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
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/7/2026 has been entered.
Claims 26-46 are now pending. Claims 34, 35, 38, and 44 remain withdrawn. Claims 26-33, 36, 37, 39-43, 45 and 46 are currently being examined.
New Rejection
(Necessitated by Amendments)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 26-33, 36, 37, 39, 45 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Cobbold et al (US 20170152316 A1; Published 6/1/2017), in view of Urech et al WO2018224443A1 (Published 12/13/2018 claiming priority to June 5, 2017).
Regarding claim 26, Cobbold teaches a composition for treating cancer in a patient comprising: [claims 1, 17-20]
A first component comprising a targeted immune cell binding agent comprising:
A first targeting moiety that binds to a tumor antigen expressed by the cancer
A first immune cell binding domain capable of immune cell binding activity when binding a second immune cell binding domain, wherein the second immune cell binding domain is not part of the first component, and wherein the first immune cell binding domain is either a VH domain or a VL domain [0034]
A first inert binding partner for the first immune cell binding domain, wherein the first inert binding partner binds to the first immune cell binding domain, such that the first immune cell binding domain does not bind to the second immune cell binding domain unless the inert binding partner is removed, wherein if the first immune cell binding domain is a VH domain, the inert binding partner is a VL domain and if the first immune cell binding domain is a VL domain, the inert binding partner is a VH domain; [claim 10]
A protease cleavage site separating the first immune cell binding domain and the first binding partner, wherein the protease cleavage site is capable of releasing the inert binding partner from the immune cell binding in the presence of a protease; [claim 6]; and
A first complementary functional domain capable of immune cell binding; and
A second component comprising a targeted immune cell binding agent comprising: [claim 1 b]
A second targeting moiety [claim 2]
A second immune cell binding domain
Regarding claim 30, Cobbold teaches that the second targeting moiety binds a tumor antigen expressed by the cancer. [0080, 0081]
Regarding claim 31, Cobbold teaches that the second component further comprises a second inert binding partner for the second immune cell binding domain, wherein the second inert binding partner binds to the second immune cell binding domain, such that the second immune cell binding domain does not bind to the first immune cell binding domain unless the inert binding partner is removed, wherein if the second immune cell binding domain is a VH domain, the inert binding partner is a VL domain, and if the second immune cell binding domain is a VL domain, the inert binding partner is a VH domain, [claim 10] Cobbold teaches that a protease cleavage site separates the second immune cell binding domain and the second inert binding partner, wherein the protease cleavage site is capable of releasing the inert binding partner from the immune cell binding domain in the presence of the protease expressed by the cancer. [claim 3]
Regarding claims 32 and 33, Cobbold teaches that wherein the first immune cell binding domain and the second immune cell binding domain are, when bound to each other, capable of binding to a T-cell. [0212]
Regarding claims 36 and 37, Cobbold teaches the first and/or second targeting moiety comprises an antibody that binds to EpCam (anti-EpCAM antibody) and p-cadherin. [0082, 0083]
Regarding claim 39, Cobbold teaches that the first and/or second targeting moiety comprises a DNA aptamer. [0088-0091]
Regarding claim 42, Cobbold teaches that the second targeting moiety binds an antigen expressed by a tumor microenvironment. [0068, 0105, 0107-0109]
Regarding claims 27-29, and 40-41, Cobbold teaches that the first and/or second targeting moiety comprises IL-2, or IL-2 receptor [0087; Table 3] Regarding claims 45 and 26, Cobbold teaches that the first complementary functional domain is covalently bound to the first component via a first linker and wherein the second complementary functional domain is bound to the second component via a second linker. Cobbold teaches that the first linker is attached to the first targeting moiety and the second linker, if present, is attached to the second targeting moiety. [0072, 0073, 0078-0080, 0112-0118]
However, Cobbold does not explicitly teach that the first complementary functional domain is independently capable of immune cell binding and is covalently bound to the first component and second) complementary functional domain is independently capable of immune cell binding and is covalently bound to the second component
Urech teaches a composition comprising a first and second component, wherein:
(a) the first component comprises:
(i) a first targeting moiety that binds to a tumor antigen expressed by a cancer, such as HER2
(ii) a first immune cell binding domain capable of immune cell binding, and the first immune cell binding domain is a VH or a VL domain, and
(iii) a first complementary binding domain capable of immune cell binding, and the first complementary binding domain is a VH or a VL domain;
(b) the second component comprises:
(i) a second targeting moiety,
(ii) a second immune cell binding domain
And that the second immune cell binding domain is a VH when the first immune cell binding domain is VL, and the second immune cell binding domain is a VL when the first immune cell binding domain is a VH domain; and
(iii) a second complementary binding domain, and the second complementary binding domain is a VH when the first complementary binding domain is VL, and the second complementary binding domain is a VL when the first complementary binding domain is a VH domain;
wherein the first and second immune cell binding domains only bind the immune cell when the binding domains are present and binding together, and the first and second complementary binding domains only bind the complementary antigen when present and binding together. (pages 9-11, 13-14, 16-19, 31-34, Example 1; Figure 10). However, Urech teaches that at least one of the domains can bind to the target antigen. [pg 17, 18, 31]
Urech further teaches each of the binding domains within the first or second components are each attached by dimerization domains and linkers, wherein the linkers range from 5-20 to 10-20 amino acid residues in length, wherein the dimerization domains are Ig domains or TCR domains (pages 19-23, 31-33, Example 1; Figure 10)
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It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to produce the composition of Cobbold, wherein first complementary functional domain is independently capable of immune cell binding and is covalently bound to the first component and second) complementary functional domain is independently capable of immune cell binding and is covalently bound to the second component. One would have been motivated, and have a reasonable expectation of success, because: (1) Cobbold teaches the instantly claimed composition, (2) Urech teaches a two-component system wherein it includes a first and second complementary binding domain hat bind to immune cells, and (3) Urech teaches that these domains have the ability to bind to target antigens independently.
Claim(s) 42 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Cobbold et al (US 20170152316 A1; Published 6/1/2017) and Urech et al WO2018224443A1 (Published 12/13/2018 claiming priority to June 5, 2017), as applied to claims 26-33, 36, 37, 39, 45 and 46 above, and further in view of Santos et al (Targeting fibroblast activation protein inhibits tumor stromagenesis and growth in mice, J Clin Invest. 2009;119(12):3613-3625).
The teachings of Cobbold and Urech are recited above. However, they do not recite that the antigen expressed by a tumor microenvironment is a fibroblast activation protein.
Santos teaches that fibroblast activation protein (FAP) is selectively expressed on tumor-associated fibroblasts and that targeting FAP inhibits tumor cell proliferation indirectly and decreases blood vessel density in tumors. [Abstract]
It is noted that claim 43 requires that the antigen targeted by the second targeting moiety may be FAP. This limitation would have been obvious to those of ordinary skill in the art because: (1) Cobbold teaches the instantly claimed component to target antigens that are expressed in the tumor microenvironment, (2) Santos teaches that FAP is expressed in tumor cells and targeting this can lead to decreased tumor cell proliferation. One of skill in the art could have applied the composition of Santos to target a tumor antigen, including FAP.
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 26, 27, 30-33, 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,035,856. in view of Urech et al WO2018224443A1 (Published 12/13/2018 claiming priority to June 5, 2017).
The U.S. Patent recites all of the limitations of the instantly claimed composition for treating cancer comprising two components.
However, the U.S. Patent does not recite that the first complementary functional domain is independently capable of immune cell binding and is covalently bound to the first component and second) complementary functional domain is independently capable of immune cell binding and is covalently bound to the second component
The teachings of Urech are recited above in the 103 rejection.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to produce the composition of the U.S. Patent, wherein first complementary functional domain is independently capable of immune cell binding and is covalently bound to the first component and second) complementary functional domain is independently capable of immune cell binding and is covalently bound to the second component. One would have been motivated, and have a reasonable expectation of success, because: (1) the U.S. Patent recites the instantly claimed composition, (2) Urech teaches a two-component system wherein it includes a first and second complementary binding domain hat bind to immune cells, and (3) Urech teaches that these domains have the ability to bind to target antigens independently.
Conclusion
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/SARAH A ALSOMAIRY/Examiner, Art Unit 1646
/Zachariah Lucas/Supervisory Patent Examiner, Art Unit 1600
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