DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s election without traverse of Group I (claims 35-44 and 51) and species of antibody 16-H16A which is characterized by the variable light and heavy chains of SEQ ID NOS: 25 and 26, respectively, containing the CDRs of SEQ ID NOS: 119, 120, 121, 122, 123, and 124 in the reply filed on 11/20/2025 is acknowledged.
3. Upon further consideration, the requirement for species election set forth in the office action mailed on Oct. 6, 2025 is withdrawn. All antibodies in claims 35 and 37 have been examined.
4. Claims 35-54 are pending. Claims 1-34 are canceled. Claims 45-50 and 52-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/20/2025.
5. Claims 35-44 and 51 are under examination.
Information Disclosure Statement
6. The information disclosure statements (IDS) submitted on 7/10/2022, 1/11/2023, 2/5/2024, 4/15/2024, 9/3/2024, 10/7/2024 and 11/21/2025 have been considered by the examiner.
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.
7. 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). See paragraph [0040], for example.
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.
Abstract
8. The abstract of the disclosure is objected to for use of the word “novel”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
Specification
9. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see paragraph [0062], for example. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
10. The disclosure is objected to for referring an amino acid sequence with a SEQ ID NO that contains a prohibited sequence, see paragraphs [0007], [0009], [0017]-[0022], [0093], [0095], [0097], [0099], [0101], [0103], [0105], [0107], [0109], [0111], [0113], [0115], [0117], [0119], [0121], [0123], [0125], [0127], [0129], [0131], [0133], [0147], [0148], and [0159]-[0161]. Prohibited sequences are those with <10 specifically defined nucleotides or <4 specifically defined amino acids. SEQ ID NOs containing prohibited sequences (skipped sequences) do not have any sequence data in sequence listing. Applicant should amend the specification to replace all relevant SEQ ID NOs with the actual sequences, if originally disclosed. All references to the relevant SEQ ID NOs must be removed from the specification. For example SEQ ID NO:123 does not have any sequence data, and should be replaced with the actual sequence DTS.
Claim Objections
11. Claims 36 and 38 are objected to for the following reasons. Claims 36 and 38 depend from claims 35 and 37, respectively. A single antibody can’t be an antagonist and an agonist for BTLA at the same time. It is unclear which antibodies of claim 35 and 37 are antagonist, and which are agonist.
Claim Rejections - 35 USC § 112
12. 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.
13. Claims 37-44 and 51 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 37-44 and 51 are indefinite for reciting SEQ ID NOs: 111, 123, 135, 141 and 153. Each of these SEQ ID NOs contains a prohibited sequence (a skipped sequence). Prohibited sequences are those with <10 specifically defined nucleotides or <4 specifically defined amino acids. These SEQ ID NOs do not have any sequence data in sequence listing. Therefore, the metes and bounds of the claimed invention cannot be determined and the claims are indefinite.
Applicant should amend the claims to replace these SEQ ID NOs with the actual sequences, if originally disclosed. For example SEQ ID NO:123 does not have any sequence data, and should be replaced with the actual sequence DTS.
Claim Rejections - 35 USC § 112
14. 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.
15. Claim 43 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 43 does not further limit the subject matter of claim 37. Specifically, claim 43 does not further limit the BTLA binding fragment of claim 37.
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
16. All claims are free of prior art. Claim 35 is allowable. Claim 37-44 and 51 are rejected. Claim 36 is objected to.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
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/HONG SANG/Primary Examiner, Art Unit 1646