DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/03/2025 (RCE 01/05/2026) has been entered.
Claim Rejections - 35 USC § 112
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, 3-14, 16, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is unclear reciting “[...] a channel structure including a main channel [...], a connection channel that connects a main channel [...]” because it is unclear whether the applicant is trying to claim the fine particle sorting mechanism having two different main channels.
Claim Rejections - 35 USC § 102
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-14, 16, and 17 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Ito et al. (JP2017-218941 filed 11/14/2017; WO 2019/098126 A1, filed 11/09/2018 published 05/23/2019, the rejection referring to US equivalent application US 2021/0170402 A1).
Regarding claim 1, Ito et al. teach:
1. A method of collecting fine particles, the method comprises:
using a fine particle sorting mechanism (e.g., microparticle sorting microchip) having a channel structure including a main channel (e.g., main channel/microparticle-containing fluid inlet 101) through which fine particles flow (¶ 0007+), a collection channel (e.g., trap chamber/pressure chamber 114 in Fig. 24) into which particles to be collected are collected from among the fine particles (¶ 0020-0021+), a connection channel (e.g., 1, 7, 2) that connects the main channel and the collection channel (see Fig. 24 for example), a liquid supply channel (e.g., 10) connected to the connection channel (see Fig. 24 for example) so as to supply a liquid (¶ 0108+);
causing a first liquid (e.g., microparticle-containing fluid) containing the fine particles to flow through the main channel (¶ 0007, 0099+);
determining whether or not the fine particles flowing through the main channel are particles to be collected (¶ 0100-0101+);
culturing the particles to be collected (¶ 0109); and
forming an emulsion () containing the particles to be collected in a collection channel (¶ 0100), wherein the emulsion contains a second liquid (e.g., sheath fluid) as a dispersion medium () and the first liquid as a dispersoid (see i.e., In a sheath flow forming portion 112, the sheath fluid merges with the microparticle-containing fluid and the microparticle-containing fluid (for example, merges with the microparticle-containing fluid from both sides of the microparticle-containing fluid) to form a laminar flow with the microparticle-containing fluid surrounded at its periphery by the sheath fluid or a laminar flow with the microparticle-containing fluid flanked by the sheath fluid, that is, what is generally called a sheath flow. The laminar flow flows toward a detection section 105. ¶ 0100; it is recognized that fine particles exist in the form of emulsion containing sheath fluid as a dispersion medium and a sample fluid as a dispersoid).
With regard to limitations in claims 1, 3, 6, 7, 8, 9, 10, 11, 12, 14, 16 (e.g., “[...] which the fine particles flow; [...] which particles to be collected are collected from among the fine particles [...]”, “[...] so as to supply a liquid”, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). It has been held that to be entitled to weight in method claims, the recited structure limitations therein must affect the method in a manipulative sense, and not to amount to the mere claiming of a use of a particular structure.
Regarding claims 3, 6-14, 16, 17, Ito et al. teach:
3. The method of collecting the fine particles according to claim 1, wherein at least a part of droplets forming the emulsion contains one of the particles to be collected (¶ 0100).
6. The method of collecting the fine particles according to claim 1, wherein a flow step, a determination step, and a collection step are performed while the second liquid is being supplied from the liquid supply channel to the connection channel (see ¶ 0100-0103 for example).
7. The method of collecting the fine particles according to claim 1, wherein the main channel bifurcates into the connection channel and at least one waste channel (e.g., 110) through which a fine particle that is determined to not flow into the collection channel flows, and the liquid supply channel supplies the liquid to the connection channel (see ¶ 0104, 0108+).
8. The method of collecting the fine particles according to claim 1, wherein a valve (e.g., pump or filter) capable for preventing the first liquid from entering the collection channel is provided in the connection channel (¶ 0228; see also Further, as a fluid to be allowed to flow through the gate channels, a solution having a blocking effect can also be used. The use of such a solution enables suppression of non-specific adsorption of cells on a collection container or bag after sorting. Blocking agents can include solutions containing one or more proteins such as albumin, solutions containing one or more amino acids such as glycine, and solutions containing one or more nonionic surfactants such as Pluronic F68. ¶ 0110; By the gate flow directed toward the side of the detection section in the trap channel, microparticles which are not to be acquired can be prevented from entering the trap channel on the side of the pressure chamber. ¶ 0116).
9. The method of collecting the fine particles according to claim 1, wherein in a flow step (), the fine particles flow through the main channel substantially in a row toward the connection channel (see Fig. 5 for example).
10. The method of collecting the fine particles according to claim 1, wherein the fine particle sorting mechanism has a channel structure in which a sample channel through which a liquid containing the fine particles flows and a sheath channel (e.g., 103) through which a liquid containing no fine particle (e.g., sheath fluid) flows are connected to the main channel at a joining portion so that the fine particles flow substantially in a row through the main channel after the joining portion, and the channel structure forms a laminar flow containing the fine particles that flow substantially in a row (see Figs. 1, 2, 11, 24, 26, ¶ 0100 & rejection to Claim 1 above).
11. The method of collecting the fine particles according to claim 1, wherein in a determination step, the fine particles flowing through the main channel are irradiated with light, and whether or not the fine particles are the particles to be collected is determined on a basis of light generated by the irradiation (see ¶ 0101 for example).
12. The method of collecting the fine particles according to claim 1, wherein in a collection step, the particles to be collected are collected into the collection channel through the connection channel due to a pressure fluctuation in the collection channel (see ¶ 0117-0127+).
13. The method of collecting the fine particles according to claim 1, wherein the main channel, the connection channel, and the collection channel are linearly arranged (see Fig. 1 for example).
14. The method of collecting the fine particles according to claim 1, wherein the fine particles are cells or cell aggregation (¶ 0090-0092+), and the first liquid is a culture solution of the fine particles (¶ 0109).
16. The method of collecting the fine particles according to claim 1, wherein the collected fine particles in the collection channel are subjected to further fine particle sorting processing (¶ 0010+).
17. The method of collecting the fine particles according to claim 1, wherein the fine particle sorting mechanism has one or more channel structures (see Fig. 1 for example).
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.
Claim(s) 1, 3-14, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitagawa et al. (US 2018/0246020) in view of Ito et al. (JP2017-218941 filed 11/14/2017; WO 2019/098126 A1, filed 11/09/2018 published 05/23/2019, the rejection referring to US equivalent application US 2021/0170402 A1).
Regarding claim 1, Kitagawa et al. teach:
1. A method of collecting fine particles, the method comprises:
using a fine particle sorting mechanism (e.g., 100) having a channel structure including a main channel (e.g., 111a) through which fine particles flow, a collection channel (e.g., 111c) into which particles to be collected are collected from among the fine particles, a connection channel (e.g., 112) that connects the main channel and the collection channel (see Fig. 21 for example), a liquid supply channel (e.g., 111b) connected to the connection channel so as to supply a liquid (see ¶ 0009 for example);
causing a first liquid (e.g., 10) containing the fine particles (¶ 0244-0249+) to flow through the main channel (e.g., 111a);
determining whether or not the fine particles flowing through the main channel are particles to be collected (see ¶ 0046 for example);
thermal cycling the particles to be collected (see i.e., The thermal cycler performs a thermal cycle process of repeating, multiple times, one cycle of changing the temperature of the mixture to a plurality of different temperatures. ¶ 0230); and
forming an emulsion (see ¶ 0244-0249+) containing the particles to be collected in a collection channel (e.g., 111c), wherein the emulsion contains a second liquid as a dispersion medium (¶ 0231) and the first liquid as a dispersoid (¶ 0231).
However, Kitagawa et al. do not explicitly teach: culturing the particles to be collected.
See Ito et al. above.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of Kitagawa et al. with culturing particles to be collected for the purpose of when collected cells are stored or transported (Ito et al. ¶ 0109). The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141.
With regard to limitations in claims 1, 3, 6, 7, 8, 9, 10, 11, 12, 14, 16 (e.g., “[...] which the fine particles flow; [...] which particles to be collected are collected from among the fine particles [...]”, “[...] so as to supply a liquid”, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). It has been held that to be entitled to weight in method claims, the recited structure limitations therein must affect the method in a manipulative sense, and not to amount to the mere claiming of a use of a particular structure.
Regarding claims 3, 4, 6-14, 16, 17, modified Kitagawa et al. teach:
3. The method of collecting the fine particles according to claim 1, wherein at least a part of droplets forming the emulsion contains one of the particles to be collected (see ¶ 0244-0249+).
4. The method of collecting the fine particles according to claim 1, wherein the first liquid is hydrophilic (e.g., water-based mixture ¶ 0231) and a second liquid is hydrophobic (e.g., oil-based dispersion medium ¶ 0231).
6. The method of collecting the fine particles according to claim 1, wherein a flow step, a determination step, and a collection step are capable of being performed while the second liquid is being supplied from the liquid supply channel to the connection channel (see ¶ 0229-0238 for example).
7. The method of collecting the fine particles according to claim 1, wherein the main channel bifurcates into the connection channel (see ¶ 0123 & Figs. 18 & 26 for example).
8. The method of collecting the fine particles according to claim 1, wherein a valve (e.g., 507) is provided in a connection channel (e.g., 522).
9. The method of collecting the fine particles according to claim 1, wherein in a flow step, the fine particles flow through the main channel substantially in a row toward the connection channel (see Fig. 21 for example).
10. The method of collecting the fine particles according to claim 1, wherein the fine particle sorting mechanism has a channel structure (see Figs. 1-5 & ¶ 0244-0249+ for example).
11. The method of collecting the fine particles according to claim 1, wherein in a determination step, the fine particles flowing through the main channel are irradiated with light (see ¶ 0237 for example).
12. The method of collecting the fine particles according to claim 1, wherein in a collection step, the particles to be collected are capable of being collected into the collection channel through the connection channel (see Fig. 20 for example).
13. The method of collecting the fine particles according to claim 1, wherein the main channel, a connection channel, and the collection channel are linearly arranged (see Fig. 20 for example).
14. The method of collecting the fine particles according to claim 1, wherein the fine particles are cells or cell aggregation, and the first liquid is a culture solution of the fine particles (see ¶ 0111-0112+ for example).
16. The method of collecting the fine particles according to claim 1, wherein the collected fine particles in the collection channel are capable of being subjected to further fine particle sorting processing (see ¶ 0239 for example).
17. The method of collecting the fine particles according to claim 1, wherein the fine particle sorting mechanism has one or more channel structures (see Figs. 1-5 for example).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitagawa et al. (US 2018/0246020).
Regarding claim 5, Kitagawa et al. do not explicitly teach: 5. The method of collecting the fine particles according to claim 1, wherein a kinematic viscosity of the second liquid is 1/100 times to 100 times as much as the kinematic viscosity of the first liquid.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to select a kinematic viscosity of the second liquid is 1/100 times to 100 times as much as the kinematic viscosity of the first liquid for selectively manipulate and separate particles based on their density. The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141. Therefore, although the specific claimed elements are not taught, selecting appropriate liquids for its suitability of intended use (for the purpose of particle sorting) would have been obvious to one of ordinary skill in the art.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ito et al. (JP2017-218941 filed 11/14/2017; WO 2019/098126 A1, filed 11/09/2018 published 05/23/2019, the rejection referring to US equivalent application US 2021/0170402 A1) in view of Kitagawa et al. (US 2018/0246020).
Regarding claim 4, Ito et al. do not explicitly teach: 4. The method of collecting the fine particles according to claim 1, wherein the first liquid is hydrophilic and the second liquid is hydrophobic.
See Kitagawa et al. above.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the first liquid as hydrophilic and the second liquid as hydrophobic, as taught by Kitagawa et al., since using an immiscible fluid as dispersion medium is well-known in the art (Kitagawa et al. ¶ 0231). The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141. Therefore, although the specific claimed elements are not taught, selecting appropriate liquids for its suitability of intended use (for the purpose of particle sorting) would have been obvious to one of ordinary skill in the art.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ito et al. (JP2017-218941 filed 11/14/2017; WO 2019/098126 A1, filed 11/09/2018 published 05/23/2019, the rejection referring to US equivalent application US 2021/0170402 A1).
Regarding claim 5, Ito et al. do not explicitly teach: 5. The method of collecting the fine particles according to claim 1, wherein a kinematic viscosity of the second liquid is 1/100 times to 100 times as much as the kinematic viscosity of the first liquid.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to select a kinematic viscosity of the second liquid is 1/100 times to 100 times as much as the kinematic viscosity of the first liquid for selectively manipulate and separate particles based on their density. The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141. Therefore, although the specific claimed elements are not taught, selecting appropriate liquids for its suitability of intended use (for the purpose of particle sorting) would have been obvious to one of ordinary skill in the art.
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground(s) of rejection.
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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