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 1-28 are the original claims filed 4/14/2021. In the Preliminary Amendment of 8/10/2021, Claims 1-28 are canceled and new Claims 29-67 are added. In the Response of 12/13/2023, Claims 29-67 are canceled and new Claims 68-83 are added. In the Response of 7/12/2024, Claims 68 and 77 are amended and Claim 78 is canceled. In the Response of 3/6/2025, no claims are amended, canceled or added. In the Response of 4/21/2026, claim 83 is amended.
Claims 68-77 and 79-83 are all the claims.
Amending claim 68 to incorporate the subject matter of claim 83 could overcome the outstanding rejections.
Priority
2. USAN 17/230,240, filed 04/14/2021, and having 1 RCE-type filing herein is a Divisional of 14/340,872, filed 07/25/2014, now U.S. Patent # 11161906 and having 4 RCE-type filings therein, and 14/340,872 Claims Priority from Provisional Application 61/858,402, filed 07/25/2013.
Information Disclosure Statement
3. As of 5/30/2026, a total of six (6) IDS are filed for this application: 4/14/2021; 1/6/2023; 6/6/2032; 12/6/2023; 12/21/2023; and 11/13/2024. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(a)
Written Description/New Matter
4. The rejection of Claim 83 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn. Applicants allege the “typographical error” in Claim 83 is amended to rectify the deficiency under the written description requirement.
Claim Rejections - 35 USC § 103
5. The rejection of Claim(s) 68-74, 77 and 79-83 under 35 U.S.C. 103 as being unpatentable over Lowman et al (US 20130315906 (published November 28, 2013 (or WO 2013163631 published October 31, 2013)) as evidenced by www.sinobiological.com/ resource /antibody-technical/bispecific-antibody is withdrawn.
Applicants allege Lowman is "not prior art" under 35 USC § 102(a)(2) or 103 because the subject matter disclosed and the claimed invention were commonly owned at the effective filing date of this application (July 25, 2013). 35 U.S.C. § 102(b)(2)(C); see also MPEP 2154.02(c).
6. The rejection of Claim(s) 68-77 and 79-83 under 35 U.S.C. 103 as being unpatentable over PCT/US14/48289 (‘289) as evidenced by www.sinobiological.com/ resource/antibody-technical/bispecific-antibody is withdrawn.
Applicants allege ‘289 is "not prior art" under 35 USC § 102(a)(2) or 103 because the subject matter disclosed and the claimed invention were commonly owned at the effective filing date of this application (July 25, 2013). 35 U.S.C. § 102(b)(2)(C); see also MPEP 2154.02(c).
Double Patenting
7. The provisional rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 18/472,748 (reference application US 20240084010) is withdrawn.
Applicant’s arguments that the claims are drawn to a single activatable anti-CD3 epsilon AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
8. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-88 of U.S. Patent No 10745481 is not “provisional” as alleged by Applicants but is nevertheless withdrawn.
Applicant’s arguments that the claims are drawn to a single activatable conjugated anti-CD166 AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable conjugated antibody.
9. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-64 of U.S. Patent No. 11753466 is withdrawn.
Applicant’s arguments that the claims are drawn to a method of treatment using a single activatable conjugated anti-CD166 AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable conjugated anti-CD166 antibody.
10. The provisional rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 101-120 of copending Application No. 18/354,353 (reference application US 20240076374) is withdrawn.
Applicant’s arguments that the claims are drawn to a single activatable conjugated anti-CD166 AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable conjugated antibody.
11. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent No. 10233244 is withdrawn.
Applicant’s arguments that the claims are drawn to a single activatable conjugated anti-CD166 AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable conjugated antibody.
12. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-51 of U.S. Patent No. 9127053 is withdrawn.
Applicant’s arguments that the claims are drawn to a treatment method using a single activatable cross-reactive anti-jagged 1/jagged 2 AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
13. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-39 of U.S. Patent No. 9688748 is withdrawn.
Applicant’s arguments that the claims are drawn to a single activatable cross-reactive anti-jagged 1/jagged 2 AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
14. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10301380 is withdrawn.
Applicant’s arguments that the claims are drawn to a single activatable cross-reactive anti-jagged 1/jagged 2 AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
15. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10261083 is maintained.
Applicant’s arguments that the claims are drawn to a single activatable cross-reactive anti-jagged 1/jagged 2 AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
16. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 11035859 is withdrawn.
While the ref claims are drawn to a method of treatment using a second activatable antibody based on the detection of a materially relevant antigen by a first activatable antibody, none of the claims are directed to a multispecific or bispecific antibody comprising the identical elements for both detection and therapy.
17. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 11867695 is withdrawn.
While the ref claims are drawn to a method of treatment using a second activatable antibody based on the detection of a materially relevant antigen by a first activatable antibody, none of the claims are directed to a multispecific or bispecific antibody comprising the identical elements for both detection and therapy.++
18. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11867695 is withdrawn.
While the ref claims are drawn to a method of treatment using a first activatable antibody based on the detection of a materially relevant antigen by a second activatable antibody, none of the claims are directed to a multispecific or bispecific antibody comprising the identical elements for both detection and therapy.
19. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of U.S. Patent No. 9120853 is withdrawn.
Applicant’s arguments that the method claims are drawn to a single activatable anti-EGFR AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
20. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-57 of U.S. Patent No. 9545442 is withdrawn.
Applicant’s arguments that the claims are drawn to a single activatable anti-EGFR AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
21. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-52 of U.S. Patent No. 9889211 is withdrawn.
Applicant’s arguments that the claims are drawn to a single activatable anti-EGFR AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
22. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 10709799 is withdrawn.
Applicant’s arguments that the claims are drawn to a single activatable anti-EGFR AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
23. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11890354 is withdrawn.
Applicant’s arguments that the method claims are drawn to a single activatable anti-EGFR AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
24. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 41-47 and 71-83 of U.S. Provisional 18/396,187 (reference US 20240398998; renumbered as 1-8, 17-20 and 9-16) now US 12502439) is withdrawn.
Applicant’s arguments that the claims are drawn to a single activatable anti-EGFR AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
25. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11472889 is withdrawn.
Ref claims are drawn to bispecific activatable antibodies comprising (AB1) and (AB2) each comprising separate MM-CM constructs. None of the claims comprise an AB2 absent its own corresponding MM-CM.
26. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11859010 is withdrawn.
Ref claims are drawn to bispecific activatable antibodies comprising (AB1) and (AB2) each comprising separate MM-CM constructs. None of the claims comprise an AB2 absent its own corresponding MM-CM.
27. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims1-13 of U.S. Patent No. 12460017 is withdrawn.
Ref claims are drawn to a polypeptide comprising a sequence SEQ ID NO: 12 for an MM.
28. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 9540440 is withdrawn.
Applicant’s arguments that the claims are drawn to a single activatable anti-EGFR AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
29. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10533053 is withdrawn.
Applicant’s arguments that the claims are drawn to a single activatable anti-EGFR AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
30. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11180562 is withdrawn.
Applicant’s arguments that the claims are drawn to a single activatable anti-EGFR AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
31. The rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12139543 is withdrawn.
Applicant’s arguments that the claims are drawn to a single activatable anti-EGFR AB are found persuasive. None of the claims are drawn to a multispecific or bispecific activatable antibody.
32. The provisional rejection of Claims 68-77 and 79-83 on the ground of nonstatutory double patenting as being unpatentable over claims 40-50 of copending Application No. 18/910,634 (reference application US 20250215094) is 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.
33. The rejection of Claims 68-77 and 10669337 is maintained.
i) Applicants allege citing three non-precedential decisions that effective filing dates and expiration dates must be considered to determine whether a reference is a proper double patenting reference (Allergan, Ex parte Baurin) and that no court has held that risk of common ownership is a sole justification for upholding an improper ODP rejection (In re Cellect).
Response to Arguments
Ex Parte Baurin is an individual Patent Trial and Appeal Board (PTAB) decision that is not formally designated as precedential.
The patent term is only one of two reasons why the Office undertakes a double patenting determination.
1) Patent term
If more than one patent could be obtained on the same invention, an inventor could extend the period of exclusivity beyond what the law intends (See In re Goodman, 11 F3d. 1046, 1053 (Fed. Cir. 1993); General Foods Corp v. Studiengesellschaft Kohle MbH, 972 F.2d 1271, 1279-80 (Fed. Cir. 1992) (“The basic concept of double patenting is that the same invention cannot be patented more than once, which, if happened, would result in a second patent which would expire sometime after the original patent and extend the protection timewise”). For example, an inventor could apply for one patent in 2005 and a second on the same invention in 2015, thereby obtaining the equivalent of a 30-year patent. Hence where the subject matter is essentially duplicative to that of the ‘377 patent and unchallenged by Applicants, the instant claims are unpatentable in the absence of a terminal disclaimer.
2) One patent to each invention per inventor
A terminal disclaimer is required to link two cases together so that two patents to the same or a similar invention cannot be sold separately. An inventor is entitled to one patent on one invention (see In re Leonardo, 119 F.3d 960, 965 (Fed. Cir. 1997).
The double patenting rejection may be obviated by filing a terminal disclaimer in accordance with 37 CFR 1.321(d). See MPEP § 804 and § 804.02.
ii) Applicants allege all claims of the cited patent are directed to a bispecific antibody comprising 2 scFvs and a full length IgG1 (AB2), not a method as in the pending claims of the present application. Furthermore, claims 1-16 of US10669337 specify that: AB2 is "full length IgG antibody"; require specific sequences for AB1; "the carboxyl terminus of each AB1 is linked to the amino terminus of each heavy chain of AB2"; two AB1 s (each a scFv that binds to CD3E); and an AB2 that is a "full length IgG antibody."
Response to Arguments
Note that while the claims of ‘337 are drawn to MM sequences none are similar to those of claim 83. Claim 83 falls from the rejection and can be used to overcome the outstanding rejection by incorporation into claim 1.
i) “claims of the cited patent are directed to a bispecific antibody comprising 2 scFvs and a full length IgG1 (AB2), not a method as in the pending claims of the present application”: the cases share no continuity nor are they related by restriction and/or speciation under 35 USC 121.
ii) “[ref] claims specify that: AB2 is "full length IgG antibody": claim 68 provides that AB2 is an antibody (or a fragment thereof). Claims from the ref patent are a species to the genus of antibody and anticipate or render obvious the antibody.
iii) “[ref] require specific sequences for AB1: Claims from the ref patent are a species to the genus of antibody AB1 and anticipate or render obvious the antibody.
iv) “[ref claims require] the carboxyl terminus of each AB1 is linked to the amino terminus of each heavy chain of AB2"; claim 68 provides that AB2 is an antibody and that AB2 can be attached alternatively to a C- or N-terminus of a HC/LC of AB1.
v) “[ref claims] two AB1s (each a scFv that binds to CD3E): claim 68 defines AB1 as an antibody fragment that binds to a cell type associated with disease. Claims from the ref patent are a species to the genus of antibody and anticipate or render obvious the antibody.
The rejection is maintained.
34. The rejection of Claims 68-77 and 11802158 is maintained.
a) Applicants allege this patent is a later-filed (effective filing date of July 25, 2015 vs. July 2014 in the present application), later-expiring patent and is not a proper double patenting reference under the decision of Allergen and Ex parte Baurin.
Response to Arguments
The reference patent is not afforded safe harbor under 35 USC 121 because the ref claims share no continuity nor a restriction/ speciation with the claims of the instant application. The analysis of the instant claims from the parent case for USPN 10669337 are incorporated from herein above.
b) Applicants allege [ref] patent claims are directed to a nucleic acid molecule and related pharmaceutical composition or method of producing claims, not a method of delivering a multispecific activatable antibody to a subject as in the pending claims of the present application. Furthermore, ref claims specify that: AB2 is "full length IgG antibody"; require specific sequences for AB1; "the carboxyl terminus of each AB1 is linked to the amino terminus of each heavy chain of AB2"; two AB1 s (each a scFv that binds to CD3E); and an AB2 that is a "full length IgG antibody."
Response to Arguments
The analysis of the instant claims from the parent case for USPN 10669337 are incorporated from herein above.
The rejection is maintained.
Conclusion
35. No claims are allowed.
36. 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.
37. 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 ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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