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 .
Response to Amendment
The Amendment filed September 17, 2024 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 1, 6 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Meyer, when modified by Reynolds and Zoechbauer, teaches or makes it obvious all limitations of amended claims 1, 9 and 16.
Applicant’s argument on page 9 “Meyer already corrects for chromatic aberrations using its compound lens, a person of ordinary skill in the art, absent hindsight reconstruction, would not have been motivated to include a light pipe to produce light having reduced chromatic differences relative to received light from a light source” is not persuasive. Meyer’ lenses solve chromatic aberration in the detection and imaging path ([0061], [0112]). Reynolds, like Jones, solves spatial color uniformity and mixing in the illumination path to ensure the sample is evenly lit by all wavelengths ([0033]). Meyer’s own use of a “homogenizing rod” acknowledges that need for uniform illumination ([0045]), therefore, it would be obvious for an ordinary skill to include the rod of Jones or of Reynolds in Meyer .
Applicant’s argument on page 13 “introducing a light pipe like that of Jones into the Meyer system would require a redesign of the Meyer system, which would discourage a person of ordinary skill in the art from introducing such a light pipe” overstates the burden of “redesign”. Integration of bent light pipe into Meyer’s system would require repositioning of downstream optics such as lens group 8. Such adjustment is a routine and predictable aspect of optical engineering and does not constitute an undue burden or a “redesign“ that would discourage a skill person.
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.
Claims 1-3, 5, 7-17 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer (US 20210223527 A1) in view of Reynolds (US20040157341A1), further in view of Zoechbauer (US 4999013 A).
Regarding claim 1, Meyer teaches a system for detecting analytes in a biochemical sample ([0003]), the system comprising: a container (chip) configured to contain the biochemical sample ([0041] The biological sample or the multiplicity of biological samples may be arranged within a microfluidic device in the form of a microfluidic chip or dPCR chip); a light source (LED arrays) ([0104]); a light conduit (rod 6), the light conduit being configured to receive light from the light source, to produce light relative to the light received from the light source, and to output the light to the container ([0105], fig. 5); an optical detector (a camera sensor 17) (102); a lens (39) disposed between the container and the optical detector ([0112]), the lens being arranged to receive at least some of the light that passed through the container, the lens being configured to output light that is based on the at least some of the light that passed through the container ([0112], fig. 4); an optical aperture (aperture stop 14) disposed between the lens (39) and the optical detector (17) ([0112], fig. 4), the optical aperture being configured to receive at least some of the light focused at the optical detector from the lens and to pass the at least some of the light focused at the optical detector to the optical detector (fig. 4);and a structure configured to house the container, the optical aperture, the lens, and the optical detector ([0003]: The scanning device may be a plate reader. One of an ordinary skill in the art would understand that a plate reader has an integrated structure that would house the container, the optical aperture, the lens, and the optical detector), but fails to disclose a light conduit having a non-linear optical path, the light conduit being configured to receive light from the light source, to produce light having reduced chromatic differences relative to the light received from the light source, and to output the light having reduced chromatic differences to the container, the lens being configured to output light focused at the optical detector.
However, Reynolds teaches a system for detecting analytes in a biochemical sample ([0001), the system comprising: a container (30) configured to contain the biochemical sample ([0023]); a light source (12) ([0021]); a light conduit (16, figs. 3a and 3b) having a non-linear optical path, the light conduit being configured to receive light from the light source, to produce light having reduced chromatic differences (even illumination distribution for each wavelength) relative to the light received from the light source, and to output the light having reduced chromatic differences to the container ([0021], [0033]); an optical detector (34) ([0026]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meyer by incorporating a light conduit having a non-linear optical path, the light conduit being configured to receive light from the light source, to produce light having reduced chromatic differences relative to the light received from the light source, and to output the light having reduced chromatic differences to the container as taught by Reynolds for improved illumination distribution and intensity ([0035]) and it useful in applications where spatial constraints do not allow for a linear light guide ([0030]).
Meyer, when modified by Reynolds, fails to disclose the lens being configured to output light focused at the optical detector
However, Zoechbauer (US 4999013 A) from the same field of endeavor, teaches the lens being configured to output light focused at the optical detector (fig. 3a, col. 3, lines 32-35).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meyer and Reynolds by incorporating the lens being configured to output light focused at the optical detector to provide predicable results of simplified device.
Regarding claim 2, Meyer, when modified by Reynolds and Zoechbauer, teaches the system of claim 1, wherein the container comprises a channel configured to hold the biochemical sample, the channel being configured to pass the at least some of the light having reduced chromatic differences ([0041] “The biological sample or the multiplicity of biological samples may be arranged within a microfluidic device in the form of a microfluidic chip or dPCR chip. Microfluidic dPCR chips usually provide microscale channels to receive microliter or nanoliter-scale samples”, these channels transmit light for detection. [0094] the optical measurement unit of the present disclosure is arranged to provide transillumination. Transillumination describes an arrangement, in which the light for illumination enters the region of interest from a first side and the light which is detected by means of the imaging system leaves the region of interest towards a second side).
Regarding claim 3, Meyer, when modified by Reynolds and Zoechbauer, teaches the system of claim 1, wherein the system is configured to capture telecentric imagery ([0045]).
Regarding claim 5, Meyer, when modified by Reynolds and Zoechbauer, teaches the system of claim 1, wherein the light source comprises two or more LEDs of different colors ([0104]).
Regarding claims 7-8, Meyer, when modified by Reynolds and Zoechbauer, teaches the system of claim 1, but fails to disclose wherein the light conduit supports total internal reflection of light received from the light source at a first end of the light conduit and delivers reflected light at a second end of the conduit, the reflected light comprising the light having reduced chromatic differences, and wherein the light conduit comprises a plastic light pipe or a glass light pipe
However, Reynolds teaches wherein the light conduit supports total internal reflection of light received from the light source at a first end of the light conduit and delivers reflected light at a second end of the conduit, the reflected light comprising the light having reduced chromatic differences (even illumination means reducing the chromatic differences), and wherein the light conduit comprises a plastic (acrylic) light pipe or a glass light pipe ([0020], [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meyer and Reynolds by incorporating wherein the light conduit supports total internal reflection of light received from the light source at a first end of the light conduit and delivers reflected light at a second end of the conduit, the reflected light comprising the light having reduced chromatic differences, and wherein the light conduit comprises a plastic light pipe or a glass light pipe as taught by Reynolds for improved illumination distribution and intensity ([0033], [0035])
Regarding claim 9, Meyer teaches an imaging apparatus for an optical analyte detection system ([0003]), the imaging apparatus comprising: a light conduit (rod 6) having an optical path, the light conduit being configured to receive light from a light source (LED array 1) and to provide, to a container containing a biochemical sample ([0041]) light from the light source ([0103]-[0105]); an optical detector (17) ([0102]); a lens assembly (39) ([0102]), the lens assembly being arranged to receive at least some of the light having that passed through the container and to provide light that is focused at the optical detector and that is based on the at least some of the light that passed through the container (figs. 3 and 4); and an optical aperture (aperture stop 14) the optical aperture being configured to receive at least some of the light from the lens assembly and to pass the at least some of the light focused at the optical detector to the optical detector (fig. 4: the aperture stop 14 is located withing the imaging path formed by the lens groups 16 and 39. The light passing through by the aperture is in the process of being focused onto the detector 17), but fails to disclose the light conduit having a non-linear optical path, light having reduced chromatic differences relative to the received light, a first receptacle configured to house the optical detector, the second receptacle configured to house the lens assembly, wherein the first receptacle, the second receptacle, and the optical aperture are portions of a single structure.
However, Reynolds from the same field of endeavor teaches a light conduit (16, figs. 3a and 3b) having a non-linear optical path, light having reduced chromatic differences relative to the received light (even illumination distribution for each wavelength) relative to the light received from the light source ([0021], [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meyer by substituting the rod with a light conduit having a non-linear optical path to produce light having reduced chromatic differences relative to the light received from the light source as taught by Reynolds for improved illumination distribution and intensity ([0035]).
Meyer, when modified by Reynolds, fails to disclose a first receptacle configured to house the optical detector, the second receptacle configured to house the lens assembly, wherein the first receptacle, the second receptacle, and the optical aperture are portions of a single structure, the light focused at the optical detector from the lens assembly.
While Meyer does not explicitly disclose a first receptacle configured to house the optical detector, the second receptacle configured to house the lens assembly, wherein the first receptacle, the second receptacle, and the optical aperture are portions of a single structure, this would have been an obvious design choice for an ordinary skill in the art before the effective filing date of the claimed invention for optical alignment and stability.
Zoechbauer (US 4999013 A) from the same field of endeavor, teaches the light focused at the optical detector from the lens assembly (fig. 3a, col. 3, lines 32-35).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meyer and Reynolds by incorporating the light focused at the optical detector from the lens assembly to provide predicable results of simplified device.
Regarding claim 10, Meyer, when modified by Reynolds and Zoechbauer, teaches the system of claim 9, further comprising a third receptacle (mount 23) configured to hold the container (chip) of a sample for the optical analyte detection system ([0053] the scanning device 19 comprises an object mount 23. The object mount 23 comprises an xyz-stage 33, [0126] the scanning device 19 includes gripper module 27, to load and unload consumables 26 from the xyz-stage 33, each consumable 26 consists of a frame and two microfluidic chips 25 with eight channels and integrated microstructures. In the channels of the chips 25, the samples 30 may be arranged), wherein the third receptacle is a portion of the single structure (chassis) ([0125] chassis can be equated to the single structure).
Regarding claim 11, Meyer, when modified by Reynolds and Zoechbauer, teaches the imaging apparatus of claim 10, wherein the container is a flow cell ([0063] the consumable is a digital PCR chip or dPCR chip, [0126] “consumable 26 consists of a frame and two microfluidic chips 25 with eight channels” that is equivalent to a flow cell’ functionality) and wherein the single structure physically contacts the flow cell without any intermediate components disposed between the flow cell and the single structure ([0121] the downholder 24 which is part of the chassis may be the only interface between the scanning device 19 and the consumable).
Regarding claim 12, Meyer, when modified by Reynolds and Zoechbauer, teaches the imaging apparatus of claim 10, wherein the container (consumable) comprises a flow cell (microfluidic chips 25 with eight channels) and one or more intermediate component (frame)s, and wherein the single structure (downholder which is part of the single structure) physically contacts the one or more intermediate components (([0063] the consumable is a digital PCR chip or dPCR chip, [0126] “consumable 26 consists of a frame and two microfluidic chips 25 with eight channels” that is equivalent to a flow cell’ functionality, [0058] “The downholder 24 is arranged to push a main surface of the consumable against a planar surface of the xyz-stage 33” a main surface corresponds to the frame).
Regarding claim 13, Meyer, when modified by Reynolds and Zoechbauer, teaches the imaging apparatus of claim 10, wherein the container (26) comprises a channel configured to hold the sample ([0126] consumable 26 consists of a frame and two microfluidic chips 25. In the channels of the chips 25, the samples 30 may be arranged), and the container is disposed such that the channel passes at least some received light towards the second receptacle ([0054] “the imaging system is arranged to detect fluorescent radiation which is emitted away from a second side of the object mount, wherein the first and the second side of the object mount are opposed to each other” the florescent light goes through the lens, the second receptacle is configured to receive a lens assembly).
Regarding claim 14, Meyer, when modified by Reynolds and Zoechbauer, teaches the imaging apparatus of claim 10, wherein the sample is a blood sample ([0004]).
Regarding claim 15, Meyer, when modified by Reynolds and Zoechbauer, teaches the imaging apparatus of claim 9, wherein the optical analyte detection system is configured to capture telecentric imagery ([0045] the imaging system is bi-telecentric and the illumination system is bi-telecentric).
Regarding claim 16, Meyer teaches a method for detecting analytes in a biochemical sample ([0003]), the method comprising: illuminating a container holding the biochemical sample ([0041]) using light from two or more light-emitting diodes (LEDs), wherein light from the two or more light LEDs is directed through a light pipe conduit (rod 6) that includes an optical path ([0089], [0104] multiple LED arrays 1, [0105] rod 6); causing at least some of the light to pass through the container to a lens assembly (38), ([0112], figs. 3 and 4); and generating one or more images of the biochemical sample based on output of the optical detector ([0089] The imaging system captures an image of the sample), but fails to disclose light having reduced chromatic differences relative to light, a light pipe conduit that includes a non-linear optical path supporting total internal reflection of light to produce the light having reduced chromatic differences, wherein the lens assembly converges the at least some of the light that passed through the container through an aperture to an optical detector .
However, Reynolds from the same field of endeavor teaches light having reduced chromatic differences relative to light (even illumination distribution for each wavelength), a light pipe (16, figs. 3a and 3b) conduit that includes a non-linear optical path supporting total internal reflection of light to produce the light having reduced chromatic differences ([0020], [0021], [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meyer by incorporating light having reduced chromatic differences relative to light, a light pipe conduit that includes a non-linear optical path supporting total internal reflection of light to produce the light having reduced chromatic differences for improved illumination distribution and intensity ([0035]).
Meyer, when modified by Reynolds, fails to disclose wherein the lens assembly converges the at least some of the light that passed through the container through an aperture to an optical detector.
However, Zoechbauer (US 4999013 A) from the same field of endeavor, teaches wherein the lens assembly converges the at least some of the light that passed through the container through an aperture to an optical detector (fig. 3a, col. 3, lines 32-35).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meyer and Reynolds by incorporating wherein the lens assembly converges the at least some of the light that passed through the container through an aperture to an optical detector to provide predicable results of simplified device.
Regarding claim 17, Meyer, when modified by Reynolds and Zoechbauer, teaches the method of claim 16, wherein illuminating the container comprises: illuminating the container using light of a first color based on light emitted from a first subset of the two or more LEDs; and subsequently (consecutively) illuminating the container using light of a second color based on light emitted from a second subset of the two or more LEDs ([0131] the illumination system illuminates the object within the field of view with the different illumination wavelength ranges consecutively).
Regarding claim 20, Meyer, when modified by Reynolds and Zoechbauer, teaches the method of claim 16, further comprising processing the one or more images to detect the analytes in the biochemical sample ([0064] “the scanning device 19 enables the quantitative analysis of the fluorescence signal of the fluorescent sample 30 and the clustering into positive and negative results” inherently requires image processing to convert captured fluorescence data into analyte detection results).
Regarding claim 21, Meyer, when modified by Reynolds and Zoechbauer, teaches the system of claim 1, but fails to disclose wherein the structure comprises an injection molded housing.
However, the examiner takes official notice that it is well-known for structures to comprise an injection molded housing.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meyer, Reynolds and Zoechbauer by incorporating wherein the structure comprises an injection molded housing for low manufacturing cost as disclosed by Kofoed (US 5789660 A: col. 6, lines 12-13).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Meyer (US 20210223527 A1), in view of Reynolds (US20040157341A1), further in view of Zoechbauer (US 4999013 A), and further in view of Chu (US2019126281A1).
Regarding claim 4, Meyer, when modified by Reynolds and Zoechbauer, teaches the system of claim 1, but fails to disclose wherein the optical aperture is defined by a geometry of the structure.
However, Chu from the same field of endeavor, teaches wherein the optical aperture is defined by a geometry of the structure ([0356] “depressions can be through-hole apertures. Through-hole apertures can be beneficial in some instruments to allow optical detection of samples contained in the sample vessels” the apertures are holes in a structural plate or the cover that serve as the optical aperture for each sample well, [372]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meyer, Reynolds and Zoechbauer by incorporating wherein the optical aperture is defined by a geometry of the structure to ensure alignment ([0357]).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer (US 20210223527 A1) in view of Reynolds (US20040157341A1), further in view of Zoechbauer (US 4999013 A), and further in view of Zeng (US20180052147A1).
Regarding claims 18-19, Meyer, when modified by Reynolds and Zoechbauer, teaches the method of claim 16, but fails to disclose further comprising separating the biochemical sample in the container; further comprising delivering acoustic energy to the container prior to or during illuminating the container
However, Zeng, from the same field of endeavor, teaches comprising separating the biochemical sample in the container; further comprising delivering acoustic energy to the container prior to or during illuminating the container ([0052] The acoustic forces partition the red blood cells (RBCs) 27 from the plasma 28 in the microchannel; the plasma 28 in the whole blood sample is analyzed by an integrated detector 19).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meyer, Zoechbauer and Reynolds by incorporating further comprising separating the biochemical sample in the container and further comprising delivering acoustic energy to the container prior to or during illuminating the container to yield predictable results of enhancing analyte detection specificity.
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.
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/MOHAMED DOUMBIA/Examiner, Art Unit 2877
/TARIFUR R CHOWDHURY/Supervisory Patent Examiner, Art Unit 2877