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 .
Status of Claims
Applicant’s election for continued examination without traverse of the species of antibody 43B1-H2L2; VH and VL sequences of SEQ ID NOs: 68 and 69, respectively; IMGT CDR sequences of SEQ ID NOs: 42-47 and AbM CDR sequences of SEQ ID NOs: 48-52 and 47, filed in the reply on 08/14/2025 is acknowledged. Claim 9 does not read on the elected species and is withdrawn from examination. Claims 1-8, 10-21, and 23-27 are currently pending and under examination.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 12/13/2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The foreign priority document is not in English, so the examiner cannot determine if it discloses the claimed invention. Therefore, for the purposes of applying prior art, the effective filing date is 12/08/2020, the date that PCT/CN2020/134438 was filed.
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 1-8, 10-21, and 23-27 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 claims contain 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.
Regarding claim 1, the limitation regarding the “sequence variant is a CDR having a substitution, deletion, or addition of one or more amino acids…” sweeps in all CDRs with up to three residue changes including additions/deletion for each of six VH and six VL sets. The Specification demonstrates the functional activity of antibodies with six specific CDR domains or with specific light and heavy chains (Specification, pgs. 54-56). The whole genus of possible 1-3 residue variants taught by claim 1 is not evidenced and is there unsupported by the Specification.
Claims 2-8, 10-21, and 23-27 directly or indirectly depend from claim 1 and fail to overcome the unsupported deficiencies of claim 1.
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 1-4, 6-7, 9, 11-12, 14, 18, 22-24, and 26 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.
1. Regarding claim 1, antibodies are claimed by CDR sequence variants of the VH and VL but limitations do not specify the numbering scheme used. Therefore, it is unclear whether the claim requires antibodies to have the amino acids that correspond to the AbM scheme, the IMGT scheme, or some other CDR numbering scheme such as Kabat or Chothia. The person of skill in the art cannot determine where the boundary of claim 1 lies, because the CDR numbering scheme is not defined.
Claims 2-8, 10-21, and 23-27 are rejected as they depend from claim 1, but do not remedy the deficiencies introduced by claim 1.
2. The use of the ambiguous expressions "at least one CDR contains a mutation" in claim 2, the use of "e.g.", "such as" appearing in claims 6, 11-12, 18, 22, and "less than about" appearing in claim 12, result in an inaccurate definition of the scope of protection of the claims, such that the scope of protection is unclear and renders the claims indefinite because it is unclear which limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
3. In addition, the use of expressions such as “preferably,” or “optionally” in claims 1-4, 6-7, 9, 14, 22-24, and 26 renders these claims indefinite because the two or more different ranges of protection introduced by such expressions creates questions or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Allowable Subject Matter
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Claims 1 is allowable over the prior art. The closest prior art that matches SEQ ID NO: 68 of claim 1 is heavy chain of a human anti-IL-2 antibody disclosed as SEQ ID NO: 241 by Butz and Thomson (WO2016164937) with an 84.0% query match.
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Furthermore, the closest prior art that matches SEQ ID NO: 69 of claim 1 is light chain variable region SEQ ID NO: 202 of a monoclonal human antibody that binds to growth differentiation factor 8 as disclosed by Stitt and Latres (WO2011150008) with a 97.1% query match.
Since elected species of claim 1, VH and VL sequences of SEQ ID NOs: 68 and 69, respectively, were found allowable over the prior art, the remaining non-elected species within claim 1 were also searched over the prior art in accordance with MPEP 803.02(III)(C)(2).
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In regard to VH SEQ ID NO: 1, the closest prior art is SEQ ID NO: 7855 Adeno-associated viral (AAV) bispecific amino acid for treating influenza disclosed by Hou et al. (WO2020223279) with a 89.8% query match.
In regard to VH SEQ ID NO: 17, the closest prior art is VH SEQ ID NO: 39 anti-OX40 antibody disclosed by Zheng et al. (WO2019214624) with a 85.3% query match.
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In regard to VH SEQ ID NO: 30, the closest prior art is heavy chain SEQ ID NO: 285 of an antibody used for strengthening or weakening insulin or insulin receptor complex binding affinity disclosed by Corbin et al. (US8926976) with a 83.5% query match.
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In regard to VH SEQ ID NO: 40, the closest prior art is VH SEQ ID NO: 241 of a human anti-IL-2 antibody disclosed by Butz et al. (WO2016164937) with a 85.1% query match.
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In regard to VH SEQ ID NO: 53, the closest prior art is VH SEQ ID NO: 1642 of a human germline-derived antibody disclosed by Bazirgan et al. (WO2010054007) with a 87.7% query match.
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In regard to VL SEQ ID NO: 2, the closest prior art is VL SEQ ID NO: 107 of an immunoglobulin polypeptide that specifically binds to cancer antigen TES7 disclosed by Mather and Liang (WO2008066691) with a 98.0% query match.
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In regard to VL SEQ ID NO: 18, the closest prior art is an anti-platelet autoantibody-related light chain SEQ ID NO: 75 disclosed by Siegel (WO2004005890) with a 97.3% query match.
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In regard to VL SEQ ID NO: 31, the closest prior art is VL SEQ ID NO: 64 of an anti-Middle East Respiratory Syndrome coronavirus (MERS-CoV) spike protein (MERS-S) antibody disclosed by Grosveld et al. (WO2020169755) with a 98.0% query match.
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In regard to VL SEQ ID NO: 41, the closest prior art is VL SEQ ID NO: 202 of an anti-growth differentiation factor 8 (GDF8) antibody disclosed by Stitt and Latres et al. (WO2011150008) with a 96.4% query match.
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In regard to VL SEQ ID NO: 54, the closest prior art is anti-Rh(D) light chain SEQ ID NO: 107 disclosed by Siegel (US8124742) with a 96.0% query match.
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Conclusion
No claim is allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS GEORGE whose telephone number is (571)270-0340. The examiner can normally be reached M-F 8:30am - 5pm EST.
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/DENNIS GEORGE/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644