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 reply filed on 1/23/2026 is acknowledged. Claim 12 is pending. Claims 1-11 and 13-85 are canceled. Claim 12 has been amended.
3. Claim 12 is under examination.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on 1/23/2026 has been considered by the examiner.
Application Data Sheet (ADS)
5. Applicant’s submission of a corrected ADS with a filing date of April 6, 2015 for Application No. 62143772 is acknowledged.
Rejections Withdrawn
6. The rejection of claim 12 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of applicant’s amendments.
7. The rejection of claim 12 under 35 U.S.C. 102(a)(1) as being anticipated by Nord et al. (Eur J Biochem, 2001, 268, 4269-4277), as evidenced by Feldwisch et al. (J Mol Biol, 2010, 398:232-247) is withdrawn in view of applicant’s amendments.
8. The rejection of claim 12 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,662,248, in view of Hey et al (TRENDs in Biotechnology, 2005, 23(10): 514-522, IDS filed on 7/14/2025) is withdrawn in view of applicant’s amendments.
Rejections Maintained
Double Patenting
9. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
10. Claim 12 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,008,397, in view of Hey et al (TRENDs in Biotechnology, 2005, 23(10): 514-522, IDS filed on 7/14/2025)
Claim 1 of U.S. Patent No. 11,008,397 discloses a de novo binding domain polypeptide (DBDpp), wherein a) the DBDpp comprises three anti-parallel alpha helices joined by linker peptides; b) the DBDpp comprises the amino acid sequence of SEQ ID NO:1 comprising 1 to 30 substitutions selected from the group consisting of substitutions of residues 5, 6, 8-10, 12, 13, 15-17, 19-27, 29, 30, 32-34, 36, 37, 39-41, 43-52, 54, 55, 57-59, 61, 62, 64-66, and 68 of SEQ ID NO: 1, substitution of residues 22-24 of SEQ ID NO: 1 with Z1, and substitution of residues 46-49 of SEQ ID NO: 1 with Z2, wherein Z1 and Z2 independently comprise 2 to 30 amino acids; c) the DBDpp does not comprise the amino acid sequence of SEQ ID NO:50; and d) the DBDpp specifically binds a target of interest,
wherein the target of interest specifically bound by the polypeptide is a cancer antigen, wherein the cancer antigen is PD-L1, CD137, or CD123.
The claims of the patent further disclose an isolated nucleic acid molecule encoding the polypeptide, and a host cell comprising the nucleic acid molecule.
The claims of the patent do not disclose using the de novo binding domain polypeptides in a method of screening a target of interest.
Hey et al. teaches “In general, the applicability of a given scaffold as an
artificial binding protein consists of two steps: diversification and selection. Both of these steps can be realized via well-established methods known from combinatorial antibody engineering approaches, for example, the generation of complex synthetic libraries combined with powerful in vitro or in vivo selection strategies.” (page 516, column 1, para 2). Hey et al. teaches that using phage display or a yeast two-hybrid system, protein binding variants could be isolated (page 517, last para).
It would have been obvious to have used the de novo binding domain polypeptides in a method of screening a target of interest, wherein the method comprises diversification as disclosed in the claims of the patent and selection of specific binders by phage display as taught by Hey et al. One would have been motivated to do so with a reasonable expectation of success because the claims of the patent disclose a scaffold with positions to be modified (diversification), and the method of selecting binders by phage display was well known in the art as shown by Hey.
Applicant’s Arguments
The response states that the cited claims in U.S. Patent Nos. 11,008,397 do not relate to any method that transforms a reference polypeptide that comprises the amino acid sequence of SEQ ID NO: 1 into a target-binding polypeptide comprising a DBDpp or any method of screening the polypeptides. Further, Hey does not teach or suggest applying diversification and selection strategies to a reference polypeptide that comprises the amino acid sequence of SEQ ID NO: 1 to generate a target-binding polypeptide comprising a DBDpp. In view of this, none of the cited references, when considered alone or in combination, render claim 12 patentably indistinct from claims 1-13 of U.S. Patent No. 11,008,397.
Examiner’s Response
Applicant’s arguments have been carefully considered but are not persuasive. Claim 1 of U.S. Patent No. 11,008,397 discloses a de novo binding domain polypeptide (DBDpp) that binds to a target of interest and comprises SEQ ID NO:1 modified by 1-30 amino acid substitutions, wherein the substitutions are selected from the group consisting of substitutions of residues 5, 6, 8-10, 12, 13, 15-17, 19-27, 29, 30, 32-34, 36, 37, 39-41, 43-52, 54, 55, 57-59, 61, 62, 64-66, and 68 of SEQ ID NO: 1, substitution of residues 22-24 of SEQ ID NO: 1 with Z1, and substitution of residues 46-49 of SEQ ID NO: 1 with Z2, wherein Z1 and Z2 independently comprise 2 to 30 amino acids. The amino acid sequence of SEQ ID NO:1 is 100% identical to instant SEQ ID NO:1.
The claims of the patent further disclose that the target of interest is a cancer antigen, such as PD-L1, CD137, or CD123.
The claims of the patent further disclose an isolated nucleic acid molecule encoding the polypeptide, and a host cell comprising the nucleic acid molecule.
Substitutions of a plurality of amino acids in SEQ ID NO:1 would necessarily result in generation of a plurality of candidate binding polypeptides (a library). To identify a binder that binds to a target of interest such as PD-L1, one would have to screening the library, as evidenced by Hey et al..
Hey et al. teaches “In general, the applicability of a given scaffold as an
artificial binding protein consists of two steps: diversification and selection. Both of these steps can be realized via well-established methods known from combinatorial antibody engineering approaches, for example, the generation of complex synthetic libraries combined with powerful in vitro or in vivo selection strategies.” (page 516, column 1, para 2). Hey et al. teaches that using phage display or a yeast two-hybrid system, protein binding variants could be isolated (page 517, last para).
It would have been obvious to have used the de novo binding domain polypeptides of the patent in a method of screening a target of interest, wherein the method comprises diversification as disclosed in the claims of the patent and selection of specific binders by phage display as taught by Hey et al. One would have been motivated to do so with a reasonable expectation of success because the claims of the patent disclose SEQ ID NO:1 with positions to be modified (diversification), and the method of selecting binders by phage display was well known in the art as shown by Hey.
Conclusion
11. No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
12. 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