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 .
Election/Restrictions
Applicant’s election without traverse of 1-3, 46-47, 51, 54, 59, 63-64, 85, 116, 145, and 160 in the reply filed on 05/19/2026 is acknowledged.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Status of Application
Applicant’s withdrawal of claim(s) 65, 76-77, 79, 81, and 84 in the reply filed on 05/19/2026 is acknowledged.
Claims 1-3, 46-47, 51, 54, 59, 63-64, 85, 116, 145, and 160 are under examination.
Drawings
The drawings are objected to because Fig 3, Fig 8B, Fig 10A, Fig 10B, Fig 11, are blurry and difficult to read. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because the abstract is included with the first page of the international application. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Interpretation
Claim 64 recites “instructions for use”. This is printed matter. The examiner notes that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. Therefore, the examiner will interpret any prior art as reading on the kit, regardless of inclusion of instructions for use, will read on this claim.
Claim(s) 1-3, 46-47, 51, 54, 59, 63-65, and 85 is/are rejected under 35 U.S.C. 103 as being unpatentable over McConell, R. E.; et al. WO 2020/191377 A1, as cited in the IDS filed on 12 April 2024.
McConell is drawn to extracellular vesicles (exosomes) bound to biologically active molecules through anchoring moieties (title; abstract). McConell teaches anchoring moieties (pg 1, para [0003], pg 2, para [0007]; pg 24, para [0109], lines 5-8; pg 155, para [0528]), cleavable or non-cleavable linkers (claim 9, pg 52, para [0221]), spacers (pg 38, para [0160], lines 1-3; pg 52, para [0221], lines 1-3), and a variety of biologically active molecules (pg 6, para [0024], lines 1-2; pg 105, para [0381], lines 3-4).
As to claim 1, McConell teaches an extracellular vesicle comprising a biologically active molecule covalently linked to the EV via an anchoring moiety (pg 1, para [0003], lines 2-3; claim 1). McConell teaches the formula: [AM]-L1-[BAM], where McConell teaches the anchoring moiety and the biologically active molecule (pg 1, para [0003], lines 2-3; claim 1), and L1 is a cleavable or non-cleavable linkage (claim 9, pg 52, para [0221]). L2 and L3 and SP1 and SP2 are optional. In such cases, language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. See MPEP 2143.03.
McConell does not expressly teach a single embodiment comprising all the features of the claimed product.
However, it would be prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments of a BAM covalently attached to an EV through an anchoring moiety with a linker between the anchoring moiety and the BAM, where the linker is a cleavable or non-cleavable linkage taught by McConell. A skilled artisan recognizes that these claim elements are known in the art and that a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 2, McConell teaches the anchoring moiety comprises a sterol and vitamin (pg 24, para [0109], lines 5-8; pg 155, para [0528]) and peptide (pg 24, para [0107], lines 5-7).
McConell does not expressly teach a single embodiment comprising all the features of the claimed product.
However, it would be prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments sterol, vitamin, or peptide taught by McConell. A skilled artisan recognizes that these claim elements are known in the art and that a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 3, McConell teaches a first spacer (pg 38, para [0160], lines 1-3) that is an alkyl (pg 52, para [0221], lines 5-6) or glycol (pg 52, para [0221], lines 1-3).
McConell does not expressly teach a single embodiment comprising all the features of the claimed product.
However, it would be prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments first spacer is an alkyl or glycol taught by McConell. A skilled artisan recognizes that these claim elements are known in the art and that a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 46, McConell teaches the anchoring moiety comprises a scaffold protein selected from the group consisting of PTGFRN, IGSF2, IGSF3, IGSF8, ITGB1, ITGA4, SLC3A2, and ATP transporter proteins (pg 6, para [0022]).
As to claim 47, McConell teaches the scaffold protein is PTGFRN (pg 6, para [0022], line 5).
As to claim 51, McConell teaches the biologically active molecule is a polypeptide, a peptide, a polynucleotide (DNA and/or RNA), a chemical compound, or any combination thereof (pg 6, para [0024], lines 1-2).
As to claim 54, McConell teaches siRNA, miRNA (pg 42, para [0183], lines 4-5) and ASO, shRNA or combinations thereof (pg 105, para [0381], lines 3-4).
McConell does not expressly teach a single embodiment comprising all the features of the claimed product.
However, it would be prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments siRNA, miRNA, ASO, shRNA, or a combination thereof taught by McConell. A skilled artisan recognizes that these claim elements are known in the art and that a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 59, McConell teaches the ASO targets a STAT6 transcript, a CEBP/β transcript, a STAT3 transcript, a KRAS transcript, a NRAS transcript, a NLPR3 transcript or any combination thereof (pg 107, para [0380], lines 1-3).
As to claim 63, McConell teaches a pharmaceutical composition (pg 178, para [0612], lines 1-2) and a pharmaceutically acceptable carrier (pg 178, para [0612], lines 2-6).
McConell does not expressly teach a single embodiment comprising all the features of the claimed product.
However, it would be prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments pharmaceutical composition and a pharmaceutically acceptable carrier taught by McConell. A skilled artisan recognizes that these claim elements are known in the art and that a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 64, McConell teaches a kit and instructions for use (pg 183, para [0633], lines 1-2).
As to claim 65, McConell teaches a method or treating or preventing a disease or disorder in a subject in need thereof comprising administering the EV to the subject (claim 71).
As to claim 85, McConell teaches an ASO covalently linked to an EV via an anchoring moiety (pg 1, para [0003], lines 2-3; claim 1) where the biologically active molecule is ASO (pg 105, para [0381], lines 3-4; pg 155, para [0530], lines 1-4; pg 158, para [0538], lines 1-3), the anchoring moiety is cholesterol (pg 24, para [0109], lines 5-8; pg 119, para [0431], lines 4-7; pg 155, para [0528, lines 1-4; Fig 25).
McConell does not expressly teach a single embodiment comprising all the features of the claimed product.
However, it would be prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments ASO covalently linked to an EV via an anchoring moiety where the biologically active molecule is ASO and the anchoring moiety is cholesterol taught by McConell. A skilled artisan recognizes that these claim elements are known in the art and that a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Claim(s) 116, 145, and 160 is/are rejected under 35 U.S.C. 103 as being unpatentable over McConell as applied to claims 1-3, 46-47, 51, 54, 59, 63-65, and 85 above, and further in view of Zhang, Y.; et al. WO 2021/030777 A1, as cited in the IDS filed on 12 April 2024. The teachings of McConell as applied in the rejections above are incorporated here by reference.
As to claim 116, McConell teaches an EV is an exosome overexpressing a protein scaffold (pg 35, para [0151], lines 14-16) where scaffold protein is PTGFRN (pg 35, para [0152], line 5).
McConell does not teach a native exosome.
Zhang is drawn to extracellular vesicles that are linked to biologically active molecules through anchoring moieties for treatment of cancers and other diseases (title; abstract). Zhang teaches native and engineered exosomes (pg 194, para [0669], line 6), a variety of linkers and spacers (pg 195, para [0671]; Fig 25), and a variety of biologically active molecules (claims 93-99).
Zhang teaches native exosomes (pg 16, para [0070]; Fig 26; pg 194, para [0669], line 6) and exosomes over-expressing PTGFRN (pg 194, para [0671], lines 2-3).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the EV attached to BAM through an anchoring moiety of McConell to include native exosomes taught by Zhang because a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
A person of ordinary skill in the art would have had a reasonable expectation of success in using a native exosome because Zhang found success using native exosomes. A skilled artisan would have been motivated to use exosomes regardless of source (native or engineered) because of the improved flexibility.
As to claim 145, Zhang teaches an extracellular vesicle linked to an BAM via an anchoring moiety and a linker (claim 1). Zhang teaches AM is cholesterol-TEG, L1 is phosphodiester, SP1 is C3, L2 is phosphorothioate, SP2 is TEG, and L3 is phosphorothioate, and an ASO (Fig 25, No. T2).
Zhang does not expressly teach a single embodiment comprising all the features of the claimed product.
However, it would be prima facie obvious prior to the effective filing date of the claimed invention to combine the embodiments of EV linked to a BAM via a anchoring moiety and a linker where the AM is cholesterol-TEG, L1 is phosphodiester, SP1 is C3, L2 is phosphorothioate, SP2 is TEG, and L3 is phosphorothioate, and an ASO taught by Zhang. A skilled artisan recognizes that these claim elements are known in the art and that a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 160, Zhang teaches an AM is cholesterol-TEG, L1 is phosphodiester, SP1 is TEG, and L2 is phosphorothioate, and an ASO (Fig 25, No. T4).
Nonstatutory 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.
Co-pending Application Nos. 19/103,894, 19/103,902, 18/050,017, 17/441,162, 17/634,897, 17/635,298, 17/635,315
Claims 1-3, 46-47, 51, 54, 59, 63, 64, 85, 116, 145, and 160 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 10, and 14-49 of copending Application No. 19/103,894 (reference application).
Claims 1-3, 46-47, 51, 54, 59, 63, 64, 85, 116, 145, and 160 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12-53 of copending Application No. 19/103,902 (reference application).
Claims 1-3, 46-47, 51, 54, 59, 63, 64, 85, 116, 145, and 160 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 31-35, 46, 75-76, 78, 80, 83-85, 88, 143-145 of copending Application No. 18/050,017 (reference application).
Claims 1-3, 46-47, 51, 54, 59, 63, 64, 85, 116, 145, and 160 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 85-104 of copending Application No. 17/441,162 (reference application).
Claims 1-3, 46-47, 51, 54, 59, 63, 64, 85, 116, 145, and 160 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-125 of copending Application No. 17/634,897 (reference application).
Claims 1-3, 46-47, 51, 54, 59, 63, 64, 85, 116, 145, and 160 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 8, 33-56, 84-99 of copending Application No. 17/635,298 (reference application).
Claims 1-3, 46-47, 51, 54, 59, 63, 64, 85, 116, 145, and 160 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31, 41, 76, 81, 89, 121-123, and 127 of copending Application No. 17/635,315 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims of application no. 18/546,131 (hereafter referred to as ‘131) are drawn to an extracellular vesicle comprising a biologically active molecule linked via an anchoring moiety; anchoring moiety comprising scaffold proteins, sterol, lipid, vitamin, or peptide; linkers comprising cleavable or non-cleavable bonds; spacers comprising alkyl or glycol spacers; and biologically active molecule comprising polypeptide, peptide, polynucleotide, chemical compound, or ASO.
The conflicting claims of copending application no. 19/103,894 (hereafter referred to as ‘894) are drawn to an extracellular vesicle comprising a biologically active molecule linked via an anchoring moiety; anchoring moiety comprising sterol, lipid, vitamin, peptide; linkers comprising cleavable or non-cleavable linkers; spacers comprising alkyl or glycol; biologically active molecule comprising peptide, protein, antibody, polynucleotide, or ASO.
The claims of ‘894 do not expressly teach a single embodiment comprising all the features of the instant claims.
However, it would be prima facie obvious to combine the embodiments of ‘894 so that the instant claims of ‘131 are achieved. A skilled artisan recognizes that these claim elements are known in the art and that a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
The conflicting claims of copending application no. 19/103,902 (hereafter referred to as ‘902) are drawn to an extracellular vesicle comprising a biologically active molecule linked via an anchoring moiety; linkers comprising cleavable or non-cleavable linkers; anchoring moiety comprising sterol, lipid, vitamin, peptide; spacers comprising alkyl or glycol; and biologically active molecule comprising peptide, protein, antibody, polynucleotide, or ASO.
The claims of ‘902 do not expressly teach a single embodiment comprising all the features of the instant claims.
However, it would be prima facie obvious to combine the embodiments of ‘902 so that the instant claims of ‘131 are achieved. A skilled artisan recognizes that these claim elements are known in the art and that a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
The conflicting claims of copending application no. 18/050,017 (hereafter referred to as ‘017) are drawn to an extracellular vesicle comprising a biologically active molecule linked via an anchoring moiety; anchoring moiety comprising sterol, lipid, vitamin, peptide; linkers comprising cleavable or non-cleavable linkers; spacers comprising glycol; and biologically active molecule comprising peptide, protein, antibody, polynucleotide, or ASO.
The claims of ‘017 do not expressly teach a single embodiment comprising all the features of the instant claims.
However, it would be prima facie obvious to combine the embodiments of ‘017 so that the instant claims of ‘131 are achieved. A skilled artisan recognizes that these claim elements are known in the art and that a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
The conflicting claims of copending application no. 17/441,162 (hereafter referred to as ‘162) are drawn to an extracellular vesicle comprising a biologically active molecule linked via an anchoring moiety; anchoring moiety comprising sterol, lipid, vitamin, peptide; linkers comprising cleavable or non-cleavable linkers; spacers comprising glycol; and biologically active molecule comprising peptide, protein, antibody, polynucleotide, or ASO.
The claims of ‘162 do not expressly teach a single embodiment comprising all the features of the instant claims.
However, it would be prima facie obvious to combine the embodiments of ‘162 so that the instant claims of ‘131 are achieved. A skilled artisan recognizes that these claim elements are known in the art and that a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
The conflicting claims of copending application no. 17/634,897 (hereafter referred to as ‘897) are drawn to an extracellular vesicle comprising a biologically active molecule linked via an anchoring moiety; anchoring moiety comprising sterol, lipid, vitamin, peptide; linkers comprising cleavable or non-cleavable linkers; spacers comprising alkyl or glycol; and biologically active molecule comprising peptide, protein, antibody, polynucleotide, or ASO.
The claims of ‘897 do not expressly teach a single embodiment comprising all the features of the instant claims.
However, it would be prima facie obvious to combine the embodiments of ‘897 so that the instant claims of ‘131 are achieved. A skilled artisan recognizes that these claim elements are known in the art and that a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
The conflicting claims of copending application no. 17/635,298 (hereafter referred to as ‘298) are drawn to an extracellular vesicle comprising a biologically active molecule linked via an anchoring moiety; anchoring moiety comprising sterol, lipid, vitamin, peptide; linkers comprising cleavable or non-cleavable linkers; spacers comprising glycol; and biologically active molecule comprising ASO.
The claims of ‘298 do not expressly teach a single embodiment comprising all the features of the instant claims.
However, it would be prima facie obvious to combine the embodiments of ‘298 so that the instant claims of ‘131 are achieved. A skilled artisan recognizes that these claim elements are known in the art and that a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
The conflicting claims of copending application no. 17/635,315 (hereafter referred to as ‘315) are drawn to an extracellular vesicle comprising a biologically active molecule linked via an anchoring moiety; anchoring moiety comprising sterol, lipid, vitamin, peptide; linkers comprising cleavable or non-cleavable linkers; spacers comprising glycol; and biologically active molecule comprising peptide, protein, antibody, polynucleotide, or ASO.
The claims of ‘315 do not expressly teach a single embodiment comprising all the features of the instant claims.
However, it would be prima facie obvious to combine the embodiments of ‘315 so that the instant claims of ‘131 are achieved. A skilled artisan recognizes that these claim elements are known in the art and that a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending Application No. 18/877,387
Claims 1-3, 46-47, 51, 54, 59, 63, 64, 85, 116, 145, and 160 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 36-62 of copending Application No. 18/877,387 in view of McConell, R. E.; et al. (WO 2020/191377 A1) and Zhang, Y.; et al. (WO 2021/030777 A1).
The instant claims of application no. 18/546,131 (hereafter referred to as ‘131) are drawn to an extracellular vesicle comprising a biologically active molecule linked via an anchoring moiety; anchoring moiety comprising scaffold proteins, sterol, lipid, vitamin, or peptide; linkers comprising cleavable or non-cleavable bonds; spacers comprising alkyl or glycol spacers; and biologically active molecule comprising polypeptide, peptide, polynucleotide, chemical compound, or ASO.
The conflicting claims of copending application no. 18/877,387 (hereafter referred to as ‘387) are drawn to an extracellular vesicle comprising a biologically active molecule linked via an anchoring moiety; linkers comprising cleavable or non-cleavable linkers; spacers comprising alkyl or glycol; and biologically active molecule comprising peptide, protein, antibody, polynucleotide, or ASO.
The conflicting claims of ‘387 do not teach an anchoring moiety comprising sterol, lipid, vitamin, or peptide.
Regarding anchoring moieties, McConell teaches the anchoring moiety (pg 1, para [0003], lines 2-3; claim 1; pg 6, para [0022]).
It would have been prima facie obvious to a person of ordinary skill in the art to modify the conflicting claims of ‘387 with McConell and Zhang because a person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
A person of ordinary skill in the art would have had a reasonable expectation of success in using an anchoring moiety because the prior art found success using them with native exosomes. A skilled artisan would have been motivated to use an anchoring moiety due to the ease, durability, and control that they can provide the linkage.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evan M Lewoczko whose telephone number is (571)272-9830. The examiner can normally be reached Monday-Friday 9-5PM.
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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights