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 Objections
Claims 4 and 19 are objected to because of the following informalities: The claims recite “the second paper channel comprise as second port size” and should be amended to recite “the second paper channel comprises a second pore size”. Appropriate correction is required.
Claims 6 and 13 are objected to because of the following informalities: The claims recite “the first paper channel is gradient channel” and should be amended to recite “the first paper channel is a gradient channel”. Appropriate correction is required.
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 2, 6-9, 13-16, 17, and 20 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 6 and 13 recite “the first paper channel is gradient channel” wherein it is unclear from the claims what structure or function of the device constitutes the “gradient”. One skilled in the art would not be able to unambiguously ascertain from the current claim recitations if the “gradient channel” comprises a gradient of pore size, width, flow rate, temperature, reagent, etc. Thus, as the “gradient” is not defined structurally or functionally by the claims, the gradient is indefinitely understood herein.
Claims 2 and 17 recite “the port is positioned to overlap with at least a portion of the first paper channel” wherein it is unclear if the phrase “overlap with” refers to direct physical contact or mere positional arrangement in plan view. If Applicant intends the port to physically contact the first paper channel to allow fluid to be injected through the port and to the channel, Applicant may wish to amend the claims on the order of “wherein the port is in fluid communication with at least a portion of the first paper channel”, if in accordance with the instant specification.
Claims 9 and 16 recite “wherein the first paper channel is water soluble” wherein it is unclear from this recitation whether it is intended that the first paper channel itself dissolves in water, or if Applicant’s intent is merely that the first paper channel allows water to pass through. If dissolution in water is desired, Applicant may wish to amend the claims on the order of “wherein the first channel is formed of a water-soluble material which dissolves in water”, if in accordance with the instant specification. If aqueous flow is desired, Applicant may wish to amend the claims on the order of “wherein the first channel is formed of a hydrophilic material”, if in accordance with the instant specification. – Further, it is unclear how a fluid flow would follow a soluble channel path given that upon dissolution in water, the soluble channel is dissolved in the water and no longer exists as a channel. The instant specification para. [0029] discusses use of the water-soluble paper as a sacrificial mask for forming a paper channel. However, the instant claims 9 and 16 discuss the paper channel as being what is dissolved, not a sacrificial mask for forming a paper channel as in the specification. Appropriate clarification is required.
Regarding Claim 20, the claim is a dependent claim which recites “a microfluidic device” but depends on Claim 10, which recites “the method of Claim 1”.
It appears Applicant may intend for Claim 20 to depend from Claim 11 instead of Claim 10. Appropriate correction is required.
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 1-3, 11, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. (Liping Xie, Xingyu Zi, Hedele Zeng, Jianjun Sun, Lisheng Xu, Shuo Chen, Low-cost fabrication of a paper-based microfluidic using a folded pattern paper, Analytica Chimica Acta, Volume 1053, 2019, Pages 131-138), hereinafter “Xie”, in view of Yang et al. (Chenying Yang, Wei Wang, and Zhihong Li; Optimization of Corona-triggered PDMS-PDMS Bonding Method, Proceedings of the 2009 4th IEEE International Conference on Nano/Micro Engineered and Molecular Systems January 5-8, 2009, Shenzhen, China), hereinafter “Yang”.
Regarding Claim 1, Xie teaches a method for producing a microfluidic device, the method comprising:
placing a first paper channel between first and second polydimethylsiloxane (PDMS) sheets (Fig. 1 and Abstract: “A novel method for fabrication of μPADs is developed in this study using a folded polydimethylsiloxane (PDMS)-coated paper mask with a specific pattern to form a sandwich structure with inserted chromatographic paper.” – Note that “between” (as an adverb used here) is defined as “in an intermediate space or interval” (Merriam-Webster Dictionary) and the paper layer and its channels lie in the region separating the two PDMS layers.);
and using heat to laminate the microfluidic device (Fig. 1 and Introduction: “A chromatographic paper and the folded paper mask form a sandwich structure, resulting in PDMS from the paper mask fully penetrating the chromatographic paper to form a μPAD after heating.”), as in Claim 1.
Further regarding Claim 1, Xie does not specifically teach the method for producing a microfluidic device discussed above comprising treating the PDMS sheets with a corona plasma treater to adhere the PDMS sheets together, as in Claim 1.
However, corona plasma treatment of PDMS surfaces is a well-known technique for improving the adhesion between two layers of PDMS, such as taught by Yang: “The principle underlying plasma treatment is that it can remove surface contaminants and generate reactive chemical groups. In particular, the –O-Si (CH3)2- unit in PDMS can be converted to silanol group, thus facilitate bonding by changing the surface chemistry from hydrophobic to hydrophilic.”
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Xie to further include treating the PDMS sheets with a corona plasma treater to adhere the PDMS sheets together, such as suggested by Yang, so as to improve adhesion between the two layers of PDMS; and would have a reasonable expectation of success therein.
Regarding Claim 11, Xie teaches a microfluidic device comprising:
a first paper channel; and first and second polydimethylsiloxane (PDMS) sheets positioned on either side of the first paper channel (Fig. 1 and Abstract: “A novel method for fabrication of μPADs is developed in this study using a folded polydimethylsiloxane (PDMS)-coated paper mask with a specific pattern to form a sandwich structure with inserted chromatographic paper.” – Note that “between” is defined as “in or along the space separating two objects or regions.” (Oxford English Dictionary) and the paper layer and its channels lie in the region separating the two PDMS layers.), as in Claim 11.
Further regarding Claim 11, Xie does not specifically teach the microfluidic device discussed above wherein the first and second PDMS sheets are adhered together from a corona treatment, as in Claim 11.
However, corona plasma treatment of PDMS surfaces is a well-known technique for improving the adhesion between two layers of PDMS, such as taught by Yang: “The principle underlying plasma treatment is that it can remove surface contaminants and generate reactive chemical groups. In particular, the –O-Si (CH3)2- unit in PDMS can be converted to silanol group, thus facilitate bonding by changing the surface chemistry from hydrophobic to hydrophilic.”
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microfluidic device of Xie wherein the first and second PDMS sheets are adhered together from a corona treatment, such as suggested by Yang, so as to improve adhesion between the two layers of PDMS; and would have a reasonable expectation of success therein.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Xie teaches the method discussed above further comprising forming a port through the first PDMS sheet, wherein the port is positioned to overlap with at least a portion of the first paper channel (Fig. 4B shows the six ports of the device, indicated by the green circles, and the channels connected to each of the ports overlapping to carry a colored sample through the channel, as seen through the figure. – See further Fig. 1B showing the ports as through the first PDMS layer.), as in Claim 2.
Regarding Claim 17, the prior art meets the limitations of Claim 11 as discussed above. Further, Xie teaches the microfluidic device discussed above further comprising forming a port through the first PDMS sheet, wherein the port is positioned to overlap with at least a portion of the first paper channel (Fig. 4B shows the six ports of the device, indicated by the green circles, and the channels connected to each of the ports overlapping to carry a colored sample through the channel, as seen through the figure. – See further Fig. 1B showing the ports as through the first PDMS layer.), as in Claim 17.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Xie teaches the method discussed above further comprising placing a second paper channel between the first and second PDMS sheets (Fig. 4B shows six channels of the device, thereby constituting placing a second paper channel between the first and second PDMS sheets as shown in Fig. 1.), as in Claim 3.
Regarding Claim 18, the prior art meets the limitations of Claim 11 as discussed above. Further, Xie teaches the microfluidic device discussed above further comprising placing a second paper channel between the first and second PDMS sheets (Fig. 4B shows six channels of the device, thereby constituting placing a second paper channel between the first and second PDMS sheets as shown in Fig. 1.), as in Claim 18.
Claims 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Xie in view of Yang, as applied to Claims 1-3, 5, 7-8, 11-12, 14-15, and 17-18 above, and in further view of Carson (Frederick T. Carson, Some Observations On Determining The Size Of Pores In Paper, Journal of Research of the National Bureau of Standards, U.S. Department Of Commerce, Volume 24, April 1940.), hereinafter “Carson”, and Kalasz et al. (Huba Kalász, Mária Báthori, Klára L. Valkó, Chapter 10 - Basis and pharmaceutical applications of thin-layer chromatography, Handbook of Analytical Separations, Elsevier Science B.V., Volume 8, 2020, Pages 523-585, ISSN 1567-7192, ISBN 9780444640703.), hereinafter “Kalasz”.
Regarding Claim 4, the prior art meets the limitations of Claim 3 as discussed above. Further, Xie teaches the method discussed above wherein:
the first paper channel comprises a first pore size; and the second paper channel comprise as second pore size that is smaller than the first pore size (See Fig. 1(C) showing all of the channels of the device comprising a first paper channel comprising a first pore size (printer/ledger paper: ~0.8 microns – As seen through Carson Table 1.) and a second paper channel having a smaller relative pore size (chromatographic paper: ~40-150 Angstroms – As seen through Kalasz section 10.2.1.1 para. [5]: “Specific Surface”.). While it is noted that each of the channels of Xie comprise both paper channels having both pore sizes, this arrangement is not precluded by the claim, wherein the arrangement of Xie provides for every limitation of the claim at the currently recited breadth as discussed above. Further note that one skilled in the art would readily recognize that chromatographic paper and printer paper have very different adsorbent properties and textures, and would infer a difference in pore size given the much slower speed through which liquid travels through chromatographic paper compared to printer paper.), as in Claim 4.
Regarding Claim 19, the prior art meets the limitations of Claim 18 as discussed above. Further, Xie teaches the microfluidic device discussed above wherein:
the first paper channel comprises a first pore size; and the second paper channel comprise as second pore size that is smaller than the first pore size (See Fig. 1(C) showing all of the channels of the device comprising a first paper channel comprising a first pore size (printer/ledger paper: ~0.8 microns – As evidenced through Carson Table 1.) and a second paper channel having a smaller relative pore size (chromatographic paper: ~40-150 Angstroms – As evidenced through Kalasz section 10.2.1.1 para. [5]: “Specific Surface”.). While it is noted that each of the channels of Xie comprise both paper channels having both pore sizes, this arrangement is not precluded by the claim, wherein the arrangement of Xie provides for every limitation of the claim at the currently recited breadth as discussed above. Further note that one skilled in the art would readily recognize that chromatographic paper and printer paper have very different adsorbent properties and textures, and would infer a difference in pore size given the much slower speed through which liquid travels through chromatographic paper compared to printer paper.), as in Claim 19.
Claims 5-6, 7-8, 12-13, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Xie in view of Yang, as applied to Claims 1-3, 5, 7-8, 11-12, 14-15, and 17-18 above, and in further view of Jeon et al. (Noo Li Jeon, Stephan K. W. Dertinger, Daniel T. Chiu, Insung S. Choi, Abraham D. Stroock, George M. Whitesides; “Generation of Solution and Surface Gradients Using Microfluidic Systems”, Langmuir, Vol. 16, No. 22, 2000, 8311-8316.), hereinafter “Jeon”.
Regarding Claims 5, 7-8, 12, and 14-15, the prior art meets the limitations of Claims 1 and 11 as discussed above. Further, Xie does not specifically teach the method/device discussed above wherein the first paper channel is a serpentine channel as in Claims 5 and 12, wherein the first paper channel is a Y-shaped channel as in Claims 7 and 14, nor wherein the first paper channel is an H-shaped channel as in Claims 8 and 15.
However, mere change in shape absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed shape is an obvious matter of design choice – see MPEP 2144.04(IV)(B). Herein, one of ordinary skill in the art would not expect the device of Xie having linear channels to function differently than the claimed device having serpentine, Y-shaped, and H-shaped channels given that the general principle of flow through paper involving capillary flow remains the same, and Xie already teaches branching channels connecting at a channel junction.
One skilled in the art would find it obvious to modify the method/device of Xie so as to form a channel shaped specifically for a desired application, such as branching channels (such as Y- and H-shaped channels, as in Claims 7-8 and 14-15) in a multiplexed and/or mixing device, or serpentine channels (as in Claims 5 and 12) for mixing and/or extending the time a flow takes to reach a destination, all of which having been explored prevalently in the prior art for specific applications and would have obvious expected results easily reasoned by one of ordinary skill in the art in Xie. For example, Jeon teaches Y- and H-shaped channels for forming a concentration gradient as well as serpentine channels for increasing a time a fluid takes to reach a destination, commensurately structured as in Claims 5, 7-8, 12, and 14-15.
If Applicant wishes these shapes of channels to hold patentable weight, Applicant must provide a criticality or unexpected result associated with the channel shape in the device, or provide specifics to the method showing how the channel shapes are formed in a novel way. – See further the 35 USC 112 section above regarding Claims 7-8 and 14-15.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Xie does not specifically teach the method for producing a microfluidic device discussed above wherein the first paper channel is gradient channel comprising a plurality of serpentine shaped channels, as in Claim 6.
However, Jeon teaches a respective microfluidic device comprising a plurality of serpentine channels forming a gradient channel (See Fig. 1(b) and note the identical arrangement as in Applicant’s instant Fig. 3A.); wherein this arrangement provides a structure capable of forming transverse concentration gradients in a microfluidic channel, important for the analysis of many biological and chemical process which rely on concentration gradients (Introduction).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Xie wherein the first paper channel is gradient channel comprising a plurality of serpentine shaped channels, such as suggested by Jeon, so as to provide a structure capable of forming transverse concentration gradients in a microfluidic channel, important for the analysis of many biological and chemical process which rely on concentration gradients; and would have a reasonable expectation of success therein.
Regarding Claim 13, the prior art meets the limitations of Claim 11 as discussed above. Further, Xie does not specifically teach the microfluidic device discussed above wherein the first paper channel is gradient channel comprising a plurality of serpentine shaped channels, as in Claim 13.
However, Jeon teaches a respective microfluidic device comprising a plurality of serpentine channels forming a gradient channel (See Fig. 1(b) and note the identical arrangement as in Applicant’s instant Fig. 3A.); wherein this arrangement provides a structure capable of forming transverse concentration gradients in a microfluidic channel, important for the analysis of many biological and chemical process which rely on concentration gradients (Introduction).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microfluidic device of Xie wherein the first paper channel is gradient channel comprising a plurality of serpentine shaped channels, such as suggested by Jeon, so as to provide a structure capable of forming transverse concentration gradients in a microfluidic channel, important for the analysis of many biological and chemical process which rely on concentration gradients; and would have a reasonable expectation of success therein.
Claims 9 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Xie in view of Yang, as applied to Claims 1-3, 5, 7-8, 11-12, 14-15, and 17-18 above, and in further view of Jefferies et al. (US 2017/0072105 A1), hereinafter “Jefferies”.
Regarding Claim 9, the prior art meets the limitations of Claim 1 as discussed above. Further, Xie does not specifically teach the method for producing a microfluidic device discussed above wherein the first paper channel is water soluble, as in Claim 9.
However, Jeffries teaches a respective microfluidic device comprising fibrous channels for inducing capillary flow through the device, wherein the device further comprises sacrificial channels and chambers for controlling and metering the flow of fluid through the device ([0025]: “the micropatterned sacrificial template is formed of a water-soluble substance, such as...carboxymethyl cellulose” – Note that carboxymethyl cellulose is a fibrous water-soluble component of paper products.), thereby reducing error due to variable flow between runs or improperly timed flow within the device, which would be similarly appreciated by Xie (See section 3.3.).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Xie wherein the first paper channel is water soluble, such as suggested by Jefferies, so as to provide further control and metering of fluid flow through the device thereby reducing error due to variable flow between runs or improperly timed flow within the device, which would be similarly appreciated by Xie (See section 3.3.); and would have a reasonable expectation of success therein.
Regarding Claim 16, the prior art meets the limitations of Claim 11 as discussed above. Further, Xie does not specifically teach the microfluidic device discussed above wherein the first paper channel is water soluble, as in Claim 16.
However, Jeffries teaches a respective microfluidic device comprising fibrous channels for inducing capillary flow through the device, wherein the device further comprises sacrificial channels and chambers for controlling and metering the flow of fluid through the device ([0025]: “the micropatterned sacrificial template is formed of a water-soluble substance, such as...carboxymethyl cellulose” – Note that carboxymethyl cellulose is a fibrous water-soluble component of paper products.), thereby reducing error due to variable flow between runs or improperly timed flow within the device, which would be similarly appreciated by Xie (See section 3.3.).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microfluidic device of Xie wherein the first paper channel is water soluble, such as suggested by Jefferies, so as to provide further control and metering of fluid flow through the device thereby reducing error due to variable flow between runs or improperly timed flow within the device, which would be similarly appreciated by Xie (See section 3.3.); and would have a reasonable expectation of success therein.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Xie in view of Yang, as applied to Claims 1-3, 5, 7-8, 11-12, 14-15, and 17-18 above, and in further view of Dungchai et al. (Wijitar Dungchai, Orawon Chailapakul, Charles S. Henry; Electrochemical Detection for Paper-Based Microfluidics, Anal. Chem. 2009, 81, 5821–5826.), hereinafter “Dungchai”.
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, Xie does not specifically teach the method for producing a microfluidic device discussed above further comprising placing an electrode between the first and second PDMS sheets, as in Claim 10.
However, Dungchai teaches a respective paper-based microfluidic chip comprising a hydrophilic paper channel in contact with an electrode for performing electrochemical detection (See Fig. 1 and the section: “Design and Preparation of Electrochemical Detector for Paper-Based Microfluidic Devices” -- “All electrodes were designed with the working portion of the electrode on the hydrophilic portion of the paper and the contact pads on the hydrophilic portion of the paper.”); wherein this arrangement “is an attractive alternative detection scheme for paper-based microfluidics due to its small size, high portability, low cost, high sensitivity, and high selectivity by proper choice of detection potential and/or electrode material.” (Introduction).
Further note that given Dungchai’s disclosure of electrodes in direct contact with a paper channel of the device, the modified method of Xie would thereby comprise the electrode as between the two PDMS sheets, given that the paper channel of Xie is provided between two PDMS sheets as discussed above regarding Claim 1.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Xie further comprising placing an electrode between the first and second PDMS sheets, such as suggested by Dungchai, so as to provide a detection scheme for the paper-based microfluidic system having a small size, high portability, low cost, high sensitivity, and high selectivity, and would be appreciated by the use of concentration analysis in Xie, for example, as seen in Xie Figs. 3(A) and 3(C).
Regarding Claim 20, the prior art meets the limitations of Claim 11 (See the 35 USC 112 section above.) as discussed above. Further, Xie does not specifically teach the microfluidic device discussed above further comprising an electrode between the first and second PDMS sheets, as in Claim 20.
However, Dungchai teaches a respective paper-based microfluidic chip comprising a hydrophilic paper channel in contact with an electrode for performing electrochemical detection (See Fig. 1 and the section: “Design and Preparation of Electrochemical Detector for Paper-Based Microfluidic Devices” -- “All electrodes were designed with the working portion of the electrode on the hydrophilic portion of the paper and the contact pads on the hydrophilic portion of the paper.”); wherein this arrangement “is an attractive alternative detection scheme for paper-based microfluidics due to its small size, high portability, low cost, high sensitivity, and high selectivity by proper choice of detection potential and/or electrode material.” (Introduction).
Further note that given Dungchai’s disclosure of electrodes in direct contact with a paper channel of the device, the modified device of Xie would thereby comprise the electrode as between the two PDMS sheets, given that the paper channel of Xie is provided between two PDMS sheets as discussed above regarding Claim 11.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microfluidic device of Xie further comprising an electrode between the first and second PDMS sheets, such as suggested by Dungchai, so as to provide a detection scheme for the paper-based microfluidic system having a small size, high portability, low cost, high sensitivity, and high selectivity, and would be appreciated by the use of concentration analysis in Xie, for example, as seen in Xie Figs. 3(A) and 3(C).
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798