The Examiner of your application in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Examiner Julie Wu.
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 .
Claim Status
Claims 1-2, 17-18, 22, 24, 110, 117, 123-125 and 128-133 are pending.
Claims 117 and 123-125 are withdrawn.
Claims 1-2, 17-18, 22, 24, 110, and 128-133 are under examination.
Objections/Rejections Withdrawn
Previous objections to the specification for sequence noncompliance and recitation of trademarks have been withdrawn in view of amendments.
All previous claim objections are withdrawn in view of claim amendments.
Previous rejections of claims 1-2, 17-18, 22, 24, 110, and 128-133 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
Previous rejections of claims 1-2, 17-18, 22, 24, 110, and 128-133 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn in view of claim amendments.
Previous rejection of claim(s) 1-2, 17-18, 22, 24, 110, and 129-132 under 35 U.S.C. 102a1 as being anticipated by Wu (US2009/0215992, published 08/27/2009) is withdrawn in view of claim amendments.
Previous provisional rejection of claims 1-2, 17-18, 22, 24, 110, and 128-133 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 41, 43, 48, 50, and 77 of copending Application No. 17/621978 (reference application) is withdrawn in view of abandonment of the copending application.
New Rejection Necessitated by Claim Amendments
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 22 limits the polypeptide of amended claim 1 to bind to CD3 epsilon, CD3 delta, CD3 gamma, CD3 zeta, CD3 alpha and CD3 beta epsilon. Because instant claim 1 is amended to recite a single monoclonal antibody comprising SEQ ID NOs:1,4, 6, and 8-10 that binds to CD3 epsilon, and not the other recited CD3 complex subunits. Thus, claim 22 does not include all the limitations of amended claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-2, 17-18, 22, 24, 110, and 128-133 remained rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12215156. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patented claim 1 is drawn to a polypeptide comprising SEQ ID NO. 34 which contains both instant SEQ ID NOs. 27-28. Thus, it meets all structural and functional limitations of the instant claims. Patented claim 3 is a pharmaceutical composition with the same and excipient(s). Thus, the patented claims teach the structures recited in the instant claims and are species of the instant claims rendering all instant claims anticipated and obvious.
Response to Arguments
In the Applicant Arguments/Remarks entered on November 14, 2025, Applicant argued that because the instant patent has an earlier patent term expiration than the instant application, the NSDP is not proper in view of Ex Parte Baurin and Allergan. Applicant also argued that a two-way test should be used for any NDSDP rejection where the reference has a later patent term filing date has been considered
Applicant's arguments have been fully considered but they are not persuasive. It is noted that Applicant did not argue that the instant claims are distinct from the patented claims. Applicant’s arguments focused on the point that the patented claims of 12215156 has an earlier patent term expiration date.
In the recent precedential decision of Ex parte Baurin, Appeal 2024-002920 (ARP Aug. 6, 2026), the Appeals Review Panel states that patent term is not the only consideration for NSDP, but also the anti-harassment rationale. Appeals Review Panel noted there are two rationales for NSDP, (1) prevention of timewise extension of a patent’s term AND (2) prevention of harassment from by multiple assignees.
MPEP 804 states that (1) The doctrine of double patenting seeks to prevent the unjustified extension of patent exclusivity beyond the term of a patent; and (2) The doctrine of nonstatutory double patenting also seeks to prevent the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982) (citing Chisum, Patents, § 9.04(2)(b) (1981)).
The argument that a two-way test should be used for any NDSDP rejection where the reference has a later patent term filing date has been fully considered but they are not persuasive. As discussed above, the purpose of the NSDP is NOT ONLY for the following as argued by the Applicant:
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Ex parte Baurin, Appeal 2024-002920 (ARP Aug. 6, 2026) clearly explained that there are two rationale for the NSDP rejection as noted in MPEP804 is: (1) prevention of timewise extension of a patent’s term AND (2) prevention of harassment from by multiple assignees.
As noted on page 13 of the Applicant Arguments/Remarks:
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Following the MPEP guidance for a two-way test, in the instant case, the Applicant could not have filed the claims in a single application. The instant claims are directed to a polypeptide that binds to CD3 comprising SEQ ID NOs:1, 4, 6 and 8-10, which is disclosed and encompassed by the patented polypeptide comprising SEQ ID NO:34 (claim 1). Further, the office is not solely responsible for any delays. As shown in the prosecution history, Applicant filed an extension of time following the Restriction requirement of May 23, 2025, and following the Non-Final rejection of July 14, 2025.
Therefore, in view of the MPEP and Ex parte Baurin, Appeal 2024-002920 (ARP Aug. 6, 2026), the NSDP rejection of record is proper.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JULIE WU whose telephone number is (571)272-5205. The examiner can normally be reached M-F 9-5PM.
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, Bonnie Eyler can be reached at 571-272-1200. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE WU/ Supervisory Patent Examiner, Art Unit 1643
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