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 . 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 - Obviousness
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.
Claim(s) 1-2, 6-10 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Tilton et al (US 2022/0184225 A1).
Tilton taught an isolated [claim 1] extracellular vesicle (EV) [claim 3], whereby the EV was contacted with Syncytin-1 (e.g., human ERV syncytin) [claims 13 and 21-22], and loaded with a therapeutic agent [0050, 0095-0097, 0099-0100].
Claim 1 is rendered prima facie obvious over the teachings of Tilton, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., isolated EV, ERV syncytin, loaded cargo) were known in the prior art (e.g., Tilton), and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would yield nothing more than predictable results (e.g., an isolated EV with ERV syncytin and loaded cargo) to one of ordinary skill in the art. MPEP 2143.A.
Tilton reads on claims 1-2.
Claims 6-10 are rendered prima facie obvious because Tilton taught RNA or DNA; TALENs; diphtheria toxins [0081, 0086, 0099-0100].
Claims 20-21 are rendered prima facie obvious because Tilton taught treating cancer [0099] comprising administering pharmaceutical compositions, in therapeutically effective amounts [0047, 0095, 0101], to subjects in need thereof [0087].
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Tilton et al (US 2022/0184225 A1), in view of Cardoso et al (Master Thesis, 2014).
The 35 U.S.C. 103 rejection over Tilton was previously discussed.
Although Tilton taught syncytin, as discussed, Tilton did not teach the amino acid sequence SDGGGX2DX2R, capable of binding to the ASCT1 receptor, as recited in claim 3.
Cardoso taught that syncytins (e.g., syncytin-1 and synctin-2) hold great therapeutic potential in the field of diagnostics and drug delivery systems [abstract], whereby (SDGGGX2DX2R) is recognized as a receptor binding domain for synctin-1 [page 3, right column last paragraph bridging to page 4].
Since Tilton taught syncytin-1, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Tilton, the amino acid sequence SDGGGX2DX2R, as taught by Cardoso. The ordinarily skilled artisan would have been so motivated, because (SDGGGX2DX2R) is recognized as a receptor binding domain for syncytin-1, whereby syncytin-1 holds therapeutic potential in the field of drug delivery systems, as taught by Cardoso at the abstract and at page 3, bridging to page 4.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tilton et al (US 2022/0184225 A1), in view of Seed et al (US 2010/0055761 A1).
The 35 U.S.C. 103 rejection over Tilton was previously discussed.
Additionally, Tilton generally taught diphtheria toxin, as previously discussed.
Tilton did not specifically teach the residues 1-389 of SEQ ID NO:4, as recited in claim 11.
Nevertheless, Seed taught that Diphtheria toxin comprises amino acids 1-389 of SEQ ID NO:4 [0019], as is well known to the skilled artisan [0234].
Since Tilton taught Diphtheria toxin, it would have been prima obvious to one of ordinary skill in the art to include, within the teachings of Tilton, amino acids 1-389 of SEQ ID NO:4, as Diphtheria toxin comprises amino acids 1-389 of SEQ ID NO:4, which is well known to the skilled artisan, as taught by Seed [0019, 0234].
Claim(s) 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tilton et al (US 2022/0184225 A1), in view of Somiya et al (Mol Pharmaceutics, 2022, 19, 2495-2505).
The 35 U.S.C. 103 rejection over Tilton was previously discussed.
Additionally, Tilton taught CD63 [0028, 0111, 0125] and rapamycin [0099].
Although Tilton taught CD63 and rapamycin, Tilton was not specific a structural polypeptide forming a dimer with a polypeptide in the presence of a compound, and further where the structural polypeptide is fused to a FRB or FKBP domain, as recited in claims 12-15.
Somiya taught [abstract] heterodimerization between FK506 binding protein (e.g., reads on FKBP2) and FKBP12−rapamycin-binding (FRB) domain, to sort cargo into EVs using the FRB−FKBP system. When CD81, a typical EV marker protein, and cargo were fused with FKBP and FRB, respectively, rapamycin induced the binding of the cargo through the FKBP−FRB interaction, and recruited the cargo into EVs.
It would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of the combined art, heterodimerization between FK506 binding protein (e.g., FKBP2) and FKBP12, as taught by Somiya. The ordinarily skilled artisan would have been motivated to enable the delivery of cargo through EV-based platforms, as taught by Somiya at the abstract.
The Examiner notes that Somiya’s FK506-FKBP12 binding system reads on a FKBP2 domain, as recited in the instant claim 15.
Nonstatutory Double Patenting
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 1-18 and 20-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 and 34 of copending Application No. 19/500,734.
Although the claims at issue are not identical, they are not patentably distinct from each other because the species (extracellular vesicles with a tethering system for cargo delivery) recited in the claims of the copending application falls within the genus (extracellular vesicles with an ERV syncytin and uses thereof for cargo delivery) recited in the claims of the instant application, and thus read on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claims 4-5 and 18 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
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
Prosecution Insights