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 .
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 the preamble reciting “using a fine particle sorting mechanism having a channel structure including a main channel through which fine particles flow, a collection channel into which particles to be collected are collected from among the fine particles, a connection channel that connects a main channel and the collection channel, a liquid supply channel connected to the connection channel so as to supply a liquid”. Although the recitation employs the active method phrase “using”, the recitation is in the preamble and therefore makes it unclear what elements which the applicant intends to claim. Examiner suggests placing the recitation after the conventional transitional phrase, i.e., comprises. In addition, the “forming an emulsion containing the particles to be collected in a collection channel, wherein the emulsion containing the second liquid as a dispersion medium and the first liquid as a dispersoid” is unclear. It is unclear if the limitations following the phrase “to be [...]” are part of the claimed invention. Further, the limitations “the emulsion containing the second liquid as a dispersion medium and the first liquid as a dispersoid” make the claim unclear whether the limitations are intended as examples within the description (i.e., the second liquid as a dispersion medium and the first liquid as a dispersoid), rather than elements of the claimed invention (the second liquid is a dispersion medium and the first liquid is a dispersoid). For this reason, dependent claims relating to these elements are also unclear.
Claim 1 recites the limitation "the fine particles" in L4. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the second liquid" in L14. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the flow step" in L1. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the determination step" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the collection step" in L2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 7, the phrase “a fine particle other than the particles to be collected flows” renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by “other [...]”), thereby rendering the scope of the claim unascertainable.
Claim 9 recites the limitation "the flow step" in L1. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the determination step" in L1. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the collection step" in L1. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 does not appear further limit the method step of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 4, 6-14, 16, and 17 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Kitagawa et al. (US 2018/0246020).
Regarding claim 1, Kitagawa et al. teach:
1. A method of collecting fine particles 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), the method comprises:
causing a first liquid (e.g., 10) containing a fine particles (¶ 0244-0249+) to flow through a 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); and
forming an emulsion (see ¶ 0244-0249+) containing the particles to be collected in a collection channel (e.g., 111c).
Regarding claim 1, Kitagawa et al. meet all the structural limitations recited by the instant invention. Applicants’ preamble recites “using a fine particle sorting mechanism having a channel structure including a main channel through which fine particles flow, a collection channel into which particles to be collected are collected from among the fine particles, a connection channel that connects a main channel and the collection channel, a liquid supply channel connected to the connection channel so as to supply a liquid”. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
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, 7-14, 16, 17, Kitagawa et al. teach:
3. The method of collecting the fine particles according to claim 1, wherein an emulsion is formed by carrying out the method of collecting the fine particles, and 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).
7. The method of collecting the fine particles according to claim 1, wherein the main channel bifurcates into a connection channel and at least one waste 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 the fine particles are capable of flowing through the main channel substantially in a row toward a 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, 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 the particles to be collected are capable of being collected into the collection channel through a 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 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) 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 Rejections - 35 USC § 103
Claim(s) 1-14, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ito et al. (US 2014/0048458) in view of Kitagawa et al. (US 2018/0246020).
Regarding claims 1, 4, 5, Ito et al. teach:
1. A method of collecting fine particles using a fine particle sorting mechanism (e.g., microparticle sorting apparatus) having a channel structure (see Figs. 1-2 for example) including a main channel (e.g. 15) through which fine particles flow (¶ 0095-0103 for example), a collection channel (e.g. 16) into which particles to be collected are collected (¶ 0095-0103 for example) from among the fine particles, a connection channel (i.e., channel formed by the communication opening 156), a liquid supply channel (e.g. 12) connected to the connection channel (see Fig. 4 for example), the method comprises:
causing a first liquid (e.g., sample fluid) containing the fine particles (e.g., microparticles) to flow through the main channel (see ¶ 0040 for example);
determining whether or not the fine particles flowing through the main channel are particles to be collected (see ¶ 0037-0039 for example).
However, Ito et al. do not explicitly teach: forming an emulsion containing the particles; 4. The method of collecting the fine particles according to claim 1, wherein the first liquid is hydrophilic and the second liquid is hydrophobic. 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.
See Kitagawa above.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use a particle sorting mechanism of Ito et al. to form an emulsion containing particles, as taught by Kitagawa et al. for various chemical and biological studies, including single cell analysis (Kitagawa et al. ¶ 0274-0283+). In addition, it is well-known in the cytometry art that a sheath fluid is hydrophilic, and technique to select desired fluid property, such as viscosity and immiscibility would have been obvious. Further, it would have been obvious to select kinematic viscosities of the liquids 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.
Regarding claim 1, modified Ito et al. meet all the structural limitations recited by the instant invention. Applicants’ preamble recites “using a fine particle sorting mechanism having a channel structure including a main channel through which fine particles flow, a collection channel into which particles to be collected are collected from among the fine particles, a connection channel that connects a main channel and the collection channel, a liquid supply channel connected to the connection channel so as to supply a liquid”. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
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 7-10, 13, 14 & 17, modified Ito et al. teach:
7. The method of collecting the fine particles according to claim 1, wherein the main channel bifurcates into the connection channel (see Fig. 2 for example) and at least one waste channel (e.g., 17).
8. The method of collecting the fine particles according to claim 1, wherein a valve is provided (¶ 0067).
9. The method of collecting the fine particles according to claim 1, wherein in the flow step, the fine particles flow through the main channel substantially in a row toward the connection channel (see ¶ 0040 for example).
10. The method of collecting the fine particles according to claim 1, comprises a sheath channel (e.g., 14), and wherein the channel structure forms a laminar flow containing the fine particles that flow substantially in a row (see ¶ 0040 for example).
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. 2 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 solution (see ¶ 0014-0015 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 Fig. 4 for example).
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
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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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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