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 .
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, 6, 8, 60-66, 68-69, and 73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims and of U.S. Patent No. 12,140,520 B2 in view of Duffy et al. (US Pub 2018/0017552 A1)(hereinafter, “Duffy”). The pending claims are obvious in view of the patented claims and Duffy.
Regarding claim 1, claim 1 of the ‘520 patent discloses a sensor for detecting presence, or quantifying an amount, of an analyte in a sample of interest (see line 1 of the patent claim ), the sensor comprising: a first region and a second region(see line 3 of the patent claim ), the first region comprising a first series of nanostructures capable of binding the analyte and producing a detectable signal indicative of a concentration of the analyte in the sample within a first concentration range, and (see lines 4-6 of the patent claim ) the second region comprising a second series of different nanostructures capable of binding the analyte and producing a detectable signal indicative of a concentration of the analyte in the sample within a second, different concentration range (see lines 7-9 of the patent claim ), wherein (i) the sensor is capable of quantifying the amount of analyte in a sample across both the first concentration range and the second concentration range and (ii) the nanostructures are integral with at least one of a planar support or a flexible substrate (see lines 10-12 of the patent claim ).
Regarding claim 1, , claim 12 of the ‘520 patent discloses wherein the binding of analyte is detected by a change in an optically detectable property of at least one series of nanostructures(see lines 10-11 of the patent claim ).
U.S. Patent No. 12,140,520 B2 does not claim the optically detectable property being at least one of color, light scattering, refraction or resonance.
However, Duffy teaches the binding of the analyte is detected by a change (ties analyte binding to a detectable signal, which it is interrogated optically, “emit a signal” inherently a change from background, “analyte molecule… analyte molecule”, [0180], “the presence or absence of an analyte molecule… may then be determined by determining the presence or absence of a labeling agent at/in the location”, [0184], “a location that comprises such an analyte molecule or binding ligand… can be made to emit a signal upon interrogation of the location”, [0182]), the optically detectable property being at least one of color(“fluorescence emission”, [0180], “chromogenic, fluorogenic, or chemiluminescent enzymatic precursor labeling agent”, “converted to a chromogenic, fluorogenic, or chemiluminescent product”, [0184]), light scattering (discloses light scattering ([0180] and [0183]), refraction or resonance (“optical interferometry and other methods based on measuring changes in refractive index”, [0183]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to claim the optically detectable property being at least one of color, light scattering, refraction or resonance to improve real-time optical detection of analyte binding.
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Regarding claim 6, claim 26 of the ‘520 patent discloses a sensor for detecting presence, or quantifying an amount, of an analyte in a sample of interest (see line 1 of the patent claim ), the sensor comprising: a first region comprising a first series of nanostructures capable of binding the analyte and producing a detectable signal indicative of a concentration of the analyte in the sample within a first concentration range (see lines 3-8 of the patent claim ), wherein the nanostructures are integral with at least one of a planar support or a flexible substrate (see lines 9-10 of the patent claim ).
Regarding claim 6, claim 12 of the ‘520 patent discloses wherein the binding of analyte is detected by a change in an optically detectable property of at least one series of nanostructures(see lines 10-11 of the patent claim ).
U.S. Patent No. 12,140,520 B2 does not claim the optically detectable property being at least one of color, light scattering, refraction or resonance.
However, Duffy teaches the binding of the analyte is detected by a change (ties analyte binding to a detectable signal, which it is interrogated optically, “emit a signal” inherently a change from background, “analyte molecule… analyte molecule”, [0180], “the presence or absence of an analyte molecule… may then be determined by determining the presence or absence of a labeling agent at/in the location”, [0184], “a location that comprises such an analyte molecule or binding ligand… can be made to emit a signal upon interrogation of the location”, [0182]), the optically detectable property being at least one of color(“fluorescence emission”, [0180], “chromogenic, fluorogenic, or chemiluminescent enzymatic precursor labeling agent”, “converted to a chromogenic, fluorogenic, or chemiluminescent product”, [0184]), light scattering (discloses light scattering ([0180] and [0183]), refraction or resonance (“optical interferometry and other methods based on measuring changes in refractive index”, [0183]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to claim the optically detectable property being at least one of color, light scattering, refraction or resonance to improve real-time optical detection of analyte binding.
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Regarding claim 8, claim 28 of the ‘520 patent discloses a sensor for detecting presence, or quantifying an amount, of an analyte in a sample of interest (see lines 1 -2 of the patent claim ), the sensor comprising: a first region comprising a first series of nanostructures capable of binding the analyte and producing a detectable signal indicative of a concentration of the analyte in the sample within a first concentration range, wherein the concentration of analyte in the sample, if within the first concentration range, is determined by analog detection of a substantially uniform change in an optically detectable property of the nanostructures in the first region as a function of the concentration of the analyte, wherein (a) the nanostructures are integral with at least one of a planar support or a flexible substrate (see lines 3 -9 of the patent claim ) and (b) the first region comprises one or more of: (i) center-to-center spacing of adjacent nanostructures of at least 1 μm; (ii) a minimum cross-sectional dimension or diameter of each nanostructure of at least 100 nm; (iii) a maximum cross-sectional dimension or diameter of each nanostructure of no more than 300 nm; or (iv) a height of each nanostructure in a range of 50 nm to 1000 nm; and optionally, wherein the sensor further comprises a second region comprising one or more of: (v) a fiducial marker; or (vi) a nanostructure fabrication control feature (see lines 11 -22 of the patent claim ).
U.S. Patent No. 12,140,520 B2 does not claim the optically detectable property being at least one of color, light scattering, refraction or resonance.
However, Duffy teaches the optically detectable property being at least one of color(“fluorescence emission”, [0180], “chromogenic, fluorogenic, or chemiluminescent enzymatic precursor labeling agent”, “converted to a chromogenic, fluorogenic, or chemiluminescent product”, [0184]), light scattering (discloses light scattering ([0180] and [0183]), refraction or resonance (“optical interferometry and other methods based on measuring changes in refractive index”, [0183]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to claim the optically detectable property being at least one of color, light scattering, refraction or resonance to improve real-time optical detection of analyte binding.
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Further claim correspondence is as follows:
Regarding claim 60, claim 6 of the ‘520 patent discloses “wherein the nanostructures are functionalized with a binding agent that binds the analyte”.
Regarding claim 61, claim 8 of the ‘520 patent discloses “wherein the first and second nanostructures are functionalized with a binding agent that binds the analyte”.
Regarding claim 62, claim 8 of the ‘520 patent discloses “wherein the first and second nanostructures are functionalized with a binding agent that binds the analyte”.
Regarding claim 63, claim 9 of the ‘520 patent discloses “wherein the analyte is a biological molecule”.
Regarding claim 64, claim 9 of the ‘520 patent discloses “wherein the analyte is a biological molecule”.
Regarding claim 65, claim 10 of the ‘520 patent discloses “wherein the sensor is capable of detecting the concentration of analyte in the sample across a range spanning at least 5, 6, 7, 8 or 9 orders of magnitude”.
Regarding claim 66, claim 24 of the ‘520 patent discloses “wherein the sensor is capable of detecting analyte in a concentration range from less than 1 fg/mL to greater than 1 mg/mL”.
Regarding claim 68, claim 11 of the ‘520 patent discloses “wherein the sample is a body fluid, tissue extract, and/or cell supernatant”.
Regarding claim 69, claim 11 of the ‘520 patent discloses “wherein the sample is a body fluid, tissue extract, and/or cell supernatant”.
Regarding claim 73, claim 4 of the ‘520 patent discloses “wherein the first region comprises one or more of: (i) center-to-center spacing of adjacent nanostructures of at least 1 μm; (ii) a minimum cross-sectional dimension or diameter of each nanostructure of at least 10 nm; (iii) a maximum cross sectional dimension or diameter of each nanostructure of no more than 200 nm; or (iv) a height of each nanostructure in a range of 50 nm to 1000 nm; and optionally, wherein the sensor further comprises a second region comprising one or more of: (v) a fiducial marker; or (vi) a nanostructure fabrication control feature”.
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.
Claims 1, 6, 8, and 58-72 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duffy et al. (US Pub 2018/0017552 A1)(hereinafter, “Duffy”).
Regarding claim 1, Duffy teaches a sensor (capture objects functionalized with capture components, [0147] and [0160]) for detecting presence, or quantifying an amount, of an analyte in a sample of interest ([0147]), the sensor comprising:
a first region and a second region (discloses the plurality of capture components, separate regions on the capture object surface, [0160]),
the first region comprising a first series of nanostructures (“the capture objects may take other physical forms (e.g., nanotubes, disks, rings, microfluidic droplets, etc.)”, “metal nanoparticle or nanocluster (e.g., a gold nanocluster or nanoparticle, silver nanocluster or nanoparticle)”, [0072], [0180] and [0182]) capable of binding the analyte and producing a detectable signal indicative of a concentration of the analyte in the sample within a first concentration range (discloses spatially distinct regions of capture components, [0160]), and
the second region comprising a second series of different nanostructures capable of binding the analyte and producing a detectable signal indicative of a concentration of the analyte in the sample within a second, different concentration range (discloses that different capture components can target the same analyte at different binding strengths, [0160] and [0163]),
wherein (i) the sensor is capable of quantifying the amount of analyte in a sample across both the first concentration range and the second concentration range (discloses capture components with different binding affinities, [0163]), (ii) the nanostructures are integral with at least one of a planar support or a flexible substrate(solid support, [0147] and [0150]), and (iii) the binding of the analyte is detected by a change in an optically detectable property of at least one series of nanostructures, the optically detectable property being at least one of color (“fluorescence emission”, [0180], “chromogenic, fluorogenic, or chemiluminescent enzymatic precursor labeling agent”, “converted to a chromogenic, fluorogenic, or chemiluminescent product”, [0184]), light scattering (discloses light scattering ([0180] and [0183]), refraction or resonance (“optical interferometry and other methods based on measuring changes in refractive index”, [0183]).
Regarding claim 6, Duffy teaches a sensor (capture objects functionalized with capture components, [0147] and [0160]) for detecting presence, or quantifying an amount, of an analyte in a sample of interest ([0147]), the sensor comprising:
a first region comprising a first series of nanostructures capable of binding the analyte and producing a detectable signal indicative of a concentration of the analyte in the sample within a first concentration range(discloses spatially distinct regions of capture components, [0160]), wherein individual nanostructures of the first series that bind the analyte are optically detected upon binding the analyte, whereupon the concentration of analyte in the sample, if within the first concentration range, is determined from a number of individual nanostructures in the first series that have bound molecules of analyte(discloses that capture components produce detectable signals for detection and quantification of analytes, [0163]),
wherein (i) the nanostructures are integral with at least one of a planar support or a flexible substrate (solid support, [0147] and [0150]), and (ii) the binding of the analyte is detected by a change in an optically detectable property of at least one series of nanostructures, the optically detectable property being at least one of color, light scattering, refraction or resonance(discloses detection of bound analytes using optical or other detection signals, [0161] and [0163], biotin-streptavidin surfaces, [0154-0155]).
Regarding claim 8, Duffy teaches a sensor (capture objects functionalized with capture components, [0147] and [0160]) for detecting presence, or quantifying an amount, of an analyte in a sample of interest ([0147]), the sensor comprising:
a first region comprising a first series of nanostructures capable of binding the analyte and producing a detectable signal indicative of a concentration of the analyte in the sample within a first concentration range (discloses spatially distinct regions of capture components, [0160]), wherein the concentration of analyte in the sample, if within the first concentration range, is determined by analog detection of a substantially uniform change in an optically detectable property of the nanostructures in the first region as a function of the concentration of the analyte (discloses that capture components produce detectable signals for detection and quantification of analytes, [0163]), wherein (a) the nanostructures are integral with at least one of a planar support of a flexible substrate (solid support, [0147] and [0150]), (b) the binding of the analyte is detected by a change in an optically detectable property of at least one series of nanostructures, the optically detectable property being at least one of color, light scattering, refraction or resonance (discloses detection of bound analytes using optical or other detection signals, [0161] and [0163], biotin-streptavidin surfaces, [0154-0155]), and (c) the first region comprises one or more of:
(i) center-to-center spacing of adjacent nanostructures of at least 1 μm (figure 14B, [0160]);
(ii) a minimum cross-sectional dimension or diameter of each nanostructure of at least
100 nm;
(iii) a maximum cross-sectional dimension or diameter of each nanostructure of no more
than 300 nm; or
(iv) a height of each nanostructure in a range of 50 nm to 1000 nm; and
optionally, wherein the sensor further comprises a second region comprising one or more
of:
( v) a fiducial marker ; or
(vi) a nanostructure fabrication control feature.
Regarding claim 58, Duffy teaches wherein the second concentration range has a higher detectable value than that of the first concentration range (discloses spatially distinct regions of capture components, [0160]).
Regarding claim 59, Duffy teaches wherein the first concentration range overlaps the second
concentration range (discloses the plurality of capture components, separate regions on the capture object surface, [0160]).
Regarding claim 60, Duffy teaches wherein the nanostructures are functionalized with a binding agent that binds the analyte(capture components, [0147]).
Regarding claim 61, Duffy teaches wherein the binding agent is a biological binding agent (discloses proteins, antibodies, receptors, [0148]).
Regarding claim 62, Duffy teaches wherein the biological binding agent is an antibody ([0148]), an aptamer, a receptor (discloses proteins, antibodies, receptors, [0148]), an enzyme, or a nucleic acid.
Regarding claim 63, Duffy teaches wherein the analyte is a biological molecule (discloses proteins, antibodies, receptors, [0148]).
Regarding claim 64, Duffy teaches wherein the biological molecule is a protein (discloses proteins, antibodies, receptors, [0148]), peptide, carbohydrate, glycoprotein, glycopeptide, lipid, lipoprotein, nucleic acid, or nucleoprotein.
Regarding claim 65, Duffy teaches wherein the sensor is capable of detecting the concentration of analyte in the sample across a range spanning at least 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 orders of magnitude (figure 25C, [0218]).
Regarding claim 66, Duffy teaches wherein the sensor is capable of measuring the concentration of analyte in the range from less than 1 pg/mL to greater than 100 ng/mL, less than 0.1 pg/mL to greater than 1 μg/mL, or from less than 0.01 pg/mL to greater than 100 μg/mL, or from less than 1 f g/mL to greater than 1 mg/mL (discloses combination of capture object binding, calibration curve and binary/analog readout inherently allows measurement across a wide concentration range, [0218]).
Regarding claim 67, Duffy teaches wherein the sample is not diluted prior to application to
the sensor (discloses direct application of untreated sample, [0174]).
Regarding claim 68, Duffy teaches wherein the sample is a body fluid, tissue extract, or a cell
Supernatant (discloses “an analyte molecule is a human body fluid (e.g., blood, serum)”, [0174]).
Regarding claim 69, Duffy teaches wherein the body fluid sample comprises blood, serum,
plasma, urine, cerebrospinal fluid, or interstitial fluid (discloses “an analyte molecule is a human body fluid (e.g., blood, serum)”, [0174]).
Regarding claim 70, Duffy teaches wherein the tissue extract comprises a biopsy sample (discloses “an analyte molecule is a human body fluid (e.g., blood, serum)”, [0174]).
Regarding claim 71, Duffy teaches wherein the nanostructures are planar-faced or curve-faced nanostructures(“the capture objects may take other physical forms (e.g., nanotubes, disks, rings, microfluidic droplets, etc.)”, [0072] and [0101]).
Regarding claim 72, Duffy teaches wherein the nanostructures are fabricated from a semiconductive material or a metal(discloses metals, [0101]).
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.
Claims 73-74 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al. (US Pub 2018/0017552 A1)(hereinafter, “Duffy”) in view of Leshem et al. (US Pub 2018/0120553 A1)( hereinafter, “Leshem”).
Regarding claim 73, Duffy teaches sensor (capture objects functionalized with capture components, [0147] and [0160]).
Duffy fails to disclose a fiducial marker.
Leshem teaches a fiducial marker(abstract).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate fiducial marker of Leshem to Duffy to enhance the imaging, quantification, and reliability of the sensor ([0135]).
Regarding claim 74, Duffy fails to disclose wherein the fiducial marker is optically detectable by at least one of light field microscopy or dark field microscopy.
Leshem teaches wherein the fiducial marker is optically detectable by at least one of light field microscopy or dark field microscopy (abstract).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate fiducial marker of Leshem to Duffy to enhance the imaging, quantification, and reliability of the sensor ([0135]).
Conclusion
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/C.X./ Examiner, Art Unit 2877
/Kara E. Geisel/ Supervisory Patent Examiner, Art Unit 2877