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
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/7/2026 has been entered.
Status of the Claims
2. Claims 1-31 are the original claims filed on 5/8/2020. In the Preliminary Amendment of 8/20/2020, Claims 1-37 are amended. In the second Preliminary Amendment of 9/22/2020, Claim 30 is amended. In the Response of 4/10/2023, Claims 1-4, 6-9, 11, and 27-31 are amended, claims 12-14 are canceled and new claims 32-37 are added. In the Response of 8/25/2023, Claims 1, 6, 10, 31, 34-35, and 37 are amended. In the Response of 2/8/2024, Claims 1 and 6 are amended. In the Response of 10/8/2024, Claims 1, 3-4, 11, 17-18, 21, 24-26, 28-31, and 36-37 are amended, claims 15, 19-20, and 22-23 are canceled, and new claim 38 is added. In the Response of 2/26/2025, Claims 1, 18, 21, 24 and 25 are amended and new Claim 39 is added. In the Response After Final Action of 7/14/2025, no claims are amended or added. In the RCE of 9/15/2025 and 10/2/2025 no claims no claims are amended, canceled or added. In the Response of 4/6/2026, claims 1, 5, 8, 11, 21, 28-29, 32, 37-39 are amended, claim 4 is canceled and new claims 40-41 are added. In the Response of 8/7/2026, claims 1, 3, 5-6, and 36-37 are amended, claim 10 is canceled and new claims 42-44 are added.
Claims 1-3, 5-11, 17-18, 21 and 24-44 are all the claims.
This Office Action contains new grounds for rejection.
Examiner’s Comments
3. A bona fide effort was made to contact the agent of record for this application to negotiate an allowance. The agent of record, Wyan-Ching Lee (agent registration no. 65,813), is not identified on 9/14/2026 at any of the telephone numbers listed of record: 617-862-6805 (Response of 8/7/2026, p. 19) and 202-429-6492 (USPTO Attorneys of Record for customer no. 21069). The Examiner of record contacted an Amgen operator at 805-447-1000 where Wyan-Ching Lee is not listed in their correspondence. The Examiner of record contacted Steptoe LLP (customer no. 21069) operator at 202-429-3000 where Wyan-Ching Lee is not listed in their correspondence.
Priority
4. USAN 16/869,793, filed 05/08/2020, and having 4 RCE-type filing therein,
claims foreign priority to EP19208417.6, filed 11/11/2019.
Information Disclosure Statement
5. As of 9/14/2026, a total of seven (7) IDS are filed for this application: 8/11/2020; 12/1/2021; 9/26/2022; 1/16/2025; 6/9/2025; 4/6/2026; and 8/7/2026. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(b)
6. The rejection of Claims 1-3, 5-11, 17-18, 21 and 24-41 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is moot for the canceled claim(s) and withdrawn for the pending claims. Claim 1 is amended to clarify the administration step(s) for at least a first cycle comprising at least three individual administrations of the antibody construct each at a dose of 800 ug/day to 12 mg/day, wherein each of said at least three individual administrations takes place on a single, separate day. Accordingly, the dependent claims comport with generic claim 1.
Double Patenting
7. The rejection of Claims 1-3, 5-11, 17-18, 21 and 24-39 (and 40-41) on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11352433 or claims 1-19 of U.S. Patent No. 10301391 in view of Cong et al (PTO 892 form)) is moot for the canceled claim and withdrawn for the pending claims.
Applicants comments and the prosecution record combined with the amendments to generic claim 1 to clarify the subject of the invention having relapsed and/or refractory multiple myeloma with the administration step(s) for at least a first cycle comprising at least three individual administrations of the antibody construct each at a dose of 800 ug/day to 12 mg/day, wherein each of said at least three individual administrations takes place on a single, separate day overcomes the rejection.
Withdrawal of Objection
Claim Objections
8. The objection to Claims 5 and 40-41 because of informalities is withdrawn.
a) Claim 5(b) is amended to recite “or b) two dose steps[,] from a first dose to a second dose, and a second dose to a third dose, during the first cycle.”
b) The objection is withdrawn for claim 40 in view of the explanation provided in the response.
New Grounds for Rejection
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.
9. Claim 42 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 42 recites the limitation "the target dose". There is insufficient antecedent basis for this limitation in the claim. Amended Claim 5 recites “a second target dose” and “a third target dose.” Claim 42 is indefinite as to the target the dose in claim 5.
Conclusion
10. Claims 1-3, 5-11, 17-18, 21, 24-41 and 43-44 are allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Julie 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.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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