DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's amendment and remarks filed on 01/14/2026 are acknowledged.
Claims 1-6, 8, 12-14, 16-18, 20-23, 27, 29-30, 32, 34, 36, 38, 40, 42-55 and 57-58 are pending.
Claims 52-55 and 57-58 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/07/2025.
Claims 1-6, 8, 12-14, 16-18, 20-23, 27, 29-30, 32, 34, 36, 38, 40 and 42-51 are presently under consideration.
3. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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 of this title, 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.
4. Claims 1-6, 8, 12-14, 16-18 and 20-23 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Jordan et al. (US 2017/0174760, "Jordan '760," of record).
The rejection set forth in section 6 of the previous office action is maintained
The grounds of rejection set forth in section 6 of the previous Office action are maintained for the reasons of record, as they apply to the amended claims, and are incorporated by reference herein as if reiterated in full.
Applicant’s arguments have been fully considered but have not been found convincing.
Applicant’s attempt to disqualify Jordan '760 as prior art under 35 U.S.C. §102(b)(2)(C) is ineffective, because Jordan '760 (published 06/22/2017) is prior art against the present application (earliest effective filing date 09/04/2019) under 35 U.S.C. 102(a)(1).
According to MPEP 2154.02(c), “The AIA 35 U.S.C. 102(b)(2)(C) exception does not apply to a disclosure that qualifies as prior art under AIA 35 U.S.C. 102(a)(1) (disclosures made before the effective filing date of the claimed invention). Thus, if the publication date or issue date of a U.S. patent document is before the effective filing date of the claimed invention, it may be prior art under AIA 35 U.S.C. 102(a)(1), regardless of common ownership or the existence of an obligation to assign.”
Applicant further asserts that amendment to claim 1 to require that the recipient be a “highly HLA-sensitized recipient whose calculated panel reactive antibody (cPRA) is > 50%” distinguishes the claims from the teachings of Jordan '760.
This is not persuasive, because Jordan '760 specifically teaches that the method applies to highly-HLA sensitized patients (e.g. [0007], [0026], [0065], [0104], [0108], [0120], [0129], [0134], [0137], and claim 19).
5. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
6. Claims 1-6, 8, 12-14, 16-18, 20-23, 27, 29-30, 32, 34, 36, 38, 40 and 42-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 17/292,025 (published as US 20210395358, of record) in view of Jordan et al. (US 20170174760, "Jordan '760," of record) and Meneghini et al. (2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the claims of USSN ‘026 in view of Jordan '760 and Meneghini.
USSN ‘025 claims a method for reducing or eliminating donor-specific antibody in HLA-sensitized human subject, comprising administering anti-IL-6 antibody clazakizumab, wherein the subject is in need of a solid organ transplantation and has calculated panel reactive antibodies (cPRA) of 90% or greater (claim 1).
Jordan '760 teaches that IL-6 inhibition with anti-IL-6 antibody in combination with costimulatory pathway blockage by CTLA4-Ig fusion protein induces graft acceptance [0130].
Meneghini teaches successful suppression of transplant rejection with CTLA4-Ig fusion protein belatacept in a highly sensitized patient with calculated panel reactive antibodies (cPRA) of 92% (p. 1410).
These teachings provide both the motivation and expectation of success for administering an IL-6 inhibitor and a CTLA4 fusion protein to a highly HLA-sensitized recipient whose calculated panel reactive antibody (cPRA) is > 50%. Accordingly, instant claims are obvious over the claims of USSN ‘025.
USSN ‘025 recites administration of calcineurin inhibitor tacrolimus in claim 21. Claims 5 and 18 are included in the rejection because IL-6 signaling inhibition can be achieved using anti-IL-6 antibodies as well as anti-IL-6R antibodies, as a person of skill in the art would be aware. The limitations of instant claims 6, 8, 14, 20-23, 29-30, 32, 34, 36, 38, 40, 42-44 and 46-48 are recited in, inherent in, or obvious in view of USSN ‘025 claims 4-9, 11, 13, 15, 17-18 and 20-25.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
7. Claims 1-6, 8, 12-14, 16-18, 20-23, 27, 29-30, 32, 34, 36, 38, 40 and 42-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 18/447,623 (published as US 20240124573, of record) in view of Jordan et al. (US 20170174760, "Jordan '760," of record) and Meneghini et al. (2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the claims of USSN ‘623 in view of Jordan '760 and Meneghini.
USSN ‘623 claims a method of preventing, stabilizing or reducing antibody mediated rejection (ABMR) in organ transplant recipient comprising administering an anti-IL-6 antibody (claim 1), wherein the recipient comprises HLA donor specific antibodies (DSA) prior to treatment (claim 11), i.e. the recipient is highly HLA-sensitized.
The teachings of Jordan '760 and Meneghini, described in section 6 above, motivation and expectation of success for administering an IL-6 inhibitor and a CTLA4 fusion protein to a highly HLA-sensitized recipient. The limitations of instant claims 2-6, 8, 12-14, 16-18, 20-23, 27, 29-30, 32, 34, 36, 38, 40 and 42-51 are recited in, inherent in, or obvious in view of USSN ‘623 claims 11, 43-44, 68-69 and 104-107 for the same reasons as presented in section 6 above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
8. Claims 1-6, 8, 12-14, 16-18, 20-23, 27, 29-30, 32, 34, 36, 38, 40 and 42-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 19/081,867 (published as US 2025/0263480, of record) in view of Jordan et al. (US 20170174760, "Jordan '760," of record) and Meneghini et al. (2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the claims of USSN ‘867 in view of Jordan '760 and Meneghini.
USSN ‘867 claims a method of reducing the severity of antibody mediated rejection (ABMR) in organ transplant recipient comprising administering anti-IL-6 antibody clazakizumab (claim 1), wherein the recipient is HLA-sensitized before the administration (claim 2), exhibits symptoms of chronic active ABMR, transplant glomerulopathy, and is donor-specific antibodies (DSAs) positive (claim 4), i.e. the recipient is highly HLA-sensitized.
The teachings of Jordan '760 and Meneghini, described in section 6 above, motivation and expectation of success for administering an IL-6 inhibitor and a CTLA4 fusion protein to a highly HLA-sensitized recipient. The limitations of instant claims 2-6, 8, 12-14, 16-18, 20-23, 27, 29-30, 32, 34, 36, 38, 40 and 42-51 are recited in, inherent in, or obvious in view of USSN ‘867 claims 5-20 for the same reasons as presented in section 6 above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
9. Claims 1-6, 8, 12-14, 16-18, 20-23, 27, 29-30, 32, 34, 36, 38, 40 and 42-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 19/082,348 (of record, now published as US 20250340618) in view of Jordan et al. (US 20170174760, "Jordan '760," of record) and Meneghini et al. (2017).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the claims of USSN ‘348 in view of Jordan '760 and Meneghini.
USSN ‘348 claims a method for treating, inhibiting, and/or reducing the severity of antibody mediated rejection (ABMR) in highly HLA-sensitized organ transplant recipient comprising administering IL-6 inhibitor, wherein the recipient exhibits symptoms of chronic ABMR, chronic transplant glomerulopathy, and is donor-specific antibodies (DSAs) positive (claims 19-20).
The teachings of Jordan '760 and Meneghini, described in section 6 above, motivation and expectation of success for administering an IL-6 inhibitor and a CTLA4 fusion protein to a highly HLA-sensitized recipient. The limitations of instant claims 2-6, 8, 12-14, 16-18, 20-23, 27, 29-30, 32, 34, 36, 38, 40 and 42-51 are recited in, inherent in, or obvious in view of USSN ‘348 claims 19-36 for the same reasons as presented in section 6 above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. Conclusion: no claim is allowed.
11. 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.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644