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 .
Status of Claims and Application
US Patent 11,007,267 issued on 5/8/21 from application 15/836,107 with claims 1-27. This reissue application was filed on 5/17/23 and amends claim 1. Claims 1-27 are pending and under examination.
Information Disclosure Statement
This application was not filed with an information disclosure statement (IDS). None of the references listed on the IDSes in the application to which this application claims benefit will necessarily appear on the face of a patent issuing from this application unless they are properly listed on an IDS in this application. See MPEP 1406.
Assignee’s Consent to Reissue
The 5/17/23 consent to reissue signed by Derek Scott is defective because it was neither signed by a person with apparent authority as defined in MPEP 325(V) nor signed by a person authorized to act on behalf of the assignee at the time of signing. MPEP 325(V) recognizes that persons with “apparent authority” to sign on behalf of an organization include officers of that organization, e.g., its chief executive officer, president, vice-president, secretary, or treasurer. Consenter Scott is none of these, being designated only as “V.P. Intellectual Property” as opposed to the vice president of the entire organization. There is also nothing in the record to indicate that consenter Scott was authorized to act on behalf of the assignee; compare assignment document, which identifies Karen Elbing as so authorized.
This matter would be overcome by submission of a replacement consent of the assignee signed by either a person authorized to act on behalf of the assignee; an officer of the assignee; or a patent practitioner already appointed power of attorney at the time of signing.
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 1-4 and 16-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, and 31 of U.S. Patent No. 10,501,545. Although the claims at issue are not identical, they are not patentably distinct from each other because the bispecific antibody of the ’545 patent anticipates the examined antibody.
The underlying ’267 patent provides a limiting definition of “antibody”:
The term “antibody” herein is used in the broadest sense and encompasses various antibody structures, including but not limited to monoclonal antibodies, polyclonal antibodies, multispecific antibodies (e.g., bispecific antibodies), and antibody fragments so long as they exhibit the desired antigen-binding activity.
(Column 10, lines 25-30, emphasis added.)
The ’545 patent claims an antibody that is bispecific for CLL-1 and CD3. (Claims 16 and 31.) The ’545 patent claims that the CD3-binding domain of the bispecific antibody may comprise a heavy chain variable region (VH) comprising the sequence of SEQ ID NO: 84 and a light chain variable region (VL) comprising the sequence of SEQ ID NO: 93.
SEQ ID NO: 84 of the ’545 patent’s bispecific antibody is 100% identical to examined SEQ ID NO: 7 and comprises hypervariable regions represented by SEQ ID NOs: 1-3. SEQ ID NO: 93 of the ’545 patent’s bispecific antibody is 100% identical to examined SEQ ID NO: 8 and comprises hypervariable regions represented by SEQ ID NOs: 4-6. (See appendix to Office action.)
The ’545 patent’s antibody therefore anticipates the antibody of examined claims 1-4 and 16-21.
Claims 26 and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, and 30 of U.S. Patent No. 10,501,545 in view of Zhong et al. (US 2013/0244255; reference A). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed immunoconjugate and composition are obvious variants of the ’545 patent’s antibody.
As discussed above, the ’545 patent claims a bispecific antibody that comprises examined SEQ ID NOs: 7 and 8.
Regarding claim 26, the ’545 patent does not claim an immunoconjugate comprising the bispecific antibody and a cytotoxic agent. Regarding claim 27, the ’545 patent does not claim a composition comprising the bispecific antibody.
Zhong teaches that anti-CD3 antibodies can be conjugated to cytotoxic agents and provided in a pharmaceutical composition for treating and/or preventing disease. (Paragraph 202.)
Regarding claim 26, it would have been obvious to form an immunoconjugate of the ’545 patent’s bispecific antibody because Zhong teaches antibodies conjugated to cytotoxic agents for therapeutic use.
Regarding claim 27, it would have been obvious to formulate the ’545 patent’s bispecific antibody in a composition because Zhong teaches anti-CD3 antibodies in compositions for therapeutic use.
Claims 1-4 and 16-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 14 of U.S. Patent No. 11,466,087. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of the ’087 patent uses a bispecific antibody that anticipates the examined antibody.
The underlying ’267 patent provides a limiting definition of “antibody”:
The term “antibody” herein is used in the broadest sense and encompasses various antibody structures, including but not limited to monoclonal antibodies, polyclonal antibodies, multispecific antibodies (e.g., bispecific antibodies), and antibody fragments so long as they exhibit the desired antigen-binding activity.
(Column 10, lines 25-30, emphasis added.)
The ’087 patent claims a method of enhancing immune function in a subject by administering antibody that is bispecific for CLL-1 and CD3. (Claims 13 and 14.) The ’087 patent claims that the CD3-binding domain of the bispecific antibody may comprise a heavy chain variable region (VH) comprising the sequence of SEQ ID NO: 84 and a light chain variable region (VL) comprising the sequence of SEQ ID NO: 93. The ’087 patent issued from an application that is a DIV of the one that issued as the ’545 patent, so the two applications’ sequence listings are identical.
SEQ ID NO: 84 of the bispecific antibody used in the ’087 patent’s method is 100% identical to examined SEQ ID NO: 7 and comprises hypervariable regions represented by SEQ ID NOs: 1-3. SEQ ID NO: 93 of the bispecific antibody used in the ’087 patent’s method is 100% identical to examined SEQ ID NO: 8 and comprises hypervariable regions represented by SEQ ID NOs: 4-6. (See appendix to Office action.)
The ’087 patent does not claim an antibody per se, but in carrying out the ’087 patent’s method, the person of ordinary skill in the art would necessarily reduce that antibody to practice. As such, the method of the ’087 patent anticipates the antibody employed to perform it.
The ’087 patent’s method of using a bispecific antibody therefore anticipates the antibody of examined claims 1-4 and 16-21.
Claims 26 and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 14 of U.S. Patent No. 11,466,087 in view of Zhong et al. (US 2013/0244255; reference A). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed immunoconjugate and composition are obvious variants of the ’087 patent’s antibody.
As discussed above, the ’087 patent claims a bispecific antibody that comprises examined SEQ ID NOs: 7 and 8.
Regarding claim 26, the ’087 patent does not claim an immunoconjugate comprising the bispecific antibody and a cytotoxic agent. Regarding claim 27, the ’087 patent does not claim a composition comprising the bispecific antibody.
Zhong teaches that anti-CD3 antibodies can be conjugated to cytotoxic agents and provided in a pharmaceutical composition for treating and/or preventing disease. (Paragraph 202.)
Regarding claim 26, it would have been obvious to form an immunoconjugate of the ’087 patent’s bispecific antibody because Zhong teaches antibodies conjugated to cytotoxic agents for therapeutic use.
Regarding claim 27, it would have been obvious to formulate the ’087 patent’s bispecific antibody in a composition because Zhong teaches anti-CD3 antibodies in compositions for therapeutic use.
Claims 1-4 and 16-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 6 of U.S. Patent No. 10,377,825. Although the claims at issue are not identical, they are not patentably distinct from each other because the bispecific antibody of the ’825 patent anticipates the examined antibody.
The underlying ’267 patent provides a limiting definition of “antibody”:
The term “antibody” herein is used in the broadest sense and encompasses various antibody structures, including but not limited to monoclonal antibodies, polyclonal antibodies, multispecific antibodies (e.g., bispecific antibodies), and antibody fragments so long as they exhibit the desired antigen-binding activity.
(Column 10, lines 25-30, emphasis added.)
The ’825 patent claims an antibody that is bispecific for HER2 and CD3. (Claims 1, 5, and 6.) The ’825 patent claims that the CD3-binding domain of the bispecific antibody may comprise a heavy chain variable region (VH) comprising the sequence of SEQ ID NO: 79 and a light chain variable region (VL) comprising the sequence of SEQ ID NO: 81.
SEQ ID NO: 79 of the ’825 patent’s bispecific antibody is 100% identical to examined SEQ ID NO: 7 and comprises hypervariable regions represented by SEQ ID NOs: 1-3. SEQ ID NO: 81 of the ’825 patent’s bispecific antibody is 100% identical to examined SEQ ID NO: 8 and comprises hypervariable regions represented by SEQ ID NOs: 4-6. (See sequence alignment in the attached Office action appendix.)
The ’825 patent’s antibody therefore anticipates the antibody of examined claims 1-4 and 16-21.
Claims 26 and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 6 of U.S. Patent No. 10,377,825 in view of Zhong et al. (US 2013/0244255; reference A). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed immunoconjugate and composition are obvious variants of the ’825 patent’s antibody.
As discussed above, the ’825 patent claims a bispecific antibody that comprises examined SEQ ID NOs: 7 and 8.
Regarding claim 26, the ’825 patent does not claim an immunoconjugate comprising the bispecific antibody and a cytotoxic agent. Regarding claim 27, the ’825 patent does not claim a composition comprising the bispecific antibody.
Zhong teaches that anti-CD3 antibodies can be conjugated to cytotoxic agents and provided in a pharmaceutical composition for treating and/or preventing disease. (Paragraph 202.)
Regarding claim 26, it would have been obvious to form an immunoconjugate of the ’825 patent’s bispecific antibody because Zhong teaches antibodies conjugated to cytotoxic agents for therapeutic use.
Regarding claim 27, it would have been obvious to formulate the ’825 patent’s bispecific antibody in a composition because Zhong teaches anti-CD3 antibodies in compositions for therapeutic use.
Allowable Subject Matter
Claims 5-15 and 22-25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Maintenance Fees
Applicant is reminded of the requirement to pay all applicable maintenance fees on the original patent. See MPEP 1415.01.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 11,007,267 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORA E BARNHART DRISCOLL, whose telephone number is (571)272-1928. The examiner can normally be reached M-F 7:00-4:00 p.m. ET.
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, Patricia Engle, can be reached on 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lora E Barnhart Driscoll/ Patent Reexamination Specialist, Art Unit 3991
Conferees:
/KSO/ Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/ SPRS, Art Unit 3991
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