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 .
DETAILED ACTION
This Non-Final Office Action is responsive to the communication received 01/28/2026.
Election/Restrictions
Applicant’s election without traverse in the Reply filed on 01/28/2026 of Group II, Claim(s) 28, 47-48, 50-51 and 54 is acknowledged.
Applicant has elected without traverse in the Reply filed on 01/28/2026 the following species:
A. the cell surface marker is EpCAM (claim 28)
B. the second biomarker is PD-L1 (claim 54)
The Restriction/Election Requirements are deemed proper and are made FINAL.
Claims 1-2, 4-5, 8, 10, 17-18, 20, 24, 26-28, 47-48, 50-51, 54, 58-59 and 66 are pending.
Claims 1-2, 4-5, 8, 10, 17-18, 20, 24, 26-27, 58-59 and 66 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply filed on 01/28/2026.
Claims 28, 47-48, 50-51 and 54 are under examination in this Office Action.
Claim Rejections - 35 USC § 102
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 28, 47-48, 50-51 and 54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nanou et al. (01/15/2020) British Journal of Cancer volume 122 pages 801 to 811 cited in the 8/15/2024 IDS (hereinafter referred to as "Nanou").
With regards to claims 28, 47-48, 50-51 and 54, Nanou teaches:
a) as in claims 28, 47-48, 50-51 and 54, a process of enriching cell-type specific extracellular vesicles (EVs) from a subject, comprising: a. providing a biological fluid sample from the subject; b. contacting the sample with antibodies specific for a cell surface marker, optionally wherein the antibodies are attached to a matrix; c. isolating antibody-bound EVs from unbound EVs in the sample; and e. contacting the EVs with a detection agent specific for a second biomarker; optionally wherein the cell surface marker is EpCAM; further comprising isolating total extracellular vesicles (EVs) from the sample by membrane capture, determining total protein levels in the isolated total extracellular vesicles; wherein isolation of antibody bound EVs from unbound EVs is through attachment to the matrix; wherein the sample is not subjected to chromatography before contacting the sample with the antibodies; wherein isolating the cell-type specific EVs from the sample consists essentially of: contacting the sample with antibodies specific for the cell surface marker for the one or more cell types; isolating the antibody-bound EVs from unbound EVs in the sample, resuspending the antibody-bound EVs in a lysis buffer, and contacting the EVs with a detection agent specific for a second biomarker; wherein the subject has cancer or is suspected of having cancer, and wherein the second biomarker is an immune checkpoint regulator is PD-L1 (see entire document especially Abstract, Table I, Figure I and pages 801 to 804).
Thus, Nanou anticipates the present claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684
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