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 Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-6, 11-14, 16, 19, 21, 27 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Bort et al (US20170241949).
Regarding claim 1, Bort et al teach a digital microfluidic device, comprising:
a first substrate (110) and a second substrate (112) aligned generally parallel to each other with a gap defined therebetween in side view (Fig. 1),
at least one of the first substrate (110) and the second substrate (112) including:
a first electrode array (Para. 0070: dispensing electrodes 122a-f) , a second electrode array (Para. 0070, Fig. 1: 118: pads) spaced from and in electrical communication with the first electrode array (Fig. 2: 118 and 112a-f are spaced from; electrical communications between 118 and 112a-f shown in Fig. 3), and
a first interstitial area defined between the first electrode array and the second electrode array (Fig. 1: area between 122a-f and 118), at least one of the first electrode array and the second electrode array configured to generate electrical actuation forces within an actuation area to urge at least one droplet within the gap along the at least one of the first substrate and second substrate (Para. 0066,0070: reagent dispensing electrodes 120 are digital microfluidic electrodes to move droplets);
at least one spacer (Fig. 1: 114 gasket) disposed in the first interstitial area to maintain the gap between the first substrate and the second substrate, and wherein the at least one spacer includes a first opening extending therethrough and aligned with the first electrode array in plan view. (Para. 0074; Fig. 1: 132a-f reagent reservoir is opening aligned with the reagent dispensing electrodes 122a-f)
Regarding claim 2, Bort et al teach the first electrode array (122a-f) are disposed proximate a central region of the at least one of the first substrate and the second substrate (Fig. 1: 122a-f are central) and the second electrode array is disposed proximate a perimeter region of and spaced from the central region of the at least one of the first substrate and the second substrate (Fig. 1: 118 are perimeter region).
Regarding claim 3, Bort et al teach the at least one of the first substrate and the second substrate further includes a third electrode array (Fig. 1: 120: sample dispensing electrodes) disposed thereon opposite the second electrode array with the first electrode array therebetween (Fig. 1) and a second interstitial area defined between the first electrode array and the third electrode array, the at least one spacer disposed in the second interstitial area. (Fig. 1: gasket 114 where the 126 sample reservoir ends before the reagent reservoirs 132a-f)
Regarding claim 5, Bort et al teach the at least one spacer includes a second opening extending therethrough and aligned with the second electrode array in plan view (Fig. 2 shows the gasket 114 ending before the electrode 118, thus having an opening).
Regarding claim 6, Bort et al teach the at least one of the first substrate and the second substrate further includes a third electrode array disposed thereon (Fig. 1: 120: sample dispensing electrodes), and the at least one spacer includes a third opening extending through a surface thereof and aligned with the third electrode array in plan view (Fig. 1: sample reservoir 126 aligned with the sample dispensing electrodes 120).
Regarding claim 11, Bort et al teach the at least one spacer is disposed between the first substrate and the second substrate at a first contact point and a second contact point, the first contact point spaced a distance along the gap from the second contact point by a span (Fig. 1: first contact point where sample reservoir 126 ends and second contact after detection window 136 (see Fig. 2), and wherein the distance is within a range of 1 mm to 60 mm. (Para. 0125: substrate dimensions (45.24mm-27.76mm) fall within this range, thus the distance from the two contact areas is within the range of 1mm-60mm).
Regarding claim 12, Bort et al teach the first substrate is spaced from the second substrate at the first contact point by a first height (Para. 0138: H1 can be 600um), and the first substrate is spaced from the second substrate proximate a midpoint of the span by a second height (Para. 0138: H2 is 750um), a difference between the first height and the second height defining a deflection amount, the deflection amount being within a range of 0.05 um and 180 um when the at least one droplet is disposed proximate the midpoint (Para. 0138: gap difference 150um read on deflection amount)
Regarding claim 13, Bort et al teach the at least one of the first substrate and the second substrate includes a non-conductive layer and a conductive layer coupled to the non- conductive layer, the conductive layer having the electrode array defined therein. (Para. 0066: conductive ink on molded plastic)
Regarding claim 14, Bort et al teach the at least one of the first substrate and the second substrate includes at least one of a hydrophobic layer and a dielectric layer disposed over the electrode array (Para. 0013).
Regarding claim 16, Bort et al teach at least one of the first electrode array and the second electrode array is configured to form external electrical connections. (Para. 0082: power/signal I/O pads 118).
Regarding claim 19, Bort teach a gasket to create a gap between the substrates by the spacer height that can be 5um to 600um (Para. 0014: reads on "spacer has a width between 100 um and 200 um").
Regarding claim 21, Bort teach at least one of the first substrate and the second substrate comprises at least one of polyethylene terephthalate (PET), poly(methyl methacrylate (PMMA), cyclic olefin polymer (COP), cyclic olefin copolymer (COC), and polycarbonate (PC). (Para. 0015)
Regarding claim 27, Bort et al teach a digital microfluidic and analyte detection device, comprising: a first substrate (110) and a second substrate (112) aligned generally parallel to each other with a gap defined therebetween in side view (Fig. 1), at least one of the first substrate (110) and the second substrate (112) including: a first electrode array (Para. 0070: dispensing electrodes 122a-f), a second electrode array spaced from and in electrical communication with the first electrode array (Para. 0070, Fig. 1: 118: pads), and an interstitial area defined between the first electrode array and the second electrode array (Fig. 1: area between 122a-f and 118); an analyte detection device defined in at least one of the first substrate and the second substrate (Fig. 1: 136 detection window), wherein at least one of the first electrode array and the second electrode array is configured to generate electrical actuation forces within an actuation area to urge at least one droplet within the gap along the at least one of the first substrate and the second substrate to the analyte detection device (Para. 0070: reagent dispensing electrodes 120 are digital microfluidic electrodes to move droplets); and at least one spacer (Fig. 1: 114 gasket) disposed in the interstitial area to maintain the gap between the first substrate and the second substrate wherein the at least one spacer includes a first opening extending therethrough and aligned with the first electrode array in plan view. (Para. 0074; Fig. 1: 132a-f reagent reservoir is opening aligned with the reagent dispensing electrodes 122a-f)
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.
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.
Claim(s) 7, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bort et al (US20170241949) in view of Bell et al (WO2010/009463) .
Regarding claim 7, Bort is silent to the first substrate, the second substrate, and the at least one spacer each include at least one fastener hole aligned to receive a fastener through corresponding fastener apertures of the first substrate, the second substrate and the at least one spacer.
Bell et al teach a droplet actuator with electrodes. The device is held together by fasteners 824 through one or more openings 822 in the 812 top substrate and the vias 820 in the bottom substrate 810. The fasteners 824 pass through an opening made between the spacers 816 and the gasket 826 (Fig. 8A; Pg. 23 para. 3-5). It is advantageous to provide fastener holes aligned to receive a fastener through corresponding fastener apertures of the first substrate, the second substrate and the at least one spacer to ensure a proper seal between the substrates and the spacer in the microfluidic devices. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the first substrate, the second substrate, and the at least one spacer each include at least one fastener hole aligned to receive a fastener through corresponding fastener apertures of the first substrate, the second substrate and the at least one spacer of Bell to the device of Bort to provide the above advantage of ensuring a proper seal between the substrates and the spacer in the microfluidic devices.
Regarding claim 20, Bort teach the at least one spacer is a gasket. Bort is silent to the spacer is at least one of a shim, a spherical bead, and a raised feature.
Bell et al teach the spacer can be formed of rigid material, glass beads or other spacer materials (Fig. 8A; Pg. 23 para. 3-5). It is desirable to provide a spacer that provides adequate spacing between substrates for droplet operations. Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the spacer of Bell made of raised feature or spherical bead because they are known spacers to provide the above advantage of providing adequate spacing between substrates for droplet operations.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bort et al (US20170241949) in view of Bell et al (WO2010/009463) and further in view of Bartsch (USP 8,940,147).
Regarding claim 8, Bort/Bell teach the first substrate, the second substrate, and the at least one spacer each include one or more openings (Fig. 8A; Pg. 23 para. 3-5), but is silent to four fastener apertures each disposed proximate corresponding corners of the first substrate, the second substrate and the at least one spacer.
Bartsch et al teach substrates 22 and 212 held together using compression members 207 and 209 held together using fasteners (col. 6 line 1-9) though holes 225-228 in 209 and corresponding holes in 207 in each of the corners (Fig. 2A). It is advantageous to provide four holes and fasteners in the corners to ensure the equal pressure to compress and seal the upper and lower substrates. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the four fastener apertures each disposed proximate corresponding corners of Bartsch et al to the first substrate, the second substrate and the at least one spacer of Bort/Bell to provide the above advantage ensure the equal pressure to compress and seal the upper and lower substrates and the spacer.
Regarding claims 9-10, Bort/Bell are silent to a frame configured to receive and align the first substrate, the second substrate and the at least one spacer; wherein the frame having at least one frame fastener hole aligned with at least one of the corresponding fastener apertures of the first substrate, the second substrate and the at least one spacer, to receive the fastener through the at least one frame fastener hole.
Bartsch et al teach a frame configured to receive and align the first substrate, the second substrate and the at least one spacer; wherein the frame having at least one frame fastener hole aligned with at least one of the corresponding fastener apertures of the first substrate, the second substrate and the at least one spacer, to receive the fastener through the at least one frame fastener hole. (Fig. 2A; col. 6 line 1-9: substrates 22 and 212 held together using compression members 207 and 209 held together using fasteners though holes 225-228 in 209 and corresponding holes in 207). It is advantageous to provide the frame to ensure a superior seal between the first, second substrate and the spacer for adequate microfluidic function and reduce and leakage. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the frame of Bartsch to provide the above advantage of ensuring a superior seal between the first, second substrate and the spacer for adequate microfluidic function and reduce and leakage.
Claim(s) 15, 17-18, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bort et al (US20170241949) in view of Huff et al (20180095067).
Regarding claim 15, Bort et al teach one or more substrates may be fabricated using a printed circuit board (Para. 0015) and electrodes made with conductive ink (Para. 0066). Bort et al is silent to the electrode array is formed on the at least one of the first substrate and the second substrate using at least one of lithography, laser ablation, and inkjet printing.
Huff et al teach electrode arrays made using laser ablation (Para. 0321, 0338, 0349) and inkjet printing (Para. 0319,0321). It is well known to fabricate electrodes by laser ablation and inkjet printing to ensure the electrodes are made with certain number of electrodes per unit area (Para. 0321). Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the forming the electrodes on the at least one of the first substrate and the second substrate using at least one of lithography, laser ablation, and inkjet printing as in Huff et al to provide the above advantage of ensuring the electrodes are made with certain number of electrodes per unit area.
Regarding claim 17, Bort is silent to the first substrate and the second substrate comprises at least one of an array of wells and a nanopore layer formed therein.
Huff et al teach the first substrate and the second substrate comprises at least one of an array of wells (Para. 0300)and a nanopore layer (Para. 0382) formed to collect the droplets for analysis. It is desirable to provide an array of wells and nanopore layer to collect the droplet and enhance the ability to analyze analytes within the droplet. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the array of wells and nanopore layer of Huff to the Bort device to provide the above advantage of collecting the droplet and enhance the ability to analyze analytes within the droplet.
Regarding claim 18, Bort teach a spacer but is silent to the spacer comprises at least one of polyethylene terephthalate (PET), poly(methyl methacrylate (PMMA),glass, silicon, and double-sided tape.
Huff et al teach a digital microfluidic with a spacer using double-sided tape. (Para. 0592) It is advantageous to provide a spacer comprising double-sided tape as it provides a means to adhere the top and bottom substrates to create a seal while providing the desired spacing. Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the spacer of Bort with the double sided tape of Huff because they are known spacers and to provide the above advantage of providing a means to adhere the top and bottom substrates to create a seal while providing the desired spacing.
Regarding claim 22, Bort teach the substrate with the electrode but is silent to the width of at least one of the first substrate or the second substrate is between 100 um and 500 um. Huff teach the manufacturing of the DMF top electrode with roll having dimension of 125μm (Para. 0587: 250mx200mmx125μm roll size). In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a dimension for the first or second substrate width between 100 um and 500 um is a result effective variable that gives the well known and expected results of providing a substrate width capable of providing electrodes for digital microfluidics. In the absence of a showing of unexpected results, the Office maintains the width of the substrate of Huff of 125um (reading on “between 100 um and 500 um”) would have been within the skill of the art as optimization of a results effective variable.
Response to Arguments
Argument regarding the claim objections to claim 1 are agreed upon. The objection has been withdrawn.
Regarding the Rejection under 35 U.S.C. § 102, Applicant's arguments filed 7/23/2025 have been fully considered but they are not persuasive.
Applicants argue that the gasket 114 in Bort is not “at least one spacer”. Applicants point to a " “spacer” described in paragraph [0014] of Bort. Here, Bort describes that a “spacer” may be provided between the substrates to determine the height of the gap therebetween. Importantly, here Bort states that such spacer may be formed of a layer of projections from the top or bottom substrates, and/or a material inserted between the top and bottom substrates. (Paragraph [0014].)" This is not convincing because the gasket is a material inserted between the top and bottom substrates as described in para 0014. Applicants also point to that "Bort does not state that the gasket is designed to have an opening that aligns with an electrode array." This is not convincing because the gasket 114 does have openings 132 that align with the electrodes 122 (see Fig. 1).
Applicants argue that in FIG. 4B, the electrode array on the bottom substrate protrudes above the gasket. This is not convincing because the electrodes 122 are not shown in Fig. 4B and the portion that protrudes above the gasket is the input ports 134 (Para. 0074) and not the electrodes 122 (see Fig. 1) Therefore, gasket of Bort reads on the limitation "spacer" as it meets the openings that align with the electrodes.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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/Dennis White/Primary Examiner, Art Unit 1758