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. Claims 65 and 67-76 are pending upon entry of amendment filed on 7/23/25.
Claims 65 and 67-76 are under consideration in the instant application.
3. The oath filed on 7/23/25 has been acknowledged.
4. In light of Applicant’s amendment to the claims field on 7/23/25, the rejection under 35 U.S.C. 112(a), 102 (a) (in part) and the double patenting rejections has been withdrawn (see sections 5, 6, 10, 13-17 of the office action mailed on 4/25/25).
5. The following rejections remain.
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
7. 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.
8. Claim(s) 65 and 67-76 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Furie et al (Arthritis and Rheumatology, vol. 69, no.2, pp. 376-386, IDS reference) as evidenced by p. 22 of the instant specification for the reasons set forth in the office action mailed on
Furie et al. teaches treatment of SLE comprising administering 300mg-1000mg of anifrolumab and SLE is assessed by BILAG with BICLA response. Furie et al. further teaches intravenous or subcutaneous administration of anifrolumab every four weeks (p. 376-384). As evidenced by the specification in p. 22, anifrolumab inherently comprises CDR’s set forth in SEQ ID NO:3-8 and heavy and light chain variable chains set forth in SEQ ID NO:1-2. Therefore, the reference teachings anticipate the claimed invention.
Applicant’s response filed on 7/23/25 has been fully considered but they were not persuasive.
Applicant has asserted that the prior art reference fails to teach the currently amended limitations where the IFNGS measures IFI27, IFI44, IFI44L and RSADS.
Unlike Applicant’s assertion, the Furie reference discloses in p. 378 that the IFN gene signature was determined to analytically validate 4 genes IFI27, IFI44, IFI44L and RSADS and the patient having SLE has lower IFN gene than baseline.
9. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
10. Claims 65-76 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub. 2017/0051066 (of record) in view of Furie et al (Arthritis and Rheumatology, vol. 69, no.2, pp. 376-386, IDS reference, of record) for the reasons set forth in the office action mailed on 4/25/25.
The ‘066 publication teaches treatment of SLE comprising administering anifrolumab (p. 3, 10-11) As evidenced by the specification in p. 22, anifrolumab inherently comprises CDR’s set forth in SEQ ID NO:3-8 and heavy and light chain variable chains set forth in SEQ ID NO:1-2.
The teachings of the ‘066 publication and Furie et al. have been discussed, supra.
Claims 66-67 are included in this rejection as the SLE patient would be expected to have greater than 2 fold expression of IFI27, IFI44, IFI44L and RSAD2.
The disclosure of the ‘066 differs from the instant claimed invention in that it does not teach the assessment and/or dose as in claims 65 and 71-75 of the instant application.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize dosage, clinical studies and patient groups that is taught by the Furie reference into the anifrolumab formulation or method of treating SLE as in the ‘066 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of known regimen and studies of SLE treatment taught by the Furie reference would facilitate optimization or treatment of SLE with different anifrolumab formulation.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicant’s response filed on 7/23/25 has been fully considered but they were not persuasive.
Applicant has asserted that the combination of the references does not result in the claimed invention as the references fails to teach the currently amended claims.
IN light of the discussion above in section 8 of the office action, the combination of the references remains obvious and the rejection is maintained.
11. The following new ground rejections are necessitated by Applicant’s amendment filed on 7/23/25.
12. 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.
13. Claims 65, and 67-76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-36 of U.S. Application No. 18/248,280 in view of Furie et al (Arthritis and Rheumatology, vol. 69, no.2, pp. 376-386, IDS reference, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘280 application discloses treatment of SLE comprising anifrolumab.
The claims of the ‘280 application from the instant claimed invention in that it does not teach the assessment and/or dose as in claims 65 and 71-75 of the instant application.
Furie et al. teaches treatment of SLE comprising administering 300mg-1000mg of anifrolumab and SLE is assessed by BILAG with BICLA response. Furie et al. further teaches intravenous or subcutaneous administration of anifrolumab every four weeks (p. 376-384). As evidenced by the specification in p. 22, anifrolumab inherently comprises CDR’s set forth in SEQ ID NO:3-8 and heavy and light chain variable chains set forth in SEQ ID NO:1-2. In addition, Furie et al. disclose in p. 378 that the IFN gene signature was determined to analytically validate 4 genes IFI27, IFI44, IFI44L and RSADS and the patient having SLE has lower IFN gene than baseline.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize dosage, clinical studies and patient groups that is taught by the Furie reference into the anifrolumab formulation or method of treating SLE as in the ‘280 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of known regimen and studies of SLE treatment taught by the Furie reference would facilitate optimization or treatment of SLE with different anifrolumab formulation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. Claims 65 and 67-76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-18, 20, 27, 28 and 34-40 of U.S. Application No. 18/698,343 in view of Furie et al (Arthritis and Rheumatology, vol. 69, no.2, pp. 376-386, IDS reference, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘343 application discloses treatment of SLE comprising anifrolumab.
The claims of the ‘343 application from the instant claimed invention in that it does not teach the assessment and/or dose as in claims 65 and 71-75 of the instant application.
Furie et al. teaches treatment of SLE comprising administering 300mg-1000mg of anifrolumab and SLE is assessed by BILAG with BICLA response. Furie et al. further teaches intravenous or subcutaneous administration of anifrolumab every four weeks (p. 376-384). As evidenced by the specification in p. 22, anifrolumab inherently comprises CDR’s set forth in SEQ ID NO:3-8 and heavy and light chain variable chains set forth in SEQ ID NO:1-2. In addition, Furie et al. disclose in p. 378 that the IFN gene signature was determined to analytically validate 4 genes IFI27, IFI44, IFI44L and RSADS and the patient having SLE has lower IFN gene than baseline.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize dosage, clinical studies and patient groups that is taught by the Furie reference into the anifrolumab formulation or method of treating SLE as in the ‘343 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of known regimen and studies of SLE treatment taught by the Furie reference would facilitate optimization or treatment of SLE with different anifrolumab formulation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
15. Claims 65 and 67-76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-66 of U.S. Application No. 18/435,476 in view of Furie et al (Arthritis and Rheumatology, vol. 69, no.2, pp. 376-386, IDS reference, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘476 application discloses treatment of SLE comprising anifrolumab.
The claims of the ‘476 application from the instant claimed invention in that it does not teach the assessment and/or dose as in claims 65 and 71-75 of the instant application.
Furie et al. teaches treatment of SLE comprising administering 300mg-1000mg of anifrolumab and SLE is assessed by BILAG with BICLA response. Furie et al. further teaches intravenous or subcutaneous administration of anifrolumab every four weeks (p. 376-384). As evidenced by the specification in p. 22, anifrolumab inherently comprises CDR’s set forth in SEQ ID NO:3-8 and heavy and light chain variable chains set forth in SEQ ID NO:1-2. In addition, Furie et al. disclose in p. 378 that the IFN gene signature was determined to analytically validate 4 genes IFI27, IFI44, IFI44L and RSADS and the patient having SLE has lower IFN gene than baseline.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize dosage, clinical studies and patient groups that is taught by the Furie reference into the anifrolumab formulation or method of treating SLE as in the ‘476 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of known regimen and studies of SLE treatment taught by the Furie reference would facilitate optimization or treatment of SLE with different anifrolumab formulation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
16. Claims 65 and 67-76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-56 and 67-70 of U.S. Application No. 18/474,601 in view of Furie et al (Arthritis and Rheumatology, vol. 69, no.2, pp. 376-386, IDS reference, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘601 application discloses treatment of SLE comprising anifrolumab.
The claims of the ‘601 application from the instant claimed invention in that it does not teach the assessment and/or dose as in claims 65 and 71-75 of the instant application.
Furie et al. teaches treatment of SLE comprising administering 300mg-1000mg of anifrolumab and SLE is assessed by BILAG with BICLA response. Furie et al. further teaches intravenous or subcutaneous administration of anifrolumab every four weeks (p. 376-384). As evidenced by the specification in p. 22, anifrolumab inherently comprises CDR’s set forth in SEQ ID NO:3-8 and heavy and light chain variable chains set forth in SEQ ID NO:1-2. In addition, Furie et al. disclose in p. 378 that the IFN gene signature was determined to analytically validate 4 genes IFI27, IFI44, IFI44L and RSADS and the patient having SLE has lower IFN gene than baseline.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize dosage, clinical studies and patient groups that is taught by the Furie reference into the anifrolumab formulation or method of treating SLE as in the ‘601 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of known regimen and studies of SLE treatment taught by the Furie reference would facilitate optimization or treatment of SLE with different anifrolumab formulation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
17. No claims are allowable.
18. 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.
19. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
September 18, 2025
/YUNSOO KIM/Primary Examiner, Art Unit 1641