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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/26/2026 has been entered.
Status of Claims/Remarks
The supplemental amendment filed on 3/26/26 has been entered.
Claim 1, 3-4, 8-10, 14-53 are under examination.
Claims 2, 5-7 and 11-13 have been canceled.
Response to Amendment
The claim amendments, received 03/26/2026, have overcome the claim objections and 112(b) rejection(s) previously set forth in the Final Rejection. Accordingly, the claim objections and 112(b) rejection(s) have been withdrawn. However, based on the amended claims, new 112(b) rejection(s) have been set forth.
Based on the amended claims and remarks received on 03/26/2026, the prior art rejection over Schmitt has been maintained with respect to claims 1, 4, 19-46, 48-50, and 52-53 and modified to address claim 54. Further, the prior art rejection over Schmitt with respect to claims 3, 8, 14-18, 47, and 51 has been withdrawn and a new prior art rejection is set forth (see below).
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 14-16 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 pre-AIA the applicant regards as the invention.
Claim 14 recites “the light guide has a first end aligned with the entrance aperture of the adaptor housing”. Claim 3 lines 15 and 29-30 has been amended to recite “one or two light-guides … different from the light guide of the passive illuminator, each having an end thereof aligned with the entrance aperture of the optical chamber”. It is unclear if the light guide of the passive illuminator, which is different from the one or two light-guides, is aligned with the entrance aperture of the adaptor housing, as recited in claim 14, or if the one or two light-guides are aligned with the entrance aperture of the adaptor housing, as recited in claim 1. Claims 15-16 are also rejected by their dependency from claim 14.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4, 20-21, 23, 27, 30, 32, 36, 41, and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt et al. (US 2021/0208010; already of record – hereinafter “Schmitt”) in view of Fan (US 2017/0160534; already of record – hereinafter “Fan”).
Regarding claim 1, Schmitt discloses a device for illuminating and imaging an object (Schmitt; fig. 7, [0058]), comprising:
(a) an imager (Schmitt; “smartphone 700 that includes a camera”, fig. 7, [0058]);
(b) a lens (Schmitt; fig. 6, #604, [0052]);
(c) a passive illuminator and a light guide for illuminating the object (Schmitt; fig. 6, #606, #614, #616, [0054]), wherein the passive illuminator optically connects with the light guide (Schmitt disclose passive illuminator 616 optically connects with the light guide 614; [0054]), accepts light from one or both ends of the light guide (Schmitt; [0054]), and emits the light from a side wall of the passive illuminator towards the object (Schmitt; fig. 6, #616, [0054]. Schmitt discloses the distal portion 616 illuminates “the camera’s field of view” and “the aperture 624 has a portion sized and located to allow light conducted through the light pipe606 to be emitted from the distal portion 616 of the light pip 606 to illuminate the area in front of the contact member 610”; [0057]. The examiner notes the term “field of view” with respect to a camera describes the viewable area that can be imaged by a lens system, and is different from an “area in front of contact member 610”, later described in [0057]. Accordingly, the distal portion 616 emits light from a sidewall to illuminate the field of view through lens 604 and out of aperture 624 to illuminate the area in from of the contact member 610);
(d) an adaptor housing (Schmitt; fig. 6, 602/610, [0052]) that houses an optical chamber that has an exit aperture (Schmitt; the adaptor 702 slidably couples with attachment 600 such that the attachment 600 can be slid into position with the camera when the functionality of attachment 600 is desired, figs. 6 & 7, [0058], and frame 602 is configured to position each of the components 604, 606, and 608 in a known relationship with a camera of the smartphone; fig. 7, [0052]. Accordingly, cylindrical portion of frame 602 that houses the components is an optical chamber having an exit aperture between the lens of the camera on the smartphone and the frame 602 to allow the components to functionally attach and capture images; fig. 8, [0059]), an entrance aperture (Schmitt; the proximal portion of the passive illuminator 614 is configured to optically couple with the light source of the smartphone; [0054]. Therefore, the device 600 comprises an entrance aperture at the interface between the light source from the smartphone 700 and the proximal end of the passive illuminator 614), and an exposure aperture on the adaptor housing (Schmitt; fig. 6, #624, [0057]); and
wherein the passive illuminator and the lens are positioned inside the adaptor housing (Schmitt; frame 602 houses components 604, 606, 608; fig. 6, [0052]), the passive illuminator surrounds the lens (Schmitt; the distal portion 616 comprises a ring with an aperture, an axis of the aperture can be aligned with an axis of the lens 604; fig. 6, [0054]), and the imager is positioned outside the adapter housing (Schmitt; the adaptor 702 slidably couples with attachment 600 such that the attachment 600 can be slid into position with the camera when the functionality of attachment 600 is desired [0058], and frame 602 is configured to position each of the components 604, 606, and 608 in a known relationship with a camera of the smartphone; fig. 7, [0052]),
wherein the light guide receives light from the entrance aperture (Schmitt; proximal portion 614 of light pipe can be configured to optically couple with the light source of the smartphone; [0054]),
wherein the exit aperture is positioned between the imager and the lens (Schmitt; the adaptor 702 slidably couples with attachment 600 such that the attachment 600 can be slid into position with the camera when the functionality of attachment 600 is desired; fig. 7, [0058], and frame 602 is configured to position each of the components 604, 606, and 608 in a known relationship with a camera of the smartphone; fig. 7, [0052]), and
wherein the adaptor housing reduces ambient light outside the adaptor housing entering inside the adaptor housing (Schmitt; frame 602 houses components 604, 606, 608; fig. 6-8, [0052]. NOTE: When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112. Accordingly, because Schmitt discloses a frame 602 configured to house components 604, 606, and 608, which is comprised of a solid material, then the frame of Schmitt would be expected to have the same physical properties as the adaptor housing of applicants instantly claimed device).
Schmitt does not teach (e) a receptacle slot for holding an assay device for holding the object, wherein the receptacle slot is positioned outside of the adaptor housing and optically aligned with the exposure aperture. However, Fan teach the analogous art of a device for illuminating and imaging an object (Fan; fig. 3, #300, [0019]), comprising an adaptor housing comprising an exposure aperture (Fan teach an adaptor housing comprising an optical chamber above the sample holder 303; fig. 3, [0021]. The examiner notes that light passes from the light emitting diode 321 and travels through the sample holder to an image sensor 343 to image the sample holder; fig. 3, [0022]. Accordingly, the adaptor housing comprising an exposure aperture to allow the image to be processed by the sensor 343) and (e) a receptacle slot for holding an assay device for holding the object therein (Fan teach a sample holder 303 for holding device 311 for holding an object; fig. 3, [0021]) wherein the receptacle slot is positioned outside of the adaptor housing and optically aligned with the exposure aperture (Fan; fig. 3, ;0022]). It would have been obvious of ordinary skill in the art before the effective filing date to modify the device for illuminating and imaging of Schmitt to comprise a receptacle slot for holding a device position outside of the adaptor housing and facing the exposure aperture, as taught by fan, because fan teaches the receptacle slot for holding a device position outside the adaptor housing allows the image sensor 343 to receive light from a light source 307 below the sample holder 303 to illuminate the device to be imaged; [0019]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Schmitt and Fan both teach devices for illuminating and imaging comprising an adaptor housing.
Regarding claim 4, modified Schmitt teach a method for illuminating and imaging an object, the method comprising: (a) providing the device of claim 1 (The device of claim 1 has previously been discussed above); (b) inserting the assay device containing the object into the receptacle slot; (c) illuminating the object using the passive illuminator; and (d) imaging the object with the imager (The modification of the device for illuminating and imaging of Schmitt to comprise a receptacle slot for holding a device position outside of the adaptor housing and facing the exposure aperture, as taught by fan, has previously been discussed in claim 1 above. Fan disclose inserting the assay device containing the object into the receptacle slot (Fan; fig. 3, #311). Additionally, the modification of the device for illuminating and imaging an object of Schmitt to comprise the receptacle slot for holding the assay device would result in illuminating the object using the passive illuminator, and imaging the object with the imager of Schmitt; [0054, 0057-0058]).
Regarding claim 20, modified Schmitt teach the device of claim 1 above, wherein the passive illuminator has a rotationally symmetric shape (Schmitt; “the distal portion 616 comprises a ring with an aperture”, fig. 6, [0054]).
Regarding claim 21, modified Schmitt teach the device of claim 1 above, wherein the passive illuminator has a rotationally non-symmetric shape (Schmitt; proximal portion 614 is linear, fig. 6, [0054]).
Regarding claim 23, modified Schmitt teach the device of claim 1 above, wherein the passive illuminator has a shape of a convex polygon, a star polygon, an ellipse, or a circle (Schmitt; fig. 6, [0054]).
Regarding claim 27, modified Schmitt teach the device of claim 1 above, wherein the passive illuminator has a ring shape that surrounds an optical axis of the lens (Schmitt; figs. 7-8, [0058-0059]).
Regarding claim 30, modified Schmitt teach the device of claim 1 above, further comprising a light source that inputs light into one end of the passive illuminator (Schmitt; fig. 7, [0054]).
Regarding claim 32, modified Schmitt teach the device of claim 1 above, further comprising a light source that is supplied by a smartphone (Schmitt; fig. 7, [0054]).
Regarding claim 36, modified Schmitt teach the method of claim 4 above, wherein the assay device is a sample holder (The modification of the adapter housing of Schmitt, to further comprise a receptacle slot for holding an assay device therein, as taught by Fan, has previously been discussed in claims 1 and 4 above. Fan additionally teach the assay device for imaging is a sample holder 303/311; [0021-0022]).
Regarding claim 41, modified Schmitt teach the method of claim 4 above, wherein the assay device is a sample, and wherein the imaging is for a measurement of an analyte in the sample (The modification of the adapter housing of Schmitt, to further comprise a receptacle slot for holding an assay device therein, as taught by Fan, has previously been discussed in claims 1 and 4 above. Fan additionally teach the assay device is a sample for sample analysis; fig. 5, [0010, 0026-0029]. Note: What the image is for relates to function/intended use. However, functional language does not add any further structure to an apparatus beyond that of a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function. See MPEP 2114).
Regarding claim 52, modified Schmitt teach the device of claim 1 above, further the receptacle slot having two side walls forming a cavity for holding the assay device therein (The modification of the adapter housing of Schmitt, to further comprise a receptacle slot for holding a device therein, as taught by Fan, has previously been discussed in claim 1 above. Fan disclose the receptacle slot is formed by an upper side wall and bottom side wall and device 311 is inserted thereinto).
Regarding claim 53, modified Schmitt teach the device of claim 1 above, wherein the exposure aperture, the lens, the exit aperture, and the imager are optically aligned in sequence to create a light path from the exposure aperture to the imager (Schmitt teach the exposure aperture 624, lens 604, exit aperture between the lens of the camera on the smartphone and the frame 602, and the imager 700 are optically aligned in sequence from the exposure aperture to the imager; fig. 7).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Schmitt in view of Fan, and further in view of Kojima (US 2006/0209417; already of record - hereinafter “Kojima”).
Regarding claim 24, modified Schmitt discloses the device of claim 1 above, comprising the passive illuminator.
Modified Schmitt does not disclose wherein the passive illuminator is a single piece of illumination fiber.
However, Kojima discloses the analogous art of a passive illuminator for illuminating an object (Kojima; fig. 2, #5, [0039]), wherein the passive illuminator is a single piece of illumination fiber (Kojima; [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the passive illuminator of modified Schmitt to be a single piece of illumination fiber, as taught by Kojima, because Kojima teaches the single piece of illumination fiber may be manufactured from a resin material; [0039], thereby providing a cost effective and durable product with fewer components required. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Kojima both teach the mobile phone as a light source that direct light to a passive illuminator within an adaptor housing.
Claims 35, 37-38, 40, and 43-45 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt, in view of Fan, and Gausepohl (US 2006/0051253; already of record - hereinafter “Gausepohl”).
Regarding claim 35, modified Schmitt teach the device of claim 1 above comprising the assay device.
Modified Schmitt does not teach the assay device comprises a sample holder, wherein the sample holder comprises first plate, a second plate, and spacers, wherein one or both plates comprise a reagent.
However, Gausepohl teaches the analogous art an assay device (Gausepohl; fig. 1a, [0103]) wherein the assay device comprises a sample holder (Gausepohl; fig. 1a; [0103], “sample of biological material 2”), wherein the sample holder comprises a first plate, a second plate, and spacers (Gausepohl teach a sample holder comprising a first plate 1, a second plate 3, and spacers 4; Gausepohl; fig. 1a, #1, #3, #4, [0103]), wherein one or both plates comprise a reagent (Gausepohl; [0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assay device of modified Schmitt with the sample holder comprising a first plate, a second plate, and spacers, as taught by Gausepohl, because Gausepohl teaches the sample holder comprising the first plate, the second plate, and spacers provides the additional benefit of enclosing the sample between the first and second plate to allow individual treatment of the assay device with reagents, thereby preventing cross contamination; [0010-0013]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Gausepohl both teach an assay device for holding a sample.
Regarding claim 37, modified Schmitt teach the method of claim 4 above comprising the assay device.
Modified Schmitt does not teach wherein the assay device is a sample holder comprising a first plate, a second plate, and spacers.
However, Gausepohl teaches the analogous art an assay device (Gausepohl; fig. 1a, [0103]) wherein the assay device is a sample holder (Gausepohl; fig. 1a; [0103], “sample of biological material 2”) and comprises a first plate, a second plate, and spacers (Gausepohl teach a sample holder comprising a first plate 1, a second plate 3, and spacers 4; Gausepohl; fig. 1a, #1, #3, #4, [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assay device of modified Schmitt with the sample holder comprising a first plate, a second plate, and spacers, as taught by Gausepohl, because Gausepohl teaches the sample holder comprising the first plate, the second plate, and spacers provides the additional benefit of enclosing the sample between the first and second plate to allow individual treatment of the assay device with reagents, thereby preventing cross contamination; [0010-0013]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Gausepohl both teach an assay device for holding a sample.
Regarding claim 38, modified Schmitt teach the method of claim 4 above, comprising the assay device.
Modified Schmitt does not teach wherein the assay device is a sample holder comprising a first plate, a second plate, and spacers, wherein the spacers function as a location marker, a scale marker, an imaging marker, or any combination thereof.
However, Gausepohl teaches the analogous art an assay device (Gausepohl; fig. 1a, [0103]) wherein the assay device is a sample holder (Gausepohl; fig. 1a; [0103], “sample of biological material 2”) and comprises a first plate, a second plate, and spacers (Gausepohl teach a sample holder comprising a first plate 1, a second plate 3, and spacers 4; Gausepohl; fig. 1a, #1, #3, #4, [0103]) wherein the spacers function as a location marker, a scale marker, an imaging marker, or any combination thereof.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assay device of modified Schmitt with the sample holder comprising a first plate, a second plate, and spacers, as taught by Gausepohl, because Gausepohl teaches the sample holder comprising the first plate, the second plate, and spacers provides the additional benefit of enclosing the sample between the first and second plate to allow individual treatment of the assay device with reagents, thereby preventing cross contamination; [0010-0013]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Gausepohl both teach an assay device for holding a sample.
Note: What the spacer are for relates to function/intended use. However, functional language does not add any further structure to an apparatus beyond that of a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function. See MPEP 2114).
Regarding claim 40, modified Schmitt teach the method of claim 4 above comprising the assay device.
Modified Schmitt does not teach wherein the assay device is a sample holder comprising a first plate, a second plate, and spacers, wherein one or both plates comprise a reagent.
However, Gausepohl teaches the analogous art an assay device (Gausepohl; fig. 1a, [0103]) wherein the assay device is a sample holder (Gausepohl; fig. 1a; [0103], “sample of biological material 2”) and comprises a first plate, a second plate, and spacers (Gausepohl teach a sample holder comprising a first plate 1, a second plate 3, and spacers 4; Gausepohl; fig. 1a, #1, #3, #4, [0103]), wherein one or both plates comprise a reagent (Gausepohl; [0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assay device of modified Schmitt with the sample holder comprising a first plate, a second plate, and spacers, as taught by Gausepohl, because Gausepohl teaches the sample holder comprising the first plate, the second plate, and spacers provides the additional benefit of enclosing the sample between the first and second plate to allow individual treatment of the assay device with reagents, thereby preventing cross contamination; [0010-0013]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Gausepohl both teach an assay device for holding a sample.
Regarding claim 43, modified Schmitt teach the device of claim 1 above comprising a sample holder (The modification of the device for illuminating and imaging of Schmitt to comprise a receptacle slot for holding a device position outside of the adaptor housing and facing the exposure aperture, as taught by fan, has previously been discussed in claim 1 above. Fan disclose a slot 303/311 for holding a sample; fig. 3, #303, #311, [0019, 0021]).
Modified Schmitt does not teach wherein the sample holder comprises a first plate, a second plate, and spacers, and wherein the spacers have a predetermined substantially uniform height 200 microns or less, and a predetermined fixed inter-spacer-distance However, Gausepohl teaches the analogous art of a sample holder (Gausepohl; fig. 1a; [0103], “sample of biological material 2”), wherein the sample holder comprises a first plate, a second plate, and spacers (Gausepohl teach a sample holder comprising a first plate 1, a second plate 3, and spacers 4; Gausepohl; fig. 1a, #1, #3, #4, [0103]), and wherein the spacers have a predetermined substantially uniform height 200 microns or less, and a predetermined fixed inter-spacer-distance (Gausepohl addition teach a gap width of 0.075 mm and spacers 4 are at predetermined fixed distance near the top and bottom of the first and second plates; [0108]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sample holder of modified Schmitt with the sample holder comprising a first plate, a second plate, and spacers, as taught by Gausepohl, because Gausepohl teaches the sample holder comprising the first plate, the second plate, and spacers provides the additional benefit of enclosing the sample between the first and second plate to allow individual treatment of the assay device with reagents, thereby preventing cross contamination; [0010-0013]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Gausepohl both teach a method for holding a sample.
Regarding claim 44, modified Schmitt teach the device of claim 1 above comprising a sample holder (The modification of the device for illuminating and imaging of Schmitt to comprise a receptacle slot for holding a device position outside of the adaptor housing and facing the exposure aperture, as taught by fan, has previously been discussed in claim 1 above. Fan disclose a slot 303/311 for holding a sample; fig. 3, #303, #311, [0019, 0021]).
Modified Schmitt does not teach further comprising a sample holder, wherein the sample holder comprises a first plate, a second plate, and spacers, and wherein the spacers have a predetermined substantially uniform height 200 microns or less, a predetermined fixed inter-spacer-distance, and a periodic inter-spacer distance.
However, Gausepohl teaches the analogous art a sample holder (Gausepohl; fig. 1a; [0103], “sample of biological material 2”), wherein the sample holder comprises a first plate, a second plate, and spacers (Gausepohl teach a sample holder comprising a first plate 1, a second plate 3, and spacers 4; Gausepohl; fig. 1a, #1, #3, #4, [0103]), wherein the spacers have a predetermined substantially uniform height 200 microns or less, a predetermined fixed inter-spacer-distance, and a periodic inter-spacer distance (Gausepohl addition teach a gap width of 0.075 mm and spacers 4 are at predetermined fixed distance near the top and bottom of the first and second plates; [0108]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sample holder of modified Schmitt with the sample holder comprising a first plate, a second plate, and spacers, as taught by Gausepohl, because Gausepohl teaches the sample holder comprising the first plate, the second plate, and spacers provides the additional benefit of enclosing the sample between the first and second plate to allow individual treatment of the assay device with reagents, thereby preventing cross contamination; [0010-0013]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Gausepohl both teach a method for holding a sample.
Regarding claim 45, modified Schmitt teach the method of claim 4 above comprising the assay device.
Modified Schmitt does not teach wherein the assay device is a sample holder comprising a first plate, a second plate, and spacers, wherein the sample holder contains the object, and wherein the spacers have a predetermined substantially uniform height of 200 microns or less, a predetermined fixed inter-spacer-distance, and a periodic inter-spacer distance.
However, Gausepohl teaches the analogous art an assay device (Gausepohl; fig. 1a, [0103]) wherein the assay device is a sample holder (Gausepohl; fig. 1a; [0103], “sample of biological material 2”) comprising a first plate, a second plate, and spacers (Gausepohl teach a sample holder comprising a first plate 1, a second plate 3, and spacers 4; Gausepohl; fig. 1a, #1, #3, #4, [0103]), wherein the sample holder contains the object, and the spacers have a predetermined substantially uniform height of 200 microns or less, a predetermined fixed inter-spacer-distance, and a periodic inter-spacer distance (Gausepohl teach a gap width of 0.075 mm and spacers 4 are at predetermined fixed distance near the top and bottom of the first and second plates; [0108]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assay device of modified Schmitt with the sample holder comprising a first plate, a second plate, and spacers, as taught by Gausepohl, because Gausepohl teaches the sample holder comprising the first plate, the second plate, and spacers provides the additional benefit of enclosing the sample between the first and second plate to allow individual treatment of the assay device with reagents, thereby preventing cross contamination; [0010-0013]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Gausepohl both teach an assay device for holding a sample.
Claims 25, 31, 33, and 48-50 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt, in view of Fan, and Mather et al. (US 2011/0123184; already of record - hereinafter “Mather”).
Regarding claim 25, modified Schmitt discloses the device of claim 1 above, comprising the passive illuminator.
Modified Schmitt does not teach wherein the passive illuminator comprises at least two segments of illumination fibers, and wherein the at least two segments form a circular shape.
However, Mather teaches the analogous art of a device for illuminating and imaging an object (Mather; fig. 3, [0030, 0038]) comprising a passive illuminator (Mather; fig. 7a, #9, [0030]), and an imager (Mather; fig. 7a, #19, [0049]), wherein the passive illuminator comprises at least two segments of illumination fibers, and wherein the at least two segments form a circular shape (Mather teaches a passive illuminator 9 arranged to extract light at least through one surface; [0009, 0030], therefore comprising illumination fibers, wherein the passive illuminator comprises at least two segments that form a circular shape (Mather; fig. 7b, [0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the passive illuminator of modified Schmitt with the passive illuminator comprising at least two segments of illumination fibers, where the at least two segments form a circular shape, as taught by Mather, because Mather teaches the passive illuminator comprising the two segments of illumination fibers is merely one of many ways to configure the passive illuminator and light source for integration with an image capture device (Mather; fig. 7a-d, [0049-0051]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Mather both teach a device for illuminating and imaging an object comprising a passive illuminator, and an imager.
Regarding claim 31, modified Schmitt discloses the device of claim 1 above, comprising a light source that inputs light into the end of the passive illuminator (Schmitt; figs. 6-7, [0054])
Modified Schmitt does not teach the light source inputs light into both ends of the passive illuminator.
However, Mather teaches the analogous art of a passive illuminator comprising a light guide (Mather; fig. 7a, #9, [0030]) and a light source (Mather; fig. 7a, #8, [0030]) wherein the light source inputs light into both ends of the passive illuminator (Mather; fig. 7a).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the passive illuminator and light source of modified Schmitt with the configuration of the light source that inputs light into both ends of the passive illuminator, as taught by Mather, because Mather teaches the light source that inputs light into both ends of the passive illuminator is merely one of many ways to configure the passive illuminator and light source for integration with an image capture device (Mather; fig. 7a-d, [0049-0051]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Mather both teach an imager and light source for inputting light into a passive illuminator.
Regarding claim 33, modified Schmitt discloses the device of claim 1 above, comprising the passive illuminator for imaging an object.
Modified Schmitt does not teach the device further comprising a diffusor that is placed between the passive illuminator and the object.
However, Mather teaches the analogous art of a device for illuminating and imaging an object (Mather; fig. 3, [0030, 0038]) comprising a passive illuminator (Mather; fig. 7a, #9, [0030]), and an imager (Mather; fig. 7a, #19, [0049]), wherein the device further comprises a diffuser that is placed between the passive illuminator and the object (Mather teaches a diffuser 12 provided on the front face of the waveguide; fig 4a in view of fig. 3, #12, [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device for illuminating and imaging an object of modified Schmitt to further comprise a diffuser placed between the passive illuminator and the object, as taught by Mather, because Mather teaches the diffuser placed between the passive illuminator and the object makes the light emission from the face of the light guide more spatially uniform; [0043]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Mather both teach an apparatus for illuminating and imaging an object comprising a passive illuminator and an imager.
Regarding claim 48, modified Schmitt discloses the device of claim 1 above, comprising the passive illuminator.
Modified Schmitt does not teach the apparatus further comprises a diffuser for diffusing the light from the passive illuminator to the object.
However, Mather teaches the analogous art of a device for illuminating and imaging an object (Mather; fig. 3, [0030, 0038]) comprising a passive illuminator (Mather; fig. 7a, #9, [0030]), and an imager (Mather; fig. 7a, #19, [0049]), wherein the device further comprises a diffuser that is placed between the passive illuminator and the object (Mather teaches a diffuser 12 provided on the front face of the waveguide; fig 4a in view of fig. 3, #12, [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device for illuminating and imaging an object of modified Schmitt to further comprise a diffuser placed between the passive illuminator and the object, as taught by Mather, because Mather teaches the diffuser placed between the passive illuminator and the object makes the light emission from the face of the light guide more spatially uniform; [0043]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Mather both teach an apparatus for illuminating and imaging an object comprising a passive illuminator and an imager.
Regarding claim 49, modified Schmitt discloses the device of claim 48 above, comprising the passive illuminator and diffuser for diffusing the light from the passive illuminator to the object.
Modified Schmitt does not teach wherein the diffuser comprises at least one of the following: (a) polished surfaces on both sides; (b) a volume diffusive material which can be but not limited to opaque white glass and opaque white plastic, wherein the transmissivity of the volume diffusive material is at least 40%, 60%, 80%, 90%; and (c) at least one textured surface, wherein the volume diffusive material can be but not limited to opaque white glass and opaque white plastic, wherein the transmissivity of the volume diffusive material is at least 40%, 60%, 80%, 90%, and wherein the grit of the textured surface is at least 100, 200, 400, 600, 800, 1,000, or 2,000.
However, modified Schmitt does teach the passive illuminator comprising the diffuser for diffusing the light from the passive illuminator to the object.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the surface of the diffuser of modified Schmitt, to have a polished surface on both sides, because the diffuser with a polished surface on both sides for optical imaging provides the additional benefit of evenly distributing light from a source while eliminating bright spots. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt teaches a diffuser for optical imaging.
Regarding claim 50, modified Schmitt discloses the device of claim 48 above, comprising the passive illuminator and diffuser.
Modified Schmitt does not teach the apparatus further comprising a reflector configured to reflect light emitted from the passive illuminator towards the diffuser, or a reflector configured to reflect light emitted from the passive illuminator towards the exposure aperture of the optics chamber.
However, Mather teaches the analogous art of a device for illuminating and imaging an object (Mather; fig. 3, [0030, 0038]) comprising a passive illuminator (Mather; fig. 7a, #9, [0030]), and an imager (Mather; fig. 7a, #19, [0049]), wherein the device further comprises a reflector configured behind the passive illuminator (Mather; fig. 3a, [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device for illuminating and imaging an object of Schmitt to further comprise a reflector placed behind the passive illuminator, as taught by Mather, because Mather teaches the reflector placed behind the passive ensures light is not lost but is returned; [0043]. The modification resulting in the device of modified Schmitt having a reflector behind the passive illuminator, and therefore being configured to reflect light toward the exposure aperture of the optics chamber. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Schmitt and Mather both teach an apparatus for illuminating and imaging an object comprising a passive illuminator and an imager.
Claims 19, 26, 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt, in view of Fan, and Khosravi Simchi et al. (US 2018/0140196; already of record – hereinafter “Simchi”).
Regarding claim 19, modified Schmitt discloses the device of claim 1 above, comprising the passive illuminator.
Modified Schmitt does not teach wherein the passive illuminator is formed by an illumination fiber, wherein the illumination fiber comprises a core and a cladding layer, and wherein a ratio of transmissivity to reflectivity at an interface between the core and the cladding layer is at least 1:100, or wherein the passive illuminator is formed by an illumination fiber, and wherein the illumination fiber comprises one or more materials selected from the group consisting of a flexible polymer, a plastic, a glass and a rigid dielectric material.
However, Simchi teaches the analogous art of an apparatus for illuminating and imaging an object (Simchi; fig. 4, #10, [0095]), comprising: (a) an imager (Simchi; fig. 4, #91, [0136]), and c) a passive illuminator for illuminating the object (Simchi; fig. 10, #190, [0122]) wherein the passive illuminator is formed by an illumination fiber, wherein the illumination fiber comprises a core and a cladding layer, and wherein a ratio of transmissivity to reflectivity at an interface between the core and the cladding layer is at least 1:100, or wherein the passive illuminator is formed by an illumination fiber, and wherein the illumination fiber comprises one or more materials selected from the group consisting of a flexible polymer, a plastic, a glass and a rigid dielectric material (Simchi teaches the passive illuminator 190 includes a plurality of fibers 191 that capture light from the mobile device light source and internally reflect the light within the fibers 191 to deliver the light to a first end 194 of each fiber. The fibers 191 are made of a clear material including plastic and/or glass, and are coated with a material having a refractive index that is higher than the refractive index of fiber 191 to enhance the efficiency of light guide 190; [0122].).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the passive illuminator of modified Schmitt with the passive illuminator formed by an illumination fiber, and wherein the illumination fiber comprises one or more materials selected from the group consisting of a flexible polymer, a plastic, a glass and a rigid dielectric material, as taught by Simchi, because Simchi teaches the passive illuminator formed by an illumination fiber comprised of plastic and/or glass is merely one of several embodiments for passive illumination (Simchi; figs. 7-10, [0118-0122]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Simchi both teach a device for illuminating and imaging an object comprising an imager, and a passive illuminator.
Regarding claim 26, modified Schmitt discloses the device of claim 1 above.
Modified Schmitt does not teach wherein the passive illuminator has a uniform cross-section.
However, Simchi teaches the analogous art of an apparatus for illuminating and imaging an object (Simchi; fig. 4, #10, [0095]), comprising: (a) an imager (Simchi; fig. 4, #91, [0136]), and c) a passive illuminator for illuminating the object (Simchi; fig. 9, #180, [0120]) wherein the passive illuminator has a uniform cross-section (Simchi; fig. 9, #180, [0120]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the passive illuminator of modified Schmitt to have a uniform cross-section, as taught by Simchi, because Simchi teaches the shape of the passive illuminator can have different configurations to direct light from various sources; [0119, 0120, 0122]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Simchi both teach a device for illuminating and imaging an object comprising an imager, and a passive illuminator.
Regarding claim 28, modified Schmitt discloses the device of claim 1 above, comprising the passive illuminator.
Modified Schmitt does not teach wherein the passive illuminator is an illumination fiber, wherein the illumination fiber comprises a core and a cladding layer, wherein a ratio of transmissivity to reflectivity at an interface between the core and the cladding layer is a value between 1:100 and 1:10.
However, Simchi teaches the analogous art of an apparatus for illuminating and imaging an object (Simchi; fig. 4, #10, [0095]), comprising: (a) an imager (Simchi; fig. 4, #91, [0136]), and c) a passive illuminator for illuminating the object (Simchi; fig. 10, #190, [0122]) wherein the passive illuminator is an illumination fiber, wherein the illumination fiber comprises a core and a cladding layer, wherein a ratio of transmissivity to reflectivity at an interface between the core and the cladding layer is a value between 1:100 and 1:10 (Simchi teaches the passive illuminator 190 includes a plurality of fibers 191 that capture light from the mobile device light source and internally reflect the light within the fibers 191 to deliver the light to a first end 194 of each fiber. The fibers 191 are made of a clear material including plastic and/or glass, and are coated with a material having a refractive index that is higher than the refractive index of fiber 191 to enhance the efficiency of light guide 190; [0122]. The examiner notes the fibers 191 made of plastic and/or glass and coated with a material having a refractive index that is higher than the refractive index of fiber 191 is structurally equivalent to the illumination fiber disclosed in para. [0235] of applicants printed publication, which states “the passive illuminator can be formed by a side illumination fiber, wherein the side illumination fiber is made of but not limited to flexible polymers, plastic, glass and rigid dielectric materials.”, and would therefore be functionally capable of having a ratio of transmissivity to reflectivity at an interface between the core and the cladding of between 1:100 and 1:10).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the passive illuminator of modified Schmitt with the passive illuminator formed by an illumination fiber, wherein a ratio of transmissivity to reflectivity at an interface between the core and the cladding layer is a value between 1:100 and 1:10, as taught by Simchi, because Simchi teaches the passive illuminator formed by an illumination fiber comprised of plastic and/or glass is merely one of several embodiments for passive illumination (Simchi; figs. 7-10, [0118-0122]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Simchi both teach a device for illuminating and imaging an object comprising an imager, and a passive illuminator.
Regarding claim 29, modified Schmitt discloses the device of claim 1 above, comprising the passive illuminator.
Modified Schmitt does not teach wherein the passive illuminator is an illumination fiber, wherein the illumination fiber comprises a core and a cladding layer, wherein a ratio of transmissivity to reflectivity at an interface between the core and the cladding layer is 1:10 to 1:1.
However, Simchi teaches the analogous art of an apparatus for illuminating and imaging an object (Simchi; fig. 4, #10, [0095]), comprising: (a) an imager (Simchi; fig. 4, #91, [0136]), and c) a passive illuminator for illuminating the object (Simchi; fig. 10, #190, [0122]) wherein the passive illuminator is an illumination fiber, wherein the illumination fiber comprises a core and a cladding layer, wherein a ratio of transmissivity to reflectivity at an interface between the core and the cladding layer is 1:10 to 1:1 (Simchi teaches the passive illuminator 190 includes a plurality of fibers 191 that capture light from the mobile device light source and internally reflect the light within the fibers 191 to deliver the light to a first end 194 of each fiber. The fibers 191 are made of a clear material including plastic and/or glass, and are coated with a material having a refractive index that is higher than the refractive index of fiber 191 to enhance the efficiency of light guide 190; [0122]. The examiner notes the fibers 191 made of plastic and/or glass and coated with a material having a refractive index that is higher than the refractive index of fiber 191 is structurally equivalent to the illumination fiber disclosed in para. [0235] of applicants printed publication, which states “the passive illuminator can be formed by a side illumination fiber, wherein the side illumination fiber is made of but not limited to flexible polymers, plastic, glass and rigid dielectric materials.”, and would therefore be functionally capable of having a ratio of transmissivity to reflectivity at an interface between the core and the cladding of between 1:100 and 1:10).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the passive illuminator of modified Schmitt with the passive illuminator formed by an illumination fiber, wherein a ratio of transmissivity to reflectivity at an interface between the core and the cladding layer is a value between 1:100 and 1:10, as taught by Simchi, because Simchi teaches the passive illuminator formed by an illumination fiber comprised of plastic and/or glass is merely one of several embodiments for passive illumination (Simchi; figs. 7-10, [0118-0122]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Simchi both teach a device for illuminating and imaging an object comprising an imager, and a passive illuminator.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Schmitt, in view of Fan, and GSMArena Apple iPhone 6s (https://web.archive.org/web/20160304054443/https://www.gsmarena.com/apple_iphone_6s-7242.php – hereinafter “GSMArena”; already of record).
Regarding claim 22, modified Schmitt discloses the device of claim 1 above, wherein the passive illuminator has a shape of a ring having a diameter thereof and a substantially uniform cross-section (Schmitt discloses the passive illuminator 606 has a ring shape [0054] and is configured to surround the camera of a smartphone; fig. 8, [0059].
Modified Schmitt does not explicitly teach the ring having a diameter in a range between 5 mm and 100 mm.
However, GSMArena teaches the analogous art of a smartphone, wherein the smartphone comprises a camera with a 29 mm and 31 mm lens.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the smartphone of modified Schmitt with an iPhone 6s smartphone having a camera with a 29 mm and 31 mm lens, as taught by GSMArena, because GSMArena teaches the iPhone 6s smartphone was a commonly used iPhone at the time of Schmitt’s disclosure. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and GSMArena both teach smartphones with cameras.
Claims 34 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt, in view of Fan, Gausepohl, and Walker (“Topical Tips: The multipurpose micrometer slide—much more than just for calibration”, October 2015, Miscape, Issue 234-235, ISSN 1365-070x, http://www.microscopy-uk.org.uk/mag/indexmag.html?http://www.microscopy-uk.org.uk/mag/artoct15/dw-micrometer.html; already of record – hereinafter “Walker”).
Regarding claim 34, modified Schmitt disclose the device of claim 1 above comprising the assay device.
Modified Schmitt does not teach the assay device comprises a sample holder, wherein the sample holder comprises a first plate, a second plate, and spacers, and the plates sandwich a sample into a thin layer.
However, Gausepohl teaches the analogous art an assay device (Gausepohl; fig. 1a, [0103]) wherein the assay device comprises a sample holder (Gausepohl; fig. 1a; [0103], “sample of biological material 2”) and comprises a first plate, a second plate, and spacers (Gausepohl teach a sample holder comprising a first plate 1, a second plate 3, and spacers 4; Gausepohl; fig. 1a, #1, #3, #4, [0103]), and the first plate and second plates are configured to sandwich a sample into a thin layer (Gausepohl teaches samples are attached to the first plate 1 in which the second plate 3 is posed across the first plate 1 with a capillary gap 9 formed between the first and second plates; [0094] with a gap width of 0.075 mm; [0108]. Accordingly, a sample suspended between the first and second plate by capillary forces formed by gap 9 being “sandwiched” into a thin layer).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assay device of modified Schmitt with the sample holder comprising a first plate, a second plate, and spacers, as taught by Gausepohl, because Gausepohl teaches the sample holder comprising the first plate, the second plate, and spacers provides the additional benefit of enclosing the sample between the first and second plate to allow individual treatment of the assay device with reagents, thereby preventing cross contamination; [0010-0013]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Gausepohl both teach an assay device for holding a sample.
Modified Schmitt does not teach wherein one or both plates comprise a scale marker.
However, Walker teaches the analogous art of a plate (Walker; image “2”, “Motic calibration slide”, paragraph 5) comprising a scale marker (Walker; image “2”, “Motic calibration slide”, paragraph 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify one or both plates of modified Schmitt to further comprise a scale marker, as taught by Walker, because Walker teaches the plate comprising a scale marker allows calibration of the imaging software used by the device (Walker; image “2”, “Motic calibration slide”, paragraph 5). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Walker both teach a device3 for imaging comprising a plate.
Regarding claim 39, modified Schmitt teaches the method of claim 4 above comprising the object.
Modified Schmitt does not teach wherein the assay device is a sample holder comprising a first plate, a second plate, and spacers.
However, Gausepohl teaches the analogous art an assay device (Gausepohl; fig. 1a, [0103]) wherein the assay device is a sample holder (Gausepohl; fig. 1a; [0103], “sample of biological material 2”) and comprises a first plate, a second plate, and spacers (Gausepohl teach a sample holder comprising a first plate 1, a second plate 3, and spacers 4; Gausepohl; fig. 1a, #1, #3, #4, [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assay device of modified Schmitt with the sample holder comprising a first plate, a second plate, and spacers, as taught by Gausepohl, because Gausepohl teaches the sample holder comprising the first plate, the second plate, and spacers provides the additional benefit of enclosing the sample between the first and second plate to allow individual treatment of the assay device with reagents, thereby preventing cross contamination; [0010-0013]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Gausepohl both teach an assay device for holding a sample.
Modified Schmitt does not teach wherein one or both plates comprise a scale marker.
However, Walker teaches the analogous art of a plate (Walker; image “2”, “Motic calibration slide”, paragraph 5) comprising a scale marker (Walker; image “2”, “Motic calibration slide”, paragraph 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify one or both plates of modified Schmitt to further comprise a scale marker, as taught by Walker, because Walker teaches the plate comprising a scale marker allows calibration of the imaging software used by the device (Walker; image “2”, “Motic calibration slide”, paragraph 5). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Walker both teach a device for imaging comprising a plate.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Schmitt, in view of Fan, and further in view of Spivey et al. (US 2001/0034068; already of record - hereinafter “Spivey”).
Regarding claim 42, modified Schmitt teach the method of claim 4 above comprising the object.
Modified Schmitt does not teach wherein the object is a sample comprising a biological sample selected from the group consisting of amniotic fluid, aqueous humour, vitreous humour, blood, breast milk, cerebrospinal fluid (CSF), cerumen (earwax), chyle, chime, endolymph, perilymph, feces, breath, gastric acid, gastric juice, lymph, mucus, pericardial fluid, peritoneal fluid, pleural fluid, pus, rheum, saliva, exhaled breath condensates, sebum, semen, sputum, sweat, synovial fluid, tears, vomit, and urine.
However, Spivey teaches the analogous art of an imager (Spivey; fig. 4, #34, [0047]) for imaging an object 10 (Spivey; fig. 4, [0047]), wherein the object is a sample comprising urine (Spivey; [0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method for illuminating and imaging an object of modified Schmitt with the method of illuminating and imaging an object wherein the object is a sample comprising urine, as taught by Spivey, because Spivey teaches the method of illuminating and imaging an object wherein the object is a sample comprising urine may be used to determine the outcome of precipitation reactions, reactions based on electrophoresis, immunoelectrophoresis, immunofixation electrophoresis, enzyme immunoassay and immunofluorescence; [0142]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Spivey both teach an imager for imaging an object.
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Schmitt, in view of Fan, Gausepohl, and further in view of Kojima.
Regarding claim 46, modified Schmitt discloses the method of claim 45, further comprising:
(a) impinging light into one light-guide, that is different from the light guide of the passive illuminator, the light guide connecting to one end of the passive illuminator (Schmitt; fig. 6, #614, [0054]);
(b) causing the impinging light to travel through the light-guide to reach the corresponding end of the passive illuminator (Schmitt; fig. 6, #616, [0054]);
(c) causing light to be emitted from a side wall of the passive illuminator after the impinging light enters the corresponding end of the passive illuminator (Schmitt; fig. 6, [0054]);
(d) generating illumination light from the light emitted from the side wall of the passive illuminator (Schmitt; fig. 6, [0054]);
(e) illuminating the object through one of the first and second plates with the illumination light (The modification of the object of modified Schmitt with the sample holder comprising the first plate, the second plate, and spacers, as taught by Gausepohl, has previously been discussed in claim 45 above. The modification illuminating the object through the first and second plates); and
(f) imaging the object with an imaging sensor through the lens (Schmitt; frame 602 includes an opening for allowing the camera of the smartphone to capture images therethrough, [0052]).
Modified Schmitt does not teach two light-guides that are different from the light guide of the passive illuminator, each of the light guides connecting to one end of the passive illuminator, light travel through each light-guide.
However, Kojima teaches the analogous art of an apparatus for illuminating and imaging an object (Kojima; fig. 1, [0035]), comprising: (a) a mobile phone that has a camera as an imager and a light source (Kojima; figs. 1 & 3, #1, #4a, #4b, [0035, 0038]), and c) a passive illuminator for illuminating the object (Kojima; fig. 2, #5, [0039]), wherein the passive illuminator comprises a light guide (Kojima; fig. 3, #5a, [0040]) and two light guides that are different from the light guide of the passive illuminator, each of the light guides connecting to one end of the passive illuminator, light travel through each light-guide (Kojima; fig. 3, #5a1, #5a2, [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the light guide 614 of modified Schmitt with the two light guides, as taught by Kojima, because Kojima teaches the two light guides change the directions of the luminous fluxes emitted and condensed; [0040]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Kojima both teach an apparatus for illuminating and imaging an object with a passive illuminator and light source.
Claims 54 is rejected under 35 U.S.C. 103 as being unpatentable over Schmitt, in view of Fan, Gausepohl, Walker, and Tcherkassov (US 2005/0227231 – hereinafter “Tcherkassov”).
Regarding claim 54, modified Schmitt teach the device of claim 34 above, comprising the first plate, the second plate, and the spacer, wherein the spacers are arranged periodically and have an inter-space distance (Gausepohl teach a gap width of 0.075 mm and spacers 4 are at predetermined fixed distance near the top and bottom of the first and second plates; [0108]).
Modified Schmitt does not teach wherein one of the first plate and the second plate is flexible plate, the fourth power of the inter-space-distance (ISD) divided by the thickness of the flexible plate (h) and the Young’s modulus (E) of the flexible plate, ISD4/(hE), is equal to or less than 106 µm3/GPa.
However, Tcherkassov teach the analogous art of a first plate, a second plate, and spacers (Tcherkassov; fig. 6B, #222, #223, [0106]), wherein the spacers form a channel between the plates having a height between 5 and 200 µm, a width between 0.1 and 10 mm, a length 10 and 40 mm, wherein the plates and spacers are constructed of PMMA or polycarbonate Tcherkassov; [0106]. Accordingly, the PMMA or polycarbonate plates and spacers would be expected to have the same physical properties as the claimed invention in view of paragraph [0358] of applicant’s printed publication which disclose the materials of the plate and spacers are selected from PMMA or PC). NOTE: When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify at least one of the first and second plate and the spacer of modified Schmitt with at least one of the first and second plate and the spacer constructed of PMMA or polycarbonate, as taught by Tcherkassov, because Tcherkassov teach the plate and spacer made of PMMA or polycarbonate are suitable for high resolution imaging allowing better identification of signals of individual molecules; [0087]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Tcherkassov both teach a device to imaging a sample between two plates.
Claim(s) 3, 8, 14, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt in view of Fan and Mather.
Regarding claim 3, Schmitt discloses an apparatus for illuminating and imaging and object (Schmitt; fig. 7, [0058]), comprising:
(a) a mobile phone that has a camera as an imager and a light source (Schmitt; “smartphone 700 that includes a camera”, fig. 7, [0054, 0058]);
(b) a lens (Schmitt; fig. 6, #604, [0052]);
(c) a passive illuminator and a light guide for illuminating the object (Schmitt; fig. 6, #606, #616, [0054]), wherein the passive illuminator optically connects with the light guide (Schmitt disclose passive illuminator 616 optically connects with the light guide 614; [0054]), accepts light from one or both ends of the light guide (Schmitt; fig. 6, [0054]), and emits the light from a side wall of the passive illuminator for illuminating the object (Schmitt; fig. 6, #616, [0054]. Schmitt discloses the distal portion 616 illuminates “the camera’s field of view” and “the aperture 624 has a portion sized and located to allow light conducted through the light pipe606 to be emitted from the distal portion 616 of the light pip 606 to illuminate the area in front of the contact member 610”; [0057]. The examiner notes the term “field of view” with respect to a camera describes the viewable area that can be imaged by a lens system, and is different from an “area in front of contact member 610”, later described in [0057]. Accordingly, the distal portion 616 emits light from a sidewall to illuminate the field of view through lens 604 and out of aperture 624 to illuminate the area in from of the contact member 610),
(d) an adaptor housing (Schmitt; fig. 6, 602/610, [0052]) comprising an optical chamber that has an exit aperture (Schmitt; the adaptor 702 slidably couples with attachment 600 such that the attachment 600 can be slid into position with the camera when the functionality of attachment 600 is desired, figs. 6 & 7, [0058], and frame 602 is configured to position each of the components 604, 606, and 608 in a known relationship with a camera of the smartphone; fig. 7, [0052]. Accordingly, cylindrical portion of frame 602 that houses the components is an optical chamber having an exit aperture between the lens of the camera on the smartphone and the frame 602 to allow the components to functionally attach and capture images; fig. 8, [0059]), an entrance aperture (Schmitt; the proximal portion of light guide 614 is configured to optically couple with the light source of the smartphone; [0054]. Therefore, the device 600 comprises an entrance aperture at the interface between the light source from the smartphone 700 and the proximal end of the passive illuminator 614), and an exposure aperture (Schmitt; fig. 6, #624, [0057]);
(g) one or two light-guides (Schmitt; fig. 6, #614, [0054]),
wherein the passive illuminator and the lens are positioned inside the adaptor housing (Schmitt; frame 602 houses components 604, 606, 608; fig. 6, [0052]), the passive illuminator surrounds the lens (Schmitt; the distal portion 616 comprises a ring with an aperture, an axis of the aperture can be aligned with an axis of the lens 604; fig. 6, [0054]), and the imager is positioned outside the optical chamber (Schmitt; the adaptor 702 slidably couples with attachment 600 such that the attachment 600 can be slid into position with the camera when the functionality of attachment 600 is desired [0058], and frame 602 is configured to position each of the components 604, 606, and 608 in a known relationship with a camera of the smartphone; fig. 7, [0052]);
wherein the lightguide receives light from the entrance aperture (Schmitt; proximal portion 614 of light pipe can be configured to optically couple with the light source of the smartphone; [0054]);
wherein the exit aperture is positioned between the imager and the lens (Schmitt; the adaptor 702 slidably couples with attachment 600 such that the attachment 600 can be slid into position with the camera when the functionality of attachment 600 is desired; fig. 7, [0058], and frame 602 is configured to position each of the components 604, 606, and 608 in a known relationship with a camera of the smartphone; fig. 7, [0052]), wherein the imager, the exit aperture, the lens, and the exposure aperture are optically aligned for imaging the object (Schmitt; frame 602 can align the optical axis of the lens 604 with an optical axis of the camera of the smartphone; figs. 6-8, [0052], an axis of the aperture of the distal portion 616 of the light pipe can be aligned with an axis of the lens 604; [0054], and the exposure aperture 624 on contact member 610 is optically aligned with lens 604; fig. 7);
wherein the adaptor housing reduces ambient light outside the adaptor housing entering inside the adaptor housing (Schmitt; frame 602 houses components 604, 606, 608; fig. 6-8, [0052]. NOTE: When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112. Accordingly, because Schmitt discloses a frame 602 configured to house components 604, 606, and 608, which is comprised of a solid material, then the frame of Schmitt would be expected to have the same physical properties as the adaptor housing of applicants instantly claimed device); and
wherein the one or two light-guides are different from the light guide of the passive illuminator, each having an end thereof aligned with the entrance aperture of the optical chamber to cause light entering such end of the light-guide to travel through the light-guide to reach a corresponding end of the passive illuminator, wherein the passive illuminator has a first end optically coupled to a second end of the light-guide to cause light received at the first end of each light-guide to travel through the light-guide to enter the first end of the passive illuminator (Schmitt disclose the proximal portion of light guide 614 is configured to optically couple with the light source of the smartphone and the distal portion is coupled with the passive illuminator 616 and light guide 606 such that light is directed from 614 towards 616 to illuminate the field of view of the camera; fig. 6, [0054]).
Schmitt does not teach (e) a receptacle slot for holding an assay device for holding the sample, wherein the receptacle slot is positioned outside of the adaptor housing and optically aligned with the exposure aperture, the imager, the exit aperture, and the lens, for imaging the object in the assay device positioned in the receptacle slot, or a diffuser placed at a predetermined distance from an illuminator, wherein the diffuser is configured to intercept all direct light paths between the illuminator and the exposure aperture of the optical chamber.
However, Fan teach the analogous art of a device for illuminating and imaging an object (Fan; fig. 3, #300, [0019]), comprising a mobile phone that has a camera as an imager (Fan; fig. 3, #343, [0018]), a lens (Fan; fig. 3, #301, [0019]), an adaptor housing comprising an exit aperture, and an exposure aperture (Fan teach an adaptor housing comprising an optical chamber above the sample holder 303; fig. 3, [0021]. The examiner notes that light passes from the light emitting diode 321 and travels through the sample holder to an image sensor 343 to image the sample holder; fig. 3, [0022]. Accordingly, the device and adaptor housing comprises an exit aperture, an exposure aperture, and a lens optically aligned to allow the image to be processed by the sensor 343) and (e) a receptacle slot for holding an assay device therein (Fan teach a sample holder 303 for holding device 311; fig. 3, [0021]) wherein the receptacle slot is positioned outside of the adaptor housing and optically aligned with the exposure aperture, the imager, the exit aperture, and the lens, for imaging the object in the assay device positioned in the receptacle slot (Fan; fig. 3, ;0022]), and a diffuser placed at a predetermined distance from an illuminator, wherein the diffuser is configured to intercept all direct light paths between the illuminator and the exposure aperture of the optical chamber (Fan; fig. 3, #329, [0021]).
It would have been obvious of ordinary skill in the art before the effective filing date to modify the device for illuminating and imaging of Schmitt to comprise a receptacle slot for holding a device position outside of the adaptor housing and optically aligned with the exposure aperture, the image, the exit aperture, and the lens for imaging the object, and a diffuser placed at predetermined distance from the illuminator, as taught by fan, because fan teaches the receptacle position for holding a device outside the adaptor housing allows the image sensor 343 to receive light from a light source 307 to illuminate the object being imaged; [0019], and the diffuser allows output light from a light source to be diffused and/or reflected toward the object for imaging; [0021]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Schmitt and Fan bot teach devices for illuminating and imaging comprising an adaptor housing.
Modified Schmitt does not teach an opening on the diffuser is configured to expose to the camera of the mobile phone at least a part of the exposure aperture when the apparatus is engaged with the mobile phone.
However, Mather teaches the analogous art of a device for illuminating and imaging an object (Mather; fig. 3, [0030, 0038]) comprising a passive illuminator (Mather; fig. 7a, #9, [0030]), an imager (Mather; fig. 7a, #19, [0049]), and a diffuser (Mather; fig. 3, #12, #15, [0031]) and an opening on the diffuser is configured to expose to the camera of the mobile phone at least a part of the exposure aperture when the apparatus is engaged with the mobile phone (Mather teach the diffusers 12 and 15 are spaced from the passive illuminator 9 and are optically placed over the output face of the passive illuminator where in the embodiments of figures 7 the diffuser would comprise an opening; figs. 3 & 7, [0031. Diffuser 12 is provided on the front face of the waveguide; [0043], and the exposure aperture with respect to the camera of the mobile phones is not obstructed by the lightguide 9 comprising the diffuser 12; fig. 7a, [0049]). Accordingly, Mather discloses an opening on the diffuser (i.e. provided on the front face of the waveguide) and is configured to expose the exposure aperture to the camera of the mobile phone when the device is engaged with the mobile phone).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the diffuser of modified Schmitt with an opening on the diffuser is configured to expose to the camera of the mobile phone at least a part of the exposure aperture when the apparatus is engaged with the mobile phone, as taught by Mather, because Mather teaches the diffuser with an opening on the diffuser configured to expose to the camera of the mobile phone at least a part of the exposure aperture when the apparatus is engaged with the mobile phone makes the light emission from the face of the light guide more spatially uniform, or the angular output of light from the flash more uniform; [0043]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Mather both teach a device for illuminating and imaging an object comprising a passive illuminator, and an imager.
Regarding claim 8, modified Schmitt teach the apparatus of claim 3 above, wherein the passive illuminator is in a form of a ring configured to surround an optical axis of the lens (Schmitt; fig. 6, [0054]).
Regarding claim 14, modified Schmitt teach the apparatus of claim 3 above, wherein the exit aperture is disposed at a first side of the adaptor housing (Schmitt; exit aperture aligns with camera on smart phone), the exposure aperture is disposed at a second side of the adaptor housing (Schmitt; exposure aperture 624 is on an opposite side of the housing as the exit aperture which aligns with the camera on the smartphone; fig. 6), wherein the light guide has a first end aligned with the entrance aperture of the adaptor housing (Schmitt; [0054]), and wherein each of the entrance aperture, the exit aperture, and the exposure aperture is optionally or removably covered with a window (Schmitt; figs. 6-8. Note: The exit aperture, the exposure aperture, and the entrance aperture have previously been discussed in claim 3 above).
Regarding claim 17, modified Schmitt discloses the apparatus of claim 3 above, wherein the diffuser is configured to make illumination on the object more uniform than without the diffuser (The modification of the diffuser of modified Schmitt with an opening on the diffuser is configured to expose to the camera of the mobile phone at least a part of the exposure aperture when the apparatus is engaged with the mobile phone, as taught by Mather, has previously been discussed in claim 3 above. Mather teach the diffuser to make the light emission from the face of the light guide more spatially uniform, or the angular output of light from the flash more uniform; [0043]).
Regarding claim 18, modified Schmitt discloses the apparatus of claim 3 above.
Modified Schmitt does not explicitly teach wherein the distance between the passive illuminator and an outside peripheral of the imager is in a range of 2 mm to 50 mm.
However, Schmitt does teach a distance between the passive illuminator and an outside peripheral of the imager (Schmitt teaches the passive illuminator 606 is disposed within the adaptor 602 that attaches to the mobile phone; fig. 7, [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the distance between the passive illuminator and an outside peripheral of the imager of Schmitt such that the distance is in a range of 2 mm to 50 mm, because the distance between the passive illuminator and an outside peripheral of the imager in the range of 2 mm to 50 mm is a design choice that would achieve a desired focal length between the lens 604 optically aligned within the passive illuminator 606 and the camera on the smart phone, thereby achieving the ability to focus on objects at various distances; [0054]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Schmitt teaches a distance between the passive illuminator and the outside peripheral of the imager for imaging an object.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Schmitt in view of Fan and Mather, and further in view of Larsen (US 2005/0148085; already of record – hereinafter “Larsen”).
Regarding claim 9, modified Schmitt discloses the apparatus of claim 3 above, further comprising a lens in the camera of the mobile phone (Schmitt discloses smartphone 700 comprises a camera; fig. 7, [0058]. NOTE: When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112. Accordingly, because Schmitt discloses a smartphone that includes a camera, then the smartphone camera of Schmitt would be expected to have the same physical lens as the smartphone lens of applicants instantly claimed device), and the adaptor housing (Schmitt; fig. 6, 602/610, [0052]).
Modified Schmitt does not teach an auxiliary lens having an optical axis aligned with an optical axis of the lens in the camera of the mobile phone when the adaptor housing is engaged with the mobile phone, wherein the auxiliary lens has a diameter in a range of 2 mm to 15 mm.
However, Larsen teaches the analogous art of a camera (Larsen; fig. 14, #1401, [0338]) comprising a lens and an auxiliary lens having an optical axis aligned with an optical axis of the camera (Larsen; fig. 14, #1402, [0338, 0342]) wherein the auxiliary lens has a diameter that is 9mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the apparatus for illuminating and imaging an object of modified Schmitt to further comprise an auxiliary lens having an optical axis aligned with an optical axis of the lens in the camera, wherein the auxiliary lens has a diameter of 9 mm, as taught by Larsen, because Larsen teaches the auxiliary lens is used for focusing the system and imaging a volume inside the sample compartments with the camera; [0338] and the auxiliary lens having a diameter of 9 mm is a low-cost achromatic lens with a focal length of 50 mm (Larsen; [0342]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Larsen both teach imaging systems comprising a lens and a camera for imaging an object.
Claims 10 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt, in view of Fan, Mather, and Kojima.
Regarding claim 10, modified Schmitt discloses the apparatus of claim 3 above.
Modified Schmitt does not teach the apparatus further comprising an optical condenser configured to be placed in front of the light source of the mobile phone when the device is engaged with the mobile phone, or an optical condenser aligned with the entrance aperture of the adaptor housing.
However, Kojima teaches the analogous art of an apparatus for illuminating and imaging an object (Kojima; fig. 1, [0035]), comprising: (a) a mobile phone that has a camera as an imager and a light source (Kojima; figs. 1 & 3, #1, #4a, #4b, [0035, 0038]), and c) a passive illuminator for illuminating the object (Kojima; fig. 2, #5, [0039]), wherein the passive illuminator comprises a light guide (Kojima; fig. 3, #5a, [0040]) that accepts light from one or both ends of the light guide (Kojima; fig. 3, #5a1, #5a2, [0040]), and d) an adaptor housing (Kojima discloses an adaptor housing 2 that is removably mounted on the camera-equipped cellular phone 1; figs. 1 & 2, #2, [0035]) further comprising an optical condenser configured to be placed in front of the light source of the mobile phone when the device is engaged with the mobile phone, or an optical condenser aligned with the entrance aperture of the adaptor housing (Kojima; fig. 3, #9, [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the apparatus of modified Schmitt to further comprise an optical condenser configured to be plated in front of the light source of the mobile phone when the device is engaged with the mobile phone, as taught by Kojima, because Kojima teaches the optical condenser condenses a luminous flux emitted from the light source of mobile device (Kojima; [0038]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Kojima both teach the mobile phone as a light source that direct light to a passive illuminator within an adaptor housing.
Regarding claim 47, modified Schmitt discloses the apparatus of claim 3 above, wherein the one or two light-guides and the passive illuminator are jointly formed by an optical fiber, (Schmitt; fig. 6, #614, #616, [0054]).
Modified Schmitt does not teach the one or two light-guides and the passive illuminator are jointly formed by an optical fiber.
However, Kojima discloses the analogous art of a passive illuminator for illuminating an object (Kojima; fig. 3, #5h, [0039, 0041]) and one or two light-guides (Kojima; fig. 3, #5a, #5a1, #5a2, [0039-0040]), wherein the passive illuminator and the one or two light-guides are jointly formed by an optical fiber (Kojima; figs. 3-5, [0039-0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the passive illuminator and one or two light-guides of modified Schmitt to be jointly formed by an optical fiber, as taught by Kojima, because Kojima teaches the single piece of illumination fiber may be manufactured from a resin material; [0039], thereby providing a cost effective and durable product with fewer components required. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Kojima both teach the mobile phone as a light source that direct light to a passive illuminator within an adaptor housing.
Claims 15 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt in view of Fan, Mather, and Gausepohl.
Regarding claim 15, modified Schmitt teach the apparatus of claim 14 above, wherein the exit aperture is optically aligned with the exposure aperture, the receptacle slot is configured to hold the assay device (The exit aperture being optically aligned with the exposure aperture has previously been discussed in claim 3 above. Further, the modification of the adapter housing of Schmitt to comprise a receptacle slot for holding an assay device therein, as taught by Fan, has previously been discussed in claim 3 above).
Modified Schmitt does not teach the assay device comprises a first plate and a second plate.
However, Gausepohl teaches the analogous art of an assay device (Gausepohl; fig. 1a; [0103], “sample of biological material 2”) wherein the assay device comprising a first and a second plates (Gausepohl teach a first plate 1 and a second plate 3 that are parallel; Gausepohl; fig. 1a, #1, #3, [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assay device of modified Schmitt with the assay device comprising parallel plates, as taught by Gausepohl, because Gausepohl teaches the assay device comprising parallel plates provides the additional benefit of enclosing the sample between the first and second plate to allow individual treatment of the assay device with reagents, thereby preventing cross contamination; [0010-0013]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Gausepohl both teach an assay device for imaging an object.
Regarding claim 51, modified Schmitt teach the apparatus of claim 3 above, wherein
(a) the receptacle slot operative to hold the assay device while exposing at least part of the assay device to a lens in the camera of the mobile phone when the assay device is inserted into the receptacle slot and the apparatus is engaged with the mobile phone (The modification of the adapter housing of Schmitt to further comprise a receptacle slot for holding an assay device therein, as taught by Fan, has previously been discussed in claim 1 above. The modification would be capable of having a configuration to expose at least part of the assay device to a lens in the camera of the mobile phone when the assay device is inserted into the receptacle slot and the apparatus is engaged with the mobile phone); or
(b) the receptacle slot operative to hold the assay device while exposing at least part of the assay device to the exposure aperture of the optics chamber when the assay device is inserted into the receptacle slot; or
(c) the receptacle slot having two side walls forming a cavity for holding the assay device therein, wherein one of the two side walls has an opening for forming the exposure aperture of the optics chamber,
wherein the light-guide has the first end configured to receive light from the light source of the mobile phone when the apparatus is engaged with the mobile phone (Schmitt; fig. 7, [0054]).
Modified Schmitt does not teach the assay device comprises a first plate and a second plate, or exposing at least part of the first plate in the assay device to a lens.
However, Gausepohl teaches the analogous art an assay device (Gausepohl; fig. 1a, [0103]) comprising a first plate, a second plate (Gausepohl teach a sample holder comprising a first plate 1, a second plate 3; fig. 1a, #1, #3, #4, [0103]). Furthermore, the modification would be capable of having a configuration to expose at least part of the first plate in the assay device to a lens in the camera of the mobile phone when the assay device is inserted into the receptacle slot and the apparatus is engaged with the mobile phone.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assay device of modified Schmitt with the assay device comprising a first plate and a second plate, as taught by Gausepohl, because Gausepohl teaches the sample holder comprising the first plate, the second plate, and spacers provides the additional benefit of enclosing the sample between the first and second plate to allow individual treatment of the assay device with reagents, thereby preventing cross contamination; [0010-0013]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Gausepohl both teach an assay device for holding a sample.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Schmitt in view of Fan, Mather, Gausepohl, and Larsen.
Regarding claim 16, modified Schmitt teaches the apparatus of claim 15 above comprising the exit aperture, the adaptor housing, the passive illuminator, the receptacle slot operative to hold the assay device, and the lens (The modification of the adapter housing of Schmitt to further comprise a receptacle slot for holding an assay device therein, as taught by Fan, has previously been discussed in claim 1 above).
Modified Schmitt does not teach the apparatus further comprising an auxiliary lens optically aligned with the exit aperture of the adaptor housing, or an auxiliary lens located between the passive illuminator and the receptacle slot operative to hold the assay device, or an auxiliary lens having an optical axis thereof coaxially aligned with an optical axis of the lens.
However, Larsen teaches the analogous art of a camera (Larsen; fig. 14, #1401, [0338]) comprising a lens and an auxiliary lens having an optical axis aligned with an optical axis of the lens (Larsen; fig. 14, #1402, [0338, 0342]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the apparatus for illuminating and imaging an object of modified Schmitt to further comprise an auxiliary lens having an optical axis aligned with an optical axis of the lens, as taught by Larsen, because Larsen teaches the auxiliary lens is used for focusing the system and imaging a volume inside the sample compartments with the camera; [0338]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Schmitt and Larsen both teach imaging systems comprising a lens and a camera for imaging an object.
Response to Arguments
Applicant’s arguments, filed 03/26/2026, have been fully considered.
Applicant’s arguments, see pages 13-14 of their remarks, towards the claim objection(s) and 112b rejection(s) were found persuasive. Therefore, the objection(s) and rejection(s) have been withdrawn.
Applicant argues, see pages 14-16 of their remarks, towards the 103 rejection of claim 3 over Schmitt that the cited references do not teach the amended limitations of claim 3. The examiner respectfully disagrees. Schmitt disclose the amended limitations directed towards the one or two light-guides different from the light guide of the passive illuminator. Specifically, Schmitt disclose the proximal portion of light guide 614 is configured to optically couple with the light source of the smartphone and the distal portion is coupled with the passive illuminator 616 and light guide 606 such that light is directed from 614 towards 616 to illuminate the field of view of the camera; fig. 6, [0054]. Additionally, Fan and Mather both disclose a diffuser and Mather teach Mather teach the diffusers 12 and 15 are spaced from the passive illuminator 9 and are optically placed over the output face of the passive illuminator where in the embodiments of figures 7 the diffuser would comprise an opening; figs. 3 & 7, [0031. Diffuser 12 is provided on the front face of the waveguide; [0043], and the exposure aperture with respect to the camera of the mobile phones is not obstructed by the lightguide 9 comprising the diffuser 12; fig. 7a, [0049]). Accordingly, Mather discloses an opening on the diffuser (i.e. provided on the front face of the waveguide) and is configured to expose the exposure aperture to the camera of the mobile phone when the device is engaged with the mobile phone.
Applicant argues, see pages 16-17 of their remarks, towards the 103 rejection of claim 1 over Schmitt that the cited references do not teach a passive illuminator and light guide configured to illuminate the object, wherein the passive illuminator light guide is optically connected to the light guide, accepts light from one or both ends of the light guide, and emits light from a side wall of the passive illuminator towards the object, nor do the references teach that the imager, exit aperture, lens, and exposure aperture are optically aligned to image the object in the assay device position in the receptacle slot. The examiner respectfully disagrees. First, applicants merely recite the claim language and then state that the prior art does not teach the claim language. Therefore, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Regarding the passive illuminator and light guide, Schmitt disclose passive illuminator 616 optically connects with the light guide 614 and accepts light from one or both ends of the light guide; [0054]), where the distal portion 616 illuminates “the camera’s field of view” and “the aperture 624 has a portion sized and located to allow light conducted through the light pipe 606 to be emitted from the distal portion 616 of the light pip 606 to illuminate the area in front of the contact member 610”; [0057]. The examiner notes the term “field of view” with respect to a camera describes the viewable area that can be imaged by a lens system, and is different from an “area in front of contact member 610”, later described in [0057]. Accordingly, the distal portion 616 emits light from a sidewall to illuminate the field of view through lens 604 and out of aperture 624 to illuminate the area in from of the contact member 610. Second, in response to applicant's arguments that the references do not teach that the imager, exit aperture, lens, and exposure aperture are optically aligned to image the object in the assay device positioned in the receptacle slot, the examiner notes that the arguments are against the references individually, and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Schmitt teach Schmitt disclose frame 602 can align the optical axis of the lens 604 with an optical axis of the camera of the smartphone; figs. 6-8, [0052], an axis of the aperture of the distal portion 616 of the light pipe can be aligned with an axis of the lens 604; [0054], and the exposure aperture 624 on contact member 610 is optically aligned with lens 604; fig. 7. Further, the modification of Schmitt with the receptacle slot for holding an assay device would be configured to align with the imager, exit aperture, lens, and exposure aperture of Schmitt.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to Applicant’s disclosure include:
Endo et al. (US Patent No. 10,474,005) disclose an imaging unit and attachment member comprising a passive illuminator and a light guide configured to interface with an entrance aperture.
Talebpour et al. (US 2014/0004501) disclose a top and bottom plate comprised of a polycarbonate and a polyimide spacer.
Conclusion
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/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
