Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim 1 is pending. Claims 2-87 are cancelled.
Claim Rejections - 35 USC § 102
2. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
3. Claim(s) 1 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Rassman et al (US 2003/0224370; hereinafter referred to as Rassman).
Rassman discloses the use of an evanescent-field-perturbing amplifier element (e.g., antibody; as seen as Applicants' instantly recited antibody) in a probe-target reaction (e.g., the nucleic acid hybridization in WANG), wherein the amplifier element reacts uniquely with and binds to the probe-target pair (e.g., DNA/RNA duplex) to amplify the detection signal (paragraph [15, 16, 18, 21, 39]). Capture probes for the analyte may comprise DNA, RNA, LNA for capturing DNA or RNA targets (para [15, 16, 124]; claims 34, 57, 59).
Figure 4 discloses a system in which total internal reflection (TIR) is used to observe the result of amplification by the antibody amplifier element. The TIR system measure changes in polarization state on specimen slide (138) as binding reactions occur on the specimen slide and interact with the evanescent field associated with TIR ([0116] to [0119]). Changes in evanescent field or polarization state are considered changes in an optical property of the TIR system.
Claim Rejections - 35 USC § 103
4. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
5. Claim 1 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wang et al (US 7,796,262; hereinafter referred to as Wang) in view of Rassman et al (US 2003/0224370; hereinafter referred to as Rassman).
Wang discloses a system for detecting an analyte of interest in a sample, comprising:
- an optical sensor comprising a ring resonator (12) coupled with at least two waveguides (14,16) serving as input and output waveguides;
- nucleic acid capture probes covalently attached to a surface of the ring resonators, wherein the capture probes bind analyte (column 3, line 62 to col. 4, I. 17; col. 12, I. 41 to col. 14, I. 27); and
- a detector (col. 3, II. 30-35) for processing the output signal from the optical sensors, wherein a change in the resonance (i.e. an optical property) of the ring resonator upon binding of analyte is related to the analyte concentration (col. 5, penultimate paragraph; claims 1 and 27).
Wang differs from the instant invention in failing to teach that the system comprises an antibody capable of binding to a duplex of the nucleic acid capture probe and the nucleic acid molecule of interest.
Rassman discloses the use of an evanescent-field-perturbing amplifier element (e.g., antibody; as seen as Applicants' instantly recited antibody) in a probe-target reaction (e.g., the nucleic acid hybridization in WANG), wherein the amplifier element reacts uniquely with and binds to the probe-target pair (e.g., DNA/RNA duplex) to amplify the detection signal (paragraph [15, 16, 18, 21, 39]). Capture probes for the analyte may comprise DNA, RNA, LNA for capturing DNA or RNA targets (para [15, 16, 124]; claims 34, 57, 59).
It would have been obvious, to one of ordinary skill in the art, at the time the invention was made, to modify the system of Wang to further comprise an antibody capable of binding to a duplex of the nucleic acid capture probe and the nucleic acid molecule of interest in order to amplify the assay signal and increase the sensitivity of the sensor, as taught by Rassman. One of ordinary skill in the art would have a reasonable expectation of success in performing such a modification since the system of Wang detects the attachment of analyte contained in samples to a micro-ring resonator using an evanescent wave and Rassman discloses the use of evanescent-field-perturbing amplifier elements to perturb an evanescent optical field to develop, enhance or "amplify" a probe-target reaction so that the target compound can be detected with less sensitive equipment or the detection limit of sensitive equipment may be effectively lowered so that smaller quantities of the target may be detected.
Double Patenting
6. 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.
7. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 10-16 of U.S. Patent No. 9,921,165. Although the claims at issue are not identical, they are not patentably distinct from each other because patent ‘165 claims a system that anticipates the instant invention.
Patent ‘165 claims:
3. A system for detecting an analyte of interest in a sample comprising:
an optical sensor that comprises a ring resonator;
a plurality of capture probes attached to a surface of the ring resonator, wherein the capture probes are capable of binding to the analyte;
a plurality of antibodies capable of specifically binding to the analyte or a plurality of complexes formed between the analyte and the capture probes;
a plurality of particles attached to the antibodies or capable of binding to the antibodies; and
a detector,
wherein said optical sensor has a resonant wavelength that is shifted by said antibodies bound to said complexes or analyte bound to the capture probes, such that said optical sensor is configured to sense said antibodies combined with said analyte or complexes, and the particles amplify the shift of the resonant wavelength, and
wherein the detector is configured to determine the concentration of the analyte in the sample based on the shift of the resonant wavelength resulting from multiple bound particles at the ring resonator.
10. The system of claim 3, wherein the analyte is a nucleic acid.
11. The system of claim 10, wherein the nucleic acid comprises ribonucleic acid (RNA).
12. The system of claim 10, wherein the capture probes comprise a DNA oligonucleotide.
13. The system of claim 3, wherein the optical sensor comprises a silicon waveguide structure.
14. The system of claim 13, wherein the optical sensor has an output portion configured to output an optical signal, and wherein the optical output yields different outputs when said capture probe binds to the analyte of interest forming said complex and said antibody binds said complex, and when said antibody does not bind to said complex.
15. The system of claim 3, wherein the ring resonator comprises an input portion and an output portion, and wherein the optical sensor further comprises an input waveguide and an output waveguide having the ring resonator therebetween configured to increase coupling of said light from said input waveguide to said output waveguide when said capture probes bind to the analyte of interest forming said complexes and said antibodies bind to said complexes.
16. The system of claim 3, wherein said optical sensor is integrated on an integrated optical chip comprising optical waveguides.
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
4/6/2026
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