Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed December 9, 2025 has been filed. Claims 1-20 remain pending
Response to Arguments
Applicant’s arguments, see pages 10-12 of Remarks, filed December 9, 2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yang ( "Miniaturized Fluorescence Excitation Platform with Optical Fiber for Bio-Detection Chips" https://doi.org/10.48550/arXiv.0711.3325).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 12-17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Yang ( "Miniaturized Fluorescence Excitation Platform with Optical Fiber for Bio-Detection Chips" https://doi.org/10.48550/arXiv.0711.3325) in view of Yoshida (JP2013217916A).
Regarding claim 1, Yang teaches an optofluidic droplet fluorescence measuring device (page 1, column 2, paragraph 3 discloses the intent to use the device in conjunction with a microfluidic chip), the device comprising:
a fluorescence excitation device configured to reflect and output a fluorescence- exciting light, which is applied in a horizontal direction, in an upward direction (laser source, optical fiber and V-groove and mirror in Fig. 9); and
a fluorescence measurement device that is configured to receive the fluorescence-exciting light (photodetector, Fig. 9) and measure fluorescence of the optofluidic droplet when fluorescence is generated from the optofluidic droplet by the fluorescence-exciting light (abstract) that is input from downward direction (see Fig. 9).
Yang does not explicitly disclose the excitation device and measurement device are physically coupled.
However, in the same field of endeavor of optofluidic analysis, Yoshida teaches a measuring device which couples the fluorescence excitation device and measurement device (102a and 82, Fig. 8 are on the same chip, thus physically coupled).
A goal of Yang is to create a miniaturized analysis device that can be portable (page 1, column 2, paragraph 3). By coupling the excitement and measurement device as taught in Yoshida, the device is able to be miniaturized (Yoshida: paragraph [0005]). Thus, it would be obvious for a person of ordinary skill prior to the effective filing date to combine the device of Yang with the physical coupling of the excitation and measurement devices of Yoshida in order to achieve the goal of miniaturization.
Regarding claim 2, Yang as modified by Yoshida teaches the invention as explained above in claim 1, and further teaches the fluorescence excitation device comprises:
an excitation channel (Yang: V-groove, Fig. 9) into which a first optical fiber that applies the fluorescence-exciting light is inserted, is formed by etching at least a part of a substrate (Yang: subsections 2.2 and 2.3; Fig. 3); and
a reflector that is formed at an end of the excitation channel, and is configured to reflect the fluorescence-exciting light in an upward direction (Yang: mirror, Figs. 5 and 9).
Regarding claim 3, Yang as modified by Yoshida teaches the invention as explained above in claim 2, and further teaches the excitation channel is formed in a 'V' shape (Yang: subsections 2.2 and 2.3 describe the channel as being a "V-groove"; Figs. 2, 4, 5, and 9 also depict the "V" shape).
Regarding claim 4, Yang as modified by Yoshida teaches the invention as explained above in claim 2, and further teaches the reflector is formed in part of regions including an end of the excitation channel that has a predetermined angle (Yang: Fig. 9).
Regarding claim 5, Yang as modified by Yoshida teaches the invention as explained above in claim 2, and further teaches a width of the excitation channel and a depth of the excitation channel are determined by a diameter of the first optical fiber (Yang: eqs. 1 and 2).
Regarding claim 12, Yang teaches a fluorescence excitation device configured to reflect and output in an upward direction each of fluorescence-exciting lights (laser source, optical fiber and V-groove and mirror in Fig. 9) applied respectively in a horizontal direction;
a fluorescence measurement device that a fluorescence-exciting light (photodetector, Fig. 9) input into from a downward direction (see Fig. 9) and measures the fluorescence of the optofluidic droplet (abstract).
Yang fails to teach the lights having different wavelengths, different fluidic channels for different wavelengths, or receiving fluorescence generated from the plurality of regions.
However, Yoshida discloses different channels corresponding to different wavelengths of input light and detecting fluorescence from the different channels (paragraph [0100]).
Yoshida discloses the use of multiple wavelengths further improves the accuracy of the measurement taken (paragraph [0100]). Thus, it would be obvious for a person of ordinary skill in the art prior to the effective filing date to combine the device of Yang with the ability to use different wavelengths taught in Yoshida in order to further improve the measurement accuracy.
Regarding claim 13, Yang as modified by Yoshida teaches the invention as explained above in claim 12, and further teaches a plurality of excitation channels into which optical fibers that apply each of the fluorescence-exciting lights (Yoshida: 902a and 912a, Fig. 9) is inserted by etching at least a part of a substrate (Yang: see subsections 2.2 and 2.3 which disclose the excitation channel is etched); and
a plurality of reflectors that are formed at an end of each of the plurality of excitation channels, and configured to reflect each of the fluorescence-exciting lights in an upward direction (Yang: mirror, Fig. 9).
As discussed above, it would be obvious for a person having ordinary skill in the art to combine the reflectors and etching taught in Yang as modified by Yoshida with the alternative embodiment of Yoshida which teaches multiple optical excitation channels in order to improve measurement accuracy.
Regarding claim 14, Yang as modified by Yoshida teaches the invention as explained above in claim 13, and further teaches the fluorescence measurement device further comprises:
a fluidic channel in which the optofluidic droplet flows (Yang: page 2, column 1, paragraph 1 discloses a microfluidic channel); and
a plurality of optical channels (Yoshida: 902b and 912b, Fig. 9) that are formed by being spaced at a predetermined distance (Yoshida: 902b and 912b are shown in Fig. 9 to be apart from each other) from each of a plurality of regions of the fluidic channel by a partition (Yoshida: the space between 912 and 902 in Fig. 9 is acting as a partition), each optical fiber configured to receive fluorescence generated from the optofluidic droplet being inserted into the plurality of optical channels (Yoshida: paragraph [0100] discloses receiving and measuring light from the sample).
Yoshida discloses a plurality of optical channels arranged in this manner is a further way to improve accuracy of measurement (paragraph [0100]) without sacrificing miniaturization (paragraph [0005]). Thus, it would be obvious for a person of ordinary skill in the art prior to the effective filing date to combine the device of Yang as modified by Yoshida and Camou with the plurality of optical channels taught in Yoshida in order to further improve the measurement accuracy.
Regarding claim 15, Yang as modified by Yoshida teaches the invention as explained above in claim 12, and further teaches a spacer that is formed between the fluorescence measurement device and the fluorescence excitation device and which is configured to maintain a predetermined space between the fluorescence measurement device and the fluorescence excitation device (Yang: page 3, column 1, paragraph 1 discloses a glass was placed over the V-shaped groove containing the fiber to separate the excitation unit from the photodetector).
Regarding claim 16, Yang as modified by Yoshida teaches the invention as explained above in claim 13, and further teaches the plurality of excitation channels are perpendicular to the fluidic channel, and are formed in parallel in one side direction of the fluidic channel (Yoshida: 902a and 912a are parallel to each other but perpendicular to the flow channel, 20, in Fig. 9).
As discussed above, it would be obvious for a person of ordinary skill prior to the effective filing date to combine the device of Yang with the placement of the optical channels of Yoshida in order to achieve the goal of miniaturization.
Regarding claim 17, Yang as modified by Yoshida teaches the invention as explained above in claim 14, and further teaches the plurality of optical channels are perpendicular to the fluidic channel and are formed in parallel in one side direction of the fluidic channel (Yoshida: 902b and 912b are parallel to each other but perpendicular to the flow channel, 20, in Fig. 9) or are formed to cross each other in a first side direction and in a second side direction respectively for the fluidic channel.
As discussed above, it would be obvious for a person of ordinary skill prior to the effective filing date to combine the device of Yang with the placement of the optical channels of Yoshida in order to achieve the goal of miniaturization.
Regarding claim 18, Yang discloses an optofluidic droplet fluorescence measurement device manufacturing method, the method comprising:
forming a first structure by forming an excitation channel, into which a first optical fiber for applying a fluorescence-exciting light is inserted by etching at least a part of a substrate, and by depositing, in at least part of regions including an end of the excitation channel, a reflection layer for reflecting the fluorescence-exciting light in an upward direction (Yang: see subsections 2.2 and 2.3; Fig. 4); and
coupling the first structure and the second structure in alignment (Yang: page 2, column 1, paragraph 1 discloses coupling he first structure (measurement device) with a second structure (chip containing the microfluidic channel)).
While Yang discloses a second structure (microfluidic chip, page 1, column 2, paragraph 3), Yang does not disclose a method to form this second structure.
However, Yoshida teaches forming a second structure containing a fluidic channel and optical channel where a fiber is inserted to receive fluorescence (paragraph [0085]).
As discussed above, a goal of Yang is to create a miniature device (page 1, column 2, paragraph 3). Yoshida uses a second structure to contain the fluidic and optical channels in a compact area. Thus, it would be obvious for a person having ordinary skill in the art to combine the method of Yang with the second structure taught in Yoshida in order to further create a miniaturized device.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Yang ( "Miniaturized Fluorescence Excitation Platform with Optical Fiber for Bio-Detection Chips" https://doi.org/10.48550/arXiv.0711.3325) in view of Yoshida (JP2013217916A) as applied to claim 2 above, and further in view of Spoto (US20140038193A1).
Regarding claim 6, Yang as modified by Yoshida teaches the invention as explained above in claim 2, but fails to teach the fluorescence excitation unit comprises a first coupling unit that is formed in at least one region of the substrate, and
wherein the fluorescence measurement device comprises a second coupling unit that is formed at a position corresponding to the first coupling unit and has a shape corresponding to a shape of the first coupling unit so that the fluorescence measurement device is capable of being physically coupled with the fluorescence excitation device.
However, in the same field of endeavor as PCR devices, Spoto teaches a first unit with a coupling unit in one region (paragraph [0186] discloses the cover portion has hooks; 124, Fig. 19) and a second unit which has a second coupling unit formed at a corresponding shape position to the first coupling to enable physical coupling (paragraph [0186] discloses apertures are coupled with the hooks; 114, Fig. 18).
The use of physical coupling units to connect two elements is not novel and is well-known. A person having ordinary skill in the art would find it routine and well-known to include physical coupling units to couple two different elements together as it allows flexibility to detach the two parts.
It would be obvious for a person having ordinary skill in the art prior to the effective filing date to combine the device of Yang as modified by Yoshida with the physical coupling units taught in Spoto as it is well-known and routine method of attaching two elements.
Claims 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Yang ( "Miniaturized Fluorescence Excitation Platform with Optical Fiber for Bio-Detection Chips" https://doi.org/10.48550/arXiv.0711.3325) in view of Yoshida (JP2013217916A) as applied to claim 1 above, and further in view of Camou ("Integrated 2-D optical lenses designed in PDMS layer to improve fluorescence spectroscopy using optical fibers," SENSORS, 2002 IEEE, Orlando, FL, USA, 2002, pp. 187-191 vol.1, doi: 10.1109/ICSENS.2002.1037079.).
Regarding claim 7, Yang as modified by Yoshida teaches the invention as explained above in claim 1, and further teaches a fluidic channel in which the optofluidic droplet flows (Yang: page 2, column 1, paragraph 1 discloses a microfluidic channel).
Yang as modified by Yoshida fails to teach a first optical channel that is formed by being spaced at a predetermined distance from the fluidic channel by a first partition, a second optical fiber configured to receive fluorescence generated from the optofluidic droplet being inserted into the first optical channel.
Yoshida discloses an issue in the art is the ability to create a miniature device that is also accurate (paragraph [0004]). Camou discloses the optical channel is spaced apart from the fluidic channel in order to create a lens effect which increases the sensitivity of the device (page 188, column 1, paragraph 3), which would create a more accurate device. Thus, a person of ordinary skill in the art prior to the effective filing date would find it obvious to combine the device of Yang as modified by Yoshida the optical channel spaced apart from the fluidic channel in order to increase sensitivity and accuracy of the device.
Regarding claim 8, Yang as modified by Yoshida and Camou teaches the invention as explained above in claim 7, and further teaches the first optical channel is formed in an orthogonal direction to a part of the fluidic channel into which the fluorescence-exciting light is input (Camou: see Fig. 2, which depicts the optical channel spaced apart from the fluidic channel in an orthogonal direction. The examiner is interpreting “in an orthogonal direction” to mean orthogonal to the flow of fluid).
As discussed above in claim 7, the configuration of Camou also for the sensitivity of the measurement device to be improved. Thus, a person of ordinary skill in the art prior to the effective filing date would find it obvious to combine the device of Yang as modified by Yoshida and Camou with the orthogonal placement taught in Camou in order to increase sensitivity and accuracy of the device.
Regarding claim 9, Yang as modified by Yoshida and Camou teaches the invention as explained above in claim 8, and further teaches the fluorescence measurement device further comprises a second optical channel (Yoshida: Fig. 9 and 10 disclose embodiments with multiple optical channels, for example: 902b/912b in Fig. 9 and 122b/132b in Fig. 10) that is formed by being spaced at a predetermined distance from the fluidic channel by a second partition (Camou: see Fig. 2, which depicts the optical channel spaced apart from the fluidic channel), and a third optical fiber configured to receive fluorescence generated from the optofluidic droplet being inserted into the second optical channel (Yoshida: paragraph [0016] discloses an optical fiber in the receiving optical channel. It is the understanding of the examiner that this would be true for multiple channels as well).
Yoshida discloses the use of multiple optical measurement channels further improves measurement accuracy (paragraph [0100]). Thus, it would be obvious for a person having ordinary skill in the art to combine the device of Yang as modified by Yoshida and Camou with the alternative embodiment of Yoshida which teaches multiple optical measurement channels in order to improve measurement accuracy.
Further, as discussed above, a person of ordinary skill in the art prior to the effective filing date would find it obvious to combine the device of Yang as modified by Yoshida and Camou with the placement taught in Camou in order to increase sensitivity and accuracy of the device.
Regarding claim 10, Yang as modified by Yoshida and Camou teaches the invention as explained above in claim 9, and further teaches the first optical channel and the second optical channel are formed to have a predetermined angle in different directions with respect to the fluidic channel (Yoshida: optical channels 122b and 132b in Fig. 10 are at a 90 degree angle with the fluidic channel and have different vertical directions).
As discussed above, it would be obvious for a person of ordinary skill prior to the effective filing date to combine the device of Yang as modified by Yoshida and Camou with the arrangement of optical channels of Yoshida in order to achieve the goal of miniaturization.
Regarding claim 11, Yang as modified by Yoshida and Camou teaches the invention as explained above in claim 7, and further teaches a spacer that is formed between the fluorescence measurement device and the fluorescence excitation device and configured to maintain a predetermined space between the fluorescence measurement device and the fluorescence excitation device (Yang: page 3, column 1, paragraph 1 discloses a glass layer was placed over the V-shaped groove, which would separate it from the measurement device).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yang ( "Miniaturized Fluorescence Excitation Platform with Optical Fiber for Bio-Detection Chips" https://doi.org/10.48550/arXiv.0711.3325) in view of Yoshida (JP2013217916A) as applied to claim 18 above, and further in view of McDonald (Poly(dimethylsiloxane) as a material for fabricating microfluidic devices. Acc. Chem. Res. 2002, 35 (7), 491– 499, DOI: 10.1021/ar010110q).
Regarding claim 20, Yang as modified by Yoshida teaches the invention as explained above, but fails to teach forming of the second structure comprise:
forming a channel layer to form the fluidic channel and the optical channel on a first substrate;
forming a polydimethylsiloxane (PDMS) layer with a predetermined thickness on the first substrate including the channel layer; and
forming the second structure by separating the PDMS layer from the first substrate.
However, McDonald teaches forming channels on a first substrate (Fig. 1 discloses using photolithography to create a master substrate with cutouts for channels) and then forming a PDMS layer on the first substrate that has the channels (Fig. 1 further depicts pouring the PDMS layer over the master layer with the channels etched out) and forming the second layer by separating the PDMS layer from the first substrate (Fig. 1 depicts separating the PDMS layer from the master layer and placed it on a flat surface thus creating the second layer).
The method of fabrication as disclosed in McDonald has the advantage of being simple, cheap and not as time-consuming compared to other methods (page 498, column 1, paragraph 1). Thus, it would be obvious to combine the method taught in Yan as modified by Yoshida with the PDMS method taught in McDonald in order to form a structure cheaply and fast.
Regarding claim 20, Yang as modified by Yoshida and McDonald teaches the invention as explained above and further teaches the coupling in alignment couples the first structure and the second structure in alignment by using a spacer to maintain a predetermined space between the first structure and the second structure (McDonald: page 495, column 2, paragraph 1 discloses using a polymeric filter between layers, acting as a spacer between structures).
McDonald discloses the method allows for selected light to be detected while also keeping the device compact (McDonald: page 495, column 2, paragraph 1).
Thus, it would be obvious to combine the method taught in Yang as modified by Yoshida with the spacer between structures (layers) taught in McDonald to ensure only the chosen light is detected while also keeping the device compact.
Conclusion
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/ALEXANDRIA MENDOZA/Examiner, Art Unit 2877
/MICHELLE M IACOLETTI/Supervisory Patent Examiner, Art Unit 2877