DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed 9/2/25 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/2/25 has been entered.
Claim 29 has been amended.
Claims 29-62 pending.
Claims 40-55 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 29-39 and 56-62 are being acted upon.
Applicant is advised that should claim 33 be found allowable, claim 59 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 29-39 and 56-62 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The specification and the claims as originally filed do not provide support for the invention as now claimed, specifically:
An isolated antibody or an antigen-binding fragment thereof, comprising:(i) a Variable Heavy Chain (VH) domain sequence that is at least 95% identical to SEQ ID NO:22, SEQ ID NO:23, SEQ ID NO:24, or SEQ ID NO:25 wherein the VH domain sequence comprises amino acids 31-34, 50-66, and 99-106 of SEQ ID NO: 22; and(ii) a Variable Light Chain (VL) domain sequence that is at least 99% identical to SEQ ID NO:26 or at least 98% identical to SEQ ID NO:27 wherein the VL domain sequence comprises amino acids 24-34, 50-56, and 89-97 of SEQ ID NO: 26 (Claim 29, and dependent claims).
A review of the specification fails to reveal support for the new limitations.
The original claims were directed to a monoclonal antibody that binds to MFAP5, peptide epitope that is at least 95% identical to the amino acid sequence of any one of SEQ ID NO: 2-15. It is noted that the specification in paragraphs 76-95 discloses that SEQ ID NO: 3-9 are MFAP5 peptide epitopes while SEQ ID NO: 10-15 are exemplary humanized antibody sequences having a VH or VL and an hIgG1CH or hIgKCL constant region. Even if the original claims and disclosure could be construed to provide support for a monoclonal antibody having at least 95% identity to the amino acid sequence of any one of SEQ ID NO: 10-15, this has a much different scope than what is presently claimed. For example, SEQ ID Nos: 22-27 represent the VH and VL regions from SEQ ID NO: 10-15. Thus, the present claims encompass 95% identity to a more limited region (VH of SEQ ID NO: 22), while the present specification, at best, would support at least 95% identity to the entire heavy chain, i.e. SEQ ID NO: 10. Furthermore, the original claims and disclosure recite at least 95% identity to any one sequence, whereas the instant claims recite at least 95% identity to a VH and at least 98% or 99% identity to a VL of SEQ ID NO 22-25 and 26-27, respectively. This particular combination of elements is not supported in the disclosure. Furthermore, the claims encompass various VH and VL pairings, such as pairing VH of SEQ ID NO: 22, with VL of SEQ ID NO: 27, which is not contemplated in the disclosure.
Additionally, the specification does not disclose the limitation of the specific residues claimed, wherein the VH comprises amino acids 31-34, 50-56, and 99-106 of SEQ ID NO: 22 and VL comprises amino acids 24-35, 50-56, and 89-97 of SEQ ID NO: 26. Applicant cites paragraphs 95 and 121 of the published application as support. Paragraph 95 of the published application describes exemplary humanized antibody sequences of SEQ ID NO; 10-15, which have a VH or VL and h IgG1 CH or hIgKCL, i.e. complete humanized heavy and light chain sequences. Paragraph 121 describes producing humanized antibodies by grafting CDRs of murine monoclonal antibodies onto the framework of human antibody heavy and light chains. However, the present claims encompass certain residues from a humanized antibody, which is not contemplated by the specification. Furthermore, CDR sequences can be defined by various numbering schemes, and mere reference to a CDR in the specification would not provide adequate support for the specific amino acid positions of the instant claims, i.e. residues 31-34 of SEQ ID NO: 22. Applicant has not cited any support in the instant application for the claimed amino acid positions of SEQ ID NO: 22 and 26. The present claims are directed to a genus of monoclonal antibodies having certain amino acid residues from a humanized antibody sequence, and also having a particular percent identity (at least 95% identity to VH, and 99% or 98% identity to VL) to the humanized VH/VL portion in various combinations. The specification does not provide any support for the combination of elements required in the present claims.
It is noted that the disclosure does provide support for humanized antibodies having CDRs from a heavy and light chain of a murine monoclonal, and discloses certain murine monoclonal antibodies such as 130A. However, that the specification does not disclose the sequence of the 130A antibody, nor does it establish anywhere that the humanized antibody sequences disclosed in paragraph 95 were even derived from 130A or that they would have the same CDRs as 130A.
The specification could potentially be amended to provide the sequence of said 130A murine antibody without intruding new matter, since the sequence would be an inherent property of the antibody. See MPEP 2163 and 2163.07, an application may be amended to recite an inherent property without introducing new matter, and inherent teachings of the specification can support newly added claim limitations. Regarding the definition of the CDRs, it is noted that the specification references a number of U.S. patents regarding humanization, the teachings of which are incorporated by reference. It is possible these could be relied upon to establish the particular CDR residue numbering of the 130A antibody that are contemplated for humanization. For example, if one of the patent references incorporated by reference discloses using Kabat numbering to provide CDRs for humanization, in response to this office action, Applicant could cite the specific patent document from the specification and teaching relied upon to provide support for Kabat numbering of CDRs. Doing so could provide support for a claim to a humanized antibody having the CDRs of the heavy and light chain SEQ ID Nos: of 130A, wherein said CDRs are identified using Kabat numbering (with the specification being amended to disclose a SEQ ID NO: for the heavy and light chain or CDRs of the 130A antibody on the basis of inherency).
It is noted that the specification does also provide support for antibodies having the defined VH/VL pairings as disclosed in paragraph 95 of the published application. For example, SEQ ID NO: 11 is disclosed as having AHF008 VH (SEQ ID NO: 23), while SEQ ID NO: 14 is discloses as having VAHF00208 VL(SEQ ID NO: 26). This would provide support for an antibody having a VH of SEQ ID NO: 23 and a VL of SEQ ID NO: 26, for example. Thus, specific pairings of VH/VL could also be claimed. It is noted that claim 29 in its present form encompass pairings not contemplated by paragraph 95, however. For example, claim 29 encompasses SEQ ID NO: 22 paired with SEQ ID NO: 27, while paragraph 95 only supports the VL of AHF00217 (i.e. SEQ ID NO: 27), paired with AHF00217-VH (i.e. SEQ ID NO: 24) . Thus, claims 60-62, for example, would be allowable if amended to be in independent from without the limitations of claim 29 reciting particular CDR numbering and percent identity that constitute new matter.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker, can be reached at telephone number 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644