Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6-8-26 has been entered.
Claims 1, 2, 5-9, 11-13, 16-18, 28, 29 and 34-40 are pending.
Claims 1, 2, 5-9, 11, 18 and 35-40 are under examination.
Claims 12, 13, 16, 17, 28, 29 and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group or species of invention, there being no allowable generic or linking claim.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The prior obviousness-type double patenting has been withdrawn in view of applicant’s claim amendments.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11 and 37-40 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 11 and 37-40 are of improper dependent form because they fail to include all the limitations of the claim upon which they depend. The rejected claims do not encompass in their breadth an EGFR-binding, second binding domain comprising a VH region and a VL region selected from the group consisting of: (a) a VH region comprising a CDR H1, CDR H2, and CDR H3 of SEQ ID NO: 441, 442, and 443, respectively, and a VL region comprising a CDR L1, CDR L2. and CDR L3 of SEQ ID NO: 444, 445, and 456, respectively.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 5-9, 18, 35 and 36 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 and dependent claims thereof, as well as claim 36, recite that the polypeptide comprises a second binding domain which binds to human EGFR, wherein said second binding domain comprises a VH comprising CDRs 1-3 of SEQ ID NOs: 441-443 and a VL comprising CDRs 1-3 “of SEQ ID NOs: 444, 445, and 456, respectively.”
However, SEQ ID NO: 456 is an LCDR1, not an LCDR3 as stated in the claim, see specification at page 213.
The skilled artisan would not be able to substitute the LCDR1 sequence of SEQ ID NO: 456 for the LCDR3 sequence that was selected with SEQ ID NOs: 441-445 to create an EGFR binding site (see specification at page 210 which provides the EGFR binding CDRs of SEQ ID NOs: 441-446) because each of the VH and VL CDRs of SEQ ID NOs: 441-446, in their correct context in the antibody framework domain are necessary to create an antigen-binding site.
To illustrate, consider that it was known in the art that antibody-antigen affinity and specificity is a function of not only direct CDR to antigen interactions, but also the interactions of the CDRs with framework residues in the same chain, e.g., Vh CDR binding to Vh framework residues, and in the opposing chain, e.g., Vh CDR binding to Vl framework residues. In addition, the CDR residues of each chain can interact with the CDRs of the opposite chain. It is for this reason that antibody humanization protocols, e.g., humanization of a murine antibody, provide extensive guidelines as to the retention of certain murine residues in the context of the human framework so as to preserve this web of interactions, the loss of any one of these interactions having the potential to ablate antibody-antigen binding (see, e.g., Eduardo Padlan, Mol Immunol. 1994 Feb;31(3):169-217, cited herewith, in particular column bridging paragraph on page 177; page bridging paragraph pages 178-179 through page 180; pages 201, 204 and Tables 8, 22 and 23 and Adair et al., United States Patent No. 5,859,205, in particular columns 1-6, 9-11 and 27-28, both cited on an IDS).
Thus, the skilled artisan would not be able to make and use the breadth of the claimed polypeptides in the absence of undue experimentation.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY S SKELDING whose telephone number is (571)272-9033. The examiner can normally be reached M-F 9-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY S SKELDING/Primary Examiner, Art Unit 1644
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