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 Group I and the following species:
Species A: an antigen which is a peptide as presented in (iv) from claim 19;
Species B: a STING agonist;
Species C: anchoring moiety - a lipid (which relates to the anchoring moiety of Species D);
Species E: maleimide moiety;
Species F: prostaglandin F2 receptor negative regulator (the PTGFRN protein); and Species G: brain acid soluble protein 1 (the BASP1 protein).
in the reply filed on March 10, 2026 is acknowledged.
Claims 1, 4, 5, 11, 12, 18, 19, 34, 39, 46, 47, 49, 53, 54, 57, 58, 62, 63, 71, and 82 are pending; claims 34, 39, and 82 are withdrawn from further consideration pursuant to 37 CFR 1.142(b); and claims 1, 4, 5, 11, 12, 18, 19, 46, 47, 49, 53, 54, 57, 58, 62, 63, and 71 are under consideration.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see paragraphs [0102 and 0104] of the instant published disclosure, USPgPub 2024/0082389. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Applicant is reminded that the incorporation of essential material in the specification by reference to a foreign application or patent, or to a publication is improper. Instant paragraphs [0275, 0279, and 0281] of the instant published application points to: WO 2019/183578, WO 2014/189805 A1, WO 2014/179335 A1, WO 2018/100558 A1, WO 2017/027646 A1, WO 2017/161349 A1, WO 2016/096174 A1, WO 2014/093936, WO 2014/189805, WO 2015/077354, Cell reports 11, 1018-1030 (2015), WO 2013/185052, Sci. Transl. Med. 283,283ra52 (2015), WO 2014/189806, WO 2015/185565, WO 2014/179760, WO 2014/179335, WO 2015/017652, WO 2016/096577, WO 2016/120305, WO 2016/145102, WO 2017/027646, WO 2017/075477, WO 2017/027645, WO 2018/100558, WO 2017/175147, and WO 2017/175156, which list STING agonists. It appears that STING agonists are essential material as a component required in claims 5, 1, 12, and 18. Incorporation of essential material, by reference to foreign applications, is improper under 37 CFR § 1.57(d). Applicant is required to amend the disclosure to include the material incorporated by reference. 37 CFR § 1.57. The amendment must be accompanied by an affidavit or declaration executed by the applicant, or a practitioner representing the applicant, stating that the amendatory material consists of the same material incorporated by reference in the referencing application. See In re Hawkins, 486 F.2d 569, 179 USPQ 157 (CCPA 1973); In re Hawkins, 486 F.2d 579, 179 USPQ 163 (CCPA 1973); and In re Hawkins, 486 F.2d 577, 179 USPQ 167 (CCPA 1973). Furthermore, if the recited materials in the instant claims, was not set forth in the specification as filed, and was not publicly available at the time the application was filed, the amendment will be treated as an attempt to introduce new matter (similar to attempts to incorporate essential material by reference to unpublished material).
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 4 and 5 are objected to because of the following informalities: the acronyms “NK” and “STING”, respectively, should be spelled out prior to first use. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12, 19, 46, 47, and 49 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The elected anchoring moiety of claim 12 is a lipid, but also recites, “including derivatives thereof” in line 4 of the claim. There is no teaching in the specification for what is encompassed by derivatives of a lipid. The metes and bounds cannot be determined.
The term “less than about” in claim 19 is a relative phrase which renders the claim indefinite. The phrase “less than about” is not defined by the respective claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. If a value greater than the “about” value is chosen, the greater value would be encompassed by the “about” limitation, but would not be “less than”, also required by claim 19. Therefore, recitation of “less than about” is an inadequate descriptive phrase for the value(s) intended. This same lack of clarity issue regarding “less than about” is recited in instant claim 49.
Claim 46 is drawn to “loading of the antigen and/or adjuvant to the EV occurs…”, with times ranging between 1 day and “25 years or more after isolating the EV from the producer cell.”. Support is noted in instant paragraphs [0023 and 0158]. It is not clear how the length of time to load EVs with an antigen and/or adjuvant occurs between 1 day and 25 years, as recited.
The term “at least about” in claim 46 is a relative phrase which renders the claim indefinite. The phrase “at least about” is not defined by the respective claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. If a value less than the “about” value is chosen, the lesser value would be encompassed by the “about” limitation, but would not be “at least”, also required by claim 46. Therefore, recitation of “at least about” is an inadequate descriptive phrase for the value(s) intended. This same lack of clarity issue regarding “at least about” is recited in instant claims 47 and 49.
Claim 47 recites, “the loading efficiency of the antigen and/or adjuvant to the EVs is increased compared to a reference loading efficiency”, but fails to provide any reference used for comparison. Therefore, the claimed loading efficiency increase “compared to a reference loading efficiency” is a subjective description that lacks a requisite objective basis for comparison. It is noted that paragraph [0024] of the instant published disclosure, USPgPub 2024/0082389, states, “a reference loading efficiency (e.g., loading efficiency of the antigen and/or adjuvant without the use of an anchoring moiety…). To overcome this rejection, it is suggested that the description of the reference loading efficiency presented in paragraph [0024], without any exemplative language, “i.e.,” “e.g.”, or equivalents, be recited in the claim.
Claim 49 recites, “the time required for manufacturing the vaccine ("manufacturing time") is reduced compared to a reference manufacturing time”, but fails to provide any reference used for comparison. Therefore, the claimed time reduction for manufacturing the vaccine “compared to a reference loading efficiency” is a subjective description that lacks a requisite objective basis for comparison. It is noted that paragraph [0025] of the instant published disclosure, USPgPub 2024/0082389, states, “(e.g., manufacturing time of a method wherein the loading of the antigen occurs by introducing the antigen into the producer cell, or manufacturing time of a method for producing a vaccine that does not comprise an EV, such as a traditional peptide vaccine…). To overcome this rejection, it is suggested that some parameter of the description of the reference reduction in time presented in paragraph [0025], be recited in the claim. As recited currently, it cannot be determined what percentage of time is reduced without a comparative reference.
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.
Claims 5, 11, 12, and 18 are 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. This is a written description rejection.
Instant claim 5 requires the adjuvant to comprise a STING agonist (elected species) applicable to dependent claims 11, 12, and 18. Instant paragraphs [0275, 0279, and 0281] of the instant published application, USPgPub 20240082389, points to foreign applications which list STING agonists, including DMXAA, STING agonist-1, ML RR-52 CDA, ML RR-S2c-di-GMP, ML-RR-S2 cGAMP, 2′3′-c-di-AM(P5)2, 2′3′-cGAMP, 2′3′-cGAMPdFHS, 3′3′-cGAMP, 3′3′-cGAMPdFSH, cAIMP, cAIM(PS)2, 3′3′-cAIMP, 3′3′-cAIMPdFSH, 2′2′-cGAMP, 2′3′-cGAM(P5)2, 3′3′-cGAMP, listed in paragraph [0279] of the instant published disclosure. However, the list of STING agonists is no commensurate with the broad genus of STING agonists encompassed by the claims. The skilled artisan would not predict or recognize any material is a STING agonist. Figures 1 and 3 of Hussain et al. (Frontiers in immunology. 2022 Jul 19; 13:808607) depict the STING signaling pathway and STING conformational changes. In the abstract, “Ligand recognition and signal transduction”, and “STING activation and inhibition via various mechanisms”, Hussain et al. teach the mechanism of STING activation is unresolved. In the paragraph above “Author Contributions”, Hussain et al. teach:
However, our current knowledge of STING structure and function is still limited. We still do not know how STING, TBK1, and IRF3 assemble into a mega-complex. It is intriguing to know how to reconcile the two controversial activation mechanisms of STING concerning the closed and open conformations induced by cGAMP and diABZI, respectively. We also do not know how STING travels from ER to the Golgi apparatus through COP II transportation machinery. It is interesting to investigate how STING achieves its ER residence via interacting with a binding partner such as STIM1 (76). Most importantly, we do not know why STING activation requires 180° rotation of the LBD.
The instant specification does not adequately describe the genus of STING agonists required and claimed.
The following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Therefore, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed. However, the presence of multiple species with in a claimed genus does not necessarily demonstrate possession of the genus. See, In re Smyth, 178 U.S.P.Q. 279 at 284-85 (CCPA 1973) (stating “where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus or combination claimed at a later date in the prosecution of a patent application.”); and University of California v. Eli Lilly and Co., 43 USPQ2d 1398, at 1405 (Fed Cir 1997)(citing Smyth for support).
Recitation of a STING agonist is a vague functional description and an invitation for further research by testing to determine which material, compound, chemical, peptide, protein, or nucleic acid possesses the requisite characteristics to activate STING, and does not satisfy written description requirement. Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1341 (Fed. Cir. 2010) (en banc.)
The applicable standard for the written description requirement can be found in MPEP 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004). To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the only STING agonists identified are DMXAA, STING agonist-1, ML RR-52 CDA, ML RR-S2c-di-GMP, ML-RR-S2 cGAMP, 2′3′-c-di-AM(P5)2, 2′3′-cGAMP, 2′3′-cGAMPdFHS, 3′3′-cGAMP, 3′3′-cGAMPdFSH, cAIMP, cAIM(PS)2, 3′3′-cAIMP, 3′3′-cAIMPdFSH, 2′2′-cGAMP, 2′3′-cGAM(P5)2, 3′3′-cGAMP. However, there is no disclosure of sufficient characteristics of the claimed genus of STING agonists to allow persons of ordinary skill in the art to recognize that applicants were in possession of the claimed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. A definition by function alone is not sufficient because it is only an indication of what a thing does, rather than what it is. Eli Lily, 119 F.3 at 1568, 43 USPQ2d at 1406. Given that the specification has only described a few STING agonists in instant paragraph [0279], the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
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, 4, 5, 11, 12, 19, 46, 47, 49, 53, 54, 57, 58, 62, 63, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over McConnell et al. (USPgPub 2019/0151456) and Kuate et al. (Virology. 2007; 362: 26-37).
McConnell et al. teach a method of manufacturing an engineered extracellular vesicle (EV) exosomes in paragraphs [0078, 0079], Example 5, and Example 10, for therapeutic use. Exosomes are loaded with a therapeutic antigen payload derived from an infectious agent such as a bacteria, virus, fungus, or protozoa, see paragraphs [0005, 0093, 0113, and 0120]. The antigen, comprising at least one epitope, i.e., antigenic determinant, is linked in the exosome lumen, see paragraphs [0088 and 0113], and the lumen-engineered exosome is derived from a producer cell, see paragraphs [0008, 0079, 0087, 0109, 0131-0138], and Examples 5 and 10. These teachings are pertinent against claim 1 and the position of the antigen within the lumen, required by instant claim 4. Paragraph [0093] of McConnell et al. teach the exosome further comprises STING agonist adjuvants, required in instant claim 5. Paragraphs [0078 and 0079] of McConnell et al. teach the antigen payload is a lipid, as required by instant claim 12.
Figures 10 and 16A depict heterologous antigenic peptide lengths of FLAG and EGFP, ranging between 6 residues for FLAG, 10 residues for EGFP, 23 residues including FLAG-linker-EGFP, and 30 residues including linker- FLAG-linker-EGFP, encompassing the length of amino acid residues expressed in the exosome lumen, recited in instant claim 19.
Figure 28 of McConnell et al. depicts CD40L trimers fused to scaffold proteins: MARCKS, MARCKSL1, and brain acid soluble protein 1 (BASP1), allowing external surface display of transmembrane proteins anchored in the exosome lumen, required by instant claims 11, 53, and 57.
Examples 9 and 10, referring back to Example 1 for collection, describe luminally engineered exosomes, collected from producer cells after 9 days (referring back to Example 1 for collection). Therefore, McConnell et al. teach loading the antigen to the EV occurs in at least about 1-2 weeks, recited in instant claim 46.
Paragraph [0005], Example 3, Figures 7-9, demonstrate that a short sequence of BASP1 is sufficient to direct several fold higher efficiency in loading of cargo molecules compared with other reference loading efficiencies, as required by instant claim 47.
Paragraphs [0017, 0042, 0122-0126, 0136, 0137], Figures 7-9, Figures 22B, and 29C show target protein present in the exosome at a 2-fold to 10,000-fold higher density than a different target protein in a different exosome. The amount of time to load and collect the exosomes from producer cells was the same. Therefore, an increased density of cargo within the exosomes in the same quantity of time is equivalent to a reduction in time required for manufacturing efficiently loaded exosomes, as required in instant claim 49.
Paragraph [0005] and Example 7 discuss the different scaffold proteins, MARCKS, MARCKSL1, and BASP1, directing high efficiency loading of therapeutic cargo molecules, i.e., the scaffold proteins, first linked to the exosome before the antigen is linked on the surface of the EV, see Figure 28, as required by instant claim 54. Example 7 and Figures 23A and 29A describe and depict expressing CD40L fused to prostaglandin F2 receptor negative regulator (PTGFRN) scaffold, as required by instant claim 62.
Figure 28 of McConnell et al. depicts surface display of CD40L from different scaffold proteins, MARCKS, MARCKSL1, and BASP1 (required in instant claim 63). Figures and 29A-29C depict B-cell activation and relative potency for each CD40L-scaffold fusion.
While McConnell et al. do not teach linking the antigen and the adjuvant from different scaffold moieties, as required by instant claim 58, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to specifically alter quantities of antigen and adjuvants tethered to the exosome and control B-cell activation and relative potency of each component, as evidenced by Figures 29A-29C of McConnell et al.
Paragraphs [0033, 0034, 0079, 0088, 0119] and Example 6 of McConnell et al. teach the exosomes further comprising a targeting moiety, loaded after paragraph [0196] or during, paragraphs [0204 and 0205], loading of the antigen, as required by instant claim 71.
Instant claim 4 additionally recites, “wherein after the loading of the antigen, the EV is capable of inducing a T-cell immune response, a B-cell immune response, a NK response, or a combination thereof”, which recites an intended use of the lumen-loaded exosome as suitable for administration. While McConnell et al. suggests facilitating administration of the composition in paragraph [0092], McConnell et al. do not describe administering antigen-lumen-loaded exosomes to induce T- and/or B-cell and/or NK immune responses or teach using the antigen-loaded exosomes as a vaccine, recited in claim 1.
Kuate et al. teach SARS spike ectodomain-containing exosomes induce neutralizing antibody titers , inhibiting virus infectivity, see the abstract, “Incorporation of S proteins into exosomes”, Figure 5B, and Figure 6.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date would have been motivated to have administered the exosome of McConnell et al. to induce a neutralizing antibody response against the antigen derived from an infectious agent, taught by Kuate et al. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have administered the exosome of McConnell et al. to induce a neutralizing antibody response against the antigen derived from an infectious agent because McConnell et al. depict B-cell activation in cell cultures contacted with CD40L-exosomes and both McConnell et al. Kuate et al. teach engineered exosomes comprising a therapeutic antigen derived from an infectious agent, see
paragraphs [0005, 0093, 0113, and 0120] of McConnell et al. and the abstract and “Incorporation of S proteins into exosomes” of Kuate et al.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over McConnell et al. and Kuate et al. as applied to claims 1, 4, 5, 11, 12, 19, 46, 47, 49, 53, 54, 57, 58, 62, 63, and 71 above, and further in view of Kooijmans et al. (Journal of Controlled Release. 2016; 224: 77-85).
See the teachings of McConnell et al. and Kuate et al. above. Neither reference teaches maleimide chemical conjugation of the antigen and/or adjuvant to the surface or lumen of the exosome, as required in instant claim 18.
Kooijmans et al. use maleimide groups to conjugate phospholipid (DMPE)-PEG derivatives prior to introduction into extracellular vesicles, see section 3.1 and Figure 1.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have used the maleimide groups of Kooijmans et al. to conjugate the antigen and/or adjuvant of McConnell et al. and Kuate et al. with a reasonable expectation of success because Kooijmans et al. teach does not compromise interactions between components, see the paragraph bridging the columns on page 80.
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 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 132 and 135 of copending Application No. 17/906,849 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 132 of ‘849 anticipates a method of manufacturing an EV for a vaccine by loading an antigen to an EV that has been isolated by a producer cell, as required by instant claim 1.
Claim 135 of ‘849 is drawn to a method of manufacturing an EV for a vaccine by loading an antigen to an EV that has been isolated by a producer cell, wherein the manufacturing time is reduced by at least about 10% to 90% or more, compared to a reference manufacturing time, recited in instant claim 49.
While claim 135 of ‘849 does not recite manufacturing time range between less than about 12 months to less than about 1 month, additionally recited by instant claim 49, the manufacturing time in months would have been within the amount of time required to manufacture the EV of ‘849 because there is no distinction between the components and method steps in EV manufacture compared to the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Qazi et al. (Blood. 2009; 13 (12: 2673-2683 teach indirectly loaded, antigen-pulsed dendritic cell exosomes, “OVA-Exo” elicit antigen-specific activation of T cells and Th1 antibody responses, see Figures 4 and 5.
Jesus et al. (European Journal of Pharmaceutics and Biopharmaceutics. 2018; 133: 1–11) teach vaccination with hepatitis B recombinant antigen (HBsAg) combined with exosomes derived from immune cells induce humoral and cellular immune responses, see Figures 4-6.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Shanon A. Foley/Primary Examiner, Art Unit 1671