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 .
Applicant's arguments filed 9/29/2025 have been fully considered but they are not persuasive.
Claims 1-107 and 117-222 have been cancelled. Claims 233-239 have been newly introduced.
As set forth in the prior Office action, antibodies recited in the instant claims correspond to those recited in the ‘810 claims.
The prior art of record does not disclose or suggest an antibody comprising a VH domain and VL domain having the CDRs recited in independent claim 108 and that specifically binds IL-33. The prior art of record does not disclose or suggest an antibody comprising a VH domain and VL domain having the sequences recited in independent claim 232 and that specifically binds IL-33.
The CDRs of claim 108 must be present in the antibodies of each of these dependent claims. See for example, claim 229. The CDRs of SEQ ID NOS: 1, 2, and 3 are found in SEQ ID NOS: 7, 25, 35, 37, 41, 43, 44, 46, 48, 50, 52, and 65. See claims 227-229 and 232. In particular, the CDRs of SEQ ID NOS: 4, 5, and 6 are found in SEQ ID NOS: 8, 26, 36, 38, 55, 57-59, 61, and 69. See claims 227-229 and 232. See Figures 1A-B and 2A-B.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 233 and 238-239 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter.
Claim 233 recites a first isolated nucleic acid and a second isolated nucleic. Claims 238-239 depend on claim 233. The claims as written are directed to two independent products having no association to each other. The claims are not directed to a single composition of matter. Applicant is reminded that a patent claim should be directed to single product.
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 233-239 are 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.
Claims 233 and 238-239 are not original claims. Claim 233 recites a first isolated nucleic acid and a second isolated nucleic. Claims 238-239 depend on claim 233. The claims as written are directed to two independent products having no association to each other. No basis is seen for this. Applicant is reminded that a patent claim should be directed to single product. No basis is seen for claims 233 and 238-239. The specification does not appear to disclose compositions containing a first isolated nucleic acid and a second isolated nucleic acid.
Claim 234 is not an original claim. It is directed to a vector. No basis is seen for a vector comprising the first nucleic acid and the second nucleic acid of claim 233, wherein the first nucleic acid sequence is operably linked to a first control sequence and the second nucleic acid sequence is operably linked to a second control sequence. None of original claims 108-116 disclose such a vector. Applicant has pointed to basis in paragraphs [0328], [0330], [0343], [0348], [0362], [0363], and [0500]-[0513] in the specification as filed. The specification paragraphs are not numbered. It is assumed that applicant is referencing PGPUB 2024/0092887. None of paragraphs [0328], [0330], [0343], [0348], [0362], [0363], and [0500]-[0513] in PGPUB 2024/0092887 disclose such a vector. No basis is seen for claims 234-237.
Claims 115-116 are 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 recombinant methods of production as discussed below, does not reasonably provide enablement for all recombinant methods of production encompassed by the claims. 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.
“An isolated nucleic acid encoding” is considered to mean a single nucleic acid molecule that encodes the VH and VL.
Claims 108 has been amended. It is now directed to an isolated nucleic acid (single nucleic acid) comprising a nucleic acid sequence encoding an antibody that specifically binds IL-33, wherein the antibody comprises a heavy chain variable (VH) domain comprising the three recited CDRs and a light chain variable domain (VL) comprising the three recited CDRs. The claim as written does not indicate whether or not the sequence encoding the VH is operably linked to the sequence encoding the VL or if the sequences encoding the VH and VL are separated on the single nucleic acid.
Claims 109 has been amended. It is now directed to a vector comprising the nucleic of claim 108, wherein the nucleic acid sequence encoding the antibody is operably linked to a control sequence. It is unclear if there is a control sequence operably linked to the sequence encoding the VH and a second control sequence operably linked to the sequence encoding the VL. It is unclear if the sequence encoding the VH and VL are operably linked in some way (e.g. as a fusion protein). At the very least, the methods of claims 115-116 rely on this vector to produce an antibody that binds IL-33. The claimed vector as written will not do so. At least for example, if there is a single control sequence and the VH and VL are not operably linked, then at least one of the antibody chains will not be produced. At least for example, if the VH and VL are directly operably linked (e.g. no linker sequence as in an scFv), then the single chain protein produced will not have sufficient flexibility to fold into an antibody with antigen binding.
Claims 109-110 as written are missing critical elements for production of an antibody as in claims 115-116.
Claims 230-231 are dependent upon claim 108 and are directed to fragments. Claim 108 does not clearly include fragments. In addition, claim 108 does not recite linker sequences that would be present in an scFv. Fab and Fv fragments require separate VH and VL sequences and not fused VH and VL sequences. The Fab fragments also require more than the VH and VL. They require at least the heavy chain constant domain CH1 and the light chain constant domain CL as well as the hinge sequences. Claim 108 as written is missing critical elements for these fragments.
If applicant intended that claims 115-116 encompass production of single chain antibodies (i.e. scFv) and diabodies, the nucleic acids do not encode the peptide linker that connects the VH to the VL to form a fusion protein and in the case of the diabody, the additional linker that connects the two binding domains as a fusion protein.
If applicant intended that claims 115-116 encompass production of an Fv fragment, these claims do not indicate how this fragment would be assembled according to the claimed method steps.. An Fv fragment lacks any disulfide bonds that would link the VH to the VL.
If applicant intended that claims 115-116 encompass production of Fab, Fab’, Fab’-SH, and F(ab')2 fragments by proteolytic cleavage of the whole or intact antibody, the method claims have no steps for this.
The claims as written would not produce the antibody or antigen-binding fragments required by the claims. Applicant is cautioned against introducing new matter if the claims are amended.
The scope of the claims is not enabled. Applicant is cautioned against introducing new matter if the claims are amended.
Applicant’s arguments are not persuasive.
Applicant is reminded that they cannot assert the presence of structural or functional features that are not recited in the claim. Applicant is reminded that they cannot read limitations from the specification into the claims. Applicant is cautioned against introducing new matter if the claims are amended.
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 109-116 and 230-231 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.
Claims 109 has been amended as discussed above. It is unclear if there is a control sequence operably linked to the sequence encoding the VH and a second control sequence operably linked to the sequence encoding the VL. It is unclear if the sequence encoding the VH and VL are operably linked in some way (e.g. as a fusion protein). The claim is confusing. At the very least, the methods of claims 115-116 rely on this vector to produce an antibody that binds IL-33 as set forth above.
Claims 109-110 as written are missing critical elements for production of an antibody as in claims 115-116.
If applicant intended that claims 115-116 encompass production of single chain antibodies (i.e. scFv) and diabodies, the nucleic acids do not encode the peptide linker that connects the VH to the VL to form a fusion protein and in the case of the diabody, the additional linker that connects the two binding domains as a fusion protein.
If applicant intended that claims 115-116 encompass production of an Fv fragment, these claims do not indicate how this fragment would be assembled according to the claimed method steps. An Fv fragment lacks any disulfide bonds that would link the VH to the VL.
If applicant intended that claims 115-116 encompass production of Fab, Fab’, Fab’-SH, and F(ab')2 fragments by proteolytic cleavage of the whole or intact antibody, the method claims have no steps for this.
Claims 115-116 are confusing.
Claims 230-231 are dependent upon claim 108 and are directed to antibody fragments. These claims do not appear to be properly dependent. Claim 108 does not clearly include fragments. In addition, claim 108 does not recite linker sequences that would be present in an scFv. Fab and Fv fragments require separate VH and VL sequences and not fused VH and VL sequences. The Fab fragments also require more than the VH and VL. They require at least the heavy chain constant domain CH1 and the light chain constant domain CL as well as the hinge sequences. Claim 108 as written is missing critical elements for these fragments. Claims 230-231 are confusing.
Applicant is again reminded that they cannot assert the presence of structural or functional features that are not recited in the claim. Applicant is reminded that they cannot read limitations from the specification into the claims. Applicant is cautioned against introducing new matter if the claims are amended.
Claims 108, 223-229, and 232 are allowable.
.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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