DETAILED ACTION
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. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 26, 2025 has been entered.
Claims 3-5, 8, 11, and 14 have been canceled.
Claims 1, 2, 6, 7, 9, 10, 12, 13, and 15-20 are pending.
Claims 16-20 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as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 December 23, 2024.
Claims 1, 2, 6, 7, 9, 10, 12, 13, and 15 are currently under consideration.
3. In view of applicant’s amendment, the previous rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description, has been withdrawn.
4. In view of applicant’s amendment, the previous rejection under 35 U.S.C. 103 has been withdrawn.
Applicant’s amendment added new limitation of substitution 397V and 409D in the CH3 region of the Fc. Yan et al. (US 2019/0248899) teach data that shows V397Y substitution in the CH3 region of the Fc substantially reduced the percentage of heterodimers compared to unmutated Fc (e.g. see [0570]), while single K409D substitution increases heterodimer formation (e.g. see [0571]). Therefore, there is no motivation to combine V397F and K409D substitutions to facilitate antibody half-molecule.
5. In view of the filing of a Terminal Disclaimer, the previous nonstatutory double patenting rejection against claims in US 12,054,544 has been withdrawn.
6. 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.
7. Claims 1, 2, 6, 7, 9, 10, 12, 13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 16-21 of copending USSN 18/756,956 (the ‘956 application) in view of Presta (US 6,737,056) for the reasons of record.
During a telephone several interviews with applicant’s representative Kenley K. Hoover starting on February 3, 2026, the Examiner requested the filing of a Terminal Disclaimer to overcome the rejection set forth here. Applicant is not willing to file a Terminal Disclaimer at this time.
In the REMARKS FILED ON December 26, 2025, applicant asserts that the claims in the ‘956 Patent are drawn to a method of treating a disease by administering a polypeptide that comprises two Fc heavy chains. Presta teaches enhance ADCC by mutation position 334 in each of the two Fc regions. Applicant asserts that an ordinary skill in the art would not reasonably expect an antibody half molecule in view of the conflicting claims and the teachings of Presta. As such, applicant asserts the rejection should be withdrawn.
This is not found persuasive for following reasons:
Contrary to applicant’s assertion relying upon the recitation of an antibody half-molecule, note that the instant claims are drawn to “an antibody half-molecule comprising a hinge region, a CH2 region, and a CH3 region…”. The use of transitional phrase “comprising” means the instant claims are not limited to one Fc region.
Here, given that the first polypeptide and the second polypeptide administered in the ‘956 application are not linked covalently (recited in copending claim 14) and given that the first or the second polypeptide in the copending application comprises the identical amino acid substitutions C226S, C229S, K334E, V3397Y, and K409D as the instantly claimed antibody half-molecule, the copending claims would anticipate or render obvious of the instant claims.
Therefore, applicant’s arguments have not been found persuasive.
8. No claim is allowed.
9. All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN DAHLE whose telephone number is (571)272-8142. The examiner can normally be reached Mon-Fri 6:30am-4:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN W DAHLE/Primary Examiner, Art Unit 1641