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 .
Claim Objections
Claim 75 is objected to because of the following informalities: "wherein the image sensor is configured to operating as part of a dark-field microscope". “Operating” should be changed to “operate” to remain consistent with the claim language. 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 44 and 66-84 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 44, lines 7-12 it recites “[…] instructions being executable by the microprocessor to perform a method, the method comprising: analyzing an image of a plurality of signals emitted by at least one type of optical reporter molecules incubated with at least one type of analyte molecules, and digitally classifying the plurality of signals as active or null […]”. It is unclear if the microprocessor is required to be capable of performing the methods, or if it is actively programmed to perform those steps. This makes independent claim 44 indefinite for not being clear on how the microprocessor is performing the given method, i.e. whether the microprocessor is actively programmed to perform these steps or just must be capable of performing them.
Claims 66-84 are additionally rejected by the 35 USC § 112 rejection for being dependent on claim 44.
Claims 82-84 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 82 recites the limitation "wherein the [...] screen capable of displaying an image [...]" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
The limitations “the […] screen capable of displaying an image” is not cited prior in
claim 82. The examiner recommends separating and correcting the limitation in the claim to “a screen capable of displaying an image” for continued prosecution of the claim.
Claims 83 and 84 are additionally rejected by the 35 USC § 112 rejection for being
dependent on claim 82.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 44 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al. (US PG-Pub US 20140243223 A1), in view of Weissleder et al. (US PG-Pub 20030044353 A1).
Regarding claim 44, the examiner is interpreting active and null signals to be acceptable data and rejected data, respectively.
Duffy et al teaches determining the concentration of analyte molecules in a fluid sample, by using a computer comprising software that can use data collected to produce a calibration curve and/or a digital reading of the measured concentration of the analyte molecules in the fluid sample. For example, a fluorescence image of an array comprising the dissociated species partitioned across a substrate may be collected and analyzed using imaging processing software of which the computer is additionally capable of executing. The dissociated species can be directly quantified, as the species comprises a molecule or moiety that may be directly interrogated and detected (e.g., fluorophore), of which it will emit a signal upon interrogation of the reaction vessel (see Duffy et al., [0180], [0193], [0203]). Additionally, Duffy et al. teaches the a method of determining the concentration of dissociated species in a fluid, the method comprising exposing the fluid to a plurality of reaction vessels under conditions so that at least one dissociated species is captured in at least some of the reaction vessels, wherein each reaction vessel comprises a microwell and an optional sealing component and each reaction vessel defines a binding surface that has a capture component immobilized thereon; determining the presence or absence of a dissociated species in each reaction vessel so as to identify the number of reaction vessels that contain a dissociated species and/or the number of reaction vessels that do not contain a dissociated species; and determining the concentration of dissociated species in the fluid sample to be tested from the number of reaction vessels that contain and/or do not contain a dissociated species. This analysis can be done via the image analysis software (see Duffy et al., [0203], [0219]).
Duffy et al. fails to teach digitally classifying the plurality of signals as active or null; and optionally, a communication interface.
However, in the analogous art of activatable imaging probes, Weissleder et al. teaches a fluorescent quenching molecule used to quench the initial signal. The quencher molecule is situated such that it quenches the optical properties of a reporter molecule (i.e., chromophore), where upon activation, the reporter molecule is de-quenched. With this, the reporter molecule and quencher molecule located on the probe will exhibit different signal intensities when the probe is active or inactive, allowing to determine whether the probe is active or inactive by identifying a change in the signal intensity of the reporter molecule, quencher molecule, or a combination thereof (see Weissleder et al., [0104]). Weissleder additionally teaches imaging recording via a low power microscope for recording the fluorescent emissions. The images were then transferred to a PowerMac 7600/120 PC (i.e., a computer), and processed using IPLab Spectrum 3.1 software, showing a transfer of data between two separate devices within the system (see Weissleder et al., [0149]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computer, image processing software within the computer and its performed methods of Duffy et al. to incorporate identifying active and inactive signals and the transferring of data between two systems (as taught by Weissleder et al.), for the benefit of high target/background ratio for improved detection of subtle disease, and non-invasive imaging of internal molecular targets based on their biological activity (see Weissleder et al., [0007]).
Regarding claim 67, the combination of Duffy et al. and Weissleder et al. teaches the exact limitations of claim 67. Specifically, Duffy et al. teaches the digital assay system of claim 44, wherein each of the optical reporter molecules is spatially resolvable (see Duffy et al., [0188], disclosing at least a fraction of dissociated species may be detected substantially simultaneously, where each of the species/molecules/particles (e.g., dissociated species) is spatially separated with respect to the other detected species/molecules/particles (e.g., dissociated species) during detection, such that detection is able to resolve individual dissociated species of the plurality of dissociated species detected.).
Claims 66, 72-74, and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al. and Weissleder et al. as applied to claim 44 above, and further in view of Hixson et al. (US PG-Pub 20120184449 A1).
Regarding claim 66, the combination of Duffy et al. and Weissleder et al. fails to teach wherein the image of a plurality of signals is sent to a virtual server in a computer cloud.
However, in the analogous art of fetal genetic variation detection, Hixson et al. teaches fetal diagnostic methods, kits and computational products useful for non-invasively detecting genetic variations for which maternal nucleic acid sequences are utilized as a reference. Systems and apparatuses may be used to conduct the methods above, of which a network cloud storage system may be used, referred as a virtual server hosted on the internet to provide web-based data storage (see Hixson et al., Abstract, [0190], [0194]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the imaging process within the computer of the combination of Duffy et al. and Weissleder et al. to incorporate the network cloud storage (as taught by Hixson et al.), for the benefit of being able to access and process data remotely from another system separate from the original that collected and stored the data (see Hixson, [0193]-[0194]).
Regarding claim 72, the combination of Duffy et al. and Weissleder et al. fails to fully teach the digital assay system comprises a communication interface.
However, Hixson et al. teaches a communication interface within the system for identifying genetic variation using maternal nucleic acid sequences as reference, allowing for the transfer of software and data between a computer system and one or more external devices (see Hixson et al., [0195]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computer based assay of the combination of Duffy et al. and Weissleder et al. by incorporating a communication interface (as taught by Hixson et al.), for the benefit of being able to access and process data remotely from another system separate from the original that collected and stored the data (see Hixson, [0193]-[0194]).
Regarding claim 73, the combination of Duffy et al. and Weissleder et al. fails to teach wherein the communication interface is wireless.
However, Hixson et al. teaches a communication interface within the system for identifying genetic variation using maternal nucleic acid sequences as reference, allowing for the transfer of software and data between a computer system and one or more external devices. Signals often are provided to a communications interface via a channel. A channel often carries signals and can be implemented using wire or cable, fiber optics, a phone line, a cellular phone link, an RF link (i.e., wireless means) and/or other communications channels (see Hixson et al., [0195]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computer based assay of the combination of Duffy et al. and Weissleder et al. by incorporating a radio frequency (RF) link as wireless means of communication (as taught by Hixson et al.), for the benefit of being able to access and process data remotely from another system separate from the original that collected and stored the data (see Hixson, [0193]-[0194]).
Regarding claim 74, the combination of Duffy et al., Weissleder et al., and Hixson et al. teaches the exact limitations of claim 74. Specifically, Duffy et al. teaches the digital assay system of claim 73, further comprising an image sensor (see Duffy et al., [0193], disclosing a optical detection system, such as that of a charged couple device (CCD) camera which images light to be processed by an imaging process software.).
Regarding claim 77, the combination of Duffy et al., Weissleder et al., and Hixson et al. teaches the exact limitations of claim 77. Specifically, Duffy et al. teaches the digital assay system of claim 74, further comprising a source of light or other electromagnetic radiation (see Duffy et al., [0132], [0192], disclosing optical fibers in a bundle that may be aligned with each microwell, of which the fiber can carry both excitation and emission light to and from the well.).
Claims 68-71 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al. and Weissleder et al. as applied to claim 44 above, and further in view of Niskanen et al. (US PG-Pub 20120100626 A1).
Regarding claim 68, the combination of Duffy et al. and Weissleder et al. fails to teach wherein the optical reporter molecules comprise plasmonic nanoparticles functionalized with a capture element.
However, in the analogous art of apparatus and associated methods, Niskanen et al. teaches an apparatus comprising a processor and memory including computer program code, of which can illuminate sensor elements configured to exhibit a specific electrical response to the illumination when a specific set of analytes are bound to one or more sensor elements. To enable detection of a particular analyte, the electrical response of an optoelectronic sensor element 101 to an illuminating radiation 102 must be dependent on the presence of the analyte 103. The selectivity of a sensor element 101 to a particular analyte 103 can be engineered. One example of a sensor element 101 that satisfies the above criteria is a graphene photodiode 104 which is coated in a layer of plasmonic nanoparticles 105 that have been functionalized (e.g. using a functionalization molecule) for binding to a specific analyte 103 (see Niskanen et al., Fig. 1, Abstract, [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluorescing dissociated species of the combination of Duffy et al. and Weissleder et al. by incorporating the plasmonic nanoparticle coating that has been functionalized (as taught by Niskanen et al.), for the benefit of specific recognition of a biological or chemical species of interest (see Niskanen et al., [0040]).
Regarding claim 69, the combination of Duffy et al., Weissleder et al., and Niskanen et al. teaches the exact limitations of claim 69. Specifically, Duffy et al. teaches the digital assay system of claim 68, wherein the capture element is chosen from: one or more nucleotide sequences that binds the analyte (see Duffy et al., [0143], disclosing that a nucleic acid may be captured with a complementary nucleic acid fragment (e.g., an oligonucleotide)); and an antibody or a fragment thereof that binds the analyte (see Duffy et al., [0142], disclosing the capture component may be an antibody specific to a post-translational modification.).
Regarding claim 70, the combination of Duffy et al., Weissleder et al., and Niskanen et al. teaches the exact limitations of claim 70. Specifically, Duffy et al. teaches the digital assay system of claim 69, wherein the analyte is chosen from an antigen (see Duffy et al., [0144], disclosing suitable analyte molecules and particles include biomolecules, such as cellular membrane antigens and receptors (neural, hormonal, nutrient, and cell surface receptors) or their ligands, etc.).) and a nucleotide sequence (see Duffy et al., disclosing that the analyte molecule is a nucleic acid.).
Regarding claim 71, the combination of Duffy et al., Weissleder et al., and Niskanen et al. teaches the exact limitations of claim 71. Specifically, Duffy et al. teaches the digital assay system of claim 70, wherein the capture element is chosen from an antibody, or a fragment thereof (see Duffy et al., [0106], disclosing that the capture component, according to one embodiment, may be an antibody that binds specifically to some portion of an analyte molecule.), and one or more nucleotide sequences complimentary to the analyte nucleotide sequence (see Duffy et al., [0143], disclosing a nucleic acid may be captured with a complementary nucleic acid fragment (e.g., an oligonucleotide) and then optionally subsequently labeled with a binding ligand comprising a different complementary oligonucleotide.).
Claims 75-76 and 78-79 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al., Weissleder et al., and Hixson et al. as applied to claim 74 and 77 above, and further in view of Richards et al. (US PG-Pub 20160289729 A1).
Regarding claim 75, the combination of Duffy et al., Weissleder et al., and Hixson et al. fails to teach wherein the image sensor is configured to operating as part of a dark-field microscope. However, in the analogous art of instruments and systems for rapid microorganism identification and antimicrobial agent susceptibility testing, Richards et al., teaches an automated microscopy system designed to provide rapid and accurate microorganism identification and antibiotic susceptibility testing results, tagging these microorganisms with fluorescent labels that binds to complementary bacterial sequences. It utilizes an optical detection system configured to obtain dark field and fluorescence photomicrographs of a microorganism contained in the plurality of microfluidic channels (see Richards et al., [0003]-[0004]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical detection system of the combination of Duffy et al., Weissleder et al., and Hixson et al. to incorporate dark-field microscopy in the optical detection system (as taught by Richards et al.), for the benefit of high contrast analysis of fluorescing molecules behind a dark background to better ascertain specific signals.
Regarding claim 76, the combination of Duffy et al., Weissleder et al., and Hixson et al. fails to teach wherein the image sensor is chosen from a megapixel camera and a complementary metal-oxide semiconductor camera.
However, Richards et al. teaches an optics system 1450 that may comprise an image sensor (not separately shown in Fig. 14A, but embedded within the camera 1457). An image sensor may be used to acquire images of the sample. In various embodiments, an image sensor can comprise a complementary metal-oxide semiconductor (“CMOS”) sensor or active pixel sensor camera. For example, a CMOS sensor camera can be a five-megapixel grayscale camera used to acquire images for processing (see Richards et al., Fig. 14A, [0186]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical detection system of the combination of Duffy et al., Weissleder et al., and Hixson et al. to incorporate a CMOS sensor camera and it being five megapixels grayscale camera system (as taught by Richards et al.), for the benefit of more accurately performing pixel-by-pixel analysis of intensities from fluorescing molecules/particles (see Richards, [0189], [0196], [0200]).
Regarding claim 78, the combination of Duffy et al., Weissleder et al., and Hixson et al. fails to teach wherein the source of light or other electromagnetic radiation is a light-emitting diode.
However, Richards et al. teaches an illuminator 1400 of which may be configured to provide a plurality of light sources, such as white light 1402 and laser diode light sources 1403, 1404. To permit image acquisition of a sample in cassette 1420, three illumination sources are used, including a green laser diode 1403 (excitation wavelength=520 nm) and a red laser diode 1404 (excitation wavelength=637 nm) for illumination used during the identification in the fluorescence fin situ hybridization process and a white light LED 1402 for dark field illumination (the “dark field LED”) (see Richards et al., Fig. 14A, [0171]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the light source of the combination of Duffy et al., Weissleder et al., and Hixson et al. to incorporate a LED light source (as taught by Richards et al.), for the benefit of being able to facilitate overlaying images containing the same image features (i.e., a field of view containing the same sample objects at the same sample object locations within the field of view) acquired using a plurality of light sources (see Richards et al., [0171]).
Regarding claim 79, the combination of Duffy et al., Weissleder et al., Hixson et al., and Richards et al. teaches the exact limitations of claim 79. Specifically, Duffy et al. teaches the digital assay system of claim 78, further comprising a sample chamber that is optionally removable (see Duffy et al., Fig. 10C, Fig. 11, [0121], disclosing reaction vessels 148 that comprises a plurality of microwells 139 to be exposed to a fluid sample 141, and a sealing component 143 to mate with the microwell containing surface 139 to form a plurality of sealed reaction vessels.).
Claim 80 is rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al., Weissleder et al., Hixson et al. and Richards et al. as applied to claim 79 above, and further in view of Niskanen et al. and Yang et al. (US PG-Pub 20090263912 A1).
Regarding claim 80, Duffy et al. teaches that the reaction vessels are formed using material such as glass, or plastics (including acrylics, polystyrene and copolymers of styrene and other materials, etc.). Individual reaction vessels may contain a binding surface. The binding surface may comprise essentially the entirety or only a portion of the interior surface of the reaction vessel or may be on the surface of another material or object that is confined within the reaction vessel, such as, for example, a bead, or a particle (for example, a micro-particle or a nanoparticle) (see Duffy et al., [0128]-[0129]).
The combination of Duffy et al., Weissleder et al., Hixson et al., and Richards et al. fails to teach to one side of the reporter surface of which optical reporter molecules comprising plasmonic nanoparticles functionalized with capture elements have been affixed, optionally in a grid or an approximation thereof; and - a waveguide that is suitable for dark-field microscopy in contact with the opposite side of the reporter surface.
However, Niskanen et al. teaches an apparatus comprising a processor and memory including computer program code, of which can illuminate sensor elements configured to exhibit a specific electrical response to the illumination when a specific set of analytes are bound to one or more sensor elements. To enable detection of a particular analyte, the electrical response of an optoelectronic sensor element 101 to an illuminating radiation 102 must be dependent on the presence of the analyte 103. The selectivity of a sensor element 101 to a particular analyte 103 can be engineered. One example of a sensor element 101 that satisfies the above criteria is a graphene photodiode 104 which is coated in a layer of plasmonic nanoparticles 105 that have been functionalized (e.g. using a functionalization molecule) for binding to a specific analyte 103 (see Niskanen et al., Fig. 1, Abstract, [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluorescing dissociated species of the combination of Duffy et al., Weissleder et al. and Hixson et al. to incorporate the plasmonic nanoparticle coating that has been functionalized onto the binding surface (as taught by Niskanen et al.), for the benefit of specific recognition of a biological or chemical species of interest (see Niskanen et al., [0040]).
Furthermore, the combination of Duffy et al., Weissleder et al., Hixson et al., Niskanen et al., and Richards et al. fails to teach a waveguide that is suitable for dark-field microscopy in contact with the opposite side of the reporter surface.
However, in the analogous art of nanowires and nanoribbons as subwavelength optical waveguides and their use as component in devices, Yang et al. teaches a waveguide that, in response to optical pumping (e.g., a laser source) the waveguide optically interrogates nearby molecular species retained within said fluidic structure to detect chemical species in response to optical characterization of small (on the order of sub-picolitre) volumes of solution. An example of this is provided by the operation of a dark-field microscope in reflection mode. Monochromatic laser light was focused onto the sample at a 35-degree angle normal to the substrate. Broadband light (FWHM greater than 200 nm) was generated in the waveguide by exciting the SnO2 nanoribbon with the 325 nm line of a continuous-wave He-Cd laser. The broad luminescence of the waveguide was used for the absorbance measurements by detecting the guided light with and without the analyte present (see Yang et al., Abstract, [0194]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the binding surface with the plasmonic nanoparticle coating and dark-field microscopy of Duffy et al., Weissleder et al., Hixson et al., Niskanen et al., and Richards et al. to further incorporate a waveguide for dark-field microscopy (as taught by Yang et al.) that may be on the other side of the reaction vessel, for the benefit of supporting multiple analytical modes for chemical identification, especially for absorption and florescence (see Yang et al., [0013]-[0014]).
Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al., Weissleder et al., Hixson et al., Niskanen et al., Richards et al. and Yang et al. as applied to claim 80 above, and further in view of Lemmer et al. (EP 2265931 B1).
Regarding claim 81, the combination of Duffy et al., Weissleder et al., Hixson et al., Niskanen et al., Richards et al., and Yang et al. fails to teach wherein each affixed optical reporter molecule is resolvable as one pixel of a recording device.
However, in the analogous art of method and apparatus for localization of single dye molecules in the fluorescent microscopy, Lemmer et al. teaches the employment of a spatially modulated illumination microscopy, allowing for the determination of the axial extension (i.e. "size") of a fluorescently labeled nanostructure (at a given x, y position) down to a few tens of nm. The position interval dz of the molecules along the optical axis (z) is determined for every single (x, y) pixel. The smaller the axial extensions dz of the labeled nanostructures are the more precisely their markers, respectively labels (fluorescent molecules) can be localized along the optical axis, and hence the better the axial effective optical resolution will be (i.e. the smallest axial distance between two labeled molecules which can be detected) (see Lemmer et al., [0180]-[0181]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluorescent optical reporting molecules of the combination of Duffy et al., Weissleder et al., Hixson et al., Niskanen et al., Richards et al., and Yang et al. to incorporate determining the fluorescing label position by the pixel (as taught by Lemmer et al.), for the benefit of subpixel precision for nanometer spatial assignment of individual fluorescent molecules (see Lemmer et al., [0178]).
Claims 82-84 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al., Weissleder et al., Hixson et al., Niskanen et al., Richards et al., Yang et al. and Lemmer et al. as applied to claim 81 above, and further in view of Cunningham et al. (US PG-Pub 20140193839 A1).
Regarding claim 82, Duffy et al. teaches a computer 438 that executes an imaging processing software to process the information obtained by the charge coupled device (CCD) camera 436 (see Duffy et al., Fig. 18, [0194]).
The combination of Duffy et al., Weissleder et al., Niskanen et al., Richards et al., Yang et al., and Lemmer et al. fails to teach that the digital assay system further comprises a screen capable of displaying an image and a communication interface, where all the components are all comprised within a single, portable device.
However, Hixson et al. teaches general components of a computer, including one or more outputs, including a display screen (e.g., CRT or LCD). The system may also comprise a communication interface, allowing for the transfer of software and data between a computer system and one or more external devices (see Hixson et al., [0192], [0195]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computer based assay of the combination of the combination of Duffy et al., Weissleder et al., Niskanen et al., Richards et al., Yang et al., and Lemmer et al. by incorporating a display screen and communication interface (as taught by Hixson et al.), for the benefit of being able to access and process data remotely from another system separate from the original that collected and stored the data, and having a visual output for such data (see Hixson, [0192]-[0194]).
However, the combination of Duffy et al., Weissleder et al., Hixson et al., Niskanen et al., Richards et al., Yang et al., and Lemmer et al. fail to teach that all the components are comprised within a single, portable device.
However, in the analogous art of smartphone biosensor, Cunningham et al. teaches a mobile computer device that includes an image sensor may be used to detect the result of a biomolecular assay. The mobile computing device could be a smartphone, handheld computer, tablet computer, or other easily portable computing device. The mobile computing device includes a display, a processor, a memory, and program instructions stored in the memory and executable by the processor to cause the mobile computing device to perform functions, such as: (i) using the image sensor to obtain at least one image of the spatially-separated wavelength components; (ii) determining a wavelength spectrum of the optical output based on the at least one image of the spatially-separated wavelength components; and (iii) displaying an indication of the wavelength spectrum on the display (See Cunningham et al., Abstract, [0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computer based assay of the combination of the combination of Duffy et al., Weissleder et al., Hixson et al., Niskanen et al., Richards et al., Yang et al., and Lemmer et al. by further incorporating all of the components of the computer assay system to be contained within a mobile device (as taught by Cunningham et al.), for the benefit of inexpensive, portable, and multifunctional systems to perform biosensor assays in contexts outside the laboratory (see Cunningham et al., [0040]).
Regarding claim 83, the combination of Duffy et al., Weissleder et al., Hixson et al., Niskanen et al., Richards et al., Yang et al., and Lemmer et al. fail to teach wherein the single, portable device is chosen from a smartphone and a tablet computer.
However, Cunningham et al. teaches that the mobile computer device can be a smartphone or a tablet computer (see Cunningham et al., [0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the digital assay system of the combination of Duffy et al., Weissleder et al., Hixson et al., Niskanen et al., Richards et al., Yang et al., and Lemmer et al. to further comprise being either a smartphone or tablet computer (as taught by Cunningham et al.), for the benefit of inexpensive, portable, and multifunctional systems to perform biosensor assays in contexts outside the laboratory (see Cunningham et al., [0040]).
Regarding claim 84, the combination of Duffy et al., Weissleder et al., Hixson et al., Niskanen et al., Richards et al., Yang et al., and Lemmer et al. fail to teach the digital assay system additionally comprising a case for positioning the portable device, sample chamber, and light source in close and stable proximity to each other.
However, Cunningham et al. teaches that for positioning the smartphone 102 so that its digital camera receives the first order of the diffraction grating 120, the smartphone can be removably mounted to a cradle 150. The cradle 150 includes a mounting portion 154 for mounting the smartphone 152 and also includes a light-sealed optical housing 156 that houses optical components (see Cunningham et al., Fig. 2B, Fig. 3A-3B, [0045]). In another example for multimode instrumentation, A smartphone could be coupled to an instrument that is capable of performing multiple different types of biomolecular assays, such as solution-based fluorescence assays, surface-based fluorescence assays, and fluorescence polarization assays. The multimode instrument 400 is coupled to a smartphone 402. The smartphone 402 includes an LED 404 and a camera 406. The camera 406 includes an image sensor, such as a CCD. The instrument 400 includes a sample chamber 408 for receiving an optical assay medium. The optical assay medium could include a PC, a cuvette, or other components depending on the type of optical assay being performed (see Cunningham et al., Fig. 16, [0079]-[0080], [0083]-[0087], [0090]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the portable digital assay system of the combination of Duffy et al., Weissleder et al., Hixson et al., Niskanen et al., Richards et al., Yang et al., and Lemmer et al. to incorporate a cradle or instrument that couples to the smartphone containing a light source that comprises a sample chamber and detection system (as taught by Cunningham et al.), for the benefit of inexpensive, portable, and multifunctional systems to perform biosensor assays in contexts outside the laboratory (see Cunningham et al., [0040]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tracy C Colena whose telephone number is (571)272-1625. The examiner can normally be reached Mon-Thus 8:00am-5:00pm.
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/TRACY CHING-TIAN COLENA/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797