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 .
DETAILED ACTION
The amendment filed October 23, 2025 in response to the Office Action of April 24, 2025 is acknowledged and has been entered.
Claims 1-3, 5, 7, 8 and 12-20 have been amended.
Claims 4, 6 and 9-11 have been cancelled.
Claims 1-3, 5, 7, 8 and 12-20 are currently under consideration as drawn to the elected invention.
The amended claims recite a method of treating polycythemia in a subject comprising administering to the subject an antibody comprising the specific HCDRs: 1-2-3 and LCDRs: 4-5-6 combination. It is noted that although the prior art teaches the antibody with the specific CDR combination and the usage of the antibody for cancer treatment, the prior art does not explicitly teach that the specific antibody has activity to treat polycythemia alone or in combination with another polycythemia treatment method. It is acknowledged that the instant application shows the activity of antibody TfR436, which comprises the recited CDRs, in treating polycythemia, see Examples 3-5.
Taken together, in view of the claim amendments and applicant’s arguments, the 112(b), 112(a), 102, 103 and Double Patenting rejections set forth in the previous Office Action of April 24, 2025 are hereby withdrawn.
In view of the specification, the amendments of October 23, 2025, the objection to the specification set forth in the previous Office Action of April 24, 2025 is hereby withdrawn.
NEW OBJECTION AND REJECTION
Claim Objections
Claim 14 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 5. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 7, 19 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites “a peptide comprising CDR”, which renders the claim indefinite. Claim 7 depends on claim 1 and claim 1 recites three heavy chain CDRs and three light chain CDRs of the claimed antibody. It is not clear whether the CDR in the term “a peptide comprising CDR” refers to CDRs recited by claim 1 or encompass other CDRs.
Similarly, claims 19 and 20 also recite “a peptide comprising CDR”. Because these claims depend on claim 1, and claim 1 recites three heavy chain CDRs and three light chain CDRs of the claimed antibody. It is not clear whether the CDR in the term “a peptide comprising CDR” refers to CDRs recited by claim 1 or encompass other CDRs.
Conclusion
Claims 1-3, 5, 8, 12, 13 and 15-18 are drawn to allowable subject matters.
Claims 7, 19, 20 are rejected.
Claim 14 is objected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHENG LU whose telephone number is (571)272-0334. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHENG LU/Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642