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 .
DETAILED ACTION
Claim Status
Applicant’s amendment filed May 24, 2023 has been received and entered.
Claims 1-47 have been canceled.
Claims 48-68 have been added.
Claims 48-68 are pending and under consideration.
Priority
This application is a 371 of PCT/IL2021/051390 filed November 23, 2021, which claims priority to U.S. Provisional Application filed November 24, 2020.
Information Disclosure Statements
The information disclosure statements (IDSs) submitted on May 24, 2023, May 26, 2023, July 17, 2023, and July 1, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 48-51, 55, 58, 62-66, and 68 are objected to for the following informalities:
Claim 48 has inconsistent use of the oxford comma. For example, line 9 recites “SEQ ID NOs: 8, 9, and 10”, while line 10 recites “SEQ ID NOs: 24, 25 and 26”.
Claim 48 - recites both SEQ ID NO: and SEQ ID NOs: when referring to multiple amino acid sequences.
Claim 48 (lines 1-3) - the language of the claim preamble is awkward. The claim should read, “A humanized monoclonal antibody (mAb), a fragment of the humanized mAb, or a conjugate of the humanized mAb that binds specifically to sialyl Lewis A glycan (SLeA)…”
Claim 48 (line 2) - sialyl should not be capitalized.
Claim 48 (line 7) - should read “the VH-CDR2 comprises an amino acid sequence…”.
Claim 48 (line 9) - should read “the VH-FR 1, 2 and 3 comprise amino acid sequences…”.
Claim 48 (line 10) - should read “the VH-FR4 comprises an amino acid sequence…”.
Claim 48 (line 11) - should read “the VL-FR1 comprises an amino acid sequence…”.
Claim 48 (line 12) - should read “the VH-FR 2, 3 and 4 comprise amino acid sequences…”.
Claim 49 part (v) - should read “the VH comprises an amino acid sequence…” and “the VL comprises an amino acid sequence”.
Claim 50 part (iii) - is missing punctuation and a preposition to connect part (iii) and part (iv). Applicant may amend the claim to read “has an IgG structure; or (iv)…” to overcome the objection.
Claim 51 - should read “the scFv comprises an amino acid sequence…”.
Claim 55 - should read “comprising an scFv…”.
Claim 58 (line 4) - should read “or any combination thereof”.
Claim 62 (line 1) - should read “comprising an scFv…”.
Claim 62 (line 4) - should read “or a combination thereof”.
Claim 63 (line 2) - should read “or a CAR…”.
Claim 64 (line 4) - should read “comprising a nucleic acid sequence…”.
Claim 64 (lines 3 and 5) - missing the colon (:) after SEQ ID NO:.
Claim 65 (line 2) - should read “a CAR comprising…”.
Claim 65 (line 3) - should read “or a nucleic acid molecule…”.
Claim 66 - should read “wherein the cell expresses or is capable of expressing…”.
Claims 63, 65, and 68 - recite “humanized monoclonal antibody”, however, the phrase was abbreviated as “humanized mAb” in claim 48 of which the objected claims depend from.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 48, 50-53, and 55-68 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 48 (lines 9-13) recites amino acid sequences for VH-FR 1, 2, and 3 (SEQ ID NO: 24, 25, and 26, respectively), VH-FR4 (SEQ ID NO: 27 or 32), and VL-FR1 (SEQ ID NO: 28 or 33). However, the claim does not recite the amino acid sequences for VL-FR 2, 3, or 4. Lines 12-13 recite the VH-FR 2, 3, and 4 have amino acid sequences 29, 30, and 31, respectively, which appear to be the VL-FR 2, 3, and 4 amino acid sequences. However, the specification only recites SEQ ID NOs: 29, 30, and 31 as VL-FR amino acid sequences one time [0008], while it recites the same SEQ ID NOs as VH-FR amino acid sequences four times [0035], [0051], [0073], and [0103]. Therefore, one of ordinary skill in the art could not determine whether the amino acid sequences represented by SEQ ID NOs: 29, 30, and 31 correspond to VH or VL framework regions.
Claims 50-53 and 55-68 are included in the rejection because they depend from or otherwise require all the limitations of a rejected independent claim and fail to clarify the issue.
Claims 49 and 54 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 49 and 54 - lack clarity because part (i) recites SEQ ID NO: 13 is a VL amino acid sequence and SEQ ID NO: 14 is a VH amino acid sequence, while part (iv) recites SEQ ID NO: 13 is a VH amino acid sequence and SEQ ID NO: 14 is a VL amino acid sequence. Although the instant specification lists SEQ ID NO: 13 as the VL sequence of the HuNative antibody and SEQ ID NO: 14 as the VH sequence of the HuRA9-23 antibody [0139], it is unclear how a VL can be a VH, or vice versa, as recited in the instant claims.
Claims 50-51 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 50 part (i) recites the humanized mAb bindis SLeA glycan with a KD of 0.1 to 30 nM, however, no methods of measuring KD are provided. One of ordinary skill in the art would recognize that there are different methods for measuring KD, and as such one would obtain different KD values. Accordingly, without a method for measuring KD, one would not know whether or not they were infringing on the claims.
Claim 50 part (ii) recites selectivity to SLeA glycan is at least 90%, however, it is unclear how selectivity is measured or what SLeA glycan selectivity is being compared to. Although the instant disclosure provides one example, SLeX, the claim language allows for binding of any closely related carbohydrate antigen with up to 90% selectivity [0062]. Therefore, one of ordinary skill would not know if they were infringing on the claims if they choose a different SLeA glycan or a different method to measure selectivity than what is disclosed in the instant specification.
Claim 50 part (iii) recites the antibody or fragment has an IgG structure. It is unclear how an antibody fragment would have an IgG structure when fragments (e.g., scFvs) do not comprise an IgG structure.
Claim 51 is included in the rejection because it depends from the rejected independent claim and fails to clarify the issues.
Claims 57-58 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 57-58 recite the phrase “an analog thereof having at least 85% amino acid identity to the original sequence”. The claims lack proper antecedent basis, because it is unclear which sequence is “the original sequence”. Therefore, one would not know whether a given sequence is at least 85% identical to the original sequence, if that sequence is undefined.
Claim 58 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 58 recites “an analog thereof having at least 85% amino acid identity to the original sequence and any combination thereof”. It is unclear what “any combination thereof” is referring. Is it a combination of the original sequence and the analog? Or does it refer to a combination of the various costimulatory domains?
Claims 65-67 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 65 (line 4) recites “the fragment of the CAR”, however, it is unclear what CAR fragment the claim is referring to.
Claims 66-67 are included in the rejection because they depend from or otherwise require all the limitations of a rejected independent claim and fail to clarify the issue.
Claims 68 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 68 recites “a composition comprising the human mAbs or fragments thereof or the conjugates according to claim 48”. It is unclear whether the composition requires all of the antibodies recited in claim 48, or if it is a composition of one or more of the antibodies recited in claim 48. Therefore, one of ordinary skill in the art would not be able to ascertain the metes and bounds of the claim.
Appropriate correction is required.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter.
Claim 48 is drawn to humanized monoclonal antibody (mAb), a fragment of the humanized mAb, or a conjugate of the humanized mAb that binds specifically to sialyl Lewis A glycan (SLeA) comprising a heavy-chain variable domain (VH) and a light-chain variable domain (VL), wherein the VH and the VL each comprises three complementarity determining regions (CDRs) and four framework regions (FR), wherein the VH-CDRs 1 and 3 comprise amino acid sequences SEQ ID NOs: 5 and 7, respectively, the VH-CDR2 comprises amino acid sequence selected from SEQ ID NOs: 6 and 11, the VL-CDRs 1, 2, and 3 comprise amino acid sequences SEQ ID NOs: 8, 9, and 10, respectively.
The anti-SLeA antibody, further comprising a VH-FR 1, 2 and 3 with amino acid sequences SEQ ID NO: 24, 25 and 26, respectively, a VH-FR4 with amino acid sequence selected from SEQ ID NO: 27 and 32, a VL-FR1 with amino acid sequence selected from SEQ ID NO: 28 and 33, and a VL-FR 2, 3 and 4 have amino acid sequences SEQ ID NO: 29, 30, and 31, respectively.
There is no prior art that teaches or suggests an anti-SLeA antibody comprising the specific CDR and framework amino acid sequences as recited in the instant claims. The closest prior art, WO 01/27159 (cited IDS 5/26/2023) is directed towards the parent anti-CA19-9 antibody 111-NS-19-9 which served as a template for the presently claimed humanized anti-SLeA antibody, however, does not teach or suggest the presently claimed method with the specific CDR and framework sequences.
Conclusion
No claim is allowed.
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/MAUREEN VARINA DRISCOLL/ Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644