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/Restriction
Inventor’s election, without traverse, of the claims of Group I (claims 1-12 and 17-21) as the claims elected to begin prosecution is acknowledged. The election/restriction is hereby made FINAL.
Claim Objections
Claim 18 is objected to because of the following informalities: the words “…sub ject…” should be a single word: subject. (This appears to be an editing error.)
Appropriate correction is required.
Inventor’s assistance is respectfully requested in correcting any other minor spelling and/or grammatical errors which may be present in the claim set.
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.
Claim 1 is 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 limitation to affect (“…providing an electroporation potential to affect the plurality of droplets…”) is unclear because it is undefined. Affect how exactly?
Furthermore, the last paragraph of the claim text “…providing an electroporation potential to affect the plurality of droplets, a droplet configured to conduct an electrical current resulting from the electroporation potential to EVs and/or exosomes positioned within the droplet [emphasis added]…” is unclear because the italicized portion of this paragraph is grammatically unconnected to the clause which precedes it. For grammatical reasons, there must be some type of conjunction between these two clauses so that the intended meaning of this portion of the claim is clear and unambiguous.
Clarification on both points is in order.
Claim 6 is 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.
It is unclear at which point in the method this extracting step is to take place.
Furthermore, the claim text “…further comprising extracting the plurality of EVs and/or exosomes from the plurality of droplets, at least some of the plurality of EVs and/or exosomes comprising the biomolecular cargo [emphasis added]…” is unclear because the italicized portion of this paragraph is grammatically unconnected to the clause which precedes it. For grammatical reasons, there must be some type of conjunction between these two clauses so that the intended meaning of this portion of the claim is clear and unambiguous.
Clarification on both points is in order.
Claim 7 is 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 limitation “…the fluid is associated with a particular conductivity…” is unclear. Associated how exactly?
Claim 9 is 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 limitation “…a threshold electroporation potential associated with the plurality of EVs and/or exosomes…” is unclear. Associated how exactly?
Claim 21 is 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 claim text “…loading a therapeutic cargo molecule into an EV and/or using the method of claim 1…” is unclear because there appears to be a lacuna in the text. The examiner respectfully suggests the text should properly be: …loading a therapeutic cargo molecule into an EV and/or exosome using the method of claim 1….
Claims 2-5, 8, 10-12 and 17-20 are also 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 claims all depend, or ultimately depend, from an indefinite claim yet do not relieve the indefiniteness. Dependent claims, 2-5, 8, 10-12 and 17-20 are also, therefore, indefinite.
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 (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.
(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 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Molecular Therapy: Methods & Clinical Development (2019), 13, pp. 133-144.
The reference teaches plasma-derived extracellular vesicles (EVs), loaded with antitumor miRNAs by electroporation, for the therapeutic treatment of cancer (abstract; page 133, INTRODUCTION).
With respect to claim 17, note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. (See MPEP 2112.02) That being the case, claim 17 simply distills to an EV and/or exosome loaded with a cargo. (Claim 18 teaches that this loaded EV or exosome is used therapeutically. Claim 19 teaches that this treatment is an immunotherapy, a gene therapy or a regenerative therapy.)
Furthermore, with respect to claims 18 and 19, note also that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the instant case, the instant composition and that of the prior art are the same (note the product-by-process argument above) and thus must necessarily exhibit the same properties. (MPEP 2112.01 (I).)
Allowable Subject Matter
The subject matter of claims 1-12 and 20-21 would be allowable once the 112 rejections outlined above have been overcome. The following is a statement of reasons for the indication of allowable subject matter:
Molecular Therapy: Methods & Clinical Development (2019), 13, pp. 133-144, cited above, may be taken as a recent representative example of the closest prior art. Significantly, the art does not teach the generation of a plurality of droplets from a fluid comprising the cargo and the EVs (page 134, RESULTS, Optimization of Electroporation Protocol to Load miRNA in EVs). While is it known in the pertinent art to manipulate drops with respect to the electroporation of cells (as evidenced by, for instance, Lab Chip (2014), 14, pp. 686-690), a representative reference), it is also known in the art that attempting to apply existing electroporation approaches to exosomes raises a number of difficulties (as evidenced by, for instance, US 2020/0070163 A1, page 1, [0009]). That being the case, one of ordinary skill, before the effective filing date of the instant invention, would not have found sufficient motivation, or any reasonable expectation of success, in combining the teachings of Molecular Therapy: Methods & Clinical Development (2019), 13, pp. 133-144, and Lab Chip (2014), 14, pp. 686-690, for example, in order to arrive at the instant method utilizing the generation of a plurality of droplets from a fluid comprising the cargo and the EVs and/or exosomes in a method for the electroporation and loading of EVs and or exosomes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EST.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 2/7/2026