DETAILED ACTION
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.
Claim(s) 1-2, 4, 6, 8-9, 13-16, 26-27, and 32 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Irvine et al. (US 2020/0377929) in view of Bradbury et al. (US 2021/0145985).
As to claim 1, Irvine teaches a microneedle for detecting a target (Abstract), the microneedle comprising: a hydrogel ([0017]); a probe coupled to the hydrogel ([0017] - peptide nucleic acid probes bound to a hydrogel), the probe for generating a measurable signal in the presence of the target ([0057]), the probe comprising a nucleic acid that binds to the target acid ([0017] - peptide nucleic acid), wherein the microneedle detects the target in-situ ([0017] – attached to skin).
Irvine does not necessarily teach that the nucleic acid comprises an aptamer, single stranded complementary probe DNA, nucleic acid enzyme, or combinations thereof. Instead, Irvine primarily discusses the use of PNA. However, it does teach the use of other detection reagents, including a fluorogenic reagent or a DNA intercalator ([0076]). Bradbury teaches a device for determining analytes (claim 1) in which the agents used for detection can comprise a wide array of materials, including PNA, ribozymes (a type of nucleic acid enzyme), aptamers, and others ([0046]). It would have been obvious to modify Irvine with Bradbury to utilize other types of reagents, including aptamers and nucleic acid enzymes, as it would result in similar, and thus predictable results.
As to claim 2, Irvine teaches the hydrogel comprises a polymer ([0033]) comprising at least one C=C functionality; an acrylated polymer, a methacrylated polymer, or a combination thereof; and/or methacrylated gelatin, methacrylated hyaluronic acid, methacrylated alginate, methacrylated chitosan, methacrylated collagen, methacrylated polyethylene glycol, methacrylated polyvinyl alcohol, methacrylated polylysine, or a combination thereof ([0059]).
As to claim 4, Irvine teaches the probe coupled to the hydrogel comprises the probe being coupled to the hydrogel by covalent bonding, intermolecular bonding, physisorption, complexation, a linker; or a combination thereof ([0017]).
As to claim 6, Irvine teaches the nucleic acid comprises a linker functional group for coupling the probe to the hydrogel ([0017] - photo-cleavable linker; [0060]).
As to claim 8, Irvine teaches the probe comprises a fluorophore; or an electroactive species, a redox active species, or a combination thereof ([0043-45], [0106-0139]).
As to claim 9, Irvine teaches the nucleic acid comprises a fluorophore or is linked to a fluorophore, or the nucleic acid comprises a redox reporter or is linked to a redox reporter ([0017], [0043-45], [0106-0139]).
As to claim 13, Irvine teaches the measurable signal is fluorescence; or an electrochemical signal ([0043-45], [0106]).
As to claim 14, Irvine teaches the target comprises a biomolecule present in interstitial fluid ([0124]).
As to claim 15, Irvine teaches the target comprises small biomolecules, proteins, or micro ribonucleic acids; or cortisol, vanomycin, gentamicin, tyrosinamide, thrombin, micro-RNA miR21, micro-RNA miR210, uric acid (UA), serotonin, insulin, adenosine triphosphate, or glucose ([0018]).
As to claim 16, Irvine teaches the microneedle has a length of about 300 pm to about 1000 pm, such as about 800 pm ([0142]).
As to claim 26, Irvine teaches an apparatus for detecting a target in a sample (Abstract), the apparatus comprising: the microneedle according to claim 1 (see above); and a detector for detecting the measurable signal (Claim 1).
As to claim 27, Irvine teaches a transdermal patch ([0017]) comprising the microneedle according to claim 1 (see above).
As to claim 32, Irvine teaches the probe being coupled to the hydrogel comprises the probe and the hydrogel being crosslinked together ([0017], claim 6).
Claim(s) 3 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Irvine et al. (US 2020/0377929) and Bradbury et al. (US 2021/0145985) in view of Cui et al. (US 2009/0005667).
As to claim 3, Irvine does not explicitly teach that the hydrogel further comprises a conductive polymer, an ionomer, or a combination thereof; or poly(3,4-ethylenedioxythiophene) polystyrene sulfonate; polyacetylene; polypyrrole; polyindole; polyaniline; a copolymer thereof; or a combination thereof. Cui teaches a hydrogel to be used in combination with an electrode system ([0099]) in which the hydrogel comprises polymers such as polypyrrole and PEDOT (i.e. poly(3,4-ethylenedioxythiophene)) to improve the electrical characteristics of the hydrogel, as well as incorporating conductive polymer within the hydrogel ([0106]). Accordingly, it would have been obvious to modify Irvine with Cui to utilize the recited materials as part of the overall hydrogel structure to improve any electrical characteristics of the hydrogel as desired.
As to claim 17, Irvine does not explicitly teach a conductive material, wherein the conductive material optionally comprises a metal nanoparticle, graphene-based material, conductive polymer, or an ionomer, or a combination thereof. Cui teaches a hydrogel to be used in combination with an electrode system ([0099]) in which the hydrogel comprises polymers such as polypyrrole and PEDOT (i.e. poly(3,4-ethylenedioxythiophene)) to improve the electrical characteristics of the hydrogel, as well as incorporating conductive polymer within the hydrogel ([0106]). Accordingly, it would have been obvious to modify Irvine with Cui to utilize the recited materials as part of the overall hydrogel structure to improve any electrical characteristics of the hydrogel as desired.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Irvine et al. (US 2020/0377929) and Bradbury et al. (US 2021/0145985) in view of Woodbury et al. (US 2020/0016567).
As to claim 7, Irvine does not explicitly teach that the linker functional group comprises a phosphoramidite functional group; or an acrydite functional group. However, Woodbury teaches that a peptide can be physically tethered via a linker molecule such as a phosphramidite functional group ([0040]). Accordingly, it would have been obvious to utilize a known material that can perform the function as it would be an obvious substitution that yields similar, and thus expected, results.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Irvine et al. (US 2020/0377929) and Bradbury et al. (US 2021/0145985) in view of Steelman (US 2020/0181710).
As to claim 10, Irvine does not teach the probe further comprises a quencher, and the probe is optionally reversibly bound to a quencher, or is optionally tethered to the quencher via covalent bonding, intermolecular bonding, physical adsorption, conjugation, or a combination thereof. Steelman teaches a device for detection of biological markers in which a probe comprise a quencher moiety is attached to the probe ([0207]). Accordingly, it would have been obvious to modify Irvine with Steelman to enable quenching of materials when the target has not been bound, thereby increasing the contrast in signal between a detected and undetected state and increasing the accuracy of the device.
As to claim 11, Steelman teaches the probe comprises a nucleic acid and the quencher comprises a sequence partially or fully complimentary to at least a portion of the nucleic acid sequence ([0207]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Irvine et al. (US 2020/0377929) and Bradbury et al. (US 2021/0145985) in view of Steelman (US 2020/0181710), and further in view of Li (US 2017/0131298).
As to claim 12, while Irvine teaches the probe comprises a nucleic acid ([0017]), the above combination fails to teach the quencher comprises a graphene-based material, wherein the graphene-based material optionally comprises graphene-oxide (GO) nanosheets, graphene- oxide (GO) nanoparticles, graphene-oxide (GO) nanocomposites, or a combination thereof. Li teaches that graphene oxide in various forms can be used as a quencher ([0066]). As such, it would have been obvious to modify the above combination with Li to utilize a known material that can act as a quencher as an obvious substitution yielding similar and thus expected results.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In addition, while moot for the current rejection, the examiner notes that the applicant has argued that PNAs are structurally distinct from aptamers. However, aptamers can be comprised of PNA, as evidenced by George et al. (US 2004/0222102) – [0012]; Hah (WO 2012/108675) – Abstract; and Chilkoti et al. (US 2003/0059537) – (claim 51), and should be considered for any future amendments.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 4/7/26