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 .
Claim Status
Applicant’s amendments and remarks, filed 01/05/2026, are acknowledged.
Claims 2-3, 5, 9, 15, and 18 are canceled.
Claim 21 is new.
Claims 1, 4, 6-8, 10-14, 16-17, and 19-21 are pending.
Claims 10-13, 16, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/13/2025.
As such, claims 1, 4, 6-8, 14, 17, 19, and 21 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Withdrawn Objections
The drawings objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the drawings on 01/05/2026.
The specification objections are withdrawn. Issues regarding minor informalities and trademarks/names have been sufficiently addressed through amendments to the specification on 01/05/2026.
Maintained Rejections
Claim Rejections - 35 USC § 112(b)
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 1, 4, 6-8, 14, 17, and 19 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 1 recites the limitations “by Kabat numbering” and “by IMGT numbering”. This limitation incorporates a reference in the claim. MPEP2173.05(s) states:
Where possible, claims are to be complete in themselves. Incorporation by reference “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
As such, claim 1 and its dependent claims are rejected.
Applicant’s Arguments
Applicant respectfully submits to withdraw the rejections under 35 USC 112(b) (see pages 7 and 8 of the Remarks filed 01/05/2026). Applicant respectfully submits that it is well known in the art relating to the present application that there is a plurality of methods to derive the CDR sequences from the amino acid sequences of a heavy chain variable region and a light chain variable region, and different methods give different numbering. For example, Kabat numbering, Chothia numbering, IMGT numbering, Martin numbering, etc. Those skilled in the art would appreciate that different numbering systems or different programs may show different CDR sequences even based on the same VH and VL sequences. The numbering reference recited in Claim 1 therefore increases the clarity and concise of its patent scope.
Response to Arguments
Applicant's arguments filed 01/05/2026 have been fully considered but they are not persuasive. Applicant indicates that the numbering reference recited in claim 1 increases the clarity and concise of its patent scope; however, the sequences recited in claim 1 are based on Kabat numbering and IMGT numbering according to the specification (see Table 2). Incorporating the reference renders the claim indefinite because the CDR sequences are either already set forth as shown in the SEQ ID NO, which would render the incorporation by reference redundant, or the sequences can be any two amino acids linked together as a sequence, selected from the sequence of the SEQ ID NO, which would mean that the numbering by the incorporated reference would not identify the CDR sequences. Applicant’s arguments suggest that the claims do not require the entire sequence listed in the SEQ ID NO, which adds further complexity to the claim interpretation. As such, the 112(b) rejection is maintained.
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.
17/925,547
Claims 1, 4, 6-8, 14, 17, 19, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending Application No. 17/925,547 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The ‘547 claims are drawn to a protein wherein the protein comprises domains of: (1) the IL-15 mutant polypeptide; (2) an immunoglobulin molecule or part thereof fused to the IL-15 mutant polypeptide; and (3) IL-15Rα fused to the IL-15 mutant polypeptide (see claim 5).
Particularly, the ‘547 claims are drawn to the protein according to claim 5, wherein the immunoglobulin is an anti-PD-L1 antibody or antigen-binding fragment; preferably, the anti-PD-L1 antibody is 794-h1-71; the anti-PD-L1 antibody comprises a heavy chain variable region and a light chain variable region, wherein the heavy chain variable region and the light chain variable region have sequences shown in SEQ ID NO: 99 and SEQ ID NO: 100, respectively; or, the heavy chain variable region and light chain variable region have sequences shown in SEQ ID NO: 97 and SEQ ID NO: 98; the IL-15Rα is IL-15Rα-sushi; preferably, the IL-15Rα-sushi has an amino acid sequence as shown in SEQ ID NO:49, SEQ ID NO:51, SEQ ID NO:53, or SEQ ID NO:55 (see claim 9). SEQ ID Nos: 97 and 98 of the ‘547 application shares 100% identity with SEQ ID Nos: 17 and 18, respectively.
As such, the ‘547 application anticipates the present invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s Arguments
Applicant respectfully traverses each rejection, each assertion regarding what the reference discloses, and each and every implicit and/or explicit reliance on Official Notice, and Applicant does not acquiesce in the validity of the rejection (see pages 8 and 9 of the Remarks filed 01/05/2026).
Claims 9 and 10 of '547 are dependent claims of claim 5. Claim 5 recites a protein comprising three domains: (1) the IL-15 mutant polypeptide of claim 1; (2) an immunoglobulin molecule or part thereof fused to the IL-15 mutant polypeptide; and (3) IL-15Ra fused to the IL- 15 mutant polypeptide. The subject matters recited in Claims 9 and 10 of '547 are a fusion protein containing a particular combination of three proteins: IL-15 mutant + anti-PD-L1 antibody + IL- 15Ra. Therefore, the subject matter recited in Claims 9 and 10 are not the CDR sequences of the anti-PD-L1 antibody, but the particular combination of three proteins, which may exhibit synthetic effect.
In contrast, presently pending Claim 1 specifically recites a combination of six CDRs indicated by specific and particular amino acid sequences "the CDR1-VH comprises a sequence of SEQ ID NO: 67, the CDR2-VH comprises a sequence of SEQ ID NO: 68 and the CDR3-VH comprises a sequence of SEQ ID NO: 69; and the CDR1-VL comprises a sequence of SEQ ID NO: 70, the CDR2-VL comprises a sequence of SEQ ID NO: 71 and the CDR3-VL comprises a sequence of SEQ ID NO: 72" or "the CDR1-VH comprises a sequence of SEQ ID NO: 121, the CDR2-VH comprises a sequence of SEQ ID NO: 122 and the CDR3-VH comprises a sequence of SEQ ID NO: 123; and the CDR1-VL comprises a sequence of SEQ ID NO: 124, the CDR2-VL comprises a sequence of SEQ ID NO: 125 and the CDR3-VL comprises a sequence of SEQ ID NO: 126."
Accordingly, Applicant submits that the presently pending claims can be patentably distinguished and nonobvious from '547. Applicant respectfully requests reconsideration and withdrawal of the obviousness-type double patenting rejection.
Response to Arguments
Applicant's arguments filed 1/05/2026 have been fully considered but they are not persuasive. The present claims are drawn to an isolated antibody or antigen-binding fragment thereof specifically binding to human PD-L1, and the claims of the copending application are drawn to a fusion protein comprising an IL-15 mutant, anti-PD-L1 antibody and IL-15Ra. Further, the copending application recites that the anti-PD-L1 antibody comprises a heavy chain variable region and light chain variable region comprising SEQ ID Nos: 97 and 98, respectively; and, SEQ ID Nos: 97 and 98 of the ‘547 application shares 100% identity with SEQ ID Nos: 17 and 18, respectively. Thus, if the heavy chain and light chain variable sequences of ‘547 application share 100% identity with the heavy chain and light chain variable sequences of the present application, then it would inherently comprise the CDRs of the present application (see MPEP 2112). Therefore, the presently pending claims are not patentably distinguished or nonobvious from the ‘547 application.
As such, the provisional double patenting rejection is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 DANAYA L MIDDLETON whose telephone number is (571)270-5479. The examiner can normally be reached M-F 9:30AM - 6PM with flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at (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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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674