DETAILED ACTION
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 received 21JAN2026 are acknowledged.
Claims 2-3, 5, 8-34, 37-46, 48-60, 65, 67, 69-96, 99-114, and 117-120 have been canceled.
Claims 1, 4, 7, 35-36, 47, 61, 97-98, and 115-116 have been amended.
Claims 1, 4, 6-7, 35-36, 47, 61-64, 66, 68, 97-98, and 115-116 are pending in the instant application (i.e., Claim(s) 1, 35, and 97-98 is/are independent).
Claims 62-64, 66, 68, and 116 remain withdrawn.
Claims 1, 4, 6-7, 35-36, 47, 61, 97-98, and 115 are examined on the merits.
Priority
The present application is a 371 National Stage of PCT International Application No. PCT/CA2020/051061, filed 31JUL2020, which claims the benefit of US Provisional Patent Application No. 62/881889, filed 01AUG2019. Applicant’s claim for the benefit of prior-filed application is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 21JAN2026 is/are acknowledged and the references cited therein have been considered.
Specification
Applicant’s arguments, see p 9, Amendments to the specification section, filed 21JAN2026, with respect to objections to the specification for minor informalities have been fully considered and said objections to the specification have been withdrawn in view of amendments to the specification filed as part of said response.
Claim Objections
Applicant’s arguments, see p 12, Claim objections section, filed 21JAN2026, with respect to objections to claim(s) 36, 79, 92, 97-98, and 115 (i.e., claim 79 is cancelled) for informalities have been fully considered and said objections to claim(s) 36, 92, 97-98, and 115 have been withdrawn in view of claim amendments filed as part of said response.
Withdrawn Rejections
Indefiniteness
Applicant’s arguments, see p 12-13, 35 USC §112, second paragraph section, filed 21JAN2026, with respect to the rejection(s) of claim(s) 24, 47, 79, 97-98, 115, and 117 (i.e., claim(s) 24, 79 and 117 have been cancelled) under 35 USC §112(b) have been fully considered and said rejections of claim(s) 47, 97-98, and 115 have been withdrawn in view of the claim amendments filed as part of said response.
Written Description
Applicant’s arguments, see p 13-15, 35 USC §112(a)—Written Description section, filed 21JAN2026, with respect to the rejection(s) of claim(s) 97-98 under 35 USC §112(a) – written description have been fully considered and said rejections of claim(s) 97-98 have been withdrawn in view of the claim amendments filed as part of said response. Furthermore, claims 3, 24, 79, 92, and 117 have been cancelled making said rejections moot.
Scope of Enablement
Applicant’s arguments, see p 15-18, 35 USC §112(a)—Enablement section, filed 21JAN2026, with respect to the rejection(s) of claim(s) 1, 3-4, 6-7, 24, 35-36, 61, 79, 92, 97-98, and 117 (i.e., claim(s) 3, 24, 79, 92, and 117 have been cancelled) under 35 USC §112(a) - enablement have been fully considered and said rejections of claim(s) 1, 4, 6-7, 35-36, 61, and 97-98 have been withdrawn in view of the claim amendments filed as part of said response.
35 USC §102
Applicant’s arguments, see p 18-19, 35 USC §102 section, filed 21JAN2026, with respect to the rejection(s) of claim(s) 1, 24, 35-36, and 61 (i.e., claim(s) 24 have been cancelled) under 35 USC §102 have been fully considered and are fully persuasive because of the claim amendments which add limitations not taught in the cited art. As such, said rejection of claim(s) 1, 35-36, and 61 under 35 USC §102 have been withdrawn.
35 USC §103
Applicant’s arguments, see p 20-21, 35 USC §103 section, filed 21JAN2026, with respect to the rejection(s) of claim(s) 3-4, 7, 79, 92, and 117 (i.e., claim(s) 3, 79, 92, and 117 have been cancelled) under 35 USC §103 have been fully considered and said rejections of claim(s) 4 and 7 have been withdrawn in view of the claim amendments filed as part of said response.
Double Patenting
Applicant’s arguments, see p 21-24, Double patenting section, filed 21JAN2026, with respect to the rejection(s) of claim(s) 1, 3-4, 24, and 35-36 as being unpatentable over claims 1-7 of U.S. Patent No. 12,214,052; claims 1 and 3 as being unpatentable over claims 1-37 of U.S. Patent No. 7,097,841 B2; and claims 3, 24, 47, 79, 92, and 117 as being provisionally unpatentable over claims 1-7, 9-10, 14-20, 35-39, 50, 77, 110-112, 125, 152, 156-159 of co-pending Application No. 18/263217 (i.e., claims 3, 24, 79, 92, and 117 have been cancelled) under (provisional) non-statutory double patenting have been fully considered and said rejections of claim(s) 1, 4, 47, and 35-36 have been withdrawn in view of the added limitations in the claim amendments filed as part of said response.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 1, 4, 6-7, 35-36, and 61 stand rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In this instance, the prior art supports careful design and engineering of self-assembled protein-based nanoparticles for therapeutic drug delivery, wherein the modification of the scaffold architecture and exterior modifications (i.e., antibodies or fragments thereof) can critically influence the pharmacokinetics, biodistribution, and efficacy of the protein-based nanoparticle (Olshefsky, et al., Bioconj Chem, 2022, 33, 2018-2034, see entire document). Furthermore, the art supports that HIV treatment refers to the use of interventions (i.e., immunotherapy) to eliminate or reduce the viral load that is already present in the body; whereas HIV prevention (i.e., prophylaxis) is an action taken to lower the chance of getting HIV (Haynes, et al., Sci Transl Med, 2020, 11, 1-7, see entire document). As presently written, the claims have been amended to recite that a specific N- or C-region apoferritin monomer subunit consisting of at least 70% identity to SEQ ID NOs: 11 or 12 and essentially any antibody or fragment thereof functions to self-assemble for use as a therapeutic or prophylactic. However, the working examples fail to disclose any data indicating that the breadth of antibody structures (i.e., a protein constructed from paired HC and LCs comprising a VH and CH1-3 and VL and CL, respectively, p 22 of the 31JAN2022 specification) or antibody fragment structures (i.e., any suitable antigen binding antibody fragment known in the art, e.g., Fv, scFv, Fc, scFc, Fab, scFab, sdAb, and multivalent presentations of any of these, p 22 of the 31JAN2022 specification) encompassed by the language of the instant claims will have the same function (i.e., self-assembly and therapeutic efficacy against HIV). Therefore, as presently written, the claimed broad genus of a specific apoferritin monomer subunit and essentially any antibody or fragment thereof functions to self-assemble for use as a therapeutic or prophylactic lacks adequate written description because there does not appear to be any correlation between the structure of the fusion protein, pair of fusion proteins, or nanocages as presently claimed and the ability to self-assemble and provide therapeutic or prophylactic effects.
Applicant argues that the specification describes the claimed invention in sufficient detail, including the apoferritin monomer subunit and exemplary antibody fragments and nanocages, so that one skilled in the art would reasonably conclude that Applicant had possession of the claimed invention (p 13-15, 35 USC §112(a)—Written Description section).
RESPONSE
Applicant’s arguments have been fully considered but are found non-persuasive essentially for the reasons of record and as described further below.
As set forth in the rejection of record and as discussed supra, the specification and working examples provides neither a representative number of the encompassed self-assembling fusion proteins comprising the specific apoferritin monomer subunit and any antibody or antibody fragment thereof, nor do they provide a description of the structural features that are common to the encompassed fusion proteins, pairs of fusion proteins, or nanocages. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant (i.e., antibody or antibody fragment thereof), the artisan cannot envision the detailed structure of the encompassed self-assembling fusion proteins and therefore Applicant was not in possession of the instant claimed invention.
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, 4, 7, 35-36, and 61 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-10, 14-20, 35-39, 50, 77, 110-112, 125, 152, 156-159 of co-pending Application No. 18/263217; herein referred to as the “’217 reference application.” Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed fusion protein(s) or nanocage especially in instant claims 1, 4, 7, and 35-36, and the therapeutic composition in instant claim 61 are obvious variations of the fusion protein(s) or nanocage in claims 1, 18, 39, 50, 77, 112, and 125 and the therapeutic composition in claim 152 of the ‘217 reference application. SEQ ID NOs: 11 and 12 are not claimed in the ‘217 reference application. However, the fusion protein in claim 1 of the ‘217 reference application, comprises a first nanocage monomer or a subunit thereof (i.e., a generic term for the N- or C-region of apoferritin of SEQ ID NOs: 11 and 12 of the instant application) linked to an Fc monomer (i.e., antibody fragment thereof). In order to determine the scope of the monomer subunits, the specification of the ‘217 reference application was consulted and the instant species of SEQ ID NOs: 11 and 12 were disclosed on p 8 of the ‘217 reference application specification as SEQ ID NOs: 15 and 16 (i.e., 100% query match, see OA.APPENDIX). Furthermore, the fusion protein of claim 18 of the ‘217 reference application comprises an HIV1 specific antigen-binding moiety selected from the group consisting of PGDM1400, 10E8.v4, and N49P7. However, claims of the ‘217 reference application are silent on the structure of the antigen-binding moiety and N- or C-regions of apoferritin. In order to determine the scope of the antigen binding moiety, the specification of the ‘217 reference application was consulted and the Fab-Ferritin structures of SEQ ID NOs: 8 or 17 were disclosed (p 36 and Fig 7A of the ‘217 reference application, see OA.APPENDIX).
In this instance, because the monomer subunit as set forth in SEQ ID NOs: 15 and 16 and the Fc monomer (i.e., antibody fragment) of the ‘217 reference application are 100% query match to SEQ ID NOs: 11 and 12 and any antibody or antibody fragment thereof of the instant application, there is no clear difference in the scope between the products of the instant and reference applications. In response, it is suggested that applicant either file a terminal disclaimer or amend the claims such that a clear and unmistakable line of separation exists between the products claimed in the instant application and those of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 6-7, 35-36, and 97-98 stand provisionally rejected (i.e., claims 3, 24, and 92 have been cancelled) on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11, 14-22, 25-26, 28-29, 31, 44-47, and 49 of co-pending Application No. 18/691267; herein referred to as the “’267 reference application.”
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed fusion protein especially in instant claims 1, 4, 6-7, 35-36, and 97-98 are obvious variations of the fusion protein in claims 1, 47, and 49 of the ‘267 reference application. SEQ ID NOs: 11 and 12 are not claimed in the ‘267 reference application. However, the fusion protein in claim 1 of the ‘267 reference application, comprises an Fc polypeptide (i.e., antibody fragment) and a nanocage monomer or a subunit thereof (i.e., a generic term for the N- or C-region of apoferritin of SEQ ID NOs: 11 and 12 of the instant application). In order to determine the scope of the monomer subunits, the specification of the ‘267 reference application was consulted and the instant species of SEQ ID NOs: 11 (i.e., N-region apoferritin) and 12 (i.e., C-region of apoferritin) were disclosed in ¶0075-0076 and ¶0092 of the ‘267 reference application specification as ferritin and apoferritin being used interchangeably and the N-half ferritin refers to amino acid residues 1-95 of SEQ ID NO: 1 (i.e., human LC ferritin) and C-half ferritin refers to amino acid residues 96-175 of SEQ ID NO: 1 (i.e., 100% query match, see OA.APPENDIX).
In this instance, because the N-half ferritin refers to amino acid residues 1-95 of SEQ ID NO: 1 (i.e., human LC ferritin) and C-half ferritin refers to amino acid residues 96-175 of SEQ ID NO: 1 and the Fc monomer (i.e., antibody fragment) of the ‘267 reference application are 100% query match to SEQ ID NOs: 11 and 12 and any antibody or antibody fragment thereof of the instant application, there is no clear difference in the scope between the products of the instant and reference applications. In response, it is suggested that applicant either file a terminal disclaimer or amend the claims such that a clear and unmistakable line of separation exists between the products claimed in the instant application and those of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant argues that as a result of the significant amendments to the claims, that the provisional nonstatutory double patenting rejections are not applicable.
RESPONSE
Applicant’s arguments have been fully considered but are found non-persuasive essentially for the reasons of record and as described further below.
As set forth in the rejections of record and as discussed supra, because the nanocage monomer or subunit thereof of both the ‘217 and ‘267 reference applications comprise the N-half ferritin/apoferritin and C-half ferritin/apoferritin and a Fc monomer (i.e., antibody fragment), which are 100% query match to SEQ ID NOs: 11 and 12 and any antibody or antibody fragment thereof of the instant application, there is no clear difference in the scope between the products of the instant and reference applications.
Allowable Subject Matter
Claims 47 and 115 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 47 and 115 are objected to.
Claims 1, 4, 6-7, 35-36, 61 and 97-98 are not allowed.
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 SAMANTHA L. HOPKINS whose telephone number is (703)756-4666. The examiner can normally be reached Mon-Thurs 6:00 AM to 4:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (571)272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMANTHA LAKE HOPKINS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641