DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 claim limitation is: “a retention portion” in claim 6.
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 limitation 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 to avoid it 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 recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1 and 5-9 are objected to because of the following informalities:
a) in claim 1, line 8, the phrase “ a pair of second electrodes disposed at positions different from positions of the pair of first electrodes” should be replaced with – a pair of second electrodes disposed at a positionthe positiona pair of electrodes cannot be in two or more positions at one time.
b) claim 1, last three lines, recites “. . . ., wherein the control voltage applied between the pair of first electrodes is corrected based on an impedance between the pair of second electrodes measured through the reference liquid injected into the liquid receiver. [italicizing by the Examiner]” This limitation could be interpreted as a method limitation in a device claim. If published in a patent as is, the public may be confused as to whether they would have to perform this step in order to infringe the claimed device (channel chip). The Examiner suggests instead -- “. . . ., wherein the control chip is configured so that the control voltage applied between the pair of first electrodes is corrected based on an impedance between the pair of second electrodes measured through the reference liquid injected into the liquid receiver. --
c) claim 5, last three lines, recites “. . . ., and the control voltage applied between the pair of first electrodes is corrected based on the impedance between the pair of second electrodes measured through the reference liquid injected into the second channel. [italicizing by the Examiner]” This limitation could be interpreted as a method limitation in a device claim. If published in a patent as is, the public may be confused as to whether they would have to perform this step in order to infringe the claimed device (channel chip). The Examiner suggests instead -- . . . ., and the control chip is configured so that the control voltage applied between the pair of first electrodes is corrected based on the impedance between the pair of second electrodes measured through the reference liquid injected into the second channel. --
d) claim 6, last three lines, recites “. . . ., and the control voltage applied between the pair of first electrodes is corrected based on the impedance between the pair of second electrodes measured through the reference liquid injected into the retention portion.[italicizing by the Examiner]” This limitation could be interpreted as a method limitation in a device claim. If published in a patent as is, the public may be confused as to whether they would have to perform this step in order to infringe the claimed device (channel chip). The Examiner suggests instead -- . . . ., and the control chip is configured so that the control voltage applied between the pair of first electrodes is corrected based on the impedance between the pair of second electrodes measured through the reference liquid injected into the retention portion. --
e) in claim 7, line 7-8, the phrase “ the pair of second electrodes are disposed at positions different from positions of the pair of first electrodes between the principal surface of the substrate and the first channel, . . . .” should be replaced with - - the pair of second electrodes is disposed at a positionthe positiona pair of electrodes cannot be in two or more positions at one time.
f) claim 7, last three lines, recites “. . . ., the control voltage applied between the pair of first electrodes is corrected based on the impedance between the pair of second electrodes measured through the reference liquid injected into the first channel in a state where the sample liquid is not injected into the first channel. [italicizing by the Examiner]” This limitation could be interpreted as a method limitation in a device claim. If published in a patent as is, the public may be confused as to whether they would have to perform this step in order to infringe the claimed device (channel chip). The Examiner suggests instead -- “. . . ., the control chip is configured so that the control voltage applied between the pair of first electrodes is corrected based on the impedance between the pair of second electrodes measured through the reference liquid injected into the first channel in a state where the sample liquid is not injected into the first channel. --
g) in claim 8, lines 11-12, the phrase “ a pair of second electrodes disposed at positions different from positions of the pair of first electrodes” should be replaced with – a pair of second electrodes disposed at a positionthe positiona pair of electrodes cannot be in two or more positions at one time.
h) claim 8, last three lines, recites “. . . ., wherein the control voltage applied between the pair of first electrodes is corrected based on an impedance between the pair of second electrodes measured through the reference liquid injected into the liquid receiver. [italicizing by the Examiner]” This limitation could be interpreted as a method limitation in a device claim. If published in a patent as is, the public may be confused as to whether they would have to perform this step in order to infringe the claimed device (channel chip). The Examiner suggests instead -- “. . . ., wherein the control chip is configured so that the control voltage applied between the pair of first electrodes is corrected based on an impedance between the pair of second electrodes measured through the reference liquid injected into the liquid receiver. --
i) in claim 9, lines 9-10, the phrase “ a pair of second electrodes disposed at positions different from positions of the pair of first electrodes” should be replaced with – a pair of second electrodes disposed at a positionthe positiona pair of electrodes cannot be in two or more positions at one time.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Note that dependent claims will have the deficiencies of base and intervening claims.
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 2, 6, and 10 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:
a) claim 2 recites the limitation "the second electrode" in line 2. There is insufficient antecedent basis for this limitation in the claim – claim 1 only mentions “a pair of second electrodes”.
b) Claim 6 limitation “a retention portion” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Applicant’s specification states on page 11,
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These figures show the pair of second electrodes 43a and a channel segment. Claim 6, though, recites, “. . . ., the pair of second electrodes are separated from the first channel and the pair of first electrodes and disposed between the principal surface of the substrate and the retention portion, . . . . [italicizing by the Examiner]” That is, the send pair of electrodes is not part of the retention portion. So, it is not clear what is meant by a retention portion, especially what are its retaining feature(s) and even what is to be retained.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
c) claim 10 recites the limitation "the second electrode" in line 2. There is insufficient antecedent basis for this limitation in the claim – claim 9 only mentions “a pair of second electrodes”.
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 1 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yasuda et al. US 9,109,197 B2 (hereafter “Yasuda”) in view of Azpiroz et al. US 2016/0367988 A1 (hereafter “Azpiroz”), Swami et al. US 2022/0091014 A1 (hereafter “Swami”), and Masataka Shinoda US 2009/0109436 A1 (hereafter “Shinoda”).
Addressing claim 1, Yasuda discloses a channel chip (Figure 8 in its entirety. Note that although Yasuda only refers to structural element 3001 as a chip (col. 16:13-39) the Examiner is construing Figure 8 in its entirety as a channel chip.) comprising:
a substrate (3001 in Figure 8) ;
a liquid receiver (3005 in Figure 8. See also col. 16:41-47 ) which is disposed on one principal surface side of the substrate (its top surface) and into which a sample liquid or a reference liquid can be injected (again see col. 16:41-47, noting especially, “A sample liquid introduced from a sample liquid inlet 3102 is delivered through a dielectrophoretic force applying portion 3105 . . . .“);
a pair of first electrodes disposed between the principal surface of the substrate and the liquid receiver (note V-shaped interdigitated electrodes 3003 in Figure 8. See also col. 16:47-51.) and can cause a dielectrophoretic force to act on dielectric particles contained in the sample liquid injected into the liquid receiver when a control voltage is applied (see Figures 9 and 10, and see also col. 16:47 – col. 17:7).
Yasuda, though, does not disclose “. . . . a pair of second electrodes disposed at positions different from positions of the pair of first electrodes between the principal surface of the substrate and the liquid receiver; wherein
the control voltage applied between the pair of first electrodes is corrected based on an impedance between the pair of second electrodes measured through the reference liquid injected into the liquid receiver.”
Azpiroz discloses a microfluidic chip with dielectrophoretic electrodes extending in a hydrophilic flow path. See the title. In addition to the dielectrophoretic electrodes (E21, E22 (62)) the microfluidic chip also includes at least one pair of control electrodes (66) at a position different from that of the dielectrophoretic electrodes. See Figures 1, 11, and 3, and paragraphs [0063] and [0107]1. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide at least one pair of control electrodes as taught by Azpiroz in the channel chip of Yasuda because Azpiroz discloses
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See also Azpiroz Figure 10, noting therein step “S70: Control Electrodes Detect Liquid Property” and step “S75: Control Circuit Provides Feedback”.
Thus, Azpiroz implicitly discloses that “the control voltage applied between the pair of first electrodes is corrected based on an impedance between the pair of second electrodes measured . . . ..”
Moreover, Swami discloses a method and system for impedance-based quantification and microfluidic control. See the title. The system comprises “a microfluidic chip, the microfluidic chip comprising a microfluidic channel with one or more electric-field-generating structures located therein, including a first electric-field-generating structure (e.g., electrodes), wherein the one or more electric-field-generating structures is configured to selectively polarize or manipulate biologic or particle components flowing within the microfluidic channel; and measuring, via an on-chip impedance sensing element (e.g., on-chip resister), impedance spectra associated with at least one internal capacitive structure (e.g., parasitic voltage due to at least one capacitive structure) of the first electric-field-generating structure or characteristic of the biologic or particle components, . . . .” See paragraph [0012] and Figure 9. The on-chip impedance sensing element may comprise a set of electrodes located in the microfluidic channel. See paragraph [0041]. Sawmi discloses several beneficial uses of the on-chip impedance sensing element, such as, “ . . . .to measure and/or assess impedance spectra for the geometric or functional quantification of internal structures of the microfluidic chip and/or to measure and/or assess the impedance characteristics of the biologic or particle components to control polarization or manipulation of the biologic or particle components. See paragraph [0081]. Most relevant to the channel chip of Yasuda as modified by Azpiroz is that Swami discloses the following
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So, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide at least one pair of control electrodes as taught by Azpiroz in the channel chip of Yasuda also because in light of Swami it can be used for real-time feedback compensation of a number of different operational deviations that may occur when using the channel chip.
As for the claim 1 limitation “wherein the control voltage applied between the pair of first electrodes is corrected based on an impedance between the pair of second electrodes measured through the reference liquid injected into the liquid receiver…[italicizing by the Examiner]”, Shinoda discloses , “A method for measuring a micro-particle caused to flow through a flow channel, includes the steps of: measuring a property of a material to be measured as a micro-particle in a predetermined position of a flow channel for measurement, and measuring properties of one or more reference materials in a predetermined position of a flow channel for reference while the material to be measured is caused to flow through the flow channel for measurement, and the one or more reference materials are caused to flow through the flow channel for reference; and processing a result of the measurement of the material to be measured in accordance with a result of the measurements of the one or more reference materials.” See the Shinoda Abstract and Figure 1. The property may be an electrical property and the micro-particle may be a cell. See paragraphs [0006] and [0007]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have in the channel chip of Yasuda as modified by Azpiroz and Swami the control voltage applied between the pair of first electrodes be corrected based on an impedance between the pair of second electrodes measured through the reference liquid injected into the liquid receiver because this would be expected to increase the accuracy of the impedance measurement by providing one or more updated baseline measurements against which the sample measurements can be compared. See Shinoda paragraphs [0008], [0009], [[0039], and [0040].
Addressing claim 7, as for the claim limitation “. . . ., wherein the liquid receiver includes a first channel, . . . .”, see Yasuda Figure 8 and col. 16:13-52, noting therein dielectrophoretic force applying portion 3105.
As for the claim limitation “. . . ., the pair of first electrodes are disposed between the principal surface of the substrate and the first channel and can cause the dielectrophoretic force to act on the dielectric particles contained in the sample liquid injected into the first channel when the control voltage is applied in a state where the reference liquid is not injected into the first channel, . . . .”, see Yasuda Figures 9 and 10, which show “how particulates having the repulsive force against a specified frequency are actually moved. FIGS. 9 and 10 show one example of the movement. FIG. 9 (and FIG. 10) are conceptual diagrams illustrating the principle of separating and purifying particulates based on the difference in polarities of dielectrophoretic forces when the particulates receiving negative (positive) dielectrophoretic force are introduced into the device.” See Yasuda col. 16:52 – col. 17:7.
As for the claim limitation “. . . ., the pair of second electrodes are disposed at positions different from positions of the pair of first electrodes between the principal surface of the substrate and the first channel, . . . .”, note that when the control electrodes (66) (pair of second electrodes) of Azpiroz are adopted into the channel chip of Yasuda, as discussed in the rejection of underlying claim 1, they will be at a position different from that of the dielectrophoretic electrodes (pair of first electrodes). See Azpiroz Figures 1, 11, and 3, and paragraphs [0063] and [0107].
As for the claim limitation “. . . ., and the control voltage applied between the pair of first electrodes is corrected based on the impedance between the pair of second electrodes measured through the reference liquid injected into the first channel in a state where the sample liquid is not injected into the first channel…”, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to do so because as discussed in the rejection of underlying claim 1 the reference liquid is used to obtain a baseline measurement free of sample, so sample contamination of the reference liquid should be avoided.
Addressing claim 8, Yasuda discloses a dielectrophoresis apparatus (Figure 8 along with the unshown necessary electrical components, such as a power supply, and fluid-handling components, such as a pump. See also col. 11:37-41 and col. 16:13-16.) comprising:
a channel chip (Figure 8 in its entirety. Note that although Yasuda only refers to structural element 3001 as a chip (col. 16:13-39) the Examiner is construing Figure 8 in its entirety as a channel chip.); and
a voltage controller (such a controller is implied by the following, “. . . .; and (d) a mechanism configured to apply a voltage to apply an external force to the cells in the cell separation area based on the information relating to the cells obtained by the cell information detector.” See col. Col. 7:52-55.); wherein
the channel chip includes a substrate (3001 in Figure 8),
a liquid receiver (3005 in Figure 8. See also col. 16:41-47 ) which is disposed on one principal surface side of the substrate (its top surface) and into which a sample liquid or a reference liquid can be injected again see col. 16:41-47, noting especially, “A sample liquid introduced from a sample liquid inlet 3102 is delivered through a dielectrophoretic force applying portion 3105 . . . .“),
a pair of first electrodes disposed between the principal surface of the substrate and the liquid receiver (note V-shaped interdigitated electrodes 3003 in Figure 8. See also col. 16:47-51.) and can cause a dielectrophoretic force to act on dielectric particles contained in the sample liquid injected into the liquid receiver when a control voltage is applied (see Figures 9 and 10, and see also col. 16:47 – col. 17:7), and
a pair of second electrodes disposed at positions different from positions of the pair of first electrodes between the principal surface of the substrate and the liquid receiver; wherein
the voltage controller corrects the control voltage applied between the pair of first electrodes based on an impedance between the pair of second electrodes measured through the reference liquid injected into the liquid receiver.
Yasuda, though, does not disclose “. . . . a pair of second electrodes disposed at positions different from positions of the pair of first electrodes between the principal surface of the substrate and the liquid receiver; wherein
the control voltage applied between the pair of first electrodes is corrected based on an impedance between the pair of second electrodes measured through the reference liquid injected into the liquid receiver.”
Azpiroz discloses a microfluidic chip with dielectrophoretic electrodes extending in a hydrophilic flow path. See the title. In addition to the dielectrophoretic electrodes (E21, E22 (62)) the microfluidic chip also includes at least one pair of control electrodes (66) at a position different from that of the dielectrophoretic electrodes. See Figures 1, 11, and 3, and paragraphs [0063] and [0107]2. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide at least one pair of control electrodes as taught by Azpiroz in the channel chip of Yasuda because Azpiroz discloses
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See also Azpiroz Figure 10, noting therein step “S70: Control Electrodes Detect Liquid Property” and step “S75: Control Circuit Provides Feedback”.
Thus, Azpiroz implicitly discloses that “the control voltage applied between the pair of first electrodes is corrected based on an impedance between the pair of second electrodes measured . . . ..”
Moreover, Swami discloses a method and system for impedance-based quantification and microfluidic control. See the title. The system comprises “a microfluidic chip, the microfluidic chip comprising a microfluidic channel with one or more electric-field-generating structures located therein, including a first electric-field-generating structure (e.g., electrodes), wherein the one or more electric-field-generating structures is configured to selectively polarize or manipulate biologic or particle components flowing within the microfluidic channel; and measuring, via an on-chip impedance sensing element (e.g., on-chip resister), impedance spectra associated with at least one internal capacitive structure (e.g., parasitic voltage due to at least one capacitive structure) of the first electric-field-generating structure or characteristic of the biologic or particle components, . . . .” See paragraph [0012] and Figure 9. The on-chip impedance sensing element may comprise a set of electrodes located in the microfluidic channel. See paragraph [0041]. Sawmi discloses several beneficial uses of the on-chip impedance sensing element, such as, “ . . . .to measure and/or assess impedance spectra for the geometric or functional quantification of internal structures of the microfluidic chip and/or to measure and/or assess the impedance characteristics of the biologic or particle components to control polarization or manipulation of the biologic or particle components. See paragraph [0081]. Most relevant to the channel chip of Yasuda as modified by Azpiroz is that Swami discloses the following
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So, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide at least one pair of control electrodes as taught by Azpiroz in the channel chip of Yasuda also because in light of Swami it can be used for real-time feedback compensation of a number of different operational deviations that may occur when using the channel chip.
As for the claim 8 limitation “wherein the control voltage applied between the pair of first electrodes is corrected based on an impedance between the pair of second electrodes measured through the reference liquid injected into the liquid receiver…[italicizing by the Examiner]”, Shinoda discloses , “A method for measuring a micro-particle caused to flow through a flow channel, includes the steps of: measuring a property of a material to be measured as a micro-particle in a predetermined position of a flow channel for measurement, and measuring properties of one or more reference materials in a predetermined position of a flow channel for reference while the material to be measured is caused to flow through the flow channel for measurement, and the one or more reference materials are caused to flow through the flow channel for reference; and processing a result of the measurement of the material to be measured in accordance with a result of the measurements of the one or more reference materials.” See the Shinoda Abstract and Figure 1. The property may be an electrical property and the micro-particle may be a cell. See paragraphs [0006] and [0007]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have in the channel chip of Yasuda as modified by Azpiroz and Swami the control voltage applied between the pair of first electrodes be corrected based on an impedance between the pair of second electrodes measured through the reference liquid injected into the liquid receiver because this would be expected to increase the accuracy of the impedance measurement by providing one or more updated baseline measurements against which the sample measurements can be compared. See Shinoda paragraphs [0008], [0009], [[0039], and [0040].
Addressing claim 9, Yasuda discloses a channel chip (Figure 8 in its entirety. Note that although Yasuda only refers to structural element 3001 as a chip (col. 16:13-39) the Examiner is construing Figure 8 in its entirety as a channel chip.) comprising:
a substrate (3001 in Figure 8) ;
a liquid receiver (3005 in Figure 8. See also col. 16:41-47 ) which is disposed on one principal surface side of the substrate (its top surface) and into which a sample liquid or a reference liquid can be injected (again see col. 16:41-47, noting especially, “A sample liquid introduced from a sample liquid inlet 3102 is delivered through a dielectrophoretic force applying portion 3105 . . . .“);
a pair of first electrodes disposed between the principal surface of the substrate and the liquid receiver (note V-shaped interdigitated electrodes 3003 in Figure 8. See also col. 16:47-51.) and can cause a dielectrophoretic force to act on dielectric particles contained in the sample liquid injected into the liquid receiver when a control voltage is applied (see Figures 9 and 10, and see also col. 16:47 – col. 17:7).
Yasuda, though, does not disclose “. . . . a pair of second electrodes disposed at positions different from positions of the pair of first electrodes between the principal surface of the substrate and the liquid receiver; . . . . .”
Azpiroz discloses a microfluidic chip with dielectrophoretic electrodes extending in a hydrophilic flow path. See the title. In addition to the dielectrophoretic electrodes (E21, E22 (62)) the microfluidic chip also includes at least one pair of control electrodes (66) at a position different from that of the dielectrophoretic electrodes. See Figures 1, 11, and 3, and paragraphs [0063] and [0107]3. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide at least one pair of control electrodes as taught by Azpiroz in the channel chip of Yasuda because Azpiroz discloses
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See also Azpiroz Figure 10, noting therein step “S70: Control Electrodes Detect Liquid Property” and step “S75: Control Circuit Provides Feedback”.
As for the claim limitations “. . . ., the control voltage correction method comprising: a step of measuring an impedance between the pair of second electrodes through the reference liquid injected into the liquid receiver; and a step of correcting the control voltage applied between the pair of first electrodes based on the impedance between the pair of second electrodes…”, it will be first noted that it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have the control voltage applied between the pair of first electrodes be corrected based on an impedance between the pair of second electrodes measured because this would be just using the channel chip of Yasuda as modified by Azpiroz as intended in part.
Moreover, Swami discloses a method and system for impedance-based quantification and microfluidic control. See the title. The system comprises “a microfluidic chip, the microfluidic chip comprising a microfluidic channel with one or more electric-field-generating structures located therein, including a first electric-field-generating structure (e.g., electrodes), wherein the one or more electric-field-generating structures is configured to selectively polarize or manipulate biologic or particle components flowing within the microfluidic channel; and measuring, via an on-chip impedance sensing element (e.g., on-chip resister), impedance spectra associated with at least one internal capacitive structure (e.g., parasitic voltage due to at least one capacitive structure) of the first electric-field-generating structure or characteristic of the biologic or particle components, . . . .” See paragraph [0012] and Figure 9. The on-chip impedance sensing element may comprise a set of electrodes located in the microfluidic channel. See paragraph [0041]. Sawmi discloses several beneficial uses of the on-chip impedance sensing element, such as, “ . . . .to measure and/or assess impedance spectra for the geometric or functional quantification of internal structures of the microfluidic chip and/or to measure and/or assess the impedance characteristics of the biologic or particle components to control polarization or manipulation of the biologic or particle components. See paragraph [0081]. Most relevant to the channel chip of Yasuda as modified by Azpiroz is that Swami discloses the following
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More especially,
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So, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide at least one pair of control electrodes (the pair of second electrodes) as taught by Azpiroz in the channel chip of Yasuda also because in light of Swami it can be used for real-time feedback compensation of a number of different operational deviations that may occur when using the channel chip.
Thus, It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to perform “step of measuring an impedance between the pair of second electrodes first electrodes based on the impedance between the pair of second electrodes…” because this would just be using the channel chip of Yasuda as modified by Azpiroz and Swami as intended.
As for the claim 9 limitation “a step of measuring an impedance between the pair of second electrodes through the reference liquid injected into the liquid receiver; and a step of correcting the control voltage applied between the pair of first electrodes based on the impedance between the pair of second electrodes… [italicizing by the Examiner]”, Shinoda discloses , “A method for measuring a micro-particle caused to flow through a flow channel, includes the steps of: measuring a property of a material to be measured as a micro-particle in a predetermined position of a flow channel for measurement, and measuring properties of one or more reference materials in a predetermined position of a flow channel for reference while the material to be measured is caused to flow through the flow channel for measurement, and the one or more reference materials are caused to flow through the flow channel for reference; and processing a result of the measurement of the material to be measured in accordance with a result of the measurements of the one or more reference materials.” See the Shinoda Abstract and Figure 1. The property may be an electrical property and the micro-particle may be a cell. See paragraphs [0006] and [0007]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to perform when using the channel chip of Yasuda as modified by Azpiroz and Swami a step of measuring an impedance between the pair of second electrodes through the reference liquid injected into the liquid receiver; and a step of correcting the control voltage applied between the pair of first electrodes based on the impedance between the pair of second electrodes because this would be expected to increase the accuracy of the impedance measurement by providing one or more updated baseline measurements against which the sample measurements can be compared. See Shinoda paragraphs [0008], [0009], [[0039], and [0040].
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yasuda in view of Azpiroz, Swami, and Shinoda as applied to claims 1 and 7-9 above, and further in view of Murton et al. US 2022/0040696 A1 (hereafter “Murton”).
Addressing claim 5, over Yasuda as modified by Azpiroz, Swami, and Shinoda
does not disclose “. . . ., wherein the liquid receiver includes a first channel which is disposed on the principal surface side of the substrate and into which the sample liquid can be injected, and a second channel which is separated from the first channel and disposed on the principal surface side of the substrate and into which the reference liquid can be injected, the pair of first electrodes are disposed between the principal surface of the substrate and the first channel, the pair of second electrodes are separated from the first channel and the pair of first electrodes and disposed between the principal surface of the substrate and the second channel, . . . .”; however, all of these limitations just amount to duplication of the fist channel to form the otherwise identical second channel in the channel chip. Such channel duplication is prima facie obvious as duplication of parts for a multiplied effect (allowing two solutions to be analyzed in parallel). See MPEP 2144.04(VI)(B). Moreover, there is motivation for such duplication as Murton, which discloses a microfluidic device with DEP (dielectrophoresis) arrays, states,
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As for the ending claim 5 limitation “. . . ., and the control voltage applied between the pair of first electrodes is corrected based on the impedance between the pair of second electrodes measured through the reference liquid injected into the second channel…”, note that Shinoda discloses a method for measuring micro-particles in which reference materials are flowed through and analyzed in a second channel that is largely parallel to and otherwise identical to a first channel through which materials to analyzed are flowed and analyzed. See Shinoda the title, Figures 1 and 2, and paragraphs [0034] and [0035]. In light of this disclosure of Shinoda, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have for the channel chip of Yasuda as modified by Azpiroz, Swami, and Shinoda (as discussed earlier in this claim rejection) the control voltage applied between the pair of first electrodes be corrected based on the impedance between the pair of second electrodes measured through the reference liquid injected into the second channel because (1) as discussed in the rejection of underlying claim 1 the reference fluid will increase the accuracy of the measurements “by providing one or more updated baseline measurements against which the sample measurements can be compared…”, and (2) making the measurements on reference liquid injected into the second channel will minimize interruptions of sample through flow in the first channel, that is sample analysis downtime will be minimized.
Allowable Subject Matter
Claims 2 and 6 would be allowable if rewritten to overcome the rejections under
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 3, 4, and 10-12 are 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.
The following is a statement of reasons for the indication of allowable subject matter:
a) the International Search Report for international application no. PCT/JP2023/019097 cites only “A” documents.
b) the Written Opinion for international application no. PCT/JP2023/019097 deems claims 1-12 to have novelty and an inventive step.
c) the combination of limitations in claim 2 requires the following underlined feature
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There is not enough information available about the channel chip of Yasuda as modified by Azpiroz, Swami, and Shinoda to determine the relative resistivity of the reference liquid to that of the second electrode. Moreover, it was common to have electrodes in dielectrophoresis and impedance sensor devices to be made of precious metals such as gold or platinum. See, for example, Azpiroz paragraph [0099], Murton the title and paragraph [0074] and see Becker et al. US 6,294,063 B1 the title, col. 20:66 – col. 21:21, and col. 26:25-30. It cannot be said that a cell suspension (see the Yasuda Abstract) would necessarily or likely have a smaller electric resistivity than a gold or platinum electrode.
d) the combination of limitations in claim 3 requires the following underlined feature
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In contrast, in the channel chip of Yasuda as modified by Azpiroz, Swami, and Shinoda only the pair of second electrodes is intended to be used to measure impedance as it provides feedback for real-time control of the pair of first electrodes. See Azpiroz paragraph [0108].
e) claim 4 depends from allowable claim 3.
f) the combination of limitations in claim 6 requires the following underlined features
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In contrast, in the channel chip of Yasuda as modified by Azpiroz, Swami, and Shinoda these is no such “retention portion”.
g) the combination of limitations in claim 10 requires the following underlined feature
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See the discussion above regarding the allowability of claim 2.
h) the combination of limitations in claim 11 requires the following underlined feature
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See the discussion above regarding the allowability of claim 3.
i) claim 12 depends from allowable claim 11.
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/ALEXANDER S NOGUEROLA/Primary Examiner, Art Unit 1795
1 In paragraph [0107] note especially, “A control circuit will comprise at least one pair of control electrodes 66, 68 extending transverse to the flow path, . . . . [italicizing by the Examiner]”
2 In paragraph [0107] note especially, “A control circuit will comprise at least one pair of control electrodes 66, 68 extending transverse to the flow path, . . . . [italicizing by the Examiner]”
3 In paragraph [0107] note especially, “A control circuit will comprise at least one pair of control electrodes 66, 68 extending transverse to the flow path, . . . . [italicizing by the Examiner]”
