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 .
Claims 1-7, 10-20, and 26-29 are pending and under consideration.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application EP 21180204.6 filed 06-18-2021. It is noted, however, that the Office was unable to retrieve a copy of this application:
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To be entitled to priority, the Office must receive a copy of the foreign application from the participating foreign intellectual property office within the pendency of the application and before the patent is granted, or receive a paper certified copy of the foreign application during that time period. If a certified copy of the foreign application is filed after the date the issue fee is paid, the patent will not include the priority claim unless corrected by a certificate of correction under 35 U.S.C. 255 and 37 CFR 1.323.
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 1-7, 10-20, and 26-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11739142 in further view of Klein et al. (“The use of CrossMAb technology for the generation of bi- and multispecific antibodies”, mAbs, 8:6, 1010-1020, 2016).
Claim 1 of the issued patent (‘142) is drawn to bispecific antibodies specific for human CCL2 wherein the first antigen binding site comprises the same VH and VL domains of the currently examined application. For example, SEQ IDs 71 and 75 are identical in amino acid composition and lengths. Similarly, the bispecific antibodies of the patent comprise a second antigen-binding site comprising the same VH and VL domains of the currently examined application. For example, compare issued claim 1, Part A:
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To pending claim 1, Part A:
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However, while the antibody binding regions are identical, the overall structures are different. The issued bispecific antibody is structurally generic compared to the structure claimed in the current application which is of the CrossMab CH1-CL species: VH1-CH1-linker-Hinge-CH2-CH3-Linker2-VL1-CL. CrossMab technology appears to have been introduced as early as 2011. For example, Klein et al. (“The use of CrossMAb technology for the generation of bi- and multispecific antibodies”, mAbs, 8:6, 1010-1020, 2016) teach (page 1010, first column), that since 2011, when they described the CrossMAb technology as a method to enforce correct light chain association in bispecific heterodimeric IgG antibodies, such technology has proven to be one of the most versatile antibody engineering technologies, allowing the generation of various bispecific antibody formats, including bi (1C1), tri- (2C1) and tetra-(2C2) valent bispecific antibodies, as well as non-Fc tandem antigen-binding fragment (Fab)-based antibodies. Further, the disclosure of the issued patent teaches [0439] that the claimed generic bispecific antibodies have preferred bispecific antibody formats – the bispecific antibody described herein may have a domain crossover in one or more binding arms of the same antigen specificity, i.e. by exchanging the VH/VL domains, or the CH1/CL domains or the complete Fab arms, also called “CrossMabs”. The specification of the patent further specifically exemplifies crossMabs that are currently claimed such as CKLO01 (see below).
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The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. Thus, it would have been obvious to modify the generic and issued bispecific anti-CCL2 to include the well-known CrossMAb technology as these are structural species to the genus.
Regarding the linkers (Claims 4-6, 29), Klein et al. further teach (1013, 2nd col.) that a CrossFab can be used to fuse to the N- or C-termini of a conventional IgG antibody to generate trivalent bispecific antibodies via a flexible (G4S)2-linker. Or that tetravalent formats (page 1015) can be generated by fusing the Fab to the N-terminus of the VH or VL domain or to the C-terminus of the VL domain via flexible G4S x-linkers. Further, glycine-serine synthetic linkers are well-known to persons of ordinary skill in this art.
The issued patent also describes particular mutations that can be Q311R or P343R or M428L or K447G similar to pending Claims 12 and 14-15.
Further, methods of producing the bispecific antibodies with host cells, pharmaceutical compositions, and treating cancer or inflammatory and autoimmune disorders are all obvious in view of the fact that the patent teaches how to use the claimed bispecific antibodies.
Claims 1-7, 10-20, and 26-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12103967 in further view of Klein et al. (“The use of CrossMAb technology for the generation of bi- and multispecific antibodies”, mAbs, 8:6, 1010-1020, 2016).
Similar to the above non-statutory double patenting rejection, US12103967 claims generic bispecific antibodies that bind to human CCL2 but the difference here is that Claim 1 of the patent claims the antigen binding sites by first identifying their CDRs:
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These claimed CDRs comprise the same CDRs in the bispecific antibody of Claim 1(A) of the current application.
For example, SEQ ID NO: 71 (VH1) is shown below with the claimed CDRs bolded and underlined.
QVQLVQSGAEVKKPGSSVKVSCKASGGTFSHYGISWVRQAPGQGLEWMGGVIPIFHTANYAQKFQGRVTITADESTSTAYMELSSLRSEDTAVYYCARYDAHYGELDFWGQGTLVTVSS
SEQ ID NO:90 (VH2) is shown below:
QVQLVQSGAEVKKPGSSVKVSCKASGLTISHTYMHWVRQAPGQGLEWMGRIDPDNHNTKFDPKFQGRVTITADTSTSTAYMELSSLRSEDTAVYYCARGVFGFFDHWGQGTTVTVSS
Not shown are the light chains but the issued CDRs are present in SEQ IDs 75 and 93 of the pending application. Thus, the CDRs claimed in the patent are also claimed in the pending application. As set forth in the prior double-patenting rejection, while the antibody binding regions are identical, the overall structures are different. The issued bispecific antibody is structurally generic compared to the structure claimed in the current application which is of the CrossMab species CH1-CL: VH1-CH1-linker-Hinge-CH2-CH3-Linker2-VL1-CL. CrossMab technology appears to have been introduced as early as 2011. For example, Klein et al. (“The use of CrossMAb technology for the generation of bi- and multispecific antibodies”, mAbs, 8:6, 1010-1020, 2016) teach (page 1010, first column), that since 2011, when they described the CrossMAb technology as a method to enforce correct light chain association in bispecific heterodimeric IgG antibodies, such technology has proven to be one of the most versatile antibody engineering technologies, allowing the generation of various bispecific antibody formats, including bi (1C1), tri- (2C1) and tetra-(2C2) valent bispecific antibodies, as well as non-Fc tandem antigen-binding fragment (Fab)-based antibodies.
As to pending claims 16-20, the issued patent also claims nucleic acids, host cells, and methods of producing the bispecific antibody which is overlapping subject matter with the current claims.
As to pending claims 12-14, issued claim 11 lists the same types of mutations to the constant domain of human IgG1.
Further, while the issued claims are not inclusive of methods of treatment to cancer or inflammatory and autoimmune diseases, the issued patent teaches how to use the bispecific antibodies in the claimed manner.
Obvious-double patenting was also considered for recently issued US12630622 (application 18/335941) in which the bispecific antibodies of the above patent (US12103967) were claimed in methods of only treating melanoma. The disclosure of the patent [1290] indicates that melanoma is but one example of a laundry list of different cancers that could be treated. Further, (Lim et al., Oncotarget, Vol. 7, No. 19, 2016, Applicant’s IDS) teach (page 28703, 2nd column) that inhibiting CCL2 can inhibit tumor growth in mouse models of metastatic melanoma but it also may have “opposing anti-tumorigenic functions in melanoma progression” where CCL2 overexpression in B16 melanoma cells enhanced Th2 cytokine production and reduced metastatic pulmonary tumor growth in mouse models. Thus, it does not appear that specifically treating melanoma would be an obvious species of cancer to treat.
No claim is currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GARY B NICKOL/Primary Examiner, Art Unit 1643
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