DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is responsive to the amendment of 01/27/2026.
Response to Arguments
Objections to the Specification
The objections to the specification are overcome by amendment.
Objection to the Claims
The objection to claim 22 is overcome by amendment.
Rejections under 35 U.S.C. § 112(b)
The specification has been amended to no longer define numbers in the claims as “about” those numbers, so the corresponding rejections under 35 U.S.C. § 112(b) are withdrawn.
Claim 4 is not currently amended, so still requires that the maximum dimension of a square be along its side, which is still unclear, even with a narrower range of values for the maximum dimension/side length, so the corresponding rejection is maintained.
The rejection of claim 17 due to an antecedent basis issue is overcome by amendment.
Rejections under 35 U.S.C. § 102
Applicant’s first argument is that the 277 nm grating periodicity of Amsden fails to meet the limitation of 30 µm to 45 µm equal surface regions, however, this argument is not persuasive. There is nothing in the language of claim 1 that requires that the equal surface regions have a maximum dimension equal to the smallest periodicity of the grating in a direction transverse to the grooves. The equal surface regions could be smaller (e.g., a small region around the trough of one of the grooves is substantially equal to an equally sized region around a different trough) or larger (e.g., one 500 nm square is substantially equal to another 500 nm square displaced by 277 nm across the grooves, by any distance along the groves, or a combination of the two). As long as the grating as a whole is large enough to include a plurality of such equal surface regions of the claimed size, potentially either side-by-side (see dependent claim 5) or overlapping (see dependent claim 6), with each comprising a diffraction grating with grooves as claimed, then the limitations are met.
Applicant’s second argument is that the inference that Amsden fabricated a grating with a maximum dimension of at least 30 µm is improper, however, this argument is moot. While the Examiner still considers the last sentence of 91 to be evidence of a general scale of the gratings produced (half a square centimeter to a full square centimeter (50-100 million µm2)) and that the figures zoom in on sections small enough to show the micro- (or even nano-) scale texture of the gratings rather than trying to show the entire pattern, the present action does not rely on such an inference, and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the pattern as a whole large enough to host a plurality of surfaces of the claimed size (see MPEP 2144.04 IV A).
Applicant’s third argument is that Amsden does not teach the limitation regarding the depth of the grooves, however, this argument is moot. Amsden is not relied on to teach that limitation.
Applicant’s fourth argument is that the random lattices of Amsden do not match the grooves claimed, however, this argument is moot. Martins, not Amsden, is relied on to teach the random patterns in the present action. Martins does refer to those patterns as grooves.
Since independent claims are rejected based on prior art, the dependent claims are not automatically allowable.
Applicant also argues that claim 22 is not anticipated by Amsden, however, this argument is moot. Neither this action nor the previous action rejects claim 22 under 35 U.S.C. § 102, but also see the responses below to similar arguments about the obviousness-type rejections of claim 22.
Rejections under 35 U.S.C. § 103
Applicant’s first argument is that Amsden does not consider a diffraction image, however, this argument is not persuasive. Amsden does image the diffraction patterns produced by the gratings. For examples of such images, see FIGs. 6B, 9C, 10B, and 10C. The imaging setup is shown in FIG. 10A.
Applicant’s second argument is that Amsden fails to disclose hitting the diffractive sensor with a laser light beam having a wavelength in the visible spectrum so that the diffractive sensor generates an image visible to the naked eye, however, this argument is not persuasive. Paragraph 100 describes how a laser is used to illuminate the sensor with white light, which would be visible.
Applicant’s third argument is that Amsden fails to disclose the step of comparing the diffraction image generated by the diffractive sensor to a reference diffraction image, however, this argument is not persuasive. The comparisons shown in FIG. 11 fall within the broadest reasonable interpretation of the language of the claim limitation as currently written. Also see paragraph 67.
Applicant’s fourth argument is that Amsden fails to disclose the step of determining a presence of a target analyte from the comparison, however, this argument is not persuasive. The difference plotted in absorbance in FIG. 11 indicates the presence of oxygen. See paragraph 67 for other sensing and detection uses disclosed by Amsden.
As claim 22 is obvious, its dependent claims are not automatically allowable.
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.
Claim 4 is 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 4 requires that each of the plurality of surface regions have a square shape and that the maximum dimension of that square shape be a dimension of the side of the square shape. The maximum dimension of a square shape is from one corner to the opposite corner, not along any of the square’s sides. This limitation is interpreted as requiring the side length of the square shape also fall within the range listed for the maximum dimension in claim 1 (in other words, that the side length also must be between 30 µm and 45 µm.
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.
Claim(s) 1, 4-6, 8, 10-11, 14, 16-17, 20, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amsden (US Patent Publication 20120034291) in view of Martins (Non-Patent Literature “Deterministic quasi-random nanostructures for photon control”).
Regarding claim 1, Amsden teaches a diffractive sensor for sensing a target analyte (paragraph 70), comprising:
a diffractive layer (FIG. 3A, for example) comprising a plurality of surface regions, each of the surface regions having the same shape and dimensions to be defined as a plurality of equal surface regions (any surface necessarily comprises a number of surface regions of the same shape and dimensions. Note that no limitation in this claim requires that the surface regions be physically separated from each other or have different properties, nor that the dimensions of each surface region have a particular relationship with the scale of the features found in that region of the surface.);
wherein each of the plurality of equal surface regions comprises a diffractive grating (FIG. 3A shows part of a diffractive grating);
wherein each of the diffractive gratings are provided with grooves having a depth (FIG. 3A shows the grooves, with a depth as shown in FIG. 3B);
wherein each of the diffractive gratings of each of the plurality of equal surface regions have an equal conformation (FIG. 3 appears to be substantially periodic, so each patch of diffractive grating would be equal to many others. Specifically, if two patches fit in regions of the same size and shape, the displacement from one patch to the other in a transverse direction relative to the grooves is an integer multiple of the period of the grooves plus any amount of displacement in a longitudinal direction of the grooves, and both patches fit within the grating, then the two patches will be substantially equal in conformation.); and
a receptor layer, overlapping the diffractive layer, and configured to be selectively bonded to the target analyte (paragraph 71, hemoglobin used to measure oxygen. Also see FIG. 11).
While the last sentence of paragraph 91 (describing the area of the masks used in forming the diffraction sensors) suggests a centimetric size scale for the devices, Amsden does not outright state that the size of the diffractive gratings, so does not explicitly state that they are large enough that each of the plurality of equal surface regions have a maximum dimension that is between 30 µm and 45 µm;
that each of the diffractive gratings are provided with grooves having a depth between 100 nm and 180 nm; nor
that the grooves of the diffractive grating of each surface region form a pattern having a random trend.
In the same field of endeavor of manipulating light using diffractive elements with random patterns, Martins does teach a diffractive device wherein each of the plurality of equal surface regions have a maximum dimension that is between 30 µm and 45 µm (the pattern is shown in FIG. 2c, including several instances of a periodic random pattern, which has a period of 1800 nm = 1.8 µm (page 3, first full paragraph). A square region of the diffractive grating that has a side length of is 17 cycles * 1.8 µm/cycle = 30.6 µm would have a maximum dimension (from one corner to the diagonally opposite corner) of about 43.275 µm, which is between 30 µm and 45 µm. Additionally, such a square region would be of equal conformation to any square of the same size that is displaced from the first square by an integer multiple of 1.8 µm along each of the x and y axes while staying within the region of the device, which has a 1 mm2 area in which to fit many such squares (caption of FIG. 5));
wherein each of the diffractive gratings are provided with grooves having a depth between 100 nm and 180 nm (the caption of FIG. 5 describes the pattern shown in FIG. 2c as having grooves 110 nm deep, which is between 100 nm and 180 nm); and
wherein the grooves of the diffractive grating of each surface region form a pattern having a random trend (the patterns used are described as quasi-random in the caption of FIG. 2c and throughout. Quasi-random patterns fall within the broadest reasonable interpretation of a pattern having a random trend). By designing the gratings with the dimensions disclosed and particular kinds of random patterns, Martins is able to improve control of photons in a way that is easy to design and fabricate (section Discussion, sentence 2).
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 diffractive sensors of Amsden with the periodic random designs of Martins in order to have a simple solution for controlling incident photons without needing to use more complicated multi-level designs.
Regarding claim 4, Amsden, as modified by Martins, teaches or renders obvious the diffractive sensor according to claim 1 (as described above).
While regions of Amsden may be chosen as square shape (FIG. 3A shows such a square), Amsden is not relied on to teach that the maximum dimension is a dimension of a side of the square shape.
In the same field of endeavor of manipulating light using diffractive elements with random patterns, Martins does teach that the maximum dimension of surface regions is a dimension of a side of the square shape (the region described above is one of many square shaped surfaces in the diffractive grating of Martins, and has a side length of 30.6 µm and a maximum dimension of about 43.275 µm, both of which fall within the claimed range of between 30 µm and 45 µm). By building a diffractive grating in the manner disclosed, including the square-based translational symmetry, Martins is able to take advantage of easy design and fabrication of that kind of structure (section Discussion, sentence 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have designed the diffractive sensor of Amsden, as modified by Martins, with the square-based translational symmetry on the scale of Martins to simplify how it is made, with predictable results and a reasonable expectation of success.
Regarding claim 5, Amsden, as modified by Martins, teaches or renders obvious the diffractive sensor according to claim 1 (as described above).
Amsden is not relied on in the present action regarding the particular sizes or shapes of surface regions or whether each of the plurality of surface regions are positioned in a side by side configuration.
In the same field of endeavor of manipulating light using diffractive elements with random patterns, Martins does teach a diffractive device wherein each of the plurality of surface regions are positioned in a side by side configuration (FIG. 2c, when choosing a first square surface region with a side length of 30.6 µm, a second equal surface region displaced from the first one by 30.6 µm along either the x or y axis is be side by side with the first). Note that not having side by side surface regions would require the gratings have gaps of some sort between the surface regions, which would change the optical properties.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have designed the diffractive sensor of Amsden, as modified by Martins, with adjacent surface regions to avoid introducing gaps in the pattern, gaps which Martins does not disclose, to maintain the benefits enjoyed by Martins, such as improved photon control and easy design and fabrication (section Discussion).
Regarding claim 6, Amsden, as modified by Martins, teaches or renders obvious the diffractive sensor according to claim 1 (as described above).
Amsden is not relied on in the present action regarding the particular sizes or shapes of surface regions or whether each of the plurality of surface regions are configured to partially overlap one another, though a surface region shifted slightly in the longitudinal direction of the grooves relative to another surface region is equal to the first surface region and the two overlap.
Similarly, in the same field of endeavor of manipulating light using diffractive elements with random patterns, Martins does teach a diffractive device wherein each of the plurality of surface regions are configured to partially overlap one another ((FIG. 2c, when choosing a first square surface region with a side length of 30.6 µm, a second equal surface region displaced from the first one by 30.6 µm along either the x or y axis is be side by side with the first). By having a periodic pattern, regions comprising multiple periods overlap while each being equal to the others.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have designed the diffractive sensor of Amsden, as modified by Martins, with periodic patterns that naturally have overlapping surface regions to gain the benefits of improving photon control (section Discussion).
Regarding claim 8, Amsden, as modified by Martins, teaches or renders obvious the diffractive sensor according to claim 1 (as described above).
Amsden further teaches that the diffractive layer comprises:
a polymer film (paragraph 3, the silk fibroin-based biopolymer structures comprise a polymer film) and
is selected among the group consisting of: polycarbonate, polyethylene terephthalate, polyvinylchloride, polypropylene, an amorphous or crystalline material (paragraph 7, the silk fibroin-based biopolymer film is described as having a glass transition temperature, a property of amorphous materials), and a fiberglass material.
The films are described as having a thickness in the range of 2 nm to 1 mm depending on fabrication parameters (paragraph 44), a range that encompasses the claimed ranges of between 5 µm and 500 µm and between 10 µm and 500 µm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have chosen fabrication parameters that result in a thickness within the claimed ranges.
Regarding claim 10, Amsden, as modified by Martins, teaches or renders obvious the diffractive sensor according to claim 1 (as described above).
Amsden further teaches g a protective layer for protecting the diffractive gratings that overlaps and is in direct contact with the diffractive layer (paragraph 46), wherein the protective layer comprises one of the following:
a sulfur; or
an oxide selected among the group consisting of titanium oxide, zinc oxide, zirconium oxide, silicon oxide (paragraph 47 lists many suitable metals and their oxides, which include all oxides listed here. Note that while silicon is often not considered a metal, it is nonetheless listed by Amsden and so its oxide is as well); or
a metal, selected in the group consisting of gold, silver, nickel, zinc, aluminum, copper (paragraph 47 lists many suitable metals, which include all metals listed here).
Regarding claim 11, Amsden, as modified by Martins, teaches or renders obvious the diffractive sensor according to claim 10 (as described above).
Amsden further teaches that the protective layer comprises nanoparticles deposited on the diffractive grating; and wherein the nanoparticles have dimensions between 4 nm and 30 nm (paragraph 71, hemoglobin, which has a diameter of around 5 nm (see Erikson (Non-Patent Literature “Size and Shape of Protein Molecules at the Nanometer Level Determined by Sedimentation, Gel Filtration, and Electron Microscopy”), section 3, penultimate paragraph)).
Regarding claim 14, Amsden, as modified by Martins, teaches or renders obvious the diffractive sensor according to claim 1 (as described above).
Amsden further teaches that the target analyte is an antigen and the receptor layer comprises an antibody adapted to be bonded to the antigen (paragraph 67).
Regarding claim 16, Amsden, as modified by Martins, teaches or renders obvious the diffractive sensor according to claim 1 (as described above).
Amsden further teaches a support layer that is at least one of transparent and semi-transparent support layer, and wherein the diffractive layer overlaps said the support layer (FIG. 12, shows application of such a diffractive layer onto an optical fiber. Optical fibers are transparent.).
Regarding claim 17, Amsden teaches a system for detecting a target analyte (paragraph 70), comprising: a diffractive sensor that includes a diffractive layer (FIG. 3A, for example) comprising a plurality of surface regions, each of the surface regions having the same shape and dimensions to be defined as a plurality of equal surface regions (any surface necessarily comprises a number of surface regions of the same shape and dimensions. Note that no limitation in this claim requires that the surface regions be physically separated from each other or have different properties, nor that the dimensions of each surface region have a particular relationship with the scale of the features found in that region of the surface.), wherein each of the plurality of equal surface regions comprises a diffractive grating (FIG. 3A shows part of a diffractive grating), wherein each of the diffractive gratings are provided with grooves having a depth (FIG. 3A shows the grooves, with a depth as shown in FIG. 3B), and wherein the diffractive sensor further comprises a receptor layer, overlapping the diffractive layer, and configured to be selectively bonded to the target analyte (paragraph 71, hemoglobin used to measure oxygen. Also see FIG. 11);
a laser light beam source that produces a laser light beam (paragraph 100, pulsed laser) having a wavelength in the visible spectrum (paragraph 6); and arranged so that the diffractive sensor is hit by the laser light beam and generates a diffraction image (paragraph 100. Also see FIG. 10A); and
a screen placed at a distance from the diffractive sensor and arranged so that the diffractive image is projected on it (paragraph 100, sensor array of camera).
While the last sentence of paragraph 91 (describing the area of the masks used in forming the diffraction sensors) suggests a centimetric size scale for the devices, Amsden does not outright state that the size of the diffractive gratings, so does not explicitly state that they are large enough that each of the plurality of equal surface regions have a maximum dimension that is between 30 µm and 45 µm;
that each of the diffractive gratings are provided with grooves having a depth between 100 nm and 180 nm; nor
that the grooves of the diffractive grating of each surface region form a pattern having a random trend.
In the same field of endeavor of manipulating light using diffractive elements with random patterns, Martins does teach a diffractive device wherein each of the plurality of equal surface regions have a maximum dimension that is between 30 µm and 45 µm (the pattern is shown in FIG. 2c, including several instances of a periodic random pattern, which has a period of 1800 nm = 1.8 µm (page 3, first full paragraph). A square region of the diffractive grating that has a side length of is 17 cycles * 1.8 µm/cycle = 30.6 µm would have a maximum dimension (from one corner to the diagonally opposite corner) of about 43.275 µm, which is between 30 µm and 45 µm. Additionally, such a square region would be of equal conformation to any square of the same size that is displaced from the first square by an integer multiple of 1.8 µm along each of the x and y axes while staying within the region of the device, which has a 1 mm2 area in which to fit many such squares (caption of FIG. 5));
wherein each of the diffractive gratings are provided with grooves having a depth between 100 nm and 180 nm (the caption of FIG. 5 describes the pattern shown in FIG. 2c as having grooves 110 nm deep, which is between 100 nm and 180 nm); and
wherein the grooves of the diffractive grating of each surface region form a pattern having a random trend (the patterns used are described as quasi-random in the caption of FIG. 2c and throughout. Quasi-random patterns fall within the broadest reasonable interpretation of a pattern having a random trend). By designing the gratings with the dimensions disclosed and particular kinds of random patterns, Martins is able to improve control of photons in a way that is easy to design and fabricate (section Discussion, sentence 2).
Regarding claim 20, Amsden, as modified by Martins, teaches or renders obvious the diffractive sensor according to claim 17 (as described above).
Amsden further teaches a vision system to detect the diffraction image projected on the screen (paragraph 100, the image sensor in the camera that is part of the microscope detects the image); and a control unit operatively connected to the vision system and configured to compare the diffraction image projected on the screen to a reference diffraction image, and to determine a presence of the target analyte on the receptor layer if the diffraction image projected on the screen is different from the reference diffraction image (FIG. 11).
Regarding claim 22, Amsden teaches a method of detecting a target analyte in a sample (paragraph 70), comprising the steps of:
providing a diffractive sensor that includes a diffractive layer (FIG. 3A, for example) comprising a plurality of surface regions, each of the surface regions having the same shape and dimensions to be defined as a plurality of equal surface regions (any surface necessarily comprises a number of surface regions of the same shape and dimensions. Note that no limitation in this claim requires that the surface regions be physically separated from each other or have different properties, nor that the dimensions of each surface region have a particular relationship with the scale of the features found in that region of the surface.), wherein each of the plurality of equal surface regions comprises a diffractive grating (FIG. 3A shows part of a diffractive grating), wherein each of the diffractive gratings are provided with grooves having a depth (FIG. 3A shows the grooves, with a depth as shown in FIG. 3B), and wherein each of the diffractive gratings of each of the plurality of equal surface regions have an equal conformation (FIG. 3 appears to be substantially periodic, so each patch of diffractive grating would be equal to many others. Specifically, if two patches fit in regions of the same size and shape, the displacement from one patch to the other in a transverse direction relative to the grooves is an integer multiple of the period of the grooves plus any amount of displacement in a longitudinal direction of the grooves, and both patches fit within the grating, then the two patches will be substantially equal in conformation.), and wherein the diffractive sensor further comprises a receptor layer, overlapping the diffractive layer, and configured to be selectively bonded to the target analyte (paragraph 71, hemoglobin used to measure oxygen. Also see FIG. 11);
applying the sample to the receptor layer (FIG. 11, oxygen or nitrogen applied for varying times);
hitting the diffractive sensor with a laser light beam having a wavelength in the visible spectrum so that the diffractive sensor generates a diffraction image visible to a naked eye (paragraph 100, pulsed laser. Note that light beams having a wavelength in the visible spectrum are typically visible to a naked eye, especially from bright sources, such as lasers);
comparing the diffraction image generated by the diffractive sensor to a reference diffraction image (FIG. 11 shows the results of such a comparison, with and without oxygen);
determining a presence of the target analyte in the sample if the diffraction image generated by the diffractive sensor is different from the reference diffraction image (FIG. 11 the change in the spectrum of light indicates the presence of oxygen).
While the last sentence of paragraph 91 (describing the area of the masks used in forming the diffraction sensors) suggests a centimetric size scale for the devices, Amsden does not outright state that the size of the diffractive gratings, so does not explicitly state that they are large enough that each of the plurality of equal surface regions have a maximum dimension that is between 30 µm and 45 µm;
that each of the diffractive gratings are provided with grooves having a depth between 100 nm and 180 nm; nor
that the grooves of the diffractive grating of each surface region form a pattern having a random trend.
In the same field of endeavor of manipulating light using diffractive elements with random patterns, Martins does teach a diffractive device wherein each of the plurality of equal surface regions have a maximum dimension that is between 30 µm and 45 µm (the pattern is shown in FIG. 2c, including several instances of a periodic random pattern, which has a period of 1800 nm = 1.8 µm (page 3, first full paragraph). A square region of the diffractive grating that has a side length of is 17 cycles * 1.8 µm/cycle = 30.6 µm would have a maximum dimension (from one corner to the diagonally opposite corner) of about 43.275 µm, which is between 30 µm and 45 µm. Additionally, such a square region would be of equal conformation to any square of the same size that is displaced from the first square by an integer multiple of 1.8 µm along each of the x and y axes while staying within the region of the device, which has a 1 mm2 area in which to fit many such squares (caption of FIG. 5));
wherein each of the diffractive gratings are provided with grooves having a depth between 100 nm and 180 nm (the caption of FIG. 5 describes the pattern shown in FIG. 2c as having grooves 110 nm deep, which is between 100 nm and 180 nm); and
wherein the grooves of the diffractive grating of each surface region form a pattern having a random trend (the patterns used are described as quasi-random in the caption of FIG. 2c and throughout. Quasi-random patterns fall within the broadest reasonable interpretation of a pattern having a random trend). By designing the gratings with the dimensions disclosed and particular kinds of random patterns, Martins is able to improve control of photons in a way that is easy to design and fabricate (section Discussion, sentence 2).
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 diffractive sensing method of Amsden with the periodic random designs of Martins in order to have a simple solution for controlling incident photons without needing to use more complicated multi-level designs.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amsden (US Patent Publication 20120034291) in view of Martins (Non-Patent Literature “Deterministic quasi-random nanostructures for photon control”) and Trilling (Non-Patent Literature “Antibody orientation on biosensor surfaces: a minireview”).
Regarding claim 15, Amsden, as modified by Martins, teaches or renders obvious the diffractive sensor according to claim 15 (as described above).
While the components of antibodies are inherent, Amsden does not go into great detail as to how to affix the antibodies to the surface, so does not explicitly teach that the antibody comprises a fraction Fab' and half of the fraction Fc of the antibody in which the disulfide bond—S-S- is reduced to a reduced disulfide bond —SH adapted to be bonded to the protective layer.
In the same field of endeavor of biosensors comprising antibodies adsorbed to surfaces, Trilling does explicitly teach that the antibody comprises a fraction Fab' (FIG. 3, upper portion of each antibody pictured (see FIG. 1 for conventions used to label parts)) and half of the fraction Fc (FIG. 3, lower part of each antibody pictured) of the antibody in which the disulfide bond —S-S- is reduced to a reduced disulfide bond —SH adapted to be bonded to the protective layer (FIG. 3, step A, in which the disulfide bonds are reduced. Also see the last twenty lines or so of the page preceding FIG. 3.). Trilling teaches that by reducing certain bonds, partial antibodies can be immobilized onto gold in an oriented manner in order to increase analyte binding, which improves detection.
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 diffractive sensor of Amsden with the disulfide bond reduction taught by Trilling in order to improve oriented adsorption of antibodies onto gold in order to improve sensor detection.
Claim(s) 18-19 and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amsden (US Patent Publication 20120034291) in view of Martins (Non-Patent Literature “Deterministic quasi-random nanostructures for photon control”) and Nicoli (US Patent 4647544).
Regarding claim 18, Amsden, as modified by Martins, teaches or renders obvious the diffractive sensor according to claim 17 (as described above).
Amsden further teaches that the laser light beam source is arranged behind the diffractive sensor so that the laser light beam hits the sensor and the diffraction image is generated by the laser light beam crossing the diffractive sensor (FIG. 10A).
Amsden does not explicitly state that the laser light beam hits the sensor at 90°.
In the same field of endeavor of antibody-based diffraction gratings for biosensing, Nicoli does teach that the laser light beam hits the sensor at 90° (FIG. 2c, which shows the sensor also positioned to receive the diffracted light). By shining the laser on the desired location on the sample at normal incidence, Nicoli maximizes intensity of the signal in a smaller area, improving measurement quality.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed the diffractive sensor of Amsden by shining the laser at normal incidence in the manner of Nicoli in order to maximize signal to noise ratio.
Regarding claim 19, Amsden, as modified by Martins, teaches or renders obvious the diffractive sensor according to claim 17 (as described above).
Amsden does not explicitly teach that the laser light beam source is arranged in front of the sensor, so that the laser light beam diagonally hits the diffractive sensor, and the diffractive image is generated by reflection from the diffractive sensor.
In the same field of endeavor of antibody-based diffraction gratings for biosensing, Nicoli does teach that the laser light beam source is arranged in front of the sensor , so that the laser light beam diagonally hits the diffractive sensor , and the diffractive image is generated by reflection from the diffractive sensor (FIG. 1). By appropriately arranging elements in a reflective geometry, the diffraction can be detected even if the substrate beneath the sensor is not sufficiently transparent to allow transmissive measurements.
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 system for detecting a target analyte of Amsden with the reflective geometry of Nicoli by placing the nanoimprinted silk film on a solid substrate to support the film without requiring the substrate be transparent enough to perform measurements through.
Regarding claim 23, Amsden, as modified by Martins, teaches or renders obvious method according to claim 22 (as described above).
Amsden does not explicitly teach, after the step of applying the sample on the receptor layer and before the step of hitting the diffractive sensor with the laser light beam, a step of washing the diffractive sensor to remove polluting substances, molecules and agents different from the target analyte from the receptor layer.
In the same field of endeavor of antibody-based diffraction gratings for biosensing, Nicoli does teach, after the step of applying the sample on the receptor layer and before the step of hitting the diffractive sensor with the laser light beam, a step of washing the diffractive sensor to remove polluting substances, molecules and agents different from the target analyte from the receptor layer (COL. 2, line 65-COL. 3, line 9). By washing the sensor after applying a sample, but before taking measurements, Nicoli is able to determine the extent to which the reaction being monitored actually occurred.
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 biosensing method of Amsden with the detection method of Nicoli, including a wash step, in order to properly measure the extent to which the reaction occurred.
Regarding claim 24, Amsden, as modified by Martins, teaches or renders obvious method according to claim 22 (as described above).
Amsden does not explicitly teach that the receptor layer is configured to be selectively bonded to a plurality of target analytes, and wherein the method further comprises the steps of:
comparing the diffraction image produced by the diffractive sensor to a plurality of stored diffraction images, each of the stored diffraction images corresponding to one of a plurality of specific target analytes;
determining the presence of one of the plurality of specific target analytes if the diffraction image generated by the diffractive sensor coincides with one of the plurality of specific target analytes.
In the same field of endeavor of antibody-based diffraction gratings for biosensing, Nicoli does teach that the receptor layer is configured to be selectively bonded to a plurality of target analytes (COL. 23, lines 42-53), and wherein the method further comprises the steps of:
comparing the diffraction image produced by the diffractive sensor to a plurality of stored diffraction images, each of the stored diffraction images corresponding to one of a plurality of specific target analytes (COL. 23, lines 53-56);
determining the presence of one of the plurality of specific target analytes if the diffraction image generated by the diffractive sensor coincides with one of the plurality of specific target analytes (COL. 23, lines 56-60). By placing several gratings close together with specificity to several analytes, Nicoli can detect each of those analytes separately.
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 method of Amsden with the parallel detection technique of Nicoli in order to gain the benefit of detecting multiple analytes simultaneously with a single device.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL D SCHNASE whose telephone number is (703)756-1691. The examiner can normally be reached Monday - Friday 8:30 AM - 5:00 PM ET.
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/PAUL SCHNASE/Examiner, Art Unit 2877
/TARIFUR R CHOWDHURY/Supervisory Patent Examiner, Art Unit 2877