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 .
Status of claims
Claims 1, 4-9, 12, 13, 15, 17, 18, 20, 22 and 23 as amended on 12/11/2025 are currently pending.
Claims 13, 15, 17, 18, 20, 22 and 23 were been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/11/2025.
Claims 1, 4-9 and 12 as amended on 12/11/2025 are under examination in the instant 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 1, 5, 7-9 and 12 as amended remain/are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by US 2016/0334398 (Weissleder et al).
US 2016/0334398 (Weissleder et al) discloses a nano-plasmonic array for detecting target extracellular vesicles (EVs) or exosomes (abstract; 0003; 0005), wherein the array comprises:
a substrate (par. 0005, lines 8-9; par, 0124, line 8);
2) a plurality of nanostructures including nanoapertures (par. 0005, lines 10-11; par. 0124 lines 14-15) arranged to form a periodic array (par. 0013; par. 0129) on the substrate, wherein the nanostructures are any structures in combination or association with nanoaperture (see par. 0056) including nanoparticles of any shape such as rod (nanorods), cube (nano-squares) or sphere (nano-disks), for example: see par. 0166. The nanostructures as a whole are arranged, dimensioned or designed to produce electromagnetic field and to amplify detection signals of electromagnetic radiation emitted, scattered, or reflected by exosomes present/bound to the array nanostructures or substrate near the nanostructures (see par. 0166; see par. 0005, lines 1-6; see par. 0124, lines 4-7 from the top or lines 4-5 from the bottom of par), wherein the detection signal includes detection of fluorescence (par. 0101, figure 6); and
3) one or more “capture agent” that specifically binds to exosome marker (par. 0005, last 2 lines) or specific “antibodies” for exosome capture (par. 0103; par. 0139) that are affinity “ligands” (specific binding molecules; see par, 0088, lines 1-8) within the broadest reasonable meaning of the claims; all being fixed/present on or adjacent to the nanostructures, wherein the capture agent and/or affinity ligands are intended to target exosomes (par. 0046) and to bind the target exosomes to the nanostructures or to the substrate adjacent to the nanostructures on the nano-plasmonic array (0038).
Thus, the cited document US 2016/0334398 (Weissleder et al) is still considered to anticipate claim 1 as amended.
As applied to claim 5: the nanostructures have sizes or diameters of about 50 nm to 300 nm (par. 0015) and the associated nanoparticles designed for signal amplification have mean diameter 50 nm (par. 0104), thus, all are within maximum size as claimed.
As applied to claim 7: the cited document discloses that affinity ligands bind to a capture agent, wherein the capture agent on the surface of array is configured to bind to surface marker on exosomes or on target exosomes; and further affinity ligands (antibody) bind to capture agent with captured exosome thereon (par. 0112, par. 0103).
As applied to claim 8: the cited document discloses that the affinity ligand (antibodies) are configured to bind to surface marker of exosomes (par. 0103) and/or to “intravesicular” marker from lysed exosomes (par. 0112).
As applied to claim 9: the cited document discloses that the periodic array of nanostructures has a periodicity of about 400 to 700 nm between nanostructures (par. 0015).
As applied to claim 12: in the cited nano-plasmonic array the plasmonic material comprises gold, silver, aluminum, or platinum (par. 0067-0068); the nanostructures comprise gold (0045) including gold nanoparticles in shape of rod, cube and sphere (par. 0166).
Thus, the cited document US 2016/0334398 (Weissleder et al) is considered to anticipate the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4-9 and 12 as amended remain/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0334398 (Weissleder et al) and US 2012/0184451 (Singamaneni et al).
The cited US 2016/0334398 (Weissleder et al) is relied upon for the disclosure of a nano-plasmonic array for detecting target extracellular vesicles (EVs) or exosomes (abstract; 0003; 0005), wherein the array comprises:
2) a plurality of nanostructures including nanoapertures (par. 0005, lines 10-11; par. 0124 lines 14-15) arranged to form a periodic array (par. 0013; par. 0129) on the substrate, wherein the nanostructures are any structures in combination or association with nanoaperture (see par. 0056) including nanoparticles of any shape such as rod (nanorods), cube (nano-squares) or sphere (nano-disks), for example: see par. 0166. The nanostructures as a whole are arranged, dimensioned or designed to produce electromagnetic field and to amplify detection signals of electromagnetic radiation emitted, scattered, or reflected by exosomes present/bound to the array nanostructures or substrate near the nanostructures (see par. 0166; see par. 0005, lines 1-6; see par. 0124, lines 4-7 from the top or lines 4-5 from the bottom of par), wherein the detection signal includes detection of fluorescence (par. 0101, figure 6); and
3) one or more “capture agent” that specifically binds to exosome marker (par. 0005, last 2 lines) or specific “antibodies” for exosome capture (par. 0103; par. 0139) that are affinity “ligands” (specific binding molecules; see par, 0088, lines 1-8) within the broadest reasonable meaning of the claims; all being fixed/present on or adjacent to the nanostructures, wherein the capture agent and/or affinity ligands are intended to target exosomes (par. 0046) and to bind the target exosomes to the nanostructures or to the substrate adjacent to the nanostructures on the nano-plasmonic array (0038).
The cited US 2016/0334398 (Weissleder et al) teaches that the nanostructures have sizes or diameters of about 50 nm to 300 nm (par. 0015) and the associated nanoparticles designed for signal amplification have mean diameter 50 nm (par. 0104), thus, all are within maximum size as claimed.
However, the cited document does not explicitly disclose or use terms such as length, width and height for nanostructures including nanorods or nanospheres-nanodisks, although the claimed ranges fully overlap size ranges of the nanostructures of the cited sizes of the cited document (ranges 50 nm to 300 nm).
However, US 2012/0184451 (Singamaneni et al) teaches that nanostructures or nanoparticles for detection of specific proteins in biological clinical samples can be rods with dimensions of about 80 nm long and 20 nm in diameter (par. 0048). They are made from noble metal or gold (0048) and functionalized with specific ligands or anti(0043, 0056). The optical signal for detection can be fluorescent signal or Raman signal (abstract; par. 0006, 0043).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to modify configurations and/or dimensions of nanostructures intended for capturing and detecting exosomes within the art recognized ranges with a reasonable expectation of success for capturing and detecting exosomes because modifications in shapes and sizes are allowed by the art for detection of exosomes. One of skill in the art is free to select within modifications and/or components knonw and available in the art.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicants' arguments filed on 12/11/2025 have been fully considered but they are not persuasive.
With regard to claim rejection under 35 U.S.C. 102 (a) (1) as being anticipated by US 2016/0334398 (Weissleder et al) Applicants argue that the cited structure contains nanoapertures but not nanorods/nano-squares and that the cited array is not designed to detect fluorescent signal.
This arguments are not found persuasive. The cited US 2016/0334398 (Weissleder et al) disclosure a nano-plasmonic array for detecting target extracellular vesicles (EVs) or exosomes (abstract; 0003; 0005), wherein the array comprises:
a plurality of nanostructures including nanoapertures (par. 0005, lines 10-11; par. 0124 lines 14-15) arranged to form a periodic array (par. 0013; par. 0129) on the substrate, wherein the nanostructures are any structures in combination or association with nanoaperture (see par. 0056) including nanoparticles of any shape such as rod (nanorods), cube (nano-squares) or sphere (nano-disks), for example: see par. 0166. The nanostructures as a whole are arranged, dimensioned or designed to produce electromagnetic field and to amplify detection signals of electromagnetic radiation emitted, scattered, or reflected by exosomes present/bound to the array nanostructures or substrate near the nanostructures (see par. 0166; see par. 0005, lines 1-6; see par. 0124, lines 4-7 from the top or lines 4-5 from the bottom of par), wherein the detection signal includes detection of fluorescence (par. 0101, figure 6).
With regard to claim rejection under 35 USC § 103 Applicants’ first argument is that nanoparticles disclosed by the cited US 2016/0334398 (Weissleder et al) at the paragraph 0166 are not nanostructures that are part of a nano-plasmonic array but a secondary label
This argument is not found persuasive because accordingly to definitions and description of the cited US 2016/0334398 (Weissleder et al) the nanostructures are any structures in combination or association of nanoaperture (see par. 0056) including nanoparticles of any shape such as rod (nanorods), cube (nano-squares) or sphere (nano-disks), for example: see par. 0166.
Applicants also argue that the cited US 2012/0184451 (Singamaneni et al) does not teach the use of a fluorescent signal for detection. This argument is not found persuasive because the cited US 2012/0184451 (Singamaneni et al) clearly contemplates the use of a fluorescent signal for detection; for example: see 0068, see 0043.
No claims are allowed.
Conclusion
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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Vera Afremova
March 9, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653