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 .
This Office Action is in response to the paper filed 12 November 2025. Claims 1, 4, and 5 have been amended. Claims 2, 7, and 8 have been cancelled. Claims 9-13 remain withdrawn.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.
Withdrawal of Objections/Rejections:
The objection to claim 5, is withdrawn.
The rejection of claims 1-8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
Maintenance/Modification of Rejections Necessitated by Amendment:
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 engineering donor cells to express GRM4 or GRM8 and producing the EVs therefrom. "[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 EVs therefrom.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
"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 functionalized EVs are produced from donor cells engineered to express mGluR4 or mGluR8, 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.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the EVs are functionalized, mGluR4/mGluR8 decorated, EVs) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As currently claimed, it is not the claimed EVs that express the mGlu4/mGlu8 receptor, but instead the donor cells the EVs are derived from. There is no limitation directed to a structural difference provided to the claimed EVs as a result of being produced as claimed. As such, the EVs as claimed, and therefore the composition containing those EVs, is still deemed to be anticipated and/or rendered obvious by the EVs of El Andaloussi et al.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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, 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.
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.
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653