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 .
DETAILED ACTION
The text of those sections of Title 35, U.S. Code not included in this action can be found
in a prior Office action.
This Action is in response to the papers filed on June 3, 2026 for a Request for Continued Examination. Pursuant to the amendment filed on May 13, 2026, claims 1, 6-7, 44, 75-76, 81, 85-86, 93, 123, 152, 154, 161, 221, 225 and 230 are currently pending of which claims 1, 6, 85, 86, 154, and 230 have been amended and claims 64, 113, and 181 have been cancelled. No claims have been added.
Claims 1, 6, 7, 44, 64, 75, 76, 81, 85, 154, 161, 181, 221, and 225, were previously withdrawn in the Office Action dated August 15, 2024. Claims 1, 6, and 154 have been amended and requested to be rejoined to the pending examined claims of Group III. As stated in the Restriction Requirement filed on May 16, 2024, a search and examination beyond the elected invention will impose a serious burden on the examiner. Despite the amended claims matching some of the limitations of Group III, the claims remain directed to different statutory categories, e.g. compositions and methods, and therefore the search burden remains, and moreover the lack of unity remains as described previously. The restriction requirement between Groups I-IV was previously made FINAL.
Therefore, claims 86, 93, 123, 152, and 230 are currently under examination to which the following grounds of rejection are applicable.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/US2020/015098, filed January 24, 2020. Applicant’s claim for the benefit of a prior-filed parent provisional applications: 62/933,302 filed on November 8, 2019, 62/933,301 filed on November 8, 2019, 62/797,187 filed on January 25, 2019, and 62/797,185 filed on January 25, 2019 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) are acknowledged.
Thus, the earliest possible priority for the instant application is January 25, 2019.
Response to Arguments
Withdrawn Objections/Rejections in response to Applicants’ arguments or amendments:
Claim Objections
In view of Applicants’ amendment to the claims dated May 13, 2026, wherein claim 86 has been amended accordingly, the objection to claim 86 has been withdrawn.
Claim Rejections - 35 USC § 112(a)
Claims 86, 93, 113, 123, 152, and 230 (claim 113 now cancelled) were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for failing to reasonably provide enablement for the scope of the claimed invention and for failing to comply with the written description requirement.
In view of Applicants’ amendment to the claims dated May 13, 2026 and in view of the Remarks with the same date, the rejections have been withdrawn. This is because of the rationale that nucleotides are encompassed as an antigen that are not normally found with the anucleate cell-derived vesicle in nature as described in paragraph 147, second to last sentence of the Specification. Secondly, for amending claim 86 by stating the comparison of reduced ATP production and increased surface phosphatidylserine levels is compared with the anucleate cell from which the anucleate cell-derived vesicle is derived.
Applicants’ arguments are moot in view of the withdrawn rejection. A response to any argument pertaining to a new or maintained rejection can be found below.
New Grounds of Rejection
Claim Rejections - 35 USC § 102/103
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 86, 93, 123, 152, and 230 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over , in view of Gilbert et al. (US 2019/0382796 A1) in view of Huang (US 8,329,161 B2; citations from US Pub. 2009/0274630 A1).
Claim 86 is directed to an anucleate cell-derived vesicle comprising: an antigen, an adjuvant, or both an antigen and an adjuvant; and wherein said anucleate cell-derived vesicle has reduced ATP production and increased surface phosphatidylserine levels compared to an anucleate cell from which the anucleate cell-derived vesicle is derived, wherein the antigen is a peptide or polypeptide, or a nucleic acid encoding the peptide or polypeptide, and said antigen is not normally associated with said anucleate cell-derived vesicle in nature, and wherein the anucleate cell comprises a red blood cell.
Gilbert teaches an anucleate cell-derived vesicles as seen by describing “delivering a compound into a cell, including passing a cell suspension through a surface containing pores, wherein the pores deform the cell thereby causing a perturbation of the cell such that the compound enters the cell” (abstract). Gilbert describes utilizing red blood cells (RBCs) with dextran particles (a known adjuvant) and antibodies, “fluorescent dextran particles or IgG antibody,” in which constriction mediated delivery was employed, i.e. “SQZ” and successful based on viability and delivery efficiencies (0485-487).
The Specification defines vesicle as the following:
The term “vesicle” as used herein refers to a structure comprising liquid enclosed by a lipid bilayer. In some examples, the lipid bilayer is sourced from naturally existing lipid composition. In some examples, the lipid bilayer can be sourced from a cellular membrane. In some examples, vesicles can be derived from various kinds of entities, such as cells. In such examples, a vesicle can retain molecules (such as intracellular proteins or membrane components) from the originating entity. For example, a vesicle derived from a red blood cell may contain any number of intracellular proteins that were in the red blood cell and/or membrane components of the red blood cell. In some examples, a vesicle can contain any number of molecules intracellularly in addition to the desired payload.
Based on the broad definition for “vesicle” recited therein, and secondly for the disclosure describing the similar method of constriction mediated delivery into RBCs using the SQZ method, it is expected that the product of Gilbert’s method is identical to the composition claimed based on there being no steps recited in the instant claims that are different from the prior art of Gilbert. Claim 86 does recite limitations pertaining to reduced ATP production and increased surface phosphatidylserine levels of the vesicle; however, this is expected to be inherent to RBC derived vesicles produced via SQZ as taught by Gilbert based on the steps and compositions used being identical. The Applicant is encouraged to provide reasoning as to why these compositions are not identical and/or method steps that would support these differences in structure/composition from Gilbert.
Gilbert is silent on teaching RBC-derived vesicles, and moreover steps of obtaining such vesicles from the treated RBCs. However, it appears the products, as claimed, are the same as in the prior art, and thus Gilbert anticipates the subject matter.
However, even if the Gilbert’s treated RBCs and the claimed RBC-derived vesicles are not one and the same and there is, in fact, no anticipation, the reference treated RBCs would, nevertheless, have rendered to one of ordinary skill in the art at the time the invention was made the claimed RBC -derived vesicles an obvious design choice based on Huang teaching method pertaining to separating -derived vesicles from treated RBCs.
In view of there being a specific step of obtaining vesicles from RBCs, wherein the product following the method of delivery of an antigen and/or adjuvant requires a step of separation to obtain the vesicles, Huang teaches the step of obtaining vesicles from RBCs after delivery into the cell.
Huang teaches anucleate cell-derived vesicles by teaching a process of obtaining vesicles from red blood cells (RBCs) wherein the isolated vesicles contain an encapsulated exogenous substance (par 0006). The reference describes that RBCs are “exploited extensively for their potential applications as carriers of different bioactive substances because of biocompatibility and biodegradability” and moreover, “Red blood cells are about 7.5-8 μm in diameter, which are larger than nanoparticles. Few cells other than macrophages are capable of internalizing particles this large.” (par 0004-5). In reference to the vesicle comprising an exogenous antigen, Huang states “an isolated RDV that contains an encapsulated exogenous substance which is at least one selected from the group consisting of fluorophores, nucleic acids, peptides, polysaccharides, superparamagnetic compounds and therapeutic agents” (par 0010).
Lastly, Huang teaches the process of centrifugation of the treated RBCs to obtain vesicles (par 0040, 43).
Thus, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the references, especially in the absence of evidence to the contrary.
Regarding claim 93, dependent on claim 86, Gilbert teaches wherein:
(i) the antigen is: (1) capable of being processed into an MHC class I-restricted peptide, (3) a disease-associated antigen (4) a tumor antigen, (5) a viral antigen, (6) a bacterial antigen, (7) a fungal antigen, (8) a lipid antigen, (9) a carbohydrate antigen, (10) a modified antigen, or (11) combinations thereof (par 0092, 0097, 0113);
(ii) the adjuvant is selected from a CpG oligodeoxynucleotide (ODN), IFN-a, stimulator of
interferon genes (STING) agonists, resiquimod, lipopolysaccharide (LPS), and
combinations thereof (par 0095); or (iii) both (i) and (ii).
Regarding claim 123, dependent on claim 86, the rejection for claim 86 is applied herein. In particular, the claim is reciting characteristics of the anucleate cell-derived vesicles claimed, and based on the method of derivation being taught by Gilbert wherein an antigen and/or adjuvant is delivered to a RBC via constriction mediated delivery, it is expected that the product of this method is similar to that claimed based on the method of delivery being the same, and therefore the recited properties of the vesicles are expected to be shared with Gilbert.
Regarding claim 152, dependent on claim 86, Gilbert teaches a pharmaceutically acceptable excipient as seen in describing “In some embodiments, the aqueous solution comprises cell culture medium, PBS, salts, sugars, growth factors, animal derived products, bulking materials, surfactants, lubricants, vitamins, amino acids, proteins, cell cycle inhibitors, and/or an agent that impacts actin polymerization… Additionally, solution buffer can include one or more lubricants (pluronics or other surfactants) that can be designed, for example, to reduce or eliminate clogging of the surface and improve cell viability.”(0115). Several of these listed compounds/substances are considered excipients based on properties of working alongside the active agent/ antigen, i.e. lubricant, surfactant.
Regarding claim 230, dependent on claim 86, the rejection to claim 86 describes that Gilbert teaches successful delivery based on delivery efficiencies for both an antigen and adjuvant, e.g. IgG and dextran (par 0487, Fig. 8A).
Conclusion
The Examiner is recommending to schedule an Interview to discuss the current rejections in order to efficiently advance prosecution. Thank you!
Claims 86, 93, 123, 152, and 230 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL A RIGA whose telephone number is (571)270-0984. The examiner can normally be reached Monday-Friday (8AM-6PM).
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, Maria G Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL ANGELO RIGA/ Examiner, Art Unit 1634
/TERESA E KNIGHT/ Primary Examiner, Art Unit 1634
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