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
Applicants’ election without traverse of Group IV, claims 13-16, in the reply filed on 02 January 2026 is acknowledged.
Applicants’ election without traversal of the species of polypeptide (SEQ ID NO: 85) and the single and specific variables for B1-B8, B11, and U1-U9 in the reply filed 02 January 2026 is acknowledged.
Claims 1-12 and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 02 January 2026.
Applicants added claims 22-29 and assert that said claims depend on claim 13 and read on the elected species.
Applicants’ amendment of claim 13, in the preliminary amendment filed 23 February 2026 is acknowledged.
Claims 13-16 and 22-29 are under consideration.
Status of Claims
The claim listing filed 23 February 2026 is pending. Claims 1-12 and 17-20 are withdrawn from further consideration for the reasons set forth above, 37 CFR 1.142(b). Claims 13-16 and 22-29 are being examined on the merits of this office action.
The search was expanded to the full scope of the claims. The closest match to the elected peptide of SEQ ID NO: 85 is a sequence described by McPherson and Tomlinson (US 9932575 B2) with 86.9% sequence similarity.
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The restriction between Groups I-V is -maintained.
Priority
The present application claims benefit under 35 U.S.C. 119(e) to U.S. Provisional Application No. 63/336,633 filed 29 April 2022. Applicants claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) submitted on 08/01/2023, 08/24/2023, 11/10/2023, 06/10/2024, 11/13/2024, 01/27/2025, 04/21/2025, 01/02/2026, and 02/23/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
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 13-14 and 22-29 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.
Claim 13 references a “wild-type affimer sequence” without clearly stating what said sequence is. The body of the claims recites “… provided that at least 1, 2, 3, 4, or 5 amino acids of B1-B4 and U1-U9 do not correspond to the amino acid of a wild-type affimer sequence”. In view of the specification, one would deduce that the affimer sequence is described in Table 2A (SEQ ID NO: 8), but this is not sufficient as importing limitations from the specification into the claims is improper. Without importing the limitation as described by the specification (para. [0060] “The wild-type affimer sequence is provided in Table 2A.”; See Table 2A), one of ordinary skill in the art would be unable to take the content of claim 13 and ascertain what an “amino acid of the wild-type affimer sequence” is.
Claims 14-16 and 22-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, due to their dependency on claim 13, a rejected claim, without informing one of ordinary skill in the art of what an “amino acid of the wild-type affimer sequence” is.
Note: Amending claim 13 to include the SEQ ID NO: of the wild-type affimer sequence would put claim 13 and the claims that depend from it in a state eligible for allowance.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Claim 13, and all its dependent clams, would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. The following claim 13 is drafted by the examiner and considered to distinguish patentably in this application, is presented to applicant for consideration:
13. (Currently Amended) A polypeptide comprising a sequence ATGVRAB1B2B6NENB3LEIEELARFAVDEHNKKENALLEFVB7VB8KAKEQVVAB4TMYYLTLEAKDB11GKKKLYEAKVWVKU1U2U3U4U5U6U7U8U9NFB5ELQEFKPVGDA (SEQ ID NO: 196), wherein each of B1-B8 and U1-U9 are independently an amino acid, provided that at least 11-B4 and U1-U9 do not correspond to amino acid residues located in positions 7, 8, 13, 50, and 76-84, or combinations thereof, according to the wild-type affimer sequence, as provided in SEQ ID NO: 8.
SEQ ID NO: 196 was not taught in the prior art in a 100% embodiment before the effective filing date of the claimed invention. The closest match to the instant sequence is a sequence disclosed by McPherson and Tomlinson (US 9932575 B2), as shown below. McPherson and Tomlinson teach SEQ ID NO: 3, which shares 93.3% sequence similarity to the instant SEQ ID NO: 196, as seen below.
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Claims 16, and 23-28 are objected to as being dependent upon a rejected base claim (claim 13), but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, due to SEQ ID NO: 85 being free of the prior art, as shown below.
SEQ ID NO: 85 was not taught in the prior art in a 100% embodiment before the effective filing date of the claimed invention. The closest match to the instant sequence is a sequence disclosed by McPherson and Tomlinson (US 9932575 B2), as shown below. McPherson and Tomlinson teach SEQ ID NO: 3, which shares 86.9% sequence similarity to the instant SEQ ID NO: 85, as seen below.
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Due to SEQ ID NO: 85 being free of the prior, the search was expanded to include SEQ ID NOs: 60, 67, 77, and 86-88 (See claim 16).
SEQ ID NOs: 60, 67, 77 and 86-88, as recited in claim 16, were not taught in the prior art in a 100% embodiment. The closest match to the instant sequences is a sequence disclosed by McPherson and Tomlinson (US 9932575 B2), as shown below. McPherson and Tomlinson teach SEQ ID NO: 3, which shares 87.4% sequence similarity to the instant SEQ ID NO: 60, 86.8% sequence similarity to the instant SEQ ID NO: 67, 85.2% sequence similarity to the instant SEQ ID NO: 77, 85.7% sequence similarity to the instant SEQ ID NO: 86, 85.0% sequence similarity to the instant SEQ ID NO: 87, and 87.4% sequence similarity to the instant SEQ ID NO: 88, as shown below.
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Therefore, the prior art neither anticipates nor reasonably makes obvious the claimed invention and therefore, the claimed invention is deemed novel and unobvious over the prior art.
Summary
Claims 13-16 and 22-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Daliyah M. Brown whose telephone number is (571)272-0136. The examiner can normally be reached Monday-Thursday 9:00 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Daliyah M. Brown/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654