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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, the certified copy of KR 10-2021-0094792 is not a certified English translation. Therefore, the claims are examined with an effective filing date of July 20, 2022.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
Paragraphs 185, 186, 206, and 262 contain amino acid sequences greater than 3 residues in length, but do not note SEQ ID NOs next to the sequences.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Objections
Claims 12 and 13 are objected to because of the following informalities:
Claims 12 and 13 recite “the anti-β-catenin antibody or antigen-binding fragment thereof”. Claims 12 and 13 depend from claim 7 which recites the cytosol-penetrating antibody according to claim 5 and claim 5 recites “the antibody binding to β-catenin or antigen-binding fragment thereof”.
While perhaps not rising to the level of indefiniteness, the claims could be made clearer by referring to the β-catenin antibody consistently throughout the claims (i.e. using either “the anti-β-catenin antibody or antigen-binding fragment thereof” or “the antibody binding to β-catenin or antigen-binding fragment thereof” throughout).
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.
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 1-24 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.
Claims 1-3 recite that the antibody comprises an antibody region (ie. a light chain CDR1, etc.) “of” a SEQ ID NO. It is unclear whether “of” means the region consists or comprises the sequence recited.
Claims 4-24 ultimately depend from claim 1 and are rejected for failing to remedy the indefiniteness of claim 1.
Claims 5 and 22-24 recite “a substance targeting a tumor cell- or tissue-specific antigen”. It is unclear whether “tissue-specific” means tumor tissue-specific or any tissue. For the purpose of compact prosecution, the claims are interpreted as requiring a substance targeting a tumor cell- or tumor tissue-specific antigen. Substance is interpreted as “a ligand, oligopeptide, antibody, fragment or aptamer” according to the exemplification in paragraph 181. Thus, substance is interpreted as anything capable of binding a tumor cell- or tumor tissue-specific antigen.
Claims 6-14, 16, 17, and 21 depend from claim 5 and are rejected for failing to remedy the indefiniteness of claim 5.
Claim 7 recites a cell-penetrating degrading antibody designed by further fusing the cytosol-penetrating antibody of claim 5 with a U-Box or E3 recruiter. The limitation “designed” makes unclear whether the product itself is claimed or the abstract idea or conceptualization of the product is claimed. For the purpose of compact prosecution, the claim is interpreted as follows: “A cell-penetrating degrading antibody comprising the cytosol-penetrating interfering antibody according to claim 5 fused to a U-Box or E3 recruiter.”
Additionally, claim 7 recites a parenthetical “(Degrobody)” which also appears to be a trade name. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the degrading antibody and, accordingly, the identification/description is indefinite.
Claims 8-14 and 21 depend from claim 7 and are rejected for failing to remedy the indefiniteness of claim 7.
Claim 21 part (1) recites “cloning a nucleic acid including a heavy chain containing a heavy chain variable region (VH) capable of targeting β-catenin”. Similar to claims 12 and 13 which were also depending from claim 7 and ultimately claim 5 and 1, claim 21 again uses different language to refer to what is presumed to be the “antibody binding to β-catenin” of claim 1. However, combined with the limitations “a heavy chain” and “a heavy chain variable region”, it makes more unclear whether we are cloning to express the heavy chain of the “antibody binding to β-catenin” of claim 1 or any antibody targeting β-catenin. A similar issue arises in part (2) regarding the light chain. Additionally, for more precise language “including” in parts (1) and (2) should be replaced with “encoding”. For the purpose of compact prosecution, the claim is interpreted as requiring cloning nucleic acids encoding a heavy chain and a light chain which comprises the CDRs of the “antibody binding to β-catenin” of claim 1.
Finally, “an antibody” in lines 5 and 9 is unclear. Is “an antibody” supposed to be the “substance” recited in claim 5? The instant disclosure (paragraph 107) states that “antibody” used herein refers to an anti-β-catenin antibody. Is the method making a product with three anti-β-catenin antibodies (one and a half split across parts (1) and (2))? If this is correct, then do all three anti-β-catenin antibodies have to comprise the CDRs of claim 1? And where is the “substance targeting a tumor-cell or tumor tissue-specific antigen” from claim 5, from which this claim ultimately depends, in this method? For the purpose of compact prosecution, the claim is interpreted as further requiring a nucleic acid encoding the “substance” of claim 5 in part (1) and/or (2).
Claims 5 and 22-24 recite products (e.g. a conjugate, a bispecific or multispecific antibody, a composition) and further recite action steps (i.e. binding to the antigen, undergoing endocytosis, and being located in the cytosol of cells through endosomal escape ability thereof). These actions, while in the context of the specification appear inherent to the cytosol-penetrating interfering antibody, only arise upon in vitro or in vivo treatment. Thus, these action limitations make unclear whether the claimed attempt to recite merely a product or a method of use.
Allowable Subject Matter
While no claim is currently allowed, the prior art does not teach an antibody or fragment thereof which binds β-catenin and comprising VL CDRs comprising SEQ ID NOs: 1, 2, and 3 or 4, and VH CDRs comprising SEQ ID NOs: 5, 6 or 7, and 8 or 9, and further comprising a VH comprising SEQ ID NOs: 17, 18, or 19 and a VL comprising SEQ ID NOs: 20 or 21.
The closest prior art is Kim et al. (KR 10-2016-0011598; Published: February 1, 2016; Cited on the IDS filed: January 19, 2024) teaches cell penetrating antibodies comprising a cytosol penetrating light chain. However, the antibodies of Kim et al. do not comprise the instantly claimed combination of CDRs.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE ANN HOLTZMAN whose telephone number is (571)270-0252. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm MT.
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/KATHERINE ANN HOLTZMAN/Examiner, Art Unit 1646
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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