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 .
Applicants’ reply to the October 1, 2025 Office Action, filed January 5, 2026, is acknowledged. Applicants previously canceled claims 5, 7, 9-11, 13-15, 18-19, 22, 25-26, 31-32, 39, 52, and 57 and now cancel claim 54. Applicants amend claims 1, 3-4, 6, 8, 12, 23-24, 41-45, and 55, and add new claim 62. Claims 1-4, 6, 8, 12, 16-17, 20-21, 23-24, 27-30, 33-38, 40-51, 53, 55-56, and 58-62 are pending in this application and are under examination.
Any objection or rejection of record in the previous Office Action, mailed October 1, 2025, which is not addressed in this action has been withdrawn in light of Applicants’ amendments and/or arguments. This action is FINAL.
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, 6, 8, 12, 16-17, 20-21, 23-24, 27-30, 33-38, 40-51, 53, 55-56, and 58-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-40 of U.S. Patent No. 11,576,872. This rejection is modified as necessitated by Applicants’ amendments.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘872 patent and the instant application claim fusosomes comprising lipid bilayers comprising a fusogenic agent comprising a re-targeted paramyxoviral fusogen and a nucleic acid comprising a payload gene encoding an exogenous agent, along with positive target cell-specific regulatory elements and non-target cell-specific regulatory elements. Both the ‘872 patent and the instant application claim target cells. Both the ‘872 patent and the instant application claim methods of delivering fusosomes to cells and subjects. While the ‘872 patent is directed to a variety of cells and diseases, rather than the instantly claimed T cells, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘872 claims for use in other cells because that would provide fusosomes and methods of treating other diseases and conditions by including different payload genes that encode different exogenous agents, including a chimeric antigen receptor (CAR). Because the claims of the ‘872 patent and the instant application overlap in scope, the claims are not deemed to be patentably distinct.
Claims 1-4, 6, 8, 12, 16-17, 20-21, 23-24, 27-30, 33-38, 40-51, 53, 55-56, and 58-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 12,378,578. This rejection is maintained as modified, and is no longer a provisional rejection due to the issuance of the issuance of the ‘578 patent.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘578 patent and the instant application claim fusosomes comprising lipid bilayers comprising a fusogenic agent a re-targeted paramyxoviral fusogen and a nucleic acid comprising a payload gene encoding an exogenous agent, along with positive target cell-specific regulatory elements and non-target cell-specific regulatory elements. Both the ‘578 patent and the instant application claim target cells. Both the ‘578 patent and the instant application claim methods of delivering fusosomes to cells and subjects. While the ‘578 patent is directed to liver cells and diseases, rather than the instantly claimed T cells, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘578 patent for use in other cells because that would provide fusosomes and methods of treating other diseases and conditions by including different payload genes that encode different exogenous agents, including a chimeric antigen receptor (CAR). Because the claims of the ‘578 patent and the instant application overlap in scope, the claims are not deemed to be patentably distinct.
Claims 1-4, 6, 8, 12, 16-17, 20-21, 23-24, 27-30, 33-38, 40-51, 53, 55-56, and 58-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,496,274. This rejection is maintained as modified, and is no longer a provisional rejection due to the issuance of the ‘274 patent.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘274 patent and the instant application claim fusosomes comprising lipid bilayers comprising a fusogenic agent a re-targeted paramyxoviral fusogen and a nucleic acid comprising a payload gene encoding an exogenous agent, along with positive target cell-specific regulatory elements and non-target cell-specific regulatory elements. Both the ‘274 patent and the instant application claim target cells. Both the ‘274 patent and the instant application claim methods of delivering fusosomes to cells and subjects. While the ‘274 patent is not directed to T-cells, as in the instantly claimed T cells, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘274 patent claims for use in other cells because that would provide fusosomes and methods of treating other diseases and conditions by including different payload genes that encode different exogenous agents, including a chimeric antigen receptor (CAR). Because the claims of the ‘274 patent and the instant application overlap in scope, the claims are not deemed to be patentably distinct.
Claims 1-4, 6, 8, 12, 16-17, 20-21, 23-24, 27-30, 33-38, 40-51, 53, 55-56, and 58-62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 11-12, 14-20, 22-28, 30-37, and 39-43 of copending Application No. 16/970,216 (reference application). This rejection is modified as necessitated by Applicants’ amendments.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘216 application and the instant application claim fusosomes comprising lipid bilayers comprising a fusogenic agent a re-targeted paramyxoviral fusogen and a nucleic acid comprising a payload gene encoding an exogenous agent, along with positive target cell-specific regulatory elements and non-target cell-specific regulatory elements, including a chimeric antigen receptor (CAR). Both the ‘216 application and the instant application claim that the target cell can be a T-cell. Both the ‘216 application and the instant application claim methods of delivering fusosomes to cells and subjects. Because the claims of the ‘216 application and the instant application overlap in scope, the claims are not deemed to be patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, 8, 12, 16-17, 20-21, 23-24, 27-30, 33-38, 40-51, 53, 55-56, and 58-62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 10-18, 28, 32-35, and 48-59 of copending Application No. 17/055,077 (reference application). This rejection is modified as necessitated by Applicants’ amendments.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘077 application and the instant application claim fusosomes comprising lipid bilayers comprising a fusogenic agent a re-targeted paramyxoviral fusogen and a nucleic acid comprising a payload gene encoding an exogenous agent, along with positive target cell-specific regulatory elements and non-target cell-specific regulatory elements, including a chimeric antigen receptor (CAR). Both the ‘077 application and the instant application claim that the target cell can be a T-cell. While the ‘077 application does not claim methods of delivering fusosomes to cells and subjects, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to administer the fusosomes of the ‘077 application in order to treat a disease or condition, as claimed in the instant application. Because the claims of the ‘077 application and the instant application overlap in scope, the claims are not deemed to be patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, 8, 12, 16-17, 20-21, 23-24, 27-30, 33-38, 40-51, 53, 55-56, and 58-62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 142-159 of copending Application No. 17/218,025 (reference application). This rejection is modified as necessitated by Applicants’ amendments.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘025 application and the instant application claim fusosomes comprising lipid bilayers comprising a fusogenic agent a re-targeted paramyxoviral fusogen and a nucleic acid comprising a payload gene encoding an exogenous agent, including a chimeric antigen receptor (CAR) along with positive target cell-specific regulatory elements and non-target cell-specific regulatory elements. Both the ‘025 application and the instant application claim target cells, which can be T cells. Both the ‘025 application and the instant application claim methods of delivering fusosomes to cells and subjects. Because the claims of the ‘025 application and the instant application overlap in scope, the claims are not deemed to be patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, 8, 12, 16-17, 20-21, 23-24, 27-30, 33-38, 40-51, 53, 55-56, and 58-62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 19, 24-29, 31-33, 36-42, 44, and 59-68 of copending Application No. 17/293,797 (reference application). This rejection is modified as necessitated by Applicants’ amendments.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘797 application and the instant application claim fusosomes comprising lipid bilayers comprising a fusogenic agent a re-targeted paramyxoviral fusogen and a nucleic acid comprising a payload gene encoding an exogenous agent. The instant application claims that the exogenous agent is a chimeric antigen receptor (CAR), along with positive target cell-specific regulatory elements and non-target cell-specific regulatory elements. Both the ‘797 application and the instant application claim target cells. Both the ‘797 application and the instant application claim methods of delivering fusosomes to cells and subjects. While the ‘797 application is directed to hematopoietic stem cells, rather than the instantly claimed T cells, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘797 claims for use in the instantly claimed T-cells because that would provide fusosomes and methods of treating other diseases and conditions by including different payload genes that encode different exogenous agents. Because the claims of the ‘797 application and the instant application overlap in scope, the claims are not deemed to be patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, 8, 12, 16-17, 20-21, 23-24, 27-30, 33-38, 40-51, 53, 55-56, and 58-62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-9, 16-17, 19-20, 23, 27, 33, 37, 39-40, 43-53, and 62 of copending Application No. 17/293,842 (reference application). This rejection is modified as necessitated by Applicants’ amendments.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘842 application and the instant application claim fusosomes comprising lipid bilayers comprising a fusogenic agent a re-targeted paramyxoviral fusogen and a nucleic acid comprising a payload gene encoding an exogenous agent, along with positive target cell-specific regulatory elements and non-target cell-specific regulatory elements. Both the ‘842 application and the instant application claim target cells. Both the ‘797 application and the instant application claim methods of delivering fusosomes to cells and subjects. While the ‘842 application is directed to CNS cells, rather than the instantly claimed T cells and the exogenous agent being a chimeric antigen receptor (CAR), it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘842 claims for use in the instantly claimed T-cells because that would provide fusosomes and methods of treating other diseases and conditions by including different payload genes that encode different exogenous agents. Because the claims of the ‘842 application and the instant application overlap in scope, the claims are not deemed to be patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, 8, 12, 16-17, 20-21, 23-24, 27-30, 33-38, 40-51, 53, 55-56, and 58-62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of copending Application No. 08/004,403 (reference application). This rejection is modified as necessitated by Applicants’ amendments.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘403 application and the instant application claim fusosomes comprising lipid bilayers comprising a fusogenic agent a re-targeted paramyxoviral fusogen and a nucleic acid comprising a payload gene encoding an exogenous agent, along with positive target cell-specific regulatory elements and non-target cell-specific regulatory elements. Both the ‘403 application and the instant application claim target cells, with the instant application claiming T cells and a chimeric antigen receptor (CAR). Both the ‘403 application and the instant application claim methods of delivering fusosomes to cells and subjects. While the ‘403 application does not disclose targeted T cells, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘403 claims for use in the instantly claimed T-cells because that would provide fusosomes and methods of treating other diseases and conditions by including different payload genes that encode different exogenous agents. Because the claims of the ‘403 application and the instant application overlap in scope, the claims are not deemed to be patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, 8, 12, 16-17, 20-21, 23-24, 27-30, 33-38, 40-51, 53, 55-56, and 58-62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14-15, 21-22, 24, 32, 34, 36, 45-47, 50, and 54-58 of copending Application No. 18/154,618 (reference application). This rejection is modified as necessitated by Applicants’ amendments.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘618 application and the instant application claim fusosomes comprising lipid bilayers comprising a fusogenic agent a re-targeted paramyxoviral fusogen and a nucleic acid comprising a payload gene encoding an exogenous agent, along with positive target cell-specific regulatory elements and non-target cell-specific regulatory elements. Both the ‘618 application and the instant application claim target cells, the instant application claiming T cells and a chimeric antigen receptor (CAR). Both the ‘618 application and the instant application claim methods of delivering fusosomes to cells and subjects. While the ‘618 application is directed to a variety of cells, rather than the instantly claimed T cells, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘618 claims for use in the instantly claimed T-cells because that would provide fusosomes and methods of treating other diseases and conditions by including different payload genes that encode different exogenous agents. Because the claims of the ‘ 618application and the instant application overlap in scope, the claims are not deemed to be patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, 8, 12, 16-17, 20-21, 23-24, 27-30, 33-38, 40-51, 53, 55-56, and 58-62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6-8, 16, 18, 22, 28-29, 31, 33-34, 36-37, 41, and 54 of copending Application No. 19/207,705 (reference application). This is a new rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘705 application and the instant application claim fusosomes comprising lipid bilayers comprising a fusogenic agent a re-targeted paramyxoviral fusogen and a nucleic acid comprising a payload gene encoding an exogenous agent, along with positive target cell-specific regulatory elements and non-target cell-specific regulatory elements. Both the ‘705 application and the instant application claim target cells, the instant application claiming T cells and a chimeric antigen receptor (CAR). Both the ‘705 application and the instant application claim methods of delivering fusosomes to cells and subjects. While the ‘705application is directed to a variety of cells, rather than the instantly claimed T cells, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘705 claims for use in the instantly claimed T-cells because that would provide fusosomes and methods of treating other diseases and conditions by including different payload genes that encode different exogenous agents. Because the claims of the ‘705 application and the instant application overlap in scope, the claims are not deemed to be patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Amendments and Arguments
Regarding the rejection under 35 U.S.C. § 112(a)/first paragraph, Applicants’ amendments and arguments have been fully considered and are deemed to be persuasive. Applicants’ amendment limiting the exogenous agent to a chimeric antigen receptor (CAR) is sufficient to obviate this rejection. Therefore, this rejection is withdrawn.
Regarding the rejections under 35 U.S.C. § 103, Applicants’ amendments and arguments have been fully considered and are deemed to be persuasive.
The closest prior art is Scholz (PCT Patent Application Publication No. WO 2018/129563) and Frost et al. (PCT Patent Application Publication No. WO 2018/009923).
Scholz discloses fusosomes comprising a lipid bilayer and a nucleic acid that encodes a therapeutic protein (i.e., a payload gene encoding an exogenous agent), which can be targeted to a cell, such as a senescent cell or a cancer cell. Scholz discloses that the fusosome can exploit unique intracellular functionality including functionality present within the target cell but absent or reduced in a non-target cell. However, Scholz fails to disclose or suggest that the paramyxoviral fusogen is covalently linked to a targeting moiety. Contrary to the instantly claimed invention Scholz achieves target cell specificity through transcriptional regulation, and does not require targeted delivery of a therapeutic compound. In addition, Scholz fails to disclose targeting T cells with fusosomes. Nor does Scholz disclose or suggest the exogenous agent is a chimeric antigen receptor (CAR).
Regarding Frost, while Frost does disclose that fusosomes can be used to deliver CARs to T cells. However, Frost fails to disclose or suggest re-targeting a fusogen through covalently linking the fusogen to a targeting moiety that binds to a target cell.
For these reasons, Applicants’ amendments and arguments are deemed to be persuasive, and the rejections under 35 U.S.C. § 103 are withdrawn.
Regarding the non-statutory double patenting rejections over U.S. Patent No. 11,576,872 and U.S. Patent Application Nos. 16/970,216; 17/055,077; 17/293,797; 17/293,842; 18/154,618; and 19/207,705, Applicants request that these rejections be held in abeyance until the outstanding rejections are overcome. It is noted that U.S. Patent Application No. 17/258,316 issued as U.S. Patent No. 12,378,578 and the U.S. Patent Application No. 17/293,830 issued as U.S. Patent No. 12,496,274, making these rejections no longer provisional.
Therefore, these rejections are maintained, as modified above.
Regarding the non-statutory double patenting rejections over U.S. Patent Application Nos. 17/218,025 and 18/004,403, Applicant correctly notes that these applications have a later effective filing date than the instant application. However, because there are remaining rejections, these non-statutory double patenting rejections are maintained, as modified above. These rejections will be withdrawn should the remaining rejections be withdrawn or overcome.
Conclusion
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 NANCY J LEITH whose telephone number is (313)446-4874. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:30 PM.
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NANCY J. LEITH
Primary Examiner
Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636