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/Restrictions
Applicant’s election without traverse of Group I, claims 1-6, 8-10, 14, 16 in the reply filed on 12/23/2025 is acknowledged.
Election of species of VSV virus and the following 10 RNAs of SEQ ID NOs: 526, 550, 586, 594, 598, 604, 638, 658, 690, and 669 is acknowledged.
Claims 14, 17, 21, 23, 25, 27, 30-31, 33, 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 8-10 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment by administering extracellular vesicles comprising specific piRNAs, does not reasonably provide enablement for treatment with any extracellular vesicles. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
Claims are broadly drawn to methods of treating an individual in need of treatment or prevention of infection with a virus, comprising administering to the individual a therapeutically effective amount of extracellular vesicles released from neural stem cells and/or neural progenitor cells.
Claims encompass treatment of any individual at risk of viral infection by administering any possible extracellular vesicles released from neural stem or progenitor cells, in some embodiments such vesicles comprising piRNAs.
Instant specification teaches that presence of groups of specific piRNAs in exosomes purified from neural stem cells provides antiviral effects, defining such groups of piRNAs for HIV and VSV viruses (see Examples 3 and 5). It is notable that such antiviral activity of exosomes is provided by not any one of piRNAs as instantly claimed, but by a large number of specific piRNAs (see, for example, Table 2). There is no evidence that the presence of only one piRNA from the group provides enough antiviral effect to treat viral infection. Also, there is no evidence in the specification of any activity of any other extracellular vesicles than exosomes.
Instant specification does not provide any working examples of actual treatment or prevention of any viral infection by administering exosomes isolated from neural stem cells.
Prior art related to studies of extracellular vesicles derived from neural stem cell teaches that some such vesicles actually deliver viruses into cells (see, for example, Vogel et al (EBioMedicine, 2018, 38: 273-282) on page 279, first column). Sims et al (International Journal of Nanomedicine, 2014, 4893-4897) clearly state that neural stem cells derived exosomes mediate viral entry (see Title, Abstract). Therefore, according to teachings of prior art administration of neural stem cells derived exosomes is expected to bring in more viruses into an organism, instead of treating a viral infection.
Thus, the guidance provided in the specification is insufficient for actual treatment or prevention of viral infections by administering neural stem cells derived extracellular vesicles.
In the absence of guidance, undue trial and error experimentation would have been required by one skilled in the art at the time invention was made to treat a subject for viral infection by administering neural stem cells derived extracellular vesicles as instantly claimed. Given the breadth of the claims, unpredictability of the art and lack of guidance of the specification, as discussed above, undue experimentation would be required by one skilled in the art to make and use the claimed invention commensurate in scope with the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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