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 claims 118-129 in the reply filed on June 30, 2026 is acknowledged.
Claims 46, 103, and 130-138 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 118-129 are examined herein.
Claim Objections
Claims 46 and 103 are objected to because of the following informalities:
Claims 46 and 103 contain abbreviations EV. Abbreviations should be completely spelled out in their first occurrence.
Appropriate correction is required.
Double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 118 and 127 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/042,902. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claim 118 is anticipated by claim 1 of ‘902 reciting a method of isolating a central nervous system (CNS) cell-derived extracellular vesicle (EV) of interest in a sample, comprising:
a. contacting the sample with a surface and selectively binding the EV of interest to:
(i) a capture reagent releasably bound to the surface, wherein the surface further comprises an anchoring reagent; and
(ii) a binding reagent;
wherein at least one of the capture reagent and the binding reagent binds to GDla, CD166, LlCAM, NCAM, NRCAM, CHLl, Glu-R2, neurofascin, DATl, CD90, CD24, PSA-NCAM, synaptophysin, GD2, N-Cadherin, ALDHlLl, GLT-1, GLAST, CD184, CD44, A2B5, aquaporin-4, ATP1B2 (ASCA-2), ceruloplasmin, CD80 or CD86;
b. binding the anchoring reagent to the binding reagent, thereby forming a complex on the surface comprising the capture reagent, the EV and the binding reagent; and
c. releasing the capture reagent from the surface and eluting unwanted components
of the sample from the surface, thereby isolating the EV of interest.
Instant claim 127 is anticipated by claim 1 of ‘902 reciting a method of isolating a central nervous system (CNS) cell-derived extracellular vesicle (EV) of interest in a sample, comprising:
a. contacting the sample with a surface and selectively binding the EV of interest to:
(i) a capture reagent releasably bound to the surface, wherein the surface further comprises an anchoring oligonucleotide;
(ii) a binding reagent, wherein the binding reagent comprises a primer oligonucleotide, thereby forming a complex on the surface comprising the capture reagent, the EV and the binding reagent;
wherein at least one of the capture reagent and the binding reagent binds to GDla, CD166, LlCAM, NCAM, NRCAM, CHLI, Glu-R2, neurofascin, DATI, CD90, CD24, PSA-NCAM, synaptophysin, GD2, N-Cadherin, ALDHlLl, GLT-1, GLAST, CD184, CD44, A2B5, aquaporin 4, ATP1B2 (ASCA-2), ceruloplasmin, CD80 or CD86;
b. binding a circular oligonucleotide template to the primer oligonucleotide to form an amplicon by rolling circle amplification, wherein the amplicon comprises a sequence that is complementary to the anchoring oligonucleotide;
c. hybridizing the anchoring oligonucleotide to the amplicon to form a second complex on the surface comprising the capture reagent, the EV, the binding reagent, and the anchoring oligonucleotide; and
d. releasing the capture reagent from the surface and eluting unwanted components of the sample from the surface, thereby isolating the EV of interest.
The cell-derived extracellular vesicle of ‘902 is the surface marker displaying agent of instant invention. The listed biomarkers are the surface markers of instant invention.
This is a provisional nonstatutory double patenting rejection.
Subject Matter Free of the Prior Art
Claims 118 - 129 are free of the prior art.
The prior art neither teaches nor suggests a method of isolating a surface marker displaying agent of interest in a sample, comprising:
(a) contacting the sample with:
(i) a surface, the surface comprising:
(A) a capture reagent that specifically binds a first surface marker of the surface marker displaying agent, wherein the capture reagent is releasably bound to the surface, and
(B) an anchoring reagent bound to the surface; and
(ii) a binding reagent that specifically binds a second surface marker of the
surface marker displaying agent;
(b) selectively binding the surface marker displaying agent of interest to the capture
reagent and the binding reagent;
(c) binding the anchoring reagent to the binding reagent, thereby forming a complex
on the surface comprising the capture reagent, the surface marker displaying agent, the
anchor reagent, and the binding reagent; and
(d) releasing the capture reagent from the surface while retaining the anchoring
reagent on the surface; and
(e) eluting unbound components of the sample from the surface, thereby isolating the
surface marker displaying agent of interest.
The closest prior art of Aghvanyan et al. (IDS; WO 2015/175856) teach a method for detecting an extracellular vesicle in a sample comprising: binding the analyte to: (i) a capture reagent on a surface comprising the capture reagent for the analyte, and an anchoring reagent; and (ii) a detection reagent for the analyte that is linked to a nucleic acid probe; thereby forming a complex on the surface comprising the capture reagent, the analyte and the detection reagent; extending the probe to form an extended sequence comprising an anchoring region that binds the anchoring reagent; binding the extended sequence to the anchoring reagent; and measuring the amount of extended sequence bound to the surface. However, the reference fails to teach a method for isolating a surface marker displaying agent.
Bombera et al. (Biosens Bioelectron. 2012 Mar 15;33(1):10-6) teach a labile linker but fail to teach two reagents bound to the surface: the capture reagent and the anchoring reagent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander Volkov whose telephone number is (571) 272-1899. The examiner can normally be reached M-F 9:00AM-5:00PM (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER ALEXANDROVIC VOLKOV/
Examiner, Art Unit 1677
/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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