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 .
DETAILED ACTION
Status of Claims
Claims 1-4, 6-7, 9 and 11-23 are pending and have been examined.
Priority
This application, Serial No. 18/254368 (PGPub: US2024/0125707) was filed 05/24/2023. This application is a 371 of PCT/EP2021/083109 filed 11/26/2021. This application claims priority to foreign application EPO 20210192.9 filed 11/27/2020.
Information Disclosure Statements
The Information Disclosure Statements filed 05/24/2023 and 10/27/2025 have been considered by the Examiner.
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 1-4, 6-7, 9 and 11-23 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.
Claim 1 is indefinite because it recites that the first and second unit cells of the first and second affinity gratings, respectively, are “configured and arranged such that coherent light…constructively interferes at a predetermined detection location”, however it is unclear what structure of the first and second gratings relative to other components of the sensor allows the gratings to carry out this function.
Claim 17 is indefinite because it recites “the planar waveguide is structured so as to guide…” but the claim does not state what structure is present that allows the coherent light to be guided.
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.
Claim(s) 1-4, 6-7, 9 and 11-21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Fattinger (US 2015/0276612, IDS) in view of Fattinger (US 2015/0338579, hereinafter “Fattinger79”).
Regarding claims 1-2, Fattinger teaches throughout the publication a diffractometric sensor (abstract and for example, Figure 1), comprising: a substrate (3); two interdigitated affinity gratings (see Figures 1 and 12, straight lines 7) arranged on the substrate (paragraph 0039), a first affinity grating (predetermined lines 7) comprising first unit cells comprising affinity elements of a first type capable of binding with target molecules of a first type (paragraph 0008, binding sites comprising capture molecules), wherein the first unit cells of the first affinity grating are configured and arranged such that coherent light of a predetermined wavelength generated at a predetermined beam generation location and diffracted by target molecules of the first type bound to the affinity elements of the first type constructively interferes at a predetermined detection location with a first phase (see paragraph 0007).
While Fattinger teaches a second affinity grating comprising second unit cells and affinity elements (paragraph 0019, deactivated capture agents on single lines 7 without active capture), the reference fails to specifically teach that the second unit cells and affinity gratings comprising affinity elements of a second type capable of binding with target molecules of a second type.
Fattinger79 teaches throughout the publication methods of preparing a planar waveguide to be capable of binding target samples along a plurality of predetermined lines (paragraph 0006). More specifically, Fattinger79 teaches at Figure 18, a plurality of predetermined lines on a planar waveguide with different types of capture molecules on each of the plurality of predetermined lines (paragraphs 0108-0109). Additionally, Fattinger79 teaches that the coherent light of the predetermined wavelength generated at the predetermined beam generation location and diffracted by target molecules bound to the affinity elements constructively interferes at the predetermined detection location with a second phase inverse to the first phase (paragraphs 0012 and 0037).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the sensor of Fattinger, an additional affinity grating as predetermined lines on the substrate as taught by Fattinger79 because it would have been desirable to provide the sensor with capabilities to detect a variety of analytes from a single sample (Fattinger79, paragraph 0109). Additionally, one skilled in the art would have a reasonable expectation of success in making this combination since Fattinger79 teaches second gratings comprising deactivated capture molecules or different capture molecules are both possible and successful uses for the sensors (see paragraphs 0095-0108-0109).
While the references do not specifically teach that the first and second affinity gratings are balanced with respect to a scattering mass of the first and second affinity gratings to generate a bias signal at the predetermined detection location that corresponds to a difference (Δm) in the scattering mass of the first and second affinity gratings which is in the range of 0.001 pg/mm2 to 30000 pg/mm2 and more specifically, wherein the bias signal corresponding to the difference (Δm) in the scattering mass of the first and second affinity gratings is in the range of 0.1 pg/mm2 to 1000 pg/mm2, more particularly in the range of 0.1 pg/mm2 to 100 pg/mm2, and even more particularly in the range of 1 pg/mm2 to 10 pg/mm2, as in claim 2, such limitation is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114 (Il)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Fattinger in view of Fattinger79 teach a sensor comprising a plurality of affinity gratings on the substrate that are affected by light scattering (Fattinger, paragraph 0008; Fattinger79, paragraphs 0005, 0012 and 0032-0033) and thus would be seen as being capable of being balanced with respect to a scattering mass to generate a bias signal.
Regarding claim 3, Fattinger in view of Fattinger79 teach the sensor wherein the concentration or the spatial arrangement of the affinity elements of the first type in the first unit cells and the concentration or the spatial arrangement of the affinity elements of the second type in the second unit cells are different (Fattinger, paragraph 0008).
Regarding claim 4, Fattinger in view of Fattinger79 teaches the sensor wherein the affinity elements of the first type and the affinity elements of the second type are different (Fattinger79, paragraph 0109).
Regarding claim 6, Fattinger in view of Fattinger79 teach the sensor wherein the affinity elements of the first type are non-binding for the target molecules of the second type or the affinity elements of the second type are non-binding for the target molecules of the first type, or both (Fattinger79, paragraphs 0108-0109).
Regarding claims 7 and 9, Fattinger teaches the sensor wherein at least one of the two interdigitated affinity gratings further comprises binding sites capable of binding scattering elements, wherein the ate least one of the two interdigitated affinity gratings further comprises scattering elements, and wherein the scattering elements are bound to the binding sites, wherein the scattering elements are arranged either in the first unit cells or in the second unit cells or in both the first and second unit cells of the two interdigitated affinity gratings. (paragraph 0008, diffraction enhancers).
Regarding claim 11, Fattinger teaches the sensor wherein the scattering elements are tunable or cleavable to allow for adjustment of the scattering power or removal of the scattering elements (paragraph 0008, diffraction enhancers such as nanoparticle or colloidal particle that can be static or dynamic).
Regarding claim 12, Fattinger teaches the sensor wherein the two interdigitated affinity gratings are arranged on a surface of the substrate (See Figure 1, gratings 7 on substrate 3).
Regarding claim 13, Fattinger teaches the sensor further comprising an optical coupler configured and arranged to direct the coherent light coming from the predetermined beam generation location to the two interdigitated affinity gratings arranged on the surface of the substrate (paragraphs 0007-0008; paragraph 0040, optical coupler 41).
Regarding claim 14, Fattinger teaches the sensor further comprising an optical decoupler configured and arranged to direct the coherent light diffracted by the two interdigitated affinity gratings to the predetermined detection location (paragraph 0007; paragraph 0040, further optical coupler 8).
Regarding claim 15, Fattinger teaches the sensor further comprising a resonant waveguiding structure arranged on the surface of the substrate (Figure 1, waveguide 2 on substrate 3), the resonant structure being configured to allow for coupling of the coherent light of the predetermined wavelength generated at the predetermined beam generation location into the resonant waveguiding structure to generate an evanescent field propagating along an outermost surface of the resonant waveguiding structure opposite to a surface of the resonant waveguiding structure facing the substrate (paragraphs 0007-0008), and wherein the two interdigitated affinity gratings are arranged on the outermost surface of the resonant waveguiding structure (paragraph 0039).
Regarding claim 16, Fattinger teaches the sensor wherein the resonant waveguiding structure arranged on the surface of the substrate is a planar waveguide, and wherein the two interdigitated affinity gratings are arranged on a surface of the planar waveguide opposite to a surface of the planar waveguide facing the substrate (see Figure 1, paragraphs 0039-0040).
Regarding claim 17, Fattinger teaches the sensor wherein the planar waveguide is structured so as to guide the coherent light of the predetermined wavelength generated at the beam generation location and coupled into the planar waveguide in one or more predetermined directions along the surface of the planar waveguide opposite to the surface facing the substrate (paragraphs 0007-0008 and for example, paragraph 0046).
Regarding claim 18, Fattinger teaches the sensor further comprising an optical coupler arranged on the planar waveguide and configured to couple the beam of coherent light generated at the beam generation location into the planar waveguide to impinge on the two interdigitated affinity gratings (paragraphs 0007-0008; paragraph 0040, optical coupler 41).
Regarding claim 19, Fattinger teaches the sensor further comprising an optical decoupler arranged on the planar waveguide and configured to decouple the coherent light diffracted by the two interdigitated affinity gratings from the planar waveguide and direct it to the predetermined detection location (paragraph 0007; paragraph 0040, further optical coupler 8).
Regarding claim 20, Fattinger teaches the sensor further comprising a detector for detecting the coherent light diffracted by the two interdigitated affinity gratings, the detector being integrated in the planar waveguide (paragraph 0007 and for example, paragraph 0040, detector 9 arranged on planar waveguide).
Regarding claim 21, Fattinger teaches the sensor further comprising a light source for generating the beam of coherent light of the predetermined wavelength arranged relative to the waveguide (paragraph 0021). While Fattinger does not explicitly teach that the light source is integrated in the planar waveguide or in the substrate, it would be obvious to incorporate the light source in the waveguide or substrate as a matter of obvious engineering choice (see MPEP 2144).
Regarding claim 23, Fattinger in view of Fattinger79 teach the sensor wherein the affinity elements of the first type contained in the first unit cells of the first grating and the affinity elements of the second type contained in the second unit cells of the second grating are obtained using bioorthogonal coupling chemistries (Fattinger79, paragraph 0109).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Fattinger (US 2015/0276612, IDS) in view of Fattinger (US 2015/0338579, hereinafter “Fattinger79”), as applied to claims 1 and 15 above, and further in view of Fattinger (US 5,479,260, hereinafter “Fattinger60”).
Modified Fattinger teaches the sensor as described above wherein the resonant waveguiding structure is arranged on the surface of the substrate (Fattinger, Figure 1, waveguide 2 on substrate 3) and the two interdigitated affinity gratings are arranged on the waveguide (paragraphs 0007-0008 and 0039. However, Modified Fattinger does not teach that the waveguide structure arranged on the substrate comprises a metal layer and the gratings are arranged on a surface of the metal layer opposite to the surface of the metal layer facing the substrate.
Fattinger60 teaches throughout the publication optical processes for analyzing substances based on the measurement of the propagation properties of optical surface waves on sensor surfaces (abstract). More specifically, Fattinger60 teaches that the waveguide layer structure includes a thin metal layer on a substrate (see claim 3).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the planar waveguide in the sensor of Modified Fattinger to include a thin metal layer as taught by Fattinger60 because Fattinger is generic regarding the types of materials that can be used for the waveguide and one skilled in the art would have been motivated to choose the appropriate waveguide material based on the desired sensor configuration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677