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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/25/2025 and 02/02/2024 was considered by the examiner.
The PCT international search report filed 02/02/2024 was also considered by the examiner.
Claim Objections
Claim 2 is objected to under 37 CFR 1.75 as comprising a first clause that is partly a substantial duplicate of the second clause while ending in a period mid-claim (i.e., it appears to be a minor drafting issue).
Under USPTO guidelines (MPEP 608.01(m)), each claim must be a single sentence that begins with a capital letter and ends with a period. Periods are generally prohibited within the body of the claim, except when used in abbreviations.
Correction: The USPTO requires that each claim be a single sentence, often necessitating the use of semicolons to connect multiple elements or steps instead of ending with a period. Also, remove the duplicate.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 – 5 and 12 -20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morioka et al. (US Pub. No. 2006/0049053 A1) in view of Ugai et al. (US Pub. No. 2006/0219559 A1).
With regards to claims 1 and 18, Morioka discloses a capillary 1 array/window unit (see cavity) having first and second holding substrates (See window substrates and glass substrates and the like throughout the figures 1 – 3 and 5 -8) that sandwich capillaries 1 arranged substantially in a plane surface (i.e., horizontal axis indicates the sequence number of the capillaries 1 arranged in a plane surface) [0006] [0030] [0031]. Notice that Morioka focuses on the window unit structure using the ends of the at least two substrates, see figures 3, 6 and 8 [0006] [0030] [0031].
Morioka further teaches light-cut off areas between adjacent light transmission areas/openings corresponding to each capillary, wherein transmission areas cut off reflected light/noise among capillaries 1, see figures 3, 4b, 6 and 8 [0006], [0030] - [0033]. Notice that the window bars may be the light cut-off areas.
Morioka fails to describe the window region as plurality of parallel open channels that are exposed on a top side, wherein a window plate or light screening member (i.e., opaque) with window holes and/or open channels.
Ugai relates to capillary arrays electrophoresis apparatus [0002]. FIG. 1 shows a schematic view of a capillary array comprising a support plate 102, capillaries 101 by the number of about 1 to 16, electrodes 110, an electrode holder 109, a capillary head 107, and a fluorescence detection section 120. The capillaries 101 are fixed to the support plate 102 and the electrode holder 109 and the detection 120 are also attached to the support plate 102 [0026].
Fig. 3 is a view shows a detection section including a condensing lens 306 made of glass or polymethyl methacrylate for condensing an excitation light, in which a through hole 309 is provided at the center thereof. The capillaries 301 are assembled by being passed through the through hole 309. The capillaries 301 arranged side by side are covered with a window plate 304 as a light screening member provided with window holes 307 for transmitting fluorescence from a sample and prevents cross-talk of fluorescence. The window hole 307 may also be constituted not as a physical aperture but by forming only the desired regions with a light transparent member [0033].
FIG. 4 is a view for explaining the arrangement of the window holes 407 in the window plate and description to be made for the advantage of arranging the window holes 407 stepwise [0034].
FIG. 5A shows a cross-sectional shape of the window plate and the effect thereof. The window plate 504 is formed by applying, for example, anisotropic etching to single crystal silicon. A capillary quartz tube 502 is positioned by a V-groove 509 fabricated in the window plate 504 and the V-groove is recessed deeply such that the capillary is substantially covered. Use of the window plate as described above provides an effect that a single light 512 passes straightly through the window but the fluorescence 515 from adjacent capillaries can be cut by the V-shaped slope 509 [0035].
Ugai teaches a window plate/light screening member with window holes preventing crosstalk and further that V-groove geometry cuts light form adjacent capillaries which further reduces noise (Figures 1 – 5) [0006], [0026] – [0035]. Notice that the top side exposure corresponds to the side where the window with the holes/openings allow light to pass to/from capillary window region.
In view of the utility, to reduce noise and improve to high precision detection, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Morioka to include the teachings such as that taught by Ugai.
With regards to claim 2, Morioka teaches a capillary array window including unit/holding/support substrate the window section lies in a capillary plane (Figures 1 – 5) [0006], [0026] – [0035].
Morioka fails to expressly disclose using a mounting feature comprising a plate lying in a mounting plane spaced from the capillary plane along an elevational axis orthogonal to the longitudinal axis and to the transverse axis.
Ugai teaches a support plate fixing capillaries and attaching the detection section, wherein the capillaries are retained on the support plate and the whole assembly is created for attachment to another apparatus via mounting (Figures 1, 3 and 13), [0026] – [0029], [0042], [0048], [0052].
In view of the utility, to order to create multiple arrangements of the window or the plate as needed to enhance specialized sensory, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Morioka to include the teachings such as that taught by Ugai.
With regards to claim 3, Morioka teaches the claimed invention according to claim 1, but fails to expressly disclose end bars defining end channels alight with open channels.
Ugai teaches capillaries fixed and/or retained along length by clips or retainers, maintaining alignment of capillaries through the detection window area (Figures 1, 2A – 2C) [0026] – [0031].
In view of the utility, to order to create multiple fixed arrangements of the window or the plate as needed to enhance specialized sensory, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Morioka to include the teachings such as that taught by Ugai.
With regards to claim 4, Morioka modified teaches the claimed invention according to claim 1, but fails to expressly disclose the sections including a first top wall covering the first end channels on the top side, and the second end section comprises a second top wall covering the second end channels on the top side.
Ugai teaches capillaries fixed and/or retained along length by clips or retainers, maintaining alignment of capillaries through the detection window area (Figures 1, 2A – 2C) [0026] – [0031]. Ugai further discloses top side retainers (i.e., clips) over capillaries (Figures 2A – 2C) [0026] – [0031].
In view of the utility, to order to create multiple fixed arrangements of the window or the plate as needed to enhance specialized sensory, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Morioka to include the teachings such as that taught by Ugai.
With regards to claim 5, Morioka modified teaches the claimed invention according to claim 1, but fails to expressly disclose the central section comprises a bottom wall located on a bottom side of the capillary array window holder opposite to the top side, and the bottom wall covers the open channels on the bottom side.
Ugai teaches grooved plate section including a base/bottom supporting groove of the window holder supporting the capillary [0035] (Figure 5A and 13).
In view of the utility, to order to eliminate any reflection light from the lower surface to greatly decrease cross-talk and to improve the detection, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Morioka to include the teachings such as that taught by Ugai.
With regards to claim 12, Morioka modified teaches the claimed invention according to claim 1, and the plurality of capillaries, each capillary disposed in a respective one of the capillary channels such that windows of each capillary are respectively positioned in the open channels [0006] [0030] [0031] (Figure 1).
With regards to claim 13, Morioka modified teaches the claimed invention according to claim 1, and the window bars each have a bar height in a transverse plane orthogonal to the longitudinal axis, and the bar height is equal to or greater than an outer diameter of the capillaries in the window section [0006] [0030] [0031] (Figure 1), (i.e., see how the groove depth tied) Ugai [0035].
With regards to claim 14, Morioka modified teaches the claimed invention according to claim 12, and a top plate disposed on or above the capillaries on the top side, wherein at least a portion of the top plate covering the window section is transparent (i.e., see how the transparent window area 5) [0006] [0030] [0031] (Figure 1).
With regards to claim 15, Morioka teaches a window unit 2 arranging multiple capillaries 1 substantially in a plane [0006] [0030] [0031] (Figures 1 - 3); a detection window 4 comprising maniple light transmission areas 5 corresponding to multiple capillaries [0006] [0030] [0031] (Figure 4(b)). Thus, Morioka teaches a mulit-capillary array configuration in which multiple transmission areas are arranged laterally across the window region.
Morioka fails to teach multiple discrete window holders arranged side by side as separate modules. So, Morioka discloses one integrated window unit, not multiple independent holders.
Ugai teaches capillaries mounted on support plate 102 via clips 108 [0026] – [0029]; (Figure 1). Ugai further teaches a window plate 120 with multiple window holes 121 corresponding to multiple capillaries [0033] (Figure 4). As such, Ugai teaches a modular capillary retention structures mounted to a support plate.
In view of the utility, to order to scale optical modules and/or window structures or to create multiple fixed arrangements of the window or the plate as needed to enhance specialized sensory, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Morioka to include the teachings such as that taught by Ugai.
With regards to claim 16, Morioka teaches the claimed invention according to claim 12 and a light receiving optical system detecting fluorescence from the detection window 4 [0002] [0006] (Figure 9). Morioka fails to expressly disclose the optical alignment with the open channels as claimed.
Ugai teaches V-grooves 123 positioning capillaries at detection section [0035] (Figures 5A-5B) and window holes 121 aligned with capillaries for fluorescent detection [0033] – [0035] (Figure 4). Notice how Ugai provides explicit structural alignment between channels and detection optics [0026], [0029], [0033] – [0035] (Abstract) (Figures 1, 4, 5A and 5B).
In view of the utility, to order to meet the demand of specialized sensory as needed, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Morioka to include the teachings such as that taught by Ugai.
With regards to claim 17, Morioka modified teaches the claimed invention according to claim 16 comprising at least one of:
a light receiving optical system (Figure 9);
an optical detection of fluorescence [0030] – [ 0033];
detection window 4 aligned with optical system [0006];
a light source positioned in optical alignment with the open channels (i.e., irradiating an excitation light and irradiating a laser light) [0002], [0029] – [0040];
a sample source from which a sample can be introduced into the capillaries [0002], [0029] – [0040];
a voltage source electrically communicating with the capillaries, and configured to apply a potential difference across the capillaries effective for performing capillary electrophoresis on samples in the capillaries [0007] [0045];
an analytical separation medium source from which an analytical separation medium can be introduced into the capillaries (see the buffer or medium in capillaries and electrophoretic separation inherently requires as taught in Morioka) [0002] [0030] [0036] [0038] [0039];
an analytical separation medium source from which an analytical separation medium can be introduced into the capillaries, wherein the analytical separation medium comprises an electrophoretic separation medium [0002] [0030] [0036] [0038] [0039].
With regards to claim 19, Morioka modified discloses the claimed invention according to claim 18 and further that the making of the optical measurement comprises one of: detecting emission light emitted from the windows, wherein the detecting is done on the top side; detecting emission light emitted from the windows [0002] (Figure 9), wherein the detecting is done on a bottom side of the capillary array assembly opposite to the top side [0006] (Figures 1 – 3); irradiating the samples with excitation light and detecting emission light emitted from the windows, wherein the irradiating and the detecting are both done on the top side; irradiating the samples with excitation light and detecting emission light emitted from the windows, wherein the irradiating is done on the top side, and the detecting is done on a bottom side of the capillary array assembly opposite to the top side [0002] [0006] ][0030] – [0033].
See how detecting window 4 with cut-off areas 6 between adjacent transmission areas 5 wherein the cut off areas reduce reflecting light and noise among adjacent capillaries [0002] [0006] ][0030] – [0033].
With regards to claim 20, see the rejections of claims 1, 12 and 16 – 19.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morioka et al. (US Pub. No. 2006/0049053 A1) and Ugai et al. (US Pub. No. 2006/0219559 A1) in view of Kojima et al. (US Pub. 2002/0003091 A1).
With regards to claim 6, Morioka modified teach the claimed invention according to claim 1, but fails to expressly disclose that the open channels are exposed to a bottom side of the capillary array window holder opposite to the top side, such that the central section allows transmission of light from the top side, through the open channels, and to the bottom side.
Notice that such an addition is generally considered only a matter of routine design choice involving ordinary skill of the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable configuration by routine experimentation.
For example, Kojima relates to an electrophoresis apparatus including a capillary array attachment portion is formed which permits attachment of a plurality of capillary arrays having different length. Thereby, a selected capillary array constituted by collecting a plurality of capillaries can be easily attached to the electrophoresis apparatus depending on measurement purpose (Abstract).
Kouima teaches a system with a plurality of capillaries removed which is detailed in figure 13. The coating removed portion of the capillaries is arranged in a plane and held on a holder substrate 4005. The holder substrate 4005 is provided with a window 4011 for passing detection light at a portion corresponding to the coating removed portion of the respective capillaries. The holder substrate 4005 further includes a light detection portion provided with a light shielding region defining the window for passing the detection light. Kouima teaches a modification of parts as claimed, see holder 4011 holding capillaries in a plane, a window 4011 formed in the substrate for passing detection light and a light shielding region defining the window [0066] – [0068] (Figures 12 and 13).
In view of the utility, to order develop a through window bounded shielding regions as needed, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Morioka to include the teachings such as the window, shielding and region architecture as discussed above and taught by Kouima in Morioka as needed.
Claim(s) 7 - 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morioka et al. (US Pub. No. 2006/0049053 A1) and Ugai et al. (US Pub. No. 2006/0219559 A1) in view of Bukshpan et al. (US Pub. 2007/0138015 A1).
With regards to claim 7, Morioka modified by Ugai teach the claimed limitations of claim 1. Notice that both teach light blocking structures between adjacent capillaries, light cut-off areas and V-grooves, see Morioka [0006] [0029]; Ugai [0035].
Morioka or Ugai fail to teach or make obvious that each window bar has a transverse cross-section in a transverse plane orthogonal to the longitudinal axis, wherein the transverse cross-section is defined by a bar width and a bar height, and the transverse cross-section has a ratio of bar height to bar width in a range from 1 to 10.
Bukshpan teaches matrixes, arrays, systems and methods for analyzing regions of interest while including detections, lanes, two-dimensional electrophoretic analysis chamber and the like [(Abstract) [0042] [0060] – [0066], [0112].
Bukshpan teaches in example 1, using a “rectangular groove” with dimension 0.1 x 0.1 (micron) [0130] – [0134]. Generally speaking, when the Prior Art teaches a range within, overlapping or touching the claimed range or where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Morioka to include the teachings such as that taught by Bukshpan, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art in addition to improving the detection as needed.
Regarding claim 8, a micron was included withing the claimed limitations. See the rejection to claim 7 above, as the rejection addresses the ranges that include a micron.
Regarding claim 9, a rectangular (rectilinear cross-section) groove was included with the claim limitations and the rejection to claim 7 addresses this configuration, see the rejection of claim 7.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morioka et al. (US Pub. No. 2006/0049053 A1) and Ugai et al. (US Pub. No. 2006/0219559 A1) in view of Kambara et al. (US Patent 5,730,850).
With regards to claim 10, Morioka discloses the claimed invention according to claim 1, and low light transmittance member 11 formed in the detection window region [0045] – [0047], Figure 12 – 13), in addition cutting off areas to block undesired light and reduce noise between adjacent capillaries [0003] [0030] – [0033].
Morioka also teaches structural opaque light blocking members in the window regions, but fails to expressly disclose that the opaque material is opaque to light propagating at wavelengths in a range from 190 nm to 800 nm.
Ugai teaches fluorescent detection at the detector [0034], but also fails to teach the numeric wavelength band, 190 to 800 nm.
Kambara teaches a capillary array electrophoresis system including fluorescence excitation and detection wavelengths in UV and Visible ranges for capillary electrophorese systems (Abstract) (Col. 6, Lines 49 – 65), (Col. 9, Lines 45 – 62).
In view of the utility, to develop larger light capacities and expand the detection as needed, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Morioka to include the teachings such Ugai and Kambara.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morioka et al. (US Pub. No. 2006/0049053 A1) and Ugai et al. (US Pub. No. 2006/0219559 A1) in view of Morioka et al. (US Pub. No. 2003/0155245 A1), hereinbelow - Morioka 2.
With regards to claim 11, Morioka modified teaches the claimed invention according to claim 1 but fails to expressly disclose wherein the window bars are composed of a material selected from the group consisting of: metals; aluminum; nickel; copper; metal alloys; silicon; ceramics; glasses; polymers; plastics; polyoxymethylene (POM); liquid-crystal polymer (LCP); polyacrylamide (PA); polycarbonate (PC); poly(methyl methacrylate) (PMMA); polyether ether ketone (PEEK); and polyethylene (PE). Notice that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.
Ugai teaches the system as discussed in the rejection of claim 1 and a support plate 102 retaining capillaries [0026].
Morioka 2 teaches a silicon substrate forming window structure and glass substrate embodiment as well in an electrophoretic device, thus silicon and glass are expressly taught in a capillary array unit electrophoretic device comprising the same (Abstract) [0030] [0031] Figure 12).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Morioka with Ugai and Morioka 2, since it has been held to be within the ordinary skill of worker in the art to select a known material on the basis of its suitability for the intended use. One would have been motivated to modify Morioka with Ugai and Morioka 2 for the purpose of improving S/N.
Conclusion
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/DJURA MALEVIC/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884