DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/3/2026 has been entered.
Claims 1-59 have been cancelled. Claims 60-77 have been newly added.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 60-63, 65, 67-71, 73, and 75-77 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
New claims 60-77 parallel the language of proposed claims 60-77 indicated as being allowable in the final Office action mailed 11/24/2025 except for the range of 170 to 340 mg in claim 60, part (ii), and claim 61, part (ii). The proposed claims had the range of 170 to 200 mg.
Applicant has pointed to basis for the 170 to 340 mg range in paragraph [0065] of the specification. This is not agreed with. This paragraph discloses the discrete dosage of 170 mg in certain situations and the discrete dosage of 340 mg in certain situations but not a dosage in the recited range. This range in the context of the methods claimed in claims 60 and 61 is not disclosed.
Paragraph [0065] discloses that when the antibody dose per subcutaneous administration in the first phase is lower than the antibody dose per subcutaneous administration in the second phase (as in the instant methods), the dose of the antibody per subcutaneous administration in the first phase is preferably 150 to 200 mg and a specific preferred dose includes 170 mg. This provides basis for the range 170-200 mg as recited in proposed claims 60-61 indicated as being allowable in the final Office action mailed 11/24/2025
The claims constitute new matter.
Claims 64, 66, 72, and 74 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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