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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/24/2025 has been entered.
Response to Amendment
The Amendment filed 11/24/2025 has been entered. Claims 1-5, 8-11, 13-19, and 23-27 remain pending in the application. Claims 24-27 are withdrawn. New grounds of rejections necessitated by amendments are discussed below.
Note that claims 11, 13-14, 16, and 23 have incorrect status identifiers, but are herein examined for compact prosecution purposes. Claims 11, 13-14, 16, and 23 has been amended and therefore should have the identifier of "(currently amended)".
Claim Objections
Claim 11 is objected to because of the following informalities: It is suggested to recite ”a mouth” as “the mouth” if referring to the same mouth as established in claim 1. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: It is suggested to recite “excitation source” in line 1 as “an excitation source”. It appears that “an” is underlined and has a strikethrough. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
In this case:
“analyzing means” of claim 19 is interpreted as a controller or any other suitable programmed microprocessor or microcontroller or other electronic or data processing means (specification, paragraphs [0014],[0087]).
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.
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 1-5, 8-11, and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cunningham et al. (US 20080014632 A1; cited in the IDS filed 02/14/2022) in view of Pollard et al. (WO 2017060239 A1). Note that Cunningham describes and fully incorporates by reference to US 2003/0059855 A1 (cited in the IDS filed 02/14/2022), the biosensors and associated detection instruments and construction details of the system of Figs. 2-3 of Cunningham (paragraphs [0013],[0017]).
Regarding claim 1, Cunningham teaches an analyzing system (Figs. 3-4; abstract) comprising:
a sample carrier (Fig. 3, biosensor apparatus 26) comprising a plurality of sample wells (Fig. 3, wells 20 of microtiter plate and sensor substrate, i.e. the wells containing liquid 22), each well having a transparent bottom (paragraphs [0022],[0060] and Fig. 3 teaches each well has a bottom substrate, i.e. sensor substrate 16, and the substrate is a transparent substrate), the bottom having an obverse face located within the well (Fig. 3, the side of sensor substrate 16 towards liquid 22) and a reverse face external to the well (Fig. 3, the side of sensor substrate 16 towards dual fiber probe 40), the obverse face having a nanostructured surface comprising a plurality of nanostructures (Figs. 3-4 shows a “sensor grating 12” on the side of sensor 16 towards liquid 22, wherein the sensor grating 12 has nanoscale dimensions as shown in Fig. 4A, i.e. nanostructured surface comprising a plurality of nanostructures);
a reader device (Fig. 3 and paragraph [0017], interpreted as comprising the X-Y addressable motion stage, an analyzing system comprising elements 30, 40, and a spectrometer) comprising a station (Fig. 3 and paragraph [0017], interpreted as comprising the X-Y addressable motion stage, an analyzing system comprising elements 30, 40, and a spectrometer; Fig. 3 shows a biosensor apparatus 26 is positioned above dual fiber probes, therefore it is inherent that the biosensor apparatus is placed on an element that holds and supports the biosensor apparatus; paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US 2003/0059855, Figs. 21-24 teaches a station including a microwell tray 458 for receiving a microtiter tray 456) for receiving the sample carrier (interpreted as an intended use of the station, see MPEP 2114; paragraph [0017] teaches the X-Y addressable motion stage for receiving a microplate+biosensor; paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US 2003/0059855, Figs. 21-24 teaches a station including a microwell tray 458 for receiving a microtiter plate 456), the station comprising a support structure having a support surface for receiving a base of said sample carrier (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Figs. 21-24 and paragraph [0221] teaches a bottom portion 602 of an incubator assembly, i.e. support structure, having a support surface structurally capable of receiving and mounting with the microtiter plate 456 with a base, i.e. base of the sample carrier), the station comprising a plurality of light guiding units (Fig. 3, plurality of dual fiber probe 40) arranged so that a respective light guiding unit is aligned with a respective well when the sample carrier is received by the station (interpreted as a functional limitation, see MPEP 2114; Fig. 3 shows a respective dual fiber probe 40 is aligned with a respective well 20 of the biosensor apparatus 26, i.e. sample carrier, when received by the station that holds biosensor apparatus 26),
wherein each light guiding unit (Fig. 3, plurality of dual fiber probe 40) comprises an optical port (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Fig. 24 and paragraph [0215] teaches apertures 764, which are interpreted as part of the light guiding units) for optically coupling the light guiding unit with the respective well when the sample carrier is received by the station (interpreted as an intended use of the optical port, see MPEP 2114; paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Fig. 24 and paragraph [0215] teaches apertures 764 are lined-up and match up with well locations on plate 456 when the plate 456, i.e. sample carrier, is received by the station, i.e. which includes the apertures 764; and wherein US2003/0059855, paragraphs [0215],[0224] teaches a collimator assembly 708, that includes dual fiber probes, and illuminating probes direct light through the apertures to the wells; therefore, the apertures 764 are capable of optically coupling the dual fiber probe from collimator assembly 708 with a respective well on plate 456), each optical port comprising a cavity formed in the support structure (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Fig. 24 and paragraph [0215] teaches apertures 764, i.e. optical ports, are formed in the bottom portion 602, i.e. support structure), each cavity having a mouth in said support surface (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Fig. 24 and paragraph [0215] teaches apertures 764, i.e. mouth, formed in the surface of the bottom portion 602, i.e. support surface of the support structure), each mouth being arranged for alignment with the bottom of the respective well when the base of the sample carrier is received by the support surface (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Fig. 24 and paragraph [0215] teaches apertures 764, i.e. mouth, are lined-up and match up with the bottom of respective wells on plate 456 when the plate 456, i.e. sample carrier, is received by the surface of the bottom portion 602, i.e. support surface of the support structure),
and wherein each light guiding unit (Fig. 3, plurality of dual fiber probe 40) is configured to direct a beam of excitation radiation to the bottom of the respective well through the respective cavity, and to direct a beam of reflected radiation from the bottom of the respective well through the respective cavity (interpreted as a functional limitation of the dual fiber probe 40; Fig. 3 shows each dual fiber probe 40 directing a beam of excitation radiation from the light source to the bottom of respective wells and directs beams of reflected radiation from the bottom of the respective wells to a spectrometer; paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Fig. 24 and paragraphs [0215],[0224] teaches a collimator assembly 708, that includes dual fiber probes, and illuminating probes direct light through the apertures, i.e. cavities, to the wells; therefore, the apertures 764, cavities, are structurally capable of directing excitation radiation to the bottom of the respective well through the cavity and direct reflected radiation from the bottom of the well through the cavity),
and
wherein each of the plurality of nanostructures comprise nano-pillars (Fig. 4A shows sensor grating 12 having pillar shaped nanostructures) having longitudinal axes that are substantially perpendicular to the obverse face (Fig. 4A interpreted as the Z axis, which is perpendicular to the side of the sensor towards liquid 22, i.e. top side).
Cunningham fails to teach: wherein each of the plurality of nanostructures comprise plasmonic metallic nano-pillars that support localized surface-plasmon resonance.
Pollard teaches an analyzing apparatus comprising a sample chamber (abstract) and analysis of chemical and biological material using a plasmonic sensor (page 1, lines 5-6). Pollard teaches analyzing apparatus using plasmonic sensors for chemical and biological materials are known, where it is desirable to provide an improved plasmonic sensor analyzing apparatus (page 1, lines 11-27). Pollard teaches the sensor (Fig. 1) comprises multiple regions R, which may be made to target different biological entities (page 6, lines 30-34). Pollard teaches plasmonic nanopillars of each region are created to have a resonant frequency that matches a respective mode of illumination, and the nanopillars resonate when illuminated by radiation at a resonant frequency (Fig. 1; page 7, lines 18-23), wherein the nanopillars are metallic (page 5, lines 10-13). Pollard teaches illuminating the sensor to allow excitation of plasmonic modes on the nanostructures (page 6, lines 1-14), and the illumination excites localized surface plasmon resonance along the nanostructures (page 11, lines 13-19). Pollard teaches with the configuration of the nanostructures, the electrical field enhancement is provided in the most sensitive part of the sensor where biological interactions occur (page 11, lines 21-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the nanostructures of Cunningham to incorporate the teachings of an improved plasmonic sensor for analysis of chemical and biological materials using plasmonic metallic nanopillars of Pollard to provide: wherein each of the plurality of nanostructures comprise plasmonic metallic nano-pillars that support localized surface-plasmon resonance. Doing so would have a reasonable expectation of successfully improving analysis and sensitivity of chemical and biological materials and biological interactions (Pollard, page 1, lines 11-27; page 11, lines 21-26).
Regarding claim 2, Cunningham further teaches wherein the sample carrier is removably locatable on the station (interpreted as a functional limitation of the sample carrier; paragraph [0017] teaches the microplate+biosensor sits about a X-Y addressable motion stage; therefore, the biosensor apparatus 26 shown in Fig. 3 would be structurally capable of being removably locatable on a stage in order for positioning of the biosensor apparatus on the stage; paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US 2003/0059855, paragraph [0221] teaches a microtiter plate may be placed or removed from a tray).
Regarding claim 3, Cunningham further teaches wherein said wells (Fig. 3, wells 20 of microtiter plate and sensor substrate) are arranged in an array (Fig. 3 shows an array of wells 20, and said light guiding units (Fig. 3, dual fiber probes 40) are arranged in an array corresponding to the array in which the wells are arranged (Fig. 3).
Regarding claim 4, Cunningham further teaches wherein said sample carrier (Fig. 3, biosensor apparatus 26) comprises a base (sensor substrate 16), the respective reverse face of the bottom of each sample well (Fig. 3, external face of the bottom of the wells 20 of microtiter plate) being located at said base (Fig. 3 shows external faces of the bottom of the wells 20 located at the side of sensor substrate 16, i.e. base, towards dual fiber probe 40) and substantially coplanar, with one another (Fig. 3 shows the external face of the bottom of the wells are substantially coplanar with one another).
Regarding claim 5, Cunningham further teaches where said sample carrier comprises a multi-well plate (Fig. 3, microtiter plate).
Regarding claim 8, Cunningham further teaches wherein said support surface (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Figs. 21-24 shows bottom portion 602, i.e. support structure, has a surface, i.e. support surface) is substantially flat (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Figs. 21-24 shows bottom portion 602 has a substantially flat surface) and is shaped and dimensioned to receive the base of said sample carrier (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Figs. 21-24 and paragraph [0221] teaches the surface of bottom portion 602, i.e. support surface, is shaped and dimensioned to be capable of receiving and mounting with the microtiter plate 456 with a base, i.e. base of the sample carrier, via microwell tray 458), wherein said optical ports are incorporated into said support surface, arranged in an array, and being exposed by the support surface for coupling with a respective well (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Fig. 24 and paragraph [0215] teaches apertures 764, i.e. optical ports, are incorporated in the bottom portion 602, i.e. support structure, arranged in an array, and exposed by the bottom portion 602 to optically couple with a respective well of plate 456).
Regarding claim 9, Cunningham further teaches wherein, the reverse face of the bottom of each sample well (Fig. 3, the external face of the bottom of the wells 20 of microtiter plate on the side of sensor substrate 16 towards dual fiber probe 40) covers the respective optical port when the sample carrier is received by the station (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, paragraph [0221] teaches the tray 458 is mounted to the bottom portion 602, and paragraph [0215] teach the wells of plate 456 are on top of and lined-up with the apertures 764, i.e. respective optical ports; therefore, the reverse face of the bottom of each well covers the respective optical port as claimed since the wells are aligned above the apertures).
Regarding claim 10, Cunningham further teaches wherein each optical port comprises the mouth (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Fig. 24 and paragraph [0215] teaches apertures 764), and wherein the reverse face of the bottom of each sample well (Fig. 3, the external face of the bottom of the wells 20 of microtiter plate on the side of sensor substrate 16 towards dual fiber probe 40) covers the mouth of the respective optical port when the sample carrier is received by the station (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, paragraph [0221] teaches the tray 458 is mounted to the bottom portion 602, and paragraph [0215] and Fig. 24 teach the wells of plate 456 are on top of and lined-up with the apertures 764, i.e. respective mouth of the optical ports; therefore, the reverse face of the bottom of each well covers the respective optical port as claimed since the wells are aligned above the apertures).
Regarding claim 11, Cunningham further teaches wherein the respective well engages with a mouth of the respective optical port when the sample carrier is received by the station (interpreted as a functional limitation of the respective well; paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Fig. 24 and paragraph [0215] teaches apertures 764 are lined-up and match up with well locations on plate 456 when the plate 456, i.e. sample carrier, is received by the station, i.e. which includes the apertures 764; therefore, the respective well engages, such as being optically coupled with, the respective optical port).
Regarding claim 13, Cunningham further teaches wherein each cavity is located below said support surface and opens onto said support surface (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Fig. 24 and paragraph [0215] teaches apertures 764, i.e. cavities, are incorporated in the bottom portion 602, i.e. support structure, and located below the upper support surface of bottom portion 602, and opens upwards onto the support surface of the bottom portion 602).
Regarding claim 14, Cunningham further teaches wherein each light guiding unit (Fig. 3, dual fiber probes 40) is connected to, or connectable to, an excitation source for generating said beam of excitation radiation (Fig. 3 shows each dual fiber probe connected to a white light source that generates a beam of excitation radiation), said light guiding unit comprising light guiding means comprising at least one optical fibre (Figs. 3-4 teach an illumination fiber 32), for directing said beam of excitation radiation to the bottom of the respective well (Figs. 3-4; paragraph [0017]).
Regarding claim 15, Cunningham further teaches wherein the light guiding units are arranged so that a respective optical port is aligned with a respective well when the sample carrier is received by the station (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Fig. 24 and paragraph [0215] teaches apertures 764, i.e. optical ports, are lined-up and match up with well locations on plate 456 when the plate 456, i.e. sample carrier, is received by the station, i.e. which includes the apertures 764).
Regarding claim 16, Cunningham further teaches wherein each light guiding unit (Fig. 3, dual fiber probes 40) is connected to, or connectable to, an optical detector (Figs. 3-4 teaches each dual fiber probe 40 connected to a spectrometer, i.e. optical detector), said light guiding unit comprising light guiding means comprising at least one optical fibre (Figs. 3-4 teach a detecting fiber) for directing said reflected beam to said detector (Figs. 3-4; paragraph [0017]).
Regarding claim 17, Cunningham further teaches wherein said light guiding means for directing said reflected beam to said detector (Figs. 3-4, dual fiber probes 40; paragraph [0017]) is arranged to direct said reflected beam light from the bottom of the respective well through said cavity to said detector (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, Figs. 19,24 and paragraphs [0215],[0221],[0224] teaches a collimator assembly 708, that includes dual fiber probes, that directs reflected light from respective wells on plate 456 through apertures 764 to a spectrometer).
Regarding claim 18, modified Cunningham further teaches the nanostructures are spaced apart from one another by a distance less than a wavelength of the excitation radiation to cause, in use, plasmonic oscillations in a direction that is normal to said obverse face (Cunningham, Fig. 4A teaches the nanostructures, i.e. raised portions of the grating, are spaced apart about 125 nm, which is less than a white light, i.e. about 400-700 nm; paragraph [0017] teaches detecting reflected resonance, i.e. plasmonic oscillation; additionally, since modified Cunningham’s plasmonic metallic nano-pillars are structurally identical to that is claimed, the claimed function are presumed to be inherent, MPEP 2112.01(I), therefore the nanostructures are capable of causing plasmonic oscillations in a direction that is normal to said obverse face).
Regarding claim 19, Cunningham further teaches the system of claim 1, further comprising:
an excitation source (Fig. 3, white light source 30) for generating the beam of excitation radiation for each light guiding unit (Fig. 3);
an optical detector (Fig. 3, spectrometer) for detecting the beam of reflected radiation from each light guiding unit (Fig. 3); and
a controller (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, paragraph [0218] teaches a controller board assembly provides functional controls for the measuring apparatus) for controlling operation of the excitation source (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, paragraph [0218] teaches a controller board assembly provides functional controls for the measuring apparatus and paragraph [0213]-[0214] teaches the measuring apparatus generates a beam of light to illuminate the wells, therefore, the controller board assembly is capable of controlling operation of the excitation source in order to generate the illumination beams), wherein the controller is configured to control the excitation source to cause a respective beam of excitation radiation to be directed to the bottom of the respective well by any one of the light guiding units individually, or by any two or more of the light guiding units simultaneously, or by all of the light guiding units simultaneously (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, paragraph [0218] teaches a controller board assembly provides functional controls for the measuring apparatus and Fig. 19 and paragraph [0213]-[0214] teaches the measuring apparatus generates a beam of light to illuminate the wells simultaneously), and
wherein the system includes analyzing means (paragraph [0017] teaches the reflected light are analyzed with a spectrometer, i.e. analyzing means; wherein, the spectrometer is interpreted as comprising at least a controller or processor in order to perform analysis), implemented by said controller (paragraph [0017] teaches construction of the system is set forth in US2003/0059855, wherein US2003/0059855, paragraph [0218] teaches a controller board assembly provides functional controls for the measuring apparatus; therefore, it is implied that the controller implements or controls the spectrometer for measuring or analysis), configured to analyze one or more output signal from said optical detector (paragraph [0017] teaches the reflected light are analyzed with a spectrometer, i.e. analyzing means, which is configured to analyze one or more output signals from the spectrometer), wherein said analyzing means is configured to analyze data from said at least one output signal in respect of any one of the wells individually, or in respect of any two or more of the wells in combination, or in respect of all of the wells individually or in combination (paragraph [0017] teaches the reflected light are analyzed with a spectrometer, i.e. analyzing means, which is configured to analyze one or more output signals from the spectrometer; Fig. 3 teaches light from each well is directed to the spectrometer, therefore it is implied that at least one output signal of any one of the wells is analyzed by a controller or processor of a spectrometer).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Cunningham in view of Pollard as applied to claim 1 above, and further in view of Gerion et al. (US 20170370836 A1; cited in the IDS filed 02/14/2022).
Regarding claim 23, while Cunningham teaches embodiments of specific binding substances may be detected with the biosensor, such as antigens and antibodies (paragraphs [0068],[0068]) and components can be attached or bound to the surface of the biosensor, wherein the sensor surface may bind to some component of the sample, such as for example streptavidin-biotin or 6His, (i.e. first member of a primary binding couple) and the biosensor may be used to detect the interaction of the bound component of the sample with an additional grouping of components in the sample, such as a polymerase complex (i.e. second member of a primary binding couple) (paragraph [0069]), Cunningham fails to teach: the system of claim 1, wherein at least a first region of the nanostructured surface is functionalised with a first member of a primary binding couple having an affinity for a second member of the primary binding couple which is functionalised upon at least some nanoentities; and/or wherein the at least some nanoentities are further functionalised with a first member of a secondary binding couple having an affinity for a second member of the secondary binding couple which comprises at least one analyte contained within a sample; and wherein the at least one analyte is functionalised with the second member of the secondary binding couple.
Gerion teaches sensor chips and devices that incorporate localized surface plasmon resonance sensors (abstract). Gerion teaches the sensor chip comprises a nanostructured top layer, which has a primary binding component immobilized thereon, such as antibodies (paragraph [0012]). Gerion teaches a first region of the nanostructured surface (Fig. 2; paragraph [0022]) is functionalised with a first member of a primary binding couple (immobilized captured antibody) having an affinity for a second member of the primary binding couple (analyte coupled to the antibody of the metallic nanoparticle) which is functionalised upon at least some of the nanoentities (Fig. 2 shows the analyte is coupled or functionalized upon a metallic nanoparticle, i.e. nanoentity). Gerion teaches strong coupling of a coupling immunoassay creates a local change in index of refraction at the surface that manifests itself as a local area with a distinct color change (paragraph [0024]). Gerion teaches a direct binding assay comprising primary binding components such as capture antibodies immobilized on a surface and antigens introduced with a sample to be tested, and secondary binding components such as detection antibodies; wherein when antigens present in the sample are captured by the immobilized captured antibodies, the labeled detection antibodies also become bound to the sensor surface and a change in an optical property of light reflected or transmitted by the surface occurs (paragraph [0051]). Gerion teaches the detection antibodies may be conjugated with beads (paragraph [0051]). Gerion teaches sensors may be multi-paneled or multiplexed, such that a different type of assay may be run in each reaction well (paragraph [0110]). Gerion teaches devices pre-functionalized with capture antibodies are configured to perform specific diagnostic tests (paragraph [0144]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a first region of the nanostructured surface of Cunningham to incorporate the teachings of primary and secondary components used as binding couples for an assay on a nanostructured sensor of Gerion (Figs. 1-2; paragraphs [0012],[0022],[0024],[0051]) and the teachings of components can be attached or bound to the surface of the biosensor to detect components in a sample via interaction between components, of Cunningham (paragraphs [0068]-[0069]) to provide: the system of claim 1, wherein at least a first region of the nanostructured surface is functionalised with a first member of a primary binding couple having an affinity for a second member of the primary binding couple which is functionalised upon at least some nanoentities. Doing so would have reasonable expectation of successfully improving selectivity and specificity for analyzing desired analytes in a sample as taught by Gerion (paragraph [0024],[0110],[0144]).
Note that the limitations of “and/or wherein the at least some nanoentities are further functionalised with a first member of a secondary binding couple having an affinity for a second member of the secondary binding couple which comprises at least one analyte contained within a sample; and wherein the at least one analyte is functionalised with the second member of the secondary binding couple” are interpreted as not required due to the “and/or” statement. Therefore the “second member of the secondary binding couple” is interpreted as not required.
Response to Arguments
Applicant’s arguments, see pages 8-9, filed 11/24/2025, with respect to the claim objections and rejections under 35 U.S.C. 112 have been fully considered and are persuasive. The claim objections and rejections under 35 U.S.C. 112 of 07/24/2025 have been withdrawn.
Applicant’s arguments, see pages 9-10, filed 11/24/2025, with respect to the rejection(s) of claims 1 and 18 under 35 U.S.C. 102, specifically regarding the amended claim 1, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Cunningham et al. (US 20080014632 A1; cited in the IDS filed 02/14/2022) in view of Pollard et al. (WO 2017060239 A1).
Applicant's arguments, see pages 10-11, filed 11/24/2025, with respect to the rejection of claim 23 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references since Cunningham does not disclose nanoentity functionalization and Gerion does not disclose a binding couple functionalized upon at least some nanoentities, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Cunningham provides teachings of suggestions of: specific binding substances may be detected with the biosensor, such as antigens and antibodies (paragraphs [0068],[0068]); components can be attached or bound to the surface of the biosensor, wherein the sensor surface may bind to some component of the sample, such as for example streptavidin-biotin or 6His, (i.e. first member of a primary binding couple) and the biosensor may be used to detect the interaction of the bound component of the sample with an additional grouping of components in the sample, such as a polymerase complex (i.e. second member of a primary binding couple) (paragraph [0069]). However, Cunningham fails to teach: wherein at least a first region of the nanostructured surface is functionalised with a first member of a primary binding couple having an affinity for a second member of the primary binding couple which is functionalised upon at least some nanoentities; and/or wherein the at least some nanoentities are further functionalised with a first member of a secondary binding couple having an affinity for a second member of the secondary binding couple which comprises at least one analyte contained within a sample; and wherein the at least one analyte is functionalised with the second member of the secondary binding couple.
Gerion provides teachings of: primary and secondary components used as binding couples for an assay on a nanostructured sensor of (Figs. 1-2; paragraphs [0012],[0022],[0024],[0051]). Specifically, Gerion teaches a first region of the nanostructured surface (Fig. 2; paragraph [0022]) is functionalised with a first member of a primary binding couple (immobilized captured antibody) having an affinity for a second member of the primary binding couple (analyte coupled to the antibody of the metallic nanoparticle) which is functionalised upon at least some of the nanoentities (Fig. 2 shows the analyte is coupled or functionalized upon a metallic nanoparticle, i.e. nanoentity). Fig. 2 shows multiple metallic nanoparticles 201, i.e. nanoentities, functionalized with an antibody, i.e. second member of a primary binding couple, and the antibodies on the nanostructure, i.e. first member of the primary binding couple, has an affinity with the antibodies of the metallic nanoparticles when analytes functionalize with the antibody of the nanoparticle. Therefore, Gerion at least teaches binding partners on nanostructures and on nanoentities.
It would have been obvious to one of ordinary skill in the art to have modified a first region of the nanostructured surface of Cunningham to incorporate the teachings of primary and secondary components used as binding couples for an assay on a nanostructured sensor of Gerion (Figs. 1-2; paragraphs [0012],[0022],[0024],[0051]) and the teachings of components can be attached or bound to the surface of the biosensor to detect components in a sample via interaction between components, of Cunningham (paragraphs [0068]-[0069]) to provide: the system of claim 1, wherein at least a first region of the nanostructured surface is functionalised with a first member of a primary binding couple having an affinity for a second member of the primary binding couple which is functionalised upon at least some nanoentities; and/or wherein the at least some nanoentities are further functionalised with a first member of a secondary binding couple having an affinity for a second member of the secondary binding couple which comprises at least one analyte contained within a sample; and wherein the at least one analyte is functionalised with the second member of the secondary binding couple. Doing so would have reasonable expectation of successfully improving selectivity and specificity for analyzing desired analytes in a sample as taught by Gerion (paragraph [0024],[0110],[0144]).
Therefore, there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have arrived at the claimed invention.
In response to applicant's argument that the references fail to show certain features of the invention and therefore the combination rests on impermissible hindsight (Remarks, pages 10-11), it is noted that the features upon which applicant relies (i.e., “the analyte in the sample must already carry a complementary binder”, Remarks, page 10, last paragraph; “chemically modifying an unknown analyte in a clinical specimen before introduction to the sensor”, Remarks, page 11, first paragraph; “pre-coat those surface nanoentities with both primary and secondary binders”, Remarks, page 11, 4th paragraph) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant’s argument that the proposed modification renders Gerion’s signal generation principle inoperable, teaches away from surface-bound dual functionalization and defeats Cunningham’s label free resonance read-out, the examiner disagrees.
First, Cunningham is modified with Gerion, Gerion is not the primary reference being modified. The test for obviousness is not whether the features of a secondary reference (Gerion) may be bodily incorporated into the structure of the primary reference (Cunningham); nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Applicant points to paragraph [0024] and Fig. 2, where Gerion teaches nanoparticles approaching a bare plasmonic surface. However, paragraph [0024] and Fig. 2 does not discuss a “nanoparticles approaching a bare plasmonic surface”. Paragraph [0024] provides motivation for coupling immunoassays: strong coupling of a coupling immunoassay creates a local change in index of refraction at the surface that manifests itself as a local area with a distinct color change.
Second, while Cunningham does discuss label-free detection methods (paragraph [0012],[0037]), Cunningham does not specifically teach away or exclude the presence of binding couples as claimed. Cunningham provides teachings of suggestions of: specific binding substances may be detected with the biosensor, such as antigens and antibodies (paragraphs [0068],[0068]); components can be attached or bound to the surface of the biosensor, wherein the sensor surface may bind to some component of the sample, such as for example streptavidin-biotin or 6His, (i.e. first member of a primary binding couple) and the biosensor may be used to detect the interaction of the bound component of the sample with an additional grouping of components in the sample, such as a polymerase complex (i.e. second member of a primary binding couple) (paragraph [0069]). It would have been obvious to one of ordinary skill in the art to have modified a first region of the nanostructured surface of Cunningham to incorporate the teachings of primary and secondary components used as binding couples for an assay on a nanostructured sensor of Gerion (Figs. 1-2; paragraphs [0012],[0022],[0024],[0051]) and the teachings of components can be attached or bound to the surface of the biosensor to detect components in a sample via interaction between components, of Cunningham (paragraphs [0068]-[0069]) to provide: the system of claim 1, wherein at least a first region of the nanostructured surface is functionalised with a first member of a primary binding couple having an affinity for a second member of the primary binding couple which is functionalised upon at least some nanoentities. Doing so would have reasonable expectation of successfully improving selectivity and specificity for analyzing desired analytes in a sample as taught by Gerion (paragraph [0024],[0110],[0144]).
Therefore, there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have arrived at the claimed invention.
It is suggested to further define the structures of the system, such as: the “first member of a primary binding couple”; remove the “and/or” statement and instead recite “and”; and further define the nanoentities, the first and second members of the secondary binding couple. Additionally, it is suggested to incorporate limitations of a tertiary binding couple as discussed in the specification, paragraphs [0094],[0096]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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