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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 9, 2026 has been entered.
Response to Arguments
The applicant's amendments and arguments/remarks have been fully considered but are moot in view of the new grounds of rejections presented herein. Specifically, the examiner has provided the van der Linden reference to teach the limitations presented in the newly amended claims.
Response to Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-21 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 broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 15 recites the broad recitation ‘at least one layer’, and the claim also recites ‘a plurality of stacked layers’ which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 15 recites the limitation "the conduits" in Line 7. There is insufficient antecedent basis for this limitation in the claim. It is believed this should read ‘one of the plurality of conduits’.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 17 recites the broad recitation ‘at least another one of layer’, and the claim also recites ‘plurality of stacked layers’ which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 20 recites the broad recitation ‘at least another one of layer’, and the claim also recites ‘plurality of stacked layers’ which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claim(s) 1 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Charest et al. (US 2011/0082563) in view of Ponjee et al. (US 2010/0156444) and van der Linden et al. (Reference U on PTO-892; 2002).
Regarding claim 1, Charest teaches a device for biofluid processing and analysis (Abstract), comprising:
a microfluidic module (Paragraph 0004; ‘microfluidic multi-channel bioreactor device’) including a plurality of stacked layers (Paragraph 0004; ‘Such bioreactor systems may, for example, include two polymer layers’),
a plurality of conduits defined in each layer of the plurality of stacked layers (Paragraph 0004; ‘ Each layer defines one or more microchannels’), and wherein a first layer of the plurality of stacked layers includes a polymeric substrate defining a respective conduit of the plurality of conduits in the first layer (Paragraphs 0021-0024 and 0033).
Charest is silent on the heater electrode and hydrogel.
Ponjee teaches wherein a first layer of the plurality of stacked layers includes a polymeric substrate defining a respective conduit of the plurality of conduits in the first layer, a heater electrode disposed along the respective conduit (Paragraph 0006), and a thermally responsive hydrogel disposed along flow path of the respective conduit and adjacent to the heater electrode (Paragraphs 0042-0043). It would have been obvious to one of ordinary skill in the art to have modified Charest with Ponjee because it allows for temperature control and better manipulation of the sample (Paragraph 0008 of Ponjee).
van der Linden teaches a thermally responsive hydrogel disposed in a flow path of the respective conduit and adjacent to the heat source wherein the thermally responsive hydrogel is configured such that microfluidic flow through the respective conduit is reversibly permitted/blocked through application of heat to the thermally responsive hydrogel by the heat source (See full disclosure, in particular sections 2. Theory and 3. Experimental). It would have been obvious to one of ordinary skill in the art to have modified Charest with van der Linden because hydrogels are powerful actuator materials that can function autonomously (section 1. Introduction of van der Linden) and because it allows for a valve to decrease or prevent fluid flow in a selective manner thus yielding predictable results.
Regarding claim 11, Charest is silent on the heater electrode. Ponjee teaches further comprising a current source connected to the heater electrode (Paragraph 0006). It would have been obvious to one of ordinary skill in the art to have modified Charest with Ponjee because it allows for temperature control and better manipulation of the sample (Paragraph 0008 of Ponjee).
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Charest et al. (US 2011/0082563) in view of Ponjee et al. (US 2010/0156444) and van der Linden et al. (Reference U on PTO-892; 2002) in further view of DeVoe et al. (US 2003/0127329).
Regarding claim 2, Charest is silent on the pumping electrodes. DeVoe teaches wherein a second layer of the plurality of stacked layers includes a polymeric substrate defining a second respective conduit of the plurality of conduits in the second layer (Paragraph 0013; ‘The top polymer layer contains the desired microscale flow channels and microfluidic EOF pumping channels.’), and a set of pumping electrodes disposed along the second respective conduit (Paragraph 0013 and 0006). It would have been obvious to one of ordinary skill in the art to have modified Charest with DeVoe because it allows for flow control using a technique known in the art (Paragraph 0006 of DeVoe). Further to have multiple layers would be obvious to one of ordinary skill in the art since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).
Regarding claim 3, Charest is silent on the pumping electrodes. DeVoe teaches wherein the set of pumping electrodes includes a first pumping electrode and a second pumping electrode spaced from the first pumping electrode and substantially parallel to the first pumping electrode (Paragraph 0028; Figure 5), but is silent on a width of the first pumping electrode and a width of the second pumping electrode are different. The applicant' s specification provides no specifical reasoning or critical functionality for the use of a width of the first pumping electrode and a width of the second pumping electrode being different, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use a width of the first pumping electrode and a width of the second pumping electrode being different as desired by the user as a matter of routine engineering design choice. It would have been obvious to one of ordinary skill in the art to have modified Charest with DeVoe because it allows for flow control using a technique known in the art (Paragraph 0006 of DeVoe).
Regarding claim 4, Charest is silent on the pumping electrodes. DeVoe teaches wherein the set of pumping electrodes includes a plurality of first pumping electrodes each of which are substantially parallel to another one of the plurality of first pumping electrodes (Paragraph 0028; Figure 5), and a second pumping electrode (Paragraph 0028) but is silent on the second pumping electrode that is substantially perpendicular to the plurality of first pumping electrodes. It would have been obvious to one of ordinary skill in the art to have made the second pimping electrode substantially perpendicular to the first pumping electrodes since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C)
Regarding claim 5, Charest is silent on the pumping electrodes. DeVoe teaches further comprising a voltage source connected to the set of pumping electrodes (Paragraphs 0006 and 0013). It would have been obvious to one of ordinary skill in the art to have modified Charest with DeVoe because it allows for flow control using a technique known in the art (Paragraph 0006 of DeVoe).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Charest et al. (US 2011/0082563) Ponjee et al. (US 2010/0156444) and van der Linden et al. (Reference U on PTO-892; 2002) in further view of Aubry et al. (US 2004/0231990).
Regarding claim 6, Charest is silent on the mixing electrodes. Aubry teaches wherein a third layer of the plurality of stacked layers includes a third polymeric substrate defining a third respective conduit of the plurality of conduits in the third layer (Figure 1; Paragraph 0028), and a set of mixing electrodes disposed along the third respective conduit (Figure 1; Paragraphs 0053-0054). It would have been obvious to one of ordinary skill in the art to have modified Charest with Aubry because it aids in accelerating the mixing process within miniature scale devices (Paragraphs 0005-0006 of Aubry). Further to have multiple layers would be obvious to one of ordinary skill in the art since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).
Regarding claim 7, Charest is silent on the mixing electrodes. Aubry teaches wherein the set of mixing electrodes includes a first mixing electrode and a second mixing electrode spaced from and interlocking with the first mixing electrode (Figure 1; electrodes 15-1, 15-2, 16-1, 16-2). It would have been obvious to one of ordinary skill in the art to have modified Charest with Aubry because it aids in accelerating the mixing process within miniature scale devices (Paragraphs 0005-0006 of Aubry).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Charest et al. (US 2011/0082563) in view of Ponjee et al. (US 2010/0156444) and van der Linden et al. (Reference U on PTO-892; 2002) and Aubry et al. (US 2004/0231990) in further view of Pamula et al. (US 2004/0055891).
Regarding claim 8, Charest is silent on the mixing electrodes. Pamula teaches wherein the first mixing electrode includes a first base member and a set of first extending members extending away from the first base member toward the second mixing electrode, and the second mixing electrode includes a second base member and a set of second extending members extending away from the second base member toward the first mixing electrode (Figures 2, 42-43; Paragraphs 0086-0087; Figure 2). It would have been obvious to one of ordinary skill in the art to have modified Charest and Aubry with Pamula because it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the mixing electrodes taught by Charest in view of Aubry with those of Pamula. Furthermore, the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Regarding claim 9, Charest is silent on the mixing electrodes. Aubry teaches further comprising a voltage source connected to the set of mixing electrodes (Paragraph 0029). It would have been obvious to one of ordinary skill in the art to have modified Charest with Aubry because it aids in accelerating the mixing process within miniature scale devices (Paragraphs 0005-0006 of Aubry).
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Charest et al. (US 2011/0082563) Ponjee et al. (US 2010/0156444) and van der Linden et al. (Reference U on PTO-892; 2002) in further view of Liu et al. (US 2003/0175947).
Regarding claim 12, Charest is silent on the sensing layer with a working electrode and reference electrode. Liu teaches wherein a fourth layer of the plurality of stacked layers includes a polymeric substrate defining a fourth respective conduit of the plurality of conduits in the fourth layer (Figure 3; Paragraph 0002), a working electrode disposed along the fourth respective conduit and including a sensing layer, and a reference electrode disposed along the fourth respective conduit and adjacent to the working electrode (Paragraph 0108). It would have been obvious to one of ordinary skill in the art to have modified Charest with Liu because helps provide a microfluidic device with enhanced mixing that is easy to manufacture and uncomplicated to operate (Paragraph 0012-0013 of Liu). Further to have multiple layers would be obvious to one of ordinary skill in the art since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).
Regarding claim 13, Charest is silent on the potentiostat. Liu teaches further comprising a potentiostat connected to the working electrode and the reference electrode (Paragraph 0108). It would have been obvious to one of ordinary skill in the art to have modified Charest with Liu because helps provide a microfluidic device with enhanced mixing that is easy to manufacture and uncomplicated to operate (Paragraph 0012-0013 of Liu).
Regarding claim 14, Charest is silent on the potentiostat. Liu teaches further comprising a controller connected to a voltage source, a current source, or the potentiostat (Paragraphs 0270-0271). It would have been obvious to one of ordinary skill in the art to have modified Charest with Liu because helps provide a microfluidic device with enhanced mixing that is easy to manufacture and uncomplicated to operate (Paragraph 0012-0013 of Liu).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Charest et al. (US 2011/0082563) in view of Ponjee et al. (US 2010/0156444) and van der Linden et al. (Reference U on PTO-892; 2002) and Liu et al. (US 2003/0175947).
Regarding claim 15, Charest teaches a device for biofluid processing and analysis (Abstract), comprising:
a microfluidic module (Paragraph 0004; ‘microfluidic multi-channel bioreactor device’) including a plurality of stacked layers (Paragraph 0004; ‘Such bioreactor systems may, for example, include two polymer layers’),
a plurality of conduits defined in each layer of the plurality of stacked layers (Paragraph 0004; ‘ Each layer defines one or more microchannels’), wherein a material of the plurality of stacked layers is configured to provide for a flow of the biofluid within the plurality of conduits, (Paragraph 0021; discloses commonly used materials in the medical arts for tubes to transport fluids without leaks) and the at least one of the plurality of stacked layers including:
Charest is silent on the heater electrode and hydrogel as well as the sensing electrode pair.
Ponjee teaches a valve disposed along one of the conduits defined in the at least one layer (Paragraph 0034 and 0042-0043), the valve comprising a heater electrode and a thermally responsive hydrogel disposed adjacent to the heater electrode (Paragraphs 0042-0043), van der Linden teaches the valve included in one of the conduits, the valve comprising a heater source and a thermally responsive hydrogel disposed adjacent to the heater source (See full disclosure, in particular sections 2. Theory and 3. Experimental) and
Liu teaches a sensing electrode pair disposed along the flow path (Paragraph 0108).
It would have been obvious to one of ordinary skill in the art to have modified Charest with Ponjee because it allows for temperature control and better manipulation of the sample (Paragraph 0008 of Ponjee). It would have been obvious to one of ordinary skill in the art to have modified Charest with van der Linden because hydrogels are powerful actuator materials that can function autonomously (section 1. Introduction of van der Linden) and because it allows for a valve to decrease or prevent fluid flow in a selective manner thus yielding predictable results. It would have been obvious to one of ordinary skill in the art to have modified Charest with Liu because helps provide a microfluidic device with enhanced mixing that is easy to manufacture and uncomplicated to operate (Paragraph 0012-0013 of Liu).
Regarding claim 16, Charest is silent on the heater electrode and hydrogel as well as the sensing electrode pair.
Ponjee teaches further comprising:
a current source connected to the valve (Paragraph 0006);
Liu teaches a potentiostat connected to the sensing electrode pair (Paragraph 0108); and
Liu and Ponjee teach a controller connected to the current source and the potentiostat to direct operation of the current source and the potentiostat (Paragraphs 0270-0271 of Liu; Paragraph 0146 of Ponjee).
It would have been obvious to one of ordinary skill in the art to have modified Charest with Ponjee because it allows for temperature control and better manipulation of the sample (Paragraph 0008 of Ponjee). It would have been obvious to one of ordinary skill in the art to have modified Charest with Liu because helps provide a microfluidic device with enhanced mixing that is easy to manufacture and uncomplicated to operate (Paragraph 0012-0013 of Liu).
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Charest et al. (US 2011/0082563) in view of Ponjee et al. (US 2010/0156444) and van der Linden et al. (Reference U on PTO-892; 2002) and Liu et al. (US 2003/0175947) and in further view of DeVoe et al. (US 2003/0127329).
Regarding claim 17, Charest is silent on the pumping electrodes as well as the sensing electrode pair. DeVoe teaches wherein at least another one of the plurality of stacked layers includes: a set of pumping electrodes disposed along a flow path provided by another one of the plurality of conduits (Paragraph 0013 and 0006); and Liu teaches a sensing electrode pair disposed along the flow path (Paragraph 0108).
It would have been obvious to one of ordinary skill in the art to have modified Charest with DeVoe because it allows for flow control using a technique known in the art (Paragraph 0006 of DeVoe). It would have been obvious to one of ordinary skill in the art to have modified Charest with Liu because helps provide a microfluidic device with enhanced mixing that is easy to manufacture and uncomplicated to operate (Paragraph 0012-0013 of Liu).
Regarding claim 18, Charest is silent on the pumping electrodes. DeVoe teaches wherein: the set of pumping electrodes includes a first pumping electrode and a second pumping electrode spaced from the first pumping electrode and substantially parallel to the first pumping electrode (Paragraph 0028; Figure 5), but is silent on a width of the first pumping electrode and a width of the second pumping electrode are different. The applicant's specification provides no specifical reasoning or critical functionality for the use of a width of the first pumping electrode and a width of the second pumping electrode being different, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use a width of the first pumping electrode and a width of the second pumping electrode being different as desired by the user as a matter of routine engineering design choice.
or the set of pumping electrodes includes a plurality of first pumping electrodes, each of which are substantially parallel to another one of the plurality of the first pumping electrodes (Paragraph 0028; Figure 5), and a second pumping electrode (Paragraph 0028) but is silent on the second pumping electrode that is substantially perpendicular to the plurality of first pumping electrodes. It would have been obvious to one of ordinary skill in the art to have made the second pimping electrode substantially perpendicular to the first pumping electrodes since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C).
It would have been obvious to one of ordinary skill in the art to have modified Charest with DeVoe because it allows for flow control using a technique known in the art (Paragraph 0006 of DeVoe). It would have been obvious to one of ordinary skill in the art to have modified Charest with Liu because helps provide a microfluidic device with enhanced mixing that is easy to manufacture and uncomplicated to operate (Paragraph 0012-0013 of Liu).
Regarding claim 19, Charest is silent on the pumping electrodes as well as the sensing electrode pair. DeVoe teaches further comprising:
a voltage source connected to the set of pumping electrodes (Paragraphs 0006 and 0013);
Liu teaches a potentiostat connected to the sensing electrode pair (Paragraph 0108); and
Liu teaches a controller connected to the voltage source and the potentiostat to direct operation of the voltage source and the potentiostat (Paragraphs 0270-0271).
It would have been obvious to one of ordinary skill in the art to have modified Charest with DeVoe because it allows for flow control using a technique known in the art (Paragraph 0006 of DeVoe). It would have been obvious to one of ordinary skill in the art to have modified Charest with Liu because helps provide a microfluidic device with enhanced mixing that is easy to manufacture and uncomplicated to operate (Paragraph 0012-0013 of Liu).
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Charest et al. (US 2011/0082563) in view of Ponjee et al. (US 2010/0156444) and van der Linden et al. (Reference U on PTO-892; 2002) and Liu et al. (US 2003/0175947) and in further view of Aubry et al. (US 2004/0231990).
Regarding claim 20, Charest is silent on the mixing electrodes as well as the sensing electrode pair. Aubry teaches wherein at least another one of the plurality of stacked layers includes: a set of mixing electrodes disposed along a flow path provided by another one of the plurality of conduits (Figure 1; Paragraphs 0053-0054) and including a first mixing electrode and a second mixing electrode spaced from and interlocking with the first mixing electrode (Figure 1; electrodes 15-1, 15-2, 16-1, 16-2); and Liu teaches a sensing electrode pair disposed along the flow path (Paragraph 0108). It would have been obvious to one of ordinary skill in the art to have modified Charest with Aubry because it aids in accelerating the mixing process within miniature scale devices (Paragraphs 0005-0006 of Aubry). It would have been obvious to one of ordinary skill in the art to have modified Charest with Liu because helps provide a microfluidic device with enhanced mixing that is easy to manufacture and uncomplicated to operate (Paragraph 0012-0013 of Liu).
Regarding claim 21, Charest is silent on the mixing electrodes as well as the sensing electrode pair.
Aubry teaches further comprising:
a voltage source connected to the set of mixing electrodes (Paragraph 0029);
Liu teaches a potentiostat connected to the sensing electrode pair (Paragraph 0108); and
Aubry and Liu teach a controller connected to the voltage source and the potentiostat to direct operation of the voltage source and the potentiostat (Paragraph 0029 of Aubry; Paragraphs 0270-0271 of Liu).
It would have been obvious to one of ordinary skill in the art to have modified Charest with Aubry because it aids in accelerating the mixing process within miniature scale devices (Paragraphs 0005-0006 of Aubry). It would have been obvious to one of ordinary skill in the art to have modified Charest with Liu because helps provide a microfluidic device with enhanced mixing that is easy to manufacture and uncomplicated to operate (Paragraph 0012-0013 of Liu).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wimberger-Friedl (US 2008/0041453) [0037] and [0044], Halas et al. (US 2003/0156991) [0058], Hood et al. (US 2007/0106331) [0117], Vergne et al. (US 2014/0373952) [0053].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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