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 .
Response to Amendment
The amendment filed 02 June 2026 in which claims 1, 3, 7-10, 13, 15, 19-20, and 22 were amended has been entered.
Claims 1-10, 12-20, and 22 are under examination on the merits.
Specification
(Previous objection, withdrawn). Applicant’s amendments to the Specification
submitted 02 June 2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 05 December 2025.
Claim Objections
(Previous objection, withdrawn as to claims 1, 3, 9-10, 13, 15, 19, and 22). Applicant’s amendments to claims 1, 3, 9-10, 13, 15, 19 and 22 submitted 02 June 2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 05 December 2025.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn as to claims 1-10 and 12-20). Claims 1-10, and 12-20 were rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claim Rejections - 35 USC § 112(b)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn as to claims 7-10, 13, 15, 19, and 20). Claims 7-10, 13, 15, 19, and 20 were 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. Applicant’s amendments to claims 7-10, 13, 15, 19, and 20 submitted 02 June 2026 have overcome the rejection previously set forth in the Non-Final Office Action mailed 05 December 2025.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, maintained as to claims 1-3, 5, 6, 9, 12-16, 19, and 20). Claims 1-3, 5, 6, 9, 12-16, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hu.
(Previous rejection, maintained and expanded as to claim 22 as necessitated by amendment to claim 22). Claim 22 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Roberts as evidenced by Grgacic, et al. (Methods. 2006 Sep;40(1):60-5., hereinafter “Grgacic”).
Regarding claim 22, Roberts discloses a kit for determining whether or not virus-neutralizing antibodies are present in a sample obtained from a subject, comprising - extracellular vesicles, which comprise one or more viral glycoprotein(s), and a label, being attached to an extracellular vesicle protein of the extracellular vesicles (¶0013). As discussed in the claim interpretation section of the Non-Final Office Action filed 05 December 2025, VLPs are considered extracellular vesicles and as evidenced by Grgacic, VLPs are non-infectious (pg. 60, section 1).
Accordingly, Roberts anticipates the claimed invention.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, maintained as to claims 4, 8, 10, and 17). Claims 4, 8, 10, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hu as applied to claims 1-3, 5-6, 9, 12-16, 19, and 20 above, and further in view of Sasaki.
(Previous rejection, maintained as to claim 7). Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hu as applied to claims 1-3, 5-6, 9, 12-16, 19, and 20 above, and further in view of Cashikar.
(Previous rejection, maintained as to claim 18). Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hu as applied to claims 1-3, 5-6, 9, 12-16, 19, and 20 above, and further in view of Tscherne.
Response to Arguments
Applicant contends on pages 10-16 of the Remarks submitted on 02 June 2026 that claims 1-10 and 12-20 are not “directed” to a judicial exception, but rather that the JE has been integrated into a practical application of determining the presence of virus-neutralizing antibodies in a sample.
In response: Applicant’s arguments, see pages 10-16, filed 02 June 2026, with respect to claims 1-10 and 12-20 have been fully considered and are persuasive. The rejection of claims 1-10 and 12-20 has been withdrawn.
Applicant contends on pages 17-22 of the Remarks submitted on 02 June 2026 that one of skill in the art would not understand that the term EVs encompasses pseudoviruses, VLPs, etc.
In response: Applicant's arguments filed 02 June 2026 have been fully considered but they are not persuasive.
The claims as they currently are do not limit themselves to the “pure” EVs that are described in Applicant’s argument. The limitations claimed only require that they be EVs, non-infectious, and comprise one or more viral glycoproteins. These limitations are described in the previous office action, do not exclude VLPS, SVPs, etc. as they are EVs as in they are a structure outside a cell enclosed in a lipid bilayer, they are noninfectious as they have been disabled such that they are not fully infectious, and they do are comprised of one or more viral proteins. They limitations argued and the limitations actually claimed are not the same limitations. If it required high throughput analysis of individual particles in determine the difference between “pure” EVs and the EVs that are encompassed in the definition provided (VLPs, SVPs, etc.) then it is nearly impossible to distinguish the two. By definition, VLPs, VSPs, etc. are extracellular vesicles. Different limitations in the claims would be required to meet the definition of EVs argued in the reply sent 02 June 2026.
Conclusion
NO CLAIMS ARE ALLOWED
THIS ACTION IS MADE FINAL. 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.
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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