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
Status of Application, Amendments, and/or Claims
The Information Disclosure Statement (IDS) filed 24 October 2023 has been entered. Applicant’s preliminary amendment of the claims filed 20 September 2023 has been entered.
Claims 1-98 are cancelled. Claims 99-151 are pending and under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because of the following informalities:
U.S. Patent Application No. 16/556,885 is now patented. The first paragraph [0001] of the specification should be updated accordingly.
Appropriate correction is required.
Claim Objections
Claims 120, 123, 134-135 and 140-141 are objected to because of the following informalities:
In claims 120 and 123, the word “or” should be added at the end of (c).
In claim 134, “the total primary dose’ should be “the total secondary dose”.
In claim 135, “the total primary dose’ should be “the total tertiary dose”.
In claims 140 and 141, “week four” should be “week 4” (to be consistent in the claims).
Appropriate correction is required.
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 104 and depending claims thereof 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 pre-AIA the applicant regards as the invention.
Claim 104 recites: “The method of claim 99, further comprising: administering fractions of a tertiary dose (D3) of the therapeutic protein in week 3 of the dosing regimen, …; and administering the maximum weekly dose of the therapeutic protein to the subject as a single dose in a subsequent week of the dosing regimen.” However, in claim 99, the last administration step is also “administering the maximum weekly dose of the therapeutic protein to the subject as a single dose in a subsequent week of the dosing regimen”. While claim 104 specifies that the tertiary dose (D3) is administered in week 3, it is unclear whether “administering the maximum weekly dose of the therapeutic protein to the subject as a single dose in a subsequent week of the dosing regimen” recited in 104 is required to perform prior to the last administration step recited in claim 99. If administering the maximum weekly dose as a single dose in a subsequent week of the dosing regimen recited in claims 99 and 104 refers to two separate steps, what is the difference between the two steps? It appears that claim 104 may be intended to require administering the tertiary dose as a single dose in part two of the administration steps. The metes and bounds of the claims are unclear.
Double Patenting
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 99-151 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-53 of U.S. Patent No. 11,590,223. Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the ‘223 patent are drawn to a method of administering a therapeutic protein of the subject claims to a subject in a dosing regimen to mitigate adverse effects of cytokine release syndrome (CRS) or infusion-related reaction (IRR) in the treatment of a CD20-expressing B-cell malignancy. The method claimed in the ‘223 patent differs from the claims of the instant application in that the claims of the instant application recite a broader range in the amounts for the dose fractions, e.g., F1D1 comprises 10% to 90% of the total primary dose and F2D1 comprises the remaining 10% to 90% of the total primary dose, whereas the claims of the ‘223 patent recites F1D1 comprises 40% to 60% of the total primary dose and F2D1 comprises the remaining 40% to 60% of the total primary dose. The instant claims are broader in scope and are anticipated by the claims of the ‘223 patent.
Conclusion
NO CLAIM IS ALLOWED.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Xiaozhen Xie, whose telephone number is 571-272-5569. The examiner can normally be reached on M-F, 8:30-5.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa L. Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/XIAOZHEN XIE/Primary Examiner, Art Unit 1674 October 24, 2025