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 .
DETAILED ACTION
Status of the Claims
1. Claims 1-17 are the original claims filed 9/30/2022. In the preliminary amendment of 9/30/2022, claims 1, 3, 5-12, and 14-16 are amended and new claims 18-20 are added. In the Response of 6/1/2026, Claims 1, 9-10 and 14 are amended.
Claims 1-20 are all the claims.
Claims 13, 15 and 20 are withdrawn.
Claims 1-12, 14 and 16-19 are all the claims under examination.
The Office Action is final.
Priority
2. USAN 17/916,275, filed 09/30/2022, is a National Stage entry of PCT/JP2021/014181, International Filing Date: 04/01/2021, claims foreign priority to JP 2020-066313, filed 04/01/2020, and claims foreign priority to JP 2020-181493, filed 10/29/2020.
Information Disclosure Statement
3. As of 8/4/2026, a total of two (2) IDS are filed: 9/30/2022 and 9/30/2022. The corresponding initialed and dated 1449 is considered and of record. The submissions are in compliance with the provisions of 37 CFR 1.97.
Withdrawal of Objections
Specification
4. The objection to the disclosure because of informalities is withdrawn. Clean and marked-up copies of the specification are filed. The amended specification rectifies the deficiencies for the improper use of the term, ATCC, Sepharose, Tris, AlphaLISA, In-Fusion, LabChip, NanoDrop, Superdex, BIGDYE, QIAquick, GeneAmp, PrimeStar, NanoTemper, BioLC, DIAION, EX-CELL, RNeasy, BiaCore, which is a trade name or a mark used in commerce.
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(b)
5. The rejection of Claims 1-12, 14 and 16-19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn.
Claims 1-12, 14 and 16-19 are amended to delete the terms “satisfy” and “satisfied”.
Claim Rejections - 35 USC § 103
6. The rejection of Claim(s) 1, 9, 10 and 14 under 35 U.S.C. 103 as being unpatentable over Chugai I/II (WO2013/002362; US 9890218 (IDS 9/30/2022) and WO2014/104165; US 10766960 (IDS 9/30/2022)) and in view of Genentech (JP 2008511337 (4/17/2008 (IDS 9/30/2022)), Chugai III (WO 2016/159213; US 11142587
(10/6/2016 ((IDS 9/30/2022)), Niwa et al (US 20210380684 (PTO 892)) and Lakatos et al (WO 2021/232162) is withdrawn.
7. The rejection of Claim(s) 1(5A; L242C/K334C), 9(6B; L242C/K334C), 10(6C; L242C/K334C) and 14 (6D; L242C/K334C) under 35 U.S.C. 103 as being unpatentable over Chugai I/II (WO2013/002362; US 9890218 (IDS 9/30/2022) and WO2014/104165; US 10766960 (IDS 9/30/2022)) and in view of Genentech (JP 2008511337 (4/17/2008 (IDS 9/30/2022)), Chugai III (WO 2016/159213; US 11142587 (10/6/2016 ((IDS 9/30/2022)), Niwa et al (US 20210380684 (PTO 892)) and Lakatos et al (WO 2021/232162) as applied to claims 1, 9 and 10 above, and further in view of Frendeus et al (WIPO; 2019-11-01 (PTO 892) and Jacobsen FW et al., JBC 2017, 292, 1865-1875 (PTO 892) is withdrawn.
8. The rejection of Claim(s) 2-5 and 7-8 under 35 U.S.C. 103 as being unpatentable over Chugai I/II (WO2013/002362; US 9890218 (IDS 9/30/2022) and WO2014/104165; US 10766960 (IDS 9/30/2022)) and in view of Genentech (JP 2008511337 (4/17/2008 (IDS 9/30/2022)), Chugai III (WO 2016/159213; US 11142587 (10/6/2016 ((IDS 9/30/2022)), Niwa et al (US 20210380684 (PTO 892)) and Lakatos et al (WO 2021/232162) as applied to claim 1 above, and further in view of Frendeus et al (WIPO; 2019-11-01 (PTO 892) and Jacobsen FW et al., JBC 2017, 292, 1865-1875 (PTO 892) is withdrawn.
9. The rejection of Claim(s) 11-12 and 18-19 under 35 U.S.C. 103 as being unpatentable over Chugai I/II (WO2013/002362; US 9890218 (IDS 9/30/2022) and WO2014/104165; US 10766960 (IDS 9/30/2022)) and in view of Genentech (JP 2008511337 (4/17/2008 (IDS 9/30/2022)), Chugai III (WO 2016/159213; US 11142587 (10/6/2016 ((IDS 9/30/2022)), Niwa et al (US 20210380684 (PTO 892)) and Lakatos et al (WO 2021/232162) as applied to claims 1 above, and further in view of Frendeus et al (WIPO; 2019-11-01 (PTO 892) and Jacobsen FW et al., JBC 2017, 292, 1865-1875 (PTO 892) is withdrawn.
10. The rejection of Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chugai I/II (WO2013/002362; US 9890218 (IDS 9/30/2022) and WO2014/104165; US 10766960 (IDS 9/30/2022)) and in view of Genentech (JP 2008511337 (4/17/2008 (IDS 9/30/2022)), Chugai III (WO 2016/159213; US 11142587 (10/6/2016 ((IDS 9/30/2022)), Niwa et al (US 20210380684 (PTO 892)) and Lakatos et al (WO 2021/232162) as applied to claims 1 above, and further in view of Frendeus et al (WIPO; 2019-11-01 (PTO 892) and Jacobsen FW et al., JBC 2017, 292, 1865-1875 (PTO 892) is withdrawn.
Response to Arguments
Applicant’s arguments and the certified, English language copy of the priority document for JP 2020-06631 (filed 4/1/2020), see pp. 10-14 of Remarks, filed 6/1/2026, with respect to the rejection of Claims 1-5, 7-12, 14 and 16-19 under 35 USC 103 have been fully considered and are persuasive. The rejection of the claims 1-5, 7-12, 14 and 16-19 are withdrawn.
Rejections Maintained
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.
11. The provisional rejection of Claims 1-5, 7-12, 14 and 16-19 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 13-21, 23 and 25-26 of copending Application No. 17/280,403 (reference application US 20210380684) is maintained.
Applicants allege the antibodies encompassed by the claims of the present application are distinct from the antibodies recited in the claims of the '403 application. For example, the antibodies of the present application each includes the following limitation: "each of the first IgG half-molecule and the second IgG half-molecule includes amino acid residue substitutions of C226A and C229A numbered according to the EU index." See, for example, element (2A) of claim 1. The claims of the '403 application do not include this limitation.
Response to Arguments
(A) Ref claim 13 teaches and discloses the substitution of residues 226 and 229 under EU numbering in the 1st and 2nd IgG half molecules:
“Ref claim 13. (previously presented) The antibody composition according to claim 1, wherein the first IgG half-molecule and the second IgG half-molecule include a hinge domain in which at least one amino acid residue of amino acid residues at position 226 and position 229 numbered according to the EU index is substituted.”
The range of substitutions in ref claim 13 is infinite in scope and is not clear whether the substitution is for a natural vs non-natural amino acid much less whether the substitution is different or shared between position 226 and 229. The POSA could not reasonably ascertain the meaning and purpose of the substitution absent consulting the ref specification.
To ascertain the meaning of a substitution for the ref hinge region residues 226 and 229, the ref specification in reliance as dictionary, clarifies that the substitutions should prevent disulfide binding between the 1st and 2nd IgG half molecules:
[0214] As the substitution of a part of a hinge domain so as not to form an inter-H chain disulfide bond between the first IgG half-molecule and the second IgG half-molecule, for example, substitution of at least one of the amino acid residues at position 226 and position 229 numbered according to the EU index is exemplified.
The specification specifically teaches a Cys[Wingdings font/0xE0] Ala substitution at hinge regions for the ref invention:
[0428] In this Example, with respect to the above 1), an attempt was made by substituting cysteine of a hinge domain with alanine.
See MPEP 804 (II)(B)(1) stating in part the propriety in using the specification as a dictionary:
The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (“Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.”).
Accordingly, and what is implied by ref claim 13 (otherwise ambiguous and indefinite) and based on the disclosure in the specification in view of Toro, is that C226 and C229 residues are substituted to avoid inter-H chain disulfide bond formation with preferred ref cysteine substituted for an alanine in a hinge.
The provisional rejection is maintained.
Conclusion
12. No claims are allowed.
13. 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.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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