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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: non-target object obtaining unit in claim 2 and 16.
a target object obtaining unit in claims 1 and 15;
a non-target object obtaining unit in claim 2 and 16.
According to Figure 1, a target and non-target object obtaining unit comprise outlets for receiving the particles.
Furthermore, according to para. [0088] of the specification, non-targeting object obtaining unit is essentially a second target object unit with similar or same structure but configured to trap a different object from the targeting object obtaining unit.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is 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.
Regarding claim 6. The claim recites a “ditch-type” channel. The term “ditch-type” uses the additional term “type” to an otherwise definite expression (ditch) extends the scope of the expression so as to render it indefinite. Consequently, “ditch-type” renders the configuration/shape of the channel unclear. “Ex parteCopenhaver, 109 USPQ 118 (Bd. Pat. App. & Inter. 1955). Likewise, the phrase “ZSM-5-type aluminosilicate zeolites” was held to be indefinite because it was unclear what “type” was intended to convey. The interpretation was made more difficult by the fact that the zeolites defined in the dependent claims were not within the genus of the type of zeolites defined in the independent claim. Ex parteAttig, 7 USPQ2d 1092 (Bd. Pat. App. & Inter. 1986).” Due to the indefiniteness of limitation, any channel in a depth direction on one side of the passage unit can be read on to the limitation for the purpose of examination.
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.
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.
Claim(s) 1-3, 9, 10, and 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song (U.S. Pub. No. 2020/0269242 A1) as cited in IDS filed on 10/09/2024 in view of Chou (U.S. Pub. No. 2018/0202903 A1).
Regarding claim 1, Song discloses a device for separating a target object (Fig. 3), comprising:
an injection unit into which a fluid including microparticles is injected (injection part 110, fig. 3; para. [0136]);
a passage unit (passage 120, fig. 3) allowing a flow of the target object to be concentrated in a predetermined direction during a process of the injected fluid flowing, the passage unit comprising a plurality of engraved structures (through a pattern of a certain shape in the passage part 120) having a groove shape (inclined pattern grooves) in a direction perpendicular to a main flow direction of the fluid (which has a predetermined angle of inclination with respect to a perpendicular direction to the main flow direction of the fluid) (para. [0141]); and
a target object obtaining unit (130) (see paragraphs [0148] and figures 3-5a).
Song does not disclose wherein at least one of the injection unit, the passage unit or the target object obtaining unit comprise a pillar structure arranged in an area other than the plurality of engraved structures.
Analogous art, Chou, discloses a microfluidic device comprising a first and a second plate (fig. 1, 4, and 5), wherein surface(s) of one or both plate(s) comprise(s) spacers that rare fixed with a respective surface, and wherein the space have pillar shape and evenly shaped throughout the device (para. [0034]-para. [0035]; fig. 1, 4, and 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporated pillar-shaped spacers as taught by Chou across the device evenly space from the injection unit to the object obtaining unit (as similarly highlighted in Fig. 5 of Chou) of the Song to derive to claimed invention. Doing so reduce local bending or sagging (para. [0050]; Fig. 5).
Regarding claim 2, Modified Song discloses the claimed invention as discussed above in claim 1. Song discloses the device comprising a non-target object discharging unit (See Fig. 3, Either 130a or 130b can be interpreted as non-target object discharging unit).
Regarding claim 3, Modified Song discloses the claimed invention as discussed above in claim 1. The claim limitation of “the target object is concentrated in a predetermined direction by a secondary flow generated in a direction perpendicular to the main flow direction of the fluid by the plurality of engraved structures” is a recitation of intended use as the target object is an article the claimed device works upon. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Moreover, Song discloses the claimed feature in para. [0154] of the specification.
Regarding claim 9, Modified Song discloses the claimed invention as discussed above in claim 1. Song discloses the plurality of engraved structure are arranged on a bottom surface or a ceiling surface of the apparatus for separating microparticles (See pattern in Figure 4a, which is arranged in a bottom surface of the device), and the plurality of engraved structures are formed being disconnected from each other (Figure 9).
Regarding claim 10, Modified Song discloses the claimed invention as discussed above in claim 1. Song discloses the plurality of engraved structures form a linear micropattern (Fig. 9), and the linear micropattern has an angle of 0 to 90 degrees with respect to the main flow direction of the fluid (para. [0042]), which overlaps with the claimed range of 45 to 135 degrees. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I.
Regarding claim 12, Modified Song discloses the claimed invention as discussed above in claim 2. The claim limitation regarding the specific target object is a leukocyte, plasma, and cell when the erythrocytes, blood cells, culture medium are obtained in the non-target object discharging unit is a recitation of intended use because the claim limitations are drawn to the articles the device works upon. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Moreover, Song discloses when the target object is leukocyte (210, Fig. 5ac; para. [0132]), erythrocytes are obtained in the non-target object discharging unit (220, Fig. 5bc; para. [0132]).
Regarding claim 13, Modified Song discloses the claimed invention as discussed above in claim 1. Chou (after incorporation into Song) discloses a height of the pillars structure corresponds to the height of the passage unit (Fig. 4 and 5b),
wherein the pillar structure has a pillar shape having a cross section of a circle, an ellipse, a streamline, or a round polygon (para. [0318]), and
wherein a maximum length of a cross-section of the pillar shape is determined so that (the height of the passage unit)/(the maximum length of the cross-section) (the ratio of the lateral dimensions of x to y direction) (para. [0336]-[0338]).
Regarding claim 14, Modified Song discloses the claimed invention as discussed above in claim 1. Chou (after incorporation into Song) discloses wherein when there are a plurality of pillar structures, a distance between the plurality of pillar structure is wider than to a diameter of a microparticle to be obtained (a predetermined constant inter-spacer distance that is at least about 2 times larger than the size of the analyte; claim 1).
Regarding claim 15, Song discloses a method for separating a target object from a fluid (Fig. 2) using an apparatus for separating the target object (Fig. 3), comprising:
Injecting a fluid including microparticles into an injection unit (S210, Fig. 2; injection part 110, fig. 3; para. [0136]);
obtaining, at a target object obtaining unit (130) (see paragraphs [0148] and figures 3-5a), in a predetermined direction during a process of flowing the fluid injected into a passage unit (S220-230, Fig. 2),
wherein the passage unit (passage 120, fig. 3) comprises a plurality of engraved structures (through a pattern of a certain shape in the passage part 120) having a groove shape (inclined pattern grooves) in a direction perpendicular to a main flow direction of the fluid (which has a predetermined angle of inclination with respect to a perpendicular direction to the main flow direction of the fluid) (para. [0141]).
Song does not disclose wherein at least one of the injection unit, the passage unit or the target object obtaining unit comprise a pillar structure arranged in an area other than the plurality of engraved structures.
Analogous art, Chou, discloses a microfluidic device comprising a first and a second plate (fig. 1, 4, and 5), wherein surface(s) of one or both plate(s) comprise(s) spacers that rare fixed with a respective surface, and wherein the space have pillar shape and evenly shaped throughout the device (para. [0034]-para. [0035]; fig. 1, 4, and 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporated pillar-shaped spacers as taught by Chou across the device evenly space from the injection unit to the object obtaining unit (as similarly highlighted in Fig. 5 of Chou) of the Song to derive to claimed invention. Doing so reduce local bending or sagging (para. [0050]; Fig. 5).
Regarding claim 16, Modified Song discloses the claimed invention as discussed above in claim 15. Song discloses obtaining a non-target object from a non-target object discharging unit (See Fig. 3, Either 130a or 130b can be interpreted as non-target object discharging unit; See a specific example in para. [0051]).
Regarding claim 17, Modified Song discloses the claimed invention as discussed above in claim 15. Song discloses the target object is concentrated in a predetermined direction by a flow generated in a direction perpendicular to the main flow direction of the fluid by the plurality of engraved structure (para. [0154]).
Claim(s) 4- 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song in view of Chou as discussed above in claim 1, and further in view of Kim (KR 20160052282 A).
Regarding claims 4 and 5. Modified Song discloses the claimed invention as discussed above in claim 1. Neither Song nor Chou explicitly disclose a highway channel extending from at least a portion of the area between the injection unit and the target object obtaining unit, wherein the plurality of engrave structures are arranged in the passage unit other than the highway channel.
In an analogous art, Kim discloses a microfluidic device (1000, Fig. 1) for comprising a filter unit (200, fig. 1) and cell capture unit (300, fig. 1), wherein the filter unit comprises pillars arrays and only cells smaller than the spacing between pillars are allowed to passed (para. [0029]. Additionally, the microfluidic device comprises a bypass channel (channel 31, fig 3) configured to allows cell of certain sizes to bypass the cell capture unit (para. [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate an additional side channel from the inlet circumventing the main passage to the outlet of the device of Song to derive the claimed invention based on the teaching of Kim, wherein the engraved structures are arranged in passage unit other than a highway/bypass channel because doing so will speed up the sorting by preemptively removing cells of smaller than certain size via a bypass channel (Kim, para. [0050], [0085]).
Regarding claim 6, Modified Song discloses the claimed invention as discussed above in claim 4. Kim, after modification with Song in view of Chou, discloses the highway channel is a ditch-type (The meaning of the term “ditch-type” is held unclear) in a depth direction on one side of the passage unit corresponding to a direction in which the microparticles are concentrated (See Figure 3 of Kim, wherein the bypass channel 31 analogous to the claimed highway channel is in a depth direction on one side/outskirt of the cell capture unit 300, analogous to claimed passage unit).
Regarding claim 7, Modified Song discloses the claimed invention as discussed above in claim 4. Neither Song, Chou nor Kim explicitly discloses the highway channel has a width of 0.1 to 50% of the width of the passage unit.
Kim discloses relationship between sorting efficiency and passband (range of cell diameter allowed to passed through the capture array) wherein a passband of 0 to 30 μm (there is only a capture space array without bypass channels) corresponds to an efficiency of 76.4% (para. [0084]), and a passband of 18-30 μm (a bypass channel with 18 μm diameter or less) corresponds to an efficiency of 99.2% (para. [0085]). As the efficiency of sorting and speed are variables that can be modified, among others, by adjusting the bypass diameter, with efficiency and sorting speed both increasing (until a certain point) as the bypass channel diameter is increased, the precise width of the highway/bypass channel would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed width cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the width of the bypass/highway channel relative to the width of the passage to obtain the desired balance between the efficiency and speed and bypass/highway channel width as taught by Kim (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Claim(s) 8 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song in view of Chou as discussed above in claim 1, and further in view of Zhao (A High-throughput sheathless and three-dimensional microparticle focusing using a microchannel with arc-shaped groove arrays, 2017) as cited in IDS filed on 05/30/2023.
Regarding claim 8 and 11, Modified Song discloses the claimed invention as discussed above in claim 1. Neither Song nor Chou explicitly discloses the plurality of engraved structures form a curved-shaped micropattern formed from a first point, which is a starting point, to a second point, which is an end point, and a tangent of the first point has an angle of 45 to 135 degrees with respect to the main flow direction of the fluid, and the tangent of the second point has an angle of 0 to 75 degrees or 105 to 180 degrees with respect to the main flow direction of the fluid.
In an analogous art, Zhao discloses a study of particles flow across a microchannel with arc-shaped groove arrays, the groove comprises an outer larger curvature (R2) with a small curvature (R1) (Figure 7; Abstract) (Arc length can be converted to angle). Zhao discloses the arc-shaped groove channel was demonstrated to have the ability to achieve high-throughput (abstract) and perform well for different size particles (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have adopt arc-shaped grooves in the passage unit of Modified Song to derive the claimed invention, as the arc-shaped groove create a helical vorticity pattern in the flow, creating a strong transverse drag force that transports cells laterally across the channel to a focused position (Secondary Flow, Page 3, para. 2-Page 4, para. 1).
Furthermore, the precise arc-shaped angles would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed arc-shaped angles cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the arc-shape angles to obtain the desired balance between induced secondary flow by the arc-shaped grooves and increased throughput as taught by Zhao (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song in view of Chou as discussed above in claim 1, and further in view of Kim.
Regarding claims 18. Modified Song discloses the claimed invention as discussed above in claim 15. Neither Song nor Chou explicitly disclose a highway channel extending from at least a portion of the area between the injection unit and the target object obtaining unit, wherein the plurality of engrave structures are arranged in the passage unit other than the highway channel.
In an analogous art, Kim discloses a microfluidic device (1000, Fig. 1) for comprising a filter unit (200, fig. 1) and cell capture unit (300, fig. 1), wherein the filter unit comprises pillars arrays and only cells smaller than the spacing between pillars are allowed to passed (para. [0029]. Additionally, the microfluidic device comprises a bypass channel (channel 31, fig 3) configured to allows cell of certain sizes to bypass the cell capture unit (para. [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate an additional side channel from the inlet circumventing the main passage to the outlet of the device of Song to derive the claimed invention based on the teaching of Kim, wherein the engraved structures are arranged in passage unit other than a highway/bypass channel. Doing so speed up the sorting by preemptively removing cells of smaller than certain size via a bypass channel (Kim, para. [0050], [0085]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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/M.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758