DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment, filed 01/16/2026, has been entered.
Claims 1, 4, 7-16, 18-22, 24 are pending.
Claims 7-16, 18-22, 24 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/30/2025.
Claims 1 and 4 are currently under examination as they read on a method for improving affinity of an antibody.
This Office Action will be in response to Applicant’s arguments/remarks, filed 01/16/2026.
The Rejections of Record can be found in the previous Office Action, mailed 10/20/2025.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maeta et al. (US 20180179298 A1; see entire document) as evidenced by the instant specification.
Applicant’s argument has been considered but has not been found convincing. The rejection of record is reiterated below for Applicant’s convenience.
Maeta et al. taught a method for improving affinity of an antibody comprising changing at least 3 amino acid residues in the framework region (FR) of the light chain (see Table 1). Although Maeta did not explicitly teach the conditions of the position in which the mutation was introduced (i.e., 1) total value of amino acid frequencies of R, S, T, V, D and E is 35% or more and 2) ratio of solvent-exposed surface area of 20% or more), given the instant specification discloses that the amino acid residue satisfying said conditions is preferably an amino acid residue present in FR3, for example, the 60th, 63rd, 65th, 67th, 69th, 70th, 72nd, 74th, 76th, 77th, 79th and 81st amino acid residues in FR3 of the light chain defined by the Kabat method (page 21, paragraph 0049); and that Maetal et al. taught introducing mutations in positions 63, 65, 67, 70 and 72 in light chain FR3 defined by Kabat (Table 1), the method taught by the prior art satisfied the said conditions as recited in the present claims. Therefore, Maeta et al. anticipated the present claims as it taught making changes in the residues in light chain FR in positions that specifically satisfy the conditions recited in the present claims.
With regards to the newly added limitations, it is noted that these steps, i.e., “obtaining”, “aligning”, “specifying”, do not recite any additional active method steps, but simply state mental steps that may be performed entirely in the human mind and are obviously not tied to any machine and do not transform any article into a different state or thing. The “obtaining”, “aligning” and “specifying” steps do not require one to conduct or perform any action that is transformative. Therefore, the “obtaining”, “aligning” and “specifying” steps are not found to further limit the method defined by the claims.
Therefore, the rejection is maintained for reasons of record.
Double Patenting
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.
Claims 1 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,267,904. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims disclosed a method for increasing affinity of an antibody by changing amino acid residues in positions 63, 65, 67, 70 and 72 defined by Chothia method. It is noted that although the patent claims did not disclose the conditions recited in the present claims, the positions of which the substitutions are introduced are the positions that would satisfy the conditions as evidenced by the instant disclosure (see specification page 21, paragraph 0049) for reasons stated in the 102 rejection. Therefore, the patent claims would anticipate the present claims.
Applicant’s argument and Examiner’s response are essentially same as above. Therefore, the rejection is maintained.
Claims 1 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,116,419. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims disclosed a method for increasing affinity of an antibody by changing amino acid residues in the light chain in positions 18, 20 and 22 defined by Kabat method. It is noted that although the patent claims did not disclose the conditions recited in the present claims, the positions of which the substitutions are introduced are the positions that would satisfy the conditions as evidenced by the instant disclosure (see specification pages 21-23) for reasons stated in the 102 rejection. Therefore, the patent claims would anticipate the present claims.
Applicant’s argument and Examiner’s response are essentially same as above. Therefore, the rejection is maintained.
Claims 1 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,122,849. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims disclosed a method for increasing affinity of an antibody by changing amino acid residues in the light chain in positions 5, 9 and 22 defined by Kabat method. It is noted that although the patent claims did not disclose the conditions recited in the present claims, the positions of which the substitutions are introduced are the positions that would satisfy the conditions as evidenced by the instant disclosure (see specification pages 21-23) for reasons stated in the 102 rejection. Therefore, the patent claims would anticipate the present claims.
Applicant’s argument and Examiner’s response are essentially same as above. Therefore, the rejection is maintained.
Claims 1 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,139,552. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims disclosed a method for increasing affinity of an antibody by changing amino acid residues in the light chain in positions 17, 18 and 20 defined by Kabat method. It is noted that although the patent claims did not disclose the conditions recited in the present claims, the positions of which the substitutions are introduced are the positions that would satisfy the conditions as evidenced by the instant disclosure (see specification pages 21-23) for reasons stated in the 102 rejection. Therefore, the patent claims would anticipate the present claims.
Applicant’s argument and Examiner’s response are essentially same as above. Therefore, the rejection is maintained.
Claims 1 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,795,237. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims disclosed a method for increasing affinity of an antibody by changing amino acid residues in the light chain in positions 3, 5 and 9 defined by Kabat method. It is noted that although the patent claims did not disclose the conditions recited in the present claims, the positions of which the substitutions are introduced are the positions that would satisfy the conditions as evidenced by the instant disclosure (see specification pages 21-23) for reasons stated in the 102 rejection. Therefore, the patent claims would anticipate the present claims.
Applicant’s argument and Examiner’s response are essentially same as above. Therefore, the rejection is maintained.
Claims 1 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 17/709,592; claims 10-11, 16-18 of copending Application No. 18/821,064; claims 1-17 of copending Application No. 18/642,188. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims disclosed a method for increasing affinity of an antibody by changing amino acid residues in the light chain in 60th, 63rd, 65th, 67th, 70th, 72nd, 74th, 76th, 77th, 79th and 81st positions defined by Kabat method. It is noted that although the copending claims did not disclose the conditions recited in the present claims, the positions of which the substitutions are introduced are the positions that would satisfy the conditions as evidenced by the instant disclosure (see specification pages 21-23) for reasons stated in the 102 rejection. Therefore, the copending claims would anticipate the present claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s argument and Examiner’s response are essentially same as above. Therefore, the rejection is maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
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/SHARON X WEN/Primary Examiner, Art Unit 1641