DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment, filed 05/26/2026, has been entered.
Claims 1, 2, 11, 12, 14-20 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, species PD-L1 and composition without further comprising an anticancer agent in the reply filed on 05/26/2026 is acknowledged.
Claims 16-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention/species, there being no allowable generic or linking claim.
Claims 1, 2, 11, 12, 14 and 15 are currently under examination.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 11, 12, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Jeon et al. (Biomaterials, 270 (2021) 120685) in view of Montemiglio et al. (Nature Communication 10, 1121 (2019); cited in IDS).
Jeon teaches a ferritin protein nanoparticle comprising a molecule capable of binding PD-L1 displayed on the outer surface of a ferritin nanocage. Jeon teaches that ferritin nanocage self-assemble into spherical nanoparticles comprising 24 ferritin monomers and are useful as immune checkpoint blockade platforms for cancer immunotherapy (see, e.g., Abstract). Jeon further teaches that blockade of the PD-1/PD-L1 pathway is an important strategy in cancer immunotherapy and specifically identifies anti-PD-1 monoclonal antibodies, including pembrolizumab and nivolumab and anti-PD-L1 monoclonal antibodies, including atezolizumab and duravlumab, as known and effective immune checkpoint inhibitors (see Introduction). Jeon additionally teaches that PD-L1-binding peptides were developed as therapeutic alternatives to antibody-based checkpoint inhibitors and further teaches that anti-PD-L1 antibodies exhibit substantially greater affinity for PD-L1 than PD-L1 binding peptides (page 2, second paragraph). Furthermore, Jeon teaches fusion of a PD-L1-binding ligand to multiple surface-exposed positions of ferritin, including the N-terminus (PpNF), the look between the fourth and firth helices corresponding to the D-E loop, and the C-terminus (PpCF), each of which is among the fusion position recited in claim 1 (see Results 3.1.; Figure 1; Discussion).
Jeon does not teach ferritin monomers having subsitutions at amino acid positions 15, 16, 23, 82 and 84 of SEQ ID NO: 1.
Montemiglio teaches engineered human H-ferritin variants comprising substitutions Q14A, D15A, R22A, F81A and Q83A (page 4, Mutations at common contacts tune ferritin-CD71 interaction). Montemiglio teaches that these residues are located at the ferritin-transfer receptor interaction interface and that substitution of these residues preserves ferritin nanoparticle assembly while substantially reducing interaction with human transferrin receptor (TfR1/CD71).
It is noted that Montemiglio numbers the ferritin amino acid sequence beginning with the mature ferritin sequence and does not include the initiator methionine residue. In contrast, Applicant’s SEQ ID NO: 1 includes the initiator methionine as amino acid position 1. Consequently, the residue numbering in the present claims is shifted by one position relative to the numbering used by Montemiglio. Accordingly, Montemiglio’s substitutions Q14A, D15A, R22A, F81A and Q83A correspond respectively to the claimed substitutions at positions 15, 16, 23, 82 and 84 of SEQ ID NO: 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ferritin nanoparticle of Jeon by incorporating the ferritin substitutions taught by Montemiglio because Montemiglio teaches that such substitutions preserve ferritin nanoparticle assembly while substantially reducing native transferrin receptor-mediated interactions. Therefore, one of ordinary skill in the art would have been motivated to make such modification to decrease non-specific uptake by healthy tissues, thereby prolonging circulation half-life of the ferritin nanocage and increasing the opportunity for the displayed PD-L1-binding molecule to reach and interact with target tumor tissues, with a reasonable expectation of success because Montemiglio demonstrates that the modified ferritin retains nanoparticle assembly and structural integrity.
Furthermore, Jeon expressly teaches that anti-PD-1 and anti-PD-L1 monoclonal antibodies are effective immune checkpoint inhibitors and teaches that PD-L1-binding peptides were developed as alternatives to antibody-based checkpoint inhibitors. Jeon additionally teaches that anti-PD-L1 antibodies such as atezolizumab and duravlumab exhibit substantially greater binding affinity for PD-L1 than PD-L1-binding peptides (Introduction). Therefore, one of ordinary skill in the art would have been motivated to employ a known anti-PD-L1 antibody or a fragment comprising an antigen-binding fragment (CDR) thereof as the PD-L1-binding molecule displayed on the ferritin nanoparticle in order to obtain the known high-affinity PD-L1 binding and checkpoint blockage activity associated with such antibodies.
Given that Montemiglio teaches the same ferritin mutant recited in claim 1 and that the mutant has significant reduced binding to transferrin receptor, it would have a binding force K greater than or equal to 10 nM (Supplementary Materials, Tables 4 and 5). Furthermore, Montemiglio expressly teaches human transferrin receptor (human CD71) and human ferritin heavy chain (see Methods).
Therefore, the invention, as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
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 1, 2, 11, 12, 14 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,206,987 in view of Jeon et al. (Biomaterials, 270 (2021) 120685) and Montemiglio et al. (Nature Communication 10, 1121 (2019)).
The patent claims disclosed a ferritin nanoparticle. Therefore, it would have been obvious to make a ferritin nanocage comprising an immune checkpoint molecule as recited in the present claims in view of Jeon and Montemiglio as discussed above (see 103).
Claims 1, 2, 11, 12, 14 and 15 aer provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of copending applications in view of Jeon et al. (Biomaterials, 270 (2021) 120685) and Montemiglio et al. (Nature Communication 10, 1121 (2019)).
Co-pending Application
Claims
18034193
1-31
17773266
1-2, 6-10, 12-14, 21-22, 31
18692984
1-11, 13
The co-pending claims disclosed a ferritin nanoparticle. Therefore, it would have been obvious to make a ferritin nanocage comprising an immune checkpoint molecule as recited in the present claims in view of Jeon and Montemiglio as discussed above (see 103).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 11, 12, 14 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 5, 12, 13, 14 of copending Application No. 18289179 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims disclosed the same ferritin nanocage with the same mutations and comprising the same immune checkpoint molecule as recited in the present claims. As such, the copending claims would anticipate the present claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
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/SHARON X WEN/Primary Examiner, Art Unit 1641
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