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 of Group II (claims 17-20) in the reply filed on12/16/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 1-16 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group I, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/16/2025.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by AU 2016357303 A1.
AU 2016357303 A1 discloses, “The disclosed EVs can be obtained in some embodiments, by culturing neural progenitor (NP) cells that were produced from pluripotent stem cells (e.g. human embryonic stem cells (ESCs) or induced pluripotent stem cells (iPSCs) in cell culture medium” (page 1 paragraph 4). Furthermore, they disclose, “EVs containing 2.7 x 10^10 vesicles/kg in 50-60 ml PBS were thawed” (page 46 paragraph 2). The disclosure describes a composition of extracellular vesicles produced from neural progenitor cells that were created from induced pluripotent stem cells (iPSC) (claim 17). Additionally, the composition is specified to be dissolved in Phosphate Buffered Saline (PBS). This anticipates claim 18 as PBS is the “carrier” and claim 19 PBS is a buffered saline solution. Additionally, the disclosure anticipates claim 20 as the EVs are derived from neural progenitor (NP) cells that were produced from induced pluripotent stem cells (iPSCs) and the composition is specified to contain 2.7 x 10^10 vesicles/kg EVs which can be referred to as a “plurality”. Importantly, the inclusion of instructions for use does not impart patentable weight to the claimed kit. The instructions constitute non-functional descriptive material that merely recites intended use of the components without structurally modifying them. Importantly, the instructions do not create a functional relationship between the components. (MPEP 2111.05 and MPEP 2112.01).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam M Smith whose telephone number is (571)272-7517. The examiner can normally be reached Monday- Friday 10:30AM-5PM.
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/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638