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 11/19/2025 has been entered. Claims 31-32, 34-35, and 37-62 remain pending in the application. Claims 46-59 are withdrawn.
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: “movement device” in claims 31 and 61-62.
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.
In this instant case, “movement device” in claims 31 and 61-62 is being interpreted as comprising a particle moving system chosen in the group consisting of: travelling waves, thermal flow, local fluid movements generated by electro thermal flow, local fluid movements generated by electro-hydrodynamic forces, dielectrophoresis, optical tweezers, opto-electronic tweezers, light-induced dielectrophoresis, magnetophoresis, acoustophoresis (and a combination thereof) (specification, page 16, lines 14-21), and equivalents thereof.
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.
Claims 31-32, 42, and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Beaumont et al. (US 20170165667 A1) in view of Hobbs et al. (US 20150151298 A1).
Regarding claim 31, Beaumont teaches a method for the isolation (abstract) of at least one first particle of a given type (Fig. 6, micro-objects 630) from a sample comprising the at least one first particle (Fig. 6, micro-objects 630), at least one second particle (Fig. 6, undesired materials 632, 634), and at least one third particles (paragraph [0266] teaches smaller micro-objects are included in the sample, i.e. at least one third particle), wherein the first, second, and third particles are each different types of particles (Fig. 6 and paragraph [0266] teaches at least 3 different types or sizes of particles), by means of a microfluidic system (Fig. 6, microfluidic device 600; paragraph [0287] teaches microfluidic device 600 may have combination of features as described for microfluidic device 100; therefore, the microfluidic system is interpreted as comprising microfluidic device 600 of Fig. 6 and media source 178 of Fig. 1A), which comprises a feeding assembly (Fig. 1A, media source 178) and a microfluidic circuit (Fig. 6, microfluidic device 600) having: at least one inlet (paragraph [0287] teaches microfluidic device 600 may have combination of features as described for microfluidic device 100; paragraph [0074] teaches a first port that functions as an inlet for entering a microfluidic circuit; therefore, the microfluidic device 600 is implied to have at least one inlet); at least one first outlet (paragraph [0287] teaches microfluidic device 600 may have combination of features as described for microfluidic device 100; paragraph [0074] teaches a second port that functions as an outlet for fluid exiting the microfluidic circuit; therefore, the microfluidic device 600 is implied to have at least one outlet); and at least one microfluidic channel (Fig. 6, channel 264 of microfluidic device 600), which is designed to fluidically connect the at least one inlet and the at least one first outlet (Fig. 6, teaches a channel 264 of microfluidic device 600; paragraph [0287] teaches microfluidic device 600 may have combination of features as described for microfluidic device 100; paragraph [0074] teaches an inlet and outlet of the microfluidic circuit; therefore, it is implied that the microfluidic channel 264 fluidically connects to the inlet and outlet);
the microfluidic channel (Fig. 6, channel 264) comprises at least one first segment (Fig. 6, interpreted as the region upstream to element 620), at least one second segment (Fig. 6, interpreted as the region comprising element 620), which is arranged downstream of the at least one first segment (Fig. 6 shows the region comprising 620 is downstream the region upstream to element 620), and at least one third segment (Fig. 6, interpreted as the region downstream of element 620), which is arranged downstream of the at least one second segment (Fig. 6 shows the region downstream element 620 is downstream the region comprising element 620);
the method comprises a feeding step (paragraph [0266] teaches a sample containing micro-objects and undesired materials are introduced into the microfluidic device), during which the feeding assembly feeds the sample (paragraph [0266] teaches a sample containing micro-objects and undesired materials are introduced into the microfluidic device; paragraph [0287] teaches microfluidic device 600 may have combination of features as described for microfluidic device 100; therefore, it is implied that the media source 178 feeds the sample as taught in paragraph [0088]) from the at least one inlet to the at least one first outlet along the at least one microfluidic channel (paragraph [0074] teaches an inlet for fluid entering the microfluidic circuit and an outlet for fluid exiting the microfluidic circuit; paragraph [0266] teaches micro-objects and undesired materials are introduced into the microfluidic device; therefore, it is implied that the media source 178 of paragraph [0088] flows the material from the inlet to the outlet along the channel 264 of Fig. 6); and
a trapping step (paragraph [0266] and Fig. 6 shows trapping of micro-objects 630 at barrier 620), during which the at least one first particle (Fig. 6, micro-objects 630) is trapped in and prevented from escaping from the at least one second segment (Fig. 6 shows micro-objects 630 is trapped and prevented from escaping the region of channel 264 comprising element 620), while letting the at least one second particle (Fig. 6, elements 632, 634), which reaches at least the at least one third segment (Fig. 6, shows elements 632, 634 reaching the region downstream element 620), pass through the at least one second segment (paragraph [0266]);
the microfluidic system comprises a movement device (paragraphs [0266],[0268], teaches “DEP forces” and “motive means”), which is configured to directly exert a selective force upon said at least one first particle (paragraphs [0099] and [0266] teaches micro-objects are selectively moved by DEP forces);
the method further comprises a selection step, which is subsequent to the trapping step (paragraph [0266] teaches moving micro-objects after micro-objects have been collected at barrier 620, i.e. trapped) and during which the movement device directly exerts a force upon the at least one first particle so as to substantially selectively move the at least one first particle (paragraph [0266] teaches DEP forces move micro-objects 630, which is interpreted as substantially selectively moving the micro-objects), along at least one part of a given path from the at least one second segment downstream of the at least one second segment itself (paragraph [0266] teaches the barrier 620 is removed or reduced to allow for DEP forces to move micro-objects 630 to another part or out of the microfluidic device, which implies that the DEP forces the micro-objects along a path from the region comprising 620 to a region downstream); the given path extends inside said microfluidic circuit (paragraph [0266] teaches DEP forces move micro-objects 630 to another part or out of the microfluidic device, thus the path would extend inside the microfluidic circuit);
wherein the microfluidic system comprises a collection area (paragraph [0266] teaches DEP forces move micro-objects 630 to another part of the microfluidic device for further culturing or processing, where the “another part” is interpreted as a collection area), which is fluidically connected to the at least one microfluidic channel (paragraph [0266] teaches DEP forces move micro-objects 630 to another part of the microfluidic device, which is implied to be fluidically connected since it is part of the microfluidic device); during the selection step, the movement device moves the at least one first particle substantially selectively from the at least one microfluidic channel to the collection area (paragraph [0266] teaches DEP forces move micro-objects 630 to another part of the microfluidic device; paragraphs [0099] and [0266] teaches micro-objects are selectively moved by DEP forces; thus, the DEP forces substantially selectively moves the micro-objects from the channel shown in Fig. 6 to another part of the microfluidic device, where the “another part” is interpreted as the collection area);
Beaumont fails to teach: the trapping step, during which at least one first particle and the at least one third particle are trapped in and prevented from escaping from the at least one second segment; and the selection step, during which the movement device directly exerts a force upon the at least one first particle so as to substantially selectively move the at least one first particle, relative to at least the at least one third particle, along at least one part of a given path from the at least one second segment downstream of the at least one second segment itself, while the at least one third particle remains trapped at the second segment.
Beaumont teaches isolation modules to discriminate between two different types of biological micro-objects (paragraph [0221]). Beaumont teaches an isolation structure may have a plurality of barrier modules to differentially permit passage of specific sized micro-objects and the size of openings between the in situ-generated barrier modules may be sized so that at least one subset of micro-objects are prevented from exiting the isolation structure (paragraph [0233]). Beaumont teaches after removal of a barrier, cells are moved selectively using DEP forces (paragraph [0268]). Beaumont teaches allowing for cellular debris to pass through a barrier, while trapping desired micro-objects (paragraph [0270]) and controllably removing a subset of a cell while ensuring that other subsets are retained within the pen (paragraph [0274]). Beaumont teaches DEP forces are used to selectively remove a micro-object from a sequestration pen (paragraph [0099]), and DEP forces are used to manipulate, transport, separate and sort micro-objects (paragraph [0101]). Beaumont teaches DEP forces used to move desired micro-objects collected at a barrier to another part of the microfluidic device for further culturing or processing (paragraph [0266]). Beaumont teaches a plurality of barriers may be introduced to be configured to allow isolation of respective subsets of at least one micro-object of a plurality of micro-objects (paragraph [0329]). Beaumont teaches an embodiment where the method includes a step of reducing or removing one or more of the barriers to release at least one micro-object from isolation and a step of exporting the micro-object from the microfluidic device after it has been released from isolation by the barrier (paragraph [0336]).
Hobbs teaches a microfluidic device comprising biological micro-objects in a sample material that can be selected for particular characteristics and disposed into regions (abstract). Hobbs teaches the device comprises a sequestration pen including an isolation region (paragraph [0003]). Hobbs teaches the mixture of micro-objects includes different types, as well as debris and other objects, i.e. at least three types of particles (paragraph [0053]). Hobbs teaches a selector configured to create selectively electrokinetic forces on micro-objects, such as optical tweezers or DEP devices (paragraphs [0069]-[0070]). Hobbs teaches each micro-object can be selected and moved into pens with a light trap (paragraph [0144]). Hobbs teaches a first and third particle trapped in a segment (Figs. 13-14 shows different sized elements 1002 are trapped in pens 256) while second particles are flushed downstream from the segment (Fig. 14; paragraph [0143]). Hobbs teaches a first particle (Fig. 26, 1802) is selected and trapped with a light trap and moved into the channel to be flushed downstream (Figs. 26-27; paragraph [0198]) while the third particle (1002) remains in the segment (Figs. 26-27). Hobbs teaches identifying, trapping, and moving individual negative biological micro-objects out of specific pens and into the channel, therefore separating different types of micro-objects trapped within a segment (paragraph [0200]; Figs. 26-27). Hobbs teaches groups with a positive signal could be separated and moved into new pens as a single cell (paragraph [0239]). Hobbs teaches an assay material can comprise multiple types of capture micro-objects, and multiple analytes of interest can be screened for at the same time (paragraph [0188]).
Since Hobbs teaches trapping, isolating, and moving micro-objects in a microfluidic device, which is similar to Beaumont, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the trapping and selection step of Beaumont to incorporate Hobbs’ teachings of trapping two different type of particles in a segment while allowing a different type of particle continue downstream (Figs. 13-14; paragraph [0143]) and then selecting and moving one of the trapped particles in the segment downstream away from the other trapped particle that remains in the segment (Figs. 26-27; paragraphs [0200],[0239]) and teachings of screening multiple analytes of interest (paragraph [0188]) and Beaumont’s teachings of discriminating between two different types of biological micro-objects (paragraph [0221]), and allowing for cellular debris to pass through a barrier, while trapping desired micro-objects (paragraph [0270]) and controllably removing a subset of a cell while ensuring that other subsets are retained within the pen (paragraph [0274]) to provide: the trapping step, during which at least one first particle and the at least one third particle are trapped are trapped in and prevented from escaping from the at least one second segment; and the selection step, during which the movement device directly exerts a force upon the at least one first particle so as to substantially selectively move the at least one first particle, relative to at least the at least one third particle, along at least one part of a given path from the at least one second segment downstream of the at least one second segment itself, while the at least one third particle remains trapped at the second segment. Doing so would have a reasonable expectation of successfully improving isolation and sorting of multiple different micro-objects as taught by Hobbs (paragraphs [0188],[0200]; Figs. 13-14,16-27), and improving discrimination and sorting of desired subsets of micro-objects while allowing other subsets to be retained in a segment (Beaumont, paragraphs [0221],[0266],[0274]).
Regarding claim 32, Beaumont further teaches wherein, during the selection step, the movement device directly exerts said force upon the at least one first particle so as to substantially selectively move the at least one first particle relative to the at least one second particle along at least said part of said given path from the at least one second segment downstream of the at least one second segment itself (paragraph [0266] teaches DEP forces move micro-objects 630 to another part of the microfluidic device; paragraphs [0099] and [0266] teaches micro-objects are selectively moved by DEP forces; thus, the DEP forces directly exerts the force to substantially selectively move the micro-objects relative to the undesired materials 632, 634 from the region comprising element 620 of Fig. 6 to another part of the microfluidic device downstream).
Regarding claim 42, Beaumont further teaches wherein, the movement device is selected from the group consisting of: dielectrophoresis, optical tweezers, opto-electronic tweezers, light-induced dielectrophoresis, magnetophoresis, acoustophoresis, and a combination thereof (paragraph [0266] and [0268], “DEP forces”, i.e. dielectrophoresis).
Regarding claim 62, Beaumont teaches a method for isolation (abstract) of one or more first particles (Fig. 6, micro-objects 630) from a sample containing the first particles (Fig. 6, micro-objects 630), second particles (Fig. 6, undesired materials 632, 634), and third particles (Fig. 6; paragraph [0266] teaches smaller micro-objects are included in the sample, i.e. at least one third particle), the method comprising:
feeding the sample (paragraph [0266] teaches a sample containing micro-objects and undesired materials are introduced into the microfluidic device; paragraph [0287] teaches microfluidic device 600 may have combination of features as described for microfluidic device 100; therefore, it is implied that the media source 178 feeds the sample as taught in paragraph [0088]) into a microfluidic circuit of a microfluidic system (Fig. 6, microfluidic device 600), the microfluidic circuit comprising at least one inlet (paragraph [0287] teaches microfluidic device 600 may have combination of features as described for microfluidic device 100; paragraph [0074] teaches a first port that functions as an inlet for entering a microfluidic circuit; therefore, the microfluidic device 600 is implied to have at least one inlet), at least one first outlet (paragraph [0287] teaches microfluidic device 600 may have combination of features as described for microfluidic device 100; paragraph [0074] teaches a second port that functions as an outlet for fluid exiting the microfluidic circuit; therefore, the microfluidic device 600 is implied to have at least one outlet), and a microfluidic channel (Fig. 6, channel 264 of microfluidic device 600) fluidly connecting the at least one inlet and the at least one first outlet (Fig. 6, teaches a channel 264 of microfluidic device 600; paragraph [0287] teaches microfluidic device 600 may have combination of features as described for microfluidic device 100; paragraph [0074] teaches an inlet and outlet of the microfluidic circuit; therefore, it is implied that the microfluidic channel 264 fluidically connects to the inlet and outlet), wherein the sample is fed from the at least one inlet to the at least one first outlet along the microfluidic channel (paragraph [0074] teaches an inlet for fluid entering the microfluidic circuit and an outlet for fluid exiting the microfluidic circuit; paragraph [0266] teaches micro-objects and undesired materials are introduced into the microfluidic device; therefore, it is implied that the media source 178 of paragraph [0088] flows the material from the inlet to the outlet along the channel 264 of Fig. 6), wherein the microfluidic channel comprises a first segment (Fig. 6, interpreted as the region upstream to element 620), a second segment arranged downstream of the first segment (Fig. 6, interpreted as the region comprising element 620), and a third segment arranged downstream of the second segment (Fig. 6 shows the region downstream element 620 is downstream the region comprising element 620);
trapping the first particles at the second segment (paragraph [0266] and Fig. 6 teach micro-objects 630 is trapped and prevented from escaping the region of channel 264 comprising barrier 620) while the second particles (Fig. 6, elements 632, 634) pass through the second segment and reach the third segment (paragraph [0266] and Fig. 6 teach elements 632, 634 reaching the region downstream element 620);
selectively isolating the one or more first particles from the first particles trapped at the second segment by exerting a force directly upon the one or more first particles to be selectively isolated (paragraph [0266] teaches moving micro-objects after micro-objects have been collected at barrier 620, i.e. trapped) and selectively moving the one or more first particles (paragraph [0266] teaches DEP forces move micro-objects 630, which is interpreted as substantially selectively moving the micro-objects) along at least a part of a given path in the microfluidic circuit from the second segment downstream to a collection area of the microfluidic system (paragraph [0266] teaches the barrier 620 is removed or reduced to allow for DEP forces to move micro-objects 630 to another part or out of the microfluidic device, which implies that the DEP forces the micro-objects along a path from the region comprising 620 to a region downstream; thus, the DEP forces selectively isolates the micro-objects from the channel shown in Fig. 6 to another part of the microfluidic device, where the “another part” is interpreted as the collection area), and the first, second, and third particles are each different in one or more of size and type (Fig. 6 and paragraph [0266] teaches at least 3 different types or sizes of particles).
Beaumont fails to teach: trapping the first particles and the third particles at the second segment while the second particles pass through the second segment and reach the third segment; and selectively isolating the one or more first particles from the first and third particles trapped at the second segment by exerting a force directly upon the one or more first particles to be selectively isolated and selectively moving the one or more first particles along at least a part of a given path in the microfluidic circuit from the second segment downstream to a collection area of the microfluidic system, wherein the third particles remain trapped at the second segment.
Beaumont teaches isolation modules to discriminate between two different types of biological micro-objects (paragraph [0221]). Beaumont teaches an isolation structure may have a plurality of barrier modules to differentially permit passage of specific sized micro-objects and the size of openings between the in situ-generated barrier modules may be sized so that at least one subset of micro-objects are prevented from exiting the isolation structure (paragraph [0233]). Beaumont teaches after removal of a barrier, cells are moved selectively using DEP forces (paragraph [0268]). Beaumont teaches allowing for cellular debris to pass through a barrier, while trapping desired micro-objects (paragraph [0270]) and controllably removing a subset of a cell while ensuring that other subsets are retained within the pen (paragraph [0274]). Beaumont teaches DEP forces are used to selectively remove a micro-object from a sequestration pen (paragraph [0099]), and DEP forces are used to manipulate, transport, separate and sort micro-objects (paragraph [0101]). Beaumont teaches DEP forces used to move desired micro-objects collected at a barrier to another part of the microfluidic device for further culturing or processing (paragraph [0266]). Beaumont teaches a plurality of barriers may be introduced to be configured to allow isolation of respective subsets of at least one micro-object of a plurality of micro-objects (paragraph [0329]). Beaumont teaches an embodiment where the method includes a step of reducing or removing one or more of the barriers to release at least one micro-object from isolation and a step of exporting the micro-object from the microfluidic device after it has been released from isolation by the barrier (paragraph [0336]).
Hobbs teaches a microfluidic device comprising biological micro-objects in a sample material that can be selected for particular characteristics and disposed into regions (abstract). Hobbs teaches the device comprises a sequestration pen including an isolation region (paragraph [0003]). Hobbs teaches the mixture of micro-objects includes different types, as well as debris and other objects, i.e. at least three types of particles (paragraph [0053]). Hobbs teaches a selector configured to create selectively electrokinetic forces on micro-objects, such as optical tweezers or DEP devices (paragraphs [0069]-[0070]). Hobbs teaches each micro-object can be selected and moved into pens with a light trap (paragraph [0144]). Hobbs teaches a first and third particle trapped in a segment (Figs. 13-14 shows different sized elements 1002 are trapped in pens 256) while second particles are flushed downstream from the segment (Fig. 14; paragraph [0143]). Hobbs teaches a first particle (Fig. 26, 1802) is selected and trapped with a light trap and moved into the channel to be flushed downstream (Figs. 26-27; paragraph [0198]) while the third particle (1002) remains in the segment (Figs. 26-27). Hobbs teaches identifying, trapping, and moving individual negative biological micro-objects out of specific pens and into the channel, therefore separating different types of micro-objects trapped within a segment (paragraph [0200]; Figs. 26-27). Hobbs teaches groups with a positive signal could be separated and moved into new pens as a single cell (paragraph [0239]). Hobbs teaches an assay material can comprise multiple types of capture micro-objects, and multiple analytes of interest can be screened for at the same time (paragraph [0188]).
Since Hobbs teaches trapping, isolating, and moving micro-objects in a microfluidic device, which is similar to Beaumont, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the trapping and selection step of Beaumont to incorporate Hobbs’ teachings of trapping two different type of particles in a segment while allowing a different type of particle continue downstream (Figs. 13-14; paragraph [0143]) and then selecting and moving one of the trapped particles in the segment downstream away from the other trapped particle that remains in the segment (Figs. 26-27; paragraphs [0200],[0239]) and teachings of screening multiple analytes of interest (paragraph [0188]) and Beaumont’s teachings of discriminating between two different types of biological micro-objects (paragraph [0221]), and allowing for cellular debris to pass through a barrier, while trapping desired micro-objects (paragraph [0270]) and controllably removing a subset of a cell while ensuring that other subsets are retained within the pen (paragraph [0274]) to provide: trapping the first particles and the third particles at the second segment while the second particles pass through the second segment and reach the third segment; and selectively isolating the one or more first particles from the first and third particles trapped at the second segment by exerting a force directly upon the one or more first particles to be selectively isolated and selectively moving the one or more first particles along at least a part of a given path in the microfluidic circuit from the second segment downstream to a collection area of the microfluidic system, wherein the third particles remain trapped at the second segment. Doing so would have a reasonable expectation of successfully improving isolation and sorting of multiple different micro-objects as taught by Hobbs (paragraphs [0188],[0200]; Figs. 13-14,16-27), and improving discrimination and sorting of desired subsets of micro-objects while allowing other subsets to be retained in a segment (Beaumont, paragraphs [0221],[0266],[0274]).
Claims 34 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Beaumont in view of Hobbs as applied to claim 31 above, and further in view of Ionescu-Zanetti et al. (EP 2731723 B1; cited in the IDS filed 08/25/2021).
Regarding claim 34, while Beaumont teaches: a system comprising an imaging device or imaging module (paragraphs [0080]-[0081],[0166]); that once biological cells have been identified, it may be useful to remove an isolation structure to continue culturing the cells (paragraph [0307]); and an assaying step that includes identifying at least one cell of cells in a sequestration pen and exporting the cells that include a selected characteristic (paragraph [0375]), modified Beaumont fails to explicitly teach wherein the selection step (paragraph [0266]) comprises a detection sub-step, which is at least partially subsequent to the trapping step and during which information concerning the content of the at least one second segment is collected in order to identify at least said at least one first particle; during the selection step, said at least one first particle is distinguished from said at least one third particle.
Ionescu-Zanetti teaches separation of particles including microfluidic devices (paragraph [0001]). Ionescu-Zanetti teaches trapping channels for isolating cells (paragraph [0059]). Ionescu-Zanetti teaches the invention allows for better analysis of captured cells and improved identification of target cells (paragraph [0088]). Ionescu-Zanetti teaches a separation and imaging region of a channel (Fig. 9; paragraph [0061]) where particles are trapped (paragraph [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the selection step of modified Beaumont to incorporate the teachings of trapping and imaging particles of Ionescu-Zanetti for analysis of captured cells and improved identification of target cells (paragraph [0061], [0088]) and identification of cells to properly export the desired cells of Beaumont (paragraphs [0307],[0375]) to provide wherein the selection step comprises a detection sub-step, which is at least partially subsequent to the trapping step and during which information concerning the content of the at least one second segment is collected in order to identify at least said at least one first particle; during the selection step, said at least one first particle is distinguished from said at least one third particle. Doing so would have a reasonable expectation of successfully improving analysis of particles within a sample to properly separate and export a desired particle from the sample.
Regarding claim 41, while Beaumont teaches: a system comprising an imaging device or imaging module (paragraphs [0080]-[0081],[0166]); that once biological cells have been identified, it may be useful to remove an isolation structure to continue culturing the cells (paragraph [0307]); and an assaying step that includes identifying at least one cell of cells in a sequestration pen and exporting the cells that include a selected characteristic (paragraph [0375]), modified Beaumont fails to teach the method according to claim 31 and comprising a detection sub-step, which is at least partially subsequent to the trapping step and at least partially prior to the selection step and during which the at least one first particle is identified by capturing at least one image; and the at least one first particle is identified by assessing one or more morphological and/or fluorescence features thereof.
Ionescu-Zanetti teaches separation of particles including microfluidic devices (paragraph [0001]). Ionescu-Zanetti teaches trapping channels for isolating cells (paragraph [0059]). Ionescu-Zanetti teaches the invention allows for better analysis of captured cells and improved identification of target cells (paragraph [0088]). Ionescu-Zanetti teaches a separation and imaging region of a channel (Fig. 9; paragraph [0061]) where particles are trapped (paragraph [0061]). Ionescu-Zanetti teaches the separation and imaging region is intended to identify a location of the microfluidic device (paragraph [0061]). Ionescu-Zanetti teaches that additional sample preparation steps may be performed before analysis steps, such as analysis of single cells separately (paragraph [0033]). Ionescu-Zanetti teaches data generated during imaging is used to characterize particles or cells of interest by looking at fluorescence signals or morphology (paragraph [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the selection step of modified Beaumont to incorporate the teachings of trapping and imaging particles of Ionescu-Zanetti for analysis of captured cells and improved identification of target cells (paragraph [0061], [0088]), the teachings of particle characterization by fluorescence or morphology of Ionescu-Zanetti (paragraph [0031]) and the teachings of identification of cells to properly export the desired cells of Beaumont (paragraphs [0307],[0375]) to provide the method according to claim 31 and comprising a detection sub-step, which is at least partially subsequent to the trapping step and at least partially prior to the selection step and during which the at least one first particle is identified by capturing at least one image; and the at least one first particle is identified by assessing one or more morphological and/or fluorescence features thereof. Doing so would have a reasonable expectation of successfully improving analysis of particles within a sample to properly separate and export a desired particle from the sample.
Claims 35, 39, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Beaumont in view of Hobbs as applied to claim 31 above, and further in view of Soh et al. (US 20080302732 A1, cited in the IDS filed 08/25/2021).
Regarding claim 35, while Beaumont teaches wherein during the trapping step, the at least one first particle is trapped by means of a mechanical trapping system (Fig. 6), modified Beaumont fails to teach wherein during the trapping step, the at least one first particle is trapped by means of a trapping system selected from the group consisting of: a vortex created in the at least one second segment, a dielectrophoretic force exerted at the at least one second segment, a magnetic force exerted at the at least one second segment, and a combination thereof.
Soh teaches a fluidic device comprising sorting stations for separating target species from other species, which employs a magnetic field gradient for separation (abstract). Soh teaches one or more traps may be employed with the magnetophoretic sorters in on-chip fluidic systems (paragraph [0042]), such as optical traps, magnetic traps, electrostatic traps, and mechanical traps (paragraphs [0042],[0091]). Soh teaches the use of barriers to form a trap and that cells may be retained by gravity alone or in combination with a particle capture force applied to the tops of the barriers (paragraph [0092]). Soh teaches that in addition to weirs, i.e. mechanical traps, microparticles may be confined by an additional particle capture force such as a magnetic or dielectrophoretic force (paragraph [0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the trapping step of modified Beaumont to incorporate the teachings of combining mechanical traps with other particle capture forces such as magnetic or dielectrophoretic forces of Soh (paragraphs [0042],[0091]-[0093]) to provide wherein during the trapping step, the at least one first particle is trapped by means of a trapping system selected from the group consisting of: a dielectrophoretic force exerted at the at least one second segment, a magnetic force exerted at the at least one second segment, and a combination thereof. Doing so would have a reasonable expectation of successfully improving capturing or trapping of desired particles as taught by Soh (paragraphs [0091]-[0093]).
Regarding claim 39, modified Beaumont fails to teach the method according to claim 31 and comprising a washing step, during which the feeding assembly conveys a washing liquid through the at least one microfluidic channel so that the at least one second particle is forced out of the given path through the at least one first outlet, whereas the at least one first particle is kept in the at least one second segment; the selection step is subsequent to the washing step; the washing step is at least partially subsequent to the trapping step; during the selection step, the fluid present in the at least one microfluidic channel is not moved such that the fluid is substantially still.
Beaumont teaches an embodiment of a washing step, which is subsequent to a sequestration step, where the microfluidic device was flushed with a washing liquid (paragraph [0433] teaches cells were placed into sequestration pens and then the microfluidic device was flushed with culture medium) and the media source can comprise multiple sections or containers for holding different fluidic medium (paragraph [0085]). Beaumont teaches an embodiment where after cells are concentrated at a barrier, the flow can be stopped, and the cells can be loaded by forces into sequestration pens, i.e. separation (paragraph [0269]).
Soh teaches a fluidic device comprising sorting stations for separating target species from other species, which employs a magnetic field gradient for separation (abstract). Soh teaches a trapping module may be configured to perform washing trapped species in the sample (paragraph [0005]). Soh teaches trapping particles, washing the captured particles, and then recovering the washed particles (paragraph [0057]). Soh teaches a buffer is passed through a trap to wash the captured particles (paragraph [0057]). Soh teaches buffer flows through the trapping module to wash away cellular debris (paragraph [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified Beaumont to incorporate the teachings of flushing cells with a buffer, containers for holding fluidic medium, and stopping flow after concentrating cells at a barrier for separation of cells of Beaumont (paragraphs [0085],[0269],[0433]) and the teachings of washing captured particles with a buffer to wash away debris of Soh (paragraph [0057],[0065]) to provide the method according to claim 31 and comprising a washing step, during which the feeding assembly conveys a washing liquid through the at least one microfluidic channel so that the at least one second particle is forced out of the given path through the at least one first outlet, whereas the at least one first particle is kept in the at least one second segment; the selection step is subsequent to the washing step; the washing step is at least partially subsequent to the trapping step; during the selection step, the fluid present in the at least one microfluidic channel is not moved such that the fluid is substantially still. Doing so would have a reasonable expectation of successfully improving washing away of undesired materials as taught by Soh (paragraph [0065]) and improve manipulation and separation of desired particles after trapping particles as taught by Beaumont (paragraphs [0085],[0269],[0433]).
Regarding claim 44, modified Beaumont fails to teach the method according to claim 31 and comprising a marking step, which is at least partially prior to the selection step; wherein during the marking step, one of the at least one first particle and the at least one second particle is marked with a selective marker.
Soh teaches a fluidic device comprising sorting stations for separating target species from other species, which employs a magnetic field gradient for separation (abstract). Soh teaches one or more traps may be employed with the magnetophoretic sorters in on-chip fluidic systems (paragraph [0042]), such as optical traps, magnetic traps, electrostatic traps, and mechanical traps (paragraphs [0042],[0091]). Soh teaches the use of barriers to form a trap and that cells may be retained by gravity alone or in combination with a particle capture force applied to the tops of the barriers (paragraph [0092]). Soh teaches that in addition to weirs, i.e. mechanical traps, microparticles may be confined by an additional particle capture force such as a magnetic or dielectrophoretic force (paragraph [0093]). Soh a pre-processing station including a labeling station for labeling target species with magnetic particles capable of specifically binding to target species and a detection station for detecting the target species (paragraph [0012]), where magnetic particles are sorted (paragraph [0035]), Soh teaches modules of integrated fluidics devices include sorting, washing, trapping, labeling (paragraph [0039]). Soh teaches particles that have been captured are marked with markers, such as labeled antibodies, for target cells, where the target cells are imaged to characterize the contents of a trap and determine the presence or quantity of target tumor cells (paragraph [0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified Beaumont to incorporate the teachings of labeling target species of Soh (paragraphs [0012],[0039],[0059], [0093]) and the teachings of combining mechanical traps with other particle capture forces such as magnetic or dielectrophoretic forces of Soh (paragraphs [0042],[0091]-[0093]) to provide the method according to claim 31 and comprising a marking step, which is at least partially prior to the selection step; wherein during the marking step, one of the at least one first particle and the at least one second particle is marked with a selective marker. Doing so would have a reasonable expectation of successfully improving sorting and isolation of a target particle and improve analysis or quantification of target particles as taught by Soh (paragraphs [0035],[0059]).
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Beaumont in view of Hobbs as applied to claim 31 above, and further in view of Medoro et al. (US 20120184010 A1).
Regarding claim 37, Beaumont further teaches the at least one first particle (Fig. 6 and paragraph [0266], micro-objects 630) is larger than the at least one second particle (Fig. 6 and paragraph [0266], undesired materials 632, 634). While Beaumont teaches moving the micro-objects to another part of a microfluidic device for further culturing or processing or alternatively exporting the micro-objects out of the microfluidic device (paragraph [0266]), modified Beaumont fails to teach the method according to claim 31, and comprising a recovery step, during which the at least one first particle is conveyed from the collection area out of the microfluidic circuit through a second outlet; during the recovery step, the fluid present in the collection area is moved so as to force the at least one first particle through the second outlet.
Medoro teaches a microfluidic system for isolating cells from a sample (abstract). Medoro teaches a method comprising a step of introducing a sample through an inlet of the system, a separation step, and a recovery step (paragraph [0148]). Medoro teaches during the separation step, particles of a given type are transferred from a main chamber to a recovery chamber, i.e. collection area (paragraph [0154]). Medoro teaches the recovery step includes flowing a carrier liquid away from the particles of the given type out of the recovery chamber through an outlet (paragraph [0158]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified Beaumont to incorporate the teachings of a recovery step after a separation step of Medoro (paragraphs [0154],[0158]) to provide the method according to claim 31, and comprising a recovery step, during which the at least one first particle is conveyed from the collection area out of the microfluidic circuit through a second outlet; during the recovery step, the fluid present in the collection area is moved so as to force the at least one first particle through the second outlet. Doing so would have a reasonable expectation of successfully improving isolation and collection of a desired particle of a given type after separation as taught by Medoro (paragraph [0154]).
Regarding claim 38, Beaumont further teaches wherein, during the selection step a plurality of first particles are moved to the collection area so as to obtain a group of first particles in the collection area (paragraph [0266] teaches DEP forces move micro-objects 630 to another part of the microfluidic device, thus the micro-objects in the “another part” is interpreted as a group of first particles in the collection area).
While Beaumont teaches concentrated cells may be moved selectively (paragraph [0268]) and an embodiment of selecting and moving each cell individually (paragraph [0273]), modified Beaumont fails to teach during the recovery step, first particles from the group of first particles are moved away from the collection area one at a time.
Medoro teaches a microfluidic system for isolating cells from a sample (abstract). Medoro teaches a method comprising a step of introducing a sample through an inlet of the system, a separation step, and a recovery step (paragraph [0148]). Medoro teaches during the separation step, particles of a given type are transferred from a main chamber to a recovery chamber, i.e. collection area (paragraph [0154]). Medoro teaches the recovery step includes flowing a carrier liquid away from the particles of the given type away of the recovery chamber through an outlet (paragraph [0158]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified Beaumont to incorporate the teachings of a recovery step to transfer particles away from a collection area of Medoro (paragraphs [0154],[0158]) and the teachings of selectively moving individual cells of Beaumont (paragraphs [0268],[0273]) to provide during the recovery step, first particles from the group of first particles are moved away from the collection area one at a time. Doing so would have a reasonable expectation of successfully improving isolation and collection of a desired particle of a given type after separation as taught by Medoro (paragraph [0154]).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Beaumont in view of Hobbs as applied to claim 31 above, and further in view of Spuhler et al. (US 20160244714 A1).
Regarding claim 43, while Beaumont teaches cells can include cancer cells (paragraph [0059]) and a sample can include smaller micro-objects (paragraph [0266]), modified Beaumont fails to teach wherein the at least one first particle is a circulating tumour cell; the at least one second particle is selected from the group consisting of: erythrocytes, lymphocytes, and a combination thereof.
Spuhler teaches a microfluidic device comprising a microfluidic channel (abstract). Spuhler teaches separation and isolation of targeted analytes from a fluid sample (paragraph [0042]). Spuhler teaches the microfluidic devices and methods can be used to detect and quantify rare cells such as primary tumor cells or CTCs (paragraph [0145]). Spuhler teaches an example of isolation of CTCs using hydrodynamic cell sorting for size-based separation of white blood cells, i.e. lymphocytes, and tumor cells from whole blood (paragraph [0155]). Spuhler teaches as a sample flows through a sorting region, small components such as red blood cells, i.e. erythrocytes, are removed from the cell sorter based on size to be separated from the main suspension (paragraph [0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one first particle and the at least one second particle of modified Beaumont to incorporate the teachings of microfluidic devices for detecting and quantifying rare cells of Spuhler (paragraph [0145]) and separating out lymphocytes and red blood cells to isolate CTCs of Spuhler (paragraph [0070],[0155]) to provide wherein the at least one first particle is a circulating tumour cell; the at least one second particle is selected from the group consisting of: erythrocytes, lymphocytes, and a combination thereof. Doing so would have a reasonable expectation of successfully improving analysis of rare cells, such as tumor or cancer cells as taught by Beaumont (paragraph [0059]) and Spuhler (paragraph [0145]).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Beaumont in view of Hobbs as applied to claim 31 above, and further in view of Suresh et al. (US 20110289043 A1).
Regarding claim 45, Beaumont further teaches wherein the sample comprises a substantially liquid base in which the at least one first particle and at least the at least one second particle are distributed (Fig. 6 and paragraph [0266] teach a liquid sample comprising micro-objects 630 and undesired materials 632, 634). Modified Beaumont fails to teach the method comprises an adjustment step, during which the temperature of the sample is changed so as to change the viscosity of said liquid base.
Suresh teaches methods and devices for evaluating properties of biological substances such as cells (abstract). Suresh teaches the method includes separating cells through the use of a microfluidic channel (paragraph [0018]). Suresh teaches perfusing a fluid through a flow test device and separating a first type a cell from another component of the fluid (paragraph [0025]). Suresh teaches a method for isolating a target cell and separating a target cell from other cell types (paragraph [0028]). Suresh noted that viscosities of buffer solution and cells decrease with increasing temperature, resulting in an overall increased local fluid velocity at elevated temperatures and an experiment was conducted to calibrate and achieve equalized fluid velocity (paragraph [0155]). Suresh teaches the effect of temperature in the experiment on viscosity of a suspending medium, where temperature was adjusted (paragraph [0407]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified Beaumont to incorporate the teachings of adjusting temperature and thus viscosity of a medium to calibrate and achieve a desired fluid velocity of Suresh (paragraphs [0155],[0407]) to provide the method comprises an adjustment step, during which the temperature of the sample is changed so as to change the viscosity of said liquid base. Doing so would have a reasonable expectation of successfully optimizing fluid flow within the microfluidic channel as taught by Suresh (paragraph [0155]).
Allowable Subject Matter
Claim 40 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claim 31, it is suggested to incorporate claim 40 and any intervening claims into claim 31.
Claims 60-61 are allowable over the prior art.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 40, the closest prior art of Beaumont et al. (US 20170165667 A1) further teaches wherein the sample has a plurality of first particles (Fig. 6, plurality of micro-objects 630) and a plurality of second particles (Fig. 6, plurality of undesired materials 632, 634); during the selection step, the movement device moves at least part of the plurality of first particles from the second segment to the collection area (paragraph [0266] teaches DEP forces move micro-objects 630 to another part of the microfluidic device, thus the micro-objects are moved from the second segment to “another part”, i.e. a collection area).
Beaumont fails to teach: the microfluidic system (as shown in Fig. 6) has a plurality of second segments; during the trapping step, at least part of the plurality of first particles is trapped by vortexes created in the plurality of second segments and at least part of the plurality of second particles passes through the plurality of second segments; during the selection step, the movement device moves at least part of the plurality of first particles from the plurality of second segments to the collection area; during the washing step, at least part of the plurality of second particles is forced out of the microfluidic circuit, whereas at least part of the plurality of first particles is kept in the plurality of second segment.
Beaumont does teach embodiments comprising a plurality of sequestration pens for trapping micro-objects (Fig. 1, elements 124, 126, 128, 130), and an embodiment of a washing step, which is subsequent to a sequestration step, where the microfluidic device was flushed with a washing liquid (paragraph [0433] teaches cells were placed into sequestration pens and then the microfluidic device was flushed with culture medium) and the media source can comprise multiple sections or containers for holding different fluidic medium (paragraph [0085]). Beaumont teaches an embodiment where after cells are concentrated at a barrier, the flow can be stopped, and the cells can be loaded by forces into sequestration pens, i.e. separation (paragraph [0269]). However, Beaumont fails to teach alone, or in combination with prior art, motivation to have arrived at all of the limitations of claim 40, specifically: at least part of the plurality of first particles is trapped by vortexes created in the plurality of second segments and at least part of the plurality of second particles passes through the plurality of second segments.
A reference Di Carlo et al. (WO 2012037030 A2; cited in the IDS filed 08/25/2021) does teach embodiments of a plurality of expansion regions, i.e. second segments (Fig. 1A, element 30; Fig. 1H; Figs. 4A-4B). Di Carlo teaches the embodiment of Fig. 1A where at least part of the plurality of first particles (12) is trapped by vortexes created in the plurality of second segments (Fig. 1A; paragraph [0048]) and at least part of the plurality of second particles passes through the plurality of second segments (Fig. 1A shows smaller particles passing elements 30 and towards element 20; paragraph [0048]). Di Carlo teaches introducing a wash solution into microfluidic channel (paragraph [0043]). Di Carlo teaches once a solution was completely processed, vortex-trapped cells were washed with PBS without disrupting the vortices to remove smaller and denser RBCs (paragraph [0063]; Figs. 4A-4B). However, Di Carlo fails to teach or suggest motivation to have modified Beaumont, which uses a motive module and/or barrier to trap, control, and move micro-objects, to arrive at the claimed limitations of the trapping the particle by means of a vortex as claimed.
A reference Hur (US 20150044750 A1) teaches a system and method include delivering cells of interest to multiple traps via a channel connecting the traps, maintaining a vortex flow in the traps to trap the cells of interest in the traps (abstract; Fig. 1). However, Hur fails to teach or suggest motivation to have modified Beaumont, which uses a motive module and/or barrier to trap, control, and move micro-objects, to arrive at the claimed limitations of the trapping the particle by means of a vortex as claimed.
None of the prior art teaches or fairly suggests, alone or in combination, all of the limitations of claim 40. Thus, claim 40 is deemed allowable.
Regarding claim 60, as discussed in the Remarks filed 08/08/2025 (see page 13, section III), new claim 60 is allowable since it represents claim 36 and written in independent form including all of the limitations of the base claim and any intervening claims (i.e. claim 36). As discussed above claim 36 is deemed allowable.
Regarding claim 61, as discussed in the Remarks filed 08/08/2025 (see page 13, section III), new claim 61 is allowable since it represents claim 40, written in independent form including all of the limitations of the base claim and the allowable claim 40. As discussed above claim 40 is deemed allowable.
Response to Arguments
Applicant’s arguments, see page 13, filed 11/19/2025, with respect to the claim objections and rejections under 35 U.S.C. 112 have been fully considered and are persuasive. The claim objections and rejections under 35 U.S.C. 112 of 08/19/2025 have been withdrawn.
Applicant's arguments, pages 13-15, filed 11/19/2025, specifically regarding claim 31 have been fully considered but they are not persuasive.
In response to applicant’s argument that the combination of Beaumont and Hobbs would not arrive at the claimed invention and in response to applicant's arguments against the references individually (Remarks, pages 14-15, regarding Hobbs), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case and as discussed above in the rejection of claim 31 under 35 U.S.C. 103, Hobbs is used in combination with Beaumont to arrive at the claimed trapping and selection step. Hobbs provides teachings of trapping two different type of particles in a segment while allowing a different type of particle continue downstream (Figs. 13-14; paragraph [0143]) and then selecting and moving one of the trapped particles in the segment downstream away from the other trapped particle that remains in the segment (Figs. 26-27; paragraphs [0200],[0239]) and teachings of screening multiple analytes of interest (paragraph [0188]). Additionally, Beaumont provides teachings of discriminating between two different types of biological micro-objects (paragraph [0221]), and allowing for cellular debris to pass through a barrier, while trapping desired micro-objects (paragraph [0270]) and controllably removing a subset of a cell while ensuring that other subsets are retained within the pen (paragraph [0274]).
Since Hobbs teaches trapping, isolating, and moving micro-objects in a microfluidic device, which is similar to Beaumont, it would have been obvious to one of ordinary skill in the art to have modified the trapping and selection step of Beaumont to incorporate Hobbs’ teachings of trapping two different type of particles in a segment while allowing a different type of particle continue downstream (Figs. 13-14; paragraph [0143]) and then selecting and moving one of the trapped particles in the segment downstream away from the other trapped particle that remains in the segment (Figs. 26-27; paragraphs [0200],[0239]) and teachings of screening multiple analytes of interest (paragraph [0188]) and Beaumont’s teachings of discriminating between two different types of biological micro-objects (paragraph [0221]), and allowing for cellular debris to pass through a barrier, while trapping desired micro-objects (paragraph [0270]) and controllably removing a subset of a cell while ensuring that other subsets are retained within the pen (paragraph [0274]) to provide: trapping the first particles and the third particles at the second segment while the second particles pass through the second segment and reach the third segment; and selectively isolating the one or more first particles from the first and third particles trapped at the second segment by exerting a force directly upon the one or more first particles to be selectively isolated and selectively moving the one or more first particles along at least a part of a given path within in the microfluidic circuit from the second segment downstream to a collection area of the microfluidic system, wherein the third particles remain trapped at the second segment. Doing so would have a reasonable expectation of successfully improving isolation and sorting of multiple different micro-objects as taught by Hobbs (paragraphs [0188],[0200]; Figs. 13-14,16-27), and improving discrimination and sorting of desired subsets of micro-objects while allowing other subsets to be retained in a segment (Beaumont, paragraphs [0221],[0266],[0274]).
Therefore, there is some teaching, suggestion, or motivation to do so found either in the references themselves (i.e. Hobbs and Beaumont) or in the knowledge generally available to one of ordinary skill in the art to have arrived at the claimed trapping and selection step, wherein one of ordinary skill in the art would have been motivated to arrive at the claimed trapping and selection step to improve isolation and sorting of multiple different micro-objects as taught by Hobbs (paragraphs [0188],[0200]; Figs. 13-14,16-27), and improve discrimination and sorting of desired subsets of micro-objects while allowing other subsets to be retained in a segment as desired by Beaumont (paragraphs [0221],[0266],[0274]).
Conclusion
THIS ACTION IS MADE FINAL. 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 HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758