DETAILED ACTION
Claim amendments filed 12/18/2024 are acknowledged and entered into the record.
Accordingly, Claims 20-22, 33-46 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-22 recites the limitation "pretreatment" in lines 1. There is insufficient antecedent basis for this limitation in the claim. Claim 20 from which claims 21 and 22 depend do not recite a limitation of “pretreatment”. Furthermore Claims 21 and 22 do not make a distinction of what this “pretreatment” is prior to? Appropriate clarification is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 20-22 and 33-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Furie et al. (Arthritis & Rheumatology, Vol. 69, No. 2, Feb 2017, pp. 376-386).
The claims are drawn to a method of treating systemic lupus erythematous (SLE) comprising administering intravenously the INFNAR1 inhibitor anifrolumab.
Furie et al. teach systemic lupus erythematous patients were randomized to receive intravenous anifrolumab (300mg or 1,000mg) or placebo. The study included patients having a >6 SLEDAI-2K score (see patients and methods). Furie et al. teach anifrolumab substantially reduced disease activity compared with placebo across multiple clinical end points in the patients with moderate-to-severe SLE. Furie et al. teach each and every limitation of instant claims 20-22 and 33-37.
Claim(s) 20, 38-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Higgs et al. (US 2015/0158949) as evidenced by SAPHNELO Prescribing Information (retrieved 6/19/2026 from https://www.saphnelo.com).
The claims are drawn to a method of treating systemic lupus erythematous (SLE) comprising administering subcutaneously the INFNAR1 inhibitor, anifrolumab.
Higgs et al. teach a method of treating SLE comprising subcutaneously administering a dose of anifrolumab (MEDI-546) of more than 105 mg and less than 150 mg (see paragraph [0124]). Higgs et al. further taught administering the dose every week, once per week (QW) for at least about 8 weeks. It is noted that anifrolumab is an FDA-approved drug marketed under the tradename Saphnelo wherein the antibody is manufactured in 150 mg/mL concentration in a single-dose vial in the same pharmaceutical composition as instantly claimed as evidenced by Saphnelo Prescribing Information (see section 11, description, page 3). Higgs et al. teach each and every limitation of instant claims 20, 38-45.
Conclusion
Claims 20-22, 33-46 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEERA NATARAJAN whose telephone number is (571)270-3058. The examiner can normally be reached M-F 9AM - 5PM.
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.
/Meera Natarajan/Primary Examiner, Art Unit 1643
Prosecution Insights