DETAILED ACTION
Election Acknowledged
Applicant's election with traverse of the invention of Group II and the species of micro RNA in the reply filed on 8/4/2025 is acknowledged. The traversal is on the ground(s) that Groups I and II have unity of invention as the claims are drawn only to one category of invention. This is not found persuasive because as noted in the restriction requirement mailed on 4/2/2025 cites US 2019/0380962 as describing a method for treating infections by administering plant-derived exosomes. Thus, as the special technical feature of the claims was previously described by the prior art, the identified groups lack unity because the cited art removes any technical relationship linking the grouped inventions as it does not provide a contribution over the prior art. See MPEP 1850.
Regarding the election of species requirement, the arguments presented by Applicant together with the cited prior art mitigates the need for an election of species. The election of species requirement is withdrawn.
The requirement for restriction is still deemed proper and is made FINAL.
Claims 1, 2, 4-20 are pending, claims 1, 2, 4-8 and 20 are withdrawn as being directed to nonelected invention and claims 9-19 are presented for examination on the merits.
The following rejections are made.
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.
Claims 9, 11, 12, 14, 15 and 16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor.
Claim 9 recites, “...an exosome-derived nanoparticle…; and a second lipid bilayer coating the exosome-like nanoparticle…”. It is not clear if the ‘exosome-derived nanoparticle’ is the same as the ‘the exosome-like nanoparticle’. The recitation of an ‘exosome-like nanoparticle’ appears to be an antecedent basis issue as ‘derived’ and ‘like’ are different in nature. For purposes of examination the Examiner is interpreting the ‘exosome-like nanoparticle’ to reference back to the ‘exosome-derived nanoparticle’, however clarification is requested.
Regarding each of claims 11, 12, 14, 15 and 16, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Clarification is requested.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 17 depends from claim 14. Claim 17 recites, “…wherein the therapeutic agent comprises a nucleic acid molecule selected from an siRNA, a microRNA, and a mammalian expression vector.” However, claim 14 does not recite any of the species recited by claim 17. Rather claim 14 recites “…wherein the therapeutic agent is selected from a phytochemical agent, a chemotherapeutic agent, and an antimicrobial agent, optionally an antiviral agent.” Claim 14 defines a scope of ‘therapeutic agent’ which claim 17 then attempts to broaden rather than narrow which is improper according to 112(d).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. For example, amending to require claim 17 to depend from claim 9 rather than claim 14 would overcome this rejection.
Claim Rejections - 35 USC § 102
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 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.
Claims 9, 10 and 12-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang (US 2017/0035700; of record- citation 16 of IDS dated 4/4/2023), evidenced by Infolfsson et al. (JACS, 2014, 136, 14554-14559).
Zhang discloses a composition comprising a microvesicle derived from an edible plant, the microvesicle being coated with a plasma membrane derived from a targeting cell and can further be utilized to encapsulated a therapeutic agent (see abstract and claim 1). The plasma membrane coating is to possess a targeting moiety/molecule so as to provide the advantage of cell-specific targeting for delivery of the therapeutic agent to desired tissues and organs of a subject (see [0005, 0008, 0046]). Zhang discloses at [0099] the preparation process for plasma membrane-coated grapefruit nanovescieles (exosomes) wherein said grapefruit nanovesicles are coated with the plasma membrane of EL4 cells. It is noted that a ‘plasma membrane’ of a cell is a bilayer assembly of lipids (i.e. a lipid bilayer) (see page 14554 of evidence).
The microvesicles are naturally occurring nanoparticles that possess a lipid bilayer (for surrounding the encapsulated therapeutic agent) (see [0050]). The term ‘microvesicle’ is synonymous with ‘exosome’ (see [0043, 0045]).
Thus, in all, Zhang discloses an exosome nanoparticle that comprises a (first) lipid bilayer and an encapsulated therapeutic agent, a plasma membrane (second lipid bilayer, see evidence) coating disposed on the bilayer of the exosome wherein the plasma membrane coating possesses a targeting molecule for the targeting of organs and tissues. See instant claims 9 and 10.
The exosome is to be derived from an edible plant (see title) such as a grape, grapefruit, and tomato (see [0005, 0009] and claim 5) (see instant claims 12 and 13).
Therapeutic agents to be encapsulated by the exosome include micoRNA (a nucleotide analogue) (see [0054, 0056] and claim 9) (see instant claims 14, 17 and 18), phytochemical agents such as curcumin (see claim 7) (see instant claims 14 and 15) and chemotherapeutic agents such as retinoic acid (see claim 8) (see instant claims 14 and 16).
The plasma membrane coated exosome may be provided together with a vehicle, carrier or excipient (see claim 10) (see instant claim 19).
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 9-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2017/0035700; of record- citation 16 of IDS dated 4/4/2023), evidenced by Infolfsson et al. (JACS, 2014, 136, 14554-14559), in view of Zhang et al. (US 2020/0268892)
Zhang is relied upon for disclosure described in the rejection of claims 9, 10 and 12-19 under 35 U.S.C. 102(a)(1) and are incorporated herein.
Zhang fails to teach the plasma membrane coating (second lipid bilayer) as being derived from a virus.
Zhang is directed to cellular or viral membrane coated nanostructures, such as nanoparticles. The nanostructures are to be coated with a cellular or viral plasma membrane to exhibit biomimetic properties so as to mimic or replicate the complex viral or cell surface properties and functions and enable effective cloaking and targeting activity (see [0005]). The presence of the viral or cellular plasma membrane enables the nanostructure to exhibit binding specificity for direct therapeutic activity (see [0052]). Thus, it would have been obvious to modify Zhang’s teaching of using a cellular plasma membrane to also/alternatively use a viral plasma membrane so as to target other desired tissues and organs. The simple substitution of a known element (viral plasma membrane) for another (cellular plasma membrane) to yield a predictable result (direct drug delivery to target tissue/organ) is indicia of obviousness. See MPEP 2143(I)(B). See also MPEP 2144.06(II).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611