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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/20/2023, 01/16/2024, 01/18/2024, 06/12/2024, 06/28/2024, and 12/31/2025 were filed. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are not of sufficient quality to permit examination. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Of particular note are Figures 5A, 6A, 7, 8, and 9, which do not have legible reference numbers.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
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 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 a claim limitation is: “sub-installation unit” in claim 34.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is 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(b)
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.
Claims 1 – 5, 8 – 10, 12, 18, 20, 22, 24, 26, 29, 31, 32, 34, 38, and 39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 – 5, 8 – 10, 12, 18, 20, 22, 24, 26, 29, 31, 32, 34, 38, and 39 use periods through-out the claims, separating the claims into several sentence. According to MPEP 608.01(m), “Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).” The separation of the claims into several sentence fragments render the claims indefinite, as it is not clear how the structural features are related.
Claim 20 recites the limitations "the inlet" and “the outlet” in lines 6 and 9, respectively. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the examiner interprets this limitation to mean “an inlet” and “an outlet.”
Claims 22, 24, 26, 29, 31, 32, 34, and 38 are rejected as indefinite due to their dependence on claim 20.
Claim 26 recites the limitation “wherein an orthographic projection of the fourth storage cavity on the box device overlaps at most a portion of an orthographic projection of the outlet hole on the box device. and wherein an orthographic projection of the fourth storage cavity on the box device falls within a orthographic projection of the outlet hole on the box device.” It is not clear how the orthographic projection could both fall within the outlet hole and also only overlap a portion of the outlet hole at most. This ambiguity amounts to a failure to particularly point out and distinctly claim the invention, rendering the claims indefinite. For the purposes of examination, the examiner interprets the claims to mean “wherein an orthographic projection […] overlaps at most […] OR wherein an orthographic projection […] falls within…” (emphasis added by examiner).
Claim 34 recites the component of a “sub-installation unit.” This limitation is being interpreted under 112(f) as reciting the generic placeholder of “unit.” However, the instant specification does not describe the structure associated with this placeholder. This failure to describe the component structure amounts to a failure to distinctly claim the invention, rendering the claim indefinite.
Claim 34 recites the limitation “the first sub-installation unit is associated with the fourth sub-installation unit. the second sub-installation unit is associated with the fifth sub-installation unit. and the third sub-installation unit is associated with the sixth sub-installation unit.” No details are given regarding what association refers to in view of the claimed “unit.” The specification suggests that a driving electrode may be associated with optical recognition devices, but it is not clear how this relationship applies in view of the claimed “units.” This ambiguity amounts to a failure to particularly point out and distinctly claim an invention. For the purposes of examination, the examiner interprets “associated” to refer to a spatial association between components of the system.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Xia et al (US 20210213452 A1, effectively filed 13 January 2020).
With regards to claim 1, Xia et al teaches;
The claimed “a first fluid” has been read on the taught ([0070], “…two sheath fluid micro-channels (140) are each configured to flow a sheath fluid…”; a sheath fluid reads on a first fluid.);
The claimed “a second fluid comprising a cell suspension” has been read on the taught ([0070], “…the sample micro-channel (110) is configured to flow a sample fluid mixture…”; [0064], “… a microfluidic chip design and methods that can isolate particles or cellular materials…”; a sample fluid mixture reads on a second fluid. The chip isolating cells reads on the fluid comprising a cell suspension.);
The claimed “a first container configured to accommodate a first fluid” has been read on the taught ([0107], “…a collapsible container having sheath or buffer fluid therein, is disposed in a pressurized vessel […] such that fluid is delivered via tubing to the sheath or buffer input of the chip.”; a collapsible container reads on a first container.);
The claimed “a second container configured to accommodate a second fluid comprising a cell suspension” has been read on the taught ([0107], “…a system having a pressurized gas which provides pressure for pumping sample fluid mixture from reservoir (i.e., sample tube) into sample input of the chip.”; a reservoir reads on a second container.);
The claimed “a delivery channel comprising a first delivery channel and a second delivery channel. the first delivery channel communicating with the first container and the second delivery channel communicating with the second container. the first delivery channel intersecting and communicating with the second delivery channel at a confluence” has been read on the taught ([0069], “A non-limiting embodiment of the microfluidic chip (100) comprises a sample micro-channel (110), two sheath fluid micro-channels (140) intersecting the sample micro-channel (110) to form an intersection region (145).”; Two sheath fluid micro-channels 140 reads on a first delivery channel. A sample micro-channel 110 reads on a second delivery channel. Intersection region 145 reads on a confluence.);
The claimed “a shape of the delivery channel being designed so that the first fluid and the second fluid merge at the confluence” has been read on the taught ([0070], “The flow of sheath fluid causes laminar flow and compression of the sample fluid mixture flowing from the sample micro-channel (110) at least horizontally from at least two sides such that the sample fluid mixture becomes surrounded by sheath fluid and compressed into a thin stream.”);
The claimed “a sorting channel downstream of the delivery channel and comprising a first sorting channel and a second sorting channel” has been read on the taught ([0076], “…the microfluidic chip (100) may further comprise a plurality of output micro-channels (170) downstream of and fluidly coupled to the expansion region (160).”; The plurality of output microchannels read on a first and second sorting channel. See also [0086]);
The claimed “a collector downstream of the sorting channel and comprising a first collector and a second collector. the first collector communicating with the first sorting channel. and the second collector communicating with the second sorting channel” has been read on the taught ([0076], “The output channels may each have an output disposed at its end. In other embodiments, the microfluidic chip may further include one or more notches disposed at a bottom edge of the microfluidic chip to separate the outputs and to provide attachments for external tubing etc.”; The output channels reads on a first and second sorting channel. The outputs and attachments read on collectors).
With regards to claim 2, the chip of claim 1 is anticipated by Xia et al.
The limitation “a portion of the first delivery channel is divided by the confluence into a first section and a second section, in each section of the first section and the second section. an area of a first cross-section of the section gradually increases along a first direction away from the confluence. the first cross- section is perpendicular to the first direction and wherein the second delivery channel is divided by the confluence into a third section and a fourth section. in each section of the third section and the fourth section. an area of a second cross-section of the section gradually increases along a second direction away from the confluence, and the second cross-section is perpendicular to the second direction” recites a narrowing of the microchannels into the confluence region (that is to say, an increase in the cross-section away from the confluence).
Xia et al teaches the use of a confluence for focusing particles, as read on the taught ([0016], “…one of the focusing regions includes introduction of a sheath fluid via one or more sheath fluid channels…”).
Xia et al further teaches the use of a narrowing cross-section for focusing particles, as read on the taught ([0016], “…the other focusing region includes geometric compression without introducing additional sheath fluid. Geometric compression refers to physical restriction due to a narrowing in size of the sample channel in both the vertical and horizontal axes…”).
Xia et al further teaches that the geometric compression may occur at the confluence, as read on the taught ([0016], “…the first focusing region may combine geometric with the sheath fluid introduction…”; [0075], “…the intersection region (145) and the downstream flow focusing region (130) are configured to focus a material in the sample fluid mixture.”).
Accordingly, Xia et al teaches narrowing towards the confluence as recited in the limitations of Claim 2.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 3, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al (US 20210213452 A1).
With regards to claim 3, the chip of claim 1 is anticipated by Xia et al.
Xia et al additionally teaches;
The claimed “wherein both a beginning of the first sorting channel and a beginning of the second sorting channel communicate with an end of the delivery channel” has been read on the taught ([0076], “…a plurality of output micro-channels (170) downstream of and fluidly coupled to the expansion region (160).”; Figure 1B shows micro-channels 170 coupled to downstream micro-channels 120, which communicates with intersection 145, which reads on an end of the delivery channel.);
The claimed “an end of the first sorting channel communicates with the first collector and an end of the second sorting channel communicates with the second collector” has been read on the taught ([0076], “The output channels may each have an output disposed at its end.”).
Regarding the limitation “the first sorting channel and the second sorting channel bend from the end of the deliver channel toward the confluence. and the first collector and the second collector are between the confluence and the end of the delivery channel,” this is held to be mere rearrangement of parts. According to MPEP 2144.04(VI)(C), rearrangement of parts is prima facie obvious as matters of design choice; please see In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chip as taught by Xia et al with the relative positions of the components for the predictable result of laying out to comply with design or manufacturing constraints.
With regards to claim 10, the chip of claim 2 is anticipated by Xia et al.
Xia et al additionally teaches;
The claimed “wherein the portion of the first deliver channel comprises a first sub-portion. a second sub-portion comprising the confluence. and a third sub-portion. the first sub-portion belongs to the first section. the third sub-portion belongs to the second section. the second sub-portion spans the first section and the second section and is between the first sub-portion and the third sub-portion” has been read on annotated Figure 2B, below;
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The claimed “areas of the first cross-section of the first sub-portion and the third sub-portion are larger than an area of the first cross-section of the second sub-portion” has been read on the taught ([0016], “…the other focusing region includes geometric compression without introducing additional sheath fluid. Geometric compression refers to physical restriction due to a narrowing in size of the sample channel in both the vertical and horizontal axes…”; [0016], “…the first focusing region may combine geometric with the sheath fluid introduction…”; [0075], “…the intersection region (145) and the downstream flow focusing region (130) are configured to focus a material in the sample fluid mixture.”);
The claimed “wherein a size of the first cross-section of the second sub-portion of the first delivery channel at the confluence is configured to allow the first fluid having a specific particle size to flow therein” has been read on the taught ([0077], “…the micro-channels and various regions of the microfluidic chip may be dimensioned so as to achieve a desired flow rate(s) that meets the objective of the present invention.”; A channel being dimensioned to achieve a desired flow rate reads on allowing the first fluid having a specific particle size to flow therein.);
Regarding the limitation “the specific particle size of the first fluid is larger than a particle size of a single cell in the cell suspension,” this describes the material worked upon by the device, and has been given the appropriate patentable weight; please see MPEP 2115.
With regards to claim 12, the chip of claim 10 is obvious over Xia et al.
Claim 2, from which claim 10 depends outlines the third section and fourth section of the claimed invention as seen below;
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The limitations of “wherein the second delivery channel comprises a first sub-channel. a second sub- channel and a third sub-channel. the first sub-channel and the second sub-channel belong to the third section. and the third sub-channel belongs to the fourth section. wherein a first end of the first sub-channel communicates with the second container. a second end of the first sub-channel communicates with a first end of the second sub-channel. a second end of the second sub-channel communicates with a first end of the third sub-channel, and both the second end of the second sub-channel and the first end of the third sub-channel are at the confluence” is interpreted as follows, in light of Xia et al;
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The claimed “wherein areas of the second cross-section of the first sub-channel and the third sub-channel are larger than an area of the second cross-section of the second sub-channel” and “wherein the area of the second cross-section of the third sub-channel gradually increases along a direction from the first end to a second end of the third sub-channel. and wherein an area of the first cross-section of the second sub-portion of the first delivery channel at the confluence is greater than or equal to an area of the second cross-section of each of the second sub-channel and the third sub-channel of the second delivery channel at the confluence” has been read on the taught ([0016], “…the other focusing region includes geometric compression without introducing additional sheath fluid. Geometric compression refers to physical restriction due to a narrowing in size of the sample channel in both the vertical and horizontal axes…”; [0016], “…the first focusing region may combine geometric with the sheath fluid introduction…”; [0075], “…the intersection region (145) and the downstream flow focusing region (130) are configured to focus a material in the sample fluid mixture.”);
The claimed “wherein a size of the second cross-section of the second sub-channel is configured to allow the second fluid having a specific particle size to flow therein” has been read on the taught ([0077], “…the micro-channels and various regions of the microfluidic chip may be dimensioned so as to achieve a desired flow rate(s) that meets the objective of the present invention.”; A channel being dimensioned to achieve a desired flow rate reads on allowing the first fluid having a specific particle size to flow therein.);
Regarding the limitation “the specific particle size of the second fluid is larger than 1 time of a particle size of a single cell in the cell suspension and smaller than 2 times of the particle size of the single cell,” this describes the material worked upon by the device, and has been given the appropriate patentable weight; please see MPEP 2115.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al () as applied to claim 1, and further in view of Ajdari et al (US 20070110631 A1).
With regards to claim 4, the chip of claim 1 is anticipated by Xia et al.
Xia et al additionally teaches;
The claimed “wherein a beginning of the first sorting channel communicates with an end of the delivery channel” has been read on the taught (See Figure 2C, which shows the outlet of sample micro-channel 113 communicating with inlet of downstream micro-channel 124. See also [0074]);
The claimed “an end of the first sorting channel communicates with the first collector” has been read on the taught ([0076], “The output channels may each have an output disposed at its end.”);
The claimed “wherein the second collector comprises at least two sub-collectors. The branches which are cascaded correspond to the sub-collectors one by one. And one of the branches which are cascaded communicates with a corresponding one of the sub-collectors” has been read on the taught ([0076], “The output channels may each have an output disposed at its end.”; an output reads on a sub-collector.);
However, Xia et al does not explicitly disclose the further limitations of claim 4.
In the analogous art of microfluidic devices for sorting particles, Ajdari et al teaches;
The claimed “wherein the sorting channel further comprises at least two connecting channels. wherein the second sorting channel comprises at least two branches which are cascaded. a connecting channel is provided between any two adjacent branches of the at least two branches which are cascaded and the any two adjacent branches communicate via the connecting channel” has been read on the taught (Abstract, “This microfluidic flow device comprises: at least one flow channel (A), flowing into a branch point (D), to which at least two branched channels (B, B') are connected, and at least one linking channel (BL) connecting the two branched channels…”).
Regarding the limitation “the first sorting channel is adjacent to a first branch of the at least two branches which are cascaded,” this limitation is held to be mere rearrangement of parts. According to MPEP 2144.04(VI)(C), rearrangement of parts is prima facie obvious as matters of design choice; please see In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
It would have been obvious to one of ordinary skill in the art to modify the chip as taught by Xia et al with the branching channels and connecting channels as taught by Ajdari et al, for the benefit of separating the fluids into different partitions in the branches, and (Ajdari et al, [0008], “A need exists in particular to improve the handling of plug streams, for example to distribute them better in various channels…”; [0100], “The preceding arrangement, shown in FIG. 5, appears to ensure, at each intersection, an equal distribution of the total upstream flow rate… However, it has been found that on two-phase systems, the equipartition is not always obtained…” [0108], “… the system of the invention which is called "bypass" has the role, for example, of accentuating the influence of the last drop passed, so that it repels the next to the other branch…”).
With regards to claim 5, the chip of claim 4 is obvious over Xia et al in view of Ajdari et al.
The limitation of “wherein the second sorting channel comprises a first branch. a second branch and a third branch which are cascaded. the at least two connecting channels comprises a first connecting channel. a second connecting channel. and a third connecting channel. and the second collector comprises a first sub-collector. a second sub-collector. and a third subcollector,” is held to be duplication of parts. According to MPEP 2144.04(VI)(B), duplication of parts may be prima facie obvious provided no new or unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
The combination of Xia et al in view of Ajdari et al as established in claim 4 teaches the use of connecting channels between branched channels (see Ajdari, abstract). Accordingly, the limitation “wherein the first sorting channel communicates with the branch via the first connecting channel. the first branch communicates with the second branch via the second connecting channel. and the second branch communicates with the third branch via the third connecting channel” is held to be duplication of parts and rearrangement of parts. According to MPEP 2144.04(VI)(C), rearrangement of parts is prima facie obvious as matters of design choice; please see In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). According to MPEP 2144.04(VI)(B), duplication of parts may be prima facie obvious provided no new or unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
The claimed “wherein an end of the first branch communicates with the first sub-collector. an end of the second branch communicates with the second sub-collector. and an end of the third branch communicates with the third sub-collector” has been read on Xia et al’s teaching of ([0076], “The output channels may each have an output disposed at its end.”; an output reads on a sub-collector.);
The limitation of “wherein the second connecting channel is closer to the collector in a second direction than the first connecting channel. and the third connecting channel is closer to the collector in the second direction than the second connecting channel” is held to be mere rearrangement of parts. According to MPEP 2144.04(VI)(C), rearrangement of parts is prima facie obvious as matters of design choice; please see In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
The limitation of “wherein the microfluidic chip further comprises two third containers. Each of a beginning of the first branch and a beginning of the second branch communicates with a corresponding one of the two third containers. And the third container is configured to accommodate the first fluid” is held to be duplication of parts. As the third containers hold the first fluid, they read on a first container. Additionally, Figure 7 of Xia et al teaches a method of flowing a sheath fluid through a plurality of fluid channels. Ajdari et al teaches a plurality of inlets, as read on ([0032], “…introducing a fluid in at least one inlet of the device as defined above…”). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Xia et al in view of Ajdari et al to include multiple containers for first fluid, for the predictable benefit of introducing additional carrier fluid to manage flow rates.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Xia et al (US 20210213452 A1) as applied to claim 1, and further in view of Ajdari et al (US 20070110631 A1) and further in view of Quake et al (US 20110201009 A1).
With regards to claim 8, the chip of claim 1 is anticipated by Xia et al.
Xia et al additionally teaches wherein “an end of the second sorting channel communicates with the second collector” has been read on the taught ([0076], “The output channels may each have an output disposed at its end.”);
However, Xia et al does not explicitly disclose the limitations of claim 8.
In the analogous art of microfluidic devices for sorting particles, Ajdari et al teaches;
The claimed “wherein the sorting channel further comprises at least two connecting channels. wherein the first sorting channel comprises at least two branches which are cascaded. a connecting channel is provided between any two adjacent branches of the at least two branches which are cascaded and the any two adjacent branches communicate via the connecting channel” and “wherein a beginning of the second sorting channel communicates with a last branch of the first sorting channel via a collecting channel” has been read on the taught (Abstract, “This microfluidic flow device comprises: at least one flow channel (A), flowing into a branch point (D), to which at least two branched channels (B, B') are connected, and at least one linking channel (BL) connecting the two branched channels…”).
It would have been obvious to one of ordinary skill in the art to modify the chip as taught by Xia et al with the branching channels and connecting channels as taught by Ajdari et al, for the benefit of separating the fluids into different partitions in the branches, and (Ajdari et al, [0008], “A need exists in particular to improve the handling of plug streams, for example to distribute them better in various channels…”; [0100], “The preceding arrangement, shown in FIG. 5, appears to ensure, at each intersection, an equal distribution of the total upstream flow rate… However, it has been found that on two-phase systems, the equipartition is not always obtained…” [0108], “… the system of the invention which is called "bypass" has the role, for example, of accentuating the influence of the last drop passed, so that it repels the next to the other branch…”).
However, Xia et al in view of Ajdari et al does not explicitly disclose wherein ends of the at least two branches which are cascaded communicate with the first collector. Rather, these references teach a collector at the end of each channel (see Xia et al, [0076]). According to MPEP 2144.04(V)(B), making components integral may be prima facie obvious as a matter of obvious engineering choice (please see In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965)). Likewise, MPEP 2144.04(III)(A) teaches that the elimination of an element and its function is obvious if the function is non-desired. In the case of the instant invention, it would have been obvious to one of ordinary skill in the art to modify the device including multiple collecting outlets as taught by Xia et al in view of Ajdari et al to have a joint collection outlet, for the predictable benefit of having a single waste outlet after sequential separation through branched channels.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Xia et al (US 20210213452 A1) as applied to claim 1, and further in view of Cho et al (US 20150268244 A1).
With regards to claim 9, the chip of claim 1 is anticipated by Xia et al.
Xia et al does not explicitly disclose the limitations of claim 9.
In the analogous art of microfluidic devices for particle sorting, Cho et al teaches;
A microfluidic device with inlets for a fluid sample and a buffer, as read on the taught ([0009], “…the flow cytometry systems include a fluidic device…”; [0134], “…a first inner inlet can be configured to receive a cell-laden solution […] and a second inner inlet is configured to receive a buffer.”)
The claimed “wherein the sorting channel further comprises a main channel. the main channel is spiral in a plane where the microfluidic chip is located. an end of the main channel communicates with the first sorting channel and the second sorting channel” has been read on the taught ([0133], “…a spiral enrichment structure can include one or more inner inlets, a fluidic channel arranged in a plurality of circular loops, and two or more outer outlets.”; two or more outer outlets read on a first sorting channel and a second sorting channel.);
The claimed “the first channel is configured to sort first droplets. The second sorting channel is configured to sort second droplets. and the first droplets sorted by the first sorting channel and the second droplets sorted by the second sorting channel have different particle sizes” has been read on the taught ([0136], “…an inner outlet and an outer outlet are located at opposite ends of a spiral fluidic channel. In some embodiments, separated cells are collected, detected, counted or otherwise analyzed at the inner and/or outer outlets.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Xia et al with the spiral structure as taught by Cho et al, for the predictable benefit of separating and enriching target cell populations ([0132], “…a spiral enrichment structure can be used to separate cells and/or particles based on physical properties such as size, shape, mass and/or density.”).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Xia et al (US 20210213452 A1) as applied to claim 1, and further in view of Gilbert et al (US 20120009619 A1).
With regards to claim 18, the chip of claim 1 is anticipated by Xia et al. However, Xia et al does not explicitly disclose the limitations of claim 18.
In the analogous art of microfluidic particle handling devices, Gilbert et al teaches;
The claimed “wherein both the first container and the second container are provided with a filter structure. The filter structure comprises a plurality of microstructures. a gap between adjacent two of the plurality of microstructures is larger than 1 time of a particle size of a single cell in the cell suspension and smaller than 2 times of the particle size of the single cell” has been read on the taught ([0042], “…the unitary particle processing cartridge 100 may perform size-based filtering of particles, such as cells. For example, a cell suspension in a first chamber of the cartridge may be pumped into a second chamber through a filter, which permits only cells or particles below a certain size to flow into the second chamber.”; A filter in a first chamber reads on a filter structure.).
It would have been obvious to one of ordinary skill in the art to modify the device of Xia et al with the filter structure as taught by Gilbert et al, for the predictable benefit of generating a size-selected subpopulation of cells (Gilbert et al, [0042], “This operation produces a size defined sub-population of cells in the second chamber.”).
With regards to the limitation “wherein both the first container and second structure are provided with a filter structure,” this is held to be mere duplication of parts. According to MPEP 2144.04(VI)(B), duplication of parts may be prima facie obvious provided no new or unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
With regards to the limitation “a gap between adjacent two of the plurality of microstructures is larger than 1 time of a particle size of a single cell in the cell suspension and smaller than 2 times of the particle size of the single cell,” this is held to be a mere change in size or proportion. According to MPEP 2144.04(IV)(A), changes in size or proportion may be prima facie obvious; please see In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) and In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). It would have been obvious to one of ordinary skill in the art to modify the device taught by Xia et al in view of Gilbert et al to include a gap smaller than 2 times of the particle size of a single cell, as part of a routine optimization of conditions for filtration.
Claim 20, 22, 24, 26, 29, 31, 38, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al (US 20210213452 A1) as applied to claim 1, and further in view of Tsao et al (US 20110008223 A1).
With regards to claim 20, the chip of claim 1 is anticipated by Xia et al.
Xia et al additionally teaches the claimed “the microfluidic chip comprising an inlet and an outlet” as read on the taught ([0042], “111 inlet of sample micro-channel…”; [0076], “The output channels may each have an output disposed at its end.”).
However, Xia et al does not explicitly disclose the further limitations of claim 20.
In the analogous art of microfluidic devices, Tsao et al teaches;
The claimed “the box device comprises: an accommodating cavity configured to accommodate the microfluidic chip” has been read on the taught ([0111], “Interface cartridge 182 includes a matching alignment hole 215 and slot 213 for positioning the interface cartridge 182 with respect to the microfluidic chip 18.”; Alignment hole 215 and slot 213 read on an accommodating cavity);
The claimed “an inlet unit communicated with the inlet of the microfluidic chip. the inlet unit being configured to store a first reagent and release the first reagent to the inlet of the microfluidic chip” and “wherein the inlet unit comprises an inlet hole and a first storage cavity. the inlet hole is a through hole and communicates with the first storage cavity” has been read on the taught ([0091], “Interface cartridge 102 includes fluid delivery channels configured to convey fluids (sample, reagents, etc.) from the wells 108, 110, 112 and sipper tube 134 to the microfluidic process channels 24 of the microfluidic chip 18.”; [0096], “The inlet ports of the microfluidic chip 18 corresponding to connection holes 120, 124 are connected to each other by a connector leg 122 formed in the microfluidic chip 18”; Inlet ports read on an inlet hole. Wells 108, 110, and 112 read on a storage cavity.);
The claimed “the inlet hole is recessed from a surface of the box device to an inside of the box device” has been read on the taught ([0087], “Each port 302 includes a tapered, circular recess 304 formed in the top of the gasket 300…”);
The limitations of “the first storage cavity is on a side of the inlet hole away from the surface of the box device. and wherein the first storage cavity is inside the box device. and an orthographic projection of the inlet hole on the box device falls within an orthographic projection of the first storage cavity on the box device” are held to be mere rearrangement of parts. According to MPEP 2144.04(VI)(C), rearrangement of parts is prima facie obvious as matters of design choice; please see In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught with Xia et al with the housing and fluid handling features as taught by Tsao et al, for the benefit of accommodating fluid handling structures without increasing the size or complexity of the microfluidic chip ([0013], “Accordingly, cost savings and other efficiencies can be achieved by minimizing the size of the microfluidic chip formed from costly materials and requiring precise manufacturing, while providing adequate ancillary fluid structures for mixing and/or routing reaction materials to the process channels without increasing the size and complexity of the microfluidic chip.”).
With regards to claim 22, 24, and 26, the device of claim 20 is obvious over Xia et al in view of Tsao et al.
Tsao et al additionally teaches that a storage cavity can be associated with the outlet unit, as read on the taught ([0016], “The interface cartridge may include waste collection wells disposed at a terminal end of each fluid removal channel.”);
The limitations of claims 22, 24, and 26 describe additional storage cavities associated with the inlet units and outlets units described in claim 20, the positions of these storage cavities, and the connections between these storage cavities. The specification of the instant application does not disclose any unexpected results occurring due to the limitations of claims 22, 24, or 26; rather, they describe fluid handling features with results predictable to one of ordinary skill in the art, as evidenced by Tsao et al. Accordingly, the further limitations of claims 22, 24, and 26 amount to the duplication of parts and rearrangement of parts. According to MPEP 2144.04(VI)(C), rearrangement of parts is prima facie obvious as matters of design choice; please see In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). According to MPEP 2144.04(VI)(B), duplication of parts may be prima facie obvious provided no new or unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 20 with the limitations of claims 22, 24, and 26, for the predictable benefit of providing additional reservoirs for storing new or used reagents.
With regards to claim 29, 31, and 38, the device of claim 20 is obvious over Xia et al in view of Tsao et al.
Regarding the limitations “the first reagent comprises the first fluid. the cell suspension. and a biochemical reagent,” this describes the material worked upon by the device, and has been given the appropriate patentable weight; please see MPEP 2115.
Xia et al teaches that the chip of claim 1 is configured to handle droplets ([0067], “…the various components in the mixture may be subjected to one or more sorting processes on-chip using various sorting techniques, such as […] droplet sorting/deflection…”), cells ([0004], “It is an objective of the present invention to provide microfluidic devices and methods that allow for focusing and orienting particles or cellular materials…”), and reagents ([0100], “…the optical interrogation region may be used in conjunction with additives, such as chemicals which bind to or affect components of the sample mixture…”).
The additional limitations of claims 29 and 31 describe additional inlet units, inlets, outlet units, and outlets, which are configured to handle reagents, cells, and droplets, and the connections between these components. The specification of the instant application does not disclose any unexpected results occurring due to the limitations of claims 29 or 31; rather, they describe fluid handling features with results predictable to one of ordinary skill in the art, as evidenced by Tsao et al. Accordingly, the further limitations of claims 29 and 31 amount to the duplication of parts and rearrangement of parts. According to MPEP 2144.04(VI)(C), rearrangement of parts is prima facie obvious as matters of design choice; please see In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). According to MPEP 2144.04(VI)(B), duplication of parts may be prima facie obvious provided no new or unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 20 with the limitations of claims 29 or 31 for the predictable benefit of providing additional reservoirs for storing new or used reagents.
With regards to claim 39, Xia et al teaches;
The claimed “a microfluidic chip” has been read on the taught (Abstract, “The microfluidic devices feature a microfluidic chip…”);
The claimed “a first fluid” has been read on the taught ([0070], “…two sheath fluid micro-channels (140) are each configured to flow a sheath fluid…”; sheath fluid reads on a first fluid.);
The claimed “a second fluid comprising a cell suspension” has been read on the taught ([0070], “…the sample micro-channel (110) is configured to flow a sample fluid mixture…”; [0064], “… a microfluidic chip design and methods that can isolate particles or cellular materials…”; a sample fluid mixture reads on a second fluid);
The claimed “a first container configured to accommodate a first fluid” has been read on the taught ([0107], “…a collapsible container having sheath or buffer fluid therein, is disposed in a pressurized vessel […] such that fluid is delivered via tubing to the sheath or buffer input of the chip.”; a container reads on a first container.);
The claimed “a second container configured to accommodate a second fluid comprising a cell suspension” has been read on the taught ([0107], “…a system having a pressurized gas which provides pressure for pumping sample fluid mixture from reservoir (i.e., sample tube) into sample input of the chip.”; a reservoir reads on a second container.);
The claimed “a delivery channel comprising a first delivery channel and a second delivery channel. the first delivery channel communicating with the first container and the second delivery channel communicating with the second container. the first delivery channel intersecting and communicating with the second delivery channel at a confluence” has been read on the taught ([0069], “A non-limiting embodiment of the microfluidic chip (100) comprises a sample micro-channel (110), two sheath fluid micro-channels (140) intersecting the sample micro-channel (110) to form an intersection region (145).”; Two sheath fluid micro-channels (140) reads on a first delivery channel. A sample micro-channel (110) reads on a second delivery channel. Intersection region 145 reads on a confluence.);
The claimed “a shape of the delivery channel being designed so that the first fluid and the second fluid merge at the confluence” has been read on the taught ([0070], “The flow of sheath fluid causes laminar flow and compression of the sample fluid mixture flowing from the sample micro-channel (110) at least horizontally from at least two sides such that the sample fluid mixture becomes surrounded by sheath fluid and compressed into a thin stream.”);
The claimed “a sorting channel downstream of the delivery channel and comprising a first sorting channel and a second sorting channel” has been read on the taught ([0076], “…the microfluidic chip (100) may further comprise a plurality of output micro-channels (170) downstream of and fluidly coupled to the expansion region (160).”; The plurality of output microchannels read on a first and second sorting channel. See also [0086]);
The claimed “a collector downstream of the sorting channel and comprising a first collector and a second collector. the first collector communicating with the first sorting channel. and the second collector communicating with the second sorting channel” has been read on the taught ([0076], “The output channels may each have an output disposed at its end. In other embodiments, the microfluidic chip may further include one or more notches disposed at a bottom edge of the microfluidic chip to separate the outputs and to provide attachments for external tubing etc.”; The output with attachments to tubing reads on a first and second sorting channel.).
Xia et al additionally teaches the claimed “the microfluidic chip comprising an inlet and an outlet” as read on the taught ([0042], “111 inlet of sample micro-channel…”; [0076], “The output channels may each have an output disposed at its end.”).
However, Xia et al does not explicitly disclose the further limitations of claim 39 with regards to the box device.
In the analogous art of microfluidic devices, Tsao et al teaches;
The claimed “the box device comprises: an accommodating cavity configured to accommodate the microfluidic chip” has been read on the taught ([0111], “Interface cartridge 182 includes a matching alignment hole 215 and slot 213 for positioning the interface cartridge 182 with respect to the microfluidic chip 18.”; Alignment hole 215 and slot 213 read on an accommodating cavity);
The claimed “an inlet unit communicated with the inlet of the microfluidic chip. the inlet unit being configured to store a first reagent and release the first reagent to the inlet of the microfluidic chip” and “wherein the inlet unit comprises an inlet hole and a first storage cavity. the inlet hole is a through hole and communicates with the first storage cavity” has been read on the taught ([0091], “Interface cartridge 102 includes fluid delivery channels configured to convey fluids (sample, reagents, etc.) from the wells 108, 110, 112 and sipper tube 134 to the microfluidic process channels 24 of the microfluidic chip 18.”; [0096], “The inlet ports of the microfluidic chip 18 corresponding to connection holes 120, 124 are connected to each other by a connector leg 122 formed in the microfluidic chip 18”; Inlet ports read on an inlet hole. Wells 108, 110, and 112 read on a storage cavity.);
The claimed “the inlet hole is recessed from a surface of the box device to an inside of the box device” has been read on the taught ([0087], “Each port 302 includes a tapered, circular recess 304 formed in the top of the gasket 300…”);
The claimed “an outlet unit communicated with the outlet of the microfluidic chip. the outlet unit being configured to receive and store a second reagent processed by the microfluidic chip and flowing into the outlet unit from the outlet of the microfluidic chip” has been read on the taught ([0016], “The interface cartridge may include waste collection wells disposed at a terminal end of each fluid removal channel.”);
The limitations of “the first storage cavity is on a side of the inlet hole away from the surface of the box device” is held to be mere rearrangement of parts. According to MPEP 2144.04(VI)(C), rearrangement of parts is prima facie obvious as matters of design choice; please see In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught with Xia et al with the housing and fluid handling features as taught by Tsao et al, for the benefit of accommodating fluid handling structures without increasing the size or complexity of the microfluidic chip ([0013], “Accordingly, cost savings and other efficiencies can be achieved by minimizing the size of the microfluidic chip formed from costly materials and requiring precise manufacturing, while providing adequate ancillary fluid structures for mixing and/or routing reaction materials to the process channels without increasing the size and complexity of the microfluidic chip.”).
Claims 32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al (US 20210213452 A1) in view of Tsao et al (US 20110008223 A1) as applied to claim 2 and further in view of Nassef et al (US 20200096436 A1).
With regards to claim 32, the device of claim 20 is obvious over Xia et al in view of Tsao et al.
Regarding the limitations “the first reagent comprises the first fluid. the cell suspension. and a biochemical reagent” and “the second reagent comprises a first droplet and a second droplet,” these describe the material worked upon by the device, and has been given the appropriate patentable weight; please see MPEP 2115.
Xia et al does not explicitly disclose an installation region. Tsao et al additionally teaches;
The claimed “wherein the box device further comprises a first installation region […] the first installation rejoin is configured to install an optical identification device” has been read on the taught ([0119], “A rectangular opening 184 is formed through the interface cartridge 182 so as to enable optical detection of properties of fluid flowing through portions of the microfluidic process channels 24 above the opening 184.”);
The limitations of lines 1 – 17 describe additional inlet units, inlets, outlet units, and outlets, which are configured to handle reagents, cells, and droplets, and the connections between these components. The specification of the instant application does not disclose any unexpected results occurring due to the limitations of claim 32; rather, they describe fluid handling features with results predictable to one of ordinary skill in the art, as evidenced by Tsao et al. Accordingly, the further limitations of claim 32 amounts to the duplication of parts and rearrangement of parts. According to MPEP 2144.04(VI)(C), rearrangement of parts is prima facie obvious as matters of design choice; please see In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). According to MPEP 2144.04(VI)(B), duplication of parts may be prima facie obvious provided no new or unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
However, Xia et al in view of Tsao et al does not explicitly disclose wherein the box device further comprises a second installation region configured to install a driving electrode.
In the analogous art of microfluidic devices, Nassef et al teaches;
The claimed wherein “a second installation region […] the second installation region is configured to install a driving electrode” has been read on the taught ([0135], “…the assembly of a […] a cartridge bearing a microfluidic chip substrate […] a base plate 1324 (e.g., as described above with reference to FIGS. 9A-9N) with electrical sensing contacts 1340…”; The base plate with electrical sensing contacts reads on an installation region configured to install a driving electrode. While the art of Nassef et al teaches electrodes for sensing, one of ordinary skill in the art would recognize that a region configured to install electrodes reads on the prior art regardless of the intended use of the electrode.).
Regarding the limitation “the first installation region and the second installation region are between the inlet unit and the outlet unit,” this limitation is held to be mere rearrangement of parts. According to MPEP 2144.04(VI)(C), rearrangement of parts is prima facie obvious as matters of design choice; please see In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Xia et al in view of Tsao et al with the installation region as taught by Nassef et al. According to MPEP 2143(I)(A), combining prior art elements according to known methods to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Xia et al, Tsao et al, and Nassef et al teaches each element claimed. One of ordinary skill in the art could have combined the element of a second installation region by known methods, and found it performs the same function of accommodating an electrode. One of ordinary skill in the art would have recognized the combination’s predictable result of allowing an electrode to be used with the box device.
With regards to claim 34, the device of claim 20 is obvious over Xia et al in view of Tsao et al.
Regarding the limitations “the first reagent comprises the first fluid and droplet comprising a single cell” and “the second reagent comprises a first droplet and a second droplet,” these describe the material worked upon by the device, and has been given the appropriate patentable weight; please see MPEP 2115.
Xia et al does not explicitly disclose an installation region. Tsao et al additionally teaches;
The claimed “wherein the box device further comprises a first installation region […] the first installation rejoin is configured to install an optical identification device” has been read on the taught ([0119], “A rectangular opening 184 is formed through the interface cartridge 182 so as to enable optical detection of properties of fluid flowing through portions of the microfluidic process channels 24 above the opening 184.”);
However, Xia et al in view of Tsao et al does not explicitly disclose wherein the box device further comprises a second installation region configured to install a driving electrode.
In the analogous art of microfluidic devices, Nassef et al teaches;
The claimed wherein “a second installation region […] the second installation region is configured to install a driving electrode” has been read on the taught ([0135], “…the assembly of a […] a cartridge bearing a microfluidic chip substrate […] a base plate 1324 (e.g., as described above with reference to FIGS. 9A-9N) with electrical sensing contacts 1340…”; The base plate with electrical sensing contacts reads on an installation region configured to install a driving electrode. While the art of Nassef et al teaches electrodes for sensing, one of ordinary skill in the art would recognize that a region configured to install electrodes reads on the prior art regardless of the intended use of the electrode.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Xia et al in view of Tsao et al with the installation region as taught by Nassef et al. According to MPEP 2143(I)(A), combining prior art elements according to known methods to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Xia et al, Tsao et al, and Nassef et al teaches each element claimed. One of ordinary skill in the art could have combined the element of a second installation region by known methods, and found it performs the same function of accommodating an electrode. One of ordinary skill in the art would have recognized the combination’s predictable result of allowing an electrode to be used with the box device.
The remaining limitations of claim 34 describe additional inlet units, inlets, outlet units, outlets, installation regions, installation units, and the connections between these components. The specification of the instant application does not disclose any unexpected results occurring due to the limitations of claim 34; rather, they describe fluid handling features with results predictable to one of ordinary skill in the art, as evidenced by Tsao et al. Accordingly, the further limitations of claim 34 amount to the duplication of parts and rearrangement of parts. According to MPEP 2144.04(VI)(C), rearrangement of parts is prima facie obvious as matters of design choice; please see In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). According to MPEP 2144.04(VI)(B), duplication of parts may be prima facie obvious provided no new or unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Conclusion
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/ALISON CLAIRE GERHARD/ Examiner, Art Unit 1797 /LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797
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