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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 1, it is suggested to recite “An” before “Optical interferometric sensor”.
In line 18, it is suggested to recite “at least one between” as “at least one of”.
In line 19, it is suggested to recite “the phase” as “a phase”.
Appropriate correction is required.
Claims 2-15 are objected to because of the following informalities: It is suggested to recite “Sensor according…” in line 1 as “The sensor according to…”. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: It suggested recite “the marker” in line 4 as “the at least one marker” for consistency of terminology. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: It suggested recite “the marker” in lines 2-3 as “the at least one marker” for consistency of terminology. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: It suggested to include a period at the end of the claim. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: In line 2, it is suggested to recite “at least one between” as “at least one of” Appropriate correction is required.. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: In line 2, it is suggested to recite “a antifouling” as “an antifouling”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, “in particular” is interpreted as required. Claims 2-15 are rejected by virtue of their dependency on claim 1.
Regarding claim 1, claim 1 recites the limitation "the Mach-Zender type" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claims 2-15 are rejected by virtue of their dependency on claim 1.
Regarding claim 1, claim 1 recites the limitation “the Mach-Zender type” in lines 1-2. The addition of the word "type" to an otherwise definite expression (e.g., Mach-Zender) extends the scope of the expression so as to render it indefinite. See MPEP 2173.05(b)(III)(E). Claims 2-15 are rejected by virtue of their dependency on claim 1.
Regarding claim 3, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, “preferably” is interpreted as required.
Regarding claim 3, claim 3 recites the limitation "said analyte" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 6, claim 6 recites “according to claim 6”. Since claim 6 is dependent upon itself, it is unclear which claim that claim 6 is dependent upon. For examination purposes, claim 6 is interpreted as dependent upon claim 5. It is suggested to recite “according to claim 6” as “according to claim 5”.
Regarding claim 6, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, “preferably” is interpreted as required.
Regarding claim 7, claim 7 recites the limitation "the second plasmonic guide" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 7, the term “thin” in line 2 is a relative term which renders the claim indefinite. The term “thin” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 7, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, “preferably” is interpreted as required.
Regarding claim 11, claim 11 recites the limitation "the recognition elements" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claims 12-15 are rejected by virtue of their dependency on claim 11.
Regarding claim 13, claim 13 recites the limitation “a first plurality of tridimensional structures…a second plurality of tridimensional structures”. It is unclear if the first and second plurality of tridimensional structures of claim 13 is the same or different from the plurality of tridimensional structures established in claim 11. It is suggested to recite “the plurality of tridimensional structures comprising a first…and a second plurality of tridimensional structures”. Claims 14-15 are rejected by virtue of their dependency on claim 13.
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, 3-5, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Koerkamp et al. (US 20110292398 A1) in view of Datesman et al. (US 20040081384 A1).
Regarding claim 1, Koerkamp teaches an optical interferometric sensor (Figs. 1-4 and abstract), in particular of the Mach-Zender type (Figs. 1-4 and [0036],[0043] teaches the interferometer is a Mach-Zehnder type), presenting a first optical path defining a sensing arm (Fig. 3, branch 3 that includes a sending window 7) and a second optical path defining a reference arm (Fig. 3, branch 4 that includes a reference window 8), said sensor comprising:
- an optical splitter upstream of the first and second optical path (Fig. 3 and [0040] teaches input an input channel waveguide 2 that splits up in two identical branches 3, 4; therefore, the branch of waveguide 2 which splits into branches 3,4 is interpreted as an optical splitter that is upstream of branches 3 and 4) configured to split an incoming optical signal equally into the sensing arm and the reference arm (Fig. 3 and [0040] teaches input an input channel waveguide 2 that splits up in two identical branches 3, 4; therefore, the split is configured to equality split incoming light into branches 3 and 4) and an optical combiner placed downstream of the first and second optical path (Fig. 3 and [0040] teaches branches 3,4 combines at the output waveguide 5; therefore, the area where branches 3,4 combines is interpreted as an optical combiner downstream of branches 3,4) and configured to recombine said optical signal (Fig. 3 and [0040] teaches branches 3,4 combines at the output waveguide 5);
- a first waveguide placed along the first optical path (Fig. 3 and [0040]-[0041] teaches sensing window 7 including a channel waveguide along branch 3) and comprising a substrate and a binding surface (Fig. 3 and [0041] teaches the sensing window includes a channel waveguide, i.e. substrate, with a surface, i.e. binding surface, including an interface layer that binds with analyte molecules of interest); said binding surface being functionalized to interact and bind at least one marker of a sample (Fig. 3 and [0041] teaches the surface of the channel waveguide is functionalized with an interface layer that binds specifically with analyte molecules of interest);
- a first optical element placed along the first optical path (Figs. 3-4 teach a thermos-optic modulator placed along branch 3);
- a second waveguide placed along the second optical path (Fig. 3 and [0040]-[0041] teaches reference window 8 including a channel waveguide along branch 4) and comprising a substrate identical to the substrate of the first waveguide (Fig. 3 and [0040]-[0041] teaches a top cladding is removed above windows 7,8 to expose the waveguides to the environment; [0041] teaches “To keep the interferometer 1 balanced, the reference window 8 is provided with an interface layer that shows no specific binding”; therefore, it is implied that the channel waveguide of reference window 8 is identical to the waveguide of sensing window 7);
- a second optical element placed along the second optical path (Figs. 3-4 teach a thermos-optic modulator placed along branch 4), and presenting the same optical response of the first optical element (interpreted as a functional limitation, see MPEP 2114; Fig. 3 and [0042] teach the thermo-optic modulator sections including polymer cladding material 9 and a metallic heaterstrip 10; therefore, since the thermos-optic modulators include the same polymer cladding material 9, the first and second optical elements would be capable of having the same optical responses); and
at least one between the first optical element (Figs. 3-4 teach a thermos-optic modulator placed along branch 3) and the second optical element (Figs. 3-4 teach a thermos-optic modulator placed along branch 4) comprises a phase shifter configured to tune the phase of the optical signal in either the sensing arm or the reference arm (Fig. 3 and [0042] teach the thermo-optic modulator sections, i.e. phase shifters, including polymer cladding material 9 and a metallic heaterstrip 10 disposed to change the polymer refractive index upon heating or cooling, and therefore will change the phase of light flowing through the channel to effect modulation of the light in the interferometer; therefore, the first and second optical elements are configured to tune the phase of optical signal in both sensing and reference arms).
While Koerkamp teaches sample material is flown over both sensing and reference windows ([0041]) and dipping the sensor into a small quantity of a substance (Fig. 4, [0043]) Koerkamp fails to explicitly teach: - a single microfluidic channel running through the first waveguide and the second waveguide.
Datesman teaches a multi-mode planar-waveguide sensor (title; abstract; Figs. 1-6) including a sensing arm and reference arm (Fig. 1). Datesman teaches a light intensity reference waveguide 120 as a means to measure and eliminate any remaining bulk index signal from the output signals ([0021]). Datesman teaches a reference included on-chip that will be passivated or "blocked" with a protein, such as bovine serum albumin, or other bio- or non-biopolymer which has no specific interactions with the analytes, which allows for correction of non-specific interaction and bulk refractive index changes ([0022]). Datesman teaches the sensor includes a single microfluidic channel (Figs. 5-6 and [0049] teach fluidic channel 504 and microchannel 604) running through first waveguide and second waveguide (Figs. 5-6) and fluid connections (610) for the microchannel (Fig. 6).
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 sensor of Koerkamp to incorporate Koerkamp’s teachings of flowing a sample over both sensing and reference windows ([0041]) and measuring a small quantity of a substance ([0043]) and Datesman’s teachings of a waveguide sensor including a single microfluidic channel running through waveguides of the sensor (Figs. 5-6; [0049]) to provide: - a single microfluidic channel running through the first waveguide and the second waveguide. Doing so would have a reasonable expectation of successfully improving controlled delivery of a sample to the first and second waveguides of the sensor.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. a single microfluidic channel running through the first waveguide and the second waveguide of a sensor) by known methods with no change in their respective functions (i.e. flowing a sample over waveguides of a sensor for analysis), and the combinations yielded nothing more than predictable results (i.e. adding a single microfluidic channel running through the first waveguide and the second waveguide would yield nothing more than the obvious and predictable result of enabling control of sample flow to desired regions of the sensor, such as the first and second waveguides representing the sensing and reference windows). See MPEP 2143(A).
Regarding claim 3, Koerkamp further teaches wherein the binding surface (Fig. 3 and [0041] teaches the sensing window includes a channel waveguide with a surface, i.e. binding surface) comprises at least one kind of recognition elements, configured to bind specifically and selectively to a respective marker of said analyte (Fig. 3 and [0041] teaches the surface of the channel waveguide is functionalized with an interface layer, i.e. at least one kind of biorecognition elements, that binds specifically with analyte molecules of interest).
Modified Koerkamp fails to teach the binding surface comprises preferably one kind of biorecognition elements.
Datesman teaches a multi-mode planar-waveguide sensor (title; abstract; Figs. 1-6) including a sensing arm and reference arm (Fig. 1) for detection of chemical and biological materials and, in particular, to a sensor involving a signal-transduction platform and novel materials capable of rapid detection, specific identification, and real-time reporting ([0001]). Datesman teaches a need for identifying biological analytes and a need for a new generation of chemical and biological sensors ([0003]-[0005]). Datesman teaches numerous couplers will be modified with various molecular receptors with sensitivity to different analytes ([0022]). Datesman teaches an example of a sensing antibody ([0051]); and other biorecognition elements ([0062] teaches biochemical ligands).
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 binding surface of modified Koerkamp to incorporate Datesman’s teachings of a waveguide sensor for detection of biological materials using biorecognition elements ([0001],[0022],[0051],[0062]) and a need for biological sensors ([0003]-[0005]) to provide: the binding surface comprises preferably one kind of biorecognition elements. Doing so would have a reasonable expectation of successfully improving specific analysis of desired biological analytes as taught by Datesman.
Regarding claim 4, Koerkamp further teaches wherein the second waveguide (Fig. 3 and [0040]-[0041] teaches reference window 8 including a channel waveguide along branch 4) is an unfunctionalized waveguide ([0041] teaches reference window 8 is provided with an interface layer that shows no specific binding, i.e. unfunctionalized waveguide).
Regarding claim 5, Koerkamp further teaches wherein the second waveguide (Fig. 3 and [0040]-[0041] teaches reference window 8 including a channel waveguide along branch 4) comprises a non-binding surface presenting the same optical response of the binding surface of the first waveguide and configured not to bind at least with the marker ([0041] teaches both branches 3,4 include channel waveguides and to keep the interferometer balanced, the reference window 8 is provided with an interface layer that shows no specific binding; therefore, the interface layer of reference window 8 that shows no specific binding is a non-binding surface presenting the same optical response of the binding surface of the first waveguide and configured not to bind at least with the marker).
Regarding claim 8, Koerkamp further teaches wherein the first optical element (Figs. 3-4 teach a thermos-optic modulator placed along branch 3) and the second optical element (Figs. 3-4 teach a thermos-optic modulator placed along branch 4) comprise a respective phase shifter configured to tune the optical signal in the sensing arm and in the reference arm respectively (Fig. 3 and [0042] teach the thermo-optic modulator sections including polymer cladding material 9 and a metallic heaterstrip 10 disposed to change the polymer refractive index upon heating or cooling, and therefore will change the phase of light flowing through the channel to effect modulation of the light in the interferometer; therefore, the first and second optical elements include respective phase shifters configured to tune the phase of optical signal in both sensing and reference arms).
Regarding claim 9, Koerkamp further teaches wherein the first optical element and/or the second optical element comprise a thermo-electric phase shifter ([0027] teaches thermos-electric cooling/heating elements, i.e. thermo-electric phase shifters, near polymer sections; Fig. 3 and [0042] teach the thermo-optic modulator sections, i.e. thermos-electric phase shifter, including polymer cladding material 9 and a metallic heaterstrip 10 disposed to change the polymer refractive index upon heating or cooling, and therefore will change the phase of light flowing through the channel to effect modulation of the light in the interferometer).
Regarding claim 10, Koerkamp further teaches the sensor according to claim 1, comprising:
- an optical source upstream of the optical splitter and configured to generate the optical signal (Fig. 3 teaches light inputted upstream of the input channel waveguide 2 that splits up in two identical branches 3, 4; therefore an optical source is implied to be present upstream of the optical spitter to generate the light);
- an optical sensor downstream of the optical combiner configured to receive a recombined optical signal (Fig. 2 and [0042] teaches outputted light intensity from recombined optical signal from branches 3,4 are transformed into a sensor response signal; therefore, an optical sensor is implied to be present downstream of the combining of branches 3,4 at output waveguide 5 to receive the recombined optical signal for analysis).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Koerkamp in view of Datesman as applied to claim 1 above, and further in view of Pleros et al. (US 20200003696 A1).
Regarding claim 2, Koerkamp further teaches wherein each substrate comprises a couple of layers presenting a first refractive index and a silicon nitride strip sandwiched between the layers and presenting a second refractive index, said second refractive index being higher than the first refractive index ([0040] teaches a high refractive index core layer, i.e. strip with second refractive index, sandwiched between low refractive index buffer layers, i.e. couple of layers with first refractive index; [0029] teaches the core layer is made of a material including Si3N4).
Koerkamp fails to explicitly teach: the couple of layers is a couple of oxide layers.
Pleros teaches a Mach-Zehnder interferometric sensor (abstract; Fig. 1) including a splitter (102) that splits into a sensing arm (upper branch 103) and reference arm (lower branch) and a combiner (109), wherein the sensing arm including a plasmonic waveguide (107), and the reference arm including thermos-optic phase shifters (104,106). Pleros teaches the plasmonic waveguide comprises a high index silicon nitride strip sandwiched between low index oxide substrates ([0018]-[0019],[0065]). Pleros teaches the plasmonic waveguide allows for an analyte to be measured ([0089]).
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 couple of layers of Koerkamp to incorporate Pleros’ teachings of sensors including a plasmonic waveguide comprising a high index silicon nitride strip sandwiched between low index oxide substrates ([0018]-[0019],[0065]) to provide: the couple of layers is a couple of oxide layers. Doing so would have a reasonable expectation of successfully allowing for measurement of an analyte as taught by Pleros.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. a silicon nitride strip sandwiched between a couple of oxide layers) by known methods with no change in their respective functions (i.e. interferometric sensing of an analyte), and the combinations yielded nothing more than predictable results (i.e. providing the couple of layers is a couple of oxide layers would yield nothing more than the obvious and predictable result of enabling measurement of an analyte with the waveguide). See MPEP 2143(A).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Koerkamp in view of Datesman as applied to claim 5 above, and further in view of Chatzipetrou et al. (Chatzipetrou et al., “A Miniature Bio-Photonics Companion Diagnostics Platform for Reliable Cancer Treatment Monitoring in Blood Fluids”, Sensors 2021, 21(6), 2230).
Regarding claim 6, while Koerkamp teaches to keep the interferometer balanced, the reference window is provided with an interface layer that shows no specific binding ([0041]), modified Koerkamp fails to teach: wherein said non-binding surface comprises at least one kind of recognition elements selected so as not to bind with the marker, preferably said recognition elements comprising polyclonal mouse IgG antibodies .
Chatzipetrou teaches a photonic biosensor for diagnostics, the biosensor including a Mach Zender interferometer waveguides and measuring phase shift caused by binding of analyte on functionalized surface (abstract). Chatzipetrou teaches each sensor is composed of a signal arm and reference arm with a sensing window and reference window respectively; wherein this balanced design allows for detection and direct comparison for bulk and background effects for multiple analyte simultaneously (page 4, paragraph starting with “Briefly…”). Chatzipetrou teaches a polyclonal mouse IgG antibody used as a negative control (section 2.2, first paragraph; section 3, first paragraph). Chatzipetrou teaches the differential signals were obtained by correcting the signal of each of the monoclonal antibody-modified sensors with its nearest reference mouse IgG-modified sensor (section 3, first paragraph). Chatzipetrou teaches the reference arm includes a polyclonal mIgG (page 9, second paragraph). Chatzipetrou teaches both arms are exposed to the same sample simultaneously and the reference arm acts as a correction for bulk and background effects to the recorded wavelength shift, as the absolute signal of each aMZI contains the information from both arms; thus, it takes into account all the background effects and discards the biochemical noise (page 9, second paragraph).
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 non-binding surface of modified Koerkamp to incorporate Chatzipetrou’s teachings of a photonic biosensor including a reference arm including a polyclonal mouse IgG antibody as a negative control to provide: wherein said non-binding surface comprises at least one kind of recognition elements selected so as not to bind with the marker, preferably said recognition elements comprising polyclonal mouse IgG antibodies. Doing so would have a reasonable expectation of successfully allowing for correction for bulk and background effects to the recorded wavelength shift and therefore improving sensitive measurement of a target marker as taught by Chatzipetrou (section 3, first paragraph; page 9, second paragraph).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Koerkamp in view of Datesman as applied to claim 1 above, and further in view of Baer et al. (US 5387833 A).
Regarding claim 7, modified Koerkamp fails to teach: wherein the first waveguide and/or the second plasmonic guide comprise a thin film coating applied to the substrate and configured to protect the substrate from oxidation, preferably said thin film coating comprising silicon nitride or an oxide.
Baer teaches an interferometric sensor (abstract; Fig. 1) including a waveguide (Fig. 1). Baer the sensor includes the waveguide includes a thin film coating applied to the substrate (Fig. 1 and column 3, line 66-column 4, line 5, “attachment layer 16”) and configured to protect the substrate from oxidation (column 3, line 66-column 4, line 5 teaches the attachment layer protects the metallic transducers and fingers from attack by chemicals), preferably said thin film coating comprising an oxide (column 3, line 66-column 4, line 5 teaches the attachment layer is silicon dioxide). Baer teaches an antibody binding layer (Fig. 1, layer 18) deposited on the attachment layer (16). Baer teaches said thin film coating binds strongly and protects the metallic transducers and fingers from attack by chemicals (column 3, line 66-column 4, line 5).
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 first waveguide and/or the second plasmonic guide of modified Koerkamp to incorporate Baer’s teachings of a waveguide sensor including a silicon dioxide layer to protect the waveguide (Fig. 1; column 3, line 66-column 4, line 5) to provide: wherein the first waveguide and/or the second plasmonic guide comprise a thin film coating applied to the substrate and configured to protect the substrate from oxidation, preferably said thin film coating comprising silicon nitride or an oxide. Doing so would have a reasonable expectation of successfully improving protection of the waveguides of the sensor from chemicals during analysis as taught by Baer.
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Koerkamp in view of Datesman as applied to claim 1 above, and further in view of Ratner et al. (US 20140315760 A1).
Regarding claim 11, while Koerkamp teaches an interface layer that binds specifically with analyte molecules of interest is provided on the surface of the sensing window (Figs. 2-3; [0041]), modified Koerkamp fails to explicitly teach: wherein the binding surface comprises a plurality of tridimensional structures apt to carry the recognition elements.
Ratner teaches photonic devices for detecting an analyte in a biological solution (abstract), including waveguide that can be a Mach-Zehnder interferometer (claim 17). Ratner teaches the device includes a binding surface (Fig. 9, substrate) comprises a plurality of tridimensional structures (Fig. 9 and [0060] teaches a first and second layers of tridimensional structures for high loading and for nonfouling) apt to carry the recognition elements (Fig. 9 and [0060] teaches the layers include a capture layer comprising at least one binding moiety, i.e. recognition elements). Ratner teaches zwitterionic films can be configured to provide antifouling properties and can be engineered to be both thin (so as to allow for evanescent detection beyond the film) and to have appropriate binding moieties on a distal surface so as to capture target moieties ([0057]). Ratner teaches coatings can be used to improve compatibility of the device with the sample, such as antifouling coatings to decrease or eliminate non-specific binding ([0055]). Ratner teaches a three-dimensional (3D) hydrogel binding matrix was previously developed, enabling very high protein loading due to an open polymer structure; and integrating 2D and 3D structures to achieve ultra low nonspecific binding and high loading of molecular recognition elements ([0131]). Ratner teaches a hierarchical architecture was demonstrated with two distinct surface-initiated techniques (Fig. 9; [0132]), which were particularly promising for the preparation of polymer brushes as they permit precise control over chemical composition, film thickness, and architecture ([0132]); and have achieved excellent resistance to nonspecific protein adsorption in the presence of complex media ([0134]). Ratner teaches through combining the benefits of 2D and 3D polymer structures, a unique binding platform with ultra low fouling and high loading was established to serve as a new model for advancing surface chemistry needs ([0141]).
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 binding surface of modified Koerkamp to incorporate Ratner’s teachings of photonic devices for detecting an analyte including 2D and 3D polymer structures as a unique binding platform with ultra low fouling and high loading (Fig. 9; [0055],[0057],[0060],[0131]-[0132],[0134],[0141]) to provide: wherein the binding surface comprises a plurality of tridimensional structures apt to carry the recognition elements. Doing so would have a reasonable expectation of successfully improving high loading of the recognition elements and improving compatibility of the device with a sample as taught by Ratner ([0131],[0132],[0141]).
Regarding claim 12, modified Koerkamp fails to teach the sensor according to claim 11, wherein the tridimensional structures comprise at least one between: a plurality of filament, tree-like structures, brush-like structures or mesh-like structures.
Ratner teaches photonic devices for detecting an analyte in a biological solution (abstract), including waveguide that can be a Mach-Zehnder interferometer (claim 17). Ratner teaches the device includes a binding surface (Fig. 9, substrate) comprises a plurality of tridimensional structures (Fig. 9 and [0060] teaches a first and second layers of tridimensional structures for high loading and for nonfouling) apt to carry the recognition elements (Fig. 9 and [0060] teaches the layers include a capture layer comprising at least one binding moiety, i.e. recognition elements); wherein the tridimensional structures comprise a plurality of filament, tree-like structures, brush-like structures or mesh-like structures (Fig. 9 shows filament, tree-like structures, brush-like structures, or mesh-like structures on the substrate; [0141] “polymer brushes”). Ratner teaches zwitterionic films can be configured to provide antifouling properties and can be engineered to be both thin (so as to allow for evanescent detection beyond the film) and to have appropriate binding moieties on a distal surface so as to capture target moieties ([0057]). Ratner teaches coatings can be used to improve compatibility of the device with the sample, such as antifouling coatings to decrease or eliminate non-specific binding ([0055]). Ratner teaches a three-dimensional (3D) hydrogel binding matrix was previously developed, enabling very high protein loading due to an open polymer structure; and integrating 2D and 3D structures to achieve ultra low nonspecific binding and high loading of molecular recognition elements ([0131]). Ratner teaches a hierarchical architecture was demonstrated with two distinct surface-initiated techniques (Fig. 9; [0132]), which were particularly promising for the preparation of polymer brushes as they permit precise control over chemical composition, film thickness, and architecture ([0132]); and have achieved excellent resistance to nonspecific protein adsorption in the presence of complex media ([0134]). Ratner teaches through combining the benefits of 2D and 3D polymer structures, a unique binding platform with ultra low fouling and high loading was established to serve as a new model for advancing surface chemistry needs ([0141]).
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 binding surface of modified Koerkamp to incorporate Ratner’s teachings of photonic devices for detecting an analyte including 2D and 3D polymer brush structures as a unique binding platform with ultra low fouling and high loading (Fig. 9; [0055],[0057],[0060],[0131]-[0132],[0134],[0141]) to provide: the sensor according to claim 11, wherein the tridimensional structures comprise at least one between: a plurality of filament, tree-like structures, brush-like structures or mesh-like structures. Doing so would have a reasonable expectation of successfully improving high loading of the recognition elements and improving compatibility of the device with a sample as taught by Ratner ([0131],[0132],[0141]).
Regarding claim 13, modified Koerkamp fails to teach: wherein the binding surface comprises a first plurality of tridimensional structures presenting a first height and a second plurality of tridimensional structures presenting a second height higher than the first height, said recognition elements being coupled to the second plurality of tridimensional structures at a height higher than the first height.
Ratner teaches photonic devices for detecting an analyte in a biological solution (abstract), including waveguide that can be a Mach-Zehnder interferometer (claim 17). Ratner teaches the device includes a binding surface (Fig. 9, substrate) comprises a plurality of tridimensional structures (Fig. 9 and [0060] teaches a first and second layers of tridimensional structures for high loading and for nonfouling) apt to carry the recognition elements (Fig. 9 and [0060] teaches the layers include a capture layer comprising at least one binding moiety, i.e. recognition elements); wherein the binding surface comprises a first plurality of tridimensional structures presenting a first height (Fig. 9, tridimensional structures of the first nonfouling layer) and a second plurality of tridimensional structures presenting a second height higher than the first height (Fig. 9, tridimensional structures of the second high loading layer), said recognition elements being coupled to the second plurality of tridimensional structures at a height higher than the first height (Fig. 9 shows bio-recognition elements coupled to the second tridimensional structures of the second high loading layer). Ratner teaches zwitterionic films can be configured to provide antifouling properties and can be engineered to be both thin (so as to allow for evanescent detection beyond the film) and to have appropriate binding moieties on a distal surface so as to capture target moieties ([0057]). Ratner teaches coatings can be used to improve compatibility of the device with the sample, such as antifouling coatings to decrease or eliminate non-specific binding ([0055]). Ratner teaches a three-dimensional (3D) hydrogel binding matrix was previously developed, enabling very high protein loading due to an open polymer structure; and integrating 2D and 3D structures to achieve ultra low nonspecific binding and high loading of molecular recognition elements ([0131]). Ratner teaches a hierarchical architecture was demonstrated with two distinct surface-initiated techniques (Fig. 9; [0132]), which were particularly promising for the preparation of polymer brushes as they permit precise control over chemical composition, film thickness, and architecture ([0132]); and have achieved excellent resistance to nonspecific protein adsorption in the presence of complex media ([0134]). Ratner teaches through combining the benefits of 2D and 3D polymer structures, a unique binding platform with ultra low fouling and high loading was established to serve as a new model for advancing surface chemistry needs ([0141]).
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 binding surface of modified Koerkamp to incorporate Ratner’s teachings of photonic devices for detecting an analyte including 2D and 3D polymer brush structures as a unique binding platform with ultra low fouling and high loading (Fig. 9; [0055],[0057],[0060],[0131]-[0132],[0134],[0141]) to provide: wherein the binding surface comprises a first plurality of tridimensional structures (i.e. nonfouling layer or surface) presenting a first height and a second plurality of tridimensional structures presenting a second height higher than the first height, said recognition elements being coupled to the second plurality of tridimensional structures at a height higher than the first height. Doing so would have a reasonable expectation of successfully improving high loading of the recognition elements, improving compatibility of the device with a sample, allowing for precise control over chemical composition, film thickness, and architecture, and improving resistance to nonspecific protein adsorption and binding as taught by Ratner ([0055],[0131],[0132],[0141]).
Regarding claim 14, modified Koerkamp further teaches sensor according to claim 13, wherein the first plurality of tridimensional structures defines a antifouling surface (see above claim 13; Modified Koerkamp in view of Ratner teaches a first plurality of tridimensional structures including the nonfouling layer or surface of Ratner; Ratner, Fig. 9 shows the first tridimensional structures are a nonfouling, i.e. antifouling, surface).
Regarding claim 15, modified Koerkamp fails to teach the sensor according to claim 13,wherein a surface density of the first plurality of tridimensional structures is higher than a corresponding surface density of the second plurality of tridimensional structures.
Ratner teaches a surface density of the first plurality of tridimensional structures is higher (Fig. 9, “high density for nonfouling”) than a corresponding surface density of the second plurality of tridimensional structures (Fig. 9, “low density for high loading”). Ratner teaches coatings can be used to improve compatibility of the device with the sample, such as antifouling coatings to decrease or eliminate non-specific binding ([0055]). Ratner teaches a three-dimensional (3D) hydrogel binding matrix was previously developed, enabling very high protein loading due to an open polymer structure; and integrating 2D and 3D structures to achieve ultra low nonspecific binding and high loading of molecular recognition elements ([0131]). Ratner teaches a hierarchical architecture was demonstrated with two distinct surface-initiated techniques (Fig. 9; [0132]), which were particularly promising for the preparation of polymer brushes as they permit precise control over chemical composition, film thickness, and architecture ([0132]); and have achieved excellent resistance to nonspecific protein adsorption in the presence of complex media ([0134]). Ratner teaches through combining the benefits of 2D and 3D polymer structures, a unique binding platform with ultra low fouling and high loading was established to serve as a new model for advancing surface chemistry needs ([0141]).
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 binding surface of modified Koerkamp to incorporate Ratner’s teachings of densities of layers of ultra low fouling and high loading (Fig. 9; [0055],[0057],[0060],[0131]-[0132],[0134],[0141]) to provide: the sensor according to claim 13,wherein a surface density of the first plurality of tridimensional structures is higher than a corresponding surface density of the second plurality of tridimensional structures. Doing so would have a reasonable expectation of successfully improving high loading of the recognition elements, improving compatibility of the device with a sample, allowing for precise control over chemical composition, film thickness, and architecture, and improving resistance to nonspecific protein adsorption and binding as taught by Ratner ([0055],[0131],[0132],[0141]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lechuga et al. (LECHUGA L M et al: "Feasibility of evanescent wave interferometer immunosensors for pesticide detection: chemical aspects", SENSORS AND ACTUATORS B: CHEMICAL, ELSEVIER BV, NL, vol. 25, no. 1-3, April 1995 (1995-04), pages 762-765, XP026903938, ISSN: 0925-4005, DOI: 10.1016/0925-4005 (95) 85169-0 [retrieved on 1995-04-01] the whole document - figures 1, 2; cited in the IDS filed 07/11/2024) teaches a waveguide Mach-Zehnder interferometer immunosensor (abstract). Lechuga teaches the immunosensor (Fig. 1) includes an optical splitter (BS1), sensing arm (s), and reference arm (r). Lechuga teaches the sensor device includes a flow cell including a microfluidic channel (Fig. 2; section 2.3) that allows for high mass-transport rate of analyte molecules to the surface to decrease net measuring time (section 2.3).
Heideman et al. (Heideman et al., “Remote opto-chemical sensing with extreme sensitivity: design, fabrication and performance of a pigtailed integrated optical phase-modulated Mach–Zehnder interferometer system”, Sensors and Actuators B 61, 1999. 100–127) teaches a Mach-Zender type optical interferometer sensing system (Fig. 4) including a sensing arm (Fig. 4, top optical path 4) and a reference arm (Fig. 4, bottom optical path 4), the system comprising: an optical splitter (2), optical combiner (7), first waveguide (6a), first optical element (5a), second waveguide (6b), second optical element (5b), and the first and second optical elements comprise a phase shifter (Fig. 4, phase-modulators 5a,5b).
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
