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 8-19, 21-24, 34-37, and 41-47 have been cancelled.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7, 20, 25, and 30-32, in the reply filed on 10/10/2025 is acknowledged.
Claims 26-29, 33, and 38-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 10/10/2025. Claim 33 as amended corresponds to Group III.
Inventorship
The petition to add inventors Edwards and Stevenson was granted on 6/20/2023.
Specification/Sequence Listing
It is acknowledged that SEQ ID NOS: 89 and 101 in the sequence listing are skipped or empty sequences. These sequence identifiers should not appear in the specification.
The disclosure is objected to because of the following informalities:
The sequence listing in this application was submitted under WIPO Standard ST.26. In compliance with these rules, SEQ ID NOS: 89 and 101 have been skipped in the sequence listing. The specification, including the claims, should not reference these sequence identifiers. The actual sequences should be used rather than referencing the sequence identifier. See at least claim 3, part (1)(ii) and part (3)(ii). See at least claim 4, part (13)(ii) and part (15)(ii). See at least page 6 within part (13)(ii), page 114 within part 3(1)(ii), and page 118 within part (13)(ii). See at least paragraph [0008, 0009, 0113, and 0115]. See at least Table 9.
Appropriate correction is required.
Claim Objections
Claims 3-4 are objected to because of the following informalities: These claims incorrectly recite SEQ ID NOS: 89 and 101. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, 6-7, 20, 25, and 31-32 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Wang et al. (U.S. Patent Application Publication 2021/0024627).
Wang et al. discloses monoclonal antibodies that specifically bind to IL-1β antigen. The antibodies can be of the subtype IgG1, IgG2, IgG3 or IgG4. Pharmaceutical compositions are disclosed. See at least abstract, sequence listing, and claims 50-64. Claim 50 discloses VH CDRs and VL CDRs. Claim 62 discloses VH and VL sequences having the recited CDRs. Bispecific and multispecific antibodies are disclosed. Hetero-conjugates are disclosed. See at least paragraph [0036].
Instant claims 1, 2, and 6 are directed to an antibody that binds IL-1β and have a VH comprising CDRS having “an amino acid sequence” of each VH CDR of a VH having “an amino acid sequence” of SEQ ID NO: 7, 9, or 11 and a VL comprising CDRS having “an amino acid sequence” of each VL CDR of a VL having “an amino acid sequence” of SEQ ID NO: 8, 10, or 12, respectively. That is, the claimed antibody is not required to have any particular CDR sequences as long as the VH and VL and CDRs of the prior art have amino acids in common with the sequences recited in the instant claims. The antibody of Wang et al. meets these limitations as illustrated by the sequence alignments below. The recitation of “an amino acid sequence” as in instant claims 1-2 and 6 encompasses common subsequences, including single amino acids.
Instant claim 4 is directed to an antibody that binds IL-1β comprising a VH comprising CDRS having “an amino acid sequence” of each VH CDR sequence recited and a VL comprising CDRS having “an amino acid sequence” of each VL CDR sequence recited for parts (1)-(15). That is, the claimed antibody is not required to have the entirety of the particular CDR sequences as long as the CDRs of the prior art have amino acids in common the CDR sequences recited in the instant claims. The antibody of Wang et al. meets these limitations as illustrated by the sequence alignments below. The recitation of “an amino acid sequence” as in instant claim 4 encompasses common subsequences, including single amino acids.
SEQ ID NOS: 7/8 correspond to antibody 05H21A (see at least part (1) of claims 1-2 and 6). SEQ ID NOS: 9/10 correspond to antibody 15N14A (see at least part (2) of claims 1-2 and 6). SEQ ID NOS: 11/12 correspond to antibody 08F17A (see at least part (3) of claims 1-2 and 6). See at least Table 4. See at least Tables 5-9 for the CDRS according to Kabat (see at least claim 4, parts (1)-(3)), Chothia, (see at least claim 4, parts (4)-(6)), AbM (see at least claim 4, parts (7)-(9)), Contact (see at least claim 4, parts (10)-(12), and IGMT (see at least claim 4, parts (13)-(15).
Alignment of SEQ ID NO: 18 of PGPUB 2021/0024627 (Qy, with CDRs of SEQ ID NOS: 26, 27, and 28 underlined) and instant SEQ ID NO: 7 (Db, with Kabat CDRs of instant SEQ ID NOS: 13, 14, and 15 underlined):
Qy 1 QVQLQQWGAGLLKPSETLSLTCAVYGGSF--SDYYWSWIRQPPGKGLEWIGEIDHSGSTN 58
|| |:: | |:||::||:||| | | | : ||||||||| |||: ||
Db 1 QVTLRESGPALVKPTQTLTLTCTFSGFSLSTSGMWVSWIRQPPGKALEWLALIDWGDDKY 60
Qy 59 YNPSLKSRVTISVDTSKNQFSLKLSSVTAADTAVYYCARASPSSGWTLDYWGQGTL 114
| |||:|:||| |||||| | :::: ||| ||||| | | |||||:
Db 61 YTTSLKTRLTISKDTSKNQVVLTMTNMDPVDTATYYCARMREGSR-AFDIWGQGTV 115
Alignment of SEQ ID NO: 17 of PGPUB 2021/0024627 (Qy, with CDRs of SEQ ID NOS: 29, 30, and 9 underlined) and instant SEQ ID NO: 8 (Db, with Kabat CDRs of instant SEQ ID NOS: 16, 17, and 18 underlined):
Qy 1 QSVLTQPPSVSVSPGQTASITCSG--DKLGDKFAFWYQQKPGQSPVLVIYLDNKRPSGIP 58
||||||||||| :| | :|:||| :|| |||| ||::| |:|| |: ||:
Db 1 QSVLTQPPSVSEAPRQRVTISCSGSSSNIGDNAVNWYQQLPGKAPKLLIYNDDLLSSGVS 60
Qy 59 ERFSGSNSGNTATLTISGTQALDEADYYCYAWADTYE--VFGGGTK 102
:||||| || :|:| ||| |: ||||||| || |: |||||||
Db 61 DRFSGSKSGTSASLAISGLQSEDEADYYCAAWDDSLNGPVFGGGTK 106
Alignment of SEQ ID NO: 18 of PGPUB 2021/0024627 (Qy, with CDRs of SEQ ID NOS: 26, 27, and 28 underlined) and instant SEQ ID NO: 9 (Db, with Kabat CDRs of instant SEQ ID NOS: 19, 20, and 21 underlined):
Qy 1 QVQLQQWGAGLLKPSETLSLTCAVYGGSFSDYYWSWIRQPPGKGLEWIGEIDHSGSTNYN 60
|||||: | ||:|||||||||| | ||| | |||:||||| |||||||| || |||: ||
Db 1 QVQLQESGPGLVKPSETLSLTCTVSGGSISSYYWTWIRQPAGKGLEWIGRIDSSGSSKYN 60
Qy 61 PSLKSRVTISVDTSKNQFSLKLSSVTAADTAVYYCARASPSSGWTLDYWGQGTL 114
|:||||||:|||||||||||||||||||||||||||| | ||||||||
Db 61 PTLKSRVTMSVDTSKNQFSLKLSSVTAADTAVYYCARGDSGYDWAFDYWGQGTL 114
Alignment of SEQ ID NO: 17 of PGPUB 2021/0024627 (Qy, with CDRs of SEQ ID NOS: 29, 30, and 9 underlined) and instant SEQ ID NOS: 10 (Db, with Kabat CDRs of instant SEQ ID NOS: 22, 23, and 24 underlined):
Qy 1 QSVLTQPPSVSVSPGQTASITC---SGDKLGDKFAFWYQQKPGQSP-VLVIY---LDNKR 53
|:||||| |:| ||| :||:|| || :| :||||||| | |: | | ::
Db 1 QAVLTQPSSLSASPGASASLTCTLRSGINVGTYRIYWYQQKPGSPPQYLLSYKSDSDKQQ 60
Qy 54 PSGIPERFSGSN--SGNTATLTISGTQALDEADYYCYAWADTYEVFGGGTK 102
||:| ||||| | | | ||| |: ||||||| | : |||||||
Db 61 GSGVPSRFSGSKDASANVGILLISGLQSEDEADYYCMIWHSSAWVFGGGTK 111
Alignment of SEQ ID NO: 18 of PGPUB 2021/0024627 (Qy, with CDRs of SEQ ID NOS: 26, 27, and 28 underlined) and instant SEQ ID NO: 11 (Db, with Kabat CDRs of instant SEQ ID NOS: 25, 26, and 27 underlined):
Qy 1 QVQLQQWGAGLLKPSETLSLTCAVYGGSFSDYYWSWIRQPPGKGLEWIGEI-DHSGSTNY 59
:||| : | ||: | :| |:|| | :|| | :|:|| |||||||: | || |
Db 1 EVQLVESGGGLVTPGGSLRLSCAASGFTFSGYSMNWVRQAPGKGLEWVSSISSSSGYIYY 60
Qy 60 NPSLKSRVTISVDTSKNQFSLKLSSVTAADTAVYYCARASPSSGWTLDYWGQGTL 114
|:| | ||| | :|| |:::|: | ||||||||| ||: ||||||||
Db 61 ADSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCAREYWGSGF--DYWGQGTL 113
Alignment of SEQ ID NO: 17 of PGPUB 2021/0024627 (Qy, with CDRs of SEQ ID NOS: 29, 30, and 9 underlined) and instant SEQ ID NO: 12 (Db, with Kabat CDRs of instant SEQ ID NOS: 28, 29, and 30 underlined):
Qy 4 LTQ-PPSVSVSPGQTASITCSGDKLGDKFAFWYQQKPGQSPVLVIYLDNKRPSGIPERFS 62
:|| | |:| | | :||| : : |||||||: | |:| : ||:| |||
Db 4 MTQSPSSLSASVGDRVTITCRASQGISYYLAWYQQKPGKVPKLLISAEFTLQSGVPSRFS 63
Qy 63 GSNSGNTATLTISGTQALDEADYYCYAWADTYEVFGGGTK 102
|| || ||||| | | | ||| : || |||
Db 64 GSGSGTDFTLTISSLQPEDVATYYCQKYNTAPRTFGQGTK 103
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.
Claims 1-2, 4-7, 20, 25, and 30-32 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. This is a written description rejection.
The specification discloses the VH and VL for three distinct antibodies against IL-1β.
SEQ ID NOS: 7/8 correspond to antibody 05H21A (see at least part (1) of claims 1-2 and 6). SEQ ID NOS: 9/10 correspond to antibody 15N14A (see at least part (2) of claims 1-2 and 6). SEQ ID NOS: 11/12 correspond to antibody 08F17A (see at least part (3) of claims 1-2 and 6). See at least Table 4. See at least Tables 5-9 for the CDRS according to Kabat (see at least claim 4, parts (1)-(3)), Chothia, (see at least claim 4, parts (4)-(6)), AbM (see at least claim 4, parts (7)-(9)), Contact (see at least claim 4, parts (10)-(12), and IGMT (see at least claim 4, parts (13)-(15). Antibodies against IL-1β having the full set of Kabat CDRs, the full set of Chothia, CDRs, the full set of AbM CDRs, the full set of Contact CDRs, and the full set of IGMT CDRs for each of antibodies 05H21A, 15N14A, and 08F17A are also considered to be adequately described.
However, the claims embrace antibodies with significantly different structures in view of the “an amino acid sequence” language as discussed above as encompassing common subsequences, including single amino acids. That is, the claims encompass antibodies having limited structural similarity to the 05H21A, 15N14A, and 08F17A antibodies. No reasonable structure-function correlation has been established that is commensurate in scopewith the claims. The specification does not describe representative examples to support the fullscope of the claims. Changes in any or all of the six CDR sequences required for antigen binding (permitted by the current claim language) would have been known to result in unpredictable binding properties. Note that claims 1-2 and 4 do not require any particular framework region sequences which also contributes to providing the requisite three-dimensional structure in combination with the CDRs to achieve antigen binding. For example, claim 5 as written permits adding multiple VH framework 1 regions to any antibody. Claim 5 permits adding VH framework regions to the VL of claim 1 and vice versa. Claim 5 permits adding framework regions from one antibody to a VH or VL of a structurally different antibody (e.g. a framework region from SEQ ID NO: 7 (claim 1, part (1)) to the antibody of claim 1, part (2)). This structural variability has not been disclosed as resulting in antigen binding.
The scope of the claims is not adequately described.
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 5 and 7 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 5 is confusing in reciting the antibody “further comprises one or more framework regions” as set forth in SEQ ID NOS: 8-11 and/or SEQ ID NO: 12. For example, this is confusing as it permits adding multiple VH framework 1 regions to any antibody. For example, this is confusing as it permits adding VH framework regions to the VL of claim 1 and vice versa. For example, this is confusing as it permits adding framework regions from one antibody to a VH or VL of a structurally different antibody (e.g. a framework region from SEQ ID NO: 7 (claim 1, part (1)) to the antibody of claim 1, part (2)). This does not appear to correspond to the structures that applicant intended to claim. Note that the framework regions in the VH of SEQ ID NOS: 7, 9, and 11 vary greatly and the framework regions in the VL of SEQ ID NOS: 8, 10, and 12 vary greatly. Clarification is requested.
Claim 7 is confusing. Each of the attributes (a)-(k) can be present simultaneously in view of the “and/or” language. This is confusing as the claim could have both kappa and lambda light chains. It is unclear what the distinction is between parts (g) and (h) as well as between parts (j) and (k). Parts (j)-(k) are confusing as this would be implicit in the requirement for binding to IL-1β in claim 1. Clarification is requested.
SEQ ID NOS: 7-12 are free of the prior art. The prior art does not disclose anti-IL1-β antibodies having these sequences.
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
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