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 .
The claims filed 7/8/2026 are under consideration.
The amendments and arguments presented in the papers filed 7/8/2026 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 1/8/2026 listed below have been reconsidered as indicated.
a) The amendments to the specification acknowledging trade name or mark usage are acknowledged.
b) The rejections of claims 1-4, 6-7, 9-11, 13-15, 19-22, 24, 46, 50-51, 54, 57 and 91 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
c) The rejections of claim(s) 1-4, 6-7, 9-11, 13-15 and 46 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Wei (WO 2018/081193 A1) are withdrawn.
d) The rejections of claim(s) 19-21 under 35 U.S.C. 103 as being unpatentable over Wei (WO 2018/081193 A1) are withdrawn.
e) The rejections of claim(s) 22, 24 and 91 under 35 U.S.C. 103 as being unpatentable over Wei (WO 2018/081193 A1) in view of Mirkin 1 (US 2016/0053260 A1) are withdrawn.
f) The rejections of claim(s) 50, 51, 54 and 57 under 35 U.S.C. 103 as being unpatentable over Wei (WO 2018/081193 A1) in view of Mirkin 2 (US 2017/0232109 A1) are withdrawn.
The Examiner’s responses to the Remarks regarding issues not listed above are detailed below in this Office action.
New grounds of rejection necessitated by amendment are detailed below.
Election/Restrictions
Applicant elected with traverse Group I, claims 1-7, 9-11, 13-15, 19-22, 24, 46, 50-51, 54, 57 and 91 in the reply filed on 11/13/2025.
Claims 29-31, 32-33, 35, 66 and 69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/13/2025.
The election of species requirement of 6/13/2025 has been withdrawn.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or on a submitted IDS, they have not been considered.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 3, 4, 7, 9, 10, 11, 13, 14, 15, 19, 20, 21, 46 and 51 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Pang (Biosensors and Bioelectronics. 2015. 66:527-532).
Regarding claims 1, 3, 4, 10 and 46, Pang teaches contacting a target “analyte” with a “spherical nucleic acid” comprising a “metallic” Ag@SiO2 “nanoparticle core” and an aptamer “oligonucleotide” attached to it. Binding the target “analyte”, e.g. the influenza protein rHA, to the aptamer leads to the “detectable marker” TO (thiazole
PNG
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517
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orange) being “situated at an internal location” within the aptamer structure. See Scheme 1, which is reproduced below:
TO is a marker with “internal rotation-dependent fluorescence” encompassed by the claim in view of the instant specification. The binding leads to “restriction of internal rotation of the marker” and fluorescence release, leading to a “detectable change” as an increase in the amount of fluorescence, allowing one to detect the target “analyte”.
Regarding claim 2, Pang teaches a plurality of the aptamer is attached to the “nanoparticle core”.
Regarding claim 7, TO is a “viscosity-sensitive marker” encompassed by the claim in view of the instant specification.
Regarding claim 9, Pang demonstrates the amount of fluorescence change detected is proportional to the concentration of the target “analyte” (Fig. 3).
Regarding claim 11, the claim limits the scope of the “ion” option of claim 10. The claim does not require the analyte to be an ion. The claim broadly encompasses a protein analyte and is rejected for the same reason as claim 10 above.
Regarding claims 13 and 14, the claims limit the scope of the ion option of claim 10. The claim does not require the analyte to be an ion. The claim broadly encompasses a protein analyte and is rejected for the same reason as claim 10 above.
Regarding claim 15, Pang teaches the aptamer is DNA (p. 529, 3.1. Characterization of the Ag@SiO2 NPs and the sensing principle verification).
Regarding claims 19, 20 and 21, Pang teaches within the aptamer/target complex the TO is “situated” at a position that is at least 1 nucleotide internal relative to the terminus of the aptamer (Scheme 1).
Regarding claim 51, Pang teaches the aptamer binds the target “analyte” as described above, leading the detectable change of blocking other molecules from binding to the target “analyte”.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 22, 24 and 91 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pang (Biosensors and Bioelectronics. 2015. 66:527-532) in view of Mirkin 1 (US 2016/0053260 A1; previously cited).
Regarding claim 22, 24 and 91, Pang teaches the elements of claims 1 above in the 102 rejections as required by claims 22, 24 and 91.
Pang does not teach the additional elements specific to claims 22, 24 and 91.
However, Mirkin 1 teaches other uses of structures of Pang includes nucleic acids to inhibit gene products (para. 8 and 20) and immune modulation (para. 20). Further, it is known that single stranded nucleic acids are immune system stimulatory. Both nucleic acids inhibiting gene products and nucleic acids for immune modulation are broadly encompassed by a “therapeutic agent”.
It would have been prima facie obvious to have modified the method of Pang by including additional nucleic acids on the nanoparticle that inhibit gene products and/or that are immune system stimulatory in the context of or related to cortisol levels.
Claim(s) 50, 54 and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pang (Biosensors and Bioelectronics. 2015. 66:527-532) in view of Mirkin 2 (US 2017/0232109 A1).
Regarding claims 50, 54 and 57, Pang teaches the elements of claims 1 and 46 above in the 102 rejections as required by claims 50, 54 and 57.
Pang does not teach the additional elements specific to claims 50, 54 and 57.
However, Mirkin 2 teaches that nanoparticle “cores” for attaching nucleic acids were known, including those made of proteins and gold-protein complexes (para. 70). Mirkin 2 further teaches the proteins are catalytically active (para. 70 and 216), the formation of a product of the reaction is an additional detectable change. Mirkin further teaches contacting an additional target with an agent, such as 5-bromo-4-chloro-3-indolyl-β-D-galactopyranoside (X-gal) (para. 235).
It would have been prima facie obvious at the time of invention to have modified the method of Pang by substituting for the use of the “cores” taught by Mirkin 2. One would have been motivated to make such modifications as it allows one to further investigate additional analytes in the context of or related to cortisol levels.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 3, 4, 7, 9, 10, 11, 13, 14, 15, 19-21, 46 and 51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-11, 22-23 and 26 (7/20/2026) of copending Application No. 17/621,088 in view of Pang (Biosensors and Bioelectronics. 2015. 66:527-532).
The claim sets are drawn to substantially similar subject matter and differ in the present claims require a nanoparticle core to which the oligonucleotide is attached.
However, this design feature was known as demonstrated by Pang as described above. It would have been prima facie obvious to have added the nanoparticle core of Pang in order to enhance fluorescent signals.
This is a provisional nonstatutory double patenting rejection.
Claims 22, 24 and 91 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-11, 22-23 and 26 (7/20/2026) of copending Application No. 17/621,088 in view of Pang (Biosensors and Bioelectronics. 2015. 66:527-532) and in further view of Mirkin 1 (US 2016/0053260 A1; previously cited).
The claim sets are drawn to substantially similar subject matter and differ in the present claims require the elements of claims 22, 24 and 91.
However, this design feature was known as demonstrated by Mirkin 1 as described above.
This is a provisional nonstatutory double patenting rejection.
Claims 50, 54 and 57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-11, 22-23 and 26 (7/20/2026) of copending Application No. 17/621,088 in view of Pang (Biosensors and Bioelectronics. 2015. 66:527-532) and in further view of Mirkin 2 (US 2017/0232109 A1).
The claim sets are drawn to substantially similar subject matter and differ in the present claims require the elements of claims 50, 54 and 57.
However, this design feature was known as demonstrated by Mirkin 2 as described above.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
The following references are made of record but have not been relied upon in the above rejections:
Dembska (Anal Methods. 2017. 9:6092);
Huang (Chem Commun. 2014. 50:15768);
Sharma (Chem Commun. 2007. 43(5):477-479);
Ebrahimi (J Am Chem Soc. 2019. 141:13744-13748; cited on a 4/26/2024 IDS);
Hovelmann (Chem Sci. 2016. 7:128; cited on a 4/26/2024 IDS);
Hovelmann (ChemBioChem. 2012. 13:2072-2081; cited on a 4/26/2024 IDS);
Hovelmann (J Am Chem Soc. 2013. 135:19025-19032; cited on a 4/26/2024 IDS); and
Pang (Scientific Reports. 2015. 5:9451).
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH G. DAUNER/ Primary Examiner, Art Unit 1682
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