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 .
Election/Restrictions
Applicant's election with traverse of Group I, corresponding to claims 1-4 and 6, as amended, in the reply filed on 06/08/2026 is acknowledged. The traversal is on the ground(s) that the shared feature of an antibody having an IgA Fc domain in view of Nawa et al defines the common technical feature too broadly. Applicant has amended claim 1 to now additionally encompass a light chain comprising the amino acid sequence of SEQ ID NO: 2. This is not found persuasive because although Claim 1 recites defined monoclonal antibody chains, Groups I – III do not share this common feature. Specifically, Group III Claim 30 does not require the defined structural limitations of Claim 1. Thus, the shared common feature between Groups I – III is an antibody wherein the heavy chain or a segment of the heavy chain comprises an Fc region characterized as IgA Fc domain.
The requirement is still deemed proper and is therefore made FINAL.
Claims 20, 21, 24 – 26, and 30 – 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claims 5, 7 - 19, 22, 23, 27 – 29, and 39 – 42 have been cancelled.
Claims 1 – 4 and 6 are under consideration.
Priority
This is a National Stage Entry under 35 U.S.C. 371 of International Patent Application No. PCT/US2022/075260, filed, on August 22, 2022. This application also claims priority to US Provisional Application No. 63/235,325, filed on August 20, 2021.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
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 incorporation-by-reference paragraph, 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
Claim 1 is objected to because of the following informalities: the claims read “an amino acid sequence of.” The claims should read “the amino acid sequence of.” Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 and 6 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.
Regarding claim 1, the transitional phrase “having” is unclear as to whether open or closed claim language is intended. The variable regions of the antibody may be defined by the exact SEQ ID NO: 1 and 2 or may be comprised of SEQ ID NO: 1 and 2. See MPEP 2111.03 (IV). For purposes of compact prosecution and examination, “having” is interpreted as “comprising”.
Regarding claim 1, there are no CDRs defined by a CDR labeling system, thus rendering the claim indefinite. The claims could read on Kabat, IMGT, or Chothia CDRs, for example, giving multiple structural interpretations. The claims could also read on composite CDRs such as those including both Kabat and IMGT CDRs. The claim may also allow mixing and matching from multiple labeling systems, some from Kabat, some from IMGT, etc. The presence of so many different interpretations render the claims indefinite.
The dependent claims do not add additional clarity and, therefore, are also indefinite.
Claim Rejections - 35 USC § 112 – Dependence
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 defines “An isolated monoclonal antibody, comprising: a heavy chain having an amino acid sequence of SEQ. ID NO. 1 and a light chain having an amino acid sequence of SEQ ID NO: 2, wherein the heavy chain or a segment of the heavy chain comprises an Fc region characterized as IgA Fc domain.” Claim 6 recites “The isolated monoclonal antibody of claim 1, wherein the isolated monoclonal antibody binds an epitope of a Deng virus, wherein the epitope is characterized as a loop.” Claim 6 does not further limit any aspect of claim 1 because claim 1 already defines the heavy and light chain regions by SEQ ID NO: 1 and 2 respectively, claim 6 merely recites a property inherent of the antibody defined in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danyal H Alam whose telephone number is (571)272-1102. The examiner can normally be reached M - F 9am - 5pm.
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/DANYAL HASSAN ALAM/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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