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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/28/2023, 2/24/2025, and 9/23/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 1: 21; Figure 2: 130, 140, 71, 81; Figure 4: 31, 32; Figure 6: 112, 114, 116, 121, 122, 123, 124, 125; and Figure 7: 13a, 13b, 14a, 14b, 15a, 15b, 16a, 16b, 130, 132, 134. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Status
Claims 12-22 are pending and being examined.
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 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.
Claims 12-15 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (CN 206008737 U; hereinafter “Chen”; already of record on IDS filed 9/23/2025; English translation attached) in view of Zhang (CN 109967150 B; hereinafter “Zhang”; already of record on 7/28/2023; English translation attached).
Regarding claim 12, Chen teaches a biological particle sorting channel (Chen; Abstract; a microfluidic device designed to focus flow, thus is capable of sorting particles), comprising a first channel unit, which comprises a first side wall and a second side wall disposed oppositely, wherein the first side wall and the second side wall are asymmetric curved surfaces (Chen; Image 1; the examiner interprets the first side wall to be the smaller/top portion of the first channel unit and the second side wall to be the larger/bottom portion of the first channel unit as annotated below in Image 1. Additionally, the first side wall and the second side wall are asymmetrical as the top portion is smaller in size compared to the bottom portion).
Chen does not teach the side of the first channel unit close to the first side wall or the second side wall is provided with a deepened channel in a recessed manner that is disposed in an extension direction of the first channel unit.
However, Zhang teaches an analogous art of a microfluidic chip (Zhang; Abstract) comprising a flow channel with a deepened channel in a recessed manner (Zhang; Fig. 3, 8, 9; pp 5, para [9]; upper half inertial flow passage 151 upper substrate and lower substrate the lower half inertial flow passage 2 of 52 are overlapped and assembled together to form a L-shaped cross section). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the base plate and the cover plate of Chen to form the “L” shaped channel as taught by Zhang as this is a known and suitable arrangement for microfluidics in the art. Further, it is a matter of engineering design to substitute the ----base plate and the cover plate in different ways, where the change in form or shape, without any new or unexpected result, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). Finally, one would have a reasonable expectation of success by changing the base plate and the cover plate of Chen to the claimed limitation as Zhang teaches this arrangement is a known and suitable arrangement in the art. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A). The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B). Thus, modified Chen teaches
the side of the first channel unit close to the first side wall or the second side wall is provided with a deepened channel in a recessed manner that is disposed in an extension direction of the first channel unit (Chen; page 8, para [2]; the chip main body comprises a base plate 9 and a cover 10, wherein the upper surface of the substrate 9 is provided with a micro-channel structure, a cover plate 10 covered on the upper surface of the base plate 9; Zhang; Fig. 3, 8, 9; pp 5, para [9]; upper half inertial flow passage 151 upper substrate and lower substrate the lower half inertial flow passage 2 of 52 are overlapped and assembled together to form a L-shaped cross section). The examiner notes that the modification of the Chen’s base plate results in the claimed limitation as the lower substrate and upper substrate form the “L” shaped channel which is interpreted as the deepened channel.
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Image 1.
Regarding claim 13, modified Chen teaches the biological particle sorting channel according to claim 12, further comprising a second channel unit that is in communication with the first channel unit (Chen; page 3, para [4, 5]; the first end of the asymmetric focusing curve, the asymmetric focusing curve of is connected with the sample liquid inlet direct focusing flow channel, the first end and the second end connected with the second end of the asymmetric focusing curve connected with the mixed liquid outlet; the second channel unit is depicted above and is in fluid communication with the first channel unit because the sample liquid flows from the inlet 2 to the outlet 6), wherein the radius of curvature of the second channel unit is less than that of the first channel unit, the deepened channel correspondingly extends into the second channel unit (Chen; page 8, para [2]; the chip main body comprises a base plate 9 and a cover 10, wherein the upper surface of the substrate 9 is provided with a micro-channel structure, a cover plate 10 covered on the upper surface of the base plate 9; Zhang; Fig. 3, 8, 9; pp 5, para [9]; upper half inertial flow passage 151 upper substrate and lower substrate the lower half inertial flow passage 2 of 52 are overlapped and assembled together to form a L-shaped cross section; The examiner notes that the modification of the Chen’s base plate results in the claimed limitation as the lower substrate and upper substrate form the “L” shaped channel which is interpreted as the deepened channel), and the second channel unit comprises a third side wall and a fourth side wall disposed oppositely, the third side wall and the fourth side wall being asymmetric curved surfaces, the third side wall being connected to the second side wall, and the fourth side wall being connected to the first side wall (Chen; Image 1; the examiner interprets the third side wall to be the smaller/top portion of the second channel unit and the fourth side wall to be the larger/bottom portion of the second channel unit as annotated above in Image 1. Additionally, the third side wall and the fourth side wall are asymmetrical as the top portion is smaller in size compared to the bottom portion). Examiner notes that Chen teaches the limitation “wherein the radius of curvature of the second channel unit is less than that of the first channel unit” because the limitation does not specify which part/portion of the second channel is less than the first channel unit. Thus, the third side wall of the second channel unit has a smaller radius of curvature than the second side wall of the first channel unit, because the third side wall corresponds to the smaller/top portion and the second side wall corresponds to the larger/bottom portion.
Regarding claim 14, modified Chen teaches the biological particle sorting channel according to claim 13, comprising a plurality of first channel units and a plurality of second channel units disposed alternately (Chen; Image 1).
Regarding claim 15, modified Chen teaches the biological particle sorting channel according to claim 14, further comprising a third channel unit that is in communication with the second channel unit at the tail (Chen; Image 1; the third channel unit is depicted above and is in fluid communication with the second channel unit because the sample liquid flows from the inlet 2 to the outlet 6), wherein the radius of curvature of the third channel unit is greater than that of the first channel unit, the deepened channel correspondingly extends into the third channel unit (Chen; page 8, para [2]; the chip main body comprises a base plate 9 and a cover 10, wherein the upper surface of the substrate 9 is provided with a micro-channel structure, a cover plate 10 covered on the upper surface of the base plate 9; Zhang; Fig. 3, 8, 9; pp 5, para [9]; upper half inertial flow passage 151 upper substrate and lower substrate the lower half inertial flow passage 2 of 52 are overlapped and assembled together to form a L-shaped cross section; The examiner notes that the modification of the Chen’s base plate results in the claimed limitation as the lower substrate and upper substrate form the “L” shaped channel which is interpreted as the deepened channel), the third channel unit is rotated by 90° relative to the first channel unit (Chen; Image 1; the third channel is turned 90 degrees and leads into the fourth channel unit and the second channel unit), and the third channel unit comprises a fifth side wall and a sixth side wall disposed oppositely, the fifth side wall and the sixth side wall being asymmetric curved surfaces, the fifth side wall being connected to the end of the third side wall away from the second side wall, and the sixth side wall being connected to the end of the fourth side wall away from the first side wall (Chen; Image 1; the examiner interprets the fifth side wall to be the left portion of the third channel unit and the sixth side wall to be the right portion of the third channel unit as annotated above in Image 1. Additionally, the fifth side wall and the sixth side wall are asymmetrical as the left portion is curve is smaller in size compared to the right portion). Examiner notes that Chen teaches the limitation “wherein the radius of curvature of the third channel unit is greater than that of the first channel unit” because the limitation does not specify which part/portion of the third channel unit is less than the first channel unit. Thus, the sixth side wall of the third channel unit has a smaller radius of curvature than the first side wall of the first channel unit, because the sixth side wall corresponds to the right/wider portion and the first side wall corresponds to the smaller/top portion.
Regarding claim 21, modified Chen teaches the microfluidic chip, comprising a functional board, wherein a first side surface of the functional board is provided with the biological particle sorting channel according to claim 12 (Chen; page 8, para [2]; the chip main body comprises a base plate 9 and a cover 10, wherein the upper surface of the substrate 9 is provided with a micro-channel structure). The examiner notes that the “functional board” is interpreted as the base plate which comprise the micro-channel structures for particle sorting.
Claims 16-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Zhang, and in further view of Kapur et al (US 20160121331 A1; hereinafter “Kapur”)
Regarding claim 16, modified Chen teaches the biological particle sorting channel according to claim 15, further comprising a plurality of fourth channel units and a plurality of fifth channel units (Chen; Image 1; the fourth channel units and the fifth channel units are depicted above in image 1), wherein the radius of curvature of the fourth channel unit is less than that of the fifth channel unit, the radius of curvature of the third channel unit is greater than that of the fifth channel unit (the limitation does not specify which part/portion of the third channel unit, fourth channel unit, and fifth channel unit is being compared. Thus, limitations are met depending on which side wall is being compared), the fourth channel unit and the fifth channel unit are disposed alternately (Chen; Image 1), and the deepened channel correspondingly extends into the fourth channel unit and the fifth channel unit (Chen; page 8, para [2]; the chip main body comprises a base plate 9 and a cover 10, wherein the upper surface of the substrate 9 is provided with a micro-channel structure, a cover plate 10 covered on the upper surface of the base plate 9; Zhang; Fig. 3, 8, 9; pp 5, para [9]; upper half inertial flow passage 151 upper substrate and lower substrate the lower half inertial flow passage 2 of 52 are overlapped and assembled together to form a L-shaped cross section; The examiner notes that the modification of the Chen’s base plate results in the claimed limitation as the lower substrate and upper substrate form the “L” shaped channel which is interpreted as the deepened channel); and the third channel unit is rotated by 90° relative to the fifth channel unit (Chen; Image 1; the third channel is turned 90 degrees and leads into the fourth channel unit and the second channel unit), and the fourth channel unit comprises a seventh side wall and an eighth side wall which are disposed oppositely and are asymmetric curved surfaces (Chen; Image 1; the examiner interprets the seventh side wall to be the bottom/smaller portion of the fourth channel unit and the eighth side wall to be the upper/larger portion of the fourth channel unit as annotated above in Image 1. Additionally, the seventh side wall and the eighth side wall are asymmetrical as the bottom portion is smaller in size compared to the upper portion), and the fifth channel unit comprises a ninth side wall and a tenth side wall which are disposed oppositely and are asymmetric curved surfaces (Chen; Image 1; the examiner interprets the ninth side wall to be the bottom/smaller portion of the fifth channel unit and the tenth side wall to be the upper/larger portion of the fifth channel unit as annotated above in Image 1. Additionally, the ninth side wall and the tenth side wall are asymmetrical as the bottom portion is smaller in size compared to the upper portion), the eighth side wall being connected to the ninth side wall, the seventh side wall being connected to the tenth side wall, the seventh side wall of the fourth channel unit at the head being connected to the end of the fifth side wall away from the third side wall, the eighth side wall of the fourth channel unit at the head being connected to the end of the sixth side wall away from the fourth side wall (Chen; Image 1; all side walls are connected).
Modified Chen does not teach wherein at least one of the fifth channel units being provided with a flow dividing hole penetrating a wall surface of the fifth channel unit.
However, Kapur teaches an analogous art of a microfluidic device (Kapur; Abstract) comprising a flow channel (Kapur; Fig. 1) comprising a flow dividing hole penetrating a wall surface (Kapur; Fig. 2b; para [66]; The 1-dimensional array of island structures 110 extends substantially in the same direction as the flow of the fluid through the second and first microfluidic channels). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the flow channel of modified Chen to comprise the flow dividing hole as taught by Kapur, because Kapur teaches island structure separates/filters particles from the fluid (Kapur; para [68]). The examiner notes that the island structures are integrated into the microfluidic channel. Thus, modified Chen teaches wherein at least one of the fifth channel units being provided with a flow dividing hole penetrating a wall surface of the fifth channel unit, because the claim does not specify which wall surface the flow dividing hole is provided on.
Regarding claim 17, modified Chen teaches the biological particle sorting channel according to claim 16 (the fifth channel unit of modified Chen is modified to comprise the flow dividing hole as taught by Kapur discussed above in claim 16), wherein the fifth channel unit is provided with a blocking member corresponding to an inlet of the flow dividing hole (Kapur; Fig. 1; para [36]; rigid island structure refers to a physical structure through which a particle generally cannot penetrate; the examiner interprets the walls of the island, interpreted as the flow dividing hole, to be the blocking member which is shown in Figure 9 of the instant specification), the blocking member being located on the side of the flow dividing hole away from the deepened channel (Chen; page 8, para [2]; the chip main body comprises a base plate 9 and a cover 10, wherein the upper surface of the substrate 9 is provided with a micro-channel structure, a cover plate 10 covered on the upper surface of the base plate 9; Zhang; Fig. 3, 8, 9; pp 5, para [9]; upper half inertial flow passage 151 upper substrate and lower substrate the lower half inertial flow passage 2 of 52 are overlapped and assembled together to form a L-shaped cross section; The examiner notes that the modification of the Chen’s base plate results in the claimed limitation as the lower substrate and upper substrate form the “L” shaped channel which is interpreted as the deepened channel), and the width of the blocking member in an extension direction of the fifth channel unit is greater than the diameter of the flow dividing hole (Kapur; Fig. 1). The Applicant does not specify the direction/orientation of the diameter of the flow dividing hole. Thus, the diameter of the wall in the direction of the liquid flow would be greater than the vertical diameter of the interior of the island.
Regarding claim 18, modified Chen teaches the biological particle sorting channel according to claim 16, further comprising a sixth channel unit that is in communication with the fourth channel unit at the tail (Chen; Image 1; the sixth channel unit is depicted above and is in fluid communication with the fourth channel unit because the sample liquid flows from the inlet 2 to the outlet 6), wherein the radius of curvature of the sixth channel unit is greater than that of the fifth channel unit (the limitation does not specify which part/portion of the sixth channel unit and fifth channel unit is being compared. Thus, limitations are met depending on which side wall is being compared), the deepened channel correspondingly extends into the sixth channel unit (Chen; page 8, para [2]; the chip main body comprises a base plate 9 and a cover 10, wherein the upper surface of the substrate 9 is provided with a micro-channel structure, a cover plate 10 covered on the upper surface of the base plate 9; Zhang; Fig. 3, 8, 9; pp 5, para [9]; upper half inertial flow passage 151 upper substrate and lower substrate the lower half inertial flow passage 2 of 52 are overlapped and assembled together to form a L-shaped cross section; The examiner notes that the modification of the Chen’s base plate results in the claimed limitation as the lower substrate and upper substrate form the “L” shaped channel which is interpreted as the deepened channel), the sixth channel unit is rotated by 90° relative to the fifth channel unit (Chen; Image 1; the third channel is turned 90 degrees and leads into the fourth channel unit and the second channel unit), the sixth channel unit protrudes in the opposite direction of the third channel unit (Chen; Image 1; the sixth channel unit and the third channel unit are on opposite sides and direct flow in opposite directions), and the sixth channel unit comprises an eleventh side wall and a twelfth side wall disposed oppositely, the eleventh side wall and the twelfth side wall being asymmetric curved surfaces (Chen; Image 1; the examiner interprets the eleventh side wall to be the left/outer portion of the sixth channel unit and the twelfth side wall to be the right/inner portion of the sixth channel unit as annotated above in Image 1. Additionally, the ninth side wall and the tenth side wall are asymmetrical as the bottom portion is smaller in size compared to the upper portion), the eleventh side wall being connected to the end of the eighth side wall away from the ninth side wall, and the twelfth side wall being connected to the end of the seventh side wall away from the tenth side wall (Chen; Image 1; all side walls are connected).
Regarding claim 19, modified Chen teaches the biological particle sorting channel according to claim 18 (the channels of Chen are modified to comprise the deepened channel as taught by Zhang), wherein the deepened channel has a depth of 50 µm to 200 µm; or the deepened channel has a depth of 70 µm to 120 µm (Zhang; page 3, para [5]; a/DH <0.07, ≥0.07 a/Dh, wherein a is the diameter of the micro-nano particles, DH is the inertial flow passage cross section of the outer wall surface height, Dh is the inertia of the transverse section of the flow passage inner wall surface height). The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the portion of a depth of 70 µm to 120 µm to correspond to the claimed range. See MPEP 2144.05(I). Examiner notes that the channel depth would be dependent on the size of the particle, thus one of ordinary skill in the art can select channel heights based on the detected particle.
Regarding claim 20, modified Chen teaches the biological particle sorting channel according to claim 18, wherein the radius of curvature of the first side wall is greater than or less than that of the second side wall, and the first side wall and the second side wall protrude toward the same side; and/or, the radius of curvature of the third side wall is less than that of the fourth side wall, and the third side wall and the fourth side wall protrude toward the same side; and/or, the radius of curvature of the fifth side wall is less than that of the sixth side wall, and the fifth side wall and the sixth side wall protrude toward the same side; and/or, the radius of curvature of the seventh side wall is less than that of the eighth side wall, and the seventh side wall and the eighth side wall protrude toward the same side; and/or, the radius of curvature of the ninth side wall is less than that of the tenth side wall, and the ninth side wall and the tenth side wall protrude toward the same side; and/or, the radius of curvature of the eleventh side wall is less than that of the twelfth side wall, and the eleventh side wall and the twelfth side wall protrude toward the same side. See above, the examiner notes that the limitation is met depending on which side walls are being compared.
Regarding claim 22, modified Chen teaches the microfluidic chip, comprising a functional board, wherein a first side surface of the functional board is provided with the biological particle sorting channel according to claim 16 (Chen; Image 1; discussed above), and a second side surface of the functional board is provided with a buffer channel of a repeatedly folded structure, the buffer channel being in communication with the flow dividing hole (Chen; Figure 4). The examiner notes that the second side of the functional board to be interpreted as the top/cover which is where fluid is supplied and leads to the repeatedly folded structures as seen in Figure 4.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/A.Q.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796