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 .
Amended claims 38-41, 43, (9/1/2026), and new claims 44-45, (9/1/2026), are under consideration by the Examiner.
Claims 1-37 and 42, have been canceled.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 9/1/2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered by the examiner.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section”.
4. Receipt of Applicant's arguments and amendments filed on 9/1/2026 is acknowledged.
5. The following previous rejections and objections are withdrawn in light of Applicants amendments filed on 9/1/2026:
(i) the rejection of claims 18, and 21 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;
(ii) the rejection of claims 18-19, 21, and 36-43 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph;
(iii) the rejection of claims 18-19, 21, 36-37, and 40-43 under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by WO 2007/147019 A2;
(iv) the rejection of claims 18-19, 21, 37, and 40-42 under 35 U.S.C. 103 as being anticipated by WO 2000/009561 Al; and
(v) the rejection of claims 18-19, 21, 36-37, and 40-43 under 35 U.S.C. 103 as being unpatentable over WO 2000/009561 Al.
Claim Rejections - 35 USC § 112(a), written description
6. 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.
6a. Claims 38-41, and 43-45, 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 rejection is maintained for reasons of record set forth at pages 5-12 of the previous action dated 5/15/2026.
Applicant argues that claim 38 has been amended to recite a nucleic acid encoding a CD131 antibody comprising an antigen binding domain comprising "a heavy chain variable region (VH) comprising the sequence set forth in SEQ ID NO: 193 and a light chain variable region (VL) comprising the sequence set forth in SEQ ID NO: 5", SEQ ID NO: 193 encompasses a genus of VH sequences derived from the VH of CD131 binding protein 9A2-VR24, wherein those VH sequences are identical except for certain positions in the HCDR2, and the instant specification exemplifies a representative number of CD131 antibodies comprising (1) a VH sequence that falls within the genus of sequences encompassed by SEQ ID NO: 193 and (2) a VL of SEQ ID NO: 5, VH libraries targeting all residues in HCDR2 of 9A2-VR24 were generated for affinity optimization, antibodies comprising one of those VH sequences (e.g., SEQ ID NOs:-24-49-79) and a VL sequence of SEQ ID NO: 5 were generated and screened for their affinity to CD131. However, contrary to Applicant’s arguments, the screening method fails to disclose which antibodies will have the functions recited in independent claim 38. There are 13 different amino acid positions in CDRH2 of SEQ ID NO:193. Therefore, there are 1320 different options for the variants of CDRH2 which results in 1.9 X 1022 (19,004,963,774,881,000,000,000) different CDRH2 variants in SEQ ID NO:193.
Thus, artisans would reasonably expect that from the screening procedure recited in Example 2, pages 146-154, and Tables 3-4, of the specification, only antibodies which have six fully defined CDR sequences obtained from the same lead clone will maintain the recited function of antigen binding based upon the data presented in the instant specification.
Therefore, it appears that the broad genus of nucleic acids encoding antibodies that bind CD131 claimed by Applicant lacks adequate written description because there does not appear to be sufficient correlation between the structure of the claimed antibodies and the function of binding to CD131. As such, a skilled artisan would reasonably conclude that Applicant was not in possession of the claimed genus of antibodies at the time the instant application was filed.
Claim Rejections - 35 USC § 112(a), scope of enablement
6b. Claims 38-41, and 43-45 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 a nucleic acid encoding a CD131 antibody comprising a heavy chain variable region (VH) comprising the sequence of SEQ ID NO: 64, and a light chain variable region (VL) comprising the sequence of SEQ ID NO: 5, does not reasonably provide enablement for an antibody as recited in claims 38-41, and 43-45. 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.
This rejection is maintained for reasons of record set forth at pages 13-18 of the previous action dated 5/15/2026.
Applicant argues that amended claim 38 recites a nucleic acid encoding a CD131 antibody comprising an antigen binding domain comprising "a heavy chain variable region (VH) comprising the sequence set forth in SEQ ID NO: 193 and a light chain variable region (VL) comprising the sequence set forth in SEQ ID NO: 5", SEQ ID NO: 5 is fully disclosed in the as-filed Sequence Listing, SEQ ID NO: 193 is also fully disclosed in the Sequence Listing and contains degenerative residues at certain positions in its HCDR2, instant Examples 1 and 2 describe an affinity optimization process of 9A2-VR24, in which VH libraries targeting all residues of HCDR2 were generated, antibodies comprising one of those VH sequences (e.g., SEQ ID NOs: 49-79) and a VL sequence of SEQ ID NO: 5 were generated and screened for their affinity to CD131, and the instant specification further reports the outcome of the affinity optimization, showing antibodies with the claimed affinity to CD131 (Table 4). Additionally, Applicant argues that regarding claim 41, instant Examples 1 and 2 also provide detailed description of how to use in vitro and in vivo methods to examine inhibition of IL-3, IL-5, and GM-CSF signaling by the CD131 antibodies, amended claim 39 is directed to a nucleic acid encoding a CD131 antibody comprising an antigen binding domain, wherein the sequences of three HCDRs (or the VH) and the three LCDRs (or the VL) are expressly recited. Furthermore, Applicant argues that amended claim 43 describes that the claimed CD131 antibodies can be conjugated to a compound, new claim 44 discloses expression constructs comprising the CD131 antibody-encoding nucleic acid, and new claim 45 describes isolated or recombinant cells comprising the claimed expression construct. Therefore, one skilled in the art would have been able to make the claimed nucleic acids encoding the antigen binding domain of a CD131 antibody by following the methods described and exemplified in the instant disclosure.
However, contrary to Applicant’s arguments, Applicant has taught how to make but has not taught how to use the all the encompassed nucleic acids encoding antibodies that are encompassed by the scope of the claims. The genus encompasses nucleic acids encoding variant antibodies that comprise disparate amino acid sequences, including numerous differences in linear and conformational epitopes. The specification does not provide sufficient guidance as to which of the 13 amino acids, for example, of the heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO:193 may be changed while structural or functional activity and specificity of the antibody is retained. It is well established in the art that the formation of an intact antigen-binding site requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three different complementarity determining regions, CDR 1,2 and 3, which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin and that single amino acid changes in a CDR can abrogate the antigen binding function of an antibody
As stated above the antibody sequences which are not fixed by the instant claim language can be effectively random and thus there does not appear to be any predictability as to which sequences will or will not maintain antigen binding activity except for those which have six fully defined non-degenerate CDR sequences, three in the VH and three in the VL. Thus, there is no disclosed data which would reasonably allow artisans to make the full breadth of what is encompassed by the instant claim language.
Claim rejections-35 USC § 112(b)
7. 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.
7a. Claim 39 is 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 pre-AIA the applicant regards as the invention.
Claim 39 is rejected as vague and indefinite because it recites CCXX (equivalent to 220 in Arabic numerals) different species of antibodies. Applicant has elected (See response filed 1/7/2026) species of antibody comprising (1) the CDRs1-3 of a VH comprising the sequence of SEQ ID NO: 64, (2) the CDRs1-3 of a VL comprising the sequence of SEQ ID NO: 5, (3) a VH comprising the sequence of SEQ ID NO: 64, and (4) a VL comprising the sequence of SEQ ID NO: 5, which corresponds to claim 39, subparts (cxvii)-(cxviii), (equivalent to 117-118 in Arabic numerals), respectively. It is unclear which of the 220 species of antibodies recited in claim 39 encompasses the elected species. Appropriate correction of the claim is requested.
Conclusion
No claim is allowed.
Claims 38-41, and 43-45 are rejected.
THIS ACTION IS MADE FINAL. 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.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PREMA MARIA MERTZ whose telephone number is (571)272-0876. The examiner can normally be reached on Monday to Thursday from 7:30am to 6:00pm.
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1674
