the antibody species of claim 1, part (i), in the reply filed on 7/7/2026 is acknowledged.
Claims 14-16 and 19-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/7/2026.
Upon further consideration, the antibody species election has been withdrawn.
Specification
The substitute specification filed 3/4/2025 has been entered. However, applicant is requested to verify the size of the XML file as being 142 bytes in size. This appears to be an error. Applicant is reminded that there is a distinction between a byte and a kilobyte. One kilobyte is 1024 bytes. The size of the file must be in bytes.
Drawings
The replacement drawings for Figures 4A and 6 were received on 3/4/2024. These drawings is acceptable.
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.
Claims 1-2, 7-9, and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berne et al. (U.S. Patent Application Publication 2016/0108131, of record).
Berne et al. discloses MAb2 which binds to the A3-B3 domain of human and Macaca fascicularis CEACAM5 protein. See at least paragraphs [0070 and 0078]. It does not cross react with other CEACAM family members. See at least paragraph [0079]. MAb2 binds to the epitope of amino acids 109-115 (SEQ ID NO: 76) and amino acids 131-143 (SEQ ID NO: 77) of human CEACAM5. SEQ ID NO: 76 corresponds to amino acids 607-613 of instant SEQ ID NO: 52 and SEQ ID NO: 77 corresponds to amino acids 629-641 of instant SEQ ID NO: ID 52. MAb2 of Berne et al. meets the limitations of instant claims 1-2. The antibody can be conjugated to a cytotoxic agent (i.e. a toxin) and pharmaceutical compositions are disclosed. The antibodies can be monoclonal. Antigen binding fragments such as Fab and scFv fragments are disclosed. See at least abstract and paragraphs [0003, 0035, and 0327]. See instant claims 7 and 12-13. Glycosylation sites can be removed which would reduce glycosylation. See at least paragraph [0139]. See instant claim 9. IgG1 isoforms are disclosed. See at least paragraph [0230]. See instant claim 11. Modification of effector functions such as ADCC is disclosed. See at least paragraph [0249]. See instant claim 8.
Claim Rejections - 35 USC § 103
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.
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Berne et al. (U.S. Patent Application Publication 2016/0108131, of record) in view of Umana et al. (WO 99/54342, of record).
Berne et al. is applied as above. The reference does not disclose antibodies with increased bisecting GlcNac structures.
Umana et al. discloses cell lines engineered to express glycoprotein-modifying glycosyl transferases (e.g., beta (1,4)-N acetylglucosaminyltransferase III (GnTIII)) such that antibodies expressed in the engineered cell lines exhibit increased bisecting GlcNac structures which results in increased ADCC activity of the antibodies. See at least abstract, claims (particularly claims 28, 32-35, and 47), Figure 10, and pages 2-3.
It would have been obvious to produce the MAb2 antibody of Berne et al. in the cells of Umana et al. to increase bisecting GlcNac structures. One would have been motivated to do so in order to increase the ADCC activity of the antibody.
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.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for SEQ is NO: 14, 15, 31, 32, 48, or 49 having substitutions in the framework regions, does not reasonably provide enablement for insertions and deletions in the framework regions. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Claim 5 depends upon claim 4 which depends upon claim 3 which depends upon claim 1. Claim 1 requires that the antibody specifically binds to human CEA at amino acid 596-674 of SEQ ID NO: 52. The antibodies of claims 4 and 5 must retain the CDRs recited in claim 3; otherwise, they would not be properly dependent. The specification does not disclose or suggest which framework amino acids (one to ten) that could be deleted and still retain the required antigen binding. The specification does not disclose or suggest where within the framework amino acids one to ten amino acids could be inserted and still retain the required antigen binding. The specification does not disclose or suggest which amino acids could be inserted and still retain the required antigen binding. Inserting and deleting amino acids in the framework would have been expected to disrupt the three dimensional configuration of the six CDRs required for antigen binding. The specification provides no examples or guidance.
The scope of the claim is not enabled.
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.
Claims 2 and 9-10 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.
Claim 2 recites “other CEACAM family members.” The specification does not provide a clear or limiting definition as to those proteins included or excluded from this family. The metes and bounds of the claim cannot be determined.
Claim 9 recites “reduced glycosylation” but fails to indicate what this is in comparison to. Claim 1 has no limitations with respect to glycosylation. The claim is confusing and indefinite.
Claim 10 recites “increased bisecting GlcNac structures” but fails to indicate what this is in comparison to. Claim 1 has not limitations with respect to bisecting GlcNac structures. The claim is confusing and indefinite.
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, 3-7, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-8, 10-16, 18, 27, 30, and 32 of copending Application No. 18/513,223 (11/17/2023 claim set). Although the claims at issue are not identical, they are not patentably distinct from each other.
The co-pending claims are directed to multispecific antibodies that bind to CEA and CD137. The antibody component that binds CEA has the same sequences as recited in the instant claims. See at least co-pending claims 1-4, 6, 11-12. At least for example, the sequence identifiers in co-pending claims 3-4 and 6 and instant claims 3-4 and 6 are the same. Co-pending claim 13 discloses the limitations of instant claim 7. Co-pending claim 32 discloses the limitations of instant claim 13. The co-pending multispecific antibodies would have put one of ordinary skill in the art in possession of the instant anti-CEA antibodies.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-7, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/940,225 (11/7/2024 claim set). Although the claims at issue are not identical, they are not patentably distinct from each other.
The co-pending claims are directed to antibody drug conjugates (ADC) of anti-CEA antibodies having the same sequences as recited in the instant claims. At least for example, the sequence identifiers in co-pending claims 1, 20, 26, and 38-41 and instant claims 3-4 and 6 are the same. The co-pending claims include antigen-binding fragments. This would fairly suggest the well-known antigen-binding fragments recited in instant claim 7. Co-pending claims 26-28 discloses the limitations of instant claim 13. The co-pending ADC would have put one of ordinary skill in the art in possession of the instant anti-CEA antibodies.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant application is a CON of WO 2022/242681 (of record, published 24 November 2022, filed 18 May 2022). The inventors are Zhuo Li, Liu Xue, Qi Liu, Lin Zhu, Penghao Wang, Hanzi Sun, and Xiaoyan Tang. The applicant for the PCT is Beigene, Ltd. U.S. Patent Application Publication 2024/0190990 (of record) is the PGPUB for the instant application. The applicant for the instant application is BeiGene Switzerland GmbH. Basis for the sequences of the antibodies of the instant claims is found in the PCT/CN2021/095113 priority document filed 21 May 2021. See at least Table 1 starting on page 32. The effective filing date of the instant claims is 21 May 2021.
Application 18/513,169 is a CON of PCT/CN2022/093564 which published as WO 2022/242679 (published 24 November 2024, filed 18 May 2022). The inventors differ from the instant application but have inventors in common with the instant application. The applicant for the PCT is Beigene, Ltd. U.S. Patent Application Publication 2024/0209106 is the PGPUB for application 18/513,169. The applicant for application 18/513,169 is BeiGene Switzerland GmbH. The 8/5/2026 claim set in 18/513,169 is directed to antibodies against human CD137. The bispecific antibody claims (see for example claims 6-8) do not recite CEA as the second antigen or sequences of the instant claims. The ‘169 specification discloses anti-CEA antibody sequences of the instant claims. See Example 6 of the ‘169 specification. At least for example amino acids 1-120 of SEQ ID NO: 87 in the ‘169 application correspond to instant SEQ ID NO: 14 and amino acids 1-107 of SEQ ID NO: 213 in the ‘169 application correspond to instant SEQ ID NO: 15. WO 2022/242679 and U.S. Patent Application Publication 2024/0209106 are not prior art against the instant claims. There are no double patenting issues with the current claims in the ‘169 application.
Application 18/513,223 is CON of PCT/CN2022/093565 which published as WO 2022/242680 (of record, published 24 November 2024, filed 18 May 2022). The inventors differ from the instant application but have inventors in common with the instant application. The applicant is Beigene, Ltd. U.S. Patent Application Publication 2024/0190989 is the PGPUB for application 18/513,223. The applicant for application 18/513,223 is BeiGene Switzerland GmbH. WO 2022/242680 and U.S. Patent Application Publication 2024/0190989 are not prior art against the instant claims.
Application 18/940,225 is a CON of PCT/IB2023/061813 which published as WO 2024/110905 (published 30 May 2024, filed 25 November 2023). The inventors differ from the instant application. The applicant is BeiGene, Ltd. U.S. Patent Application Publication 2025/0115677 is the PGPUB for application 18/940,225. The applicant for application 18/940,225 is BeiGene Switzerland GmbH. WO 2024/110905 and U.S. Patent Application Publication 2025/0115677 are not prior art against the instant claims.
The prior art of record does not disclose the antibodies of BGA113K, BGA190, and BGA288. See at least Table 1 at page 32 of the specification and claims 3-4 and 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
mpa
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