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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 18 June 2026.
Claims 1-15 are pending.
No claims are cancelled.
No claims are withdrawn.
No claims are newly added.
Claims 1, 10-11, 13, and 15 are amended.
Claim Interpretation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are:
“an illumination system to provide an excitation light” as in Claims 1 and 13.
“an outcoupler...to redirect the excitation light…in a plurality of directions” as in Claims 1 and 13.
“a detection system to detect” as in Claims 1 and 13.
“illumination elements to emit excitation light” as in Claim 4.
“a dispersion element...to spatially separate wavelengths” as in Claims 6 and 13.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
At least one light source, as in Fig. 1 of Applicant’s instant drawings...and equivalents thereof.
“a lens or a lens array...a layer of translucent material that diffuses the excitation light...a roughened portion of a microfluidic chamber wall” as in para. [0048] of Applicant’s instant pre-grant publication US 2024/0377324 A1...and equivalents thereof.
“a charge coupled device (CCD) or a complementary metal-oxide semiconductor (CMOS) device” as in para. [0050] of Applicant’s instant pre-grant publication US 2024/0377324 A1...and equivalents thereof.
“light-emitting diodes” as in para. [0070] of Applicant’s instant pre-grant publication US 2024/0377324 A1...and equivalents thereof.
“dichroic filters” as in para. [0081] of Applicant’s instant pre-grant publication US 2024/0377324 A1...and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5-6, 8, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (Park DS, Young BM, You BH, Singh V, Soper SA, Murphy MC. An integrated, optofluidic system with aligned optical waveguides, microlenses, and coupling prisms for fluorescence sensing. J Microelectromech Syst. 2020 Aug;29(4):600-609.), hereinafter “Park”, in view of Sandro et al. (US 2020/0209146 A1), hereinafter “Sandro”.
Regarding Claim 1, Park teaches a fluorescence detection system (See the Introduction section: “An integrated, thermoplastic LOC system with optical readout, consisting of a PMMA cover plate and fluidic substrate, with COC optical components was designed and fabricated for molecular analysis.”), comprising:
a microfluidic chamber to receive a sample containing a compound to be detected (See the LOC configuration section: “six parallel fluidic microchannels with the sampling zone defined by the position of the waveguide”, the Optical characterization section: “fluidic reservoirs”, and the Fabrication of components section discussing “complete filling of the recessed microchannels”.);
an illumination system to provide an excitation light to excite fluorophores in the microfluidic chamber (See Fig. 3 and the Optical characterization section: “For optical characterization of the integrated optical system (see Fig. 3), a 635 nm laser diode (LDM21, 14 mW, Thorlabs Inc., Newton, NJ, USA) was coupled into a fiber optic cable (M15L01–201818, Thorlabs) with an OFR fiber port (PAF-X-2-B, Thorlabs).”.);
an outcoupler between the illumination system and the microfluidic chamber to direct the excitation light to fill the microfluidic chamber (Figs. 1b, 2f, and 3 show the coupling prism/outcoupler in yellow. Fig. 1a shows the prism/outcoupler directing light to fill the microfluidic chambers.);
and a detection system to detect fluorescence generated by the excitation of the fluorophores in the microfluidic chamber (See Fig. 3 and the Image acquisition section: “All fluorescence images were acquired using a charge-coupled device (CCD) camera (Spec-10, Roper Scientific, Trenton, NJ, USA).”.),
as in Claim 1.
Further regarding Claim 1, Park does not specifically teach the fluorescence detection system discussed above wherein the outcoupler is to redirect the excitation light in a plurality of different angles, as in Claim 1.
However, Sandro teaches a liquid-containing microfluidic assay device having a sample chamber 108 and a diffuser 126 positioned in a light path between a light source 122 and the sample chamber 108 (See Fig. 1 and [0005 and 0041].) Therein, the diffuser 126 increases the angular of range of light reaching the assay device, thereby increasing the consistency of the angular profile of the light reaching the light receiver, thereby sufficiently equalizing signal to noise ratios across runs and instruments by filling the chamber 108 with light rather than requiring a precisely aligned beam be implemented ([0006-0009]). Further, Sandro teaches an embodiment where the diffuser is integrated with a surface of the sample chamber ([0027]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the fluorescence detection system of Park wherein the outcoupler is to redirect the excitation light in a plurality of different angles, such as suggested by Sandro and such as implemented by modifying a surface of the outcoupler forming the sample chamber seen in Park Fig. 1 to diffuse/redirect light into the sample chamber at a plurality of angles so as to fill the sample chamber, thereby permitting light from a variety of angles to reach the detector rather than requiring a precisely aligned beam subject to calibration error.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Park teaches the fluorescence detection system discussed above wherein the illumination system is perpendicular to a longitudinal axis of the microfluidic chamber (Fig. 3 shows the laser as being perpendicular to the longitudinal axis of the microfluidic chambers. Further, the “longitudinal axis” is interpreted broadly herein as any front-to-back axis running through a length of the device as Applicant has not required a particular orientation of the longitudinal axis, such as being parallel to a longest edge of the device.), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Park teaches the fluorescence detection system discussed above wherein:
the illumination system and detection system are perpendicular to one another (Fig. 3 shows the laser and CCD as perpendicular to one another.);
and the detection system is aligned with a longitudinal axis of the microfluidic chamber (Fig. 3 further shows the detection system as aligned with a longitudinal axis (an axis going into the page when viewed through Fig. 3) of the microfluidic chamber. Further, the term “aligned with” is broad to encompass any position respective to the axis. Applicant may intend “parallel with”.),
as in Claim 3.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Park teaches the fluorescence detection system discussed above further comprising a second outcoupler between the microfluidic chamber and the detection system (See Fig. 3 and the Optical characterization section: “The fluorescence emission was collected by the on-chip microlenses and imaged onto the CCD camera using a 2X (N.A. = 0.08) and 1.5X (N.A. = 0.04) objective lenses.”), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 5 as discussed above. Further, Park teaches the fluorescence detection system discussed above further comprising a dispersion element integrated with the second outcoupler, the dispersion element to spatially separate wavelengths of emission light emanating from excited fluorophores (See Fig. 3 and the Optical characterization section: “A band pass filter (660–680 nm, Omega Optical, Brattleboro, VT) was used for spectrally isolating the fluorescence.”), as in Claim 6.
Regarding Claim 8, the prior art meets the limitations of Claim 1 as discussed above. Further, park teaches the fluorescence detection system discussed above further comprising a substrate (See the Fabrication of components section: “PMMA was used for the fluidic substrate”), wherein the microfluidic chamber is separable from the illumination system (Fig. 3 shows the microfluidic chambers as separate from the laser.), as in Claim 8.
Further regarding Claim 8, Park does not specifically teach the fluorescence detection system discussed above wherein the illumination system and detection system are attached to the substrate, as in Claim 8.
However, merely making integral as one piece what exists in the prior art as separate pieces absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04 (V)(B). Herein, one skilled in the art would not expect the prior art device of Park having an illumination system and detection system as a non-integral arrangement with the substrate to function differently than the claimed integral arrangement given that the functionality of providing excitation light and detecting emission light remains the same regardless of what specific structures the illumination/detection systems are attached to.
Regarding Claim 10, Park teaches a method, comprising:
introducing a sample comprising a target compound to be detected into a microfluidic chamber (See the Optical characterization section: “100 nM of the fluorescent dye (DyLight 650) was hydrodynamically shuttled through the microchannels”.);
introducing an excitation light into the microfluidic chamber through a surface that is perpendicular to a longitudinal axis of the microfluidic chamber (See the Optical characterization section: “coupling the laser light into the integrated prism”. – Further, Fig. 3 shows the entry surface as perpendicular to the longitudinal axis interpreted herein as an axis going into the page when viewed through Fig. 3.);
directing the excitation light through an outcoupler to fill the microfluidic chamber (See the Optical characterization section: “coupling the laser light into the integrated prism”.); and
monitoring the target compound within the microfluidic chamber by detecting, at a detection system, the fluorescence that is indicative of the target compound within the microfluidic chamber (See the Characterization of optical waveguides section: “The evanescent excitation of the resulting fluorescent dye in the fluidic microchannels and the fluorescent signals as collected by the microlenses were confirmed”.),
as in Claim 10.
Further regarding Claim 10, Park does not specifically teach the method discussed above wherein the outcoupler redirects excitation light in a plurality of different angles, as in Claim 10.
However, Sandro teaches a liquid-containing microfluidic assay device having a sample chamber 108 and a diffuser 126 positioned in a light path between a light source 122 and the sample chamber 108 (See Fig. 1 and [0005 and 0041].) Therein, the diffuser 126 increases the angular of range of light reaching the assay device, thereby increasing the consistency of the angular profile of the light reaching the light receiver, thereby sufficiently equalizing signal to noise ratios across runs and instruments by filling the chamber 108 with light rather than requiring a precisely aligned beam be implemented ([0006-0009]). Further, Sandro teaches an embodiment where the diffuser is integrated with a surface of the sample chamber ([0027]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Park wherein the outcoupler is to redirect the excitation light in a plurality of different angles, such as suggested by Sandro and such as implemented by modifying a surface of the outcoupler forming the sample chamber seen in Park Fig. 1 to diffuse/redirect light into the sample chamber at a plurality of angles so as to fill the sample chamber, thereby permitting light from a variety of angles to reach the detector rather than requiring a precisely aligned beam subject to calibration error.
Regarding Claim 11, the prior art meets the limitations of Claim 10 as discussed above. Further, Park teaches the method discussed above wherein:
the microfluidic chamber is a microfluidic channel; and the method further comprises introducing a continuous flow of the sample through the microfluidic channel (See the Introduction section: “fluorescent dyes flowing through parallel microchannels”), as in Claim 11.
Regarding Claim 12, the prior art meets the limitations of Claim 10 as discussed above. Further, Park teaches the method discussed above further comprising generating a line-shaped excitation light beam (Fig. 3 shows the excitation beam as line-shaped so as to efficiently enter the optical fiber. Further, a laser source is known in the art to produce a linear beam as required by the linear coherence needed to produce such high intensity light.), as in Claim 12.
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Sandro, as applied to Claims 1-3, 5-6, 8, and 10-12 above, and in further view of Maher et al. (US PAT 6,838,680 B2), hereinafter “Maher”.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Park does not specifically teach the fluorescence detection system discussed above wherein the illumination system comprises multiple illumination elements to emit excitation light in different wavelength range, as in Claim 4.
However, Maher teaches a respective fluorescence detection system wherein “The light source may be a multiple-wavelength light source.” (col. 3, line 6) and “The optical detection and orientation system can also have multiple light sources, each emitting light at a different wavelength.” (col. 3, line 41), so as to achieve a desired sensitivity for detection (col. 3, line 19), and to provide a system capable of being used with different fluorophores having different excitation wavelength ranges (col. 4, line 51). Therein, this arrangement allows for multiplexed analysis and broader use across diverse fluorophores.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Park wherein the illumination system comprises multiple illumination elements to emit excitation light in different wavelength range, such as suggested by Maher, so as to allow for multiplexed analysis and broader use across diverse fluorophores.
Regarding Claim 13, Park teaches a fluorescence detection system (See the Introduction section: “An integrated, thermoplastic LOC system with optical readout, consisting of a PMMA cover plate and fluidic substrate, with COC optical components was designed and fabricated for molecular analysis.”), comprising:
a longitudinal microfluidic chamber to receive a sample containing a compound to be detected (See the LOC configuration section: “six parallel fluidic microchannels with the sampling zone defined by the position of the waveguide”, the Optical characterization section: “fluidic reservoirs”, and the Fabrication of components section discussing “complete filling of the recessed microchannels”.);
an illumination system, perpendicular to a longitudinal axis of the microfluidic chamber to provide an excitation light to excite fluorophores in the microfluidic chamber (See Fig. 3 and the Optical characterization section: “For optical characterization of the integrated optical system (see Fig. 3), a 635 nm laser diode (LDM21, 14 mW, Thorlabs Inc., Newton, NJ, USA) was coupled into a fiber optic cable (M15L01–201818, Thorlabs) with an OFR fiber port (PAF-X-2-B, Thorlabs).”. Further, Fig. 3 shows the laser as being perpendicular to the longitudinal axis of the microfluidic chambers. Further, the “longitudinal axis” is interpreted broadly herein as any front-to-back axis running through a length of the device as Applicant has not required a particular orientation of the longitudinal axis, such as being parallel to a longest edge of the device.),
an outcoupler between the illumination system and the microfluidic chamber to direct the excitation light to fill the microfluidic chamber (Figs. 1b, 2f, and 3 show the coupling prism/outcoupler in yellow. Fig. 1a shows the prism/outcoupler directing light to fill the microfluidic chambers.),
wherein the outcoupler is to direct excitation light to impinge on interior walls of the microfluidic chamber at angles greater than a critical angle for the microfluidic chamber and sample interface (Figs. 1a and 3 show the light beam impinging on interior walls of the microfluidic chamber at an angle greater than a critical angle of total internal reflectance.);
a dispersion element to spatially separate wavelengths of light emanating from excited fluorophores (See Fig. 3 and the Optical characterization section: “A band pass filter (660–680 nm, Omega Optical, Brattleboro, VT) was used for spectrally isolating the fluorescence.”);
and a detection system to detect spatially-separated bands of fluorescence generated by the excitation of the fluorophores (See Fig. 3 and the Image acquisition section: “All fluorescence images were acquired using a charge-coupled device (CCD) camera (Spec-10, Roper Scientific, Trenton, NJ, USA).”.),
as in Claim 13.
Further regarding Claim 13, Park does not specifically teach the fluorescence detection system discussed above wherein illumination system comprises multiple illumination elements to redirect the excitation light in a plurality of different angles, as in Claim 13.
However, Sandro teaches a liquid-containing microfluidic assay device having a sample chamber 108 and a diffuser 126 positioned in a light path between a light source 122 and the sample chamber 108 (See Fig. 1 and [0005 and 0041].) Therein, the diffuser 126 increases the angular of range of light reaching the assay device, thereby increasing the consistency of the angular profile of the light reaching the light receiver, thereby sufficiently equalizing signal to noise ratios across runs and instruments by filling the chamber 108 with light rather than requiring a precisely aligned beam be implemented ([0006-0009]). Further, Sandro teaches an embodiment where the diffuser is integrated with a surface of the sample chamber ([0027]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the fluorescence detection system of Park wherein the illumination elements redirect the excitation light in a plurality of different angles, such as suggested by Sandro, to diffuse/redirect light into the sample chamber at a plurality of angles so as to fill the sample chamber, thereby permitting light from a variety of angles to reach the detector rather than requiring a precisely aligned beam subject to calibration error.
Further regarding Claim 13, Park does not specifically teach the fluorescence detection system discussed above wherein the illumination system comprises multiple illumination elements; a lens, per illumination element, to direct respective excitation beams towards the microfluidic chamber, as in Claim 13.
However, Maher teaches a respective fluorescence detection system wherein “The light source may be a multiple-wavelength light source.” (col. 3, line 6) and “The optical detection and orientation system can also have multiple light sources, each emitting light at a different wavelength.” (col. 3, line 41), so as to achieve a desired sensitivity for detection (col. 3, line 19), and to provide a system capable of being used with different fluorophores having different excitation wavelength ranges (col. 4, line 51). Therein, this arrangement allows for multiplexed analysis and broader use across diverse fluorophores. Further, Maher provides for “individual light sources may be used for each confocal microscope system” (col. 3, line 4) wherein each individual light source thereby comprises its own lens of the confocal system.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Park wherein the illumination system comprises multiple illumination elements; a lens, per illumination element, to direct respective excitation beams towards the microfluidic chamber, such as suggested by Maher, so as to allow for multiplexed analysis and broader use across diverse fluorophores.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Sandro, as applied to Claims 1-3, 5-6, 8, and 10-12 above, and in further view of Battrell et al. (US 2013/0011912 A1), hereinafter “Battrell”.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Park does not specifically teach the fluorescence detection system discussed above further comprising a reflective coating on an interior surface of the microfluidic chamber to redirect excitation light and emission light towards a center of the fluorescence detection system, as in Claim 7.
However, Battrell teaches a respective fluorescence detection system wherein a reflective coating on an interior surface of the microfluidic chamber to redirect emission light to the detector ([0087]: “a highly reflective optical finish”), thereby increasing the amount of light received by the detector so as to improve the sensitivity of detection ([0125]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Park further comprising a reflective coating on an interior surface of the microfluidic chamber, such as suggested by Battrell, so as to increase the amount of fluorescence emission received by the detector, thereby increasing the sensitivity of detection.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Sandro, as applied to Claims 1-3, 5-6, 8, and 10-12 above, and in further view of Tomei et al. (WO 1998/023945 A1), hereinafter “Tomei”.
Regarding Claim 9, the prior art meets the limitations of Claim 1 as discussed above. Further, park teaches the fluorescence detection system discussed above further comprising a substrate (See the Fabrication of components section: “PMMA was used for the fluidic substrate”), as in Claim 9.
Further regarding Claim 9, Park does not specifically teach the fluorescence detection system discussed above wherein the illumination system and detection system are attached to the substrate, as in Claim 9.
However, merely making integral as one piece what exists in the prior art as separate pieces absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04 (V)(B). Herein, one skilled in the art would not expect the prior art device of Park having an illumination system and detection system as a non-integral arrangement with the substrate to function differently than the claimed integral arrangement given that the functionality of providing excitation light and detecting emission light remains the same regardless of what specific structures the illumination/detection systems are attached to.
Further regarding Claim 9, Park does not specifically teach the fluorescence detection system discussed above wherein the illumination system and detection system are collinear with a longitudinal axis of the microfluidic chamber, as in Claim 9.
However, Tomei teaches a respective fluorescence detection system wherein the illumination system, detection system, and interrogated sample are collinear along a same axis (Page 2: “When a sample emitting fluorescent light is embedded within a homogeneous and optically clear medium, and/or contained between two plates of an optical material, the emitted fluorescence is conventionally detected in either the forward or backward direction... Forward detection involves collecting the light within a cone along the axis of the excitation beam (e.g., for a light source, sample, and light detector which are collinear, the source and detector are on opposite sides of the sample, generally along the same optical axis). Backward detection involves collecting the light emitted in a cone opposite from the direction of the excitation beam (e.g., for a light source, sample, and light detector which are collinear, the source and detector are on the same side of the sample).”) wherein this arrangement is a mere alternative to the perpendicular arrangement of Park.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Park wherein the illumination system and detection system are collinear with a longitudinal axis of the microfluidic chamber, such as suggested by Tomei, as a mere obvious alternative arrangement of the elements performing and achieving the identical functions as in Park.
Regarding Claim 14, the prior art meets the limitations of Claim 13 as discussed above. Further, Park teaches the fluorescence detection system discussed above wherein:
the detection system is perpendicular to a longitudinal axis of the microfluidic chamber (Fig. 3 further shows the detection system as perpendicular to a longitudinal axis (an axis going into the page when viewed through Fig. 3) of the microfluidic chamber.),
as in Claim 14.
Further regarding Claim 14, Park does not specifically teach the fluorescence detection system discussed above wherein the detection system and illumination system are disposed along a same side of the microfluidic chamber, as in Claim 14.
However, Tomei teaches a respective fluorescence detection system wherein the illumination system, detection system, and interrogated sample are collinear along a same axis (Page 2: “When a sample emitting fluorescent light is embedded within a homogeneous and optically clear medium, and/or contained between two plates of an optical material, the emitted fluorescence is conventionally detected in either the forward or backward direction... Forward detection involves collecting the light within a cone along the axis of the excitation beam (e.g., for a light source, sample, and light detector which are collinear, the source and detector are on opposite sides of the sample, generally along the same optical axis). Backward detection involves collecting the light emitted in a cone opposite from the direction of the excitation beam (e.g., for a light source, sample, and light detector which are collinear, the source and detector are on the same side of the sample).”) wherein this arrangement is a mere alternative to the perpendicular arrangement of Park.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Park wherein the detection system and illumination system are disposed along a same side of the microfluidic chamber, such as suggested by Tomei, as a mere obvious alternative arrangement of the elements performing and achieving the identical functions as in Park.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Sandro and Maher, as applied to Claims 4 and 13-14 above, and in further view of Lim et al. (WO 2014/117937 A1), hereinafter “Lim”.
Regarding Claim 15, the prior art meets the limitations of Claim 13 as discussed above. Further, Park/Maher does not specifically teach the fluorescence detection system discussed above wherein each of the lenses is integrated on an exterior surface of the longitudinal microfluidic chamber, as in Claim 15.
However, Lim teaches a respective microfluidic device having lenses for focusing light into and out of the microfluidic chambers, wherein the lenses are integrated on an exterior surface of the longitudinal microfluidic chambers (Fig. 1 and Abstract: “the focusing lenses (121) comprise refractive lenses being arranged on at least one of the substrate plate (111) and the cover plate (112)”.) wherein this arrangement is a mere obvious alternative arrangement to that of Park wherein the lens arrangement is not attached directly to the substrate.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Park wherein the lenses are integrated on an exterior surface of the longitudinal microfluidic chamber, such as suggested by Lim, as a mere obvious alternative arrangement to that of Park wherein the lenses remain as performing the identical function of focusing light into a sample chamber for interrogating a fluorescent sample.
Response to Arguments
Drawings
Applicant’s remarks have clarified the drawings objection set forth by the previous office action. As such, the drawings objection is withdrawn herein.
35 USC 112(b)
Applicant’s amendments sufficiently overcome those 112(b) antecedent basis issues set forth by the previous office action over Claims 11 and 15. As such, those rejections of Claims 11 and 13 as being indefinite under 35 USC 112(B) are withdrawn herein.
35 USC 102 and 103
Applicant’s arguments are on the alleged grounds that Park does not satisfy the amended Claim 1, 10, and 13 recitations requiring the outcoupler be to redirect the excitation light in a plurality of different angles.
Applicant’s arguments are not persuasive because the prior art of Sandro, newly cited herein as necessitated by Applicant’s amendment noted above, teaches a liquid-containing microfluidic assay device having a sample chamber 108 and a diffuser 126 positioned in a light path between a light source 122 and the sample chamber 108 (See Fig. 1 and [0005 and 0041].) Therein, the diffuser 126 increases the angular of range of light reaching the assay device, thereby increasing the consistency of the angular profile of the light reaching the light receiver, thereby sufficiently equalizing signal to noise ratios across runs and instruments by filling the chamber 108 with light rather than requiring a precisely aligned beam be implemented ([0006-0009]). Further, Sandro teaches an embodiment where the diffuser is integrated with a surface of the sample chamber ([0027]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the fluorescence detection system of Park wherein the outcoupler is to redirect the excitation light in a plurality of different angles, such as suggested by Sandro and such as implemented by modifying a surface of the outcoupler forming the sample chamber seen in Park Fig. 1 to diffuse/redirect light into the sample chamber at a plurality of angles so as to fill the sample chamber, thereby permitting light from a variety of angles to reach the detector rather than requiring a precisely aligned beam subject to calibration error.
Further therein, it would be expected that one of ordinary skill in the art implement the diffusers of Sandro with the waveguide channel (outcoupler) of Park to maintain the total internal reflection in park, such as by implementing the diffusers only in select regions, so as to maintain the waveguide function in Park.
Thus, Examiner sets forth the rejection of Claims 1-3, 5-6, 8, and 10-12 under 35 USC 103 as being unpatentable over Park in view of Sandro (and Claim 13 over Park in view of Sandro and Maher), as necessitated by Applicant’s amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
Prosecution Insights