DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 June 2026 has been entered.
Claim 1 has been amended. Claims 9 and 10 have been cancelled. Claims 11-13 remain withdrawn. Claims 1 and 3-6 are currently pending and under examination.
This application claims benefit of priority to U.S. Provisional Application No. 62/990783, filed 5 March 17, 2020.
New/Modified Rejections:
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 1 and 3-6 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.
Claim 1 recites a “composition comprising extracellular vesicles (EVs) functionalized with a metabotropic glutamate receptor-4 (GRM4) or a metabotropic glutamate receptor-8 (GRM8), wherein the EVs are produced from donor cells engineered to express the GRM4 or GRM8.” This claim is indefinite, because as currently written, it is unclear if “functionalized” as currently claimed in intended to indicated that the EVs themselves express GRM4 or GRM8, or instead if the EV’s do not express GRM4 or GRM8, and only the cells producing the claimed EVs express GRM4 or GRM8. For the purposes of examination, this claim is interpreted as the EV’s themselves do not express GRM4 or GRM8, and only the cells producing the claimed EVs express GRM4 or GRM8.
Claims 3-6 are included in this rejection, as these claims depend from above rejected claim 1, and fail to remedy the noted deficiencies.
Claim Rejections - 35 USC § 102/103
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.
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 and 3-6 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over El Andaloussi et al. (IDS; US 2016/0137716, Published 2016).
Claim 1 is directed to a composition comprising extracellular vesicles (EVs), which are produced by the claimed process of being functionalized with GRM4 or GRM8 by production from donor cells engineered to express GRM4 or GRM8. "[E]ven 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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
El Andaloussi et al. teach a composition comprising EVs (Abs.; Para. 8). Here, the composition comprising EVs of El Andaloussi et al. is likewise produced from donor cells, and is used for the same purpose as claimed: to deliver a therapeutic (Abs.; Para. 8). Functionally, the EVs of El Andaloussi et al. are the same as the claimed EVs. Therefore, the composition comprising EVs of El Andaloussi et al. is the same as, or would have rendered obvious, the composition comprising EVs produced by the claimed process of engineering donor cells to express GRM4 or GRM8 and producing functionalized EVs therefrom.
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"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
Claim 3 is likewise rejected as being anticipated by, or obvious in view of El Andaloussi et al., as this claim further define the process of making the claimed composition.
With regard to claims 4 and 5, El Andaloussi et al. teach that the EVs encapsulate a therapeutic cargo, including collagen and glycosaminoglycans (Para. 61, 63-65), which are anti-inflammatory molecular cargo.
With regard to claims 4 and 6, El Andaloussi et al. teach that the EVs encapsulate fluorescent dye for detection with fluorescence microscopy (Para. 72), wherein the fluorescent dye is diagnostic cargo, and a molecular beacon.
Response to Arguments
Applicant urges that the EVs are functionalized with GRM4 or GRM8, where mGluR4/mGluR8-decorated EVs unexpectedly favor homing to brain tissue when being delivered intranasally into C57BL6 mice, and provide for selective uptake by neurons shortly after exposure. Thus, decoration with mGluR4/mGluR8 surprisingly helps narrow down the range of action of EVs to brain tissue, thus minimizing size effects.
Applicant’s arguments have bene fully considered, but have not been found persuasive.
With regard to Applicant’s arguments, as discussed in the indefiniteness rejection above, it is unclear if “functionalized” as currently claimed in claim 1 is intended to indicate that the EVs themselves express GRM4 or GRM8, or instead if the EV’s do not express GRM4 or GRM8, and only the cells producing the claimed EVs express GRM4 or GRM8. Wherein for the purposes of examination, this claim was interpreted as the EV’s themselves not being required to express GRM4 or GRM8.
It is noted that the invention is directed to a composition comprising EVs and not to a method of making EVs. As discussed previously, Claim 1 is directed to a composition comprising EVs, which are produced by the claimed process of being functionalized with GRM4 or GRM8 by production from donor cells engineered to express GRM4 or GRM8. El Andaloussi et al. teach a composition comprising EVs (Abs.; Para. 8). Here, the composition comprising EVs of El Andaloussi et al. is likewise produced from donor cells, and is used for the same purpose as claimed: to deliver a therapeutic (Abs.; Para. 8). Functionally, the EVs of El Andaloussi et al. are the same as the claimed EVs. Therefore, the composition comprising EVs of El Andaloussi et al. is the same as, or would have rendered obvious, the composition comprising EVs produced by the claimed process of engineering donor cells to express GRM4 or GRM8 and producing functionalized EVs therefrom.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G. Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
