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 .
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 1-5, 16, 38 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 extracellular vesicles comprising all piRNAs of SEQ ID NOs: 522-815, does not reasonably provide enablement for treatment by extracellular vesicles comprising just one piRNA out of SEQ ID NOs: 522-815. 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 comprising any of piRNAs of SEQ ID NOs: 522-815.
Instant claims encompass methods of treatment comprising administering extracellular vesicles comprising at least one piRNA out of SEQ ID NOs: 522-815.
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, of record) on page 279, first column). Sims et al (International Journal of Nanomedicine, 2014, 4893-4897, of record) 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 any neural stem cells derived extracellular vesicles comprising only one piRNA claimed.
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 comprising only one piRNA 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.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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 16 depends on claim 1 and provides additional structural features of piRNAs. Claim 1 already defines specific sequences of piRNAs, which comprise structural features listed in claim 16. Thus, claim 16 does not further limit claim 1.
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.
Response to Arguments
Applicant's arguments filed 06/11/2026 have been fully considered but they are not persuasive.
No particular arguments were provided by Applicant.
Conclusion
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 EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571)272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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