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 .
Response to Amendment
The amendment filed 23 December 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “a first outlet adjacent to the first wall surface of the first channel; and a second outlet adjacent to the second wall surface of the first channel”.
Applicant is required to cancel the new matter in the reply to this Office Action.
Additionally, per Applicant’s amendment filed 23 December 2025, the U.S.C. 112 rejections of claims 1-15 have been withdrawn. It is recognized that claims 1, 3, and 8 have been amended, claims 2, 4, 9, 10, and 12-15 have been cancelled, and claims 16-18 have been added by Applicant. Accordingly, claims 1, 3, 5-8, 11, and 16-18 are under full consideration.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 8have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5-8, 11, and 16-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claims 1 and 8, the newly added limitation claiming “a first outlet adjacent to the first wall surface of the first channel; and a second outlet adjacent to the second wall surface of the first channel” is not supported by the original disclosure. According to both the specification and the drawings, there are a number of structures separating a first outlet from the first wall, and separating a second outlet from the second wall. While the term “adjacent” is broad, it is not reasonable to interpret one object as being adjacent to another when there are a multitude of structures separating the two objects. For the purpose of examination, this limitation will be interpreted as “a first outlet disposed on the same side of the apparatus as the first wall of the first channel; and a second outlet disposed on the same side of the apparatus as the second wall of the first channel”.
Claims 3, 5-7, 11, and 16-18 are rejected by virtue of their dependence on claims 1 or 8.
Claim Rejections - 35 USC § 103
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, 3, 6-8, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (US-20190030534-A1), hereinafter “Hong”, in view of Han et al. (US-9789485-B2), hereinafter “Han”.
Regarding Claim 1, Hong discloses a fine object separation device (particle separation apparatus; see Abstract) comprising: a first channel (first input flow path; see Abstract) in which a subject solution including a plurality of different fine objects having a size of 1 micrometer or less flows (plurality of particles may be nanoparticles; see [0070]) in from one side and flows to the other side (through which a first fluid containing a plurality of particles of different sizes is introduced; see [0008] and Fig. 1, Part In_P1); and a second channel (a second input flow path; see [0009]) that communicates with a first wall surface of the first channel at an angle greater than 00, parallel to a flow direction of the subject solution, and less than 900, perpendicular to the flow direction of the subject solution (see Fig. 1 Parts In_P1 and In_P2), wherein the second channel merges a buffer solution (second fluids may comprise… phosphate buffer saline; see [0032]) with the first channel (connection flow path is connected to the first input flow path and the second input flow path so that the first fluid and the second fluid are mixed; see [0010]); and an output channel that has one side communicating with the other side of the first channel and has a width greater than a width of the first channel to allow the fine objects to be classified and discharged, wherein the buffer solution supplied through the second channel separates the fine objects (plurality of particles of the first fluid move toward the first side of the connection path by the second fluid; see [0078]) according to size in a direction intersecting with the flow direction of the subject solution (when passing through the connection path (CP), they move separately from one another according to the particle size; see [0086] and Fig. 2), wherein the output channel includes: an inclined portion extending from the other side of the first channel and configured to communicate with the first channel, a horizontal portion extending from the inclined portion to communicate with the inclined portion (see annotated Fig. 1 below), and a plurality of outlets configured to communicated with the horizontal portion (see annotated Fig. 1 below) and to classify the fine objects according to size to be discharged (The plurality of discharge flow path can separate and discharge a plurality of particles… according to the size of the particles; see [0132]), the plurality of outlets being formed to be spaced apart from each other in the direction intersecting with the flow direction of the subject solution (plurality of discharge flow paths may be spaced apart from each other in a direction crossing the flow direction of the third fluid on the other end of the connection flow path; see [0024]), wherein the plurality of outlets includes: a first outlet disposed on the same side of to the first wall surface of the first channel (see Fig. 1), and a second outlet disposed on the same side of the apparatus as the second wall surface of the first channel (see Fig. 1).
Regarding the limitation claiming “the fine objects are separated such that the smaller fine objects are disposed closer to the first wall surface and the larger fine objects are disposed closer to a second wall surface that is spaced apart from and is opposite to the first wall surface” this is a functional limitation. 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)). 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). Hence, the limitation of the direction of degree of separation does not further define the actual structure of the separation device, but merely sets forth a manner of operating the separation device. Functional limitations that do not limit the structure need not be given further due consideration in determining patentability of an apparatus.
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Hong does not explicitly teach varying outlet sizes. However, Han discloses wherein a first outlet has a smaller diameter than a second outlet (two outlet channels with a channel width ratio of 3:7 (inner:outer); see Col. 30 Lines 32-33) and is configured to prevent the larger fine objects having a size greater than the diameter of the first outlet from being discharged through the first outlet (This is a natural consequence of the structure. It is well established that a particle will not fit through an outlet that is smaller than the particle itself).
Hong and Han are both considered to be analogous to the claimed invention because they are in the same field of microfluidic separation devices. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Hong by incorporating the teachings of Han and providing outlets with different sizes. Doing so would enable collection of different samples from different outlets (The inner outlet was defined to be the WBC outlet… and the outer outlet to be the RBC waste outlet; see Han, Col. 30 Lines 34-36).
Regarding Claim 3, Hong and Han together disclose the fine object separation device of claim 1, wherein the inclined portion includes a first inclined portion extending obliquely from the first wall surface of the first channel and a second inclined portion extending obliquely from the second wall surface of the first channel (see annotated Fig. 1 below); and the horizontal portion includes first and second horizontal portions extending parallel to the first wall surface and the second wall surface, respectively (see annotated Fig. 1 below).
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Regarding Claim 6, Hong and Han together disclose the fine object separation device of claim 1, wherein the fine objects comprise fine particles (nanoparticles such as… fine dusts; see [0051]).
Regarding Claim 7, Hong and Han together disclose the fine object separation device of claim 1, wherein the fine objects comprise bio-molecules (the present example can be applied to … a DNA array; see [0141]; it is well known in the art that a DNA array consists of biomolecules).
Regarding Claim 8, Hong and Han together disclose a fine object separation method (particle separating method; see [0001]) comprising: a subject solution flowing step in which a subject solution including a plurality of different fine objects having a size of 1 micrometer (plurality of particles may be nanoparticles; see [0070]) or less flows in a first channel (Introducing a first fluid containing a plurality of particles having different particles sizes into a first input flow path; see [0035]); a buffer solution merging step in which a buffer solution (second fluids may comprise… phosphate buffer saline; see [0032]) merges into the first channel through a second channel (passing the first fluid and the second fluid through a connection flow path which is connected to outlet parts of the first input flow path and the second input flow path; see [0037]) that communicates with a first wall surface of the first channel at an angle greater than 00, parallel to a flow direction of the subject solution, and less than 900, perpendicular to the flow direction of the subject solution (see Fig. 1 Parts In_P1 and In_P2); and a fine object separating step in which the buffer solution supplied through the second channel separates the fine objects (plurality of particles of the first fluid move toward the first side of the connection path by the second fluid; see [0078]) according to size in a direction intersecting with the flow direction of the subject solution (when passing through the connection path (CP), they move separately from one another according to the particle size; see [0086] and Fig. 2), and a discharging step in which the separated fine objects are classified and discharged via an output channel (the plurality of particles coming out of the other end of the connection flow path are separated and discharged according to the size of the particle; see [0011]).
Regarding the limitation claiming, “the fine objects are separated such that the smaller fine objects are disposed closer to the first wall surface and the larger fine objects are disposed closer to a second wall surface that is spaced apart from and is opposite to the first wall surface”, this is a consequential limitation that appears as a result of the claimed method and the claimed structural limitations of an associated device. Therefore, because the method steps are disclosed by Hong, and the structural limitations are disclosed by Hong, then the consequential direction and degree of particle separation should occur.
The remaining structural limitations of claim 8 do not exceed those of claim 1. Please refer to the claim 1 rejection as the rejection of these structural limitations follows the same rationale.
Regarding Claim 16, Hong and Han together disclose the fine object separation device of claim 3. Hong further discloses wherein the first outlet is disposed closer to the first horizontal portion and the second outlet is disposed closer to the second horizontal portion (see Fig. 1, wherein Ex9 is considered the first outlet and Ex1 is considered the second outlet).
Regarding Claim 17, Hong and Han together disclose the fine object separation method of claim 8. The remaining limitations of claim 17 do not exceed those of claim 3. Please refer to the claim 3 rejection as the rejection of claim 17 follows the same rationale.
Regarding Claim 18, Hong and Han together disclose the fine object separation device of claim 17. The remaining limitations of claim 18 do not exceed those of claim 16. Please refer to the claim 16 rejection as the rejection of claim 18 follows the same rationale.
Claims 5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (US-20190030534-A1), hereinafter “Hong”, in view of Han et al. (US-9789485-B2), hereinafter “Han”, and Giddings (US-5141651-A).
Regarding Claim 5, Hong and Han together disclose the fine object separation device of claim 1.
Hong does not explicitly teach a temperature gradient. However, forming a temperature gradient in the channel is a functional limitation. 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)). 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). Hence, the limitation of forming a temperature gradient does not further define the actual structure of the separation device, but merely sets forth a manner of operating the separation device. Functional limitations that do not limit the structure need not be given further due consideration in determining patentability of an apparatus.
With that said, Giddings discloses a temperature gradient in which temperature decreases from a first wall surface to a second wall surface, being formed in a channel (gradient is used… in a direction across the thin dimension perpendicular to the flow axis; see Claim 1; and “gradient is selected from the group consisting of… temperature gradient”; see Claim 5 and see Fig. 1).
Hong and Giddings are both considered to be analogous to the claimed invention because they are in the same field of particle separation using a channel structure. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Hong by incorporating the teachings of Giddings and including a temperature gradient. Doing so would induce a driving force on the particles in a direction perpendicular to the flow axis (see Giddings Claim 1).
Regarding Claim 11, Hong and Han together disclose the fine object separation method of claim 8. The remaining limitations of claim 11 do not exceed those of claim 5. Please refer to the claim 5 rejection for the associated rationale.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA LEE KUYKENDALL whose telephone number is (571)270-3806. The examiner can normally be reached Monday- Friday 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.L.K./Examiner, Art Unit 1774
/CLAIRE X WANG/Supervisory Patent Examiner, Art Unit 1774